chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Fatigue; Headache; Weakness; Fever; Shivering; Shakes; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, several hours after receiving Shingrix, the patient experienced injection site pain, fatigue, headache, weakness, fever, shivers and tremor. In September 2020, the outcome of the fatigue, headache, weakness, fever, shivers and tremor were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, headache, weakness, fever, shivers and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 6 weeks ago sometime in September and within a couple of hours she developed injection site pain that lasted for 3 days and then resolved. The patient stated that about 12 hours after receiving dose woke up feeling fatigue, headache, weakness, fever, shivering and shakes. All these symptoms resolved within one day. The reporter did not consent to follow up and declines follow up for this adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Fatigue; Headache; Weakness; Fever; Shivering; Shakes; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, several hours after receiving Shingrix, the patient experienced injection site pain, fatigue, headache, weakness, fever, shivers and tremor. In September 2020, the outcome of the fatigue, headache, weakness, fever, shivers and tremor were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fatigue, headache, weakness, fever, shivers and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 6 weeks ago sometime in September and within a couple of hours she developed injection site pain that lasted for 3 days and then resolved. The patient stated that about 12 hours after receiving dose woke up feeling fatigue, headache, weakness, fever, shivering and shakes. All these symptoms resolved within one day. The reporter did not consent to follow up and declines follow up for this adverse event.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Heart rate irregular, Injection site erythema, Injection site swelling
Clinical narrative: redness at the injection site; swelling and redness at the injection site; pulse rate went as high at 120; erratic heart rate; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2020, the patient received the 1st dose of Shingrix. On 19th November 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, high pulse rate, heart rate irregular and headache. On an unknown date, the outcome of the injection site erythema, injection site swelling and headache were recovered/resolved and the outcome of the high pulse rate was unknown and the outcome of the heart rate irregular was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, high pulse rate, heart rate irregular and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and the next day she observed swelling and redness at the injection site, and headache which all resolved. But also had erratic heart rate which had not resolved and was seen at the emergency room and multiple tests were done and was under observation for 7 hours and the doctor would not find the cause of the erratic heart rate.  The blood pressure was normal at 110/75 and currently due to the erratic heart rate her pulse rate went as high at 120.  The reporter was scheduled to see a cardiologist for further examination. The reporter consented to follow up and emergency room visit required.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Breast pain, Injection site pain, Injection site swelling, Insomnia, Pruritus
Clinical narrative: swelling / at the injection site; pain at the injection site; itch all over her body / middle of her back. torso, both legs / arms / underarms; red dots and they itch; cannot sleep well at night; states both her breast hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included psoriasis.   On 23rd September 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site swelling, injection site pain, pruritus, red spotty rash, difficulty sleeping and breast pain. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the pruritus, red spotty rash, difficulty sleeping and breast pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, pruritus, red spotty rash, difficulty sleeping and breast pain to be related to Shingrix.  Additional details were reported as follows: The patient reported that she received 1st dose of Shingrix vaccine on left arm and on same day received Pneumonia vaccine on right arm. The patient experienced there was a swelling and pain at the injection site on the left arm which was resolved, but later, started to itch all over her body, the middle of back, torso, both legs and arms and also underarm. Sometimes they appeared as a red dots and they itch, but red dost went away. The patient stated most of her itching was at the torso. The patient stated because of the itching, she could not sleep well at night. The patient reported that both her breast hurts. The patient was seen by dermatologist who started some hydrocortisone cream. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash macular
Clinical narrative: swelling / at the injection site; pain at the injection site; itch all over her body / middle of her back. torso, both legs / arms / underarms; red dots and they itch; cannot sleep well at night; states both her breast hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included psoriasis.   On 23rd September 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site swelling, injection site pain, pruritus, red spotty rash, difficulty sleeping and breast pain. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the pruritus, red spotty rash, difficulty sleeping and breast pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, pruritus, red spotty rash, difficulty sleeping and breast pain to be related to Shingrix.  Additional details were reported as follows: The patient reported that she received 1st dose of Shingrix vaccine on left arm and on same day received Pneumonia vaccine on right arm. The patient experienced there was a swelling and pain at the injection site on the left arm which was resolved, but later, started to itch all over her body, the middle of back, torso, both legs and arms and also underarm. Sometimes they appeared as a red dots and they itch, but red dost went away. The patient stated most of her itching was at the torso. The patient stated because of the itching, she could not sleep well at night. The patient reported that both her breast hurts. The patient was seen by dermatologist who started some hydrocortisone cream. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Off label use
Clinical narrative: presented redness at the site of topical administration; reporter performed a skin test using the Boostrix; reporter performed a skin test using the Boostrix; This case was reported by a physician via call center representative and described the occurrence of erythema in a female patient who received DTPa (Reduced antigen) (Boostrix) for skin test.   Previously administered products included DT vaccine with an associated reaction of cyst (cyst formation after the tetanus diphtheria vaccine received vaccine in 1979).   On an unknown date, the patient received Boostrix (topical). On an unknown date, less than a week after receiving Boostrix, the patient experienced erythema, off label use in unapproved indication and exposure via skin contact. On an unknown date, the outcome of the erythema and off label use in unapproved indication were unknown and the outcome of the exposure via skin contact was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter performed a skin test using the Boostrix vaccine to assess patient's reactivity and the initial test was negative.  The patient returned after the test and presented redness at the site of topical administration it was mentioned that this redness started from 24 - 48 hours after the skin test.  The reporter consented to follow up. The reporter agreed to follow up but mentioned that the first series, was not Boostrix. This case linked with US2020AMR234330, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234330:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cognitive disorder, Cough, Diarrhoea
Clinical narrative: eye and mouth swelling; eye and mouth swelling; injection site pain; unable to think straight; low energy; sweats; mild diarrhea; Chills; headache; bodyache; cough; dry throat; This is a spontaneous report from a non-contactable Other HCP reported that an adult patient receives first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot/Batch Number and Expiration Date unknown) intramuscularly on 25Dec2020 at single dose for covid-19 immunization. The patient's medical history included allergies to Pollen/dust, extreme weather. The concomitant medications were not reported.  The patient experienced Chills, sweats, headache, bodyache, cough, dry throat, eye and mouth swelling (after 24 hours), injection site pain, unable to think straight, low energy, mild diarrhea. Adverse event start date: 25Dec2020.  The patient been tested for COVID-19 and no COVID-19 prior vaccination. There is other vaccine in four weeks. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dry throat, Eye swelling, Headache, Hyperhidrosis, Mouth swelling
Clinical narrative: eye and mouth swelling; eye and mouth swelling; injection site pain; unable to think straight; low energy; sweats; mild diarrhea; Chills; headache; bodyache; cough; dry throat; This is a spontaneous report from a non-contactable Other HCP reported that an adult patient receives first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot/Batch Number and Expiration Date unknown) intramuscularly on 25Dec2020 at single dose for covid-19 immunization. The patient's medical history included allergies to Pollen/dust, extreme weather. The concomitant medications were not reported.  The patient experienced Chills, sweats, headache, bodyache, cough, dry throat, eye and mouth swelling (after 24 hours), injection site pain, unable to think straight, low energy, mild diarrhea. Adverse event start date: 25Dec2020.  The patient been tested for COVID-19 and no COVID-19 prior vaccination. There is other vaccine in four weeks. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: eye and mouth swelling; eye and mouth swelling; injection site pain; unable to think straight; low energy; sweats; mild diarrhea; Chills; headache; bodyache; cough; dry throat; This is a spontaneous report from a non-contactable Other HCP reported that an adult patient receives first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot/Batch Number and Expiration Date unknown) intramuscularly on 25Dec2020 at single dose for covid-19 immunization. The patient's medical history included allergies to Pollen/dust, extreme weather. The concomitant medications were not reported.  The patient experienced Chills, sweats, headache, bodyache, cough, dry throat, eye and mouth swelling (after 24 hours), injection site pain, unable to think straight, low energy, mild diarrhea. Adverse event start date: 25Dec2020.  The patient been tested for COVID-19 and no COVID-19 prior vaccination. There is other vaccine in four weeks. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dyspnoea, Eating disorder
Clinical narrative: Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization.  Medical history included high cholesterol from an unknown date and unknown if ongoing.  Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown.  The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Muscle spasms, Oropharyngeal pain, Pain, Palpitations
Clinical narrative: Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization.  Medical history included high cholesterol from an unknown date and unknown if ongoing.  Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown.  The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Vomiting
Clinical narrative: Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization.  Medical history included high cholesterol from an unknown date and unknown if ongoing.  Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown.  The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (BNT162B2 reported as Covid 19 vaccine or Pfizer-Biontech Covid-19 Vaccine; lot number: EL0140; expiration date: Mar2021), via an unspecified route of administration on 29Dec2020 08:15 at single dose for Covid-19 vaccination. The patient has no medical history. Concomitant medication includes unspecified birth control pills. The patient reported that she got the vaccine this morning and about maybe 30-45 min after getting the vaccine, she started being nauseous and vomiting. She doesn't have a prescribing doctor. She vomited 15 minutes ago. She has vomited 2-3 times in the last hour. She is trying to drink sprite and crackers to settle her stomach, but it is still there. She is not taking any other medication. She does take birth control but doesn't think it is pertinent. She is calling to see what she should do for symptom management and how long these side effects will last for. She mentioned that vomiting started after nausea. The patient reported that her employer does not believe she is having side effects. The outcome of the events was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: muscle pain; joint pain; severe chills; headache; nausea; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old male patient received bnt162b2 (lot number: EL1284), via an unspecified route of administration at left arm, first dose on 24Dec2020 11:15, at single dose, for COVID-19 immunization. No relevant Medical history. No known allergies to medications, food, or other products. No concomitant medication was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Age at vaccination was 37 years old. The patient experienced muscle pain, joint pain, severe chills, headache, nausea on 28Dec2020 14:00. No treatment was received for the adverse event. The events were reported as non-serious. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Myalgia, Pain
Clinical narrative: worsening muscle aches; pains; joint site symptoms; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included muscle aches. Concomitant medications were not reported. He usually takes an anti inflammatory for muscle aches but decided to hold it prior to receiving the first dose of the vaccine. After getting the vaccine, he started to experience worsening muscle aches, pains, and joint site symptoms. He thinks nothing was out of the ordinary. He get these symptoms any time he receive a vaccine. Outcome of the events was unknown.  The following information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 24Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is a male nursing student. He received COVID vaccine 24Dec2020 and then realized he wasn't going to be available to receive the second dose at his facility until 26Jan2021 and was wondering if it would be too long to wait. He also reported he had a reaction to the 1st dose, a "tiny headache off and on, chills, low energy on 25Dec2020" all of which resolved within approximately 30 hours. He had also heard that the 2nd dose has "worse side effects". The outcome of events tiny headache off and on, chills and low energy was recovered in Dec2020.     Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; pain under her left arm near her left breast; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EJ1685, expiration date: unknown), intramuscularly on the left arm on 21Dec2020 at 12:00 PM at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; there were no allergies to medications, food, or other products. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the first (1st) day after vaccine (22Dec2020), the patient experienced very sore arm, but no other effects until the 8th day after vaccine. On 28Dec2020 at 08:00, the patient started with pain under her left arm near her left breast. On 29Dec2020, the injection site was itchy, red, warm, and firm. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events "very sore arm, pain under her left arm near her left breast, and injection site was itchy, red, warm, and firm."
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; injection site was itchy, red, warm, and firm; pain under her left arm near her left breast; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EJ1685, expiration date: unknown), intramuscularly on the left arm on 21Dec2020 at 12:00 PM at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; there were no allergies to medications, food, or other products. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On the first (1st) day after vaccine (22Dec2020), the patient experienced very sore arm, but no other effects until the 8th day after vaccine. On 28Dec2020 at 08:00, the patient started with pain under her left arm near her left breast. On 29Dec2020, the injection site was itchy, red, warm, and firm. The reporter assessed the events as non-serious. The patient did not receive any treatment for all the events. The patient was not recovered from the events "very sore arm, pain under her left arm near her left breast, and injection site was itchy, red, warm, and firm."
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Fatigue, Hypersomnia, Influenza like illness
Clinical narrative: pain in the administration site; tired; feeling dehydrated; had a low degree fever; her nostrils were stuffed or clogged.; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid 19 vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2. The patient reported that she experienced a few symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. The consumer reported that she was in observation for 30 minutes after she was administered with the second dose of the Pfizer's COVID-19 vaccine and she felt only pain in the administration site. Then at night she felt really tired and she went to sleep 3 hours earlier than she usually does, waking up five hour later with pain in the arm and feeling dehydrated and with the need of sugar, also feeling like she was about to had flu. The patient measured her temperature and she reported that she had a low degree fever but maybe the thermometer was malfunctioning, also she noticed that her nostrils were stuffed or clogged. The consumer reported that today on 29Dec2020 in the morning she woke up feeling much better and with one nostril unclogged. The consumer reported that the same symptoms were experienced by a friend of hers after the administration of the second dose of the Pfizer's COVID-19 vaccine. The outcome of the events was recovering.  Information on the lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519005 same reporter and drug and AE, different patient;US-PFIZER INC-2020519005 Same Reporter and Drug/Diffrent Patient
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: pain in the administration site; tired; feeling dehydrated; had a low degree fever; her nostrils were stuffed or clogged.; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid 19 vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2. The patient reported that she experienced a few symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. The consumer reported that she was in observation for 30 minutes after she was administered with the second dose of the Pfizer's COVID-19 vaccine and she felt only pain in the administration site. Then at night she felt really tired and she went to sleep 3 hours earlier than she usually does, waking up five hour later with pain in the arm and feeling dehydrated and with the need of sugar, also feeling like she was about to had flu. The patient measured her temperature and she reported that she had a low degree fever but maybe the thermometer was malfunctioning, also she noticed that her nostrils were stuffed or clogged. The consumer reported that today on 29Dec2020 in the morning she woke up feeling much better and with one nostril unclogged. The consumer reported that the same symptoms were experienced by a friend of hers after the administration of the second dose of the Pfizer's COVID-19 vaccine. The outcome of the events was recovering.  Information on the lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519005 same reporter and drug and AE, different patient;US-PFIZER INC-2020519005 Same Reporter and Drug/Diffrent Patient
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain bilaterally; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced lower back pain bilaterally on 28Dec2020.  She mentioned she didn't lift anything heavy or do anything since yesterday to cause the lower back pain. She clarified the pain started in her lower back and spread bilaterally. She asked if lower back pain is a common side effect of the COVID-19 Vaccine. She said she has never had lower back pain like that before. Event outcome was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Body height, Dizziness, Palpitations, Pruritus
Clinical narrative: light headed; heart was racing; itchy in one part of my right arm (back of the shoulder)/Itching like all over my body; abdomen were itchy and bumps/rashes and some bumps in my body; some rashes; it is like an allergy/like the allergic reaction the medication that causes it; This is a spontaneous report from a contactable Nurse reporting for himself. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left deltoid on 28Dec2020 15:00 at single dose for prevention for Covid-19. The patient medical history included electrolyte imbalance. Concomitant medications included ascorbic acid, rosa canina (VITAMIN C WITH ROSE HIPS), zinc, vitamin  D3, all started from Dec2020 (18 or 19Dec2020) and ongoing for "immune system". At 3pm yesterday (28Dec2020) he received the vaccine. He experienced feeling light headed and his heart was racing a minute after receiving the vaccine. Around 11-12pm he was itching on his arm, abdomen and back. He took an allergy pill and rubbed hydrocortisone cream on his back, arm and armpit. After taking the medication and rubbing the cream the bumps went down 30 minutes to an hour later. He woke today and everything was clearing. These symptoms usually hit him from having an electrolyte imbalance. He had missed the past 2 doses of Vitamin C, Zinc and Vitamin D3. He had 2 Covid test prior to getting the vaccine. His height was 6 feet 3 or 6 feet 4. He started like itching like all over his body. He noticed some rashes and some bumps in his body, it was like an allergy. He was just wondering if this was like the allergic reaction the medication that causes it. The outcome of the events light headed and heart was racing was recovered on 28Dec2020 15:01 and the outcome of the other events was recovered on an unknown date in Dec2020.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Skin disorder
Clinical narrative: light headed; heart was racing; itchy in one part of my right arm (back of the shoulder)/Itching like all over my body; abdomen were itchy and bumps/rashes and some bumps in my body; some rashes; it is like an allergy/like the allergic reaction the medication that causes it; This is a spontaneous report from a contactable Nurse reporting for himself. A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left deltoid on 28Dec2020 15:00 at single dose for prevention for Covid-19. The patient medical history included electrolyte imbalance. Concomitant medications included ascorbic acid, rosa canina (VITAMIN C WITH ROSE HIPS), zinc, vitamin  D3, all started from Dec2020 (18 or 19Dec2020) and ongoing for "immune system". At 3pm yesterday (28Dec2020) he received the vaccine. He experienced feeling light headed and his heart was racing a minute after receiving the vaccine. Around 11-12pm he was itching on his arm, abdomen and back. He took an allergy pill and rubbed hydrocortisone cream on his back, arm and armpit. After taking the medication and rubbing the cream the bumps went down 30 minutes to an hour later. He woke today and everything was clearing. These symptoms usually hit him from having an electrolyte imbalance. He had missed the past 2 doses of Vitamin C, Zinc and Vitamin D3. He had 2 Covid test prior to getting the vaccine. His height was 6 feet 3 or 6 feet 4. He started like itching like all over his body. He noticed some rashes and some bumps in his body, it was like an allergy. He was just wondering if this was like the allergic reaction the medication that causes it. The outcome of the events light headed and heart was racing was recovered on 28Dec2020 15:01 and the outcome of the other events was recovered on an unknown date in Dec2020.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever -102; Chills; Headache; Left arm pain and swelling; Left arm pain and swelling; General body aches; Nausea; Tired; Unwell; Dizzy; This is a spontaneous report from a contactable other HCP (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E49899) (Brand: Pfizer), via an unspecified route of administration at 28Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever -102, chills, headache, left arm pain and swelling, general body aches, nausea, tired, unwell, dizzy at 29Dec2020 11:00 AM. It's unknown if patient received treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Fever -102; Chills; Headache; Left arm pain and swelling; Left arm pain and swelling; General body aches; Nausea; Tired; Unwell; Dizzy; This is a spontaneous report from a contactable other HCP (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E49899) (Brand: Pfizer), via an unspecified route of administration at 28Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever -102, chills, headache, left arm pain and swelling, general body aches, nausea, tired, unwell, dizzy at 29Dec2020 11:00 AM. It's unknown if patient received treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever -102; Chills; Headache; Left arm pain and swelling; Left arm pain and swelling; General body aches; Nausea; Tired; Unwell; Dizzy; This is a spontaneous report from a contactable other HCP (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E49899) (Brand: Pfizer), via an unspecified route of administration at 28Dec2020 15:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever -102, chills, headache, left arm pain and swelling, general body aches, nausea, tired, unwell, dizzy at 29Dec2020 11:00 AM. It's unknown if patient received treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered. The events were reported as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, SARS-CoV-2 test, Somnolence
Clinical narrative: Tiredness; sleepy; headache; malaise; This is a spontaneous report from a contactable Other HCP (patient). A 55-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in arm Left on 16Dec2020 12:45 at single dose for COVID-19 immunisation. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced tiredness, sleepy, headache, malaise on 16Dec2020 16:00. The patient underwent lab tests and procedures which included Nasal Swab: negative on unknown date in Dec2020.  The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. No treatment received for the adverse event. Case was non-serious. The outcome of events was recovered in Dec2020.  Information on the Batch/Lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Diarrhoea, Dysmenorrhoea, Fatigue
Clinical narrative: sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pain in extremity, Somnolence
Clinical narrative: sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling a few hours after administration of vaccine and that the symptom has not resolved/from her elbow to her hand was tingling like she hit her funny bone; This is a spontaneous report from a contactable physician (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Dec2020, the patient experienced tingling a few hours after administration of vaccine and that the symptom has not resolved. She got her vaccine, and a few hours later, from her elbow to her hand was tingling like she hit her funny bone, and she was wondering if this was a known side effect of the vaccine. Clinical outcome of the event was not recovered.  Information on Lot/Batch has been requested.