chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: Tested positive on 11Jan2021; Tested positive on 11Jan2021; This is a spontaneous report from a contactable consumer (daughter reporter for her father). An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no and expiry date not reported), via an unspecified route of administration on 28Dec2020 at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Daughter calling on behalf of father, aged 88, who lives in assisted living received his first dose on 28Dec2020. However, patient tested positive on 11Jan2021, and was moved to a covid facility.  He is scheduled to receive his second dose on 18Jan2021. The daughter asked if her father could get the second covid vaccine after being sick. She also asked what if his father can't go back to his regular nursing home in time? Does he have to restart the vaccination schedule? The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Malaise, Myalgia
Clinical narrative: Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for self). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular (right arm) on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history included sciatica and Allergy: sulphur drugs. Concomitant medication included Multivitamins (unspecified). The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially after the vaccine (Jan2021; unspecified date), she experienced soreness in injection site and muscles aches, but these symptoms were mild. On 11Jan2021, the patient experienced intense abdominal cramps, chronic diarrhea, muscle aches, chills, and feeling unwell (also reported that these symptoms developed 5 days after vaccine). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination: Covid test type post vaccination was Nasal Swab, Covid test name post vaccination=Pcr; Covid test date=13Jan2021; Covid test result=Negative. The outcome of events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for self). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular (right arm) on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history included sciatica and Allergy: sulphur drugs. Concomitant medication included Multivitamins (unspecified). The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially after the vaccine (Jan2021; unspecified date), she experienced soreness in injection site and muscles aches, but these symptoms were mild. On 11Jan2021, the patient experienced intense abdominal cramps, chronic diarrhea, muscle aches, chills, and feeling unwell (also reported that these symptoms developed 5 days after vaccine). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination: Covid test type post vaccination was Nasal Swab, Covid test name post vaccination=Pcr; Covid test date=13Jan2021; Covid test result=Negative. The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the first of 20 reports.  A patient of unspecified age and gender received 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 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021042231 same reporter, same drug/event, different patient;US-PFIZER INC-2021042229 same reporter, same drug/event, different patient;US-PFIZER INC-2021042217 same reporter, same drug/event, different patient;US-PFIZER INC-2021042222 same reporter, same drug/event, different patient;US-PFIZER INC-2021042224 same reporter, same drug/event, different patient;US-PFIZER INC-2021042225 same reporter, same drug/event, different patient;US-PFIZER INC-2021042230 same reporter, same drug/event, different patient;US-PFIZER INC-2021042220 same reporter, same drug/event, different patient;US-PFIZER INC-2021042218 same reporter, same drug/event, different patient;US-PFIZER INC-2021042234 same reporter, same drug/event, different patient;US-PFIZER INC-2021042233 same reporter, same drug/event, different patient;US-PFIZER INC-2021042221 same reporter, same drug/event, different patient;US-PFIZER INC-2021042219 same reporter, same drug/event, different patient;US-PFIZER INC-2021042223 same reporter, same drug/event, different patient;US-PFIZER INC-2021042228 same reporter, same drug/event, different patient;US-PFIZER INC-2021042226 same reporter, same drug/event, different patient;US-PFIZER INC-2021042216 same reporter, same drug/event, different patient;US-PFIZER INC-2021042232 same reporter, same drug/event, different patient;US-PFIZER INC-2021042227 same reporter, same drug/event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Disease recurrence, Dysgeusia, Headache
Clinical narrative: slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Paraesthesia
Clinical narrative: slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: experienced side effect of rash 2 to 3 hours later; This is a spontaneous report from a non-contactable physician (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine 2 days ago and experienced side effect of rash 2 to 3 hours later. The patient wanted guidance on 2nd dose. She was unsure if it was due to taking a shower with warm water. She took Benadryl and was fine afterwards. She was asking if she can take steroids before the second dose, if there is any contraindication of steroids and the vaccine, and about taking Benadryl before the second dose. She was asking for any specific data on participants in the study that had taken steroids that were permitted in the study. She also stated that they were doing a great job. Therapeutic measures were taken as a result of experienced side effect of rash. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Malaise
Clinical narrative: chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Muscle pain; Fatigue; Chills; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), intramuscular in left arm, on 11Jan2021 at 14:15, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension, Hashimoto's, and allergies to sulfa. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 19Dec2020 at 08:00 AM (intramuscular in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 10:30 PM, the patient experienced nausea, vomiting, muscle pain, fatigue, and chills. No treatment was administered for the events. The patient had not been tested for COVID-19 post-vaccination. The patient was recovering from the events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain
Clinical narrative: tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint and right hip joint/It was so severe she could hardly get out of bed; Headache; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686, expiration date unspecified), via an unspecified route of administration on 31Dec2020 11:00 at single dose (left arm) for COVID-19 immunization. Medical history included arm soreness from flu shot 2-3 months ago. There were no concomitant medications. It was reported that she received her 1st dose of the vaccine on her left arm on 31Dec2020 as she works with elderly at nursing home and she was of age. Two days after her shot, on 02Jan2021, she experienced little headache which lasted all day but was gone by the following day. On 12Jan2021, 2 days ago, when she woke up and got of bed with severe pain in right shoulder joint and right hip joint which lasted for maybe 10 minutes. It was so severe she could hardly get out of bed. Currently, she had no joint pain. The right shoulder and right hip pain were so odd she thought, but it has also improved since. It's been 2 weeks and she never had this happen before. This lasted a little while, but thought it was from the cold weather since it's been 2 weeks since having the vaccine. She still has a bit of tenderness on the left arm where she received the vaccine dose on an unspecified date. She mentioned this to her supervisor and was encouraged to call and she wants to know if this could be a side effect. The patient had no vaccines the same day or 4 weeks prior. She had the flu shot before in past and the area would be sore for a few days, but now with this Covid vaccine this arm was still tender. Also, she had gotten the shingles shot the same day as the flu shot but that was about 2-3 months ago, at least 2 months ago. The patient had no additional vaccines administered on same date of the Covid vaccine. The patient had no prior vaccinations within 4 weeks prior to the first administration. Outcome of event headache was recovered on 03Jan2021; severe pain in right shoulder joint and right hip joint/it was so severe she could hardly get out of bed was recovered in Jan2021; and outcome of tenderness on the left arm where she received the vaccine dose was not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: soreness in left arm; feeling kind of achy; was wanting to run a fever/Very high fever in excess of 102 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EJ1686) via an unspecified route of administration on 04Jan2021 at a single dose on the left arm for vaccination. Medical history included ongoing hypothyroidism. Concomitant medication include levothyroxine (manufacturer unknown) from an unspecified date probably 2-3 years ago and ongoing for hypothyroidism. The patient reported that the first dose was administered of the Pfizer COVID-19 Vaccine on 04Jan2021. He had onset of soreness in left arm that day, 14Jan2021 which he recovered completely from by 05Jan2021. He stated that starting maybe 05Jan2021 or 06Jan2021, he had onset of feeling kind of achy and like he was wanting to run a fever. Starting 08Jan2021, he started running a very high fever in excess of 102 degrees Fahrenheit which has been ongoing and persistent since then. He has been taking Tylenol every 6 hours to try to control the high fever but the high fever is just not going away. He was wondering if there is anything he can do because his primary care physician (PCP) can't really help him at the clinic; He was wondering if Pfizer is familiar with this reaction and if there are any recommendations regarding them. He has taken Tylenol to help, but it is not making it go away. He wanted to know if steroids could be used to counteract this side effect. He added that he is supposed to get the second dose 25Jan2021 but he does not plan to get the second dose, at this point he does not want to do that. He was administered the vaccine because his mother lives in an assisted living facility where the vaccine was offered to residents; and because he acts as a sitter at the facility it was offered to him. On 11Jan2021 he went to Urgent Care for these events, and was given a Rapid COVID-19 Test which had negative result. The outcome of the event soreness in left arm was recovered on 05Jan2021, the outcome of the event was wanting to run a fever/very high fever in excess of 102 degrees fahrenheit was not recovered and the outcome of the event feeling kind of achy was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased, Nervousness
Clinical narrative: Rapid heart rate; Feeling shaky and anxious; Feeling shaky and anxious; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:EL0142, expiration date unknown) , via an unspecified route of administration in the left arm on 14Jan2021 at 09:15 AM at a single dose for COVID-19 immunization.  Medical history included COVID-19 on unknown date prior to vaccination, patient had no known allergies. Patient is not pregnant. Concomitant medications included over the counter (OTC) vitamins. The patient had not received other vaccines in four weeks. On 14Jan2021, the  patient experienced rapid heart rate noted in the 150s approximately five minutes after receiving first dose lasting only a few minutes and was feeling shaky and anxious. There was no treatment received for the adverse events. The patient was not tested for COVID post vaccination. The outcome of the event rapid heart rate was recovered on 14Jan2021 while the rest of events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: 101 Temperature; Headache; Chills; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 50-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his right arm, via an unspecified route of administration on 13Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included covid-19.  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced 101 Temperature, Headache, Chills, Fatigue; all on 13Jan2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; headache; body aches; This is a spontaneous report from a contactable other health professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, intramuscular in the right arm, on 12Jan2021 17:00 at a SINGLE DOSE for covid-19 immunization. Prior vaccination, the patient had COVID-19 on an unspecified date.  Concomitant medications included venlafaxine hydrochloride (EFFEXOR), rosuvastatin calcium (CRESTOR), colecalciferol (VITAMIN D), ibuprofen, paracetamol (TYLENOL).  Patient was not pregnant during vaccination. The patient previously took Tetracycline and Wellbutrin; she experienced allergy to both on unspecified dates. On 13Jan2021 17:00, the patient experienced chills, headache and body aches. outcome of events was recovered. The patient did not receive any treatment due to events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: High fever (102); chills; lymphadenopathy; headache; This is a spontaneous report from a non-contactable physician. A 36-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 11Jan2021 07:00 at a single dose for COVID-19 immunization. The 1st dose was received on 21Dec2020 07:00. The patient's medical history and concomitant medications were not reported. The patient experienced high fever (102), chills, lymphadenopathy, headache on 11Jan2021. Outcome of the events was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Lymphadenopathy
Clinical narrative: Fever 102; chills; headache; back pain; lymphadenopathy in cervical, axilla, and groin; This is a spontaneous report from a contactable other healthcare professional (hcp, reported for herself).  A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin. The patient was not pregnant at the time of the report. The patient had no covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had first dose of COVID-19 vaccine bnt162b2 on 23Dec2020 08:30 AM in the left arm (at the age of 34 years old). On 13Jan2021 12:00 PM, patient experienced fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin. No treatments received in response to the events reported. The patient was not COVID tested post vaccination. The outcome of the events fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin was recovering.   Information on batch/lot number was requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102; chills; headache; back pain; lymphadenopathy in cervical, axilla, and groin; This is a spontaneous report from a contactable other healthcare professional (hcp, reported for herself).  A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin. The patient was not pregnant at the time of the report. The patient had no covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had first dose of COVID-19 vaccine bnt162b2 on 23Dec2020 08:30 AM in the left arm (at the age of 34 years old). On 13Jan2021 12:00 PM, patient experienced fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin. No treatments received in response to the events reported. The patient was not COVID tested post vaccination. The outcome of the events fever 102, chills, headache, back pain, and lymphadenopathy in cervical, axilla, and groin was recovering.   Information on batch/lot number was requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: For the first dose, individual stated the only had a sore shoulder (at point of injection) and foggy head for the few hours; For the first dose, individual stated the only had a sore shoulder (at point of injection) and foggy head for the few hours; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 35-year-old male received first single dose BNT162B2 (Solution for injection, Lot number: EJ1685, exp date not reported), via an unspecified route of administration (anatomical location: shoulder [not further specified]) on 23Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. For the first dose, patient only had a sore shoulder (at point of injection) and foggy head for the few hours on an unspecified date. No treatment was provided for the adverse events. It was unknown if patient had Covid prior vaccination. It was unknown if patient was Covid tested post vaccination. The patient recovered from the events on an unspecified date.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: I developed COVID positive test; I developed COVID positive test; Had mild to moderate illness; This is a spontaneous report from a contactable physician reporting for himself. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, on 23Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medication was reported as none. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with COVID before vaccination. On 30Dec2020 at 4:15 PM, after the first vaccine dose, within a week the patient developed COVID positive test. The patient had mild to moderate illness on an unspecified date. Therapeutic measure taken in response to the events included administration of Tylenol. The patient underwent covid test via nasal swab on 31Dec2020 and showed positive result. Outcome of the events was not recovered.  Information for Lot/Batch number has been requested; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain, redness, and swelling at injection site; pain, redness, and swelling at injection site; pain, redness, and swelling at injection site; has a bruise and a palpable lump about the size of an almond at the injection site; has a bruise and a palpable lump about the size of an almond at the injection site; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; Ek9231), via an unspecified route of administration (left arm) on 04Jan2021 (15:00) at single dose for Covid-19 immunization. The patient's medical history included "known allergies: Whey". Concomitant medications included colecalciferol (VITAMIN D), curcuma longa rhizome (TURMERIC), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC), and Multivitamin (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially on 05Jan2021, she had pain, redness, and swelling at injection site. She also experienced a bruise and a palpable lump about the size of an almond at the injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle aches; pain at injection site; headache; chest pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included sulfa allergy, canteloupe allergy. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient previously received 1st dose of BNT162B2 (lot# EJ1685) via intramuscular in right arm on 22Dec2020 13:00 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, muscle aches, pain at injection site, headache, chest pain on 12Jan2021 17:00. The patient was not pregnant. No treatment received for the events. The outcome of events was recovered on an unspecified date of Jan2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; chills; muscle aches; pain at injection site; headache; chest pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included sulfa allergy, canteloupe allergy. The patient's concomitant medications were not reported. No any other medications the patient received within 2 weeks of vaccination. The patient previously received 1st dose of BNT162B2 (lot# EJ1685) via intramuscular in right arm on 22Dec2020 13:00 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, muscle aches, pain at injection site, headache, chest pain on 12Jan2021 17:00. The patient was not pregnant. No treatment received for the events. The outcome of events was recovered on an unspecified date of Jan2021. This case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: a coin-sized redness that is flat and not raised; She wasn't sure if it was subcutaneous or what but the injection was way too lateral and low; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The second dose was low laterally and 48 hours later the caller started seeing a coin-sized redness that was flat and not raised on 14Jan2021. The second vaccine was given way too low and lateral and she has developed a coin shaped redness at the injection site as if the vaccine was given subcutaneously instead of intramuscularly. She mentions were arm is a little fat, too. Patient wanted to know does she need antibody testing or a repeat dose? Does the COVID vaccine even work if they are given subcutaneous? She wasn't sure if it was subcutaneous or what but the injection was way too lateral and low. It was 8 fingerbreadths away from the top of her arm. Event was reported as non-serious. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Exanthema on fingers and back; This is a spontaneous report from a contactable Other Health Professional reported for herself. The 46-year-old female patient that received second dose of bnt162b2 ( COVID 19, Pfizer Biotech, lot number: EL9231), via Intramuscular on 11Jan2021 09:30 AM on Left arm at a single dose for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included Migraine w aura. No allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) Zyrtec, vitamin D and vitamin C. The patient previously took first dose of bnt162b2 (COVID 19, BioNTech/Pfizer, lot number: EL5730) via Intramuscular on 21Dec2020 01:00 PM on Left arm at single dose for covid-19 immunisation. The patient experienced Exanthema on fingers and back from 14Jan2021 06:00 AM. The outcome of the event was recovering. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain, Peripheral swelling
Clinical narrative: Muscle pain; swelling of upper arm; body aches; headache; chills; slight fever; This is a spontaneous report from a contactable consumer reported for himself. A26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 12Jan2021 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine at workplace clinic. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. 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. The patient experienced muscle pain and swelling of upper arm, body aches, headache, chills, slight fever on 12Jan2021 23:30. No treatment was received for the events. The events did not result in Emergency Room visit or physician office visit. The outcome of events was recovered.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle pain; swelling of upper arm; body aches; headache; chills; slight fever; This is a spontaneous report from a contactable consumer reported for himself. A26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 12Jan2021 16:00 at single dose for COVID-19 immunisation. The patient received the vaccine at workplace clinic. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. 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. The patient experienced muscle pain and swelling of upper arm, body aches, headache, chills, slight fever on 12Jan2021 23:30. No treatment was received for the events. The events did not result in Emergency Room visit or physician office visit. The outcome of events was recovered.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Glycosylated haemoglobin, Nausea
Clinical narrative: experience nausea; This is Spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246), via an unspecified route of administration on left upper arm on 13Jan2021 09:30 at single dose COVID-19 vaccination.  Medical history included high blood pressure and prediabetic. Patient reported that she has high blood pressure that she is on medication for. She said she takes Metformin twice a day, clarifying she is pre-diabetic according to her Hemoglobin A1C. Patient was on top of her bloodwork, saying she has her bloodwork done regularly. Reported patient's height was 4'11" or 5'. Concomitant medications included Metfiormin as patient is pre-diabetic. Reported she has had the flu and Shingles vaccines in the past, and never had any prior reactions to vaccines. No prior vaccinations (within 4 weeks). The patient had her first dose of the Pfizer COVID-19 Vaccine yesterday morning, 13Jan2021, at 9:30. She said she had some nausea last night. She said she woke up in the middle of the night with nausea. She said she woke up this morning and had nausea again, but ate something and got better. She said the nausea is like morning sickness, clarifying if she eats something the nausea goes away, but once her stomach is empty, the nausea comes back. She said she has not had a fever. She asked how long should she expect her nausea to last. The event did not require a visit to Emergency Room or Physician. The outcome of the event was not recovered.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspepsia, Fatigue, Headache
Clinical narrative: mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperalgesia; headache; fatigue; grogginess; This is a spontaneous report from a contactable physician reported for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 07Jan2021 08:45 at single dose in left arm for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included triamcinolone 1% cream and diphenhydramine 2% cream.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on 17Dec2020 05:00 PM at single dose in left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced moderate deltoid soreness at injection site within 2-3 hours; chills, myalgias, hyperalgesia, headache, fatigue, grogginess from 12-36 hours post injection (on 07Jan2021); mild dyspepsia and loose stools 24-36 hours post-injection (on 08Jan2021). The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Myalgia, Somnolence, Vaccination site pain
Clinical narrative: mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperalgesia; headache; fatigue; grogginess; This is a spontaneous report from a contactable physician reported for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 07Jan2021 08:45 at single dose in left arm for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included triamcinolone 1% cream and diphenhydramine 2% cream.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on 17Dec2020 05:00 PM at single dose in left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced moderate deltoid soreness at injection site within 2-3 hours; chills, myalgias, hyperalgesia, headache, fatigue, grogginess from 12-36 hours post injection (on 07Jan2021); mild dyspepsia and loose stools 24-36 hours post-injection (on 08Jan2021). The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Cold sweat, Myalgia
Clinical narrative: severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma.  There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma.  There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.