chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Photophobia
Clinical narrative: light sensivity. Light hurts my eyes almost like migraine; migraine; This is a spontaneous report from a contactable consumer reported that a 70-year-old female patient (consumer) (non-pregnant) received BNT162B2 (Solution for injection, lot number: El3249) on 27Jan2021 at 11: 00 AM in single dose for Left arm, dose number: 2, for covid-19 immunization. Patient medical history included Controlled BP, cholesterol, thyroid, known allergies: sulfa drugs. Patient previously took cimetidine sodium alginate (TAGAMET) and had Tagamet allergy, tetracycline and had tetracycline allergy, Iodine and had Iodine allergy. Historical vaccine included BNT162B2 on 06Jan2021 at 11:00AM (lot number=EK9231, vaccine location=Left arm, dose number=1) for covid-19 immunization. Concomitant medications were not reported. On 28Jan2021, at 08:00AM, patient had light sensitivity and Light hurts my eyes almost like migraine. If this was still like this Monday she will go to doctor. No treatment was received for adverse event. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Toes swollen; painful feet; itchy; red on bilateral feet; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN53.8), via an unspecified route of administration in left arm on 23Jan2021 12:30 at single dose for Covid-19 immunization in facility type of other. The patient's medical history included dysthymia, and there was no allergies to medications, food, or other products. Patient did not have any allergies to medications, food, or other products. Concomitant medication included bupropion within 2 weeks of vaccination in 2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient experienced toes swollen, painful feet, itchy, red on bilateral feet on 26Jan2021 08:00. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender.; about 9 hours after right above my clavicle on my right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender.; This is a spontaneous report from a contactable Nurse reported for herself. A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Pfizer) second dose at right arm intramuscularly on 09Jan2021 07:30 AM at single dose for covid-19 immunisation. The historical vaccine include bnt162b2 on 19Dec2020 07:45 AM first dose at right arm intramuscularly at single dose for covid-19 immunisation in hospital. Medical history included ongoing covid-19. Prior to vaccination was the patient diagnosed with COVID-19. There was no allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included paracetamol (TYLENOL), ibuprofen, omeprazole (PRILOSEC) and gummy hair skin and nails vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second shot on 09Jan2021 about 9 hours (05:00 PM) after right above her clavicle on her right side was swollen and tender to touch. It took until day 8 or 9 to still be swollen and palpable but not tender. As of 30Jan2021, it's been 3 weeks and still there just as big but not tender. There was no seriousness criteria for the events results in death, life threatening, Disabling/Incapacitating and congenital anomaly/birth defect. Since the vaccination, has the patient not been tested for COVID-19. There was no events treatment for the events. The outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Fatigue; nausea; light headedness; pain at injection site; This is a spontaneous report from a contactable other healthcare professional reported for a 50-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported) intramuscularly on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, nausea, light headedness, pain at injection site after vaccination on 28Jan2021. No treatment received for the adverse events. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since having the vaccine. The outcome of events fatigue, nausea, light headedness, pain at injection site was recovering.  No follow-up attempts are possible, Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by armpit)is pink slightly swollen tender to touch; Below injection site (by armpit)is pink slightly swollen tender to touch; This is a spontaneous report from a contactable nurse (patient) reported that a 38-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number : EL9263) via an unspecified route of administration on left arm on 27Jan2021 13:30 at single dose for covid-19 immunisation at workplace clinic. Medical history included allergies to sulfa, nickel and latex. The patient's concomitant medications included prenatal vitamins within 2 weeks of vaccination. The patient previously received first single dose of bnt162b2 on 06Jan2021 01:45 PM via unknown route on left arm for Covid-19 immunization (Lot number: EK09231). On 29Jan2021, patient had below injection site (by armpit) is pink slightly swollen tender to touch. The events did not result in emergency room or physician visit. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient had been tested for COVID-19, patient underwent covid test type post vaccination nasal swab, rapids and PCR in 2021, all results were unknow. The outcome of the events was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperaesthesia teeth
Clinical narrative: teeth are extra sensitive to cold and sugar; headache; some chill; This is a spontaneous report from a contactable consumer reporting for himself. A 41-year-old male patient received bnt162b2 (BNT162B2, Lot no: EN5318), via intramuscularly on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications was 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 has not been tested for COVID-19. The patient stated: "my teeth are extra sensitive to cold and sugar a day or two after my vaccine. Otherwise just a headache and some chill, but those went away after 12 hours. Tooth sensitivity persisted 48 hours after vaccine." No treatment was received for the events. The outcome of sensitivity of teeth was not recovered, headache and chills was recovered on an unspecified date.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Chills; brain fog; fatigue/exhaustion; nausea; headache; site pain; fever; This is a spontaneous report from a contactable health professional reporting for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not known) on 27Jan2021 at 09:00 via an unspecified route of administration at single dose in the right arm for COVID-19 immunization in the workplace clinic. The patient has no medical history. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID 19 vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. On 29Jan2021 at 7:00 AM the patient experienced chills, brain fog, fatigue/exhaustion, nausea, headache, site pain and fever. The patient has not been tested for Covid-19 since the vaccination. The events were assessed as non-serious. The patient did not receive treatment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Chills; brain fog; fatigue/exhaustion; nausea; headache; site pain; fever; This is a spontaneous report from a contactable health professional reporting for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not known) on 27Jan2021 at 09:00 via an unspecified route of administration at single dose in the right arm for COVID-19 immunization in the workplace clinic. The patient has no medical history. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID 19 vaccine and no other medications received within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination. On 29Jan2021 at 7:00 AM the patient experienced chills, brain fog, fatigue/exhaustion, nausea, headache, site pain and fever. The patient has not been tested for Covid-19 since the vaccination. The events were assessed as non-serious. The patient did not receive treatment. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; mild chills; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982) second dose in left arm via an unspecified route of administration on 29Jan2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history included hypertension, diabetes type 2, migraine, ADHD/Attention deficit hyperactivity disorder. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, losartan, amlodipine, nabumetone. The patient previously took lamotrigine (LAMICTAL) and had allergies; also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) first dose at the age of 33 years in left arm on 08Jan2021 at 04:15 PM for COVID-19 immunization. On 30Jan2021 10:30 am, the patient experienced sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes. No pain at injection site. Experiencing mild chills. No treatment was received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Pain in the injection site; Tiredness; Chills; This is a spontaneous report from a non-contactable pharmacist (patient). An adult female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 24Jan2021 at single dose for COVID-19 immunization at a Pharmacy or Drug Store. No known allergies, other medical history was reported as none. There were no concomitant medications, no other vaccine in four weeks, no other medications in two weeks. On 25Jan2021, the patient experienced pain in the injection site, tiredness, chills, and fever. Therapeutic measures were taken as a result of the events: acetaminophen. The outcome of the events was not recovered. Patient did not had COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible;Information on lot/batch number could not be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain
Clinical narrative: dizziness; malaise; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 23-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 at single dose for covid-19 immunisation. Concomitant medications included Sertraline, Iron supplement, calcium levomefolate (DEPLIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient experienced Body aches, malaise, dizziness on 10Jan2021 08:00 AM. Treatments Ibuprofen, Acetaminophen were received. Outcome of the event was recovered in Jan2021.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a contactable consumer reporting for self. This 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 at 07:30 AM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included neuropathy, IBS (irritable bowel syndrome). No known allergies. Concomitant medications in two weeks included: duloxetine hydrochloride (CYMBALTA), venlafaxine hydrochloride (EFFEXOR) and birth control. Patient was not pregnant, and did not receive other vaccine in four weeks. The patient experienced extreme nausea on 24Jan2021 at 10:00 PM and got fine until about 14 hours after receiving shot (as reported). No treatment received. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of event was recovered in Jan2021.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia
Clinical narrative: Left ear has gone mostly numb. When he turn head to the right side, he feel a nerve shoot up his ear. Hasn't impacted hearing at all.; Left ear has gone mostly numb. When he turn head to the right side, he feel a nerve shoot up his ear. Hasn't impacted hearing at all.; This is a spontaneous report from a non-contactable pharmacist (patient). A 28-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL9261) on 21Jan2021 11:45 at SINGLE DOSE in left arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. No Other medications in two weeks. Medical history included covid prior vaccination.  There were no concomitant medications.  On 24Jan2021, the patient experienced Left ear has gone mostly numb. When he turn head to the right side, he feel a nerve shoot up his ear. Hasn't impacted hearing at all. The outcome was Not recovered. No treatment for AE. No Covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Pain injection site/pain at the injection site; This is spontaneous report from a contactable consumer (patient's spouse). This consumer reported similar events for two patients. This is the second of two reports. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 21Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the COVID-19 vaccination "yesterday" (21Jan2021), and experienced "all of the reactions that you have listed here on the page." The reporter stated it was "nothing severe that all of the one that have listed" like pain at the injection site, headache, muscle pain, chills, joint pain, "that kind of things" (Jan2021). The reporter wanted to know how long side effects should last and was there anything to take to be more comfortable. The outcomes of headache, muscle pain, chills, joint pain, and pain at injection site were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093630 same drug, same event, different patient
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Got a cold overnight/her cold was a runny nose and sneezing; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in her left upper arm on 24Jan2021 15:30 at 0.3 mL, single for COVID-19 prophylaxis. Medical history was reported as none. There were no concomitant medications. The patient said that she got the vaccine at 15:30 yesterday on 24Jan2021. She was told not to take Tylenol. She said that she got a cold overnight on 24Jan2021 and her friend told her to take Tylenol and she did and she wanted to know if she was going to die. The patient clarified that her cold was a runny nose and sneezing. She stated that the cold pill helped. The patient said that the Tylenol helped her cold symptoms and it is not as bad as it was, it was over the counter Tylenol Cold Medication. The outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Inappropriate schedule of product administration, Nausea, Vomiting
Clinical narrative: Chest pain radiating into the back; nausea; vomiting; diarrhea; received first dose of BNT162B2 on 04Jan2021, received second dose on 19Jan2021; This is a spontaneous report from a contactable other HCP (Parent). A 29-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number-EL3248), intramuscular on 19Jan2021 12:00 at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient was not Pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history was none. Comcomitant medications in two weeks included birth control. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number- EK9231), intramuscular on 4Jan2021 10:00 at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient experienced Chest pain radiating into the back, nausea, vomiting, diarrhea on 20Jan2021 05:45 AM. AEs Chest pain radiating into the back, nausea, vomiting, diarrhea Resulted in Emergency room/department or urgent care. The outcome of Chest pain radiating into the back, nausea, vomiting, diarrhea was Recovered in Jan2021, of other event was unknown. No treatment for events Chest pain radiating into the back, nausea, vomiting, diarrhea. Unknown if covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Energy increased, Limb discomfort, Pain
Clinical narrative: energy level was throught the roof; energy level was throught the roof; no energy and was unable to get out of bed; felt really weak; Appetite lost; Pain; left shoulder felt heavy with first dose; This is a spontaneous report from a contactable consumer.   A 52-years-old male patient started to receive bnt162b2 (BNT162B2) Lot# EL1686 via an unspecified route of administration on 03Jan2021 16:00  1 dose at SINGLE DOSE for covid-19 immunisation. Vaccination Facility Type: Nursing Home. Anatomical Location of vaccine left arm. Medical history included diabetes mellitus from Nov2020 and ongoing.  Concomitant medication included glipizide (GLIPIZIDE), metformin (METFORMIN). The patient experienced left shoulder felt heavy with first dose on 03Jan2021 with outcome of recovered, pain on 06Jan2021 with outcome of recovered  felt really weak on 07Jan2021 with outcome of recovered, appetite lost on 07Jan2021 with outcome of recovered, no energy and was unable to get out of bed on 08Jan2021 with outcome of recovered, energy level was through the roof on 15Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jan2021. The reporter stated "Following the first dose his left shoulder felt heavy. On 06Jan2021 he had pain. It was in his waist. It was constant and was on both sides of his waist. On 07Jan2021 the pain moved from his waist to between his shoulder blades. It was like that for the whole day. He also felt really weak. He was unable to keep his upper body up. He struggled all day while at work. He thought he had Covid but was tested and the result was negative. The pain became worse and moved from his spinal cord to his head. This caused him to miss work. He did not have any energy and was unable to get out of bed. He also lost his appetite. Then on 15Jan2021 his energy level was through the roof like he was on steroids" The action taken was not applicable.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: energy level was throught the roof; energy level was throught the roof; no energy and was unable to get out of bed; felt really weak; Appetite lost; Pain; left shoulder felt heavy with first dose; This is a spontaneous report from a contactable consumer.   A 52-years-old male patient started to receive bnt162b2 (BNT162B2) Lot# EL1686 via an unspecified route of administration on 03Jan2021 16:00  1 dose at SINGLE DOSE for covid-19 immunisation. Vaccination Facility Type: Nursing Home. Anatomical Location of vaccine left arm. Medical history included diabetes mellitus from Nov2020 and ongoing.  Concomitant medication included glipizide (GLIPIZIDE), metformin (METFORMIN). The patient experienced left shoulder felt heavy with first dose on 03Jan2021 with outcome of recovered, pain on 06Jan2021 with outcome of recovered  felt really weak on 07Jan2021 with outcome of recovered, appetite lost on 07Jan2021 with outcome of recovered, no energy and was unable to get out of bed on 08Jan2021 with outcome of recovered, energy level was through the roof on 15Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jan2021. The reporter stated "Following the first dose his left shoulder felt heavy. On 06Jan2021 he had pain. It was in his waist. It was constant and was on both sides of his waist. On 07Jan2021 the pain moved from his waist to between his shoulder blades. It was like that for the whole day. He also felt really weak. He was unable to keep his upper body up. He struggled all day while at work. He thought he had Covid but was tested and the result was negative. The pain became worse and moved from his spinal cord to his head. This caused him to miss work. He did not have any energy and was unable to get out of bed. He also lost his appetite. Then on 15Jan2021 his energy level was through the roof like he was on steroids" The action taken was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: Pain injection site/pain at the injection site; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. This patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: unknown) via an unspecified route of administration, as a single dose on 21Jan2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported receiving the COVID-19 vaccine with their husband "yesterday" (as of 22Jan2021). The reporter stated they experienced all of the reactions listed on "the page" and questioned if they should take anything. The patient stated nothing severe "that all of the one that have listed " like pain at the injection site, headache, muscle pain, chills, joint pain "that kind of things" (Jan2021). The patient wanted to know how long it should last and if there was anything they could take to make themselves more comfortable. The clinical outcomes of pain injection site/pain at the injection site, headache, muscle pain, chills, and joint pain were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093513 same drug, same event, different patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin disorder, Vaccination site haemorrhage
Clinical narrative: bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle; there was soreness; bleeding from where the nurse injected her; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration injected into right arm on 24Jan2021 at 05:45PM or 05:44PM at single dose for COVID-19 vaccination. Medical history included Graves' disease, she was diagnosed in the 1980s with Graves' disease, which became Hashimoto's so she took Synthroid, because she believes it switched from hyperthyroid to hypothyroid, and Lichen sclerosus. Concomitant medication included levothyroxine sodium (SYNTHROID) for Graves' disease and Hashimoto's, furosemide, and fluocinolone acetonide for Lichen sclerosus. On 24Jan2021, the patient experienced bump in the arm, She said that the bump in her arm had gone up and down in feeling, she has a tiny black mark in the middle, at its largest it was bigger than a half dollar, now it's a quarter. She said that they did no treatment, there was soreness, but it has not required treatment, the discomfort was bearable. She said after she was given her shot she was bleeding nurse from where the nurse injected her, she sometimes did that, it was not related at all, blood dripped down her arm, she had to wipe her arm. The outcome of the events was unknown. She said she would like to know if Pfizer had info information about whether she should have her supplements, like Vitamin B, C, D and her Furosemide, and whether she could have Zinc or Magnesium as well.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the information available a possible contribution of the vaccination with BNT162B2 towards the onset of vaccination site bleeding cannot be fully excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Diarrhea; muscle aches; extreme fatigue; Headache; This is a spontaneous report from a contactable consumer (patient's wife). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via unspecified route on left arm single dose for keeping from getting COVID on 21Jan2021 at 68-year-old. No medical history and concomitant medication. The patient had headache and diarrhea on 22Jan2021, muscle aches and extreme fatigue on 23Jan2021. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event diarrhea was resolved on 25Jan2021; outcome of the other events was not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint stiffness, Paraesthesia
Clinical narrative: Tingling/numbness in both arms and hands; Tingling/numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted; This is a spontaneous report from a non-contactable Other HCP (patient).  This 41-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on the left arm, on 22Jan2021 (at 12:00 PM) at single dose for COVID-19 immunisation, administered at Clinic. No other vaccine was received in four weeks. Relevant medical history included hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID), ibuprofen, colecalciferol (VITAMIN D), curcuma longa root (TURMERIC CURCUMIN) and sertraline hydrochloride (ZOLOFT). On 25Jan2021, the patient developed tingling/ numbness in both arms and hands; stiff joints in hands and feel like circulation is restricted. The patient was not treated for the events. The patient had not recovered from the events.  No follow up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: very dizzy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He is calling about the Pfizer Covid vaccine. He got the vaccine on Saturday. He woke up this morning on 25Jan2021 very dizzy. He is asking what to do or if he can take Tylenol. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of the lymph nodes; This is a spontaneous report from a contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced swelling of the lymph nodes on an unspecified date with outcome of unknown.    Information about batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Phantom smells have occurred twice. Once smelled nail polish remover and a couple days later smelled burnt toast; This is a spontaneous report from a contactable Other-HCP. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), intramuscular in left arm on 06Jan2021 09:00 at first single dose for COVID-19 immunization. Medical history included was none. No known allergies. No covid prior vaccination. Other medications in two weeks: possibly bupropion, quit near this time. No other vaccine in four weeks. The patient experienced phantom smells have occurred twice. Once smelled nail polish remover and a couple days later smelled burnt toast. Adverse event start date: 21Jan2021. No treatment received for the event. No covid was tested post vaccination. Outcome of the event was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Bad headache; Nausea; Chills; Vomiting; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL0140) at single dose on 16Jan2021 07:00 for Covid-19 immunisation, at healthcare facility where she worked (she worked in a kitchen, the hospital gave her the shot).  The patient medical history and concomitant medications were not reported. The patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK and maybe A or O, 231) at single dose 23Dec2020 5 o'clock for Covid-19 immunisation.  On 21Jan2021 morning the patient woke up with really bad headache, vomiting and chills. She had first the major headache and then nausea, chills and then vomited. She thought side effects happen right away. No treatment in response to event received. On 21Jan2021 she went to work.  She got the vaccine at work and then they tested her for COVID not positive in Jan2021. She also reported that on 21Jan2021 she took the COVID test and the results was unknown. The outcome of events was unknown.  Information on Lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Malaise, Pain, Pyrexia
Clinical narrative: Not feeling well; My body is just kind of hurting all over my aches and pains; Low grade fever all day, it was 99 this morning after work today it was a 100.7; Being sick; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer.  A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL3302, via an unspecified route of administration on 16Jan2021 (at the age of 26 years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) daily for allergy relief.  On 20Jan2021, the patient reported that she was not feeling well/being sick, "My body is just kind of hurting all over my aches and pains, Low grade fever all day, it was 99 this morning after work today it was a 100.7." Clinical course verbatim as follows: "I took the vaccine on Saturday. My body is just kind of hurting all over my aches and pains kind of. I have been running a low grade fever all day, it was 99 this morning but then it got better but then after work today it was a 100.7 when I got home from work. So, I didn't know if it is just may be side effects of getting the vaccine or if I may be go to an urgent care and get checked out or what. I was just wondering if that was side effects of the vaccine or if it has been long enough that maybe I have something else and I may be go to an urgent care and checked out for being sick.". She added that I took EXCEDRIN this morning and it (EXCEDRIN) made me feel better, but then when it wore off like I still got again. I took 'two caplets every 6 hours, I have only taken it once for the day' (not clarified further). It has 250 mg of Acetaminophen in it and 250 mg of Aspirin in it and it also has 65 mg Caffeine." The clinical outcome of the events was not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Dizziness; tingling up neck and right-side of face; numbness sensation on right brow, eyelids and cheek/intermittent numbness; headache; This is a spontaneous report from a contactable Other HCP.  A 45-year-old female no pregnant patient received , at hospital , the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL8982 on  21Jan2021 15:15 at SINGLE  DOSE for covid-19 immunisation .  Medical history included diabetes .Concomitant medication included metformin (METFORMIN), glyburide (GLYBURIDE), sitagliptin phosphate (JANUVIA ).The patient previously took codeine and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity, cortisone and experienced adverse reaction. On 21Jan2021 at 15:30  the patient experienced Dizziness, tingling up neck and rightside of face, numbness sensation on right brow, eyelids and cheek. 2 hours later teeth chattering for hour and half, headache for 4 days, intermittent numbness for 3 days.Outcome of the events was reported as recovered with sequel. No COVID prior vaccination, No COVID tested post vaccination
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful left supraclavicular lymphadenopathy developed 2 days after second dose vaccination. Still persistent on day 4; This is a spontaneous report from a contactable physician (patient). A 30-year-old female non-pregnant patient received second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot/batch number and expiry date unknown), intramuscular on 21Jan2021 at single dose for covid-19 immunization. Vaccine facility type was hospital. Medical history included none. No known allergies. Concomitant medication included ethinylestradiol, norgestimate (MONO LINYAH). No other vaccine in four weeks. No covid prior vaccination and covid was not tested post vaccination. The patient experienced painful left supraclavicular lymphadenopathy developed 2 days after second dose vaccination 23Jan2021. It was still persistent on day 4. The outcome of the event was not recovered. No treatment received.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test, Vaccination site induration
Clinical narrative: left arm weakness; injection site feels hard after the second dose; This is a spontaneous report from a contactable consumer (patient) and contactable physician.  A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm left in Jan2021 at single dose for COVID-19 immunization.  The patient medical history included diabetes from Nov2020 and ongoing. The patient's concomitant medication included glipizide from Nov2020 at 2.5 mg twice daily and metformin at 500 mg twice a day, both for diabetes. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1686) via an unspecified route of administration on 03Jan2021 at 16:00 single dose for COVID-19 immunization and experienced left shoulder felt heavy, pain, felt really weak, appetite lost and "energy level was through the roof".  The patient experienced injection site feels hard on 24Jan2021, left arm weakness on 25Jan2021 with outcome.  The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 24Jan2021.  The patient outcome of injection site feels hard was not recovered and the outcome of left arm weakness was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Nausea; Swollen lymph nodes; This is a spontaneous report from a contactable consumer reported for herself. This 34-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 08:45 AM on Arm right at single dose for covid-19 immunisation. Medical history included Achondroplasia. No allergies to medications, food, or other products. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ). 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) on 21Dec2020 09:00 AM on Arm right at single dose (Lot EH 9899) for covid-19 immunisation and experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, injection site swelling, injection site redness, nausea, feeling unwell on 21Dec2020. With second injection: injection site pain, tiredness, headache, nausea, swollen lymph nodes. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient).  A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation.  Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Oropharyngeal pain, Pallor, Pyrexia
Clinical narrative: covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient).  A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation.  Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.