chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Extreme soreness in the arm that received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration in arm on 28Jan2021 10:15 AM at single dose for COVID-19 immunization in workplace clinic. The patient's medical history and concomitant medications were none. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced extreme soreness in the arm that received the shot on 28Jan2021. The event was considered as non-serious by the consumer. No treatment was received for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Investigation, Pruritus
Clinical narrative: itching/ itching on her face, arms, head/ itching in her scalp, ears, head, face, neck and a little bit in my arms and legs; itching/ itching on her face, arms, head/ itching in her scalp, ears, head, face, neck and a little bit in my arms and legs; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiration date: Unknown, NDC number: Unknown), intramuscularly in left arm on 26Jan2021 14:00 at single dose for COVID-19 immunisation in clinic. The patient's medical history included thyroid issues, back issues, she had done some reading and she has allergies to some antibiotics, one of them being sulfa, allergic to bicillins, she has a whole host of antibiotic allergies which she investigated prior to receiving the vaccine and she was told it wasn't an issue. Concomitant medications were none. The patient previously took azithromycin (ZITHROMAX), levofloxacin (LEVAQUIN), omeprazole (PRILOSEC), levothyroxine and experienced allergy to all drugs. The patient did not receive prior vaccinations (within 4 weeks). The patient did not administer additional vaccines on same date of the Pfizer suspect. It was reported that the caller received her COVID-19 vaccine yesterday at 14:00. She had no problems at all. She was feeling some itching on her face, arms, head on 28Jan2021. She was wanting to know was there any kind of sulfa product in the COVID-19 vaccine. Caller confirms she had no problems at all with the administration of the vaccine. She didn't feel a thing. It was very organized. The caller states the itching began about an hour ago on 28Jan2021. Caller clarifies she actually received her first vaccine on 26Jan2021 14:00. On her vaccine record card, she sees EL and the third digit was either a 9 or 4. She was able to look at her husband's vaccine card and it looks like a different person wrote on his and she sees "EL9262" on his card so she assumes that was what was written on hers. Caller explains she has thyroid issues and back issues, but she considers herself to be in pretty decent health. Caller states she received her first Pfizer vaccine dose 2 days ago and today around 5 pm started itching in her scalp, ears, head, face, neck and a little bit in my arms and legs. No rash. Allergic to sulfa, also allergic to "the cillins", caller states she did her research before she got the vaccine. "Enquired was there any sulfa in the vaccine or not." No investigation assessment. The patient did not require a visit to emergency room and physician office. No relevant tests. The outcome of the events was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: arm very sore; her son received 6 times the amount of the vaccine dosage/overdosed 6 times the normal amount/over dosed him on the amount by 6 times, a huge mistake; This is a spontaneous report from a contactable consumer company CEP 2191. A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 04Feb2021 via an unspecified route of administration in the arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The reporter stated her son received 6 times the amount of the vaccine dosage. The patient had not administered pfizer vaccine on same date and not had prior vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine. The patient had no AE's prior vaccinations. The patient had no any illness at time of vaccination and was not diagnosed with allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient experienced her son received 6 times the amount of the vaccine dosage/overdosed 6 times the normal amount/overdosed him on the amount by 6 times, a huge mistake on 04Feb2021 and arm very sore on an unspecified date. The patient was concerned about side effects. The patient has been feeling fine and has not mentioned any issues since the overdose. The patient had no relevant test and no had any illness. The outcome of the events was not recovered.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling jittery, Heart rate increased, Pain in extremity
Clinical narrative: Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient).  A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization.  Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE).  The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue
Clinical narrative: bad stomach ache; severe chills; tired; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration in the left arm, on 02Feb2021 19:30, at single dose, for COVID-19 immunization, at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 04Feb2021 at 14:00, the patient had a bad stomachache, severe chills and was tired. No treatment was given for the events. The patient was recovering from the events. The reporter assessed the events as non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling cold, Nausea
Clinical narrative: dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 51-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration on the left arm, on 03Feb2021 15:00, at single dose, for covid-19 immunization. Medical history included high blood pressure and, diagnosed with COVID-19. The patient has unspecified concomitant medications. The vaccine was received at the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Feb2021 around 12NN, the patient started feeling cold and chills. By 17:00 on 04Feb2021, she had fever of 99 and was freezing and achy. Around 20:00 on 04Feb2021, she started sweating and sweated all night. She felt better on 05Feb2021 around 14:00. On 06Feb2021 she got up, and then was dizzy and nauseous. At the time of the report, the patient was recovering from all the adverse events with no treatment received. The patient has not been tested for COVID-19 since the vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: dizzy; nauseous; sweating and sweated all night; fever of 99; achy; feeling cold/freezing; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 51-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration on the left arm, on 03Feb2021 15:00, at single dose, for covid-19 immunization. Medical history included high blood pressure and, diagnosed with COVID-19. The patient has unspecified concomitant medications. The vaccine was received at the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Feb2021 around 12NN, the patient started feeling cold and chills. By 17:00 on 04Feb2021, she had fever of 99 and was freezing and achy. Around 20:00 on 04Feb2021, she started sweating and sweated all night. She felt better on 05Feb2021 around 14:00. On 06Feb2021 she got up, and then was dizzy and nauseous. At the time of the report, the patient was recovering from all the adverse events with no treatment received. The patient has not been tested for COVID-19 since the vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: very bad headache; nausea; muscle aches; fatigue; vomited; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 12:15 at a single dose in the right arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications  included bupropion hydrochloride (BUPROPION HCL XL) and topiramate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 08:00, the patient experienced very bad headache, nausea, muscle aches, and fatigue. The patient also vomited on 21Jan2021 at 08:00. The patient took Tylenol as instructed by her doctor and rested. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness too much of the time; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN5318), via an unspecified route of administration on 04Feb2021 14:30 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included allergies: yes, Idiopathic Neuropathy.  Concomitant medication included alendronate sodium. On 05Feb2021 06:30, the patient experienced tiredness too much of the time. The patient did not receive treatment for the event. The outcome of the event was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia, Swelling
Clinical narrative: where she's had the fillers, she was swollen and it's very painful; fever; body aches; chills; too sick to get out of bed; This is a spontaneous report from a contactable nurse (patient herself). A 27-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscularly on the left arm, on 04Feb2021 16:15, at single dose, for covid-19 immunization. Medical history included having had fillers before. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on an unknown date at 27-years-old for covid-19 immunization. The vaccine was received at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. She was not diagnosed with COVID-19 prior to vaccination. She stated having had fillers before and now where she's had the fillers, she was swollen and it's very painful. This was also besides the fever, body aches, and chills she has. As for the lot number of the vaccine, she was too sick to get out of bed to look for it. All the adverse events happened on 05Feb2021. The outcome of all the adverse events was unknown. The patient has not been COVID-19-tested post-vaccination.   Information about the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in torso, arms and legs almost like pins and needles sensation; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN9581, expiry date not reported), via an unspecified route of administration at the left arm on 05Feb2021 10:15 at single dose for COVID-19 immunization. Medical history included hyperlipidaemia, COVID-19, and sulfa drugs. The patient was vaccinated at a hospital. Concomitant medications included atorvastatin (LIPITOR) and fish oil. Historical vaccine included first dose of bnt162b2 (lot number: EK9231, expiry date not reported) in the right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. The patient experienced tingling in torso, arms and legs almost like pins and needles sensation on 05Feb2021 16:00 with outcome of unknown. No therapeutic measurement was given as a result of the event.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: severe dizziness on arising from bed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration in the left arm on 31Jan2021 13:15 at a single dose for covid-19 immunization. Medical history included allergy to artificial crabmeat, NIDDM (non-insulin-dependent diabetes mellitus), HBP (high blood pressure), GERD (gastrooesophageal reflux disease) and BPH (benign prostatic hyperplasia). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but has other medications the patient received within 2 weeks of vaccination. On 04Feb2021, the patient experienced severe dizziness on arising from bed at 0800 hours. The dizziness subsided approximately 6 minutes later with no recurrence. The event did not require treatment. The event was considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 04Feb2021 0806 hours.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Headache; Tired; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3247),  dose  1, single dose via an unspecified route of administration in the left arm on 14Jan2021 at 20:30 for COVID-19 vaccination. There was no relevant medical history. There were no known drug allergies. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D), estradiol (VIVELLE) patch .05 estrogen only and famotidine (PEPCID). On 04Feb2021 at 12:00, the patient had headache, tired and arm soreness. No treatment was received for headache, tired and arm soreness. The clinical outcome of headache, tired and arm soreness was recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hot flush, Insomnia, Nausea
Clinical narrative: generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain, Vomiting
Clinical narrative: generalized aches and pains; fatigue; head fog; hot and cold flashes; Nausea; vomiting; insomnia; Site pain persisted; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiry date: unknown), via an unspecified route of administration on the right arm, 04Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included HTN and Asthma. Patient was not pregnant at the time of administration. Concomitant medication included Olmesartan, bupropion hydrochloride (WELLBUTRIN), loratadine and vitamins. The patient previously took sulfur and morphine and experienced allergies. Events began with insomnia the night of injection on 04Feb2021 23:00. The following morning of 05Feb2021, patient woke with generalized aches and pains, fatigue, head fog, and hot & cold flashes. She had nausea and vomiting midday. Symptoms resolved by second day on 05Feb2021 but site pain persisted on Feb2021. TYLENOL and ibuprofen were given as treatments for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Headache; Tired; feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 02Feb2021 at the age of 72 years old at a single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient previously took keflex [cefalexin monohydrate] and experienced allergy, first dose of BNT162B2 (lot number: EI8982) on arm left on 12Jan2021 04:00 PM at the age of 72 years old for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. It was reported that on 02Feb2021 20:00 PM, Headache started about 5-7 hours after injection. Continued for another 24 hours. Tired and feeling unwell also for the 30-36 hours after injection. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Nausea, Vaccination site pain
Clinical narrative: Diarrhea; Joint pain; Arm pain at injection site; Nausea; This is a spontaneous report from a contactable consumer (patient). A 57 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm on 05Feb2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received COVID-19 vaccine on 05Feb2021 and experienced diarrhea, joint pain, arm pain at injection site, and nausea on unspecified dates. The patient wanted to know if these are side effects of the vaccine. The patient took Imodium for diarrhea. Outcome of the events was unknown. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on right arm on 04Feb2021 at 12:30 (at the age of 49years) at single dose for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure and high cholesterol. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on right arm on 14Jan2021 at 08:00 (at the age of 49years) at single dose for Covid-19 immunization. The patient experienced loss of taste and smell on 05Feb2021 at 18:00. Treatment was received for the adverse events. The events were considered non-serious as did not result in death, non-life threatening, did not cause/prolong hospitalization, non- disabling/incapacitating and no congenital anomaly/birth defect. The facility where the most recent COVID-19 vaccine was administered was in a military base. 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 outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: has a lump at the site where vaccine was administered; started scratching the arm at the injection site; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9263), via an unspecified route of administration on 29Jan2021 at 16:45 at a single dose in the left arm for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), hypertension, and allergies. Concomitant medications were not specified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Feb2021, the patient started scratching the arm at the injection site and has a lump at the site where vaccine was administered. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Fatigue; severe chills; slight fever; received second dose of bnt162b2 on 04Feb202; received the first dose of bnt162b2 on 12Jan2021; This is a spontaneous report from a contactable other health professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, on 04Feb2021 13:30 at SINGLE DOSE for covid-19 immunization. Medical history included IgA nephropathy, chronic kidney disease, hypertension, familial hyperlipidemia and pre diabetes/metabolic syndrome. The patient received the first dose of bnt162b2 on 12Jan2021 at 14:15 in the left arm, covid-19 immunization. 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 hasn't been tested for COVID-19. Concomitant medication included losartan and labetalol, both from an unspecified date for an unknown indication. On 05Feb2021 07:15, the patient experienced fatigue, severe chills and slight fever. The outcome of events fatigue, severe chills and slight fever was recovering. Outcome of the other event was unknown.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mammogram
Clinical narrative: sharp, unremitting R axillary pain; lymphadenopathy/swelling; This is a spontaneous report from a contactable physician, reporting for herself. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), intramuscularly at the right deltoid on 04Feb2021 12:30 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no other medications received within 2 weeks of vaccination. There were no known drug allergies. The patient previously received fist dose of BNT162B2 (lot number: EL3246), intramuscularly at the right arm on 14Jan2021 14:30 for COVID-19 immunization. On 05Feb2021 22:00, the patient developed sharp, unremitting right axillary pain and lymphadenopathy. She had a normal mammogram earlier this year and no injuries or other reasons to suspect this pain and swelling was due to anything other than a reaction to the 2nd COVID-19 vax. The patient was not worried nor upset, just wanted to pass along this information. No treatment was received. The outcome of the events was not recovered.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Ear discomfort, Ear disorder, Gait disturbance, Hypoacusis
Clinical narrative: ears plugged with fluid (cannot hear well); ears plugged with fluid (cannot hear well); ears plugged with fluid (cannot hear well); loss of balance; unstable walking around; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EN6201), via an unspecified route of administration, on 05Feb2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included diabetes, high blood pressure, pancreatic cancer in 2012 and fully recovered no treatment since 2013 and NED all scans have been clear. Concomitant medications included ondansetron (ZOFRAN), prochlorperazine (COMPAZINE SPANSULE), and oxycodone (OXYCODONE). The patient previously took Zocyn and experienced migraines (Allergies to medications, food, or other products: The antibiotic Zocyn causes migraines). On 06Feb2021 at 12:45 AM, the patient woke up in the middle of the night with ears plugged with fluid (cannot hear well) and had a loss of balance. He was unstable walking around. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if patient received treatment for the reported adverse events. Outcome of the events was not recovered. The patient assessed the events as non-serious.   No follow up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: extreme fatigue; feeling of faint; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) at the hospital, via an unspecified route of administration on 03Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization.  Medical history included 10 nerves killed in back lumbar region on an unknown date (reported as '5/02'). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (manufacturer unknown), gabapentin (manufacturer unknown) and tamsulosin hcl (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue and feeling of faint on 05Feb2021 at 07:00. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. The events were reported as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Hypersensitivity
Clinical narrative: allergies; allergy induced asthma; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for 2 patients. This is the first of two reports. A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension, Asthma, Allergies and allergy to penicillin.  Concomitant medication included varicella zoster vaccine rge (SHINGRIX), olmesartan (OLMESARTAN), nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide and triamterene (MAXZIDE).  It started several days after the vaccine. Patient have allergies and allergy induced asthma on 25Jan2021. It started slowly and became worse. Patient had to take allergy pills and double his steroid inhalent. Its the middle of winter and this never happens. No treatment was received. Outcome of the events was not recovered. The reporter considered the events non-serious.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021125841 Same reporter/product/event, different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my left arm to my middle and ring finger; Occasional thoracic spasms; chills; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELD26U, expiry date: unknown), via an unspecified route of administration in the left arm, on 05Feb2021 09:00, at single dose, for COVID-19 immunization, at a physician's office. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3303, expiry date: unknown) received at 57 years of age, via an unspecified route of administration in the left arm, on 15Jan2021 10:45, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 06Feb2021 at 10:00, the patient experienced "numbness and tingling down my left arm to my middle and ring finger and occasional thoracic spasms and chills". It was unknown if treatment was provided. The outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, via an unspecified route of administration, on 31Jan2021 12:00 pm at single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies. There are no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EL3248) on 10Jan2021 at 08:00 am on the left arm for COVID 19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications taken with 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, 48 hours after the second dose, it was reported that the patient had very painful arm, chills, and extreme fatigue. On an unspecified date, 8 days after the second dose, the patient had moderate prefrontal headaches and mild nausea. No treatment was received for the events. The events were considered as non-serious and the events did not result in death, life-threatening condition, hospitalization, disability or congenital anomaly. The patient was tested for COVID-19 since the vaccination on 02Feb2021 via nasal swab with a negative result. The patient was vaccinated in a hospital. The outcome of the events was reported as recovering.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: very painful arm; chills; extreme fatigue; Moderate prefrontal headaches; mild nausea; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), on the left arm, via an unspecified route of administration, on 31Jan2021 12:00 pm at single dose for COVID-19 immunization. Medical history was reported as none. The patient has no allergies. There are no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number: EL3248) on 10Jan2021 at 08:00 am on the left arm for COVID 19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications taken with 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date, 48 hours after the second dose, it was reported that the patient had very painful arm, chills, and extreme fatigue. On an unspecified date, 8 days after the second dose, the patient had moderate prefrontal headaches and mild nausea. No treatment was received for the events. The events were considered as non-serious and the events did not result in death, life-threatening condition, hospitalization, disability or congenital anomaly. The patient was tested for COVID-19 since the vaccination on 02Feb2021 via nasal swab with a negative result. The patient was vaccinated in a hospital. The outcome of the events was reported as recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Motion sickness, Nausea
Clinical narrative: Extreme dizziness; nausea; It felt like the worst motion sickness all day; Disorientation/Hard time with orientation; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the left arm on 04Feb2021 09:00 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 05Feb2021 09:00, the patient experienced extreme dizziness, nausea, it felt like the worst motion sickness all day, and disorientation/hard time with orientation. No treatment was given as a result of the events. Clinical outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Severe flu like symptoms; fatigue; muscle and joint pains; muscle and joint pains; headache; fever and chills; This is a spontaneous report from a contactable physician (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number LTM 2), via an unspecified route of administration (arm right) on 04Feb2021 00:00 (12 AM) at SINGLE DOSE for covid-19 immunisation, at 79 years old. Medical history included prostate cancer from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. No allergies to medications, food or other products. 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's concomitant medications were not reported. The patient experienced severe flu like symptoms; fatigue; muscle and joint pains; headache; and fever and chills on 04Feb2021. Treatment was not received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe flu like symptoms; fatigue; muscle and joint pains; muscle and joint pains; headache; fever and chills; This is a spontaneous report from a contactable physician (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number LTM 2), via an unspecified route of administration (arm right) on 04Feb2021 00:00 (12 AM) at SINGLE DOSE for covid-19 immunisation, at 79 years old. Medical history included prostate cancer from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. No allergies to medications, food or other products. 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's concomitant medications were not reported. The patient experienced severe flu like symptoms; fatigue; muscle and joint pains; headache; and fever and chills on 04Feb2021. Treatment was not received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: Headache; Low grade fever; Nausea; Diarrhea; Sore injection site; Dose 1 administration date:21Jan2021/ Dose 2 administration date:04Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL3248), via an unspecified route of administration on right arm on 04Feb2021 at 14:00 (at the age of 28years) at single dose for covid-19 immunization. Medical history included asthma. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and an unspecified multivitamin which were received within 2 weeks. Historical vaccine included first dose of bnt162b2 (lot: EL3248) on left arm on 21Jan2021 at 16:30 (at the age of 28years) for COVID-19 immunization. On 05Feb2021 at 12:00, the patient experienced headache, low grade fever, nausea, diarrhea, and sore injection site. No treatment was received for the adverse event. The events were considered by the patient as non-serious as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered at the workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events headache, pyrexia, nausea, diarrhoea and vaccination site pain was recovered in Feb2021.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Low grade fever; Nausea; Diarrhea; Sore injection site; Dose 1 administration date:21Jan2021/ Dose 2 administration date:04Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL3248), via an unspecified route of administration on right arm on 04Feb2021 at 14:00 (at the age of 28years) at single dose for covid-19 immunization. Medical history included asthma. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and an unspecified multivitamin which were received within 2 weeks. Historical vaccine included first dose of bnt162b2 (lot: EL3248) on left arm on 21Jan2021 at 16:30 (at the age of 28years) for COVID-19 immunization. On 05Feb2021 at 12:00, the patient experienced headache, low grade fever, nausea, diarrhea, and sore injection site. No treatment was received for the adverse event. The events were considered by the patient as non-serious as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered at the workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events headache, pyrexia, nausea, diarrhoea and vaccination site pain was recovered in Feb2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Sore at injection site; numbness to elbow; This is a spontaneous report from a contactable consumer.  A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: 10T EL 9262), via an unspecified route of administration on 05Feb2021 13:30 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included hypersensitivity allergies: Yes. Concomitant medications included ashwagandha, ascorbic acid (VIT C). On 06Feb2021 04:00, the patient experienced Sore at injection site and numbness to elbow. The patient did not receive treatment for the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 70-year-old female patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809), on the left arm, via an unspecified route of administration on 05Feb2021 17:45 (5:45 pm) at single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP) and  allergies to medications, food, or other products, both from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received an unspecified medication within 2 weeks of vaccination. On 05Feb2021, it was reported that the patient experienced pain in arm. No treatment was received. The event was considered as non-serious and it did not result in death, life threatening condition, hospitalization, disability, or congenital anomaly. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient was vaccinated in a school. The outcome of the event was reported as not recovered. The patient is not pregnant.