chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; injection site that was raised, red, itchy and warm; knot at her injection site; This is a spontaneous report from a non-contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9262, first dose (at the age of 40 years), intramuscular on 28Jan2021 at single dose for covid-19 immunisation.  COVID-19 vaccine was administered at hospital. The patient medical history and concomitant medications were not reported.  It was unknown if the patient was pregnant at the time of vaccination. On 29Jan2021 the patient experienced injection site that was raised, red, itchy and warm.  One week later she still had a knot at her injection site but it was getting smaller daily. It was unknown if treatment was received for the  events. The patient contacted per PCP and it was explained that it was secondary to the vaccine administration. It was recommended to receive the 2nd dose of the vaccine in the opposite arm. The events were non serious with outcome of recovering. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hot flush, Lymphadenopathy, Neck pain
Clinical narrative: Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered.   No follow-up attempts are possible. No further information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered.   No follow-up attempts are possible. No further information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at the injection site; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, benralizumab (FASENRA), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced itching at the injection site (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event for benralizumab was unknown. Caller was a consumer, asking if it was too soon after receiving benralizumab to get the covid vaccine.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: she woke up with a toothache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient woke up with a toothache on 09Feb2021, unrelated to vaccine, for which the dentist put her on clindamycin 150mg dosed 4 times daily. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the reported toothache is likely an intercurrent medical condition and unrelated to BNT162B2.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL926lt) via an unspecified route of administration in the left arm on 07Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. The patient did not have allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received infliximab (REMICADE) infusions from an unknown date for ulcerative colitis; and received the first dose of BNT162B2 (lot number El3247) in the left arm on 17Jan2021 at 12:00 (at the age of 44-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within the 4 weeks prior to the COVID vaccine. On 08Feb2021 at 00:15 the patient experienced chills, fever, body aches, dull headache, and vomiting. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The events of chills, fever, body aches, dull headache, and vomiting were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes left arm pit; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982) on 20Jan2021 at 15:00, in left arm, for COVID-19 immunisation. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products: no. Within 2 weeks of vaccination the patient was taking unspecified blood pressure/lipid medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 at 01:00 AM the patient experienced swollen lymph nodes left arm pit. The event required a physician office visit. No treatment was received. Since the vaccination the patient had been tested for COVID-19 (nasal swab was negative on 08Feb2021). The event was reported as non-serious and was resolving.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph node in armpit and another between armpit and elbow; Fever of 100 degrees; Deep muscle pain in small areas that lasted few seconds, moved from one part on body to another; Headaches; Congestion; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9269) via an unspecified route of administration on 05Feb2021 at 13:30 (at the age of 66-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and pre-hypertensive. The patient had COVID-19 prior to the vaccine on an unknown date. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included HCTZ and levothyroxine sodium (LEVOTHYROXIN) from unknown dates for unspecified indications. The patient previously took penicillin from an unknown date for an unknown indication and experienced allergy. On 05Feb2021 at 14:30 the patient experienced swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcomes of swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph node in armpit and another between armpit and elbow; Fever of 100 degrees; Deep muscle pain in small areas that lasted few seconds, moved from one part on body to another; Headaches; Congestion; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9269) via an unspecified route of administration on 05Feb2021 at 13:30 (at the age of 66-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and pre-hypertensive. The patient had COVID-19 prior to the vaccine on an unknown date. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included HCTZ and levothyroxine sodium (LEVOTHYROXIN) from unknown dates for unspecified indications. The patient previously took penicillin from an unknown date for an unknown indication and experienced allergy. On 05Feb2021 at 14:30 the patient experienced swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcomes of swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, Blood immunoglobulin G decreased, SARS-CoV-2 antibody test negative
Clinical narrative: have very low IgG (374); My concern is I did not make any antibody because I don't have any; This is a spontaneous report from a contactable physician (the patient).  This 73 year-old male patient received the first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose, the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose, both for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia.  The patient's concomitant medications were not reported. The patient reported, "I received both Pfizer vaccines 19 days apart, waited a month and got a spike protein antibody test. I have very low IgG (374), when I got my series of Hep B 3 injections I had 0 antibodies. He stated "I see now your vaccine is now effective with variants. My concern is I did not make any antibody, because I don't have any. My concern is my low IgG". The patient had lab tests and procedures in Feb2021 which included antibody test: negative, "I had 0 antibodies", blood immunoglobulin G: 374, very low. The clinical outcome of the events was unknown.   Information on the lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: small hives; rash on lower abdomen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration in the left arm on 10Jan2021 15:00 at a single dose for COVID-19 immunisation. There were no medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced small hives and rash on lower abdomen on 19Jan2021 08:00. Therapeutic measures were taken as a result of the events and included treatment with topical cream. Outcome of the events was recovering. The events were considered non-serious. The patient took the second dose of bnt162b2 (lot number: ENS318) in the right arm on 29Jan2021 15:00.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer.  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 31Jan2021 via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea on 04Feb2021. Event took place 4 days after injection. Not sure if food related. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from a non-contactable consumer. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 03Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis; osteoarthritis; and allergies to medications, food, or other products; all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam from an unknown date for osteoarthritis, which the patient had discontinued 2-3 days prior to immunization. The patient received the vaccine on 03Feb2021, the following day, 04Feb2021, the patient felt like she "got hit by a truck;" she complained of extreme joint pain, severe muscle pain, headache, chills and nausea. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The patient reported she gradually improved over the next 3-4 days and resolved. The clinical outcomes of extreme joint pain, severe muscle pain, headache, chills, and nausea were recovered in Feb2021. It was also reported the patient had not been tested for COVID-19 since vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache
Clinical narrative: Abdominal cramps/really bad cramps in my abdomen; a bit of a headache; This is a spontaneous report from a consumer. A 67-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EN9581, expiration date:31May2021) as first dose, on left arm, via an unspecified route of administration on 28Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included Kidney transplant recipient from 1995 and ongoing. There were no concomitant medications was not reported. This consumer reported that she was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine 28Jan2021 about 15:30. On 28Jan2021 about 19:30 she had onset of abdominal cramps. Patient also reported that she received the Pfizer shot yesterday at around 3:30, then at around 7:30 she experienced really bad cramps in her abdomen, along with a bit of a headache. She asked if that is one of the side effects of the Pfizer-BioNTech COVID-19 Vaccine. She was a little concerned because she heard that if you had a reaction or side effects to the first dose of the Pfizer-BioNTech COVID-19 Vaccine that they would be worse with the second dose. She had abdominal cramps all night long off and on. She reported outcome as ongoing but a little bit better. She did better if she just stays still. When she gets up and starts doing things the abdominal cramps occur more. She described the abdominal cramps as being kind of like menstrual cramps, which she has not had in a long time, but they are low like that in the abdomen; not like stomach cramps that are up higher. Usually with something like this kind of abdominal cramps she would have diarrhea but she was not having any diarrhea. The abdominal cramps are weird feeling. Outcome of the event abdominal cramps/really bad cramps in my abdomen was recovering and outcome of other event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: felt feverish and achy; felt feverish and achy; This is a spontaneous report from a non-contactable physician (patient, self-reported) via Pfizer sales representative. A patient of an unspecified age and gender, received second and first doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided); both were via an unspecified route of administration, on an unknown dates, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that received first dose of vaccine. 8 hrs later felt feverish and achy for about 8 hours. After second dose felt feverish and achy for 20 hrs. Outcome of the events was unknown.  No follow-up attempts are possible. Information regarding batch/lot number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm, on 05Feb2021 at 11:45 (at the age of 48-years-old) at a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included fingolimod hydrochloride (GILENYA), baclofen (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies and ibuprofen (MANUFACTURER UNKNOWN) and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and fatigue on 05Feb2021 and nausea, vomiting, headache, feeling feverish (no fever), and feeling beat up on 06Feb2021 at 13:30. The events were reported as non-serious. The clinical course was reported as follows: Within one to two hours (as reported), on and off, the patient felt dizziness and fatigue. After 26 hours (as reported), the patient felt nausea, vomiting, headache, fatigue, feeling feverish (no fever) and feeling beat up. The feeling beat up lasted 12-14 hours and the headache lasted 2 days. The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue, nausea, vomiting, and feeling feverish (no fever) was recovered on an unspecified date, feeling beat up was recovered on 07Feb2021, and headache was recovered on 08Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm, on 05Feb2021 at 11:45 (at the age of 48-years-old) at a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included fingolimod hydrochloride (GILENYA), baclofen (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies and ibuprofen (MANUFACTURER UNKNOWN) and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and fatigue on 05Feb2021 and nausea, vomiting, headache, feeling feverish (no fever), and feeling beat up on 06Feb2021 at 13:30. The events were reported as non-serious. The clinical course was reported as follows: Within one to two hours (as reported), on and off, the patient felt dizziness and fatigue. After 26 hours (as reported), the patient felt nausea, vomiting, headache, fatigue, feeling feverish (no fever) and feeling beat up. The feeling beat up lasted 12-14 hours and the headache lasted 2 days. The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue, nausea, vomiting, and feeling feverish (no fever) was recovered on an unspecified date, feeling beat up was recovered on 07Feb2021, and headache was recovered on 08Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after first dose of vaccine; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of two reports (the husband). An 8-decade-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 03Feb2021 the patient tested positive for covid after first dose of vaccine. The patient lab tests which included sars-cov-2 test: Positive on 03Feb2021. The consumer stated they were both tested for Covid on 01Feb2021 and found out they were positive for Covid on Wednesday.  The consumer stated they were due to get second vaccine "yesterday", but are confused about when to get it or if they can get it, stated the doctor told them they could get it but she was calling to see what Pfizer had to say, stated they are confused. The clinical outcome of tested positive for Covid after first dose of vaccine was unknown.  Information on the Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021137791 Same reporter/drug/AE and different patients.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Facial pain, Headache, Myalgia, Pyrexia
Clinical narrative: He has got a 100 fever; He got up this morning with a high fever; Very bad headache in his head and in the front of the head, it hurts a lot; The face, the top and the front is hurting a lot going through the eyes; sleeping a lot; bodyaches; This is a spontaneous report from a consumer (patient's father). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient's medical history included low potassium. Concomitant medication included potassium. On an unknown date, patient had got a 100 fever and very bad headache in his head and in the front of the head, it hurts a lot. And the face, the top and the front is hurting a lot going through the eyes. He has got fever and what I did is I gave him Tylenol treatment, patient also experiencing minor side effects such as sleeping a lot due to bodyaches from the second dose. The outcome of the event He has got a 100 fever; He got up this morning with a high fever was not recovered and unknown for the other events.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: He has got a 100 fever; He got up this morning with a high fever; Very bad headache in his head and in the front of the head, it hurts a lot; The face, the top and the front is hurting a lot going through the eyes; sleeping a lot; bodyaches; This is a spontaneous report from a consumer (patient's father). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. The patient's medical history included low potassium. Concomitant medication included potassium. On an unknown date, patient had got a 100 fever and very bad headache in his head and in the front of the head, it hurts a lot. And the face, the top and the front is hurting a lot going through the eyes. He has got fever and what I did is I gave him Tylenol treatment, patient also experiencing minor side effects such as sleeping a lot due to bodyaches from the second dose. The outcome of the event He has got a 100 fever; He got up this morning with a high fever was not recovered and unknown for the other events.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sinuses shut down yesterday; muscles hurt and legs hurt; muscles hurt and legs hurt; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; This is a spontaneous report from a contactable consumer reported for himself.  A 66-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9269 via unspecified route of administration at the left shoulder on 08Feb2021 11:00 AM (at the age of 66-years-old) for COVID-19 immunization. The patient received the vaccine at hospital. Medical history included a bypass surgeries (18 stents), a chronic obstructive pulmonary disease and he donated a kidney in 1997 and immunosuppressed. The patient had COVID at the end of December.Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81 mg, 1x/day, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 1x/day (200/25 one puff), sacubitril valsartan sodium hydrate (ENTRESTO) twice a day, fenofibrate 160 mg, 1x/day, isosorbide mononitrate (IMDUR) 120 mg, 2x/day, metolazone 5 mg, 1x/day, as needed, metoprolol 100 mg, 2x/day, famotidine (PEPCID) 40 mg, 2x/day, clopidogrel bisulfate (PLAVIX) 75 mg, 1x/day, potassium (POTASSIUM) as needed,  10mEq, evolocumab (REPATHA) 140 mg, biweekly, ranolazine (RANEXA) 1000 mg, 2x/day, montelukast sodium (SINGULAIR) 10 mg, 1x/day, torasemide as needed(40mg up to 160mg ), colecalciferol (VITAMIN D [COLECALCIFEROL]) 50,000 units once a week, nitroglycerin. On 08Feb2021 about midnight, he woke up and had shortness of breath and chest pain, he took 6mg Nitro and he took two at midnight; He took another one at 1:00AM and it had pretty much gone away. Around 2:30AM the chest pain hit again big time, he woke up on morning and felt awful. On 08Feb2021 his muscles hurt and legs hurt. He was mainly fighting fatigue now and feeling rough. His sinuses shut down on unknown date. The patient recovering from muscles hurt and legs hurt and recovered from chest pain. The outcome of the other adverse events was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sinus disorder
Clinical narrative: He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sinuses shut down yesterday; muscles hurt and legs hurt; muscles hurt and legs hurt; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; This is a spontaneous report from a contactable consumer reported for himself.  A 66-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9269 via unspecified route of administration at the left shoulder on 08Feb2021 11:00 AM (at the age of 66-years-old) for COVID-19 immunization. The patient received the vaccine at hospital. Medical history included a bypass surgeries (18 stents), a chronic obstructive pulmonary disease and he donated a kidney in 1997 and immunosuppressed. The patient had COVID at the end of December.Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81 mg, 1x/day, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 1x/day (200/25 one puff), sacubitril valsartan sodium hydrate (ENTRESTO) twice a day, fenofibrate 160 mg, 1x/day, isosorbide mononitrate (IMDUR) 120 mg, 2x/day, metolazone 5 mg, 1x/day, as needed, metoprolol 100 mg, 2x/day, famotidine (PEPCID) 40 mg, 2x/day, clopidogrel bisulfate (PLAVIX) 75 mg, 1x/day, potassium (POTASSIUM) as needed,  10mEq, evolocumab (REPATHA) 140 mg, biweekly, ranolazine (RANEXA) 1000 mg, 2x/day, montelukast sodium (SINGULAIR) 10 mg, 1x/day, torasemide as needed(40mg up to 160mg ), colecalciferol (VITAMIN D [COLECALCIFEROL]) 50,000 units once a week, nitroglycerin. On 08Feb2021 about midnight, he woke up and had shortness of breath and chest pain, he took 6mg Nitro and he took two at midnight; He took another one at 1:00AM and it had pretty much gone away. Around 2:30AM the chest pain hit again big time, he woke up on morning and felt awful. On 08Feb2021 his muscles hurt and legs hurt. He was mainly fighting fatigue now and feeling rough. His sinuses shut down on unknown date. The patient recovering from muscles hurt and legs hurt and recovered from chest pain. The outcome of the other adverse events was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Loss of consciousness, Pyrexia
Clinical narrative: Passed Out; upset stomach; Dry heaving; Stomach Cramps; Chills; Fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (lot number unknown), via an unspecified route of administration, at Left arm, on 05Feb2021 16:15 at SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The patient experienced woke up out of her sleep, upset stomach. Dry heaving. Stomach Cramps. Chills. Fever. Passed Out. Adverse event started on 06Feb2021 12:00 AM. No treatment AE. The outcome of the event was recovered in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Passed Out; upset stomach; Dry heaving; Stomach Cramps; Chills; Fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (lot number unknown), via an unspecified route of administration, at Left arm, on 05Feb2021 16:15 at SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The patient experienced woke up out of her sleep, upset stomach. Dry heaving. Stomach Cramps. Chills. Fever. Passed Out. Adverse event started on 06Feb2021 12:00 AM. No treatment AE. The outcome of the event was recovered in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: nausea; vomiting; headache; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (not pregnant, occupation: pharmacist) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced nausea, vomiting and headache on an unspecified date. It was unknown if treatment received for the adverse events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Rash papular, Vaccination site mass
Clinical narrative: Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it feels like kind of sore when I touch it; She is getting red bumps today on the part where she got injected; Sore arm; I get this pain in my pointer finger in my right hand; A little weakness in my right leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 75-years-old) as a single dose for covid-19 immunisation. Medical history included high blood pressure, osteoporosis and overactive bladder. The patient concomitant medications were not reported. The previously had first dose (first shot) of BNT162B2 for covid-19 immunisation and had sore arm. It was reported that she is getting red bumps today (on 07Feb2021) on the part where she got injected. The consumer stated after second shot also, I had no symptoms except for sore arm on an unspecified date in Feb2021. The only thing that I noticed which was from second shot and which was really crazy is, once in a while I get this pain in my pointer finger in my right hand and that was it, it comes and it goes. But today, and in the last couple of days I noticed a little weakness in my right leg, but today when I went to work somebody said what is that big red bump on your forehead and I looked and there was a big red circle, there was a bump, like a real bump on my forehead. I didn't hide it, I didn't even think if it was allergic as I only had a banana before I went to work and a cup of coffee which I have lot of time. I am wondering if this bump that I have on my forehead which looks ridiculous and it is a big red bump, like a tumor bump, it feels like kind of sore when I touch it, is from the vaccine because I haven't had anything but the vaccine." Consumer stated, "Main thing I am concerned about is the big red bump on my forehead." Treatment: Consumer stated, "I never had that before, it is very slight. The main thing was the bump on my head that came today and I didn't have it when I left the house. I didn't hit my head or anything. I just took two Tylenol and an allergy pill in case if it was some kind of allergy." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: chills; body aches; presumed fever; This is an initial spontaneous report from a contactable consumer. A 26-year-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot: unknown), via an unspecified route of administration on 13Jan2021 at single dose for an Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose on 22Dec2020 for Covid-19 immunisation. The patient stated eleven hours after dose, person woke up with chills, body aches, and presumed fever (temp not taken at that time). Continued throughout the day. Next morning, temp taken by person and was 99. Still slightly chilled at the time. Estimating adverse event start date as not sure if it was on 13 or 14Jan. Only that adverse events started 11 hours after dose. The patient underwent lab tests and procedures which included body temperature: 99 on. The outcome of the events for chills and presumed fever was not recovered and for body aches was recovered on an unspecified date of 2021.  Information about Lot/Batch has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Eye pain, Gait disturbance, Headache
Clinical narrative: became completely disoriented; felt drained of all energy; could barely walk/unable to walk much; had a heavy pain behind my left eye; heavy headache; couldn't relax or think; couldn't relax or think; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318) via an unspecified route of administration in left arm on 06Feb2021 09:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, chronic kidney disease. The patient had no known allergies. Concomitant medication included amlodipine, lisinopril, pantoprazole, multi Vitam. No other vaccine was received in four weeks. No Covid prior vaccination. No covid tested post vaccination. The patient thought he had a 72 hour delay reaction to the vaccine. Tuesday on 09Feb2021, about midmorning 10:00 AM, he felt drained of all energy, could barely walk, had a heavy pain behind her left eye and a heavy headache, and became completely disoriented and unable to walk much. He couldn't relax or think. Then overnight it all went away. No treatment was received for events. The outcome of events was recovered on 10Feb2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Psychomotor hyperactivity, Thinking abnormal
Clinical narrative: became completely disoriented; felt drained of all energy; could barely walk/unable to walk much; had a heavy pain behind my left eye; heavy headache; couldn't relax or think; couldn't relax or think; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318) via an unspecified route of administration in left arm on 06Feb2021 09:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, chronic kidney disease. The patient had no known allergies. Concomitant medication included amlodipine, lisinopril, pantoprazole, multi Vitam. No other vaccine was received in four weeks. No Covid prior vaccination. No covid tested post vaccination. The patient thought he had a 72 hour delay reaction to the vaccine. Tuesday on 09Feb2021, about midmorning 10:00 AM, he felt drained of all energy, could barely walk, had a heavy pain behind her left eye and a heavy headache, and became completely disoriented and unable to walk much. He couldn't relax or think. Then overnight it all went away. No treatment was received for events. The outcome of events was recovered on 10Feb2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the Lot/Batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the Lot/Batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Chills; fever 100.4; joint pain; mild headache; This is a spontaneous report from a contactable consumer for himself. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 09Feb2021 11:45 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included arthritis from an unknown date and unknown if ongoing. The patient had casein and dairy allergy. The patient's concomitant medications included Levothyroxine sodium (Levothyroxine), Amlodipine, Metoprolol and Omeprozole. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 19Jan2021 11:45 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. On 09Feb2021 20:00 the patient experienced chills, fever 100.4, joint pain and mild headache. The events were assessed as non-serious by the reporter. The patient received Advil and Tylenol as treatment medications. The outcome of the event was recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got his first shot a couple weeks ago and then after that he Covid tested positive; Got his first shot a couple weeks ago and then after that he Covid tested positive; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 reported as Pfizer Covid-19 Vaccine; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got his first shot a couple weeks ago (unspecified date) and then after that he tested Covid positive on unspecified date. He would like to know if he could still take his second dose as his quarantine will end tomorrow (09Feb2021). The outcome of the events was unknown.  Information on the lot/batch number has been requested.