chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Investigation, Vitamin D decreased, Wrong technique in product usage process
Clinical narrative: Person who administered took three separate vials that were almost empty and put the needle in and took to the bottom of whatever there was in each vial out and gave him the vaccine; Vitamin D was 25, a bit low; This is a spontaneous report from a contactable nurse. A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982) via unknown route of administration on 27Jan2021 at single dose in left arm for COVID-19 immunization at hospital. Medical history included high cholesterol and blood pressure high both are ongoing. Concomitant medication included amlodipine at 5 mg for blood pressure high, atorvastatin at 20 mg for high cholesterol. The patient previously took first dose (at 60-year-old age) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 for COVID-19 immunization. It was stated, "So my husband went to get his second dose of Pfizer COVID-19 Vaccine today and the person who administered it took three separate vials that were almost empty and put the needle in and took to the bottom of whatever there was in each vial out, three different vials and gave him the vaccine. Further stated, "Yes, he had a CBC and I think it went well and the only thing that was his Vitamin D was 25, a bit low in 2021 other than that everything is normal." The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Decreased appetite, Headache
Clinical narrative: Allergic reaction; no energy; no appetite; he is not feeling good at all; has been in bed all day; fever; splitting headache; Pfizer COVID-19 vaccine made him sick as hell; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot: Number: EN5318, Expiration Date: May2021, NDC: Unknown) via an unspecified route of administration from 04Feb2021 14:24 at single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Historical vaccine included unspecified flu vaccine 2-3 months ago and patient received made him sick as hell, zero energy and losing weight. The reporter stated that Pfizer COVID-19 vaccine made him sick as hell: Consumer says he got his first dose of the COVID-19 vaccine yesterday at 02:24 PM and had an allergic reaction to it, he is not feeling good at all and he has never been allergic to anything before. COVID-19 vaccine NDC: Unknown, this was not provided on his handwritten vaccine card. Caller says he also had the flu vaccine 2-3 months ago and the flu vaccine also made him sick as hell, the same thing happened. unspecified flu vaccine NDC/LOT/EXP: Unknown. Caller says that his allergic reaction is that he has no energy and no appetite. He says after the flu vaccine he had zero energy and ended up losing weight. He says he has felt like this again since getting COVID-19 vaccine yesterday and has been in bed all day. He says he had a fever this morning and a splitting headache. He says his fever temperature was unknown, he had done no treatment for that, he laid in bed all day, and he has done no treatment for the headache either, though he is thinking about taking some Tylenol in a minute. He says he wants to get better and he might need to call his doctor for information about what to do to get better, he just wanted to see if Pfizer could provide any solutions for him. The clinical outcome of the events was reported as unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Malaise, Pyrexia
Clinical narrative: Allergic reaction; no energy; no appetite; he is not feeling good at all; has been in bed all day; fever; splitting headache; Pfizer COVID-19 vaccine made him sick as hell; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot: Number: EN5318, Expiration Date: May2021, NDC: Unknown) via an unspecified route of administration from 04Feb2021 14:24 at single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Historical vaccine included unspecified flu vaccine 2-3 months ago and patient received made him sick as hell, zero energy and losing weight. The reporter stated that Pfizer COVID-19 vaccine made him sick as hell: Consumer says he got his first dose of the COVID-19 vaccine yesterday at 02:24 PM and had an allergic reaction to it, he is not feeling good at all and he has never been allergic to anything before. COVID-19 vaccine NDC: Unknown, this was not provided on his handwritten vaccine card. Caller says he also had the flu vaccine 2-3 months ago and the flu vaccine also made him sick as hell, the same thing happened. unspecified flu vaccine NDC/LOT/EXP: Unknown. Caller says that his allergic reaction is that he has no energy and no appetite. He says after the flu vaccine he had zero energy and ended up losing weight. He says he has felt like this again since getting COVID-19 vaccine yesterday and has been in bed all day. He says he had a fever this morning and a splitting headache. He says his fever temperature was unknown, he had done no treatment for that, he laid in bed all day, and he has done no treatment for the headache either, though he is thinking about taking some Tylenol in a minute. He says he wants to get better and he might need to call his doctor for information about what to do to get better, he just wanted to see if Pfizer could provide any solutions for him. The clinical outcome of the events was reported as unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (Lot Number: EL3248), via an unspecified route of administration in left arm, on 02Feb2021 at 07:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 at 11:00 PM (23:00), the patient experienced headache, chills, body aches, and sore arm. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Headache, Limb discomfort, Muscle tightness, Myalgia
Clinical narrative: Muscle ache in left arm/soreness in left arm; heaviness in left arm; headache off and on on right side,brain hurt in the back left side of head; muscle tension in left side of neck; 2 boil in buttocks; This is a spontaneous report from a contactable healthcare professional (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), intramuscular at the left arm on 29Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included high cholesterol, obesity and arthritis. 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 was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 03Feb2021 03:00, the patient experienced muscle ache in left arm, heaviness in left arm, soreness in left arm, headache off and on on right side, brain hurt in the back left side of head, muscle tension in left side of neck and 2 boil in buttocks. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Muscle ache in left arm/soreness in left arm; heaviness in left arm; headache off and on on right side,brain hurt in the back left side of head; muscle tension in left side of neck; 2 boil in buttocks; This is a spontaneous report from a contactable healthcare professional (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), intramuscular at the left arm on 29Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included high cholesterol, obesity and arthritis. 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 was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 03Feb2021 03:00, the patient experienced muscle ache in left arm, heaviness in left arm, soreness in left arm, headache off and on on right side, brain hurt in the back left side of head, muscle tension in left side of neck and 2 boil in buttocks. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The next day injection site was sore.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) Lot number EL9265, via an unspecified route of administration on 31Jan2021 11:30 (at the age of 46 years old) as a SINGLE DOSE for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing.  Concomitant medication included amlodipine, montelukast sodium, fluticasone propionate, salmeterol xinafoate (ADVAIR) 500/50.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccination was administered in a hospital. The patient experienced the next day injection site was sore on 01Feb2021.  The patient did not receive treatment. Outcome of event was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid in between first and second dose; positive for Covid/ PCR and it tested positive; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EX9231 and expiry date: unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid in between first and second dose on 2021. The physician told the patient to go for a test that day. The first test was a rapid test and it tested negative and the second test was PCR and it tested positive on 2021. So, physician said that patient was positive for Covid. Patient had no reaction, was fine and was doing okay. This coming Thursday, 11Feb2021, patient was scheduled to go for the second shot but she can't go because her husband was sick. She cancelled the appointment but wanted to know how soon will she be able to go get the second shot if she needs the second shot. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: dental emergency; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was reporting on behalf of her husband. After receiving their first shot of the Pfizer vaccine, her husband (patient) now had a dental emergency for which the dentist had requested he took antibiotics; clarithromycin (BIAXIN), in order to extract a tooth. Outcome of event was unknown.    Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness for 48hrs at vaccination site; This is a spontaneous report received from a contactable nurse (patient). A 37-year-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: EL3247), via an unspecified route of administration on left arm on 04Feb2021 12:30 at single dose for COVID-19 immunisation at workplace clinic. The patient medical history included known allergies with Sulfa drugs and Dust mites. The patient concomitant medications included daily multivitamin (unspecified) received within two weeks of vaccination. The patient was not received other vaccine in four weeks. On 04Feb2021 18:00, the patient experienced soreness for 48hrs at vaccination site. No treatment was received for the event. The patient not had COVID prior vaccination. The patient not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid/ headache, fever, chills; This is a spontaneous report from a Pfizer sponsored program. Contactable consumer (patient's daughter) reported similar events for two patients. This is the first of two reports. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was contacting Pfizer for her father, 57-year-old male. He got 1st dose on 18Jan2021, on the 31Jan2021 he got a few symptom: Headache, fever, chills. On 01Feb2021, father tested positive for Covid. On 07Feb2021 repeat Covid test was negative. They were asking if he can get his 2nd dose today or should he wait? Her father tested positive for the COVID virus. Her father only had symptoms for one day. She stated that on 31Jan2021, her father had a headache and a few chills, but that was about it. On 01Feb2021, her father went and got tested for COVID and it was positive. Her father stayed home and quarantined, and then on 07Feb2021, he went back to repeat the test and it came back negative. Caller states that today, her father is supposed to get the second round of the vaccine, but he does not know if he can get it today since he just had COVID last week, or if he should wait. Her dad received his first 1st dose on 18Jan and 2nd dose is scheduled today 08Feb. Last 31Jan, her dad had fever and little chills and on the 01Feb her dad tested positive. The daughter is asking if her dad can get the 2nd dose today even though he tested positive before. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136628 same reporter/ drug, similar event, different patient.;US-PFIZER INC-2021136628 same reporter and drug, different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19
Clinical narrative: they got the virus; is still weak; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information Team. This consumer reported similar events for two patients. This is the first of two reports.  An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included leukaemia. The patient's concomitant medications were not reported. The reporter reported that her parents received the first dose of bnt162b2 vaccine. Then, after a week, they got the virus on an unspecified date. The reporter said that they got it from the doctor's office. The reporter also mentioned that her parents are still recovering and are still on quarantine. The reporter also mentioned that her father who has leukemia, was still weak and was under hospice care on an unspecified date. The reporter wanted to know if they should still receive the 2nd dose of the vaccine. The reporter was also concerned because they were scheduled to receive the 2nd dose 3 days earlier than the recommended 3-week-interval, and wanted to know if that was acceptable. The patient was recovering from all the events.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170461 same reporter/drug, similar event, different patient
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (self-reported) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, expiry date unknown), via an unspecified route of administration, in arm left, on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history included Obesity and difficult time metabolizing medications. Family history included her daughter and grand daughter have EDS. She would probably be the genetic carrier. The patient concomitant medication included ongoing esomeprazole sodium (NEXIUM) and she has been on it about 2years, ongoing valsartan and she has been on it about 2 years. It was reported that the patient had experienced Tiredness, headache, muscle pain, joint pain, nausea and feeling unwell; all events on 07Feb2021, and everything is ongoing. The outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (self-reported) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, expiry date unknown), via an unspecified route of administration, in arm left, on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history included Obesity and difficult time metabolizing medications. Family history included her daughter and grand daughter have EDS. She would probably be the genetic carrier. The patient concomitant medication included ongoing esomeprazole sodium (NEXIUM) and she has been on it about 2years, ongoing valsartan and she has been on it about 2 years. It was reported that the patient had experienced Tiredness, headache, muscle pain, joint pain, nausea and feeling unwell; all events on 07Feb2021, and everything is ongoing. The outcome of the events was not recovered.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Chills, Drug ineffective
Clinical narrative: he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Product use issue
Clinical narrative: Slight muscle ache in arm; Other vaccine same date vaccine; Other vaccine same date vaccine; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via unspecified route of administration in the left arm on 05Feb2021 at 15:45 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included sulfa allergy from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medications included ascorbic acid (VITA C), ergocalciferol (VITA D), biotin, fexofenadine hydrochloride (ALLERFEX), magnesium, and glucosamine hydrochloride (GLOCOSAMIN), all from unknown dates for unknown indications. The patient did not receive any other vaccines in the four weeks prior to the COVID vaccine. On 05Feb2021 at 22:00 the patient experienced slight muscle ache in arm during the first night; and on 05Feb2021 the patient experienced other vaccine same date vaccine. No treatment was provided for the events. The clinical outcome of slight muscle ache in arm was recovered in Feb2021; the clinical outcomes of other vaccine same date vaccine were recovered on 05Feb2021. It was also reported the patient was not COVID tested post vaccination.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: The next day got a nose bleed that lasted for 2 days.; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 at 10:00 (at the age of 78 years) in right arm at single dose for covid-19 immunisation.  No other vaccine given in four weeks. No covid prior vaccination and no covid tested post vaccination. Not Known allergies. Medical history included Heart trouble, cancer (cancer survivor), high blood pressure, Alzheimer, bleeding ulcer, chronic obstructive pulmonary disease.  Concomitant medication included lisinopril, isosorbide mononitrate, metoprolol tartrate.  On 06Feb2021 at 16:00 the patient experienced a nose bleed that lasted for 2 days.  No treatment was given. The event was non-serious with outcome of resolved. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19; tested positive for covid-19; This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program Pfizer First Connect and medical information. A 6-decade-old (reported as in her late 50's) female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH 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 pharmacist reported that they had a patient who works in a long-term care facility (nursing facility reporting). The reporter stated that she has a nurse patient reporting she had first dose on an unspecified date and then tested positive for COVID-19 on an unspecified date. The reporter mentioned that the patient is scheduled to receive the second dose on 18Feb2021. The pharmacist inquired if the patient should receive the second dose on 18Feb2021 or if it should be delayed. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient received the Pfizer COVID-19 vaccine/got the COVID infection; patient received the Pfizer COVID-19 vaccine/got the COVID infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer COVID-19 vaccine on an unspecified date and she and her husband both got the COVID infection on an unspecified date. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: Swollen, Tender Armpit lymph node on the same arm as injection site; Hives; This is a spontaneous report from a contactable other hcp (patient).   This 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL1283), intramuscular at single dose in the left arm on 20Jan2021 09:45 for COVID-19 immunisation. Medical history included Penicillin allergy.  Concomitant medications were not reported. On 01Feb2021, the patient experienced swollen, tender armpit lymph node on the same arm as injection site with outcome of not recovered (as reported), hives with outcome of not recovered (as reported). Treatment was required and included Benadryl and Cortisone cream for hives. The events were described as follows: "Swollen, tender armpit lymph node on the same arm as injection site, noticed a week after injection and resolved 10 days post injection. Hives reaction approx 2 weeks post injection, has continued 3 days". The events required a visit to the physician's office. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: She has since tested positive for Covid after the first dose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration (left arm) on 03Feb2021 17:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies to sulfa from an unknown date. Patient is not pregnant during vaccination. Patient did not have COVID prior vaccination.  Concomitant medication included escitalopram oxalate (LEXAPRO), therapy date and indication unspecified (other medications in two weeks). No other vaccine in four weeks. The patient experienced she has since tested positive for COVID after the first dose, on 08Feb2021 16:00 via Nasal swab (also reported as 04Feb2021 and 07Feb2021). No treatment given. She was asking if she should get the second dose. Outcome of the event was reported as recovering. Reporter considered the event was non-serious.  Information on the lot/ batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore right arm; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers (including the patient) reported that an 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176, expiration date: Mar2021) intramuscular on the right arm on 21Jan2021 14:00 at 0.3 mL, single for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. She had the first shot. She was going for the second shot on Thursday. She had a sore right arm on Jan2021, so she took ibuprofen (ADVIL) and she was hoping she did not ruin the fact that she had the first shot. The Advil took the soreness away and she has not had any problems since. The soreness started late in the evening when she went to bed around 11:30 or 12 and that was when she took Advil. The sore arm recovered the next day. She heard rumors from people that people should not take Advil or Tylenol after receiving the shot. She asks if this was true. She is asking if she can take Advil for her second dose. The events did not require a visit to physician office or Emergency Room. The facility where the vaccine was administered was in a convention center. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovered on an unspecified date in Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Had a patient who got vaccinated and was tested with # SARS COVID 2 Semi quantitative Total antibody test and come out negative; This is a spontaneous report from a contactable Physician. A patient of unspecified gender and age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unknown date, single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient got vaccinated and was tested with # SARS COVID 2 Semi quantitative Total antibody test and come out negative. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 test, Serology test
Clinical narrative: had no antibodies, serology showed no antibodies/a faint line of IgG but no IgM antibodies with reference to a control; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration first dose on 30Dec2020 and second dose on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. One month after first vaccine dose and 2 weeks after second dose the patient still has no antibodies, serology showed no antibodies. Has a question about the Pfizer Covid vaccine. HCP received her 1st vaccine dose on 30Dec2020. 3 weeks later she received her 2nd vaccine dose. Lab results per HCP: "SARS- COV-2(Covid 19) AB total IGG/IGM/IGA your sample does not contain any antibodies." She needed to know what to do next. The patient got the first dose of vaccine 30Dec2020 and second dose was 3 weeks later and now one month after 1st dose, 2 weeks after 2nd dose (Feb2021), still no anti-bodies per serology test. She wanted to volunteer to give vaccinations but wanted to ensure she's fully covered before she does. She received the first dose of the vaccine on 30Dec2021 and the second dose on 20Jan2021. She had no reaction after either injection, which she realized can be normal. She had a covid-19 finger stick drug store test for antibodies through (Name), not designed for the vaccine, but to show IGG/IGM antibodies. This was done 2 weeks after the second vaccine. There was a faint line of IgG but no IgM antibodies with reference to a control. The internist ordered a serology blood draw for SARS-COV-2 antibodies which she had done through (Name) and this did not contain detectable SAR-COV-2. She stated she is not immunosuppressed so it seemed it must be a problem with the vaccine or the process. She stated she got a response (from "the local analogy of Dr. (Name)") stating that the (Name) test that was ordered tests for nucleocapsid protein but not caps protein so the test would not be useful to test for the vaccine. She wants to volunteer to give the vaccine, but she does not know if she was adequately covered. She asked how she knows if she needs another dose and asked what the next steps are. She needs evidence-based information to be able to determine if she needs another dose. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Little headache; Tiredness; Couldn't exercise; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for immunization. Relevant medical history was unknown. Concomitant medications included raloxifene hydrochloride (EVISTA) and rosuvastatin calcium (CRESTOR). On an unspecified date, the patient experienced a little headache, tiredness and she couldn't exercise. Clinical outcome of the events was unknown at time of this report.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: injection site soreness and pain; fever of 104; muscle aches; This is a spontaneous report from a contactable consumer (patients wife).  A 70-years-old male patient received bnt162b2 (BNT162B2) , via  an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The reporter reports her husband received the second dose on 26Jan2021. Her husband didn't experience any symptoms except injection site soreness and pain. On Saturday, (30jan2021) her husband began to have a fever of 104 and muscle aches. She gave her husband Tylenol for his fever and it helped. Her husband went to have a rapid COVID test and it came back negative. She  would like to know if it is possible for her husband to be having a delayed reaction to the vaccine. The outcome of the event of fever was recovered , the remaining events was not reported.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer vaccine and has now tested positive for Covid after this dose; received the first dose of the Pfizer vaccine and has now tested positive for Covid after this dose; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information Team. A 73-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that the patient received the first dose of the Pfizer vaccine and has now tested positive for COVID after this dose on an unspecified date. He was scheduled to get the second dose on 12Feb2021 and she (reporter) wanted to know if it was ok for him to proceed with the second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm, via an unspecified route of administration on 29Dec2020 15:45 at single dose (lot number: FH9899), then received the second dose on the left arm, via an unspecified route of administration on 19Jan2021 15:45 at single dose (lot number: EL3302) for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. There were no other vaccines in 4 weeks and no other medications in two weeks. The patient started having flu like symptoms on 07Feb2021. She went to the clinic. She tested positive for Covid on rapid test. They took 2nd swab and sent to lab. It's positive too. She had temp 99 even after Tylenol. Headache, chills, running nose, sneezing, and body aches. She just thought you all should know. She doesn't know if the lab tested for other strains. The adverse event started on 07Feb2021 07:00. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The patient had no Covid prior to vaccination and was Covid tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: Vomiting; Diarrhea; Sweating and shivering all night; Sweating and shivering all night; This is a spontaneous report from a contactable consumer (patient).   A 67-year-old female patient received the second dose of received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL1283) in the left arm, at single dose, on 03Feb2021 at 07:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included hypertension. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. The patient previously, on 12Jan2021, at 07:00 AM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK9231) in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol, simvastatin, telmisartan and buspirone hydrochloride (BUSPAR). On 05Feb2021, at 10:00 PM, the patient experienced vomiting and diarrhea, sweating and shivering all night. Post the vaccination, the patient has not been tested for COVID-19. No treatment was received. The patient recovered from the events on an unspecified date.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Gastrooesophageal reflux disease, Nausea
Clinical narrative: Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous report receive from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EL9626) via an unspecified route of administration on the left arm on 28Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included ongoing Reflux. Concomitant medication included esomeprazole sodium (NEXIUM). Patient previously took BNT162B2 on 07Jan2021. On 28Jan2021 20:00 the patient experienced slightly nauseous, slightly dizzy, thinks it activated her reflux and clogged up. Seriousness was reported as non-serious. Outcome of events was recovering.  No follow-up attempts are possible. No further information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pyrexia, Sneezing
Clinical narrative: He has a lingering cough; Chills; Sneezing; Fatigue; fever; This is a spontaneous report received from a contactable nurse. A 67-year-old male patient (Husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included patient considers it to be an actual heart attack. The doctor put a stent in but they think the pain was coming from muscle spasm because the widow maker was blocked. That was in the fall of 2014. He has cholesterol medication. He has medication for high blood pressure and it is controlled with medication. Concomitant medication was not reported. They were vaccinated on 15Jan2021 with first dose. The Wednesday after which was about 5 days after the vaccine her husband got chills, sneezing and fatigue. He didn't call the doctor and didn't get tested. About a week later her son had nasal congestion and cough. This is the third day for that. Called her son's doctor since this is the second person in the house to have symptoms. He had COVID test and it came back positive. Maybe he will develop a fever down the line. She is at a quandary. She has to quarantine in case it is. A week in between her husband and son and it is hard to believe. It should have been her to get it worse since she sleeps with her husband. She and her husband have not been tested for COVID. Only her son was COVID tested. Her husband's chills, fever, and fatigue started on 20Jan2021. They have stayed home. Occasionally he will still sneeze. Then caller clarified that the night before 20Jan2021 her husband had chills and was tired. He went back to sleep and that was unusual. He had enough fatigue he had to rest more. He went to bed early. Outcome of events was unknown.  No follow-up attempts are possible. No further information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19; after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for three patients. This is the third of three reports.   The mother reported that the patient (her second child) of unspecified age and gender 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 an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after administering the first dose of COVID-19 vaccine, the patient was diagnosed with COVID-19 on an unspecified date. The patient was administered monoclonal infusion as treatment. The mother asked if the patient can still get the second dose of the COVID-19 vaccine as scheduled. The outcome of the events was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130061 same reporter/ vaccine, different patient, similar event;US-PFIZER INC-2021133627 same reporter/ vaccine, different patient, similar event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (mother). The consumer reported similar events for three patients. This is the 2nd of 3 reports.   The mother reported that the patient (first child) of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that after administering the first dose of COVID-19 vaccine, patient was diagnosed with COVID-19. The patient was administered Eli Lilly monoclonal infusion and the mother asked if the patient can still get second dose of COVID-19 vaccine as scheduled. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021133622 same reporter/ vaccine, different patient, similar event;US-PFIZER INC-2021130061 same reporter/ vaccine, different patient, similar event