chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: woke up hurting all over; This case was reported by a consumer and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unspecified date).   On 8th December 2020, the patient received the 2nd dose of Shingrix. On 9th December 2020, 1 days after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and woke up hurting all over and no problem with the first dose.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash, Vaccine positive rechallenge
Clinical narrative: blisters all over his entire body. which are painful.; blisters all over his entire body. which are painful.; This case was reported by a consumer and described the occurrence of blister in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (received 1st dose in september 2020, refer case US2020244427).   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced blister and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the blister and pain were unknown.   It was unknown if the reporter considered the blister and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and breaking out in blisters all over entire body which are painful.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244427:same reporter
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel terrible; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix shot and a flu shot at the same time and feel terrible.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever; Weakness; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and weakness. On an unknown date, the outcome of the fever and weakness were unknown.   It was unknown if the reporter considered the fever and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever and weakness. The reporter asked how long did the fever and weakness last after the 2nd Shingrix shots.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; arm pain; feeling bad; This case was reported by a nurse and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR246222).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain in arm and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, pain in arm and feeling bad were unknown.   It was unknown if the reporter considered the fever, pain in arm and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm pain, fever and feeling bad for 3 days. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR246222:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: became nauseous; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the dose and became nauseous.  The patient asked was there any advice to minimize this side effect and he or she was scheduled to get the second dose soon.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I may have a blood clot in my leg.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 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 got the first dose of the vaccine on 20Jan2021 and is going to visit his doctor because they think that he may have a blood clot on his leg on an unspecified date. He wanted to know if it was okay if they give him a shot of something like contrast to see the ultrasound. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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 expiration date were not reported) in Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient had contracted shingles. The outcome of the event, shingles, was unknown. The patient would like to know if she should receive the second dose of vaccination.  Information about batch/lot number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue, Vaccination site pain
Clinical narrative: experiencing some arm pain where the injection was given; This was supposed to be under 70 Degrees Fahrenheit. They were keeping it out side and giving the injection; This was supposed to be under 70 Degrees Fahrenheit. They were keeping it out side and giving the injection; This is a spontaneous report from a contactable consumer (consumer). A 79-year-old male patient received first dose of BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This patient reports receiving his first injection of the Pfizer-BioNTech COVID-19 vaccine and experiencing some arm pain where the injection was given. Also he just noticed that when the nurse was going to give it to him that she had the syringe with the vaccine in it in her hand. She talked to him several minutes before administering. He thought this was supposed to be under 70 Degrees Fahrenheit. They were keeping it outside and giving the injection. He doesn't understand why they had it out in the weather. It was kind of warm in the state. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site extravasation, Wrong technique in product usage process
Clinical narrative: did not get enough dose of the vaccine; not administered to her properly because as soon as the syringe from her deltoid, a big gush of blood came out; was not administered to me properly because as soon as she took the needle out, a bunch of blood just ran down my arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 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 was given the vaccine yesterday and she was afraid that it was not administered to her properly because as soon as the syringe from her deltoid, a big gush of blood came out. The patient was thinking she did not get enough dose of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: severe headache; extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686), intramuscular in left arm on 28Dec2020 at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included metoprolol. The patient was not pregnant. About 8 hours after the first shot  in Dec2020, the patient had extreme fatigue and a severe headache for about 24 hours. The facility where the most recent COVID-19 vaccine was administered was in the nursing home. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test, Swelling
Clinical narrative: allergic reaction; swelling; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 had an allergic reaction on an unspecified date, after receiving the 1st dose of vaccine. The patient experienced swelling. The reporter wanted to know if it is still advisable for the patient to get the 2nd dose of the vaccine. The patient did covid testing the same day he received his 1st dose, patient tested negative. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hallucination, Heart rate increased, Illness, Pyrexia
Clinical narrative: hallucination; fever; fast heartbeat; Sick; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein, lot number and expiration date unknown), at a single dose, and influenza vaccine at an unspecified dose, both, via an unspecified route of administration, on an unspecified date for immunization. Medical history included heart trouble, asthma and low blood trouble/low blood sugar. The patient's concomitant medications were not reported. Patient was concerned about getting the Covid- 19 vaccine. Patient would like to know if she can get the covid vaccine with her history of medical conditions. The patient reported that the last time she got a flu and pneumonia shot together it made her sick on an unspecified date. She had a fast heart beat, fever and hallucinations, all on an unspecified date. She was told it could have been too much giving them together. She would be getting the Covid-19 vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Nasal congestion, Rash, Sinus congestion, Wheezing
Clinical narrative: angio edema of lips and periorbital area; Nasal and sinus congestion; rash on chest and face; wheezing; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 17Jan2021 at a single dose for COVID-19 immunization. Medical history included mixed hyperlipidemia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on Jan2021 via intramuscular. On 17Jan2021, the patient experienced nasal and sinus congestion, rash on chest and face, angioedema of lips and periorbital area and wheezing. The outcome of the events was not recovered. The patient received an OTC antihistamine and monitored the condition.   Information on the batch/lot number has been requested.; Sender's Comments: Based on a chronological association and known product safety profile, a causal relationship between event angioedema and BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red swollen big bump on arm that didn't go away for 5 days; Red swollen big bump on arm that didn't go away for 5 days; This is a spontaneous report from a non-contactable healthcare professional (the patient).  A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 30Dec2020 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included the patient had COVID prior to vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 30Dec2020, the patient experienced red swollen big bump on arm that didn't go away for 5 days. The patient did not receive any treatment for the events. The clinical outcome of red swollen big bump on arm was recovered on 04Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Body temperature increased, Diarrhoea, Fatigue
Clinical narrative: upset stomach; diarrhea; temperature to 101.7; I was tired and sleepy; I was tired and sleepy; fever; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), second dose on 07Jan2021 07:00 (lot number: EJ1685) via an unspecified route of administration in the left arm at a single dose for covid-19 immunization. Medical history included diabetes mellitus (DM), coronary artery disease (CAD), hypertension (HTN), HLD, glaucoma, retinal tears and overweight. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in the left arm, first dose on 31Dec2021. The patient previously received first dose of bnt162b2 on 18Dec2020 16:45 (lot number: EL3248) for covid-19 immunization. On 08Jan2021 07:00, the patient experienced upset stomach, diarrhea, temperature to 101.7, tired and sleepy and fever. The patient received Pepto-Bismol and Azithromycin as treatment for the events. The patient did not have covid prior vaccination and had not tested positive for covid post vaccination. Events fever ad temperature to 101.7 recovered on 09Jan2021; event diarrhea recovered on 11Jan2021; all other events resolved with sequel.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: upset stomach; diarrhea; temperature to 101.7; I was tired and sleepy; I was tired and sleepy; fever; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), second dose on 07Jan2021 07:00 (lot number: EJ1685) via an unspecified route of administration in the left arm at a single dose for covid-19 immunization. Medical history included diabetes mellitus (DM), coronary artery disease (CAD), hypertension (HTN), HLD, glaucoma, retinal tears and overweight. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in the left arm, first dose on 31Dec2021. The patient previously received first dose of bnt162b2 on 18Dec2020 16:45 (lot number: EL3248) for covid-19 immunization. On 08Jan2021 07:00, the patient experienced upset stomach, diarrhea, temperature to 101.7, tired and sleepy and fever. The patient received Pepto-Bismol and Azithromycin as treatment for the events. The patient did not have covid prior vaccination and had not tested positive for covid post vaccination. Events fever ad temperature to 101.7 recovered on 09Jan2021; event diarrhea recovered on 11Jan2021; all other events resolved with sequel.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247, expiration date was unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 08:45 at a single dose for COVID-19 immunization administered at the clinic. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced sore arm, which was assessed as non-serious. The patient did not receive any treatment for the adverse event. The outcome of the event was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-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 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Malaise, Vaccination site pain
Clinical narrative: she felt very cold and unwell; she felt very cold and unwell; dizziness; headache; extreme fatigue; fogginess/Foggy brain was described as she was not able to focus very well; Strong chills was not going away almost like a feeling of ice in her veins; Arm ache at the site; She was not able to get work done due to extreme fatigue and foggy brain/It was very disturbing and interfering with ability to do work; This is a spontaneous report from a contactable consumer (patient). A 74-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 16Jan2021 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had her first COVID19 vaccine dose. Immediately, on 16Jan2021, she felt very cold and unwell. She also experienced dizziness, headache that started right after the shot, extreme fatigue that started later in the day and fogginess that started right after the shot. Strong chills was not going away almost like a feeling of ice in her veins. She is taking paracetamol (TYLENOL) and ibuprofen for these. The events were not improving. She was just surprised, she was ok with a day's worth, but it was hanging on dizziness (not enough to fall down), but she has to hold onto a rail to go upstairs which was not normal. She doesn't feel like she is real anchored. Headache was described as very bad and is not changing. Foggy brain was described as she was not able to focus very well. She was not able to get work done on Jan2021 due to extreme fatigue and foggy brain. She also experienced arm ache at the site on 06Jan2021 for which the patient expected. It is reducing some, the ache is not as bad as it was while the other things seem to be growing and it is still there. She had to be set aside when she took the shot, because she had these reactions after she got the shot. She had to be watched because of her almost immediate reactions. The patient wants an advice on what to do now, if there is any help for the side effects, and if this will go away. It was very disturbing and interfering with ability to do work. Outcome of the vaccination site pain was recovering while of the remaining events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I broke out in shingles; Relevant medical history: type 1 diabetes mellitus and lupus; Relevant medical history: type 1 diabetes mellitus and lupus; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 08Jan2021 at 11:00 to 11:45 (as reported), at single dose, for COVID-19 immunization, in the hospital. Medical history included ongoing type 1 diabetes mellitus (diagnosed at 8 years old, maybe around 1993-1994), lupus from 2004 and ongoing, TTP (blood clotting disorder) from 2019 and ongoing and allergies to sulfa drugs. There were no concomitant medications. Historical vaccine included flu shot for immunization which she believes that was well before 4 weeks. The patient stated, 'My doctor wanted me to call and get information. I received my first vaccine but a week later I broke out in shingles and I'm due to get my second dose in a week or so. Any advice on that? My doctor suggesting putting the second dose off for a few weeks. Does it become ineffective? Is there a timeline? What is the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine, and can I receive it earlier or later than 3 weeks?". The patient reported that she received the first dose of the COVID vaccine. A week after, she came down with shingles. She was wondering if she could get the second dose after coming down with shingles. She clarified that on 15Jan2021 (Friday), she went with what she initially thought was a pinched nerve. She had radiating pain starting from her shoulder coming down into her hands and fingers. She had the rash probably on Friday (22Jan2021). She then started getting a small blister/rash on 23Jan2021. On 24Jan2021, she returned to the Urgent Care and the rash had spread at that point and they were pretty sure it was the shingles virus. She reported she had gone to Urgent Care over the weekend twice, they suspected that was what it was. She saw the doctor on 19Jan2021 (yesterday) and gave the official diagnosis of shingles. The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730), via an unspecified route of administration (left arm), on 22Dec2020 19:00, at single dose, for covid-19 immunization. Medical history included asthma and; Covid (prior to vaccination). The patient has no known allergies. Concomitant medications included niacin; colecalciferol (D3); cyanocobalamin (B12); loratadine and; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was also taking ginger. The patient experienced temp 100, malaise, body aches, and very sore arm - all on 23Dec2020 10:00. The patient recovered from all the events on an unspecified date. No treatment was received for all the events reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and; have not been COVID tested post vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Urticaria
Clinical narrative: Skin redness/hands were red/red patches; hands were red and itchy; hands were red and itchy, burning.; extensive hives starting over dorsal hand surface, then wrists,eventually covering entire arms and patches over knees and lower legs; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 19Jan2021 09:15 at a single dose on the left arm for COVID-19 immunization. Medical history included COVID-19 and allergies: PCN. Concomitant medication included colecalciferol (VITAMIN D). The patient received no other vaccine in four weeks. Patient is not pregnant. On 20Jan2021 08:30, the patient developed skin redness, her hands were red, itchy, and burning. This was followed by extensive hives starting over dorsal hand surface, then wrists, and eventually covering entire arms. The patient also had patches over knees and lower legs. The events resolved with 20 mg prednisone and Allegra after a couple hours, except for the flat red patches which remained over the knees and surrounding skin. The patient has not been tested for COVID-19 post-vaccination. Outcome of the event "skin redness/hands were red/red patches" was not recovered and of the other events was recovered on an unspecified date.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced  "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: her arm got really really sore for several days up into her shoulder; her arm got really really sore for several days up into her shoulder; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 80, no unit) 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. Medical history was not reported. The patient has a lot of unspecified underlying conditions. The patient had a flu shot on an unknown date and she stated even with the regular flu shot it makes her arm sore at the site every time. The patient was on unspecified blood thinners. On an unspecified date, her arm got really really sore for several days up into her shoulder. Investigation assessment was not provided. The outcome of the events was unknown.   Information on the batch/lot number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient would like to know if there's anything in the ingredients of the COVID vaccine that will stimulate the heart, she states she takes medication because she has a rapid heart rate. The patient states her niece received the second shot of the vaccine today and she didn't know that she should not take Tylenol or Ibuprofen and she took two Tylenol or Ibuprofen, patient would like to know if her niece should receive the second dose again. Patient heard that several people died after receiving the vaccine, she would like to know if this is true. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Feeling cold, Headache, Influenza like illness
Clinical narrative: flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral coldness
Clinical narrative: flu-like symptoms; chills; headache; left arm was bruised - still black and blue; Pain in arm; body ache; changes from her lower extremities freezing and sometimes it was her whole body; changes from her lower extremities freezing and sometimes it was her whole body; This is a spontaneous report from a contactable consumer (patient's husband). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231), via an unspecified route of administration in the right arm on 12Jan2021 at a single dose for covid-19 prophylaxis; apixaban, oral from an unspecified date and ongoing at 5 mg, twice daily as blood thinner medication and atrial fibrillation. Medical history was not reported. Concomitant medication included ongoing dronedarone hydrochloride (MULTAQ) for blood pressure and heart beat, ongoing pravastatin for cholesterol, and dronedarone for blood pressure. For the past couple of days, she had had flu like symptoms. She has had a headache, body aches and chills. It changes from her lower extremities freezing and sometimes it was her whole body. Patient also had a pain in arm. Her left arm was bruised - still black and blue. All of these occurred on 13Jan2021. She did not have a fever. Today (20Jan2021), she was ok. When they went through the check in they asked if patient was on a blood thinner and she was. The patient's husband was wondering if the reactions had anything to do with the vaccine and if the blood thinner medication (Apixaban) she was taking would have caused the bruise. The patient was supposed to get the second vaccine 02Feb2021. Reporter was asking if it is ok to get the second dose. The action taken in response to the event for apixaban was unknown. Outcome of event chills was recovered on 19Jan2021, after 6 days; events flu like symptoms and lower extremities freezing and sometimes it was her whole body was unknown while recovering for other events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; Caller got the first dose of the pfizer covid 19 vaccine on 26Dec2020 and tested positive for covid on 30Dec2020.; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL5738)on 26Dec2020 at single dose into right arm for COVID-19 immunization.  Medical history was none.  Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid . She was tested negative on 03Jan2021 and 04Jan2021 (both via COVID-19 PCR tests). She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. Patient stated that other than having positive tests for COVID she has had no symptoms. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021077994 same patient, different dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient.  A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included asthma.  The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache, Lymph node pain
Clinical narrative: fever; dizziness; aching joints; headache; shortness of breath; swollen and painful lymph nodes in left armpit only; swollen and painful lymph nodes in left armpit only; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 39-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: unknown), intramuscular on the left arm on 30Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history included gastroparesis, low thyroid, iron anemia, and known allergies: latex, apples, kiwi and avocado. Concomitant medications included bifidobacterium infantis (ALIGN), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), duloxetine hydrochloride (CYMBALTA), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), folic acid (FOLIC ACID), levothyroxine (LEVOTHYROXINE), omeprazole (OMEPRAZOLE), and pantoprazole (PANTOPRAZOLE). The patient had no other vaccine in four weeks. On 30Dec2020, the patient experienced (first shot) fever, dizziness, aching joints, headache, shortness of breath, swollen and painful lymph nodes in left armpit only, 24 hours after the shot and lasted for two weeks. The patient had no COVID prior vaccination and tested negative post-vaccination through nasal swab on 13Jan2021, which resulted negative. No treatment was administered for the events. The event swollen and painful lymph nodes in left armpit only resolved on 14Jan2021 while the rest of the events had not resolved.   Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; dizziness; aching joints; headache; shortness of breath; swollen and painful lymph nodes in left armpit only; swollen and painful lymph nodes in left armpit only; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 39-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: unknown), intramuscular on the left arm on 30Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history included gastroparesis, low thyroid, iron anemia, and known allergies: latex, apples, kiwi and avocado. Concomitant medications included bifidobacterium infantis (ALIGN), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), duloxetine hydrochloride (CYMBALTA), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), folic acid (FOLIC ACID), levothyroxine (LEVOTHYROXINE), omeprazole (OMEPRAZOLE), and pantoprazole (PANTOPRAZOLE). The patient had no other vaccine in four weeks. On 30Dec2020, the patient experienced (first shot) fever, dizziness, aching joints, headache, shortness of breath, swollen and painful lymph nodes in left armpit only, 24 hours after the shot and lasted for two weeks. The patient had no COVID prior vaccination and tested negative post-vaccination through nasal swab on 13Jan2021, which resulted negative. No treatment was administered for the events. The event swollen and painful lymph nodes in left armpit only resolved on 14Jan2021 while the rest of the events had not resolved.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain assessment
Clinical narrative: more arthralgias than usual/ developed arthralgias in his DIP joints of his left hand/ pain was about 3-4/10. Mostly 3rd and 4th digit/ persisted for more than a day or two; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 31Dec2020 15:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included hand arthralgias from an unknown date and unknown if ongoing. The patient's known allergies indicated codeine. There were no concomitant medications. The patient did not receive any other medication within two weeks and did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after vaccination, almost three weeks ago, on 01Jan2021, the patient felt more arthralgias than usual. He developed arthralgias in his DIP joints of his left hand (vaccine was in left arm), pain was about 3-4/10. Mostly 3rd and 4th digit. No warmth or swelling that he can discern. It was odd to him because he has had hand arthralgias, but nothing that has persisted for more than a day or two. It seems to be a bit better now. Therapeutic measures which includes administration of Ibuprofen was done in response to the event. The outcome of the event was not recovered  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: chills; fatigue; muscle aches; fever of 101; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:30 at a single dose for COVID-19 immunization. There were no medical history. Patient was not pregnant at the time of vaccination. There were no other medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks. The patient chills, fatigue, muscle aches and fever of 101 on 20Jan2021 11:00. No treatment was received. Outcome of the events was recovering.