chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe joint pain in right elbow and left shoulder; severe joint pain in right elbow and left shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: FW017s) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "covid" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN; ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: ER873y, Administration time: 12:00, Vaccine location: Right arm), administration date: 02Apr2021, when the patient was 57 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 29Apr2021, outcome "not recovered" and all described as "severe joint pain in right elbow and left shoulder". The event "severe joint pain in right elbow and left shoulder" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia, arthralgia.   Additional information: The patient did not get COVID tested post vaccination. The patient had no known allergies. The patient did not receive treatment for adverse event. The patient experienced covid prior vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, SARS-CoV-2 test
Clinical narrative: Severe joint pain all over the body/ continue to have joint pain after the 2nd dose as well; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 15:00 (Lot number: FE3592) at the age of 54 years as dose 2, single and administered in arm left, administration date 02Sep2021 16:00 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cashew nuts" (unspecified if ongoing), notes: Known allergies: Cashew nuts; "Penicillin allergy" (unspecified if ongoing); "Shortness of breath", start date: Jul2020 (ongoing), notes: shortness of breath since having covid Ju2020; "COVID-19", start date: Jul2020 (unspecified if ongoing), notes: who had COVID infection a year ago. Concomitant medication(s) included: NEXIUM; CRESTOR. The following information was reported: ARTHRALGIA (non-serious) with onset 03Sep2021 08:00, outcome "not recovered", described as "Severe joint pain all over the body/ continue to have joint pain after the 2nd dose as well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia.  Additional Information: Prior vaccination within 4 weeks was reported as none. Prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Device Date: 06Oct2021 Severe joint pain all over the body that lasted for 3 weeks to the point it was difficult to get in and out of a car. I continue to have joint pain after the 2nd dose as well.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: 19 h after vaccine started getting rashes on elbows, knees, ankles, butt, and neck that were very itchy / 28 hours after vaccine the rashes started getting worse and itchy ness increased significantly; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Aug2021 at 18:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included MAGNESIUM and unspecified birth control, taken for an unknown indication from an unknown date and unknown if ongoing. On 12Aug2021 at 13:30, 19 hours after the vaccine, the patient started getting rashes on elbows, knees, ankles, butt, and neck that were very itchy. 28 hours after the vaccine, the rashes started getting worse, and itchy-ness increased significantly. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rashes on elbows, knees, ankles, butt, and neck that were very itchy and the rashes started getting worse and itchy-ness increased significantly was not resolved at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.  This follow-up report is being submitted to amend previously reported information, Vaccination Facility was added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: Severe muscle pains through out entire body starting 1 week after injection; daily headaches; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 10:00 (Lot number: Fc3180) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Renal tubular acidosis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LINZESS. Past drug history included: Reglan, reaction(s): "known allergies: reglan". The following information was reported: MYALGIA (non-serious) with onset 07Aug2021, outcome "not recovered", described as "Severe muscle pains through out entire body starting 1 week after injection"; HEADACHE (non-serious) with onset 07Aug2021, outcome "not recovered", described as "daily headaches"; FATIGUE (non-serious) with onset 07Aug2021, outcome "not recovered", described as "extreme fatigue". The events "severe muscle pains through out entire body starting 1 week after injection", "daily headaches" and "extreme fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, headache, fatigue.  Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient did not test for COVID tested post vaccination. The patient did not receive other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Hypoaesthesia, Pyrexia, Vomiting
Clinical narrative: Left big toe numbness with bruising; Left big toe numbness with bruising; vomiting; fever; severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 12:30 (Lot number: FC3180) (at the age of 59 years) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Product: COVID 19, brand=Pfizer, Lot number: FA7485, Lot unknown: False, Administration date: 30Jul2021, Administration time: 16:30, Dose number: 1, Vaccination location: Left arm, ), administration date: 30Jul2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), CONTUSION (non-serious) all with onset 21Aug2021, outcome "unknown" and all described as "Left big toe numbness with bruising"; VOMITING (non-serious) with onset 21Aug2021, outcome "unknown", described as "vomiting"; PYREXIA (non-serious) with onset 21Aug2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 21Aug2021, outcome "unknown", described as "severe headache". Therapeutic measures were not taken as a result of hypoaesthesia, contusion, vomiting, pyrexia, headache.  Additional information: Facility type for vaccine was noted as pharmacy or drug store. Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient had not been tested for covid-19. Patient did not receive any other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chest pain, Dyspnoea, Headache
Clinical narrative: Difficult breathing/chest pain; Difficult breathing/chest pain; severe headache; muscle pain all over body; injection site swelling; weakness throughout the body; was bedridden for 24hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 09Sep2021 02:00 (Lot number: 301358A) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing), notes: known_allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "Difficult breathing/chest pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "severe headache"; MYALGIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "muscle pain all over body"; VACCINATION SITE SWELLING (non-serious) with onset 10Sep2021, outcome "not recovered", described as "injection site swelling"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "weakness throughout the body"; BEDRIDDEN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "was bedridden for 24hrs". Therapeutic measures were not taken as a result of dyspnoea, chest pain, headache, myalgia, vaccination site swelling, asthenia, bedridden.  Additional information: Facility where the most recent COVID-19 vaccine was administered was noted as military base. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling
Clinical narrative: Difficult breathing/chest pain; Difficult breathing/chest pain; severe headache; muscle pain all over body; injection site swelling; weakness throughout the body; was bedridden for 24hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 09Sep2021 02:00 (Lot number: 301358A) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing), notes: known_allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), CHEST PAIN (non-serious) all with onset 10Sep2021, outcome "not recovered" and all described as "Difficult breathing/chest pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "severe headache"; MYALGIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "muscle pain all over body"; VACCINATION SITE SWELLING (non-serious) with onset 10Sep2021, outcome "not recovered", described as "injection site swelling"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "weakness throughout the body"; BEDRIDDEN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "was bedridden for 24hrs". Therapeutic measures were not taken as a result of dyspnoea, chest pain, headache, myalgia, vaccination site swelling, asthenia, bedridden.  Additional information: Facility where the most recent COVID-19 vaccine was administered was noted as military base. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Therapeutic response unexpected
Clinical narrative: we elected to have our 11 year old twins vaccinated; we elected to have our 11 year old twins vaccinated; Their resistance to allergens was better; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "we elected to have our 11 year old twins vaccinated"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Their resistance to allergens was better".  Additional information: Reporter stated that when announced the vaccine safe for 1216-year-olds, reporter elected to have 11 year old twins vaccinated. Reporter only had to give verbal approval, parental signature etc, so advised they were of age to receive the vaccine. Technically, they'll be 12 this year, reporter didn't want them to be restricted for summer camps/events planned. Reporter wanted to share information and the fact they have not had any adverse effects, not even a sniffle, and if anything noticed their resistance to allergens was better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198669 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Immunisation
Clinical narrative: Severe Reaction; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61 year-old male patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunization; Bnt162b2 (dose 2), for covid-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe Reaction"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  Additional information: Reporter stated that she couldn't tell between the 2 Pfizer vaccines, if it's Comirnaty or the Pfizer Covid BioNTech Vaccine. Reporter stated that with patient's booster, he had been having more severe reaction. Lot and Expiry were Unknown for patient's booster vaccine, reporter thought since he got it at the same office as she did that the Lot number could be the same. Reporter stated that her (Reporter) and her brother (Patient) are the same age, they were twins being 10 months apart. RA Communication reported as Report 2 of 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular vascular disorder
Clinical narrative: had a stroke behind his eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization. The following information was reported: OCULAR VASCULAR DISORDER (medically significant) with onset 31Aug2021, outcome "unknown", described as "had a stroke behind his eye". The event "had a stroke behind his eye" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ocular vascular disorder. Follow-up attempts completed. No further information is expected.  Additional information: It was reported that inquiring about receiving the booster dose of the Pfizer Covid-19 vaccine and that her husband received his second dose of the Pfizer Covid-19 vaccine on 06Apr2021, and he had a stroke behind his eye on 31Aug2021 and was diagnosed with a stroke on 01Sep2021 and started treatment. She reported that he had a stroke behind his right eye, her husband had no health issues whatsoever, stating there were no precursors to this, he was not diabetic, he doesnt have high blood pressure, there was no warning signals or reasons for this and asks could it be related to this vaccine and is he okay to receive the booster dose. Her husband was not on any medication and got the 2 doses of the Pfizer Covid shots. The second dose was taken last 06Apr2021 and last 01Sep he had a stroke. She stated that he had all the symptoms on the 31Aug2021 and went to the doctor on 01Sep2021. Went to the ophthalmologist was diagnosed by 2 different doctors and the same day they both stated he had a stroke behind the right eye. Last seen by the eye doctor a little over a year ago and his eyes were so good that he did not have to even wear his glasses. She wants to make sure because the vaccine is the only thing different, and she wants to make sure there is no link to that and if its considered safe to get. Is scheduled in a week from today for the booster.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Tenderness
Clinical narrative: swelling under left arm; left arm- tender to touch; Received Booster (3rd shot) of Pfizer vaccine at work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 09:00 (Lot number: EW0217) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heartburn", start date: 01Nov2020 (ongoing), notes: Currently taking Famotidine 2x daily; "Acid reflux", start date: 01Nov2020 (ongoing), notes: Currently taking Famotidine 2x daily. Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease, dyspepsia, start date: Jul2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Time (24 hr): 13:20, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 09Mar2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "minor soreness at the site of injection"; Bnt162b2 (Dose: 2nd, Time (24 hr): 13:20, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 30Mar2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "minor soreness at the site of injection". The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Received Booster (3rd shot) of Pfizer vaccine at work"; LYMPHADENOPATHY (non-serious) with onset 24Oct2021, outcome "recovered" (07Nov2021), described as "swelling under left arm"; TENDERNESS (non-serious) with onset 24Oct2021, outcome "recovered" (07Nov2021), described as "left arm- tender to touch". Therapeutic measures were not taken as a result of lymphadenopathy, tenderness.  Additional information: Description of Event: Experienced swelling under left arm two days after receiving Pfizer COVID-19 vaccine (booster, 3rd shot) in left arm. Optional Information: Experience no side effects from dose 1 and 2 except minor soreness at the site of injection. Relevant tests: None. Specific Relevant tests for thromboembolic events with thrombocytopenia: None. Comments/narrative: Received Booster (3rd shot) of Pfizer vaccine at work (Pfizer (name withheld)) on 22Oct2021. Two days later I noticed swelling under my left arm- tender to touch but not painful. It disappeared after two weeks. I did not experience any side effects from the first two shots except for mild soreness at site of injection.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery disease
Clinical narrative: quadruple bypass; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: CORONARY ARTERY DISEASE (medically significant), outcome "unknown", described as "quadruple bypass".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain, Vaccination site swelling
Clinical narrative: I had Pfizer Booster shot; right underneath the shot, it's like a swollen area; it does hurts; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "I had Pfizer Booster shot"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "right underneath the shot, it's like a swollen area"; PAIN (non-serious), outcome "unknown", described as "it does hurts". Additional Information: When probed for consumer's name and Telephone#, consumer stated "I am calling because I had Pfizer Booster shot (unspecified shot) yesterday and I am having a side effect, it's little blue where the shot was given, so it feels like a mosquito bite and it's a little swollen (and it hurts)." Distortion on the line. Consumer stated, "My husband has the same thing (side effects) but he has right underneath the shot, it's like a swollen area and it looks like a big mosquito bite and if you touch it, it does hurts." Consumer was informed about the Role of Pfizer Drug Safety. When paraphrased the concern, consumer stated "Still have swelling."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Approximately 3 hours later got suddenly very itchy all over left torso and underarm. No visible hives.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 13:00 (Lot number: FK5127) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALLEGRA. Past drug history included: No. The following information was reported: PRURITUS (non-serious) with onset 06Nov2021 16:00, outcome "recovered" (2021), described as "Approximately 3 hours later got suddenly very itchy all over left torso and underarm. No visible hives.". Therapeutic measures were not taken as a result of pruritus.  Additional information: The patient had not received any other vaccine within four weeks. The patient received other medication in two weeks (several days ago). The patient was not tested since vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, Vaccination site pain
Clinical narrative: fatigue; body aches; headache; pain at injection site; Received third dose of comirnaty vaccine on 04Nov in left deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 04Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 04Nov2021, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 04Nov2021, outcome "not recovered", described as "pain at injection site"; IMMUNISATION (non-serious) with onset 04Nov2021, outcome "unknown", described as "Received third dose of comirnaty vaccine on 04Nov in left deltoid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Chills, Cough, Immunisation, Off label use
Clinical narrative: Chills; Fever 103.9; Pulseox92; Cough; DOSE 3 on 01Nov2021 and Flu vaccine on 01Nov2021; DOSE 3 on 01Nov2021 and Flu vaccine on 01Nov2021; dose received 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 12:00 (Lot number: 32030BD) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 01Nov2021 (Batch/Lot number: unknown) as dose 1 for immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Secondary hypogonadis" (unspecified if ongoing), notes: Secondary hypogonadis; "Hyperthyroid" (unspecified if ongoing), notes: Hyperthyroid. Concomitant medication(s) included: ANDROGEL; TAPAZOLE; MAXZIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,Lot number: E29261, Anatomical location: Left arm, Administration time: 11:00.), administration date: 22Jan2021, when the patient was 79 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE,Lot number: BN6201, Anatomical location: Left arm, Administration time: 10:45.), administration date: 12Feb2021, when the patient was 79 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Nov2021 12:00, outcome "unknown" and all described as "DOSE 3 on 01Nov2021 and Flu vaccine on 01Nov2021"; IMMUNISATION (non-serious) with onset 01Nov2021 12:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Chills"; PYREXIA (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Fever 103.9"; OXYGEN SATURATION DECREASED (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Pulseox92"; COUGH (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Cough". Relevant laboratory tests and procedures included Body temperature was 103.9, Pulse oximetry was 92, PCR Nasal swab was Negative are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, oxygen saturation decreased, cough.  Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Oxygen saturation, Oxygen saturation decreased, Product use issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever 103.9; Pulseox92; Cough; DOSE 3 on 01Nov2021 and Flu vaccine on 01Nov2021; DOSE 3 on 01Nov2021 and Flu vaccine on 01Nov2021; dose received 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 12:00 (Lot number: 32030BD) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 01Nov2021 (Batch/Lot number: unknown) as dose 1 for immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Secondary hypogonadis" (unspecified if ongoing), notes: Secondary hypogonadis; "Hyperthyroid" (unspecified if ongoing), notes: Hyperthyroid. Concomitant medication(s) included: ANDROGEL; TAPAZOLE; MAXZIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE,Lot number: E29261, Anatomical location: Left arm, Administration time: 11:00.), administration date: 22Jan2021, when the patient was 79 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE,Lot number: BN6201, Anatomical location: Left arm, Administration time: 10:45.), administration date: 12Feb2021, when the patient was 79 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Nov2021 12:00, outcome "unknown" and all described as "DOSE 3 on 01Nov2021 and Flu vaccine on 01Nov2021"; IMMUNISATION (non-serious) with onset 01Nov2021 12:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Chills"; PYREXIA (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Fever 103.9"; OXYGEN SATURATION DECREASED (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Pulseox92"; COUGH (non-serious) with onset 03Nov2021 01:00, outcome "recovered" (Nov2021), described as "Cough". Relevant laboratory tests and procedures included Body temperature was 103.9, Pulse oximetry was 92, PCR Nasal swab was Negative are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, oxygen saturation decreased, cough.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Immunisation
Clinical narrative: fell down, went down like a rag doll; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 11:45 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: COPD" (unspecified if ongoing), notes: Verbatim: COPD, diagnosed about 10 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot: EN6201, Expiration: unknown), administration date: 13Feb2021, when the patient was 74 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, Lot: EN6205, Expiration: unknown), administration date: 06Mar2021, when the patient was 74 years old, for COVID-19 Immunization; Flu shot, administration date: 01Oct2021, for Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021, outcome "unknown", described as "booster"; FALL (non-serious) with onset 03Nov2021, outcome "unknown", described as "fell down, went down like a rag doll". Therapeutic measures were not taken as a result of immunisation, fall.  Additional information: It was reported that, this is report 1 of 2. Caller reporting on herself. 02Nov2021 her and her husband got the covid vaccine booster at the doctor office. They both waited the 15 minutes. On Wednesday morning when she got out of bed, she went down, she fell like a rag doll. She has never experienced anything like that.  She did not have her vaccination card available for the booster dose. Treatment: declined any, she called doctor's office and talked to the office and stated she may not want to go to ER due to covid pandemic. She cannot get in to see the doctor till 30Nov2021 but the nurse said she could go to immediate care center if she needed to. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient did not require a visit Emergency Room for adverse events. Prior Vaccinations (within 4 weeks):  She had her flu shot 01Oct2021. She does not have the name or lot number to provide. Family Medical History Relevant to AE(s): no. Relevant Tests: none. Investigation Assessment: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Swelling, Vaccination site pain
Clinical narrative: He is 10; He is 10; mild injection site pain; what could be mild swelling in his armpit; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "mild injection site pain"; SWELLING (non-serious) with onset 2021, outcome "recovered", described as "what could be mild swelling in his armpit"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OFF LABEL USE (non-serious) all with onset 06Oct2021, outcome "unknown" and all described as "He is 10".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Erythema, Immunisation, Pain in extremity
Clinical narrative: raised fever on day 6; arm was sore; Swollen feels like a tennis ball under skin red; Swollen feels like a tennis ball under skin red; Booster; sore under arm and Armpit and side of my Breast; sore under arm and Armpit and side of my Breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 (Lot number: 320301317) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 07May2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Nov2021, outcome "not recovered", described as "arm was sore"; SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "not recovered" and all described as "Swollen feels like a tennis ball under skin red"; PYREXIA (non-serious) with onset 16Nov2021, outcome "not recovered", described as "raised fever on day 6"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "sore under arm and Armpit and side of my Breast"; IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were not taken as a result of pain in extremity, swelling, erythema, pyrexia, axillary pain, breast pain.  Additional information: clinical course was reported as, 2 days after Booster arm was sore Swollen feels like a tennis ball under skin red and raised fever on day 6, day 7 sore under arm and Armpit and side of my Breast. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. 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. List of any other medications the patient received within 2 weeks of vaccination was reported as yes (unspecified). No hospitalization prolonged and no treatment received.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: raised fever on day 6; arm was sore; Swollen feels like a tennis ball under skin red; Swollen feels like a tennis ball under skin red; Booster; sore under arm and Armpit and side of my Breast; sore under arm and Armpit and side of my Breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 (Lot number: 320301317) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left), administration date: 07May2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Nov2021, outcome "not recovered", described as "arm was sore"; SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "not recovered" and all described as "Swollen feels like a tennis ball under skin red"; PYREXIA (non-serious) with onset 16Nov2021, outcome "not recovered", described as "raised fever on day 6"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "sore under arm and Armpit and side of my Breast"; IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were not taken as a result of pain in extremity, swelling, erythema, pyrexia, axillary pain, breast pain.  Additional information: clinical course was reported as, 2 days after Booster arm was sore Swollen feels like a tennis ball under skin red and raised fever on day 6, day 7 sore under arm and Armpit and side of my Breast. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. 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. List of any other medications the patient received within 2 weeks of vaccination was reported as yes (unspecified). No hospitalization prolonged and no treatment received.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia
Clinical narrative: dose number=3; insomnia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose brand=Pfizer, Batch/Lot No: 73529), when the patient was 20 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Dose brand=Pfizer, Batch/Lot No: 73529), when the patient was 20 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number=3"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Rash
Clinical narrative: Rash all over body; current_age: 6; current age: 6 Years; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 13:00PM (Lot number: Fk5127) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: Known allergies: Peanuts (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious) with onset 11Nov2021, outcome unknown, described as current age: 6; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Nov2021, outcome unknown, described as current age: 6 Years RASH (non-serious) with onset 13Nov2021, outcome recovering, described as Rash all over body. Therapeutic measures were taken as a result of rash.  Additional information: The patient treatment received: Steroid cream. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Booster; Severe chills; Fever; Fatigue; Body ache; Even more rapid heartbeat (approx. 140-150 bpm when resting); Even more rapid heartbeat (approx. 140-150 bpm when resting); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing), notes: Other medical history: Bicuspid aortic valve. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Drug allergy", notes: Known allergies: Bactrim. Vaccination history included: Bnt162b2 (Dose no: 1, Anatomical location: Left arm), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Body ache"; Bnt162b2 (Dose no: 2, Anatomical location: Left arm), administration date: 11Apr2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Very rapid heartbeat (approx. 120-130 bpm when resting)", "Body ache". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Severe chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body ache"; HEART RATE INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Even more rapid heartbeat (approx. 140-150 bpm when resting)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, fatigue, pain, heart rate increased, condition aggravated.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Additional information:  The rapid heartbeat continued for 24 hours before it stopped. For female 3rd dose, patient took Propanalol to regulate it. If Covid prior vaccination: No, if Covid tested post vaccination: Yes. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR, Covid test date: 03Nov2021, Covid test result: Negative. if other vaccine in four weeks: No, other medications in two weeks: No