chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye inflammation, Eye swelling, Hordeolum, Ophthalmological examination
Clinical narrative: had it like 3 or 4 days rapid heart beat; rapid heart beat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485; Expiration Date: 31Oct2021) via an unspecified route of administration, administered in arm right on 06Aug2021 17:00 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On 06Aug2021 the patient experienced had it like 3 or 4 days rapid heart beat; rapid heart beat. Concern: Reporter stated, I wanted to be found out that, I have been reporting. I've been reporting everyday about my side effects (further not clarified) but is the rapid heart beat suppose to be one of the side effect. I want them to document, report it, rapid heart beat, I had my 1st shot. Well, I had it like 3 or 4 days rapid heart beat. When probed for date of administration, reporter stated, 06Aug2021, I have started heart rate. When probed for expiration date, reporter stated, 31Oct2021, 30th. Anatomical location: Reporter stated, On my right arm, my right upper arm. Medications and Medical conditions: Reporter stated, No. Time of the vaccine: Reporter stated, About 5 o' clock in the afternoon, 5pm at withheld. Route of administration: Reporter stated, No When probed if received any other vaccine: Reporter stated, No, haven't had any vaccine. The patient underwent lab tests and procedures which included heart rate: rapid on 06Aug2021.Patient did not receive treatment for the adverse event. Outcome of the event was resolved on an unspecified date in Aug2021.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, SARS-CoV-2 antibody test
Clinical narrative: I am now a diabetic; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 66-years-old via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:15 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included Stage 3 Kidney Disease, rheumatoid arthritis and known allergies: penicillin, sulfa from an unknown date. Concomitant medication included etanercept (ENBREL); escitalopram oxalate (LEXAPRO); levothyroxine sodium (SYNTHROID) and rosuvastatin calcium (CRESTOR) all taken for an unspecified indication, start and stop date were not reported.  The patient previously took Macrobid [nitrofurantoin] and experienced allergies (known allergies: Macrobid). The patient reported that she have a healthy diet and had stable glucose her entire life. All of a sudden, last week 10Aug2021, her glucose spiked to 760. She was hospitalized for 3 days and have been sent home on an insulin program. She is now a diabetic since 10Aug2021. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient underwent lab tests and procedures which included blood glucose: spiked to 760 on 10Aug2021, sars-cov-2 antibody test: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included an insulin program. The outcome of the events was recovered with sequel.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Heart rate, Heart rate decreased
Clinical narrative: Heart Rate was 36; Having Trouble Breathing; Upper back pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (given in the morning) on 21Jul2021 (Lot Number: EW0196) as single dose (at the age of 62-years-old) for COVID-19 immunization. Medical history included ongoing anxiety (she takes Venlafaxine for Anxiety), bronchitis (issues with bronchitis), and hysterectomy. Concomitant medications included venlafaxine hydrochloride taken for anxiety. No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. The patient experienced having trouble breathing and upper back pain on 23Jul2021 (Afternoon on Friday), then heart rate was 36 on 12Aug2021. She had the vaccine probably now over 3 weeks ago. Over the course of the 3 weeks she was having trouble breathing and long story short, she ended up getting a pacemaker. She also saw her Chiropractor, because she figured it was a chiropractic issue at first. The trouble breathing and back pain started within 2 days after her vaccine, which was on 21Jul2021. The pacemaker was placed on 12Aug2021. Treatment: Pacemaker and Ran Tests. She was working for her daughter at a horse show for 1.5 weeks, which is why she didn't go sooner. The events required a visit to Emergency Room. She was transported by Ambulance from the doctors. Pulse rate at that time was 36 and that is when they panicked. On 10Aug2021, she didn't go earlier because she figured it was just her lungs, because it was not that she couldn't breathe, just trouble getting her air. Daughter kept texting her to see how she was, didn't want her to get her vaccine. Figured it was her back. Didn't think it was heart related. The events (Trouble Breathing Pulse Rate and Back Pain) required a visit to Physician Office on 10Aug2021. She didn't realize her pulse was that low, no experience before. The patient was hospitalized for the events from 10Aug2021 to 12Aug2021 (for 2 days). The patient underwent lab tests and procedures which included heart rate: 36 on 12Aug2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered on 12Aug2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: Missed Miscarriage at 8 weeks; This is a spontaneous report from a non-contactable consumer or other non HCP (Patient reported for self). A 36-years-old (pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: E40584), via an unspecified route of administration, administered in Arm Left on 07Jul2021 14:00 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. Patient did not receive other medications in two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 10Aug2021 17:00, the patient experienced missed miscarriage (also reported as gestational period: 1'). The mother reported she became pregnant while taking bnt162b2. The mother was pregnant at the onset of the event. Last menstrual date was 20May2021. The mother was due to deliver soon after. The pregnancy resulted in spontaneous abortion. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. COVID tested post vaccination, the patient underwent lab tests and procedures which included sars-cov-2 test (covid test type post vaccination=Nasal swab): Negative on 13Aug2021. Patient was received treatment for event. Adverse event was treated with D and C. The event was serious (Congenital anomaly or birth defect). The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: Covid test result: Positive; sore thraot; sneezing; runny nose; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 25-year-old male patient.   A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via intramuscular route of administration on 03Feb2021 (at the age of 25-year-old), as dose 2, single in right arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via intramuscular route of administration on 13Jan2021 (at the age of 25-year-old), as dose 1, single in right arm for COVID-19 immunization at Workplace clinic. The patient's medical history and concomitant medications were not reported. On 16Aug2021, 6 months and 13 days after vaccination, the patient experienced sore throat, sneezing and runny nose. On 17Aug2021, post vaccination, the patient's nasal swab test or COVID test result was positive. It was reported as unknown that patient received treatment for adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): positive, on 17Aug2021. It was reported as unknown if patient had COVID prior vaccination and patient was tested COVID post vaccination. The clinical outcome of all the events was reported as resolving.   No follow-up attempts possible. No further information expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event SARS-CoV-2 test positive and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Hives; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received second dose of BNT162B2 (PFIZER COVID 19 VACCINE; Solution for injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Right on 11Aug2021 (age at the time of vaccination was 55-year-old) as single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 for COVID-19 immunisation on 16Jul2021 with Lot Number / Expiry Date: FA7485/ 31Oct2021 on right Arm reaction included sick, Fever, Pain, Eyes dilated, Sweating, Aches and Neoplasm malignant from Feb2019 to an unknown date. The patient's medical history included cancer, Bladder operation from 01Apr2021 to an unknown date had surgery to take his bladder out. There were no concomitant medications. The patient experienced Rash, Hives on 13Aug2021, Tested positive for covid-19 on 11Aug2021. The patient underwent lab tests and procedures which included pyrexia: 100 on an Unspecified date Fever of a hundred, Sars-cov-2 test: positive on 11Aug2021. Therapeutic measures were taken as Benadryl for hives. Patient did not require a visit to Physician Office or Emergency Room. Prior Vaccinations within 4 weeks no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  number of COVID-19 vaccine was unknown. The outcome of event for Rash and tested positive for covid-19 was unknown, outcome for Hives was Not recovered.  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fear of death
Clinical narrative: After getting the first shot, she fell/she fell and was in the hospital and two nursing homes; was scared to death to get the second vaccine; This is a spontaneous report from a contactable consumer (Patient). A 85-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration on 12May2021 (at the age of 85-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, CHF. The patient's concomitant medications were not reported. On 12May2021, the patient after getting the first shot, fell/she fell and was in the hospital and two nursing homes. On an unspecified date, first dose 12May2021, 98 days after first dose. After getting the first shot, she fell, and was in the nursing home. She thought they would give her second dose there, but they did not,  said she was scared to death to get the second vaccine. Caller stated she should have had her second vaccine on 02Jun2021. Caller asked about booster dose and if she would need that, if it is recommended for her to now get the second vaccine. Patient was hospitalized for event. The clinical outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient later tested positive for COVID-19 and requires treatment at a hospital.; The patient later tested positive for COVID-19 and requires treatment at a hospital.; This is a spontaneous report from a non-contactable Consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown, whether the patient was pregnant or not. It was unknown, whether the patient had COVID prior vaccination. On an unspecified date, the patient later tested positive for COVID-19 and requires treatment at a hospital. The patient was hospitalised for event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient was tested post vaccination. Outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She had tested positive for COVID this summer; She had tested positive for COVID this summer; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of bnt162b2 (Pfizer-bioNtech covid-19 vaccine, Solution for injection), via an unspecified route on an unspecified date in Feb2021 (age at vaccination: 71-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-bioNtech covid-19 vaccine, Solution for injection), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. On an unknown date, patient had tested positive for covid this summer and had an antibody therapy on 10Aug2021. Patient wants to know the timing on when she can have the booster dose of the vaccine. She wants to confirm if she needs to wait 90 days or 8 months from the time, she had her infusion before she can have the booster dose. She mentioned if you had antibody in the past you can wait for 8 months. COVID-19 vaccine can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. These interim considerations state mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection. Patient mentioned that you were not able to answer my question whether she should wait 90 days or 8 months before she can have the booster dose. The patient underwent lab test and procedure which included SARS-CoV-2 test positive. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Oedema, Rash pruritic
Clinical narrative: he developed skin rash/ rash itches very bad; It came back as some form of edema; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533, NDC number, expiry date: unknown) via an unspecified route of administration on 02Apr2021 in the morning (at the age of 80-years-old) in left arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, allergies to penicillin and ibuprofen, stage II diabetes all from an unknown date and unknown if ongoing. He takes Glipizide 1 tablet twice daily, 5mg for diabetes. This report is related to a study or programme. No additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included glipizide (GLIPIZIDE) taken for type 2 diabetes mellitus from an unspecified start date and ongoing. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, lot number EN6208) on 12Mar2021 in the morning in left arm for covid-19 immunization. The patient experienced skin rash on an unknown date in 2021 few weeks after second dose. He tried multiple creams and ointments and shots, but nothing had helped. He tried to heal up his leg and he had hard time getting it to heal. The doctor took biopsy of his legs where the rash was, and It came back as some form of oedema. The rash itched very bad that it wakes him up at night. It was mainly on his feet, legs and some on his waist, back and stomach. He took Prednisone for 5 days and it did help a little, but once he finished it the rash came back but was somewhat improved. He read about the booster and asked if he had rash, should he get the booster and should the rash last this long. He had gone to several doctors for the rash. They have tried many different medications that don't seem to work. The adverse event required physician office visit. The patient underwent lab tests and procedures which included biopsy on an unknown date in 2021. Treatment medication included Clotrimazole cream USP 1 percent, antifungal, yellow label with no NDC/lot/expiration; Triamcinolone Acetonide ointment USP 0.25 percent, Lot: 1TT1CT0592, Feb2023; Ammonium Lactate 12 percent lotion: expiration: Aug2022, lot: 0KT0432; Augmentin cream, no NDC/lot/expiration reported; Benadryl allergy tablet 25mg tablet, he doesn't see a UPC/lot/expiration on them (over the counter); Hydrocortisone 1 percent cream no NDC/lot/expiration; Mupirocin Bactroban ointment: 22g, no NDC/lot/expiration; Prednisone 20mg tablets. The sample of the product was available to be returned. The outcome of both the events was not resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: face becoming numb as well as numbness in her fingers and legs; This is a spontaneous report from a contactable other healthcare professional. A 57-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date was not reported), via an unspecified route of administration on 13May2021 as dose 1, single (at the age of 57-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13May2021, immediately after having the first dose, patient started having complaints of her face becoming numb as well as numbness in her fingers and legs that lasted approximately thirty minutes then resolved. The outcome of the event was recovered on 13May2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable pharmacist. A female patient in her 60's (5-decade-old female patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included hepatitis c from an unknown start and stop dates. The patient experienced headache on an unspecified date. The reporter stated the patient reports that the headache has lasted for 10 days and has not subsided, and patient is concerned whether the headache is related to the new medication or the Pfizer BioNTech COVID-19 Vaccine. The reporter stated she consulted the Prescribing Information for the Hepatitis C medication and it states that severe headache accounts for 10% to 20% of reported side effects. The adverse event was considered as non-serious. The outcome of the event was reported as not recovered.  Information on Lot/Batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Herpes zoster, Rash
Clinical narrative: outbreak of shingles in the face, right ear, and neck; ear pain; rash; This is a spontaneous report from a contactable physician. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced outbreak of shingles in the face, right ear, and neck, ear pain and rash on an unspecified date. Outcome of the events was unknown.  Follow-up (18Aug2021): This is a Follow-up spontaneous report from a contactable Physician.  Information about lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urine alcohol test
Clinical narrative: Pain in arm after first dose of Covid Vaccine; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0181), via an unspecified route of administration in left arm on 09Jul2021 at in-between 16:00 and 17:00 (at the age of 52-year-old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history included sleep apnoea from an unknown date and unknown if ongoing, GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medications included modafinil taken for sleep apnoea syndrome, start and stop date were not reported; omeprazole (PROTONIX) taken twice a day for gastrooesophageal reflux disease, start and stop date were not reported. Unspecified cholesterol medication taken for cholesterol, start and stop date were not reported. Family medical history relevant included cancer and high blood pressure in family. The patient's mother has high cholesterol. On 09Jul2021, experienced pain in arm after the first dose of COVID vaccine it lasted for about a week. The adverse event was not resulted in emergency room and physician office. Caller stated that in between her two doses of the vaccine she had a urine test done and it was perfectly clean. The outcome of the event was reported as resolved on an unknown date in Jun2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070481 Same patient, different drug, different event (split)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: two of her patients are breakthrough cases; two of her patients are breakthrough cases; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This consumer reported similar events for two patients. This is the second of two reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history included blood pressure abnormal and diabetes mellitus. The concomitant medications for patient were not reported. The consumer's daughter (physician) working in ICU stated that two of her patients were breakthrough cases who had conditions such as blood pressure and diabetes. These two were in critical conditions and they had to be put on ventilator. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070268 same  drug/reporter/events, different patients
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy test
Clinical narrative: Miscarriage; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, NDC number, Expiry Date: Unknown) via an unspecified route of administration on an unspecified date in Jun2021 (Age at vaccination: 37- years-old) as dose 2, single (patient partner got both doses) for COVID-19 immunization. No medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine which the patient partner took was BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that the stated that she was not sure if it was a reportable event, but her partner got both doses of the vaccination and she got pregnant after he was fully vaccinated (03Jul2021) and she miscarried (14Aug2021), she did not get the Pfizer COVID-19 vaccine but her partner got both doses, she did not have her partners vaccine card to provide the NDC/LOT/EXP or dates of vaccination from it. She says she believes her partner got both doses of the vaccine and was fully vaccinated in Jun (unspecified date). She was experiencing the miscarriage/miscarrying now (14Aug2021), which started Saturday, and she just left the doctor's today (unspecified date) and she confirmed that it was dead. The patient underwent lab tests and procedure which included pregnancy test: positive on 03Jul2021. The event miscarriage was considered as serious (Medically Significant). The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Urine analysis
Clinical narrative: Pain in arm after second dose of the Covid Vaccine; Dizziness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 52-year-old female patient received (BNT162B2, Solution for injection, Batch/Lot Number: FA7484), dose 2 via an unspecified route of administration, administered in Left arm on 31Jul2021 (at the age of 52-year-old) as single for covid-19 immunization. Vaccination was given between the time of 16:00 and 17:00. Medical history included Sleep apnoea and GERD/Reflux from an unknown date and unknown if ongoing. Family medical history included high cholesterol, cancer and high blood pressure in family. Additional Vaccines Administered on Same Date of the Pfizer Suspect were reported as none. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine and AEs following prior vaccinations were reported as none. Concomitant medications included ongoing modafinil taken as single for sleep apnoea syndrome and omeprazole (PROTONIX) taken as twice daily for gastrooesophageal reflux disease. Historical vaccine included BNT162B2 (solution for injection, Lot Number: EW0181) dose 1 administered in left arm on 09Jul2021 (at the age of 52-years-old), as single for COVID-19 immunisation and experienced pain in arm after first dose of Covid Vaccine. On 31Jul2021 the patient experienced pain in arm and dizziness after second dose of the covid vaccine. The patient stated that so far she was doing good after her vaccines. Stated that her and her boyfriend had pain in their arms that lingered for days (with the second dose it lasted about 3-4 days). Said so far that was the only side effect she knows of. Stated there was a little bit dizzy also after the second vaccine, but that only lasted about an hour or 45 minutes, otherwise they were doing good. Stated that was wasn't anything extreme it was just lightheadedness. The AEs does not required a visit to emergency room and physician office. The patient stated that in between her two doses of the vaccine she had a urine test done on an unspecified date in 2021and it was perfectly clean. Outcome of the event dizziness was resolved on 31Jul2021 and pain in arm resolved on an unspecified date in Aug2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070234 Same patient, different drug, different event (split)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Depressed mood, Drug ineffective, Pneumonia
Clinical narrative: Positive for covid; Positive for covid; Pneumonia; Depressed/ "feel's discouraged; This is a spontaneous report from a contactable other hcp. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 74 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included asthma, rheumatoid arthritis. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication. It was reported that after taking the therapy, noted improvement in rheumatoid arthritis symptoms. However, in the past month a lot of joint pain all over the body feels miserable. Pain level 8/10 missed doses a couple of times due to mail in her area is slow no adverse effects mention due to missed doses. It was reported that the patient received covid 19 vaccine dose 1 on Mar2021 however, before receiving the second dose was positive for covid 19, hospitalized for one night only, unspecified  date May2021 . The patient was diagnosed with pneumonia however, she said it was her asthma, prescribed with antibiotics. no missed doses. While receiving the covid 19 vaccine. (unknown if the therapy was held due to covid 19 positive, taking antibiotics). Generally, it's been hard for her to cope with rheumatoid arthritis and sometimes she feels discouraged and/or depressed, feel's discouraged. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Covid 19 and Pneumonia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus after both vaccines; Tested positive for Covid virus after both vaccines; Tested positive for Covid virus after both vaccines on an unspecified date in Feb2021; This is a spontaneous report from a contactable consumer (patient wife) reported for a male patient (reporter husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 1, SINGLE and dose 2 (Lot number: not reported) via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were not reported. Other products, patient history and investigation assessment was not provided. Caller states that her family caught COVID, reclarified her husband did also. The patient experienced tested positive for COVID virus after both vaccines and inappropriate schedule of vaccine administered on an unspecified date in 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date in 2021. The outcome of the events were unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Haemorrhage, Pruritus, Rash macular, Scratch
Clinical narrative: The itch intensely and bleed when scratched.; patient was getting small bumps with a little white spot in the center; The itch intensely and bleed when scratched.; The itch intensely and bleed when scratched.; They itch intensely and swell up to the size of a quarter.; Patient also seem to be having extreme reactions to bug bites like mosquitos; This is a spontaneous report from a contactable consumer (the patient). A 51-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150), via an unspecified route of administration, in the left arm, on an unspecified date in Mar2021 (at the age of 51-year-old), as single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration, in the right arm, on an unspecified date in Mar2021 at 09:45 (at the age of 51-year-old), as single dose, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. On 28Apr2021, patient was getting small bumps with a little white spot in the center. The itch intensely and bleed when scratched. They started within a week after the second vaccine dose. At first patient thought they were bug bites, but the keep occurring intermittently without reason. They also take several weeks to heal. Patient also seem to be having extreme reactions to bug bites like mosquitos. They itch intensely and swell up to the size of a quarter. This was not the case in the past. Patient used steroid cream to help with the itching and events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: The itch intensely and bleed when scratched.; patient was getting small bumps with a little white spot in the center; The itch intensely and bleed when scratched.; The itch intensely and bleed when scratched.; They itch intensely and swell up to the size of a quarter.; Patient also seem to be having extreme reactions to bug bites like mosquitos; This is a spontaneous report from a contactable consumer (the patient). A 51-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150), via an unspecified route of administration, in the left arm, on an unspecified date in Mar2021 (at the age of 51-year-old), as single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration, in the right arm, on an unspecified date in Mar2021 at 09:45 (at the age of 51-year-old), as single dose, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. On 28Apr2021, patient was getting small bumps with a little white spot in the center. The itch intensely and bleed when scratched. They started within a week after the second vaccine dose. At first patient thought they were bug bites, but the keep occurring intermittently without reason. They also take several weeks to heal. Patient also seem to be having extreme reactions to bug bites like mosquitos. They itch intensely and swell up to the size of a quarter. This was not the case in the past. Patient used steroid cream to help with the itching and events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: 8 days after the vaccination (on 14Aug2021), I started having extreme hives all over my body; They flare up every 2 hours and are extremely itchy and painful.; They flare up every 2 hours and are extremely itchy and painful.; This is a spontaneous report from a contactable consumer (patient). A 37 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: FC3180) via an unspecified route administered in Right Arm on 05Aug2021 at 10:00 (37-year-old at vaccination) as dose 1, single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included known allergies to egg, penicillin, singulair. There were no concomitant medications. The patient's past medications included, singulair. Facility type vaccine was reported as Pharmacy or Drug Store. The patient had not received any other vaccine within four weeks prior to Covid -19 vaccination. The patient was neither diagnosed with Covid prior vaccination nor tested post vaccination. On 14Aug2021 at 18:00 (9 days after the vaccination) she started having extreme hives all over her body. This was 18Aug2021 and the hives had not disappeared. They flare up every 2 hours and are extremely itchy and painful. She had reported this to her doctor. These adverse events resulted to doctor or other healthcare professional office/clinic visit. The patient received Zyrtec as treatment medication for resulted events. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: I have lymphedema in my right leg and my lymphedema got considerably worse for 2 weeks afterwards; This is a spontaneous report from a contactable Nurse (patient). A 63-years-old female non-pregnant Nurse patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 at 13:00 (at the age of 64-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. No known allergies were reported. Other medical history was none. No other vaccine was administered in four weeks. Other medications in two weeks were none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient said, I have lymphedema in my right leg and my lymphedema got considerably worse for 2 weeks afterwards on 25Jan2021 at 16:00. No treatment was received for events. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 13:00 (at the age of 64-years-old) as a DOSE 2, SINGLE for covid-19 immunisation. Outcome of the event was recovering.    Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Faeces discoloured, Gastric ulcer, Gastric ulcer haemorrhage
Clinical narrative: He has had a ulcer in his stomach,and he had bleeding inside; and his stomach liner opened up; Black stools; Black stools was reported as worsened.; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0169; Expiration Date: 31Aug2021) via an unspecified route of administration at arm left on 17Aug2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included gastric ulcer from an unknown date and unknown if ongoing Verbatim: Stomach ulcer. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. He got the Pfizer COVID shot on Tuesday 17Aug2021. Then, he noticed the next day his stool was black. He had this before, and he had bleeding inside. His stool is really black. It is really bad now. The dark stools started 18Aug2021. It had worsened. He hasn't seen a doctor or went to the Emergency room. He hasn't had treatment yet. He just went to the bathroom and noticed it was really bad. He just came from the bathroom. He will probably tell his boss today he will need to go get checked out. He has had a ulcer in his stomach, and his stomach liner opened up (gastric disorder). They asked if he had ever had an issue with bleeding before. on 18Aug2021 condition aggravated. Outcome of the events faeces discoloured and condition aggravated was not recovered, gastric ulcer and gastric disorder was unknown.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 104 degrees Fahrenheit; Muscle Aches; Nausea; Headache; This is a spontaneous report from a contactable healthcare professional. A 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) dose 1, intramuscularly administered in deltoid right on 12Aug2021 08:15 (Lot number CN1583; Expiration Date: Aug2022, NDC number: 0005010005) as 0.5 mL, single for immunisation in physician office; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP, Sanofi-Pasteur) dose 1 intramuscularly in left deltoid on 12Aug2021 (Lot Number: U6969AB; Expiration Date: 04Mar2023) at unknown dose for immunisation. The patient medical history and concomitant medications were reported as none. No Family Medical History Relevant to AE. The patient experienced fever of 104 degrees Fahrenheit, muscle aches, nausea, headache on 13Aug2021 with outcome of recovering. He also required a visit to the ER. Patient was admitted due to all of the adverse events listed. Nausea medication and ibuprofen or Motrin was given at the Emergency room. There was no admission to the hospital. Events were reported as medically significant. Patient's symptoms all started less than 24 hours after receiving the vaccine. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: first shot given a migraine began. Every day since I battle the same migraine. Was worsened with second shot; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization (vaccinated at the age of 38-years). Medical history included food allergy (Apples, Bananas, Penicillin, kiwi, latex, adhesives, Niacin, all antibiotics), rubber sensitivity, dermatitis, polycystic ovaries, endometriosis, adenomyosis, fibrocystic breast disease, Heart attack. Concomitant medication(s) included rosuvastatin calcium (CRESTOR), fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ibuprofen (MOTRIN [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient previously took bnt162b2 for covid-19 immunization and experienced migraine, niacin and experienced drug hypersensitivity. On an unspecified date the patient reported first shot given a migraine began. every day since she battle the same migraine was worsened with second shot. The outcome of event was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lethargy, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid test result=Positive; fever; coughing; lethargy; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 32-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported as patient had Covid tested post vaccination. On an unknown date, patient experienced covid test result=positive, fever, coughing and lethargy. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on an unknown date. On an unknown date, patient had recovered with sequel (lasting effects) from the event fever, coughing and lethargy while outcome of the event covid test result=positive was reported as unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected