chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Scan, Suspected COVID-19, Thrombosis
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19 / did not test positive for COVID-19"; THROMBOSIS (medically significant), outcome "unknown", described as "Clot in my leg"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Leg swollen up"; MALAISE (non-serious), outcome "unknown", described as "Fell ill"; CHILLS (non-serious), outcome "recovered"; COUGH (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "Soreness on the right side"; GAIT INABILITY (non-serious), outcome "unknown", described as "Could not walk". The events "positive for Covid-19 / did not test positive for Covid-19", "clot in my leg", "leg swollen up" and "could not walk" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown; SARS-CoV-2 test: Negative, notes: Around the holidays the family gathered after being tested and we all tested negative; Scan: clot, notes: The doctor came and did a scan and they found a clot in my leg. Therapeutic measures were taken as a result of thrombosis. Clinical information: Patient was fully vaccinated. 2 doses and then one booster. Everything was fine after the booster. Just a little sore. Around the holidays the family gathered after being tested and they all tested negative. However, her grandson fell sick. He had a fever, cough, congestion. He was taken to the doctor and the fever went down. A day after fell ill. By the third day, at home, felt chills, cough, fever, soreness on the right side. The next day it was gone. The next 3 or 4 days it was fine. Then, on 18Jan to 19Jan2022 ended up in the ER with leg swollen up. The doctor came and did a scan and they found a clot in leg. Patient was administered heparin and all that kind of stuff. He was sent to be taken an X-ray and the hematologist put on blood thinners for a minimum of three months. For 2 weeks straight patient couldn't walk. The doctor said that, according to the timeframe, most probably patient got the clot from a mild case of COVID-19. So now patient on a blood thinner. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster; is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "parathyroidectomy" (unspecified if ongoing), notes: caller had a parathyroidectomy and during the previous year; "knees replacements." (unspecified if ongoing), notes: caller had 2 knees replacements. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid Sunday, 08May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Taking Paxlovid for Covid and wanted to know how long after taking the medication to get her Pfizer booster shot.  The caller confirmed the details provided by the transfer agent. Clarified she is wanting to know how long she has to wait to get her Pfizer COVID-19 vaccine booster. She had two regular COVID-19 shots and one booster already. She has her second COVID-19 Vaccine booster scheduled. Her and her husband both has COVID.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162b2.,Linked Report(s) : US-PFIZER INC-202200700315 Same product and event, different patient
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parathyroidectomy, SARS-CoV-2 test
Clinical narrative: is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster; is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "parathyroidectomy" (unspecified if ongoing), notes: caller had a parathyroidectomy and during the previous year; "knees replacements." (unspecified if ongoing), notes: caller had 2 knees replacements. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid Sunday, 08May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Taking Paxlovid for Covid and wanted to know how long after taking the medication to get her Pfizer booster shot.  The caller confirmed the details provided by the transfer agent. Clarified she is wanting to know how long she has to wait to get her Pfizer COVID-19 vaccine booster. She had two regular COVID-19 shots and one booster already. She has her second COVID-19 Vaccine booster scheduled. Her and her husband both has COVID.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162b2.,Linked Report(s) : US-PFIZER INC-202200700315 Same product and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: develop cancer quickly and die after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "develop cancer quickly and die after receiving the vaccine". The patient date of death was unknown. Reported cause of death: "develop cancer quickly and die after receiving the vaccine". It was not reported if an autopsy was performed. This case is reported as non-serious. The reporter stated, "my sister was going on and on about deaths related to covid injections" later clarifying she was speaking about the Pfizer-Covid19 vaccine. She stated, "We've had several friends up and die. she's had 4 friends develop cancer quickly and die after receiving the vaccine. This one lady didn't have cancer and she was dead in three weeks." Later adding "I think she's worried about long-term side effects" not those close to administration but "5 months later they got sick and died, people who had cancer and it came back quickly". She stated her sister had been doing a lot of research online, but she's not sure what sources she's reading. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: develop cancer quickly and die after receiving the vaccine
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional Information: The report is cross referenced to report ID: withheld. Warm transfer from agent withheld Pfizer (name withheld) has a caller who took the Covid shot and did not feel well. Stated that he was told that the shot may have been expired. Information confirmed as provided. Stated that his son got the vaccine and was not feeling well and recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 at 15:00 as dose 1, single (Lot number: EL9269), in left arm, on 06Aug2021 at 10:00 as dose 3 (booster), single (Lot number: EW0198) at the age of 78 years, in left arm and on 27Feb2021 at 15:00 as dose 2, single (Lot number: EN6200), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No other medication received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 11Feb2021 as dose 2, single (Lot number: EL9262), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for Covid-19 immunisation; rosuvastatin calcium (ROSUVASTATIN CALCIUM), (Batch/Lot number: unknown) at 5 mg 1x/day (5 mg, 1x/day (once a day, in the evening)) for blood cholesterol abnormal. The patient's relevant medical history included: "underactive thyroid" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Blood thinners" (unspecified if ongoing), notes: Her partner was with her but he can't take Blood thinners on this medication; "arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder; CALCIUM. Past drug history included: Synthroid, notes: this runs in her family and she has been taking the Synthroid for 20 years, probably. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid, after being fully vaccinated". Suspect Products: Covid vaccine: Clarified that the caller had all four doses in the left arm. Indication: She was trying to be diligent and not get Covid. Description of complaint was tested positive for Covid, after being fully vaccinated. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: lost a few pounds, notes: She is 137 now and has lost a few pounds. The action taken for rosuvastatin calcium was temporarily withdrawn. Therapeutic measures were taken as a result of sars-cov-2 test positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 31-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "moderate to severe symptoms 09May2022 and Covid Ag test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: Home Ag; Covid Ag test positive. It was unknown if therapeutic measures were taken as a result of Vaccination Failure, Covid-19. Additional information: facility type vaccine: Workplace clinic, If other vaccine in four weeks: Unknown, If treatment AE: Unknown, If Covid prior vaccination: Unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1 , single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 as dose 3 (booster) , single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Breast Cancer" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: Aug1999; PROVIGIL [CHORIONIC GONADOTROPHIN], start date: May2007; LAMOTRIGINE, start date: Feb2011. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 02May2022 at 10:00, outcome "recovered" (09May2022) and all described as "Covid-19". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: 11 days after first dose Covid-19 symptoms re-occurred. Symptoms were worse the second time. Paxlovid treatment reported with start date as 21Apr2022 nd stop date as 26Apr2022 with indication as Treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  Additional information: Patient did not received other medication in 2 weeks. Reporters husband started taking Paxlovid on 6May and on 9May started experiencing GI upset. On 10May started with bad diarrhea for about 4 hours straight. He had to take Imodium to stop it.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Antibiotics for known allergies: Antibiotics. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 14:00 as dose 1, single (Lot number: Eh9899), in left arm, on 06Feb2021 at 14:00 as dose 2, single (Lot number: El1284), in left arm, on 23Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 3013584), in right arm and on 18Apr2022 at 11:00 as dose 4 (booster), single (Lot number: Fp4554) at the age of 78 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Double bypass heart surgery" (unspecified if ongoing), notes: Other medical history: Double bypass heart surgery and diabetic; "diabetic" (unspecified if ongoing), notes: Other medical history: Double bypass heart surgery and diabetic; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Tetracycline. The patient's concomitant medications were not reported. Past drug history included: Tetracycline for Known allergies: Tetracycline, notes: Known allergies: Sulfa drugs, Tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "recovering" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Paxlovid had a rebound effect approximately 10 days after testing negative; (26Apr2022) Positive, notes: Tested positive for Covid on 26Apr. Therapeutic measures were taken as a result of Covid-19. Clinical course: Other medication in 2 weeks was reported as unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 43-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FJ1620), at the age of 42, in left arm, on Nov 11, 2021, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine, (batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history included mild hypertension (unspecified if ongoing) and dairy (unspecified if ongoing). Concomitant medications not reported. The patient experienced COVID-19/tested positive for COVID-19 (medically significant) and ineffective drug (medically significant), with outcome of not recovered. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (May 8, 2022) negative; (Apr 30, 2021) positive, notes: Tested positive for COVID-19 on April 30. Therapeutic measures were taken as a result of COVID-19 and ineffective drug. Clinical course: Patient did not receive other medication in 2 weeks of vaccination. No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe chronic allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 25Jul2021 at 11:00 as dose 1, single (Lot number: FA6780) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe chronic allergic reaction". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Patient's Medical History (including any illness at time of vaccination) was None. Prior Vaccinations (within 4 weeks) were None. Vaccination Facility Type was Pharmacy or drug store. Relevant tests were none. Since Jan 2nd week and up today, the patient tested negative and healthy. After 4 months after the 2nd dose (03Jan2022) covid-19 vaccine, the patient got sick/tested positive. 7 to 8 months taking anti-histamine (Zyrtec/allergy 24hours allergy). A healthy 43 years old female individual, who does not have any allergy history, who does not have any medication maintenance yet developed a severe chronic allergic reaction after taking the 1st and 2nd vaccine covid-19, specially the 2nd dose.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8737), in left arm, on 21Apr2021 as dose 2, single (Lot number: ER8729), in right arm and on 13Nov2021 at 16:30 as dose 3 (booster) single (Lot number: 3230BD) at the age of 57 years, in right arm for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIOTHYRONINE. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 Treatment/tested positive and Started Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of Covid-19. Additional information: Adverse event- Had symptoms but tested negative. Next day, tested positive and Started Paxlovid. (Calling this Day 1). Took full course (5 days) Paxlovid. Felt much better by Day 4 but still slight symptoms. Rapid test had bold line Days 1-6. Day 7 test showed very faint line. Day 10 got sick again, different symptoms (sinuses involved now), felt very fluey, had fever again, and rapid test showed bold line again. Felt better after several days. Rapid tests continued to be positive until Day 16 when I tested negative. Anti-viral details- Product-COVID 19 Treatment includes, Brand- Paxlovid. Treatment start date was 18Mar2022, Treatment stop date was 22Mar2022, Lot number-FW6343. Indication was Treatment of COVID-19. Adverse event start date was 27Mar2022, patient was recovered. Adverse event stop date was 02Apr2022.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, in left arm, as dose 2, single (Batch/Lot number: unknown) for 1 day, in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Adhd" (unspecified if ongoing); "reactive airways" (unspecified if ongoing); "non-allergic rhinitis" (unspecified if ongoing); "Known-allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) medication taken in 2weeks of product included: ADDERALL taken for 7 years, MUCINEX, other medication in 2weeks brand= Have taken 1-2x daily to treat nonallergic rhinitis for 9 months.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative for covid on day 7 (antigen) since initial diagnosis; tested. negatively repeatedly in subsequent days, with improvement of symptoms; Positive, notes: tested positive again (antigen) on day 12 and day 14 (today is day 14). Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product COVID 19 Treatment, bran: Paxlovid, treatment start date:27Apr2022, treatment stop date:02May2022, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 07Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2595) at the age of 65 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Bad knees" (unspecified if ongoing), notes: Other medical history: bad knees,; "Over weight" (unspecified if ongoing), notes: Other medical history: overweight; "Known allergies: several, not serious allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Dec2021, stop date: 09May2022; TRIAMTERENE, start date: 01Dec2021, stop date: 09May2022. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01May2022) Negative; (07May2022) Positive; (09May2022) Positive. Therapeutic measures were taken as a result of Covid-19 with Paxlovid, treatment start date: 25Apr2022, treatment stop date: 29Apr2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of Covid-19; Treatment of Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seronegative arthritis" (unspecified if ongoing); "Beta thalassemia" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; GABAPENTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of Covid-19". Therapeutic measures were taken as a result of suspected covid-19 which included Paxlovid from 29Apr2022 to 05May2022.  Clinical course: Rebound Covid symptoms started a few days after finished medicine. Mild Covid symptoms so far.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypertension, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccine dose number=3, 04Sep2021; COVID 19 Treatment; vaccine dose number=3, 04Sep2021; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 at 04:00 as dose 1, single (Batch/Lot number: unknown), on 22Jan2021 at 02:00 as dose 2, single (Batch/Lot number: unknown) and on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ XR, start date: 03Jul2019; OMEPRAZOLE; AMERGE; HYDROCODONE. Past drug history included: Amoxicillin for Allergy:Amoxicillin; Imitrex for Allergy:imitrex; Demerol for Allergy:Demerol.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "vaccine dose number=3, 04Sep2021; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Hypertension: High BP; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient had treatment with anti-viral product, brand paxlovid, treatment start date: 30apr2022, treatment stop date: 04may2022, indication: treatment of covid-19. The patient had very High BP while taking. Recurrence of covid symptoms and positive covid test again 5 days post completion of treatment. The patient had other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 23 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (09May2022) Positive; (10May2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: Other medication in 2 weeks was reported as no. No known allergies. Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" 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 drug 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Obese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99 degrees; SARS-CoV-2 test: (27Apr2022) Positive, notes: tested positive on home test; (02May2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL3249), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FH80220) at the age of 74 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. The patient had no Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Adverse event: Ill with symptoms for 5 days. 2 negative tests on 6th day and 9th day. Relapsed with symptoms on 10th day. Tested positive on 11th day. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: 2 negative tests on 6th day and 9th day; (May2022) Negative, notes: 2 negative tests on 6th day and 9th day; (May2022) Positive, notes: Tested positive on 11th day. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Treatment started on 27Apr2022 and stopped on 01May2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had clear discharge from my nose on 18Apr2022 and I tested positive for COVID with an antigen test. The discharge just lasted a day and I tested negative for COVID on 23Apr2022.; I had clear discharge from my nose on 18Apr2022 and I tested positive for COVID with an antigen test. The discharge just lasted a day and I tested negative for COVID on 23Apr2022.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 1, single (Lot number: EW0150), in right arm, on 27Apr2021 at 12:00 as dose 2, single (Lot number: EW0176), in right arm and on 27Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Mar2022 at 15:30 as dose 4 (booster), single (Lot number: EW0176), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to penicillin" (unspecified if ongoing), notes: Allergic to penicillin and I am lactose, intolerant; "lactose intolerant" (unspecified if ongoing), notes: Allergic to penicillin and I am lactose, intolerant. Concomitant medication(s) included: VITAMIN D3, start date: 09Feb2017. The following information was reported: DRUG INEFFECTIVE (medically significant), 5 years 2 months 9 days 12 hrs 45 min after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 5 years 2 months 9 days 12 hrs 45 min after the suspect product(s) administration, outcome "recovered" and all described as "I had clear discharge from my nose on 18Apr2022 and I tested positive for COVID with an antigen test. The discharge just lasted a day and I tested negative for COVID on 23Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) positive; (23Apr2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Antiviral details product: COVID 19 Treatment, brand: Paxlovid. Treatment start date: 31Mar2022, Treatment stop date: 04Apr2022, Indication: Treatment of COVID-19. Adverse event: Consumer had clear discharge from her nose on 18April2022 and she tested positive for COVID with an antigen test. The discharge just lasted a day and she tested negative for COVID on 23April2022.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: her husband just received a booster shot of Pfizer COVID-19 vaccine; has rashes all over the body; it's like a red blackish rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A male patient received BNT162b2 (BNT162B2), on 10May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but unknown manufacturer.), for Covid-19 immunization.  The following information was reported: RASH (non-serious) with onset 10May2022, outcome "unknown", described as "her husband just received a booster shot of Pfizer COVID-19 vaccine; has rashes all over the body; it's like a red blackish rash".  Additional information: The reporter stated that her husband just received a booster shot of Pfizer COVID-19 vaccine and her husband now has rashes all over the body. It was like a red blackish rash. Husband received the booster shot two hours ago.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: ff2593) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastroperesis" (unspecified if ongoing); "Motility disorder" (unspecified if ongoing); "constipation" (unspecified if ongoing); "IBS" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: LINZESS, start date: 20May2020; MOTEGRITY, start date: 20May2020; YAZ taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Anti-viral Paxlovid as treatment therapy from 05May2022 to 08May2022. Had to stop taking the medicine after day 3 because of extreme nausea. The nausea had persisted since patient stopped it for 3 days now and was there the whole day. Patient stomach was also extremely sensitive even to touch. So nauseous hard to eat, stand, and walk. Zofran, which usually helps for patient nausea, was not helping. No vomiting just nausea. patient experienced nausea on 07May2022 and received treatment of Zofran and patient was not recovered from nausea.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 12:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10May2022) Positive, notes: Rebound Covid infection, 10May. Therapeutic measures were taken as a result of drug ineffective, covid-19. other medication in 2weeks was No. Rebound Covid infection, 10May. This is one week after completing. Paxlovid 5 day dose age.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Vision blurred
Clinical narrative: almost blinded; He ended up with blurred vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: EW0168) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (hospitalization), outcome "unknown", described as "almost blinded"; VISION BLURRED (hospitalization), outcome "unknown", described as "He ended up with blurred vision".
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder, Vaccination site discomfort
Clinical narrative: She has noted that the muscle under the skin of the injection site started to go away; She has noted that the muscle under the skin of the injection site started to go away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2022 at 16:00 as dose 1, single (Lot number: FK9729) at the age of 47 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), MUSCLE DISORDER (non-serious) all with onset Apr2022, outcome "not recovered" and all described as "She has noted that the muscle under the skin of the injection site started to go away". Therapeutic measures were not taken as a result of vaccination site discomfort, muscle disorder.  Additional information: Patient does not have history of all previous immunization with the Pfizer vaccine considered as suspect Patient does not had any additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse events does not require a visit to: Emergency Room or Physician Office.  There were no prior Vaccinations(within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine(s). Family Medical History Relevant to AE(s) was provided as none
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She has been experiencing fever ever since (5 days) which usually starts at night time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 1, single (Lot number: FL8095) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to all citrus, pineapples, apples." (ongoing), notes: States daughter is allergic to all citrus, pineapples, apples. There were no concomitant medications.  The following information was reported: PYREXIA (non-serious) with onset 06May2022, outcome "not recovered", described as "She has been experiencing fever ever since (5 days) which usually starts at night time".