chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Malaise, Nausea, Photosensitivity reaction
Clinical narrative: she experianced about 3 bumps at around the injection site ( she received all injections in the same arm).  it was like  " mosquito  bites" swelling, itching all over the site; she experianced about 3 bumps at around the injection site ( she received all injections in the same arm).  it was like  " mosquito  bites" swelling, itching all over the site; it happened again when she went out in the sun (she went on a cruise, direct sun light) she had those bumps again at the site.; not feeling good; nausea; did not want to eat; coughing; swelling; 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 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "recovered" and all described as "she experianced about 3 bumps at around the injection site (she received all injections in the same arm).  it was like  " mosquito  bites" swelling, itching all over the site"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "it happened again when she went out in the sun (she went on a cruise, direct sun light) she had those bumps again at the site."; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; NAUSEA (non-serious), outcome "unknown"; DECREASED APPETITE (non-serious), outcome "unknown", described as "did not want to eat"; COUGH (non-serious), outcome "unknown", described as "coughing"; SWELLING (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Attempted warm transfer. Patient on the line calling because she received two Pfizer Covid vaccines in 2020 or 2021 and a booster shot as well. After shot, one day when she went out in the sun and experienced bumps around the injection site. It was like mosquito bites, was itching, swelling, and it resolved at that time. Now again, it happened when she went out in the sun. Said she went on a cruise and was in the direct sunlight and the bumps came back again. This time she wasn't feeling good and had nausea with the bumps, and did not want to eat. She was diagnosed with Covid on 13Jun2022. The bumps for the Covid vaccine happened last year. Caller also reported that she took Paxlovid and that made her very sick. She only took four days of the medication. Had a cough with the Paxlovid as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: she experianced about 3 bumps at around the injection site ( she received all injections in the same arm).  it was like  " mosquito  bites" swelling, itching all over the site; she experianced about 3 bumps at around the injection site ( she received all injections in the same arm).  it was like  " mosquito  bites" swelling, itching all over the site; it happened again when she went out in the sun (she went on a cruise, direct sun light) she had those bumps again at the site.; not feeling good; nausea; did not want to eat; coughing; swelling; 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 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "recovered" and all described as "she experianced about 3 bumps at around the injection site (she received all injections in the same arm).  it was like  " mosquito  bites" swelling, itching all over the site"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "it happened again when she went out in the sun (she went on a cruise, direct sun light) she had those bumps again at the site."; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; NAUSEA (non-serious), outcome "unknown"; DECREASED APPETITE (non-serious), outcome "unknown", described as "did not want to eat"; COUGH (non-serious), outcome "unknown", described as "coughing"; SWELLING (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Attempted warm transfer. Patient on the line calling because she received two Pfizer Covid vaccines in 2020 or 2021 and a booster shot as well. After shot, one day when she went out in the sun and experienced bumps around the injection site. It was like mosquito bites, was itching, swelling, and it resolved at that time. Now again, it happened when she went out in the sun. Said she went on a cruise and was in the direct sunlight and the bumps came back again. This time she wasn't feeling good and had nausea with the bumps, and did not want to eat. She was diagnosed with Covid on 13Jun2022. The bumps for the Covid vaccine happened last year. Caller also reported that she took Paxlovid and that made her very sick. She only took four days of the medication. Had a cough with the Paxlovid as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: Constant headaches of varying degrees for 14 months; Nearly debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 14May2021 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: coviD-19 vaccine (UNKNOWN MANUFACTURER, administrated on 01May2021 at 03:00 AM, dose number: 1, vaccine location: right arm), administration date: 01May2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 14May2021 at 18:45, outcome "not recovered", described as "Constant headaches of varying degrees for 14 months"; ASTHENIA (non-serious) with onset 14May2021 at 18:45, outcome "not recovered", described as "Nearly debilitating". The events "constant headaches of varying degrees for 14 months" and "nearly debilitating" required physician office visit. Therapeutic measures were taken as a result of headache, asthenia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. No other medications in two weeks. The 4 hours after the 2nd shot in May2021, the patient have had constant headaches of varying degrees for 14 months. Nearly debilitating. Multiple treatments over 14 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 74-year-old male patient received BNT162b2 (BNT162B2), on 16May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: No known allergies. Antiviral details: COVID 19 treatment start date was 06Jul2022.
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 (consumer). The reporter is the patient. A 31-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), as dose 1, single (lot number unknown) and as dose 2, single (lot number unknown) for covid-19 immunisation; and covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Dec2021 at 12:00 as dose 3 (booster), single (lot number unknown), in left arm 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) and SUSPECTED COVID-19 (medically significant), outcome "unknown" and described as "COVID-19". Therapeutic measures were taken as a result of the events which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 12Oct2021 as dose 3 (booster), single (Lot number: FF3580) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2022 at 11:00 as dose 4 (booster), single (Lot number: 001M21A), 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); "diabetes" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at injection after each 3 doses/She then stated that her arms stay sore and still are. This occurred after she got the vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 18Feb2022 as dose 1, single (Lot number: FK9729) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "eye problems" (unspecified if ongoing), notes: She had eye problems since she was 14 years old; "Crippling Arthritis in leg" (unspecified if ongoing), notes: Crippling Arthritis in leg, She has had it since 15; "blood pressure be high" (unspecified if ongoing), notes: blood pressure be high , She has had that since she was 18.; "nervous" (unspecified if ongoing), notes: She has had that since she was 18. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection after each 3 doses/She then stated that her arms stay sore and still are. This occurred after she got the vaccine.". Therapeutic measures were taken as a result of vaccination site pain.  Additional Context: Patient already got 3 does of the Pfizer COVID 19 vaccine and saying she had scheduled for booster shot, which was first dose of the vaccine. The HCP who was supposed to give the vaccine did not come to her place, so she was calling to get the 4th dose. She missed her 4th dose. Caller stated she just turned 85 on her birthday. She then stated that her arms stay sore and still are. This occurred after she got the vaccine. She said she was tall and provided her height as between 5'8"-5'9". 18Feb2022, 1st one in Right arm Lot FK9729. She later came back and said that it could be RK9729. 16Mar2022, 2nd one in Left arm Lot FK9894, and later said it could be RK9894. She then thought the card said she got two shots on the same day. She started providing 26th of a month and unable to confirm which month. She was not sure about that number and then gave number of RK9729 again when asked when the 3rd dose was given and what that lot number was. She did not remember if she had two on one day and was unable to read the card to see what was given. It is confusing her. Caller stated her eyes are so bad. She could not hardy read. She had eye problems since she was 14 years old. She has got one of her eyes she could hardly see out of. She was frustrated because she cannot make out the numbers on the vaccine card and decided to disconnect.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200941012 Same patient/drug and different dose/AEs.;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Sjogren's disease" (unspecified if ongoing), notes: Other medical history: Sjogren's disease and non-RA currently unspecified inflammatory arthritis; "non-RA currently unspecified inflammatory arthritis" (unspecified if ongoing), notes: Other medical history:Sjogren's disease and non-RA currently unspecified inflammatory arthritis; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs and cephalosporin antibiotics. The patient took concomitant medications. Past drug history included: Cephalosporin antibiotics, reaction(s): "Known allergies: cephalosporin antibiotics", notes: Known allergies: Sulfa drugs and cephalosporin antibiotics. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received treatment drug as Paxlcovid from 28Jun2022 to 02Jul2022 for COVID-19. Other medication was in 2weeks Tylenol extra strength from 25Jun2022 to 07Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 21Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "ocular hypertension" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL LUPIN, start date: 01Jul2021; BUPROPION HCL XL, start date: 01Jul2021; DIPHENHYDRAMINE HCL, start date: 01Jan2020; VITAMIN D 3; LUTEIN, start date: 01Jan2020; CETIRIZINE HYDROCHLORIDE, start date: 01Jan2020; ESOMEPRAZOLE MAGNESIUM, start date: 01Jan2020; CENTRUM WOMEN 50+, start date: 01Jan2020; BENZONATATE, start date: 27Jun2022; AZITHROMYCIN, start date: 07Jul2022; PREDNISONE, start date: 07Jul2022; FLAXSEED OIL [LINUM USITATISSIMUM OIL], start date: 01Apr2022; IBUPROFEN, start date: 22Jun2022. Past drug history included: Dextromethorphan, reaction(s): "known allergies: dextromethorphan", notes: known allergies: dextromethorphan; Guaifenesin, reaction(s): "known allergies: Guaifenesin", notes: known allergies: Guaifenesin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Adverse event: Sore throat but not painful, more of a swollen throat, hard to swallow, cold feels worse then warm. Foods irritate it. Cough, difficulty breathing and shortness of breath. Fatigue. Felt better after taking Paxlovid but feels worse now. Adverse event start date was 04JUl2022. The patient was Not recovered, If treatment AE: Yes, AE Treatment: Antibiotics and steroids.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: she cut her thumb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; SINGLE), administration date: 28Dec2020, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; SINGLE. Lot number: EL3248), administration date: 18Jan2021, when the patient was 64-year-old, for COVID-19 immunization; Flu vaccine (Has gotten the flu vaccine and no reactions that she can remember, nothing extreme); Pneumonia vaccine (Has gotten the pneumonia vaccine and no reactions that she can remember, nothing extreme). The following information was reported: SKIN LACERATION (non-serious), outcome "unknown", described as "she cut her thumb". Therapeutic measures were taken as a result of skin laceration.  Additional Information: The patient had tetanus shot, because she cut her thumb.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Information: Reporter stated other medication in 2 weeks as Dextroamphetamine. Patient received Paxlovid on an unknown date for covid-19 treatment and experienced Acidity in throat and mouth, abdominal pain and diarrhea within hours of taking medication for the first time. If vaccine received Yes. other medication in 2weeks: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Nail polish" (unspecified if ongoing); "Known allergies: Codeine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was given as Anti-viral for treatment of COVID-19 on 06Jul2022. Treatment stop date: 06Jul2022, Lot no-GA8851, Administration route: Oral. Other medication details: other medication in 2weeks product: Aurobindo (Fluoxetine 10mg), from 22Jun2022 to 06Jul2022, lot number: 957241257669 via Oral route of administration. Solaray (Quercetin) from 29Jun2022 to 06Jul2022, lot number: 1060560, via Oral route of administration. (Vitamin D3 5000IU) from 22Jun2022 to 06Jul2022, lot number: 496080-01 AW2 via Oral route of administration. Finest Nutrition (Zinc 50mg) from 29Jun2022 to 06Jul2022, lot number: Illegible, via Oral route of administration. Plant (Black seed oil) from 29Jun2022 to 06Jul2022, lot number: 2162337, via Oral route of administration. Patient took Paxlovid at around noon on 06Jul2022. About an hour later, patient noticed metallic taste in mouth. About 6 hours after the dose, patient noticed rash on both arms (upper and lower arms), and on front of both thighs. Patient did not take another dose. Metallic taste is gone, and rash is improving (only slightly visible now). Adverse events start date: 06Jul2022 at 01:00 pm, patient was recovering, treatment was received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 at 10:00 as dose 1, single (Lot number: el9261), in left arm, on 10Feb2021 at 12:00 as dose 2, single (Lot number: el9266), in left arm, on 15Aug2021 at 10:00 as dose 3 (booster), single (Lot number: fc3180), in left arm and on 17Mar2022 at 14:30 as dose 4 (booster), single (Lot number: fk9899) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), on 31Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The covid-19 treatment included pfizer paxlovid started on 23Jun2022, discontinued on 28Jun2022.  Additional information: Paxlovid rebound. Developed symptoms (mild allergy-like symptoms) on 06Jul2022; had completed course of Paxlovid on 28Jun2022. Tested positive on 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 19-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 1, single (Batch/Lot number: unknown) and on 27Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CLONAZEPAM. 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: SARS-CoV-2 test: Negative, notes: being asymptomatic and initially testing negative; Positive, notes: Became symptomatic on day 12 with new symptoms and positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication details included Clonazepam medication in 2weeks product. Adverse event included patient had rebound COVID within 2 days after completing 10 day quarantine, being asymptomatic and initially testing negative. Became symptomatic on day 12 with new symptoms and positive rapid test. There was no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy
Clinical narrative: having covid; having covid; Pregnancy Due Date 31Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 34-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0164), in left arm and on 09May2021 as dose 2, single (Lot number: EW0167) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Dec2021 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. Date of last menstrual period: 17Jan2022. The patient is expected to deliver a baby(s) on 31Oct2022. Concomitant medication(s) included: ENOXAPARIN [ENOXAPARIN SODIUM]; L-METHYLFOLATE; B-12; D3; PRENATAL + DHA; MULTI COMPLETE PRENATAL VITAMINS; ASPIRIN BAYER.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "having covid"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Pregnancy Due Date 31Oct2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details includes: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 17Jun2022, Treatment stop date: 22Jun2022, Lot number: GC4027, Indication: Treatment of COVID-19. After having covid and starting to feel better, I became sick again with the following symptoms: Congestion (26Jun2022 - present), Runny Nose (27Jun2022 - 3Jul2022), Tiredness (27Jun2022 - present), low fever (99.7) (28Jun2022 - 29Jun2022), Cough (28Jun2022 - present), Headache (29Jun2022 - 1Jul2022).
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Should have received moderna 6mo-4yr; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 4-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 at 17:30 as dose 1, single (Lot number: FL8094) intramuscular, in left arm for covid-19 immunisation. The patient didn't receive coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 01Jul2022, outcome "unknown", described as "Should have received moderna 6mo-4yr".
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, SARS-CoV-2 antibody test, Tinnitus
Clinical narrative: Tinnitus; other vaccine same date vaccine date=16Mar2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Monoclonal Gammopathy" (unspecified if ongoing), notes: Monoclonal Gammopathy Kappa over the Lambda; "Known allergies: Nylon" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; MAGNESIUM; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, at 12:00 PM, in Left arm), administration date: 23Feb2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Mar2021, outcome "unknown", described as "other vaccine same date vaccine date=16Mar2021"; TINNITUS (non-serious) with onset 31Mar2021, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient received other vaccine product (PFIZER) on 16Mar2021, lot number unknown, dose number was reported as dose1, at right arm. Facility type vaccine in Hospital. No other vaccine in four weeks. Other medications in two weeks included Loratidine 38 c Magnesium 1.86 Vitamin d3. Covid tested post vaccination was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EH19899), in right arm and as dose 2, single (Lot number: EL1283), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 3 (booster), single (Lot number: 12F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "sticky platelets" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jun2022; TURMERIC [CURCUMA LONGA], start date: 01Jun2022; ASPIRIN 81, start date: 01Jun2022; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL], start date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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. Additional information: No known allergies.; Sender's Comments: The causal association of reported events in relation to suspected BNT162B2 vaccine cannot be totally excluded based on temporal relation.  Case will be reassess pending QA investigation and ff-up reports.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: lost weight; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 16 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number-EW0183), administration date: 16May2021, when the patient was 16-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; lot number-EW0186), administration date: 07Jun2021, when the patient was 16-year-old, for Covid-19 immunization, reaction(s): "vaccination failure", "COVID-19". The following information was reported: WEIGHT DECREASED (non-serious) with onset May2022, outcome "unknown", described as "lost weight". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was also reported that the patient received his first booster of the gray cap formulation of the Pfizer BioNTech Covid 19 vaccine on 29Jan2022, but was accidently given another booster on the reporting day of the gray cap. Nurse clarified that caller had Covid in Dec2021 around Christmas and then lost weight (post Covid weight loss in May 2022) for three months afterward, but is otherwise healthy, and not immunocompromised.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: had Covid in Dec2021; had Covid in Dec2021; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 16May2021 as dose 1, single (Lot number: EW0183) and on 07Jun2021 as dose 2, single (Lot number: EW0186) at the age of 16 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 Dec2021, outcome "unknown" and all described as "had Covid in Dec2021". The patient underwent the following laboratory tests and procedures: COVID-19: (Dec2021) Positive, notes: Had Covid-19 around in Dec2021 around Christmas.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 17Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Metronidazole, reaction: "Known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jun2022, outcome "recovering" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive; (01Jul2022) Negative; (04Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid. Clinical course: Using an at-home test patient tested positive for COVID on 23Jun2022 after having symptoms starting on the previous night. Symptoms included fever, headache, sore throat, and severe fatigue. Her symptoms got worse the next day, the headache became much more severe and she also began having a very stuffy nose and earaches. She had a telemedicine call with her doctor on 24Jun2022 and asked for a prescription for Paxlovid. She began taking a 5-day course of Paxlovid in the evening of 24Jan2022. Her symptoms gradually diminished and by 01Jul2022 she tested negative with an at-home test. She still felt tired and had some soreness in the back of her throat. On 04Jul2022 she started feeling worse and again tested positive using an at-home test. She was still recovering from this rebound of the disease. She believed the Paxlovid just put the disease "on hold" for 5 days and then after she finished the medication the virus started replicating again and caused the second bout.
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 a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) 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 included: "Asthma" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medications in 2 weeks included: AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]; LEVOTHYROXINE; MONTELUKAST; QVAR REDIHALER; RALOXIFENE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (05Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included COVID 19 anti-vial treatment, brand-Pfizer, from 17Jun2022 to 21Jun2022. Covid rebound on 25Jun2022 and patient experienced headache, sore throat, chest congestion. COVID recovered on 05Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE), on 22Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 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: "Obesity" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Other medication in 2 weeks product: Paxtol (as reported). Past drug history included: Macrodantin, reaction: "Known allergies: macrodantin". 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: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Penile rash, Rash, Urticaria
Clinical narrative: Rash on his abdomen, penis, cheek, side of neck. Now the rash is spreading to his legs.; Rash on his abdomen, penis, cheek, side of neck. Now the rash is spreading to his legs.; Appears to be urticaria; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number=FK5618, Intramuscular, Left arm), administration date: 07Dec2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, lot number=FK5127, Intramuscular, Left arm), administration date: 16Nov2021, when the patient was 7-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (medically significant) with onset 02Jul2022, outcome "not recovered", described as "Appears to be urticaria"; RASH (medically significant), PENILE RASH (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "Rash on his abdomen, penis, cheek, side of neck. Now the rash is spreading to his legs.". The events "rash on his abdomen, penis, cheek, side of neck. now the rash is spreading to his legs." and "appears to be urticaria" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash, penile rash, urticaria, included Benadryl, Zyrtec, and prednisone.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug 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