chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Trigger finger
Clinical narrative: Rapid heartbeat; Dizziness; Blood pressure went to 200/104; Trigger thumb; right hand ring finger became trigger; Both palms of hand and fingers became very painful; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 at 10:00 as dose 1, single (Lot number: ER8733) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Degenerated disk disease" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Allergies to eggs" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; LISINOPRIL; HYDROCHLOROTHIAZIDE; NAPROX [NAPROXEN]. Past drug history included: Codeine, reaction(s): "Drug allergy"; Demerol, reaction(s): "Drug allergy"; Morphine, reaction(s): "Drug allergy"; Loritab, reaction(s): "Drug allergy". The patient had no other vaccine in four weeks. The following information was reported: BLOOD PRESSURE INCREASED (disability) with onset 05Jul2021 at 08:00, outcome "recovered", described as "Blood pressure went to 200/104"; PAIN IN EXTREMITY (disability) with onset 05Jul2021 at 08:00, outcome "not recovered", described as "Both palms of hand and fingers became very painful"; DIZZINESS (disability) with onset 05Jul2021 at 08:00, outcome "recovered"; HEART RATE INCREASED (disability) with onset 05Jul2021 at 08:00, outcome "recovered", described as "Rapid heartbeat"; TRIGGER FINGER (disability) with onset 05Jul2021 at 08:00, outcome "not recovered", described as "Trigger thumb; right hand ring finger became trigger". The events "rapid heartbeat", "dizziness", "blood pressure went to 200/104", "trigger thumb; right hand ring finger became trigger" and "both palms of hand and fingers became very painful" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (05Jul2021) 200/104; Heart rate: (05Jul2021) Rapid. Therapeutic measures were taken as a result of trigger finger. Per clinical course, the patient experienced rapid heartbeat, dizziness, and blood pressure went to 200/104 on 05Jul2021. On 05Jul2021, the patient had trigger thumb (R hand), orthopedic injected steroid shot in Sep2021. Following month (Aug2021), left thumb became trigger thumb, another steroid shot. In Dec2021, right hand ring finger became trigger, another steroid shot. Within a month, both palms of hand and fingers became very painful (starting on 05Jul2021) and are getting worse. The patient had seen other doctors including RA physicians on 08Sep2022 with no results. The patient did not suffer any of this until she had the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: still not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 series complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "still not feeling well". Additional information: Patient got the omicron vaccine (COVID-19 vaccine bivalent) over a week prior and patient was still not feeling well and patient guessed, patient wanted to get an idea how long the event could last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, Urticaria
Clinical narrative: I broke out in hives all over my body.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Anti inflammatories, reaction(s): "Known allergies: Anti inflammatories". Vaccination history included: Bnt162b2 (DOSE: 1, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "recovered with sequelae", described as "I broke out in hives all over my body.". The event "i broke out in hives all over my body." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional Information: Patient was not having COVID prior vaccination and patient was tested with Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose 1, Dose 2, Dose 3: BNT162B2; Dose 4: MODERNA COVID-19 VACCINE; 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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), on 01Apr2021 as dose 2, single (Lot number: ER8734) and on 02Oct2021 as dose 3 (booster), single (Lot number: Ff8839) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 002M214) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1, Dose 2, Dose 3: BNT162B2; Dose 4: MODERNA COVID-19 VACCINE"; VACCINATION FAILURE (medically significant), 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: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  Additional information: The patient has no known allergies.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: Nausea; tired; feeling hot (sweating); feeling hot (sweating); weak; loss of appetite; diarrhea; feeling unwell; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9646) at the age of 64 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SHINGRIX, on 04Sep2022 as dose number unknown, single. Past drug history included: Batrim, reaction: "known allergies: Batrim". Vaccination history included: BNT162b2 (Dose 1, Lot Number:  EN6198), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number: EN6208), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Lot Number: 301308H), administration date: 24Sep2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose 4, Lot Number: FT4989), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 12Sep2022, outcome "not recovered"; DIARRHOEA (non-serious) with onset 12Sep2022, outcome "not recovered", described as "diarrhea"; FEELING HOT (non-serious), HYPERHIDROSIS (non-serious) all with onset 12Sep2022, outcome "not recovered" and all described as "feeling hot (sweating)"; MALAISE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "feeling unwell"; DECREASED APPETITE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "loss of appetite"; FATIGUE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "tired"; ASTHENIA (non-serious) with onset 12Sep2022, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Symptoms have not improved in over a week. The patient had no COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: Nausea; tired; feeling hot (sweating); feeling hot (sweating); weak; loss of appetite; diarrhea; feeling unwell; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9646) at the age of 64 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SHINGRIX, on 04Sep2022 as dose number unknown, single. Past drug history included: Batrim, reaction: "known allergies: Batrim". Vaccination history included: BNT162b2 (Dose 1, Lot Number:  EN6198), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number: EN6208), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Lot Number: 301308H), administration date: 24Sep2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose 4, Lot Number: FT4989), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 12Sep2022, outcome "not recovered"; DIARRHOEA (non-serious) with onset 12Sep2022, outcome "not recovered", described as "diarrhea"; FEELING HOT (non-serious), HYPERHIDROSIS (non-serious) all with onset 12Sep2022, outcome "not recovered" and all described as "feeling hot (sweating)"; MALAISE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "feeling unwell"; DECREASED APPETITE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "loss of appetite"; FATIGUE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "tired"; ASTHENIA (non-serious) with onset 12Sep2022, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Symptoms have not improved in over a week. The patient had no COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Immediate post-injection reaction, Tachycardia
Clinical narrative: Tachycardia immediately following vaccine dose .  The next morning I had chest pain which lasted for three days .
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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.  The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional information: Caller was considering to get the Pfizer-BioNTech COVID-19 Vaccine, bivalent booster, but she was concerned because recently, she has had hair loss. Caller also has had the Pfizer vaccine (primary vaccination and booster doses) and she was wondering if there could be a correlation between the vaccine and her hair loss or it's just simply age-related. She received the last dose of the vaccine about 3 or 4 months ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg and on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), 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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in right arm, on 17Sep2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "Vitiligo" (unspecified if ongoing); "Known allergies: adhesive tape" (unspecified if ongoing), notes: Known allergies: adhesive tape. The patient's concomitant medications were not reported. Past drug history included: Statins, reaction(s): "known allergies: Statins", notes: known allergies: Statins; Zetia, reaction(s): "known allergies: zetia", notes: known allergies: zetia. The following information was reported: VACCINATION FAILURE (medically significant), 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: (19Sep2022) Positive, notes: did a home test for COVID-19. It was positive; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 73.0
Sex: M
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) (Nurse) from product quality group.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EM9810), on 01Mar2021 as dose 2, single (Lot number: EN6202), on 24Sep2021 as dose 3 (booster), single (Lot number: 3013SBA), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) and on 16Sep2022 as dose 5 (booster), single (Lot number: FP7137) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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.  Clinical course: Retired registered nurse calling who thought they got the COVID bivalent today but they got a call from the pharmacy where her husband and she went to get it, which was around 3:30 their time. The pharmacy let them know that they had received an old booster dose and not the bivalent. They did tell her, which she was very upset as a nurse herself she doesn't understand how they could make the mistake to give the wrong vaccine, they would have to wait two months to get the bivalent. The only reason they went for vaccine today was for the Omicron booster, and now they have to wait two months, and it is prevalent in the (withheld) area. Caller would like to know if it is a packaging problem, if the bivalent and old booster are packed the same way. Fifth dose was 16Sep2022 of LOT: FP7137, which her card says it was bivalent but it wasn't. Their vaccine cards are handwritten and the only information provided on them was LOT and manufacturer name for each dose, no EXP/NDC. All five doses were Pfizer COVID shots. Caller says she doesn't want to have Omicron, and she thinks it is terrible they went there for getting the booster for Omicron and now have to wait two months, in a medium risk area with back to school. Her grandkids are just getting over COVID, they have been boosted, and she doesn't want to get Omicron because she has seen what the kids have gone through. Her husband had COVID at the beginning of Aug and was very sick. Caller clarifies getting the old booster instead of bivalent is not serious.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: still have tenderness in the area of the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 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 series complete, unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (kept thinking it would go away, but it was still the same, no change, as when first got the booster. DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization, reaction(s): "still have tenderness in the area of the shot"; Flu shot (flu shot. The 'pain' was similar to how patient's arm would feel a couple of days after the flu shot.), for Immunization, reaction(s): "The pain was similar to how patient's arm would feel a couple of days after the flu shot.". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still have tenderness in the area of the shot".  Additional information: Patient received the Pfizer booster last Dec2021, but still have tenderness in the area of the shot. Patient can't seem to find any answers to questions about that and was hoping you could help. The pain was similar to how patient's arm would feel a couple of days after the flu shot. Patient kept thinking it would go away, but it was still the same, no change, as when patient first got the booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective
Clinical narrative: had Covid-19 & COVID pneumonia in Jan2021; had Covid-19 & COVID pneumonia in Jan2021; had Covid-19 & COVID pneumonia in Jan2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Crohn's disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), COVID-19 PNEUMONIA (medically significant) all with onset Jan2021, outcome "unknown" and all described as "had Covid-19 & COVID pneumonia in Jan2021". Therapeutic measures were taken as a result of drug ineffective, covid-19, covid-19 pneumonia.  Clinical course: It was reported that the patient had Covid-19 and COVID pneumonia in Jan2021. Reportedly the patient has taken the Pfizer vaccine and boosters, also had the antiviral treatment in Feb2021. Any way the patient can help advance would be wonderful.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 18.0
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 a contactable reporter(s) (Nurse).  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Lot number: EW0177) and on 17May2021 as dose 2, single (Lot number: EW0171) at the age of 18 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Dec2021 as dose 3 (booster), single (Lot number: 051F21A) for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Migraine" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Montelukast, reaction(s): "Allergy"; Chlorhexidine gluconate, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient had no other medication in 2weeks.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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: "Type 1 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG; TRESIBA. 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, notes: COVID 19 Treatment Paxlovid. Therapeutic measure, Paxlovid,  was 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive covid test result; positive covid test result; This is a spontaneous report received from a non-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 23Feb2021 as dose 1, single (Lot number: EN6203) and on 31Dec2021 as dose 2, single (Lot number: EN6199) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. 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 "positive covid test result". The event "positive covid test result" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Sep2022) Positive; (15Sep2022) Negative; (20Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient woke up feeling sick on 10Sep2022, got a positive covid test result, went to the walk in clinic. Patient was given Paxlovid and completed 5 day dose, and began to feel better. On 15Sep2022, patient had a negative covid test result. On the evening of 19Sep2022, patient began to have flu like symptoms. In the morning on 20Sep2022, patient tested positive for covid. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Dry eye, Wound infection
Clinical narrative: Dry eyes; Wound infection; both eyes cataract; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4433870-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Non-Tobacco User" (unspecified if ongoing); "Abstains from Alcohol" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; PRAMIPEXOLE; KLONOPIN; LITHIUM CARBONATE CAMBER; METFORMIN; VALTREX; CEPHALEXIN [CEFALEXIN]. Vaccination history included: BNT162b2 (First dose (1 in 1 Once)), administration date: 08Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "Dry eyes", "Wound infection"; BNT162b2 (Second dose (1 in 1 Once)), administration date: 05Apr2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "non-serious cut on right leg", "dry eyes", "infection after hit by truck", "infection after hit by truck", "staphylococcus infection". The following information was reported: CATARACT (medically significant) with onset 2022, outcome "not recovered", described as "both eyes cataract"; DRY EYE (medically significant), outcome "unknown", described as "Dry eyes"; WOUND INFECTION (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of cataract, dry eye, wound infection.  Clinical course: The patient has other concomitant therapy of Penicillin. On unknown dates, the patient experienced dry eyes, got an infection after hit by truck. In 2022, the patient experienced both eyes cataract. She was told early this year in 2022 to have a cataract surgery. Doctor had it sooner since it had gotten worse. She had it on two occasions, one eye each time. Right eye was on 13Apr2022 and left eye was on 27Apr2022. She mentioned she was given four kinds of eye drops, an anti-inflammatory, and antibiotic. She was prescribed an antibiotic and she said after seven days it cleared up pretty quickly. She held off Humira for a week after she received her Covid booster on 31Aug2021. But she said she might had been on her off week with Humira at that time as well. She was taking unspecified supplements. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with Doxycycline.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 42-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no known allergies. There were no concomitant medications, no other medication in 2weeks. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 10Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: daughter had pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "daughter had pain".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
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(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 1, 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), 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, notes: COVID 19 Treatment. The patient received COVID 19 Treatment Paxlovid from 11Sep2022 to 15Sep2022.  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: Vaccination site haemorrhage
Clinical narrative: tiny pin point of blood in his arm after the administration; 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 male 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 HAEMORRHAGE (non-serious), outcome "unknown", described as "tiny pin point of blood in his arm after the administration".  Additional Information: Reporter stated that for the first four doses, he did not have any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177794 same patient/drug/event, different dose number;US-PFIZER INC-202201177795 same patient/drug/event, different dose number;US-PFIZER INC-202201177796 same patient/drug/event, different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: tiny pin point of blood in his arm after the administration; 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 male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, ), for Covid-19 immunization, reaction(s): "tiny pin point of blood in his arm after the administration"; Bnt162b2 (Dose 2, Single), for Covid-19 immunization, reaction(s): "iny pin point of blood in his arm after the administration". The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "tiny pin point of blood in his arm after the administration". Additional Information: Reporter stated that for the first four doses, he did not have any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177784 same patient/drug/event, different dose number.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Her period was not regular when she received the booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer: Pfizer BioNTech Covid-19 vaccine), for COVID-19 Immunization, reaction(s): "Menstruation irregular". The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Her period was not regular when she received the booster".  Additional information: Daughter received the primary series last year. She received the booster in November. Since then, she has not had her period. Her period was not regular when she received the booster, however, it is non existent at this time.  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; had 4 Pfizer shots; COVID; had 4 Pfizer shots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID; had 4 Pfizer shots". The patient underwent the following laboratory tests and procedures: COVID-19 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid.  Additional information: patient took her last morning dose of Paxlovid on 12Sep2022.  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: Heart rate increased
Clinical narrative: rapid heart situation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "two months after receiving second dose vaccine, whenever caller was laying in bed caller was getting an irregular heart beat every 3 to 4 days".  The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart situation".  Additional information: Patient was reporting that he had rapid heart situation a couple years ago, and he was noticing that it happened again a couple weeks ago, after he got the COVID 19 vaccine. Caller is 82 years old. He has a question. Caller also happen to make an unclear statement about his daughter and that Pfizer is making a profit. Caller disconnected prior to completion of transfer. No Additional information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101442725 same reporter/patient, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient. A 47-year-old 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 included: "Asthmatic" (unspecified if ongoing), notes: Comments: Asthmatic. Concomitant medication(s) included: BREO ELLIPTA taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "had Covid first week of Aug2022. He had taken first and second Covid vaccine and booster Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: He had Covid first week of Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid treatment from Aug2022.He had Covid first week of Aug2022 and started Paxlovid on either day 1 or day 2 of Covid. He did finish the complete course. He did say he was on Motrin, Tylenol, and cough medication right at the beginning. He was so nauseated for two weeks. He also had a metallic taste. He didn't mention when the nausea or metallic taste started when on Paxlovid. He had taken first and second Covid vaccine and booster Covid vaccine. They were all Pfizer vaccines. 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 available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information.
Sex: U
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: Pancreatitis; The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 15Sep2022, this case now contains all required information to be considered valid.    A child 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: PANCREATITIS (medically significant), outcome "unknown".  VAERS is a national passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination. VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities preferred terms (MedDRA PTs) by VAERS staff. Reports of serious events to VAERS were reviewed by CDC and FDA physicians to form a consensus clinical impression based on available data. VAERS reports were described by serious and nonserious status, demographic characteristics, and MedDRA PTs. VAERS is a passive reporting system and is subject to reporting biases and underreporting, especially of nonserious events.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 cannot be excluded for the reported event pancreatitis. The detailed clinical course would be helpful for further assessment. The case can be reassessed based on the follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-202201169694 same article/drug, different patient/event;US-PFIZER INC-202201169689 same article/drug, different patient/event;US-PFIZER INC-202201169691 same article/drug, different patient/event;US-PFIZER INC-202201169690 same article/drug, different patient/event;US-PFIZER INC-202201169693 same article/drug, different patient/event;US-PFIZER INC-202201169695 same article/drug, different patient/event;
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: the patient flinched and moved its arm. The patient did not receive a full dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: UNDERDOSE (non-serious), outcome "unknown", described as "the patient flinched and moved its arm. The patient did not receive a full dose". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: deleted the event 'Product administration error'.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Drug hypersensitivity
Clinical narrative: anaphylaxis; allergic reaction; This is a spontaneous report received from contactable reporter (Other HCP). Other Case identifier(s): 2022NVX-US-000003400.  A female 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction".  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 temporal association and known safety profile of the product, a causal relationship between the events or anaphylaxis, allergic reaction and can be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, Pyrexia
Clinical narrative: Fever; She is pregnant; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 (Dose number unknown, Primary immunization completed, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "She is pregnant". Additional information: MD self reported had a fever after receiving omicron booster. She is pregnant. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: caller can't breathe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "caller can't breathe".  No follow-up attempts are possible. No further information is expected.