chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vascular injury
Clinical narrative: originally had Moderna for first two shots and first booster; month long hospitalization for pneumonia; ARDS; COPD; left arm 90% paralyzed; Believe left arm blood vessel poked by shot.; Arm black and blue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2022 at 15:30 as dose 4 (booster), single (Lot number: 59267102501W) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1 , (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization; Moderna (Dose: 2, (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization; Moderna (First booster, (originally had Moderna for first two shots and first booster)), for COVID-19 Immunization. The following information was reported: ACUTE RESPIRATORY DISTRESS SYNDROME (hospitalization, medically significant) with onset 11Aug2022, outcome "not recovered", described as "ARDS"; SKIN DISCOLOURATION (non-serious) with onset 11Aug2022, outcome "not recovered", described as "Arm black and blue"; VASCULAR INJURY (non-serious) with onset 11Aug2022, outcome "not recovered", described as "Believe left arm blood vessel poked by shot."; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) with onset 11Aug2022, outcome "not recovered", described as "COPD"; MONOPLEGIA (medically significant) with onset 11Aug2022, outcome "not recovered", described as "left arm 90% paralyzed"; PNEUMONIA (hospitalization, medically significant) with onset 11Aug2022, outcome "not recovered", described as "month long hospitalization for pneumonia"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 11Aug2022, outcome "unknown", described as "originally had Moderna for first two shots and first booster". The events "month long hospitalization for pneumonia", "ards", "copd", "left arm 90% paralyzed", "believe left arm blood vessel poked by shot." and "arm black and blue" required physician office visit.  Clinical course: Believe left arm blood vessel poked by shot. Arm black and blue. Also, left arm 90% paralyzed as of 30Sep. May have contributed to month long hospitalization for pneumonia, ARDS, COPD. Still in hospital. Had originally had Moderna for first two shots and first booster. This would be 4th shot with switch to pfizer. (Name withheld) was still in the hospital. No Covid prior vaccination. No Covid tested post vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: bad runny noses; sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 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 completed but unknown manufacturer), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 28Sep2022, outcome "unknown", described as "bad runny noses"; SNEEZING (non-serious) with onset 28Sep2022, outcome "unknown".  Additional information: It was reported He and his wife both got the shot a little less than two days ago within 24 hours with him worse than his wife, they had a bad runny nose and sneezing and he happens to be the worst and today is no better or maybe slightly better than yesterday. Has no fever or anything like that but it is constant blowing the nose and sneezing and is wondering if that is one of the symptoms to be expected and how long it will last; did not experience this when they got the original shots and had little to no side effects from those and this was the result of the shot. The patient said that he and his wife received the new Pfizer covid-19 booster shot two days ago and both of them developed a terrible runny nose and sneezing. Caller wanted to know if these symptoms were caused by the booster shot and how long its supposed to last.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197796 Same reporter/vaccine/event, different patients;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash throughout trunk of body from neck to groin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 10:45 as dose 4 (booster), single (Lot number: GJ5342) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing), notes: Other medical history: Childhood asthma; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 16Sep2022 as dose number unknown, single; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205), administration date: 10Mar2021, when the patient was 37-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6206), administration date: 21Mar2021, when the patient was 37-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Fj8757), administration date: 20Nov2021, when the patient was 37-year-old, for Covid-19 immunization.  The following information was reported: RASH PRURITIC (non-serious) with onset 30Sep2022 at 07:00, outcome "not recovered", described as "Itchy rash throughout trunk of body from neck to groin". Therapeutic measures were taken as a result of rash pruritic, Benedryl was taken.  Additional Information: It was reported that, the patient had covid prior to vaccination. Also reported that, patient was not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Speech disorder
Clinical narrative: stroke; He's got the shakes a few garbled words; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 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. Vaccination history included: Covid-19 vaccine (Primary immunization series completed ;unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 01Oct2022, outcome "unknown", described as "He's got the shakes a few garbled words"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 01Oct2022, outcome "unknown", described as "stroke".  Clinical course: The patient had his 4th booster shot yesterday, Pfizer, and this morning he was having something similar to a stroke.  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.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test was positive; Covid test was positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:45 as dose 4 (booster), single (Lot number: Gj5342) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0191), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "not recovered" and all described as "Covid test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198063 same patient, different events after different doses of the vaccine;
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Decreased appetite, Dizziness, Headache, Insomnia
Clinical narrative: Covid test was positive; Covid test was positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:45 as dose 4 (booster), single (Lot number: Gj5342) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0191), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "not recovered" and all described as "Covid test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198063 same patient, different events after different doses of the vaccine;
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Covid test was positive; Covid test was positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:45 as dose 4 (booster), single (Lot number: Gj5342) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0191), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "not recovered" and all described as "Covid test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198063 same patient, different events after different doses of the vaccine;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Faeces discoloured
Clinical narrative: Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool; Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool; Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 09:45 as dose number unknown [booster], single (Lot number: GJ5342) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing); "shell fish" (unspecified if ongoing); "polysporum" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown.), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious), FAECES DISCOLOURED (non-serious) all with onset 29Sep2022 at 20:00, outcome "recovering" and all described as "Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, faeces discoloured.  Additional information: It was reported that Severe Stomach cramps and diarrhea for two days. Followed by 1 day of black stool. Other medical history reported that patient had excellent health. No Other medication in 2weeks
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor, Wrong product administered
Clinical narrative: I'm having chills. Woke up at 130am in the morning shaking; I'm having chills. Woke up at 130am in the morning shaking; Brand: booster/ is bivalent: true/ dose number: 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 08:30 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Sep2022 at 08:30, outcome "unknown", described as "Brand: booster/ is bivalent: true/ dose number: 1"; CHILLS (non-serious), TREMOR (non-serious) all with onset 01Oct2022 at 01:30, outcome "recovering" and all described as "I'm having chills. Woke up at 130am in the morning shaking". Therapeutic measures were not taken as a result of chills, tremor.  Additional information: Adverse event reported as having chills. Woke up at 1:30 am in the morning shaking. Hospitalization prolonged reported as no. No other vaccine received in four weeks. COVID tested post vaccination reported as no. The patient was not diagnosed with COVID-19 in Prior to vaccination. The patient had not been tested for COVID-19, since vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disturbance in attention, Incorrect dose administered, Pain
Clinical narrative: Severe chills for 5 hours (95.2 degrees); Followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours; Severe achiness; Lack of ability to concentrate; Dose number=5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 17:30 as dose 5 (booster), single (Lot number: CRH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: SIMVASTATIN; TRAZODONE. Past drug history included: Levofloxacin, reaction(s): "Known allergies: levofloxacin", notes: Known allergies: levofloxacin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer"), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03; Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04; Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 30Sep2022 at 17:30, outcome "unknown", described as "Dose number=5"; PYREXIA (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours"; DISTURBANCE IN ATTENTION (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Lack of ability to concentrate"; PAIN (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Severe achiness"; CHILLS (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Severe chills for 5 hours (95.2 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain, disturbance in attention.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No; Reported Event: 4 hours after injection \severe chills for 5 hours (95.2 degrees), followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours; severe achiness & lack of ability to concentrate. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19?:No
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chills for 5 hours (95.2 degrees); Followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours; Severe achiness; Lack of ability to concentrate; Dose number=5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 17:30 as dose 5 (booster), single (Lot number: CRH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: SIMVASTATIN; TRAZODONE. Past drug history included: Levofloxacin, reaction(s): "Known allergies: levofloxacin", notes: Known allergies: levofloxacin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer"), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03; Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04; Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 30Sep2022 at 17:30, outcome "unknown", described as "Dose number=5"; PYREXIA (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours"; DISTURBANCE IN ATTENTION (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Lack of ability to concentrate"; PAIN (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Severe achiness"; CHILLS (non-serious) with onset 30Sep2022 at 20:45, outcome "not recovered", described as "Severe chills for 5 hours (95.2 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain, disturbance in attention.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No; Reported Event: 4 hours after injection \severe chills for 5 hours (95.2 degrees), followed by 4 hours of fever (102.7 degrees); repeated for 2 more periods of 8 hours; severe achiness & lack of ability to concentrate. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19?:No
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Rash
Clinical narrative: She has started getting rashes all over her body; Cough; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2022 as dose number unknown (orange cap), 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: COUGH (non-serious) with onset Sep2022, outcome "unknown"; ILLNESS (non-serious) with onset Sep2022, outcome "unknown", described as "Sick"; RASH (non-serious) with onset 29Sep2022, outcome "not recovered", described as "She has started getting rashes all over her body".  Additional Information: Patient had taken the Pfizer COVID 19 Vaccine for 5 to 11 years of age on 28Sep2022 and after around 24 hours she had started getting rashes all over her body followed by some cough. She was 07-year-old so reporter wanted to report the side effect and also wanted to check if it was a or can it be a side effect of COVID vaccine. It was further reported that it happened on 29Sep2022 (reported as yesterday) the episode of rashes and now (at the time of this report) again it was happening again. Patient was sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6025), on 31Mar2021 as dose 2, single (Lot number: EP6955) and on 12Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension - Controlled" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 21Sep2022 to 25Sep2022 for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Headache; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 22:00 as dose 4 (booster), single (Lot number: 6H9693) at the age of 30 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 29Sep2022 at 14:00, outcome "recovering"; FATIGUE (non-serious) with onset 29Sep2022 at 14:00, outcome "recovering"; PYREXIA (non-serious) with onset 29Sep2022 at 14:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 29Sep2022 at 14:00, outcome "recovering". Therapeutic measures were not taken as a result of pyrexia, headache, chills, fatigue.  Additonal information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Bad runny noses/constant blowing the nose; Sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose number unknown (bivalent; booster), single (Batch/Lot number: unknown) at the age of 62 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, Had little to no side effects), for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 28Sep2022, outcome "not recovered", described as "Bad runny noses/constant blowing the nose"; SNEEZING (non-serious) with onset 28Sep2022, outcome "not recovered".  Additional information: Called about the most newest booster Pfizer COVID vaccine and he and his wife both got the shot a little less than two days ago within 24 hours with him worse than his wife, they had a bad runny nose and sneezing and he happens to be the worst and today is no better or maybe slightly better than yesterday. Had no fever or anything like that but it was constant blowing the nose and sneezing and was wondering if that was one of the symptoms to be expected and how long it will last; did not experience this when they got the original shots and had little to no side effects from those and this was the result of the shot.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197573 Same reporter/vaccine/event, different patients;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 5 (booster), single (Lot number: K9895) 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), 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 included: "High blood pressure" (unspecified if ongoing), notes: Managed; "hypothyroidism" (unspecified if ongoing), notes: Managed. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Sep2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (02Sep2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other medication in 2 weeks, Return of Covid symptoms after taking Paxlovid and testing negative. Note testing positive again. Flu like symptoms. Adverse event start date 02Sep2022, patient was recovering, treatment ae No, No known allergies.
Age: 75.0
Sex: M
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 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 was not reported. Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment included Paxlovid (start date 22Sep2022, stop date 26Sep2022). Known allergies: None known.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 10Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: Jun2022. The patient was 12 weeks pregnant at the event onset. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". 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 drug ineffective, covid-19.  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 limited information in the case , a possible causal association between  all  the reported events ,Drug Ineffective COVID 19and the suspect drug cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19, 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 product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2021 as dose 2, single (Lot number: Ew0168), in left arm and on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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 "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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment from 11Sep2022 to 16Sep2022. Patient has not received any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 at 12:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Oct2021 at 12:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 00:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, 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), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details Treatment start date 28Sep2022 and stop date 30Sep2022, Lot number 1923793A, Indication for Treatment of COVID-19. Other medication details: Other medication in 2 weeks product Amoxicillin start date: 14Sep2022 and stop date: 20Sep2022. Adverse event Severe abdominal area discomfort Rapid weight loss, without change in diet. Oily stool. Seemed like food not being absorbed. Stopped taking paxlovid due to suspected adverse effects on liver. Waking up at night with weird bad taste in mouth. Adverse event start date 29Sep2022, If patient Recovering, no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received paxlovid treatment; Patient received paxlovid 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose number unknown, single (Lot number: FH8027), in left arm and on 08Jul2022 as dose number unknown, single (Lot number: FM7553) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN. Past drug history included: Lisinopril, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Patient received paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid given on 20Sep2022 to 25Sep2022.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 11:15 as dose 4 (booster), single (Lot number: GJ5342) at the age of 31 years intramuscular, in right arm 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 (Dose 3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Sep2022 at 01:15, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: If other vaccine in four weeks was reported as no. If COVID prior vaccination was reported as no. If COVID tested post vaccination was reported as no. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: lactose intolerant" (unspecified if ongoing); "Known allergies: jack fruit  Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (02Sep2022) Negative, notes: Day 9 felt better, tested negative; (05Sep2022) Positive, notes: 2 days later I felt worse and tested positive on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Bitter grape fruit aftertaste for duration of course of medicine Lost of appetite and was nauseous I also had a relapse. Day 9 felt better, tested negative and then 2 days later I felt worse and tested positive on day 12. Known Allergies: lactose intolerant and jack fruit  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 at 11:00 as dose 3 (booster), single (Lot number: EW0219) at the age of 56 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: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure,; "osteoarthritis" (unspecified if ongoing), notes: Other medical history: osteoarthritis. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid orally (Lot number: GF1750) from 20Sep2022 to 25Sep2022 as treatment for Covid-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Swelling
Clinical narrative: Swelling under right armpit; dose number 5; dose number 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number: 1, lot number: FL397), for COVID-19 immunization; Bnt162b2 (dose number: 2, lot number: FF2589), for COVID-19 immunization; Bnt162b2 (dose number: 3, lot number: EL3247), for COVID-19 immunization; Bnt162b2 (dose number: 4, lot number: EL3247), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 29Sep2022 at 11:00, outcome "unknown" and all described as "dose number 5"; SWELLING (non-serious) with onset 30Sep2022 at 08:00, outcome "not recovered", described as "Swelling under right armpit". Therapeutic measures were not taken as a result of swelling.  Additional Information: It was reported that the patient did not have Covid prior vaccination and not tested post vaccination.
Age: 33.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8735) and on 07May2021 as dose 2, single (Lot number: ER8735) at the age of 33 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 066F21A) 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), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After testing negative, have been testing positive again for multiple days; Positive, notes: After testing negative, have been testing positive again for multiple days. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
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 58-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history/other medical history. The patient had no known allergies. There were no concomitant medications and no other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and the patient received treatment with anti-viral Paxlovid from 18Sep2022 to 22Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: prescribed the medicine for COVID; prescribed the medicine for COVID; 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), 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: "Hospitalization" (unspecified if ongoing), notes: I have already been in the hospital. 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 "prescribed the medicine for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: prescribed the medicine for COVID.  Clinical course: Patient was just prescribed the medicine for COVID, the Paxlovid. Patient had not taken yet. Patient just got it yesterday. Patient was reading some other side effects and stuff. Patient stated, Yes because patient was just kind of leery like patient said he/she mean patient knew patient  need to take it but patient was just kind of leery of the side effects. Patient mean had not got booster yet. Patient had gotten the first two shot but they were Pfizer (Further not clarified over the call hence suspect captured as Unspecified shot and Is this a Pfizer product checked as Yes). Patient was not saying patient did not trust Pfizer but patient was just leery of what patient read on the side effects. Patient knew patient need to take it but patient hope it did not make patient worse than what patient was now (Further clarifications unknown hence event captured as per verbatim; prescribed the medicine; Paxlovid). patient stated, Okay because that only patient had already been in the hospital and suffer (Further clarifications unknown) and patient did not want to go back because of the side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.