chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago; Product storage error; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Product storage error ).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Left arm is painful/ Arm is still sore today; Worse body ache than after her first dose; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today), MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today), MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today) had not resolved and MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever) outcome was unknown.            Concomitant products also included high cholesterol medication (unspecified).  No treatment medications were reported.   This case was linked to MOD-2022-653217, MOD-2022-653180 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Left arm is painful/ Arm is still sore today; Worse body ache than after her first dose; Slight fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today), MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today), MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE PAIN (Left arm is painful/ Arm is still sore today) had not resolved and MYALGIA (Worse body ache than after her first dose) and PYREXIA (Slight fever) outcome was unknown.            Concomitant products also included high cholesterol medication (unspecified).  No treatment medications were reported.   This case was linked to MOD-2022-653217, MOD-2022-653180 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypertension, Memory impairment
Clinical narrative: Patient has become forgetful after Covid-19 infection.; high blood pressure which started in April of 2022 and may be related to her Covid-19 infection.; patient caught Covid-19 after her first Moderna Covid-19 booster dose.; This spontaneous case was reported by a patient and describes the occurrence of MEMORY IMPAIRMENT (Patient has become forgetful after Covid-19 infection.), HYPERTENSION (high blood pressure which started in April of 2022 and may be related to her Covid-19 infection.) and COVID-19 (patient caught Covid-19 after her first Moderna Covid-19 booster dose.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J212A and 053B22A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension and Hypercholesteremia. Concomitant products included METOPROLOL and PARACETAMOL (TYLENOL) for an unknown indication.   On 02-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced HYPERTENSION (high blood pressure which started in April of 2022 and may be related to her Covid-19 infection.) and COVID-19 (patient caught Covid-19 after her first Moderna Covid-19 booster dose.). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Patient has become forgetful after Covid-19 infection.). At the time of the report, MEMORY IMPAIRMENT (Patient has become forgetful after Covid-19 infection.), HYPERTENSION (high blood pressure which started in April of 2022 and may be related to her Covid-19 infection.) and COVID-19 (patient caught Covid-19 after her first Moderna Covid-19 booster dose.) outcome was unknown.            Patient was using unspecified high Cholesterol medication as a concomitant product. Patient was experienced Fever, cough, muscular weakness and headache as a symptom of covid-19. All the events were experienced after the covid-19 infection.  No treatment information was provided by the reporter. The patient had headaches and high blood pressure which started in April of 2022 and may be related to her Covid-19 infection.   This case was linked to US-MODERNATX, INC.-MOD-2022-653180, US-MODERNATX, INC.-MOD-2022-653189 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653180:Dose 1 US-MODERNATX, INC.-MOD-2022-653189:Dose 2
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine). At the time of the report, RASH (minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-653596, MOD-2022-653585 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After the second shot of Moderna COVID-19 Vaccine, more severe rash appeared on his arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (After the second shot of Moderna COVID-19 Vaccine, more severe rash appeared on his arms and legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (After the second shot of Moderna COVID-19 Vaccine, more severe rash appeared on his arms and legs). At the time of the report, RASH (After the second shot of Moderna COVID-19 Vaccine, more severe rash appeared on his arms and legs) had resolved.            No concomitant medication information was provided.  It was reported that the patient had more severe rash that appeared on his arms and legs which took 2-3 weeks to go away.  No treatment information was provided.   This case was linked to MOD-2022-653596, MOD-2022-653582 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: The individual later took Moderna COVID-19 Vaccine as his second booster shot  and his reaction was much more severe as rash occurred on more than 50% of his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (The individual later took Moderna COVID-19 Vaccine as his second booster shot  and his reaction was much more severe as rash occurred on more than 50% of his body) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (The individual later took Moderna COVID-19 Vaccine as his second booster shot  and his reaction was much more severe as rash occurred on more than 50% of his body). The patient was treated with CORTISONE ACETATE (CORTISOL [CORTISONE ACETATE]) at an unspecified dose and frequency. At the time of the report, RASH (The individual later took Moderna COVID-19 Vaccine as his second booster shot  and his reaction was much more severe as rash occurred on more than 50% of his body) had resolved.            No concomitant medication was provided.  It was reported that the rash took 5-6 weeks to completely clear.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-653582, MOD-2022-653585 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) 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: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Patient reported mild fever and chills for less than 24 hours after bivalent. Stated symptoms were less than with initial COVID-19 vaccine and previous booster. 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose: 4 BNT162B2, Dose: 3 MODERNA COVID-19 VACCINE; 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), on 14Feb2022 at 13:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 72 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 at 13:00 as dose 1, single (Lot number: 030L20A), in right arm, on 13Feb2021 at 13:00 as dose 2, single (Lot number: 042L20A), in right arm and on 24Aug2021 at 13:00 as dose 3 (booster), single (Lot number: 023C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies: ARBs, angiotensin synthesis inhibitors" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Feb2022 at 13:00, outcome "not recovered", described as "Dose: 4 BNT162B2, Dose: 3 MODERNA COVID-19 VACCINE"; DRUG INEFFECTIVE (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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine lot unknown reason: Unable to locate or read the details. Other Medication in 2 weeks: No. Patient took Paxlovid (Lot number: 1919256A) from 26Sep2022 till 28Sep2022 for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
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) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 10:00 as dose 1, single (Lot number: En6205), in right arm, on 25Mar2021 at 10:00 as dose 2, single (Lot number: Er8733), in right arm, on 20Jan2022 at 10:00 as dose 3 (booster), single (Lot number: Fl5683), in right arm and on 27Jul2022 at 10:00 as dose 4 (booster), single (Lot number: Ff7137) at the age of 61 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Other medical history: Mild asthma; "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19 with paxlovid.  Clinical course: Patient received Other medication in 2weeks. Patient had no known allergies.
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 51-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: negative, notes: initial negative test after Paxlovid; positive, notes: tested positive 8 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 22May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: LEVOTHYROXINE; MONTELUKAST. 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; Total number of days since initial positive test is 16; (20Sep2022) Negative, notes: COVID rebound - positive test with symptoms three days after negative test and six days after finishing Paxlovid,; (23Sep2022) Positive, notes: COVID rebound - positive test with symptoms three days after negative test and six days after finishing Paxlovid; (28Sep2022) Positive, notes: Still testing positive five days after the test indicating rebound. Total number of days since initial positive test is 16. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Treatment included Paxlovid from 12Sep2022 to 17Sep2022.
Sex: U
Vaccine: COVID19
Symptoms: Coeliac disease
Clinical narrative: celiac disease; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 10-year-old patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) and as dose 2 (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: COELIAC DISEASE (medically significant), outcome "unknown", described as "celiac disease".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot 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: M
Vaccine: COVID19-2
Symptoms: Malaise
Clinical narrative: Patient reported they were not feeling well. No other information was provided; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 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: 2 (unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 1 (unknown manufacturer), for COVID-19 immunization.  The following information was reported: MALAISE (non-serious) with onset 28Sep2022, outcome "recovering", described as "Patient reported they were not feeling well. No other information was provided". It was unknown if therapeutic measures were taken as a result of malaise.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; 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 66-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 19May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "supraventricular tachycardia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Sep2022, outcome "not recovered", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset Sep2022, outcome "not recovered". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received paxlovid from 19Sep2022 (Lot number: GE4606) to 24Sep2022 for covid-19 treatment. Patient did not had any known allergies.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Nasopharyngeal swab, Pain
Clinical narrative: Flu like symptoms; Low grade fever; achy; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TOPIRAMATE; OMEPRAZOLE; SIMVASTATIN; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid- 19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid- 19 immunization.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "Low grade fever"; PAIN (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "achy"; FATIGUE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pyrexia, pain, fatigue.  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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms; Low grade fever; achy; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TOPIRAMATE; OMEPRAZOLE; SIMVASTATIN; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid- 19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid- 19 immunization.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "Low grade fever"; PAIN (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "achy"; FATIGUE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "severe fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pyrexia, pain, fatigue.  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: Hyperhidrosis, Night sweats
Clinical narrative: the patient had night sweats for four or five nights after having his second dose; he would wet his bed sheets with sweat and they had to be changed; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 3-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (maroon cap), 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 (MAROON CAP), SINGLE), for Covid-19 Immunization. The following information was reported: NIGHT SWEATS (non-serious), outcome "recovered", described as "the patient had night sweats for four or five nights after having his second dose"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "he would wet his bed sheets with sweat and they had to be changed".  Additional information: The patient got the first two doses of the Maroon cap Pfizer Biontech COVID-19 vaccine. The doctor referred the patient had night sweats for four to five nights after having his second dose, he would wet his bed sheets with sweat and they had to be changed. He had no other symptoms and after five nights the sweats stopped. This report is not serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Migraines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Topamax, reaction(s): "Known allergies". 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 (lot 2815225) from 27Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pain in extremity
Clinical narrative: Arm pain; Off label; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 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., Manufacturer unknown.), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 3, Manufacturer unknown.), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 4, Manufacturer unknown.), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 26Sep2022, outcome "unknown", described as "Off label"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm pain". Therapeutic measures were not taken as a result of pain in extremity.   Additional information: The patient did not have covid prior to vaccination and patient had not tested for 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: Amenorrhoea, Cardiac disorder
Clinical narrative: Haven't had her period since getting the vaccine; Heart problems; 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 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: AMENORRHOEA (non-serious), outcome "not recovered", described as "Haven't had her period since getting the vaccine"; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "Heart problems".  Clinical course: Reporter stated she haven't had her period since getting the vaccine and is now having heart problems because of "your stupid vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
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 53-years-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jul2022 at 15:30 as DOSE 4 (BOOSTER), SINGLE (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunization; 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 immunization. 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: (27Sep2022) Negative, notes: Tested negative yesterday (2 antigen tests), (27Sep2022) Negative, notes: Tested negative yesterday (2 antigen tests); (28Sep2022) Positive, notes: testing very positive again today. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical information: Patient was healthy with no risk factors. She had no known allergies. She had no other medical history. She had no other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
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 71-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 at 15:00 as dose 3 (booster), single (Lot number: wh90730), in left arm and on 10May2022 at 14:00 as dose 4 (booster), single (Lot number: fm7553) at the age of 70 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: "Crohn's disease" (unspecified if ongoing); "Bee Sting" (unspecified if ongoing), notes: Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovering" 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; (Sep2022) Positive, notes: Rebound- Positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 09Sep2022, Treatment stop date: 14Sep2022, Indication: Treatment of COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CETIRIZINE; VITAFUSION MULTIVITES. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "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 drug ineffective, covid-19.  Clinical information: The patient was received other medication in 2 weeks. No Known allergies was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune system disorder, Multiple sclerosis
Clinical narrative: Multiple Sclerosis; immune system is weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient 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 COMPLETED, MANUFACTURER UNKNWON), for COVID-19 immunisation. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system is weaker". Clinical course: patient stated he can relate because he was initially diagnosed with Multiple Sclerosis. It meant his immune system is weaker than normal.   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, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Multiple Sclerosis; immune system is weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient 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 COMPLETED, MANUFACTURER UNKNWON), for COVID-19 immunisation. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system is weaker". Clinical course: patient stated he can relate because he was initially diagnosed with Multiple Sclerosis. It meant his immune system is weaker than normal.   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, COVID19, COVID19
Symptoms: Immune system disorder, Multiple sclerosis
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). The reporter is the patient.  A 35-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; 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed with COVID 19; Negative. Clinical course: The patient was diagnosed with COVID 19. He self-isolated and quickly get the 2nd booster as soon as he tested COVID negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, 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), Program ID: (176890). The reporter is the patient.  A 35-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; 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: diagnosed with COVID 19; Negative. Clinical course: The patient was diagnosed with COVID 19. He self-isolated and quickly get the 2nd booster as soon as he tested COVID negative.  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: Auditory disorder, Headache, Impaired work ability, Vertigo, Visual impairment
Clinical narrative: vertigo; hearing and vision issues; hearing and vision issues; significant headaches; This has affected my ability to work from the often and I would like to know if others have reported; 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 patient (no qualifiers provided) 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), for COVID-19 immunization, reaction(s): "hearing and vision issues", "significant headaches", "vertigo", "hearing and vision issues". The following information was reported: VERTIGO (non-serious), outcome "unknown"; AUDITORY DISORDER (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "hearing and vision issues"; HEADACHE (non-serious), outcome "unknown", described as "significant headaches"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "This has affected my ability to work from the often and I would like to know if others have reported".  Additional information:Description of Event Outcome: The patient received the first and second Pfizer vaccines for Covid and have been having vertigo, hearing and vision issues as well as significant headaches over the past several months. This has affected patients ability to work from the often and the patient would like to know if others have reported.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive; Tested positive; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), on 11Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "Tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive; (18Jul2022) Negative; (23Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: HCP shared his personal experience with Paxlovid Viral Rebound. Tested positive: 11Jul2022.Started Paxlovid from 11Jul2022 to 15Jul2022.Tested negative: 18Jul2022.Tested positive: 23Jul2022. COVID antigen test correlated with symptoms. Initial symptoms includes headache, sore throat, fatigue, diarrhoea for 24hrs, loss of appetite  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events Vaccination failure, COVID19 and bnt162b2 cannot be ruled out.