chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Female is experiencing bothersome pruritus at the site of injection; This Initial case was previously missing the following minimum criteria: reporter has no first hand knowledge. Upon receipt of reporter has First-hand knowledge per ID #: 2209551., this case now contains all required information to be considered valid.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).   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: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Female is experiencing bothersome pruritus at the site of injection". Additional Information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site (arm)/arm was sore/ arm pain went away in a day or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at injection site (arm)/arm was sore/ arm pain went away in a day or two". Clinical course: The patient's mother stated the patient had pain at injection site (arm) after a second Covid shot, that her son's arm was sore after getting a Covid vaccination.   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: Investigation, Pericarditis
Clinical narrative: symptoms consistent with pericarditis; This is a spontaneous report received from contactable reporter (Physician).  A 32-year-old male patient received BNT162b2 (COMIRNATY), in 2021 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: PERICARDITIS (medically significant), outcome "unknown", described as "symptoms consistent with pericarditis". Clinical course: the 32-year-old male patient reported to long Covid clinic at a university, with symptoms consistent with pericarditis that has not responded to any standard TMT (NSAIDs, steroids). Autoimmune work up was negative. The patient has not had a Covid illness but received Comirnaty doses in Mar/Apr of 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contribution role of vaccine BNT162b2 (COMIRNATY) to the onset of pericarditis cannot be entirely excluded, considering temporal relationship and no other risk factors reported in this case, based on current information provided.  This case will be reassessed should additional information become available.  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.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Depression, Product administered to patient of inappropriate age
Clinical narrative: 13, 14, and 18 year old patients were given 0.3mL of Orange Cap as their first primary dose; correct dose, wrong strength, gave 0.3cc of 5-11yo vaccine; Depression; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 18-year-old patient received BNT162b2 (BNT162B2), on 25May2022 at 12:00 as dose 1, 0.3 ml single (Lot number: FL8095) at the age of 18 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Migraine", start date: 18Sep2017 (ongoing); "Unequal leg length", start date: 21Sep2004 (ongoing); "Eczema", start date: 07Nov2006 (ongoing). There were no concomitant medications. The following information was reported: DEPRESSION (non-serious) with onset 25May2022, outcome "not recovered"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 25May2022 at 12:00, outcome "unknown", described as "13, 14, and 18 year old patients were given 0.3mL of Orange Cap as their first primary dose"; ACCIDENTAL UNDERDOSE (non-serious) with onset 25May2022 at 12:00, outcome "unknown", described as "correct dose, wrong strength, gave 0.3cc of 5-11yo vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (27Jun2022): New information received from a contactable Nurse reported for the patient in response to HCP letter sent via follow-up letter which included updated information: At risk classification has been deleted. Reporter details updated, new reporter added added. Patient name updated. Patient age at vaccination added. RMH 'Migraine, Unequal leg length and Eczema' added. Start date, time, lot number, route of administration and anatomical location of suspect added. Vaccine facility name, address, city, state, type, phone number and Vaccine Administered at Military Facility added. Event onset date and time added for ' Inappropriate age at vaccine administration and Accidental under dose'. New events (Accidental under dose and Depression) added. Concomitant therapy captured as None.  Additional Information: Type of medication error reported as Dispensing issue with stage of medication error: Correct dose, wrong strength, gave 0.3 cc of 5-11 yo vaccine. Contributing factors to the medication error include Vials and clipboards placed on small table in medical room side by side. 12+ always kept to left on 5-11 yo on right. On 25May2022 clipboards were reversed on this (word illegible) drew up the wrong medicine. The medication error affected the patient or consumer with clinical consequences with reported outcome that patient needed to return the next day for a full dose of 0.3 cc, 12+ year old vaccine per guidelines. Medical room reconfigured 50 vials now in separate areas with separate tables; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200766227 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: "Known allergies: sulfa drugs" (unspecified if ongoing); "hypertrophic cardiomyopathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "reflux" (unspecified if ongoing); "hearing loss" (unspecified if ongoing); "eczema" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Never tested negative, but test line did get very faint; Positive, notes: Relapsed on Day 14 with slightly different symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Never tested negative, but test line did get very faint. Relapsed on Day 14 with slightly different symptoms. Patient received other medication within 2 weeks. Patient received Paxlovid from 08Jun2022 to12Jun2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; The initial case was missing the following minimum criteria: Unidentifiable Reporter. Upon receipt of follow-up information on 16Jun2022, this case now contains all required information to be considered valid.  This is a literature report. The reporter is the parent.  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "seizure". The following information was reported: SEIZURE (medically significant), outcome "not recovered". It was reported that with first Pfizer dose the patient had a seizure within 30 days. Got the second vaccine in Dec, had another seizure. Had the third booster, and had 4-6 seizures a day. The patient was an active soccer player and a good student, now unable to play sports or attend class in person.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events seizures cannot be excluded. The case will be reassessed if additional information becomes available. 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.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years 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 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Aug2021 as dose 2 (booster), single (Lot number: Ew0185) at the age of 45 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 04Apr2021 as dose 1, single (Lot number: 1805020), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Jun2022 at 16:00 as dose 3 (booster), single (Lot number: 056 M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19,  which included Paxlovid from 19Jun2022. Patient did not received other medication in 2 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: Allergies developed to all dairy, seafood, nuts, beef, dust, pollen. 2022 has been my worst year ever with pollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 at 17:00 as dose 2, single (Lot number: Er8734) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pollen" (unspecified if ongoing); "Beef" (unspecified if ongoing); "Seafood" (unspecified if ongoing); "nuts beef" (unspecified if ongoing); "All-mycin" (unspecified if ongoing); "Dairy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: Er8737, administration date: 05Apr2021, administration time: 02:00 PM, vaccine location: Right arm), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: FOOD ALLERGY (disability) with onset 04Aug2021 at 13:00, outcome "not recovered", described as "Allergies developed to all dairy, seafood, nuts, beef, dust, pollen. 2022 has been my worst year ever with pollen". Therapeutic measures were taken as a result of food allergy.  Clinical course: Allergies developed to all dairy, seafood, nuts, beef, dust, pollen. 2022 has been my worst year ever with pollen. AE treatment: All allergy remedies but non-works. AE resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient had Known allergies: Pollen, beef, diary, seafood, nuts beef, all-mycin prescribed medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications within two weeks: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination: Yes.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200875058 similar report from same reporter;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pharyngeal swelling, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Tachycardia; Rash; Chronic fevers; Severe fatigue; swelling of throat; This is a spontaneous report received from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 30Oct2021 at 17:00 as dose 1, single (Lot number: 301308A), at the age of 33 years, in left arm, for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient did not receive any concomitant medications. Past drug history included: Erythromycin, reaction: "Drug allergy", notes: known allergies: Erythromycin.  The following information was reported: TACHYCARDIA (non-serious) with onset 30Oct2021, outcome "recovered with sequelae"; RASH (non-serious) with onset 30Oct2021, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 30Oct2021, outcome "recovered with sequelae", described as "Chronic fevers"; FATIGUE (non-serious) with onset 30Oct2021, outcome "recovered with sequelae", described as "Severe fatigue"; PHARYNGEAL SWELLING (non-serious) with onset 30Oct2021, outcome "recovered with sequelae", described as "swelling of throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia, rash, pyrexia, fatigue and pharyngeal swelling.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events Tachycardia, rash, chronic fevers, severe fatigue, swelling of throat were evaluated at the physician office visit. Treatment included Benadryl received within 5 minutes after vaccination for TACHYCARDIA, RASH, PYREXIA, FATIGUE and PHARYNGEAL SWELLING . Since the vaccination, the patient had been tested for COVID-19. The patient also received bnt162b2 (BNT162B2) on 28Nov2021 at 10:15 as dose 2, single (Lot number: FF8839) in right arm, for COVID-19 immunisation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; Rash; Chronic fevers; Severe fatigue; swelling of throat; This is a spontaneous report received from a contactable reporter (Other healthcare professional). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 30Oct2021 at 17:00 as dose 1, single (Lot number: 301308A), at the age of 33 years, in left arm, for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient did not receive any concomitant medications. Past drug history included: Erythromycin, reaction: "Drug allergy", notes: known allergies: Erythromycin.  The following information was reported: TACHYCARDIA (non-serious) with onset 30Oct2021, outcome "recovered with sequelae"; RASH (non-serious) with onset 30Oct2021, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 30Oct2021, outcome "recovered with sequelae", described as "Chronic fevers"; FATIGUE (non-serious) with onset 30Oct2021, outcome "recovered with sequelae", described as "Severe fatigue"; PHARYNGEAL SWELLING (non-serious) with onset 30Oct2021, outcome "recovered with sequelae", described as "swelling of throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia, rash, pyrexia, fatigue and pharyngeal swelling.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events Tachycardia, rash, chronic fevers, severe fatigue, swelling of throat were evaluated at the physician office visit. Treatment included Benadryl received within 5 minutes after vaccination for TACHYCARDIA, RASH, PYREXIA, FATIGUE and PHARYNGEAL SWELLING . Since the vaccination, the patient had been tested for COVID-19. The patient also received bnt162b2 (BNT162B2) on 28Nov2021 at 10:15 as dose 2, single (Lot number: FF8839) in right arm, for COVID-19 immunisation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Inappropriate schedule of product administration, Menstruation delayed, Premenstrual syndrome
Clinical narrative: Pre period symptoms, emotional and psychological symptoms are totally different; My period occurs later and lighter; My period occurs later and lighter; Dose 1: 17Jan2022; Dose 2: 31Jan2022; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 31Jan2022 at 11:00 as dose 2, single (Lot number: unknown), at the age of 40 years, in the left arm, for COVID-19 immunisation. Relevant medical history included: "Chronic infection" (unspecified if ongoing), notes: Chronic sinus infections and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient received unspecified birth control pills. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical Location: Left arm; Administration Time: 10:00), administration date: 17Jan2022, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jan2022 at 11:00, outcome "unknown", described as "Dose 1: 17Jan2022; Dose 2: 31Jan2022"; PREMENSTRUAL SYNDROME (non-serious) with onset 01Mar2022, outcome "unknown", described as "Pre period symptoms, emotional and psychological symptoms are totally different"; MENSTRUATION DELAYED (non-serious), HYPOMENORRHOEA (non-serious) all with onset 01Mar2022, outcome "unknown", and all described as "My period occurs later and lighter". Therapeutic measures were not taken as a result of premenstrual syndrome, menstruation delayed and hypomenorrhoea.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified birth control pills since age 25. Prior to vaccination, the patient was diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 50.0
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) (Pharmacist) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 at 06:45 as dose 1, single (Lot number: EJ1685), on 13Jan2021 at 06:45 as dose 2, single (Lot number: EK9231), in left arm, on 28Oct2021 at 09:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 24Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "h/o asthma" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 08Jul2019; ESTROGEN, start date: 08Jul2019; PROGESTERONE, start date: 08Jul2019. 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: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks were reported as, Yes. Anti-viral details contain; Product, COVID 19 Treatment, Paxlovid. Treatment start date was 08Jun2022 and Treatment stop date was, 12Jun2022 for the treatment of 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 the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose number unknown, single (Batch/Lot number: unknown) 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). There were no concomitant medications. 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: (20Jun2022) negative; (21Jun2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course of the events: Adverse event: Chemical bitter taste, and diarrhoea during Tx (treatment), which lasted through 19Jun2022. No fever after 17Jun2022. Tested negative 20Jun and 21Jun2022. Developed low grade fever 100 on 22Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: Fk9893) 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: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "known allergies: cashews" (unspecified if ongoing), notes: known allergies: cashews; "known allergies: soy" (unspecified if ongoing), notes: known allergies: soy. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (20Jun2022) Negative, notes: Tested negative 20Jun and then tested positive (21Jun-22Jun); (21Jun2022) Positive, notes: Tested negative 20Jun and then tested positive (21Jun-22Jun); (22Jun2022) Positive, notes: Tested negative 20Jun and then tested positive (21Jun-22Jun). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.     .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Suspected COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 28Mar2021 as dose 2, single (Lot number: ep6955), in right arm and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetic" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "bp" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; LEVOTHYROXINE; ALLEGRA; BENAZEPRIL; ROSUVASTATIN; METFORMIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022 at 13:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 92/61. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient got a rebound case of COVID, 5 days symptom free then runny nose started 6th day followed by stuffy nose and loss of all taste and smell which didn't happen the first time. No Known allergies.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I had covid rebound occur 15 days after my first positive test; (20Jun2022) Positive, notes: positive antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective. Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 05Jun2022 Treatment stop date: 09Jun2022, indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
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). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunization; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "esophageal spasms" (unspecified if ongoing); "IBS" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "perioral dermatitis" (unspecified if ongoing); "MDD" (unspecified if ongoing); "known allergies: Almonds" (unspecified if ongoing); "known allergies: hazelnuts" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 07May2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication Bupropion in 2 weeks of vaccination. The patient received treatment with Paxlovid.   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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2022 as dose 4 (booster), single (Lot number: FJ5682), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: NSAIDs" (unspecified if ongoing). Concomitant medication(s) included: SILDENAFIL oral, start date: Dec2017. Past drug history included: Sudafed, reaction(s): "Known allergies: sudafed". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0175 and the expiry date was not reported), in left arm and on 18May2021 as dose 2, single (Lot number: EW0183 and the expiry date was not reported) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Walnuts" (unspecified if ongoing). The patient was 30 weeks pregnant at the event onset. The patient's 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". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reportedly the patient did not receive any other medication in 2 weeks. Reportedly the patient received Paxlovid for COVID 19 Treatment (start date: 20Jun2022). It was reported that the patient experienced nausea/reflux and a persistent bad taste in mouth and back of throat considered as symptoms of covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: was nursing at that time/child experienced side effects after the Pfizer dose also; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-016614 (Moderna).  A 3-year-old female patient (not pregnant) was exposed to BNT162b2 (BNT162B2), transmammary, administration details for the mother: on 27May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The mother's relevant medical history was not reported. The patient's and the mother's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose: 2 (booster), Caller stated first booster dose (Moderna)), administration date: 16Dec2021, when the patient was 2-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose: 1, Caller stated first COVID-19 vaccination received was J&J), for Covid-19 immunization. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "was nursing at that time/child experienced side effects after the Pfizer dose also".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200008197 Mother Case;
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid indication=COVID-19 Treatment; Paxlovid indication=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 37-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid indication=COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was confirmed that patient received the vaccine. It was reported that no other medication in 2 weeks. Patient received treatment for COVID 19 with Anti-viral as Paxlovid (lot number: GC8236). Treatment starts on 21Jun2022 and stop on 22Jun2022 due to some side effect with treatment drug as Bitter, metallic taste present in mouth after taking dose of medication on the same of treatment received at 07:00 PM. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 73-year-old patient received BNT162b2 (BNT162B2), on 02May2022 at 16:00 as dose 4 (booster), single (Lot number: Pk9893) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myocardial ischaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 04Jun2020, stop date: 07Jun2022; LISINOPRIL, start date: 04Jun2022, stop date: 22Jun2022; BUPROPION, start date: 30Jun2010, stop date: 22Jun2022; CARVIDOL, start date: 04Jun2020, stop date: 22Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 11 years 11 months 21 days after the suspect product(s) administration, outcome "recovering" and all described as "COVID- 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medical history: Ischemic heart disease.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I believe he tested for COVID after getting Pfizer COVID-19 Vaccine; I believe he tested for COVID after getting Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I believe he tested for COVID after getting Pfizer COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I believe he tested for COVID after getting Pfizer COVID-19 Vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information: He tested for COVID after getting Pfizer COVID-19 Vaccine and he was treated with Paxlovid.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Pain in armpit; Swollen Lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 19Jun2022 at 19:00 as dose 3 (booster), single (Lot number: FP7135) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FL0007, Location of injection: Arm Left), administration date: 29Nov2021, when the patient was 11-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left), administration date: 08Nov2021, when the patient was 11-year-old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 20Jun2022 at 01:00, outcome "not recovered", described as "Pain in armpit"; LYMPHADENOPATHY (non-serious) with onset 20Jun2022 at 01:00, outcome "not recovered", described as "Swollen Lymph node". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. No COVID prior vaccination. COVID did not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 10:00 as dose 1, single (Lot number: FL2249), in left arm, on 08Feb2021 at 13:00 as dose 2, single (Lot number: FL9262), in left arm, on 18Aug2021 at 09:00 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 16Feb2022 at 10:00 as dose 4 (booster), single (Lot number: Fl3209) at the age of 75 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "CVID" (unspecified if ongoing), notes: Have CVID take subcutaneous, Xembify weekly. The patient had no known allergies. Concomitant medication(s) in 2 weeks included: XEMBIFY, start date: 31May2021. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; virus free, notes: Tested almost virus free; Positive, notes: Test showed strong virus presence, stronger than any prior test. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient felt better after third day, completed the course. Tested almost virus free. A couple of days symptoms flared back up and got worse than before treatment. Test showed strong virus presence, stronger than any prior test. Started running a fever again. Still felt pretty lousy. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date was on 10Jun2022 and treatment stop date was on 14Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Joint swelling, Joint warmth
Clinical narrative: joint motion limitation; joints swollen; joints hot; joints very painful/severe arthralgia; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lichen sclerosis et atrophicus" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "atrophic vaginitis" (unspecified if ongoing); "penacillin" (unspecified if ongoing); "scallops" (unspecified if ongoing); "dairy" (unspecified if ongoing). Concomitant medication(s) included: COMBIPATCH; CLOBETASOL topical; METRONIDAZOLE topical; VIT D [VITAMIN D NOS]; CALCIUM; PATANOL. Past drug history included: Codiene, reaction(s): "known allergies: codiene". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunisation; Bnt162b2 (DOSE 3, SINGLE; Lot number: FD0809; Anatomical location: Left arm.), for Covid-19 Immunisation. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joint motion limitation"; JOINT WARMTH (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joints hot"; JOINT SWELLING (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joints swollen"; ARTHRALGIA (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joints very painful/severe arthralgia". The events "joint motion limitation", "joints swollen", "joints hot" and "joints very painful/severe arthralgia" required physician office visit. Therapeutic measures were not taken as a result of joint range of motion decreased, joint swelling, joint warmth, arthralgia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200886854 Same patient and drug, different event;
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose number unknown, single (Batch/Lot number: unknown) and on 30Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine Janssen (COVID-19 VACCINE JANSSEN), on 12Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAQUENIL S. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Adverse event: Tested positive for Covid 07Jun2022 & started paxlovid. Finished meds on 11Jun2022, w/a negative test. Tested negative everyday after that. Tested positive 22Jun2022  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.