chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9266), in right arm, on 12Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 06Dec2021 as dose 3 (booster), single (Lot number: FG3524), in left arm and on 02May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN, start date: Apr2021; ATORVASTIN, start date: 02Dec2021; PAPAYA ENZYMES, start date: Apr2021; ALEVE, start date: Apr2020; FISH OIL NATURE MADE, start date: Apr2021; HEAL N SOOTHE, start date: Apr2022; BRAIN BOOSTER, start date: May2022; VITAMIN D3, start date: Apr2020; ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE], start date: Apr2021. Past drug history included: Known allergies: magnesium, reaction(s): "Known allergies: Magnesium". The following information was reported: VACCINATION FAILURE (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, notes: Indication=Treatment of COVID-19 - start date: 19Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Illness, Monkeypox
Clinical narrative: Monkeypox; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Lot number: EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endocrine disorder" (unspecified if ongoing), notes: Caller said she has an endocrine disorder and is undiagnosed and she treats herself; "hormonal disorder" (unspecified if ongoing); "delta", start date: Apr2020 (unspecified if ongoing); "Long COVID" (unspecified if ongoing), notes: she had long Covid and lost sense of smell and all the symptoms; "COVID-19", start date: Jan2020 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: They had Covid several times. There were no concomitant medications. Past drug history included: Tylenol, reaction(s): "severe hormonal reaction". Vaccination history included: BNT162b2 (1st dose, NDC: Unknown), administration date: 21Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "Sick", "diarrhea". The following information was reported: MONKEYPOX (medically significant), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: Body temperature: 103 Fahrenheit, notes: Caller said she had a 103 fever. The clinical course was reported as follows: caller said is home sick and very increasingly bothered and when statistics come out, they don't include people that have every time and in the beginning.  Got in this Jun and had monkey pox and felt like getting better after 3 weeks and went out and caught whichever variate in early July.  All symptoms of monkey pox and they have friends who are homosexual, and they are not homosexual and are in a heterosexual relationship and they hug there friends and yet when she called the department in (city withheld) City for monkey pox testing in Jul they asked if they were a homosexual male and she said no and they could not get test.  Caller said she is a heterosexual female and the only reason showing up homosexual male because cannot get test.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Monkeypox; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Lot number: EW0183) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endocrine disorder" (unspecified if ongoing), notes: Caller said she has an endocrine disorder and is undiagnosed and she treats herself; "hormonal disorder" (unspecified if ongoing); "delta", start date: Apr2020 (unspecified if ongoing); "Long COVID" (unspecified if ongoing), notes: she had long Covid and lost sense of smell and all the symptoms; "COVID-19", start date: Jan2020 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: They had Covid several times. There were no concomitant medications. Past drug history included: Tylenol, reaction(s): "severe hormonal reaction". Vaccination history included: BNT162b2 (1st dose, NDC: Unknown), administration date: 21Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "Sick", "diarrhea". The following information was reported: MONKEYPOX (medically significant), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: Body temperature: 103 Fahrenheit, notes: Caller said she had a 103 fever. The clinical course was reported as follows: caller said is home sick and very increasingly bothered and when statistics come out, they don't include people that have every time and in the beginning.  Got in this Jun and had monkey pox and felt like getting better after 3 weeks and went out and caught whichever variate in early July.  All symptoms of monkey pox and they have friends who are homosexual, and they are not homosexual and are in a heterosexual relationship and they hug there friends and yet when she called the department in (city withheld) City for monkey pox testing in Jul they asked if they were a homosexual male and she said no and they could not get test.  Caller said she is a heterosexual female and the only reason showing up homosexual male because cannot get test.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE, start date: 01Sep2022; BUDESONIDE, start date: 01Sep2022; SINGULAIR, start date: 01Sep2022; ZYRTEC ALLERGY, start date: 01Sep2022. Past drug history included: Azithromycin, reaction(s): "Drug allergy". The patient tested positive in a COVID -19 virus test on an unspecified date and received PAXLOVID as treatment for Covid-19 starting from 02Oct2022. The outcome of the event was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
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 a contactable reporter (Consumer). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Lot number: Ff2590) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLOMAX [TAMSULOSIN HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: indication=Treatment of COVID-19; (unspecified date) Positive, notes: COVID rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: patient had a Covid-19 rebound (cold-like symptoms, running nose, headache, sneezing, fever, cough) on 03Oct2022 after treatment with Paxlovid from 17Sep2022 (as reported).
Age: 31.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Erythema, Headache, Neck pain, Pain
Clinical narrative: Left arm was red and swollen; Left arm was red and swollen; Pain radiating from shoulder to neck and head; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 31-year-old female patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 14Sep2022 at 11:04 as dose number unknown, 0.5 ml single (Lot number: FJ2598, Expiration Date: 30Jun2023) at the age of 31 years, in left arm for immunisation. The patient's relevant medical history included: "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN as 500 mg, daily.  The following information was reported: ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 16Sep2022, outcome "recovering" and all described as "Left arm was red and swollen"; PAIN (non-serious) with onset 16Sep2022, outcome "recovering", described as "Pain radiating from shoulder to neck and head". The events "left arm was red and swollen" and "pain radiating from shoulder to neck and head" required physician office visit.  Additional information: The patient took PREVNAR 20 and had a reaction to it. The patient had the reaction two days after the vaccine was given. Vaccine was given on 14Sep2022 and she had a reaction on 16Sep2022. Her left arm was red and swollen. Then, she had a pain radiating from her shoulder to her neck and head. This occurred two days after the vaccine. Then, the patient was seen again on 26Sep2022, and she had improved. She had decreased pain in her shoulder.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: Left arm was red and swollen; Left arm was red and swollen; Pain radiating from shoulder to neck and head; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 31-year-old female patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 14Sep2022 at 11:04 as dose number unknown, 0.5 ml single (Lot number: FJ2598, Expiration Date: 30Jun2023) at the age of 31 years, in left arm for immunisation. The patient's relevant medical history included: "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN as 500 mg, daily.  The following information was reported: ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 16Sep2022, outcome "recovering" and all described as "Left arm was red and swollen"; PAIN (non-serious) with onset 16Sep2022, outcome "recovering", described as "Pain radiating from shoulder to neck and head". The events "left arm was red and swollen" and "pain radiating from shoulder to neck and head" required physician office visit.  Additional information: The patient took PREVNAR 20 and had a reaction to it. The patient had the reaction two days after the vaccine was given. Vaccine was given on 14Sep2022 and she had a reaction on 16Sep2022. Her left arm was red and swollen. Then, she had a pain radiating from her shoulder to her neck and head. This occurred two days after the vaccine. Then, the patient was seen again on 26Sep2022, and she had improved. She had decreased pain in her shoulder.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: developed pneumonia 3 weeks after receiving the vaccine; developed pneumonia 3 weeks after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "developed pneumonia 3 weeks after receiving the vaccine".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and pneumonia are related to pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20) administration cannot be excluded. The vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be reassessed should additional information become available.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Adenoid cystic carcinoma, Ear operation, Radiotherapy to ear
Clinical narrative: proton therapy to right ear; right ear canal resection; Adenoid cystic carcinoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 50 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site Arm upper, Batch/lot number: EN6208), administration date: 16Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site Arm upper, Batch/lot number: EW0153), administration date: 13Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: ADENOID CYSTIC CARCINOMA (medically significant) with onset Dec2021, outcome "not recovered"; EAR OPERATION (medically significant) with onset 15Feb2022, outcome "unknown", described as "right ear canal resection"; RADIOTHERAPY TO EAR (medically significant) with onset 28Mar2022, outcome "recovered" (10May2022), described as "proton therapy to right ear". Clinical Course: It was reported that patient received Pfizer/BioNTech COVID-19 Vaccine Details: Dose: 4, Date: 01Apr2021, Anatomical site of injection: Arm- Upper, Batch/lot number: FJ6369, Vaccination Facility type: Hospital, 4th dose/booster. Prior vaccinations (within 4 weeks): Vaccine Name: Shingrix, Route: Injection, Anatomical site: Arm-upper, Date: 04Dec2021 and 01Oct2021.Prior vaccinations (within 4 weeks).  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Her arms were slightly sore; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02829 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 02Nov2020 as dose 1, single (Lot number: EK4244244) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Inhaler: Asthma; "Medication for fibromyalgia" (unspecified if ongoing), notes: Medication for fibromyalgia. Concomitant medication(s) included: COCODAMOL; MORPHINE. The following information was reported: HEADACHE (non-serious) with onset 02Nov2020, outcome "recovered" (03Nov2020); PAIN IN EXTREMITY (non-serious) with onset 02Nov2020, outcome "recovered" (03Nov2020), described as "Her arms were slightly sore". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201201534 same patient/drug, similar event, different dose number.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose number unknown (booster), single (Lot number: GH9702) at the age of 26 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. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2022, outcome "unknown".  Additional information: Patient reported fever and chills after receiving the bivalent vaccine. Event took place after use of product.  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: Fatigue, Pain, Pyrexia
Clinical narrative: Achy; fever; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 16-year-old male patient received BNT162b2 (COMIRNATY), 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: PAIN (non-serious), outcome "unknown", described as "Achy"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown".  Additional information: the event took place after the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: no reaction to the Pfizer shots other than fever for first one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 04Mar2021 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: PYREXIA (non-serious), outcome "unknown", described as "no reaction to the Pfizer shots other than fever for first one".  Additional information: Patient reportedly received Pfizer on 30May2021, 21Nov2021, and on 12Apr2022. She also received Moderna Spikevax Bivalent BA.1 Covid-19 Lot # 017F22A booster on 28Sep2022 at 12 pm. She had pain throughout the night, hard to sleep. Pain was more tolerable but swelling continued. It subsided by Sunday 02Oct2022. She also reported having similar swelling with shingles vaccine.   No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Product use issue
Clinical narrative: Patient developed lymphadenopathy in left axillary lymph node; administered flu shot at the same time as the COVID-19 bivalent booster vaccine; administered flu shot at the same time as the COVID-19 bivalent booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Patient developed lymphadenopathy in left axillary lymph node"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "administered flu shot at the same time as the COVID-19 bivalent booster vaccine".  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: U
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: Pemphigus/Valgaris; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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 patient experienced "Pemphigus/Valgaris" on an unspecified date. The reporter was unsure if the Covid-19 vaccine was Pfizer or Moderna. The event took place after use of the product. The outcome of the event was unknown.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Pemphiguswith the suspect product covid vaccine  cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "resident in a long-term care facility" (unspecified if ongoing), notes: with many comorbid conditions. The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  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 available information in the case, the causal association between the event unknown cause of death and the suspect drug 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.; Reported Cause(s) of Death: death
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Atrial Fibrillation condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old patient received BNT162B2, BNT162B2 OMI BA.4-5, on 30Sep2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 02Oct2022, outcome "recovered" (03Oct2022 at 18:00), described as "Atrial Fibrillation condition". The patient underwent the following laboratory tests and procedures: EKG (Electrocardiogram): unknown result, notes: waveforms are available. Additional information: The reporter stated, "I received my 4th Pfizer booster shot on 30Sep2022 at 10 AM. On Sunday 02Oct2022 my (name) Watch notified me of an Atrial Fibrillation condition. This condition lasted until Monday 03Oct2022 at 6 PM. I'm 69 and in great health. EKG waveforms are available. Though you should know."  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Electrocardiogram, Magnetic resonance imaging, Mammogram, Ultrasound scan
Clinical narrative: heart murmur; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: ER8730) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis in knees" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Low vitamin D3" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing); VITAMIN D3 1000 taken for vitamin d deficiency (ongoing); REPLESTA oral taken for vitamin supplementation; PANTOPRAZOLE taken for gastrooesophageal reflux disease (ongoing); LOSARTAN taken for blood pressure measurement (ongoing). Vaccination history included: BNT162b2 (Dose 1; lot number: EN6203, left arm), administration date: 02Mar2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: CARDIAC MURMUR (non-serious) with onset Apr2021, outcome "unknown", described as "heart murmur". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did an EKG before surgery and that was fine. They thought she had a heart murmur last Apr2021 and she had a workup that was perfect. They did pictures, ultrasounds and put dye through her and she knows she is ok on all that. Had an MRI to see if her other breast is ok and that is fine that was just a week before the surgery. They wanted to see what they are dealing with. Her mammogram last Jul2021 was fine, it said she has dense breasts but didn't show anything and she has always had dense breasts.  Follow-Up (06Oct2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case via health professional.   This case involves pediatric patient (Patient-09) being administered Influenza Quadrival A-B Vaccine [Fluzone QIV] post-excursion with no reported adverse event and reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   This case is linked to cases 2022SA409526, 2022SA409520, 2022SA409707 and 2022SA408679.   On 23-SEP-2022, the health care professional reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error).  On 23-SEP-2022, the adult patient being administered post-excursion suspect Fluzone QIV NP vaccine at dose 0.5 ml (lot:  UT7689LA, expiration date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (poor quality product administered) (latency same day).  Action taken: Not applicable.   At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SAD20220927002156:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered post excursion with no reported adverse event; temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409520(CLUSTER) and 2022SA409694(CLUSTER).  This case involves Adult and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022 the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event (product storage error).  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7689LA) (formulation, strength, dose not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SAD20220927002156:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case via health professional.   This case involves adult patient being administered Influenza Quadrival A-B Vaccine [Fluzone QIV] post-excursion with no reported adverse event and reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA409526, 2022SA409694, 2022SA409707 and 2022SA408679.   On 23-SEP-2022, the health care professional reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error).  On 23-Sep-2022, the adult patient being administered post-excursion suspect Fluzone QIV NP vaccine at dose 0.5 ml (lot:  UT7689LA, expiration date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.   At time of reporting, the outcome was Unknown for both events.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: the temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult (patient-7) and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes due to unknown cause with no reported adverse event (product storage error).  On 23-Sep-22, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (lot UT7689LA) (formulation, strength, dose not reported) via unknown route in unknown administration site for prophylactic immunization.  On 23-Sep-22, the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered)  following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered post excursion with no reported adverse event; Temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022 the suspect INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event (product storage error).  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength and dose not reported; lot UT7689LA) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SANOFI-01296467: SAD20220927002156:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no adverse event; patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion with no adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2022SA408679.  This case involves Adult and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from pre-filled syringes after a temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE , Suspension for injection (Dose, strength expiry date: unknown) lot UT7689LA via unknown route in unknown administration site for immunization (poor quality product administered) (Latency: same day) after temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no adverse event (product storage error) (unknown latency) .  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccine administered post temperature excursion with no adverse event; Initial information received on 26-Sep-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409520 and 2022SA409694.  This case involves an unknown age and unknown gender  patient and reporter stated that there was a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event and vaccine administered post temperature excursion with no adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.  On 23-Sep-2022 , there was a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error) involving INFLUENZA QUADRIVAL A-B VACCINE. The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case.  In Sep-2022 the patient developed a non-serious event of vaccine administered post temperature excursion with no adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE ( formulation: suspension for injection, strength, route, administration site was unknown, batch  number: UT7689LA and expiry date was unknown for prophylactic vaccination).  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SAD20220927002156:
Sex: F
Vaccine: FLUR3
Symptoms: Hypoaesthesia
Clinical narrative: received Flublok and experienced left facial numbness; numbness started at the top of cheek to the corner of mouth; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 35 years old female patient who experienced left facial numbness; numbness started at the top of cheek to the corner of mouth after receiving vaccine Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2022, the patient received 0.5 ml total dose of suspect Influenza quadrivalent recombinant vaccine(strength, formulation: unknown) (lot QFAA2225, 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 28-SEP-2022 the patient developed a left facial numbness; numbness started at the top of cheek to the corner of mouth (hypoaesthesia) following the administration of Influenza quadrivalent recombinant vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on 28-Sep-2022 for the event.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received the first MENACTRA at 11 then another one at 13 with no reported AE; Initial information received on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old and unknown gender patient who received the first MeningococcaL A-C-Y-W135 (D conj) vaccine [Menactra] at 11 then another one at 13 with no reported AE (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MeningococcaL A-C-Y-W135 (D conj) vaccine (dose, strength, formulation and lot number: unknown) via unknown route in unknown administration site for Immunization at 11 then another one at 13 with no reported AE (inappropriate schedule of product administration) (latency: same day). This situation is reported as a medication error due to--2 doses may have been given too close together according to the package insert.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.