chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Pain in extremity, Suspected COVID-19, Vaccination site pain
Clinical narrative: COVID-19; COVID-19; Vaccination site pain/mild sore arm; mild sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4214557-00.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis, psoriatic arthropathy. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Vaccination site pain/mild sore arm"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild sore arm". The action taken for adalimumab was unknown.  Causality for humira (adalimumab): The reporter's causality for the event(s) of vaccine caused a mild sore arm and covid was not provided and for Vaccination site pain and covid-19: not reported. Causality as per reporter for PFIZER BIONTECH COVID-19 Vaccine for events Vaccination site pain:  possible and for Covid-19 (covid-19) and mild sore arm: not reported   Clinical Course: On an unknown date, the patient experienced covid. In 2021, the patient experienced vaccine caused a mild sore arm and covid with humira (adalimumab). In 2021, the vaccine caused a mild sore arm resolved. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, the vaccine caused a mild sore arm resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events drug ineffective, suspected COVID-19 and vaccination site pain , Pain in extremity  and suspect drug BNT162B2 cannot be excluded.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Newly onset Type 1 diabetes; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 (Lot number: EP6955) as dose 1, single and administered in arm right, administration date 13Apr2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ALLEGRA. Past drug history included: Cedax, reaction(s): "Known allergies: Cedax"; Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: TYPE 1 DIABETES MELLITUS (disability, life threatening) with onset 2021, outcome "not recovered", described as "Newly onset Type 1 diabetes". The event "newly onset type 1 diabetes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of type 1 diabetes mellitus with Daily T1D treatment. Clinical course: event resulted in life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient had not covid prior vaccination. The patient was tested for covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: massive stroke; This is a spontaneous report received from a non-contactable consumer or other non hcp for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Dec2021 (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Dec2021, outcome "unknown", described as "massive stroke". Caller mentioned that she was involved in the situation where she got massive stroke twice after taking the COVID-19 vaccine 2 weeks ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: both caught covid; both caught covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single 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) all with onset Dec2021, outcome "unknown" and all described as "both caught covid". The reporter stated that, the both patient had (mother and father) caught COVID around December, and it may have started even closer to November.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information, a possible contributory role of BT162B2 to the events DRUG INEFFECTIVE and COVID-19 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Her dad had also caught the virus and it may have been where she got the virus from; Her dad had also caught the virus and it may have been where she got the virus from; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her dad had also caught the virus and it may have been where she got the virus from".  It was reported that the reporter was talking to someone yesterday and they said they felt like "everyone in the world has Covid". Specifically, they mentioned an adolescent girl (Initial "withheld", approximately 16 years old, female, withheld) who had caught coronavirus recently (end of Dec/Jan) that they know, even though her twin had not. Her dad had also caught the virus and it may have been where she got the virus from. There is a strong chance "withheld" is vaccinated, and unknown regarding the dad. Unsure which vaccine and when received and what dosage.  The lot number for bnt162b2 was not provided and will be requested during follow up ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200004461 same reporter/drug/AE, different patient
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; COVID-19 positive; COVID-19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer) from RA.  A 46-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Nov2021 (Lot number: EW0217) at the age of 46 years as dose 3, (booster) single, (Lot number: EL3247) as dose 2, single and (Lot number: EL3247) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: COVDI-19 test: positive.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Chills, Dyspnoea, Heart rate
Clinical narrative: booster; chills; chest pain; they would stop my breathing for a second or more but ended after 5 minutes; Heartrate was over 130; at 11:30 blood pressure was measured 128/88 1:30 124/82; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 12:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=12Jun2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 12Jun2021, when the patient was 15 years old, for Covid-19 immunization, reaction(s): "heartrate at over 100"; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=21May2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 21May2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 12:00, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset Dec2021, outcome "recovered", described as "chills"; CHEST PAIN (non-serious) with onset Dec2021, outcome "recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset Dec2021, outcome "recovered", described as "they would stop my breathing for a second or more but ended after 5 minutes"; HEART RATE INCREASED (non-serious) with onset Dec2021, outcome "recovered", described as "Heartrate was over 130"; HYPERTENSION (non-serious) with onset Dec2021, outcome "recovered", described as "at 11:30 blood pressure was measured 128/88 1:30 124/82". The events "chills", "chest pain", "they would stop my breathing for a second or more but ended after 5 minutes", "heartrate was over 130" and "at 11:30 blood pressure was measured 128/88 1:30 124/82" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, chest pain, dyspnoea, heart rate increased, hypertension.  Additional information: The patient underwent lab tests and procedures which included Nasal Swab of COVID-19 virus test,- Negative COVID-19 test on 28Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; chills; chest pain; they would stop my breathing for a second or more but ended after 5 minutes; Heartrate was over 130; at 11:30 blood pressure was measured 128/88 1:30 124/82; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 12:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=12Jun2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 12Jun2021, when the patient was 15 years old, for Covid-19 immunization, reaction(s): "heartrate at over 100"; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand_unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=21May2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 21May2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021 12:00, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset Dec2021, outcome "recovered", described as "chills"; CHEST PAIN (non-serious) with onset Dec2021, outcome "recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset Dec2021, outcome "recovered", described as "they would stop my breathing for a second or more but ended after 5 minutes"; HEART RATE INCREASED (non-serious) with onset Dec2021, outcome "recovered", described as "Heartrate was over 130"; HYPERTENSION (non-serious) with onset Dec2021, outcome "recovered", described as "at 11:30 blood pressure was measured 128/88 1:30 124/82". The events "chills", "chest pain", "they would stop my breathing for a second or more but ended after 5 minutes", "heartrate was over 130" and "at 11:30 blood pressure was measured 128/88 1:30 124/82" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, chest pain, dyspnoea, heart rate increased, hypertension.  Additional information: The patient underwent lab tests and procedures which included Nasal Swab of COVID-19 virus test,- Negative COVID-19 test on 28Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I am pregnant; I got vaccinated back in February; I just got COVID; I am tested positive; I got vaccinated back in February; I just got COVID; I am tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EL3247) at the age of 33 years as dose 2, single and administered in arm left, administration date 01Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FERROUS SULFATE; IRON; PRENATAL [FOLIC ACID;IRON]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "I got vaccinated back in February; I just got COVID; I am tested positive"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "I am pregnant". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; sars-cov-2 test: (28Dec2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. with Tylenol. Patient takes one pill 500 milligrams. Patient took 3 pills in the past two days and that was it.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Scan
Clinical narrative: stage four Cirrhosis of the liver; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknow, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "stage four Cirrhosis of the liver". The patient underwent the following laboratory tests and procedures: scan: cirrhosis of the liver. Two months prior to taking the Covid-19 vaccine the patient was a breast cancer survivor. She had a full body scan after taking the vaccine she was told that she had stage four Cirrhosis of the liver which she did not have prior to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dehydration, Headache, Immunisation, Product use issue, Therapeutic response unexpected
Clinical narrative: booster in Sep2021; headaches; gets dehydrated when she takes it; cuts the pill, taken it twice and not gone through an entire pill yet; it did stop her headaches.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AGN282322 (Allergan).  A 68 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; atogepant (ATOGEPANT), oral since 2021 (Batch/Lot number: unknown) at cuts the pill, taken it twice and not gone through an entire pill for migraine. Relevant medical history included: "Migraines" (ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset Sep2021, outcome "unknown", described as "booster in Sep2021"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headaches"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "gets dehydrated when she takes it"; PRODUCT USE ISSUE (non-serious) with onset 2021, outcome "unknown", described as "cuts the pill, taken it twice and not gone through an entire pill yet"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "it did stop her headaches.". The action taken for atogepant was unknown.  Additional information: It was unknown if patient was breastfeeding. The patient was not hospitalized as a result of the Adverse event. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Nightmare, Pain
Clinical narrative: received the J&J covid vaccine in mid Oct2021. On about 29Dec2021, he received a Pfizer covid vaccine dose as a booster dose; booster dose; had bad nightmares the first night; subsequently felt tired; had body aches for the two days after; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&J covid vaccine (Dose: 1), administration date: Oct2021, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Dec2021, outcome "unknown", described as "received the J&J covid vaccine in mid Oct2021. On about 29Dec2021, he received a Pfizer covid vaccine dose as a booster dose"; IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster dose"; FATIGUE (non-serious) with onset Dec2021, outcome "recovered", described as "subsequently felt tired"; PAIN (non-serious) with onset Dec2021, outcome "recovered", described as "had body aches for the two days after"; NIGHTMARE (non-serious) with onset 29Dec2021, outcome "unknown", described as "had bad nightmares the first night".  Additional information: It was reported that, patient was 50yo male who received the J&J covid vaccine in mid Oct2021. On about 29Dec2021, he received a Pfizer covid vaccine dose as a booster dose and subsequently felt tired and had body aches for the two days after and had bad nightmares the first night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Thyroid disorder, Thyroid function test
Clinical narrative: They scanned her thyroid came back high; Severe anterior neck pain for so many weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 40 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Subacute thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "They scanned her thyroid came back high"; NECK PAIN (non-serious), outcome "unknown", described as "Severe anterior neck pain for so many weeks". The patient underwent the following laboratory tests and procedures: thyroid function test: high, notes: that's where her lymph nodes are. Therapeutic measures were taken as a result of neck pain. 4 days after second dose the patient experienced severe anterior neck pain for so many weeks treated with Prednisolone, they scanned her thyroid came back high, that's where her lymph nodes were.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Immunisation
Clinical narrative: booster; chronic upper back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 12Feb2021, for Covid-19 immunization, reaction(s): "covid-19"; Bnt162b2 (Dose 2), administration date: 26Feb2021, for Covid-19 immunization, reaction(s): "covid-19". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "booster"; BACK PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "chronic upper back pain".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: breakthrough symptomatic COVID infection; breakthrough symptomatic COVID infection; sore throat; fever; cough; general body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 05Jun2021 (Lot number: EW0187) at the age of 14 years as dose 2, single and intramuscular, administered in arm left, administration date 15May2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "breakthrough symptomatic COVID infection"; OROPHARYNGEAL PAIN (non-serious) with onset 22Dec2021, outcome "recovered", described as "sore throat"; PYREXIA (non-serious) with onset 22Dec2021, outcome "recovered", described as "fever"; COUGH (non-serious) with onset 22Dec2021, outcome "recovered", described as "cough"; PAIN (non-serious) with onset 22Dec2021, outcome "recovered", described as "general body aches". The events "breakthrough symptomatic covid infection", "breakthrough symptomatic covid infection", "sore throat", "fever", "cough" and "general body aches" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: PCR. Nasal Swab; (24Dec2021) positive, notes: Rapid. Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure, oropharyngeal pain, pyrexia, cough, pain. No known allergies and none Other medical history. Patient was tested post vaccination. No covid prior vaccination. Patient received treatment for event as Mucinex D; Advil. Adverse event breakthrough symptomatic COVID infection; fever, cough, general body aches, sore throat.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough symptomatic COVID infection; breakthrough symptomatic COVID infection; sore throat; fever; cough; general body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 05Jun2021 (Lot number: EW0187) at the age of 14 years as dose 2, single and intramuscular, administered in arm left, administration date 15May2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "breakthrough symptomatic COVID infection"; OROPHARYNGEAL PAIN (non-serious) with onset 22Dec2021, outcome "recovered", described as "sore throat"; PYREXIA (non-serious) with onset 22Dec2021, outcome "recovered", described as "fever"; COUGH (non-serious) with onset 22Dec2021, outcome "recovered", described as "cough"; PAIN (non-serious) with onset 22Dec2021, outcome "recovered", described as "general body aches". The events "breakthrough symptomatic covid infection", "breakthrough symptomatic covid infection", "sore throat", "fever", "cough" and "general body aches" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: PCR. Nasal Swab; (24Dec2021) positive, notes: Rapid. Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure, oropharyngeal pain, pyrexia, cough, pain. No known allergies and none Other medical history. Patient was tested post vaccination. No covid prior vaccination. Patient received treatment for event as Mucinex D; Advil. Adverse event breakthrough symptomatic COVID infection; fever, cough, general body aches, sore throat.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dry mouth, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mouth gets really dry; tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine.; tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine.; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2020 (Lot number: EL1284) as dose 1, single, administration date 20Jan2021 (Lot number: EL1284) as dose 2, single and administration date 05Oct2021 (Lot number: 301358A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome "unknown", described as "Booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine."; DRY MOUTH (non-serious), outcome "not recovered", described as "mouth gets really dry". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive. Therapeutic measures were taken as a result of dry mouth.Caller said that she was on the phone and holding but then it was disconnected. She had explained that she had took the Pfizer vaccine twice and had the booster and she ended up with COVID. Product clarified to be the Pfizer COVID vaccine. Her symptoms started a week from today on last Tuesday, 28Dec2021. The only symptoms that she had was cough, headache and nausea from COVID. At first her symptoms were worse, and she stayed in bed and drank a lot of fluids. She had tried to keep moving around and she took some Emergen-C stuff and that helped her out a whole lot. Inquired for outcome of her COVID symptoms and she stated that the only thing she had now was the cough and her mouth got really dry every now and then and she was nauseated still. She tested positive on 28Dec2021 with an at home COVID test. She also had another test when she got back to work that said she was still positive.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: mouth gets really dry; tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine.; tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine.; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 30Dec2020 (Lot number: EL1284) as dose 1, single, administration date 20Jan2021 (Lot number: EL1284) as dose 2, single and administration date 05Oct2021 (Lot number: 301358A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Oct2021, outcome "unknown", described as "Booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "tested POSITIVE for COVID-19 on 28Dec2021.  She continues to test positive today.  She received all 3 doses of the Pfizer Covid-19 Vaccine."; DRY MOUTH (non-serious), outcome "not recovered", described as "mouth gets really dry". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive. Therapeutic measures were taken as a result of dry mouth.Caller said that she was on the phone and holding but then it was disconnected. She had explained that she had took the Pfizer vaccine twice and had the booster and she ended up with COVID. Product clarified to be the Pfizer COVID vaccine. Her symptoms started a week from today on last Tuesday, 28Dec2021. The only symptoms that she had was cough, headache and nausea from COVID. At first her symptoms were worse, and she stayed in bed and drank a lot of fluids. She had tried to keep moving around and she took some Emergen-C stuff and that helped her out a whole lot. Inquired for outcome of her COVID symptoms and she stated that the only thing she had now was the cough and her mouth got really dry every now and then and she was nauseated still. She tested positive on 28Dec2021 with an at home COVID test. She also had another test when she got back to work that said she was still positive.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive with symptoms; Covid positive with symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26May2021 (Lot number: EW0168) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8736, Location of injection: Arm Left), administration date: 05May2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "Covid positive with symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Nov2021) negative, notes: PCR Nasal Swab; (03Jan2022) positive, notes: At home antigen test, Nasal Swab; (03Jan2022) positive, notes: At home antigen test, Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had no known allergies, Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: Tested positive for Covid on 12/31/2021; Tested positive for Covid on 12/31/2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 (Lot number: EL3247) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: El3247, Location of injection: Arm Right), administration date: 08Feb2021, for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "recovered" and all described as "Tested positive for Covid on 12/31/2021". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No other vaccine taken in four weeks. No covid was detected prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed covid positive/coughing, congestion, body aches all like a common cold and lost sense of taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 19 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Apr2021 (Lot number: EP7533) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "vitiligo" (unspecified if ongoing), notes: diagnosed with vitiligo in 8th grade; "mild cough" (unspecified if ongoing); "post nasal drip" (unspecified if ongoing); "stuffy nose" (unspecified if ongoing); "skipping heart beat" (unspecified if ongoing). Family history included: "high blood pressure" (unspecified if ongoing), notes: maternal; "diabetes" (unspecified if ongoing), notes: paternal. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 23Dec2021, outcome "unknown", described as "diagnosed covid positive/coughing, congestion, body aches all like a common cold and lost sense of taste". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior to covid symptoms the patient experienced mild cough, post nasal drip, stuffy nose during the start of winter season. It was reported that symptoms (included coughing, congestion, body aches all like a common cold and lost sense of taste) started on 20Dec2021. Coughing, congestion, body aches all like a common cold resolved in 1-2 days and lost sense of taste recovered in few days. Taste recovered most but still was slightly off at the time of the event. Quarantine was required and ended on 30Dec2021. The patient might have spread covid to his biological father. It was unclear where did he got COVID. The patient did not receive booster. It was reported that event did not take place after use of product.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy - tested positive for COVID; Lack of efficacy - tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Feb2021 12:00 (Lot number: EL3247) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1,Lot No: EL3247, Location of injection: Arm Right,Time: 12:00, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021 12:00, outcome "recovered" and all described as "Lack of efficacy - tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course:No other vaccine was received in four week. No other medications received in two week. No covid prior vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pneumonitis
Clinical narrative: Heart and Lung inflammation; Heart and Lung inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MYOCARDITIS (death, medically significant), PNEUMONITIS (death) all with onset May2020, outcome "fatal" and all described as "Heart and Lung inflammation". Therapeutic measures were not taken as a result of myocarditis, pneumonitis. The patient date of death was May2021. The reported cause of death was myocarditis, pneumonitis. It was not reported if an autopsy was performed.Clinical comment: The patient was not tested positive for COVID-19 post vaccination. It was unknown if the patient took any other vaccine in four weeks and other medications in two weeks. It was unknown if the patient had COVID-19 prior to vaccination. Known allergies and other medical history were unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart and Lung inflammation; Heart and Lung inflammation
Age: 37.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: test
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood loss anaemia, Haemoglobin decreased, Platelet count decreased, Pulmonary embolism, Pulmonary haemorrhage
Clinical narrative: Patient presented to hospital with Thrombocytopenia Plt of 1.  Pulmonary Embolism, and what appears to be lung hemorrhages.  Acute Blood loss anemia Hgd 5.  Hypoxia,  Covid test was negative.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Thrombocytopenia
Clinical narrative: Patient presented to hospital with Thrombocytopenia Plt of 1.  Pulmonary Embolism, and what appears to be lung hemorrhages.  Acute Blood loss anemia Hgd 5.  Hypoxia,  Covid test was negative.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: Supraventricular tachycardia diagnosed on January 6 in the ER and subsequently hospitalized for two days. Placed on beta blocker.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID Discharged home
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol Patient discharged home
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after final dose. Patient was diagnosed with COVID. Tylenol, Multivitamin, Discharged home
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Ehlers-Danlos syndrome, Erythema, Injection site warmth, Oedema
Clinical narrative: Pt was pre medicated with Zyrtec the night before and immediately after he was given Benadryl. When we got home about 45-60 mind later he took Neurofen (Motrin). I noticed the next night that he had the beginning signs of ELS. He had ELS from a flu shot back in 2017 and hasn't had it since but this started to show signs from the COVID vaccine. He had edema, redness, and the site was warm to touch. I gave him more Benadryl and Neurofen that night.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol Discharged home
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Headache, Pyrexia
Clinical narrative: Fever over 101.5 and severe headache for 48hrs.  About 16hrs  after the vaccine my left eye began to twitch.  The twitch will come and go.  But occurs more than if is not occurring.  The twitch is still occurring at this time on 1/12/2022
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter made a general statement regarding adverse events seen with Bexsero and stated she regularly sees a sore arm following a patient receiving a dose of Bexsero. The reporter denied consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suffering from shingles/suspected vaccination failure; suffering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated he/she still right now was suffering from shingles 5 weeks now. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.