chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test
Clinical narrative: Severe headache; dull intractable headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2022 at 17:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing). Concomitant medication(s) included: TECFIDERA; UBRELVY; ZOLOFT; BLISOVI FE 1/20; SEROQUEL. Vaccination history included: Covid-19 vaccine (Primary immunization series complete. , MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 05Jul2022, outcome "not recovered", described as "Severe headache"; HEADACHE (non-serious) with onset 05Jul2022, outcome "not recovered", described as "dull intractable headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, headache.  Additional Information: No other vaccine in four weeks. No COVID prior to the vaccination. No known allergies. Severe headache starting on 05Jul (four days post-vaccination). Since then, dull intractable headache most days for the last two weeks. Migraine abortives don't seem to help. OTC painkillers help temporarily. Prednisone seems to help temporarily. COVID test post vaccination: COVID test type post vaccination: Nasal Swab on 07Jul2022, COVID test result : Negative.   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
Symptoms: COVID-19, Drug ineffective
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) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 13:15 as dose number unknown, single (Lot number: FE3590) at the age of 67 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient not received other medication in 2weeks. Received treatment for COVID-19 with Anti-viral start date 02Jul2022 and stop date 06Jul2022. The patient had no known allergies.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1,single (Lot number: EN6208), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 15Oct2021 as dose 3 (booster) single (Lot number: KH8027) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Severe asthma" (unspecified if ongoing); "chronic pneumonia" (unspecified if ongoing). Concomitant medication(s) included: SPIROLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID rebound after taking paxlovid. Started paxlovid same day as positive covid test. Completed 5 day tx; Positive, notes: 7 days after final dosage, had return/new COVID symptoms, tested positive. Had little to no symptoms during first quarantine. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Inappropriate schedule of product administration, Slow speech, Swollen tongue
Clinical narrative: First dose, Received: 06Apr2022/Second dose, 02Jun2022; Swollen tongue; has affected her speech and she speaks slowly; having a little bit of problem swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 2, single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose:, Lot Number: FK9893), administration date: 06Apr2022, for COVID-19 Immunization, reaction(s): "Swollen tongue", "has affected her speech and she speaks slowly", "having a little bit of problem swallowing". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "First dose, Received: 06Apr2022/Second dose, 02Jun2022"; SWOLLEN TONGUE (non-serious), outcome "not recovered"; SLOW SPEECH (non-serious), outcome "not recovered", described as "has affected her speech and she speaks slowly"; DYSPHAGIA (non-serious), outcome "unknown", described as "having a little bit of problem swallowing".  Additional information: Caller is a consumer that was calling for side effects after receiving her vaccine. Caller clarified that she was calling about the Pfizer Covid-19 vaccine.  She reported that she had a swollen tongue and is still experiencing it. It has affected her speech and she speaks slowly. The tip of her tongue feels swollen and she is having a little bit of problem swallowing now.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200961565 same product, different dose and event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 27Sep2021 as dose 3 (booster), 0.3ml single (Lot number: 30135BA) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Shingles (Event: arm swelled from elbow to shoulder, Brand: Shingles, unknown brand, Age: probably 65, Vaccination date: unknown, NDC, Lot, expiration: unknown), for Immunization, reaction(s): "arm swelled from elbow to shoulder". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "recovered" and all described as "tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Caller is a retired pharmacist calling for herself who stated she was given Paxlovid on 30Apr due to a positive COVID test. Caller is asking when she can receive her 2nd booster of Pfizer COVID19 vaccine since she is already overdue for it. She already has 2 doses and 1 booster of Pfizer COVID19 vaccine. She wanted to know when she can receive her booster shot after treatment with Paxlovid. Tested positive for Covid 19, on 30Apr2022, and took Paxlovid after diagnosis of Covid from 30Apr2022 to 05May2022 as 3 tablets in the morning and 3 tablets in the evening. She has a child and mother to protect. Caller stated that she was told, she could not get a second booster dose for 90 days after taking Paxlovid, that came from another source. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. The adverse event did not require any emergency room visit. Prior Vaccinations (within 4 weeks): unknown if she had a flu shot. There are no predisposing factors. Other conditions and medical history were none.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0153), on 29Apr2021 as dose 2, single (Lot number: EW0121), on 12Aug2021 as dose 3 (booster), single (Lot number: FC3181) and on 31Mar2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency and chronic rhinitis" (unspecified if ongoing), notes: Common Variable Immune Deficiency, and chronic rhinitis; "Chronic rhinitis" (unspecified if ongoing), notes: Common Variable Immune Deficiency, and chronic rhinitis. The patient had no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: I tested positive for covid on 28Jun2022; (07Jul2022) Negative, notes: I tested negative on a rapid test on 07Jul2022 and 08Jul2022; (08Jul2022) Negative, notes: I tested negative on a rapid test on 07Jul2022 and 08Jul2022; (11Jul2022) Positive, notes: By 11Jul2022, I wasn't feeling 100% and took a rapid test and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other medication within 2 weeks. The reporter stated that I tested positive for covid on 28Jun2022. Doctor prescribed PAXLOVID for COVID-19 treatment. I started a course on 30Jun2022 and completed on 05Jul2022. By 11Jul2022, I tested positive again. Symptoms are mild head cold like symptoms and are very similar to the initial onset symptoms. On 29Jun2022, He had a fever but did not experience a fever the second time. First time, the patient did not lose taste or smell, second time he cannot taste or smell.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 18May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received COVID 19 treatment with oral paxlovid from 30Jun2022 till 05Jul2022. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (unspecified if ongoing), notes: Other medical history: Hbp. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: No other medication in 2weeks. Anti viral details: Product: COVID 19 Treatment with Brand: Paxlovid. Treatment start date: 01Jul2022. Treatment stop date: 06Jul2022. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: er8734), on 27Apr2021 as dose 2, single (Lot number: er8735) and on 19Nov2021 as dose 3 (booster), single (Lot number: 32030bd) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's" (unspecified if ongoing), notes: other medical history: Crohn's. Concomitant medication(s) included: VITAMIN B12 [CYANOCOBALAMIN]; IRON; QVAR REDIHALER. Past drug history included: Flagyl, reaction(s): "known allergies: Flagyl", notes: known allergies: Flagyl. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information includes the patient received other medication in 2weeks.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing), notes: Other medical history: Low thyroid. Concomitant medication(s) included: BUPROPION, start date: 01Dec2020, stop date: 14Jul2022; LEVOTHYROXINE, start date: 01May2006, stop date: 14Jul2022; ESTRADIOL, start date: 01Mar2014, stop date: 14Jul2022; PROGESTERONE, start date: 01Mar2014, stop date: 14Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course included: The patient had no known drug allergies. Other medication in 2 weeks included Bupropion, Levothyroxine, Estradiol & Progesterone. The patient received COVID 19 Treatment drug (lot number-1916517A) from 12Jul2022 to 14Jul2022 for treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVOD-19 using a rapid antigen test on 13Jul2022; Tested positive for COVOD-19 using a rapid antigen test on13Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 23Feb2021 as dose 2, single (Lot number: EL3247), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 24Jun2022 as dose 4 (booster), single (Lot number: FP7153) at the age of 57 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported as no other vaccine in four weeks and no covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jul2022, outcome "recovering", described as "Tested positive for COVOD-19 using a rapid antigen test on 13Jul2022"; COVID-19 (medically significant) with onset 13Jul2022, outcome "recovering", described as "Tested positive for COVOD-19 using a rapid antigen test on13Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 22Apr2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma but currently not taking any treatments" (unspecified if ongoing); "Prescription antacids" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound Covid symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment (Paxlovid from 03Jul2022 to 07Jul2022, Lot number=Unknown). No other medication in 2weeks. Adverse event: Rebound Covid symptoms and positive test (start date: 11Jul2022 at 04:00 PM), If patient recovered: Recovering, If treatment ae: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Immobile, Pulmonary embolism
Clinical narrative: Pulmonary embolism; immobile; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for Covid-19 Immunization, reaction(s): "Covid-19", notes: Primary series of immunization complete., Manufacturer: Unknown. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown"; IMMOBILE (hospitalization, medically significant), outcome "unknown". Clinical information: The caller was told by her friend about the friend's mother. The friend stated that they think her mother's pulmonary embolism was caused by the friend's mother's booster dose of the Pfizer BioNTech Covid 19 Vaccine. Caller stated that the friend's mother is hospitalized and immobile, the issue is serious. Pulmonary Embolism: Caller stated that the patient was in (withheld) when the event occurred. She was hospitalized in (withheld) for a few weeks until she was stable enough to be moved to a hospital back home in (withheld). Caller states that it has been 72 days that the patient has been diagnosed and hospitalized related to the Pulmonary Embolism. The patient was in a hospital in (withheld) and a hospital in (withheld). The patient is in a rehab facility currently per the caller. Caller reported this event occurred after the booster dose of the Pfizer BioNTech Covid 19 Vaccine, but information related to previous doses of the vaccine was unknown by the caller. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s):  None  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: Axillary mass, Epistaxis, Insomnia
Clinical narrative: he had a lump in his armpit; nose bleeds; had a hard time sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team,).  A 33-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: AXILLARY MASS (non-serious), outcome "unknown", described as "he had a lump in his armpit"; EPISTAXIS (non-serious), outcome "unknown", described as "nose bleeds"; INSOMNIA (non-serious), outcome "unknown", described as "had a hard time sleeping".  Additional information: A 33 years old male who experienced some side effects after his second dose of the Pfizer COVID-19 Vaccine Apr2021. As per agent, he experienced a hard time sleeping, which was later denied by caller. But confirmed he had a lump in his armpit and nose bleeds. Caller wanted to know if he should get the booster dose. After the second dose, he had a hard time sleeping and a lump in his armpit. Its been over a year and are asking if its okay for him to get the booster dose. Verified above information with caller. The boyfriends arm pit lump went away in a day. He had 5 or so nose bleeds then they went away. Declines to complete report at this time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Two incidences of COVID; Two incidences of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in Jul2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "EGFR exon", start date: Jun2022 (unspecified if ongoing), notes: EGFR exon, 20 insertion in Jun2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Two incidences of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Unknown results, notes: two incidences of COVID (Jan2022 and Jul2022); (Jul2022) Unknown results, notes: two incidences of COVID (Jan2022 and Jul2022). Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: No Covid prior to vaccination. Patient received 1st booster Dec2021 and had two incidences of COVID (Jan2022 and Jul2022). Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Non-small cell lung cancer stage III
Clinical narrative: Two incidences of COVID; Two incidences of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in Jul2021 as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "EGFR exon", start date: Jun2022 (unspecified if ongoing), notes: EGFR exon, 20 insertion in Jun2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Two incidences of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Unknown results, notes: two incidences of COVID (Jan2022 and Jul2022); (Jul2022) Unknown results, notes: two incidences of COVID (Jan2022 and Jul2022). Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: No Covid prior to vaccination. Patient received 1st booster Dec2021 and had two incidences of COVID (Jan2022 and Jul2022). Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), administration date: Jul2021, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), administration date: Jun2021, for COVID-19 Immunization. The patient had no COVID prior vaccination. The following information was reported: NON-SMALL CELL LUNG CANCER STAGE III (medically significant) with onset Jun2022, outcome "unknown", described as "Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022". Therapeutic measures were not taken as a result of non-small cell lung cancer stage iii.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Non-small cell lung cancer stage III
Clinical narrative: Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), administration date: Jul2021, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), administration date: Jun2021, for COVID-19 Immunization. The patient had no COVID prior vaccination. The following information was reported: NON-SMALL CELL LUNG CANCER STAGE III (medically significant) with onset Jun2022, outcome "unknown", described as "Patient was diagnosed with stage 3 non-small cell lung carcinoma with EGFR exon 20 insertion in Jun2022". Therapeutic measures were not taken as a result of non-small cell lung cancer stage iii.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pain, Pruritus, Rash, Skin disorder
Clinical narrative: Skin got real leathery, like lizard skin and was peeling and was horrible; severe rash; painful/the pain wasn't even that bad; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; Skin got real leathery, like lizard skin and was peeling and was horrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 18Jul2021 as dose 2, single (Lot number: EW0181) in arm left at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER 1, SINGEL, EW0178), administration date: 27Jun2021, for COVID-19 immunization.  The following information was reported: SKIN EXFOLIATION (non-serious), SKIN DISORDER (non-serious), outcome "unknown" and all described as "Skin got real leathery, like lizard skin and was peeling and was horrible"; RASH (non-serious), outcome "unknown", described as "severe rash"; PAIN (non-serious), outcome "unknown", described as "painful/the pain wasn't even that bad"; THERMAL BURN (non-serious), PRURITUS (non-serious), SWELLING (non-serious), CRYING (non-serious), outcome "unknown" and all described as "painful and burned, itched, was swelling and weepy".  Additional Information: Patient did not required a visit to: Emergency Room. Patient had no prior Vaccinations (within 4 weeks). Did not even get flu vaccine. Has not had flu vaccine since 70's when swine flu was out. Had no prior vaccinations. Patient had no medical History. Family Medical History Relevant to AE: Not that she knows of. Time of Onset: about 7 or 10 days after second vaccine, 18Jul2022. Had both vaccines at Pharmacy, different pharmacists did each injection.  She is actually one of those people who don't do medications. Does a lot of juice and exercises, is a very healthy person. It wasn't something where she could use anything topical either. Severe rash and reaction: It felt like she had razor blades or glass coming out from inside the skin. It was that painful and  burned, itched, was swelling and weepy. Skin got real leathery, like lizard skin and was peeling and was horrible. Lasted 3 or 4 months. Started tapering off toward the end, then would flare a little bit. When flares were farther apart finally it did slow down. Last part to heal were her knuckles. Was both arms, under her arms, worst was rash in the trunk and had rash on legs. Was not as severe but was behind her knees. Arms were the worst.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Swelling, Thermal burn
Clinical narrative: Skin got real leathery, like lizard skin and was peeling and was horrible; severe rash; painful/the pain wasn't even that bad; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; painful and burned, itched, was swelling and weepy; Skin got real leathery, like lizard skin and was peeling and was horrible; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 18Jul2021 as dose 2, single (Lot number: EW0181) in arm left at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER 1, SINGEL, EW0178), administration date: 27Jun2021, for COVID-19 immunization.  The following information was reported: SKIN EXFOLIATION (non-serious), SKIN DISORDER (non-serious), outcome "unknown" and all described as "Skin got real leathery, like lizard skin and was peeling and was horrible"; RASH (non-serious), outcome "unknown", described as "severe rash"; PAIN (non-serious), outcome "unknown", described as "painful/the pain wasn't even that bad"; THERMAL BURN (non-serious), PRURITUS (non-serious), SWELLING (non-serious), CRYING (non-serious), outcome "unknown" and all described as "painful and burned, itched, was swelling and weepy".  Additional Information: Patient did not required a visit to: Emergency Room. Patient had no prior Vaccinations (within 4 weeks). Did not even get flu vaccine. Has not had flu vaccine since 70's when swine flu was out. Had no prior vaccinations. Patient had no medical History. Family Medical History Relevant to AE: Not that she knows of. Time of Onset: about 7 or 10 days after second vaccine, 18Jul2022. Had both vaccines at Pharmacy, different pharmacists did each injection.  She is actually one of those people who don't do medications. Does a lot of juice and exercises, is a very healthy person. It wasn't something where she could use anything topical either. Severe rash and reaction: It felt like she had razor blades or glass coming out from inside the skin. It was that painful and  burned, itched, was swelling and weepy. Skin got real leathery, like lizard skin and was peeling and was horrible. Lasted 3 or 4 months. Started tapering off toward the end, then would flare a little bit. When flares were farther apart finally it did slow down. Last part to heal were her knuckles. Was both arms, under her arms, worst was rash in the trunk and had rash on legs. Was not as severe but was behind her knees. Arms were the worst.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A female patient received the 4th dose (second booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jul 6, 2022, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st, 2nd and 3rd dose (first booster) of the COVID-19 vaccine (primary immunization series complete, manufacturer unknown), for immunization. The patient had fatigue/very tired, with outcome of not recovered. Additional information: The patient received her 2nd booster shot on Jul 6. She was still very tired and fatigued. She wanted to know if this was normal? The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Sex: F
Vaccine: COVID19
Symptoms: Polyarteritis nodosa
Clinical narrative: there could be a link between Polyarteritis Nodosa (PAN) with the Pfizer Covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: POLYARTERITIS NODOSA (medically significant), outcome "unknown", described as "there could be a link between Polyarteritis Nodosa (PAN) with the Pfizer Covid-19 vaccine". Clinical course: Caller wants to know if there are any AE reports of Polyarteritis Nodosa (PAN) or anyone that has developed this condition. Caller wants to check if there are reports of Polyarteritis Nodosa outside the clinical trials. Caller states that this condition (Polyarteritis Nodosa) is serious as her brother died from it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: Rebound symptoms and positive home test starting on 08Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Paxlovid included as a treatment drug.  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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), on 10Mar2021 as dose 2, single (Lot number: EN6205) and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ58762) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "Tested positive for Covid-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 3 (booster), single (Lot number: 301ssba) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 3; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment from 29Jun2022 to 03Jul2022.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal stiffness, Pain in extremity, Vaccination site erythema
Clinical narrative: Fatigue; Pain in legs; Redness around injection site; Warmness/firmness around injection site; Shoulder hurts/stiffness; Shoulder hurts/stiffness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jul2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Insulin resistance" (unspecified if ongoing); "Depression" (unspecified if ongoing); "OCD" (unspecified if ongoing), notes: OCD; "known allergies: Lactose" (unspecified if ongoing), notes: known allergies: Lactose. Concomitant medication(s) included: VIIBRYD; ARMODAFINIL; NORETHINDRONE [NORETHISTERONE]; REXULTI. The following information was reported: FATIGUE (non-serious) with onset Jul2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "recovering", described as "Pain in legs"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jul2022, outcome "recovering", described as "Redness around injection site"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset Jul2022, outcome "recovering" and all described as "Shoulder hurts/stiffness"; VACCINATION SITE WARMTH (non-serious) with onset Jul2022, outcome "recovering", described as "Warmness/firmness around injection site". Therapeutic measures were not taken as a result of fatigue, pain in extremity, vaccination site erythema, vaccination site warmth, arthralgia, musculoskeletal stiffness.  Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19, since the vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The device date was reported as: 14Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Fatigue; Pain in legs; Redness around injection site; Warmness/firmness around injection site; Shoulder hurts/stiffness; Shoulder hurts/stiffness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jul2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Insulin resistance" (unspecified if ongoing); "Depression" (unspecified if ongoing); "OCD" (unspecified if ongoing), notes: OCD; "known allergies: Lactose" (unspecified if ongoing), notes: known allergies: Lactose. Concomitant medication(s) included: VIIBRYD; ARMODAFINIL; NORETHINDRONE [NORETHISTERONE]; REXULTI. The following information was reported: FATIGUE (non-serious) with onset Jul2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "recovering", described as "Pain in legs"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jul2022, outcome "recovering", described as "Redness around injection site"; ARTHRALGIA (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset Jul2022, outcome "recovering" and all described as "Shoulder hurts/stiffness"; VACCINATION SITE WARMTH (non-serious) with onset Jul2022, outcome "recovering", described as "Warmness/firmness around injection site". Therapeutic measures were not taken as a result of fatigue, pain in extremity, vaccination site erythema, vaccination site warmth, arthralgia, musculoskeletal stiffness.  Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19, since the vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The device date was reported as: 14Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.