chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result: Positive; COVID test result: Positive; heaviness in left arm and left leg; Chest pain; rapid heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 at 11:30 as dose 1, single (Lot number: FJ5682), in left arm, on 03Jun2021 at 09:45 as dose 2, single (Lot number: EW0183), in left arm and on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "COVID test result: Positive". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Jan2022) Rapid; SARS-CoV-2 test: (21May2022) Positive, notes: Nasal Swab; (08Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of chest pain included Ibuprofen.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Limb discomfort
Clinical narrative: COVID test result: Positive; COVID test result: Positive; heaviness in left arm and left leg; Chest pain; rapid heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 at 11:30 as dose 1, single (Lot number: FJ5682), in left arm, on 03Jun2021 at 09:45 as dose 2, single (Lot number: EW0183), in left arm and on 07Jan2022 at 11:30 as dose 3 (booster), single (Lot number: FJ5682) at the age of 9 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: CHEST PAIN (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 10Jan2022 at 08:00, outcome "not recovered", described as "rapid heart rate"; LIMB DISCOMFORT (non-serious) with onset 26Jan2022, outcome "not recovered", described as "heaviness in left arm and left leg"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "COVID test result: Positive". The events "chest pain", "rapid heart rate" and "heaviness in left arm and left leg" required physician office visit. The patient underwent the following laboratory tests and procedures: Heart rate: (10Jan2022) Rapid; SARS-CoV-2 test: (21May2022) Positive, notes: Nasal Swab; (08Feb2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of chest pain included Ibuprofen.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: prescribed Paxlovid after vaccination; prescribed Paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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 had no relevant medical history. Concomitant medication(s) included: AZITHROMYCIN, start date: 03Jun2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "prescribed Paxlovid after vaccination". Clinical course: Patient had no known allergies. On 03Jun2022, patient had bad taste in mouth, diarrhea and stomach pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "kidney stone" (unspecified if ongoing), notes: kidney stone in the past; "handicapped" (unspecified if ongoing), notes: left side weak (handicapped); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: need to watch for high blood pressure; "Grape Allergy" (unspecified if ongoing); "Pork allergy" (unspecified if ongoing). The patient's 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 "covid".  Clinical course: Patient didn't received other medication in 2 weeks. Adverse Event: Strong Stomach pain with hard time with bowel movement. Urine color bit dark even when drinking a lot water and color of poop is bit light. Adverse event start date: 01Jun2022. If patient recovered: Not Recovered. If treatment ae: No  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN5318) and on 17Feb2021 as dose 2, single (Lot number: EN5318) at the age of 53 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovering" and all described as "I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: covid-19; 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 70-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: PF1ZCCFF2528) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Negative, notes: 2 and 4 days later, tested Covid negative; (unspecified date) Positive, notes: 2 days later Covid symptoms reappeared and tested positive again; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: Report about Covid treatment reported as Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 24May2022, Treatment stop date: 29May2022, Indication: Treatment of COVID-19. If vaccine received reported as Yes. Other medication in 2weeks reported as No. Tested positive 23May2022. Took Paxlovid 5 days. 2 and 4 days later, tested Covid negative. 2 days later Covid symptoms reappeared and tested positive again. Known allergies reported as No. Other medical history reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer/BioNTech Dose Number: 3/Treatment of COVID-19 25May2022; Pfizer/BioNTech Dose Number: 3/Treatment of COVID-19 25May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right 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: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer/BioNTech Dose Number: 3/Treatment of COVID-19 25May2022". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Positive; (30May2022) Negative; (02Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications was received in 2weeks. Patient was treated with Paxlovid. Treatment start date was 25May2022. Treatment stop date was 29May2022. Indication was treatment of COVID-19. Tested negative for COVID on 30May after completing Paxlovid on 29May. Symptoms returned and tested positive again on 2Jun.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Developed peripheral neuropathy after 2nd dose and it got worse after boosters.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; IRON; PREVACID. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (disability) with onset 15Apr2021, outcome "not recovered", described as "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The events "developed peripheral neuropathy after 2nd dose and it got worse after boosters." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral.  Additional information: Patient Developed peripheral neuropathy after 2nd dose. Patient did not have any prior vaccination also patient tested for covid post vaccination.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Developed peripheral neuropathy after 2nd dose and it got worse after boosters.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; IRON; PREVACID. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (disability) with onset 15Apr2021, outcome "not recovered", described as "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The events "developed peripheral neuropathy after 2nd dose and it got worse after boosters." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral.  Additional information: Patient Developed peripheral neuropathy after 2nd dose. Patient did not have any prior vaccination also patient tested for covid post vaccination.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Developed peripheral neuropathy after 2nd dose and it got worse after boosters.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years and on 03Jun2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: other medical history: GERD. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; IRON; PREVACID. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant), outcome "not recovered", described as "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The events "developed peripheral neuropathy after 2nd dose and it got worse after boosters." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral. Clinical course: Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:Yes. Known allergies: No. Treatment includes Chiropractic and then Neurology. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Developed peripheral neuropathy after 2nd dose and it got worse after boosters.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years and on 03Jun2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: other medical history: GERD. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; IRON; PREVACID. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant), outcome "not recovered", described as "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The events "developed peripheral neuropathy after 2nd dose and it got worse after boosters." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral. Clinical course: Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:Yes. Known allergies: No. Treatment includes Chiropractic and then Neurology. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No.    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: Breakthrough COVID-19, Drug ineffective, Investigation, Karyotype analysis, SARS-CoV-2 antibody test
Clinical narrative: 1 patient (P-8) having prolonged hospitalization but ultimately recovered; breakthrough SARS-CoV-2 infection; This is a literature report for the following literature source(s):  A 52-year-old male patient received BNT162b2 (BNT162B2), 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: "MDS" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Seasonal influenza vaccination, for immunization. The following information was reported: DRUG INEFFECTIVE (prolonged hospitalization, medically significant), outcome "recovered", described as "1 patient having prolonged hospitalization but ultimately recovered"; BREAKTHROUGH COVID-19 (prolonged hospitalization, medically significant), outcome "recovered", described as "breakthrough SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: IPSS-R/ELN/DIPSS: 2.5, notes: low; Unknown results; Karyotype analysis: normal; SARS-CoV-2 antibody test: Unknown results. Clinical details: The patient had documented breakthrough SARS-CoV-2 infection after 2 vaccine doses.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200798599 same article/drug and different patient/event
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: TK9893) at the age of 75 years, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3(BOOSTER), SINGLE, 3rd dose administered on 30Sep2021 with lot 20145BA), administration date: 30Sep2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, 2nd dose administered on 22Mar2021 with lot EN6208), administration date: 22Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, first dose administered 01Mar2022 with lot EN6203), administration date: 01Mar2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Apr2022, outcome "not recovered", described as "shortness of breath". The event "shortness of breath" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient received his second Pfizer booster shot on 04Apr2022. Within the next week he began symptoms of shortness of breath. This feeling continues as of this Date, 04Jun2022. He had seen his cardiologist and had undergone several tests to see if heart related. The results seem to be not heart related. He believed that the cause of shortness of breath was due to the booster shot and also noted he had seen reports of young people getting myocarditis due to the vaccine and have shortness of breath accompanied by the myocarditis. He also stated that the shortness of breath was ongoing and was somewhat better but had been acting up more frequently in the last couple of days maybe the last 4 to 5 days. He further stated that after he saw the cardiologist and had the shortness of breath, they started giving him tests and had a heart catheterization the day after he saw the cardiologist and had that right away; he did not know the date but it was within a few days and was on the 14th or 18th of Apr2022 and also had a cat scan to see if he had a blood clot in his lung causing the shortness of breath and it was negative; states the echocardiogram seemed to be ok as well.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies to trees, weeds" (unspecified if ongoing); "allergies to mold" (unspecified if ongoing); "allergies to dust" (unspecified if ongoing); "allergies to grass" (unspecified if ongoing); "allergies to cat, dog" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; RESTASIS; HCTZ; VITAMIN D3; ALLEGRA 24 HOUR; SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (30May2022) Negative, notes: Day 5; (31May2022) Negative; (01Jun2022) Negative; (02Jun2022) Negative; (03Jun2022) Negative; (04Jun2022) Positive, notes: fifth day after the end of the Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: After testing positive for Covid, patient started the 5-day Paxlovid meds. Patient's symptoms were mild (sneezing, stuffy nose, slight headache, ears felt full). On Day 5 (30May2022) patient was negative at night. Patient tested negative for four more days. On the fifth day after the end of the Paxlovid patient test positive again. Mild symptoms were returned. Patient had bad allergies and take an Allegra every morning. Patient was also doing allergy immunotherapy. Patient had reached the maintenance dose. Patient received an allergy shot four days after the end of Paxlovid. Two days after that patient was "+" again. Patient had a strong reaction to the allergy shot. First time in 7 months.   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: Asthenia, Hypoaesthesia, Magnetic resonance imaging, Neuritic plaques, Spinal pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURITIC PLAQUES (non-serious), outcome "unknown", described as "increased brain plaques"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in legs"; SPINAL PAIN (non-serious), outcome "unknown", described as "spine pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient has increased brain plaques, weakness and numbness in legs, spine pain after receiving COVID vaccine Doctor said this MRI shows that consumer have more splotches than the previous MRI, and so, the medicine hasn't been working perfectly, none of them do, but as consumer have noticed, consumer have been having more and more symptoms. This MRI certainly supports the idea of switching. Causality was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all tested positive for Covid last week. No hospitalizations resulted.; The seven year old tested positive on 04Jun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 04Jun2022, outcome "unknown", described as "The seven year old tested positive on 04Jun"; DRUG INEFFECTIVE (medically significant) with onset 04Jun2022, outcome "unknown", described as "all tested positive for Covid last week. No hospitalizations resulted.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: The seven year old tested positive on 04Jun.  Clinical course: My Wife and all three of the children who were all fully vaccinated with Pfizer Covid vaccine all tested positive for Covid last week. No hospitalizations resulted. My wife is 46 years old and has had other medical issues. She was prescribed Paxlovid and reports a foul taste in her mouth after starting the initial does on 02Jun22. The children are 11, 8 and 7 years old and had only received the initial two doses. Thanks for the reply. I am up to date on my training and am aware of the time constraints for reporting. It initially did not occur to me to report until I spoke to my wife about her treatment and then realized that everyone had had Pfizer vaccine and I needed to report. The first positive case was on 30May22 for the oldest son. The 8 year old tested positive on 01Jun22. My wife tested positive on 01Jun. The seven year old tested positive on 04Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Other medication in 2 weeks was reported as no. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 25May2022, Treatment stop date: 30May2022, via oral route for the indication of Treatment of COVID-19. Device timestamp was on 04Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Infected with Covid-19; Infected with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 10:00 as dose 3 (booster), single (Lot number: FL3197) at the age of 50 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 was not reported. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16May2022 at 13:00, outcome "unknown", COVID-19 (medically significant) with onset 16May2022 at 13:00, outcome "recovered" and all described as "Infected with Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient had no covid prior to vaccination. Patient had no known allergies. Facility type vaccine was workplace clinic. Facility type vaccine was workplace clinic.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "many allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (04Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; paracetamol (TYLENOL), (Batch/Lot number: unknown) for headache. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer"), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "I couldn't keep nothing down"; PYREXIA (non-serious), outcome "unknown", described as "Just a little fever". The action taken for paracetamol was unknown. Additional information: The patient stated, that she had the vaccine, the booster on Thursday and now  got up this morning and  had a headache and then she had something to eat, now she take some Tylenol then after that she couldn't keep nothing down and tonight trying to pushup or trying to take some 'crackers' and I want to take some Tylenol for regular headache and she think 'cracker' they made it came back right up. She just a headache and right now, just a little fever with the headache and that's it. She wanted to have a talk to nurses around as she I haven't talked to anybody. She want to know to find out what to do or what. Other medical conditions: The patient stated that she don't have diabetes. Concomitant medications: The patient stated she was trying to take Tylenol. So, she was going to get some food down. Treatment for Adverse events included ice on her head because she do know it get some greater. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 20Oct2021 at 17:00 as dose 3 (booster),single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Mar2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "gerd" (unspecified if ongoing); "high blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Feb1996, stop date: 26May2022; LOSARTAN, start date: Sep2021 (ongoing); PANTOPRAZOLE, start date: Aug2007 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details: product of COVID 19 treatment, brand was Paxlovid, treatment start date was on 27May2022, treatment stop date was on 31May2022. The first BNT162B2 was at 01:00 pm on unspecified date, the second BNT162B2 was at 03:00 pm on unspecified date.  The lot number for BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza, Loss of personal independence in daily activities, Myalgia, Vaccination site haemorrhage
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 23Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; unknown manufacturer), for Covid-19 immunization. The following information was reported: INFLUENZA (non-serious), DYSPNEA (non-serious), outcome "unknown" and all described as "Had a flu last February and mentioned that she couldn't breathe"; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Took the vaccine there was blood dripping after the vaccine"; MYALGIA (non-serious), outcome "unknown", described as "Still experiencing muscle pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Unable to drive for 4 months"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Already lost around 30 pounds on her weight". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Transferring agent stated "We have a caller, so the caller mention that she took her second Pfizer COVID-19 Vaccine 23Jun2021 and when she took the vaccine there was blood dripping after the vaccine and almost after a year she mentioned that she is still experiencing muscle pain and she also had a flu last February and mentioned that she couldn't breathe because of the flu. And she also mention that she was unable to drive for 4 months and already lost around 30 pounds on her weight. And she was also asking on when the vaccine will 'wear off'? That's all information and she did not provide any phone# or address. I think she already hung up I apologize then." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 23Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; unknown manufacturer), for Covid-19 immunization. The following information was reported: INFLUENZA (non-serious), DYSPNEA (non-serious), outcome "unknown" and all described as "Had a flu last February and mentioned that she couldn't breathe"; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Took the vaccine there was blood dripping after the vaccine"; MYALGIA (non-serious), outcome "unknown", described as "Still experiencing muscle pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Unable to drive for 4 months"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Already lost around 30 pounds on her weight". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Transferring agent stated "We have a caller, so the caller mention that she took her second Pfizer COVID-19 Vaccine 23Jun2021 and when she took the vaccine there was blood dripping after the vaccine and almost after a year she mentioned that she is still experiencing muscle pain and she also had a flu last February and mentioned that she couldn't breathe because of the flu. And she also mention that she was unable to drive for 4 months and already lost around 30 pounds on her weight. And she was also asking on when the vaccine will 'wear off'? That's all information and she did not provide any phone# or address. I think she already hung up I apologize then." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
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) (Physician). The reporter is the patient.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "recovering" and all described as "COVID-19". The clinical course was reported as following: Started Paxlovid 18May2022 (day 1 of symptoms onset). Completed course. Symptoms (slightly different ones) reemerged 02Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Bell's palsy, Dizziness
Clinical narrative: Bell's palsy; hard time maintaining balance; constantly dizzy; 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 73-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing), notes: Diabetic diagnosed 22 years ago; "quadruple bypass" (ongoing), notes: quadruple bypass diagnosed 22 years ago. There were no concomitant medications. The following information was reported: BELL'S PALSY (medically significant) with onset Mar2021, outcome "not recovered"; DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "constantly dizzy"; BALANCE DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "hard time maintaining balance".  Clinical course: Reported as, He stated that there are a lot of patients who have contracted Bell's palsy from the vaccine and his doctors have confirmed that his Bell's palsy was caused by the vaccine. The doctors did not have a solution. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. He developed Bell's Palsy after the first dose, stated the second and booster did not affect him. He clarified that he got the first shot in Mar2022, and the Bells Palsy started 6-7 days later. He stayed away from any medications within two weeks of the injection. He wanted to add that he was constantly dizzy, that he had fallen so many times, he was walking without a walker but walking very carefully.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: she got COVID between the first and second vaccine doses; she got COVID between the first and second vaccine doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER8733) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "she got COVID between the first and second vaccine doses".
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menarche
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 12-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2021 at 15:00 as dose 2, single (Lot number: FH8020) at the age of 12 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "sleep support" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN oral taken for sleep disorder, start date: Mar2021 (ongoing). Vaccination history included: BNT162b2 (Dose:1, Vaccination time:14:00, Anatomical site of injection: Left arm, Batch/Lot number: FH8020), administration date: 27Oct2021, when the patient was 12-year-old, for COVID-19 Immunization, reaction(s): "she got her first period", "first period was heavy, with a lot of red blood (bright)". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 23Nov2021, outcome "unknown", described as "heavy flow in a bright red blood color"; MENARCHE (non-serious) with onset 23Nov2021, outcome "unknown", described as "her period was back, believe it is a side effect of the vaccine on the menstrual cycle. period would probably happen in spring 2022, After Arm pit hair and more breast dev.". Therapeutic measures were not taken as a result of menarche, heavy menstrual bleeding. Additional information: Prior Vaccinations were none. Concomitant medications included vitamins used for Health support via oral route, Start date:2018, Ongoing. The patient got her first dose of COVID vaccine on 27Oct2021 and on the very next day 28Oct2021, she got her first period my daughter first period was heavy, with a lot of red blood (bright) it lasted seven days approximately. One month later, withheld went for her second COVID shot 22Nov2021 and on the very next day her period was back. Again, heavy flow in a bright red blood color. She don't believe this was a coincidence. She believes it was a side effect of the vaccine on the menstrual cycle of girls and women, specially because withheld pediatrician asserted on Aug2021 that she was on tanner stage 2 heading to stage 3 and its growth spurt in height: period would probably happen in spring 2022, After Arm pit hair and more breast dev. Follow-up (08Jun2022): Follow-up attempts are completed. No further information is expected.