chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Head discomfort, Headache, Impaired driving ability, Laboratory test
Clinical narrative: she got such a bad headache; she couldn't even drive; she can't bare; it is still very sour, her head; she started running out of great fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEAD DISCOMFORT (non-serious) with onset Apr2022, outcome "not recovered", described as "she can't bare; it is still very sour, her head"; PYREXIA (non-serious) with onset Apr2022, outcome "not recovered", described as "she started running out of great fever"; HEADACHE (non-serious) with onset 26Apr2022, outcome "not recovered", described as "she got such a bad headache; she couldn't even drive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, head discomfort, pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: she got such a bad headache; she couldn't even drive; she can't bare; it is still very sour, her head; she started running out of great fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEAD DISCOMFORT (non-serious) with onset Apr2022, outcome "not recovered", described as "she can't bare; it is still very sour, her head"; PYREXIA (non-serious) with onset Apr2022, outcome "not recovered", described as "she started running out of great fever"; HEADACHE (non-serious) with onset 26Apr2022, outcome "not recovered", described as "she got such a bad headache; she couldn't even drive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, head discomfort, pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, SARS-CoV-2 test
Clinical narrative: severe eczema outbreak occurred all over my body; 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 01Apr2021 at 15:45 as dose 1, single (Lot number: EW0150) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ECZEMA (non-serious) with onset 06Apr2021, outcome "not recovered", described as "severe eczema outbreak occurred all over my body". The event "severe eczema outbreak occurred all over my body" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Severe eczema outbreak occurred all over body one week after first dose. Managed it with a prescribed ointment. After second dose eczema returned just as bad within days. It leads me to Moderna as my booster in January of 2022 but that also caused an outbreak (was told to expect this). Immune system had not returned to normal yet.  Still have a severe rash. . Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive RAT and PCR on 16Apr2022; Tested positive RAT and PCR on 16Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 55-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 12:00 as dose 1, single (Lot number: EN6208), in left arm, on 07Apr2021 at 12:00 as dose 2, single (Lot number: ER8729), in left arm and on 21Oct2021 at 13:15 as dose 3 (booster), single (Lot number: 32020BD) at the age of 54 years, in right arm for covid-19 immunisation. The patient relevant medical history included: "Viral Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), "coronary artery disease" (unspecified if ongoing), "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: Aug2021, stop date: Aug2021, LISINOPRIL, start date: Aug2021, ASPIRIN [ACETYLSALICYLIC ACID], start date: Aug2021, ALLOPURINOL, start date: Aug2021, ATORVASTATIN, start date: Aug2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "unknown" and all described as "Tested positive RAT and PCR on 16Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Positive, (16Apr2022) Positive, (22Apr2022) Negative, (23Apr2022) Negative, (24Apr2022) Negative, (25Apr2022) Positive, (26Apr2022) Positive, (27Apr2022) Positive, notes: 'rebound' of positive Covid with symptoms. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received other medication in 2 weeks: Metoprolol, brand-Pharmac, Lisinopril, brand- Pharmaceuticals, Aspirin, brand- Aspirin 81 MG, Allopurinol, brand- Lab, Atorvastatin (lot number-ATC2211142C), brand- Pharmaceuticals. Treatment start date: 16Apr2022 evening, Anti-viral details: Treatment stop date: 21Apr2022, Lot number: Paxlovid. By third dose on 17Apr symptoms completely disappear. Final dose 21Apr morning. Symptom free all week. 25Apr symptoms begin to return, 25Apr RAT test positive. 26Apr Full symptoms (chest, throat, head, nose, GI, fatigue), test positive RAT. 26Apr advair and prednisone prescribed. 27Apr (today) full symptoms. I am documenting a 'rebound' of positive Covid with symptoms (minus fever) three days post end of Paxlovid which included three negative RAT testing and zero symptoms during Paxlovid course. Adverse event started on 25Apr2022 at 12:00, treated with Prednisone, Advair Inhaler.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Immune system disorder, Rash, SARS-CoV-2 test
Clinical narrative: severe ecezma outbreak occurred all over my body; immune system has not returned to normal yet; I still have a severe rash; 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 22Apr2021 at 15:45 as dose 2, single (Lot number: EW0164) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer/AMIRAC, prev dose brand unknown=False, prev dose lot number=EW0150 , prev dose lot unknown=False, prev dose administration date=01Apr2021, prev dose administration time=03:45 PM , prev dose dose number=1 , prev dose vaccine  location=Left arm, SEVERE ecezma outbreak occurred all over my body one week after first dose), administration date: 01Apr2021, when the patient was 51-year-old, for COVID-19 Immunization, reaction(s): "SEVERE ecezma outbreak occurred". The following information was reported: RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "I still have a severe rash"; IMMUNE SYSTEM DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "immune system has not returned to normal yet"; ECZEMA (non-serious) with onset Apr2021, outcome "not recovered", described as "severe ecezma outbreak occurred all over my body". The events "severe ecezma outbreak occurred all over my body", "immune system has not returned to normal yet" and "i still have a severe rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, immune system disorder, rash.  Additional Information: Vaccination type facility was other. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had  been tested for COVID-19. The patient had no known allergies.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 03Apr2022: Tested positive for Covid; 03Apr2022: Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-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 10Oct2021 at 15:45 as dose 3 (booster), single (Lot number: EW0202) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 03Apr2022, outcome "recovered" (25Apr2022) and all described as "03Apr2022: Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2022) Positive; (13Apr2022) Negative; (19Apr2022) Positive; (23Apr2022) Positive, notes: Symptom free; still test positive for Covid; (25Apr2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient did not received other medication in 2weeks. Patients symptoms returned 7 days after completing my course of Paxlovid. On 03Apr2022: Tested positive for Covid. 04Apr2022 Started Paxlovid and Finished Paxlovid on 09Apr2022. On 10Apr2022, Symptom free - felt great. On 13Apr2022 Tested negative for Covid, 16Apr2022, Covid symptoms re-emerge. On 19Apr2022, Tested positive for Covid and  23Apr2022, Symptom free; still test positive for Covid. On 25Apr2022, Test negative for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0164), in left arm and on 04May2021 as dose 2, single (Lot number: EW0173) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Dec2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm. The patient had no relevant medical history. No known allergies. No other medication in 02 weeks. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. Brand was Pfizer Paxlovid. Treatment start date was 09Apr2022 and treatment stop date was 13Apr2022.  Clinical course: No treatment for AE. Reoccurrence of testing positive for COVID-19 less than two weeks after ending Paxlovid treatment of initial infection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oestrogen receptor assay, Progesterone receptor assay, 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) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 at 08:30 as dose 1, single (Lot number: EN6206), in right arm, on 28Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 10Nov2021 at 11:00 as dose 3 (booster), single (Lot number: F148028) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2006 (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperthyroid" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jun2005, stop date: Apr2022; SERTRALINE, start date: May2006, stop date: 27Apr2022; LEVOTHYROXINE, start date: Feb2006, stop date: Apr2022; ATORVASTATIN, start date: May2018, stop date: Apr2022; GLUCOSAMINE & CHONDORITIN, start date: May2005, stop date: Apr2022; VITAMIN D [VITAMIN D NOS], start date: Feb2002, stop date: Apr2022; CALCIUM + MAGNESIUM, start date: Feb2021, stop date: Apr2022; ALIGN, start date: May2020, stop date: Apr2022. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "not recovered" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: Oestrogen receptor assay: (unspecified date) Positive; Progesterone receptor assay: (unspecified date) Positive; SARS-CoV-2 test: (25Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: I finished the course of Paxlovid on 20Apr2022. Tested negative for COVID on 25Apr2022. Upper respiratory symptoms recurred on 26Apr2022. Tested positive for COVID on 27Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE; SYMBICORT; CETIRIZINE oral; MONTELUKAST oral; BUDESONIDE nasal; AZELASTINE nasal. Past drug history included: None, reaction(s): "Allergy". The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 27Apr2022, outcome "not recovered", described as "Sore throat"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test:  positive, notes: Positive Covid test on day 9; negative, notes: Patient tested negative and had symptom resolution on days 4-8. Therapeutic measures were not taken as a result of oropharyngeal pain.  Clinical course: Patient received paxlovid on 19Apr2022 via oral route of administration for COVID 19 Treatment and stopped on 24Apr2022. Sore throat and positive Covid test on day 9 after Paxlovid treatment (days1-5). Patient tested negative and had symptom resolution on days 4-8 adverse.   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 event Drug Ineffective, Covid 19 and Sore throat and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 52.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0162), in right arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 52 years, in left arm 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), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: No other medications in two weeks. Tested negative after 5 days of Paxlovid anit-viral. Then 10 days later tested positive again with cold-like symptoms.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid and was vaccinated; got covid and was vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  An adult 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. It was unknown whether the patient took other medications (Including over-the-counter medications, nutritional and herbal supplements, etc.) or not. It was unknown whether the patient had past medical history, family history and social history (Including occupational history, use of alcohol, tobacco, or recreational drugs) or not. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid and was vaccinated". Clinical course: patient was not thrilled about the vaccine even though patient had both doses of Pfizer vaccine. Then my 19-year-old daughter got covid and she was vaccinated, so patient guess, patient considered that one of the rare breakthrough cases and then patient got covid. Also had very little symptoms, but it seems like now it wasn't just rare breakthrough cases, it was everybody's getting covid whether you're vaccinated or not.  No follow-up attempts are possible: Batch or lot number is not available. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Neuropathy peripheral
Clinical narrative: experienced neuropathy in his hands 6 days after he received his booster dose; 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 69-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose number unknown, (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: Covid-19 vaccine (Primary series complete but unknown manufacture.), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (non-serious) with onset 05Apr2022, outcome "unknown", described as "experienced neuropathy in his hands 6 days after he received his booster dose". The event "experienced neuropathy in his hands 6 days after he received his booster dose" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: negative.  Additional Information: Caller stated that he called the Safety Department to report about the side effect he experienced after receiving his booster dose last 30Mar2022 and was provided with a report number: MZWBKATH. He said that he experienced neuropathy in his hands 6 days after he received his booster dose. He said that he contacted the department 5 mins before he called Pfizer and was provided the number of Pfizer to ask about the side-effect he experienced. He also mentioned that he already went to his doctor, did his blood work and other tests which all came out negative. He concluded that the neuropathy may have been caused by the booster shot. He wanted to know if there's any recommendations for the neuropathy he experienced after getting the booster shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with Covid and he is on the morning dose of day 4 of Paxlovid; diagnosed with Covid and he is on the morning dose of day 4 of Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533), in left arm, on 24Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 05Jan2022 as dose 3 (booster), single (Lot number: 331308A) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 05Jan2022 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Prior to vaccines and states he is now 8 years cancer free. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022, outcome "recovering" and all described as "diagnosed with Covid and he is on the morning dose of day 4 of Paxlovid". The events "diagnosed with covid and he is on the morning dose of day 4 of paxlovid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Can I get my fourth booster dose or do I need to wait" Caller states all three doses of the Covid 19 vaccine he has received are Pfizer.  He has a compromised immune system and he had cancer. Agent states the caller is a consumer who states he has been vaccinated with both Pfizer vaccines, and boosted, and was just diagnosed with Covid and is on the morning dose of Paxlovid, Day 4. Agent states the caller's question was, after he completed the Paxlovid should he get his booster dose or should he wait-agent states she was unable to answer his question because they did not study this in the trials. Patient did not require a visit to Emergency Room.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Pericarditis, Pulmonary embolism
Clinical narrative: Pulmonary embolism; I have suspected side effects from a shot; Pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose number unknown (booster), single (Lot number: JH8028) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization completed: Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown", described as "I have suspected side effects from a shot; Pericarditis". The patient underwent the following laboratory tests and procedures: Fibrin D dimer: Negative, notes: Date: Not Provided; Result: Negative; Unit: Not Provided.Consumer stated, that he had suspected side effects from a shot. The side effect was diagnosed with Pericarditis, which he knew is a rare side effect noted for the mRNA vaccines but the time difference is not quite that would classically expect from the side effects in the vaccine. So because he took that last vaccine the booster shot.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Lot number: ew0183) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 2, single (Lot number: 027h21b). The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "interchange of vaccine administered" (unspecified if ongoing), notes: Dose 1: BNT162B2, Dose 2: Moderna. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient did not received Other medication in 2weeks. Anti-viral COVID 19 Treatment included paxlovid from (23Apr2022 to 28Apr2022). Patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye disorder, Hypermetropia, Hypersensitivity, Interchange of vaccine products
Clinical narrative: prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine; Caller said that she had an allergy couple days ago.; eyes foggy; second dose it got worse,; cloudy vision; difficulty to see at distance; not to see things that are close; eyes are kind of funky/she needs to have an eye surgery; prior to the Pfizer vaccines, she had the Moderna 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 73-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 73 years, in arm for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (1st Dose, Lot: 028L20A, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 21Jan2021, when the patient was 73-year-old, for Covid-19 immunization; moderna coviD-19 vaccine (2nd Dose, Lot: Unknown, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 18Feb2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (3rd Dose, Lot: 301458A, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 26Oct2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "eyes foggy". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller said that she had an allergy couple days ago."; VISION BLURRED (non-serious), outcome "unknown", described as "eyes foggy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "second dose it got worse,"; VISION BLURRED (non-serious), outcome "unknown", described as "cloudy vision"; MYOPIA (non-serious), outcome "unknown", described as "difficulty to see at distance"; HYPERMETROPIA (non-serious), outcome "unknown", described as "not to see things that are close"; EYE DISORDER (non-serious), outcome "unknown", described as "eyes are kind of funky/she needs to have an eye surgery".
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myopia, Off label use, Vision blurred
Clinical narrative: prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine; Caller said that she had an allergy couple days ago.; eyes foggy; second dose it got worse,; cloudy vision; difficulty to see at distance; not to see things that are close; eyes are kind of funky/she needs to have an eye surgery; prior to the Pfizer vaccines, she had the Moderna 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 73-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 73 years, in arm for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (1st Dose, Lot: 028L20A, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 21Jan2021, when the patient was 73-year-old, for Covid-19 immunization; moderna coviD-19 vaccine (2nd Dose, Lot: Unknown, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 18Feb2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (3rd Dose, Lot: 301458A, NDC/Exp: Unknown, Anatomical Location: Arm), administration date: 26Oct2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "eyes foggy". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "prior to the Pfizer vaccines, she had the Moderna Covid-19 Vaccine"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Caller said that she had an allergy couple days ago."; VISION BLURRED (non-serious), outcome "unknown", described as "eyes foggy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "second dose it got worse,"; VISION BLURRED (non-serious), outcome "unknown", described as "cloudy vision"; MYOPIA (non-serious), outcome "unknown", described as "difficulty to see at distance"; HYPERMETROPIA (non-serious), outcome "unknown", described as "not to see things that are close"; EYE DISORDER (non-serious), outcome "unknown", described as "eyes are kind of funky/she needs to have an eye surgery".
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort
Clinical narrative: He has been continuously taking medication for his stomach since then.; 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 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Stress" (unspecified if ongoing); "HIV" (unspecified if ongoing); "Hyper S Protein deficiency" (unspecified if ongoing); "for his stomach" (ongoing), notes: He got his first dose. He has been continuously taking medication for his stomach since then. Concomitant medication(s) included: BIKTARVY taken for hiv infection. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "He has been continuously taking medication for his stomach since then.". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient aged 65 (will be 66 in two weeks,) stated that he has Hyper S Protein deficiency, and urgently needed Paxlovid before he got the virus. He does not currently have Covid, he just has difficulty leaving the house, he can't drive and he has no family in the area to drive him to a hospital if he gets sick. He needs to have the medication at home readily available. He stated that patients with Hyper S Protein Deficiency the covid vaccine is only about 20% to mid 30s effective at best. The protein used doesn't have enough strength that he needs. He stated his condition is 1 in 20,000 but the hypo S protein deficiency rate is 1 in 500. He has been home bound since October, it is urgent that he has this stuff. He states he is under such a heavy life threatening situation. The patient is on HIV medication BIKTARVY, he is on a list of medications, all kinds, blood pressure, medications for the stress from Covid, things for his stomach, he takes it morning and evening for his stomach. He has received four doses of the Pfizer BioNTech Covid 19 vaccine. He experienced side effects from all four, He got his first dose one and half to two years ago. He has been continuously taking medication for his stomach since then. He is currently getting ready for a doctor's appointment and is getting picked up by a metavan. He has to get ready an hour and half early so he can get to his appointment on time. He also had to fight to get the HPV vaccine at his age. He was going to be in a trial for HIV.   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, COVID19
Symptoms: Drug ineffective, Immunisation reaction, Pityriasis rosea, Suspected COVID-19
Clinical narrative: He has been continuously taking medication for his stomach since then.; 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 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Stress" (unspecified if ongoing); "HIV" (unspecified if ongoing); "Hyper S Protein deficiency" (unspecified if ongoing); "for his stomach" (ongoing), notes: He got his first dose. He has been continuously taking medication for his stomach since then. Concomitant medication(s) included: BIKTARVY taken for hiv infection. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "He has been continuously taking medication for his stomach since then.". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient aged 65 (will be 66 in two weeks,) stated that he has Hyper S Protein deficiency, and urgently needed Paxlovid before he got the virus. He does not currently have Covid, he just has difficulty leaving the house, he can't drive and he has no family in the area to drive him to a hospital if he gets sick. He needs to have the medication at home readily available. He stated that patients with Hyper S Protein Deficiency the covid vaccine is only about 20% to mid 30s effective at best. The protein used doesn't have enough strength that he needs. He stated his condition is 1 in 20,000 but the hypo S protein deficiency rate is 1 in 500. He has been home bound since October, it is urgent that he has this stuff. He states he is under such a heavy life threatening situation. The patient is on HIV medication BIKTARVY, he is on a list of medications, all kinds, blood pressure, medications for the stress from Covid, things for his stomach, he takes it morning and evening for his stomach. He has received four doses of the Pfizer BioNTech Covid 19 vaccine. He experienced side effects from all four, He got his first dose one and half to two years ago. He has been continuously taking medication for his stomach since then. He is currently getting ready for a doctor's appointment and is getting picked up by a metavan. He has to get ready an hour and half early so he can get to his appointment on time. He also had to fight to get the HPV vaccine at his age. He was going to be in a trial for HIV.   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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He has been continuously taking medication for his stomach since then.; 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 65-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Stress" (unspecified if ongoing); "HIV" (unspecified if ongoing); "Hyper S Protein deficiency" (unspecified if ongoing); "for his stomach" (ongoing), notes: He got his first dose. He has been continuously taking medication for his stomach since then. Concomitant medication(s) included: BIKTARVY taken for hiv infection. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "He has been continuously taking medication for his stomach since then.". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient aged 65 (will be 66 in two weeks,) stated that he has Hyper S Protein deficiency, and urgently needed Paxlovid before he got the virus. He does not currently have Covid, he just has difficulty leaving the house, he can't drive and he has no family in the area to drive him to a hospital if he gets sick. He needs to have the medication at home readily available. He stated that patients with Hyper S Protein Deficiency the covid vaccine is only about 20% to mid 30s effective at best. The protein used doesn't have enough strength that he needs. He stated his condition is 1 in 20,000 but the hypo S protein deficiency rate is 1 in 500. He has been home bound since October, it is urgent that he has this stuff. He states he is under such a heavy life threatening situation. The patient is on HIV medication BIKTARVY, he is on a list of medications, all kinds, blood pressure, medications for the stress from Covid, things for his stomach, he takes it morning and evening for his stomach. He has received four doses of the Pfizer BioNTech Covid 19 vaccine. He experienced side effects from all four, He got his first dose one and half to two years ago. He has been continuously taking medication for his stomach since then. He is currently getting ready for a doctor's appointment and is getting picked up by a metavan. He has to get ready an hour and half early so he can get to his appointment on time. He also had to fight to get the HPV vaccine at his age. He was going to be in a trial for HIV.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: had a period after menopause (last one 4 years prior).  Period lasted 5 days.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 02Apr2022 at 10:00 as dose 4 (booster), single (Lot number: RJ9943) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination :Yes. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications in two weeks. Past drug history included: Keflex, reaction(s): "known allergies: Keflex". Vaccination history included: BNT162b2 (dose 1, lot number: ER5733, administration time=11:00AM, vaccine location=Right arm), administration date: 30Mar2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (dose 2, lot number:EW0151, administration time: 10:00AM, vaccine location: Right arm), administration date: 27Apr2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (dose 3, lot number: FP2593, administration time: 10:00AM, vaccine location: Right arm), administration date: 23Oct2021, when the patient was 58-year-old, for Covid-19 immunization. The patient had not received any other vaccine within 4 weeks. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 18Apr2022 at 03:00, outcome "unknown", described as "had a period after menopause (last one 4 years prior).  Period lasted 5 days.". The event "had a period after menopause (last one 4 years prior).  period lasted 5 days." required physician office visit. Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Dose Number: 3, Positive Binax test result 4/8/22; Dose Number: 3, Positive Binax test result 4/8/22; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Mar2021 as dose 1, single (Lot number: 037A21B), in left arm and on 26Apr2021 as dose 2, single (Lot number: 045B21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "Dose Number: 3, Positive Binax test result 4/8/22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: Positive Binax test result 08Apr2022. Therapeutic measures were taken as a result of covid-19 treatment drugs which include Advil and Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result Positive/ I have covid; covid test result Positive/ I have covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 41 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 23Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering" and all described as "covid test result Positive/ I have covid". The patient underwent the following laboratory tests and procedures: Body temperature: (23Apr2022) 100; SARS-CoV-2 test: (23Apr2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Reported Event- Patient have COVID with: fever of 100 for 2 days, headache for 2 days, back pain, fatigue.  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: Tested Positive for COVID-19; Tested Positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) 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 24Apr2022, outcome "recovered" (Apr2022), DRUG INEFFECTIVE (medically significant) with onset 24Apr2022, outcome "unknown" and all described as "Tested Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Clinical Course: Prior to vaccination, the patient had no diagnosed with COVID-19 and  Since the vaccination, the patient tested positive for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.