chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Croup infectious, Respiratory tract infection viral
Clinical narrative: Croup; Respiratory virus; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported similar events for three patients. This is the first of three reports. Only this case is serious.  A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 14May2021 17:00 (Batch/Lot Number: EW0182) (at the age of 13 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Prior vaccinations within 4 weeks was none. The patient experienced Respiratory virus which led to croup on 27May2021 with outcome of recovered on 31May2021. Therapeutic measures were taken as a result of events. Prednisolone and Benadryl were used. Household (Father, Mother, Patient) all contracted a respiratory virus. Patient was not tested for COVID-19. Patient was susceptible to croup when he contracts respiratory viruses. On the evening of 22May, his croup was so bad it necessitated a dose of Prednisolone which was kept on hand for emergencies. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101046560 same reporter and drug, similar event, different patient;US-PFIZER INC-202101046571 same reporter and drug, similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a sponsored program. This consumer reported for a 63-year-old male patient that. A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as dose 1, single for covid-19 immunization. Medical history included none. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced then got covid a week later. Patient had not yet received his second dose so he has also passed for 42 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2021 got Covid, sars-cov-2 test: negative on 19Apr2021, sars-cov-2 test: negative on 07Jul2021. Therapeutic measures taken as a result of then got covid a week later (covid-19) included C-Pak (Captured as verbatim however intent of Z-Pak). The outcome of the event then got covid a week later (covid-19) was recovered on 19Apr2021.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Lymphadenopathy, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: pain at the site of the injection; lymph nodes that are inflamed; Stiff neck; swollen lymph nodes; This is a spontaneous report from a contactable other hcp (patient). A 32-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 16Jul2021 (Batch/Lot number was not reported) at the age of 32 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient did not receive other vaccines 4 weeks prior to COVID vaccine. The patient received her COVID vaccine in July 16th of this year and that was the first vaccine shot. Her question was, one of the side effects is pain at the site of the injection on 16Jul2021. She asked how long that pain would last for. Immediately after the vaccine, same day as vaccine, there was definitely lingering pain for the pain, so the immediate reaction was the pain obviously and that was normal and the lymph nodes was a week after, the one week after the vaccine (Jul2021), her lymph nodes were inflamed and her neck was completely stiff. The patient had lymph nodes that were inflamed and swollen in her neck on Jul2021. This is a non-serious report. There was no treatment taken by the patient for the events. Outcome of stiff neck was unknown, while outcome of the remaining events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caught COVID; Caught COVID; This is a spontaneous report from a contactable consumer. This consumer reported for a 31-year-old male patient. A 31-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: ER8737; Expiration Date: 31Jul2021), via intramuscular route of administration in arm left on 06Apr2021 (age at vaccination was 31-year-old) as dose 1, single dose for covid-19 immunization. The patient had no known allergies. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 24Jul2021 patient caught Covid (drug ineffective). The patient underwent lab tests which included sars-cov-2 test by using nasal swab, positive on 26Jul2021. No treatment received for the events. The patient recovered from events on an unspecified date in 2021.   The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: I have diabetes; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID VACCINE) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that he heard that Pfizer was doing clinical trials for booster shots of the Covid vaccine which was done in a state. The patient mentioned that I stay in the state of (withheld) and I'm willing to travel". The patient mentioned that "I'm 71 years old and I have diabetes (unknown date)". The patient received second dose of the Pfizer vaccine on 18Feb2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination complication
Clinical narrative: Having numbness on the left side, this is the same side where she get the, received the vaccine on/Tingling in her arms and her fingers and in her leg and also the numbness; Tingling in her arms and her fingers and in her leg; she is having some complication and side effects from taking the Pfizer (Covid-19 Vaccine); This is a spontaneous report from a contactable consumer. This consumer(parent) reported for 24-year-old female patient(daughter) that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0198) via an unspecified route of administration on an unknown date in Jul2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On an unknown date in Jul2021 the patient had numbness on the left side, this was the same side where she received the vaccine on, she had tingling in her arms and her fingers and in her leg and also the numbness and complication and side effects from taking the Pfizer (Covid-19 Vaccine). The patient had not recovered. Reporter stated, that patient had reported some of the side effects, the side effects is not listed. So, will need to inform you all this and to also know, to see exactly what can be done about it. Reporter was provided with the number of Pfizer Medical Information.  QR Comment: Due to poor internet connectivity issue at Call handlers end, voice did not get through to the caller.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Herpes zoster, Rash
Clinical narrative: Raised, painful rash diagnosed as Cellulitis on left shin and ankle; Rash aligned with shingles diagnostic pattern for lower leg; Rash aligned with shingles diagnostic pattern for lower leg; This is a spontaneous report from a non-contactable other healthcare professional.   A 44-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Right Arm on 17Feb2021, at the age of 44-years-old, (Lot Number: EN 5318) as DOSE 2, SINGLE for covid-19 immunisation.  The patient is not pregnant at the time of vaccination. Medical history included penicillin group allergy. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes BNT162b2 (lot number: EN 5318) received on 25Jan2021 in right arm, dose 1, single. Prior to vaccination, the patient was not diagnosed with COVID-19. On Jun2021, the patient experienced raised, painful rash diagnosed as cellulitis on left shin and ankle; Rash aligned with shingles diagnostic pattern for lower leg (only reporting due to recent news of potential shingles events after vaccinations. The events involved emergency room/department or urgent care and physician office visit. Since the vaccination, the patient has not been been tested for COVID-19. Treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer reported for a male patient. A 48-year-old male patient received bnt162b2 (Formulation: solution for injection, Lot Number: Unknown), dose 1 via an intramuscular route of administration on an unspecified date in Apr2021 as dose 1, single and dose 2 via an intramuscular route of administration on an unspecified date in May2021 (Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jul2021, the patient experienced COVID-19 and Vaccination failure. On an unspecified date in Jul2021, the patient was tested positive for COVID after being fully vaccinated. The patient did not receive treatment to treat the events. The outcome of the event was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted covid 19; contracted covid 19; This is a spontaneous report from a contactable consumer.  A 38-years-old female patient (not-pregnant) received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation when 38 years old. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced contracted covid 19 on 19Jul2021 with outcome of recovered in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not treated due to the event. Since the vaccination, the patient has been tested for COVID-19 on unknown date (positive).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID19 test by PCR; Positive COVID19 test by PCR; This is a spontaneous report from a contactable other hcp  (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:00 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) (at the age of 61-year-old) as dose 1, single for covid-19 immunisation. Medical history included HBP. There were no concomitant medications. On 01Aug2021 12:00, the patient experienced positive covid19 test by pcr. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. Upon follow-up on 04Aug2021, the product Quality Complaint group provided additional investigational results which indicated the following: Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events were reported as recovering.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The case will be reassessed if additional information becomes available on the vaccination dates of the second dose.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in Deltoid Left on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date of 2021 the patient experienced fever. Reporter stated that he had a problem and it seemed as if it was not only me but I had the vaccine but, I thought this effect will go away and it never went away and first shot I had because I took the Pfizer, the first one on left shoulder and initially I did get any experience any side effect other than just slight fever. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (24Aug2021) This Follow-up activities closed: Batch/lot number not available for vaccine/BNT162B2.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994048 same reporter/ AE/ drug, different patient;US-PFIZER INC-202100994049 same reporter/ drug, different AE/ patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: heat was a sign of an allergic reaction; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; Big red area around the injection site that is red, raised, hot, and itchy; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0153) via an unspecified route of administration, administered in right upper arm towards back of arm, on 31Jul2021 at 09:00 (at the age of 70 years old) as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure high and Meniere's disease; cancer wherein the patient had it twice in 2014 and 2017, and COVID-19 on unspecified date in Dec and Jan. Concomitant medications included calcium taken for an unspecified indication from an unspecified start date and ongoing; multivitamins (MULTIVITAMINS) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) taken for high blood pressure, and Meniere's disease which is an inner ear disease and it helps with the fluid from an unspecified start date and ongoing; vitamin b complex taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication from an unspecified start date and ongoing; verapamil taken for hypertension from an unspecified start date and ongoing; and zinc taken for an unspecified indication, start and stop date were not reported. On 01Aug2021, it was reported that the patient experienced big red area size of a nickel around the injection site and each day it was getting bigger and bigger; this area was red, raised, hot, and later added itchy (medically significant). This area was concerning to her because the redness was spreading. It is now very big, halt the size of the palm of her hand. It was itchy, red, raised, hot. The patient mentioned she took allergy shots in the past and knew that heat was a sign of an allergic reaction. The patient took diphenhydramine (BENADRYL) as a treatment. The patient started to notice this redness around injection site the next day. She brushed against her arm and was rubbing her forearm and felt a knot. She looked at it and noticed it was red and then later on it started itching and hot. At end of call, the patient reiterated she was just concerned about the heat coming from her arm. It was hot and spreading. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Pain in extremity, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single, and received second dose via an unspecified route of administration on an unspecified date as dose 2, single both for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that, patient have received full vaccination and then had an exposure to COVID on an un-specified date, but didn't contract the COVID 19 infection. Mentioned the incubation was 10 to 14 days, and they were on day 12, taking care of a COVID kid. The patient and patient's wife, both exposed to COVID and did not get sick at that time. Also reported that, on an unspecified date, patient's arm was  being sore. The patient underwent lab tests and procedures which included SARS-COV-2 test was negative (Direct exposure to COVID 19 and did not get COVID). The outcome of events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up. Follow-up (17Aug2021): New information received from the same contactable consumer (patient's wife) includes: event details (new event: arm being sore).
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: husband has some bad reactions/ your vaccines do not work, they are useless; husband has some bad reactions/ your vaccines do not work, they are useless; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced has some bad reactions/your vaccines do not work, they are useless. The caller stated that, patient have some questions about your COVID-19 vaccines. Sadly patient's family and patient received it and her husband had some bad reactions, so no we will never, ever get another booster shot. Especially when they do not work. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid/contracted covid after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient) received from Pfizer Sponsored Program. A female patient of an unspecified age (Age: 42, Units: Unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 09Jul2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, 11 days after vaccination, the patient contracted COVID-19 and tested positive for COVID-19. It was reported that patient missed the appointment for her second dose which scheduled on 30Jul2021, and did not received it because she tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Jul2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), intramuscular, administered in Arm Right on 07Jun2021 20:00 (Age at vaccination 47 years) as dose 2, single, dose 1 intramuscular, administered in Arm Right on 17May2021 20:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient diagnosed with COVID-19). There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. On 01Aug2021, the patient experienced lack of efficacy. Patient was diagnosed with positive covid-19 test on 01Aug2021. Patient was not received treatment for event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021 Nasal Swab. Facility where the most recent COVID-19 vaccine was administered at pharmacy. Patient was visited to physician office. Vaccine Facility information available. Outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Asthma, Dysphagia, Dyspnoea
Clinical narrative: felt very weak and winded; felt very weak and winded; an immense amount of pressure in her ears; congestion in her nose; throat began to hurt; throat began to swell; swallowing and speaking became close to impossible; swallowing and speaking became close to impossible; asthma flare up; ear infection; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 29Jul2021 at 10:15 am (Batch/Lot Number: EW0186) (at the age of 18-yrs-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Doctor office/urgent care. Medical history included bronchitis in 2011. The patient has no past drug history and concurrent conditions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received birth control within 2 weeks of vaccination. On 29Jul2021 at 14:00 (4 hours after receiving the vaccine), the patient's throat began to hurt. As more hours passed, her throat began to swell and swallowing and speaking became close to impossible. It was like this for three days following. On the third day (on 01Aug2021) of her throat swelling, she developed an immense amount of pressure in her ears as well as congestion in her nose. The fourth day after receiving the vaccine (on 02Aug2021), she felt very weak and winded. The fifth day after (on 03Aug2021), she went to urgent care as she was still experiencing these symptoms and was informed that she had an asthma flare up. For context, she hasn't had an asthma flare up since she had bronchitis 10 years ago. She was also informed that she had an ear infection. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment which included Amoxicillin, Benzonatate, Inhaler, and Pseudoephedrine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 Since the vaccination. The outcome of the events was recovering/resolving.    No follow-up attempts are needed. No further information is expected.~
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear infection, Nasal congestion, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: felt very weak and winded; felt very weak and winded; an immense amount of pressure in her ears; congestion in her nose; throat began to hurt; throat began to swell; swallowing and speaking became close to impossible; swallowing and speaking became close to impossible; asthma flare up; ear infection; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 29Jul2021 at 10:15 am (Batch/Lot Number: EW0186) (at the age of 18-yrs-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Doctor office/urgent care. Medical history included bronchitis in 2011. The patient has no past drug history and concurrent conditions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received birth control within 2 weeks of vaccination. On 29Jul2021 at 14:00 (4 hours after receiving the vaccine), the patient's throat began to hurt. As more hours passed, her throat began to swell and swallowing and speaking became close to impossible. It was like this for three days following. On the third day (on 01Aug2021) of her throat swelling, she developed an immense amount of pressure in her ears as well as congestion in her nose. The fourth day after receiving the vaccine (on 02Aug2021), she felt very weak and winded. The fifth day after (on 03Aug2021), she went to urgent care as she was still experiencing these symptoms and was informed that she had an asthma flare up. For context, she hasn't had an asthma flare up since she had bronchitis 10 years ago. She was also informed that she had an ear infection. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment which included Amoxicillin, Benzonatate, Inhaler, and Pseudoephedrine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 Since the vaccination. The outcome of the events was recovering/resolving.    No follow-up attempts are needed. No further information is expected.~
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted covid four months after fully vaccinated; COVID-19; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) (age at vaccination 41-years-old) via an unspecified route of administration on an unspecified date as dose 2 single and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 25Mar2021 (age at vaccination 41-years-old) as single dose for COVID-19 immunization. The patient had no known allergies. The patient had no other medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 25Jul2021 the patient experienced contracted COVID four months after fully vaccinated. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Rapid Covid-19 Antigen Test was positive on 25Jul2021 Nasal Swab (Rapid Covid-19 Antigen Test). The outcome of the events was recovering.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Blood pressure measurement, Blood test, Cardiac stress test, Cardiac stress test abnormal
Clinical narrative: It was as high as 210/105 but always high; Realized loss of certain smells Felt like I was jumping out of my skin; My inflammation number was 29 and should be under 2; Stress test bad; Realized loss of certain smells; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 15Mar2021 10:00 (at the age of 67 years) as single for covid-19 immunization along with patient also received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:00 (at the age of 67 years) as single for covid-19 immunization. Medical history included autoimmune issues from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 10Apr2021 the patient experienced blood pressure during third week of April. It was as high as 210/105 but always high but Generally 185/92 and realized loss of certain smells felt like patient was jumping out of my skin and patient stated that my inflammation number was 29 and should be under 2 and stress test bad. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. On unspecified date the patient underwent lab tests and procedures which included blood pressure measurement found to be 210/105, blood test was 1.5 on inflammation numbers down dramatically to 1.5, cardiac stress test which was found to be bad, and echocardiogram found to be good, and electrocardiogram was fine as per report. Patient treatment received Various heart related tests and blood work for the adverse event. The outcome of the events was not recovered.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Feeling abnormal, Hypertension, Inflammation
Clinical narrative: It was as high as 210/105 but always high; Realized loss of certain smells Felt like I was jumping out of my skin; My inflammation number was 29 and should be under 2; Stress test bad; Realized loss of certain smells; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 15Mar2021 10:00 (at the age of 67 years) as single for covid-19 immunization along with patient also received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:00 (at the age of 67 years) as single for covid-19 immunization. Medical history included autoimmune issues from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 10Apr2021 the patient experienced blood pressure during third week of April. It was as high as 210/105 but always high but Generally 185/92 and realized loss of certain smells felt like patient was jumping out of my skin and patient stated that my inflammation number was 29 and should be under 2 and stress test bad. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. On unspecified date the patient underwent lab tests and procedures which included blood pressure measurement found to be 210/105, blood test was 1.5 on inflammation numbers down dramatically to 1.5, cardiac stress test which was found to be bad, and echocardiogram found to be good, and electrocardiogram was fine as per report. Patient treatment received Various heart related tests and blood work for the adverse event. The outcome of the events was not recovered.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A adult female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on unknown date in Apr2021 as single dose for COVID-19 immunisation. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on unknown date in May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Jul2021, the patient experienced lack of efficacy tested positive for COVID after being fully vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jul2021 for COVID after being fully vaccinated. The outcome of the events was recovered on unknown date in 2021.  Information on lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive to covid 19 on 08/02/21; Tested positive to covid 19 on 08/02/21; This is a spontaneous report from a contactable consumer or other non hcp. A 20-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient experienced tested positive to covid-19. The patient underwent lab tests and procedures which included covid-19: positive on 30Jul2021.   Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID 19 VACCINE lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records deviation investigations and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207 fill lot EN5340 and the formulated drug product lot EN5328.A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Scope of complaint investigation: The scope of this investigation included the reported finished goods lot EN6207 fill lot EN5340 and the bulk formulated drug product EN5328. Acceptable review of related documentation including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Document Review Summary: DEVIATIONS: Complete (Acceptable): There was one deviation investigation initiated related to in scope lots. QAR 5637107 The purpose of this investigation was to identify the root cause for exceeding the Time Out of Refrigeration limit of 46 hours during the production of the Covid 19 vaccine. Outcome for the event covid-19 was unknown. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cerebral venous sinus thrombosis, Headache, SARS-CoV-2 test
Clinical narrative: Severe headaches; increased high blood pressure; Diagnosed with acute cerebral venous sinus thrombosis.; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in arm right on 15Apr2021 08:30 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe headaches, increased high blood pressure and was diagnosed with acute cerebral venous sinus thrombosis on 17Apr2021. The patient was hospitalized for the events for 3 days. The clinical course was as follows: Severe headaches began 2 days following vaccine which continued straight for 2 1/2 weeks followed by extremely increased high blood pressure. Sent to hospital emergency. Admitted and diagnosed with acute cerebral venous sinus thrombosis. The patient underwent lab tests and procedures which included blood pressure measurement: increased (Extremely increased high blood pressure), SARS-COV-2 test: negative (Nasal Swab), both on 03May2021. The adverse events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all events (Blood Thinners and BP Medication). The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died after getting the vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a patient (Doctor). A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. The reporter was asking about a doctor in (Withheld) that died after getting the vaccine. She wanted to know what the reports are. She said that this happened in the beginning around Dec2020. She wanted to know what the cause of death was. she insisted on getting information or a supervisor or anyone that could give her answers. The patient died on Dec2020. It was not reported if an autopsy was performed.  The following information was provided to the reporter from CDC website: The Centers for Disease Control and Prevention (CDC) conducted descriptive analyses of safety data from the first month of vaccination with COVID-19 vaccines in the United States (14Dec2020-13Jan2021). During this period, 13,794,904 vaccine doses of Pfizer-BioNTech and Moderna COVID-19 vaccines were administered and a total of 113 deaths were reported to the CDC's Vaccine Adverse Event Reporting System (VAERS). Initial doses were recommended for healthcare personnel and long-term care facility (LTCF) residents. This analysis, which evaluated available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers, concluded that a causal relationship between COVID-19 vaccination and death was not suggested  No follow-up attempts are possible; Information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Died after getting the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Fatigue, Investigation
Clinical narrative: Fatigue; tried to rehydrate; fever 100.3 that lasted for 3 days; Chills; This is a spontaneous report from a contactable consumer reported for herself that. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 69 years). The patient past medical history and concomitant medication was not reported. The patient is calling to order Sildenafil for her mother for her mother's heart failure. She wanted to report a reaction she (the caller) had to the COVID vaccine. The caller confirmed the details provided by the transferring agent. The caller had a mild reaction to the COVID 19 vaccine. She hears about reporting side effects in the recording. It was the Pfizer COVID vaccine. She got both Pfizer doses: first shot: 19Apr2021, ER8733, 31Jul2021, right arm; last shot 10May2021, ER8729, 31Jul2021, left arm She got both doses at (address withheld). On an unspecified date the patient experienced side effects after the second dose. She had a fever 100.3 that lasted for 3 days. She had chills that lasted for 3 days. She just tried to sleep it off and drink it off. She just tried to rehydrate. The fatigue lasted a couple of days. These just happened after the last dose. She went to the internist recently, and her numbers were really good. She has no diabetes. Her numbers were all well under everything. Her husband and 99-year-old mother got both COVID vaccines the same day as her, and neither one of them had a reaction to either dose. Her husband is a big baby, so she is glad he didn't. Two of her former coworkers had the Moderna vaccine and had the same reaction. She thought it was funny because they all worked together for so long. She doesn't want to do a report for them. The patient underwent lab tests and procedures which included body temperature: 100.3 on an unspecified date and investigation: were good on  has no diabetes. were all well under everything. The event outcome was recovered on an unspecified date.