chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: I developed Bells Palsy affecting the left side of face On 04Jul, 4 months after my 2nd Pfizer vaccine on 04Mar; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6200), via unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 74-years-old and she was not pregnant at the time of vaccination) as Dose 2,Single for COVID-19 immunization. The patient's medical history was none. Other medications in two weeks included atorvastatin calcium (LIPITOR) 10 mg daily. There was no other vaccine in four weeks. There was no covid prior vaccination and not tested COVID post vaccination. There was no known allergies. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9265), via unspecified route of administration, administered in arm left on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation at hospital. The patient experienced Bell's Palsy affecting the left side of face on 04Jul2021 at 6:00 AM, 4 months after my 2nd Pfizer vaccine on 04Mar2021. The adverse event resulted into Emergency room visit, Hospitalization for one day. She received treatments for adverse event included CT Scan, MRI, medication. The patient underwent lab tests and procedures included CT Scan, MRI on unspecified date. The outcome of event was not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Menstruation irregular, Myalgia
Clinical narrative: Chest cold symptoms; Missed period X5 days (still awaiting cycle as of date); extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose); This is a spontaneous report from a contactable consumer (patient). This 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Aug2021 at 10:0 AM, at the age of 38 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history included breast cancer, allergy to taxol chemo drug, dairy and bee venom. The patient received the first dose of BNT162B2 vaccine on 13Jul2021 at 10:00 AM, at the age of 38 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medications were none. On an unspecified date in Aug2021, after the second dose, the patient experienced chest cold symptoms for 3 weeks, missed period for 5 days (still awaiting cycle as of date), extreme muscle pain (every muscle in body hurt for 1 day approximately 1 week after 2nd dose). The events required treatment with OTC pain medications. Events outcome was unknown. COVID was not tested after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She states she is very upset and very furious with this product; pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date, NDC and UPC number: unknown), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated on an unspecified date she was very upset and very furious with this product, because if she knew it was not fully approved, she would not have gotten it and would never allowed her 12-year-old to get it. The patient recently had, when she had first got it, the patient was experiencing the pain on an unknown date. So then when the patient got the second shot the patient was having the same pain. The report was non-serious. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Lichen planus
Clinical narrative: it's an auto immune which I believe got triggered after the vaccine; developed Lichen Planus in the mouth; This is a spontaneous report form a contactable consumer (patient).   A 39-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot number was not reported) at the age of 38-year-old,  as single dose for covid-19 immunisation. The patient had received the first dose of the same vaccine on unknown date. The patient medical history was none. The patient's concomitant medications were not reported.  On 22Apr2021 at 12:00 AM after the second dose of Pfizer COVID Vaccine, he developed Lichen Planus in the mouth, it's an auto immune which he believes got triggered after the vaccine. The outcome of the events was not recovered. The patient received an unspecified treatment. No covid prior vaccination and no covid test post vaccination.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis, Maternal exposure during pregnancy
Clinical narrative: bad reaction" to "a vaccine" that resulted in her being admitted to the hospital with encephalitis; 7 months pregnant; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient was 7 months pregnant  and experienced a bad reaction to vaccine that resulted in her being admitted to the hospital with encephalitis. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: got diagnosed with Covid today; got diagnosed with Covid today; This is a spontaneous report from a contactable consumer or other non hcp (reporters sister-in-law).     A 42-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got diagnosed with COVID today on 24Aug2021. Caller stated, the patient actually have several questions and the patient also recording for information internet channel to help clear up a lot of misinformation about COVID vaccination hopefully this can help some people, the patient know a lot of people afraid to take it. The patient know the FDA approved Monday vaccination for 16 and older, totally different vaccination than the one that was produced back in Feb/Mar. Can you confirm or deny that. Caller continued, Pfizer initially did their preliminary tests the vaccination was about 95% effective from people getting Covid versus the placebo in the 22000-some people that they did and now the patient believed its around 38% with the breakthrough cases but with those 72% that have broke through the patient believed that those cases were considered mild compared to those that have not had their vaccination so yes there may be breakthrough cases but those tend to be less severe than those that have not had the vaccination if could confirm that as well. The last question would be on the breakthrough cases do you have research as far as how many of those breakthrough cases that had the vaccination were actually continuing to also wear the mask at the same time or did they get the vaccination and think okay we are good we do not need to wear masks anymore and that was how they got it you know if you could come up with those kinds of information it sure would help clear up a lot of misinformation that was out there. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 24Aug2021 diagnosed with COVID-19 infection today. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Body aches; Her wife got the first dose of the Pfizer BioNTech covid-19 vaccine on 17Aug2021 and tested positive for covid last 23Aug2021; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 39-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 17Aug2021 12:47 (at the age of 39 years-old) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included Seasonal Allergies, mostly mold from onset Date: 2-3 years ago, from an unknown date and unknown if ongoing. Concomitant medications paracetamol (TYLENOL), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL), vitamin c [ascorbic acid] taken for an unspecified indication start and stop date were not reported. The patient experienced her wife got the first dose of the pfizer biontech covid-19 vaccine on 17aug2021 and tested positive for covid last 23Aug2021 on 23Aug2021 05:16, nausea on unknown date in Aug2021, body aches on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test is positive on 23Aug2021: Positive released 23 Aug 2021 at 5:16 am. Blood PCR test is done. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.s
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 19) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported an event that happened on 04Jul2021 with 400 people about 60% of those who were vaccinated got infected with the covid-19 virus but only 2 of those people had to go to the hospital. A PCR test confirmed their covid-19 infection. Consumer reported he is 19 received first doses of Pfizer covid-19 vaccine. On an unspecified date, he got symptoms and was tested positive for covid-19 with a PCR test on an unspecified date. The reporter asked what their effectiveness after just one shot was. The reporter was seeking information about the 3rd dose of Comirnaty vaccine being offered for immunocompromised patients and if this was the same dose as the first and second. Consumer stated that recent studies showed that you can still inquire infection after the vaccine and was asking regarding the efficacy rate. Outcome of event was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID months after receiving the vaccine; tested positive for COVID months after receiving the vaccine; This is a spontaneous report from a contactable patient reporting via representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: 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 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID months after receiving the vaccine it was reported that event took place after use of product. The events assessed as medically significant. The patient underwent lab tests and procedures which included Covid-19 (sars-cov-2 test): positive on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. The information available in this report is limited, and the reported events covid19 and drug ineffective cannot be totally excluded or assessed. The case will be reassessed when the new information available.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a report based on the information received from a non-contactable female consumer (patient) (No. 21K-163-4037026-00).   A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular in Feb2021 (Batch/Lot number was not reported, at age of 69 years old) as single dose, dose 1 intramuscular on Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. HUMIRA subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date for psoriatic arthritis and moderate to severe rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive for COVID-19 in May2021. The patient underwent lab tests and procedures which included COVID-19 virus test positive in May2021. The action taken in response to the events for Humira was unknown. The outcome of events was recovered in 2021. The reporter's causality for the event(s) of Tested positive for COVID-19 with HUMIRA was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. Sender's Comments: The causal association between the suspect product BNT162B2 and the reported events Covid-19 and Drug ineffective was assessed as unrelated. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is as expected. Vaccination per does not contribute to the infection of this disease, so it is difficult to attribute covid-19 infection to vaccination, so the causal relationship between covid-19, drug ineffective and BNT162B2 is considered as unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Hypoaesthesia
Clinical narrative: stroke like symptoms; problems walking without being tired; face on the left still sags; This is spontaneous report from contactable consumer.  A patient of unspecified age and gender reported that received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that had both shots the first and 2nd shots. Each time had problems after had stroke like symptoms and still suffered about 2 months in. The patient had problems walking without being tired. The face on the left still sags. 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: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis aggravated/flare up of psoriatic arthritis; This is a solicited report based on information received by Pfizer.  Solicited report by a consumer of a 68-year-old female with an event of non-serious after second Pfizer vaccine, had a flare up of psoriatic arthritis with adalimumab (HUMIRA). The patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen) via subcutaneous in 2021 for psoriatic arthritis. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. In Mar 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer for COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, patient received 1st dose COVID-19 Vaccine via intramuscular manufactured by Pfizer for COVID-19 vaccination.  There was no reported medical history. The patient's concomitant medications were not reported. In 2021, the patient experienced after second Pfizer vaccine, had a flare up of psoriatic arthritis/psoriatic arthritis aggravated. The action taken in response to the event for the suspect drug adalimumab was unknown. In 2021, the after second Pfizer vaccine, had a flare up of psoriatic arthritis resolved.  Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event of after second Pfizer vaccine, had a flare up of psoriatic arthritis with adalimumab (HUMIRA) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product Pfizer Biontech COVID-19 vaccine (tozinameran) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Muscle spasms, Paraesthesia, SARS-CoV-2 test
Clinical narrative: chest pain upon inspiration while sitting down; numbness and tingling to face; numbness and tingling to face; arms and left hand cramping/contracted; This is a spontaneous report from a contactable Nurse (patient). A non-pregnant 38-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 19Aug2021 15:00 (Batch/Lot Number: FC3180) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, covid-19 prior vaccination. Concomitant medication(s) included curcuma longa root (TURMERIC CURCUMIN). No other vaccine in four weeks. On 20Aug2021 14:00, approximately 24 hours after received the vaccine at about 2 pm, patient began to experience chest pain upon inspiration while sitting down (she works from home). Symptoms got worse and also felt numbness and tingling to face and arms and left hand cramping/contracted. Treatment Benadryl 50mg received for the events. The outcome of events was unknow. Nasal Swab Covid test BinaxNow conducted post vaccination was Negative on 11Aug2021. Case reported as serious due to medically significant.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events paraesthesia, chest pain, hypoaesthesia and muscle spasm and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chromatopsia, Dizziness, Hyperhidrosis, Hypoacusis, Loss of consciousness
Clinical narrative: Going to pass out; Immediately got dizzy; Sweating; Vision was grey and unclear; Vision was grey and unclear; All face and arm colors turned white; Could barely hear; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient had allergies to Clindamycin and penicillin, green beans, raspberries, coffee, and tea. Patient was not pregnant. Patient received the first dose of bnt162b2 on 08Aug2021 (as reported), at the age of 17 years old. Concomitant medication included unspecified birth control rod in arm 3 months ago. Patient immediately got dizzy, started sweating, vision was grey and unclear, all face and arm colors turned white, could barely hear, and felt Like going to pass out on 08Aug2021. Pharmacist gave glucose tablets (4) not diabetic. Outcome of events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vision blurred
Clinical narrative: Going to pass out; Immediately got dizzy; Sweating; Vision was grey and unclear; Vision was grey and unclear; All face and arm colors turned white; Could barely hear; This is a spontaneous report from a contactable consumer (patient). A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient had allergies to Clindamycin and penicillin, green beans, raspberries, coffee, and tea. Patient was not pregnant. Patient received the first dose of bnt162b2 on 08Aug2021 (as reported), at the age of 17 years old. Concomitant medication included unspecified birth control rod in arm 3 months ago. Patient immediately got dizzy, started sweating, vision was grey and unclear, all face and arm colors turned white, could barely hear, and felt Like going to pass out on 08Aug2021. Pharmacist gave glucose tablets (4) not diabetic. Outcome of events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, SARS-CoV-2 test negative
Clinical narrative: Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left in Mar2021 01:00 AM (at the age of 47-year-old) (Batch/Lot Number: EN6198) as single dose, and dose 1 via an unspecified route of administration, administered in arm left on 25Mar2021 01:00 AM (Batch/Lot Number: ER2613) as single dose for COVID-19 immunisation, administered at hospital.  Medical history included autoimmune disorder. The patient's concomitant medications were not reported. Past drug history was none. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Patient was not pregnant. The patient experienced psoriatic arthritis (medically significant) on 02Apr2021 with outcome of not recovered. The adverse event psoriatic arthritis resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative on 22May2021.  Therapeutic measures were taken as a result of psoriatic arthritis: topical solution.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Muscular weakness, Paraesthesia
Clinical narrative: started semi-paraesthesia in the lower and upper limbs as well as muscle weakness; muscle weakness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. In Jul2021, a month later after the second dose, the patient experienced started semi-paraesthesia in the lower and upper limbs as well as muscle weakness.  The patient has always been healthy. The patient was wondering if it could be a reaction to the vaccine since neurologist and orthopedist were unable to give an explanation after TAC scan and magnetic resonance that excluded possible pathologies. Outcome of events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: terrible tinnitus after receiving your vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event in two patients. This is the second of two reports. A consumer (patients husband) reported that his wife of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknow date in 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. After receiving the vaccine the patient experienced terrible tinnitus in 2021. The patient has been to the doctor once including an ENT visit. The reporter told CDC and they don't care. The doctors just shrug. It's nowbeen 5 months with no improvement. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101102231 Same drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: after the second one a undisclosed problem with my colon caused hospitalization; This is a spontaneous report from a contactable consumer reporting for self:  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included scalp psoriasis, itching scalp. Historical vaccine dose 1 of bnt162b2 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced after the second one a undisclosed problem with my colon caused hospitalization in 2021 with outcome of unknown. Therapeutic measures included "many bags of saline and antibiotics drips".  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: I woke up just freezing; one of them chills or just being very cold; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, on unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that patient woke up just freezing and one of them chills or just being very cold. Patient stated that, "About a reaction possibly, patient had a shot about 7:09 here where patient located. Patient probably had it about 3 o'clock this afternoon so it was been 16 hours and patient woke up just freezing like never had been just cold patients entire life and live-in world's wintertime and understand side effects and patient was looking in this was got a bunch of side effects was that one of them were chills or just being very cold. Patient queried if Is that a side effect to that. Patient was informed about Pfizer Medical Information Department, Patient just wanted to know that was a side effect this time. Because patient had never been this cold in life. Patient stated that patient was sure, it was a side effect. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Nausea, Oropharyngeal discomfort
Clinical narrative: Throat is scratchy; Feeling nauseous; Extremely horse voice; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 2021 as a single for covid-19 immunisation. Medical history included allergy to plants from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity, morphine, and experienced drug hypersensitivity. She also has allergies with codeine, morphine, and penicillin. On an unspecified date the reporter stated that her throat was scratchy, feeling nauseous, had extremely horse voice. She took Benadryl and seemed to be okay. She had a similar reaction with other products. Therapeutic measures were taken as a result of throat is scratchy, feeling nauseous, extremely hoarse voice. Outcome of the events was recovered on unspecified date in 2021.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: Keep coughing, it is so hard on heart and really bad dry cough; he is not doing very well; not doing very well; This is a spontaneous report from a contactable consumer reporting for the son. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date on 21Aug2021 (at an unspecified age of age) (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation.  The patient medical history included need for new heart and lung (further not clarified). The concomitant medications were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date in 2021 3 weeks ago (at an unspecified age of age) (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation (received in the Hospital) and experienced needed "new Heart and Lung".  In Aug2021 the patient experienced got so hard and kept coughing, it was so hard on heart and really bad dry cough; he was not doing very well with outcome of unknown.  Coughing was so hard on his heart. This report was not related to a study or programme.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Tremor
Clinical narrative: Bell's Palsy; Quivering, shaking; This is a spontaneous report from a non-contactable other health care professional (NURSE) received via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, 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 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bell's palsy, quivering and shaking on an unspecified date. Caller, a registered Nurse wanted to know more information about the vaccine, if there was a fact sheet or website to check. Caller was also asking about the ingredients because she was allergic to sulfur chloride and Benzalkonium Chlorides (which she experienced a heart attack). Caller was an immunocompromised patient. Caller was asking for the information if she and her patients should take the vaccine or not. Caller said from what I have heard, I am very much against this vaccine. I had a friend who had a neurological reaction. Quivering, shaking, Bell's Palsy. These people are not getting these reactions back to their doctors and it was not something that they were allowing other people to know about. I really need to know what was in this drug for myself and whether or not I participate in giving it to others. 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. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's palsy and the suspect drug bnt162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: itchy all over; rash on both my arms; plus red itchy blotches; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Protein in red meat allergy and multiple allergies. The patient's concomitant medications were not reported. The patient experienced itchy all over (medically significant) on 2021 with outcome of unknown, rash on both my arms (medically significant) on 2021 with outcome of unknown, plus red itchy blotches (medically significant) on 2021 with outcome of unknown.  Therapeutic measures were taken "Benadryl since the end of Jun2021". 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: Antibody test, Beta-2 glycoprotein antibody, Beta-2 glycoprotein antibody positive, Burning sensation, Cardiolipin antibody
Clinical narrative: Blood clot; burning sensation throughout my body; B2 glycoproteins I (igm) ab and the value is 73.6 high; cardiolipin AB (igm) and this value is 23.4 also high; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 08Mar2021 (at the age of 67-years-old) at dose 2, single for COVID-19 immunization. Medical history included known allergies to penicillin and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (METOPROLOL ER) and acetylsalicylic acid (ASPIRIN). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En5318), via an unspecified route of administration in left arm on 13Feb2021 (at the age of 67-years-old) at dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as hospital. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of vaccine on 08Mar2021. She had no out of ordinary reaction, however, she has been experiencing a burning sensation throughout her body since 14Jun2021 (also reported as mid Jun). After many tests, her antibody level was only 2.93 on an unspecified date in 2021. A rheumatologist ordered two other tests: B2 glycoproteins I (IgM) AB and the value was 73.6 which was high and cardiolipin AB (IgM) and the value was 23.4 which was also high on an unspecified date in 2021. The patient was asked about blood clot experience (14Jun2021) but was never diagnosed with one. Her question was whether COVID vaccines play a significant role in these tests and if there could be a correlation. After all, they heard about people developing blood clots. The events required doctor or other healthcare professional office/clinic visit. She did not receive any treatment in response to the events. The outcome of the events was not recovered. The case was reported as serious, medically significant.  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: Cardiolipin antibody positive, Thrombosis
Clinical narrative: Blood clot; burning sensation throughout my body; B2 glycoproteins I (igm) ab and the value is 73.6 high; cardiolipin AB (igm) and this value is 23.4 also high; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 08Mar2021 (at the age of 67-years-old) at dose 2, single for COVID-19 immunization. Medical history included known allergies to penicillin and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (METOPROLOL ER) and acetylsalicylic acid (ASPIRIN). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En5318), via an unspecified route of administration in left arm on 13Feb2021 (at the age of 67-years-old) at dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as hospital. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of vaccine on 08Mar2021. She had no out of ordinary reaction, however, she has been experiencing a burning sensation throughout her body since 14Jun2021 (also reported as mid Jun). After many tests, her antibody level was only 2.93 on an unspecified date in 2021. A rheumatologist ordered two other tests: B2 glycoproteins I (IgM) AB and the value was 73.6 which was high and cardiolipin AB (IgM) and the value was 23.4 which was also high on an unspecified date in 2021. The patient was asked about blood clot experience (14Jun2021) but was never diagnosed with one. Her question was whether COVID vaccines play a significant role in these tests and if there could be a correlation. After all, they heard about people developing blood clots. The events required doctor or other healthcare professional office/clinic visit. She did not receive any treatment in response to the events. The outcome of the events was not recovered. The case was reported as serious, medically significant.  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: Pain
Clinical narrative: soreness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support.     A 68-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EB5313 and Expiration date was unknown), via an unspecified route of administration, administered in right arm on 05Feb2021, as dose 1, single (at the age of 67-years-old) for COVID-19 immunisation. Medical history included immunocompromised from and unknown date and ongoing, primary immune deficiency disease from 2017 (Spring of 2017) and ongoing, Mycobacterium avium complex infection (has been fighting it for 4 years) from 2017 and ongoing and also diagnosed with something else that was related to her being immunocompromised. Patient previously had the Shingrix vaccines for immunisation and had no problems, but they were kind of painful, but caused no problems, had Prevnar 13 on 24Aug2018 (does not have the lot or expiration date for the product) and Pneumovax vaccine both for immunisation and had no problems with either of them. Patient mom died of cancer. Patient had no prior vaccinations (within 4 weeks), prior to the first administration date of the suspect vaccine. Concomitant medication (s) included immunoglobulin human normal (Cuvitru) taken for immunodeficiency from Jun2017 and ongoing (takes the medication at least 48 hours apart from her vaccines, as she will be on it for life). On an unspecified date of 2021, patient had soreness after the first dose. No relevant tests were performed. Patient had no physician office and emergency room visit. Patient weight was 100-102lbs. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump under my armpit; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. It was reported that patient received the second shot, and 2 days after, on 25Aug2021, morning, patient woke up with lump under the armpit and patient was unsure if that was the possible side effect. No treatment was given in response to the event. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Neck pain, Pain, Pyrexia, Vomiting
Clinical narrative: neck hurting; body hurting; vomiting; fever; sick; This is a spontaneous report from a contactable nurse. This nurse reported for a male patient (reporter's grandson) that.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Aug2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced neck hurting, body hurting, vomiting, fever, sick on an unspecified date. It was reported that Caller is calling on behalf of her grandson who received the second dose of the Pfizer Covid-19 vaccine 25Aug2021 1 PM (time zone not provided) and now he is having complaints of his neck hurting, body hurting, vomiting, and fever per Reugulatory Authority. Caller declined to provide a safety report, zip code, and age of grandson. Caller is asking if she should have her grandson go to a hospital. Call was disconnected before warm transfer could occur. Callback at 2:10 PM EST 26Aug2021. Confirmed above information and inquiry with Caller. Caller also stated that her grandson is "super sick" and in "super pain". The events were assessed as Non serious by reporter. The outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Rash, T-lymphocyte count decreased, White blood cell count
Clinical narrative: My face had broken out a little bit by my cheek and at the base of one of the sides of my nose; my platelet count is down; white count is down; my T-cell count is down; This is a spontaneous report from a contactable consumer or other non hcp. A 8-decade-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cardiac failure congestive from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced my t-cell count is down on 2021, my face had broken out a little bit by my cheek and at the base of one of the sides of my nose on Aug2021, my platelet count is down on 2021, white count is down on 2021. The patient underwent lab tests and procedures which included platelet count: down on 2021 my platelet count is down, t-lymphocyte count decreased: down on 2021 my T-cell count, white blood cell count: down on 2021 My white count is down. Therapeutic measures were taken as a result of my face had broken out a little bit by my cheek and at the base of one of the sides of my nose was Amoxicillin 500mg three times daily and bacitracin and cortisone via topical route of administration. The outcome of the events t-lymphocyte count decreased, rash, platelet count decreased, white blood cell count decreased was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: My face had broken out a little bit by my cheek and at the base of one of the sides of my nose; my platelet count is down; white count is down; my T-cell count is down; This is a spontaneous report from a contactable consumer or other non hcp. A 8-decade-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cardiac failure congestive from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced my t-cell count is down on 2021, my face had broken out a little bit by my cheek and at the base of one of the sides of my nose on Aug2021, my platelet count is down on 2021, white count is down on 2021. The patient underwent lab tests and procedures which included platelet count: down on 2021 my platelet count is down, t-lymphocyte count decreased: down on 2021 my T-cell count, white blood cell count: down on 2021 My white count is down. Therapeutic measures were taken as a result of my face had broken out a little bit by my cheek and at the base of one of the sides of my nose was Amoxicillin 500mg three times daily and bacitracin and cortisone via topical route of administration. The outcome of the events t-lymphocyte count decreased, rash, platelet count decreased, white blood cell count decreased was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed. No further information is expected.