chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Micturition disorder, Myalgia, Pyrexia
Clinical narrative: Extreme difficulty thinking; lower back pain; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; Slurred speech an difficulty swallowing; Slurred speech an difficulty swallowing; Feet felt super heavy and awkward; Significant urination; muscle aches; low-grade fever; very tired; Slight headache; numbness in tongue, throat, lips, cheeks, hands, feet; numbness in tongue, throat, lips, cheeks, hands, feet; blood sugar plummeted; This is a spontaneous report from a contactable consumer (patient).  A 49-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Apr2021 15:45 (Batch/Lot Number: CR8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Type 1 diabetes, Some allergy medications like zyrtec, topamax, Nortriptyline, allergic asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included insulin lispro (HUMALOG); bisoprolol (BISOPROLOL); fexofenadine hydrochloride (ALLEGRA). Historical Vaccine included product=COVID 19, brand=Pfizer, lot number=EP7533, administration date: 04Apr2021, administration time =04:00 PM, dose number =1, vaccine location =Left arm for covid-19 Immunization. Reported Event: About 3 hrs after 2nd dose, lower back pain for 20 minutes followed by numbness in tongue, throat, lips, cheeks, hands, feet, slurred speech an difficulty swallowing. Extreme difficulty thinking. Feet felt super heavy and awkward, like they were bricks. She was a type 1 diabetic and her blood sugar plummeted. She had to stop her basal delivery for an hour, then she halved her basal rate for several hours. After laying down for a few hours, symptoms improved, but worsened when standing. Significant urination every 40 - 60 mins for several hours. In the morning, muscle aches throughout body, low-grade fever, very tired. Slight headache. Adverse event start date: 25Apr2021, Adverse event start time: 06: 30 PM, No treatment for AE. Lab data included blood sugar: plummeted on 25Apr2021. The event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: A non-contactable physician reported for a patient of unspecified age and gender received BNT162B2 (Solution for injection), subcutaneous on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received vaccine via subcutaneous. It was reported that a person who received the Pfizer covid vaccine last week and said they got it subcutaneous (sub Q) and it bubbled up.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: However she had Covid-19 and was in quarantine until 14Apr2021.; However she had Covid-19 and was in quarantine until 14Apr2021.; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient).  A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 15Mar2021, she was scheduled to receive the second dose of the vaccine on 05Apr2021, however she had Covid-19 and was in quarantine until 14Apr2021. The patient underwent lab tests and procedures which included COVID-19: positive she had Covid-19 on 2021.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Anger, Head discomfort, Sensory disturbance, Tinnitus
Clinical narrative: Tinnitus in both ears; Have odd sensations in the top and back of our head; 24/7 tinnitus is driving us downright mad; Odd sensations in the top and back of our head; This is a spontaneous report received a contactable consumer. This consumer reported similar events for two patients with the same product; this case is the second of two. A male of unspecified age received the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on an unspecified date in Mar2021 for COVID-19 immunisation. There was no medical history, concomitant or past drug history reported. The consumer reported that about fifteen minutes or so after receiving the first dose of the Pfizer COVID vaccine the patient experienced new onset tinnitus in both ears. The consumer stated that the patent is also experiencing odd sensations in the top and back of his head. The cosumer exclaimed that the 24/7 tinnitus is driving him downright mad. The consumer reported the her and her husband received the second dose even though he is still experiencing side effects because he wanted to do his part and get vaccinated. The outcome of the events tinnitus in both ears, and odd sensations on the top and back of his head, was not recovered. The outcome of the event 24/7 tinnitus is driving him downright mad was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :  PFIZER (Same reporter/product, similar event in different patient)
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was administered vaccine. Shortly afterwards tested positive for covid.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a patient that the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. The past medical history and concomitant medication was not reported. The reporter stated that shortly after vaccination, the patient tested positive for COVID. Patient was transferred to hospital where they were told to wait 90 days before receiving the second dose.   The clinical outcome for the event was unknown. It was unknown if the reporter is a Health Care Professional. The reporters contact information was available to you or a sub-contracted party.   It was unknown if the reporter was the prescribing HCP. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Polyuria, Pyrexia
Clinical narrative: fever; body aches; urinate a lot; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program. A male patient of unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 21Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever, body aches and urinate a lot after taking the first dose yesterday. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritic pain in his hands (which he has had for many months) has improved; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 15Apr2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient received his first dose of the Pfizer Covid vaccine on 15Apr2021. On 17Apr2021, he noticed arthritic pain in his hands (which he has had for many months) has improved. Patient wants to know if this a reported side effect. The outcome of the event was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: developed severe nose bleeds after receiving the first dose of vaccine; This is a spontaneous report from a contactable nurse received from Medical Information Team.  A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 (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 developed severe nose bleeds after receiving the first dose of vaccine on an unspecified date.  She was referred to an ENT and had to be cauterized.  The patient outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on a temporal association, a causal relationship between the event nose bleeds and BNT162B2 cannot be completely 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: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling abnormal, Headache, Illness
Clinical narrative: dizziness; elevated B/P of 189/99; headache; sore left arm with difficulty moving her left hand; not feeling well; I was sick for a week; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced dizziness, elevated b/p of 189/99, headache, sore left arm with difficulty moving her left hand, not feeling well and i was sick for a week. The patient underwent lab tests and procedures which included blood pressure increased: 189/99 on 17Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: dizziness; elevated B/P of 189/99; headache; sore left arm with difficulty moving her left hand; not feeling well; I was sick for a week; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced dizziness, elevated b/p of 189/99, headache, sore left arm with difficulty moving her left hand, not feeling well and i was sick for a week. The patient underwent lab tests and procedures which included blood pressure increased: 189/99 on 17Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Developed a small ball in the clavicle/ lymph node area; Pain in arm; Tired; Little bit of body pain; This is a spontaneous report received from a contactable consumer. A female patient of unspecified age (age was reported as aged 31) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration on 17Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed a small ball in the clavicle/ lymph node area, pain in arm, tired and little bit of body pain. Seriousness of the event was reported as non-serious. The outcome of event the swollen lymph node was not recovered and other events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Which resulted to an appearance of dimple where injection  site was. It was a white mark and faint white ring; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose of the Pfizer covid 19 vaccine last 11Apr2021, in the vaccination site she stated that they placed a band aid like round adhesive that had clear center and they injected needle through that. Which resulted to an appearance of dimple where injection site was. It was a white mark and faint white ring. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash which started Friday all over my arms, legs, chest, stomach and back.; This is a spontaneous report from contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 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 experienced a rash which started friday all over my arms, legs, chest, stomach and back on an unspecified date. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial discomfort, Headache
Clinical narrative: facial symptoms; Bell's Palsy.; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 25Mar2021 10:30 AM (Lot Number: ER8733) at the same age as single dose for COVID-19 immunisation. Medical history included Herpes (although no symptoms or outbreaks for 20+ years). Concomitant medications included estradiol (ESTROGEN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 04Mar2021 11.30am (Lot Number: EN6206) as single dose for COVID-19 immunisation. The patient experienced Bell's Palsy and first had headache on 12Apr2021, first facial symptoms appeared on 16Apr2021. The adverse event result in: Doctor or other healthcare professional office/clinic visit. Treatment was received for the events including Prednisone and anti-viral. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: she noticed that her 'under arm is tender and sore"; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 22Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she received her second vaccine dose on Thursday, 22Apr2021 and on 23Apr2021 (Friday) she noticed that her under arm is tender and sore. Stated that she does not see anything on her arm but there was a tender a sore area, not at the injection site. Reporter stated that she had read the most common side effects but asks if we have heard of someone having soreness and tenderness to the under arm that is tender to touch. The outcome of the event she noticed that her under arm is tender and sore was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm felt a little sore after the 1st dose; This is a spontaneous report from a Pfizer Sponsored Program consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient mentioned that her arm felt a little sore after the 1st dose. It was reported that Patient had her 1st shot of the Pfizer Covid-19 Vaccine on the 31st together with her son. Together with her son have an appointment for the 2nd dose today (21Apr2021) as stated on the vaccination card. They went to the vaccination site today. And in the site, here's an army boy who checks people on the list before getting the shot, but their name was not on the list to take the 2nd dose today. They ended up missing the 2nd dose today. The outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: her tremor got worse.; This is a spontaneous report from a contactable consumer (patient) and physician via medical information team. A 71-year-old female patient received second dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration on 21Mar2021 as a single dose for covid-19 immunization. The patients medical history included essential tremor from Jan2020 to Jan2020. Patient had brain surgery in Jan2020 to improve the tremor and did fine until she got the first dose of the Pfizer Covid 19 vaccine on 28Feb2021. Concomitant medications were not reported. The patient previously received first dose of  as a single dose on 28Feb2021 for COVID-19 immunization. Patient states a few days later her tremor got worse on an unknown date in 2021. Patients Neurologist said it was possible it was due to the vaccine and that it might happen again after the second dose. She received the second dose of the vaccine on 21Mar2021 and she states the tremor got worse again and has not gotten better. The Neurologist said it should go back to baseline but they didn't know how long it would take. Stated that the PI for the vaccine contains no information about tremor being reported as a side effect. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after the first dose; tested positive for Covid after the first dose; This is a spontaneous report received from a contactable Pharmacist. A male patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunisation. Medical history and concomitant medication were unknown. The caller stated they have a patient who received the first dose on 05Apr2021 and tested positive for Covid after the first dose. He quarantined for 14 days and was currently done with quarantine. He stated he was in for his second dose and he asked if they can still give the vaccine at the 3 weeks period. The caller declined the full recommendations/information in writing and stated he can go online and check these recommendations. The caller stated if the second dose of the vaccine can be given up to 4 days early or up to 6 weeks after the first dose. The caller asked whether that was okay if someone was due at 5 weeks and went beyond the 6 week window. Outcome of the event was unknown.     Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Illness, Myalgia, Nausea
Clinical narrative: having Covid all over again/it felt as if she had Covid twice; temperature of 101.6 degrees Fahrenheit; extreme muscle pain; chills; achiness; shaky; weak; nausea; soreness at the injection site; felt really sick; This is a spontaneous report from a contactable patient. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunizations. Medical history included covid-19 from an unknown date, and she had a bad case of Covid at the end of November. The patient's concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine on 22Apr2021. The patient reported that she had a very, very bad reaction to the vaccine in which she describes as having Covid all over again. She had a temperature of 101.6 degrees Fahrenheit, extreme muscle pain, chills, achiness, was shaky and weak, nausea, and soreness at the injection site. she could not get out of bed for 2 days and she felt really sick. The patient stated her symptoms were really bad and it felt as if she had Covid twice. she was afraid to get the second dose and decided that she was not receiving the second dose. Her kids and husband have had the vaccine and have not had many reactions. The patient stated the reaction after the second dose was worse than the first dose. she stated that she cannot handle another reaction like she did with the first injection. The outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Suspected COVID-19, Tremor, Vaccination site pain
Clinical narrative: having Covid all over again/it felt as if she had Covid twice; temperature of 101.6 degrees Fahrenheit; extreme muscle pain; chills; achiness; shaky; weak; nausea; soreness at the injection site; felt really sick; This is a spontaneous report from a contactable patient. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunizations. Medical history included covid-19 from an unknown date, and she had a bad case of Covid at the end of November. The patient's concomitant medications were not reported. The patient received the first dose of the Pfizer Covid-19 vaccine on 22Apr2021. The patient reported that she had a very, very bad reaction to the vaccine in which she describes as having Covid all over again. She had a temperature of 101.6 degrees Fahrenheit, extreme muscle pain, chills, achiness, was shaky and weak, nausea, and soreness at the injection site. she could not get out of bed for 2 days and she felt really sick. The patient stated her symptoms were really bad and it felt as if she had Covid twice. she was afraid to get the second dose and decided that she was not receiving the second dose. Her kids and husband have had the vaccine and have not had many reactions. The patient stated the reaction after the second dose was worse than the first dose. she stated that she cannot handle another reaction like she did with the first injection. The outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Suicidal ideation
Clinical narrative: suicidal thoughts; Depressed; anxiety; This is a spontaneous report from a contactable consumer reported for self. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:45 PM (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram received within 2 weeks of vaccination. Historical Vaccine included the first dose of BNT162B2 (lot number: EP7534) on 23Mar2021 02:30 PM in Right arm for COVID-19 Immunization. The patient experienced suicidal thoughts, depressed, anxiety on 16Apr2021, no treatment was received. Outcome of the events was not recovered.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Currently experiencing a slight headache.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Mar2021 for covid-19 immunisation. The patient currently experiencing a slight headache on an unspecified date with outcome of unknown. The patient wants to know if he can take pain relievers.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: CSF glucose increased, CSF glucose normal, CSF protein increased, Confusional state, Headache
Clinical narrative: generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown.  Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely 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.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown.  Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: A  female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on 23Apr2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications.  The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. She has been experiencing side effects after vaccination, which she described as "not that bad". Patient subsequently has not been feeling well. She specified she searched through our website and the CDC website for the list of potential side effects post vaccination. She explained she found info on nausea it was reported as 1.1%, she couldn't find info on the Pfizer-BioNTech COVID-19 vaccine's impact on the menstrual cycle. She added she knows that symptoms resolve a few days after vaccination, thus she explained she was hoping to feel better this morning 3 days post vaccination and but it wasn't the case. The clinical outcome of the event was unknown.  Follow up(26Apr2021): This is a Follow up spontaneous report from a Pfizer sponsored program COVAX US support. Patient reported patient information, suspect drug information added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: "ache" in the middle finger of her hand; she "doesn't feel much" as if her arm is numb; she cannot do much with that arm, her hand is also "stiff"; hurting ang burning when she moves her arm; swollen gland/lymph between her shoulder and neck, near the bone; she feels the "pressure" in that arm; "ache and a bruise" where the vaccine was injected; "ache and a bruise" where the vaccine was injected; This is a spontaneous report from a contactable consumer (reported herself). A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 20Apr2021 as SINGLE DOSE for covid-19 immunization. Historical vaccine included first dose of BNT162B2. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated after receiving second dose on left arm patient had "ache and a bruise" where the vaccine was injected, "but it was gone the next day". On 21Apr2021, patient had experienced "swollen gland/lymph between her shoulder and neck, near the bone" on the same side she received the injection, plus it is "hurting ang burning" when she moves her arm. She specified her left arm "is hurting" all the way to her "shoulder" and the pain extends to "the back of that shoulder". She said she feels the "pressure" in that arm but when she "pinches it", she "doesn't feel much" as if her arm "is numb". She mentioned she cannot do much with that arm, her hand is also "stiff", and she has difficulty using it. She added yesterday, she started to have "ache" in the middle finger of her hand. She asked if her symptoms were reported as side effects to the vaccine. The outcome of the events were unknown.   No follow-up attempts were needed; Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: "ache" in the middle finger of her hand; she "doesn't feel much" as if her arm is numb; she cannot do much with that arm, her hand is also "stiff"; hurting ang burning when she moves her arm; swollen gland/lymph between her shoulder and neck, near the bone; she feels the "pressure" in that arm; "ache and a bruise" where the vaccine was injected; "ache and a bruise" where the vaccine was injected; This is a spontaneous report from a contactable consumer (reported herself). A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 20Apr2021 as SINGLE DOSE for covid-19 immunization. Historical vaccine included first dose of BNT162B2. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated after receiving second dose on left arm patient had "ache and a bruise" where the vaccine was injected, "but it was gone the next day". On 21Apr2021, patient had experienced "swollen gland/lymph between her shoulder and neck, near the bone" on the same side she received the injection, plus it is "hurting ang burning" when she moves her arm. She specified her left arm "is hurting" all the way to her "shoulder" and the pain extends to "the back of that shoulder". She said she feels the "pressure" in that arm but when she "pinches it", she "doesn't feel much" as if her arm "is numb". She mentioned she cannot do much with that arm, her hand is also "stiff", and she has difficulty using it. She added yesterday, she started to have "ache" in the middle finger of her hand. She asked if her symptoms were reported as side effects to the vaccine. The outcome of the events were unknown.   No follow-up attempts were needed; Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush
Clinical narrative: dizziness; hot flashes; This is a spontaneous report from contactable nurse reported for herself. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 06Apr2021 16:30 as 1st dose, single for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) were none. Medical history included breast cancer (2 Time Breast Cancer Survivor). Family Medical History included her brother is a prostate cancer survivor and it came back twice, her sister is a breast cancer survivor, and her mother is breast cancer survivor. Concomitant medications included fulvestrant (FASLODEX) (H2 receptor blocker) on 23Mar2021. Historical vaccine included hepatitis vaccine she had 10 years ago for immunisation, she did not seroconvert. She just retested 4 months ago, and she never got any antibodies from the vaccine. She did it twice at different intervals. The patient experienced dizziness (medically significant) on 09Apr2021, hot flashes (medically significant) on 09Apr2021. The event clinical course was as follows: Sometimes at night she was like a heater. States she didn't have hot flashes before the vaccine, she hasn't had them in 20 years. No treatment was received, she just deals with it. The patient started as short waves of dizziness lasting 1-2 minutes. There was no AEs required a visit to emergency room or physician office. The patient was due to get her vaccine but was not sure if there were side effects when taking fulvestrant and the vaccine together. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event hot flashes and dizziness cannot be completely 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: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Muscle twitches; This is a spontaneous report from a contactable consumer (Patient) and received from a Pfizer sponsored. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (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 experienced muscle twitches on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: pain in the left area of my chest; had a fast heartrate; I had muscle pain; I had muscle pain, headaches, chills, fever and fatigue.; I had muscle pain, headaches, chills, fever and fatigue.; I had muscle pain, headaches, chills, fever and fatigue.; I had muscle pain, headaches, chills, fever and fatigue.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient reported that she got her first dose yesterday and while in the waiting room she had a pain in the left area of her chest that came and went throughout the day. She had a fast heartrate, and It was now gone. The patient asked was this a side effect. The pain in the chest was like a sharp pain and then it disappeared and come back. She also had muscle pain, headaches, chills, fever, and fatigue. The patient should be concerned when she get her second vaccine. Outcome of the event had a fast heartrate was recovered on an unknown date and for all other events, it was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: pain in the left area of my chest; had a fast heartrate; I had muscle pain; I had muscle pain, headaches, chills, fever and fatigue.; I had muscle pain, headaches, chills, fever and fatigue.; I had muscle pain, headaches, chills, fever and fatigue.; I had muscle pain, headaches, chills, fever and fatigue.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient reported that she got her first dose yesterday and while in the waiting room she had a pain in the left area of her chest that came and went throughout the day. She had a fast heartrate, and It was now gone. The patient asked was this a side effect. The pain in the chest was like a sharp pain and then it disappeared and come back. She also had muscle pain, headaches, chills, fever, and fatigue. The patient should be concerned when she get her second vaccine. Outcome of the event had a fast heartrate was recovered on an unknown date and for all other events, it was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills; Headache; Body ache and pain; This is a spontaneous report from contactable consumer (patient) via medical information team. A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 20Dec2020 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced chills, headache, body ache and pain after receiving the Pfizer COVID-19 vaccine. Patient stated that she did not want to miss work. It was reported that the side effects she had are commonly reported with the vaccine. The outcome of the events were unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: has experienced her wrist hurting; sharp pains in the palm of her hands. It's also hard to move her hand.; I had the arm with the bad pain and that only lasted 1 day, but this showed up out of 2 weeks after the vaccine. It is hard to blow dry my hair."; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received single dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 IMMUNISATION. The patient medical history and concomitant medications was not reportedIt was reported that she received the Pfizer COVID vaccine 8 days before Easter and had experienced her wrist hurting and sharp pains in the palm of her hands. It's also hard to move her hand. She asked Is this normal from the vaccine, and hard to blow dry my hair, Caller is wondering should she take the second dose and Caller is afraid of second dose if she don't get the second dose, she thought it would be dangerous with side effects. On an unspecified date, the patient had experienced her wrist hurting, sharp pains in the palm of her hands. it's also hard to move her hand and had the arm with the bad pain and that only lasted 1 day, but this showed up out of 2 weeks after the vaccine. it is hard to blow dry my hair. The outcome of the events Arthralgia and pain in extremity was unknown and other event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained