chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Loss of consciousness, Paraesthesia oral, Tremor
Clinical narrative: Passed out because her sugar went down 1.30 and blood pressure went down; Shaking; Started having twinkle tongue, tongue started getting heavy; A spontaneous report was received from a consumer, a 74-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced started having twinkle tongue, tongue started getting heavy/ paresthesia oral, passed out because her sugar went down 1.30 and blood pressure went down/ loss of consciousness and shaking/tremor.  The patient's medical history included was asthma from an unknown date. Products known to have been used by the patient, within two weeks prior to the event, included "advitrol inhaler" as an indication for asthma from an unknown date, levocetirizine dihydrochloride, "blood pressure pills" and "asthma medication" from an unknown date.  On 18 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) and expiration date 03 Jul 2021 intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 18 Jan 2021, approximately fifteen minutes after the vaccine, the patient started having twinkle tongue, tongue started getting heavy when she was on her way home. The patient had asthma so she took her medication and was okay. One week later on an unknown date, the patient passed out because her sugar went down 1.30 and blood pressure went down and was shaking which lasted for ten seconds. The patient mentioned something like that never happened before. The patient also mentioned she was having asthma issues so was waiting to see her allergies Doctor and was tested for covid-19 on an unknown date but had no result yet. Treatment information was not provided.  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, started having twinkle tongue, tongue started getting heavy was considered as recovered on 18 Jan 2021. The outcome of events, passed out because her sugar went down 1.30 and blood pressure went down and shaking were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The patient reports that she passed out because her sugar went down and blood pressure went down. Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; A spontaneous report was received from a physician concerning a 54 year old female patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 03Feb2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On 04Feb2021, the patient experienced waking with Bell's Palsy.  No treatment was reported.  Action taken with the mRNA-1273 in response tot he event was not reported.  The outcome of the event, facial paralysis, was unknown.; Reporter's Comments: This report concerns a 54-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273). (Lot # not reported) and experienced Bell's palsy. Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Eye haemorrhage, Vascular occlusion
Clinical narrative: Occlusion on right eye; Can't see out of his right eye; hemorrhage in right eye; Case reference number MOD-2021-012734 is a spontaneous case report sent by a Non-Healthcare Professional on 09-FEB-2021, which refers to a male patient who received the first dose of Moderna's COVID-19 Vaccine (mRNA-1273) and experienced occlusion of the right eye and blindness in the right eye which required hospitalization and the event of hemorrhage in the right eye.   The patient's medical history included a shunt installation for hydrocephalus.   The patient's medication history included amoxicillin, omeprazole, potassium citrate, sertraline hydrochloride, tamsulosin, amoxicillin trihydrate, benzydamine hydrochloride, bromhexine hydrochloride, trospium and unspecified sinus medications.   On 15JAN2021, the patient received the first dose of Moderna COVID-19 (mRNA-1273) Vaccine (Lot: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17JAN2021, the patient's wife reported that the patient couldn't see out of his right eye. He went to the emergency room and his ophthalmologist reported that the patient had an occlusion on the right eye which was not a result of the vaccine.   On 19JAN2021, the patient left the hospital. Later that same week, the patient visited another ophthalmologist that observed a hemorrhage on his right eye with an unknown etiology.   On 04FEB2021, the patient went to the dentist where multiple infections and molars were identified. Treatment included amoxicillin 875mg for 10 days.   Action taken for the events of occlusion of the right eye, blindness in the right eye and hemorrhage in the right eye associated with mRNA-1273 was not reported.   The outcome of the events was unknown.; Reporter's Comments: This case concerns a 73-year-old male patient, who experienced a serious unexpected events of vascular occlusion, blindness, and eye hemorrhage, after receiving first dose of mRNA-1273 (lot # 041L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Several drops of vaccine squirted out of the arm; Several drops of vaccine squirted out of the arm; A spontaneous report was received from a consumer concerning a 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when given the vaccine, several drops of the vaccine squirted out of the arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) on 10-FEB-2021.  On 10-FEB-2021, the patient received the second dose of Moderna vaccine. Consumer reported that when given the vaccine, several drops of vaccine squirted out of the arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The event outcome was considered resolved on 10-FEB-2021.; Reporter's Comments: This report refers to a case of Vaccine Underdose and exposure via skin contact for mRNA-1273, lot #030L20A with no associated Adverse event.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Occupational exposure to product, Urticaria
Clinical narrative: and the nurse ended up sticking herself; Hives; A spontaneous report was received from a nurse concerning a 49 year old, female patient who received 2 doses of the vaccine in a fairly quick succession and experienced hives.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 09-FEB-2021, at approximately 9:29AM for prophylaxis of COVID-19 infection.    A nurse from the Health Department stated that a patient called her complaining about receiving two doses of the Moderna Covid-19 vaccine too close together. The patient stated that the nurse who administered the vaccine to her stuck her, the patient felt a sting and jumped, and the nurse ended up sticking herself. The syringe was immediately discarded into the sharps container and the patient was given another dose of the vaccine. The patient was asked to wait for 10 minutes and as she was leaving, she noticed hives. But the next day when she called the nurse at the health department, she was better. Patient (PJ) is a 49-year-old female. Patient received the vaccine at her workplace RHA health.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, person who received 2 doses of the vaccine in a fairly quick succession, was considered recovered/resolved on 10-FEB-2021. The outcome of the event hives was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; A spontaneous report was received from a consumer concerning a 77-year old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient passed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273. Batch number not provided on an unknown date.   On 09 Feb 2021,  prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273: LOT 041L20A. intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 10 Feb 2021, She got up this morning and passed out while standing at the kitchen island for 2-3 minutes. She wants to know if she should be checked out.   Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head injury, Influenza like illness, Joint swelling, Pain
Clinical narrative: swelling to head; swelling to left back knee; swelling to left hip; swelling to left foot; hit  head; bump on back of the head; fainted; sleepiness; left arm pain; acute body aches; fatigue; flu like symptoms; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip.  The patient's medical history was not provided. Concomitant medications included warfarin (5mg, 7.5mg).   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the right arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient experienced flu like symptoms which lasted 8 hours. On 02 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient reported experiencing acute body aches, sleepiness, fatigue, and left arm pain.  On 03 Feb 2021, approximately at 3am, the patient fainted and was out for 10-15 mins. She is on blood thinner and is concerned about a cerebral bleed because she hit her head.   On an unspecified date, the patient was experiencing swelling of left back knee, swelling of left foot, swelling of left hip and swelling of head. Treatment included paracetamol and ondansetron.  Action taken with mRNA-1273 was not applicable as the subject had already received both scheduled doses.  The events flu like symptom was resolved on 05 Feb 2021.    The outcome for the events, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip were unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported event of swelling of the head and mRNA-1273 use ids assessed as not related as swelling was due to subject hitting her head. Based on temporal association between the other reported events and mRNA-1273 use, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Somnolence, Swelling, Syncope
Clinical narrative: swelling to head; swelling to left back knee; swelling to left hip; swelling to left foot; hit  head; bump on back of the head; fainted; sleepiness; left arm pain; acute body aches; fatigue; flu like symptoms; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu like symptoms, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip.  The patient's medical history was not provided. Concomitant medications included warfarin (5mg, 7.5mg).   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) in the right arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient experienced flu like symptoms which lasted 8 hours. On 02 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient reported experiencing acute body aches, sleepiness, fatigue, and left arm pain.  On 03 Feb 2021, approximately at 3am, the patient fainted and was out for 10-15 mins. She is on blood thinner and is concerned about a cerebral bleed because she hit her head.   On an unspecified date, the patient was experiencing swelling of left back knee, swelling of left foot, swelling of left hip and swelling of head. Treatment included paracetamol and ondansetron.  Action taken with mRNA-1273 was not applicable as the subject had already received both scheduled doses.  The events flu like symptom was resolved on 05 Feb 2021.    The outcome for the events, acute body aches, sleepiness, fatigue, left arm pain, fainted, on blood thinner and worried about a cerebral bleed because she hit her head, bump on the back of the head, swelling to head, swelling to left back knee, swelling to left foot, and swelling to left hip were unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported event of swelling of the head and mRNA-1273 use ids assessed as not related as swelling was due to subject hitting her head. Based on temporal association between the other reported events and mRNA-1273 use, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Anosognosia, Body temperature, Dysstasia, Feeling abnormal, Hallucination
Clinical narrative: Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch.   The patient's medical history was not provided. No concomitant medications were reported.  On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch.  Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Urinary incontinence
Clinical narrative: Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch.   The patient's medical history was not provided. No concomitant medications were reported.  On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch.  Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: erectile dysfunction; A spontaneous report was received from a consumer reporting on himself, a male of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erectile dysfunction.  The patient's medical history was not provided. Concomitant medication use was not provided.   On 13Jan 2021, the patient received an unknown dose number of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced erectile dysfunction.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the erectile dysfunction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Chest pain, Dizziness
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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, COVID19
Symptoms: Dysarthria, Dysstasia, Gait inability, Limb discomfort, Neck pain
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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, COVID19
Symptoms: Peripheral coldness, SARS-CoV-2 test
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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, COVID19
Symptoms: Aphasia, Balance disorder, Blood test normal, Chest pain, Computerised tomogram normal
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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, COVID19
Symptoms: Discomfort, Dizziness, Dysarthria, Dyspnoea, Eyelid function disorder
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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, COVID19
Symptoms: Feeling abnormal, Impaired driving ability, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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, COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: inability to stand or walk; slurred speech; inability to stand or walk; left sided pain in chest; left sided pain in chest, neck & scapular area; left sided pain in chest, neck & scapular area; elevated BP; lightheadedness; left hand started become cold & felt heavy; left hand started become cold & felt heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 48-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown), intramuscular (arm left) on 06Jan2021 17:45 (05:45 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included endometriosis from an unknown date. The patient's concomitant medications were not reported. The patient did not take other vaccines in four weeks and no other medications were taken in two weeks. Patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination (Unknown results in 2021). On 07Jan2021 11:30 (also reported as less than 24 hours post vaccination), the patient experienced left hand started becoming cold and felt heavy. On 08Jan2021 12:00 (reported as around noon), the patient experienced inability to stand or walk, elevated BP, slurred speech, lightheadedness; and left sided pain in chest, neck and scapular area. The patient was taken to urgent care and emergency room due to events left sided pain in chest, neck and scapular area, inability to stand or walk, elevated BP, slurred speech and lightheadedness. BP came to baseline by 1am (unspecified date in 2021). Treatment was given for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Dysstasia, Dysarthria, and Gait inability cannot be excluded.  The case will be reassessed if additional information becomes available.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure measurement, Chest pain, Chills
Clinical narrative: tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship.  The case will be reassessed should additional information become available.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Headache, Heart rate
Clinical narrative: tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship.  The case will be reassessed should additional information become available.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Hypertension, Nausea, Pain, Tachycardia
Clinical narrative: tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship.  The case will be reassessed should additional information become available.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship.  The case will be reassessed should additional information become available.  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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body height, Chest pain, Hypersomnia, Investigation
Clinical narrative: did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain;  chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events.  A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.