chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe headache; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable female consumer (patient herself) non pregnant of Age 71 (units: unknown) received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number/Expiration date: unknown) via an unspecified route of administration on 27Jan2021 04:00PM in left arm and first dose (Lot number: unknown) on 06Jan2021 04:00 PM in left arm both as single dose for COVID-19 immunisation. Patient was not having any known allergies. Patient was not on other vaccine within four weeks of vaccination. Medications within two weeks included Vascepa, Valacyclovir, Amlodipine, Levothyroxine, sta. Patient had covid prior to vaccination and had tested for covid post vaccination. On 27Jan2021 04:00 pm, Patient experienced Severe headache, nausea, vomiting, diarrhea. Therapeutic measures were taken which included Ondansetron, Ibuprofen. On 08Feb2021, patient underwent lab tests post vaccination which included Nasal Swab PCR test which results negative. Outcome of the event was recovering on an unspecified date.  Information about Lot/batch has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: felt like a mad truck had hit her/she feels horrible; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9267, Expiration date: unknown) via an unspecified route of administration on 15Feb2021 at single dose for COVID-19 Immunization. Patient medical history included Covid in last October. Concomitant medication was not reported. Patient stated that she already spoke to a Nurse about the side effects she experienced before she was transferred . The patient reported that she received first dose of the vaccine yesterday and at first, she felt fine but on 16Feb2021 when she woke up, she felt like a mad truck had hit her. The patient also had low-grade fever; it was very unusual for her as she usually an energetic person. Patient took lowest dose of Tylenol for events and was not sure whether it was ok to take any medications with the vaccine since she saw some add on TV about the side effects. The patient added that she was expected to experience these side effects after taking her second dose of the vaccine not after first dose. Also wanted to know if the side effects she experienced right now could possibly be related with her having Covid last October. Patient also reported that she disappointed with the information provided to her, as she expected little bit more help. The patient wanted to have information on the effects of the vaccine on people who previously had Covid. Patient confirms saw the Pfizer COVID 19 vaccine. She also saw the batch number EL9267. She does not see and expiration date or NDC number. Patient went to bed after her vaccination and she felt fine, life was normal but when she woke up this morning, she felt horrible. The product complaint was reported. The outcome for the events was unknown.  Upon follow-up on 16Feb2021: This is a follow-up spontaneous report from a contactable consumer included Patient age, weight, height, lot number of suspect products, events with onset date.    No follow-up attempts possible. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: felt like a mad truck had hit her/she feels horrible; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9267, Expiration date: unknown) via an unspecified route of administration on 15Feb2021 at single dose for COVID-19 Immunization. Patient medical history included Covid in last October. Concomitant medication was not reported. Patient stated that she already spoke to a Nurse about the side effects she experienced before she was transferred . The patient reported that she received first dose of the vaccine yesterday and at first, she felt fine but on 16Feb2021 when she woke up, she felt like a mad truck had hit her. The patient also had low-grade fever; it was very unusual for her as she usually an energetic person. Patient took lowest dose of Tylenol for events and was not sure whether it was ok to take any medications with the vaccine since she saw some add on TV about the side effects. The patient added that she was expected to experience these side effects after taking her second dose of the vaccine not after first dose. Also wanted to know if the side effects she experienced right now could possibly be related with her having Covid last October. Patient also reported that she disappointed with the information provided to her, as she expected little bit more help. The patient wanted to have information on the effects of the vaccine on people who previously had Covid. Patient confirms saw the Pfizer COVID 19 vaccine. She also saw the batch number EL9267. She does not see and expiration date or NDC number. Patient went to bed after her vaccination and she felt fine, life was normal but when she woke up this morning, she felt horrible. The product complaint was reported. The outcome for the events was unknown.  Upon follow-up on 16Feb2021: This is a follow-up spontaneous report from a contactable consumer included Patient age, weight, height, lot number of suspect products, events with onset date.    No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: Two days after second Covid vaccine patient began to see dry and cracking hands and feet.  Two to three days after this, patient noticed skin began to peel, crack (fissure), bleed, and become extremely painful. Patient was given multiple topical creams to try. Patient was given oral prednisone to try. Patient was given IM kenalog.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Chest X-ray, Dry skin, Skin exfoliation
Clinical narrative: Two days after second Covid vaccine patient began to see dry and cracking hands and feet.  Two to three days after this, patient noticed skin began to peel, crack (fissure), bleed, and become extremely painful. Patient was given multiple topical creams to try. Patient was given oral prednisone to try. Patient was given IM kenalog.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin fissures
Clinical narrative: Two days after second Covid vaccine patient began to see dry and cracking hands and feet.  Two to three days after this, patient noticed skin began to peel, crack (fissure), bleed, and become extremely painful. Patient was given multiple topical creams to try. Patient was given oral prednisone to try. Patient was given IM kenalog.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Eczema, Haemorrhage, Hypersensitivity, Onycholysis
Clinical narrative: Two days after second Covid vaccine patient began to see dry and cracking hands and feet.  Two to three days after this, patient noticed skin began to peel, crack (fissure), bleed, and become extremely painful. Patient was given multiple topical creams to try. Patient was given oral prednisone to try. Patient was given IM kenalog.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Skin exfoliation
Clinical narrative: Two days after second Covid vaccine patient began to see dry and cracking hands and feet.  Two to three days after this, patient noticed skin began to peel, crack (fissure), bleed, and become extremely painful. Patient was given multiple topical creams to try. Patient was given oral prednisone to try. Patient was given IM kenalog.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbness and weakness around my mouth and my left cheek area; numbness and weakness around my mouth and my left cheek area; sore arm; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 45-year-old female patient (not pregnant, age at vaccination: 45-year-old) received bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 vaccine, lot EN6205), via an unspecified route of administration in right arm on 05Mar2021 12:00 as SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and weakness around his mouth and left cheek area (no treatment) on 06Mar2021 06:00. She also had sore arm on 05Mar2021. The outcome of facial numbness was recovered; for other events was unknown.  No follow up attempts needed. Lot number obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paresis, Hypoaesthesia, Pain in extremity
Clinical narrative: numbness and weakness around my mouth and my left cheek area; numbness and weakness around my mouth and my left cheek area; sore arm; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 45-year-old female patient (not pregnant, age at vaccination: 45-year-old) received bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 vaccine, lot EN6205), via an unspecified route of administration in right arm on 05Mar2021 12:00 as SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and weakness around his mouth and left cheek area (no treatment) on 06Mar2021 06:00. She also had sore arm on 05Mar2021. The outcome of facial numbness was recovered; for other events was unknown.  No follow up attempts needed. Lot number obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Hypoaesthesia oral, Pain in extremity
Clinical narrative: numbness and weakness around my mouth and my left cheek area; numbness and weakness around my mouth and my left cheek area; sore arm; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 45-year-old female patient (not pregnant, age at vaccination: 45-year-old) received bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 vaccine, lot EN6205), via an unspecified route of administration in right arm on 05Mar2021 12:00 as SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and weakness around his mouth and left cheek area (no treatment) on 06Mar2021 06:00. She also had sore arm on 05Mar2021. The outcome of facial numbness was recovered; for other events was unknown.  No follow up attempts needed. Lot number obtained.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in systemic hives all over boy; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported) via an unspecified route of administration at arm left on 06Mar2021 as single dose for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included rash developed  when get a TB test, drug hypersensitivity, urinary tract infection and antibiotic for UTI, hypersensitivity. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for contraception and antibiotics. on 10Mar2021 07:00,the patient experienced broke out in systemic hives all over boy . Therapeutic measures were taken as a result of broke out in systemic hives all over boy was Prednisone. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Death, Malaise, Respiratory arrest, Seizure
Clinical narrative: Sudden death. His father was holding him during a seizure. When it was over, patient relaxed, exhaled, and stopped breathing.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling of relaxation, Respiratory arrest, Seizure, Sudden death
Clinical narrative: Sudden death. His father was holding him during a seizure. When it was over, patient relaxed, exhaled, and stopped breathing.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Adrenal haemorrhage, Adrenal mass, Asthenia, Cerebral haemorrhage
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal, Headache, Mental status changes, Nausea
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Renal haemorrhage, Retching, Subarachnoid haemorrhage
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain herniation, Brain oedema, Computerised tomogram abdomen, Computerised tomogram head abnormal, Computerised tomogram thorax
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Fibrin D dimer increased, Haemorrhage intracranial, Mental status changes, Neurosurgery
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Adrenal haemorrhage, Brain injury, Cerebral haemorrhage, Computerised tomogram abdomen abnormal
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Death, Deep vein thrombosis, Dependence on respirator, Diarrhoea
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Life support, Malaise, Platelet count decreased, Pulmonary embolism
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Surgery, Thrombosis, Unresponsive to stimuli, Vomiting
Clinical narrative: My sister, received the J & J vaccine on March 5th.  I now know that she was not feeling well for a few days afterwards.  She then felt better until day nine after the vaccine.  On the evening of the ninth day,  she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening.  Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning.  Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands.  She was given platelets, pain meds and admitted into the hospital.  Later that night staff felt she wasn?t responsive and a head CT was performed.  It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point.  During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a  DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes.  On the morning of the 13th day patient was removed from life support and she passed.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Vision blurred
Clinical narrative: blurred/double vision; blurred/double vision; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 16Mar2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin (reported as "pennacillin") allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took procaine (NOVOCAINE) and experienced allergies. Approximately 28 hours after vaccination, on 17Mar2021 at 12:00, the patient developed blurred/double vision. There was no treatment received for the events. The outcome of the events was not recovered.   No follow up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Nervousness, Oropharyngeal discomfort
Clinical narrative: Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off.  Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off.  Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Paraesthesia, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off.  Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat clearing
Clinical narrative: Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off.  Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Chest discomfort, Dyspnoea, Hypoaesthesia, Paraesthesia
Clinical narrative: Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off.  Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal disorder, Throat clearing
Clinical narrative: Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off.  Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Pt states had "severe kidney pain" that extended into lower back resulting in a trip to the doctor's office. He was using a heating pack/icyhot patch for pain and took ibuprofen. He also drank plenty of fluids to help with the pain. He stated the pain lasted for about a week at severe pain level. The doctor still advised him to get the second shot and continue to drink more fluids and use the icyhot patches as needed.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal pain
Clinical narrative: Pt states had "severe kidney pain" that extended into lower back resulting in a trip to the doctor's office. He was using a heating pack/icyhot patch for pain and took ibuprofen. He also drank plenty of fluids to help with the pain. He stated the pain lasted for about a week at severe pain level. The doctor still advised him to get the second shot and continue to drink more fluids and use the icyhot patches as needed.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Renal pain
Clinical narrative: Pt states had "severe kidney pain" that extended into lower back resulting in a trip to the doctor's office. He was using a heating pack/icyhot patch for pain and took ibuprofen. He also drank plenty of fluids to help with the pain. He stated the pain lasted for about a week at severe pain level. The doctor still advised him to get the second shot and continue to drink more fluids and use the icyhot patches as needed.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia oral, Rash
Clinical narrative: 59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About 10 minutes later, she c/o lips and nose numbness. Several minutes later she c/o hands itching followed by soft palate itching, followed by face( B/L maxillary region)- itching/numb. At this point she had been with us for 30 mins so we gave Benadryl IN 50mg. She told us that she had chest tightness and racing heart with her lips/nose became numb. She maintained no SOB or DIB. BP 142/92 HR 80. One hour later she again c/o chest tightness and left side of tongue burning. Other symptoms had resolved. EMS called. EMS checked BP 124/82. EKG NSR and O2 sat 100%. She was taken to Hopsital. She was in no apparent distress.