chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood lactic acid normal, Blood potassium decreased, C-reactive protein normal, Chest discomfort
Clinical narrative: Patient had Moderna COVID-19 vaccine about 10 minutes prior to reaction and began having coughing and itchiness to her throat, difficulty breathing, chest tightness, the constant sensation to cough, and rash to trunk and upper extremities. ED physician ordered NS 1000 mL IV x1, albuterol HFA, diphenhydramine 50 mg IV x1, epinephrine 0.3 mg IM x1, famotidine 20 mg IV x1, guaifenesin-codeine 200/20 mg, and methylprednisolone 125 mg IV x1 while in ED.  Potassium chloride 20 mEq PO x1 also given to correct incidental hypokalemia. Pt improved, rash resolved, coughing resolved, lung sounds clear, O2Sat normal, and HR improved prior to discharge from SCH ED.  Patient given scripts for diphenhydramine, Epipen, and prednisone. Moderna COVID-19 vaccine was added to patient allergies in medical chart.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Feeling abnormal, Full blood count normal, Glomerular filtration rate normal
Clinical narrative: Patient had Moderna COVID-19 vaccine about 10 minutes prior to reaction and began having coughing and itchiness to her throat, difficulty breathing, chest tightness, the constant sensation to cough, and rash to trunk and upper extremities. ED physician ordered NS 1000 mL IV x1, albuterol HFA, diphenhydramine 50 mg IV x1, epinephrine 0.3 mg IM x1, famotidine 20 mg IV x1, guaifenesin-codeine 200/20 mg, and methylprednisolone 125 mg IV x1 while in ED.  Potassium chloride 20 mEq PO x1 also given to correct incidental hypokalemia. Pt improved, rash resolved, coughing resolved, lung sounds clear, O2Sat normal, and HR improved prior to discharge from SCH ED.  Patient given scripts for diphenhydramine, Epipen, and prednisone. Moderna COVID-19 vaccine was added to patient allergies in medical chart.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemia, Rash, Throat irritation
Clinical narrative: Patient had Moderna COVID-19 vaccine about 10 minutes prior to reaction and began having coughing and itchiness to her throat, difficulty breathing, chest tightness, the constant sensation to cough, and rash to trunk and upper extremities. ED physician ordered NS 1000 mL IV x1, albuterol HFA, diphenhydramine 50 mg IV x1, epinephrine 0.3 mg IM x1, famotidine 20 mg IV x1, guaifenesin-codeine 200/20 mg, and methylprednisolone 125 mg IV x1 while in ED.  Potassium chloride 20 mEq PO x1 also given to correct incidental hypokalemia. Pt improved, rash resolved, coughing resolved, lung sounds clear, O2Sat normal, and HR improved prior to discharge from SCH ED.  Patient given scripts for diphenhydramine, Epipen, and prednisone. Moderna COVID-19 vaccine was added to patient allergies in medical chart.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: on 1/2 to 1/4 experienced extreme fatigue on 1/4 developed chills and fever of 102 which lasted 2 days along with body aches and headache  last day of fever was 1/5 returned to work on 1/7. was feeling fine then on 1/9 at night started with chills, fever of 102 extreme weakness, tiredness, headache dizziness,  on 1/10 continued with chills and fever, tiredness, weakness, and dizziness vomited x1.  had loss of appetite but was able to keep fluids down fever continued until the evening of 1/11 which was 101.8 but was unable to keep fluids down but only vomited x 2.   I remained NPO for 2 hrs and then was able to tolerate small sips of fluids  on 1/12 no fever in am was able  to tolerate plain toast and fluids  appetite returning later that night and was able to tolerate soup had no fever since 1/11 Monday evening and was able to return to work on 1/13. I was unable to work on 1/11 and 1/12
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid intake reduced, Headache, Impaired work ability, Pain, Pyrexia
Clinical narrative: on 1/2 to 1/4 experienced extreme fatigue on 1/4 developed chills and fever of 102 which lasted 2 days along with body aches and headache  last day of fever was 1/5 returned to work on 1/7. was feeling fine then on 1/9 at night started with chills, fever of 102 extreme weakness, tiredness, headache dizziness,  on 1/10 continued with chills and fever, tiredness, weakness, and dizziness vomited x1.  had loss of appetite but was able to keep fluids down fever continued until the evening of 1/11 which was 101.8 but was unable to keep fluids down but only vomited x 2.   I remained NPO for 2 hrs and then was able to tolerate small sips of fluids  on 1/12 no fever in am was able  to tolerate plain toast and fluids  appetite returning later that night and was able to tolerate soup had no fever since 1/11 Monday evening and was able to return to work on 1/13. I was unable to work on 1/11 and 1/12
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: on 1/2 to 1/4 experienced extreme fatigue on 1/4 developed chills and fever of 102 which lasted 2 days along with body aches and headache  last day of fever was 1/5 returned to work on 1/7. was feeling fine then on 1/9 at night started with chills, fever of 102 extreme weakness, tiredness, headache dizziness,  on 1/10 continued with chills and fever, tiredness, weakness, and dizziness vomited x1.  had loss of appetite but was able to keep fluids down fever continued until the evening of 1/11 which was 101.8 but was unable to keep fluids down but only vomited x 2.   I remained NPO for 2 hrs and then was able to tolerate small sips of fluids  on 1/12 no fever in am was able  to tolerate plain toast and fluids  appetite returning later that night and was able to tolerate soup had no fever since 1/11 Monday evening and was able to return to work on 1/13. I was unable to work on 1/11 and 1/12
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Allergies: Swelling; This spontaneous report was received from an other health professional and refers to a currently 58-year-old female patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included mycophenolate mofetil (CELLCEPT), albuterol sulfate, albuterol, alprazolam (XANAX), betamethasone valerate (DEL-BETA), budesonide (+) formoterol fumarate(SYMBICORT), cetirizine hydrochloride (ZYRTEC), cholecalciferol (VIT D3), doxepin hydrochloride (SINEQUAN), filgrastim (NIVESTYM), omeprazole (PRILOSEC), ondansetron hydrochloride (ZOFRAN), thyroid (ARMOUR THYROID), tramadol hydrochloride (ULTRAM), valsartan (DIOVAN), folic acid (FOLVITE), hydroxychloroquine sulfate (PLAQUENIL), levofloxacin (LEVAQUIN), losartan potassium (COZAAR), megestrol acetate (MEGACE), metformin hydrochloride (GLUCOPHAGE), mometasone furoate (NASONEX) and montelukast sodium (SINGULAIR).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced allergies: swelling.  The outcome of the event was unknown.   The relatedness between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) ant the event was not provided.
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: he received 1 dose of regular hepatitis B on unknown date and two doses of combination of hepatitis B and HIB in 2008.; he received 1 dose of regular hepatitis B on unknown date and two doses of combination of hepatitis B and HIB in 2008.; No AE; This spontaneous report was received from a nurse refers to a male patient of unknown age. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that he received 1 dose of regular hepatitis B  vaccine, on unknown date, and two doses of combination of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) in 2008 (interchange of vaccine products and inappropriate schedule of product administration). The reporter referred that she was trying to figure the name of the vaccine to determine if he needed another dose due to state records indicating patient needing a fourth dose of hepatitis B.  No adverse event was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: day 1 ?..12 hours following vaccination. chills. within 30 minuteslater, vomiting. The vomiting continued for 6 hours until I took Pepto Bismol. Fatigue followed with aches and pains from vomiting all night. Day 2....Slept the entire day was dehydrated and drank Pedi light no appetite had I slice of bread. Day 3 began to feel better with mild diarrhea, still experiencing aches and pains in chest and ribs from the results of the horrific vomiting. Day 4.. Feeling better than day 3 with still mild diarrhea and less aches and pains. could actually cough without feeling my lungs may implode. day 5 back to work still mild gastrointestinal issues. definitely on the mend
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Musculoskeletal chest pain, Pain, Vomiting
Clinical narrative: day 1 ?..12 hours following vaccination. chills. within 30 minuteslater, vomiting. The vomiting continued for 6 hours until I took Pepto Bismol. Fatigue followed with aches and pains from vomiting all night. Day 2....Slept the entire day was dehydrated and drank Pedi light no appetite had I slice of bread. Day 3 began to feel better with mild diarrhea, still experiencing aches and pains in chest and ribs from the results of the horrific vomiting. Day 4.. Feeling better than day 3 with still mild diarrhea and less aches and pains. could actually cough without feeling my lungs may implode. day 5 back to work still mild gastrointestinal issues. definitely on the mend
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No other AE or PQC identified. No other information available.; Caller reports administration of expired dose of GARDASIL 9; This spontaneous report was received from a 24-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 05-JAN-2021, the patient was vaccinated with expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot# R009614 was confirmed to be valid, expiration date 30-NOV-2020 (route and site of administration were not provided) for prophylaxis. No additional adverse event was reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Nausea, Throat tightness
Clinical narrative: Anaphylaxis reaction; A spontaneous report was received from a nurse concerning her co-worker, a 28 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced anaphylaxis reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within five minutes of vaccine administration, the patient experienced anaphylaxis reaction. The patient had symptoms of throat tightness, dizziness, nausea, weakness, and increased heart rate. Treatment for the event included an epinephrine pen  On 29 Dec 2020, the nurse reported that the patient was still having some of the symptoms, including dizziness, nausea, and weakness.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis reaction, was considered not resolved.  The reporter assessed the event, anaphylaxis reaction, as related to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 28 year old female patient, who experienced a serious unexpected event of anaphylactic reaction. The event occurred apparently 5 min after first dose of mRNA-1273 (Lot# unknown) vaccine administration. She was treated with epinephrine pen. 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.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Condition aggravated, Feeding disorder
Clinical narrative: Moderna COVID-19 Vaccine EUA I received the first dose of my vaccine at about 8:30am on January 12. Around 6pm on January 12 I started to experience chills. As the night went on the chills got worse and I developed a terrible throbbing headache. In addition to that I was feeling hot and sweating profusely. I fell asleep around 10pm and woke up around 11pm, at this time the headache was worse, the chills were getting better, and I was still hot and drenched in sweat. I was able to fall back to sleep shortly after. I then woke up at 1am on the 13th, I still had a headache, the chills were gone, I was still hot and sweaty. At this time I also started vomiting. I preceded to vomit until there was nothing left in me and went back to bed. I woke up at 3am and proceeded to dry heave as there was nothing left to come up. My headache was extremely bad at this point and I was still hot and sweaty. I could not keep down Tylenol so I used a cold wet rag to help with the headache. I was finally able to sleep again. I woke up at 5am still with a headache and still hot at this time I was able to take my temperature and it was 99.8. I fell asleep again and woke up at 9am with a temperature of 100.1, at this time I was able to take Tylenol and keep it down which broke my fever and alleviated the headache. Now at about 1pm on the 13th I am still only able to sip liquids and my stomach is upset. This was the sickest I have been in a long time. I have spoken on the phone with a triage nurse at my doctors office and I am waiting for her to consult with a doctor and call me back.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Illness, Retching
Clinical narrative: Moderna COVID-19 Vaccine EUA I received the first dose of my vaccine at about 8:30am on January 12. Around 6pm on January 12 I started to experience chills. As the night went on the chills got worse and I developed a terrible throbbing headache. In addition to that I was feeling hot and sweating profusely. I fell asleep around 10pm and woke up around 11pm, at this time the headache was worse, the chills were getting better, and I was still hot and drenched in sweat. I was able to fall back to sleep shortly after. I then woke up at 1am on the 13th, I still had a headache, the chills were gone, I was still hot and sweaty. At this time I also started vomiting. I preceded to vomit until there was nothing left in me and went back to bed. I woke up at 3am and proceeded to dry heave as there was nothing left to come up. My headache was extremely bad at this point and I was still hot and sweaty. I could not keep down Tylenol so I used a cold wet rag to help with the headache. I was finally able to sleep again. I woke up at 5am still with a headache and still hot at this time I was able to take my temperature and it was 99.8. I fell asleep again and woke up at 9am with a temperature of 100.1, at this time I was able to take Tylenol and keep it down which broke my fever and alleviated the headache. Now at about 1pm on the 13th I am still only able to sip liquids and my stomach is upset. This was the sickest I have been in a long time. I have spoken on the phone with a triage nurse at my doctors office and I am waiting for her to consult with a doctor and call me back.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Moderna COVID-19 Vaccine EUA I received the first dose of my vaccine at about 8:30am on January 12. Around 6pm on January 12 I started to experience chills. As the night went on the chills got worse and I developed a terrible throbbing headache. In addition to that I was feeling hot and sweating profusely. I fell asleep around 10pm and woke up around 11pm, at this time the headache was worse, the chills were getting better, and I was still hot and drenched in sweat. I was able to fall back to sleep shortly after. I then woke up at 1am on the 13th, I still had a headache, the chills were gone, I was still hot and sweaty. At this time I also started vomiting. I preceded to vomit until there was nothing left in me and went back to bed. I woke up at 3am and proceeded to dry heave as there was nothing left to come up. My headache was extremely bad at this point and I was still hot and sweaty. I could not keep down Tylenol so I used a cold wet rag to help with the headache. I was finally able to sleep again. I woke up at 5am still with a headache and still hot at this time I was able to take my temperature and it was 99.8. I fell asleep again and woke up at 9am with a temperature of 100.1, at this time I was able to take Tylenol and keep it down which broke my fever and alleviated the headache. Now at about 1pm on the 13th I am still only able to sip liquids and my stomach is upset. This was the sickest I have been in a long time. I have spoken on the phone with a triage nurse at my doctors office and I am waiting for her to consult with a doctor and call me back.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain
Clinical narrative: Received COVID vaccine on 1/6.  On 1/7 had body aches and chills, which resolved.  On 1/13 had nausea and diarrhea which resolved.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Rash, Tenderness
Clinical narrative: Rash, erthema to injection site, tender
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of throat, face and weakness
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Coordination abnormal, Hypoaesthesia, Muscular weakness
Clinical narrative: severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies to medications, food, or other products. On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs. Pricking, pins and needles sensations in the hands and feet. Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg. The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test). Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment. Outcome of all events was not recovered.; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies to medications, food, or other products. On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs. Pricking, pins and needles sensations in the hands and feet. Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg. The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test). Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment. Outcome of all events was not recovered.; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure within 15 min post vaccination. BP 180/94/BP rose to 202/110; This is a spontaneous report from a contactable nurse. An adult female (age:18-64 Years) patient (pregnant: No) received first dose of BNT162B2 (Pfizer), intramuscularly in left arm on 05Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was received other concomitant drugs. The patient experienced high blood pressure within 15 min post vaccination. BP (blood pressure) 180/94 rose to 202/110 on 05Jan2021 10:45. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events were reported as non-serious. Recipient experienced high blood pressure within 15 min post vaccination. Went to hospital where her pressure was 202/110, vaccine given on 05Jan2021 at 10:30 am, by 10:45 am BP was 180/94, recipient refused hospitalization. Sister took her home but made her go to the hospital where her BP rose to 202/110. IV (intravenous) steroids given. The outcome of event was resolved in Jan2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination: Protein drink. Unknown whether was the patient diagnosed with COVID-19 prior to vaccination. Unknown whether the patient been tested for COVID-19 Since the vaccination. Unknown allergies to medications, food, or other products.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported event hypertension. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: area red , sore, swelled up to the size of two half dollars , hard
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: First dose on 16Dec2020, second dose on 05Jan2021; Tinnitus; constant ringing in ears; louder this time; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: EH9899) on 16Dec2020 via intramuscular route, with second dose (lot number: EK4176) on 05Jan2021 via an unspecified route of administration, both at single dose for covid-19 immunization. Medical history included allergies: penicillin. Concomitant medication included famotidine, ibuprofen (DUEXIS), iron (IRON) and multivitamins, all received within two weeks of vaccination. On 17Dec2020, the patient experienced tinnitus, constant ringing in ears that started 24 hours after first vaccine, lasted about 2-3 days and went away. Ringing in ears started again and is louder this time on 06Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event was identified as serious and resulted in disability or permanent damage. The outcome of event tinnitus was not recovered. The outcome of the other event was unknown.; Sender's Comments: Based on the compatible temporal association with positive rechallenge result, the Company considers the event tinnitus is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Haematoma, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fluid collection and discomfort of left axilla, no erythema, hematoma starting  approximately  1.5 days after injection and ongoing.  Also had low grade temp and dizziness that was self-limiting.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: - lots of pain at injection sight, hard to move arm, especially the next day after shot - whole body fatigue - chills
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red and a little swollen the next day and has become increasingly larger.  Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger.  Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; Injection site was red and a little swollen the next day and has become increasingly larger.  Today (3 days later) the injection site is red, warm, swollen, and about the size of a grapefruit.; This is a spontaneous report from a contactable other HCP. A 39-yearsold female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in left arm on 04Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), fluoxetine (FLUOXETINE), bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), etonogestrel (NEXPLANON) , ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), cyanocobalamin (VIT B12), and iron. On 05Jan2021, the patient experienced injection site was red and a little swollen and has become increasingly larger. 3 days later, on 08Jan2021, the injection site was red, warm, swollen, and about the size of a grapefruit. The outcome of the event was not recovered. Treatment included over the counter medications and ice. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported injection site reactions. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Pt reports hard knot day after vaccine at injection site that resolved and then several days later noticed redness, hard knot and itching in the left arm that is at injection site and then moves down arm toward elbow.  No fever or chills associated with s/s.  Pt was evaluated and note placed in pt chart by MD.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Computerised tomogram normal, Flushing, Headache, Laboratory test normal
Clinical narrative: felt flushed; BP elevated 226/97; dull occipital headache/dull headache; This is a spontaneous report from a contactable other HCP (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided) via an unspecified route of administration (vaccination location: left arm) on 06Jan2021 09:30 at SINGLE DOSE for COVID-19 immunisation.  Medical history was reported as 'none'. It was also reported that patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, and prior to vaccination, the patient was not diagnosed with COVID. The patient has no allergies to medications, food, or other products (no known allergies). The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899; expiration date not provided), via an unspecified route of administration (vaccination location: left arm) on 18Dec2020 18:00 at SINGLE DOSE for COVID-19 immunisation. It was reported that patient received second dose of Pfizer Covid vaccine on 06Jan2021 at 09:30 am. One hour after the 2nd dose (10:30 am), patient experienced dull occipital headache. Patient took paracetamol (TYLENOL). At 10:45 am, patient felt flushed. The nurse took patient's vital signs and noted no fever, normal heart rate and respiratory rate. BP elevated 226/97 (reported at 10:30, no unit provided; normal BP: 130's/80's). At 12:45, patient was taken to ED. CT scan and lab work were reported as all normal. BP continues to be elevated. Amlodipine (NORVASC) 10 mg was given at 17:00. BP slowly came down. Twenty-four hours later, BP was normal at 137/72 (no unit provided). No additional medication taken. It was reported that patient continues to have dull headache. No arm soreness or other symptoms. It was also reported that since the vaccination, the patient has not been tested for COVID-19. Outcome of the events 'BP elevated 226/97' and 'felt flushed' was recovering, outcome of the event 'dull occipital headache/dull headache' was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, the Company considers the reported event blood pressure increased is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pain, Pain in extremity
Clinical narrative: Arm Sore, fatigue, weak, body aches, not feeling well
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Sleep disorder
Clinical narrative: rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021."  Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown.   Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose increased, Fatigue, Hypotension, Limb discomfort
Clinical narrative: passed out; blood pressure was lowered; blood sugar high; weakened; feeling tired and her legs are heavy; feeling tired and her legs are heavy; This is a spontaneous report from a contactable consumer (Patient's Mother). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 Monday at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced passed out 12 hours post injection (Jan2021). She specified that her daughter was therefore brought to hospital by ambulance. She continued explaining that her blood pressure was lowered, her blood sugar high and that she was weakened (Jan2021).  On 08Jan2021, "day 4", she said that her daughter had been feeling tired and her legs are heavy (Jan2021). The event outcome was unknown. She then asked if those side effects were experienced after the vaccine. It was not reported as serious.  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; blood pressure was lowered; blood sugar high; weakened; feeling tired and her legs are heavy; feeling tired and her legs are heavy; This is a spontaneous report from a contactable consumer (Patient's Mother). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 Monday at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced passed out 12 hours post injection (Jan2021). She specified that her daughter was therefore brought to hospital by ambulance. She continued explaining that her blood pressure was lowered, her blood sugar high and that she was weakened (Jan2021).  On 08Jan2021, "day 4", she said that her daughter had been feeling tired and her legs are heavy (Jan2021). The event outcome was unknown. She then asked if those side effects were experienced after the vaccine. It was not reported as serious.  Information on the batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Muscular weakness, Syncope
Clinical narrative: Systemic: Exhaustion-Medium, Systemic: Fainting-Medium, Systemic: muscle tightness and weakness-Medium
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable nurse. A 33-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported a patient developed Bell's Palsy after receiving the first dose of the vaccine. This patient was a physician, the reporter stated that the patient was scheduled to receive the second dose on Monday (unspecified date) and questioned if he should or should not get the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Deafness, Headache, Tinnitus
Clinical narrative: hearing loss; ringing and pulsating in her ears; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in in the left arm on 04Jan2021 at single dose for covid-19 immunization. Medical history included ongoing acid reflux. The patient had no concomitant medications. The patient previous received the flu shot. The patient experienced hearing loss, ringing and pulsating in her ears on 05Jan2021, headache on 04Jan2021, chills on 05Jan2021. Treatment was none. She had the vaccine on Monday at work and some of the symptoms that she has had have not resolved. She was having ringing in her ears and hearing loss. Went to see them and had her ears looked at. Everything was normal. Got the vaccine on 04Jan2021. Ringing in ears and hearing loss: Had been very consistent with no improvement. If anything, it had worsened. She was going to re-contact her doctor. She was also going to ask, should she go on Prednisone or something. She was worried she was going to lose her hearing. Her doctor said that a hearing test may need to be done. History: Takes one medication that she has been taking for years. She has never had an adverse event to any vaccine before. She got the flu shot every year. She was expecting the chills and headache, but they resolved fast. The next vaccine was 25Jan2021, the patient was asked whether she should get the second dose. The outcome of events for hearing loss, ringing and pulsating in her ears was not resolved, for headache and chills was resolved on 06Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Increased insulin requirement
Clinical narrative: -Pt received COVID19 Moderna Vaccine today around 10:30 on 01/08/2021.  -Pt has type 1 diabetes. -Just before and after vaccine was given, her sugars climbed to 299 (she has a monitor that checks constantly). Her normal sugars range from 120-150. -She reports that reaction is normal for her in stressful situations. Patient has history of mid anxiety. No hx of allegies. -She gave herself 1.5 units of insulin.  -She denied blurry vision, headache, dizziness, polydipsia polyuria, polyphagia, headache, chest pain, shortness of breath, difficulty breathing, rash, itchiness, nausea, vomiting, abdominal pain, fatigue.  -I evaluated patient.  -Vitals normal. -After a couple of hours, her sugars were back to normal.  -Pt was observed for multiple hours, as she was also simultaneously working in the vaccine clinic.  -Pt discharged after 4-5 hours.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Unresponsive to stimuli
Clinical narrative: she was dying as her blood pressure dropped to 70/40 and to come for a last visit; This is a spontaneous report from a contactable consumer. A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization.  Medical history included COVID in Dec2020, urinary tract infection (UTI), dehydration and Covid sickness (vomiting) (was treated earlier in month for UTI and dehydration from the Covid sickness (vomiting)). Known allergies: no. The patient's concomitant medications were not reported. After testing positive in mid December to COVID and being declared Covid free on 30Dec by the nursing staff and in good health, with normal vitals and oxygen levels, the patient was given a vaccination on 02Jan2021. In the early evening the patient's blood pressure dropped to 70/40 and the reporter was told to come for a last visit. The patient was sleeping comfortably. She did not wake up when spoke with her. No one expected her to make it through the night. The next morning she work up, ate breakfast, watched TV, got IVs and oxygen and her vitals improved significantly. Lab tests and procedures included blood pressure: 70/40 on 02Jan2021, oxygen levels: normal, COVID test: positive in Dec2020 (testing positive in mid December to COVID and being declare Covid free on 30Dec), vitals: normal; improved significantly. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been tested for COVID-19: No. AE resulted in: Life threatening illness (immediate risk of death from the event). Serious: Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Swelling
Clinical narrative: Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms lasted 0 days
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Hypoaesthesia oral, Pain, Respiratory tract congestion
Clinical narrative: Numbness of tongue, change in taste, congestion, body aches, diarrhea, cough
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Numbness of tongue, change in taste, congestion, body aches, diarrhea, cough
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Condition aggravated, Decreased appetite, Feeling abnormal
Clinical narrative: horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded.  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.