chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Feeling abnormal, Feeling hot, Head titubation
Clinical narrative: Felt like she was having a seizure, her head kept moving back and forth; Tremendous amount of mucous in her naval cavity; Didn't feel good; Got really hot; A spontaneous report was received from a consumer who was a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity.    The patient's medical history included vagus nerve problems. No relevant concomitant medications were provided.   On 02 Jan 2021, at 11: 30 am, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19.  On 02 Jan 2021, about 8:30 pm, the patient stated she got really hot and didn't feel good. She mentioned she had a history of vagus nerve problems, and this reminded her of that experience when she felt like she would pass out. The patient said she felt like she was having a seizure and her head kept moving back and forth. She mentioned having a tremendous amount of mucus in her nasal cavity. She stated she still didn't feel like herself at the time.   On 19 Jan 2021 the patient stated she felt a bit better.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity, were resolving.; Reporter's Comments: This case concerns a 76-year-old, female patient with medical history of vagus nerve problems, who experienced serious, unexpected event of seizure like phenomenon and non serious, unexpected event of hot flush, malaise and mucus discharge. The event occurred 9 hours after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea, Seizure like phenomena
Clinical narrative: Felt like she was having a seizure, her head kept moving back and forth; Tremendous amount of mucous in her naval cavity; Didn't feel good; Got really hot; A spontaneous report was received from a consumer who was a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity.    The patient's medical history included vagus nerve problems. No relevant concomitant medications were provided.   On 02 Jan 2021, at 11: 30 am, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19.  On 02 Jan 2021, about 8:30 pm, the patient stated she got really hot and didn't feel good. She mentioned she had a history of vagus nerve problems, and this reminded her of that experience when she felt like she would pass out. The patient said she felt like she was having a seizure and her head kept moving back and forth. She mentioned having a tremendous amount of mucus in her nasal cavity. She stated she still didn't feel like herself at the time.   On 19 Jan 2021 the patient stated she felt a bit better.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, really hot, didn't feel good, felt like she was having a seizure, head kept moving back and forth, and tremendous amount of mucus from her nasal cavity, were resolving.; Reporter's Comments: This case concerns a 76-year-old, female patient with medical history of vagus nerve problems, who experienced serious, unexpected event of seizure like phenomenon and non serious, unexpected event of hot flush, malaise and mucus discharge. The event occurred 9 hours after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 16Jan2021 21:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Jan2021, the patient experienced right side of her eye was completely blood shot. This morning 17Jan2021 there seems to be a raised vessel which is dark red in the same eye. The patient was not in pain, nothing scratching. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got lightheaded and a decrease in the blood pressure that got her to the ER for monitoring during 1 h. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dermatitis, Rash papular, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She was calling because she had the first dose of the Pfizer COVID vaccine on 28Dec2020. She developed a rash after one week and a half (in Jan2021). It was all over the body, extremely itchy and raised in certain areas of the body. Her body was unhappy, she had chills but no fever. She contacted her dermatologist and he suspected it was a reaction to the COVID- 19 vaccine. She had been taking meds as per dermatology since last Thursday (14Jan2021). The rash was fading but was still pretty obvious. She was a healthcare worker. She didn't notice any reaction for a couple of weeks. A week before or maybe a week and a half before (in Jan2021), she noticed dermatitis on her whole body. The dermatologist said she possibly had a reaction to the COVID vaccine. He told her to take Benadryl and Zyrtec. She saw him on Wednesday of last week and today (18Jan2021) was Monday. This rash was incredibly itchy. She thought it was fading a little bit. The second dose was due on the 20th, which was the day after tomorrow (20Jan2021). She read in the materials she was given that people who had serious reactions shouldn't get the second dose. Also she had had some muscle cramping in the stomach. She didn't have a follow up with the Dermatologist. She was assuming she should continue taking Zyrtec and Benadryl. Caller clarified that she got the generic, not the brand names. She took one Zyrtec a day that was 10mg. She took the Benadryl substitute and it was every 4 to 6 hours. If she had to drive in the afternoon she shouldn't take the Benadryl. She was wondering about the second dose. The outcome of the events a reaction to the COVID vaccine, rash/extremely itchy and raised in certain areas of the body was recovering, of the rest events was unknown. Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Oedema peripheral, Pruritus, Superficial vein prominence
Clinical narrative: have a bruised appearance in the left palm; Itching; redness; puffiness; prominent bright blue vein in palm of left hand; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1283), via an unspecified route of administration in left arm on 15Jan2021 14:30 at first single dose for COVID-19 immunization. Medical history included hypertension, high cholesterol. No COVID prior vaccination. No known allergies. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ), rosuvastatin, celecoxib (CELEBREX), ergocalciferol (VIT D). No other vaccine received in four weeks. On 15Jan2021 15:00, the patient experienced Itching, redness, puffiness, and prominent bright blue vein in palm of left hand. This subsided somewhat after about an hour, but even three days later she had a bruised appearance in the left palm. Treatment included longer post-vaccination observation and Benadryl. COVID was not tested post vaccination. Outcome of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day.  All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021.  Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative
Clinical narrative: feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day.  All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021.  Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Mild to moderate hives and rash all over body; Mild to moderate hives and rash all over body; This is a spontaneous report from a contactable consumer (patient's husband). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergy to penicillin as a child, high blood pressure. The patient has no known food allergies. Concomitant medication included unspecified high blood pressure medication for a month and half. The patient experienced mild to moderate hives and rash all over body on 13Jan2021. She was prescribed with cetirizine (ZYRTEC), diphenhydramine hydrochloride (BENADRYL) and unspecified steroid. The outcome of the events was unknown. She is scheduled for her to take the second dose on 25Jan2021, the reporter was asking if the patient can still take it.   Information about batch/lot number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Eye infection
Clinical narrative: trouble with dry eyes; infection in her eye; blood sugar 54 mg/dl two hours after dinner with insulin, 147 mg/dl after candy, 85 mg/dl after oatmeal without insulin, 196 mg/dl after; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ6796), via an unspecified route of administration in the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes mellitus, bladder cancer from 2005 and ongoing (cleaned it out, but has to go for check ups every 6 months), stent in artery in neck on right side on 2011, atrial fibrillation (Afib), knee total replacement on 2010 and on 2015, and ablations on Jan2010 and on Jun2010. Ongoing concomitant medications included insulin lispro (HUMALOG) and insulin glargine (LANTUS) both for type 2 diabetes mellitus. She took her regular insulin last night (19Jan2021) at dinner time and her blood sugar went down to 54 mg/dl about 2 hours later. She ate some candy and it went back up to 147 mg/dl. This morning (20Jan2021), it was 85 mg/dl. She just had oatmeal without taking any insulin which is unusual for her. She just took her blood sugar again and it's 196 mg/dl, which after eating oatmeal is not really high. The patient want to know if anyone else had this response. She felt great afterward and didn't even felt it. She also had an incident with an infection in her eye yesterday (19Jan2021), but the doctor didn't think it was related to the vaccine. She just had one little tingle of it on an unspecified date and went right to the doctor and they gave her medication for the infection. She has plugs in both eyes so she has trouble with dry eyes on an unspecified date. Outcome of the eye infection was recovering while of the remaining events was unknown.  Information on lot number/batch number was requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Oropharyngeal discomfort, Tinnitus
Clinical narrative: severe ringing to ears for four days; throat was a bit congested; difficulty of swallowing; something stuck in the throat; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to ask if it is normal to have severe ringing to ears especially in the morning. The patient received the COVID 19 vaccine last 16Jan2021. The patient reported symptoms which she has been experiencing for 4 days now with the COVID 19 vaccine, Pfizer's. She experienced severe ringing to ears for four days since 16Jan2021, it has been happening for four days, and usually happens in the morning and also, in Jan2021, there was something stuck in the throat, like her throat was a bit congested with difficulty of swallowing. The throat was being ok now, it's getting better, but the severe ringing to her ears was her main concern. The patient was recovering from the events "something stuck in the throat", "throat was a bit congested" and "difficulty of swallowing" while the event "severe ringing to ears for four days" had not resolved.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Pharyngeal swelling, Sensation of foreign body, Tinnitus
Clinical narrative: severe ringing to ears for four days; throat was a bit congested; difficulty of swallowing; something stuck in the throat; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to ask if it is normal to have severe ringing to ears especially in the morning. The patient received the COVID 19 vaccine last 16Jan2021. The patient reported symptoms which she has been experiencing for 4 days now with the COVID 19 vaccine, Pfizer's. She experienced severe ringing to ears for four days since 16Jan2021, it has been happening for four days, and usually happens in the morning and also, in Jan2021, there was something stuck in the throat, like her throat was a bit congested with difficulty of swallowing. The throat was being ok now, it's getting better, but the severe ringing to her ears was her main concern. The patient was recovering from the events "something stuck in the throat", "throat was a bit congested" and "difficulty of swallowing" while the event "severe ringing to ears for four days" had not resolved.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Incorrect dose administered, Pain
Clinical narrative: Bell's Palsy; This is a spontaneous report from a non-contactable nurse (patient's wife). A 4-decade-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included Herpes Zoster (chicken pox and shingles), and hypogammaglobulinemia from an unknown date. The patient's concomitant medications were not reported. The reporter asked if her husband should receive his 2nd dose of vaccine after experiencing Bell's Palsy 12 hours after 1st dose. The patient had history of herpes zoster (chicken pox, shingles) on the same side of his face as the paralysis now (Bells Palsy). The patient was in a lot of pain and asked how serious Bell's Palsy is. Outcome of the event was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received first dose 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 patient experienced bell's palsy on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Syncope, Tracheitis
Clinical narrative: faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunodeficiency, SARS-CoV-2 test positive
Clinical narrative: Immunocompromised; tested positive for SARs-Cov-2; tested positive for SARs-Cov-2; This is a spontaneous report from a contactable pharmacist. A 6-decade-old (reported as 50s) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose, and then received the second dose in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller on behalf of patient in ED.  Frontline medical worker received the second dose of vaccine twelve days before in Jan2021. Patient was tested positive for SARs-Cov-2. Immunocompromised.  Questioning the administration of Bamlanivimab. Potential AE. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  Immunocompromised is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Possible Bells Palsy; This is a spontaneous report from contactable other healthcare professional (HCP). A 66-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), intramuscular on 13Jan2021 at a single dose for COVID-19 Immunization. Medical history included hyperlipidemia, chronic kidney disease, essential hypertension, obesity, hyperuricemia, iron deficiency anemia, type 2 DM and obstructive sleep apnea. The patient has no known allergies. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE), glimepiride (AMARYL [GLIMEPIRIDE]), levothyroxine sodium (LEVOTHYROXINE SODIUM), metformin (METFORMIN), losartan potassium (LOSARTAN POTASSIUM), ascorbic acid, calcium, minerals NOS, retinol, tocopheryl acetate, vitamin B NOS, vitamins NOS, zinc (CENTRUM SILVER [ASCORBIC ACID; CALCIUM; MINERALS NOS; RETINOL; TOCOPHERYL ACETATE; VITAMIN B NOS; VITAMINS NOS; ZINC]), sucralfate (SUCRALFATE), glimepiride (GLIMEPIRIDE), furosemide (FUROSEMIDE), atorvastatin (LIPITOR [ATORVASTATIN]), pantoprazole sodium (PANTOPRAZOLE SODIUM), cyclobenzaprine (CYCLOBENZAPRINE), cholestyramine (CHOLESTYRAMINE). Other vaccine in four weeks included the first dose of influenza vaccine, intramuscular on the left deltoid, on 22Dec2020, lot number: UJ475AA. The patient has no COVID prior vaccination and had not tested post vaccination. The patient experienced possible Bell's palsy on 14Jan2021. Treatment for the event was unknown. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event.     Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: allergic to the following: Allergies  Lipitor, valium, Cardizem, heparin, prednisone, Procardia XL, dobutamine thallium, and  pneumonia vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported 66 with unknown unit) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization, the patient also started to receive atorvastatin calcium, heparin sodium, nifedipine (PROCARDIA XL), dobutamine hcl, diazepam (VALIUM), diltiazem (CARDIZEM) and prednisone, all via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history included asthma and angina. Concomitant medication included aspirin [acetylsalicylic acid], furosemide (LASIX), salbutamol sulfate (PROAIR), ipratropium, budesonide, rosuvastatin, cetirizine, montelukast sodium (SINGULAIR) and other medications for asthma and angina. The patient experienced allergic to the following: lipitor, valium, cardizem, heparin, prednisone, procardia xl, dobutamine thallium and pneumonia vaccine on an unspecified date. The action taken in response to the event for atorvastatin calcium, heparin sodium, nifedipine, dobutamine hcl, diazepam, diltiazem and prednisone was unknown. The outcome of events was unknown.  Pfizer is a marketing authorization holder of heparin sodium and dobutamine hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of heparin sodium and dobutamine hcl has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia
Clinical narrative: numbness in right hand and finger; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer (patient) reported that an 88-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVENAR 13, Formulation: Solution for injection in pre-filled syringe, lot number, expiration date: not provided) via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. The patient previously received pneumococcal vaccine polysacch 23v (PNEUMOVAX) for immunization, amoxicillin and clindamycin and had reaction. It was not clarified which PNEUMOVAX vaccine was received by the patient and what kind of reaction though. She was experiencing numbness in right hand and finger on an unspecified date. Told her she will need to talk to her HCP about that. The outcome of event was unknown.  No follow-up attempts are needed. Information on lot/batch cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: headache, joint and muscle aches, chills, fatigue, nausea
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: headache, joint and muscle aches, chills, fatigue, nausea
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: C/O numbness tingling sensation in both arms and buttocks area.  Lightheaded feeling.  All symptoms have subsided at 0515.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site urticaria
Clinical narrative: About 5 or 6 hours after the shot: chills, low temp at first ( 94.6) then 100.9, aches (generalized,), nuchal rigidity, severe headache, fatigue, vomiting; hive at injection site with marked deltoid tenderness
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nuchal rigidity, Pain, Pyrexia, Vomiting
Clinical narrative: About 5 or 6 hours after the shot: chills, low temp at first ( 94.6) then 100.9, aches (generalized,), nuchal rigidity, severe headache, fatigue, vomiting; hive at injection site with marked deltoid tenderness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: The site of my injection seems to be getting worse 10 days after the injection. It?s not very painful, but is a little warm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema of eyelid, Fatigue, Gait disturbance, Headache
Clinical narrative: Covid-19 #1 Moderna reaction 1/7. Next day left arm arm soreness/fatigue/neck/back pain. 1/11 began having tingling/pain and swelling lt arm and axilla, then headache described as "terrible", associated with conjunctival erythema. 1/17 headache worst, left leg numbness, which progressed to entire left side, had trouble walking. Numbness went away by 1/18 but needed to be driven to work by husband, doctors assessed her at work and vitals were ok but she was sent home early. She went to her PCP 1/26, did bW, has IGG covid. Symptoms resolved and started feeling back to herself 14days. after vaccine.  Have recommended neurology evaluation.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Covid-19 #1 Moderna reaction 1/7. Next day left arm arm soreness/fatigue/neck/back pain. 1/11 began having tingling/pain and swelling lt arm and axilla, then headache described as "terrible", associated with conjunctival erythema. 1/17 headache worst, left leg numbness, which progressed to entire left side, had trouble walking. Numbness went away by 1/18 but needed to be driven to work by husband, doctors assessed her at work and vitals were ok but she was sent home early. She went to her PCP 1/26, did bW, has IGG covid. Symptoms resolved and started feeling back to herself 14days. after vaccine.  Have recommended neurology evaluation.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Chills, Fatigue
Clinical narrative: Shoulder Injury Related, tiredness, headache, muscle and bones pain, chills, joint pain,  fever, feeling unwell, back pain, pain in the lower abdomen as with menstruation, no energy
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Limb injury, Malaise, Myalgia
Clinical narrative: Shoulder Injury Related, tiredness, headache, muscle and bones pain, chills, joint pain,  fever, feeling unwell, back pain, pain in the lower abdomen as with menstruation, no energy
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shoulder Injury Related, tiredness, headache, muscle and bones pain, chills, joint pain,  fever, feeling unwell, back pain, pain in the lower abdomen as with menstruation, no energy
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 100.4-100.5, body aches, fatigue - lasted about 5 hours. Body aches continued overnight and around 13 hours post vaccine experienced diarrhea for several hours.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID?19 Vaccine EUA
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: I awoke with a headache, fever of 99.7, and feel very nauseous
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Big red hard spot at injection site about 3 days after shot itches and very swollen still a week later.
Age: 88.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Vomiting
Clinical narrative: Extreme chills and vomiting  episode lasting approximately 5 hours and weak for about a day.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Eye swelling, Pain, Urticaria
Clinical narrative: On 1/20/21 I received the vaccination. The next day I felt achy but not in distress.  On Saturday 1/23/21 I woke up with hives on my left arm and chest and a swelling on my left eye.  I took benadryl which had no effect. The next day the hives had progressed to blisters, my hand swelled  and my eye had almost swollen shut.  I contacted my health care advisers and they prescribed predinosne.  This reversed the reaction and the wounds are healing.  I have pictures of how I looked.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial discomfort, Headache, Neck pain, Pain in jaw
Clinical narrative: right side neck pain, pain behind right ear and  jaw with constant headache and heaviness in right eye. Symptoms started suddenly 5 days after vaccination without any trauma or change in my daily routine and are still present at this time.  Pain relieved by Nsaids for about 4 hours then symptoms return.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Pain, Pyrexia
Clinical narrative: Chills and fevers (102.6) for 5 straight days, non stop.  Body aches.  no appetite.  No energy.
Age: 92.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Vomiting
Clinical narrative: Direahea, vomiting, weakness lasting Sunday night, all day Monday and Tuesday.  Feel good Wednesday.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Chills Headache  Muscle aches Joint aches Nausea  All worse during the night
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills, muscle pain, tiredness
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site induration, Injection site pain, Pruritus
Clinical narrative: Immediately my left arm bleed at the injection site so much that the person administering  the injection stated "Oh Oh NO Oops a Daisy"  It took four ETOH swabs to clean the blood running down my arm.  A nodule welled up on my arm the size of 50 cent piece that was very painful.  The person who injected me was not a professional they were incompetent failed to meet the standard of care (competent nursing practice) as outlined in the nurse practice act & should be reported to the Board of Nursing.  The nodule stayed on my arm for 4 days.  It turned black/blue badly bruised.  The day after the injection I began to itch I had a raised red itchy rash on my back that lasted for 72 hours.  I immediately begin taking 25 mg of Benadryl  three times a day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Immediately my left arm bleed at the injection site so much that the person administering  the injection stated "Oh Oh NO Oops a Daisy"  It took four ETOH swabs to clean the blood running down my arm.  A nodule welled up on my arm the size of 50 cent piece that was very painful.  The person who injected me was not a professional they were incompetent failed to meet the standard of care (competent nursing practice) as outlined in the nurse practice act & should be reported to the Board of Nursing.  The nodule stayed on my arm for 4 days.  It turned black/blue badly bruised.  The day after the injection I began to itch I had a raised red itchy rash on my back that lasted for 72 hours.  I immediately begin taking 25 mg of Benadryl  three times a day.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Glossodynia, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Large red spot on are at site of the injection, 3 in by 6 in.  swollen and itching.  headache just for a day, itchy eyes and nasal drip similar to allergies, sores on sides of tongue similar to thrush,
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Rhinorrhoea
Clinical narrative: Large red spot on are at site of the injection, 3 in by 6 in.  swollen and itching.  headache just for a day, itchy eyes and nasal drip similar to allergies, sores on sides of tongue similar to thrush,
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling, Swollen tongue
Clinical narrative: 12 hours after vaccine lips, tongue and neck started swelling requiring ER visit
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea, Rash
Clinical narrative: ADR occurred prior to arrival. NKA. PT presented to ED 1/25/21 with nausea, decreased appetite that is documented to have started 2 weeks prior. PT received first Moderna Covid vaccine 1/6/21.  Documentation in ED record notes patient tolerated Covid vaccine fine. No fever or chills, no vomiting or diarrhea. Patient was treated with normal saline bolus and discharged home same day with instruction to follow up with PCP. .PT seen by CNP 2/2. Documentation notes PT ?started prior to vaccines and became more severe after vaccine?. Documentation notes ?rash and then symptoms worsen. Took allergy relief".
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Heart rate increased, Hypoaesthesia, Myositis
Clinical narrative: I had a fast beating heart felt like anxiety as my pulse read regular on my watch. My right side of my face around the cheek, eye, and ear area began to tingle and feel numb around 20 to 30 min. After the shot was administered. It was only on the side of my face that Moderna covid vaccine was given. It ended up going away after 4 hours or so. The next day I had normal reactions to the shot for someone that had covid such as low fever, muscle inflammation, aches, and this brain fog, chills in my sleep.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: I had a fast beating heart felt like anxiety as my pulse read regular on my watch. My right side of my face around the cheek, eye, and ear area began to tingle and feel numb around 20 to 30 min. After the shot was administered. It was only on the side of my face that Moderna covid vaccine was given. It ended up going away after 4 hours or so. The next day I had normal reactions to the shot for someone that had covid such as low fever, muscle inflammation, aches, and this brain fog, chills in my sleep.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Injection site reaction, Lymph node pain
Clinical narrative: Large red injection site , whole body tingling sensation, face burning, eye lid and brow itching, eye itching, lymph nodes in neck, arms and especially groin area(hurt the most) burning on right side of foot and heal, all over body aches and tiredness, headache
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Paraesthesia
Clinical narrative: Large red injection site , whole body tingling sensation, face burning, eye lid and brow itching, eye itching, lymph nodes in neck, arms and especially groin area(hurt the most) burning on right side of foot and heal, all over body aches and tiredness, headache
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient reports tingly fingers and worried injection was given too high on arm. Injection was given higher than deltoid.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever of 102, muscle ache, chills
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headaches, head congestion.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pharyngeal swelling, Swelling, Swollen tongue
Clinical narrative: Felt tongue, roof of mouth, throat swelling, but observation did not show it.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident, Heart rate irregular, Neurological symptom
Clinical narrative: Positive Covid case investigation with the PA DOH. Spoke with case's daughter. States her mother recieved vaccine at clinic on 01/27/21. Had no complaints of illness or exposure to a positive case prior to vaccine. Daughter states she's independent and stays alone at night. Felt fine the day and the day after of the vaccine. Per daughter, case's last known well time was Friday 1/29/21 at 730pm. Daughter states they found her Saturday morning with stroke like symptoms and was admitted to Hospital step down unit. She was also informed by the doctor that her heart was irregular with atrial fibrillation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills,severe body aches, fatigue. Headache for 7 days
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Pruritus
Clinical narrative: Days 1-4 - Very, very sore arm with  localized redness, about half dollar in size. Another symptom was my arm was very itchy.  Days 5 and 6- The soreness went away however the redness continued to stay and become a deeper shade of red and grow about a quarter inch. Itching continued. Day 7: I woke up and the redness had grown significantly in size.  The  size was approximately 3.5 inches in diameter, was red and bumpy and worse with itchiness. I ended up using a prescription hydrocortisone ointment which made it go away. For weeks later my arm was still itching and faint redness could still be visible.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Vaccine was administered Thursday and my father Died early Monday morning unexpectedly
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain
Clinical narrative: On 1/26/21 I felt chills, headache, body aches and very weak. These symptom's lasted five days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Very sore are for 2 days. Extreme tiredness for 1 week I'm now at the 2 week mark and just developed swelling, redness, hardness & warmth at the injection site.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Very sore are for 2 days. Extreme tiredness for 1 week I'm now at the 2 week mark and just developed swelling, redness, hardness & warmth at the injection site.