chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: She had pain in right arm and right leg; A patient received the contents of the entire vial of undiluted Pfizer-Biontech Covid19 vaccine earlier this afternoon as her second dose; A patient received the contents of the entire vial of undiluted Pfizer-Biontech Covid19 vaccine earlier this afternoon as her second dose; This is a spontaneous report from a contactable physician. A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6205), via an intramuscular on 07Mar2021 at 12:45 (at age of 21-years-old) as single dose, for COVID-19 immunization. The patient's medical history included migraine and covid-19 (prior to vaccination). The patient was not tested post vaccination. The patient's concomitant medications included amitriptyline and estradiol (ESTROGEN). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 07Mar2021, the patient received the contents of the entire vial of undiluted Pfizer-Biontech Covid19 vaccine earlier this afternoon as her second dose. On 08Mar2021, the patient had pain in right arm and right leg but no other side effects. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 12:15 (at the age of 64-year-old), at a single dose for COVID-19 immunization in other. Medical history included asthma, high cholesterol and patient previously had Covid and was diagnosed 65 days ago. Patient did not have known allergies. Concomitant medications included clarithromycin (CLARITIN) and rosuvastatin calcium (CRESTOR). Patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient felt fine after the injection. On 07Mar2021 at 12:30, (reported as almost exactly 24 hours), later patient was so fatigued, had chills and body aches. Patient did not receive any treatment for the events. Patient was wondered if she should wait and should get the 2nd dose. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: diarrhea (11 times); Throw up 3 times; Chills; Weak; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 07Mar2021 at 11:32 (Batch/Lot Number: EN6205) as 1st dose, single dose for covid-19 immunization. Medical history included asthma and Chronic Obstructive Pulmonary Disease (COPD). Allergies to medications, food, or other products included all cillins, sulfer drugs and Lomotil. Concomitant medications received within 2 weeks of vaccination included acetylsalicylic acid (ASPIRINE), montelukast (MONTELUKAST) and pravastatin (PRAVASTATIN).Prior to vaccination, patient was not the diagnosed with COVID-19. Patient received no other vaccines within 4 weeks prior to the COVID vaccine.The Patient got the first vaccine on Sunday, 07Mar2021 at 11:32 hours, patient sat around for 15 minutes and left.On 07Mar2021, at 17:15PM, patient had severe episodes of throwing up (three times), diarrhea (11 times), had chills and was weak. Patient stated she drank sports drink but spent 8 hours in the bathroom and slept in the bathroom for hours.It was reported that patient waited on phone for 2 hours and none picked up and stated she should never had taken the vaccine. Patient called again and still waiting and stated will be going to ER if this does not stop.It was reported on page 2, that do not get the 2nd vaccine if you had a severe reaction. Her second dose was scheduled on Sunday the 28Mar2021 and she does not know what to do. she had COPD but her breathing issues were not affected. All the doctors suggest she get the second dose except one doctor.The patient had heard of people who have had reactions, just not as bad as hers, and they got the second vaccine. Some people say she won't have a severe reaction after the second if she had this type of reaction from the first and some say some say it could be worse. She asked what she should do about her second dose. After verbal response she reported that she was still going to go on the 28th for her second dose and will let them know about her symptoms but wondered if it was up to their discretion if she gets the vaccine or not. She stated her healthcare professional offered her a Zofran prescription before the next dose but she said she was not nauseous. Patient asked if there was anything she could take for these symptoms before her next dose and stated she had reported this. Since the vaccination, patient had been tested for COVID-19 by rapid COVID test, result: unknown. Patient received no treatment. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiration date: Unknown) via an unspecified route of administration in left arm on 06Mar2021 at 08:30 AM (65-year-old age at vaccination) as UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history included diabetes type2 and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included lisinopril, metformin, sitagliptin (Jenuvia), glimepiride and pimozide (Mozep). Patient has no known allergies. Patient did not receive any other vaccine in four weeks. Since vaccination, patient has not been tested for covid. On 06Mar2021 at 15:00, the patient experienced slightly sore arm. Patient has not received any treatment for the event. The clinical outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, PCV20 Adult Consumer Quant DTC Testing. A 56-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date not reported) as  unknown, single for immunization. Medical history and concomitant medications were not reported. The patient reported, "That i might had Prevnar. But it didn't work for me cause of covid", on an unspecified date. Clinical outcome of the events was unknown.  No follow-up attempts are needed. Information about the batch/lot number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via unspecified route of administration in left arm on 01Mar2021 03:15 PM (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. Vaccination facility type was reported as hospital. The patient's medical history was not reported. No COVID prior vaccination was reported. No concomitant medications were taken by the patient within 2 weeks. No other vaccine was administered within 4 weeks. On 03Mar2021 08:00 AM the patient experienced tight chest, dry cough, and compromised breathing. No treatment was received due to the events. Patient was not tested for COVID post vaccination. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-Health Care Professional (Patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number and Expiration date was not provided) via an unspecified route of administration in Arm Left on 05Mar2021 at 14:00 (at the age of vaccination 52-years-old) as 2 ND DOSE, SINGLE for COVID-19 immunization at Public Health Clinic/Veterans. The patient medical history included type 1 diabetes mellitus. The patient had known allergies to Tetracycline. The patient received medications within 2 weeks of vaccination included insulin (INSULIN). The patient previously took tetracycline and experienced drug hypersensitivity and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, in Left arm on 12Feb2021 at 02:30 PM as single dose for COVID-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 06Mar2021 at 12:00 AM, the patient had experienced fever of 102, fatigue, muscle pain and weakness. The patient underwent lab tests and procedures which included body temperature: 102. The seriousness of the event was reported as non-serious. The clinical outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: her arm swelled up; she had some soreness and swelling; she had some soreness and swelling; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) unknown, single, for immunisation. The patient's medical history and concomitant medications were not reported. About 3 years ago, the patient received a pneumonia shot and her arm swelled up on unspecified date. She stated that was pretty much it, she had some soreness and swelling. Other than that, she had no other reactions. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)  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 pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable consumer (patient). A 45-years-old, non-pregnant, female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in a Pharmacy or Drug Store, administered via an unspecified route in right arm on 06Mar2021 15:30, at 45 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included ibuprofen and naproxen sodium (ALEVE), both taken for an unspecified indication, since an unknown date. The patient previously took amoxicillin and experienced drug hypersensitivity. On 07Mar2021 06:00 AM the patient experienced migraine. She didn't receive any treatment. At the time of the report the reported event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Inflammation and Joint Pain in Hips, shoulders, hands. Intensity would vary day by day; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via unspecified route in the left arm, as 1st dose, single on 27Jan2021 at 15:45 for COVID-19 immunization (at the age of 71-years). There was no relevant medical history and no concomitant medications. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021, the patient experienced inflammation and joint pain in hips, shoulders, hands. intensity would vary day by day. Pain was greatest after sleep or extended inactivity. Treatment included hot spa baths, Ice packs, Ibuprofen, deep tissue massage. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness around the injection site; Swelling around the injection site; Soreness around the injection site; Bad itching around the injection site/ itches like crazy; Around the injection site, warm to touch; This is a spontaneous report from a non-contactable consumer or other non hcp. A 77-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Feb2021 14:15 as SINGLE DOSE for COVID-19 immunization. Medical history included atrial fibrillation, hypertension (high blood pressure), blood cholesterol increased, hypertension; all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS), metoprolol, atorvastatin and diazepam (DIAZEPAM) taken for an unspecified indication, start and stop date were not reported. The patient previously administered Bactrim and Iodine experienced allergy for both. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Feb2021 14:15 as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 07Mar2021 05:00 exactly 7 days from the 2nd dose of Pfizer, the patient experienced redness, swelling, soreness and bad itching around the injection site, warm to touch, itches like crazy. The patient stated that she did not experience fever and chills. When I received the second vaccine, the volunteer nurse was irritable and wanting to get it over with. I am not sure if she was new or not. A man walked by and talked and she got very irritated to the point she said she was giving me my shot whether I was ready or not. I did not know the man and just wanted the shot. That shot she gave me hurt and bruised. Now 7 days later I have a big red area a few inches in diameter around the injection site. The events were assessed as non-serious. The patient had a telemedicine visit with the local urgent care. Therapeutic measures included Hydrocortisone cream for the itching, Zyrtec once a day, and maybe Tylenol for any pain or if patient develop a fever, recommended outlining the red area to see if it spreads. Outcome of the events were reported as Unknown at this time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Hypoaesthesia, Ocular hyperaemia, Swelling face
Clinical narrative: About 4 hours after the vaccine my left eye started to get very red & swollen; About 4 hours after the vaccine my left eye started to get very red & swollen; Numbness on the left side of my face; Swelling on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:30 as SINGLE DOSE for covid-19 immunization (Facility type vaccine: Pharmacy or Drug Store). The patient's mdical history was reported as none. Patient has been not taking any other vaccine in four weeks. And no other medications in two weeks. Patient has not tested covid-19 positive prior to vaccination. Patient has no known allergies. It was reported as on 07Mar2021 at 04:30 PM about 4 hours after the vaccine his left eye started to get very red and swollen along with some numbness and swelling on the left side of his face. Four hours later it was started to get better with cold compress. Patient has not tested covid-19 positive post vaccination. The outcome of the events was reported as resolving.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: About 4 hours after the vaccine my left eye started to get very red & swollen; About 4 hours after the vaccine my left eye started to get very red & swollen; Numbness on the left side of my face; Swelling on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:30 as SINGLE DOSE for covid-19 immunization (Facility type vaccine: Pharmacy or Drug Store). The patient's mdical history was reported as none. Patient has been not taking any other vaccine in four weeks. And no other medications in two weeks. Patient has not tested covid-19 positive prior to vaccination. Patient has no known allergies. It was reported as on 07Mar2021 at 04:30 PM about 4 hours after the vaccine his left eye started to get very red and swollen along with some numbness and swelling on the left side of his face. Four hours later it was started to get better with cold compress. Patient has not tested covid-19 positive post vaccination. The outcome of the events was reported as resolving.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Suffered an allergic reaction from first dose; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number was not reported)), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient suffered an allergic reaction from first dose from Pfizer Covid-19 vaccine on an unspecified date. She wanted to ask I have been advised not to take the second dose, so my question is, what protection do I have since I only had one dose of the vaccine. The outcome of unknown event was unknown.   Follow-up (04Mar2021): She wants to know how much protection she has with only just 1 dose of the vaccine. I offered to warm transfer the consumer to DSU, but she declined. DSU: E transmitting due to AE.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Reaction to food additive
Clinical narrative: Polysorbate allergy/intolerance After receiving the Prevnar 13 vaccine; Polysorbate allergy/intolerance After receiving the Prevnar 13 vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) unknown, single, for immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced polysorbate allergy/intolerance after receiving the Prevnar 13 vaccine. Patient never had a reaction like these before. Patient stated "Polysorbate is in Prevnar 13, I have not found it in other vaccines but it is also present by relationship to PEG in the Pfizer and Moderna vaccines. I would like to get the vaccine but it is contraindicated with a diagnosed allergy and sofar I have not been able to find an allergist to test for Polysorbate-80. It is a precaution without a diagnosis. What defines "precautions"". Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: my right arm hurts; I have bad pains; my hands are swollen; fingers are swollen/Four or five fingers; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose (at the age of 74-years-old) for covid-19 immunization; tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, Prolonged-release tablet) 11 mg, via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient reported that her right arm hurts. The patient also experienced bad pains and her hands are swollen, fingers are swollen. Four or five fingers. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Very bad headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6204), dose 1 via an unspecified route of administration on 05Mar2021 (at the age of 69-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021 04:00, the patient suffered with very bad headache. On an unknown date of Mar2021, patient had chills. Therapeutic measures were taken as a result of very bad headache and chills with Ibuprofen as suggested. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other health care professional reported that. A 42-years-old non-pregnant female patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 04Mar2021 at 11:15 (at the age of 42-years old) as single dose for COVID-19 immunization. The Medical history included none. The patient's concomitant medications were not reported. The patient previously took Levaquin (Levocetirizine) and experienced allergy. The patient has not suffered from COVID-19 prior vaccination. The patient had not done COVID tested post vaccination. Patient has not received other vaccine in four weeks. 2 days after 1st dose, on 06Mar2021 at 06:00 AM, the patient reported my skin was very itchy, mostly around chest, neck and face, but day 3 the itchy sensation turned into a slight itchy burning sensation in same areas of body, took a Benadryl and it went away, by day 4, same burning sensation but now in hands and arms, went to Dr and he told, had some hives. The patient received treatment for the events. Prescribed Levocetirizine 5g for a week and also advised to take OTC Zyrtec after week daily for allergies. Patient do not suffer from allergies nor have ever had a reaction to a vaccine before. The outcome for the events skin was very itchy, mostly around chest, neck and face, but day 3 the itchy sensation turned into a slight itchy burning sensation in same areas of body, sensation but now in hands and arms, hives were recovering. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration in 2018 (Batch/Lot number was not reported) as single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got sick in 2018 after vaccination. The outcome of event was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache
Clinical narrative: headache; increased temperature; This is a spontaneous report from a program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age (Age: 65, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 10Mar2021, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache and increased temperature (reported as for a few minutes) on an unspecified date. Reporter inquired if patient can take paracetamol (TYLENOL). The patient underwent lab tests and procedures which included body temperature: increased on an unspecified date. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body mass index, Cough, Pain in extremity, Pain of skin
Clinical narrative: Bright red rash starting at the wrists and extending up to forearm; Red rash was tender almost like a sunburn; Red rash was tender almost like a sunburn; Itching throat; Slight wheezing; Mucous causing cough; Mucous causing cough; Feeling of anxiousness; Arm was also sore enough that it hurt to lay on it; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER COVID-19 vaccine, Lot Number: GN6198), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 15:45 (at the age of 54 years old) as single dose for covid-19 immunization. Medical history included body mass index (BMI) more than 30, known allergies included: penicillin, latex sensitive, allergic to propylene glycol. The patient did not have COVID prior vaccination. The patient did not have any other vaccine in four weeks and did not pregnant at time of vaccination. Concomitant medication in two weeks included Vitamins. On 04Mar2021 at 01:00 AM, the patient Woke up from sleep with itching throat, slight wheezing, and mucous causing cough. It caused her to have a feeling of anxiousness because it happened so suddenly. After about 1 hour, it stopped just as suddenly as it all started. Arm was also sore enough that it hurt to lay on it. No swelling at injection site. This lasted for about 1 hour. On 09Mar21 noticed a bright red rash starting at the wrists and extending up to forearm. The red rash was tender almost like a sunburn. The patient had not been tested for COVID-19 post vaccination. No treatment for AEs. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Secretion discharge, Skin burning sensation, Throat irritation, Wheezing
Clinical narrative: Bright red rash starting at the wrists and extending up to forearm; Red rash was tender almost like a sunburn; Red rash was tender almost like a sunburn; Itching throat; Slight wheezing; Mucous causing cough; Mucous causing cough; Feeling of anxiousness; Arm was also sore enough that it hurt to lay on it; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER COVID-19 vaccine, Lot Number: GN6198), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 15:45 (at the age of 54 years old) as single dose for covid-19 immunization. Medical history included body mass index (BMI) more than 30, known allergies included: penicillin, latex sensitive, allergic to propylene glycol. The patient did not have COVID prior vaccination. The patient did not have any other vaccine in four weeks and did not pregnant at time of vaccination. Concomitant medication in two weeks included Vitamins. On 04Mar2021 at 01:00 AM, the patient Woke up from sleep with itching throat, slight wheezing, and mucous causing cough. It caused her to have a feeling of anxiousness because it happened so suddenly. After about 1 hour, it stopped just as suddenly as it all started. Arm was also sore enough that it hurt to lay on it. No swelling at injection site. This lasted for about 1 hour. On 09Mar21 noticed a bright red rash starting at the wrists and extending up to forearm. The red rash was tender almost like a sunburn. The patient had not been tested for COVID-19 post vaccination. No treatment for AEs. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Paraesthesia oral, Pruritus, Swelling face
Clinical narrative: itchiness body wide; headache; tingling in mouth and face; tingling in mouth and face; swollen face; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 13:00 (Lot Number: EN6207) (at the age of 52-years-old) as 1st Dose, single dose for covid-19 immunization. Medical history included PFO/ASD (Atrial Septic Defect) , TIA (transient ischaemic attack), asthma, high BP (blood pressure),  diabetic and obesity. Patient has known allergies in cinnamon, cloves, allspice, adhesives, mold and pollens. The patient was not pregnant and did not have COVID prior to vaccination. Concomitant medications included BP medication, zolpidem and cholesterol medication. The patient did not receive other vaccine in four weeks. The patient experienced itchiness body wide, headache, tingling in mouth and face and swollen face even after taking 2 BENADRYL on 09Mar2021 at 13:15. The patient was not tested for COVID post vaccination. The outcome of events  was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea; vomiting; stomach cramps; explosive diarrhea; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201 expiration date: unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 50-years-old) at unknown, single dose for covid-19 immunization. Medical history included hypothyroidism and high blood pressure. The patient was not pregnant at the time of reporting. Concomitant medications included rosuvastatin, losartan, levothyroxine, liothyronine sodium (LIOTHYRONIN). Patient previously received TOPAMAX and experienced allergies and adverse side effect. The patient did not have COVID prior to vaccination. The patient did not receive other vaccine in four weeks. On 10Mar2021 at 02:45, the patient experienced nausea, vomiting, stomach cramps, and explosive diarrhea. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Breast pain, Chest pain
Clinical narrative: blood pressure was up and it was 150/83; Left arm pain; Pain across right breast immediately after shot which passed right away; pain across chest; whole left side of the body where patient got the shot hurts/ pain on left side; left side of the face, whole left side of the body where patient got the shot hurts; pain on left side, left shoulder; pain on left side, ear; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 08Mar2021 17:00 (Batch/Lot Number: LAB-1451-1.1) at 63 years old as 1st dose, single dose for COVID-19 immunisation. Medical history included High blood pressure. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, she was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine and olmesartan, both taken for unspecified indications, start and stop dates were not reported. The patient previously took acetaminophen and experienced allergies. On 08Mar2021 17:15, the patient experienced left arm pain and pain across right breast immediately after shot which passed right away (as reported). The patient woke up with pain across chest. She called an ambulance and they checked her out. Her left side of the face, whole left side of the body where patient got the shot hurts. Her left ear, left shoulder. Felt like someone has taken a bat and hit me on my left side. The patient called the ambulance, and they came because patient thought she was having a heart attack, but she was not. The patient had pain across chest, pain on left side, ear and chest and shoulder and all on her left side have that pain. Events started on 08Mar2021 17:15, right away on Monday when she had the vaccine, right away it happened and then it stopped (as reported). When the ambulance came, they said patient's blood pressure was up and it was 150/83 mmHg on an unspecified date and her blood pressure was never that high. Patient stated that she was still experiencing the events and it worsened. At the emergency they told me to take 4 Baby Aspirin and it was 81 mg. Also, she has been rubbing alcohol on chest, on ears everywhere it is hurting, shoulder because she was hoping that would calm the pain. Events resulted in Emergency room/department or urgent care. No seriousness criteria provided. Outcome of event "blood pressure was up and it was 150/83" was unknown; while all other events were not outcome of not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial pain, Pain, Pain in extremity
Clinical narrative: blood pressure was up and it was 150/83; Left arm pain; Pain across right breast immediately after shot which passed right away; pain across chest; whole left side of the body where patient got the shot hurts/ pain on left side; left side of the face, whole left side of the body where patient got the shot hurts; pain on left side, left shoulder; pain on left side, ear; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 08Mar2021 17:00 (Batch/Lot Number: LAB-1451-1.1) at 63 years old as 1st dose, single dose for COVID-19 immunisation. Medical history included High blood pressure. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, she was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amlodipine and olmesartan, both taken for unspecified indications, start and stop dates were not reported. The patient previously took acetaminophen and experienced allergies. On 08Mar2021 17:15, the patient experienced left arm pain and pain across right breast immediately after shot which passed right away (as reported). The patient woke up with pain across chest. She called an ambulance and they checked her out. Her left side of the face, whole left side of the body where patient got the shot hurts. Her left ear, left shoulder. Felt like someone has taken a bat and hit me on my left side. The patient called the ambulance, and they came because patient thought she was having a heart attack, but she was not. The patient had pain across chest, pain on left side, ear and chest and shoulder and all on her left side have that pain. Events started on 08Mar2021 17:15, right away on Monday when she had the vaccine, right away it happened and then it stopped (as reported). When the ambulance came, they said patient's blood pressure was up and it was 150/83 mmHg on an unspecified date and her blood pressure was never that high. Patient stated that she was still experiencing the events and it worsened. At the emergency they told me to take 4 Baby Aspirin and it was 81 mg. Also, she has been rubbing alcohol on chest, on ears everywhere it is hurting, shoulder because she was hoping that would calm the pain. Events resulted in Emergency room/department or urgent care. No seriousness criteria provided. Outcome of event "blood pressure was up and it was 150/83" was unknown; while all other events were not outcome of not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: fever, 101 degrees; head congested; headache; body aches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the right arm, on 09Mar2021 at 11:00 (at the age of 50 years old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and acid reflux. The patient had no known allergies. The patient's concomitant medications were not reported. On 09Mar2021, 10:00 PM, the patient experienced fever, 101 degrees, head congested, headache, and body aches. The patient reported that the events lasted for about 5 hours then he felt fine and they started 10 hours after he received the shot. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 09Mar2021. No treatment was received for the events. The outcome for the events was recovered on 10Mar2021, at 03:00.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in my mouth continues; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the right arm on 09Mar2021 16:45 (at the age of 65-years-old) as first dose, single dose for COVID-19 immunisation at a pharmacy/ drug store. The patient's medical history was not reported. Concomitant medications included calcium carbonate (CALTRATE) and vitamin C; both taken for an unspecified indication, start and stop dates were not reported. The patient was healthy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 09Mar2021 17:00, the patient experienced metallic taste in her mouth continued. No treatment was taken for the event. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: fatigue; Pain at the sight of injection; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date not reported), via an unspecified route of administration, administered in the right arm on 08Mar2021 09:00 (at the age of 48-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included chronic bronchitis, penicillin allergy, and COVID-19. Concomitant medications included losartan (manufacturer unknown); cod liver oil (manufacturer unknown); and unspecified multivitamin, all taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, pain at the sight of injection, and headache on 09Mar2021 07:00. Patient was scheduled for 2nd dose on 30Mar2021. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia
Clinical narrative: tingling in left hand / tingling of right hand, both feet; tightness in left forearm and bicep; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EL0140, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 25Feb2021 15:30 (at the age of 64-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included granuloma annulare and hypothyroidism both from an unknown date; breast cancer from 1991 and unknown if ongoing. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN), levothyroxine sodium (SYNTHROID), macrogol 3350 (MIRALAX), colecalciferol (VIT D3) and more unspecified medications all taken for an unspecified indication, start and stop date were not reported.  The patient has known allergies: LEVAQUIN (reaction not allergic). The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 27Feb2021 22:00, the patient experienced tingling in left hand / tingling of right hand, both feet and tightness in left forearm and bicep. No treatment was received for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache; Body ache; Sore throat; Chills; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 1283, expiration date: unknown), via an unspecified route of administration on 01Mar2021 (at the age of 39-years-old) at 1st dose, single dose in right arm for covid-19 immunization at clinic. The patient has no known allergies. The patient did not have COVID prior to vaccination.The patient medical history was not reported. Concomitant medication included metoprolol. It was reported that the patient was not pregnant. On 02Mar2021, the patient experienced headache, body ache, sore throat, and chills. The patient has not been tested for COVID post vaccination. Outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: A feeling of tingling of my hands and feet and arms and legs... I'm feeling some on my torso too..more like little picks or stings/ bites... and like bugs crawling on me.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN9581; Expiration date was not reported), via an unspecified route of administration in the left arm on 04Mar2021 11:00 (at the age of 58-years-old) as unknown, single dose for COVID-19 immunisation at a church. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included type 2 diabetes controlled with diet and neuropathy experienced with one of the chemotherapy drugs, both from an unknown date and unknown if ongoing; and Breast cancer (which was treated four years ago) from 2017 to an unknown date. Concomitant medications included metoprolol, lisinopril, omeprazole and electrolytes; all taken for an unspecified indication, start and stop dates were not reported. The patient previously took Ciprofloxacin (CIPRO), Clindamycin, Celecoxib (CELEBREX) and Fluconazole (DIFLUCAN) and experienced drug allergy. On 05Mar2021, the patient experienced a feeling of tingling of her hands and feet and arms and legs and some on her torso too more like little picks or stings or bites and like bugs crawling on her. No treatment was taken for the event. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected