chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Feeling abnormal, Pharyngeal swelling
Clinical narrative: Every joint hurts; light headed; diarrhea; feeling awful; throat feeling swollen; This is a spontaneous report from a non-contactable consumer (patient).  A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 06Mar2021 08:00 (at the age of as 34-year-old) unknown, single dose for COVID-19 immunisation. Medical history included allergy to NSAIDS. The patient's concomitant medications were not reported. On 13Feb2021, patient received other vaccine was administered in Arm. Patient did not receive any other vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. On 06Mar2021 at 13:00 (01:00 PM), patient experienced every joint hurts, light headed, diarrhea, feeling awful, throat feeling swollen. There was no treatment for the events. The clinical 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Migraine, Neck pain, Somnolence
Clinical narrative: fatigue, slept for five days; fatigue, slept for five days; severe headaches (tension and migraines) that don't go away; severe headaches (tension and migraines) that don't go away; neck and left shoulder pain; neck and left shoulder pain; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 at 05:00 PM as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included migraines, depression from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX 20 mg); linaclotide (LINZESS 290 mg); buspirone (BUSPIRONE 30 mg) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 18Feb2021 at 09:00 AM, patient experienced fatigue, slept for five days, severe headaches (tension and migraines) that don't go away, neck and left shoulder pain, had to go to emergency room twice for headaches, prescription medication for migraine doesn't work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken with IV tramadol, Compazine, Benadryl. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: fatigue, slept for five days; fatigue, slept for five days; severe headaches (tension and migraines) that don't go away; severe headaches (tension and migraines) that don't go away; neck and left shoulder pain; neck and left shoulder pain; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 at 05:00 PM as unknown, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included migraines, depression from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX 20 mg); linaclotide (LINZESS 290 mg); buspirone (BUSPIRONE 30 mg) for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 18Feb2021 at 09:00 AM, patient experienced fatigue, slept for five days, severe headaches (tension and migraines) that don't go away, neck and left shoulder pain, had to go to emergency room twice for headaches, prescription medication for migraine doesn't work. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken with IV tramadol, Compazine, Benadryl. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness and redness on injection site; Itchiness and redness on injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 24Feb2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced itchiness and redness on injection site and he wanted to know if this was normal after getting the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broken out in hives on my chest; This is a spontaneous report from contactable Nurse (reported as Other Health Professional) (patient reported herself) via Pfizer-sponsored program COVAX US Support. A 68-year-old female received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, NDC/UPC number: Unknown) via an unspecified route of administration on 14Feb2021 (Batch/Lot number: EL9269, Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history included blood pressure. Consumer stated, "she took blood pressure medications". On an unspecified date, the patient experienced broken out in hives on chest. Consumer stated, "she hoped it was not a big deal, she was getting second COVID vaccine on Friday the fifth and for the first time, last two days she had broken out in hives on chest and it was so long since she had the vaccine, she did not think it had anything to do with the vaccine. She might be having an allergic reaction to 'celery' that was the thing she got the last 2 days in a row and wondered if there was an issue getting her vaccine". Consumer was provided with the number of Pfizer Medical information Department. Consumer stated, "she had first one though and she was getting her vaccine one the fifth if she needed to know when she was getting her second". Consumer stated, "she really did not think it had anything to do with the vaccine. She wondered if she had history in the system if should had another. She got to ask medical people". It was reported that the patient received the first dose last 14Feb2021 and after a week she experienced hives on the chest. Caller was concerned if she could take the second dose of vaccine after the incident. The patient took Benadryl as a treatment. Outcome of the event was unknown. Causality: Consumer stated, "No".  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord oedema
Clinical narrative: Extreme swelling in the spinal column; This is a spontaneous report from contactable consumer reported for the patients mother via Pfizer. A female patient of an unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch number and expiry date were not reported) via an unspecified route of administration on 18Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 26Feb2021 the patient experienced extreme swelling in the spinal column. The patient hospitalized on 26Feb2021. The patient was transferred to an educational facility with more doctors and staff. The reporter wanted to confirm if there was any information from Pfizer that can help the medical doctors of his mother. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report from a Pfizer-sponsored program received via contactable consumer or other non-health care professional (patient).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.The patient got tested positive for Covid after that. The 2nd dose was coming up and she was wondering how long she can put it off. She states there's no information published out there that recommends getting the vaccine outside of the 21-day period. She states CDC mentions to get the vaccine as soon as you feel better. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date.The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Felt tingling in the chest; This is a spontaneous report from a non-contactable consumer (patient) through a Pfizer sales representative. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a 2nd dose, single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient had felt tingling in the chest. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), 1st dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that on an unspecified date after receiving the first dose of vaccine the patient experienced the cold sore. Caller would like to advise that she took Valacyclovir for her cold sore which was anti-virus. Today (i.e., 07Mar2021) was the schedule for her 2nd dose vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: 101 fever; body aches; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 101 fever, body aches on an unspecified date. Reportedly, patient received the 1st dose of the vaccine the other day and woke up this morning with 101 fever and body aches reporter wanted to know if they should to go the hospital. The patient underwent lab tests and procedures which included body temperature 101. Reportedly, no patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. There were no unaddressed medical questions referred or forwarded to medical information. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity
Clinical narrative: cold sore; arm is a little sore; This is a spontaneous report from a contactable female consumer (patient). A female patient with unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number/Expiration date: unknown), via unspecified route, on an unknown date as unknown dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced a cold sore and little arm sore (pain). The patient gets cold sore regularly and wanted to know if she can take her anti-bacterial medication she has been prescribed previously by her doctor. The reporter assessed all events as non-serious. The outcome of the events reported was unknown.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: feeling headachy; his stomach is not feeling real great; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient said that he had no side effect but on unspecified date of Mar2021, patient had been feeling headachy and his stomach was not feeling real great. Patient specified that was normal for him and stated it could be related to caffeine or diet. Patient asked if the mild side effects last more than a day or two after vaccination. The clinical outcome of both the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Arthralgia, Depressed mood, Feeling abnormal, Mood altered
Clinical narrative: Every joint in my body is painful; Need a nap in order to function; Mood changes (very sad and angry); Mood changes ( very sad and angry); Mood changes ( very sad and angry); This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 12:45 (Batch/Lot Number: En6203) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma, depression, food allergy from an unknown date and unknown if ongoing. Concomitant medications included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient previously took septocaine and experienced drug hypersensitivity. On 10Mar2021 the patient experienced every joint in my body is painful, need a nap in order to function, mood changes (very sad and angry). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: fatigue; upset stomach; Still experiencing headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 08Mar2021 at 08:00 as 2nd dose single for covid-19 immunization. The patient previously received first dose of BNT162B2 on 15Feb2021 via unspecified route, administered in right arm on 15Feb2021 as 1st dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included Losartan for blood pressure and Multivitamin Active. On 09Mar2021, after the second dose of Covid-19 vaccine, the patient experienced headaches for a week. He heard of 24-36 hours, but this is dragging. On 11Mar2021, the patient experienced upset stomach and fatigue The outcome of the events Still experiencing headache and upset stomach were not recovered and fatigue was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Hives over the injection site about 1 inch in diameter; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). An elderly patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021 10:00 as a single dose for Covid-19 immunisation. Patient's medical history and concomitant medications were reported as none. No known allergies were reported. The patient has not had symptoms associated with Covid-19. The patient is not enrolled in clinical trial. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not receive any other medications within 2 weeks prior to the Covid vaccine. Patient was not diagnosed with Covid-19 prior to vaccination and also since the vaccination. The patient had not been tested for Covid-19 since the vaccination. On 16Mar2021, the patient experienced hives over the injection site about 1 inch in diameter that didn't appear until 8 days after the 'shop'. No therapeutic measures were taken for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's last name was added. Protect Confidentiality checked since reporter is the patient self. Patient's full name and country added in patient tab. Removed the duplicate reported Indication of BNT162B2. BNT162B2 stop date/time was added. Lot# Unknown was removed from vaccine information tab and frequency "Single" was added in dosage regimens tab. Event treatment received was ticked as No as per source. Final sentence updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained". Relevant medical history added as none. Vaccination facility information "facility name/City/State/postal code" was added. Event term was updated as "Hives over the injection site about 1 inch in diameter" as per source; coding was updated from "Injection site hives" to "Vaccination site urticaria". Initial missed narrative was added "if other vaccine in four weeks: No", "If other medications in two weeks: No", "adverse event: Hives over the injection site about 1 inch in diameter that did not appear until 8 days after the 'shop'", "if treatment for adverse event AE: No, known allergies: No", "other medical history: None", "Prior to vaccination, was the patient diagnosed with Covid-19: No; Since the vaccination, has the patient been tested for Covid-19: No".
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Vaccination site pain
Clinical narrative: Headache; some pain in the same gluteal muscle; some pain in the same gluteal muscle; little achiness; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date of Feb2021 (4 weeks ago from 12Mar2021) as 1st dose, single for covid-19 immunisation. Medical history included previous injury from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took Pristiq 1 year ago and had to gradually increase her dose but eventually had a reaction to it, patient had a very severe pain in her left gluteal muscle. Patient supposed it was there due to a previous injury, but it only showed up when patient increased the (Pristiq) dose and went away when patient got off of it. On unspecified date of Feb2021 (in the first day or two after vaccination), besides some little achiness and headache, patient also had some pain in the same gluteal muscle, it was not nearly as severe, it did not last more than a day or two. Patient 2nd COVID-19 vaccination was scheduled for tomorrow (13Mar2021). It was stated that polyethylene glycol was an ingredient present in Pristiq and was also part of the molecule in a vaccine ingredient. Patient was referred to a healthcare professional/the vaccination provider for additional guidance before vaccination, if she considers she had an allergic reaction to Pristiq and was concerned she may develop a similar reaction after the 2nd COVID-19 vaccine dose, suggested to mention her clinical history, allergies and other conditions. Patient asked what were the symptoms of an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine, was muscle pain (gluteal muscle) one of them and in response it was mentioned that the incidence of muscle pain in patients above 56 years old. The outcome of the events was recovered on an unspecified date of Feb2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen and painful lymph nodes in left armpit; Swollen and painful lymph nodes in left armpit; This is a spontaneous report from a contactable other hcp (patient).A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 46-years-old), as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history of the patient was not reported. Concomitant medications included colecalciferol (VITAMIN D 3,50000 IU) taken for an unspecified indication, start and stop date were not reported; omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported. The patient did not have any allergies to medications, foods or other products. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had tested for COVID-19 as well. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 13Mar2021 at 17:00, the patient experienced swollen and painful lymph nodes in left armpit.The patient did not received any treatment for the events reported.The patient underwent lab tests and procedures which included nasal swab test on 30Jan2021 and the test result was found to be negative. Outcome of the events were reported as recovering at this time of the report.  No follow-up attempts are needed. No further information is expected.  Follow Up (25May2021): The following information was updated reporter, VAERS Primary Reporter Addl Qualification updated to patient,Age/Units captured as 46 years per event's onset:13Mar2021. relevant medical history none, for both events: Treatment Received  captured No Vit D, recoded as VITAMIN D 3, PRILOSEC recoded as PRILOSEC [OMEPRAZOLE] concomitant medication reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report received from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: EN6205), via an unspecified route of administration as 1st dose, single dose on 16Mar2021 (at the age of 36-years-old) for COVID-19 immunization. Medical history included ongoing asthma on Symbicort and Albuterol, ongoing seasonal allergy, affective disorder from an unknown date. Concomitant medications included cetirizine hydrochloride (Zyrtec) taken for seasonal allergy from an unknown date; bupropion hydrochloride (Wellbutrin) taken for affective disorder from an unknown date; albuterol salbutamol (Albuterol) taken for asthma (from an unknown date; budesonide, formoterol fumarate (Symbicort) taken for asthma, from an unknown date. On 16Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling PMH includes asthma (on Symbicort and albuterol). Takes Zyrtec daily for seasonal allergies and on Wellbutrin for mood stabilizing. She did not eat or drink anything today other than coffee. She has not taken her zyrtec or albuterol dose today. The seriousness criteria of the event was reported as non-serious by the reporter. Treatment included: water and snacks. Follow up response to treatment was excellent. The patient was discharged and stable to go home and follow up with PCP. The clinical outcome of the event light-headedness was resolved on an unspecified date.  No follow-up attempts were possible. No further information was expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension
Clinical narrative: High blood pressure with High heart rate and headaches daily; High blood pressure with High heart rate and headaches daily; High blood pressure with High heart rate and headaches daily; This is a spontaneous report received from a contactable other healthcare professional. A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 48-years) as single dose for COVID-19 immunisation. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581) on 02Feb2021 at 07:00 hours as a single dose for COVID-19 immunisation. Medical histories included high cholesterol, hormonal hair loss and ocular migraines. The patient had allergies to phenergan, compazine, tigan, sulfa, demerol and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), Nexium, Advil, atorvastatin (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN) and finasteride (MANUFACTURER UNKNOWN). Patient received all these medications within 2 weeks of vaccination and exact therapy dates and indications of these medications were not reported. On 24Feb2021 at 06:30 hours, the patient experienced high blood pressure with high heart rate and headaches daily. The patient was treated with blood pressure and heart rate control medication. At the time of this report, the patient was not recovered from the events high blood pressure, high heart rate and headaches.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: small welts all over my back, neck and arms; This is a spontaneous report received from consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration in the left arm on 16Mar2021 at 18:15 (at the age of 39 years old), as a single dose for COVID-19 immunisation. The patient's medical history included hypertension and diabetes from unknown date. Concomitant medications included amlodipine(unknown manufacturer), losartan(unknown manufacturer) and hydrochloric (unknown manufacturer) and all for unknown indication from unknown date and is unknown if ongoing. The patient has shell allergy and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 16Mar2021 at 19:30, the patient experienced small welts all over back, neck and arms . The patient did not receive any therapeutic measures for the event. The clinical outcome of the event welts was recovered on unknown date in MAR2021.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site swelling
Clinical narrative: brusing around site; Swollen; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown), via an unspecified route of administration on the left arm on 16Mar2021 at 15:30 as single dose for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced sore arm, swollen and bruising around site on 16Mar2021. No therapeutic measures were taken for the adverse events. The clinical outcome of the events vaccination site bruising, vaccination site swelling and painful arm were recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Overwhelming exhaustion; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206), via an unspecified route administration in the left arm on 08Mar2021 at 16:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and obesity. Concomitant medications included multivitamin, simvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date. Patient reported that he had known allergy penicillin, erythromycin, gluten sensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced overwhelming exhaustion, dizziness on 08Mar2021 at 19:15 (three hours after the vaccination). The patient reported that he was remained very tired for at least 24 hours longer. Therapeutic measures were not taken for the event. The clinical outcome of the exhaustion and dizziness was recovered on 08Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body pain; Chills; Mild fever; This is a spontaneous report received from a contactable non-healthcare professional reporting for a patient. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concomitant therapies were not reported. The patient experienced chills, mild fever and body pain on 16Mar2021.The patient did not receive treatment for the reported events. The clinical outcome of the chills, fever and general body pain was resolving at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Hypersensitivity, Urticaria
Clinical narrative: Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; This is spontaneous report received from contactable healthcare professional, the patient. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 16Mar2021 at 12:45 hours, (at the age of 52-year) as a single dose for COVID-19 immunisation. Medical history included asthma, dust mite allergy, fibroids, low iron/calcium and high platelets. It was unknown whether the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient received concomitant medications within 2 weeks of vaccination however, the medications were not reported. On 16Mar2021 at 13:00 hours, the patient had allergic reaction and heart burn feeling with hive reaction. It was unknown whether the patient received any treatment for these events. The clinical outcome of the events allergic reaction, heart burn feeling with hive reaction was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest pain, Dizziness, Eructation, Flatulence
Clinical narrative: Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; This is spontaneous report received from contactable healthcare professional, the patient. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 16Mar2021 at 12:45 hours, (at the age of 52-year) as a single dose for COVID-19 immunisation. Medical history included asthma, dust mite allergy, fibroids, low iron/calcium and high platelets. It was unknown whether the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient received concomitant medications within 2 weeks of vaccination however, the medications were not reported. On 16Mar2021 at 13:00 hours, the patient had allergic reaction and heart burn feeling with hive reaction. It was unknown whether the patient received any treatment for these events. The clinical outcome of the events allergic reaction, heart burn feeling with hive reaction was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease, Headache, Hypersensitivity, Irritability, Paraesthesia
Clinical narrative: Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; This is spontaneous report received from contactable healthcare professional, the patient. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 16Mar2021 at 12:45 hours, (at the age of 52-year) as a single dose for COVID-19 immunisation. Medical history included asthma, dust mite allergy, fibroids, low iron/calcium and high platelets. It was unknown whether the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient received concomitant medications within 2 weeks of vaccination however, the medications were not reported. On 16Mar2021 at 13:00 hours, the patient had allergic reaction and heart burn feeling with hive reaction. It was unknown whether the patient received any treatment for these events. The clinical outcome of the events allergic reaction, heart burn feeling with hive reaction was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased
Clinical narrative: Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; This is spontaneous report received from contactable healthcare professional, the patient. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 16Mar2021 at 12:45 hours, (at the age of 52-year) as a single dose for COVID-19 immunisation. Medical history included asthma, dust mite allergy, fibroids, low iron/calcium and high platelets. It was unknown whether the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient received concomitant medications within 2 weeks of vaccination however, the medications were not reported. On 16Mar2021 at 13:00 hours, the patient had allergic reaction and heart burn feeling with hive reaction. It was unknown whether the patient received any treatment for these events. The clinical outcome of the events allergic reaction, heart burn feeling with hive reaction was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling
Clinical narrative: Right side breast has been feeling pressure/pain - close to armpit.  No lump but feels a bit swollen and hurts when there is pressure; Right side breast has been feeling pressure/pain - close to armpit.  No lump but feels a bit swollen and hurts when there is pressure; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on right arm on 11Mar2021 at 14:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were reported by the patient. Prior to vaccination, the patient was diagnosed with covid 19. Since the vaccination patient had not been tested for COVID-19 virus. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No relevant past drug history was reported by the patient. On 13Mar2021 patient experienced right side breast pain and breast swelling. The patient also reported that her right-side breast was feeling pressure or pain- close to armpit and no lumps, but felt a bit swollen and hurt when there was pressure. No therapeutic measures were taken for the adverse events. The clinical outcome of the events breast pain and breast swelling were not recovered at the time of this report.   No follow up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: headache; fever; chills; arthralgia; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient. A 57-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EP7534) via unspecified route of administration in left arm on 16Mar2021 at 14:30 hours (at the age of 57-years approximately) as a single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patients medical history included asthma from an unknown date. The patient reported to be allergic to shellfish from an unknown date. The patients past drug history includes BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EL9266) (1st dose, single) via unspecified route of administration in left arm on 24Feb2021 for COVID-19 immunisation. On 17Mar2021 at 04:00 hours, the patient experienced headache, fever (up to 101.8 degrees F), chills and arthralgia, that began approximately 12 hours after the vaccine was administered. Therapeutic measure for adverse event includes treatment with acetaminophen. The clinical outcome of the events headache, fever, chills and arthralgia was found to be recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Feeling muscle aches; FEBRILE; SORE THROAT; HEADACHE; This is a spontaneous report received from a contactable nurse. A 21-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), intramuscularly in her left arm on 19Jan2021 (age at vaccination 21-year-old), at 07:15 for COVID-19 immunisation. On 09Feb2021, the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in her right arm. The patients medical history was not reported. Concomitant medication included loratadine (MANUFACTURER UNKNOWN) 10 mg, ESTARYLLA 0.25mg/0.035mg, calcium supplement (MANUFACTURER UNKNOWN) 500mg, multivitamin (MANUFACTURER UNKNOWN), FLONASE for an unknown indication from an unknown start date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Jan2021, the patient experienced muscle aches, sore throat and she was febrile for 2-3 weeks until second dose, regular symptoms like headache happened for first 48 hours. The patient did not receive any treatment for the events. The clinical outcome for the events headache (happened for first 48 hours), muscle aches, febrile and sore throat was resolved on an unknown date (2-3 weeks until second dose).   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Slight temperature; Soreness atinjection site; This is a spontaneous report from a contactable patient. A 59-year-old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, lot number: EL3247), via unknown route of administration in left arm on 16Mar2021 at 9.30 hours (at the age of 59 years of vaccination) as a single dose for Covid-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to medications, food or other products. Concomitant medication included olmesartan medoxomil 20 mg (MANUFACTURER UNKNOWN) for an unknown indication and its unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks of vaccination. On 17Mar2021 at 16.00 hours, the patient experienced chills, slight temperature and soreness at injection site. Patient received treatment with two Tylenol for the events. The clinical outcome for the events chills, slight temperature and soreness at injection site was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Sore arm; Felt light headed; left side of my face becoming numb; restricted breathing threw my nose; pain forming in the left side of my neck; left cheek on my face began to swell; top left part of my throat began to swell; tingling feeling on the left side of my face.; This is a spontaneous report from a contactable consumer, the patient.   A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 16Mar2021 at 03:15 PM as a single dose for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications included ZYRTEC D for unknown indication from an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 03:30 PM the patient experienced pain in arm, light headed (waited the recommended 15 minutes and left), numbness in face, breathing difficulty, neck pain (immediately went back to the facility that administrated the shot, was put under observation), cheek swelling, throat swelling and tingling. Treatment received for the events included diphenhydramine and Tylenol. The clinical outcome of the events pain in arm, light headed, numbness in face, breathing difficulty, neck pain, cheek swelling, throat swelling and tingling was resolving.   No follow-up attempts are possible. No further information is expected.