chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, Sepsis
Clinical narrative: Pneumonia; Sepsis; Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SEPSIS (Sepsis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), SEPSIS (Sepsis) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, PNEUMONIA (Pneumonia), SEPSIS (Sepsis), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication was not given.   No treatment information was provided.  On 2 May 2021, SARS-CoV2 test was performed, results not provided.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Magnetic resonance imaging, Tinnitus
Clinical narrative: Completely lost hearing in her right ear; Pulsatile tinnitus/ringing is coming from my left ear/pulsating in my left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Completely lost hearing in her right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TINNITUS (Pulsatile tinnitus/ringing is coming from my left ear/pulsating in my left ear). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Completely lost hearing in her right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Completely lost hearing in her right ear) and TINNITUS (Pulsatile tinnitus/ringing is coming from my left ear/pulsating in my left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Magnetic resonance imaging: normal (normal) MRI Fine.         Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Myelitis transverse; This spontaneous case was reported by a nurse and describes the occurrence of MYELITIS TRANSVERSE (Myelitis transverse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced MYELITIS TRANSVERSE (Myelitis transverse) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Myelitis transverse) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had 5 MRIs and numerous doctor's appointments since Jan-2021. The symptoms began within hours of receiving his first Moderna shot in Jan-2021.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Patient hospitalized because chemotherapy is not working properly.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CONDITION AGGRAVATED (Patient hospitalized because chemotherapy is not working properly.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.   On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced CONDITION AGGRAVATED (Patient hospitalized because chemotherapy is not working properly.) (seriousness criterion hospitalization). At the time of the report, CONDITION AGGRAVATED (Patient hospitalized because chemotherapy is not working properly.) outcome was unknown.            Treatment medication was not provided.  Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information is not expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hot flush, Hypertension
Clinical narrative: Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), via an unspecified route of administration, administered in right arm on 25Jan2021 13:45 (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, asthma and hypertension. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination (not reported details of medications). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 14:30, the patient experienced hot flash in the face within 45 minutes of the shot. On 26Jan2021 02:45, the patient had tachycardia and high blood pressure which started at approximately 13 hours after the shot. High Blood pressure remained for about the next six days, but the elevated pulse has continued. The adverse event resulted patient to doctor or other healthcare professional office/clinic visit. The patient received treatment - increase in blood pressure medication.   Outcome of the event elevated pulse was not recovered and the outcome for other events was recovered with sequel.  Follow-up attempts are completed. No further information was expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), via an unspecified route of administration, administered in right arm on 25Jan2021 13:45 (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, asthma and hypertension. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination (not reported details of medications). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 14:30, the patient experienced hot flash in the face within 45 minutes of the shot. On 26Jan2021 02:45, the patient had tachycardia and high blood pressure which started at approximately 13 hours after the shot. High Blood pressure remained for about the next six days, but the elevated pulse has continued. The adverse event resulted patient to doctor or other healthcare professional office/clinic visit. The patient received treatment - increase in blood pressure medication.   Outcome of the event elevated pulse was not recovered and the outcome for other events was recovered with sequel.  Follow-up attempts are completed. No further information was expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achy; bit tired; This is a spontaneous report from a contactable Other Health Professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as (At the age of 43-years) SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced achy and bit tired on an unspecified date. It was reported that patient Did not have headache with second dose but felt achy and a bit tired. The outcome of events was unknown. The patient provided information regarding the reported adverse event(s) with the use of the product. The patient considered the Pfizer product had a causal effect to the adverse event.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Overdose, Product preparation error, Tremor
Clinical narrative: 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine; 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine; chills; shakes; This is a spontaneous report from a non-contactable other health care professional (Nurse). This nurse reported similar events for 5 patients. This is 5th of 5 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 05Feb2021 as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Patient did not received other vaccines in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested COVID post vaccination. The patient medical history and concomitant medications were not reported. It was reported that the 6 individuals received a 0.3ml dose of undiluted pfizer covid-19 vaccine, had chills and shakes at 24 hours on 05Feb2021. No side effects observed/reported at 1 hour post vaccination. No side effects/adverse effects were observed/reported at 48 hours post vaccination. No treatment was received. The patient was recovered from chills and shakes. The outcome of the event 6 individuals received a 0.3ml dose of undiluted pfizer covid-19 vaccine was unknown.   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 includes: Recoded event "Drug maladministration event" to "Overdose", Removed "At risk" classification.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021161810 same reporter/drug/similar AE with different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Muscle pain; Headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 56-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 11:00 as dose 2, single for COVID-19 Immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received first dose of (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 13:15 as dose 1, single for covid-19 immunisation. The patient previously took zyrtec and clindamycin and had allergies to them. The patient experienced muscle pain and headache on 18Feb2021 at 22:00. The patient was not diagnosed with COVID-19 prior and post vaccination. Therapeutic measures were taken as a result of muscle pain, headache as hot shower and Tylenol/advil. The outcome of the event were recovering.   Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Tightening of throat (thickening) some itch.; Minor difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 11:00 as single dose (at the age of 73-years-old) for covid-19 immunisation. Medical history included breast cancer, coronary artery, hypertension, hypothyroidism. Patient has known allergies which included anaphylactic history to fin fish. Concomitant medications included levothyroxine sodium, lisinopril, atorvastatin and vitamin D. The patient experienced tightening of throat (thickening) some itch and minor difficulty swallowing on 01Mar2021 12:00. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were not taken in response to the events. Patient did not take any other vaccine in 4 weeks. Patient did not have covid prior to vaccination. Patient was not tested for covid post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: for a root canal; bad allergy; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the vaccine on 23Feb2021 (yesterday afternoon), and she was going to a dentist for a root canal on an unspecified date. The patient said she will take ZYRTEC as therapeutic measure (for bad allergy which started on an unspecified date in between doses and was asking if it was okay since she was also scheduled for a 2nd dose. Therapeutic measures were taken as a result of the event tooth disorder. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report from a contactable consumer reported for a patient (mother). This is a report received from Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for Covid 19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced urinary tract infection on an unspecified date. The patient underwent lab tests which included investigation: tested positive for urinary tract infections. The caller is asking for his mother who is due to get the second dose of the Covid19 vaccine because his mother tested positive for urinary tract infections. The caller is asking how long her mother can take the second dose since her mother still has urinary tract infections. The outcome for event urinary tract infection was not recovered.  Information about lot /batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: upper arm soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Mar2021 at 15:15 PM (age at vaccination: 54 Years), as a single dose for COVID-19 immunization at workplace clinic. The patient's medical history Meniere's disease and spring allergies from pollen and mold. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Simvstatin, Lisinopril, and Tranmadol. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 04Mar2021, he experienced upper arm soreness. The patient became aware of these symptoms the day after the injection. The patient did not receive treatment for the adverse event. Outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypertension, Pyrexia
Clinical narrative: high blood pressure; fever; chills; This is a spontaneous report from a Pfizer sponsored program, reported from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 26Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced high blood pressure, fever and chills on an unspecified date. The patient took Tylenol after the 1st dose dated 26Feb2021. Outcome of all the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: mild tightening in my throat; slight discomfort in swallowing; This is a spontaneous report from a contactable consumer (patient). A 61-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 Left arm on 10Mar2021 14:15 (at the age of 61-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included high cholesterol, hay fever (seasonal) allergies. No other known allergies reported. Concomitant medication included Atorvastatin 10 mg daily. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and had not covid tested post vaccination. On 10Mar2021 15:30, about an hour after the injection, patient felt a mild tightening in throat and slight discomfort in swallowing. Enough to notice but not cause any real difficulty in swallowing. It lasted for about an hour and a half. Patient did not receive any treatment for adverse events. The outcome of the events was recovered on 10Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection
Clinical narrative: bacterial infection; This is a spontaneous report from a contactable consumer (reporter's wife) via Pfizer-sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 18Feb2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history included battling a bacterial infection. The patient's concomitant medications included series of antibiotics. The reporter stated that she and her husband are both due to get their second dose tomorrow 11Mar2021. Her husband had been battling a bacterial infection since January and he had been on and off antibiotics since then. He just started another series of antibiotics, and his bacterial infection which leads him to take Amoxiclav. Since Sunday he was taking 2 tablets a day, 875 mg per tablet. They want to know if it was ok, if that was possible. He started taking that Sunday and she doesn't know if that interfered with anything with the vaccine, she wanted to know if there are any known interactions with those 2 things. She said it has been 3 weeks tomorrow since the first shot, but she does not know if they should extend that period until he stops taking the antibiotic, his last day on it the antibiotic would be Saturday. She clarified her husband had been dealing with an antibacterial infection since before this first dose of the Pfizer COVID 19 vaccine. She also reported that, they are fine after the 1st dose of the vaccine last 18Feb2021 but, she had a little rashes in her lower eye that going to her cheek. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphonia, Headache, Oropharyngeal pain, Throat tightness
Clinical narrative: Sore throat; Throat got tighter and hoarsed; Throat got tighter and hoarsed; Chest started to get a little tight; Headache; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN 6202), via an unspecified route of administration, administered in left arm on 03Mar2021 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included multiple sclerosis, rheumatoid arthritis, breast cancer female from 2014 to an unknown date breast cancer 2014 and 2021, food allergy, seasonal allergy. Concomitant medication and in two weeks included gabapentin (NEURONTIN), lamotrigine (LAMICTAL), levothyroxine sodium (SYNTHROID) and prednisone. The patient had allergies with Rituxan, seafood, pineapple, watermelon, seasonal allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 16:05, the patient experienced headache with 5 minutes, at 16:15 started out as sore throat but the throat got tighter and hoarsed, chest started to get a little tight. She ended up taking Tylenol about 1/2 hour later and took Benadryl about an hour later. The patient received treatment. Outcome of the event was recovered.   No follow-up attempts are possible. No further information was expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Hypersensitivity, Paraesthesia, Throat tightness
Clinical narrative: I had tingling down my injection arm, up my neck, up the side of my face, and into my scalp all on the right side. In addition to the burning tingling; Burning tingling sensation,; Throat tightness.; Chest pain; Allergic reaction; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old non pregnant female received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via unspecified route in right arm on 18Mar2021 09:15 (at the age of 34-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not prior vaccination and COVID tested post vaccination. The patient medical history included 2 c-sections and wisdom teeth surgery. The patient concomitant medications include omeprazole, Ibuprofen and levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously received promethazine (PHENGRAN) and experienced allergies. On 18Mar2021 10:00 patient experienced tingling down her injection arm, up neck, up the side of her face, and into scalp all on the right side and to the burning tingling sensation, she had chest pain, and throat tightness also diagnosed with an allergic reaction. Patient went to the emergency room and he was given an iv, fluids, solu-Medrol, Benadryl, and sent home with a prescription for a steroid dose pack to take for the next 8 days, Benadryl, and epi pens. The outcome of all events was resolved with sequel.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: was diagnosed with sudden idiopathic hearing loss of my right ear with unrestricted hearing of the left ear; I started with pulsating tinnitus in my right ear several hours after my first Pfizer vaccination on March 15. I'm 62 years old with no prior hearing issues.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration in Arm Left on 15Mar2021 13:30(at the age of 62 years old) as single for COVID-19 immunisation. Medical history included hypertension and sleep apnoea syndrome both from an unknown date and unknown if ongoing. Allergies to medications, food, or other products was none. Concomitant medication taken within two weeks included acetylsalicylic acid (BABY ASPIRIN), nebivolol hydrochloride (BYSTOLIC), dronedarone hydrochloride (MULTAQ), and tamsulosin (TAMSULOSIN) all taken for an unspecified indication, start and stop date were not reported. Other vaccine taken within 4 weeks of COVID vaccine included SHINGLES dose 2 administered on 23Feb2021. The patient did not have COVID prior vaccination. Reported as, "I started with pulsating tinnitus in my right ear several hours after my first Pfizer vaccination on March 15 (15Mar2021). I'm 62 years old with no prior hearing issues. I was diagnosed with sudden idiopathic hearing loss of my right ear with unrestricted hearing of the left ear by an ENT on March 19 (19Mar2021). I am on a 13 day progressive intervention of prednisone, which I started on March 20 (20Mar2021)." Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event with Prednisone. Since the vaccination, the patient was not tested for COVID-19. Outcome of all the events were not recovered.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaginal haemorrhage
Clinical narrative: Vagina Bleeding and cramping; Vagina Bleeding and cramping; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, Expiry date: not reported, age at the time of vaccination: 60-year-old), via an unspecified route of administration, administered in Arm Right on 17Mar2021 08:15 as dose 2, single for covid-19 immunisation in facility. Medical history included High Blood Pressure, known allergies include Penicillin, Menopause (I have been post menopause for over 15 years.) Concomitant medication within 2 weeks included metoprolol succinate (TOPROL XL) at 50 mg. Previously the patient received first dose of bnt162b2 (Lot number EN6198), in Arm left on 25feb2021 12:00 for covid-19 immunization. On 17Mar2021 20:00, patient experienced vagina bleeding and cramping and the patient had received a treatment as she had contacted her physician. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19, prior to vaccination and since the vaccination. The outcome of events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling abnormal, Headache, Paraesthesia oral
Clinical narrative: headache; lightheaded and getting worse; lightheaded and getting worse; my lips were tingling; my cheeks, then my tongue, my checks got red and a bit swollen; breathing started to feel weird; breathing started to feel weird; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (at the age of 45-years-old) (Batch/Lot Number: EN6208) as Dose 1, Single for Covid-19 immunisation. Medical history included fibromyalgia, hypertension, vertigo, food allergy allergies tamiflu, meloxicam, coke, chocolate, food allergy from an unknown date. Concomitant medications included Montelukast, fexofenadine hydrochloride (ALLEGRA), Olmesartan, zinc taken for an unspecified indication, start and stop date were not reported. The patient previously took tamiflu and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity.Treatment medication includes benadryl, methylprednisolone IV, Pepcid, metoclopr. On 17Mar2021 15:15 the patient experienced after 10 min, got a headache, then felt lightheaded and getting worse every minute, then my lips were tingling, then my cheeks, then my tongue, my checks got red and a bit swollen, then my breathing started to feel weird. At this point I agreed to go on rescued. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of headache (headache), lightheaded and getting worse (dizziness), lightheaded and getting worse (condition aggravated), my lips were tingling (paraesthesia oral), my cheeks, then my tongue, my checks got red and a bit swollen (swelling), breathing started to feel weird (respiration abnormal), breathing started to feel weird (feeling abnormal). Events were considered as medically significant. Outcome of events were resolved on unspecified date in 2021 with no sequels.    Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Swelling
Clinical narrative: headache; lightheaded and getting worse; lightheaded and getting worse; my lips were tingling; my cheeks, then my tongue, my checks got red and a bit swollen; breathing started to feel weird; breathing started to feel weird; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (at the age of 45-years-old) (Batch/Lot Number: EN6208) as Dose 1, Single for Covid-19 immunisation. Medical history included fibromyalgia, hypertension, vertigo, food allergy allergies tamiflu, meloxicam, coke, chocolate, food allergy from an unknown date. Concomitant medications included Montelukast, fexofenadine hydrochloride (ALLEGRA), Olmesartan, zinc taken for an unspecified indication, start and stop date were not reported. The patient previously took tamiflu and experienced drug hypersensitivity, meloxicam and experienced drug hypersensitivity.Treatment medication includes benadryl, methylprednisolone IV, Pepcid, metoclopr. On 17Mar2021 15:15 the patient experienced after 10 min, got a headache, then felt lightheaded and getting worse every minute, then my lips were tingling, then my cheeks, then my tongue, my checks got red and a bit swollen, then my breathing started to feel weird. At this point I agreed to go on rescued. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken as a result of headache (headache), lightheaded and getting worse (dizziness), lightheaded and getting worse (condition aggravated), my lips were tingling (paraesthesia oral), my cheeks, then my tongue, my checks got red and a bit swollen (swelling), breathing started to feel weird (respiration abnormal), breathing started to feel weird (feeling abnormal). Events were considered as medically significant. Outcome of events were resolved on unspecified date in 2021 with no sequels.    Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Blood pressure increased, Blood pressure measurement, Dyspnoea
Clinical narrative: Blood pressure was 196\85/Blood Pressure was up next day; Pain in arm, then next day down into right lung area; Pain in arm, then next day down into right lung area; Pleurisy in lung; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Lost voice completely; Inflammatory reaction; Weakness this bad; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were unknown), via an unspecified route of administration in right arm on 22Feb2021 at 11:15 (at the age of 71-year-old) as unknown dose, single, for COVID-19 immunization, at Clinic. The patient's medical history included asthma, hypertension, penicillin allergy and silver drug allergy; stop date and start dates for all were unknown and unknown if ongoing. Concomitant medications included unspecified medications (within 2 weeks of vaccination). Patient experienced pain in arm, then next day down into right lung area. Went to doctor then to ER, ER did, X-Ray said had pleurisy in lung. Patient's blood pressure was 196\85. Awful pain in right lung. Hurt to talk, walk, breathe or even move, Lost voice completely, had Inflammatory reaction and Weakness this bad: all events were occurred on 23Feb2021 at 09:00 AM. Blood Pressure was up next day after vaccine 154/86. Patient took pain pills, steroids antibiotics and inflammatory medications. Lasted for over 3 weeks. Just now finally getting better. Patient went to primary care doctor, ER. Cardiologist and Going to lung doctor this Wednesday. Patient still have some pain in right lung area. Cardiologist said it sounded like an inflammatory reaction to the shot. Patient do have asthma so didn't, think much at first but never have this much pain. Nor high blood pressure. I laid on couch or bed for days after the shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19, Prior to vaccination. The patient was tested for COVID-19 and resulted as negative on 19Mar2021. Patient administered into ER and went to physician office visit for all the events. Seriousness of the events was reported as non-serious. Patient received the treatment for all the events. Outcome of the events was recovering.   Information about lot/batch number is requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Inflammation, Movement disorder, Pain in extremity, Pleurisy
Clinical narrative: Blood pressure was 196\85/Blood Pressure was up next day; Pain in arm, then next day down into right lung area; Pain in arm, then next day down into right lung area; Pleurisy in lung; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Lost voice completely; Inflammatory reaction; Weakness this bad; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were unknown), via an unspecified route of administration in right arm on 22Feb2021 at 11:15 (at the age of 71-year-old) as unknown dose, single, for COVID-19 immunization, at Clinic. The patient's medical history included asthma, hypertension, penicillin allergy and silver drug allergy; stop date and start dates for all were unknown and unknown if ongoing. Concomitant medications included unspecified medications (within 2 weeks of vaccination). Patient experienced pain in arm, then next day down into right lung area. Went to doctor then to ER, ER did, X-Ray said had pleurisy in lung. Patient's blood pressure was 196\85. Awful pain in right lung. Hurt to talk, walk, breathe or even move, Lost voice completely, had Inflammatory reaction and Weakness this bad: all events were occurred on 23Feb2021 at 09:00 AM. Blood Pressure was up next day after vaccine 154/86. Patient took pain pills, steroids antibiotics and inflammatory medications. Lasted for over 3 weeks. Just now finally getting better. Patient went to primary care doctor, ER. Cardiologist and Going to lung doctor this Wednesday. Patient still have some pain in right lung area. Cardiologist said it sounded like an inflammatory reaction to the shot. Patient do have asthma so didn't, think much at first but never have this much pain. Nor high blood pressure. I laid on couch or bed for days after the shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19, Prior to vaccination. The patient was tested for COVID-19 and resulted as negative on 19Mar2021. Patient administered into ER and went to physician office visit for all the events. Seriousness of the events was reported as non-serious. Patient received the treatment for all the events. Outcome of the events was recovering.   Information about lot/batch number is requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, SARS-CoV-2 test, Speech disorder, X-ray
Clinical narrative: Blood pressure was 196\85/Blood Pressure was up next day; Pain in arm, then next day down into right lung area; Pain in arm, then next day down into right lung area; Pleurisy in lung; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Hurt to talk, walk, breathe or even move; Lost voice completely; Inflammatory reaction; Weakness this bad; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were unknown), via an unspecified route of administration in right arm on 22Feb2021 at 11:15 (at the age of 71-year-old) as unknown dose, single, for COVID-19 immunization, at Clinic. The patient's medical history included asthma, hypertension, penicillin allergy and silver drug allergy; stop date and start dates for all were unknown and unknown if ongoing. Concomitant medications included unspecified medications (within 2 weeks of vaccination). Patient experienced pain in arm, then next day down into right lung area. Went to doctor then to ER, ER did, X-Ray said had pleurisy in lung. Patient's blood pressure was 196\85. Awful pain in right lung. Hurt to talk, walk, breathe or even move, Lost voice completely, had Inflammatory reaction and Weakness this bad: all events were occurred on 23Feb2021 at 09:00 AM. Blood Pressure was up next day after vaccine 154/86. Patient took pain pills, steroids antibiotics and inflammatory medications. Lasted for over 3 weeks. Just now finally getting better. Patient went to primary care doctor, ER. Cardiologist and Going to lung doctor this Wednesday. Patient still have some pain in right lung area. Cardiologist said it sounded like an inflammatory reaction to the shot. Patient do have asthma so didn't, think much at first but never have this much pain. Nor high blood pressure. I laid on couch or bed for days after the shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19, Prior to vaccination. The patient was tested for COVID-19 and resulted as negative on 19Mar2021. Patient administered into ER and went to physician office visit for all the events. Seriousness of the events was reported as non-serious. Patient received the treatment for all the events. Outcome of the events was recovering.   Information about lot/batch number is requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension
Clinical narrative: High blood pressure; This is a spontaneous report from a contactable consumer (patient himself).  A 75-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route in left arm on 04Mar2021 as single dose for COVID-19 immunization. The patient medical history included High Cholesterol. The patient concomitant medication included Atorvastatin (LIPOTOR) received within 2 weeks of vaccination. The patient medical history included prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested positive for COVID-19 since the vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EP6955 and expiration date was not reported), via unspecified route in left arm on 12Feb2021 at 10:00 as single dose for COVID-19 immunization. On 05Mar2021 patient had to take him to the emergency room with an unexplained high blood pressure of 220/106 pulse rate 100. It came down to 170/90 and was given a blood pressure medication. Two days later we had to make another emergency room visit with the same pressure readings. the blood pressure medication was doubled. a week later a third emergency room visit with the same pressure readings. For a person with no history of blood pressure this was baffling. Saw an article about an doctor with the same symptoms and decided to record it. The patient had Allergies to medication included Penicillin and he received as treatment Beta blockers for blood pressure. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood insulin
Clinical narrative: Then on 19Mar2021 the number was 176 and checked the morning of 21Mar2021 the number was 184.; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Solution for injection, Lot number: EN6208 and Expiration date: unknown) via an unknown route of administration, in left arm on 18Mar2021 11:45 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization. Medical history included diabetes, HPB and high cholerterol from an unknown date. Concomitant medications included insulin glargine (LANTUS, losartan, amlodipine besilate, fenofibrate and glibenclamide taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 18Mar2021 in the morning, my diabetic number was 129 and lower, then I got the vaccine, then on 19Mar2021 at 10:00, the number was 176 and on 20Mar2021 was 162. So, he increased insulin in the night of 20Mar2021 and checked the morning of 21Mar2021, the number was 184. He increased insulin dosage again in the night of 21Mar2021 and checked the morning of 22Mar2021 and the number was 176. This may not be correlated to the vaccine, but he wanted to report these events. No treatment was received for the event. The outcome of the event was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Nausea; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 18Mar2021 at 09:00 (at the age of 40 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 after vaccination. On 19Mar2021, the patient experienced nausea and lethargy. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea and lethargy was reported as not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information include in patient tab, patient name updated , for event lethargic no treatment  was received. Final sentence should be updated to no follow-up attempts are possible; information about lot/batch number cannot be obtained. Relevant history none added since not provided, pending PSSR review.