chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Much heavier more painful period with palm sized blood clot; Much heavier more painful period with palm sized blood clot; Much heavier more painful period with palm sized blood clot; 2nd dose: Fatigue for 24 hours; This is a spontaneous report received from a contactable consumer (patient) or other non-health care professional.   A 45-years-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EPV0150, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 as 2nd dose, single  for covid-19 immunisation. Medical history included, Hashimoto hypothyroid (from an unknown date and unknown if ongoing). Concomitant medications included levothyroxine sodium, bupropion, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6207), via an unspecified route of administration, administered in Arm Left on 15Mar2020 at 17:00 PM (at the age of 45-yesr-old) first dose, single for covid-19 immunisation and experienced Migraine headache with scintillating scotoma after 12 hours fatigue for one week much heavier more painful period. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient did not tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Doctor office/urgent care. The patient experienced after 2nd Dose fatigue for 24 hours, On Apr2021 and much heavier more painful period with palm sized blood clot, On unknown date. No treatment was received for the events. The outcome of the event fatigue was reported as recovered on Apr2021 and while for others was recovered on unknown date.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: my friend is vomiting her guts out and she needs to get her 2nd shot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patients friend) reported for a female patient of an unspecified age who received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller stated my friend was vomiting her guts out and she needs to get her 2nd shot. she reported her symptoms this morning to college location. Outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: After having the 2nd dose she developed bumps on her face that is very hard and hot to touch. It started to grow on the temple area and spread towards the nose, left eye, and left ear; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. An 82-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Jun2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 on 18May2021 single dose for covid-19 immunisation. On an unspecified date, after having the 2nd dose she developed bumps on her face that is very hard and hot to touch, it started to grow on the temple area and spread towards the nose, left eye, and left ear. Bumps are similar to size of a walnut- asking if it was a reported side effect of the vaccine and wants to get some recommendations from Pfizer. She mentioned that after the second dose, she had on her skin a bump on her face. Now it had spread in the direction of her eyes to her left ear. Patient confirmed that everything was on the left side of her face. She said she needed to know what to do about it. She wondered if she needed to go to the emergency room or if she needed to have surgery. She said she did not know what to do. She does not know how far it was going to spread. Patient stated that she did not want to do safety report and wanted to be transferred to Medical Information to find out what to do. Patient was very upset because of the side effects that she had, and she mentioned that she encountered big problem because of the vaccination. Investigation assessment was not provided. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: This is a spontaneous report received from a contactable consumer (parent reporting for son) via Medical Information Team. A 28-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in May 2021 as 1st dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Son got the first dose Pfizer vaccine in early May 2021. On an unspecified date in 2021, he developed Bell's Palsy after getting the vaccine. Looking for any medical expert for someone who has had this happened to them after getting the first dose and should he get the second dose. She was asking if this will happen again if he gets the second dose. Reporter seriousness for he had a bells palsy reaction after the first dose was unspecified. The outcome of the event was unknown. Information on the lot/batch number has been requested
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: tested for COVID19 and result came out positive,cough; tested for COVID19 and result came out positive; runny nose; This is a spontaneous report from a non-contactable other HCP. A female patient in her 40's received her second dose Pfizer COVID19 vaccine. This is Case No. 12294 as announced by the press release on 10Jun2021. This other HCP reported for a female patient of 40-years-old received second dose of bnt162b2 (Pfizer-Biontech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Apr2021 as 2ND dose single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was unknown that the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the list of any other medications the patient received within 2 weeks of vaccination. Previously patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified) on 09Apr2021 as 1st dose, single dose for covid-19 immunization. She travelled on 03Jun2021 with negative COVID19 test result within 3 days prior to her departure. On 07Jun2021 while she was traveling she developed cough and runny nose but she did not seek medical attention. On 09Jun2021, her household members developed fever and were tested positive for COVID 19. This patient was then also tested for COVID19 and result came out positive. The outcome of the events was unknown.  No follow-up attempts possible. information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via medical information team. This is report 2 of 3. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: ENO179) via an unspecified route of administration, administered in left arm on 07Jun2021 as 1st single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Jun2021, the patient experienced sore left arm and headache. On an unspecified date in June 2021, the patient experienced nausea but it only lasted 24 hours. The patient informed that she experienced a really bad headache, soreness in her arm & nausea for a short period and she was fine already. The patient took Advil as treatment on 08Jun2021 for arms were sore. The outcome of the events was resolved on an unspecified date in June 2021. No follow-up attempts needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Started getting more frequent PVC's (Premature ventricular contractions) on a daily basis lasting for hours; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Left arm on 05Apr2021 at 01:00 PM as a single dose for covid-19 immunisation at hospital. The patient medical history was not reported. Concomitant medication included metoprolol and diuretic. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6208), via an unspecified route of administration, administered in Left arm on an unknown date as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four weeks of vaccination. On 19Apr2021, after the 2nd dose the patient started getting more frequent PVCs (premature ventricular contractions) on a daily basis lasting for hours. Treatment with metoprolol increased to 50 mg 2 times per day for the event. The event resulted in Emergency room/department or urgent care. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Shortness of breath; Sore throat; Headache; Runny nose; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 46-year-old female patient received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0168) via an intramuscular route of administration at deltoid right on 21May2021 as 1st dose, single dose (at the age of 46-year-old) for COVID-19 immunization. The NDC number of Pfizer COVID vaccine was unknown. Patient's medical history included asthma, bruit in carotid artery, mitral valve pro lapse (diagnosed years before), chronic bronchitis and demyelinating disease of the central nervous system (CNS). She did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. It was reported that post vaccination of 1st dose on an unspecified date (24May2021 or 25May2021), patient experienced shortness of breath, sore throat, headache and runny nose. In line with the side effects, she experienced after her 1st dose, she would like to seek recommendation in regards getting her 2nd dose. It was reported that she experienced body aches anyway from her condition and did not think it was related. She got Chronic Bronchitis every year but she did not get it this year. It was reported that she did not went for the doctor. No one can get her in until next week, which was when she was going to her ENT. She was going to ENT because she was pretty sure she has an ear infection. She is not sure if it was relevant to the shot or not. The other symptoms just happened not long ago. It was reported that, events was not-resolved.  No further details provided.  Follow up#1(PRD 11Jun2021): This is a follow-up spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 46-year-old female consumer (patient) reported for herself that: (She provided start date for all of her symptoms as either 24May2021 or 25May2021, which would have been 2-3 days after getting the first dose. She thought they would go away but they have not. All her other medications she has been taking for 17-18 years.  No further details provided. She did not go to the doctor.  No one can get her in until next week, which is when she is going to her ENT.  She is going to because she is pretty sure she has an ear infection.  She is not sure if it is relevant to the shot or not.)   No further details provided. Information on Lot/Batch number was available.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: he had fever and headache; he had fever and headache; This is a spontaneous report from a contactable consumer (patient's mother). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in left arm on 07Jun2021 at 11:00 (at the age of 14-years-old) as single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown) administered in left arm on 17May2021 at 11:00 as single dose for COVID-19 immunization and did not had reaction to it. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and did not administer additional vaccines on the same date of the Pfizer suspect. On 08Jun2021, the patient experienced fever (at 14:00) and headache. The fever was resolved shortly thereafter and was not much of a concern. It has been 4 days and the headache still persists. The consumer described that the headache happened when he moved his head. When he sat down or laid down, it didn't hurt. The consumer gave him Tylenol. No other treatment given. The pain would go away then it and came back. She was very worried. She wanted to know if that was normal and what she should do about it. She did not know the patient's weight but reported that he was skinny. The patient did not have a doctor (primary healthcare provider). The adverse event did not require a visit to emergency room or physician office. There was no family medical history relevant to adverse event. The patient did not undergo relevant tests. The outcome of the event pyrexia was resolved and headache was not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain of skin, Rash
Clinical narrative: rash; a stinging feeling under breast area that now goes around to her back.; spreading more to her back and on the side and it is stinging; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: EW0187) as 2ND DOSE, SINGLE DOSE for covid-19 immunizations. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient took first dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0177) for covid-19 immunizations. On an unspecified date, patient woke up today with a stinging feeling under breast area that now goes around to her back. She was unbale to see if here was a rash. The patient experienced some problems. She stated she was supposed to get the 1st one so great and that last night her body while she was sleeping maybe she woke up this morning and the stinging had spread to her back and more to the side. It was a stinging that she wanted to scratch and that she was not scratching it. Last night she thought something wasn't right. She showered this morning and thought it would go away and it was spreading more to her back and on the side and it was stinging. The stinging felt like a sting you want to scratch, not like something but you but like you have to rub or scratch it. It was like she has to scratch it and she doesn't want to as she doesn't know what will happen. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Injection site pain; Tiredness; headache; muscle /body aches; chills /fever; chills /fever; rash/hives; rash/hives; nausea; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EP6955) via an unspecified route of administration (age at vaccination 62-years-old) in Right Arm on 07Jun2021 08:30 am as 2nd dose, single for COVID-19 immunization.  Medical history included Stage 4 Metastatic Breast Cancer and asthma from an unknown date and unknown if ongoing. Concomitant medications included other medications within two weeks was palbociclib (IBRANCE); letrozole; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); curcuma longa (TURMERIC [CURCUMA LONGA]) and metoprolol taken for an unspecified indication, start and stop date were not reported. The patient had known allergies included lisinopril, amoxicillin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EP6955), on 17May2021 01:30 pm in right arm as 1st dose, single for COVID-19 immunization. Patient did not receive other vaccine within four weeks. Patient has not been tested for COVID, prior and post vaccination. On 07Jun2021 02:30 pm, the patient experienced injection site pain, tiredness, headache, muscle /body aches, chills /fever, rash/hives and nausea. No treatment was taken for the events caused. The outcome of the events was recovering.  No follow-up attempts needed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; headache; muscle /body aches; chills /fever; chills /fever; rash/hives; rash/hives; nausea; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EP6955) via an unspecified route of administration (age at vaccination 62-years-old) in Right Arm on 07Jun2021 08:30 am as 2nd dose, single for COVID-19 immunization.  Medical history included Stage 4 Metastatic Breast Cancer and asthma from an unknown date and unknown if ongoing. Concomitant medications included other medications within two weeks was palbociclib (IBRANCE); letrozole; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); curcuma longa (TURMERIC [CURCUMA LONGA]) and metoprolol taken for an unspecified indication, start and stop date were not reported. The patient had known allergies included lisinopril, amoxicillin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EP6955), on 17May2021 01:30 pm in right arm as 1st dose, single for COVID-19 immunization. Patient did not receive other vaccine within four weeks. Patient has not been tested for COVID, prior and post vaccination. On 07Jun2021 02:30 pm, the patient experienced injection site pain, tiredness, headache, muscle /body aches, chills /fever, rash/hives and nausea. No treatment was taken for the events caused. The outcome of the events was recovering.  No follow-up attempts needed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Loss of consciousness, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: 27May21 approximately 5:45 P.M had blacked out fell down approximately 10 stairs paramedics was called taken to ER admitted on 27May21 CT showed bilateral pulmonary embolism without; 27May21 approximately 5:45 P.M had blacked out fell down approximately 10 stairs paramedics was called taken to the hospital, admitted on 27May21. CT showed bilateral pulmonary embolism without; 27May21 approximately 5:45 P.M had blacked out fell down approximately 10 stairs paramedics  was called taken to hospital and admitted on 27May21 CT showed bilateral pulmonary embolism without; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0168, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 26May2021 at 12:15 pm (age at vaccination was 68 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history and known allergies. The patient did not receive concomitant medications or any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0176, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 12:15 pm (age at vaccination was 68 years) as 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27May2021 approximately 5:45 pm, the patient had blacked out fell down approximately 10 stairs paramedics was called taken to withheld admitted on 27May2021. CT showed bilateral pulmonary embolism without right heart strain. The adverse events resulted in Emergency room/department or urgent care and hospitalization. The patient was hospitalized for 4 days from 27May2021 to 31May2021. The patient received the treatment with Eliquis for the adverse events. Since the vaccination, the patient has been tested for COVID-19 which included nasal swab Coronovirus Sar-Cov-2 test on 28May2021, and the result was negative. The device date and device timestamp date was reported as 12Jun2021. The events were reported as serious (hospitalization). The outcome of the events was resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Monoplegia, Pain, Pleurisy, Weight
Clinical narrative: he couldn't move his shoulders or his arms; alarming reaction of pleurisy/I believed it was pleurisy there's inflammation of the lining of the lungs it lasted about a day; hard time breathing; Had a real severe sharp pain about few inches below his clavicle; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in arm Left on 28May2021 17:00 (Age At vaccination 21years) as 1st dose, single dose for covid-19 immunisation. Medical history included seasonal allergy (Verbatim: Pollen allergy), allergy to animal (Verbatim: Allergic to cats), Allergy to some nuts (Verbatim: Allergies to some nuts, allergy to animal (Verbatim: Allergies to crustaceans) He's not taking any of the drugs for it. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jun2021 the patient experienced about 20 minutes he couldn't move his shoulders or his arms, alarming reaction of pleurisy/he believed it was pleurisy there's inflammation of the lining of the lungs it lasted about a day, hard time breathing, had a real severe sharp pain about few inches below his clavicle. After 20 minutes he was able to go to sleep but then it woke him up in the middle of the night and but after a day it was pretty much gone. Reporter is wondering if he should receive the second vaccine which is due on the Friday 18Jun2021. Reporter has a friend who had the exact same thing happen after the moderna shot. She went to the urgent care and was given ibuprofen. She wanted to know if her son really needs that second shot, he does not want him to get the second dose, if her son was in the age group that is immune after the second dose or not. Reporter requested to speak to team studying myocardia because son's health care. reporter don't think he needs the second shot for immunity because of his age and his lung linings something being inflamed his organs that scares him about his heart. He got the Pfizer COVID-19 Vaccine about 2 weeks ago. reporter want to say 5 foot 9 and he's probably 160 maybe a 160 pounds I think so yeah it's either 155 or 160 he is not sure. he was thinking of taking him to get an antibody test, just to find out that he can get the second shot. Patient received treatment of Advil for Had a real severe sharp pain about few inches below his clavicle, reporter think he just took one pill. The patient underwent lab tests and procedures which included weigh was he's probably 160, weight was it's either 155 or 160 on an unspecified date, weight was maybe a 160 pounds lbs on. Onan unspecified date in 2021, the patient had recovered from the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Bleeding 2 weeks prior to period; This is a spontaneous report from a contactable other-HCP (patient herself). A 40-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0193, Expiry date: Unknown) via an unspecified route on 02Jun2021 at 14:00 (at the age of 40-years) as 1st dose, single dose in the right arm for COVID-19 immunisation. The patient medical history included anaemia. The patient concomitant medications included fluoxetine 40 mg (FLUOXETIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 13Jun2021, the patient experienced bleeding 2 weeks prior to period. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Oropharyngeal pain, Pain, Throat irritation
Clinical narrative: little bit of body pain.; Tiredness; throat was already kind of itchy, irritated, 2 days before I got the 2nd dose of vaccine because I had consumed raspberry juice; Soar throat; This is a spontaneous report from a from a Pfizer-sponsored program, received from contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation, streptococcus salivarius (BLIS K12), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at an unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 on 14May2021 as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced little bit of body pain, tiredness, throat was already kind of itchy, irritated and he wanted to know if he can take oral probiotic because after getting the 2nd dose, he took some raspberry juice and right now he is having a sore throat and itchy throat. He just mentioned oral probiotic and that one is containing the Manuka also he didn't mention the brand. Honey and the probiotic is for oral probiotic like throat health Known as K 12. The type of probiotic it has in it is Streptococcus K 12, 10 mg. It has honey in it it's of different type like it's Kamahi and Manuka honey. The patient throat was already kind of itchy, irritated, 2 days before he got the 2nd dose of vaccine because he had consumed raspberry juice and also got, it was really sour, it immediately hit his throat like when he consumed it. But the patient takes the nasal steam every other day any ways regardless of whether it is pandemic or what doesn't matter. He takes this probiotic for last year and a half like once in a while or as it is just one or two, every other week and it stays fine, I had no problem in throat or anything. So, he was just wondering if he can do it again or not, is there going be any kind of interaction with vaccination or defense mechanism. The patient would like to know if they can eat yoghurt after vaccination as yoghurt also has various kind of like culture and bacteria. The patient was not experiencing like any life threatening or any sickness kind of thing because of the vaccination and wanted to know if he can take that because he consumes lemon also every day in hot water or cold water so he was just wondering if he can take that probiotic you know. It should not be an issue, still want to make sure. The outcome of the events was unknown.  Follow up attempt needed, Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Myocardial infarction, Weight, Weight increased
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at around 9:00 to 10:00 (at the age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. The patient had no medical history. The patient had no family medical history relevant to adverse event. There were no concomitant medications. The patient had no other products. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks). It was reported that, the patient was calling about the Pfizer covid vaccine. Unfortunately, he had a heart attack in Apr 2021. It turns out the day before his heart attack, he received the first dose of the covid vaccine. He had a heart attack on Saturday, 10Apr2021 at around 16:30 to 17:00. He was sitting down eating dinner and had a heart attack. The patient required emergency room and physician office. He was hospitalized for the heart attack on 10Apr2021. His cardiologist suggested that he call to report this to Pfizer. His cardiologist told him that he has cardiac ectasia, which may have been exacerbated by the first dose of the covid vaccine. He actually feels good now. He feels good and was not getting worse. He was not cleared for physical activity from his cardiologist, so he cannot work out yet. He was starting to put weight back on. Whenever he left the hospital, he was 211 pounds. Now he was 215 pounds. It may be water weight; may his sodium be high. But he was starting to increase in weight. His wife was older. He has a 92-year-old mother-in-law with health issues that lives downstairs. He runs basketball training and was around a lot of kids. He has no idea he had any heart conditions. His wife had gotten the COVID-19 vaccine, and his wife let him know that he was getting it too. The patient had no relevant test done. The patient was remained in the hospital for 6 days and discharged on 15Apr2021. The outcome of the event heart attack was recovered on an unspecified date in 2021. The outcome of the events Weight increased and cardiac ectasia was unknown. Follow up needed, further information was requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium, Blood sodium increased, Fluid retention, Weight, Weight increased
Clinical narrative: He left the hospital, he was 211 pounds. Now he is 215 pounds; It may be water weight, may his sodium is high.; It may be water weight, may his sodium is high.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0170), via an unspecified route of administration, administered in arm left on 30Apr2021 (at the age of 48-year-old) as single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient did not administer with additional vaccines on same date of the Pfizer suspect. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 09Apr2021 around 9:00 to 10:00 (at the age of 48-year-old) as single dose, for Covid-19 immunization and experienced Heart attack. The patient has no idea he had any heart conditions and his wife had gotten the covid vaccine, hence his wife let him know that he was getting it too. He was being pressured by his wife to get vaccine. After the second dose, the patient was starting to put weight back on. On an unspecified date in 2021, whenever he left the hospital, he was 211 pounds and now he was 215 pounds. It might be water weight, and might his sodium was high, but he was starting to increase in weight. The patient underwent lab tests and procedures which included blood sodium: high (increased) , weight: 211 (increased) and weight: 215 (increased) on an unspecified date in 2021.The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Monoparesis, Pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, via in left arm on Mar2021 (Batch/Lot Number: EN6205) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included deep vein thrombosis, allergies PCN (penicillin). Concomitant medication(s) that patient within 2 weeks of vaccination included apixaban (ELIQUIS). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, via in left arm on 13Feb2021 08:30 am as 1st dose, single dose for covid-19 immunisation. The patient did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19The patient experienced entire right side from head to toe affected. pains, numbness, tingling, limb sleep paralysis on 23Mar2021 at 07:00. The patient underwent lab tests and procedures which included (nasal swab) sars-cov-2 test: negative on 24Apr2021. Patient visited emergency room/department or urgent care for reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.   Follow-up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep paralysis
Clinical narrative: Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; Entire right side from head to toe affected. Pains, numbness, tingling, limb sleep paralysis.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, via in left arm on Mar2021 (Batch/Lot Number: EN6205) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included deep vein thrombosis, allergies PCN (penicillin). Concomitant medication(s) that patient within 2 weeks of vaccination included apixaban (ELIQUIS). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, via in left arm on 13Feb2021 08:30 am as 1st dose, single dose for covid-19 immunisation. The patient did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19The patient experienced entire right side from head to toe affected. pains, numbness, tingling, limb sleep paralysis on 23Mar2021 at 07:00. The patient underwent lab tests and procedures which included (nasal swab) sars-cov-2 test: negative on 24Apr2021. Patient visited emergency room/department or urgent care for reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.   Follow-up attempts are possible. Further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Nausea, Palpitations
Clinical narrative: Had a really headache; Heart raced; Fatigued; Nauseated; Sick; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0217, Expiry Date: Unknown), via an unspecified route of administration in the left arm on 09Jun2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she got the first COVID vaccine on wednesday afternoon (09Jun2021) and within three hours she was sick and still sick. The patient stated that no one else reacted to it that way. She wanted to know if she should go to the hospital, see her doctor or if it was expected. She stated that being sick was that she had a really bad headache and heart raced initially but she has been fatigued and nauseated since then. Patient received Tylenol as a treatment for events. The outcome of the events sick was not recovered, fatigued was recovering, and the rest of the events was recovered on 10Jun2021.  Information on lot/batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: chronic diarrhea for approx 100 days after vaccine.; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 2nd single dose for COVID-19 immunisation. Patient medical history included underlying condition of postherpetic neuralgia. Patient had no concomitant medications. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st single dose for COVID-19 immunisation. On an unspecified date, the patient experienced chronic diarrhea for approximately 100 days after vaccine. The outcome of event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Bradycardia, Palpitations, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified  age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0180) via an unspecified route of administration on 07Jun2021 at single dose for Covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT62B2 [PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0187 on 17May2021 via an unspecified route of administration at single dose for Covid-19 immunization. On 08Jun2021,the patient's heart feeling so fast and sometimes patients heartbeat so slow; like suddenly it disappears and suddenly its appears, like those things keep happen frequently. The patient heart start beat kind of fast then usual like much more than usual that and the patient can feel it, this happened every day in the afternoon and sometimes, when patient get up and patient have those heart beat fast problem. The patient did not receive any treatment for the adverse events. The outcome of event was unknown. Information on lot/batch number was available. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Her 15 year old son experienced a really bad headache and soreness in his arm; Her 15 year old son experienced a really bad headache and soreness in his arm; This is a spontaneous report from a contactable consumer (patient mother). A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ENO179, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Monday) (at the age of 15-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Jun2021 (on Tuesday), patient experianced a really bad headache and soreness in his left arm and that lasted a short period. Reporter stated her son didn't really have a problem and fine already. Patient received Advil on 08Jun2021 for arm was sore. Reporter inquired the chances of the same side effects with the second Pfizer Covid 19 Vaccine. The outcome of events was recovered on Jun2021.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cough, Feeling abnormal, Headache, Illness
Clinical narrative: has a cold; Her sugar is high; sick; coughing; runny nose; doesn't feel good; not feeling well; headache; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21May2021 as 1st dose, single dose for covid-19 immunization. Patient didnt receive any another products. Other investigational assessment was not performed. The patient medical history and concomitant medications were not reported. Patient was scheduled for her 2nd dose today but she is not feeling well and has a cold. Transfer agent reports that the caller got her first dose on 21May2021, and she was calling to reschedule her 2nd dose appointment. Transfer agent states that she informed the caller that she needed to call the facility for the reschedule. Caller says, so can she come in next week for her 2nd dose? She does not understand. Her sugar was high, she has a cold and she doesnt feel good so can this agent give her another date for her second dose. She needs another appointment. Caller says she got her 1st dose at (Withheld). She exclaims, oh my goodness. (Withheld) didnt give her a paper with their number on it. She called the phone number on the paper that (Withheld) gave her, what is their number? So this agent can schedule her another appointment and send an email with the appointment to her? Maybe tomorrow she will feel better. When she took the vaccine, she got sick, she got a cold, coughing and cold, runny nose and a headache. The caller states that she called because she cannot go to her appointment today, so she needs a new appointment. This is the second number she has called and no one can help her. The patient underwent lab tests and procedures which included blood glucose increased: high. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Rhinorrhoea
Clinical narrative: has a cold; Her sugar is high; sick; coughing; runny nose; doesn't feel good; not feeling well; headache; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21May2021 as 1st dose, single dose for covid-19 immunization. Patient didnt receive any another products. Other investigational assessment was not performed. The patient medical history and concomitant medications were not reported. Patient was scheduled for her 2nd dose today but she is not feeling well and has a cold. Transfer agent reports that the caller got her first dose on 21May2021, and she was calling to reschedule her 2nd dose appointment. Transfer agent states that she informed the caller that she needed to call the facility for the reschedule. Caller says, so can she come in next week for her 2nd dose? She does not understand. Her sugar was high, she has a cold and she doesnt feel good so can this agent give her another date for her second dose. She needs another appointment. Caller says she got her 1st dose at (Withheld). She exclaims, oh my goodness. (Withheld) didnt give her a paper with their number on it. She called the phone number on the paper that (Withheld) gave her, what is their number? So this agent can schedule her another appointment and send an email with the appointment to her? Maybe tomorrow she will feel better. When she took the vaccine, she got sick, she got a cold, coughing and cold, runny nose and a headache. The caller states that she called because she cannot go to her appointment today, so she needs a new appointment. This is the second number she has called and no one can help her. The patient underwent lab tests and procedures which included blood glucose increased: high. The outcome of events was unknown.  Information on the lot/batch number has been requested.