chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Extra dose administered, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: fever; stomach aches; 25May2021, dose_number=1, dose_number=2, dose_number=3; 25May2021, dose_number=1, dose_number=2, dose_number=3; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25May2021 (Batch/Lot Number: Unknown) as 3rd dose, single, via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 (Batch/Lot Number: Unknown) as 2nd dose, single, via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 (Batch/Lot Number: Unknown) as 1st dose, single; at 37-years-old for COVID-19 immunization. The patient medical history was not reported. Facility where the most recent COVID-19 vaccine was administered: clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. Patient had fever, stomach aches. His bad, he thought it would be funny to get vaccinated 4 times to show the world it has nothing to fear. He was still planning to get his 4th shot. He would also like to try getting more just of the other ones. He was really inquisitive. The patient experienced fever and stomach aches on 26May2021 15:00. No treatment given. The outcome of the events fever and stomach aches was recovering.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Body height, Fatigue, Loss of consciousness, Mobility decreased
Clinical narrative: he had to have passed out; he defecated himself among other things; could not move; the fatigue.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a 76-year-old elderly male received the second dose of BNT162b2 (solution for injection; Lot EWO187 expiry information not provided) as a single dose via an unspecified route on an 19May2021 (at 76 years-old) for COVID-19 immunization. Relevant medical history included ongoing Type V hyperlipidaemia (12Aug2020), ongoing Coronary artery disease (31Oct2018), ongoing elevated Prostatic specific antigen (PSA; 10Jun2014), ongoing extradural extramedullary spinal tumor (04Apr2018), ongoing Dizziness (04Apr2018), ongoing Obesity (03Mar2021), Acute kidney injury (AKI), swelling of joint right upper arm, urinary tract infection associated with indwelling catheter (05Jun2020), pneumonia due to COVID-19 virus (hospitalized for two and one half months; 26Apr2020-02Jun2020), pneumonia due to COVID-19 virus (05Jun2020), restless leg syndrome, depression, and Atrial fibrillation (Afib), stent in his heart, and chest pain. Concomitant medications included pramipexole dihydrochloride for restless leg syndrome from unspecified date; venlafaxine hcl for depression from 1992; atorvastatin calcium (LIPITOR) for unspecified indication from unspecified date; SOTALOL for Afib from an unspecified date; tamsulosin hydrochloride (FLOMAX) for unspecified indication from unspecified date; apixaban (ELIQUIS) for unspecified indication from unspecified date; and esomeprazole magnesium (NEXIUM) for unspecified indication from 1998. The patient also received unspecified concomitant medications for the stent in his heart though he could not recall the name. The patient received the first dose of BNT162b2 (solution for injection; Lot EWO171 expiry information not provided) as a single dose in the left upper arm an 19Apr2021 (at 76 years-old) for COVID-19 immunization and experienced no adverse effect. The patient reported that on 19May2021 when he got home, he passed out and had to be taken by ambulance. When questioned, the reporter stated he had to have passed out. The patient reported that de does not really know, except he could not move; described as 'had a heck of a time moving'. The patient reported that he literally defecated himself among other things. The patient reported that his neighbor heard him screaming and called an ambulance who took the patient to the hospital, the emergency hospital and then the hospital itself. The patient reported that he was hospitalized from 21May2021 to 24May2021. The patient yawned and stated that this was another problem, the fatigue. The outcome of the events passed out, defecated himself, and could not move was recovering. The outcome of the fatigue was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen
Clinical narrative: he had to have passed out; he defecated himself among other things; could not move; the fatigue.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a 76-year-old elderly male received the second dose of BNT162b2 (solution for injection; Lot EWO187 expiry information not provided) as a single dose via an unspecified route on an 19May2021 (at 76 years-old) for COVID-19 immunization. Relevant medical history included ongoing Type V hyperlipidaemia (12Aug2020), ongoing Coronary artery disease (31Oct2018), ongoing elevated Prostatic specific antigen (PSA; 10Jun2014), ongoing extradural extramedullary spinal tumor (04Apr2018), ongoing Dizziness (04Apr2018), ongoing Obesity (03Mar2021), Acute kidney injury (AKI), swelling of joint right upper arm, urinary tract infection associated with indwelling catheter (05Jun2020), pneumonia due to COVID-19 virus (hospitalized for two and one half months; 26Apr2020-02Jun2020), pneumonia due to COVID-19 virus (05Jun2020), restless leg syndrome, depression, and Atrial fibrillation (Afib), stent in his heart, and chest pain. Concomitant medications included pramipexole dihydrochloride for restless leg syndrome from unspecified date; venlafaxine hcl for depression from 1992; atorvastatin calcium (LIPITOR) for unspecified indication from unspecified date; SOTALOL for Afib from an unspecified date; tamsulosin hydrochloride (FLOMAX) for unspecified indication from unspecified date; apixaban (ELIQUIS) for unspecified indication from unspecified date; and esomeprazole magnesium (NEXIUM) for unspecified indication from 1998. The patient also received unspecified concomitant medications for the stent in his heart though he could not recall the name. The patient received the first dose of BNT162b2 (solution for injection; Lot EWO171 expiry information not provided) as a single dose in the left upper arm an 19Apr2021 (at 76 years-old) for COVID-19 immunization and experienced no adverse effect. The patient reported that on 19May2021 when he got home, he passed out and had to be taken by ambulance. When questioned, the reporter stated he had to have passed out. The patient reported that de does not really know, except he could not move; described as 'had a heck of a time moving'. The patient reported that he literally defecated himself among other things. The patient reported that his neighbor heard him screaming and called an ambulance who took the patient to the hospital, the emergency hospital and then the hospital itself. The patient reported that he was hospitalized from 21May2021 to 24May2021. The patient yawned and stated that this was another problem, the fatigue. The outcome of the events passed out, defecated himself, and could not move was recovering. The outcome of the fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Secondary cerebellar degeneration
Clinical narrative: para neocerebellar degeneration; This is a spontaneous report from Pfizer-sponsored program. A non-contactable consumer reported a female of unspecified age received a dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on an unspecified date for COVID-19 immunization. There was no medical history or concomitant medications reported. The consumer inquired if para neocerebellar degeneration was a reported side effect of the vaccine. The outcome of the event para neocerebellar degeneration was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after being vaccinated/Tested positive yesterday; tested positive for COVID-19 after being vaccinated/Tested positive yesterday; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose at single dose, then via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as second dose at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient wanted to inform that he/she is one of the 0.02% who tested positive for COVID-19 after being vaccinated. The patient tested positive yesterday (May2021) and had the second dose on 21Apr2021. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: gave my mom the COVID vaccine and now she is dead; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported on behalf of a pharmacy technician's mother (the patient). An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, unknown if first or second dose) solution for injection intramuscular on an unknown date as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included unspecified medication but has never taken morphine sulfate. The pharmacy technician stated, " I gave my mom the COVID vaccine and now she was dead." The outcome of the event was fatal. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information currently available is limited and does not allow a meaningful case evaluation. However,  based on chronological connection to the vaccine a causal relationship between event of death (unknown cause) and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: gave my mom the COVID vaccine and now she is dead
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Ocular hyperaemia
Clinical narrative: Right eye itchiness; red eye; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 02Mar2021 at10:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Patient relevant medical history included sensitive skin/eczema when under stress. Patient was allergic to any medications, food, or other products was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 04Mar2021 at 18:00, the patient experienced right eye itchiness and moderately red (lower half) for 3-4 days. The patient did not take any treatment for adverse events. The clinical outcomes of eye itchiness and moderately red (lower half) was recovered.    No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaccination site pain
Clinical narrative: pain in her arm around the area of the vaccine/  The doctor said he had seen 5 patients with this; This is a spontaneous report from a contactable consumer or other non healthcare professional. This is the first of [5] cases. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734, Expiration Date: Jul2021, NDC number: unknown), via an unspecified route of administration, administered in Left arm on 07Apr2021 10:45 (at the age of 49-years-old) as 1st dose, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 07Apr2021, the patient experienced pain in her arm around the area of the vaccine. The doctor said that he had seen 5 patients with this pain in her arm around the area of the vaccine. The outcome of the event was unknown.  Follow-up attempts are needed. further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness; nausea; This is a spontaneous report from non-contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, mRNA-1273, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Not moderna, patient got first pfizer shot and had dizziness and nausea. The outcome of the events were unknown.  Additional information requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate irregular, Palpitations
Clinical narrative: Heartbeats irregular; I can feel it almost daily specially like in the afternoon time even during late nighttime sometimes a whole day so I just feel bothered I think I never had this feeling this type of like heartbeat.; I can feel strong stronger and weaker and the timing between is the longer it so called of palpitation/can barely feel my heart was beating; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 24Apr2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced irregular heartbeats, the reporter also mentioned that the patient can feel it almost daily specially like in the afternoon time even during late night time sometimes a whole day so he just feel bothered he think he never had this feeling this type of like heartbeat. The reporter mentions that the patient can feel strong stronger and weaker and the timing between is the longer it so called of palpitation due to which he can barely feel his heart was beating. The outcome of the events was unknown.  Follow-up attempts not completed. No information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021640418 same reporter/different patient
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient herself) via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date in Feb2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. On an unknown date reported as three months ago since the second vaccine, the patient experienced metallic taste in mouth. The patient still has the metallic taste in her mouth. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Skin burning sensation
Clinical narrative: I had very bad pain in my left side in my back like where my lungs would be; I am starting to get burn on my skin, on my fingers and I am getting some kind of strange thing; I had a severe pain in my left leg that, it was like to the bone; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP7534) via an unspecified route of administration on 18Mar2021 at 1st dose, single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0153) via an unspecified route of administration on an unspecified date in Apr2021 at a 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced i had very bad pain in my left side in my back like where my lungs would be, i am starting to get burn on my skin, on my fingers and i am getting some kind of strange thing, on an unspecified date in May2021 i had a severe pain in my left leg that, it was like to the bone. Additional Context: Concern: patient stated, patient have some questions may be six days ago patient was in a store and patient had to leave it because patient had a severe pain in my left leg that, it was like to the bone and patient couldn't do anything with the food that patient had, since then patient had very bad pain in my left side in my back like where my lungs would be and patient had got a COVID shot in 18Apr and then because patient started to get burn on my skin, on my fingers and patient am getting some kind of strange thing happening automatically and patient don't know its something from the vaccine and there is something to worry about patient do wanna check with self. LOT: Consumer stated, Ok, EP7534 (First dose) and that shot was given on 18Mar and the next shot the number is EW0153 (Second dose captured in tab) and that was given on 8Apr and that is in (city name). Date of first shot: 18Mar2021, Date of second shot: 08Apr2021. Outcome of the events was unknown.  Further probing could not be done as the consumer hung up abruptly. Hence limited information available over the call.; Sender's Comments: :
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Vaccination site pain
Clinical narrative: 1 dose severe muscle pain for one day; radiating from the injection site right arm then over all muscle pain; stiffness; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 41-year-old (age at vaccination) non-pregnant (at vaccination) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via intramuscular route, administered in arm right on an unspecified date as 1st dose, single dose for covid-19 immunisation. Medical history included hypothyroid was on normal levels, had known allergies: gluten. No other vaccine received in four weeks. No COVID reported prior vaccination. Concomitant medications included quetiapine (QUETIAPINE) via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; sertraline hydrochloride (SERTRALINE [SERTRALINE HYDROCHLORIDE]), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; lisdexamfetamine mesilate (VYVANSE), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; metformin, via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; lamotrigine, via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; and levothyroxine sodium, via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took zolpidem and experienced known allergies. On 24May2021 at 18:00, the patient experienced 1 dose severe muscle pain for one day, radiating from the injection site right arm then over all muscle pain and stiffness. 1 dose severe muscle pain for one day, radiating from the injection site right arm then over all muscle pain and stiffness. The clinical outcome of the 1 dose severe muscle pain for one day, radiating from the injection site right arm then over all muscle pain, stiffness were recovering.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oropharyngeal pain
Clinical narrative: chest started hurting; throat hurt really, really bad; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187 and Expiration Date was not reported) via an unspecified route of administration, administered in Arm Left (near the shoulder) on 18May2021 (at the age of 31-years-old) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, she took the vaccine on 18May2021 and she was fine. Then starting yesterday (on 31May2021), the patient chest started hurting and throat hurt really, really bad. The patient was supposed to get the second dose on the 08Jun2021 and so the patient wanted to know if she should still get the second dose and should she go to the doctor. The patient stated that, she was going to call her doctor. The outcome of events was unknown.  No further information was provided or obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: A bubble of clear liquid came up at  the injection site on her right arm; bubble the size of a Q-tip and it is really hot outside; This is a spontaneous report received via Pfizer sponsored program. A contactable consumer (patient) reported a 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Jun2021 (at an age of 44-years-old) on arm right as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jun2021, the patient experienced a bubble of clear liquid came up at  the injection site on her right arm, bubble the size of a q-tip and it is really hot outside. Caller states she got the vaccine, what they did was put the band aid on first the right arm, it was round white circle with clear middle and gave the shot through the band-aid on her arm, the patient saw a big bubble of liquid on her arm and wanted to know if all of this was going to be fine. Patient stated that band-aid started to come up and a bubble of clear liquid came up at the injection site on her right arm 2 hours after the administration. The bubble was the size of a Q-tip and it is really hot outside. Patient also stated that the person who administered did not get her temperature first and asked if this process is correct. Patient also enquired if placing a band aid on prior to administration is appropriate. The clinical outcome of the a bubble of clear liquid came up at the injection site on her right arm, bubble the size of a q-tip and it is really hot outside were not recovered.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Wrong product administered
Clinical narrative: first dose of the Moderna/got Pfizer for the second shot; sick for 2 days; soreness; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution of injection, Batch/Lot Number: Unknown, Expiration Date: unknown), dose 2 via unspecified route of administration on an unspecified date as single dose instead of second dose of MRNA 1273 (MODERNA COVID 19 VACCINE) at single dose for covid-19 immunization. Medical history was not reported. The patients concomitant medications were not reported. Historical Vaccination included first dose of the Moderna and patient felt some pain and soreness, sick for a couple of hours after and it was gone by the morning. The Patient got Pfizer for second shot and was sick for 2 days, very sore but did not take any medication and after that he was good and the soreness went away on an unspecified date. Caller asked if vaccines could be mixed and if there will be a booster dose and about the size of the needle. Caller asked if it was OK to get the flu shot after getting the Pfizer covid 19 vaccine and wanted to know how much protection did the Pfizer covid 19 vaccine give after the first and second dose. Caller asked if it was possible for some adults to have 100 percent efficacy and asked to explain why it is 100 percent for 12-16 year olds but only 95 percent for adults, asking if it was the same vaccine or different. Caller also asked was it ok to get the vaccine even if he has never had covid. The Outcome of the events were resolved on an unknown date.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin disorder
Clinical narrative: hurt more; little bumps on legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE (at the age of 60-years-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced immediate allergy. On an unspecified date, the patient experienced hurt more, little bumps on legs. The patient questioned whether she can be put on Benadryl. The patient received second dose on 27May2021. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Magnet sticking to arm where vaccine was administered; This is a spontaneous report from a non contactable consumer (patient's wife).  This consumer reported for a male patient of an unknown age who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and Expiration date was not reported) as a single dose for COVID immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband both got the Pfizer shot and then some people her husband worked with started to talk about this thing on the web where people talking about the magnet sticking to the shot. On an unknown date, the reporter and her husband thought they were kind of crazy but they tried it and the magnet does stick to their arms. Reporter stated that other people have told her if they have or didn't have the shot and states some of the people haven't tried the magnet thing and she would have never tried it except for the people at her husband's work mentioning it and they had obviously tried it and then they asked them didn't you just have the vaccine, so her husband tried it. Reporter stated she did not believe this conspiracy theory thing about a chip or anything like that but she was concerned that a magnet truly does stick to her arm it has been 21 days and it still does. Reporter stated they tried it last night because they have been on vacation and it still sticks, 21 days in and it was still sticking to their arms (vaccination site discomfort). The clinical outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021634416 same product and event, different patient;US-PFIZER INC-2021636192 same product and event, different patients
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pigmentation disorder, Urticaria
Clinical narrative: redness and hives on her neck.; redness and hives on her neck.; Caller states they are starting to spread on her neck and the other side and she is starting to see dots all over her body; This is a spontaneous report from a contactable consumer (Patient). A 33-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 12:00 (Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included allergic to Penicillin. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 (Batch/Lot Number: EWO175 or EW0175) as 1st DOSE, SINGLE for covid-19 immunization. For AE(s) following prior vaccinations, stated none and stated last vaccines were as a child. On 03Jun2021, the second day after her shot, the patient when she woke up, she had developed redness and hives on her neck which started to spread on her neck and the other side, and she was starting to see dots all over her body. She would like to know if this was normal, and what to do next. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Nasal congestion, Rhinorrhoea
Clinical narrative: Runny nose; Tiredness; My left, my left nose was stopping runny and then I put on the Monday, the Wednesday and the next morning, the left nose is blocked and until today my left nose is kind of half blocked; The symptom is I am having a flu one and hour after the shot, the vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0175, Expiration date: Unknown) via an unspecified route of administration in left arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atorvastatin taken for blood cholesterol increased, start, and stop date were not reported. On an unknown date, one hour after the first vaccination, the patient experienced that her left nose was stopping runny and then she put on the Monday and Wednesday and the next morning, the left nose was blocked and until today my left nose was kind of half blocked, runny from time to time during the (Voice breakage) So, can she get normal flu medicine whole tab (not sure as not clarified hence captured as unspecified medication), that can help me on the runny nose. The patient enquired that she could get that kind of flu medicine. The patient stated that she had runny nose and felt tired. So, the patient wants to know from you if she can take the cold medicine over the counter of that kind, the normal so that can stop my runny nose. The seriousness of the events was reported as non-serious. The outcome of the events runny nose and fatigue was not recovered, and the other events was unknown.  No follow-up attempts are possible; information about lot/batch number has obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: lot of pain in her bilateral armpits; This is a spontaneous report from a contactable consumer.   A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported), via unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Previously patient took first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported), via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The reporter stated that the (patient mother), patient received her second dose of the Pfizer Covid vaccine 7 weeks ago and had been experiencing a lot of pain in her bilateral armpits. Reporter wanting to know if this was normal? Reporter wants to know if her daughter should wait a certain time period before getting a mammogram? She was concerned that the pain in her armpits could cause a false reading. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Product dose omission issue, Spinal disorder, Spinal pain
Clinical narrative: headache; spinal pain and pressure; numbness in hands and feet; spinal inflammation; missed her second dose; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 23Dec2020 as single dose for COVID-19 immunization. Medical history included COVID-19 tested positive on 12Dec2020. The patient's concomitant medications were not reported. The patient received first dose while still battling Covid-19 symptoms. On an unspecified date after the vaccination, the patient experienced headache, spinal pain and pressure, numbness in hands and feet, spinal inflammation. The clinical course included: when the Pfizer Covid vaccine became available at her hospital, she received the 1st dose of Pfizer Covid vaccine on 23Dec2020 but was still battling Covid-19 symptoms. Caller stated that days after receiving the 1st dose of the vaccine she began to have severe symptoms which included, headaches, spinal pain and pressure, numbness in hands and feet. After vaccination, the patient also had bad over immune response where there was spinal inflammation and missed her second dose. She was seen by neurology, and other specialist, which at that time advised her not to proceed with taking the second dose of the Pfizer Covid vaccine. Caller has been recovered and wanted to know if she can go ahead and take the second dose of the Pfizer Covid vaccine now or do need to start the series over. The clinical outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/Ringing in ears; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 18May2021 14:00 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypothyroidism (from many years) , tinnitus from an unknown date (might have been noticing it from time to time in last 10 years). The patient had no family medical history. The patient did not have history of all previous immunization with the vaccine considered as suspect. The patient did not administered additional vaccines on same date of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for hypothyroidism, start and and ongoing. On Saturday 22May2021, he had ringing on his ears. He wanted to know if that was from the vaccine or not. At the time that it happened, he was pressure washing and he was not sure if the loud noise contributed to his tinnitus. He has a history 10 years ago of tinnitus. The pressure washer was very loud. Then he started to wonder. He had pressured washed before and never had it before. Caller stated that he still had the ringing. It was not as bad as it was at first. The patient stated he did not do anything but try to stay away from loud noises. The outcome of the event was improving.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise, Neck pain, Pyrexia
Clinical narrative: extreme malaise; neck pain; having very bizarre symptoms; extreme fatigue; fever for a week; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number, NDC number and expiry date were not provided), via an unspecified route of administration on 16May2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for COVID-19 immunization. It was reported as patient wanted to know if there is a test to see if her reaction is related to the second shot of the Pfizer COVID-19 vaccine. She said that her doctors are basically running every blood test to see if it is a reaction to the vaccine. She said that she had a fever for a week, extreme malaise, and neck pain. Her last shot of the Pfizer COVID-19 vaccine is on 16May2021 and her fever did not start until 21May2021. She also mentioned that she had a delayed reaction to the vaccine (a month later) and this was not verified to caller as she disconnected before clarifying. She also said that her reaction was delayed. She said that it happened a month later. It was reported as she seems to behaving very bizarre symptoms that her doctor is also having a hard time diagnosing. She would like to report this or see if there are any similar symptoms being reported by others with these adverse effects with the Pfizer Covid vaccine. She seems to have had a delayed reaction, if she is having one to the shot. Later provides bizarre symptoms as extreme fatigue and fever for a week. No further details provided. Investigation assessment was not provided. Reporter seriousness for the events was unspecified. The outcome of events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Whenever he tries to grab something his center middle finger hurts and is swollen. His third finger is purple right now.; Whenever he tries to grab something his center middle finger hurts and is swollen. His third finger is purple right now.; Whenever he tries to grab something his center middle finger hurts and is swollen. His third finger is purple right now.; This is a spontaneous report from a contactable consumer (patient, reported for himself). The report was not related to a study or programme. A male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry dates were not provided), via an unspecified route of administration, on an unspecified date in 2021 (reported as two days ago), as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, after the vaccination, the patient reported that whenever he tries to grab something his center middle finger hurts, and it was swollen. He also reported that his third finger was purple right now. It was reported that he had flight first aid health experience. The patient was asking whether he should go to the hospital to have this checked out. The patient was really concerned about this being a blood clot. The investigation assessment was not provided. The events were reported as non-serious. The outcome of the events was unknown.  No further information provided. Unable to clarify details provided or gather additional information.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Herpes zoster, Pregnancy test
Clinical narrative: Had the shingles outbreak on left leg 3-4 days after COVID 19 shot; Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a contactable consumer. A 24-year-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 26May2021 17:15 (Batch/Lot Number: EW0175, Expiration date: unknown) as 1st dose, single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) and prenatal vitamins. The patient previously took NSAIDs and experienced Allergy. The most recent COVID-19 vaccine was administered in hospital. 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. Since the vaccination, the patient has not been tested for COVID-19. On 29May2021 20:00 the patient experienced had the shingles outbreak on left leg 3-4 days after covid 19 shot. No hospitalization. Patient had received treatment as Pills for shingles outbreak and resulted in Emergency room/department or urgent care. Pregnancy at time of vaccination: yes, the mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included pregnancy test: positive on. Outcome of event shingles was recovering, while with other event was unknown.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Chills; Headache; Felt really lousy; This is a spontaneous report from a contactable consumer (mother). A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient had chills, headache, and felt really lousy after 1st dose of vaccination. Reporter reported that people with history of COVID-19 experience more side effects with the first dose, it was happened to patient and heard that people feel sicker after receiving the first dose of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results (Patient had history of Covid). Reported mentioned that patient was due for the second dose the day before her sister's graduation, and they were not sure if they should postpone it. Reporter wanted to know if people experienced side effects after the second dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Malaise
Clinical narrative: weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient's son). A 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 02Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient diagnosed with shingles. Caller stated that they did not want to give second dose until the patient's shingles resolved and her shingles had cleared since last week. Caller would like to know if his mother can get second dose, or does she need to restart vaccination series. The outcome of the event was reported as recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.