chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable physician reporting same event under the same suspect product for 6 patients. This is one of the 6 reports. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date after the use of product. The outcome of event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Pharyngeal hypoaesthesia, Rash
Clinical narrative: Rash on face and chest; periodic numbness and tingling in left side of face/cheek is ongoing still/Numbness and pins and needles feeling in left side of face and cheek; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; Numbness in left side of face, tongue and throat; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0172, Expiration date: unknown) via unspecified route of administration, administered in left arm on 05May2021 at 16:30 pm (age at vaccination was 40 years) as first dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient had known allergies to penicillin and carmel color, eggs, pistachios. Concomitant medications the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT WITH VIT C & HERBS) and Multi Vitamin. The patient previously took amoxicillin, erythromycin, z-pac, codeine and experienced drug allergy. 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 05May2021 at 16:45 pm, the patient experienced numbness in left side of face, tongue and throat, starting 15 minutes after the shot. Throat and tongue were back to normal after 24 hours. Numbness and pins and needles feeling in left side of face and cheek continually for 3 weeks, periodic numbness and tingling in left side of face/cheek was ongoing still. Rash on face and chest began 48 hours after shot and lasted 3 days. The device timestamp and device date was reported as 07Jun2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: nausea; vomiting; low grade temp 100; general tiredness; continuous stomach ache; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via intramuscular route of administration, administered in arm left on 04Jun2021 17:30 (05:30 PM) (at the age of 13-year-old and non-pregnant at the time of vaccination) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced about 36 hours after the injection patient had nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache on 06Jun2021 05:00 AM. The patient underwent lab tests and procedures which included low grade temp was 100 on 06Jun2021. The patient received Pepto bismol tablets and Tylenol as a treatment medication for the events nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache. Outcome of the events was recovered on an unspecified date in 2021.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea; vomiting; low grade temp 100; general tiredness; continuous stomach ache; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via intramuscular route of administration, administered in arm left on 04Jun2021 17:30 (05:30 PM) (at the age of 13-year-old and non-pregnant at the time of vaccination) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced about 36 hours after the injection patient had nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache on 06Jun2021 05:00 AM. The patient underwent lab tests and procedures which included low grade temp was 100 on 06Jun2021. The patient received Pepto bismol tablets and Tylenol as a treatment medication for the events nausea, vomiting, low grade temp 100, general tiredness continuous stomach ache. Outcome of the events was recovered on an unspecified date in 2021.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 102°F; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. After taking 2nd dose of vaccine, the patient experienced fever of 102°F in 2021. The patient underwent lab tests included body temperature: 102°F in 2021. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Blood folate decreased, Blood test, Dyskinesia, Fatigue
Clinical narrative: My hand and feet and the tops of my thigh kind of started feeling numb; like partially numb;; My hand and feet and the tops of my thigh kind of started feeling numb; like partially numb; then I didn't have like a steady balance or anything; The only thing in my blood work he said my folate was low my B6 was low;  I have never experience what I am experiencing; The only thing in my blood work he said my folate was low my B6 was low;  I have never experience what I am experiencing; They don't feel numb except both my thigh; that they hurt; They don't feel numb except both my thigh; that they hurt and they super sensitive both my feet and my hand; then I am also having involuntary muscle spasm; I am just exhausted I fall sleep right away my body does kind of jerk, jerking motion; I am just exhausted I fall sleep right away my body does kind of jerk, jerking motion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0175, Expiry date: 31Aug2021) intramuscularly, administered in left arm on 06May2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included gastroenterology issues. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0162, Expiry date: 31Jul2021) on 15Apr2021 for COVID-19 Immunization. It was reported that patient stated, "Well I am having some issues and I don't know if they related to the vaccine, just kind of want to talk to someone about it." patient stated, "So about maybe I had my second dose of Pfizer may 6th I am just say with then about 7 to 10 days then my hand and feet and the tops of my thigh kind of started feeling numb, like partially numb and then I didn't have like a steady balance or anything and I went to the doctor here a local doctor in, the only thing in my blood work he said my folate was low my B6 was low but I have never experience what I am experiencing and I just wanted to know now they don't feel numb except both my thigh, that they hurt and they super sensitive both my feet and my hand and then I am also having involuntary muscle spasm, when I lay down to go to bed at night like I am just exhausted I fall sleep right away my body does kind of jerk jerking motion, so I don't know if you heard this from another person, when I am this kind of figure out what it was all in May2021" No treatment was received for events. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity, Vitamin B6 decreased
Clinical narrative: My hand and feet and the tops of my thigh kind of started feeling numb; like partially numb;; My hand and feet and the tops of my thigh kind of started feeling numb; like partially numb; then I didn't have like a steady balance or anything; The only thing in my blood work he said my folate was low my B6 was low;  I have never experience what I am experiencing; The only thing in my blood work he said my folate was low my B6 was low;  I have never experience what I am experiencing; They don't feel numb except both my thigh; that they hurt; They don't feel numb except both my thigh; that they hurt and they super sensitive both my feet and my hand; then I am also having involuntary muscle spasm; I am just exhausted I fall sleep right away my body does kind of jerk, jerking motion; I am just exhausted I fall sleep right away my body does kind of jerk, jerking motion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0175, Expiry date: 31Aug2021) intramuscularly, administered in left arm on 06May2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included gastroenterology issues. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0162, Expiry date: 31Jul2021) on 15Apr2021 for COVID-19 Immunization. It was reported that patient stated, "Well I am having some issues and I don't know if they related to the vaccine, just kind of want to talk to someone about it." patient stated, "So about maybe I had my second dose of Pfizer may 6th I am just say with then about 7 to 10 days then my hand and feet and the tops of my thigh kind of started feeling numb, like partially numb and then I didn't have like a steady balance or anything and I went to the doctor here a local doctor in, the only thing in my blood work he said my folate was low my B6 was low but I have never experience what I am experiencing and I just wanted to know now they don't feel numb except both my thigh, that they hurt and they super sensitive both my feet and my hand and then I am also having involuntary muscle spasm, when I lay down to go to bed at night like I am just exhausted I fall sleep right away my body does kind of jerk jerking motion, so I don't know if you heard this from another person, when I am this kind of figure out what it was all in May2021" No treatment was received for events. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Pain, Pain in extremity
Clinical narrative: 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; This is a spontaneous report from a consumer (patient's mother). A 14-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified rout of administration on the left arm on 05Jun2021 at 09:00 (Lot number: ew0178) at 14-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to the COVID vaccine, the patient didn't received any other vaccines within 4 weeks. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergies was none. Concomitant medication included ascorbic acid (VIT C), ibuprofen and cetirizine hydrochloride (ZYRTEC ALLERGY) within 2 weeks of vaccination.The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13May2021 (Lot number: ew0169) at 14-year-old as single dose for COVID-19 immunization. On 06Jun2021 at 17:00, the patient experienced arm pain which radiate across muscles in upper back/shoulders. The reporter was aware the evening of 06Jun2021 and reported 07Jun2021 morning. The patient received ibuprofen as treatment. The outcome of events were recovering.  No follow-up attempts are possible; no further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood calcium, Blood creatine, Blood urine present, Cardiac fibrillation, Extra dose administered
Clinical narrative: Clot in bladder; little blood in urine; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; This is a spontaneous report from a contactable other HCP (patient).  A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration at age of 66-year-old on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included axitinib (INLYTA) from 29Mar2021 to 2021. The patient previous took fist dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), both at age of 66-year-old as single dose for COVID-19 immunisation and 2nd shot was not viable (as reported). Patient got third shot 23Apr2021 in a fib and fever, CA levels, creatine levels. On 27May2021, patient went to oncologist, little blood in urine. Hospitalized (in 2021) due to clot in bladder and haven't been on Inlyta for last 5 days, doctor wanted to get him back on it. Patient was to be released from the hospital and has an appointment on 03Jun2021 with his oncologist. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported urinary bladder haemorrhage and fibrillation were likely due to intercurrent/concurrent disease, and unlikely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urinary bladder haemorrhage, Urine analysis
Clinical narrative: Clot in bladder; little blood in urine; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; This is a spontaneous report from a contactable other HCP (patient).  A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration at age of 66-year-old on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included axitinib (INLYTA) from 29Mar2021 to 2021. The patient previous took fist dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), both at age of 66-year-old as single dose for COVID-19 immunisation and 2nd shot was not viable (as reported). Patient got third shot 23Apr2021 in a fib and fever, CA levels, creatine levels. On 27May2021, patient went to oncologist, little blood in urine. Hospitalized (in 2021) due to clot in bladder and haven't been on Inlyta for last 5 days, doctor wanted to get him back on it. Patient was to be released from the hospital and has an appointment on 03Jun2021 with his oncologist. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported urinary bladder haemorrhage and fibrillation were likely due to intercurrent/concurrent disease, and unlikely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Pyrexia
Clinical narrative: Arm is red; Running a fever of a 102.7; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for COVID-19 immunisation. It was reported that when the patient got his Pfizer shot on Saturday, the second dose. His arm was red and running a fever of a 102.7 but the rest of him was fine. The patient didn't think its anything. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Pharyngitis streptococcal
Clinical narrative: Strep throat; He is sick; Sore throat; This is a spontaneous report from a contactable consumer (patient).A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185,Expiry date:Unknown), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter asked if he should still get the second dose of the Pfizer Covid-19 vaccine as he supposed to get the 2nd dose on 08Jun2021, but currently he had strep throat. The reporter stated that he was kind of sick and had sore throat. The reporter had provided only limited information over call. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Headache, Pain in extremity
Clinical narrative: High fever; Tired; So cold; Headache; Sore arm/achy; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 11May2021 as 1ST DOSE, SINGLE DOSE and received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 13:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got a flu shot 6 or 7 or 8 years ago. She lost the pigmentation on her arm. She has not had a flu shot since. She gets allergy shots but that is weekly. She has not had one in over a month. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first vaccination last month and she did have a reaction of soreness, high fever, tired, and headache on an unspecified date of May2021. Yesterday she got her second dose and now she is back to the way she was with the first dose. Fever went as high as 99.3 which is not high, but the last time with first dose she got up to almost 103. It was 102.98 or something like that. Time of fever with first dose: it was within that night of getting it. Second dose was same thing. She got it yesterday at 1:00 and by 8:00 she was crying about being tired, so cold, achy, and fever. Caller clarified that all adverse events with second dose started at the same time around 20:00 the night of the 2nd dose. Patient had not received any treatment. Caller reported that the last time she did call the hospital and they said it would subside, which it did within 48-72 hours. Then she was back to being normal except with sore arm. Caller clarified it was left arm soreness. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; Tired; So cold; Headache; Sore arm/achy; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0175), via an unspecified route of administration, administered in Arm Left on 11May2021 as 1ST DOSE, SINGLE DOSE and received BNT162B2 (Pfizer COVID Vaccine: Solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 03Jun2021 at 13:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got a flu shot 6 or 7 or 8 years ago. She lost the pigmentation on her arm. She has not had a flu shot since. She gets allergy shots but that is weekly. She has not had one in over a month. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first vaccination last month and she did have a reaction of soreness, high fever, tired, and headache on an unspecified date of May2021. Yesterday she got her second dose and now she is back to the way she was with the first dose. Fever went as high as 99.3 which is not high, but the last time with first dose she got up to almost 103. It was 102.98 or something like that. Time of fever with first dose: it was within that night of getting it. Second dose was same thing. She got it yesterday at 1:00 and by 8:00 she was crying about being tired, so cold, achy, and fever. Caller clarified that all adverse events with second dose started at the same time around 20:00 the night of the 2nd dose. Patient had not received any treatment. Caller reported that the last time she did call the hospital and they said it would subside, which it did within 48-72 hours. Then she was back to being normal except with sore arm. Caller clarified it was left arm soreness. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia 5-10 minute episode; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0187 and expiration date: unknown), via intramuscularly in arm left on 04Jun2021 14:00 (at the age of 12 years old) as a 2nd dose, single dose for COVID-19 immunisation. The patient Previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0173 and expiration date: unknown), via intramuscularly in arm left on 14May2021 14:00 (at the age of 12 years old) as a single dose for COVID-19 immunisation. Medical history included allergies to Peanuts/tree nuts. Concomitant medications included lisdexamfetamine mesilate (VYVANSE 40mg) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 07Jun2021 at 04:15 PM, the patient experienced tachycardia 5-10 minute episode which resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The reporter considered the event as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not tested for COVID-19 since the vaccination. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I'm seeing colors brilliantly/ it has helped my blood pressure; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The Medical history included repaired cones/rods (eye disorder), blood pressure abnormal and cardiac disorder:(Prior to this, I've had very negative side effects from cardiac meds). The patient's concomitant medication included progesterone. On an unspecified date, after the administration of covid shot vaccine, the patient seeing color brilliantly. He or she knew that's not something there concerned with, but he/she wonder if it had somehow repaired my cones/rods. Also wondering if it has helped his/her blood pressure, of it is having started using progesterone. Prior to this, had very negative side effects from cardiac meds, so he/she started progesterone and it seems to be helping. But he/she wonder if the shot was somehow fixing things. The outcome for the event was unknown. No PQC involved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Illness
Clinical narrative: Bad reaction; Bad reaction/ been feeling sick; Feeling very tired all day; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) on unspecified date for COVID-19 immunisation. On unspecified date patient mentioned that she had a bad reaction after getting 2nd Pfizer vaccine. She has been feeling sick and she was feeling very tired all day. The outcome of the events was reported as unknown. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Short stabbing pain on the upper left of the back, close to the shoulder; This is a spontaneous report received from a Pfizer sponsored program. A non-contactable consumer (patients mother) reported that a 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 27May2021, as a single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, a little over a week ago the patient experienced short stabbing pain on the upper left of the back, close to the shoulder. It was reported that the consumer wanted to know if this was a symptom of the vaccine or if it was unrelated to the vaccine. It was stated that in a clinical study, adverse reactions in adolescents 12 through 15 years of age included muscle pain was 42.2 percent. The event was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia
Clinical narrative: A lot of Muscle Pain; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via intramuscular route of administration, administered in arm left on 05Jun2021 (at the age of 56-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via intramuscular route of administration, administered in arm right on 30Apr2021 (at the age of 56-year-old) at a 1st dose, single dose for COVID-19 immunization. The patient experienced a lot of muscle pain, tiredness, feeling unwell on 06Jun2021. Patient stated, I am just calling because the pains that they gave me when I got my shot that they report side effects. I got my second shot and I am having side effects. Patient stated, a lot of muscle pain, tiredness and just basically feeling unwell. Patient confirmed that he experienced the side effects after the second shot. The patient received Aspirin as a treatment medication for the events a lot of muscle pain, tiredness, feeling unwell. Outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: joint pain at base of thumbs/joint pain in elbows; joint pain at base of thumbs; This is a spontaneous report received from a contactable Physician. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, in deltoid left, on an unknown date, two weeks ago on a friday (at the age of 67 years), as 2nd dose, single dose for COVID-19 immunisation. The patient family medical history included bit of arthritic things (His mother when she got to be 90 years old she started to get quite a bit of arthritic things). Concomitant medications included zinc (Tablet, MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 15 mg (4 in morning and 4 at night) for unspecified indication (started taking 4 weeks ago, stopped as soon as elbows started hurting which was a week following the second shot. The patient had been taking concomitant products more than normally recommended dose of zinc because zinc was supposed to be beneficial and kill the virus. So he started taking extra zinc. He doesn't know if the zinc did it or what. It is not a lifesaving deal, but they said if you get a side effect you should report it. It is not a big deal, but it is definitely present). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, in deltoid left, on an unknown date, as a single dose for COVID-19 immunisation. There was no other relevant Tests done. There was no history of previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines Administered on Same Date of the Pfizer Suspect. There was no prior vaccinations within 4 weeks. There was no adverse event reported prior vaccinations. He is healthy and did not miss a day of work for 31 years. Caller stated that he got the two shots and about one week after the second shot he got quite significant joint pain, pain in the base of his thumbs started about 7 days (Morning) after second injection. Not life threatening or disabling, but it hurts enough. He is picking up stones and he cant do that task as well as he would like to. The pain is exactly the same as it was the day that it started and his elbows started about 7 days (Morning) after second injection at the medial epicondyle of both arms. It is not a terrible pain, but he has not ever had joint pains or anything like that. The pain started about 4 weeks after first dose and 1 week after the second dose. Reporter seriousness for joint pain at base of thumbs, joint pain in elbows was reported as not serious. The clinical outcome of the events was reported as not recovered. The events relatedness for events joint pain at base of thumbs/ joint pain in elbows were related.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain
Clinical narrative: headaches; body aches; chills; joint pain; This is a spontaneous report received from a contactable consumer (Patient). This 52-Year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, on 08May2021 as first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 30May2021, the patient experienced headache, body pain, chills and joint pain. The Patient was denied to receive the second dose. It was reported that the patient asked if those symptoms have been reported this late after the first dose. The patient asked if the fact that his symptoms started 22 days after first dose, does this mean his symptoms are not related to his Covid vaccine. The patient also asked if data on side effects was collected from the clinical trial only or it was based on real world data, like people like him calling and self reporting about the events. The outcome of the events was not recovered.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from Pfizer sponsored program. The consumer (patient's husband) reported for his wife.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. The patient received the second shot of vaccine and couple of days later she experienced shingles on an unspecified date. She visited a doctor one or two days after shingles showed up. Therapeutic measures were taken, and the patient was treated with unspecified medicines. The outcome of the event was recovered after few days.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Fungal infection, Furuncle, Musculoskeletal pain, Pain
Clinical narrative: blood pressure started going up; the pain from the shot in her arm went down her arm and into her butt; and gave her a boil, and now getting boils all over her buttstocks; she saw gynecologist, for a pap smear,  who told her she had a yeast infection; the pain from the shot in her arm went down her arm and into her butt; her body is aching all over; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, administered in arm on 14May2021, as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included she got the shot is because her baby has asthma. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation and the patient experienced very very tired, sleepy and weak. The patient previously took Tylenol for an unspecified indication and had allergy. On an unspecified date in May2021, blood pressure started going up, the pain from the shot in her arm went down her arm and into her butt butt and gave her a boil, and now getting boils all over her buttstocks and her body is aching all over. The reporter stated that, after the second shot a week later her blood pressure started going up, the pain from the shot in her arm went down her arm and into her butt and gave her a boil, and now getting boils all over her buttstocks "like an infection is coming out of her body" she saw gynecologist, for a pap smear, who told her she had a yeast infection, because she was taking so many baths for the boils but after she was given the medication for the yeast infections, she saw another doctor and he said to see a skin doctor, caller states she knows when something is trying to come out of her body, it will do something like this, it will bring boils out, and she would have to sit on ice pack to help. The outcome of the events she saw gynecologist, for a pap smear, who told her she had a yeast infection was unknown and for other events were not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: blood pressure started going up; the pain from the shot in her arm went down her arm and into her butt; and gave her a boil, and now getting boils all over her buttstocks; she saw gynecologist, for a pap smear,  who told her she had a yeast infection; the pain from the shot in her arm went down her arm and into her butt; her body is aching all over; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, administered in arm on 14May2021, as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included she got the shot is because her baby has asthma. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation and the patient experienced very very tired, sleepy and weak. The patient previously took Tylenol for an unspecified indication and had allergy. On an unspecified date in May2021, blood pressure started going up, the pain from the shot in her arm went down her arm and into her butt butt and gave her a boil, and now getting boils all over her buttstocks and her body is aching all over. The reporter stated that, after the second shot a week later her blood pressure started going up, the pain from the shot in her arm went down her arm and into her butt and gave her a boil, and now getting boils all over her buttstocks "like an infection is coming out of her body" she saw gynecologist, for a pap smear, who told her she had a yeast infection, because she was taking so many baths for the boils but after she was given the medication for the yeast infections, she saw another doctor and he said to see a skin doctor, caller states she knows when something is trying to come out of her body, it will do something like this, it will bring boils out, and she would have to sit on ice pack to help. The outcome of the events she saw gynecologist, for a pap smear, who told her she had a yeast infection was unknown and for other events were not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient self-reported). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sinus infection and she was scheduled for her second dose of Pfizer vaccine on Tuesday, next week. The patient wanted to know if she would be able to take antibiotics for the infection or if it would have an effect the Pfizer vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm and pain in arm; This is a spontaneous report from a contactable male consumer (patient) reported for himself. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unspecified), via unspecified route, administered in left arm on 09Apr2021 at 10:00am (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes cancer, Caller clarified that he had had chemo, radiation and 5 surgeries with sarcoidosis of lungs in 2007-2008. Concomitant medications were not reported.  On 09Apr2021 10:00 am, after the vaccination, the patient experienced sore arm and pain in arm. The reporter assessed the event as non-serious. Caller clarified that the pain was just from the needle. He did not have any discomfort where he had symptoms. Caller also states he lost his card, and he wants it back, He stated that he can go back to his vaccine site, but they are talking about closing the massive vaccination sites. He does not know if it is closed yet. He heard them say they are starting to close the sites as they have them at the drugs stores now. The caller also said everybody he knows that took other vaccines were halfway sick, but he took Pfizer, and he did not feel anything except for pain in his arm. He heard other things besides Pfizer that people were getting sick a little bit, but not him. The outcome of the event pain was recovered/resolved on an unspecified date.  No follow-up attempts possible. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Pyrexia, Renal pain
Clinical narrative: Feels very sick; She has fever; pain in her kidney and legs; pain in her kidney and legs; This is a spontaneous report from a contactable consumer or other non hcp.  An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. On an unspecified date, caller withheld, feels very sick after getting the first dose. She wanted to know what to do. She has fever and was experiencing pain in her kidney and legs. She had COVID before but wanted to know if the side effects will go away and how long will it last. Advised to transfer her to PMI but it was closed already. The outcome of all the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was more sore right now than in her first shot.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported) dose 2 on 07Jun2021 via an unspecified route of administration for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: number was not reported) dose 1 on unspecified date via an unspecified route of administration for covid-19 immunisation and had sore arm. The patient said on an unspecified date in Jun2021, her arm was more sore right now than in her first shot. The patient had the second shot of the Pfizer COVID-19 vaccine yesterday (07Jun2021) and she wanted to know why she was reacting differently than when she had her first shot. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.