chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac flutter, Chest discomfort, Feeling abnormal
Clinical narrative: Heart is fluttering; Erratic heartbeat; Feeling a distress in the chest; Feeling like a "bu-bump, bu-bump"; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) and ARRHYTHMIA (Erratic heartbeat) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), ARRHYTHMIA (Erratic heartbeat) (seriousness criterion medically significant), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump"). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), ARRHYTHMIA (Erratic heartbeat), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient reported that he was experiencing heart fluttering (2 or 3 times a day); at least twice a day, usually in the morning, he was feeling a distress in the chest, like a "bu-bump, bu-bump" for the last week and a half, along with erratic heartbeat, but not shortness of breath. The patient stated that he never felt this before. Treatment information was unknown.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eating; Started having memory issue; Soreness at the injection; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating) and MEMORY IMPAIRMENT (Started having memory issue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Serious breathing problem) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling lousy all over) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion hospitalization), VOMITING (Spitting up) (seriousness criterion hospitalization), DECREASED APPETITE (Not interested in eating) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Started having memory issue) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating), MEMORY IMPAIRMENT (Started having memory issue), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The patient went to hospital 7 times in the past 2 months. The smallest time spent in hospital was three days and the longest time was nine days. The patient was scheduled for second dose on 28-FEB-2021.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pain in extremity, Vomiting
Clinical narrative: Serious breathing problem; Feeling lousy all over; Upset stomach; Spitting up; Not interested in eating; Started having memory issue; Soreness at the injection; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating) and MEMORY IMPAIRMENT (Started having memory issue) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Serious breathing problem) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling lousy all over) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion hospitalization), VOMITING (Spitting up) (seriousness criterion hospitalization), DECREASED APPETITE (Not interested in eating) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Started having memory issue) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Serious breathing problem), FEELING ABNORMAL (Feeling lousy all over), ABDOMINAL DISCOMFORT (Upset stomach), VOMITING (Spitting up), DECREASED APPETITE (Not interested in eating), MEMORY IMPAIRMENT (Started having memory issue), PAIN IN EXTREMITY (Soreness at the injection) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The patient went to hospital 7 times in the past 2 months. The smallest time spent in hospital was three days and the longest time was nine days. The patient was scheduled for second dose on 28-FEB-2021.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Swelling of her upper lip; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Swelling of her upper lip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  Two Cases of Well Controlled Chronic Spontaneous Urticaria Triggered by the Moderna COVID-19 Vaccine. Allergy and Rhinology.. 2021;12:1-3     The patient's past medical history included Allergic rhinitis, Chronic spontaneous urticaria (Her last known flare was in 1973.) and Angioedema (For multiple years until her symptoms became controlled with a first generation H1 antihistamine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGIOEDEMA (Swelling of her upper lip) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Swelling of her upper lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Swelling of her upper lip) to be possibly related.    No concomitant medication was reported. Past medication included first generation H1 antihistamine to control Chronic spontaneous urticaria (CSU).  The patient's CSU symptoms included angioedema of the upper lip. Her last known flare was in 1973. The patient had spontaneous angioedema for multiple years until her symptoms became controlled with a first generation H1 antihistamine. When the patient received her first Moderna Covid-19 vaccine, she experienced the same swelling of her upper lip that she had last experienced in the 1970's. The edema appeared 30 minutes after injection and resolved within 30 minutes without pharmacological intervention.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-256134 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Mild flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 12:00 (at the age of 66 years old) (Batch/Lot Number: EL3247) as single dose, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 14Jan2021 15:45 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history includes hypersensitive reactions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has allergies to medications, food, or other products. The patient received medication within 2 weeks. On 05Feb2021 at 20:00 the patient experienced mild flu-like symptoms. No treatment was received for the adverse event. The reporter considered the events as non-serious. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Nausea, Neck pain, Pyrexia
Clinical narrative: Nausea; Vomiting for full 3 days so far; Mild headache; Pain in left side of neck; Stiff joints; Feverish; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,), via an unspecified route of administration, administered in left arm on 06Feb2021 08:30 AM (age at vaccination was 50 years) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history included seasonal allergy, asthma, food allergy with walnut, anxiety, bipolar disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 06Feb2021 08:45 the patient experienced moderate nausea and vomiting for full 3 days so far, (trying to find out how many days this will go on) mild headache, pain in left side of neck, stiff joints, feverish. No treatment was received for the event. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting for full 3 days so far; Mild headache; Pain in left side of neck; Stiff joints; Feverish; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,), via an unspecified route of administration, administered in left arm on 06Feb2021 08:30 AM (age at vaccination was 50 years) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history included seasonal allergy, asthma, food allergy with walnut, anxiety, bipolar disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 06Feb2021 08:45 the patient experienced moderate nausea and vomiting for full 3 days so far, (trying to find out how many days this will go on) mild headache, pain in left side of neck, stiff joints, feverish. No treatment was received for the event. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Administration date=04Feb2021, Administration time=03:45 PM; Administration date=28Dec2020, Administration time=01:00 PM; right side underarm was swollen and painful; arm pain; Fever; Body aches; This is a spontaneous report from a contactable Other Health Care Professional (patient). A 46-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9265/Batch number was not reported) via an unspecified route of administration, administered in arm right on 04Feb2021 at 15:45 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Medical history included headache, covid-19 from 08Jan2021 to an unknown date (COVID dx. 08Jan2021 (mild sx) recovered) and known allergies Sulfa. Concomitant medications included vitamin c [ascorbic acid] (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; zinc (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; vitamin b complex (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; famotidine (PEPCID [FAMOTIDINE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication;magnesium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; meloxicam (MEL) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. Patient didn't receive other vaccinations within 4 weeks prior to vaccination patient had COVID prior to vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL1284) via an unspecified route of administration in arm right on 28Dec2020 at 15:45 as dose 1, single for covid-19 immunization. On 05Feb2021 (Friday) at 02:00 AM, the patient experienced body aches and at 07:00 PM, fever began. On 06Feb2021 at 06:00 AM, felt arm pain and noticed my right side underarm was swollen and painful. Reviewed side effect profile and saw that some people did have lymphadenopathy and therefore I decided to wait it out. I did not seek medical attention. As of 08Feb2021 (Monday), the swelling has diminished considerably on its own and the pain reduced to only if I touch it. On 09Feb2021, the swelling is gone and the pain only when deeply touch is almost gone. The clinical outcome of the right side underarm was swollen and painful, body aches, fever, arm pain was recovering and of the administration date=04Feb2021, administration time=03:45 PM; administration date=28Dec2020, administration time=01:00 PM was unknown.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Dizziness, Fall, Fatigue, Headache
Clinical narrative: She vomited; She was dizzy; Nausea; Tired all day; headache; vomited again; she fell getting up; Ended up getting heart rate went up; This is a spontaneous report from a contactable Consumer (daughter) reported for mother. A 58-year-old female patient (mother) received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for Injection, Lot number: EL9269, Expiration date: May2021), via an unspecified route on 07Feb2021, Sunday at 13:30 (Age at vaccination: 58-year-old) as Dose 1, single for covid-19 immunization. Medical history included asthma and blood pressure. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for Injection, Lot number: EL3247) as a single dose for covid-19 immunization. On 09Feb2021, patient experienced vomiting since 3am, no fever, no change in heart rate, only dizziness and nausea, she was just very tired all day yesterday, last night she ended up getting her heart rate went up a little bit and she got slightly dizzy, and it was all about 11 0'clock in night she went to bed and woke up at 3 am today extremely dizzy that she couldn't even stand up on her feet she fell getting up and vomited. About 11PM last night had a headache. She woke up at 4am to use the bathroom, was very dizzy, vomited, drank water and vomited again. She was vomiting non-stop. This morning she was feeling better, but she hasn't vomited till 5 :30 in the morning but she is still extremely dizzy, dizziness will like a severe reaction, but it's been almost 36 hours caller don't think she would have a severe reaction 36 hours later. Caller would like to know if this is a normal reaction to be this dizzy. Therapeutic measures taken as a result of headache included Tylenol, after that she went to bed and was fine. The patient underwent lab test and procedure which included no change in heart rate and heat rate went up in Feb2021. The clinical outcome of headache was resolved on Feb2021,vomiting, dizziness was not recovered and nausea, all day tired, vomiting again, fell getting up ,ended up getting her heart rate went up was unknown.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea, Vomiting
Clinical narrative: She vomited; She was dizzy; Nausea; Tired all day; headache; vomited again; she fell getting up; Ended up getting heart rate went up; This is a spontaneous report from a contactable Consumer (daughter) reported for mother. A 58-year-old female patient (mother) received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for Injection, Lot number: EL9269, Expiration date: May2021), via an unspecified route on 07Feb2021, Sunday at 13:30 (Age at vaccination: 58-year-old) as Dose 1, single for covid-19 immunization. Medical history included asthma and blood pressure. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for Injection, Lot number: EL3247) as a single dose for covid-19 immunization. On 09Feb2021, patient experienced vomiting since 3am, no fever, no change in heart rate, only dizziness and nausea, she was just very tired all day yesterday, last night she ended up getting her heart rate went up a little bit and she got slightly dizzy, and it was all about 11 0'clock in night she went to bed and woke up at 3 am today extremely dizzy that she couldn't even stand up on her feet she fell getting up and vomited. About 11PM last night had a headache. She woke up at 4am to use the bathroom, was very dizzy, vomited, drank water and vomited again. She was vomiting non-stop. This morning she was feeling better, but she hasn't vomited till 5 :30 in the morning but she is still extremely dizzy, dizziness will like a severe reaction, but it's been almost 36 hours caller don't think she would have a severe reaction 36 hours later. Caller would like to know if this is a normal reaction to be this dizzy. Therapeutic measures taken as a result of headache included Tylenol, after that she went to bed and was fine. The patient underwent lab test and procedure which included no change in heart rate and heat rate went up in Feb2021. The clinical outcome of headache was resolved on Feb2021,vomiting, dizziness was not recovered and nausea, all day tired, vomiting again, fell getting up ,ended up getting her heart rate went up was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lymphadenopathy. Caller stated if it is a reported side effect. Did not wish to provide further demographics. The outcome of the event was reported as unknown.   Information of lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bacterial disease carrier, Condition aggravated, Macule
Clinical narrative: a spot on the medial side of his arm, opposite from the injection site, that is getting bigger; a spot on the medial side of his arm, opposite from the injection site, that is getting bigger; He thinks the MRSA has come back; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jan2021 as a Dose 1,Single dose for COVID-19 immunization. The patient's medical history included methicillin-resistant staphylococcus aureus (MRSA), rheumatoid arthritis, diabetes and hypertension.The patient's concomitant medications were not reported. The patient reported last night the patient noticed a spot on the medial side of his arm, opposite from the injection site, that was getting bigger. The patient had the same thing on the opposite arm 12 years ago and it was MRSA. The patient thinks the MRSA has come back. He was waiting for the doctor to call him back. The treatment for the events was not reported.The outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Lymphadenopathy, Pain
Clinical narrative: had sore glands; it got worst; coughing; aching; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of 68 an unspecified unit received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history included coughing and aching. Concomitant medications were not reported. Patient got her second covid vaccine shot this Saturday. The morning and night before that she is already experiencing coughing and aching and 2-3 days after her second covid vaccine shot it got worst and she had sore glands which she is unsure is this is normal. The patient wanted to ask what specific test she should be taking to test for covid. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: his back around his waist "like a perfect circle all around my body" aches and still aches now/pain above his tail bone that goes all around the waist; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 08Feb2021 as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, at night, the patient experienced his back around his waist "like a perfect circle all around his body" aches and still aches now/pain above his tail bone that goes all around the waist. The patient read an article in the news about some doctor who states to not take Ibuprofen, Tylenol, or Advil 2 days before and 2 days after the vaccine because it may reduce the effectiveness of the vaccine. He asked if Ibuprofen, Tylenol, or Advil may reduce the effectiveness of Pfizer's COVID vaccine and if pain above his tail bone that goes all around the waist has been a reported side effect with Pfizer's COVID vaccine. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch; at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch; at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 93-Year-Old male patient (father) that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that her 93-year-old father got the first Pfizer vaccine on 29Jan2021. He didn't say anything about it until yesterday but "at the area of the injection, it is red, hot, warm to touch, about the size of an egg and kinda hard to touch". "It seems to be redder today. What does she do. The outcome of the event vaccination site erythema was reported as not recovered. and outcome of other events was unknown.  Information regarding batch/lot has been requested.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: slight rash on the right side of her chest, on the side where she received the shot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 74; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced slight rash on the right side of her chest, on the side where she received the shot. She states the rash was subsiding. The Outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: am in a lot of pain; migraine headache; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Jan2021 as DOSE 1, SINGLE for COVID -19 immunization. The patient medical history and concomitant medications were not reported. The patient was given her first dose of the pfizer covid vaccine 3 weeks ago. She was supposed to get the second dose of the vaccine yesterday but was unable to because she was being quarantined after going to an appointment outside of the facility. She was told that the next time they can provide her with the second dose will be 01Mar2021. On an unspecified date, patient was in a lot of pain and migraine headache. She wants to know if she can safely receive the second dose this far apart from the first. No PQC Present.  She was really upset that she was not given the shot and they kept telling her that they were on their way and then they told the nurse that they will be back for first dose next month which just means she was going to be quarantined in her room longer, three weeks longer. Right now, she got a migraine headache and she can't even talk about it." The outcome for all the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: concerned; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A non-contactable female consumer reported for herself.  A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on an unspecified date in Feb2021 (last week) as single dose for COVID-19 immunisation. The patient's medical history included allergic reactions to sulfa, prednisone/cortisone, penicillin, codeine. Concomitant medications were not reported. The patient stated that she was very concerned about receiving second dose. She was more concerned about having a fast heart rate or allergic reaction. The caller reported that she had no side effects from the first vaccine and was not concerned about minor side effects like fever, chills and body aches. The caller stated that she read online that people with penicillin can have a bad reaction to the vaccine. The caller was asking whether she can be totally okay with the first shot, and then have a severe allergic reaction for the second vaccine shot. Caller was also asking whether she can stay at the vaccination clinic longer than 30 minutes and wanted to stay all day to make sure she doesn't have a reaction. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Dysphonia, Feeling hot
Clinical narrative: the lymph nodes are swollen under her throat/for sick feeling in her lymph nodes (swollen; chills; dizziness; nausea/sick to the stomach; having hoarseness; problems speaking; in pain; her arm feels hard as a brick where he gave the injection; Her arm is hard like one of those body builders where their muscle sticks out; has been sick to the stomach; hot; Her arm has been hurting for over 11 days; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231, Expiration date was not reported),via an unspecified route of administration, administered in Arm Left on 26Jan2021(age at vaccination 74 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 the patient experienced her arm has been hurting for over 11 days , nausea/sick to the stomach, having hoarseness, problems speaking, in pain, her arm feels hard as a brick where he gave the injection, her arm is hard like one of those body builders where their muscle sticks out, has been sick to the stomach, feeling hot. chills on 30Jan2021, dizziness on 27Jan2021 ,sick feeling in her lymph nodes (swollen) /lymph nodes are swollen under her throat feeling on 08Feb2021. Patient stated She just started having chills again and they come and go, and she never knows. She stated everyone else said they had pain 2-3 days so it must be the way he gave it to her. She asked are these normal side effects. Is it normal for them to last this long?Is there such a thing as having a bad batch. Her second dose is scheduled 20Feb2021, four days late. the man who gave her shot told her to put out her arm shoulder length and stated, 'make a muscle by squeezing your hand' and he didn't use an alcohol swap and then he put a Band-Aid on it. The outcome of events was dizziness was recovered on 31Jan2021, her arm is hard like one of those body builders where their muscle sticks out was unknown, rest of all events was not recovered.  Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Covid vaccine: Stated that it must have been a bad batch.  Product strength and count size dispensed: unknown strength; one count Is a sample of the product available to be returned, if requested (Y/N): N Packaging sealed and intact? Unknown  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Limb discomfort, Lymphadenopathy, Nausea, Pain
Clinical narrative: the lymph nodes are swollen under her throat/for sick feeling in her lymph nodes (swollen; chills; dizziness; nausea/sick to the stomach; having hoarseness; problems speaking; in pain; her arm feels hard as a brick where he gave the injection; Her arm is hard like one of those body builders where their muscle sticks out; has been sick to the stomach; hot; Her arm has been hurting for over 11 days; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231, Expiration date was not reported),via an unspecified route of administration, administered in Arm Left on 26Jan2021(age at vaccination 74 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 the patient experienced her arm has been hurting for over 11 days , nausea/sick to the stomach, having hoarseness, problems speaking, in pain, her arm feels hard as a brick where he gave the injection, her arm is hard like one of those body builders where their muscle sticks out, has been sick to the stomach, feeling hot. chills on 30Jan2021, dizziness on 27Jan2021 ,sick feeling in her lymph nodes (swollen) /lymph nodes are swollen under her throat feeling on 08Feb2021. Patient stated She just started having chills again and they come and go, and she never knows. She stated everyone else said they had pain 2-3 days so it must be the way he gave it to her. She asked are these normal side effects. Is it normal for them to last this long?Is there such a thing as having a bad batch. Her second dose is scheduled 20Feb2021, four days late. the man who gave her shot told her to put out her arm shoulder length and stated, 'make a muscle by squeezing your hand' and he didn't use an alcohol swap and then he put a Band-Aid on it. The outcome of events was dizziness was recovered on 31Jan2021, her arm is hard like one of those body builders where their muscle sticks out was unknown, rest of all events was not recovered.  Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Covid vaccine: Stated that it must have been a bad batch.  Product strength and count size dispensed: unknown strength; one count Is a sample of the product available to be returned, if requested (Y/N): N Packaging sealed and intact? Unknown  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Speech disorder
Clinical narrative: the lymph nodes are swollen under her throat/for sick feeling in her lymph nodes (swollen; chills; dizziness; nausea/sick to the stomach; having hoarseness; problems speaking; in pain; her arm feels hard as a brick where he gave the injection; Her arm is hard like one of those body builders where their muscle sticks out; has been sick to the stomach; hot; Her arm has been hurting for over 11 days; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK9231, Expiration date was not reported),via an unspecified route of administration, administered in Arm Left on 26Jan2021(age at vaccination 74 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 the patient experienced her arm has been hurting for over 11 days , nausea/sick to the stomach, having hoarseness, problems speaking, in pain, her arm feels hard as a brick where he gave the injection, her arm is hard like one of those body builders where their muscle sticks out, has been sick to the stomach, feeling hot. chills on 30Jan2021, dizziness on 27Jan2021 ,sick feeling in her lymph nodes (swollen) /lymph nodes are swollen under her throat feeling on 08Feb2021. Patient stated She just started having chills again and they come and go, and she never knows. She stated everyone else said they had pain 2-3 days so it must be the way he gave it to her. She asked are these normal side effects. Is it normal for them to last this long?Is there such a thing as having a bad batch. Her second dose is scheduled 20Feb2021, four days late. the man who gave her shot told her to put out her arm shoulder length and stated, 'make a muscle by squeezing your hand' and he didn't use an alcohol swap and then he put a Band-Aid on it. The outcome of events was dizziness was recovered on 31Jan2021, her arm is hard like one of those body builders where their muscle sticks out was unknown, rest of all events was not recovered.  Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Covid vaccine: Stated that it must have been a bad batch.  Product strength and count size dispensed: unknown strength; one count Is a sample of the product available to be returned, if requested (Y/N): N Packaging sealed and intact? Unknown  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Insomnia, Loss of personal independence in daily activities
Clinical narrative: back left hip and upper thigh pain; back left hip and upper thigh pain/little pain in lower left shin; pain on the left back side; she was not able to sleep well.; It hurts walking and standing up straight; Is tired today; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 05Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included hip pain and concomitant medications included pain killers (unspecified). Patient reported, felt fine on Friday and all-day Saturday. On Sunday shortly she got up she started having pain in her back hip on the left side. Has had sciatica nerve inflammation on the right hip before and that is what it felt like. She was not able to sleep well. Most of Sunday it would come and go and she tried to move around, but by Sunday afternoon she started feeling pain in the front upper left thigh. Ever since then all day yesterday it would go back and forth between the two areas. Yesterday was the left front upper thigh and today has been both, back and forth. It hurts walking and standing up straight. Had a little pain in lower left shin. Slept okay on Sunday, but last night she tossed and turned all night. Is tired today and she does not know if it's from not sleeping. Wants to know if this is a normal side effect or not or whether or not should she just take pain killers and how long will this last. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: back left hip and upper thigh pain; back left hip and upper thigh pain/little pain in lower left shin; pain on the left back side; she was not able to sleep well.; It hurts walking and standing up straight; Is tired today; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 05Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included hip pain and concomitant medications included pain killers (unspecified). Patient reported, felt fine on Friday and all-day Saturday. On Sunday shortly she got up she started having pain in her back hip on the left side. Has had sciatica nerve inflammation on the right hip before and that is what it felt like. She was not able to sleep well. Most of Sunday it would come and go and she tried to move around, but by Sunday afternoon she started feeling pain in the front upper left thigh. Ever since then all day yesterday it would go back and forth between the two areas. Yesterday was the left front upper thigh and today has been both, back and forth. It hurts walking and standing up straight. Had a little pain in lower left shin. Slept okay on Sunday, but last night she tossed and turned all night. Is tired today and she does not know if it's from not sleeping. Wants to know if this is a normal side effect or not or whether or not should she just take pain killers and how long will this last. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had a severe allergic reaction/having a rash yesterday; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history included drug allergy to sulfa medicatoins. The patient's concomitant medications were not reported. On an unknown date the patient had a rash and her HCP stated she had a severe allergic reaction and not to get the second dose of the vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo very intense for two days.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 28Jan2021 09:30 Am (age at vaccination was 69 years) (Batch/Lot Number: EL9264) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 29Jan2021 the patient experienced vertigo very intense for two days and have some residual. The event led to Doctor or other healthcare professional office/clinic visit. No treatment was received for the event. The outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle tightness
Clinical narrative: Recurrent headache (frontal); local tightening of the muscles deltoids and triceps of the left arm; This is a spontaneous report from a contactable Other HCP. A 33-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EL3247), via unspecified route in left arm on 23Jan2021 01:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. No known allergies reported. Patient previously took first dose of BNT162B2 (BNT162B2, Solution for injection, batch/Lot number Ek9231 and expiration date was not reported), via unspecified route in left arm on 02Jan2021 10:00 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take other medication in 2 weeks. On 24Jan2021 at 18:00 the patient experienced Recurrent headache (frontal), and local tightening of the muscles deltoids and triceps of the left arm. The patient was not taking any treatment medications. The outcome of both event was not recovered.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.