chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Blood pressure decreased, Blood pressure measurement, Chills
Clinical narrative: Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 55-year-old, via an unspecified route of administration, administered in left arm on 16Feb2021 08:30 (Lot Number: EN6200) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 20Feb2021, the patient started developing some tingling and the right side of his face doesn't work anymore. The next day (21Feb2021) he went to the doctor and he was diagnosed with Bell's Palsy. He has got full blown, right side of his face was flop, bell's palsy. He went to the doctor and they put him on Prednisone, which he was still treating. The event required a visit to the physician office. The outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arrhythmia, Dizziness, Fall, Fatigue
Clinical narrative: Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events.   Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product.    The impact of this report on the benefit/risk profile of the Pfizer drug 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain, Vomiting
Clinical narrative: Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events.   Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product.    The impact of this report on the benefit/risk profile of the Pfizer drug 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Pain in extremity, Skin exfoliation
Clinical narrative: bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fingers and the feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249, expiration date not reported) via unspecified route of administration in the arm right on 21Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. The patient previously took iodine and experienced drug allergy; also received first dose of bnt162b2 (Lot number: EJ1685) via unspecified route of administration in right arm on 30Dec2020 14:00 for COVID-19 immunization. Facility type vaccine: clinic. It was reported that on 23Jan2021, couple of days after the second shot, patient experienced skin on hands and the bottom of my feet started to peel off and bleeding and very painful in the fingers and the feet.  The events resulted in both: Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if treatment received for the events. Outcome of all events was recovering.; Sender's Comments: Based on plausible temporal relationship and known drug profile, a contributory role of the suspect BNT162B2 cannot be excluded in the development of bleeding, skin exfoliation and pain in extremity.  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: F
Vaccine: COVID19, UNK
Symptoms: Body mass index, Dizziness, Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism; shortness of breath; dizziness; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation; and apixaban (ELIQUIS), via an unspecified route of administration from Feb2021 (batch/lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On Feb2021, three weeks following the patient's TK (unspecified), patient experienced shortness of breath, dizziness (notable with exertion), and pulmonary embolism. The patient underwent lab test and procedure which included body mass index: 42.19 on Feb2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, the reported pulmonary embolism is likely an intercurrent medical condition in this 76 year old female patient and unrelated to BNT162B2. Of note, medical history and indication for apixaban were not provided to determine pre-existing risk factors that may have led to the event.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Ammonia, Ammonia increased, Blood uric acid increased, Dizziness, Gait disturbance
Clinical narrative: Seizure like episodes.; Dizzy spells; High ammonia levels of 267 at the highest; Hit uric acid; She can not walk; Numbness on her right side; Terrible headache; Nausea; This is a spontaneous report from a contactable consumer.  A female patient (mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter wanted to write because the patient (mother) has been in the hospital almost 18 days with no end in sight. She is going to a rehab facility soon. She had a terrible reaction to the vaccine and the reporter thought it should be noted somewhere. She is an interesting case because lots of things react bad with her. She has dizzy spells, seizure like episodes, high ammonia levels of 267 at the highest, hit uric acid, she can not walk, numbness on her right side, terrible headache, nausea and more from an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Seizure
Clinical narrative: Seizure like episodes.; Dizzy spells; High ammonia levels of 267 at the highest; Hit uric acid; She can not walk; Numbness on her right side; Terrible headache; Nausea; This is a spontaneous report from a contactable consumer.  A female patient (mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter wanted to write because the patient (mother) has been in the hospital almost 18 days with no end in sight. She is going to a rehab facility soon. She had a terrible reaction to the vaccine and the reporter thought it should be noted somewhere. She is an interesting case because lots of things react bad with her. She has dizzy spells, seizure like episodes, high ammonia levels of 267 at the highest, hit uric acid, she can not walk, numbness on her right side, terrible headache, nausea and more from an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: tends to have blood clots; This is a spontaneous report from a Pfizer-sponsored program, patient. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled to get the second shot this afternoon (02Mar2021), on a blood thinner and tends to have blood clots. Outcome of the event was unknown.    Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: got hospitalized due to sepsis after the first dose.; This is a spontaneous report from a Pfizer-sponsored program, patient's daughter. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter asked to make a schedule change since her mother got hospitalized due to sepsis after the first dose. The first dose was on 10Feb2021, next dose is on 04Mar2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation
Clinical narrative: numbness in right hand; This is a spontaneous report from a contactable consumer (patient reporting for himself). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration at the left arm on 06Mar2021 15:00 (reported as 3:00 PM) at single dose for covid-19 immunization. Medical history included allergies: fish oil, shellfish from an unknown date and unknown if ongoing.  The patient was not covid tested post vaccination; no covid prior vaccination; and no other vaccine in four weeks. The patient experienced numbness in right hand on 06Mar2021 at 07:00 PM. It was noted that the event resulted in Emergency room/department or urgent care and considered Life threatening illness (immediate risk of death from the event). It was reported that treatment includes tests (on unspecified date), new medication (unspecified medication). The outcome of the event was recovered with sequel (reported as Recovered with lasting effects).
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: has Problems with getting an erection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received first dose 25Feb2021 and now has problems with getting an erection. The event started on an unspecified date with unknown outcome.  Information on the batch/lot number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Nausea, Seizure
Clinical narrative: seizure; loss of energy; flu-like symptoms; bouts of nausea; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266), via an unspecified route of administration at the age of 73-year-old at arm left on 27Feb2021 02:45 PM at single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medications in two weeks included allopurinol; zonisamide; vitamin D and glutathione. There was no other vaccine in four weeks. There was no covid prior vaccination and no covid tested post vaccination. The patient had Pfizer COVID vaccine Sat, 27Feb2021 afternoon. Then 24 hrs after vaccine had loss of energy with flu-like symptoms and bouts of nausea on 28Feb2021 6:00 PM. Then at 4a.m. early Monday 01Mar2021 morning had seizure. There was no treatment for events. The event seizure was serious for being medically significant. The outcome of events was recovering.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nephrolithiasis
Clinical narrative: Classic kidney stones symptoms in person with no prior history, and on no medications; headache; fatigue; This is a spontaneous report from a contactable physician. A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: EN6203), intramuscular, administered in left arm on 26Feb2021 at 10:15, at a single dose, for covid-19 immunization. Medical history included early stage prostate cancer more than 2 years ago; surgery only, no meds. 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. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. On 02Mar2021 at 8:00, the patient experienced classic kidney stones symptoms, with no prior history and on no medications. All other symptoms were more typically reported for the vaccine (ie. headache, fatigue, etc). Patient has pending doctor appointment. The outcome of events was unknown.    No follow-up attempts possible. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: weakness in area spreading to groin area; Sever left hip pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER-BIOTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 68-year-old via an unspecified route of administration in the left arm on 28Feb2021 11:00 as a single dose for covid-19 immunisation. Medical history included diabetes, high blood pressure and asthma. The patient has no known allergies. There were no concomitant medications. The patient did not have Covid prior vaccination. The patient has not received other vaccine in four weeks. On 01Mar2021 08:00 AM, the patient had weakness in area spreading to groin area and severe left hip pain. The adverse events resulted in disability or permanent damage. No treatment was received for the adverse events. The patient has not been tested post vaccination. The outcome of the events was not recovered.  The following information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Supraventricular tachycardia
Clinical narrative: atrial fibrillation; She experienced a supraventricular tachycardia event that would not stop was pretty high like 250; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her first dose of her Pfizer vaccine on 16Feb2021 and then one week after, on 23Feb2021, she experienced a supraventricular tachycardia event that would not stop was pretty high like 250 and so, on 23Feb2021 and 25Feb2021, had attack of atrial fibrillation, she went to the hospital and had a cardiac operation surgery on 23Feb2021. She was recovering at home now and was scheduled to receive the second dose of her Pfizer vaccine sometime next week, she was supposed to go in 11-15 days after the surgery. The reporter was asking if the patient is good for her second dose. Outcome of the events was recovering.  Information on lot number/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Pulmonary fibrosis, Respiratory distress
Clinical narrative: severe ARDS and pulmonary fibrosis; severe ARDS and pulmonary fibrosis; presented to the hospital on 26Feb with severe resp distress; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 18Feb2021 16:00 (Lot Number: EN6203) (at 67-year-old) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Store. Medical history included Malignant neoplasm of sigmoid colon, hypertension (HTN). Concomitant medications included tamsulosin; tipiracil hydrochloride/trifluridine (LONSURF), hydrochlorothiazide/lisinopril (ZESTORETIC), docusate sodium (COLACE), hyoscyamine sulfate (LEVSIN/SL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 (Lot number: AL9265) at 27Jan2021 12:30 PM, Intramuscular at right arm for covid-19 immunization. Patient received 2nd vaccine on 18Feb2021 and presented to the hospital on 26Feb2021 with severe respiratory distress. Currently intubated/paralyzed with severe Acute respiratory distress syndrome (ARDS) and pulmonary fibrosis. Unknown if any correlation, Adverse event start date was on 26Feb2021. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Adverse event treatment included: Intubation/paralytics. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A contributory role of BNT162B2 to events respiratory distress, Acute respiratory distress syndrome (ARDS) and pulmonary fibrosis cannot be excluded based on temporal association. 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea
Clinical narrative: He was having trouble breathing; His heart is working at 25% capacity; This is a spontaneous report from a contactable consumer.  A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Lot number: was not reported) (at the age of 77-year-old)  as single dose for COVID-19 immunisation.  Medical history included wears a heart pacemaker and cholesterol issue, both from an unknown date and unknown if ongoing. On 09Mar2021, the patient experienced trouble breathing, it was reported that his heart was working at 25%.  The patient was admitted to emergency room and subsequently he was hospitalized for 3 days, the events were life-threatening.  The patient outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: A patient received 2 vaccinations within same pregnancy one month apart, no AE; Vaccine exposure during pregnancy; Initial information was received on 01-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist in the United States.  This case involves a female patient (age not reported) who received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Suspension for injection, batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination within same pregnancy one month apart (at 31 weeks and 35 weeks) on an unknown date (Extra dose administered) on an unknown date while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Past medical treatment, vaccination and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  It was case of vaccine exposure during pregnancy.   Pregnancy outcome was unknown at the time of report.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine were not reported.  It was unknown if there were lab data/results available.  This was a case of actual medication error due to extra dose administered (latency unknown).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Patient received ADACEL transdermal instead of Tubersol via intradermal route, with no adverse event; Patient received ADACEL transdermal instead of Tubersol via intradermal route, with no adverse event; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 60 years old female patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot 7SY34 and expiration date: 13-Jan-2023) via intradermal route in the left mid forearm for prophylactic vaccination instead of TUBERCULIN TEST [TUBERSOL] (lot number and expiration date were not reported) (Wrong product administered and Incorrect route of product administration) on 01-Mar-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was an actual medication error case due to wrong vaccine administered and inappropriate route of vaccination (on same day).  It was reported that nurse took out Adacel which was ordered, however got confused and injected the patient. This occurred because of the new nurse making an error and not because of any error with our product, Adacel or Tubersol.  The reporter asked if this dose is considered valid, if the patient should be re-dosed, and what AE's (adverse events) should they be on the look out for due to the ID injection. Escalated case to TA (transfer) due to no information regarding these questions in standards or PI.  The reporter would like a call back as soon as possible.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: The patient was inadvertently administered an expired dose of vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via Global Medical Information (GMI) (Reference number- 00509255) and transmitted to Sanofi on 08-Mar-2021.  This case involves an 11 year old male patient who was inadvertently administered a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6521AA, expiry date: 26-Jan-2021) via unknown route in the right deltoid on 17-Feb-2021 for prophylactic vaccination (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no concomitant vaccines.   It was a case of an actual medication error due to Expired vaccine used (latency same day).  The reporter had a question on the expiration date for Menactra as it was given to a patient past the expiration date  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case involves a female patient  of unknown age who was vaccinated with already expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date in 2021, as well as reported that it was left from the 2019-2020 season (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used (same day latency). Patient did not provide any AE (adverse event) details. Also reported that MIS (Medical Information System) discussed expired vaccine, overdose, adverse events per PI (present illness) and interactions. Physician was asked about spacing before re-vaccination, side effects, and whether acetaminophen or benadryll would help with the side effects. Physician was impatient with transfer, and irate. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: at approximately the 17  hour mark, began to feel aches that escalated and expanded out from hip area to a general body ache. headache began at the 23 hour mark. both conditions existed through approximately the 36 hour mark.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: It?s been 8 days since the vaccine. I went to the doctor 2 days ago to follow up on blood tests. I was prescribed Lipitor 10mg and I took it for the first time around 12am on 3/19/21. About 2 hours later I noticed itching, so when I looked there was a cluster of hives. The hives are right where I got the vaccine.
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Severe hives throughout my body. Swollen lip began March  16,2021. Treating with prednisone and benedryl
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Severe hives throughout my body. Swollen lip began March  16,2021. Treating with prednisone and benedryl
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Client verbalize feeling heaviness to right arm.  Pt. denies any other symptom. Pt seen by EMD and vital signs are:  149/71, HR 70, O2 98. Pt. cleared to go home by EMT.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Headache, myalgia, dizzness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Allergy or Rash all over the body (arms, legs).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Pain, Sleep disorder
Clinical narrative: Each day after second COVID-19 vaccination I had an upset stomach and aches; but was not that severe.  However, last night (3/18) the stomach pain and aches got intense and kept me up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itchy red rash 3-4? in diameter around injection site, skin is hot, muscle is hard, slightly tender to touch.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Itchy red rash 3-4? in diameter around injection site, skin is hot, muscle is hard, slightly tender to touch.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash at injection site 9 days after first dose of vaccine
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever, muscle pain
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: 4 days after 2 nd dose on 3/18/2021 my father/patient has growing rash, unusually large swelling of injection site arm, left arm. increasing sensitivity to shot, soreness.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the vaccine contributed to it. Around 530 pm I started feeling fatigue and a slight wave of nausea. The nausea did not last long. By 6:30 pm  I was exhausted and began having chills - my feet especially felt cold. I then crashed hard and slept for a few hours. The next morning my arm was slightly sore and by the evening I felt extra tired.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: I had a slight headache prior to the vac one that lasted through the next day so I?m not sure if the vaccine contributed to it. Around 530 pm I started feeling fatigue and a slight wave of nausea. The nausea did not last long. By 6:30 pm  I was exhausted and began having chills - my feet especially felt cold. I then crashed hard and slept for a few hours. The next morning my arm was slightly sore and by the evening I felt extra tired.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, upset stomach, headache, nausea, body aches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: After initial vaccination, I experienced common muscle soreness that disappeared after 2-3 days. One week after vaccination, muscles soreness came back and the injection site is red and swollen.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Immediately after the injection I felt dizzy for approx. one hour. Experienced severe itching and mild pain at injection site one week after injection. I had a red area about the size of an apple. Telephone conversation on 3/16/2021 with family physicians' office resulted in treatment to use TRIAMCINOLONE ACETONIDE CREAM, .1% twice a day. Cream reduced itching for approximately 4 to 5 hours after each application.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Neck mass, Swelling
Clinical narrative: Localized swelling, mass and lump neck, acute onset mass in left neck near clavicle.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills very early in the morning, however, I guess I'm feeling Ok now.  But I'm wearing warmer cloths now.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient experienced an infection at the injection site, started 8 days after the injection. Urgent care gave her cephalexin and triamcinolone cream
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient reports lymph node under armpit feels swollen. He noticed injection site reaction within 1-2 hours of receiving vaccine, but has not experienced any other systemic reactions.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Rash erythematous, Swelling
Clinical narrative: Injection site was warm and still tender to the touch. About 3 inch perimeter raised, red and rash-like (persistent 3/19)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chills-Medium, Systemic: Hot to touch/ Cellulitis-Severe, Additional Details: MD diagnosed the patient with Cellulitis. She described that her injection site is hot and was rash-like and about a credit card site for the first day. Day 3 she still has the rash it is just traveling down her arm to her elbow now it is hot to the touch and the doctor diagnosed her with cellulitis. She did complain that it has progressively get worse over the couple of days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash, Skin warm
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chills-Medium, Systemic: Hot to touch/ Cellulitis-Severe, Additional Details: MD diagnosed the patient with Cellulitis. She described that her injection site is hot and was rash-like and about a credit card site for the first day. Day 3 she still has the rash it is just traveling down her arm to her elbow now it is hot to the touch and the doctor diagnosed her with cellulitis. She did complain that it has progressively get worse over the couple of days.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms, stomach and legs.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: Hives on arms, stomach and legs.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Arm site became itchy, red and warm,
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE; Temperature excursions; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot  No. S014430, exp. date 09-MAY-2021) (rHA) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. S030243, exp. date 26-SEP-2021) that went through temperature excursion (product storage error). Temperature excursions occurred between August and September 2020. The issue was identified on 12-AUG-2020. No additional adverse event information was reported.  Temperature: 6.5F Time frame: for 45 minutes
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse event; Varivax administered to a patient during a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021821, expiration date 25-JUN-2022, 0.5 milliliter, for prophylaxis.     On 22-FEB-2021, the reporter noticed the excursion.    Temperature -7.4 C Time frame 3 hours and 54 minutes Previous temperature excursion? No Was call because of a "data logger"? (YIN) Y
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; a female patient informed her she has been receiving "yearly flu and PNEUMOVAX 23 vaccines at Walgreen's pharmacy for the last 3 years"; This spontaneous report was received from a nurse practitioner via a company representative, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug allergies were not reported.   On approximately an unknown date in 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at the dose of 0.5 milliliter for prophylaxis (strength, route of administration, anatomical location, lot number, and expiration date were not reported).   It was stated that the patient informed that she was receiving yearly flu and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for the last 3 years (onset date: approximately 2020) (inappropriate schedule of product administration). No additional adverse event reported, nor product quality complain involved.    The outcome of the event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Dysarthria, Facial paralysis, Hemiparesis, Ischaemic stroke, Muscular weakness
Clinical narrative: acute Ischemic stroke; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. In or about 26-JUL-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prevention of shingles (herpes zoster) (prophylaxis). Shortly after the receipt of zoster vaccine live (ZOSTAVAX) vaccine, the pt experienced left sided weakness, slurred speech, arm and facial droop and was diagnosed with an acute ischemic stroke. As a direct and proximate result of the administration of this vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well a significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the pt had not recovered from the event. The reporter considered the event to be related to suspect therapy and disabling.