chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: high fever - 102 F; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet; abnormal horrific headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0179 and expiration date was not reported), via an unspecified route of administration in left arm, on 17May2021 at 14:30 (at the age of 40 years old) as second dose, single for COVID-19 immunization in a Public Health Clinic/Veterans Administration facility. The patient's medical history was not reported. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced drug allergy. Concomitant medications included esomeprazole sodium (NEXIUM) and celecoxib (CELEXA). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0172 and expiration date was not reported), via an unspecified route of administration in left arm, on Apr2021 at 10:30 (at the age of 40 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and post-vaccination, the patient was tested for COVID-19 with nasal swab and the result was negative on 16Apr2021. The patient experienced high fever with a temperature of 102 F, very swollen and painful lymph nodes in left armpit and right but not as bad sweaty feet and abnormal horrific headache on 17May2021 at 14:30. This case was considered as non-serious and no treatment was given to the patient for these events. The outcome of these events was recovering at the time of report.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0187 and expiration date was not reported), via an unspecified route of administration in left arm, on 17May2021 at 16:45 (at the age of 13 years old) as 1st dose, single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history was not reported. There were no concomitant medications. 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 and since the vaccination, the patient was never tested for COVID-19. The patient experienced vomiting on 19May2021. This event resulted in doctor or other healthcare professional office/clinic visit. The event was non-serious. It was reported that the patient received an unspecified treatment for this event. The outcome of the event was recovering at the time of report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body pain; This is a spontaneous report from a contactable consumer (patient's son). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0169 and expiration date was reported), via an unspecified route of administration in arm (reported as shoulder), on 18May2021 between 14:00 to 15:00 (at the age of 40 years old) as second dose, single for COVID-19 immunization in the patient's home. The vaccine was not administered in a military facility. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731 and expiration date was reported), via an unspecified route of administration in shoulder, on 26Apr2021 (at the age of 40 years old) as first dose, single for COVID-19 immunization. No other vaccinations was administered within four weeks prior to the first dose of the COVID-19 vaccine. The patient experienced body pain on the night of 18May2021 and fever on 19May2021. The patient events did not require emergency room (ER)/physician's office. The outcome of fever was unknown and body pain was not recovered at the time of report.  No follow attempts are possible; no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient's son). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown formulation) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller stated that his mother had a fever after getting the Covid-19 vaccine. The outcome of the event was unknown.  Information related to lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Illness, Pain
Clinical narrative: Chills; Sickness; I got the soreness/I am achy, the achiness; upset stomach; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 AVCCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, sickness, got soreness/had achy, the achiness and upset stomach on an unspecified date. The patient just wondering what can she do about it. The outcome of these events was unknown at the time of report.    Information about batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: Very sore arm; Swollen lymph nodes; Felt sick; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1685), intramuscularly in left arm on 29Dec2021 (at the age of 34-years-old), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic. On 19Jan2021, the patient had a very sore arm, swollen lymph nodes and felt sick for weeks. The events resulted in doctor or other healthcare professional office/clinic visit. After the first dose the patient was put in medications (unspecified) to help to prevent the same symptoms with second dose. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  Information on Lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021570459 same reporter/patient/vaccine, different dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Vision blurred
Clinical narrative: Pressure and blurry vision in my right eye; Pressure and blurry vision in my right eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female (no pregnant) patient received the first dose of BNT162B2 via an unspecified routed of administration on the right arm on 17Apr2021 at 13:15 (Lot Number: EW0250) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. Known allergies is sulfa. The patient was not diagnosed with COVID-19 prior vaccination. The patient had not been tested for COVID-19 post vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included hydroxychloroquine (PLAQUENIL). On 21Apr2021 at 12:00, the patient experienced pressure and blurry vision in right eye. The treatment was not received. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of events was both not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after couple of minutes of receiving the vaccine.; This is a spontaneous report from a non-contactable consumer (patient). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0185), via an unspecified route of administration at right arm on 19May2021 (at the age of 12-year-old) as unknown, single for COVID-19 immunisation. Medical history included allergies: Cashews. Patient other medical history was none. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. 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 had not been tested for COVID-19. On 19May2021, patient felt dizzy after couple of minutes of receiving the vaccine. Treatment was not received for the adverse event. Due to event Doctor or other healthcare professional office/clinic visit. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was recovered in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: mild cough with throat irritation for about 3 weeks; mild cough with throat irritation for about 3 weeks; This is a spontaneous report from a contactable other health care professional (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route, administered in right arm on 23Dec2021 at 08:00 (at the age of 30-year-old), as first dose, single, for COVID-19 immunization at hospital. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen (IBUPROFEN) and certolizumab pegol (CIMZIA). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild cough with throat irritation for about 3 weeks on an unspecified date. The outcome was reported as recovered on an unknown date of 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021576704 same patient, different event, different dose of vaccine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: insomnia; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el64 and expiration date was not reported), via an unspecified route of administration in left arm, on 13Feb2021 (at the age of 71 year old) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications included fluoxetine hydrochloride (PROZAC) and hydrochlorothiazide. The patient previously took erythromycin and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 3247 and expiration date was not reported), via an unspecified route of administration in left arm, on 23Jan2021 (at the age of 71 year old) as 1st dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and 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 and since the vaccination, the patient was not tested for COVID-19. The patient experienced insomnia in the evening on 13Feb2021 and continued for 3 months. Slowly getting back to normal which is when the patient fall asleep within a few minutes after going to bed. It was reported that the patient would still take the vaccine again. The event was considered to be non-serious. No treatment was given for this event. The outcome of the event was recovering at the time of report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Abnormal thought process; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW 0172), via an unspecified route, administered in left arm on 20May2021 at 08:15 (at the age of 26-year-old) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), depression and anxiety. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8736), via an unspecified route, administered in left arm on 28Apr2021 at 10:00 (at the age of 26-year-old) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient did not receive any other medications the patient within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 12:00, the patient had abnormal thought process. The events were reported as non serious. The outcome was not recovered for the reported event.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain that comes and goes; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FW0182 and expiration date was not reported), via an unspecified route of administration in left arm, on 17May2021 at 11:30 (at the age of 34 year old) as 2nd dose, single for COVID-19 immunization in a Pharmacy or Drug Store. Medical history included penicillin allergy. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in right arm, on 20Apr2021 at 11:30 (at the age of 34 year old) as 1st dose, single for COVID-19 immunization. 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 and since the vaccination, the patient was not tested for COVID-19. The patient experienced abdominal pain that comes and goes on 18May2021 at 12:00. The event was considered non-serious. No treatment was received for this event. The outcome of the event was not recovered at the time of report.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pain, Tinnitus
Clinical narrative: Body aches; loss of appetite; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 2 via an unspecified route of administration in left arm on 19May2021 13:45 (at the age of 21-years-old) as second dose, single for COVID-19 immunization. Medical history included COVID-19. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), dose 1 via an unspecified route of administration in left arm on 28Apr2021 13:45 as first dose, single for COVID-19 immunization. Prior to vaccination, the patient did not receive any vaccines within four weeks and was not pregnant. Concomitant medications included lorazepam, gabapentin, and mirtazapine. The patient experienced body aches, loss of appetite and tinnitus on 20May2021 12:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache, Musculoskeletal stiffness, Pallor
Clinical narrative: Headache; Episode of stiffness, going pale; Episode of stiffness, going pale; 15 seconds of memory loss; This is a spontaneous report from a non-contactable female other HCP reported for herself. A 19-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration on 19May2021 16:45 (at the age of 19-year-old) as single dose for COVID-19 immunization. Medical history was none, and no allergies were reported. Concomitant medication included sarecycline(SARECYCLINE) contraceptive pill via oral route of administration. On 20May2021 11:00 AM, the patient experienced headache, episode of stiffness, going pale, 15 seconds of memory loss. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment medications for events. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine, diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The events were reported as non-serious. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness/started getting dizzy; vertigo; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 22Apr2021 at first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started getting dizzy on 22Apr2021, 2 hours after the first dose. The patient also stated that she had a unique reaction and experienced dizziness and vertigo for 14 days after getting the first dose. it had gotten better, and she did not have the symptoms anymore. The primary care provider suggested she pushed the second dose back, so patient would be getting the second dose on 21May2021 at 5 weeks after the first dose. Additionally, she wanted to know information or guidance regarding dizziness and the second dose. The outcome of the events was recovered in May2021.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Joint swelling, Pain, Peripheral swelling
Clinical narrative: right leg/knee became severely swollen; right leg/knee became severely swollen; couldn't walk; fatigue; fever; aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration, administered in left arm on 18Feb2021 at 12:00 (at the age of 74-year-old), as first dose, single, for COVID-19 immunization at school or student health clinic. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included atorvastatin calcium (LIPITOR); morniflumate (FLOMAX) losartan potassium (LOSARTAN POTASSIUM) and plus more (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's right leg/knee became severely swollen and he couldn't walk and also the patient had fatigue, fever and aches on an unspecified date on 2021. The events were reported as non-serious. No treatment was received for the events. The outcome was reported as recovered on an unknown date in 2021 for the reported events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: right leg/knee became severely swollen; right leg/knee became severely swollen; couldn't walk; fatigue; fever; aches; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration, administered in left arm on 18Feb2021 at 12:00 (at the age of 74-year-old), as first dose, single, for COVID-19 immunization at school or student health clinic. Medical history included high blood pressure. The patient had no known allergies. Concomitant medications included atorvastatin calcium (LIPITOR); morniflumate (FLOMAX) losartan potassium (LOSARTAN POTASSIUM) and plus more (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's right leg/knee became severely swollen and he couldn't walk and also the patient had fatigue, fever and aches on an unspecified date on 2021. The events were reported as non-serious. No treatment was received for the events. The outcome was reported as recovered on an unknown date in 2021 for the reported events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody positive, Urticaria chronic
Clinical narrative: chronic urticaria began and has not stopped; increase thyroid antibodies; This is a spontaneous report from a contactable other health care professional (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142), via an unspecified route, administered in right arm on 13Jan2021 at 08:00 (at the age of 30-year-old), as second dose, single, for COVID-19 immunization at hospital. Medical history included rheumatoid arthritis. Concomitant medications included ibuprofen (IBUPROFEN) and certolizumab pegol (CIMZIA). The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route, administered in right arm on 23Dec2020 at 08:00 (at the age of 30-year-old), as single dose, for COVID-19 immunization and experienced mild cough with throat irritation for about 3 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jan2021, 5 days after the second vaccination, chronic urticaria started and had not stopped as well as increase thyroid antibodies was reported. The events were reported as non serious and resulted in Doctor or other healthcare professional office/clinic visit. At the time of the report the patient was receiving unspecified medications for the events. The outcome was not recovered for the reported events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021575962 same patient, different event, different dose of vaccine
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm.; This is a spontaneous report from a Pfizer sponsored program support received from a contactable consumer reporting for her husband. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on an unspecified date (Batch/Lot Number: not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm. The event outcome was unknown at the time of the report.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired/fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program  and Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on Monday (an unspecified date), 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was wondering why he was experiencing severe side effects, due to people telling him side effects happened 1 to 3 days after Pfizer COVID-19 vaccine. The patient felt only a bit tired and fatigue. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Scab, Scratch, Urticaria
Clinical narrative: scratching; his injection site on the left arm had a wheal; some rashes on his left arm; the rashes are still there and is now up to his face; developed scabs that are now bleeding; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 14Apr2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient previously received first dose of BNT162B2 (Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration (at the age of 77 years) in right arm on 23Mar2021 for covid-19 immunization and experienced his injection site on his right arm also had a wheal. Patient had no allergies to anything. Patient consulted with his regular dermatologist on 27Apr2021 and doctor noticed that he was scratching. On an unspecified date in Apr2021, patient experienced his injection site on the left arm had a wheal and there had been some rashes on his left arm; rashes are still there and is now up to his face. They are not healing and he had developed scabs that are now bleeding. Therapeutic measures were taken, prescribed a cream for 2 weeks as a result of scratching, his injection site on the left arm had a wheal, some rashes on his left arm; the rashes are still there and is now up to his face with cream for 2 weeks. The events assessed as non-serious. The clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: tooth abscess; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient is scheduled to get the second dose of the Pfizer covid vaccine on Monday, but on an unspecified date she experienced a tooth abscess. Patient wanted to know if its ok to take the second dose. The outcome of event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: Lip swelling and pain/swollen to 4x the regular size of lip; Lip swelling and pain/swollen to 4x the regular size of lip; This is a spontaneous report from a non-contactable consumer (patient, herself). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0178 and expiry date was not provided), via an unspecified route of administration, administered in Arm Left on 19May2021 13:15 (at the age of 31-years old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. No known allergies. No other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 12:00 AM, the patient experienced lip swelling and pain, swollen to 4 times the regular size of lip. No treatment received for the events. Seriousness of the events was reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Little ball behind the armpit where the second dose was administered/ little ball was painful; Little ball behind the armpit where the second dose was administered/ little ball was painful; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient  received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number was not reported) via an unspecified route of administration on 22May2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not received any other products and investigation assessment was not reported. She stated that she had a little ball behind the armpit where the second dose was administered, the little ball was painful. She had her second dose administered on saturday i.e. 22May2021 and by Sunday i.e. 23May2021 it was painful. The outcome of both the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: TDAP
Symptoms: Illness
Clinical narrative: sick for several days; Initial information regarding an unsolicited valid non-serious case from a pharmacist via Agency (Reference number- 00606030) and transmitted to Sanofi on 18-May-2021.  This case involves a female patient who was sick for several days (illness), while she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious, sick for several days (illness), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported that the consumer has received a Tetanus shot in the past that contained horse serum.  No laboratories details reported.  It was not reported if the patient received a corrective treatment for the other events.  At time of reporting, the outcome was unknown.  There will be no information available regarding batch number in this case.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram, Crying, Electroencephalogram, Encephalitis viral
Clinical narrative: My daughter started to experience headaches 2 days after her first dose. On May 13th the headache had become so bad that she would cry and then suddenly became unable to speak or grab. She could not formulate actual words and was unable to smile . This lasted 15 minutes. A trip to the nearest Emergency room was inconclusive and resulted in discharge. 24 hours later , we had the same incident only this time magnified times 10. Where she remained in a catatonic like state for 7 hours only to snap out of it independently without medical treatment. After multiple test she was diagnosed with viral encephalitis. All major causes of encephalittis were ruled out and we were told it was possible a side affect of her first Moderna Covid Vaccine dose. We are still seeing doctors and testing but she seems to have improved without medication which is even more alarming .
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Headache, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: My daughter started to experience headaches 2 days after her first dose. On May 13th the headache had become so bad that she would cry and then suddenly became unable to speak or grab. She could not formulate actual words and was unable to smile . This lasted 15 minutes. A trip to the nearest Emergency room was inconclusive and resulted in discharge. 24 hours later , we had the same incident only this time magnified times 10. Where she remained in a catatonic like state for 7 hours only to snap out of it independently without medical treatment. After multiple test she was diagnosed with viral encephalitis. All major causes of encephalittis were ruled out and we were told it was possible a side affect of her first Moderna Covid Vaccine dose. We are still seeing doctors and testing but she seems to have improved without medication which is even more alarming .
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 2nd shot (first shot was fine) :Round lesion about 4 inches in diameter around injection site.  Area was swollen and hot to the touch . It was also very sore and itchy.  This did not happen with the first shot. About 12 hours after 2nd shot, I woke up with chills and body aches. Neck and shoulders were so painful. Headache  was a 7 out of 10 on pain level. Felt like I had a fever and had the flu. Took 4 Advil. Helped with aches and pains. Also kept hydrated with Pedialyte.  Slept on and off for 24 hrs. Woke up  on the third day and felt much better. All aches and pains were gone with the exception of the round lesion on arm. Also was still a bit tired. Overall main flu like symptoms only lasted a full day. Covid arm is still sticking around as of day 4. But it?s not as red and swelling has gone down.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 2nd shot (first shot was fine) :Round lesion about 4 inches in diameter around injection site.  Area was swollen and hot to the touch . It was also very sore and itchy.  This did not happen with the first shot. About 12 hours after 2nd shot, I woke up with chills and body aches. Neck and shoulders were so painful. Headache  was a 7 out of 10 on pain level. Felt like I had a fever and had the flu. Took 4 Advil. Helped with aches and pains. Also kept hydrated with Pedialyte.  Slept on and off for 24 hrs. Woke up  on the third day and felt much better. All aches and pains were gone with the exception of the round lesion on arm. Also was still a bit tired. Overall main flu like symptoms only lasted a full day. Covid arm is still sticking around as of day 4. But it?s not as red and swelling has gone down.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin lesion, Vaccination complication
Clinical narrative: 2nd shot (first shot was fine) :Round lesion about 4 inches in diameter around injection site.  Area was swollen and hot to the touch . It was also very sore and itchy.  This did not happen with the first shot. About 12 hours after 2nd shot, I woke up with chills and body aches. Neck and shoulders were so painful. Headache  was a 7 out of 10 on pain level. Felt like I had a fever and had the flu. Took 4 Advil. Helped with aches and pains. Also kept hydrated with Pedialyte.  Slept on and off for 24 hrs. Woke up  on the third day and felt much better. All aches and pains were gone with the exception of the round lesion on arm. Also was still a bit tired. Overall main flu like symptoms only lasted a full day. Covid arm is still sticking around as of day 4. But it?s not as red and swelling has gone down.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Pain of skin, Pruritus
Clinical narrative: Raised, firm, swollen red patch at injection site. Painful to the touch for 3 days after injection. Patch remains sames size 1 week after injection and has become itchy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red, warm patch on upper arm that has spread over the course of 4 days.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Fibromyalgia, Illness, Influenza like illness
Clinical narrative: I was sick with moderate flu-like symptoms for two days, then recovered from those. However, I am continuing to experience a major increase in my fibromyalgia/Chronic Fatigue Syndrome symptoms (excessive daytime drowsiness where I need at least a 4-hour nap each day with 7 hours sleep/night, and also full body muscle and joint pain that is not getting better with usual treatments of Lyrica, hot baths or heat pad, light activity, rest, or ibuprofen). My symptoms were being managed daily by those treatments to get down to a ?3 or 4-out-of-10 scale? level.  Since my second Pfizer vaccine I am averaging about  ?7-out-of-10 scale? pain, and unmanageable fatigue. I have never had any reactions to vaccines before and am fully vaccinated.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Somnolence
Clinical narrative: I was sick with moderate flu-like symptoms for two days, then recovered from those. However, I am continuing to experience a major increase in my fibromyalgia/Chronic Fatigue Syndrome symptoms (excessive daytime drowsiness where I need at least a 4-hour nap each day with 7 hours sleep/night, and also full body muscle and joint pain that is not getting better with usual treatments of Lyrica, hot baths or heat pad, light activity, rest, or ibuprofen). My symptoms were being managed daily by those treatments to get down to a ?3 or 4-out-of-10 scale? level.  Since my second Pfizer vaccine I am averaging about  ?7-out-of-10 scale? pain, and unmanageable fatigue. I have never had any reactions to vaccines before and am fully vaccinated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred Vision
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rHA) (strength, dose and route were not provided; lot# was U002535 and expiration date was 24-JUL-2021) for prophylaxis, which was involved a temperature excursion (product storage error). No additional adverse event was reported.  The administered dose experienced an temperature excursion from -50 degree Celsius (C) to -15 degree C (16.8 degree C) for 1 hour 45 minutes 0 seconds. There was no previous temperature excursion. It was detected by a data logger.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 01-MAR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA006116: US-009507513-2105USA006117: US-009507513-2105USA006118: US-009507513-2105USA006119: US-009507513-2105USA006120: US-009507513-2105USA006121: US-009507513-2105USA006122: US-009507513-2105USA006123: US-009507513-2105USA006124: US-009507513-2105USA006125:
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects; Hepatitis B (shot 2): Approximately May 2020, Hepatitis B (shot 3): Approximately August 2020, Hepatitis B (shot 4): Approximately September 2020; This spontaneous report has been received from a lawyer, regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (1808USA010560), referring to a 70 years old male patient.  Information about medical history, concurrent conditions and concomitant therapies was not provided.  The patient was vaccinated with hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 1) (route, strength, dose, batch/lot # and expiration date were not reported) on an unknown date, hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 2) (route, strength, dose, batch/lot # and expiration date were not reported) in approximately May 2020, hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 3) (route, strength, dose, batch/lot # and expiration date were not reported) in approximately August 2020 and hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 4) (route, strength, dose, batch/lot # and expiration date were not reported) in approximately September 2020 without any side effects (Inappropriate schedule of vaccine administered).  This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-1808USA010560:
Age: 17.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 17 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 15-MAR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 14.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 14 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 24-MAR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 15-APR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.32 degree Celsius. The time frame was 0.77 hours on 02-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 19-APR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.32 degree Celsius. The time frame was 0.77 hours on 02-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 11 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 19-APR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.32 degree Celsius. The time frame was 0.77 hours on 02-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Age: 16.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No additional AE information; temperature excursion; Information has been received from an administrator referring to a 16 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 03-MAY-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 0.34 degree Celsius. The time frame was 0.77 hours on 18-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751: