chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching and rash all over and hasn't stopped / Itching; itching and rash all over and hasn't stopped / Nothing Working ongoing Rashes; This is a spontaneous report from a contactable consumer (Patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER3782) via intramuscular route, administered in Arm Left on 27Mar2021 11:00 (at the age of 83-years) as dose1, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease. There were no concomitant medications. No known allergies reported. Prior to vaccination, patient was not diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 03Apr2021 03:00 the patient experienced itching and rash all over and hasn't stopped / itching, itching and rash all over and hasn't stopped / nothing working ongoing rashes (rash). Events assessed as non-serious. Therapeutic measures were taken as a result of events. Since the vaccination, patient has not been tested for Covid-19. Patient refused to take 2nd dose Covid-19 vaccine. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Headache, Heart rate
Clinical narrative: within the first 15 minutes that my heart rate spead up dramatically; chest pain; Headache; blood pressure measurement 140/96; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 40-years-old female(non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EW0196), an unspecified route of administration, administered in Arm Left on 12Jul2021 14:00 (at the age of 40-year-old) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included migraine, pituitary adenoma, PCOS (polycystic ovaries), endometriosis, BPPV (vertigo positional), asthma, allergies and sulfa medications allergies from an unknown date and unknown if ongoing. Concomitant medications included galcanezumab (EMGALITY  [GALCANEZUMAB]) taken for migraine, phentermine (PHENTERMINE) and spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date for all the concomitant medicines were not reported. The patient not had COVID prior to vaccination and not tested COVID post vaccination. The patient did not taken other vaccine in 4 weeks. On 12Jul2021 at 14:00  the patient experienced within the first 15 minutes that her heart rate speed up dramatically (heart rate increased) ,chest pain. The patient had a blood pressure 140/96. She did not experience hives, swelling, or shortness of breath, but it has been 5 hours and her resting heart rate is 98-101bpm. The patient underwent lab tests and procedures which included blood pressure measurement: 140/96  and increased heart rate: 98-101 on 12Jul2021 .The only other medication taken was an Emgality injection. It is her 3rd and do not have reactions at all to it. It is a migraine medicine, yet isn't helping the headache which she also got after the vaccine. Not yet anyway. Again, she is continuing to monitor the situation. The treatment received for the event unknown .The outcome of the event was not recovered. The outcome of event blood pressure measurement 140/96 was unknown. Upon Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: within the first 15 minutes that my heart rate spead up dramatically; chest pain; Headache; blood pressure measurement 140/96; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 40-years-old female(non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EW0196), an unspecified route of administration, administered in Arm Left on 12Jul2021 14:00 (at the age of 40-year-old) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included migraine, pituitary adenoma, PCOS (polycystic ovaries), endometriosis, BPPV (vertigo positional), asthma, allergies and sulfa medications allergies from an unknown date and unknown if ongoing. Concomitant medications included galcanezumab (EMGALITY  [GALCANEZUMAB]) taken for migraine, phentermine (PHENTERMINE) and spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date for all the concomitant medicines were not reported. The patient not had COVID prior to vaccination and not tested COVID post vaccination. The patient did not taken other vaccine in 4 weeks. On 12Jul2021 at 14:00  the patient experienced within the first 15 minutes that her heart rate speed up dramatically (heart rate increased) ,chest pain. The patient had a blood pressure 140/96. She did not experience hives, swelling, or shortness of breath, but it has been 5 hours and her resting heart rate is 98-101bpm. The patient underwent lab tests and procedures which included blood pressure measurement: 140/96  and increased heart rate: 98-101 on 12Jul2021 .The only other medication taken was an Emgality injection. It is her 3rd and do not have reactions at all to it. It is a migraine medicine, yet isn't helping the headache which she also got after the vaccine. Not yet anyway. Again, she is continuing to monitor the situation. The treatment received for the event unknown .The outcome of the event was not recovered. The outcome of event blood pressure measurement 140/96 was unknown. Upon Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: The patient was tired and could only drag herself out of bed to use the bathroom; Headache; Diarrhea; Low grade fever; Joint and muscle pain; Joint and muscle pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO217) via an unspecified route of administration in the arm left on 11Jul2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus (DMII), chronic kidney disease stage 3, syndrome restless legs (RLS), complex post-traumatic stress disorder (CPTSD) and hypertension; all from unknown date and unknown if ongoing at the time of this report and known allergies to penicillin. The patient previously took bee venom (MANUFACTURER UNKNOWN), amphetamine (MANUFACTURER UNKNOWN) for diet pills and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to vaccination. On 12Jul2021 at 05:00, the patient was so tired and could only drag herself out of bed to use the bathroom, headache, diarrhea, low grade fever, joint and muscle pain, joint and muscle pain and nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was so tired and could only drag herself out of bed to use the bathroom, headache, diarrhea, low grade fever, joint and muscle pain, joint and muscle pain and nausea was recovered on an unknown date in Jul2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: The patient was tired and could only drag herself out of bed to use the bathroom; Headache; Diarrhea; Low grade fever; Joint and muscle pain; Joint and muscle pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO217) via an unspecified route of administration in the arm left on 11Jul2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus (DMII), chronic kidney disease stage 3, syndrome restless legs (RLS), complex post-traumatic stress disorder (CPTSD) and hypertension; all from unknown date and unknown if ongoing at the time of this report and known allergies to penicillin. The patient previously took bee venom (MANUFACTURER UNKNOWN), amphetamine (MANUFACTURER UNKNOWN) for diet pills and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to vaccination. On 12Jul2021 at 05:00, the patient was so tired and could only drag herself out of bed to use the bathroom, headache, diarrhea, low grade fever, joint and muscle pain, joint and muscle pain and nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient was so tired and could only drag herself out of bed to use the bathroom, headache, diarrhea, low grade fever, joint and muscle pain, joint and muscle pain and nausea was recovered on an unknown date in Jul2021.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Dose 1: 01Apr2021, Dose 2: 15Apr2021; Extremely enlarged lymph nodes: left collarbone, neck; The lymph nodes have been sore and enlarged (about a golf ball size) for more than 8 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 15Apr2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced extremely enlarged lymph nodes in the left collarbone, neck. The lymph nodes had been sore and enlarged (about a golf ball size) for more than 8 weeks. The issue remained the same. The blood test did not detect any issues. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were not taken as a result of the events. On an unknown date in 2021, the patient underwent blood test and the result was the blood test did not detect any issues. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely enlarged lymph nodes: left collarbone, neck and the lymph nodes have been sore and enlarged (about a golf ball size) for more than 8 weeks was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Patient reporting chest pain within a few hours after receiving shot and lasting 24 hours after receiving; This is a spontaneous report from a contactable pharmacist. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via intramuscular route of administration in the right arm on 14Jul2021 at 14:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had any medical history and known allergies. It was unknown whether the patient was pregnant at the time of this report. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0202) via intramuscular route of administration in the left arm on 22Jun2021 at 22:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 14Jul2021 at 18:00, within a few hours after receiving shot, the patient reported chest pain that lasted 24 hours after receiving. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event chest pain was resolved on 15Jul2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm. Soreness has lasted over 24 hours so far; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 14Jul2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included vitamin d nos (MANUFACTURER UNKNOWN), multi vitamin (MANUFACTURER UNKNOWN) and collagen (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jul2021 at 01:00, the patient experienced very sore arm and soreness had lasted over 24 hours till the time of report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events, very sore arm and soreness had lasted over 24 hours was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Eating disorder
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#  EW0179), at the age of 45,  via an unspecified route of administration, in left arm, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included gastritis from unknown date and unknown if ongoing. Concomitant medication included Gasvenz for her gastritis. Patient did not have any vaccination four weeks prior to the COVID-19 vaccine. On Jul 14, 2021, patient experienced side effects such as tiredness, headache, muscle pain, chills, injection site pain, swelling, feeling unwell, joint pain, injection site swelling, not eating at all, increased  body temperature (99.5ºF), arm pain, weakness, nausea and heartbeat feels a little faster. Patient want to know how long these side effects will last (seeking treatment recommendations). The patient underwent lab tests and procedures, which included body temperature: 99.5ºF on Jul 14, 2021. No treatment received for the events. The outcome of the events: unknown (at the time of report). Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Malaise, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#  EW0179), at the age of 45,  via an unspecified route of administration, in left arm, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included gastritis from unknown date and unknown if ongoing. Concomitant medication included Gasvenz for her gastritis. Patient did not have any vaccination four weeks prior to the COVID-19 vaccine. On Jul 14, 2021, patient experienced side effects such as tiredness, headache, muscle pain, chills, injection site pain, swelling, feeling unwell, joint pain, injection site swelling, not eating at all, increased  body temperature (99.5ºF), arm pain, weakness, nausea and heartbeat feels a little faster. Patient want to know how long these side effects will last (seeking treatment recommendations). The patient underwent lab tests and procedures, which included body temperature: 99.5ºF on Jul 14, 2021. No treatment received for the events. The outcome of the events: unknown (at the time of report). Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#  EW0179), at the age of 45,  via an unspecified route of administration, in left arm, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included gastritis from unknown date and unknown if ongoing. Concomitant medication included Gasvenz for her gastritis. Patient did not have any vaccination four weeks prior to the COVID-19 vaccine. On Jul 14, 2021, patient experienced side effects such as tiredness, headache, muscle pain, chills, injection site pain, swelling, feeling unwell, joint pain, injection site swelling, not eating at all, increased  body temperature (99.5ºF), arm pain, weakness, nausea and heartbeat feels a little faster. Patient want to know how long these side effects will last (seeking treatment recommendations). The patient underwent lab tests and procedures, which included body temperature: 99.5ºF on Jul 14, 2021. No treatment received for the events. The outcome of the events: unknown (at the time of report). Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#  EW0179), at the age of 45,  via an unspecified route of administration, in left arm, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included gastritis from unknown date and unknown if ongoing. Concomitant medication included Gasvenz for her gastritis. Patient did not have any vaccination four weeks prior to the COVID-19 vaccine. On Jul 14, 2021, patient experienced side effects such as tiredness, headache, muscle pain, chills, injection site pain, swelling, feeling unwell, joint pain, injection site swelling, not eating at all, increased  body temperature (99.5ºF), arm pain, weakness, nausea and heartbeat feels a little faster. Patient want to know how long these side effects will last (seeking treatment recommendations). The patient underwent lab tests and procedures, which included body temperature: 99.5ºF on Jul 14, 2021. No treatment received for the events. The outcome of the events: unknown (at the time of report). Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: The doctor described the large swelling in my arm pit as edema.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 24Jun2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, shingles, lymes, menopause and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received sulfur (MANUFACTURER UNKNOWN), erenumab (AIMOVIG) and galcanezumab (EMGALITY) on unknown dates for unknown indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Jun2021 at 18:00, the patient experienced large swelling in arm pit described as edema by the doctor, which took over 2 weeks to go down. The patient reported that it was the size of a B cup bra. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large swelling in arm pit described as edema by the doctor, which took over 2 weeks to go down was resolved on an unknown date in Jul2021.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 1-year-old-female patient received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date which was further reported that when her daughter was a baby she would experience a fever after getting her Prevnar 13 doses. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Migraine; Exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 14Jul2021 at 16:00 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included graves disease, known allergies to narcotics, analgesics, sulfa drugs and other antibiotics, latex, dyes, fragrances and suspected COVID-19 from unknown date in Mar2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); all for unknown indication from unknown start date and unknown if on going. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 23Jun2021 at 14:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation and experienced no adverse event. On 15Jul2021 at 06:00, the patient experienced fever, body aches, migraine and exhaustion. The patient was sure, but had no proof that patient had contracted COVID-19 in Mar2020 and was ill for 2 months, no hospitalization was needed then. The patient had the same symptoms after second dose as she had when she contracted COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, migraine and exhaustion was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Jul2021 at 11:45 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 14Jul2021, the patient experienced vomiting. The event vomiting did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional in the United States.  This case involves a 60 years old female patient who received expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 09-Mar-2021, the patient received a dose of suspect once 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (frequency: once, strength: standard, solution for injection, batch number: QFAA2017 and expiry date not reported) via an intramuscular route in the left deltoid.  No other vaccines.  It was reported ''There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients.''  It was an actual medication error case due to expired vaccine used (latency: same day).  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 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: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Gillian Barre; Initial information was received on 18-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an adult (unknown gender) patient who experienced Gillian Barre (Guillain-Barre syndrome) after patient received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Gillian Barre (Guillain-Barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for the event.  The information on the batch number for this case has been requested.; Sender's Comments: This case concerns an adult (unknown gender) patient who experienced Guillain-Barre syndrome (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Headache, Injection site reaction
Clinical narrative: injection site reaction; tiredness; headache; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a physician (under reference US-SA-SAC20211022000419).  This case involves a 52 years old female patient who experienced injection site reaction (vaccination site reaction), tiredness (fatigue), headache when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious injection site reaction (vaccination site reaction), tiredness (fatigue), headache (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of this report, outcome of the events (vaccination site reaction, fatigue, headache) were not resolved.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Rash, Urticaria
Clinical narrative: rash; hives; Initial information received on 23-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involved a patient (unknown demographic) who experienced rash and hives (urticaria) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious rash, hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I couldn't get a flu shot because I break out in a rash and hives and end up in the ER. But I think it was important to get one every year for those who didn't get reactions."  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Infection
Clinical narrative: infection; Initial information received on 22-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves Adult male patient who had infection after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious infection (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  No laboratory data reported.  It was reported "Anybody get sick I got a infection several days on antibiotics no shot for me this year."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Movement disorder, Near death experience
Clinical narrative: almost killed me; 3 days without be able to get off the bed; without be able to move my limbs; Initial information received on 23-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via.  This case involves a patient (unknown demographic) who had almost killed me (unevaluable event), 3 days without be able to get off the bed (bedridden) and without be able to move my limbs (limb immobilisation) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious almost killed me (unevaluable event),without be able to move my limbs (limb immobilization) (unknown latency) and 3 days without be able to get off the bed (bedridden) (3 day latency) following the administration of INFLUENZA VACCINE.  It was reported "Last one almost killed me, 3 days without be able to get off the bed or move my limbs. never again."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: i got sick as shit; Initial information was received on 21-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional (under reference number: US-SA-SAC20211026001521).  This case involves an adult patient with an unknown gender who got sick as shit while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event I got sick as shit (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Last time I took a flu shot I got I got sick as shit. "  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case
Sex: M
Vaccine: FLUX
Symptoms: Death, Neoplasm malignant
Clinical narrative: cancer; Initial information was received on 22-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's son or daughter) via social media.  This case involves an unknown age male patient who experienced cancer (neoplasm malignant) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed serious cancer (neoplasm malignant) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  It was unknown if an autopsy was done. The cause of death was reported as neoplasm malignant.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns an unknown age male patient who had neoplasm malignant and died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. It was unknown if an autopsy was done. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cancer
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: frozen product was accidently administered with no adverse event; Initial information was received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via a physician under Medical Information Inquiry Number: 00814948.  This case is linked to cluster case 2021SA345065.  This case involves an 88 years old male patient who was accidently administered a frozen INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 21-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ716AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen, that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  It was case of an actual medication error due to product storage error temperature too low (latency was on same day)  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 the 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.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Neck pain
Clinical narrative: abnormal pain in the neck; abnormal pain in the joint and shoulder; Initial information received on 19-Oct-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00819410).  This case involves a 70 year old female patient who experienced abnormal pain in the joint, shoulder and neck (arthralgia) (neck pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 19-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once in total, immunization, lot number VJ690AA and expiry date not reported) via unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed non-serious abnormal pain in the joint, shoulder and neck (arthralgia) (neck pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data were provided.  It was reported "Caller received FLUZONE HD at a pharmacy. Caller states that she is in a lot of pain, and the pain is located in the joint, shoulder, and neck. Caller states that she believes she received the shot up too high by the shoulder. Patient is not sure if the pain is due to the vaccine itself or the shot technique. Patient did ask agent on how to handle the pain, agent directed caller to their primary care physician (PCP), and if the pain is to severe to there local urgent care or emergency room.Patient calling to report abnormal pain in the shoulder, joint, and neck surrounding a recent FLUZONE HD immunization. Caller states that she believes the pharmacist injected the vaccine too far up her arm which is causing her pain."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for both the reported events.
Sex: F
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: Patient pulled her arm away, while administering the product, this caused them to administer an incomplete dose to the patient with no reported adverse event; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via Media information (under the reference 00820789).  This case involves a female patient of who pulled her arm away, when received the vaccine, this caused them to administer an incomplete dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (once, oral solution, total, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  This case was a special situation due to vaccine underdose (latency: same day).  It was reported "Medical assistant states that they were vaccinating a patient with ADACEL, states while they were administering the product, the patient pulled her arm away, this caused them to administer an incomplete dose to the patient. Medical assistant states they do not know how much ADACEL the patient actually received, asks if they should re-vaccinate the patient and how long they should wait if re-vaccination is required."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  There will be no information on batch number for this case.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: IPOL was given to a patient after the expiration date, with no reported AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00822451).  This case involves a nine-year-old female patient who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL] (expired vaccine used).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for Immunisation.  On 20-Oct-2021, the patient received a 0.5 ml first dose of suspect IPV (VERO) (lot R1F971M and expiry date: 03-Oct-2021) (Frequency: Once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At 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 holder's compliance with the requirements set out in the 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.