chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Crying, Decreased appetite
Clinical narrative: day after dose 2: flu-like symptoms; severe: body aches, esp in joints; severe: body aches, esp in joints; elevated temperature; feeling super hot; headaches; reduced appetite; difficulty sleeping; Menstrual cycle started 4-5 days early (4 days after vaccine); pms mood changes (crying spells) and cramps day 1 were notably more severe than usual; pms mood changes (crying spells) and cramps day 1 were notably more severe than usual; crying spells; This is a spontaneous report from a contactable consumer (patient). A 39-year-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, administered in left arm on 23Apr2021 16:15 (at the age of 39 years) as dose 2, single for COVID-19 immunization.  The patient medical history was not reported. The patient concomitant medications included prenatal vitamin, probiotic received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (at the age of 39 years) as dose 1, single for COVID-19 immunization and experienced mild-moderate body aches, especially in joints, severe fatigue on 02Apr2021 09:00. The patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient did not have COVID-19 prior vaccination. The patient did not get COVID-19 tested post vaccination. On 24Apr2021 the patient experienced flu-like symptoms, severe: body aches, especially in joints, elevated temperature, feeling super-hot, headaches, reduced appetite, difficulty sleeping. Menstrual cycle started 4-5 days early (4 days after vaccine), pms mood changes (crying spells) and cramps day 1 were notably more severe than usual. The outcome of the events was recovered with sequelae on an unspecified date of 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Influenza like illness, Insomnia, Menstrual disorder
Clinical narrative: day after dose 2: flu-like symptoms; severe: body aches, esp in joints; severe: body aches, esp in joints; elevated temperature; feeling super hot; headaches; reduced appetite; difficulty sleeping; Menstrual cycle started 4-5 days early (4 days after vaccine); pms mood changes (crying spells) and cramps day 1 were notably more severe than usual; pms mood changes (crying spells) and cramps day 1 were notably more severe than usual; crying spells; This is a spontaneous report from a contactable consumer (patient). A 39-year-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, administered in left arm on 23Apr2021 16:15 (at the age of 39 years) as dose 2, single for COVID-19 immunization.  The patient medical history was not reported. The patient concomitant medications included prenatal vitamin, probiotic received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (at the age of 39 years) as dose 1, single for COVID-19 immunization and experienced mild-moderate body aches, especially in joints, severe fatigue on 02Apr2021 09:00. The patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient did not have COVID-19 prior vaccination. The patient did not get COVID-19 tested post vaccination. On 24Apr2021 the patient experienced flu-like symptoms, severe: body aches, especially in joints, elevated temperature, feeling super-hot, headaches, reduced appetite, difficulty sleeping. Menstrual cycle started 4-5 days early (4 days after vaccine), pms mood changes (crying spells) and cramps day 1 were notably more severe than usual. The outcome of the events was recovered with sequelae on an unspecified date of 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Muscle spasms, Pain
Clinical narrative: day after dose 2: flu-like symptoms; severe: body aches, esp in joints; severe: body aches, esp in joints; elevated temperature; feeling super hot; headaches; reduced appetite; difficulty sleeping; Menstrual cycle started 4-5 days early (4 days after vaccine); pms mood changes (crying spells) and cramps day 1 were notably more severe than usual; pms mood changes (crying spells) and cramps day 1 were notably more severe than usual; crying spells; This is a spontaneous report from a contactable consumer (patient). A 39-year-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, administered in left arm on 23Apr2021 16:15 (at the age of 39 years) as dose 2, single for COVID-19 immunization.  The patient medical history was not reported. The patient concomitant medications included prenatal vitamin, probiotic received within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (at the age of 39 years) as dose 1, single for COVID-19 immunization and experienced mild-moderate body aches, especially in joints, severe fatigue on 02Apr2021 09:00. The patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient did not have COVID-19 prior vaccination. The patient did not get COVID-19 tested post vaccination. On 24Apr2021 the patient experienced flu-like symptoms, severe: body aches, especially in joints, elevated temperature, feeling super-hot, headaches, reduced appetite, difficulty sleeping. Menstrual cycle started 4-5 days early (4 days after vaccine), pms mood changes (crying spells) and cramps day 1 were notably more severe than usual. The outcome of the events was recovered with sequelae on an unspecified date of 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Tinnitus in both ears; Mild dizziness; Mild sore shoulder; Mild latent fatigue; administration date: 09Apr2021, 1st dose/administration date: 14Apr2021, 2nd dose; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in right arm on 14Apr2021 at 11:15 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization at hospital. Medical history included was reported as none. There were no concomitant medications. No known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiry date: unknown), via an unspecified route of administration, administered in right arm on 09Apr2021 at 10:15 (at the age of 56 years old) as DOSE 1, SINGLE for covid-19 immunisation and experienced mild sore shoulder. 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. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient had inappropriate schedule of product administration (date: 09apr2021, 1st dose/administration date: 14Apr2021, 2nd dose) on 14Apr2021 at 11:15, and experienced tinnitus in both ears, mild dizziness, mild sore shoulder, mild latent fatigue on 14Apr2021 18:00. The patient did not receive any treatment for the events. The outcome of the event tinnitus in both ears, mild sore shoulder, mild latent fatigue was not recovered, and mild dizziness was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100952509 Same patient, same product in different dose, partial same event
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer (reported for herself). A 58-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# EW0150), via an unspecified route of administration, in left arm, on Apr 6, 2021, at 05:30, single dose, for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing high blood pressure. Concomitant medication included lisinopril for an unspecified indication (start and stop date not reported). The patient previously took cosine and experienced rash. On Apr 8, 2021 (after dose 1), patient experienced mild aching joints. After dose two, she had an extremely aching thumb, wrist and shoulder joints in both arms. No treatment received for the events. She did not have COVID-19 prior to vaccination. She has not tested for COVID-19 post vaccination. The outcome for the events: not recovered. No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Rash
Clinical narrative: burns when I shower; rash on both arms, underneath the upper arm, just above the armpit, localized right now; red splotchy color; This is a spontaneous report from a non-contactable consumer (patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER 8736), via an unspecified route of administration, in left arm on 30Apr2021 at 15:15 (at the age of 39-years-old) as a dose 1, single for covid-19 immunization. The patient's medical history included asthma, known allergies to dust, sulfa drug and scented items all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not tested for COVID post vaccination. The concomitant medications were not reported. On 30Apr2021 at 20:00, the patient experienced rash on both arms, underneath the upper arm, just above the armpit, localized at that time, burns when shower and red splotchy colour. Patient received the treatment of hydrocortisone cream for the reported events. The outcome for all the events was not resolved.  No follow-up attempts are required. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema, Swelling, Ultrasound scan
Clinical narrative: Unusual soft tissue edema.; Also had swelling following the second injection (3x3x8cm)/a persistent fullness in both axilla; This is a spontaneous report from a contactable physician, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the right arm on 11Feb2021 at 12:00 PM (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included osteopenia and COVID-19. Concomitant medications included bisoprolol fumarate (ZEBETA) taken from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 11Jan2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and experienced a significant swelling in the left axilla (4cmx3cmx14cm) which improved by 50 percent following the first injection. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient experienced swelling following the second injection (3x3x8cm) on 11Feb2021 in the left axilla which had improved but was not back to normal. The patient reported that it felt more like an unusual soft tissue edema on 15Apr2021. This did not appear to be lymphadenopathy or lymphedema as there were no palpable nodes or swelling of the hands or arms. The patient had no pain, fever or redness or sign of infection and just felt a persistent fullness in both axillae. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with five physical therapy sessions on unknown dates. On 15Apr2021, the patient underwent an ultrasound of both axillae and it was observed that there was a small node on the left axilla (3-4mm and normal architecture) but otherwise normal and the right side was normal (no fluid collections identified bilaterally). The clinical outcome of the events swelling following the second injection (3x3x8cm), a persistent fullness in both axilla and soft tissue edema was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had hives since the 1st shot; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0161 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Apr2021 at 10:45 hours as dose 1, single (at the age of 50 years old) for COVID-19 immunization. The patient medical history included low thyroid (Hashimoto's) and anxiety (both from an unknown date and unknown if ongoing). Patient previously took penicillin for unknown indication and stated that penicillin gives her diarrhea not allergic, just intolerant. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications/other medications within 2 weeks of vaccination included levothyroxine, escitalopram oxalate (Lexapro), progesterone and estrogen not otherwise specified (NOS) (all taken for an unspecified indication, start and stop dates were not reported). Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 18Apr2021 at 10:45 hours, patient had hives since the first shot, it got a bit better in the 3 weeks in between shots. Patient had no prolonged hospitalization for the event. Patient had doctor or other healthcare professional office/clinic visit for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: sore arm; chills; fever; body ache; headache; fatigue; nausea; vomiting; brain fog; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0171 and Expiration Date was not reported), via an unspecified route of administration in arm right on 23-APR-2021 at17:30 (age at vaccination: 43 years), as dose 2, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151and Expiration Date was not reported), via an unspecified route of administration, in Arm left, on 02Apr2021 at 7:00 PM (age at vaccination: 43 years), as dose 1, single dose, for COVID-19 immunisation. The Patient did not have Covid prior vaccination. The Patient was Covid tested post vaccination. The patient stated that no side effect other than a sore arm after the first dose. The day after the second dose she had the following symptoms: Sore arm, chills, fever and body aches, headache and fatigue. Symptoms lasted for approximately 36 hours, except the fatigue. She said that she still has fatigue. 8 days after the injection she had the same symptoms plus nausea and vomiting. These symptoms lasted approximately 36 hours. She still suffering from fatigue, headaches that come and go and brain fog. On 24Apr2021 at 09:00 AM, the patient experienced sore arm, chills, fever, body ache, headache, fatigue, nausea, vomiting and brain fog. The patient underwent lab test and procedure include nasal swab (COVID-19 (SARS-CoV2) Molecular Assay By- PCR) negative on 13Apr2021. Outcome of the event fatigue was not recovered; headache was recovering and for other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: sore arm; chills; fever; body ache; headache; fatigue; nausea; vomiting; brain fog; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0171 and Expiration Date was not reported), via an unspecified route of administration in arm right on 23-APR-2021 at17:30 (age at vaccination: 43 years), as dose 2, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151and Expiration Date was not reported), via an unspecified route of administration, in Arm left, on 02Apr2021 at 7:00 PM (age at vaccination: 43 years), as dose 1, single dose, for COVID-19 immunisation. The Patient did not have Covid prior vaccination. The Patient was Covid tested post vaccination. The patient stated that no side effect other than a sore arm after the first dose. The day after the second dose she had the following symptoms: Sore arm, chills, fever and body aches, headache and fatigue. Symptoms lasted for approximately 36 hours, except the fatigue. She said that she still has fatigue. 8 days after the injection she had the same symptoms plus nausea and vomiting. These symptoms lasted approximately 36 hours. She still suffering from fatigue, headaches that come and go and brain fog. On 24Apr2021 at 09:00 AM, the patient experienced sore arm, chills, fever, body ache, headache, fatigue, nausea, vomiting and brain fog. The patient underwent lab test and procedure include nasal swab (COVID-19 (SARS-CoV2) Molecular Assay By- PCR) negative on 13Apr2021. Outcome of the event fatigue was not recovered; headache was recovering and for other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: Conjunctivitis (bilateral) beginning directly after shot and slowly progressing over 24-48 hours; This is a spontaneous report from a contactable Physician. This physician reported for a 12-year-old female patient (reporter's daughter) .A 12-year-old female patient received bnt162b2 (BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), DOSE 2 intramuscular on 06Jun2021 at 12:30 into arm left (Lot Number:EW0179 ) as DOSE 2, SINGLE (at age of 12 years) and received DOSE 1 intramuscular on 16May2021 at 12:30 into arm left (Lot Number: EW0177 as DOSE 1, SINGLE for covid-19 immunization (at age of 12 years) at school or student health clinic. The patient medical history had included ongoing anxiety and concomitant medication included included Ergocalciferol(vitamin D) and fish oil for unknown indication. Concomitant therapy included ongoing oral Deptlin for Anxiety. It was reported that patient was not pregnant at the time of vaccination. The patient did not take any vaccination within four weeks. The patient had no known allergies. The patient did not experienced Covid prior to vaccination and did not underwent from any Covid-19 test after vaccination. On 16may2021 at 01:00 the patient had experienced  bilateral conjunctivitis irritation within 15minutes of 1st vaccine. Improved within 72 hours and recovered shortly after 2nd vaccine but was less intense and shorter in duration. It was reported that after second dose on 06Jun2021 at 01:00, patient also experienced Conjunctivitis. Therapeutic measures were taken for the AE and treatment was given with Benadryl orally and Cat scan, X-ray, MRI as reported. Seriousness criteria was reported as not serious. The clinical outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin discolouration
Clinical narrative: Left arm broke out in red, itchy marks; there are still large markings on my arm where the skin has a strange texture and white/pink color; This is a spontaneous report from a contactable consumer (patient).   A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534) via intramuscular, administered in Arm Left on 16Mar2021 at 13:45 (at the age of 67-year-old) as dose 2, single for COVID-19 immunisation. Medical history included elevated cholesterol (none other than elevated cholesterol but treated with a mild statin). Concomitant medications included pravastatin and multi-vitamins 20mg. Patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9809) via intramuscular, administered in Arm Left on 21Feb2021 at 14:00 (at the age of 66-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 16:00 the patient experienced left arm broke out in red, itchy marks, there are still large markings on my arm where the skin has a strange texture and white/pink colour. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient relevant tests reported as none. Patient received treatment for the events with triamcinolone Acetonide Cream USP- 0.1% on 29Apr2021. It was reported that purchased over the counter creams including cortizone 10 and Benadryl- applied topically. Outcome of the events was recovered with sequelae on 16Jul2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Initial information received on 08-Nov-2021 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an unknown age and gender patient who experienced stroke (cerebrovascular accident) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past 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 serious stroke (cerebrovascular accident) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.; Sender's Comments: This poorly documented social media case concerns an unknown age and gender patient who experienced cerebrovascular accident after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, 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.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: The patient went to five different free Flu shot providers and got the shot, no adverse event; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown age and gender) who went to five different free flu shot providers and got the INFLUENZA VACCINE shot (intentional extra dose administered).  The patient had no medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a five doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of actual medication error case due to extra dose administered (unknown latency).  It was reported "Flu Shot Fridays I went to five different free Flu shot providers yesterday and got the shot. My doctor told me NOT to get more than one shot but also told me it was 100 percent safe. So 5 is better than 1. 5 times the protection."  It was unknown if the patient experienced any additional symptoms/events.  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.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: only time I got a flu shot became so sick; Initial information received on 09-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who got a flu shot became so sick (illness) 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 got a flu shot became so sick (illness, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "The only time I got a flu shot became so sick. Use copper now. Make my own wands, rings. Have not had cold or flu in 5 years."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event, Pain in extremity
Clinical narrative: sore arm for a couple days; Initial information received on 09-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who had sore arm for a couple days (pain in extremity) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination 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 sore arm for a couple days (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "no side effects, just a sore arm for a couple days. Never had any side affects".  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.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: flu; covid;Initial information received on 08-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had flu (influenza) and covid (Covid-19) (corona virus disease-19) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's 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 flu (influenza) two weeks later following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a non-serious covid (Covid-19) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got the flu shot once. Two weeks later got the flu. Then got covid. No thanks for 20 years didn't get the flu. First time the shot. Then got it. Never again".  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  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 available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 08-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) patient who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's vaccination included flu shot after patient experienced influenza.  The patient's medical treatment, 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 a subcutaneous route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "At age 25 through 28, I got the flu shot. EVERY TIME I also got the flu. All the years prior and not since 29 have I got the shot. Neither have I had the flu! So it's a hard pass from me".  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.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance
Clinical narrative: Dizziness, unstable gait, almost falling down, especially in the morning on awakening.  Fully resolved by 11/06/21 before I could get into see a doctor
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: tinnitus in both ears, constant, still present
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram ST-T change, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Patient developed chest pain and shortness of breath starting 36-48 hours after receiving booster shot. Patient had diffuse ST changes on EKG and elevated troponins suggestive of peri/myocarditis.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Prohormone brain natriuretic peptide increased, Troponin I increased
Clinical narrative: Patient developed chest pain and shortness of breath starting 36-48 hours after receiving booster shot. Patient had diffuse ST changes on EKG and elevated troponins suggestive of peri/myocarditis.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: Seven days of intense exhaustion, not able to perform any normal tasks.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Biopsy, Breast mass, Dysmenorrhoea, Food allergy
Clinical narrative: Heavy menstrual  bleeding with cramps, menstruation increase from 4-5 days to 6-7 days. Blood per day from normal to heavy. acne severely increased. Gained egg sized breast lump in one breast
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Ultrasound scan
Clinical narrative: Heavy menstrual  bleeding with cramps, menstruation increase from 4-5 days to 6-7 days. Blood per day from normal to heavy. acne severely increased. Gained egg sized breast lump in one breast
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: The most concerning symptom I had was a 4 hour period of continual tachycardia and palpations with a heart rate ranging from 160 to 180 while lying in bed trying to sleep (I have never had tachycardia or palpitations before). It  began  about 11  hours after the vaccination.  It self-resolved after about 4 hours.  Prior to developing the tachycardia (about 8 hours vaccination, I developed severe chills (for approx 10 hours despite being wrapped in layers of clothing and tripled blankets and having the heater on), strong headache, diffuse myalgia, SOB, and significant fatigue (i.e. I am a runner and I could not walk from my bed to the bathroom- approx 10 feet- without having to stop and sit down on the floor to breath and then muster up enough energy to make it the additional 5 steps). . All symptoms self-resolved within 24 hours and then I felt completely returned to normal and back to baseline. as if nothing had ever happened.  I had no reaction to the initial vaccine other than a mildly  sore arm at the injection site.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: The most concerning symptom I had was a 4 hour period of continual tachycardia and palpations with a heart rate ranging from 160 to 180 while lying in bed trying to sleep (I have never had tachycardia or palpitations before). It  began  about 11  hours after the vaccination.  It self-resolved after about 4 hours.  Prior to developing the tachycardia (about 8 hours vaccination, I developed severe chills (for approx 10 hours despite being wrapped in layers of clothing and tripled blankets and having the heater on), strong headache, diffuse myalgia, SOB, and significant fatigue (i.e. I am a runner and I could not walk from my bed to the bathroom- approx 10 feet- without having to stop and sit down on the floor to breath and then muster up enough energy to make it the additional 5 steps). . All symptoms self-resolved within 24 hours and then I felt completely returned to normal and back to baseline. as if nothing had ever happened.  I had no reaction to the initial vaccine other than a mildly  sore arm at the injection site.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Developed DVT in lower right leg
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Bell's palsy, Facial nerve disorder, Serology negative
Clinical narrative: Bell's Palsy of left facial nerve.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Balance disorder, Blood immunoglobulin M decreased, C-reactive protein increased, Clumsiness
Clinical narrative: dizziness, clumsiness, chronic diarrhea, cognitive deficits, memory issues, fatigue. itching, heaches, feeling unbalanced, falling.  Currently  no treatment. Going to see neurologist, rheumatologist, hematologist.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Diarrhoea, Dizziness, Fall, Fatigue
Clinical narrative: dizziness, clumsiness, chronic diarrhea, cognitive deficits, memory issues, fatigue. itching, heaches, feeling unbalanced, falling.  Currently  no treatment. Going to see neurologist, rheumatologist, hematologist.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Memory impairment, Pruritus, Red blood cell sedimentation rate increased, Red cell distribution width increased
Clinical narrative: dizziness, clumsiness, chronic diarrhea, cognitive deficits, memory issues, fatigue. itching, heaches, feeling unbalanced, falling.  Currently  no treatment. Going to see neurologist, rheumatologist, hematologist.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old male patient was accidently administered FLUZONE HD QIV vaccine with no reported adverse event; 17 year old male patient was accidently administered FLUZONE HD QIV vaccine with no reported adverse event; Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a other healthcare professional/consumer via the Agency (Reference number- 00850414).  This case involves a 17-year-old male patient who was accidently vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 09-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AB and expiry date: 30-Jun-2022) (Frequency: once) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration and Overdose (latency on same day).  It was reported "Nurse states the FLUZONE HD QIV vaccine was accidently administered to a patient under the age of 65. Nurse is looking for information in regard to possible adverse effects as well as what they should inform the patient. Agent gathered some AE (adverse event) information. Nurse states FLUZONE HD QIV was administered to patient who was 17 years of age on 09Nov2021".   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: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Death, Food refusal, Laboratory test normal, Organic brain syndrome
Clinical narrative: My Mother, at 92, almost 93, was given the Booster shot on Oct. 12.  Although she had the start of Dementia, Mom was still Mom.  After the booster, Mom went into a spiral downfall.  The Dr. diagnosed her with Organic Brain Syndrome.  My mother passed away Nov. 6, 2021.  She had stopped eating, was in pain, could not speak from approximately Oct 22 - Nov 6.  Organic Brain Syndrome is triggered by too many toxins in your body.  At 92, her body was not equipped to take such a powerful vaccination and my sisters, nurse and I believe the Booster pushed her into a toxic state that escalated her untimely death.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Speech disorder
Clinical narrative: My Mother, at 92, almost 93, was given the Booster shot on Oct. 12.  Although she had the start of Dementia, Mom was still Mom.  After the booster, Mom went into a spiral downfall.  The Dr. diagnosed her with Organic Brain Syndrome.  My mother passed away Nov. 6, 2021.  She had stopped eating, was in pain, could not speak from approximately Oct 22 - Nov 6.  Organic Brain Syndrome is triggered by too many toxins in your body.  At 92, her body was not equipped to take such a powerful vaccination and my sisters, nurse and I believe the Booster pushed her into a toxic state that escalated her untimely death.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash morbilliform
Clinical narrative: Two days after receiving booster dose, patient experienced a "measles-like" rash  on her neck, stomach, back, and at injection site. By day 6, rash had resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Palpitations, Paraesthesia
Clinical narrative: Ongoing extreme headache for about a week. Rapid heart palpitations currently still on-going.  Tingling down my left arm down to my hand, still on-going.  Heaviness on my chest.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Dizziness, nausea, muscle aches, joint pain, headache, fatigue, tiredness (sleepiness), soreness at injection site, light headed
Age: 23.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Myalgia, Nausea, Somnolence
Clinical narrative: Dizziness, nausea, muscle aches, joint pain, headache, fatigue, tiredness (sleepiness), soreness at injection site, light headed
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Tigthness in chest, burning inside body, headache & dizziness, sweaty.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Insomnia, Neuralgia, Neuritis
Clinical narrative: Aside from expected side effects, also had face tingling for 2 or 3 weeks as well as pain right shoulder.  Immediately after vaccine, right shoulder paiin was intense probably because shoulder has history of injury, although hasn't hurt for a long time.  I thought that was OK, no concern.  But as the weeks go by, and I contiinue to have this nerve pain, a feeling of neuritis, along with intense itching around entire shoulder girdle, I'm thinking some nerves were injured during the acute reaction of the vaccine.  The pain is prickly and continual, but the worst part is intense itch which keeps me from falling asleep.  It involves right side only, upper back, shoulder, deltoid, back of arm, front shoulder, and down side of arm (deltoid) almost to elbow.  It's always there but varies in intensity.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus
Clinical narrative: Aside from expected side effects, also had face tingling for 2 or 3 weeks as well as pain right shoulder.  Immediately after vaccine, right shoulder paiin was intense probably because shoulder has history of injury, although hasn't hurt for a long time.  I thought that was OK, no concern.  But as the weeks go by, and I contiinue to have this nerve pain, a feeling of neuritis, along with intense itching around entire shoulder girdle, I'm thinking some nerves were injured during the acute reaction of the vaccine.  The pain is prickly and continual, but the worst part is intense itch which keeps me from falling asleep.  It involves right side only, upper back, shoulder, deltoid, back of arm, front shoulder, and down side of arm (deltoid) almost to elbow.  It's always there but varies in intensity.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Dizziness, Dyspnoea, Headache
Clinical narrative: Headache, body aches, sore skin, muscles, joints, dizziness, breathlessness, nausea, loss of appetite, tips of fingers hypersensitive sending pain through my fingers and hands, similar sharp shooting pain in toes and feet - nothing like I have ever felt before. All subsided after one week except for the pain in my hands, arms, feet, and legs - weird, unusual pain unlike anything I?ve experienced before.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Headache, body aches, sore skin, muscles, joints, dizziness, breathlessness, nausea, loss of appetite, tips of fingers hypersensitive sending pain through my fingers and hands, similar sharp shooting pain in toes and feet - nothing like I have ever felt before. All subsided after one week except for the pain in my hands, arms, feet, and legs - weird, unusual pain unlike anything I?ve experienced before.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Headache, body aches, sore skin, muscles, joints, dizziness, breathlessness, nausea, loss of appetite, tips of fingers hypersensitive sending pain through my fingers and hands, similar sharp shooting pain in toes and feet - nothing like I have ever felt before. All subsided after one week except for the pain in my hands, arms, feet, and legs - weird, unusual pain unlike anything I?ve experienced before.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase increased, Blood calcium normal
Clinical narrative: 74-year-old gentleman received COVID19  booster dose today at dialysis appointment, sometime around 1300 hours.  Experienced rigors afterwards.  Admitted to the emergency department tonight, and subsequently to ICU in shock state requiring vasopressors.  Admission to the hospital approximately 12 hours after administration of vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride normal, Blood creatinine increased, Blood glucose increased, Blood lactic acid, Blood magnesium normal
Clinical narrative: 74-year-old gentleman received COVID19  booster dose today at dialysis appointment, sometime around 1300 hours.  Experienced rigors afterwards.  Admitted to the emergency department tonight, and subsequently to ICU in shock state requiring vasopressors.  Admission to the hospital approximately 12 hours after administration of vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood phosphorus increased, Blood potassium normal, Blood sodium normal, Blood urea increased, Brain natriuretic peptide
Clinical narrative: 74-year-old gentleman received COVID19  booster dose today at dialysis appointment, sometime around 1300 hours.  Experienced rigors afterwards.  Admitted to the emergency department tonight, and subsequently to ICU in shock state requiring vasopressors.  Admission to the hospital approximately 12 hours after administration of vaccine.