chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced feeling unwell, injection site pain and pain in arm. On an unknown date, the outcome of the feeling unwell and injection site pain were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the feeling unwell, injection site pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient felt sick a few days after the vaccination and that resolved in 12 to 14 hours. The patient also experienced injection site pain but that was resolved. The patient experienced arm pain below the injection site area that had persisted and was not resolved.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 09-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 744 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. The is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # numbers of L015048, M015731, M025871, L048468 and a lot # reported as "M027344", with expiration dates of 29-APR-2017, 30-MAR-2018, 24-MAY-2018, 02-DEC-2017 and 01-JUN-2018 respectively (concentration, dose, route and anatomical place of vaccination were not provided). Nevertheless, no adverse symptoms reported. Additional information has been requested.
Diarrhea & NauseaVomiting Narrative:  Developed diarrhea and nausea without vomiting in the evening after  receiving the vaccination. Diarrhea persisted for 2x days before spontaneously  resolving, nausea persisted for 3x days prior to also spontaneously resolving. The  nausea occasionally cause dry heaves, but not active vomiting. Also states she had an intermittent headache on 5-7 days of the following 14 after the vaccination. Symptoms were not a/w abdominal cramping, fever, chills, skin symptoms,  palpitations, hypotension. No other adverse effects noted.
fever (went up to 102.9), nausea resulting in throwing up, throbbing headache, chills, couldn't get out of bed / walk lasted from 9 AM (April 6) to 5 AM (April 7)  woke up Wednesday (no fever, no headache, no nausea) felt very weak
swelling-pain in lateral aspect of lt arm extending distally to wrist-w/erythematous rash on dorsum;
I have auto immune issues and began with a rash on my scalp ears upper back the morning after the skin in my mouth sloughed off and tongue was sore
Received injections on morning of 07/17/2003.  Afternoon of 07/18/2003, childs left arm, red, swollen, hot and hard to touch.  Encourage motrin/tylenol for pain.  Apply ice to effect area.  Call Pediatrician.
Bruise about 3-4 inches wide and 2-3 inches in hieght.  Brusie surrounded the point of the shot.  Also 2 days later, area itches and bruise has decreased but still visible.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "immunosuppressed" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE. Past drug history included: Antibiotics, reaction(s): "Reaction", notes: Reaction to an antibiotic 5 years ago.The following information was reported: CHILLS (non-serious) with onset Jan2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset Jan2021, outcome "unknown", described as "Headache"; NECK PAIN (non-serious) with onset Jan2021, outcome "unknown", described as "Neckache"; LYMPHADENOPATHY (non-serious) with onset 22Jan2021, outcome "recovered" (23Jan2021), described as "Pain under her arm which she believes was a swollen lymph node"; BURSITIS (non-serious) with onset Jan2021, outcome "recovered" (Feb2021), described as "Hip bursitis"; MOVEMENT DISORDER (non-serious) with onset Jan2021, outcome "unknown", described as "She had difficulty moving in and out of bed". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was concerned and upset that the vaccine may not work for her because she is immunosuppressed. She wants Pfizer to know that this information should be "out there" more and it creates a "false sense of security" in individuals who are on immunosuppressants. Patient was upset that she tested negative for antibodies after the vaccine series. Patient received several weeks of physical therapy after the 1st Pfizer shot. She is on an immunosuppressant drug. Patient began taking immunosuppressant medication BEFORE receiving the Pfizer Covid vaccines. She states she will be going back to her MD for another test to determine if she has immunity against Covid. Caller upset that information about immunosuppressed individuals and the Covid vaccine is not more "out there" for the public to know. She is upset that this population was not included in the clinical trials and is upset that she has been told to proceed with her life as if she wasn't vaccinated. Patient wanted to know if Pfizer will be studying the vaccine with immunosuppressed individuals. Patient stated no one is giving clear warnings that the vaccine may or may not work including her doctor at (withheld). Went for antibody test which came back negative. Doctor told her it does not mean the vaccine did not work but that they do not know how effective it may be. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 17Feb2021 as dose 2, single (Lot number: 030M20A), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: 029H21B) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESOMEPRAZOLE, start date: 07Nov2012, stop date: 06Aug2022; ZYRTEC ALLERGY, start date: 04Jul2016, stop date: 06Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for COVID; Negative, notes: tested negative within 8 days of first positive test; positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had no known allergies. Patient started Paxlovid the evening she tested positive for COVID. She did very well and tested negative within 8 days of first positive test. She began having symptoms again, after 8 days of finishing full 5-day course of Paxlovid. She tested positive again on the 9th day after finishing full 5-day course of Paxlovid. Patient anti-viral medication included Paxlovid for COVID 19 Treatment. Treatment started on 22Jul2022 and stopped on 26Jul2022.
Report headache to back of head 2 days post vaccination that is intermittent. Treatment: ASA  Outcome: Report today headache has completely resolved.
I gave him the TIV flu vaccine as well as his wife. I explained to them to hang around for about 15 minutes in case they had a reaction. They sat in the waiting room and his wife comes running over to the pharmacy saying "help, he is having convulsions and not responding." I run out there and notice his eyes rolling back into his head and seemed to have lost muscle control and tone. He slid off of his chair on to the floor. I had a technician call 911. I checked for a pulse and did not notice one. I performed about 10 chest compressions and finally he slowly started to respond. He was confused and did not know how he ended up on the floor. His shirt was drenched in sweat. He appeared to be fine once the emergency crew showed up. They took him on a stretcher out of the store.
Syncopal event approximately 1 minute after vaccine was administered. Woke up on floor to EMS. Sustained bump on left forehead with persisting headache but no follow-up care sought.
Fever chills Narrative:  5 hours of chills and fever which began about 20 hours post vaccine
On 12th day after vaccine, I began to have bizarre, frightening and persistent mental images about harm to my body. Not visual or auditory hallucinations. Not images that directed my behavior. Experience was unique in my life. After 10 days of symptoms I contacted a mental health professional with whomI had worked 15 months previous as a grief counselor. We spent 5 sessions exploring possible reasons for the problem and decided it might be a side effect of the vaccine because it did not seem to be related to any previous life experiences. Symptoms have lessened significantly but persist. 2nd dose of vaccine did not increase symptoms.
On Monday Sept. 13th, the patient received her 1st Moderna vaccine around 4:30 pm. About 2 hours later, the patient started to report symptoms of nausea and vomiting. She reports that she passed out for about 45 sec to 1 minute per the reports of her healthcare colleges. She was assessed at her job (nurse in a hospital) and her father was called and asked to come pick her up. The next day (Tuesday Sept. 14th), the patient reports she awoke with a severe migraine, and a swollen left deltoid that was sore, tender, hot to touch with visible red inflammation. Patient reports she never spiked a fever during this process. Patient proceeded to go to work where she later became very nauseous and began vomiting blood. Patient was sent home from job. On her way home, she began vomiting again and blood with still present in her vomit. Once home, patient took at 19 hour naps. Patient reports that she never when to see a physician or the emergency room but did speak with multiple healthcare professionals from her place of work. On Wednesday Sept. 15th, patient went to a local doctor's office to get labs drawn. Patient does not know which labs were order but she did request a D-dimer and her platelets to be drawn. She hasn't not received any results on her labs at the time of this report. Patient when home after her lab appointment and continued to vomit with blood still present. The patient proceeded to go get Botox to help with her migraine. Today, Sept. 17th, patient reports that she is still feeling fatigued, low appetite, chills are present, and sweaty palms but is at work today. She complains that nausea is still present but has not vomited today.
Pt recvd flu vax & devel alopecia; pt reports had same reaction last year when recvd flu shot OCT91;
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown multiple dates, the patients were vaccinated with a doses of VAQTA lot # M027879, expiration date 24-JAN-2018 (dose and route of administration were not reported). The administered doses of vaccines were exposed to a temperature of 9 Celsius degrees, for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Resident has a 8cm X 6cm reddened area to left upper arm, same area that the Covid Vaccine was given 2 weeks ago. Area is red, warm to touch and hard. This first appeared Saturday 1/16/21. Resident's daughter did wish to make an appt with her primary care physician. Appt is Tuesday 1/19/21.
large local rxn consisting of a 2x2 in area of erythema & induration around vax site w/an extending 1x12inch strip which extended to wrist;no fever;
I realized vaccinations dont work because I caught covid even though i was fully vaccinated with boosters; I realized vaccinations dont work because I caught covid even though i was fully vaccinated with boosters; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dosr number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I realized vaccinations dont work because I caught covid even though i was fully vaccinated with boosters". Clinical Course:Reporter considered that the event caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
achy; under arm it was rough and burning; rash in her back, rash in back and chest, left arm and elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), SKIN BURNING SENSATION (under arm it was rough and burning) and RASH (rash in her back, rash in back and chest, left arm and elbow) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), ATORVASTATIN CALCIUM (LIPITOR), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), FUROSEMIDE, ACETYLSALICYLIC ACID (ASPRIN), APPLE CIDER VINEGAR, ZINC, MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and VITAMIN B12 NOS for an unknown indication, NIFEDIPINE (ADALAT).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (achy), SKIN BURNING SENSATION (under arm it was rough and burning) and RASH (rash in her back, rash in back and chest, left arm and elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (achy), SKIN BURNING SENSATION (under arm it was rough and burning) and RASH (rash in her back, rash in back and chest, left arm and elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The other concomitant medication include electrozole 2.5mg .
One Wednesday  - I had a temperature - this time it went to 101.8 and when I got up on Thursday morning, I had a fever of 100.2  - Friday - it was 97.8 and in PM it went up to 99.5; Saturday the 6th - 99.5 Sunday the 99.5. 8th - 98.6 and I have been normal ever since. No dizziness with second dose of vaccine.
ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 38 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) at the age of 38 years as dose 3, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 26Jan2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2022, outcome "recovering" and all described as "ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20"; CARDIAC DISORDER (non-serious), RHINORRHOEA (non-serious) all with onset 18Jan2022, outcome "recovering" and all described as "ST and rhinorrhea after houseguest who is COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, cardiac disorder, rhinorrhoea. Clinical course: ST and rhinorrhea after houseguest who was COVID positive with home Ag, so she started to feel worst ST and rhinorrhea and home test + 1/20. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. C. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19, cardiac disorder and rhinorrhoea cannot be totally excluded.
Local reaction: 26 x 20 cm erythematous, raised, well-circumscribed papule centered on the injection site.  Central vesicle 3 x 3 cm.  Systemic symptoms of fever (101.4F), myalgia and fatigue.  Seen in my office today 12/1/2014.
Cant sleep for the last 8 days; dizziness; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cant sleep for the last 8 days), DIZZINESS (dizziness) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (Cant sleep for the last 8 days), DIZZINESS (dizziness) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Cant sleep for the last 8 days), DIZZINESS (dizziness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt c/o "feeling different".  Paramedic assessed pt- HR- 49; B/P- 190/91; R-12; SpO2- 99%.  Pt states she was nauseated.  Per caregiver, pt tends to be hypotensive.  Rechecked B/P- 180/80; P-42.  Continued to talk with pt and caregiver.  Pt requested PHN call her PMD.  Attempted to call PMD- he was not in the office and staff didn't know what time he would be back.  Decision made to send pt to ER for evaluation as B/P continued to be elevated and HR was low.  Final vitals as leaving- B/P 191/91; HR-40.  Pt given Zofran in ambulance for nausea.
My calves lower legs (both) was really sore lasted overnight. I called my doctor and next day I felt better.
Information has been received from a health professional concerning a female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). Subsequently, the pt experienced swelling at the site of injection, numbing of the lips, and itching eyes. No product quality complaint was involved. No other information was provided. The pt recovered. It was also reported that another pt had a similar reaction (WAES0512USA04076). Additional information has been requested.
Information has been received from a physician and a registered nurse (R.N.) concerning a 13-month-old Caucasian male who on 06-APR-2007 was vaccinated subcutaneously in the left thigh with a first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot # 657031/0231U).  Subsequently, it was reported that on "23-APR-2007" the patient developed an injection site reaction first reported as injection site induration which the physician was able to notice when the baby patient was brought to the clinic for follow up "3 weeks after administration" of the vaccine.  In follow-up, it was reported that the injection site reaction occurred 14 days after vaccination and was a red welt with dimensions of 20 x 25 mm on the left thigh.  It was reported that the patient was seen by a physician and that he recovered "within 2 weeks".  There was no product quality complaint involved.  Additional information is not expected.
Information has been received from a medical assistant concerning a patient, who on 04-MAR-2013 or 05-MAR-2013 was vaccinated with a dose of improperly stored GARDASIL (dose, route and lot # not reported), which had been drawn up into a plastic syringe on 02-MAR-2013. No adverse effect was reported. Additional information has been requested.
Pt started having grand mal seizures one day post vaccination. 3 episodes of seizures since vaccination date. Pt is still unwell. GI upset, hair falling out, seizure activity daily. Now on seizure precautions and medication for prevention.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (Lot#: L013429, expiry date: 21-JUL-2017, exposure to 55 F for 48.25 hours from 16-SEP-2015 to 29-NOV-2015; L007560, expiry date: 15-JUN-2017; L014415, expiry date: 25-JUL-2017; L020015, expiry date: 16-AUG-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.