chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, dose number, route of administration, injection site, lot number and expiration date were not reported). It was stated that the patient received ZOSTAVAX instead of VARIVAX (prescribed dose, dose number, route of administration, injection site, lot number and expiration date were not reported) due to product confusion. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Headache, Sedation, Myalgia, Arthralgia, Phlebitis & visit Fever
passed away from the Delta Variant; passed away from the Delta Variant; This is a spontaneous report from a contactable consumer (relative) from a Pfizer-sponsored program . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 and 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient daughter had just received an email from Pfizer stating that the patient should come in for a third dose to cover for the Delta Variant. The patient passed away from the Delta Variant on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away from the Delta Variant; passed away from the Delta Variant
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2017, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt c/o pinching to the heart, some tightness on chest;mom states collapsed in school, was taken to nurse office & still c/o of heart tightening; mom has not taken to MD;
A report has been received from a Pharmacist concerning a 37 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Oct-2013. When pharmacist administered the FLUMIST quadrivalent to a patient today, the patient reported that she thought all of the dose went into the first nostril and none in the second on 16-Oct-2013. The outcome of the event of patient reported that she got all of the dose into the first nostril is unknown. The report was considered to be non-serious.
pt recv vax 26FEB97 & 5MAR97 pt exp a varicella-like rash w/20 non-pruritic lesions on the torso;
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic  condition,  Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, GlaxoSmithKline. In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FULARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified. For the 79 linked subjects please see cases: A0756483A - A0756495A, A0756497A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received stated: AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (ALFUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Generalized urticarial 24 hs after vaccine. Seen in office, rx'd BENADRYL and ZYRTEC.
runny nose; sore throat; sneezing; This is a spontaneous report received from a contactable consumer (parent) via medical information team. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included exposed to someone who was possibly Covid positive on 05Apr2021. Concomitant medications were not reported. It was reported that patient received her first Pfizer Covid vaccine dose on 09Apr2021. Before she received the dose patient had been exposed to someone who was possibly Covid positive, on 05Apr2021. Her runny nose, sore throat, and sneezing in Apr2021 and have continued. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # reported as L033589 exp date 02-SEP-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
on 1/22/22 patient developed nausea, feeling of something in his throat & gagging, vomited, then developed red warm rash on face
I had my vaccination on 03/18/2022. On 12/21/2022 I got very bad vertigo. I am still working through it on 04/12/2023. I am still unsure what is causing it. My eyes were jiggling and I have vomiting dizziness. I saw physical therapist who gave me tips on the Epley Maneuver. I am working on getting referrals to ENT to see if it is something more serious.
I have tinnitus; This is a spontaneous report from Pfizer sponsored program Pfizer Rx pathways from a contactable (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that since second covid shot had tinnitus. Patient never had it before. Patient thought it would be temporary but it had been a couple of months and is still going on. Patient had not recovered from the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Around 10pm on the date of the 2nd dose of vaccine I started to feel mildly nauseous but ignored it and went to bed. Slept well, but briefly awakened 2 or 3 times with an awareness of h/a and nausea. I got up to feed my pets shortly before 5am on 1/28/21 with body aches, chills, mod-severe h/a, mod nausea, malaise, and overwhelming weakness (I had to try 5 times to peel back the aluminum foil top from a plastic cat food container).  I found that I was fine as long as I was sleeping, so I slept most of the morning. By 11am the h/a was so bad I finally took 2 extra-strength Tylenol, which I had not taken previously because I was quite sure I would vomit. I went back to sleep and woke up at 11:45am with all symptoms gone except for a mild loss of energy. I went to bed around 9pm that evening, slept through the night, and felt fantastic in the morning with no residual symptoms at all.
High fever (101-102), chills (lasted two days), brain fog (lasted 5-7 days). Tylenol and Advil; resolved issues.
patient called next day stating that she had ringing in ears. she wasn't sure if was from the vaccine or sinus pressure
Chill, malaise, malaise started that night.  Headache/malaise next day. Slight runny nose 2 days later. Nasal congestion starting 4 days later. Diagnosed with active COVID-19 infection 6 days later.
unable to document an adverse effects pt died of SIDS 24DEC92 vaxed 16DEC92;
No adverse effects; in removing the needle from the patient's right thigh, some product spilled out of the syringe and the patient subsequently had an inadvertent low or invalid dose; This spontaneous report as received from a registered nurse refers to a 12-months-old patient of an unknown gender.  The patient's medical history, concurrent conditions, concomitant medications, past drugs and allergies were unknown.  On 30-MAY-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), via subcutaneous route in right thigh (therapy type: rHA, lot # R028225 and expiration date 02-OCT-2020) for prophylaxis. It was reported that while removing the needle from the patient's right thigh, some product spilled out of the syringe and the patient subsequently had an inadvertent lowor invalid dose (underdose). No adverse effects and product quality complaint reported. It was also reported that the therapy was not discontinued.
Information has been received from a nurse on 07-MAY-2015, referring to unspecified patients of unknown age and gender. The nurse reported that on unspecified dates in 2015 (since 31-MAR-2015) these unspecified patients had been administered doses of VARIVAX (Merck) (dose, route not reported, lot# K003422 with expiration date 06-MAR-2016), which had been exposed to temperatures outside of the recommended range. No adverse experience had been observed or reported. This is one of two reports received from the same reporter (other linked MARRS# 1504USA000335). Additional information has been requested.
Redness and Swelling at the injection site; Redness and Swelling at the injection site; Redness and Swelling at the injection site; vaccine was given in Left Vastus Lateralis to 8 year old; Initial information received regarding an unsolicited valid non-serious case received from a nurse and was transmitted to Sanofi on 07-Nov-2019.  This case is linked to case 2019SA312611.  This case involves a 8 years old female patient who experienced redness and swelling at the injection site and redness (vaccination site inflammation) while they received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were none.  On 05-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number UJ237AB and exp date 30Jun20 via intramuscular route in Left Vastus Lateralis.  On an unknown date (latency unknown), the patient developed a non-serious redness and swelling at the injection site (vaccination site inflammation with symptoms vaccination site swelling and vaccination site erythema) following the administration of ENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED vaccine.  It was a case of actual medication error due to Vaccine administered at inappropriate site.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for injection site swelling and injection site erythema.  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
Patient came in about an hour afterwards complaining of itching.  After looking at the patient, she was showing signs of redness through face, neck and chest.
10JUL woke up w/stiff joints, neck, wrist & knee-lasted about 6 hrs; was fine until morning of 15JUL; 15JUl could barely get out of bed;
Feeling of left ear congestion early in the morning today. Afternoon a  loud whistle like sound and unable to hear lasting approx. 40 seconds.  It now feels like I am getting a possible ear ache... different though almost feels like my inner left ear has been scratched or cut open? Not throbbing like an ear ache.
Patient filled out consent form. I asked her if she had flu shot before as she answered not known to question #5 to screen if the patient had Guillain-Barre syndrome. She said she had it before. I gave her FLUZONE HIGH DOSE 2018-2019 pre-filled syringe at about 4:55pm. I got a call from front store associate at 5:34 pm that the patient lying on the floor at the front store register with paramedic. She was taken to the hospital later on.
On 12/7/22 the patient was administered the COVID19 vaccine as a booster vaccine. (Bivalent vaccines should have been used for booster dose)
P/receiving a dose of Td, pt devel a sore, edematous (edema 2+) arm from the shoulde to the elbow, w/massive redness; Also c/o dizziness & recvd APAP & warm compresses for pain & swelling;
I contracted Herpes zooster in 1990, and  was treated with Valtrex (3 times a day for 3 days) which help to keep control of the virulence of the episodes. Through the years the number of episodes went down (2-3 times a year). In the last 5 years they were so mild that I did not need to use any medication. However, after receiving the COVID vaccine I had a bad case of Herpes in the genital area but in addition and first time since I contracted it I also have blisters in one eye and the mouth.  I first had a blister in the right side of my lips and a couple of days later I had another one on the left side of my eyelid. It is painful and I am alarmed because I never had these before.
Lt facial numbness, tremors to lt hand, arm, hard. Pain to left side of head. Stutters. Mother evidenced sxs with HPV and MCV4. Has been seen in hospital, neuro clinic. Unknown Dx - possible complex partial seizure/? Psychogenic component.  5/9/08 Reviewed neuro clinic records of 1/29-2/21/08. FINAL DX: stress induced conversion reaction Records reveal patient experienced left sided numbness, left hand twitching which included face & leg intermittently w/periodic vertigo & HA.  Exam found very blunted affect, poor eye contact, slow speech, mild decreased sensation of LUE w/normal strength, tone & reflexes.  By 2/21, tremors had increased & now included stuttering.  Referred for counseling.
Client received the 1st COVID vaccine of Pfizer (lot # EW0171 and expiration date 4/25/21) at approximately 2:16pm . Client reported to EMT that as she was leaving the waiting room and "stood up she felt dizzy." Client was alert and oriented X 4 and sitting in a chair near EMT station when Nurse  arrived. At 2:31PM vitals were oxygen:96%, blood pressure:132/88 and pulse:88.  Transfer client to gravity chair.  Client reports blurred vision, a slight headache and tingling in her right arm although she received the shot in her left arm.  At 2:36 pm vitals were oxygen:96%, blood pressure:134/88 and pulse:91. At this time client reports dizziness is subsiding, arm tingling has resolved but now she is getting tingling in her left leg, sensation and movement intact.  Client reports feeling weak and that her left wrist is also tingling. Offer client water. At 2:41PM oxygen:97%, blood pressure:136/86 and pulse:88. Client reports tingling in lower left leg and by left thumb.  At 2:46pm client reports right foot tingling on the top.  At 2:51PM oxygen:96%, blood pressure:134/86 and pulse:88. Client reports dizziness has subsided and that the tingling in her left leg is coming and going but right foot tingling has resolved.  At 3:01pm vitals were oxygen:96%, blood pressure:134/86 and pulse:85 and reports that tingling has improved. Client reports having a history of asthma and environmental allergies. Client takes montelukast (singulair), wixela, ventolin, proventil, loratadine, and vitamins. Client was provided ER precautions and to follow up with provider. Client left facility with a steady gait at 3:04PM.
Information has been received from a nurse practitioner concerning a 49 year old female patient with penicillin allergy, hypertension, hyperlipidaemia and a family risk of shingles (her sister had shingles recently) who on 21-MAY-2012 at 18:30 hours was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not provided) in the right arm at a pharmacy. Concomitant therapy included BYSTOLIC, hydrochlorothiazide (manufacturer unknown) and simvastatin (manufacturer unknown). The nurse stated that on 22-MAY-2012, the patient experienced "hot flash" all over and redness at the injection site on the right arm. The patient was seen in the office by another provider on the morning of 23-MAY-2012 because the redness was worse at the injection site, there was warmth and small areas were weeping at the injection site area. The patient was given doxycicline. The patient was in the office on 25-MAY-2012, because the redness had extended to the elbow area, the area was warm and there were blisters. The nurse practitioner intended to treat the patient with prednisone (manufacturer unknown) and a different unspecified antibiotic (the doxycycline, manufacturer unknown was making the patient sick) and FAMVIR. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The patient sought medical attention at the physician's office. Hot flash all over, redness at the injection site on the right arm, warmth at the injection site , small areas were weeping at the injection site, elbow area with blisters and patient sick were considered to be disabling by the nurse practitioner, "patient was unable to work". This is one of several reports received from the same source. Additional information has been requested.
Received Pfizer vaccine 12/29/2020. On 1/3/2021 developed fever, chills, body aches, and headache.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 24-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, injection (lot # N021170 with expiration date on 27-OCT-2018; dose and route of administration were not reported) for prophylaxis. Sterile diluent which was used to reconstitute vaccine and was properly stored. The vaccine experienced a temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour. Previous temperature excursion also from 15 to 46 degrees Fahrenheit, lasted for 4 hour 30 minutes. The temperature excursion was detected by a digital data logger. No adverse reaction was reported.
415PM pt awoke crying; mom attempted to feed, but pt's head drawn to left pt's whole body bowing to left;
16JUL98 around 4-5PM pt started c/o of eye hurting & about every 1-2xec was squinting eyes cont & rubbing;eye lids became puffy;took to MD, eye exam & prescribed glasses;itching & burning of eyes;dx focusing spasm;
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 13 months old. The patient demographics were updated. On 18-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
after recv inject of vax pt 10 to 14 days later developed hives, arthralgia, low-grade fevers, fatigue & anorexia. m.d. prescribed ativan & benadryl