chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 5/5/2022, I experienced total exhaustion and coughing. On 5/6/2022, I had a fever that reached about 101.5 and constant coughing. I had no appetite and lost 8 lbs. in 4 days, because I couldn't keep anything down other than a little bit of chicken broth, because I kept on throwing up. On 5/6/2022, I took a home test for COVID, and the result was positive; it was a breakthrough case. I called my doctor; since I was able to breathe without pain, he saw no need to prescribe me medication or to send me to the hospital. He just told me to rest and keep in touch with him. He also advised me to take OTC medicines, such as TYLENOL or cough syrup, to treat the symptoms, which I did. I spent the next few days afterwards mostly sleeping, coughing, and trying to keep down chicken broth. On about 5/10/2022, I was able to eat a little more and keep it down; I had to gradually reintroduce solid food to my diet. My fatigue improved, and I became more clear-headed. I spent the next several days recovering. I work as a waitress on weekends, and I had to miss 3 weekends of work, because the coughing continued and I had to wait until my energy levels returned to normal. Before I became infected, I always wore a mask in public as a precautionary measure. I went on a trip and wore a mask there the whole time, yet I still became infected.
experienced elevated heart rate and blood pressure approximately 24 hours post vaccination, which prompted visit to ER. a rapid covid test was administered in the ER which had a positive result. was admitted to the hospital for fever and possible PNA
This spontaneous report as received from a physician via Pfizer, Inc. in the format of a medical record refers to a female patient who is currently 62 years old. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (the dose, dosage number, anatomical location, lot # and expiration date were unknown) for prophylaxis. No concomitant therapies were reported. Subsequently, on an unknown date, the patient developed an allergic reaction to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The outcome of the event was unknown but it was considered to be related to the vaccination with the suspect vaccine. All medical records will be provided upon request. Additional information has been requested.
Received his first Moderna vaccine on 2-17-21, got COVID infection on 3-5-21 and received BAM (monoclonal antibodies) on 3-5-21. Received his second Moderna vaccine on 3-17-21 (did not wait 90 days following the antibody infusion). Patient states he was informed that his 2nd vaccine was invalid and to return in 90 days for another COVID vaccine booster since he had his 2nd one too soon. Received 3rd Moderna vaccine on 6-22-21.
SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN  IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Breakthrough Covid; Breakthrough Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EJ1685), in left arm, on 23Mar2021 as dose 2, single (Lot number: EJ1685), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: EP6955), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient did not have COVID prior to vaccination. Concomitant medication(s) included: LOSARTAN. Past drug history included: Erthromyocin, reaction(s): "Allergy". The patient did not receive any other vaccine in four weeks prior to vaccination.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "recovered" and all described as "Breakthrough Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient was tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, vaccination failure of the suspected vaccine BNT162B2 cannot be completely excluded.
pt recvd vax;7 days later exp ha & altered vision; unresolved;
Pt states he has had headache, dizziness, sore throat, cough and muscle aches since H1N1 vaccination. On 11/19/09 T = 97.6 BP 110/74 at 109/72 AP=64.
Patient had initial injection site pain that lasted approximately 1 week.  Since injection he has had pain that migrates around entire left arm.  He states it is a deep muscle like pain.  It is not constant but comes and goes.  Patient has taken Tylenol and Ibuprofen but neither relieves the pain.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 15-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On an unspecified date, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210441627.; Sender's Comments: V0: 20210440724 -covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient's leg started turning red at the injection site. The redness quickly spread from the injection site and covered her entire lower half of her body from her belly button to her knees. The redness looked like scalded burns.
Edema, muscle ache, swelling in hands and feet. Joint swelling, inflammatory arthritis.
Havrix adult dose, pediatric patient; Havrix adult dose, pediatric patient; This case was reported by a physician via call center representative and described the occurrence of overdose in a 18-month-old female patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 20th January 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The physician reported that an adult dose of Havrix was administered into a 18 months old patient, which led to overdose and adult product administered to child. The reporter consented to follow up.
Left thigh generally erythematous, warm, swollen on anterior part, not indurated, no limit of motion on either leg. Able to bear weight on leg.
after the vaccine I develop a headache that is not going away since I received the vaccine, also feeling tired all the time.
Her whole body started shaking. She wanted to go to the grocery store  BP elevated, 151/115  and "could barely get out of the store." She really does not know what happened. "Husband (she says) did not know if she was having a heart attack or seizing" he states "she was twisted to the left and heaving. Left side of mouth drooping legs were kicking mild then pounding the bed." This lasted  for 90 minutes. Hospitalized 2 days.
Parent called 9/11/03 to report left deltoid area red, swollen with "knot".
Spotting, vaginal bleeding, cramping, back pain. Seen in ER, pregnancy test returned negative-the day I got my vaccine I was 4 weeks 3 days pregnant. I miscarried 2 days after recieving H1N1 vaccine (shot). 12/10/09:  ED Records received for date of service 12/4/09:  Dx:  Complete abortion.  Gravida 3, Para 1 Presented at 4.5 weeks gestation with vaginal bleeding.  US revealed empty uterus.
This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had an allergic reaction to SHINGRIX but when tried to gather additional information, the patient hung up the call. The patient was very angry and almost incomprehensible.
1/24/12 - Onset of Sx c/w Guillain-Barre. 1/27/12 - Seen in Clinic & sent for admission at the Hospital. 2/6/12 - Intubated. 1st day of Plasmapheresis following failed IVIG.
Little faint when i move around; Sore arm; Feeling light headed; Nauseous; Feverish this morning; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Little faint when i move around) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Little faint when i move around) (seriousness criterion medically significant), VACCINATION SITE PAIN (Sore arm), DIZZINESS (Feeling light headed), NAUSEA (Nauseous), PYREXIA (Feverish this morning) and MYALGIA (Body aches). At the time of the report, SYNCOPE (Little faint when i move around), VACCINATION SITE PAIN (Sore arm), DIZZINESS (Feeling light headed), NAUSEA (Nauseous), PYREXIA (Feverish this morning) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication was not provided by the reporter. No treatment medication was not provided by the reporter.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
painfull soreness at injection site; swelling; knee swelling; inflammation on knee; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, swelling, swelling of knees and knee arthritis. On an unknown date, the outcome of the injection site pain, swelling, swelling of knees and knee arthritis were unknown.   It was unknown if the reporter considered the injection site pain, swelling, swelling of knees and knee arthritis to be related to Shingrix.  Additional details were provided as follows:  No any patient demographics was given. The age at vaccination was not reported.  After receiving dose of Shingrix, the patient experienced painful soreness, swelling and knee swelling. The reporter did not consent to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 12:30 as dose 1, single (Lot number: EN6199), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 04Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 302308D), in right arm and on 09Jun2022 at 15:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: NALTREXONE, start date: Oct2019; FISH OIL, start date: Jan2018; VITAMIN D [VITAMIN D NOS], start date: Dec2018; B COMPLEX [VITAMIN B COMPLEX], start date: Jul2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date: 02Aug2022.  No follow-up attempts are possible. No further information is expected.
Approximately 2 days after my 2nd dose vaccination, I experienced the following symptoms: Arm swelling, Rash spreading in the injection site and spreaded toward the back of my arm and to my bicep. I did not take anything for treatment until I saw my doctor and was prescribed with an antibiotic. It helped with the rash and my symptoms subsided.
SEIZURE THAT LASTED APPROXIMATELY 15 MINUTES ON 1/29/2011 WITH PERIODS OF APNEA AFTER SEIZURE. SEIZURE THE FOLLOWING DAY 1/30/2011 THAT LASTED APPROXIMATELY 45 MINUTES.
1st dose june 2022, 2nd jul 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 38-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   In July 2022, the patient received the 2nd dose of Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. In July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's Comment: The reporter was the mother of the patient. The reporter reported that the patient received both doses of Havrix vaccine in 1 month apart. The reporter stated that the patient received 1st dose of Havrix vaccine on June 2022 and 2nd dose on July 2022 in an unknown arm. The reporter did not give permission to contact healthcare professional. Additional supportive information: The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccinations schedule. This case had been linked with US2022181000 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022181000:Same reporter
1 April, woke up at 0800 with slight headache and felt fatigued but most noticeably my voice sounded weird and my throat was extremely hoarse while talking in work meeting and I had to constantly cough to clear it. I was having a bit of trouble swallowing as well. In the afternoon, my headache got worse and I had diarrhea. Around 7:45pm I started feeling extreme itchiness and swelling in my tongue. This didn't improve, so I took 25mg Benedryl at 8:20pm, at which time my vitals were normal, but noticeably lower than usual with a HR of ~60, BP of 100/70, O2 sat 99% and normal temp. I also took another 1000mg Tylenol at 9:30pm and went to bed.  2 April, 0730 woke up and my throat and tongue started swelling again and were very itchy. I began have difficulty breathing and swallowing saliva. I also could not swallow a banana easily, so I stopped eating it. I also had some wheezing that would only go away with a cough. Took 25mg more of Benedryl and went to urgent care immediately because breathing was becoming increasingly difficult.   Treatment: At urgent car I was diagnosed with anaphylactic reaction due to vaccination and given another 25mg Benedryl injection and 10mg Prednisone. Vitals were BP:144/90, HR:83, TMP 98.5. Doctor considered epinephrine instead of Benedryl but "didn't want to have to send me to the ER". I was monitored for about 45 minutes and while my difficulty breathing did not improve much, it also did not worsen. I was sent home with Medrol steroid pack, Atarax and an EpiPen. My breathing ability did not return to normal until about ~3 days later.
Within an hour after receiving the vaccine, I had a tingling on my tongue, face and legs. I was observed at the pharmacy for 15 minutes and then I went home. I took Prednisone to help with my symptoms, but it didn't work.  As of today, I still have the tingling but it's not as bad or often.
The patient developed a maculo-papular rash on her face 30 minutes after her Prevnar injection. The patient was treated with Varivax, comvax, and Atarax. The patient was treated with Atarax. T
Pt recvd vax 10AUG92 on 11AUG92 in the evening had 30 min sz seen in clinic 12AUG92 dx w/URI & conjunctivitis;
no adverse event; Inbound call from HCP reporting that an MMR-II which was expired was inadvertently administered to a patient. HCP stated product had not experienced any temp excursions and patient had not reported any symptomatic side effect. No additional AE detail; This spontaneous report as received from a nurse refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 31-MAY-2022, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA; 0.5 milliliter,  lot # T018669 expiration date 29-MAY-2023) for prophylaxis.  The product had not experienced any temperature excursion and the patient had not reported any adverse event.
This spontaneous report as received from a physician refers to a 76 year old female patient. The patient's current condition reported as allergic reaction to antibiotics (reported as CIPRO). On 04-SEP-2013, the patient was vaccinated with the dose of ZOSTAVAX (route intramuscular, lot/batch #1621628-04397, dose not reported). Lot number 1621628-04397 is an invalid lot number for ZOSTAVAX. Concomitant therapies included lithium, gemfibrozil, tretinoin, DITROPAN, levothyroxine sodium (manufacturer unknown), DEXILANT and LEXAPRO. On unspecified date in October 2014, the patient experienced outbound of shingles on lower thoracic and chest (disability and intervention required). The patient required emergency room visit. The outcome of outbound of shingles was not reported. The relatedness between the event and to ZOSTAVAX was not provided. The event, outbound of shingles, was considered to be medically significant by reporter due to requirement of medically or surgical intervention to prevent of the serious criterion. The event, outbound of shingles, was considered to be disabling and medically significant by reporter. Additional information has been requested.
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
pt recv vax & devel a hive-like rxn on head & face;pt recovered;
THE VACCINE WAS GIVEN LOWER IN THE ARM THAN THE PREFERRED MAJOR DELTOID REGION.  IT WAS HALF WAY TO THE ELBOW AREA, ON THE SIDE, SLIGHTLY BACK FARTHER THAN THE MIDDLE.  THE PATIENT PUSHED HIS SLEEVE UP, BUT DIDN'T GET IT HIGH ENOUGH FOR THE VACCINE TO GO INTO THE APPROPRIATE AREA OF THE ARM. HE DID SAY IT HURT SOME.
Covid Arm - Itchy, red area on left arm at injection site that started 7 days after 1st dose. It's been a few days and I'm still Itchy, but I understand it could last up to a week. I'm waiting it out and not seeking medical attention at this time.