chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was very nervous about getting the shot. He would not look at the needle. He got the shot then went to sit out side for 20 minutes to watch for reaction. In 5 minutes he was slumped over in the chair. When I tapped him on the shoulder he did not respond.  I repeatedly tapped him on the shoulder and he woke up but was very confused. When I asked him his name he could not answer me.  After a minute or two ,he was still confused but knew his name. He was very sweaty and seemed agitated. He did not have any difficulty breathing and I told him to take slow deep breaths. We had called 911. EMT  to assess the patient. His BP was low and he was still sweaty.   EMT kept monitoring him. He did not want to go to the hospital and did not want pharmacy or EMT to contact anyone. EMT monitored patient.  Patient had left his driver's license on a chair when he was being watched by the EMT. He came back and looked in good health when he picked up his license.  He said it was due to him being scared of needles.
DIED; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "the patient died within 24 hours of the shot". It was unknown if an autopsy was performed.  On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211229952 -covid-19 vaccine ad26.cov2.s- Died. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Blood and mucus in stool after event. I suspect that this is infant protein allergic colitis related to maternal soy ingestion, but given timing of event was within 24 hours of rotavirus vaccine, unable to rule this out as a cause at this time. No evidence of intussusception.
Pt. received injection at 11;34    at 11:38 pt had LOC( approx. E seconds . pt fell from chair and hit his R temple when he hit the floor before staff could get there. Pt rolled to back with spinal precautions EMS called., pt was then alert and oriented x3, Perla, BUE strength equal.O2sats 88% pt encouraged to do deep breathing and O2 sats 91%  Hr 46 BP 101/51, Pt c/o head pain and did not want to lay down. pt was attended to by FNP and RN on duty. 11:43 pt was placed in Trendelenburg O2 sats 94% Hr 98, 11:45 EMS arrived and took over care.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 02-JUL-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) and on 03-JUL-2014 the patient was administered with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015 which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Red, sore, hot, fever, blister pustules popping - oozing liquid.
Information has been received from a physician and a practice manager via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 mcg/0.5 ml, lot # L045117 and expiration date 06-OCT-2018 (administration route was not provided). No adverse effects were reported. The vaccine had two temperature excursions, both of 144 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)) and for the other a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient tested positive to COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient tested positive to COVID-19) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). At the time of the report, COVID-19 (Patient tested positive to COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 14-MAR-2023 10:35, patient had 2nd dose of 0.5 milliliter in left arm with batch number 071B22A.  No treatment information was provided.   This case was linked to MOD-2023-718111 (Patient Link).
VOMITING; DIARRHEA; PAIN IN STOMACH; NO APPETITE; CANNOT HOLD DOWN FOOD; FEVER; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced vomiting. On 07-JUN-2021, the subject experienced diarrhea. On 07-JUN-2021, the subject experienced pain in stomach. On 07-JUN-2021, the subject experienced no appetite. On 07-JUN-2021, the subject experienced cannot hold down food. On 07-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting, diarrhea, pain in stomach, no appetite and cannot hold down food was not reported. This report was non-serious.
First menstrual cycle after vaccination resulted in spotting for several days after typical menstruation end date. Spotting varied from minor to medium somewhat randomly for several days past the typical cycle end of ~7 days. Patient has never experienced this type of spotting before. Second menstrual cycle during the following month was both heavier and more painful (cramp inducing) than normal, though this time it did not result in spotting after the normal cycle number of days.
This spontaneous consumer report (initial receipt 15-Apr-2016) concerns a female patient who had medical history of asthma and bronchitis. On an unspecified date, the patient received unspecified flu medication (manufacturer and batch number not provided) for the prevention of the flu. On an unspecified date while on an unspecified flu medication, the patient got the flu. No further information available. The outcome was not reported. Seriousness: Serious. Medically significant Causality: Unassessable. Time of vaccination in reference to influenza was not specified. Seroconversion conferring immunity generally takes 2 weeks to develop and lasts approximately 6 months following vaccination. Laboratory confirmation of influenza was not specified hence causality is unassessable to consider vaccine failure.
29 year old male patient received expired dose of Tenivac with no adverse event; Initial and additional information regarding an unsolicited valid non-serious case was received on 04-Jun-2021 and 7-Jun-2021 from a pharmacist via Agency (Reference number- 00628884).  This case involves a 29-year-old male patient who was vaccinated with 0.5 mL (standard) expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6187AA, expiry date: 06-Feb-2021] via intramuscular route at left deltoid for prophylactic vaccination (expired product administered).  Caller with question on whether dose needs repeating and whether they had any safety data to provide regarding expired dose.  The patient's medical history, past medical treatments, and family history were not provided. No concomitant therapy was given.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  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.
dark urine,  retaining urine, severe myalagias and arthralgias, mild, constant headache.  No fever or rash.  Still ongoing
Baby slept heavily for 6 hours. Woke screaming and screamed for three days, passing out for 30 minute periods. Bit mom's nipples and shook head back and forth. The next week, he started having bloody stool, which turned out to be life-threatening allergies to tree nuts and dairy. The week after, severe eczema developed on a majority of his body and lasted for a year.
started with localized pain/discomfort that migrated to shoulder with numbness in shoulder and neck
HARD LUMP IN ARM WHERE SHOT WAS GIVEN, SORE TO TOUCH.  BEEN BOTHERING HER PAST WEEK.
Symptoms started about 10 pm the day after the injection and consisted of fevers reaching 104.3; severe headaches, chills, body aches, weakness and dizziness/confusion continued until the morning of Jan. 25.  This time frame includes one bout of vomiting; multiple bouts of diarrhea. Felt like the proverbial truck had hit me. Mild fever, headaches, body aches, and more diarrhea on Jan, 25 - but felt slightly human. Jan. 26, diarrhea and weakness, bit of headache but no fever. Feel more human, life will, thankfully, go on.
The weekend of Jan 18 started smelling cigarette smoke. I went to see ENT on 1/25 and checked my nasal  passages prescribed Flonase everyday and ordered MRI on 2/8 (negative for any abnormalities,no Brain tumor). Also got my Dose 2 on 1/25 stop smelling the cigarette smell on 1/28.Then 3 weeks from Dose 2 started back smelling the cigarette smell. I had a follow up on phone visit on 2/22 doctor stated MRI is fine it was a adverse reaction referred to Neurology for EEG. I'm still exp intermittent smells as of today.
11.5 x 7 cm area of erythema and warmth to left arm on extensor aspect. Pinpoint lesion noted to area of erythema. Clindamycin (75mg/5cc) 6 mL PO TID x 10 days. Dx: cellulitis of L arm.
Fever of 100 degrees 2 spells of vomiting. Treated with acetomenaphin drops and Boron Homeopathic "thuja occiodentalis".
Administered Hep B to right deltoid 30 min later c/o "can't lift my right arm", "tingling lips". Called Dr. - on call doc. Administered 50mg BENADRYL IM and EPIPEN, sent to ER.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced chills, injection site warmth and injection site induration. On 18th October 2018, the patient experienced injection site pain. On an unknown date, the patient experienced feeling unwell, feeling hot and fever. In October 2018, the outcome of the chills and injection site induration were recovered/resolved. On an unknown date, the outcome of the injection site pain, feeling unwell and injection site warmth were not recovered/not resolved and the outcome of the feeling hot and fever were unknown. It was unknown if the reporter considered the injection site pain, chills, feeling unwell, feeling hot, injection site warmth, fever and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. Within the 24 hours after receiving the vaccine the patient began to experience soreness at the injection site. In October 2018, less than a week after receiving SHINGRIX, the injection site of the patient was also hard and warm. He also began to experience fever and chills. The patient took his temperature at night on 21st October 2018 and it is was 99.1 C.  The patient took his temperature while on the phone call at the time of reporting on 22nd October 2018, at 10:20am and his temperature was 98.1 C. The patient said that he still just did not feel right. The contact details of the physician was provided.
Type III local reaction and pt complaining of throat fullness, trouble catching breath. Started a few hours, post vax. Seen in ER the next day and treated with Benadryl for local reaction. Other symptoms resolved.
Diffuse rash that started on face and spread to the rest of her body, coughing, diarrhea, low-grade fever, chills, facial edema.
right arm pain, swelling, erythema, fever to 102 degrees, burning into entire arm
Fever 102F Same day as 2nd dose  Again fever 101.9f day 8 after 2nd dose  Again fever 102f day 10 after 2nd dose  Hives on arm 9 days after 2nd dose
Can feel a ball; Area is red where she was vaccinated; Itches; Hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches), VACCINATION SITE PAIN (Hurts), VACCINATION SITE ERYTHEMA (Area is red where she was vaccinated) and VACCINATION SITE INDURATION (Can feel a ball) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itches) and VACCINATION SITE PAIN (Hurts). On 06-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area is red where she was vaccinated). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Can feel a ball). At the time of the report, VACCINATION SITE PRURITUS (Itches), VACCINATION SITE PAIN (Hurts), VACCINATION SITE ERYTHEMA (Area is red where she was vaccinated) and VACCINATION SITE INDURATION (Can feel a ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The caller was wondering that  if she could give her Benadryl, as It's like a late reaction.  No concomitant medications were reported.  No treatment information was provided by the reporter.
Terrible headache, body aches, chills, no energy, extremely tired. Going on 48+ hours with body aches and terrible headaches and sweating.
Friday evening around that evening I was laying on the couch and felt dizzy. I got up to go to sleep and it was hard to keep my balance. It felt like a downward pressure was over me while walking and I fell to the floor. I got up the next morning, I also felt nauseous and the ringing in my ears intensified. It has gotten worse today. I made a appointment to my PCP and urgent care and the sent me to ER for about four hours. I did test that came back as normal.  They gave a dose of meclizine 25mg that was to help with the symptoms.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. No demographic data or medical records of the patients were provided. The reported stated that on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 doses (unspecified number) of VARIVAX (Merck) and PROQUAD (Merck) were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time and they have been administered (on an unknown date in 2014) to unspecified number of patients since the temperature were above the recommended storage temperature. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. Additional information has been requested.
Light period until day 5. I normally bleed heavy first 1-2 days, but it was light/dark brown blood for four days until the fifth day, where it came heavy and bright red.
I tested positive for Covid 19 on 1/4/23 and became symptomatic despite receiving 4 prior Pfizer covid vaccines including the bivalent booster listed above. I then even developed a rebound case of covid symptoms and tested positive on a rapid covid test again on 1/16/23 despite being fully vaccinated.
Large red mark on left arm, well below the site of injection, noticed it Monday evening 2/1/21; have been icing it.  It is not worse today, but it's not better either.
Fever 102 with chills, body ache,  headache. Fever started 24 hours post vaccination. Subsided with ibuprofen then relapsed 48 hours post vaccination.
No adverse effect; the patient was administered a dose of improperly stored ROTATEQ; This spontaneous has been received from a medical assistant, concerning an approximately 8 week patient of unknown gender and ethnicity.    The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 18-MAR-2019, the patient received a dose of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002700 and expiration date 24-AUG-2019), taken orally as prophylaxis.  In addition, the vaccine was exposed to temperature: 1.2C for timeframe 30 minutes with previous excursion: -2.13C for 3 hours. The excursion call was made by a data logger. No adverse effects reported.  This is the third of the three patients.; Sender's Comments:  US-009507513-1905USA012679: US-009507513-1905USA011943:
Fever, chills, headache, nausea, and intermittent rapid heartrate that evening.  Also had lump at injection site, with swelling and soreness. Took Motrin/Advil which helped s/s.  Symptoms subsided by early afternoon the next day. Feels fine now (2-29-12).
Received 2nd dose one year after 1st dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.    Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: The caller reported patient receiving second dose of Shingrix approximately one year after receiving the first dose. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
deep muscular pain developed following day after vaccine. pain has continued to increase over the last 4 weeks and is now radiating into shoulder. patient has difficulty raising hand above head.
pt recvd vax;approx 1 day later,exp pain at inject site;pain abated,2 days p/ inj,exp swelling in rt posterior metacarpal area accompanied by pain;3 days later swelling/warmth were observed at inj site;pt cont to have dec use of 3 rt finger
Went limp and was staring into space.  Couldn't get his attention.  Later, his limbs kept going stiff and jerking.  He stopped rolling over that day.  He stopped pushing up on his arms that day.  He stopped babbling that day.  He didn't regain any of those skills until he was almost 11 months old.  He started developing severe recurring ear infections within a week.  He developed severe eczema.  His GERD was out of control.  He developed an anaphylactic allergy to eggs that sent him to the ER the first time he tried eggs at 9 months, and we also found out he was allergic to peanuts.  He developed progressive infantile scoliosis and laryngomalacia.
Pt recvd vax 25SEP91-t99.2 & local rxn @ inject site-pain, swelling & inc warmth x 4 days;
Patient fainted and ended up falling and hitting her head on the floor. Once she came to, she felt "tingling" and ended up breaking into a sweat.