chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist. A 75-year-old female patient received PREVNAR 13 (Lot# N47827, Exp date Nov2017, NDC# 00005197102, UPC# 30005197102), via an unspecified route of administration, on 27Oct2016, at single dose, for immunisation. The patient was vaccinated at the pharmacy. Medical history included hypercholesterolaemia. There were no concomitant medications. The patient experienced whenever she had anything to eat, she had a bad taste in her mouth on 28Oct2016 with outcome of unknown and not able to eat on 28Oct2016 with outcome of unknown. No therapeutic measures were taken in response to the adverse events.
Information has been received from a consumer concerning his wife who on 23-JUL-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently, the patient developed an injection site reaction, including itching, swelling and pain at the injection site.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
She received vaccine on Saturday. The next day she had a headache that didn't go away. On Monday she became very ill and called the ER who said it sound like she was having a reaction to the flu vaccine.  She had symptoms of fatigue, weakness, pain behind eyes, temp of 102 F, vomiting, can't keep anything down, felt like arm was paralyzed, body aches especially on the left side of body starting in neck all the way down to leg. (Vaccine was given in right deltoid). Followed up with patient Tuesday, she felt a little better but has to stay laying down or she has to throw up. Feels really nauseous.
painful stabbing pain around the above part of her stomach; tenderness in upper body on the side where she got vaccinated; Piercing pain, going to her shoulder; Felt beat up; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history included autoimmune diseases like Sjogren's syndrome and Hashimoto's disease. Patient concomitant medications were not reported.   On an unspecified date, (Starting Day 10) patient experienced weird symptoms, had very painful stabbing pain around the above part of her stomach. On an unspecified date, patient also had tenderness in upper body on the side where she got vaccinated, She said she feels like she has been beat up. On an unspecified date, patient experienced Piercing pain, going to her shoulder. Patient stated can't quite explain it, but one area felt like stabbing on the stomach, on one side and did not injure herself, or anything. patient said does not know, if it was 10 days later, if it was related to the vaccine, and she was trying to figure that out. Patient felt a little nervous. Patient said that supposed to get the second dose of the Pfizer COVID-19 vaccine tomorrow. However, patient was concerned about her reaction. patient wanted to know if what had experienced was normal with people who had autoimmune diseases. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
I completely lost my sense of taste and have not regained any sense of taste thus far.  I have not gone to see my doctor.
Within no more than 4-6 hours, I was losing my appetite.  By the next morning I had low-grade fever- about 1 degree or less higher than normal; tingling in body and extremities, fatigue, pain all over my body and especially in my lower back. By midday, nausea began and the fatigue that had begun in the morning, had me pretty much confined to bed.  By that evening, I had a large - about 1/4 -1/2 size of a baseball that was very painful and deep in my armpit, and headache that was unbearable - it had started about midmorning and got worse throughout the day.  I had multiple brief cardiac arrythmias throughout the day.  By 9:00 p.m., I was in so much pain and discomfort (the headache was the worst pain) and severe naseau ( I began vomiting about an hour before that) and the headache was beyond horrible.   I had called my doctor around 7:30 p.m. and 8:00 p.m., but she had not called back.  I was unable to care for myself or pets and called a relative to come and help me.  She tried to talk with me but I told her I was to sick to help, even by talking.   Took ibuprofin around 8:30, but was unable to hold it down. By around 9:30 I had about the 5th or 6th (estimate) cardiac arythimia.  It was only a few seconds - like the others.  I could feel my tightness in my chest and could feel my heart pounding - beyond the arrythmia.   Doc finally called at 11:11 p.m.  Called in a Rx for nausea, and said I could take an injection of Imitrex which my husband did for me as I was too sick to do on my own. I was finally able to go to sleep around midnight.  I had slept most of the day until about 2:00 p.m., but then stayed pretty much awake with pain after that until about midnight.   Next day I had some improvement of intensity of symptoms and was able to eat and a little.  I was unable to eat or drink (drank about 8 oz) the day before.   Running out of time - so I regressed and it went on for days.  Today is the first day - more than a week - that I have felt remotely normal.  This all happened with dose 2 too.
Localized swelling, erythema on right arm involving 2/3 of upper arm.
Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received form pharmacist considering a 63 years old patient of unknown gender, who on 21-NOV-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005679, 1212USA005681, 1212USA005682). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Dizziness, hot, sweaty right after vaccine administration. Patient has hx of vasovagal episodes. No nausea, vomiting, chest pain, shortness of breath nor trouble breathing. Patient felt better after laying down. Given water. Discharged to home
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. No information about medical history, concurrent conditions or concomitant therapy was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L032184, expiry date 25-NOV-2016 (dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 14-NOV-2015, the patients were vaccinated with doses of VARIVAX (Merck) (dose and route of administration were not reported, lot number was reported as L025209, expiry date: 07-JUL-2017). The nurse reported that the doses had been reconstituted with sodium chloride instead of sterile water diluent. She stated that the sodium chloride diluent is manufactured by Sanofi and there is 0.6 ml in each dose of diluent. No adverse events were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received vaccines 5-15-13. Pt with temp of 101.9 at home on 5-19-13 and was "walking like he was dizzy". Pt was seen at facility on 5-19-13. Pt was given morphine and VALIUM at facility to obtain CT scan of head. CT scan normal. Pt was transferred to hospital on 5-19-13 and was discharged 5-21-13. MRI at hospital showed questionable subtle signal abnormality within the subarachnoid space of bilateral occipital lobes on flair imaging, raising possibility of meningitis.
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 52 year old not Hispanic or Latino white male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypotension, seasonal allergies, alcohol use, and non-smoker. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the patient had antibody test which showed no antibodies (confirmed immunological vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with the Product Quality Complaint number: 90000183211 The suspected product quality complaint has been confirmed to be not voided (meets PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210637818-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
heart area felt sore or inflamed for 2-3 days shortly after both injections. issue appears to have resolved itself without known side effects.
Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke overnight into Sunday with severe itching which lasted all day Sunday despite Benadryl and Pepcid and lotion. I saw patient Monday morning and she had hives on back, abdomen, arms, and some starting on legs. Given extent of hives, we administered IM steroid and prescribed Medrol Dosepak. No airway involvement. No prior history of reactions to vaccines. Will not know how effective steroids are as this is an urgent care, but she was feeling some improvement after sitting for 10 minutes after the steroid injection.
Pt recvd 6 doses of Engerix-B & was determined to be a non-responder;
Information has been received from a health professional concerning a patient in fifth grade who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
Moderna Covid -19 EUA  vertigo, nausea, vomitting began about 27 hours post injection severe vertigo and nausea lasted only about 30 minutes, but general malaise for about 24 hours
she started bleeding as if she has a period and it hasn't stopped.; her 8 year old daughter got her first dose on nov 5th; This is a spontaneous report from a contactable consumer or other non health care professional . A 8-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 05Nov2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccine in four weeks. It was unknown if the patient had covid-19 prior to vaccination and it was unknown if the patient had tested for covid-19 post vaccination. It was reported that, the patient got her first dose on nov 5th and next day (06Nov2021) she started bleeding as if she had a period and it has not stopped. It was unknown if the patient received any treatment for the events. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Poison ivy; has experienced a rash on her elbows/ she developed rash somewhere in the middle after 1st dose not just arm all over body; This case was reported by a consumer via call center representative and described the occurrence of poison ivy rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced poison ivy rash and generalized rash. The patient was treated with prednisone. On an unknown date, the outcome of the poison ivy rash and generalized rash were unknown.   It was unknown if the reporter considered the poison ivy rash and generalized rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022125564, US2022125565   Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's comments: The patient had reported that she had got her 1st dose of Shingrix on May 2022. The patient said that she had developed rash somewhere in the middle after 1st dose on her elbow, not just arm, but all over the body and had no clue if it was due to shingles. Elbow first and was treated for poison ivy with prednisone and topical did not go away. Also a biopsy was done. No other details were available. The reporter had consented to follow-up. Additional supportive information: For Tolerance of 2nd dose refer case US2022125564.; Sender's Comments:  US-GSK-US2022125565:Same reporter
Onset of loud intermittent crying spells, non-bloody/non-bilious emesis and refusal to take PO. At 5am the next day, the mother brought the baby to ED, where he had normal physical exam but abdominal x-ray suspicious for intussusception. Abdominal ultrasound at 9:30am revealed ileocolic intussusception successfully reduced by subsequent air enema. Pt had a currant jelly stool prior to ultrasound.  Pt observed for 24 hours with one further currant jelly stool and later normal stool and was able take PO. No recurrence of intussusception.
6OCT92 woke w/upset stomach & sl dizziness which lasted the day; 19OCT92 legs began to feel weak & achy; this feeling ascended to shoulders then upper extremities & neck legs discomfort deminished; felt feverish shook w/t99.8;
My hip feels like it's being snapped like a rubber band, it hurts when straighten leg, when sitting down & hurts when walking for no reason. I had an online visit with the doctor, she referred me to physical therapy, but they are backed up, they told me just to exercise & walk.
Back pain; Feeling very tired; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) at the age of 47 years as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ibrance, start date: 04Dec2020, for Breast Cancer, reaction(s): "Tired", notes: Strength: 100mg, Frequency: Once a day, Route: by mouth, Feeling very tired; Ibrance, start date: 04Dec2020, for Breast Cancer, reaction(s): "Hot flashes", notes: Strength: 100mg, Frequency: Once a day, Route: by mouth; Ibrance, start date: 04Dec2020, for Breast Cancer, reaction(s): "Back pain", notes: Strength: 100mg, Frequency: Once a day, Route: by mouth. The following information was reported: BACK PAIN (non-serious) with onset May2021, outcome "unknown", described as "Back pain"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Feeling very tired".  Additional Information: patient states she had covid vaccine on 17May2021 and since then she has back pain and feeling very tired. Md not aware. advised to contact md. Patient takes for 21 days on and 7 days off.  No follow-up attempts are possible. No further information is expected.
Swelling, itching, rash on hands. Severe arm pain. Hives all over body
First appeared as hives and rash on scalp neck and ears and then spread to the rest of body. Has been daily and continuous going on for 5 weeks now.  Being treated with Cetirizine (Zyrtec) 1-2 times daily to relive symptoms. Have been seen initially by primary care  MD then allergist who gave diagnosis as dermatographic uticaria, skin writing .
Recieved Varivax # 2 on 7/21/08.  Woke in the morning on 7/22/08 with red swollen arm.  Seen in our office 7/22/08 diagnosed with left arm cellulitis and treated with Keflex.
10/8/19 got 2nd dose shingles vaccine 10/11/19 started painful shingles @ right L3 dermatome and abd pain
After Vax had shortness of breath for 5 minutes. In the afternoon had some soreness, felt tired and sleepy. 7/27 felt exhausted, had fever in evening took Ibuprofen but it did not help. Had mild cramps but was able to fall asleep.
Patient received SHINGRIX vaccine on 03/20/18. it was administered via subcutaneous route instead of intramuscular route. Patient reported injection site reaction to her Dr's office on 3/22/18. Described reaction as warm, hard, redness, pain at site of injection. Pharmacist who administered the vaccine, gave it by the wrong route, subQ instead of IM. He followed up with the manufacuter's and was informed that patient does not need revacination but will experience more localized reaction when SHINGRIX is given subQ.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 21-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 5th June 2019, the patient received Bexsero. On an unknown date, less than a week after receiving Bexsero, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Bexsero.  Additional details were provided as follows: In Jun 2019, the patient experienced an episode of syncope. This case is one of 4 cases, reported by same reporter.
pt recv vax 1130AM on 12MAR97 10 min later pt w/hive to inj site approx 1/2 inch in size, white in color surrounded by redness, approx redness 3inch length by 2in width;cold pack to area x 2min then 3min did not relieve hive;
This occurred on the 12th day after my injection.  Earlier in the day yesterday I noticed my arm itched a bit around the area of my injection site.  It wasn?t bad, so I did not pay much attention.  Approximately 4:00 pm I looked at my arm and noticed a sizable red hive-type mark just below my injection site and it was hot to touch.  It was pear-shaped.   Approximately 3-4 inches wide at its widest part and about 5 inches from top to bottom.    Today it is faded in the middle still outlined in light red and is still a bit warm to touch.
Tingling of tongue short of breath little dizziness. Called 911 gave one shot of EPIPEN in left thigh. Paramedics took her to hospital. Pt was awake & talking.
Left posterior leg/knee pain started on 4/26. DVT left leg diagnosed via ultrasound, started on Xarelto
A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 27-Jan-2014. It was reported that expired FLUMIST was inadvertently administered on 27-Jan-2014. The outcome of the event of INADVERTENTLY ADMINISTERED EXPIRED FLUIST is unknown. The report was considered to be non-serious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) for prophylaxis that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Rash began 6 days ago, very itchy, rash mostly on legs, abdomen and face.  Crusted lesions, vesicles on red base.  BENADRYL - CALAMINE.
31 hours, post vax of Prevnar, awoke from nap with a temperature of 101.5F and shaking movements of whole body. Fever increased and then decreased X 72 hours (up to 102F) and hypotonia X 48 hours with lethargy. Poor fluid intake. Treatment with alternating Tylenol and Motrin every 3 hours and push fluids. Rechecked 24 hours later and fever persists but recovering; normal tone.
Patient came into receive a Pfizer Covid-19 vaccine, after administration it was discovered during processing that the patient received previous covid-19 vaccine.