chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a 1st dose of Hiberix, Pediarix, and Rotarix on 02Jun2021 and received a 2nd dose of Hiberix, Pediarix, and Rotarix on24Jun2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old female patient who received Hib (Hiberix) (batch number UJ437AB, expiry date 3rd May 2022) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included Hib (Hiberix), DTPa-HBV-IPV (Pediarix) and Rota (Rotarix lyophilized formulation).   On 24th June 2021, the patient received the 2nd dose of Hiberix, the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 24th June 2021, unknown after receiving Hiberix, Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and an unknown time after receiving Hiberix, Pediarix and Rotarix lyophilized formulation, 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 details provided were as follows: A medical assistant had reported that a patient received a 1st dose of Hiberix, Pediarix, and Rotarix on 02 June 2021 and received a 2nd dose of Hiberix, Pediarix, and Rotarix earlier than the recomended interval, which led to drug administration interval too short. No symptoms were  reported. Reporter consented to follow-up.
seen in ED after a dr's appointment for complaint of pain in L buttock area, COVID test done - positive; confusion, decreased appetite and drinking x 2days; mildly hypoxic; pt wanted to go home; dc'd to home with O2; pt died at home 5 days later
This spontaneous report as received from a nurse refers to a 1 month old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Historical drugs included hepatitis b virus vaccine given on 29-OCT-2017. On 30-NOV-2017, the patient was inadvertently vaccinated with one dose of VAQTA intramuscularly, lot # N019924 (formulation, strength and dose were not reported) for prophylaxis, instead of intended hepatitis B vaccine. The patient had no illness at time of vaccination. The nurse reported that this was due to user error because " a certified medical assistant took the box of hepatitis A vaccine out of the refrigerator instead of hepatitis B". The vaccines were located next to each other in the refrigerator. The patient's mother was notified. No treatment was given to the patient. No adverse event was reported.
3/22/2023 in the evening I noticed chills, shortness of breath, cough, and fever of 99. Felt like I was coming down with bronchitis. The next day, 3/23 symptoms got worse, fatigue developed and cough deepened. Tested with an at home COVID-19 test, positive. Televisit with doctor. Doctor proscribed PAXLOVID and to treat symptomatically. Started PAXLOVID that day. Symptoms stayed the same for about 4 days. Started to feel better on 3/27 and things gradually got better but fatigue and cough linger to time of reporting.
Pt recv vax on 1/4/99; on same day pt exp erythema, raised induration, soreness, itching
Received Moderna for 1st dose & was inadvertantly given Pfizer for 2nd dose.
Pt recvd 3 doses of Engerix-B vax 30MAY90; 11JUL90 & 12JUL90 & it was determined that pt did not seroconvert;
administered the Moderna COVID-19 vaccine after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine after the published expiration date) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine after the published expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient did not report any symptoms after receiving this dose of the vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-609499 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-609499:Patient 1 (Same reporter)
diarrhea; abdominal pain; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 26Jan2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea, abdominal pain, and fatigue on an unspecified date in 2021 and was reported to be ongoing. Patient asked what is the efficacy of the vaccine after just one dose and if she can get the second vaccine. She also reported that her doctor did not know how to advise her. The outcome of events was not recovered.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Vaccine was given on 10/3, late at night patient experience SOB, swollen face, HA. See MD the next day and was given Toradol and advise to take Benadryl.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Pt was given Pneumococcal vaccine that was expired.  Expiration date was 7/01/2021
Bursitis; Flulaval in the Bursa of her joint; This case was reported by a pharmacist via call center representative and described the occurrence of bursitis in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   In October 2020, the patient received FluLaval Tetra 2020-2021 season. In October 2020, less than 2 weeks after receiving FluLaval Tetra 2020-2021 season, the patient experienced bursitis and inappropriate route of vaccination. On an unknown date, the outcome of the bursitis and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the bursitis to be related to FluLaval Tetra 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the female patient got her dose of Flulaval in the Bursa of her joint, which led to inappropriate route of vaccination. The patient developed bursitis after vaccination. No other information was provided. The reporter consented to follow up.
Myalgia employee may have received inadvertent 3rd dose  Narrative: Employee may have reeived inadvertent 3rd dose of Moderna product on same day as second dose
pt recvd vax;began sz at about 1 wk of age;MD said classical infant spasm;adm to hosp;EEG abnl;discharged home on anticonvulsants but sz cont & worsened;to hosp 9mar;sz subsided;now spacey episodes,no sz;delayed motor skills;in physical the
One day after receiving Pfizer 2023-2024 COVID 19 Vaccine Atrial Fibrillation started
Generalized red, slightly raised rash (small bumps, all bumps identical in appearance) BENADRYL given soon after appearance of rash, mom states immediate improvement following BENADRYL, 90% of rash resolved by 9/11 (otherwise asymptomatic).
As soon as shot was given my left ear clogged up, then my face and sinuses felt pressure. All within a minute. Within a few minutes i felt a migraine coming on. Then my throat, also left side felt pressure and pain. I told the person on the waiting line, he didnt seem concerned. So I didn't bOther to mention it again. I left after 15 minutes. My throat was hard to swallow. It went away in an hour. But i was sick with a headache sinus pressureand dizziness for 11 hours. Besides the normal tiredness. It was the severe sinus pressure in my ear and throat that scared me. Where i had a problem swallowing. And it camen almost immediately.
SEVERE STOMACH ISSUES; DIARRHEA; STOMACH CRAMPS; GAS; This spontaneous report received from a patient concerned a female 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 an unspecified date, the subject experienced severe stomach issues, diarrhea, stomach cramps, and gas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe stomach issues, diarrhea, stomach cramps and gas was not reported. This report was non-serious.
SORENESS IN ARM, SEVERE ACHING IN JOINTS, SEVERE HEAD AND NECK PAIN, SEVERE HEADACHE. SYMPTOMS STILL PERSIST A WEEK LATER.
Twenty minutes post 1st vaccine dose on her left arm, patient began feeling light headed, tingling, and warmth in her bilateral forearms. She then developed tingling at the tip of her tongue and had facial flushing. She developed rashes (hives in bilateral UE). She was brought for evaluation. Benadryl 50mg was given, Vitals taken and water was provided as well. She denies any SOB, CP, swelling or numbness. Physical exam: S1,S2, CTA, hives positive in bilateral UE, facial flushing, and neuro exam WNL. She reports her daughter had the Moderna vaccine a few weeks ago and developed full blown anaphylaxis. Her second daughter also had an allergic reaction to the MMR vaccine. She denies any history of allergic reaction to vaccines herself but does report allergies to several medications.  About 10 mins post Benadryl administration, facial flushing resolved and the rashes in her forearms began to improve as well. Patient was recommended transport to the hospital/ER but she declined. She was instructed to contact her PCP for further evaluation. She was informed her second vaccine will have to be administered at an ER or facility that provides higher level of care. She was escorted to her vehicle to meet her husband.
Very strong pins/needles throughout body; This is a spontaneous report from a contactable consumer reporting for self.  A 65-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jan2021 (at the age of 65-years-old) 17:00 as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, arrythmia, high sugar, and penicillin allergy. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included metoprolol succinate (TOPROL), lisinopril, amlodipine, and esomeprazole sodium  (NEXIUM). On 16Jan2021 at 10:00, the patient experienced very strong pins/needles throughout body. There was no treatment provided for the event. The outcome of the event very strong pins/needles throughout body was not recovered. The patient was not COVID-tested post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient presented with vesicular rash and after being admitted to hospital became hypotensive and with concern for seizure activity, ultimately leading to being transferred to pediatric intensive care unit and intubated. It was later identified that patient's CSF PCR was positive for VZV. Now being managed for VZV encephalitis. Patient is usually followed by our pediatric nephrology service.
Boostrix - Use in patient younger than 10 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 11-APR-2016, the patient received Boostrix. On 11-APR-2016, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix - Use in patient younger than 10 years of age). The outcome of the inappropriate age at vaccine administration 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: 12-SEP-2023 The reporter reported that the 8 years old patient received Tdap vaccine. The reporter asked why the state immunization information system recommends Tdap vaccination to this patient since a booster dose was recommended every 10 years. On 3rd October 2023 after a follow up call with the reporter she confirmed that Boostrix was administered. The reporter did not shared patient information patient initials, gender nor data about the Boostrix dose given in 2016 like lot number and expiry date. The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
NIGHT SWEATING; INTENSE FATIGUE; This spontaneous report received from a patient 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced night sweating, and intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense fatigue and night sweating was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410723.
2/6/19 patient reports cannot move arm behind her back, pain with lifting over her head, pain radiates down her left arm.
Patient states she severe pain, stiffness, and aches in her muscle and joints. Symptoms first began on right arm, shoulder, and neck. Then radiated down to her hips. Time course: approximately 03/2021- 07/2021. Pt was diagnosed in July 2021 by rheumatologist with polymyalgia rheumatica.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Unexplained abdominal pain to the left of belly button after both injections that lasted 24 hours. Lymphedema in left arm post second shot that lasted 24 hours. Elevated heart rate and palpitations starting 10/09/2021 and resolved 10/24/2021. Chest pain that started 10/12/2021 and resolved 10/28/2021. Oral sores on tongue and gums started 10/21/2021 and still unresolved.
A week later there were a lot of symptoms like I had COVID, shortness of breath, and chest pain and it has been so long ago I can't really remember.
2 hours after the injection my arm mottled from the right wrist to mid bicep. Mottling resolved after approximately 30 to 45 minutes. Pain and swelling to the right hand and shoulder started approximately 2 hours after the injection and remains today. Best I can explain is joint pain in the right shoulder and joint pain in the right hand with the middle knuckle being swollen. Pain is a dull ache somewhat relieved with position. Pain remains  with over the counter medications.
On 10/13/2018, 24 hours after my Hepatitis A vaccination in my LEFT ARM, the left shoulder muscle pain was extremely tender. No surprise, I thought that was expected. By bedtime a severe headache (HA) began. Initially the HA came on as a wallop of excruciating sudden onset pain on my LEFT-SIDE. Similar to a migraine HA but with no sensitivity to smell, light or sound. It was deep in the skull from crown of my head behind left temple & ear to right above my cervical spine. I had also kinked my neck several times as I turned my head, so I thought it was a cervical pressure issue. The HA was followed by verious nerve pains, causing tingling to numb extremities. The nerve pain did not last, however a slight tingling numbness near the left temple has remained. The next morning a lump on the muscle over my left shoulder blade was found, and for a short time my right shoulder was also cramping. All the above pain reactions occurred at various times over the course of the first 10 days, beginning within 24 hours of the Hep A vaccination shot. Every day since 10/13/2018 at 4pm... the day following my HepA immunization pain began. First in my left shoulder, nearest the injection site. By 2am, a sudden onset severe migraine headache (9) began. Then again (3-9) occurring intermittently.Sudden onset intermittent waves of LEFT side skull pain(2-8) was persistent through the next four days.   10/17 - Day 5  I took 50mg Benadryl to help me get to sleep, but headache pain(8) came back before daylight. On Thursday 10/18 - Day 6  I began taking Tylenol PM, 1000mg Acetaminophen with 50mg Benadryl, at bedtime. Before daylight I was awaken by LEFT side throbbing headache skull & cervical pain(8).  On Friday 10/19 - Day 7 I began taking 1000mg of Acetaminophen every 8 hours with waves of relief lasting only about 2-4 hours (1-8).  On Monday 10/22 - Day 10 I got an appointment at HEALTH ADULT CARE to see my Physician's Assistant.  Due to my past history of Lyme Disease and several previous migraines treated by Imitrex, plus our recent move; my PA concluded that this headache may be caused by muscle spasms rather than the recent Hep A vaccination. I was instructed to stop using heat and only use ice - no heat. PA prescribed:  1) Methylprednisolone (steroid)  2) Cyclobenzaprine (muscle relaxer)
Severe pain at injection site which has persisted since the vaccination and occurs with reaching back with her left arm
Not feeling so well; All joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling so well) and ARTHRALGIA (All joints hurt) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 29-Dec-2021, the patient experienced MALAISE (Not feeling so well) and ARTHRALGIA (All joints hurt). At the time of the report, MALAISE (Not feeling so well) and ARTHRALGIA (All joints hurt) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Break out rash little clumps Not hives or Shingles, by doc consultation. Nickle sized. Sparse.  Was prescribed Acyclovir and Triamcinolone Acetonide.
Patient received Janssen Covid-19 vaccine 8/15/2021; after 7 minutes in the waiting room, he fainted and was unconscious. 911 was called immediately. He was very pale and sweaty. After several minutes, he gained consciousness and was able to sit in his chair. Ambulance arrived and they assessed patient. Patient stated he was fine, and was able to answer several questions from ambulance team. Patient walked out of the store and went home.  He was advised to seek medical attention if the adverse event occurs again in the future.
The Moderna dose #3 was given late afternoon, by 10:00 pm I began to have chills, fever and felt like I had been run over by a truck. It drug on until the end of March -the fever subsided but my joints were sore and I had congestion in my head. I took 3 rounds of antibiotics, two steroid rounds.
I got super nauseous I couldn't walk away from the bathroom. I was super weak that I couldn't do anything. I had a  bad migraine, aches, and chills.
ADMINISTERED VACCINE WITHOUT DILUTING . PARENT STATED CHILD HAS HAD FEVER FOR 2 DAYS AND IS TIRED