chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of H1N1 LAIV inadvertently administered to 53 year old was received from a health professional concerning a 53-year-old patient of unknown gender. No past medical history or concomitant medication was reported for this patient. The patient received H1N1, Intranasal for an unknown indication between 24-Oct-2009 and 05-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Possibly had COVID; Possibly had COVID; experienced cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4432232-00.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1157153), oral for rheumatoid arthritis. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "experienced cold"; DRUG INEFFECTIVE (medically significant),SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Possibly had COVID". The action taken for upadacitinib was unknown.  Clinical course: On an unknown date, the patient experienced possibly had COVID. In 2022, the patient experienced cold. On an unknown date, possibly had COVID resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. Patient had a cold and possibly COVID. She felt good again. She got COVID booster right before getting the cold. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event (s) of possibly had COVID with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event (s) of cold was not provided.  The reporter considered "possibly had covid" and "experienced cold" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
PHN mistakenly gave this 53 year old female an additional BV booster who is not immunocompromised or over 65
No side effects reported; HCP calling to report VAQTA was administered after it experienced a temperature excursion; This spontaneous report has been received from a medical assistance referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with an impropered storage dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milligram, lot number 1971534 hat was verified to be valid for syringe with an expiration date established as 06-OCT-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (improper storage of product in use). The excursion occurred with a temperature of 50 Grades Farenheit (F) for 1 hour, 40 minutes, and 0 seconds. There was no previous temperature excursion reported. No additional adverse event provided.  No side effects were reported (no adverse event).
travel rash; itched/hurt; bad vertigo; lip swelled; A spontaneous report was received from a (Consumer) concerning a  79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced travel Rash, itched, hurt, lip swelling and bad vertigo.  The patient's medical history included that patient had slight case of COVID-19. No relevant concomitant medications were reported.    On 14 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route and in left upper arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced travel Rash, itched, hurt, lip swelling and bad vertigo. Laboratory details not provided. Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of the event Lip swelling and Vertigo were Recovered. At the time of this report, the outcome of the events travel rash, itched, hurt were unknown.
itching, redness over lateral rt upper arm beginning 12 days p/vax;improved p/another 24hr, although still present to a milder degree for next 2 days
numbness in limbs, blurriness in sight, loss of appetite/weight loss, nausea, diarrhea
Information has been received from a physician concerning his wife who in 1981 was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. Subsequently, she developed a sore arm. Unspecified medical attention was sought. Additional information has been requested.
a breakout of the hives over parts of my body; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a breakout of the hives over parts of body on 2021. On advice from doctor, patient took one Benadryl for 3 nights. Every time he took the pill it would disappear for a few hours. Finally it vanished after 4 days completely.  Patient was asking if it could be  that he had too many antibodies from the previous 2 Pfizer shots. Outcome of the event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Case number PHEH2014US024988, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 81-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 22 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
She was also diagnosed with pneumonia couple weeks ago; breathing problems; She also felt dizzy; chills; Fatigue; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included GABAPENTIN, GLIPIZIDE, LORAZEPAM and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication, METFORMIN.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Mar-2021, the patient experienced DYSPNOEA (breathing problems), DIZZINESS (She also felt dizzy), CHILLS (2 hours later, she experienced chills), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain). On 25-Mar-2021, the patient experienced PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (She was also diagnosed with pneumonia couple weeks ago), DYSPNOEA (breathing problems), DIZZINESS (She also felt dizzy), CHILLS (2 hours later, she experienced chills), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Client given PROQUAD and VARIVAX on same day. No issues noted from vaccine.
Itchy injection site. Rash began and then a round ring swelling and soreness faded after about 4 days. On day,9 noticed return of ring of redness. Maybe a little swollen but not itching
presents with c/o R arm pain redness and allergic reaction to flu or PNA shot. Received on Friday 11/1/19, then subsequntly had + fever nausea, chills, "sick in bed all day". Had ibuprofen, improves pain and fevers, swelling, and has significantly improved from yesterday. Pt looked up reactions on the internet and feels that is what happened. Denies difficulty breathing, n/v/d, chest pain, or sob.
Patient complained of rash on left leg and right hip after 5 days of vaccination.  Patient treated with Loratidine and monitor for several days.
states sore arm for 2 weeks and rash that just went away.  she is concerned because had no reaction with first shot
Rec'd vaccine + 5 days later I went numb on the left side of my body. Less then 1 month later I was diagnosed w/ Multiple Sclerosis. No previous symptoms existed. DC Summary for DOS 08/31-09/06/05. DC DX: Probably Multiple sclerosis-1st event Hospital course: No previous medical problems, presented with worsening numbness on left side of body for 1 week prior to admission. Initial physical exam was remarkable for hemi-anesthesia of the left side arm body and leg. Basic lab tests were unremarkable. Neurology consult and MRI of brain showed a small lesion left front lobe and MRI cervical cord revealed a 7mm focus of increased signal intensity consistent with an MS plaque on the posterior spinal cord at level of C5. It was felt this lesion could explain her symptoms. LP spinal fluid showed slight decrease in protein but unremarkable otherwise. Oligoclonal bands and IgG level pending. Developed worsening of symptoms in hospital and hence high dose IV Solu-Medrol 500mg BID given for 3 days. Subsequently felt better was discharged.  Also submitted office notes from Health Center for DOS 9/19/05-4/7/06- follow up visits for multiple sclerosis and medical management. 60 day Follow-up Information 29-SEP-2006: Still numb on left side of my body. My neurologist pointed out the link between this vaccine and the onset of M.S.
Reports swelling, redness, soreness, warm to the touch at injection site. No fever, growth in size, streaking reported. Denied s/s of serious allergic reaction.
pt had previous hospitalization for increasing agitation, confusion, combativeness; tested positive for COVID and was transferred to Medical Center for COVID care; started on dexamethasone; remained on Eliquis; was dc'd where per death certificate pt died
Hives, lip swelling, difficulty breathing; treated in ER with steroids and Benadryl.
usual chills; Swollen lymph nodes same side as vaccine in neck and throat; feeling of lump in throat; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; dull pain from lower throat all along up to inner ear/dull ache up to inner ear; strep throat.; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ED753Y) via an unspecified route of administration, administered in the right arm on 24Mar2021(age at the time of vaccination was 59-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Osteoarthritis, gastritis, coiled and stented aneurysm and Tetracycline allergy. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. On 25Mar2021 besides the usual chills 24 hours later. Swollen lymph nodes same side as vaccine in neck and throat. Constant feeling of lump in throat and dull pain from lower throat all along up to inner ear. Lymph node under neck reduced but still lump in throat feeling and dull ache up to inner ear at end of week 2. Getting next shot in 5 days. Doctor prescribed antibiotics to rule out strep throat. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event resulted in treatment with antibiotics. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected
Headache, fatigue, nausea and a red flat rash all over my entire body from my neck down which appeared  2 days after both vaccines, lasting 2-4 weeks . The first vaccine the rash lasted about 1-1 and 1/2 weeks, the second vaccine the rash lasted 3-4 weeks. I was told by the RN who administered the second vaccine that it was either my immune system on hyperdrive, I may have had COVID and wasn?t aware. (My antibodies were NEG.) she was not concerned and let me leave immediately after the second vaccine. Not sure why.
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
Lethargic/unresponsive 02/25/05, staring, seizure like symptoms 02/09/05, Diagnosis: Acid Reflux and Torticollis. Information from 60 day report states she still has spasms and Torticollis felt still in pt. Is there a safe way to test to see if she will have future reactions before we put more in her?
Diarrhea, fever of 101.1, muscle aches, fatigue, weakness, chills Diarrhea at 3 am on 02/13/2021.  Fever at 5 pm 02/13/2021.  Weakness, fatigue, chills persisted from 02/12 through approximately 3 am 02/14/2021. Significant (migrainous) headache starting the day after injection and daily through 02/13/2021, not responding to Tylenol A significant desire for salt starting approximately 02/11/2021, which is very unusual for me.  I tend to crave sweets, never salty food. I ate broth and bouillion for dinner, drinking bouillion, and eating green beans with a bowl of broth both evenings for dinner, and through Saturday, as well as craving olives, 02/13/2021.  Not interested in having sweets during that time.
Adrenal crisis required EMS with hospitalization  for 3 days.  Treatment with IV  hydrocortisone  and IV fluids
Approximately 5 hours after injection,  I started to lose my appetite and have body aches. I then progressed to chills and severe aches. I switched to over heated quickly and vomited. At this point I had a severe head ache. For about the next 38 hours, I had no appetite, severe body aches and head ache and nausea. After that period (as of now), not really having any symptoms besides a slightly sore throat.
Chest pain (middle of chest); wheezing; back pain; disorientation; light headed
"One week after I received the smallpox shot, I broke out with little itchy bumps on my arm.  Two weeks later, it spread to my chest and the bumps dried up in a few days.  The itch is much better but can get very irritated after I take a shower."
heartburn, nausea, vomit precipitated 18 hours of high fever (103) and chills. Fatigue for 2 days following fever
Mom reports that Friday (8/7/09)evening patient began itching her feet.  She didn't make much of it and went to a friends to swim.  She spent the following day walking around town at a local craft fair (in the heat).  On Sunday (8/9/09) morning, the rash was not only on feet but up legs and on torso and down arms.  You could feel raised bumps all over her body.  She went to the ER at 9am on 8/9/09.  The ER doctor told her it was a reaction to the Hep A vaccine and not to receive the second dose in 6 months.  They gave her a shot of steroid in the hip, a RX for Medrol and told her to take Benadryl by mouth every four hours.  Mom reports this morning (Monday 8/10/09) that the rash is much better, almost gone.
Information has been received from a registered nurse concerning a 14 year old female patient who on 06-Nov-2008 was vaccinated with a first IM dose of GARDASIL (Lot # 661044/0548X) into her right arm. On 30-Dec-2008 the patient was vaccinated with as second IM dose of GARDASIL (Lot # 661703/0651X) into her left arm and on 16-APR-2009 was vaccinated with a third dose of GARDASIL (Lot # 661952/1129X) into her right arm. Since the patient received the third dose of GARDASIL she has had really bad abdominal pain on and off. The pain has worsened and been more persistent now since she finished the vaccination series. She also has had emesis and diarrhea. The patient was seen by a gastroenterologist (GI). An endoscopy with a biopsy and "lots of lab work" had been performed with no results provided. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccines cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Pt had red swollen local rxn at site of this vaccine later the same day after both the 4 & 6 mo vaccines.
Patient received her first COVID vaccination on 1/8/21. On 1/16/21, she had a significant local reaction with redness, swelling, warmth, & fine, itchy rash.  In two days time, it had extended 3/4 of the way down her arm. She went to her local Clinic & received antibiotics (cephalexin x 10 days) & a Medrol dose pack.  She is not convinced the medications helped.  After about a week, the redness and swelling suddenly went away.  Her arm still itches.  She received her second dose of Moderna vaccine in the opposite arm and also developed the same reaction about 2 days later but not as red or as hot.
Nausea, fever, high blood pleasure, heart burn, head ache, sore arm, left leg cramps, fatigue, chills, sore throat, runny nose.
p/vax pt lost consciousness became stiff w/jerky movements in extremities for approx 15seconds;awoke spontaneously AAOx3;given food & water & allowed to rest 30min;
Approximately a few weeks after my booster shot I experienced the following symptoms: High fever, fatigue, and red spots all over my body which spread continuously and it lasted for about 15 days. I went to the urgent care for consultation and I was diagnosed with Chickenpox and was advised to quarantine for 10 days and I extended it to 15 until I can further recover.
I am writing this report for my mother who is now dead due to these shots.  Prior to these shots she was in good health.  Right after her first shot she started showing signs of dementia.  Not long after she had some tests done which showed she had multiple small strokes.  She was having trouble walking and needed a wheelchair. She had more tests done and it was found she was full of blood clots.  We had a procedure done to stop one of the big clots in her leg but she died two days later.  I looked up her batch numbers on a website and found that all of her lot numbers were a part of bad batches with multiple deaths and injuries.  I believe Pfizer murdered my mother.
I had sudden onset itching and tenderness, swelling, redness about 8 days after receiving the Pfizer vaccine, about an inch below the injection site in a wide band across my outer upper arm. It was bad enough that cellulitis briefly crossed my mind bc the redness and tenderness continued spreading for about 24 hrs. It started resolving on post vaccine day 11, but I?m still having mild itching and redness on post vaccine day 12.
S.O.B. & pain under breast after flu shot hurt to take deep breaths. Tachycardia - dizzy & lightheaded within 15 mins after flu shot. ER via EMS.
11 hours after vaccination I began to feel like someone was carving on my bones. I felt flu like symptoms and felt achy. Took 400mg NSAIDS every 8 hours for two days.
Patient received Pfizer Pedi dosage of (0.2 ml) instead of recommended standard dose (0.3 ml).
pt was given 1ml instead of 0.5ml of vax;pt devel 5-6cm induration & soreness @ the inj site;the local rxn lasted about 2 days & pt now fine;
A non-serious spontaneous report of two children were inadvertently given the field corrected expired H1N1 LAIV was received from a nurse/health professional concerning a 33-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 19-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Itching, redness, and swelling at injection site that began 1 week after vaccination. Patient took Benadryl.
Slight itching the day of the shot. As the days went on, the injection site got redder, itched more and felt hard. It reached the size of 3 inches across and about 2.5 inches tall. In addition, I'm feeling slight itching at different times at random places on my body. I refer to them as twitch itching. They itch briefly, and then another one starts somewhere on my body. The redness is still visible on my arm, but not to the degree it was. I am unclear if I should get another shot.
Patient began complaining that her legs were hurting where the shots were given at about 2:00 pm on the date that she received the shots. That night she began running a fever of 102 degrees. At approximately 11:00pm that night she began vomiting. She continued to vomit several more times throughout the night. On the morning of July 8th, she no longer had a fever. However, that night she had a fever again of 102 degrees and complained of joint pain in her knees.
Vomiting, diarrhea onset about 24 hrs after vaccines administered.  Follow up - ENGERIX-B lot number AHBVB833DA - Record updated.