chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Numbness in hands, numbness has continued if hands are motionless for long periods of time or under constant pressure like riding a bike.
On 10/16/20, 30 minutes after shot was given pt experience tongue swelling, pt went to ER for treatment
Developed hives. Treated with antihistamines for 48 hours till rash went away.
Swelling at the base of where my neck and right shoulder meet, arm pit swelling, headache, fatigue and sore throat and left ear ache
Day after shot I felt terrible bodyaches. My arm became red. Three weeks post shot I have a peach size bright red mark At the injection site. I?ve had a low-grade fever for a few weeks now. I broke out in cold sores. I?m having difficulty walking. My joints all swelled up. I have a headache that will not go away.
I have had flu-like symptoms (exhaustion, shortness of breath, body aches) every night since receiving the vaccine (1/24), which was a week and a half ago. Tonight, I now have extremely flushed cheeks, and they are warm to the touch. It is like a sunburn, but I have not been outside in the sun the past few days.
Mom stated that patient complained of thigh pain later that day after vaccine was given but she didn't look at the area until the next morning, 07/18/13 and noted that the area was swollen, red and warm to the touch. Patient did not have a fever. Mom brought child in later that day, 07/18/13 for evaluation. On exam patient noted to have cellulitis at the vaccine site. Patient was started on appropriate antibiotic. Mom was told to call for worsening symptoms.
Patient received the shot without incident.  A few minutes later started shaking and complaining she was dizzy and the room was spinning. She said she had a very bad headache.  She was given water and acetaminophen.  She initially did not want 9-1-1 called but eventually agreed.  EMS came and put her on oxygen and took her to the hospital.
2 days following the J&J covid vaccine administration, I began to develop mild achy headaches, intermittently, at the lower parietal area of my head. The headaches remain, even today. The intensity and consistency remain unchanged. They occur on a daily basis for short periods of time. I do not take any medications to alleviate the symptoms. I wait for the headaches to dissipate.  On 12/16/21, I reported these symptoms to my PCP, and was seen on 12/20/21 by the NP. She ordered a series of labs to rule out any clotting issues, as well as an MRI. All were negative. Today, I still suffer from mild, achy intermittent headaches in the exact location (parietal area). I continue to abstain from any medications to alleviate the symptoms.
The day following my booster shot, I began having tinnitus in my right ear. It has continued, uninterrupted, since November 16th.
Pt recvd mumps virus vac live ID instead of mumps skin test on 08JAN91; @ time of report there were no noted problems;
flu like symptoms; extreme aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (extreme aches) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included BOSENTAN (TRACLEER [BOSENTAN]), SILDENAFIL CITRATE (REVATIO) and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 22-Apr-2009, the patient started TREPROSTINIL SODIUM (Intravenous) .16 microgram/kilogram continously. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (extreme aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (extreme aches) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
about 4 hours after injection, began fatigue, fatigue worsened, began feeling chills. No elevated temp at that time; elevated temp (99.5F) began about 6-7 hours after injection; temp is the same 8 hours out from injection.
Anterior itching, redness, & bumps on both wrists 36-48 hours after receiving vaccine.
I developed lymphadenitis right over my left collar bone on day after the vaccine. This never happened before with any vaccine.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Had bivalent before this vaccine
Headache muscle ache, fatigue, chills, RIGHT underarm tender, side of vaccine, BILAT breast tenderness NarrativeL as of jan 13, employee still has RIGHT side  underarm tenderness
1325 Client received vaccinations 1330 Client lost consciousness x2, experienced dizziness, nausea, gurgling, possible apnea, and arm flexion Placed client on side 1338 Called EMS 1348 EMS arrived and evaluated client, clients symptoms resolved and client declined transport
LUA + ERYTHEMA/ WARMTH, NON TENDER, SKIN INTEGUMENT INTACT. RECEIVED SHOTS ON MONDAY AND ARM SWELLED UP LATER THAT DAY.
pentacel was given to a consumer 4 days after the expiration date with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 15 months old female patient received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was given to a consumer 4 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (lot UJ808AB, Expiry date : 23-Oct-2023, strength was unknown) via intramuscular route in the thigh not otherwise specified and pentacel was given to a consumer 4 days after the expiration date with no reported adverse event (expired product administered) (latency : same day) .  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was given to a consumer 4 days after the expiration date with no reported adverse event.  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.
Headache, Myalgia, Fever, Diarrhea, lg lump in l axilla & breast area, pain in L shoulder, Jaw, neck & temple. Still feels "foggy" today Narrative: Employee reports she had been taking Ibuprofen for the discomfort but, stopped 2 days ago. Most symptoms are now gone and now just has headache
receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  Concomitant medications were provided.  Reporter stated that 4 doses of 1 expired vial of the Moderna COVID19 vaccine were administered   No Treatment medications were provided.
I started having a sore arm near the injection site around 3 p.m. on the date of the vaccine, which increased in intensity over the next 24 hours. The next morning (4/15) I started having body aches and about 24 hours after the vaccine was administered, I began experiencing chills. I also had a temperature of 100.2F at around 4 p.m. on 4/15. By Friday, April 16th, the side effects had disapeared.
Patient reports medicine taste in her mouth without associated difficulty swallowing, itchiness,sob. Patient given ER precautions and told to follow-up with PCP if persistent symptoms.
Constant dull ringing in right ear 2 days after injection. Vomiting and nausea day after injection. Chills and aches for two days after injection.
Patient complaint of chills, fever and headache around 4pm (12-29-2020). Pt was vaccinated 12-28-2020. Patient reports taking Tylenol @ 1630, to where fever reduced and neo acumed around 9pm that same night, while the body chills, aches and headache persisted. VS taken: BP  134/84, HR of 74. Patient states as of 12-30-2020, generalized weakness and headache remain. 98% on RA, despite reports of SOB while wearing mask. Patient reported she had COVID for approx 2 months in March, 28, 2020. Patient was never tested after that, she may have been negative. Sept of 2020, Patient will have a COVID test done and results will be obtained and documented. MD to be notified.
patient stated his arm immediately hurt after receiving vaccine and has hurt since, moderate pain, cant lift arm very high
Began 10/10/15 is red and swollen around 8pm by 11pm more soreness and greater swelling. 10/11/15 greater inflammation sore and warm to touch and pt took ADVIL to help. Went to emergency care 10/12/15 - diagnosed with cellulitis and severe allergic reaction.
Nausea, dizziness, headache, body aches - began 2 hours after vaccine, ended 36 hours later.  Blistery rash on hands, wrists, feet, arms, thighs, abdomen, face, and neck began 2 days after vaccine and continued for 10 days. Rash was very itchy and Benadryl did not help.
got shingles right after we got vaccinated/suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination and age group were not reported. The case was reported by the patient's wife. The reporter said that her husband got shingles right after they got vaccinated. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Given zyrtec PO, symptoms improved. Doctor and EMT on site and released to go home.
About 15 min later, I noticed my right thumb was half numb.  This persisted for about 2 weeks.  I still feel some numbness but only at the very tip of my thumb.  It has now been six weeks.
caller reported receiving Gardasil 9 vaccine after the first pregnancy test was administered and reported the doctor said their was an error with the first pregnancy test not being very clear, the second pregnany test came back as positive; This spontaneous prospective pregnancy report was received from a patient of unknown age who was reporting on herself. The patient's pertinent medical history, drug, reactions, allergies and concomitant medications were not reported.   On an unspecified date, the patient became pregnant. The dates of last menstrual period (LMP), approximate date of conception, and estimated date of delivery (EDD) were not provided and were unable to calculate. The pregnancy outcome was pending.  On 05-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported). During visit at the doctor's office (before vaccination), she had pregnancy test which came back negative. A doctor stated that there was an error with the first pregnancy test which was not being very clear. On the same day, she had another pregnancy test given a second time and reported the second pregnancy test came back as positive.
Runny nose, congestion, low fever, muscle pain. Fever gone in 24 hours. Nasal congestion continues after 1 week.
I had bad headaches for about a day, a rash on my shoulders for a few days. Minor nose bleed after dose 2.
Covid-19 vaccine associated myocarditis.; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis.".  Clinical course: Subsequently leading to myocardial injury through molecular mimicry. Whether this iatrogenic catalyst of myocardial injury results in a similar duration and cumulative burden of inflammatory injury compared with community-acquired viral myocarditis was previously unknown. recently, a single case series of 5 subjects was published casting preliminary insights from convalescent CMR-based findings following mRNA covid-19 vaccination-induced injury.; Sender's Comments: Based on limited information in the case, a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded
I had been feeling run down before the vaccine. I had even made an appointment to see my dr the following week, however my symptoms (shortness of breath, angina) significantly worsened after the vaccination (Moderna), and I ended up being admitted to the hospital and diagnosed with 2nd degree Type II heart block. There were unable to determine that cause of my heartblock (heart cath showed no structural issues or blockages), lyme panel was negative, drug toxicity screen was negative. I had a pacemaker inserted on March 17. At the time of discharge, I was pacing 22% in the atria and 44% in the ventricle. I received my second dose of Moderna on April 6 and subsequent to that developed pacemaker mediated tachycardia (3400 episodes in one 24 hour period). They determined that my heart block was nearly complete (pacing 83% in the atria and 100% in the ventricle). The dr ordered a cardiac MR, but because of scheduling it wasn't done until the end of June. The MR showed no signs of an infiltrative cardiomyopathy or other structural issues. My ejection fraction was 67%. Based on these results, the drs assume that the genesis for the heart block is infectious. As stated earlier the test for Lyme was negative. While I'm certain that my heart was already struggling prior to the Moderna shots, I feel strongly that the vaccinations pushed it over the edge.
Body and joint aches all over within 1 hour of injection.  Also with nausea. Increased temperature 100 degrees F.  No respiratory symptoms.
Fatigue; Headache; aches all over; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "aches all over"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain and discomfort with sudden onset shingles outbreak(for the first time ever), patient suffering, receiving treatment to date
Patient received vaccine and experienced syncope shortly after causing her to fall. 911 was called and patient was taken to the emergency room.
Felt throat swelling, went into tachycardia, hives all over and passed out. Was treated in the urgent care and released once recovered with home medications.
Pt, who was deaf, arrived for 2nd Moderna vaccine.  Vaccine card showed she had received 1st Moderna vaccine on June 8.  Nurse gave 2nd Moderna vaccine.   Later, through software, found out she had also received both Pfizer vaccines in April, 2021.  Pt, while in waiting area,  nurse wrote a note asking about getting the Pfizer vaccine in April.  She acknowledged that she had received both Pfizer vaccine in April.
Narrative:  COVID infection after completion of COVID vaccine series: 01/22/2021 COVID vaccine dose #1 02/12/2021 COVID vaccine dose #2 03/23/2021 COVID negative per facility nasopharyngeal swab 07/08/2021 Pt reported attending a party with contacts who later tested positive. Pt also reported starting to experience flu-like symptoms, mainly fatigue and sore throat. 07/12/2021 Pt presented to ED c/o continued flu-like symptoms and wanting to get tested for COVID since spouse not vaccinated. 07/12/2021 COVID positive per facility nasopharyngeal swab
urticaria & fever to 102.8;seen in acute care facility on 20FEB97;dx of allergic rxn secondary to Hep B vax;seen by MD;
Chest pains beginning two days after the shot, then shingles following one month after, lots of headaches and neck pain from the initial vaccination date.
Pt was given 2nd booster dose too early. 1st booster was given 3/4/22. 2nd booster 5/25/22. Pt experienced no adverse effects.
Left thigh swelling and warm to the touch at the injection site. Afebrile,playing without difficulty, treating with tylenol and benadryl. Seen i office on 05/30/2019 size of redness was noted as 5x4 inches area traced for follow up. Talked with mother on 05/31 and noted to be slightly less swollen. advised follow up if area changes or worsens
This information is regarding the description of adverse events and treatment. Most of the information is basically being obtained from the pediatric intensivist information when the child was in the pediatric intensive care unit. At the time of vaccination, which was on May 28, 2015 Mom stated that her daughter had some cold symptoms that had actually gotten better. She was otherwise doing well. She did well the day of the vaccines and her visit for the well check with no issues nor significant exam findings. She apparently on May 29, 2015, the following day, decreased her oral intake and slept a lot during the day. At 1830 in the evening she had normal feed and went to sleep after 2 loose stools. At 2100 she refused to feed and was not crying and was limp. Once Mom put her in the car seat she was alert and looking around, crying, and kicking and at 2200 she went to sleep. On May 30, 2015 the mother woke her up at 8 o'clock in the morning and she began "gasping" and was limp after 1 ounce of formula feeding. The mother assessed or believed the child to be in cardiopulmonary arrest and started CPR. The EMS was called and intubated her and gave her epinephrine and continued CPR. She was taken to the local emergency room and then taken to the referral center with the pediatric intensive care unit.
I was having trouble breathing. I haven't had an asthma attack like this for 40 years. I called my Family doctor and he gave me two rounds of Prednisone and two rounds of antibiotic at the same time as each round of Prednisone. Each round was 5 day each - Erythromycin pack - did that twice. I was about an 1/8 better after both of these. He told me to go to ER but instead I saw a lung doctor in office. When it didn't' clear up and I had been on two courses of Prednisone and I changed my inhaler. Lung doctor put me back on the generic purple inhaler. It didn't seem to work on it's own so he put me on a drug called Montelukast Sodium tablets to take one every night- generic for Singulair. He was convinced it was a medication allergy. He made me use Flonase and Claritin and the Montelukast and the purple inhaler and within 5 days I was breathing perfect again. I'm still on the Montelukast; Purple inhaler (with hopes of dropping it down to 10  mg in a month or two) and I'm still on the Flonase and Claritin too.
felt less tired but still not back to normal; flu-like symptoms; body aches; extremely tired; headaches; nausea; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A 53-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-02 ), via an unspecified route of administration, administered in Arm Left on 19May2021 at 14:30 (Age at vaccination: 53 years ) as dose 1, single for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. Patient did not received other vaccines in 4 weeks. Patient did not received other medications in two weeks. Patient did not have COVID prior vaccination. Patient was tested COVID post vaccination. Patient did not had allergies. The patient experienced extremely tired, headaches, nausea on 21May2021 at 19:00 , flu-like symptoms, body aches on 31May2021, felt less tired but still not back to normal on 06Jun2021. There was no treatment received for the events. The day of her first vaccine, and the day after, she felt fine. For the next three days (21May-23May), she felt extremely tired, had headaches and nausea. 24May-30May, she felt fine. 31May-05Jun very tired with flu-like symptoms of body aches. 06Jun-07Jun felt less tired but still not back to normal. She was supposed to get second vaccine on 09Jun. The patient underwent lab tests and procedures which includ-ed sars-cov-2 test Nasal swab test was negative on 30May2021. The outcome of the event extremely tired, headaches, nausea, flu-like symptoms, body aches, felt less tired but still not back to normal was recovering.   No follow-up attempts are possible. No further information is expected.