chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 4th dose - ALT 48/Elevated liver enzymes after each Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 as dose 4 (booster), single (Lot number: GH9703), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Exparel, reaction(s): "known_allergies: possibly Exparel", notes: known_allergies: possibly Exparel. Vaccination history included: Bnt162b2 (dose 1; lot EL9262, location : right arm), for COVID-19 immunization, reaction(s): "Elevated liver enzymes"; Bnt162b2 (dose 2; lot EL9269; location: right arm), for COVID-19 immunization, reaction(s): "ALT 1,010", "Bilirubin 5.1H", "Elevated liver enzymes"; Bnt162b2 (dose 2; lot EL9269; location right arm), for COVID-19 immunization, reaction(s): "AST 312"; Bnt162b2 (dose 3; lot FD7218; location: right arm), for COVID-19 immunization, reaction(s): "ALT 42", "Elevated liver enzymes". The following information was reported: ALANINE AMINOTRANSFERASE INCREASED (hospitalization) with onset 2023, outcome "recovered with sequelae", described as "After 4th dose - ALT 48/Elevated liver enzymes after each Covid Vaccine". The patient was hospitalized for alanine aminotransferase increased (hospitalization duration: 4 day(s)). The event "after 4th dose - alt 48/elevated liver enzymes after each covid vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (2023) 48, notes: levels return to normal levels after 2-3 months; Hepatic enzyme: (2023) Elevated, notes: after each Covid Vaccine. Therapeutic measures were taken as a result of alanine aminotransferase increased.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300090561 same patient/event, different dose;US-PFIZER INC-2021196091 same patient, different dose, different event;US-PFIZER INC-2021154607 same patient, different dose, different event;
Patient received full dose (100mcg) of Moderna for booster shot on 2/15/22. As of 2/15/22 10AM, no adverse events observed/reported.
Patient had a syncopal episode post vaccine, as well as dizziness, diaphoresis.
I woke up with a scratchy throat. Later that night I started feeling sick I knew I had a fever coming on so I took my temperature and it was 100.2 & later it was 101.4. So I took COVID-19 test & it was negative. I called my Dr. and was told to take EMERGEN C & rest. I went to urgent care and was tested again for COVID-19 and it was positive.
Pt reported arm soreness immediately that has continued for 4 months past the vaccination.  It only hurts if she tries to raise her arm above her shoulder or reach behind her.  She is fine when her arm is down, but in pain when she raises it.
Within 10 mins of vaccination generalized muscle and joint pain/headache. No GI symptoms. No pain. Vaccination site 3d later mild sore and slight warm to touch no erythema no joint swelling or limited ROM. TX - Ibuprofen OTC prn.
REDNESS AT AND AROUND INJECTION SITE. PT DID NOT TAKE ANYTHING FOR TREATMENT.
Tired at midnight, passed out at 3am on trip to bathroom, headache at 6am, still a little feverish at 10am.
Short term side effects. Joint pain. Exhaustion, malaise. Longer term side effects are depressed mood, fatigue.
Whole body ache, severe chills, body warm to the touch, nausea/vomiting, headache (lasted from 9 at night to around 3 in the morning) Body ache (for about 3 days) Diarrhea and nausea (lasted about 3 days) Sore arm at injection site (Going on day 4)
Psoriasis flare-up; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and IMMUNISATION REACTION (Vaccination related malaise) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Concurrent medical conditions included Psoriasis (Moderate To Severe Chronic Plaque Psoriasis).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second 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) UNK, Citrate Free. In 2021, the patient experienced PSORIASIS (Psoriasis flare-up) and IMMUNISATION REACTION (Vaccination related malaise). In 2021, IMMUNISATION REACTION (Vaccination related malaise) had resolved. At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient experienced plaque psoriasis flare up began with both elbows and legs and a little on back and sick for a day after Covid vaccinations.  The reporter's causality for the event of Psoriasis flare-up and Vaccination related malaise was not provided for Humira.  No treatment medication were provided.  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.
Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comments: This case was reported by a patient's wife interactive digital media. The patient reported avoided shingles shot. Two of people got shingles within days of their shots this year. Additional Supportive Information:  This case is linked with US2023AMR025312 same reporter different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR025312:Same reporter
Pain, swelling, redness at injection site. Headache, nausea, vomiting, fatigue, fever 24 hrs.
none-administration error without adverse event r/t incorrect timing (3 weeks apart)-6/28 number one and 7/19 number two
she was underage; arm was sore; A spontaneous report was received from a 17-year-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore/vaccination site pain, and she was underage/inappropriate age at vaccine administration.  The patient's medical history was not provided. No concomitant product use was reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 16-Jan-2021, the patient reported that her arm was sore for 2 days.  On an unspecified date, the patient reported that she did not receive her second vaccination as she was underage.  Action taken with mRNA-1273 was unknown.  The outcome of the event, arm was sore/vaccination site pain was resolved on 18 Jan 2021.  The outcome of the event, she was underage/inappropriate age at vaccine administration was resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration and vaccination site pain for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start of vaccination site pain, a causal relationship cannot be excluded.  The causality for inappropriate age at vaccine administration is assessed to be not applicable.
Approximately two days following my second Moderna covid vaccine I began having Premature Ventricular Contractions. I would estimate approximately 30-45 per hour. This is below the number required before it is "concerning" however, I had  not been having PVCs at all prior to this. In the subsequent weeks, the PVCs have diminished but have not fully subsided. I have had an EKG,ECG, and stress test and all results were normal
Headache occipital and frontal aspect. Itching at injection site on (R) arm. Right upper arm 2.5 x 1 in erythematous patch. Slightly raised mild erythema extended 3 inches downward not passing elbow. Rash warm to touch. (Tx: Levofloxacin 500mg 1 TID x 10 days).
pt recv vax 28JUN96 & 2JUL96 pt devel a rash on face;
Got shingles after each dose /Suspected vaccination failure; Got shingles after each dose (1st dose); Got shingles after each dose (2nd dose); This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after each dose /Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles after each dose (1st dose)) and shingles (Verbatim: Got shingles after each dose (2nd dose)). Rechallenge with Shingles vaccine was positive. The outcome of the vaccination failure was unknown and the outcome of the shingles and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both shingles shots and got shingles after each shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
hives Tx: EDvisit, given benadryl Received vaccine 12/22, noticed hives arm/Flank 12/25 Allergy evaluation - recommend 2Nd dose with increased 30 min of monitoring time Dose #2 given 1/11/2021 - NO adverse reaction. First dose ReactioN , WAs not considered allergic
Information has been received from a physician and a practice manage referring to a patient of unknown age and gender. On 27-JUL-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot # L014878, expiration date 17-JAN-2018, dose and route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 128 hours with highest recorded temperature of 49 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
"Overwhelming sensation of dizziness, feeling off balance, and feeling feverish" since date of vaccine
redness,warmth at injection site,staff was education to apply ice to the area medication for warmth/pain, Seek medical attention if necessary
pt recvd vax 8JUN95 & 12JUN95 pt devel fever, raised welts & fever blisters;No further details were provided;
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patient's medical history was not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, route, strength and lot# unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not provided. This is one of several reports received from the same source. Additional information has been requested.
I experienced a sore arm and felt very tired for two days following the vaccination.  A few days after I started to feel nerve and muscle pain on my right shoulder blade.  The pain did not go away and I started to feel nerve and itching on my chest on the right side and light red rash appeared on my back and chest.  On March  27th the rash blistered and had spread and I began having intense pain.  I was diagnosed with Shingles on March 30 and have been taking Valacylovir for 6 days.  It has now crusted over and the pain is much less severe.  Three days ago I got a sore throat and bladder pain.  Those appear to be better so I have chosen not to seek treatment .
01/11/23 presents to ED for "chest pain". PMHx of "hypertension"
The HIB part of the vaccine was not administered to the patient, just the DTaP and IPV. It was not re Parent was notified and there was no adverse reaction at the time of the phone call.
pt recv vax;did not seem to have T inc; took apap before sleep; pt seemed unresponsive; called ER and taken to hosp; MD arouse pt;
regaining some of my taste & smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, (booster) single (Batch/Lot number: unknown) and as dose 4, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sinus infection" (unspecified if ongoing), notes: 8 years ago I lost my sense of taste & smell due to a sinus infection & bronchitis; "bronchitis" (unspecified if ongoing), notes: 8 years ago I lost my sense of taste & smell due to a sinus infection & bronchitis. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "regaining some of my taste & smell".  Additional information: Patient received all Pfizer shots & boosters. With that said, 8 years ago the patient lost the sense of taste & smell due to a sinus infection & bronchitis & treated with Levaquin. In the past few weeks, patient started regaining some of taste & smell. Very little but for patient it was outstanding. CEP Number: CEP 005570. Case Category: Patient Assistance Programs. Event Awareness Date: 20Jun2022. Date Sent to DSU: 20Jun2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has a syncopal event while waiting in line after being vaccinated. Fall was atraumatic on visual exam, pt initially lethargic, and slowly became more alert. Brought into medical tent by RN via wheelchair. Pt states she has not eaten anything since this morning. Juice, water and pretzels offered to patient. Pt states feeling better after having a snack and laying down. She drove herself to this appointment and has no ride to pick her up. Patient agrees to be moved to general waiting area to be monitored for an additional 30 minutes prior to release. Vital signs during event:   1200: BP 108/78 P 88 RR 20 SPO2 98% 1205: BP 111/82 P 96 RR 18 SPO2 98% 1215: BP 106/78 P 95 RR 18 SPO2 97%
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K021548, expiration date 06-MAY-2016, dose, frequency and route were unknown). No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Developed a stomach ache the next day and a full-blown appendicitis by the end of the week
Headache, NauseaVomiting, malaise,fatigue,allodynia sore arm Narrative:
Lumbar pain left side starting early morning of 02/17 needed hotpad to sit or sleep mostly to distract the nerves. Worse pain on morning of 02/18. Took a leftover vicodin and advil. Pain down front of thigh by 10:30 am getting more severe over next few hours. By noon had trouble walking and was nauseous from the pain. In addition to left side back pain had continued severe burning pain in front of left thigh and groin & could not initiate urination. Reduced movement and kept taking vicodin and advil and applying heat until doctor's appointment on Wednesday 02/24.  Doctor prescribed Prednizone pack and physical therapy. Immediate improvement. Fixed in 4 weeks.
Information has been received from a medical assistant referring to an 11 months old (not yet 12 months) patient of unknown gender. On 29-JUN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expired date, dose and route unknown), a dose of M-M-R II (lot number, expired date, dose and route unknown), and a dose of VAQTA (lot number, expired date, dose and route unknown). The vaccines were given 4 days too early which was considered as inappropriate schedule of vaccine administration. No adverse effects were reported. Additional information has been requested.
3/6/2023  I thought I had a head cold. The mucus from my nose was clear. My ears were clogged, but they are always clogged.  On 3/18/2023 My nose was full and I was sick. The mucus from my nose was yellow and thick instead of clear. I had no fever or cough.  I started taking Coricidin HBP, Coricidin (different type), Robitussin and none of it worked.  My nose got worse. I went to Urgent Care on 3/18/23. They took my blood pressure, looked in my ears and nose, a normal examination and everything was fine.  I was diagnosed with a sinus infection. I was prescribed Cefdinir which I began taking the next day.  It is clearing up, but not all the way clear.
Pt reported to us on 05/06/14 that she developed rash under her arm and on her neck. She said it is very itchy.
Arm, neck pain, and back pain on both sides of body shot at 11 am sand pain started at about noon per patient.
Began with papular rash on torso, arms, face & neck. Put on Acyclovir and AMOXIL (pt had (+) strep also).
client received 2nd dose Pfizer Covid vaccine today. Client asked EMT if he could check her blood pressure as she was feeling dizzy with shortness of breath. PHN  joined shortly after. Vitals at 1531: blood pressure 132/90, pulse 62, oxygen 98%. Client stated feeling dizzy, and feeling like she "could  not catch a full breath". PHN assessed for swelling, client speaking in full sentences, alert and oriented x4. Client declined feeling itchiness of throat, tingling sensation or throat closing. Per client seeing blurry, only ate breakfast today. EMT brought client juice, instructed to take small sips. Client denied any trouble swallowing juice. At 1535 client stated breathing improving. Vitals at 1537: blood pressure 116/82, pulse 60, oxygen 100%. Shortness of breath and blurry vision resolved per client. Per client dizziness improving. Vitals at 1544: blood pressure 120/90, pulse 58, oxygen 98%. Client stated all symptoms had resolved. PHN discussed with client if someone could pick her up, client stated "I feel fine to drive". Client advised to follow up with provider and ER precautions given. Last vitals at 1550: blood pressure 120/88, pulse 70, oxygen 99%. Client reports all symptoms resolved and wants to leave. Client left facility with steady gait at 1553.
Malaise, fever, chills followed by slow onset of asthma (with wheezes), photophobia, conjunctivitis (with thick yellow discharge).  treated with Albuterol inhaler & Advair (spaced 3 hours apart), 2 tabs of benadryl and another 2 puffs of albuterol before bed (12am).  Symptoms resolved completely by the 8am.  Considered visiting the emergency room, but symptoms improved by the evening.  I am a medical professional- if I wasn't I would have definitely gone to the ER.
4 days after vaccine an early menstrual cycle began. It has continued for 12 days.
Pfizer 3/18/21, 4/8/21, 12/29/21. Positive on 9/3/22
Janssen COVID-19 Vaccine EUA Flu-like symptoms (muscle soreness throughout body progressing to body aches; feeling of being cold rather than having chills, progressing to mild fever (temp not taken); mild headache.  Symptoms began at 8:30 p.m., about 9.5 h. after vaccination, and lasted about 16 h.  Slight soreness at injection sight still apparent.
Starting on 07-29-13, patient started itching at the injection site. I noticed today, the injection site is very red, hot to the touch, and hard to the touch.
Extreme weakness, tremors, numbness, pain, limbs not functioning correctly, intense facial nerve pain
Two hours after receiving the vaccine, she experienced heart palpitations, dizziness, confusion, nausea, and vomiting which lasted two days.
with significant history per chart review of ESRD on hemodialysis, DM2, hypertension without heart failure, and COVID + 1/2022 in setting of Pfizer vaccinated x 3 who presents cyanotic, hypoxic, in severe respiratory distress, afebrile, tachycardic, hypertensive with limited history as patient is unable to speak, being found this morning by son short of breath when getting picked up for dialysis    Vaccine appears to be given at outside facility. Unknown type of Vaccine, or lot number
Pregnant in 2nd trimester when vaccinated. My son was born with a congenital bleeding disorder (doctors are still unsure of diagnosis since he does not present like typical factor 1 deficiency patient). Many unknowns to the new diagnosis and no family history. Son is currently in NICU. My daughter is 2 yrs old and has no health concerns .