chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vision change for a approximately 3 months. I was able to see better in one of my eyes. Vision went back to normal before I could see an opthomologist. Also, my period was late by 70 days. It resumed to normalcy after this lapse.
Positive COVID test with symptoms of achy joints, GI issues, fever, exhaustion. Treatment with Paxlovid  (completed full course of treatment over the 5 days) and then tested negative. 5 days later had the same symptoms again and then tested positive for COVID, i.e. Paxlovid rebound.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current or medical history were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX vial injection, 0.65 ml (route, anatomical location, lot number and expiration date not reported). On an unspecified date in September 2014, the patient experienced pain and welt at the injection site, the patient returned to the pharmacy on 29-SEP-2014 and stated that she still had pain and welt at the injection site. Outcome of the events was unknown at the time of the report. Additional information is not expected as the reporter did not wanted follow up contact.
COVID Breakthrough. First vax 4/5/2021.  38 y/o male presents to the ED with the CC of LLQ abdominal pain x1 day.  Patient described abdominal pain as sharp, 7/10, constant pain, localized to LLQ.  Patient admits to fever, chills, headache but denies nausea, vomiting, diarrhea, chest pain, dysuria, dizziness, or any other symptoms at this time. discharged 8/30/2021
Vaccine booster 10/6/22. Adverse event  May be totally unrelated. Transient cerebral ischemic attack, unspecified onboard ship in middle of Atlantic Ocean
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STOMACH ACHE; HEART PALPITATIONS; METALLIC TASTE/RUINED SENSE OF TASTE COMPLETELY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: anxiety, sleeplessness, and antibiotics allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21 expiry: unknown), dose was not reported, 1 total administered on 11-MAY-2021 at 13:15 on left arm for prophylactic vaccination. Age at time of vaccination 65 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure, The patient was prescribed with non-company suspect drug Paxlovid (form of admin and route of admin were not reported, batch number: GC4035, expiry: Unknown) does not reported, administered first dose on 21-JUN-2022 for covid-19.  On 21-JUN-2022 at 22:45, patient immediately had the metallic taste side effect and it ruined sense of taste completely and had stomach ache, heart palpitations and headache.  Treatment with Paxlovid was stopped on 22-JUN-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach ache, headache, heart palpitations, metallic taste, ruined sense of taste completely, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint (PQC).; Sender's Comments: V0:20220706508-COVID-19 VACCINE Ad26.COV2.S-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Vaccinator administered a child's dose 0.5 mL of  Energrix-B using a pre-filled syringe from the childhood vaccine inventory rather than an adult 1.0 mL dose from the vaccine for adults inventory.  The child dose is 1/2 of the adult dose.  The patient had left the clinic when the error was realized.  We are contacting the patient to request that they return for the full dose per guidelines.   The two inventories of vaccine were stored in separate refrigerators in clearly labeled bins for clarity prior to the error.  Now additional staff training and refrigerator labeling are in place to ensure this error does not happen again.
This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 18-MAY-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-SEP-2016 (dose, dose number, route, albumin status and anatomical location were unspecified). Concomitant therapies were not reported. On 25-JUN-2015, the patient was revaccinated with an unspecified lot of MMR II (dose, dose number, albumin status, lot number, route and anatomical location were unspecified). No adverse effects reported. Additional information has been requested.
Immediately after receiving influenza vaccine for the first time the patient began scratching at the site of the injection.  We had patient wait due to first time vaccination and he developed a spotty rash on both arms and his cheeks were more rosey  in color than when he initially came in.  Pt was very calm and cooperative, no difficulty breathing, no difficulty swallowing, normal respiratory rate, pulse ox was 98 percent, heart rate 106.  EMS was called for an evaluation of patient.  Mom left with EMS to have patient evaluated and seen at the Hospital. Will follow up with mom on status.
Patient became febrile on the morning of 03/03/23 around 2:00 am. Patient did have an episode of emesis. Mom gave fever reducing meds. Threw up 6 times per mom between 2:00 AM AND 9 AM. Patient began to seize @ 9:50 am. Mom took a video for 1.5 min. Mom took to the ED @ 10:42. ED physician feels in talking with mom that may have lasted 5-7 min from the time mom recorded and eyes open and him responding to parents.
large 6-7" diameter, local rxn that is itchy, dark blue discoloration;sore groin w/lymph node swelling;last tetanus dose in 1984;
Vaccine received at approximately 1:30pm.  Around 6pm, had noticeable chills, progressing to severe chills by 7pm.  Muscle aches and headache also began about that time.  Went to sleep.  Around 1:30 woke up with nausea and sweaty chills.  Walking to the bathroom was difficult due to extreme fatigue.  Fever measured at 103 degrees.  Took Tylenol.  Nausea resolved by 7am 4/10, but had no appetite. Fatigue throughout day (4/10) - slept most of the day.  As of 7am on 4/11, mostly better.  Remaining symptoms are a lingering headache, moderate fatigue, and vaccine site muscle soreness.  Perhaps some brain fog, as this form seems challenging and it shouldn't. Note:  I had had little sleep the week prior to the vaccine, which may have affected my reaction.
shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age  at vaccination was not reported. The patient received the Shingrix vaccine and 2 to 3 weeks/ within weeks later developed Shingles. This case was linked with US2021AMR234679 and US2021AMR234703, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR234703:same reporter US-GLAXOSMITHKLINE-US2021AMR234679:same reporter US-GLAXOSMITHKLINE-US2021235278:same reporter - initial
Pt. recieved the MMR at about 4 PM on 9-22-23. That night, while asleep, he woke up screaming and crying, slapping hands together, wringing hands, extending lower extremities, feet appearing to tremble, calling out, "Mommy, Mommy, Mommy," over and over, not fully awake but no longer asleep. He had never done anything like that before. In the following 2.5 weeks, he had similar episodes- another at night waking from sleep, and three other episodes during or shortly after waking from daytime naps. He had another episode  seven weeks later after a nap on 11-11-2023.  So far, he exhibits no abnormal behavior changes or abnormal behaviors while awake and fully conscious. With an event occurring three days prior to my filing this report, I consider the ongoing episodes unresolved.
suspected vaccination failure; Shingles; Pain not good for your wrist enmity; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received Shingles vaccine and a year later got the shingles and been with the patient for a year and still got the pain not good for your worst enemy the shot did not help me. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation for shingles infection were unknown.
Local injection site reaction, warm, red told to try Ibuprofen and BENADRYL.
20 MCG of Engerix-B given to a woman in the 1st trimester of pregnancy;
whole arm was red; whole arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red). At the time of the report, VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red) outcome was unknown.            No concomitant and treatment information was provided by the reporter.   This case was linked to MOD-2021-048102 (E2B Linked Report). This case was linked to MOD-2021-048102, MOD-2021-048808 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document is received on 26-MAY-2021 and it doesn't have any new information; Sender's Comments:  MOD-2021-048102:crosslink
Pt received vaccine on 10/24 and called 1025 in the evening after nurse was gone stating that her arm was right arm where she received pneumovax was red, swollen, painful and had a hard knot on it.  When I called pt on Monday am when I got message to check on her she said she was 90% better and had no concerns.  At that time only had mild, redness and swelling and was pain free.
Prevnar and Hib were administered right thigh (injected separately) with resulting 2.5 cm area of erythema, swelling and apparent tenderness.  Resolved.
Leg and ankle swelling and overall fluid retention, Prescribed Spironolactone, Furosemide, and Potassium HCL (Last two medications prescribed by Cardiologist)
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH 9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 at 16:45 as dose 1, single (Lot number: EN 6203), in left arm, on 20Mar2021 at 16:45 as dose 2, single (Lot number: ER 2613), in left arm and on 01Nov2021 at 16:15 as dose 3 (booster), single (Lot number: FH 8030), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 at 15:15 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: received 2 heart stents in 2019; "known allergies: Shellfish" (unspecified if ongoing); "known allergies: bee stings" (unspecified if ongoing); "received 2 heart stents", start date: 2019 (unspecified if ongoing); "known allergies: ACE inhibitors" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022 at 15:15, outcome "unknown", described as "vaccine brand other Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) positive; (29Jan2023) Negative; (02Feb2023) positive; (03Feb2023) positive; (04Feb2023) positive; (05Feb2023) positive; (06Feb2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was on a small ship in.Ship guests were from all over, so no idea where exposure came from. Felt Covid symptoms (fever 104F, very sore throat, chest congestion, coughing, runny nose) evening of 21Jan2023 (8th day of cruise). Tested positive 22Jan2023. Started Paxlovid on 22Jan2023, Paxlovid was obtained in on 09Jan2023 before departing to meet the ship. Symptoms worsened to include shortness of breath and difficulty breathing by 24Jan2023. Treated by ship's doctor on 24Jan2023 with over-the-counter decongestants & cough medicine and was put on a course of Ciprofloxacin for possible pneumonia. Tested negative for Covid 29Jan2023. Felt better but very weak. Began to feel poorly again (but not as sick) on 01Feb2023. Tested positive on 02Feb2023. Tested positive until 06Feb2023.
shingles; This initial spontaneous report as received from a lawyer refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-JUL-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. On an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX),the patient suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
SOB, hypoxia, COVID positive. sepsis, NSTEMI, AKI,  Intubated. treatment decadron, cefepime, lasix. PT extubated on 1/24 and reintubated 1/25 due to acute pulm edema. extubated 1/29 to bipap, NC on 1/31.  On RA by DC.
This case was reported by a healthcare professional via sales representative and described the occurrence of injection site reaction in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  Previous and/ or concurrent vaccination included MMR II (non-gsk); Merck; unknown given on 21 May 2009; VARIVAX (non-gsk); Merck; unknown given on 21 May 2009.  On 21 May 2009 the subject received 1st dose of KINRIX (.5 ml, unknown).  On 23 May 2009, 2 days after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the event was resolved.  The healthcare professional considered the event was probably related to vaccination with KINRIX.
After first dose I had wobbly legs; Fatigue; Slept all the day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (After first dose I had wobbly legs), FATIGUE (Fatigue) and SOMNOLENCE (Slept all the day) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, VALSARTAN, METOPROLOL SUCCINATE (TOPROL XL), ROSUVASTATIN CALCIUM (CRESTOR OD), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), FOLIC ACID and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (After first dose I had wobbly legs), FATIGUE (Fatigue) and SOMNOLENCE (Slept all the day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (After first dose I had wobbly legs), FATIGUE (Fatigue) and SOMNOLENCE (Slept all the day) outcome was unknown.        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.   This case was linked to MOD-2021-368875 (Patient Link).
Event occurred after 2nd dose. Patient was diagnosed of COVID Tylenol Discharged home
my menstrual cycle had concluded 2 days prior to the vaccine and since I received the vaccine, my menstrual cycle has restarted and been going on nonstop since.
On 09/09/2022 I received my Covid-19 vaccine. On 02/21/2023 I had back pain, heart burn, sore throat, cough, nasal congestion. After reaching out to my doctor I was diagnosed with Covid-19 and prescribed PAXLOVID. Symptoms lasted approx. two weeks.
Menses delayed by 3 months, then 2 months, then back to regular schedule.  Estrogen and FSH levels are testing at post-menopausal levels even though I am not experiencing any menopausal symptoms,  I did FSH and Estrogen labs 3x during the menses pause and after they resumed to regular schedule.  All three lab results show levels consistent with post-menopause.   My ob-gyn is confused.  Also 4 hours after the first dose of my vaccine, I experienced covid-like symptoms, shortness of breath, heart palpitations, and high BP.  I went to Urgent Care the next morning and was referred to ER where they ran blood tests to ensure I was not having a heart attack, tests came clean and after 4 hours of IV, my BP came down and they released me.  I felt woozy and weak for the next 4 days, the doctor said they have seen this reaction before and said I should expect to feel the same way after the 2nd dose but for a two week time span.  She told me to monitor my oxygen and BP levels and come back if they dipped. It was okay, I was just very fatigued and out of breath a lot for the next few days.   It was scary.   I finally got my 2nd dose 8 months later and so far no adverse symptoms.   This time I made to sure to sleep well consistently before the shot.  For the first dose I was averaging less than 4 hours of sleep per day, I think sleep may be related to reaction for me.
Sore arm - started 2 hours after dose Headache - started 4 hours after dose Pain and swelling in left armpit - started 26 hours after dose and continues; shooting pain down to fingertips, into left breast and down left side of torso.
Patient received 2 doses of the pfizer vaccine  on 4/08/2021 and 4/29/2021. Patient became ill on 8/28 and tested PCR positive for COVID on 8/29
pt recvd vax 9AUG94 1215PM & mom called 1PM to report rash on abdo; had give APAP p/immun; to ER that noc w/hives; still had hives on torso 10AUG in afternoon; adv by MD DC all meds x/DPH; pt had been on Ceclor x 1wk for OM
Information has been received from a nurse concerning patients of unknown age and gender. The nurse reported that multiple unspecified patients received either MMR II (strength, dose and route were unknown) or VAQTA (strength, dose and route were unknown) that were improperly. No adverse event was reported. Additional information has been requested.
Dramatic increase in tinnitus, bordering on unbearable within 2 hours. This occurred with the previous 3 doses as well. It subsided over many months after each previous dose, but it never decreased close to the level of tinnitus that I had before the 1st dose.  Previous doses were as follows: Dose #1 - 3/17/2021 Dose #2 - 4/7/2021 Dose #3 - 8/27/2021
Interview obtained by LPN. Patient was seen for a well care on 6/29. Patient received her third HPV shot. During the night she woke up with chills and sweats. Pain, denies numbness in right hand and foot. Mom even described her color being off. She has decreased appetite, but Mom is pushing fluids. Her symptoms were relieved with the MOTRIN, but pain is still present. Shot site has no redness or swelling at this time. Has been hot and cold, with chills. Skin very sensitive to touch. Tired. Seems to get better after MOTRIN. Was very dizzy when she woke up, lightheaded, but now does not feel that way. Back pain for a few months. Forgot to mention it yesterday but pain seems intensified today.
Case number PHEH2013US024966, is a spontaneous report from a physician received on 25 Nov 2013 and a follow up received from physician on 07 Jan 2014. This report refers to a 57-year-old female patient. Past medical history included cerebrovascular accident, stroke with residual left hemiplegia, hypertension, chronic pain, bipolar I disorder, rhinitis allergic, obstructive sleep apnea, irritable bowel syndrome, needs flu shot, insomnia, urinary frequency, ganglion cyst, knee pain, yeast infection of the skin, knee effusion, leg edema, deep venous thrombosis after surgery, obsessive-compulsive disorder, depression, degenerative disc disease, arthritis, total knee replacement, B total hip, cholecystectomy, tubal ligation and attempted hand wrist tendon repair-multiple. She had no known drug allergies. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1309081) inadvertently one dose from opened and unopened MDVs that were stored below the recommended mentioned temperature, at dose of 0.5 ml intramuscularly into the right deltoid on 30 Nov 2013 at 13:28. The reporter stated that, the vaccine was not frozen upon administration and was unsure if the vaccine had frozen during the temperature excursion. It was reported that, FLUVIRIN was opened and unopened MDVs reached 32 Fahrenheit (F) for six hours on 14 Nov 2013 and 16 Nov 2013. On 17 Nov 2013, it reached for 31 F for six hours. No adverse reaction was reported following the medication error. Follow-up received from physician on 07 Jan 2014: Updated patient demographics, medical history, concomitant medications, date of vaccination, site of vaccine administration, batch number and event onset date.