chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red welt at injection site; red welt at injection site; headache; fever; SOB; aches, pains; chills; arm sore; lungs burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 14:00 (Lot number: 3302680) at the age of 51 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: en9581, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), URTICARIA (non-serious) all with onset 15Dec2021 01:00, outcome "recovering" and all described as "red welt at injection site"; HEADACHE (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "fever"; DYSPNOEA (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "SOB"; PAIN (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "aches, pains"; CHILLS (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "arm sore"; PLEURITIC PAIN (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "lungs burning". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site reaction, urticaria, headache, pyrexia, dyspnoea, pain, chills, pain in extremity, pleuritic pain.  Additional Information:if other vaccine in fourweeks: No.other medications in twoweeks: NO.Ae resulted in: None of the above.if covid prior vaccination: No.if covid tested post vaccination: No.other medical history: n/a.known allergies: No.  No follow-up attempts are possible. No further information is expected.
No Adverse event reported post vaccine, however vaccine was administered 30 min after expiration time.  Error was identified the following day when Pharmacist questioned nurse that administered the vaccine.  Patient notified and declined  re-vaccination.  Patient was not re-vaccinated
it made me worse; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious social media case received from non-health care professional.  This case involves a patient of unknown demographics who reported that it made worse (Feeling abnormal), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported that patient had the shot it made worse so the shot was a joke (Feeling abnormal , non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for feeling abnormal, at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Tingling (Chin)
I started getting small hives on my legs, torso and face- consulted my doctor who I had seen earlier in the week for a poison ivy infection.  New hives looked very different from area affected by poison ivy. Dr. changed my morning antihistamine from Allegra to Levocetirizine to help as well as prescribing a steroid cream for the spots on my face. Steroid cream did help the spots on my face. However, I am now 8 days post injection and new small hives are still appearing all over my body.
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 21-JUL-2015, the patient was vaccinated with a dose of an improperly stored (Oka/Merck) VARIVAX, lot number K021486, expiration date 03-NOV-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Patient received Hep A vaccine today at 1300. Pt came to medical clinic 4 hours later with welts/hives to head, chest, back and arms. Appears as allergic reaction from vaccine. Provider contacted, new orders for Benadryl 100mg po now and Benadryl 50 mg po bid x 5 days. Pt for welfare check in 4 hours. Pt denies any shortness of breath or difficulty swallowing.
3/11/03 result confirmed as "take" 3/12-3/15 lymphangitis 3/15/03 small satellite lesion appeared 3/21/03 multiple vesicles noted over arms and front and back trunk. Dr. examined patient at approx. 3:30pm at Hospital and confirmed with Dr. that several of these had appeared since he examined earlier in am. Diagnosed as Generalized Vaccinia by Dr. Taken off duty until all lesions resolved.
Information has been received from a physician concerning a female who was vaccinated with RECOMBIVAX HB (manufacturer unknown) and subsequently broke out in hives.  Lot number not provided.  No further information is available.
pt recv vax & devel an inj site rxn characterized by redness, pain, induration, warmth, swelling the size of softball or larger;
rash; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date:15-FEB-2023 Reporter's comment:  The pharmacist reported that the patient had 1st dose of Shingrix. On day 3, the patient developed rash which got better by day 7. The reporter agrees to follow up from GlaxoSmithKline.
administrated /batch recall on July 6 2021. /recall date 10feb2021; administrated /batch recall on July 6 2021. /recall date 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. The Vaccine Administration Facility was the same as primary reporter. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Saem reporter US-GLAXOSMITHKLINE-US2021169129:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
Sudden appearance of circular rash around injection site, area is tender (feels like a bruise), now fading
acute thrombotic ischemic stroke in the sylvian branch of left middle cerebral artery
Report 20010002601 describes shakes in a 16 year old female who received an injection of hep B vaccine Engerix-B. Concurrent medical conditions included possible asthma. Concurrent medications included cetirizine. The vaccinee received her first injection of Engerix-B on 11/08/1999. Within 15 mins of receiving the injection, she developed shakes, muscle aches, and nausea. She recovered after 48 hours without treatment.
Death ruled SIDS but was 6 days after vaccines. Received Autopsy Report which revealed COD as undetermined; manner of death undetermined.  Patient found supine cosleeping with twin sibling.  Found 4 healing rib fractures which ME ruled as resulting from excessive force precluding SIDS.
shingles; Retinal detachment; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 61-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 24-JUL-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at physician office. On 10-DEC-2015, the patient suffered acute retinal detachment. On an unspecified date, the patient experienced shingles. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of acute retinal detachment and shingles (herpes zoster) were not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, the event of retinal detachment was considered to be medically significant. And both events were considered disabling events.
Marked swelling and redness of upper half of anterior thigh where Prevnar given. This was 2nd dose. No pain, and no fever. Benadryl helped  but did not resolve swelling.
My daughter experienced a very painful shot of the gardasil.  While we were walking to the check out she felt dizzy, sat in a chair next to me..passed and hit her head against the wall.  Her head and body were arched over the side/back of the chair. I thought she was having a seizure but was told her body was like that from just passing out. She woke up woozy and had a sore head and ankle (which apparantly hit or got twisted in some part of the chair.
Post vax, on 6/1/2000 AM, the mother stated that infant was fine when he was put in bed with her and then when she tried to awaken the child, he was lying on his stomach with mucus from mouth and not breathing. Autopsy shows cause of death as sudden infant death, pulmonary congestion and edema, splenic congestion, renal congestion, unresponsive.
1st - minimal pain right deltoid area at vaccination site; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Flo140, expiry date: 31Mar2021), via an unspecified route of administration in the right arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine, vitamin c (ascorbic acid) (VITAMIN C), and colecalciferol (VITAMIN D). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced 1st - minimal pain right deltoid area at vaccination site on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Dec2020. Clinical outcome of the event was unknown.
14DEC89, 12JAN, 08JUN, 1990 pt vax w/hepta B; titer indicated non-responder.  13NOV90 recd booster vax. Titer to be done Dec90.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. Between (reported as "may have been administered between") 24-FEB-2016 and 04-MAR-2016, the patients were vaccinated with the first doses of RECOMBIVAX HB injection, lot # L019298 with expiration date 22-JUN-2017 and L027733 with expiration date 13-SEP-2017 (dose and route of administration were not reported) that were improperly stored. It was not specified which patients received which of the reported lot numbers of RECOMBIVAX HB. The vaccines were exposed to temperature of 33.6 Fahrenheit (F) for 40 minutes and administered. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
blood shot eyes  periodic muscle aches especially when still for long period, sitting, bed. It's day 17 since my first shot.
Child received immunization and was ok when left Health Department.  Child went to daycare.  After a short time at daycare, child turned "blue" and was rushed to ER.  Case manager stated child's temperature was 101.
Patient presents reporting tingling in arms and legs a few minutes after injection was given. She denies weakness or pain. VSS. She was informed we would observe for 30 minutes. Patient was given juice pouch and upon re-evaluation a staff member saw patient driving away, out of the lot noting she feels much better
Some vomiting 2 times with rash on right thigh where vaccine given. Warm to touch.
Hives forming on face near ears; itchy skin on arms and legs; Tired; weak mildly achy limbs; weak mildly achy limbs; cognitively slower; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included dry inflamed eyes and MGD of eyes (Meibomian gland dysfunction), thyroidectomy, thyroid cancer, pulmonary sarcoidosis, lymphedema and hypertension. The patient previously took ciprofloxacin and experienced drug hypersensitivity and food allergy (sulfa drugs, tree nuts, raw orchard fruits). Concomitant medication(s) included levothyroxine, liothyronine, losartan, clonazepam. The patient had no other vaccine within four weeks. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 11Mar2021 21:00, the patient had hives forming on face near ears, itchy skin on arms and legs, tired, weak mildly achy limbs, cognitively slower. The patient received treatment for the events. Outcome of the events was not recovered, at the time of this report. No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist via a company representative, who referred to a 60-year-old female patient. The patient did not have any allergies, birth defects, relevant medical history and illnesses at time of vaccination. On 14-JUN-2017, the patient was vaccinated with ZOSTAVAX 1 dose, subcutaneously in the left arm (lot# M041510 and expiration date: 27-JUL-2017) for prevention of Herpes Zoster. The patient's concomitant medications included lansoprazole and estradiol (YUVAFEM). On 14-JUN-2017, within 12 hours from the vaccination, the patient experienced a large, itchy, bothersome rash around the injection site. It was reported that the rash started out small and grew to 3 inches in diameter. The rash was slightly raised and itched. The patient did not seek for medical attention but she used hydrocortisone to relieve the itching, which lessened the itch, but it did not go away. It was also reported that the experience did not require drug treatment prescription. The rash lasted approximately 7 days - resolved on approximately 21-JUN-2017. At the time of the report the patient did not recover from the itching. The relatedness between the events and the suspect therapy was not reported.
TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a pharmacist (PVX2019-528) on 27-Feb-2019. The report described a female consumer who "took two doses in a row". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took two doses of Vivotif in a row. The doses were taken on 26-Feb-2019 and 27-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
A physician reported that a female patient received an injection of Flu Shield (2002-2003 Formula) on 10/29/02. She subsequently developed pain in her shoulder and difficulty moving her arm 2 to 2.5 weeks after receiving the vaccine. She was instructed to see her primary physician who diagnosed her with bursitis. This is 1 of 3 patients from this facility who developed pain at the injection site following administration of lot 4020029. The reporter noted that they suspected lot 4020029 was administered, but were not sure. This lot was the product in the office as of 11/29/02. See related HQ5550627NOV2002 and HQ5549427NOV2002.
Around 15 minutes after the injection my ear was red/hot. By the late evening I was itching.on 2/6 I had a migraine with nausea that went away Sunday. The itching continued Saturday2/6 and Sunday 2/7. I had experienced covid arm with the first injection. On 2/7 my pcp prescribed prednisone 2x a day for 5 days and to continue taking Benadryl. When itching, I would get blanching/broken blood vessels on my stomach and breasts. .  I would also get hives at times. On 2/14 I went to the Clinic due to the itching/hives. I was prescribed a methyl prednisone taper pack and to continue Benadryl. On 2/16 I experienced increase heart rate, flushing and high blood pressure. I also had raised hives that covered my entire back.   The hives seem to come and go and occur at random locations on my entire body. I continue to itch today. I am no longer taking a steroid but continue with Benadryl every 6 hours. Once the 6 hours passes, the itching returns and hives.
pooping blood; 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hemorrhoids" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "pooping blood". Clinical course: The reported stated that the patient got the booster shot and pooping blood. The patient had hemorrhoids already and thought that this may just be from patient's aggressive wiping due to patient's stress of getting COVID. The patient queried if poopy blood was side effect from getting booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Report A0367904A describes elevated liver enzyme concentrations in a 49 year old female who received hep A vaccine. Medical history, concurrent conditions, and concurrent medications were not provided. On 4/4/02, the vaccinee received an injection of Havrix. On 4/26/02, the vaccinee gave blood. At that time, lab tests revealed elevated concentrations of unspecified liver enzymes.
First menstrual cycle after booster has been heavy and continues since December. Had to go on a prescription to stop heavy bleeding and large clots, got biopsy to rule out issues, now on birth control to try to get the bleeding to stop. Only had about a week of not bleeding in months. Iron is now low, getting infusion.
administration date= 04Jan2021/Other vaccine same date vaccine date=21Jan2021; Lightheaded/Dizzy; vomiting; This is a spontaneous report from a contactable other HCP. This 24-year-old female other HCP (no pregnant) received 2nd dose of BNT162B2 (lot number=EL3249) on 21Jan2021 at single dose on Left Arm for covid-19 immunization. Medical history was Total colonic Hirschsprung's disease, POTS, asthma, chronic migraines, recurrent pneumonia, GERD. Historical Vaccine was 1st dose of BNT162B2 (Lot number= EL1284 on 04Jan2021 09:30 AM on Left arm). Known allergies: Erythromycin, azithromycin (Z-PACK), metoclopramide (REGLAND), diphenhydramine hydrochloride (BENADRYL). Concomitant drug included topiramate (TOPAMAX), esomeprazole sodium (NEXIUM), famotidine (PEPCID), ondansetron (ZOFRAN), budesonide/formoterol fumarate (SYMBICORT). No other vaccine in four weeks. Patient experienced Lightheaded, dizzy, vomiting on 21Jan2021 11:15 PM with outcome was recovered. No treatment. No Covid prior vaccination. No covid tested post vaccination.  No follow-up attempts possible. No further information expected.
Employee reports that following the vaccination, her left upper arm exhibited more soreness than she usually notices following a flu vaccination.  In subsequent days, she noted weakness to her left arm and pain.  She has developed subsequent decreased range of motion to the left shoulder/uppper arm with ongoing discomfort localized to the left upper arm.
Ct was to receive TB skin test on 08/16/04 instead Ct. received Adult Td 0.5cc ID to left forearm. On 8/17/04 Ct.  began to experience redness/swelling/itching- followed up at health center.
hx of dementia at the hospital with worsening dementia and hallucinations and covid concern. Son had covid recently. she was hypoxic to 70s per ems. She was placed on O2. She is vaccinated and had received the 3rd dose previous week.
Patient received 1 ml IM dose of FLUVIRIN.  Instead of recommended dose of .5 ml.  Patient reports onset of rash on 9/18/09 that has not resolved with topical OTC creams.  Provided referral to clinic for f/u.
No adverse event occurred. The vaccine was mistakenly given at the patient age of 47, less than the recommendation of 50. Miscommunication about which vaccine.
After receiving the vaccine my arm started to get tight and itchy and I called the doctor the next day. Then I saw the doctor and he gave me a medicine for the itching. I was also having issue with sleeping for about four days. Then I saw the doctor again and he said it may be a pulled muscle but it has been a year.