chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 696 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Moderate to severe fatigue; loss of appetite; memory was temporarily impacted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, MANUFACTURER UNKNOWN, These effects were more, pronounced than side effects the individual had as of the first or second vaccine dose.), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, MANUFACTURER UNKNOWN, These effects were more, pronounced than side effects the individual had as of the first or second vaccine dose.), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "Moderate to severe fatigue"; DECREASED APPETITE (non-serious), outcome "recovering", described as "loss of appetite"; MEMORY IMPAIRMENT (non-serious), outcome "recovering", described as "memory was temporarily impacted".  Additional information: I received the following adverse event report for the Comirnaty booster injection (3rd injection) today: Side effects was moderate to severe fatigue and loss of appetite lasting 3 or more days after the injection. Subject indicated that memory was temporarily impacted, which could have been due to fatigue noted above. The individual was recovering as of my receiving this report. These effects were more pronounced than side effects the individual had as of the first or second vaccine dose. Date adverse event report received: 26Jan2022 at ca. 7:30 PM.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Raised, red rash over back and chest, spread to extremities and genitals over the course of several days. And Malaise. Also, a warm, red ring around the vaccination site, with swelling, erythema and induration.  10 days after vaccine administered, patient still has induration the size of a walnut, bluish hematoma, rash subsided.
Shortness of breath for several hours (better now).  It felt like I was at high altitude. I couldn't sleep because I couldn't seem to catch my breath. I think it was due to extremely intense chills, but it subsided around 4am.
Temp 100.2, chills, shivers, muscle and joint pain, fatigue, headache for  26 hours. Continue with headache and joint/ muscle pain.  Treated with Advil
From review of form employee had difficulty within minutes of receiving flu vaccine on 9/16/11 at 15:20. She went to Emergency Dept. An IV was started she was given BENADRYL 12.5 mg IV & within 10 minutes her feeling that her throat was closing improved. Her vitals signs remained stable. She had no hives or trouble breathing. Diagnosis: Anaphylaxis as reported on ED note. Mild case fully resolved with only BENADRYL 12. 5 mg IV.
Fatigue, muscle and joint pain, chills, redness around injection site. On second day the redness covers bicep muscle in a ring the size of a blood pressure cuff, however  the other adverse effects are much better.
No additional AE reported.; Inbound call from medical assistant who reports VARIVAX that expired 4/1/2023 was administered to one patient today 4/12/2023.; This spontaneous report has been received from a medical assistant, referring a patient of unknown sex and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 12-APR-2023, the patient was vaccinated with and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number U010398 has been verified to be a valid lot number, expiry date 01-APR-2023) (strength, dose, frequency, and administration route were not provided) (expired product administered) concomitantly with sterile diluent (manufacturer unknown), both indicated as prophylaxis  No additional adverse events were reported.
administration of improperly stored ROTATEQ; This spontaneous report was received from customer and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, concomitant medications, or relevant medical history.  On 05-JUL-2023, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered orally for prophylaxis (improper storage of product in use). Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023). There was no previous temperature excursions reported.  This is one of several cases received from the same reporter (cross-referenced with US-009507513-2307USA009292).; Sender's Comments:  US-009507513-2307USA009292:mother case
21JAN98 pt to report rxn to vax; pt had rt arm  very sore, not able to raise arm, T elevated, chills last noc;lasted bout 4-5hr;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JAN-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L019127 and expiry date on 27-MAY-2017, (route, frequency and dose were not reported). No adverse effects were reported and no product quality complaint was involved. Additional information is not expected since the reporter did not want to be contacted.
Sore arm, extreme fatigue, followed by fainting for a few seconds later that night around 2am
wiped out completely the next day after the vaccine both times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (wiped out completely the next day after the vaccine both times) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (wiped out completely the next day after the vaccine both times). At the time of the report, VACCINATION COMPLICATION (wiped out completely the next day after the vaccine both times) outcome was unknown.            Concomitant product use and treatment information not provided.   Reporter did not allow further contact
This spontaneous report as received from Registered Nurse via field representative refers to a 6 year old male patient. On an unknown date the patient was vaccinated with the second dose of VARIVAX (Merck) (route of administration and dosage unknown) (lot number and expiration date not provided). After unspecified amount of time from the second dose of VARIVAX (Merck) the patient experienced varicella breakthrough. The outcome of varicella breakthrough was reported as not recovered. The patient sought medical attention via office visit. The relatedness between headache and of VARIVAX (Merck) was not reported. Additional information has been requested.
Approximately 20 minutes after vaccine, patient had a sudden, sharp intake of breath mid-sentence, followed by shortness of breath and accompanied by a flush and non-raised pink rash from cheeks to chest. The reaction was nearly identical to her previous anaphylactic reaction to Gadolinium after an MRI at a younger age; however, this time the breathing issues resolved after a few minutes and the rash did not continue to the rest of her body. The rash resolved completely with a 50mg dose of Benadryl in approximately one hour.   Patient experienced pain and redness at the injection site for a few days. On day five post injection she ran a fever of 101.5 and was fatigued all day.
Pt is in her trimester of pregnancy. Patient came back one day after the vaccine injection if she need to worry about the swelling she has (just a little bit of swelling), no redness or fever noted. A little pain and a touch of warmness at the injection site.
Fluarix and Boostrix were exposed to -2.04 C and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 5KT7B, expiry date 30-JUN-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 31-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season and Boostrix. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Fluarix and Boostrix were exposed to -2.04 C and was administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-NOV-2023 The vaccine administration facility was the same as primary reporter The Clinical Resource Nurse stated Fluarix and Boostrix were exposed to -2.04 C and was administered to a patient, which led to incorrect storage of drug. The reporter consented to follow up via postal.
When I had the 4th dose, I notice a couple hours later I was really tired I was laying on the sofa. I was feeling weird on the 23rd of March 2022 I was awake with a headache. So, it just lingered and felt like a sinus infection was coming. I took EXCEDRIN to go to sleep. I kept waking up in the middle of the night. Then I talked to my doctor and a cocktail of antibiotics and gave me some nasal spray. Then I start to feel a pain on the side of my head and then I had a leaking eye my nose on one side was stuffed up. I couldn't do anything with my left side of my face. I called the doctor again and he prescribed more antibiotics. I was really tired because I couldn't get any sleep. All of the left side was in very intense pain and leaking. I couldn't do anything couldn't use ice at all. I would have a headache for 3 to 4 hours and sometimes 6. I was able to get an appointment with my doctor. They sent me to neurologist May 24th, 2022. I still have headaches. My life has changed for the worse. I am not the same person, and I am not happy.
This report describes the occurrence of arm pain in a 50 year old female who was vaccinated with Lyme disease vaccine recombinant OsaP (Lymerix) for prophylaxis.  This report was received from the subject and has not been verified by a physician or other health care professional.  Reportedly, the subject's medical history included glaucoma.  The subject stated that she experienced no adverse events following previous immunizations.  The subject reported that her concurrent medications included bimatoprost (Lumigan) eyedrops and alendronate sodium (Fosamax).  The subject stated that from 1998 to 1999 she received three injections of Lymerix.  Reportedly, beginning in November 2002, she noticed that her arms were aching and that it was difficult to lift them.  She stated that the pain started in her left arm and she now had discomfort in both arms.  It was typically worse in the morning, improved throughout the day, but did not completely resolve.  As of 02/26/03, the events were reportedly "worse".  The subject had not sought medical attention.
Pt received FLUZONE HD vaccination at 255pm on 9/16/10. She woke up at 530am on 9/17/10 with swelling/hives presenting from top of her head throughout her trunk. She also experienced difficulty breathing &  loss of bowels before being treated by ER.
burning sensation on skins and body; painful sensation on skins/Painful and annoying; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation and pain were not recovered/not resolved.   It was unknown if the reporter considered the burning sensation and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced burning sensation on skins on body and would not go away.  The patient experienced very painful and annoying. The patient was asking how long this would last. The patient did not want to take second vaccine.  The patient did not have rush just awful painful sensations on skins. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
ULCERATIVE COLITIS FLARE; STRESSFUL TIME AT WORK; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported,1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On MAR-2021, the patient experienced ulcerative colitis flare and stressful time at work. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s, was not applicable. The patient was recovering from ulcerative colitis flare, and the outcome of stressful time at work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210425538-covid-19 vaccine ad26.cov2.s -Ulcerative colitis flare. This event(s) is considered not related. The event(s) has an unknown/unclear 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: UNDERLYING DISEASE
OBSTRUCTIVE SLEEP APNEA ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOXEMIA
Given Meningococcal (MCV4) vaccine on 01/09/09 in left arm SC instead of IM.  Pt was brought to Urgent Care on 01/11/09 with pain, erythematous in left upper arm. Dx with cellulitis, secondary to vaccine reaction.  Rx for Bactrim DS 800 mg P.O. BID for 10 days and Medrol dosepak one tab P.O. for 5 days.
Headaches, left arm pain, blurred vision from early cataracts, memory loss, increased urinary frequency.  Experienced his first headache in June 2003, after experiencing his 3rd episode of heat injury.  Initially, headaches were experienced only in the morning; then later, the headaches occurred more in the evening, and now the headaches are at random and are occurring almost daily.  Duration of headaches vary, but usually last several hours.  The headache pain is described as a sharp, throbbing pain.  The location of the headache pain varies.  The level of pain varies from a level 4-9 on a pain scale of 0-10.  He denies accompanying nausea or vomiting.  Sometimes experiences photophobia and pain behind left eye, with some blurring vision.  Unable to identify precipitating, aggravating or alleviating factors.  Recently tried on Zoloft 25mg every day for 2 weeks without improvement and has also tried Fioricet, Tylenol and Advil without relief.  Previously evaluated by Neurology and has follow up appointment in Neurology today.  Headaches have previously been attributed to stress and depression, but pt denies feeling stressed or depressed.  Since returning stateside, experienced one episode of passing out following one headache; said he had been in the heat during an SRP around November; not sure how long he was out; denies any incontinence or seizure-like activities; experienced another episode of passing out at Christmas; said his family though he was asleep and did not try to arouse him, but he says he passed out.  Left arm pain started approximately 1 month ago, which started at shoulder and is now experienced from the shoulder to his fingers. Describes as sharp pain and feels a sensation of "fullness" in his left axilla. Rates pain as a level 7-9 on a pain scale.  Pain worse with movement.  Denies sensations of numbness of tingling; has not noticed weakening or decreased strength in that extremity.  Seen by a civilian neurologist and told he may have a pinched nerve.  Denies injury or trauma to his left upper extremity.  Onset of blurred vision approximately 6 months ago. Evaluated by ophthalmologist last month and was told he has early cataracts of left eye and recommended eye exams every 6 months.  No previous problems with vision or history of eye disease.  Onset of memory loss around June 2003.  Noted difficulty remembering names of best friends and frequently called telephone numbers. While at medical center, experienced difficulty following conversation with MD who was evaluating him following his 5th episode of heat stroke; heard what he was saying, but did not understand. Reports gradual improvement of memory and comprehension over past few months.  Noted increased urinary frequency over past few months. Denies increased urgency or increased volume when urinating. Denies polydipsia or polyphagia or unexplained weight loss.  Reports more tied than usual since returning stateside. Denies history of elevated blood sugars.
receieved 1/11/21 and one week later started to notice generalized itching. Started to notice small purple polygonal plaques on the wrists and dorsal hands. pt states that he started to notice these lesions spreading onto the chest, back and legs at the end of 2/2021. Pt states that he saw outside dermatologist and was informed that this was Lichen Planus. pt does have a history of this diagnosis, however has not had a flare in about ten years before this last one. Pt then came to healthcare facility for eval 5/4/2021 and discussion of treatment. Pt ultimately wanted to monitor condition and think about potential treatment options.
This spontaneous report as received from a nurse refers to a 10 year old patient of unknown gender. On 06-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot number G006863 exp 20-JUL-2013), 0.5 ml, subcutaneous. On 06-AUG-2013, 1 day after onset of therapy the patient received an expired dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.
Information has been received from a pharmacist concerning a 12 month old male with no known allergies who 2 weeks ago, on approximately 08/01/2001 was vaccinated with one dose of varicella vaccine. There was no concomitant medication. On 08/12/2001 the pt developed fever of 103 deg F that had persisted at the time of report. The pt sought unspecified medical attention. Additional info has been requested.
I awoke in the middle of the night with body pain symptoms, thirst, and slept terribly the rest of the night. In the morning I had above symptoms, painful lymph nodes in neck and groin, and elevated body temp of 100. But the most significant reaction was swelling and BRUISING around the eyes. Left side definitely worse than the right. I haven't heard of this, so I thought I'd reach out to you.
Shot area was red, swollen and hot. Treated with Zyrtec and hot packs. If size increases, start on Keflex. On 8/20/02, it looks normal.
Tdap shot ~16 hr. later soreness at site, around 24h. later redness started - no itching - some pain. 14cm x 13cm upper (L) arm area.
Vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 16:50 (Lot number: FK5127) at the age of 6 years as dose 2, single and intramuscular, administered in arm left, administration date 10Nov2021 18:15 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Born prematurely at 27 weeks" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 10Nov2021 19:15, outcome "recovered" (2021), described as "Vomited". Therapeutic measures were not taken as a result of vomiting.  Additional information: Adverse event About 30 min after receiving the first dose of paediatric COVID vaccine, (name withheld) (my son) had sushi for dinner. About 30 minutes later (1 hour after the vaccine dose), he vomited. There was a single vomiting incident, and he said he felt better. So far, he has not had any other adverse events. Facility where the most recent COVID-19 vaccine was administered was School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Leg pain with 24 hours of vaccine, no swelling at the injection site. Joint NL. Would not bear wt. better after 72 hours.
1 hour after the vaccination, she felt discomfort ,with fast hear beat, while she was at the hospital where the vaccine was given. The symptoms resolved on their own after a few hours. She reported the symptoms to me on 03/16/2022, Physical examination did not reveal any abnormality and she was referred to a cardiologist for further advice and management
Pt became dizzy with tingling sensation "all over" 1-2 minutes post injections.  Pt proceeded to lose consciousness for 3-5 sec. with 1-2 secs. of twitching.  Pt regained consciousness immediately post injections and appears alert & oriented at this time.  HR-76 Resp Rate-20 B/P-120/78.  Waited 20 minutes after injections.