chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's like there's some kind of nerve damage.; Patient's left arm, thumb & index finger had the sensation that they were sleep/It's like there's some kind of nerve damage.; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (It's like there's some kind of nerve damage.) and SENSORY LOSS (Patient's left arm, thumb & index finger had the sensation that they were sleep/It's like there's some kind of nerve damage.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced NERVE INJURY (It's like there's some kind of nerve damage.) and SENSORY LOSS (Patient's left arm, thumb & index finger had the sensation that they were sleep/It's like there's some kind of nerve damage.). At the time of the report, NERVE INJURY (It's like there's some kind of nerve damage.) outcome was unknown and SENSORY LOSS (Patient's left arm, thumb & index finger had the sensation that they were sleep/It's like there's some kind of nerve damage.) was resolving.            No concomitant medications was reported.  Patient had that sensation for the past 4hrs. No treatment medication was reported.   This case was linked to MOD-2021-392085, MOD-2021-392086.
Patient woke up feeling very warm and crying in pain, unable to get a temperature. Patient expressed pain in both legs and stated they could not walk. Patient was given Tylenol at home. Patient was able to stand and walk in office, no redness or swelling to areas were noted.
Right-sided back/flank pain, 8/10 pain, beginning within 48 hours of vaccination.  Related ED visit 6 days following vaccination; all labs within normal, no evidence of UTI/kidney stones.  Provider diagnosis "possible transient effect of vaccine", could not rule out correlation.  Pain resolved within 2 days following ED visit.
Arm was swollen and hot with restricted movement d/t swelling and pain.  There was also a red hot rash on the entire upper arm.
12/18/12 vaccine given 12/18/12 pm c/o (L) arm sore, red blotches.
discharge coming from her eye; neoplasm of unknown behavior/neoplasm lid leash; lump in her eye/Lump under eye; sick "like everyone else"; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021. The most recent information was received on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick "like everyone else"), EYE DISCHARGE (discharge coming from her eye), NEOPLASM (neoplasm of unknown behavior/neoplasm lid leash) and EYE SWELLING (lump in her eye/Lump under eye) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included AMLODIPINE BESYLATE from 06-Jun-2019 to an unknown date for Blood pressure.    On 26-Mar-2021 at 2:37 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS (sick "like everyone else"). On 28-Mar-2021, the patient experienced EYE DISCHARGE (discharge coming from her eye), NEOPLASM (neoplasm of unknown behavior/neoplasm lid leash) and EYE SWELLING (lump in her eye/Lump under eye). The patient was treated with POLY-L-LACTIC ACID (SCULPTRA) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick "like everyone else"), EYE DISCHARGE (discharge coming from her eye) and NEOPLASM (neoplasm of unknown behavior/neoplasm lid leash) outcome was unknown and EYE SWELLING (lump in her eye/Lump under eye) had resolved.            Patients was taking eye ointment with antibiotic and steroid as treatment medication .   This case was linked to MOD-2021-270779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up received contains patients demographic include height , weight, rash information , treatment medication, concomitant medication , Patient medical history,  updated event out com e
Blister and rash, hives below site. Hives around mouth. Pain in R UE and decreased AROM R UE only.
pt had 30 second generalized sz w/inc fever; fever first documented 20 hrs p/shot given;
Per physician's progress note, "DEVELOPED VESICULAR RASH AFTER H1N1 VACCINE"
product was exposed at 19 degree Celsius for 2 days/no AE; Extra dose administered; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-healthcare professional via call center via the Agency (Reference number- 00862480).  This case involves a 61-year-old female patient who was administered extra dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] as she was given vaccine exposed to temperature at 19 degree Celsius for 2 days (product storage error and extra dose administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On 08-Nov-2021, the patient received a 0.5 mL  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: VT7316LA and expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to product storage error and extra dose administered (latency: same day).  It was reported "A patient received a dose of the Fluzone that was from this reported excursion: and immediately after was given a second injection of the Fluzone. Was the dose appropriate to give? Was it correct to re-dose Fluzone QIV if a product was not suitable for use due to a temperature excursion?"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 30-MAR-2022; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 30-MAR-2022) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 2:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022 at 2:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 30-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 30-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. Dose was given at 30-Mar-2022. No treatment medication was reported by reporter.
sicker; headache; Couldn't get out of bed; chills; muscle ache; dizziness; sweats; nausea; bone/joint pain; bone/joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical information team, Pfizer-sponsored program COVAX US SUPPORT and Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at the age of 82 years old (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included pulmonary fibrosis, trouble breathing (wear oxygen all the time), "pressure reducer for my eye", cardiomyopathy, lung cancer, lung surgery for cancer and poor vision all from an unknown date; COVID-19 from 01Apr2020, (hospitalized for 6 days and I was on 'Remdesivir' (not clarified) and all, everything they gave you). Concomitant medications included levothyroxine, acetylsalicylic acid (BABY ASPIRIN), dexamethasone (DEXALONE), spironolactone, cetirizine hydrochloride (ZYRTEC), clonazepam, hydroxyzine, trazodone,  famotidine, amitriptyline, pirfenidone (ESBRIET), esomeprazole sodium (NEXIUM), lovastatin and clopidogrel; all taken for an unspecified indication, start and stop date were not reported. The patient stated, "I had a bad reaction. I woke up the next day and I was really very sick, probably for 6 days. I had the Covid like symptoms. I had the headache, dizziness, chills, sweats, nausea, muscle pain, bone/joint pain. I had everything that I had, but of course not to the extent. Thursday I finally could get up and stay up. I'm not sure. Do I have enough antibodies to not receive the second dose? What does Pfizer recommend? Will the blood test or antibodies show either? If I should or not get the second dose? I thought I read something yesterday that Pfizer announced one shot would be efficient". The patient got the first dose last 05Feb and she mentioned that after getting the first dose she was very ill, she had chills and muscle ache. The patient further stated, "I am 83. I have pulmonary fibrosis and cardiomyopathy and I have had lung cancer. I had the Pfizer vaccine on 06Feb, first shot of Pfizer COVID-19 Vaccine. Before we had it, I also had COVID on April 1st and I was hospitalized for 6 days and I was on 'Remdesivir' (not clarified) and all, everything they gave you. I was not on a ventilator. Anyway, we talked to the doctor before I got my vaccine and told them that I had COVID. His advice was to take the vaccine and to see what my reaction was. If it was minor, have the second shot, if it was major don't have the second shot. The day after, I woke up, I had chills, I had sweats, I never had a fever even during COVID, I had muscle and joint aches, I had nausea, I had a headache, I was dizzy. I had it all and I couldn't get out of bed from Sunday to Thursday. My question is do you advice that I take the second vaccine which I am due to have a week from today." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt reports "eye twitching"  that developed later that night following the vaccine, and then after a couple more days, noticed he had lost muscle tone on one side of face when he tried to drink some water and in was running out of his mouth ;  he went to the ER and was diagnosed with Bell's Palsy; he began treatment with prednisone 20 mg, 3 tablets daily for 7 days
patient became sweaty and panicked after receiving her 1st covid shot. her pupils dilated and she complained of throat pain. EMS was called, and upon arrival she was starting to feel better, they checked her vitals and cleared her.
A legal complaint was received from an attorney concerning a 5 year old male child who received HibTiter vaccine and Tripedia vaccine in or about 1999, when he was approximately 2 years old. It is alleged that as a result of cumulative doses of mercury in the thimerosal containing vaccine, the child developed "toxic neurological effects of mercury poisoning including but not limited to autism." Mercury poisoning was considered medically important (OMIC).
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No medical history was reported. It was unknown if patient was diagnosed with COVID-19 test positive and it was unknown if patient had acute and chronic illness.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccine was administrated after the beyond use date  and after the thaw process. The patient had no adverse reactions and no reports of any reactions after the administration of the vaccine was reported.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (dose and route were not reported) lot # J007023 expiration date 05-JUN-2015 that were improperly stored. The temperature excursion for the (Oka/Merck) VARIVAX was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
seizure; This is a literature report.  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "not recovered".  Clinical information: She was an active soccer player and a good student, now unable to play sports or attend class in person.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Has redness and swelling on right upper arm. Feels hot and swollen. Keflex 250 mg bid x 10 days.
No known side effects; however, on 1/20 the decedent suffered lethargy.  On 2/12/2021, the decedent had a possible seizure and was transported to emergency department where shortly after arrival, he was pronounced dead.
pt ran fever 17MAR & 18MAR93 of 102.2 R; pt was treated w/APAP & baths; pt cried a lot & emitted a high pitched scream but could be comforted; mom called MD who felt did not need to be seen & told mom 2nd series OK;
Dec 21- vaccine  Dec22- soreness right arm Dec23- nothing Dec24, 4pm... I was cleaning up, getting everything tidy for Christmas Day. All of a sudden, I felt very nauseated and sick and just bad. I laid on the couch, and around 5, I noticed my left  forearm getting swollen and splotchy. It continued to get more swollen, red and hot. I put an ice pack on my arm. It was very tender to touch or graze over. I realized then that I had a temp of 99.8. I had body aches, headache, was still nauseous, and I had diarrhea.  Dec 25- felt terrible, fever, extreme fatigue, body aches,and arm still the same. Dec 26- get tested for Covid, only slight headache and little fever Dec 27-Covid test negative, arm still swollen, but not as red
LYMErix vaccine given 5/9/99, 6/3/99 and 5/11/2000. In April 2001 dentist suspected Trigeminal Neuralgia. On 4/17/01 neurologist diagnosed TN and he prescribed Neurontin. I have since had daily signs of TN, and 2 additional severe episodes. Am now on Tegretol (200mg 3 x per day) and maximum dose of Neurontin. Experience progressive memory loss in the past year. Also, severe pain in right shoulder (comes and goes). Follow up on 11/26/03: "I called my MD office, and spoke with the nurse, she said that the lot # was not recorded." The review of medical record received on 1/23/04 confirms the diagnosis of trigeminal neuralgia on 4/21/01. Pain symptom had been present since 4/4/01.  I've been diagnosed with Trigeminal Neuralgia. A full blown attack is excruciating. The pain is undesirable. At other times I get feelings in my lips, jaws, cheeks, ears, teeth, gums that are burning, tingling, or shooting. My memory once excellent, has deteriorated. I had experienced none of this until the vaccine. The burning of my gums/teeth began first, but I thought it was a toothache. Thing progressed worse until my 1st bad attach on April 17, 2001. I need to take drugs several times a day to control the symptoms. (Neurontin, 600 mg four times a day, and Trileptal, 300 mg, twice a day).
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Description: Developed joint and muscle pain x3 weeks after 1st AVA.  Needed high dose NSAIDS round the clock to maintain function.  Sxs abated after 3 weeks.  One month after vaccine receipt developed a fatigue  state that has continued to be present.  Lacks the stamina he had before receiving the shots and needs more frequent rest periods.  Symptom: Joint Pain, multiple joints.  Symptom: Muscle Pain.  Symptom: Fatigue, malaise >60 Days.  Has recovered from myalgias/arthralgias.  Has not recovered from fatigue.
Drug Reactions/ Allergies: hives and periocular swelling with Varivax; This spontaneous report was received from a physician referring to a 27-year-old male patient. His pertinent medical history and concomitant were unknown.  On an unknown date in 2008, the patient was vaccinated with one injection of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (strength, lot # and expiration date were not reported) subcutaneously for varicella vaccination (prophylaxis).   About 20 minutes after the vaccination, the patient developed hives and periocular swelling which was considered as drug hypersensitivity. He was taken to the emergency room where corticosteroids (unspecified) was used. It was unknown if any lab diagnostics was performed. On an unknown date, the patient recovered from this event. Physician did not want to give patient demographics. There was no further information provided.  The causality assessment between drug hypersensitivity and varicella virus vaccine live (Oka/Merck) (VARIVAX) was related.
First symptom noticed was a very high heart beat rate.  I assumed it was a reaction to the sucrose, which appeared as an  ingredient in the literature about the vaccine that the pharmacy provided. However, this symptom persisted for 4 days, the rate slowing somewhat on the 4th day. It was so uncomfortable it prevented getting sleep. I made a point of staying well hydrated before and for 4 days after the injection. Other symptoms included jumpy, jittery muscles, feeling I had 4 or 5 rods extending from my shoulders to my brain, a very localized but intense pain in my left shoulder,  general muscle ache and stiffness , and an overall feeling of being unwell.
Highest temp measured 104.4 (@ hosp); pt taken to Hosp from pizza hut by ambulance; dx poss febrile sz; acute pharyngitis; anemia; pt came in w/inc temp; eyes rolled back in head; cold s & s x 24 hrs;
low grade fever of 99.3; aches; This is a spontaneous report from a contactable consumer reported for himself. A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3248; Expiration date was not reported), second dose via an unspecified route of administration, administered in arm right on 23Mar2021 08:00 (at the age of 43-years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3248) in right arm on 03Mar2021 08:00 (at the age of 43-years-old) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. Approximately 14 hours after second dose, the patient experienced low grade fever of 99.3 along with aches on 24Mar2021 00:30 hr. Lasted about 4 hours. Went away on the day of this report (reported as today). The patient underwent lab tests and procedures which included body temperature: 99.3 on 23Mar2021. AE resulted in none of the above (unspecified details). No treatment was received. Clinical outcome of events was recovered on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.