chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted hospital for experiencing chills with sudden onset fatigue and weakness in the evening post vaccination given that afternoon. Pt also had elevated HR so wife called 911
Graying of my front top 4 teeth, breaking off at the gum lines. Holes in teeth 8 teeth breaking apart. Last dental exam I was told that all but 2 teeth need work done, my problem areas are my top front teeth and the bottom back teeth on the left 8 right.
Patient was administered 0.25 cc of the Blue Cap Child Moderna (6-11yo) which resulted in the patient receiving half the dose that should have been given for an adult booster.
I had been having some testicle pain before the vaccine.    I went to get this evaluated and was given Levofloxacin and Naproxen for it.     I took my first dose of these on 03/11/21.     The morning of 03/12/21 i woke up with numbness and tingling in my arms.   I immediatly thought it was the Levofloxacin because the Medication Guide for it indicates you can get possible nerve damage (Peripheral Neuropathy) from taking it.    I did not take any more doses.     I sought medical help for this that next week thru Urgent Care, ER and Family Physician.     No one seemed to think it was the medicine, however there was no cause given.    Only treatment was to start taking vitamin B12 to see if that helped. I had EMG testing done after the feeling of numbness and tingling spread to legs and eventually felt it on my face as well.     EMG tests did not find any muscle/nerve issues.     I did not feel any new symptoms after my second dose of Moderna Covid vaccine on 04/01/21.     The symptoms i had been feeling continues for a few weeks and over the course of the Summer and into the Fall started to improve.     I got my booster shot of Moderna Covid vaccine on 10/24/21.     That was on a Sunday.    On that following Tuesday night i started to feel those same symptoms start coming back in my arms again and eventually legs.     Probably not as bothersome as initially but still worse than i had been feeling.     I had a Neurologist appointment on 11/09/21.    They indicated that it was unlikely what i was experiencing was related to the one dose of Levofloxacin.   They have seen people with Neuropathy after taking that medicine and it is something that happens with many doses over time.    They felt it was possible to be related to the Vaccine considering it is new could have side effects such as this.    They were also hesitant to say i had  Peripheral Neuropathy as well.      Over the course of the spring/summer my doctor labeled me as diabetic and i do take Metformin now for it.      The Neurologist indicated that some of it could be related to Blood Suger level as well even though my numbers are currently fine.      Basically not sure what possible combination of Vaccine, Medicine or Diabetes has played a role in this.
received covid and flu vaccine on 9/21. Extreme heaviness in Right arm around 2am on 9/22 "like a bag of cement had been poured on shoulder"  had headache, malaise, low grade fever the day after (9/23).  on 9/28 between 9 and 10 am, developed confusion and amnesia that fully resolved by 9/29 at 0500.  Was taken to  ER around 11am on 9/28 .  Inital treatment was for TIA and treated with Aspirin 81mg and plavix 75mg.  CT with and without contrast, MRI, echocardiogram, EEG performed.  Clinical diagnosis was TGA (transient global amnesia).  discharged on 9/29 around 630pm.
No known adverse event.  Patient was given Menactra on 2-11-08 from our supply.  This nurse did not check the expiration date.  When later entered was found to be 2-7-08.  Spoke with doctor and he recommends repeating dose at anytime.  Patient advised.
During waiting period, pt experienced syncope. She lost consciousness for a few seconds and fell (did not get injured in fall). She came back too, was very pale and sweaty. We contacted 911 and they dispatched EMS but patient refused to be evaluated. We gave water to drink, layed her down flat with elevated legs and put cold washcloths on her forehead. After approx 30 minutes she was well and able to walk away.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 73-year-old female patient who received Boostrix (batch number 54B74, expiry date 14th September 2020) for prophylaxis. On 8th May 2018, the patient received the 1st dose of Boostrix (intramuscular). In June 2018, 30 days after receiving Boostrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved. It was unknown if the reporter considered the vesicular rash to be related to Boostrix. Additional details reported as follows: The healthcare professional stated the patient received Boostrix and a month later developed a shingles like rash (unconfirmed) on her neck that ran down to her breast area. It was really mild, not really pronounced. The healthcare professional agreed to be re-contacted if necessary.
a lump in her left breast; She woke up this morning with a pain, and noticed the lump in her breast.; felt discomfort all over and in my left breast; Did not feel well; felt discomfort all over and in my left breast; felt very hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 (Lot number: PF12ER) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for depression. The following information was reported: BREAST MASS (non-serious) with onset 10Aug2021, outcome "not recovered", described as "a lump in her left breast"; BREAST DISCOMFORT (non-serious), DISCOMFORT (non-serious) all with onset 09Aug2021, outcome "not recovered" and all described as "felt discomfort all over and in my left breast"; FEELING HOT (non-serious) with onset 09Aug2021, outcome "not recovered", described as "felt very hot"; BREAST PAIN (non-serious) with onset 10Aug2021, outcome "unknown", described as "She woke up this morning with a pain, and noticed the lump in her breast."; MALAISE (non-serious) with onset 09Aug2021, outcome "not recovered", described as "Did not feel well".  Additional information: Caller received her 1st Pfizer covid vaccine dose on 07Aug2021, then last night felt discomfort all over and in my left breast, I felt very hot. When she woke up this morning she had a lump in her left breast. Concomitant Products Lexapro was started 4 weeks ago. She got the first Pfizer BioNtech COVID 19 vaccine dosage on Saturday 07Aug2021 around 4-5 pm. Her side effect started last night, and she woke up with a large lump in her breast today 10Aug2021. She is wondering if this is a side effect. She did not have a prescribing doctor. She started with discomfort all over and in her breast last night around 10-10:30 PM on 09Aug2021. She was also hot and did not feel well. She woke up this morning with a pain and noticed the lump in her breast. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. AE(s) does not require any visit to emergency room/physician office. No prior vaccinations (within 4 weeks). No patient's medical history (including any illness at time of vaccination) or provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. No relevant tests, list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).  No follow-up attempts are possible. No further information is expected.
No additional adverse events reported; VARIVAX was administered via intramuscular route versus subcutaneous route to a patient; This spontaneous report was received from a registered nurse, referring to a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 06-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter once, via intramuscular route instead of subcutaneous route (incorrect route of product administration), lot # U002400, with expiration date of 22-JAN-2023, for prophylaxis (anatomical location not reported). No additional adverse events were reported.
Received first dose on August 30 2021, expected menstrual cycle began September 1 2021. Cycle stopped the 6th of September, but continued to spot through out September 15 2021. Started another ?period? on September 16 2021,  lasted  5 days. As of September 20th I have spotting again.
I had severe headache for two days and fever one day; I had severe headache for two days and fever one day; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), via unspecified route of administration on 27JAN2021 at 16:45 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medication included celecoxib (CELEXA [CELECOXIB]).On 29Jan2021 at 17:00 the patient experienced severe headache for two days and fever one day. The events were considered as non-serious. The outcome of the events was Recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
feel like I have the flu; sharp pains in my chest; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (feel like I have the flu) and CHEST PAIN (sharp pains in my chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced INFLUENZA (feel like I have the flu) and CHEST PAIN (sharp pains in my chest). At the time of the report, INFLUENZA (feel like I have the flu) and CHEST PAIN (sharp pains in my chest) 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.   No Concomitant medication was reported.     No treatment medications were reported.
UPSET STOMACH; CHILLS; ARM SORENESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 18-MAR-2021, the subject experienced upset stomach. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced arm soreness. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, arm soreness, upset stomach, and headache. This report was non-serious.
mom called 19APR93 stating pt leg hurts so bad won't get off couch; no swelling or redness noted; no fever; seen by MD 19APR93; was given Ibuprofen for treatment;
'This Monday, the patient came to the office with a mild rash; This spontaneous report has been received from a physician via a company representative referring to a 1-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.       On 06-SEP-2019 (reported as last Friday), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot number and expiration date were not reported) for prophylaxis (reported as routine vaccine) along with all vaccines related to the one year old visit (no further details).         On 09-SEP-2019 (reported as this Monday), the patient came to the office with a mid rash. The outcome of rash was unknown. The causality between rash and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
He only had some arm soreness.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He only had some arm soreness.) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He only had some arm soreness.). At the time of the report, PAIN IN EXTREMITY (He only had some arm soreness.) outcome was unknown.            No concomitant product use was reported.   The patient received previous 2 doses of vaccine.  The patient had virtually no side effects with new strain. Patient was wondering if it was because of the mixed strains or a lower dose. In Sep-2022, the patient only had some arm soreness. Patient stated that his body was more used to the vaccine.  No treatment information was provided.   This case was linked to MOD-2022-642246, MOD-2022-642281 (Patient Link).   Reporter did not allow further contact
PATIENT GIVEN DTAP VACCINATION AT THE AGE OF 24. WAS TO RECEIVE TD VACCINE.
Patient received an expired dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via regulatory authority (Reference number- 00665299) and transmitted to Sanofi on 01-Jul-2021.  This case involves a 6 years old female patient who received an expired dose DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 30-Jun-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA) which was expired on 08-Jun-2021 via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "reports a patient was given the DTAP/IPV combination that had expired on 18 June and wants to know if they need to revaccinate. Reporter did not know which dose in the series it was."  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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 the 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.
States symptoms began 2 hours, post vax. Complained of nausea, diarrhea, fever and a fine red rash over body with itching. Sent to ER for assessment/treatment. Dx'd "allergic reaction to MMR vaccine". Rx: Hydroxyzine 25mg qid. Off work today.
Information has been received from a 64 year female with allergic reaction to antibiotics and intestinal problems, weakened immune system and "possibly had Ecoli" whose husband "about two weeks ago", on approximately 20-APR-2011 was vaccinated a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). Concomitant therapy included "blood pressure" drug. "On this past Sunday", 01-MAY-2011 the patient was diagnosed with shingles. Patient reported that she had a one-inch rash on her face that had little tiny sores on it. On the inside of her mouth where her jaw was, there were white pussy sores and she horrible pained. The pain shot down and hit nerves. She went to the doctor and the doctor said right away that she had shingles. Patient also reported that their 9-month old granddaughter was exposed and had also visited her doctor. Patient was treated with ADVIL and VALTREX. No lab diagnostics studies were performed. Patient sought medical attention by visiting the doctor. At the time of reporting, the patient had not recovered. Additional information has been requested.
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm 197 protein) injection) was received from a healthcare professional regarding a pt who developed autism. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. It was reported that a pt developed autism on an unspecified dated. No additional information was available at the time of this report.
A few weeks after receiving my second COVID vaccine, I realized that I'd been having an increased frequency and severity of tinnitus.  I am not sure exactly when the frequency and severity changed; it just sort of "clicked" in my head one day that, while I'd had a mild and intermittent tinnitus for years, it had become much worse lately.  I suffered for several weeks, with the tinnitus interfering with falling asleep at night.  I made an appointment for a hearing evaluation.   At some point between the time I made the appointment and the ENT doctor's visit (which occurred June 23, 2021), I read online that there was some anecdotal evidence of tinnitus as a rare side effect from the COVID vaccine, usually occurring after the second shot, and lasting a month or two.   The tinnitus began to improve shortly before the ENT appointment, but I chose to keep the appointment.  I underwent a comprehensive audiological evaluation with bilateral audiometry and tympanometry (records available), which found normal hearing with mild loss in higher frequencies on both ears, and nothing else notable.  Following the evaluation, the doctor spoke to me about the course of the tinnitus.  I mentioned what I had read and she was unaware of the potential COVID vax-tinnitus connection.  She looked it up while we were there together, and she agreed that with no other explanation for the temporary worsening of tinnitus and the fact that it followed the general pattern in the emerging literature, that was a likely cause.   The tinnitus at that point had improved and I didn't notice any unusual levels, so nothing further was needed. However, I got COVID in January 2022, and the worsened tinnitus returned and has persisted to this date (April 2022).  It may have slightly improved recently, but I'm not yet sure.   Interestingly, when I got COVID, the first symptoms days before any others was pressure and discomfort in my ears, to the point that I asked my husband to do ear candles on both ears, as a hail Mary to see if it would relieve any clogging.   I feel like it can't be a coincidence that I had noticeably worsened tinnitus following my second COVID vaccine AND an actual COVID infection.  Maybe my body just responds to the immune response stimulation with tinnitus, for some reason.  I wanted to report this in case it can help draw any links in others that it's not just the vaccine, but also an infection that can trigger this condition.
fever over 103 with 7/10 bodyaches that lasted approx. 9 hours, then tylonol, then about 7 hours later 7/10 headache, 8/10 bodyaches, fever of 102 with nausea, tylonol, slept most of next 24 hours. Lingering lethergy for approx. 3 days, lingering nausea 7 days
relapse for Rheumatoid arthritis (that she didn't had for 20 years); chills; fever; swelling of her hands and not being able to lift her arms; swelling of her hands and not being able to lift her arms; A spontaneous report was received from consumer, concerning herself, a 79 year-old, elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis, chills, fever, swelling of her hands/peripheral swelling and not able to lift her arms/vaccination site movement impairment.  The patient's medical history, as provided by the consumer, included rheumatoid arthritis and low count of white blood cells. Concomitant medications reported included clopidogrel, unspecified high blood pressure medication, unspecified cholesterol medication and unspecified thyroid medication.   On 18 Feb 2021, the patient received the first of two planned doses of mRNA (Lot number: 031M20A) in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced chills, fever, swelling of her hands and not being able to lift her arm 3 days after receiving the vaccine.   Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, rheumatoid arthritis, chills, fever, swelling of her hands and not being able to lift her arms, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
FOCAL MOTOR SEIZURE ACUTE STROKE DUE TO OCCLUSION OF BILAT MIDDLE CEREBRAL ARTERIES
Approximately 2 1/2 hours after the vaccine administered, he felt lightheaded and nauseated. Began sweating, and shaking for about 5 minutes. Continued to have episodic dizziness over the next 4 hours.
patient states she is experiencing an itching and tingling sensation in her left arm . patient took oral Benadryl and topical hydrocortisone cream if no relief patient was advised to go to the ER or contact her doctor
pt reported receiving 2 doses of covid vaccine and now when she takes Alleve prior to her Avonex injections she is experiencing fatigue and body aches.  Prior to the covid vaccine she could take 2 Alleve prior to Avonex and she would not experience fatigue or body aches.  Post covid vaccine Alleve is not working.
This spontaneous report was received from a registered nurse via company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced a local injection site reaction of redness and hardness after receiving the vaccination. The patient sought medical attention (doctor visit). The patient was treated with BENADRYL (manufacturer unknown). It was unspecified if any lab tests were performed. On an unknown date, the patient recovered from the local injection site reaction of redness and hardness. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.