chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With my first dose, dizziness didn't happen until nearly a weak later"; During the next several days, both lost their balance; This is a spontaneous report form a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced dizziness 3 to 4 days after the shot which lasted a while then stopped. Patient wanted information if this is a side effect of the vaccine and how long they will last. Caller mentioned that she "researched online and read a bunch of people talking about their experience with the vaccine and several people had the same experience as her husband dizziness, almost like a vertigo effect". Patient mentioned that with my first dose, dizziness did not happen until nearly a weak later. It scared me enough to get COVID tested. Results were negative. It seemed to go away until the second dose. Patient figured it had to be from the vaccine. Patient mentioned the next day, and after her husband caller got the vaccine, both almost fell over getting out of bed. It did not last very long. During the next several days, both lost their balance and caller had been reading that all over the internet that people losing their balance, getting dizzy. The patient underwent lab tests and procedures which included sars-cov-2 test: results were negative on an unspecified date. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Fever for 2 days post vaccine with chills. Red area (R) arm where inj. given.
Case number PHEH2011US01749 is an initial spontaneous report received from a health care professional on 02 Aug 2011. This report refers to an 18 years old female patient. She was given only the MenCWY liquid conjugate component of MENVEO (batch number M10053) intramuscularly 02 Aug 2011. No other adverse reaction was reported.
Per Mother: He had severe abdominal pain for 2 weeks after receiving his first and second GARDASIL shots. Refused the third on 2-19-14. 1st: 08-12-13 Lot # H021608. 2nd: 10-15-13 Lot # H021608.
Three weeks later, her inflammation was down at least 60%; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8733) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune diseases" (unspecified if ongoing), notes: has a history of autoimmune diseases; "Hashimotos" (unspecified if ongoing); "mixed connective tissue disease" (unspecified if ongoing); "psoriasis on her ankle" (unspecified if ongoing), notes: Its just psoriasis on her ankle that she puts coconut oil on. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Three weeks later, her inflammation was down at least 60%".  Additional information: Reported as, History of autoimmune diseases, including Hashimotos, mixed connective tissue disease, and the other one is like no big deal, its annoying, but no one sees it. Its just psoriasis on her ankle that she puts coconut oil on. It just kind of soothes it so it doesn't get itchy. With her autoimmune disease, when she has one of them attacks, tendons and ligaments, they get inflamed, and she can't move. She was actually in a nasty flare up at that time. It was at a fairground. Because of where you had to park, you were supposed to walk all around the build and she wasn't going to be able to do it, it was too far. So, they actually figured out a way for her to cut through all this stuff and just to come through the front so she could get the vaccine. It was great because it would've been nasty. Three weeks later, her inflammation was down at least 60%, not pain free but could move, she said oh my gosh this is amazing, she hasn't felt this good in at least 15 years.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204036 same patient/event, different dose;
pt devel lupus following vax w/a series of Hep B; No further details were provided;
i got them, i cant get the 2nd dose they suck; they hurt; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced Shingles after that which hurt a lot. The patient could not receive the second dose due to shingles experience. Consent to follow up was not possible as no contact details were available.
Patient has reported significant pain in shoulder, warm, tender when trying to move her arm to do some daily functions. Symptoms started about 1-2 hours after immunizations.
Felt drunk; Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area; Had problems with talking; Wasn't thinking that well; Felt extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness). The patient was treated with BACLOFEN at a dose of 5 milligram three times a day. At the time of the report, FEELING DRUNK (Felt drunk), MUSCLE SPASMS (Muscle spasms in right top part of right elbow/ Muscle spasms in left area and thigh area), SPEECH DISORDER (Had problems with talking), THINKING ABNORMAL (Wasn't thinking that well) and FATIGUE (Felt extreme tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.   This case was linked to MOD-2021-256655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Added treatment medication Baclofen, Updated events outcome as Resolved. Rechallenge date and results were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Redness, irritation, warm to touch around injection site. Slightly worse each day. Red, warm area about 2 inches in diameter. Noticed after second round of vaccinations 2 days after yellow fever vaccination (Hep A and Hep B IM on right arm; Typhoid IM on left arm near yellow fever site).
Patient received 1st dose Pfizer Lot EN6204 in RA on 3/12/2021 at a LCPH vaccination clinic. Subsequently returned for a second dose of the COVID-19 series and was given the Moderna vaccine to complete her series.
On 03/24/2021 @ 0730 am, I experienced drooping and weakness of right side of face and mouth. Diagnosed with Bells Palsy at emergency room. CT was negative for mass. Prescribed Prednisone 20 mg  3 tab daily for 7 days, & Acyclovir 800mg 5 tablets daily for 10 days..
soreness at injection site x 2 days,  bruising, and edema at site of injection x ~ 1 week, Diarrhea x 5-8 days, colon pain/inflammation x 3-4 days, indigestion/chest heaviness continue til yesterday not as bad worse the first 3 to 8 days, now briefly during day
Initial unsolicited report received from a consumer (patient's mother)  on 30-Mar-2017. This case involves a two-month-old female patient who was vaccinated with first dose of ACTHIB (Batch number: UH768AA; expiry date: 17-Dec-2012; dose and route of administration were not reported) in left thigh on 14-Feb-2013. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The patient did not received any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 14-Feb-2013 on that night, same day following the vaccination, the patient had developed redness, swelling and heat at the injection site, small palpable lump in left thigh that feels like a grain of rice and constantly itches the site. The patient required ER/ doctor visit. It was reported that the patient had been referred to a surgeon and an oncologist looking for possible cancer at the site. Laboratory investigations included ultrasound, biopsy, xray, blood work and other testing to rule out cancers. Corrective treatments were not reported. Patient was not recovered from the events. It was reported that patient was still under evaluation and the lump continues. List of documents held by sender: none.
Rash to (B) arms. Dx rash following immunizations. BENADRYL given. Strict ER warning also given.
38 year old patient received fluzone high dose quadrivalent vaccine instead of flublok quadrivalent with no reported adverse event; 38 year old patient received fluzone high dose quadrivalent vaccine with no reported adverse event; 38 year old patient received fluzone high dose quadrivalent vaccine with no reported adverse event; Initial information was received on 08-Nov-2021 regarding an unsolicited valid non-serious case received from pharmacist and consumer/non-health care professional via Agency (under reference number - 00847903).  This case involves a 38-years old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the flublok quadrivalent with no adverse event (Wrong product administered,  Product administered to patient of inappropriate age and Overdose).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On 06-Nov-2021, the patient received 0.7ml {total} dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ759AD and expiry date 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered, Inappropriate age at vaccine administration and Overdose (latency was on same day).  There were no laboratory data/results available.  At the time of report, no adverse event reported.  Event outcome was unknown.  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.
Syncopal reaction, loss of consciousness, clonic contractions, regained consciousness on own within 1 min. We lowered him to the floor, where he stayed until starting to feel better. Removed mask to increase air flow. Gave 2 bottles of water. Pt reported that he hadn't eaten or drank much water today. Recommended strongly to have a good breakfast & lunch, plus lots of water before second dose. Checked BP twice, initially 80/47, repeat reading 100/70. Pt reported feeling better & planned to take service car home.
This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a neonate patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to ENGERIX B. Additional details were provided as follows: The patient was 4 years old at the time of reporting. The patient received a dose of ENGERIX B vaccine at birth. On an unknown date, the patient might had an allergic reaction to the ENGERIX B. The healthcare professional (HCP) was unable to clarify what specific reaction did the patient experience. The HCP was unsure if the report was previously reported.
Information has been received from a consumer concerning her 13 years old daughter who on approximately 30-AUG-2007 was vaccinated with her first dose of Gardasil (lot# unspecified).  There was no concomitant medication.  Approximately one week later the patient began experiencing dizziness and vomiting.  It was reported that initially she experienced the dizziness and vomiting at least once a week and then once every couple of months.  Unspecified medical attention was sought.  At the time of this report, the patient was still recovering from her experience.  No additional information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a physician and a consumer concerning her 12 years old daughter with allergic rhinitis and no known drugs allergies who on 22-AUG-2007 was vaccinated in the left deltoid with her first dose of GARDASIL (lot# 658222/0927U). Unspecified medical attention was sought when patient's mother called the physician's office on 27-Aug-2007 regarding the patient's complaint of headache, nausea and dizziness. No additional information was provided. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning an 8-year-old female with a peanut allergy, who on 30-NOV-1998 was vaccinated with a dose of Varivax (lot# not available). There was no illness at the time of vaccination. On 26-APR-2006 the patient developed a red, itchy rash with approximately 12 lesions. It was reported that the patient's rash was diagnosed on 01-MAY-2006 when the lesions were crusted over; though no diagnosis was reported. No diagnostic or laboratory were performed. It was noted that the patient recovered on 01-MAY-2006. No further information is available.
Dizziness, difficulty breathing  for 3 days, fever in excess of 101.6 for 2 days,  loss of taste, loss of appetite, severe fatigue, body aches especially in neck and chest,
Extreme runny nose and sneezing.   Minor body aches.  Taken an antihistamine with minor improvement.  Also using oxymetazoline hydrochloride nasal decongestant with temporary improvement.
Booster shot 8 months after 2nd COVID shot.  All 3 have been moderna. Extreme fatigue, moderate headache that comes and goes, extreme lethargy, sinus/tooth pain.  No fever. No cough.
No additional adverse event.; inadvertent administration of MMR II and Varivax via intramuscular rather than subcutaneous route; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 13-MAR-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live ( (unknown albumin status) (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) both for prophylaxis, via intramuscular route instead of the subcutaneous route (incorrect route of product administration) (concentration and anatomical location of vaccination were not reported for either therapy; dose, frequency of vaccination scheme, lot number, and the expiry date was unknown by the reporter for both therapies) Other suspect therapy included the sterile diluent (indication, concentration, and dose were not reported; lot number and expiry date were unknown to the reporter).   No adverse events were reported.
pt states that after she got the vax her sinuses cleared up.  On 3/7/2021 her gums started bleeding while brushing her teeth.  On 3/8/2021 she started using a different tooth paste and the next day the bleeding had stopped.  On 3/8/2021 she noticed that she her lymph nodes were swollen under her neck.  The swelling started to subside on 3/10 and today 3/11 the swelling is almost gone.  Pt has an appt w/ her Dentist today 3/11/2021 @ 4PM.
This spontaneous report as received from a medical assistant (nurse) refers to a 78 year old female patient with type II diabetes, high blood pressure and no known drug reactions/allergies. On 05-OCT-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose route and frequency not provided). Concomitant therapies included atorvastatin (manufacturer unknown), GLUCOPHAGE, hydrochlorothiazide (manufacturer unknown), FOSAMAX, aspirin (manufacturer unknown) and enalapril maleate (manufacturer unknown). On 29-JUL-2013, the patient began to experience pain and lots of red spots on her right arm. The patient was seen in the office on 04-AUG-2013, and presented with left shoulder, posterior aspect a dermatome pattern with papules and vesicles, some in clusters. The patient was diagnosed with Herpes Zoster. The patient was treated with VICODEN, but it did not agree with the patient. The patient was then treated with famciclovir (manufacturer unknown), ibuprofen (manufacturer unknown) and TYLENOL. No laboratory tests were performed. The nurse stated that she spoke with patient on 12-AUG-2013, and patient was currently experiencing pain, numbness, achiness and trouble moving the affected arm. The patient also reported that her daughter is taking care of her and if her daughter was not able to help her, the patient was going to be placed "in a home". The reporter considered the Herpes Zoster to be disabling. Additional information has been requested.
All within 24 hours. Rash-maculopapular. Not involving mucous membrane. No petechaie. Excessive crying 3 hours, high pitched. Started in PM. Irritability. Fever 100 (subjectively was higher).
had one shot of Shingrix and then I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingrix and then he/she got shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
The area surrounding the injection site became bruised and red, itchiness was felt on upper arm, neck, and face. Symptoms lasted approximately 4 days.
Chest pain that was much more severe when sitting or sleeping. Sleep was disrupted nightly and I was not able to sleep on my left side. The chest pain lasted about 6 weeks and occurred most severely 3-4 times per day. I visited my PCP and he said that he heard a loud murmur or wooshing sound. He checked for a fib but heart ECG was normal. We scheduled an echo but the echo was not performed until 2 months post onset of the symptoms. Symptoms seem to point to subacute pericarditis.   Increase of Petechiae on the torso. One spontaneously bled. Seems to be fading after three months.
1/13 AT 2AM AWOKE WITH CHILLS, FEVERISH (t99) HEADACHE FROM TOP OF HEAD DOWN TO POSTERIOR NECK, SORE THROAT, FATIGUE, MYALGIA AND ARTHRALGIA Did not work on 1/14/21-  by 1/14/21 afternoon improved
Mom reports petechiae next day after shot off and on - earlobes, cheeks, wrist. 12-22-10 c/o dr for increased temp- ITP dx at Med Center.
Shot hurt when given. Did not feel well by 17:00. 21:00 temp 102.8 F through Sunday. Arm red, bruised (20cm), swollen at site (80cmX90CM) on Monday. Temp 97.5. Monday AM, took tylenol 2 tabs 500mg/eq. Ice applied.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Before vaccination, patient briefed pharmacist regarding very probable likelihood of fainting. Per patient's own account, this event occurs very frequently when recieving vaccines. Pharmacist understood and with conset of patient continued vaccination. Within a minute after administration patient did pass out into catatonic state, followed by epileptic-like convulsions. RPh provided physical support with patient as she was convulsing out of chair and onto floor. Convulsions ended within 2 minute
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 25-AUG-2009 the patient was vaccinated with the first dose of VARIVAX (Merck) (0.5 mg, lot number and expiration date not reported) subcutaneous. On 22-AUG-2012 the patient was vaccinated with the second dose of VARIVAX (Merck) (0.5 mg, lot number and expiration date not reported) subcutaneous. On 29-JUL-2013 the patient was vaccinated with a third dose of VARIVAX (Merck) (0.5 mg, lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
Post vax, the pt experienced a fever. Approximately one week later, the pt experienced a non-specific genital lesion that has not resolved.   The most recent information received on 11/23/99, reports the condition of the pt as ongoing.
Patient complains of swelling/pain to left arm at injection site. Also having generalized body aches, swelling to his face and eyes. Symptoms started day of vaccination, one hour after administration. Patient waited at home to see if symptoms would improve, presented to ER 1 day later. Patient took no over the counter medications at home. Received IM TORADOL 30 mg and IM BENADRYL 50 mg. After administration of medications, patient reported relief of angioedema and pain.
Information has been received from a healthcare worker referring to a 51 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose 1, lot# K003604 with expiry date 20-MAR-2015; dose and route were not reported). On 03-AUG-2015 the patient was inadvertently vaccinated with a second dose ZOSTAVAX, (lot # L006379 with expiry date 25-MAY-2015; dose and route were not reported (extra dose administered). No adverse experience had been observed or reported. Additional information has been requested.