chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling @ inj site, numbness in fingers, swelling of hand;onset that same evening;went to clinic;DPH & ice pack;swelling subsided Monday 4MAR96
1038 patient in lobby of observation  BP: (!) 132/93 (!) 147/93 (!) 153/129 BP Patient Position: SITTING SITTING SITTING BP Location: RA-RIGHT ARM LA-LEFT ARM RA-RIGHT ARM Cuff Size: Standard Adult Large Adult Standard Adult Pulse: 64 74 75 Resp: 18 18   SpO2: 96%   95%   Patient awake, alert, clear speech Denies difficulty swallowing Unlabored breathing "never get the flu shot because of a reaction", stated patient  Last pfizer shot had fever and chills Patient will remain for further observation  Lung sounds clear no wheezing RN,BSN,PHN 9/17/2021 11:02 AM
Information has been received from a physician concerning a pediatric male who was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently the patient experienced an allergic reaction to the gelatin in the vaccine. The child was treated with an epi pen and he is now fine. Subsequently, the patient recovered. No product quality complaint was involved. The allergic reaction was considered an other important medical event (OMIC) by the reporter. Additional information has been requested. Follow up information from the physician indicated that additional vaccine information was unknown because she did not give the vaccination at the office. On 15-JAN-2009, at age one, the patient received a dose of MMR II, PREVNAR, Hib conj vaccine (manufacturer unknown), and VARIVAX (Merck) and within less than 30 minutes he developed hives and started vomiting profusely. He was treated with BENADRYL and did well. He recovered that same day. On 18-JAN-2005 the patient was vaccinated with doses of MMR II, IPV, and DTaP and right away started sneezing, had hives, started vomiting and had swelling around his eyes. He was given BENADRYL and responded very well. He had been taking amoxicillin for 4 days and completed the course over the succeeding 4 days. He was noted to be recovered on the same day, 18-JAN-2005. It was noted that his IgE bovine was positive for porcine gelatin. Other business partner numbers include E2006-00994.
I remember sneezing in the middle of the night and woke up with slight congestion, fatigue and some body aches. I tested myself for COVID-19 on January 02, 2023 and the test was positive. I called the doctor and was prescribed PAXLOVID due to my age. I took the 1st dose and woke up extremely nauseous. I stopped taking the medication and I then I woke up with a fever around 101.0 at its highest and generally felt worse. I was out of commission for the next 5 days. Mostly my symptoms were fatigue. I might have had a bit of dizziness and took meclizine to treat those symptoms. It took a couple of weeks to feel 100%.
Extreme stomach upset, muscle- joint ache and pain, muscle spasm, headache, constipation, fatigue, sinus pain, blurry vision
Lt. upper arm swelling, hot, reddened, then increase in size - 7 cm. in diameter: Also developed acute resp. issues 4 hours later requiring (2) albuterol resp. Tx's. BENADRYL 50 mg taken at 2100 then S/S resolved slightly then reoccurred the next day w/area swelling and redness accompanied by resp. distress requiring sev. doses of bronchodilators. S/S subsiding and slowly improving.
Age: 45 at time of 1st dose (9/22/21) and 46 at time of 2nd dose (10/13/21)- both around 8:30am   Female Pfizer BioNTech (lot: EW0182) received at the Health Center I started losing large amounts of hair every time I washed my hair, and a lot more than usual was falling out throughout the day. This began immediately (9/23/21). After a friend suggested I take Vitamin D, I began taking it on 12/6/21. The major hair loss stopped immediately. In this 2 1/2 months, I lost about half my hair.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult female patient of unspecified age. This case refers to 20th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Pt developed swelling of right leg (thigh) area with redness and was also febrile.
RN noted red, flushed, hot, swollen left deltoid on assessment. Pt. was started on Vancomycin and Piperacillin-tazobactam antibiotics on 9/28/13. Swelling was noted as improved by 10/3.  No rashes or blisters were present.
Information has been received from a nurse practitioner concerning a female coworker with no medical history and a latex allergy who in October 2006 was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a sore throat with white bumps on the back of her throat and headache. After the second dose of the vaccine, the patient experienced a fever, vomiting, diarrhea, blurry vision, headache and dizziness. Subsequently, the patient recovered. It was reported that the nurse practitioner is not the coworker's healthcare professional and does not want to be contacted. No product quality complaint was involved. Additional information is not expected.
Heart palpitations and racing; Tingling finger on right hand; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date an unknown date in Jun2021 at 15:30 (Lot number: EW0178) at the age of 54 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: No; Known allergies: No. Concomitant medication included: IBUPROFEN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0178; Anatomical site: Left arm; Administration time: 15:45), administration date: an unknown date in May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: PALPITATIONS (non-serious) with onset 01Aug2021, outcome "not recovered", described as "Heart palpitations and racing"; PARAESTHESIA (non-serious) with onset 01Aug2021, outcome "not recovered", described as "Tingling finger on right hand". Therapeutic measures were not taken as a result of palpitations and paraesthesia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
15x11 cm area reddness and swelling L upper arm 36 hours after injection
Adult dose given to pediatric patient; 1year received adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix 1440 adult) (batch number 5%M72, expiry date 13-DEC-2024) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Havrix 1440 adult. On 29-MAR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: Adult dose given to pediatric patient) and adult product administered to child (Verbatim: 1year received adult dose). The outcome of the accidental overdose and adult product administered to child were 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: 31-MAR-2023 The reporter was a medical assistant. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The pediatric patient was accidentally administered with Havrix 1440 adult vaccine, which led to accidental overdose and adult product administered to child. The case is linked with case US2023048543, reported by same reporter.; Sender's Comments:  US-GSK-US2023048543:Same report/other patient
She has under left armpit a lump that has come up about 1 cm in size.  She also started having hands and feet turning red and itching.
2:00 p.m. began with pain in right ear and jaw, dizziness, nausea and tinnitus,   Pain alleviated with warm compresses.  Next two days dizziness and nausea continued with tinnitus.  Tinnitus continues.
Bright red rash on the entire shoulder of injection site.  Light itching on and around rash.
gen macular rash start 31MAR95; ER visit 1APR95 730PM; recv DPH;
temperature excursion that was intermittent beginning 7/28/2020 involving PROQUAD states that there have been administered doses; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of minus 14 degrees Celsius to 10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 13-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) as prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014853:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-APR-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Felt ill with sore throat, ear discomfort, chills after 3 hours of receiving vaccine on 12-13-07. Joint pain about 10 days after vaccine. Measles rash (mild) over chest upper arms and face began approx 12-26-07. Presented to place of vaccination for reporting and asks about risk of contageon. No treatment offered. Off work until rash resolved.
Vaccine they received was expired but it was given to 6 patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine they received was expired but it was given to 6 patients).    No concomitant medication details was reported. Vaccine was administered on 24-Feb-2023, 28-Feb-2023, 01-Mar-2023 and 06-Mar-2023. The vial was initially stored in the refrigerator on 16-Feb-2023.  The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715780, US-MODERNATX, INC.-MOD-2023-715730, US-MODERNATX, INC.-MOD-2023-715785, US-MODERNATX, INC.-MOD-2023-715792, US-MODERNATX, INC.-MOD-2023-715804 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715730: US-MODERNATX, INC.-MOD-2023-715780: US-MODERNATX, INC.-MOD-2023-715792: US-MODERNATX, INC.-MOD-2023-715804:same reporter US-MODERNATX, INC.-MOD-2023-715785:
6/11/09 - syncopal episode in restaurant. EEG Nl. To Dr.-neuro - Dx syncope, pos migraine. 12/09 - 1/10 loss of awareness. 2/10 - Dr. watch. EEG - ? 6/2010 - Dr. - no further events. 6/22/10 syncopal episode at funeral outdoors. 3/23/11 - Dizziness, confusion. 4/4/11 - EEG abnormal. 4/19/11 - Brain CT normal. 10/5/11 Brain MRI normal.
Numbness and tingling in fingers and hands, shortness of breath, tightness in chest.
Hard to breathe.  Did not advance to more severe issues.  P- 70, B/P 117/75.
Red and swollen arm; hot to touch; developed rash on shoulders extending to back; patch of red, raised rash on left cheek and jawline and chin. Treated with Benadryl and Prednisone taper.  Complete recovery.
Patient presented to ER 3 days after administration of vaccine with pain, erythema, nausea, fevers. Diagnosed with cellulitis to right arm, given Keflex 500mg 1 tablet every 6 hours for 10 days
Pain in arm, morning after injection 2/23/2022 continuing till 3/8/2022, still occurring Intermittent right Finger tips Numbness starting on 3/6/2022, still occurring Complete right arm numbness intermittent starting 3/7/2022, still occurring Diarrhea 2/23/2022
Information has been received from a physician concerning an 18 year old female who on 14-SEP-2006 was vaccinated intramuscularly with a first 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  About an hour after receiving the vaccine, the patient developed shortness of breath and a fever.  The patient was directed to the emergency room. It was noted that the patient's symptoms improved "on therapy" (unspecified).  No product quality compliant was involved.  Shortness of breath and fever were considered to be other important medical events.  Additional information has been requested. (OMIC)
grand mal seizure; This is a spontaneous report received from contactable reporter (other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Dec2021, for COVID-19 immunization; Bnt162b2 (dose 2; 20 days after 2nd shot, she suffered a grand mal seizure), administration date: Dec2021, for COVID-19 immunization, reaction(s): "grand mal seizure". The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "unknown", described as "grand mal seizure". Clinical course: The patient also received the booster and 19 to 20 days after receiving the booster, she suffered another grand mal seizure.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200096896 same reporter/patient/event, different dose;
No feeling of shot.  Sick 3 days after wife.  Achy, shot throbbed. Violent vomiting, tired next day, no appetite and none for next day.
redness at injection site and a red spot further down the left arm; She also mentions being fatigued for a few days, starting the day after vaccine, but has since subsided.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 26-MAY-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site and a red spot further down the left arm) and fatigue (Verbatim: She also mentions being fatigued for a few days, starting the day after vaccine, but has since subsided.). The outcome of the injection site erythema was not resolved and the outcome of the fatigue was resolved.   It was unknown if the reporter considered the injection site erythema and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site erythema and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The patient reported that she received dose 1 Shingrix. The patient stated that the next day she noticed redness at injection site and a red spot further down the left arm which was not resolved yet at the time of reporting. The patient also mentioned being fatigued for a few days, started the day after vaccine, but had since subsided.  The patient was referred to Health care professional. The reporter did not consent to follow-up.
On 3/10/2021 the patient presented to the ED with dizziness with palpitations. Upon admission, it was found that the patient has an aneurysm in the ascending aorta. Reason for admission: dizziness and palpitations.
Pt recvd 3rd dose of vax 24AUG92 & devel a sore arm @ the inject site; No further details were provided;
About 20 minutes after Havrix injection patient noted onset of tongue swelling and tightness in his neck No wheezing or rash. Patient responded well within 20 minutes after 0.3cc SQ Epi. 10/8/07-records received for DOS 3/30/07 seen for allergic rhinitis. Visit on 10/1/07-25 minutes after vaccine swelling of tongue, mild contriction in throat, wheezing.  Follow up call to patient, doing well. Assessment: anaphylaxis due to vaccine.
It started with increased fatigue and increased heart rate upon standing. I saw many doctors and was diagnosed with POPS and Mamats. I also grew an allergy with all fragrances. I have more brain fog, muscle weakness, fatigue, GI issues, food allergies, and intolerance to heat. I am on a lot of medication now but the symptoms seem to not be clearing and remaining stagnant.
A non-serious spontaneous report of positive for influenza B has been received from a consumer and a physician concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 09-Sep-2009. On 14-Sep-2009 the patient tested positive for Type B Influenza. Outcome and causality were not reported. Additional information was received on 14-Sep-2009 from the patient's physician that included the following: reporter information and event onset.
itchy on my outer thighs, buttocks and the trunk of my body; sore extensive rash on my outer thighs, buttocks and the trunk of my body; flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PRURITUS (itchy on my outer thighs, buttocks and the trunk of my body) and RASH (sore extensive rash on my outer thighs, buttocks and the trunk of my body) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 09-Jun-2021, the patient experienced PRURITUS (itchy on my outer thighs, buttocks and the trunk of my body) and RASH (sore extensive rash on my outer thighs, buttocks and the trunk of my body). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PRURITUS (itchy on my outer thighs, buttocks and the trunk of my body) and RASH (sore extensive rash on my outer thighs, buttocks and the trunk of my body) outcome was unknown.            No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.
Temp 102 degrees x 3 days; x2 loose stools and fussiness.
high temp, rash started on face & spread to trunk & limbs, eyes sensitive to light first 12hr of sx;dx rubeola d/t vax;
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 11-APR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (dosing regimen unspecified) lot #K023537, expiry date 22-JUN-2016. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Temperature: 34.1F. Time frame: 48 hours. Data Logger: no. Was it administered (AE): Yes. Previous temperature excursion: no. This is one of the several reports for the same reporter. Additional information has been requested.