chrisvoncsefalvay/vaers-outcomes huggingface dataset:
four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine; This is a literature report for the following literature source(s): An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, 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: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: positive, notes: (range 6.21-11.87 IU/L).; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event hyperthyroidism and suspect drug BNT162B2 cannot be 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-202300182391 Same article/drug/event and different patient; US-PFIZER INC-202300182392 Same article/drug/event and different patient; US-PFIZER INC-202300182393 Same article/drug/event and different patient.
Had PVCs; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Had PVCs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions (Caffeine related.).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (Had PVCs). At the time of the report, VENTRICULAR EXTRASYSTOLES (Had PVCs) had resolved.            The patient also stated that previously had PVC but they had been caffeine related. Patient also stated that had been reading about myocarditis and the vaccine and wondered if patient should do some more investigation before receiving vaccine.   Symptoms resolved in 3-5 days without medical attention/treatment No concomitant medications were reported  No treatment information was provided  This is a spontaneous case concerning a 66-year-old male patient with relevant medical history of Premature ventricular contractions (caffeine related), who experienced non serious, AESI, unexpected event of Ventricular extrasystoles. The event occurred unknown days after the second dose of mRNA-1273. The event resolved in 3-5 days without medical attention/treatment.  Diagnostic tests were not performed. Rechallenge is not applicable. Medical history of Premature ventricular contractions remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-370430 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 66-year-old male patient with relevant medical history of Premature ventricular contractions (caffeine related), who experienced non serious, AESI, unexpected event of Ventricular extrasystoles. The event occurred unknown days after the second dose of mRNA-1273. The event resolved in 3-5 days without medical attention/treatment.  Diagnostic tests were not performed. Rechallenge is not applicable. Medical history of Premature ventricular contractions remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
minor rash 2wk p/vax probable frustrated rubella event MMR given post partum to non nursing mom;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients concomitant therapies, medical history and concurrent conditions were not reported. On an unknown dates in August 2015 (reported as some time in August 2015), the patients were vaccinated with unspecified doses of PEDVAXHIB injection, lot # L004740, expiration date 16-NOV-2017 (route of administration and dose were not provided) that were improperly stored. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Pt. states that after receiving the 2nd dose of Shingrix 08/19/2021, started experiencing symptoms 08/19/2021 of fatigue, muscle ache, nausea, and arm pain. Lasting 24hrs, no noted lingering side effects. No noted Primary visit.
Youth reports flu-like symptoms the day after vaccines given: fever, chills, body aches. Then had generalized upper body pain/tenderness with movement x5 days; raising arms to shoulder level is painful. Ibuprofen 600mg prn for muscle discomfort.
Mom called our office the day after pt received Flu vaccination 10/17/14 pt developed the following sx: pt arm was swollen from shoulder to hand. Arm felt warm/hard per mom. Pt developed hives all over her face; etc.
Breakthrough case admission after 3 vaccines 3/29/21 Pfizer no lot# available Pfizer 4/19/21 no lot# available 12/4/21 Pfizer FD0809
Patient states that she developed rash in June, Was told that rash was allergic reaction to vaccine. Hospitalized for kidney failure (5days), rash is more severe now. Has sores all over body.
She had called to notify about the Temperature excursion of one of her shipments; A spontaneous report  was received from a  Physician concerning (no patient identifier) Moderna's COVID-19 vaccine (mRNA-1273) temperature excursion of one of the shipments/ product storage error.   The patient's medical history was not provided.  Concomitant medications was not reported.  On an unknown date, the event temperature excursion of one of the shipments occurred. The whole carton was stored at -16 F from 9am to 4 pm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, temperature excursion of one of the shipments/ product storage error was considered resolved. on an unknown date.     .; Sender's Comments: This report refers to a case of Product storage error, for mRNA-1273, lot # unknown, with no associated AEs.
Case number PHEH2012US007554, is an initial spontaneous report received from a physician on 02 Apr 2012 with a follow up information received on 16 Apr 2012: This report refers to 31-years-old female patient whose medical history, past drugs and current conditions were not specified. Her concomitant medications included birth control pills. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A11033), intramuscularly, without reconstituting with Men A lyophilized conjugate on 30 Mar 2012. No adverse event was occurred during this administration error. She was revaccinated with 0.5 ml dose of MENVEO (batch number: M11042, expiry date: 31 Mar 2014) on 02 Apr 2012. No other details were provided. Follow up received on 16 Apr 2012: Concomitant medication added, revaccination details added.
Medication was diluted incorrect Diluted with 1.8 mL instead of 2.2 mL
Information has been received from a physician concerning a 60 to 65 year old male patient who on 20-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 658673/0990U). On 22-OCT-2008 the patient experienced severe arm pain, swelling and redness that looked like cellulitis. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Pain noted in left deltoid muscle after vaccine. Initially she felt it was normal but did not resolve so was seen in office on 10/26/15. Physician felt was related to muscle inflammation. Provided MEDROL dose pack. Symptoms continue at this time - pain in left deltoid with abduction.
NEUROPATHY 12/2/2021 C DIFFICILE INFECTION HYPOTENSION 1/12/2022 C DIFFICILE INFECTION
Received MMR, VZV, and GARDASIL 9 on Oct. 5. Next day had low grade fever and headache. 12 days later developed a rash generalized to body with chills and body aches.
Raised, itchy bumps and general swelling started approximately 12 hrs after immunizations given.
Information has been received from a nurse concerning a 24 year old female who on an unknown date was vaccinated with 3 dose series of RECOMBIVAX HB (dose, route and lot # not reported). It was reported that the patient "had a negative titer" after completing the 3 dose series of RECOMBIVAX HB. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Follow up information has been received from the nurse who did not have any information the person was hired. She stated that she had the series of RECOMBIVAX HB (dose, route and lot# not reported) injection, but she had no immunity on the blood work. This is an amended report. The trade name for primary therapy was changed from RECOMBIVAX to RECOMBIVAX HB. Additional information is not expected.
Fever, rash on neck within 24 hours, itching, light sensitivity at area of rash, fatigue, diarrhea, nausea, headache, chills, sore ankles, weight loss. Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks.   Treatment with dermatologist- steroid cream to address rash, treatment with general practitioner- prescription strength antihistamine.  Restricted diet. Outcomes- 9 days after shot still have rash, fatigue, and intermittent nausea and headaches.
Information has been received from a pharmacist concerning a female who on approximately Dec 13, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid. A couple of days post vaccination,on approximately Dec 15, 2002, the patient experienced pain in her left arm and under her armpit, which has now resolved. As reported on Dec 27, 2002, the patient was still experiencing pain from injection site and pain radiates down her arm. It was reported that no medications or treatment were provided for the patient. Additional information has been requested.
swollen lymph nodes in the neck, chest, left side,. Dizzy, tired , nausea, left arm feels numb, headache that starts in the back of the neck and goes into my head.
Patient has a past medical history of neurogenic orthostatic hypotension well controlled with medication management for over 2 years. Patient began to experience uncontrolled hypotension within 12 hours of receiving first vaccine. He additionally has increased fatigue, particularly after eating. Had to be placed on daily steroids for 6 months along with midodrine to re-regulate his blood pressure.
Employee reports staying in bed for two days with fever and chills. Right arm is swollen and red patch around injection site.
I am also allergic; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I am also allergic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ADRENALINE [EPINEPHRINE] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (I am also allergic). At the time of the report, ALLERGY TO VACCINE (I am also allergic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Fever (100.6), chills, aches, pains.  All joints hurt as if being attacked.  Injection arm is extremely sore and painful when moved
W/in one month of vax developed UTI w/Salmonella; Rec'd 2nd dose of vax 2 to 3 months p/1st & 3rd dose six months p/1st; On 3OCT89 lab eval revealed Hep-B surface antibody negative;
Pt asked for a Flublok vaccine.  I gave him a Fluzone HD.   The boxes look similar, and the peel-off stickers look almost identical. I called him about 48 hours later and he said his only side effect was a "sore arm." No treatment.
Fever, vesicular rash.  Started with small red bumps, quickly spread and became vesicular over 2 days.  Had been exposed to chickenpox 10 days prior to office visit - 06/13/2005.
Pt received the 5-11 yr Pfizer vaccine instead of the 12+ Pfizer vaccine.
Persistent severe pain left shoulder with limited ROM secondary to pain, more than 7 weeks after the vaccination.
Pain at time of injection that was unusual for flu vaccines she has had in the past. Site soreness that progressed to limited movement of her right arm. Saw a Dr and is now going through physical therapy to get range of motion back. Told she had soft tissue injury.
Fluzone PF quadrivalent dose was given in error to 2 month old infant on 11/15/23. When error caught, medical assistant notified physician immediately. Parent was notified. Follow up call with family on 11/16/23.  During follow up call mom stated  infant had temperature of 100 degrees and was a little sleepy  No worrisome side effects and temperature was down later in the day.  Mom is monitoring and will call clinic with concerns.
Dizzy and body aches 09-06-2023 and 09-07-2023 plus extra pain in left arm into left chest  Treated with (2 ) 500 mg Tylenol which I continued q 4-6 hours. On morning of 09-08-2023, I woke at 6:00 am with red rash on left side of neck.  Rash progressed back of neck, front and back of truck.  I went to Urgent Care at 8:00 am.
pt recv vax 1145AM & APAP given prior to vax & instructed to cont for at least 24hr-grandma states that pt temp was 103 that evening w/APAP;
The pt experienced localized erythema with swelling at the injection site which was 3" x 3" whish was lymph reported on 9/27/01. Benadryl, ice and warm compressed were used for tratement.
pt recvd vax 8NOV93 & was found dead 11NOV93; pt had not exp any side effect p/vax & appeared happy; autopsy performed-dx SIDS; infant was given prophylactic tylenol, had no post-vax rxns;
The first day i received vaccine I had ringing in my ears for about an hour.  I heard the ringing on and off for about two weeks. I have heard the ringing 3 or 4 times since then. Today, I had an episode again but it was louder than usual. I have never had an issue with tinnitus before I received the vaccine.
Blood was gushing out when shot was given. Immediately after arm was aching. Months later I still have excruciating pain on my left arm. Especially at night I cannot move my arms without having to support it with my other arm. Went back to the doctor to tell her what happened. She said sorry for what happened and gave me muscle relaxer and blood thinners which I have been taking but has not worked. Please tell me what I need to do to fix this pain.
Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; This is a literature report for the following literature source(s): "Concomitant mood disorder and stutter in a post-COVID-19 patient A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "major depressive disorder" (ongoing); "stutter" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Angiogram: revealed no abnormalities; Computerised tomogram head: revealed no abnormalities; C-reactive protein: normal limits; CSF test: an elevated protein level; Fibrin D dimer: normal limits; within normal limit; Laboratory results: unremarkable; Magnetic resonance imaging head: revealed no abnormalities; Protein total (15-45): 73 mg/dl; SARS-CoV-2 test: Positive; Negative; Serum ferritin (26-388): 530 ng/ml.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
ARMPIT SORENESS; SOME SWELLING AT INJECTION SITE; INJECTION SITE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced armpit soreness, some swelling at injection site, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some swelling at injection site, injection site soreness and armpit soreness was not reported. This report was non-serious.
3 days after vaccine administered, pt presented to the office with area of cellulitis surrounding injections site. Patient c/o pain since receiving shot than began to turn red and swollen. Presented with 13x13 cm area surrounding site with decreased ROM of elbow.
Booster administered too early. Last COVID vaccine given in Feb. 2022. Pt walked in today, Thurs. April 14, 2022 for Booster. Pt made aware that vaccine was given too early. Medial director made aware immediately. Pt waited 15 mins after vaccine administration. No adverse reaction voiced by patient.
No additional AE reported.; 4 month old patient was administered GARDASIL 9 today, 21-MAR-2023; This spontaneous report has been received from a licensed practical nurse (L.P.N.) referring to a 4-month-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 21-MAR-2023, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter (mL), lot# U031051, expiration date 14-JUN-2024, strength, route of administration and anatomical location were unknown) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) reported (no adverse event).
This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (developed ulcers in her mouth) in a 67-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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced MOUTH ULCERATION (developed ulcers in her mouth). At the time of the report, MOUTH ULCERATION (developed ulcers in her mouth) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment for the included Benadryl and a swishing solution.
Had the shot but still got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot but still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-APR-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she know few patients who received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
August 10, 13 mother took pt to ER for red painful right arm. Redness, whelps itching painful and warmth at injection site.
Fever at 102.7 both arms red and swollen, he?s crying and fussy. Irritable and making weird noises. Staying up can?t sleep. Both arms are very hot. I?ve traced the red circle it?s getting bigger. These shots are stupid. He had a strong immune system before getting any shots, now he?s sick all the time. I?m waiting 6 months til the next ONE shot required for school.
POSITIVE SIDE EFFECT; HAIR GROWTH; NAIL GROWTH; This spontaneous report received from a patient concerned an 80 year old male. The patient's weight was 150 pounds, and height was 71 inches. The patient's past medical history included malignant melanoma removed, and food poisoning, and concurrent conditions included nail fungus, and other pre-existing medical conditions included took black walnut husk and it affected gut flora, so patient started taking a probiotic as well. The patient was previously treated with juglans nigra fruit for food poisoning, influenza vaccine for prophylactic vaccination; and experienced asthma, edema and high eosinophil count when treated with naproxen sodium, and severe allergy/anaphylactic when treated with diethyltoluamide.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805031, and expiry:10-JUL-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced hair growth. On 26-MAR-2021, the subject experienced nail growth. On an unspecified date, the subject experienced positive side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hair growth, nail growth and positive side effect was not reported. This report was non-serious.
local rxn @ site of inject, temp to 100 w/in 24hrs of inject, fretful, inability to sleep longer than 1 1/2hr;
Patient reported a reddened area about 3 inches in diameter, raised, hard to the touch, and bumpy, on her right arm in the mid-back of upper part of arm. Reported it was very tender and slowly went away after 2 months.