chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nonserious report of expire dose of vaccine administered has been received from a nurse concerning a four year-old female patient.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history no concomitant medications were provided.  The patient received FluMist on 24-Jan-2008.  The FluMist had expired on 10-Jan-2008.  At the time of the report, no adverse events were reported from this error.  Rechallenge is not applicable.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
18 y/o M who on 19 Jan 2016 noticed rash starting on the chest. No other symptoms, no fever, no known eczema or immunocompromising conditions. On 22 Jan 2016, patient evaluated by local provider who contacted CDC with concerns that rash could be generalized vaccinia, and vaccine lives in dormitory setting (Patient has roommate and shares facilities with others whose health hx is not known). Patient was admitted to local hospital where specimens from lesions were sent for vaccinia PCR --> negative (See lab data that follows). Patient's hospital course (3 days - discharged on 25 Jan 2016) was uneventful, but he did spike a temperature of 102.2. No other systemic symptoms.
8cm x 11cm hot indurated area where site of vaccine administered. c/o h/a myalgia. Seen by RN.
Immediate excruciating pain going from my shoulder to my hand.  Chronic Pain and limited range of motion within 24 hours.  Diagnosed with infraspinatus tendinopathy and frozen shoulder.  Cortisone shot, exercises, medication given.  Still in pain and range of motion still not back to normal.
pt developed central retinal artery occlusion received bivalent covid-19 pfizer booster 12/5/22 developed eye irritation/foreign body sensation  12/8/22 started noticing left eye painless visual loss 12/12/22 seen in our ed 12/13/22 found to have acute centeral retinal artery occlusion of left eye
Sore arm, aches across neck and shoulders, minor chills, extreme fatigue, brain fog
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J001698, expiration date 08-MAY-2014, 0.65 ml, subcutaneous. On 12-MAY-2014, the patient received an expired dose of ZOSTAVAX. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Headache, running nose, cough, extreme tiredness, 11/10/2011 fever, congestion, runny nose, sore throat, cough, tiredness, achy muscles, earache OTC 11/12/2011 fever, congestion, sore throat, tiredness, nausea OTC 11/13/2011 congestion, earache, runny nose and headache, tiredness and slight fever OTC 11/11/2011  OTC - Sinus Headache caps, ThermaFlu, Vicks Vapor Rub
Developed fine pin point rash, hives all over body within 24 hours of shot given, face swollen, 6/4 dx by ER possible allergic reaction to vax. Treatment Benadryl by mouth but while in ER had Benadryl Injection.
first dose back on 8/24/2020 / never received the second one; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th August 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix and never received the second one, which led to incomplete course of vaccination. The reporter inquired if they should give the second dose or restart the Shingrix series for this patient. The reporter was unable to provide vaccine or patient details. The reporter did not consent to follow-up. This case has been linked to US2021213496, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213496:same reporter
This spontaneous report was received from a pharmacist and refers to a 12 year old male patient. The patient's medical history included hives due to penicillin allergy. Concomitant therapies included multivitamins. On an unknown date in 2017 (reported as "one year ago"), the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscular (lot # and expiration date unknown) to prevent human papillomavirus (HPV). On 05-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9 injection, intramuscular for prophylaxis. On 07-MAY-2018, the patient developed hives on unspecified areas of the body. As a result, on that day, the patient started 2 days of therapy with diphenhydramine hydrochloride (BENADRYL). On 09-MAY-2018, the patient went to see a physician and was started on 5 days of therapy with prednisone (manufacturer unknown) 30 mg twice daily. On 19-MAY-2018, the patient was started on therapy with cetirizine hydrochloride (ZYRTEC). The patient had not recovered at the time of reporting. No laboratories were performed for the event. The outcome of inappropriate schedule of drug administration was unknown. The reporter did not provide a causality assessment between the event and the suspect vaccine.
pt recvd vax; rash & redness Bil. cheeks w/ bumps under orbital region; heat radiating bil. cheeks;
Patient describes nausea, weakness, fatigue that occurred a day after receiving the high dose flu vaccine (9/9). She received it at lab diagnostics while getting lab work and called us, her PCP office to report symptoms. She feels slightly better today (9/10) but still feels fatigued and weak.
Pt received Moderna vaccine for second  shot in error, had Pfizer  for first vaccine, experienced low grade fever x 1 day, denies any problems on second day. Missed work on 9/23/21, returned to work on 9/24/21
Patient complained of the following symptoms the day after receiving Shingrix vaccine:  fever, muscle aches, weakness, tiredness, headache, shivering and upset stomach
99.1 Fever erythematous rash on chest and back. Bilateral legs and arms; Tx- given. BENADRYL elixer 125mg 1 tsp 1/2 top aid 10/23/09 called pt, spoke to mother baby recovering well.
Severe knee pain in both legs few hours after vaccine received.  Unable to walk, stayed in bed the rest of the day.  Hands swollen at knuckles and painful.
Patient was given Moderna Monovalent instead of being given Moderna Bivalent for their booster.  Patient's 1st Moderna shot was 9/13/21 and 2nd shot was 10/11/21.  On Nov 19, 2022, he was supposed to receive a booster with Bivalent.
Rash, erythema, pruritus, red, swelling, inflammation, hard, hot, warm, urticarial, antihistamine, cold compress, ice, moved arm a lot and mod. outcome. Sxs started w/n 30 mins. of immunization until today.
Pain in shoulder 1st day after injection, peaked at 1 week, continued since then and increased over last 3 days. Painful motion, especially abduction/elevation of shoulder, weakness of ratator cuff, no direct nerve injury, but poss. auto-immune phenomenon like Parsonage-Turner syndrome. Onset of Sx over period of 1-14 days, improved for 12 weeks, reacurred and worsened about 11-01-09. Sought care beginning 11-06-09. Sx weakness and pain in left arm, especiall with abduction of arm. No readness, swelling, nodules, masses, no redness or warmth. Left supra-spinatous muscle atrophy in supraspinous fossae, pain wit ext. rotation and abduction. Referred to sports medicine physician. Last exam 12-03-09: Feels tight in should with abduction >90 degree, supraspinatous atrophy, weakness, and pain. 1+= infraspinatinatous weakness, referred for physical therapy.
Information has been received from a nurse concerning her 17 year old granddaughter with a history of amoxicillin allergy who on an unknown date in 2007 was vaccinated with an unknown number of doses of Gardasil (lot # not reported). Sometime 2007 the patient experienced hearing loss in her left ear. At the time of this report, the patient's hearing loss in her left ear persisted. The patient was seen twice by a physician and it was suggested that she be rechecked for the hearing loss in one year. The nurse (grandmother) had limited information. Upon internal review, the hearing loss was considered to to be an other important medical event. Additional information has been requested.
About a week and a half ago I started feeling brain fog and was experiencing a floating sensation. Monday while on lunch I was driving and the world completely shifted and flipped in front of me causing me to pull over out of risk of wrecking my car. I do not have a history of dizzy spells or vertigo per se and there would be absolutely nothing that could have triggered this but the vaccine. I have an article where I am not the only one. Though I can still function im still scared to drive far and I occasionally feel like my eyes are floating
first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021; first dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021) outcome was unknown.        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 medication were reported No treatment medication were reported   This case was linked to MOD-2021-250536 (Patient Link).
pt recvd vax 23SEP93 & arm turned red immediately was still red when pt left office-10 min sl hot;
Dizziness after injection. Bp 80/60. Rechecked after 5 minutes-94/62.
Pt received shots DTaP, IPV, HIb at about 3om on 04/15/2002. fussy after shots then 2 hrs later pt noted to be "groggy" then pt noted to be "shaky" with arms. Not awake. This occurred "turned blue." Brought to ER had seizure at ER with a temp of 101 deg. F. Given Tylenol and Manageal at ER.
pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot 042L20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-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 VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.   Reporter did not allow further contact
Have intermittently in the past had periorbital eye swelling, but currently have sustained periorbital and perioral swelling, redness for last month. Diarrhea for a week starting 7/5/22, then was positive with Covid on 7/13/22, Covid positive still on 7/18/22. For the periorbital and perioral swelling, itching and burning, I went to the Urgent care on 6/23/22. I was given Solumedrol 125 mcg  IM and Rx of pred pack for a week to reverse the swelling  and itching that otherwise would not go away. They worked at first, but the perioral swelling came back, the eye swelling returned, but not the itching and burning...yet. The periorbital swelling has been intermittent for probably the past 2 years, but I never really thought about the vaccines causing it...maybe. Never had them prior to any of the vaccines. None of the rest of the family has had these symptoms. But of course they could be from allergies, I'm working with an allergist at this time also.
ACTHIB was given today with the sterile diluent from the box that expired on 17SEP2022 with no adverse event.; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was given today with the sterile diluent from the box that expired on 17-Sep-2022 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 12-Oct-2022, the patient received today 0.5 ml dose 3 of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ581AAA; Expiration: 17-SEP-2022) via intramuscular route in the left thigh for Immunization with the sterile diluent from the box that expired on 17-Sep-2022 with no adverse event (expired product administered).  Action taken : not applicable.  Outcome :  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 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.
polymyalgia rheumatica; Information has been received from a lawyer, regarding a case in litigation and concerning a patient (pt) of unknown age and gender, who at the time of suspect vaccine's administration was approximately 59 or 60 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 27-JUL-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: polymyalgia rheumatica. The outcome of the event of polymyalgia rheumatica was not reported. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of polymyalgia rheumatica was determined to be medically significant.
Call from mother on 8/25/09. States "pt. had a reaction to his vaccines." Relates that on 8/19/09 around 8 pm (bath time) she noticed his left arm was red, warm and swollen. ( a 4 by 2 inch area). Resolved by 8/21/09. "Did not seem to cause him pain"
Employee received vaccine, within 10minutes, c/o of weakness, dizziness, shaking.... no complaints of Shortness of breath or tightness... refused to receive any additional treatment.  Continued monitoring for another 2 hours, no additional symptoms, then developed numbness and tingling around mouth and trouble swallowing....  sent to ER.
was diagnosed yesterday at the hospital with COVID; She was very sick all week long; was diagnosed yesterday at the hospital with COVID; 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 female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Dec2021, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 05Feb2022, outcome "unknown" and all described as "was diagnosed yesterday at the hospital with COVID"; ILLNESS (non-serious), outcome "unknown", described as "She was very sick all week long". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Feb2022) positive. Therapeutic measures were taken as a result of covid-19, illness. Does Pfizer know how long it lasts before it wears out? Like with the flu vaccine every year you have to have a flu vaccine so does Pfizer know how long it lasts. Product clarified to be the COVID vaccine. Inquired if caller has received the COVID vaccine and she did not answer the question but states that she was diagnosed yesterday at the hospital with COVID. She was very sick all week long and then realized that's what the problem was, yesterday morning, early, she found out that she has COVID 19. They gave her Paxlovid because of her age, the pills, she is a senior, but she is just curious about the vaccine itself.  Caller mentioned having concerns/ questions regarding if Pfizer know how long the COVID vaccine lasts before it wears out? Like with the flu vaccine every year you have to have a flu vaccine so does Pfizer know how long it lasts. Inquired if caller has received the COVID vaccine and she did not answer the question but states that she was diagnosed yesterday at the hospital with COVID. She was very sick all week long and then realized that's what the problem was.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-JAN-2019 the patient was vaccinated with LIQUID PEDVAXHIB, 1 dosage form, intramuscular for prophylaxis. On 29-JAN-2019, 1 day after onset of therapy the patient experienced product storage error. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Twitches; not been sleeping or eating right; not been sleeping or eating right; nauseous from pain; his left calf has like a knot in it and it hurts/nauseous from pain / he is hurting; cramp on my left calf; 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. Other Case identifier(s): US-PFIZER INC-2021424408 (pfizer).  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER8729) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "cramp on my left calf"; MUSCLE TWITCHING (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Twitches"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious), DECREASED APPETI TE (non-serious) all with onset 08Apr2021, outcome "not recovered" and all described as "not been sleeping or eating right"; NAUSEA (non-serious) with onset 08Apr2021, outcome "not recovered", described as "nauseous from pain"; PAIN (non-serious) with onset 08Apr2021, outcome "not recovered", described as "his left calf has like a knot in it and it hurts/nauseous from pain / he is hurting". Therapeutic measures were taken as a result of muscle spasms, pain.  Additional information: patient states that he got the shot on the 05Apr 2021 and by Wednesday  he has had a cramp in the calf of his left leg and it has hurt ever since then. Patient said that he went to bed fine and woke up with it. It has gone on for 7 days now. He states that he doesn't normally get cramps like that. He drinks plenty of water, takes magnesium and has been stretching. He has done everything possible and the cramp is still there. Patient states that nothing seems to work. He wants to know  if it would that be from the shot? He said that nothing seems to work. He states that his left calf has like a knot in it and it hurts. He states that it comes and goes when you rub it and massage it with Bengay or whatever  he has handy. He states that it goes away a little bit while using Bengay but it comes right back. He states that the only thing that kind of helps is a little bit of walking. He also states that he has not been sleeping or eating right since Thursday. He has been nauseous from the pain. He states that these side  effects are still on going and persisting. Patient also added that last night when he was sleeping he was woke up by two big twitches. No Emergency Room/Physician Office visit, no Prior Vaccinations (within 4 weeks). Bengay, patient states he was using Bengay on his cramp and it goes away for a little bit but then it comes right back. Lot number not queried.   No follow-up attempts are possible. No further information is expected.
felt like had a really bad case of the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had a really bad case of the flu) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Nov-1957, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like had a really bad case of the flu). At the time of the report, INFLUENZA LIKE ILLNESS (felt like had a really bad case of the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.