chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a not serious spontaneous case from a pharmacist of throbbing head. The reporter causality is not provided to FluMist. A pharmacist reported the complaint of a throbbing in the head in a 49 year old pt one day after receiving FluMist. The pt received FluMist on 02Nov04 at 8:30AM. The reporter stated the pt's head throbbing started at an unspecified time on 03Nov04 and has continued for almost a week. The pt's head would throb in five minute episodes.
2 days following vaccine, patient was brought to office with red, firm area on left thigh were vaccine was given.  Axillary temp 96.8.  Treated with Augmentin suspention 200/5cc, 5cc per mouth bid x 7 days for early cellulitis.
Pt recvd vax 6DEC91 & 8DEC91 mom called MD office stated pt was limping on rt leg started that morning seen by MD that p/noon; had full ROM @ ankle & hip; pain w/motion @ knee; saw effusion @ rt knee but no erythema or warmth; admit hosp;
I woke up with two dark blind spots in my right eye. I called the doctor to inform them on what was going on. They informed me to go to the emergency room. They thought I had a CRVO but they ran me through a CT scan, drew blood twice, and took an MRI scan. I saw an ophthalmologist yesterday 01/12/2023 and was diagnosed with a retina artery occlusion.
fall; injured her back; headache that won't go away; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), FALL (fall) and BACK INJURY (injured her back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included PARACETAMOL (TYLENOL).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced SINUSITIS (Sinus infection) with HEADACHE (headache that won't go away). On an unknown date, the patient experienced FALL (fall) and BACK INJURY (injured her back). At the time of the report, SINUSITIS (Sinus infection), FALL (fall) and BACK INJURY (injured her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No additional AEs were reported; patient received an improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 08-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U015677 with an expiration date on 18-MAY-2023) for prophylaxis (product storage error) (strength, dose, anatomical location, and route of administration were not reported).   The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of 39.55 degrees Fahrenheit (°F)  during a time frame of 10 hours. There was no prior temperature excursions.   No additional adverse events were reported.
Shortness of breath Chest pain Dizziness Generalized rash Muscle pain From initial information received on 11/20/2003 from a registered nurse regarding an adverse event occurring in the U.S.A., it was reported that a 38 year old female patient, after having had an unspecified reaction to the 'flu vaccine' the previous year, received FLUZONE SV '2003-'2004 USP in two 0.25 ml. split doses. She received the first dose, lot number not reported, administered intra-muscularly in the left deltoid on 10/24/2003. Sometime after the first injection, the patient developed local redness and tenderness at the injection site. The patient received her second dose, lot number U1089AA, administered intra-muscularly in the left deltoid on 11/07/2003. Three days after receiving the second dose, on 11/10/2003, the patient complained of shortness of breath, chest pain, muscle pain in her left arm, dizziness and generalized red rash. The patient was evaluated by a doctor. The reporter stated that the condition has resolved, but she unsure of the exact timing of the events.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M029233, expiration date 09-AUG-2018 and lot# M023892, expiration date: 15-SEP-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016").  On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of RECOMBIVAX HB were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007121: US-009507513-1612USA007248: US-009507513-1612USA007249:
This spontaneous report as received from a physician via a company representative refers to a 33 year old female patient. The patient's medical history and concurrent conditions were not reported. On 04-FEB-2017, the patient was vaccinated with a dose of VARIVAX (intramuscularly; dose, lot # and expiration date were not reported) for prophylaxis. Concomitant therapies included cetirizine hydrochloride. On 08-FEB-2017, the patient experienced several adverse reactions: she had tenderness in the upper right arm that was red and swollen, her body was swelling, she also developed weight gain and diarrhea. On the same date, the patient complained about her blood pressure fluctuating. The patient sought medical attention and the physician prescribed her an unspecified medication and requested that she return in a week. The outcome of the adverse events was reported as not recovered at the time of this report. The relatedness between the adverse events and VARIVAX was not provided. Additional information has been requested.
Pt. was a 22 yr old Female, inprocessing received a G6PD blood draw with no complications. Pt. received a TwinRix # 3 vaccination to the R-Bicep, immediately upon receiving vaccination pt. began seizing, to include lose of muscle control with immediate onset of décorticate posture bilateral, foaming at mouth, clenching of teeth that lasted approximately 3 minutes.
The patient presents with Shortness of breath and Patient started getting ill on 17 November she tested positive
Information has been received from an LPN concerning a female patient who was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient experienced pain in her arm in excess of 5 days. There was no swelling or rash, only the pain. Medical attention was sought. The pain was reported to have improved on therapy. It was unknown whether this was an injection site reaction. Additional information has been requested.
Patient had a vasovagal response. Dad got her to the floor and was fanning her with papers. She was extremely pale. We got her back up into her chair. I provided her with a cold cloth which we applied to the back of her neck. I got her a cold bottle of water. She vomited and her color started returning to normal. I had her sit another 15 minutes before she left the store. I called Mom after 7pm to see how she was doing and Mom said she was feeling much better.
small red area with 2-3 blisters (approx 12mm at injection site Lt, approx 21st of Sept
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 15-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Feb-2012. On 27-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Bruising on arms on Sunday and Bruising and Petechial Rash showing up on legs and feet on Tuesday , Blood Work Drawn and Visit to Doctor on Thursday , Doctor had me rush to the hospital to be emergently admitted with a platelet count of 3. A hematologist was called in and I was admitted to hospital for four day had received 2 days if IVIG and 4 Days of IV Dexamethasone, on day 2 of admission had pain in my right lower leg calf area a doppler showed a DVT , upon discharge 4 days later my platelets came to 195 and I was started in Eliquis to treat DVT and will be on the Eliquis for next 3 months.
a patient had accidentally received a dose of Infanrix despite being an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 24-AUG-2023, the patient received Infanrix. On 24-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient had accidentally received a dose of Infanrix despite being an adult).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 24-Aug-2023 Partial information about event, patient and vaccine was given. The vaccine administration facility was the same as Primary Reporter The medical assistant called in to report that a patient had accidentally received a dose of Infanrix despite being an adult, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV on 16th October 2014. The subject's estimated date of delivery was 10th November 2014. The subject received Flu Seasonal QIV at week 35 of the pregnancy and during the third trimester of pregnancy. On 16th October 2014, an unknown time after receiving Flu Seasonal QIV the subject developed drug exposure during pregnancy (Non-serious). The outcome of the drug exposure during pregnancy was unknown. The pregnancy outcome was unknown. It was unknown if the investigator considered the drug exposure during pregnancy to be related to Flu Seasonal QIV. Investigator comments received: Received flu vaccine while pregnant. No other AEs reported. Gestational age when received vaccine: 35 weeks. Due date: 11/10/2014.
SLURRED SPEECH Narrative:  patient reports slurred speech x 1 month since second vaccine.
Dose 1: I had a high fever (101.6), serve body ache and migraines this lasted for about 2 1/2 days. This caused me not to drive  Dose 2: Fever 102-104 took Tylenol , body ache and bad migraine
Area is really red; Area is swollen; Hot to touch; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced erythema, swelling and feeling hot. On an unknown date, the outcome of the erythema, swelling and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the erythema, swelling and feeling hot to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had received Shingrix shot two days before the reporting date, and the area was really red and swollen and hot to touch.
Headache (for the past 2 weeks), and Rash (neck)  Bell's Palsy-Patient presents with mild worsening weakness of the right side of the face.
Pt recvd 2nd vax on 15APR91 & exp an allerg react hives on arms,legs,back & stomach w/ arthralgia & pruritus.
Diagnosed with Graves disease approx 4 years ago.   Got treatment and went into remission.  Got my covid booster on Oct29, 2021 and approx 1 week later I was having symptoms.  Was diagnosed as recurring Graves Disease.  Was prescribed Methimazole and Atenolol.  I will be dealing with this for the rest of my life.
patient stated that she experienced extreme headache, nerve pain, and pan from the back of spine to her head.  She  experienced pain in her back and was unable to move from Saturday 9/7/19 to Monday 9/9/19
worse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (worse reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (worse reactions). At the time of the report, ADVERSE REACTION (worse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-029147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029147:
pt recv vax 09feb96; approx 25jan97 pt was exposed to chickenpox; 06feb97 pt devel a rash w/ f-6 lesions on the back of his left ear & on his chest.  Pt recv meds for itching; pt recovered
This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955) administered in the left arm on 18Mar2021 at 10:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, high blood pressure and hypothyroidism. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included enalapril (MANUFACTURE UNKNOWN), levothyroxine (MANUFACTURE UNKNOWN), albuterol (MANUFACTURE UNKNOWN). The patient was allergic to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 18Mar2021 at 0100 hours, the patient experienced generalised muscle aches and headache. The patient reported muscle pain throughout entire body, including lower back, arms, and legs and very very mild headache which was noticeable only if paid attention. The patient did not receive any treatment for the events. The clinical outcome for generalised muscle aches and headache was not resolved.   Information about lot/batch number cannot be obtained. No further information is expected.
upon  injection,  arm become numb.  After a few minutes,  left side of face was numb and still continues to be  a week later.  Went to doctor yesterday and she said all the vitals are good.
Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.
PAtient has been having nausea and vomiting since 4/23/21, improving, however she is only able to drink fluids.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 23May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto Disease" (unspecified if ongoing), notes: other autoimmune disease in process of diagnosis; "obesity" (unspecified if ongoing); "tobacco user" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclore for allergy, notes: known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Other Medication In 2weeks was reported as Yes with Hydroxychoroquine started on 15Sep2021 and Levothyroxine started on 17Mar2021, Liothyonine started on 16Feb2022, Prazosin started on 09May2022, Cymbalta started on 11Mar2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti-viral drug Paxlovid started on 13Jul2022 and stopped on 18Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4/11 vaccination 12:46 12:51 They had us go sit in observation. I felt fine and all of a sudden I felt dizzy and felt near syncope, sweaty. I raised my hand. 2 EMT monitored my HR and BP; both high. Gave me some water, cold compress. Symptoms went away. I went to bed Sunday night, woke up at 230am to chills, shaking, sweats, feverish. That lasted thru till 8/9am and all day Monday I was pretty fatigued.  Tuesday symptoms I was pretty much back to normal.  I contacted my PCM with recent J&J news. My platelet numbers were normal (blood work done a few weeks before vaccine). Monitored by endocrinologist
Site injection pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Nov2022 at 02:00, outcome "recovering", described as "Site injection pain"; HEADACHE (non-serious) with onset 23Nov2022 at 02:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine within the four weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19.  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.
Patient's provider called County Health and Human Services to report that patient came in 10 days after receiving MMR, and had a rash along with a low grade fever. MMR administered was Merck Lot number 0279U.
limping of Leg (left) Very large indurated warm erythematous lesion on left thigh. pain to touch, wall emaciated and a bit dusky in the center. still recovering.
This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received GARDASIL (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
10/11/21 pt positive for COVID and treated outside hospital with remedesivir; admitted to this hospital on 10/16/21 with worsening hypoxemia; pt found to have bilateral PE; chest tubes placed; experienced cardiac arrest with intubation; ROSC, but experienced severe shock requiring multiple vasopressors; worsening AKI; coded a second time; ROSC not obtained this time; pt passed away in the hospital.
started with minor swelling in glands, then tightness of chest, breathing difficulty, then eyes began to swell,
Fuzzy head, upset stomach causing fall from loss balance.  No reaction to vaccine 1 or 2.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 16-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient stated that she has been lethargic/tired and has no appetite since receiving the Comirnaty 12+ COVID-19 vaccination
EXTREMELY SORE ARM; SEVERE FATIGUED; HORRIBLE HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced extremely sore arm, severe fatigued, horrible headache, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely sore arm, severe fatigued, horrible headache, and low grade fever. This report was non-serious.
on 04/07/2021, patient received J and J vaccine  for COVID-19. On 08/19/2021, patient requested a dose for Moderna vaccine. Upon completing COVID screening form, he indicated he didn't receive previous COVID-19 vaccine on intake form. Pharmacist was unaware patient had receive vaccine due to patient not reporting he received vaccine previously.