chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 20 minutes of the injection into my right arm, my right eye began to twitch. My right eye twitched consistently and frequently for approximately 15-20 minutes. I began to experience throbbing pain in my arm which then traveled down my right side down to my legs and up to my neck at which point I took 2 Aleve. For the remainder of the day I only suffered from pain in my right arm. The next day 5/2/2021, I still had pain in the injection site. At approximately 2:00pm I began to feel cold. I put on a sweater but continued to feel cold and then began to shiver. After putting on layers the shivering became so violent it was difficult to stand so I laid in bed. For 45min-60min I shivered so violently my bed shook. After the shivering subsided I was able to get up but had a noticible fever. By 9pm the fever had subsided and I was left with injection site pain that eventually subsided. I have since made a full recovery.
Blinking and slurred speech x 1 week after H1N1 vaccine. *not sure if exact date/time of onset - mom noted sx for a week after vaccine.
Covid 19 Vaccine EUA   I experienced pain and tenderness  around vaccination site, soreness of lymph nodes under left arm, muscle and joint pain, fever, chills, mild headache.  I took Tylenol late in the afternoon of 3/15/ 21 and that helped with the fever and discomfort. These symptoms subsided in the morning of Mar. 16th.  As of March 17 I only have some residual tenderness in my left arm.
Headache, dry mouth, body aches, shoulder pain, weakness, nausea, diarrhea, fever up to 103.2, neck pain,loss of energy and strength.
he had covid in Mar2022 / pfizer covid-19 vaccine (EUA); he had covid in Mar2022 / pfizer covid-19 vaccine (EUA); This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 43-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation; VENOFER; ESCITALOPRAM OXALATE; VITAMIN D NOS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "not recovered" and all described as "he had covid in Mar2022 / pfizer covid-19 vaccine (EUA)".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events covid 19/ drug ineffective  and the suspect drug BNT162B2 cannot be excluded.
This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. On 10-DEC-2012, the patient was vaccinated with dose 3 of ROTATEQ (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On 29-JAN-2013, the patient went to an emergency room of the hospital and was diagnosed with intussusception. The patient sought medical attention (visited hospital). The patient received treatment during hospitalization. It was unspecified if any lab tests were performed. The outcome of intussusception was unknown. The relatedness for intussusception was unknown for ROTATEQ. Additional information has been requested.
diagnosed with Asymptomatic Cardiac Ischemia Pilot; has no energy; really depressed; trouble to sleep; shortness of breath; whistle on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) (seriousness criteria hospitalization and medically significant), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest). At the time of the report, MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reportedly, the patient needs to get an implant device on her heart.  Date of birth of patient given as   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Wheezing, resp difficulty approx 12 hours after vaccine, called EMS admit to hospital x 2 day DX with bronchiolitis.  1/23/07 Received medical records from hospital which reveal patient admitted 12/28-12/30/06 for 3 day hx of cough & congestion who became limp & had oral cyanosis.  Temp 101.2 in ER & admitted for r/o sepsis. Had mod amount of resp secretions which required frequent suctioning & bulb suctioning upon d/c to home. No antibiotics given but required IV rehydration. FINAL DX: acute life threatening event; bronchiolitis; & fever.
headache; fever; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.
Within 24 hours generalized achy lower half. At one week my arm at the injection site had swollen, it was inflamed and red. It also had significant bruising. It was about 4 inches circular in shape. It continued to grow for about three days. It was itchy and broke out in some places.
Got my shot I had shingles/suspected vaccination failure; shingles once in the eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and had the shingles once in the eye and that was no fun and could get them more than once. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
dizziness, h/a & aches & pains w/a few hrs p/the 1st dose given @ hosp; was poss provoked attack; pt lunged @ raccoon;
This case was reported by a healthcare professional and described the occurrence of passed out in a 10-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (non-gsk) (Sanofi) given on 23 July 2009; VARIVAX (non-gsk) (Merck) given on 23 July 2009. On 23 July 2009 at 10:30 the subject received unspecified dose of BOOSTRIX (unknown route, left arm). On 23 July 2009, approximately 10 minutes after vaccination with BOOSTRIX, the subject experienced passed out, hit head and hit shoulder. The subject passed out at the check-out counter and hit her head and shoulder as she feel down at the check-out counter. This case was assessed as medically serious by GSK. On 23 July 2009, the event of passed out was resolved. At the time of reporting the outcome of the hit head and hit shoulder events were unspecified. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. The healthcare professional also reported a male subject who passed out after receiving BOOSTRIX (see case ID A0798931A) and mentioned approximately 7 to 8 cases where the subject had passed out or vomited after receiving BOOSTRIX (see case ID A0798942A).
PATIENT RECEIVED A DOUBLE BOOSTER OF PFIZER VACCINE. NO ADVERSE REACTIONS HAVE BEEN REPORTED. I WILL REVIEW POLICY AND PROCEDURE .
LEFT HAND HAS TREMBLING SENSATION THAT COMES AND GOES AWAY; TINGLING SENSATION IN THE TIPS OF FINGERS; This spontaneous report received from a patient concerned a 60 year old female. 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 and batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and ergocalciferol.  On an unspecified date, the patient experienced left hand fingers trembling sensation that comes and goes away, and tingling sensation in the tips of fingers. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in the tips of fingers, and had not recovered from left hand fingers trembling sensation that comes and goes away. This report was non-serious.
Headache next day adn for 4 days following shot.  Chills and fever for 3 days, congestion, sore throat and cough, now into week 2.  Taking cold tablets and cough syrup over the counter.
Mother brought infant to clinic on 7/8/11 in PM.  Raised red blotchy rash noted on face, body & extremities. No s/s of distress or discomfort noted on infant. Infant was afebrile.  Instructed mother to inform MD of infants condition. Also instructed mother to call 911 if any s/s of breathing difficulty. P/c to mother on 7/11/11, mother states infants rash got worse following visit to our clinic on 7/8/11. Did not take infant to MD, gave infant Benadryl q 4 hrs. & rash started disappearing. Mother states infant is doing fine @ this time.
donor states 4-5 hours after shot, had LOC for about 10 minutes, "but aware of surroundings the entire time" No other symptoms associated with episode. Donor returned to normal with no other adverse events.
This case was reported by a consumer (the subject) and described the occurrence of fever in a 29-year-old female subject who was vaccinated with DTPa (with small D + P), manufacturer unspecified). A physician or other health care professional has not verified this report. On 18 March 2011 at 15:00 the subject received booster dose of  DTPa (with small D + P) (unknown route, unknown arm). On 19 March 2011, 24 hours after vaccination with  DTPa (with small D + P), the subject experienced fever, fatigue, injection site redness, swelling injection site and tightness at injection site. On 21 or 22 March 2011, 3-4 days after vaccination with  DTPa (with small D + P), the subject experienced headache. At the time of reporting the events were unresolved.
Approximately 8 weeks post vax, the pt was found to have elevated liver enzymes. The most recent information received reports the condition of the pt is ongoing.
p/vax pt exp fever  104.2F for 2wk; lethargy; problems sleeping; continued h/a; myalgia; foggy mental function; sweating;  lab: albumin 3.5, IgG for viral capsid Ag titre 1:2560; tx advil & doxycycline
pt recvd vax 20SEP95 & on 29SEP95 c/o spitting up & also some shaking or jerking episodes all occurring w/in the past week; sz activity cont but less frequent;
About 6 hours later, started to developed major chills,  body aches, headache and fever. The headache was intolerable. Tylenol and Motrin helped slightly. Felt better around the 24 hour mark and almost back to normal at 48 hours.
On 11/26/13, patient states that is still having pain in her arm after receiving flu shot. She shows that she received her flu shot in the middle of her upper arm (bicep/tricep area).
Began vomiting p/feeding w/SMA formula or APAP administration about 3 hrs p/vax given; up all noc only vomited p/mom tried to feed; lasted about 24 hrs; Did not take to MD;
I had nausea and diarrhea for a week starting the next morning after taking the J and J vaccine.  For 3 months I also experienced very severe heartburn, stomach cramps, diarrhea at times, and nausea.  My sinuses are also worse with thicker snot and mucus.  My nose is also impossible to clear.  Dr check up was fine so I didn't think much about it.  However, I still am having heartburn, nausea at times.  I have to take an antacid daily when I have never had any problems like this prior the this vaccine.  When drawing up moderna and Pfizer to give to patients my skin would have big whelp, redness, and burning with any contact to my skin.  My sinuses are still awful and my nose stays clogged up with thick especially at night.  I never had an issue with this every day in the past.  Maybe once or twice a year.  I have decreased energy since that shot and go fatigued easily.  Before this shot I never had any issues with fatigue unless I just did not sleep the night before.
Rash on upper arm with significant itching. Rash not consistent with Varicella.
After 4 hrs of injection, fever of 100 degrees; body aches, difficulty in swallowing lasting 24 hours.
Mom called in to day baby started to cry and shake and really scare her, while out shopping. Nurse advised her to seek medical attention at ER as baby was "breathing funny." Spent 5 hours in ER, Tylenol given. Baby settled down that evening and is acting fine now. Mother states baby's father had reaction to pertussis vaccine as a baby. Advised mom to report incident to private doctor for decision regarding next shots.
Congestion; Covid virus; upper respiratory tightness; Flu like symptoms; Cough; fever; Headache; 36 days have passed since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bronchitis and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, FAMOTIDINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and COVID-19 (Covid virus). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (36 days have passed since 1st dose) had resolved and NASAL CONGESTION (Congestion), COVID-19 (Covid virus), RESPIRATORY DISORDER (upper respiratory tightness), INFLUENZA LIKE ILLNESS (Flu like symptoms), COUGH (Cough), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, COVID-19: positive (Positive) positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, an Inhaler, Steroid-Prednisone and Monoclonal Antibody treatment.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: FU source document attached on 16th April and it contains Adverse event information On 14-Jun-2021: received; Sender's Comments: Although a temporal association exist between the product use and reported events.  Patient was most-likely infected with COVID-19 prior to mRNA-1273 administration.  Other events are likely symptoms of the infection.  However, based on temporal association and known safety profile of the vaccine, the event of headache cannot be excluded.
left arm became sore/soreness; "felt like" she was getting a fever/"felt like fever"; swollen, itchy left arm; itchy left arm; red, swollen, itchy left arm; soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 3AG4G, expiry date unknown) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, swelling arm, pruritus, erythema of extremities and pain. On 9th September 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling arm and pruritus were not recovered/not resolved and the outcome of the erythema of extremities and pain were unknown.   It was unknown if the reporter considered the pain in arm, fever, swelling arm, pruritus, erythema of extremities and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was updated from 38G4G to 3AG4G, as per sales data sheet. The patient received Shingrix and her left arm became sore and felt like she was getting a fever.  The patient had red, swollen, itchy left arm.  The soreness, red, swollen, itchy left arm symptoms have improved, but all persist at the time of reporting. The reporter did not consent to follow up. The reporter declines to provide any additional information for this AE and did not consent to HCP follow up.
Left shoulder pain that radiated to her anterior neck. Patient states that it was sharp and burning. She was treated with Ibuprofen 600 mg three times daily and instructed to put ice on the area of discomfort three times a day.
Narrative:  Patient with Moderna Covid doses 2/16/21 and 3/16/21. He presented to ER on 10/27/2021 O2 sats were 93%, pulse 86. Labs were BNP of 157, negative troponins, D dimer was not performed. He was found on CT scan to have bilat lower lobe PEs, and also possible opacities. Chest CT IMPRESSION: 1. Acute bilateral lower lobe subsegmental PE with no evidence of infarct or right-sided heart strain. 2. Small loculated right and tiny simple left pleural effusion with associated subsegmental atelectasis. 3. Bilateral lower lobe patchy airspace opacities and vascular crowding likely combination of developing consolidation atelectasis. 4. Cardiomegaly without pulmonary edema. 5. Mediastinal lymphadenopathy, likely reactive but technically indeterminate. 6. Abnormal liver morphology suggestive of cirrhosis is not fully evaluated.
COVID 19 Treatment; COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=ModernaModerna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Lot number: 010A21A), on 24Mar2021 as dose 2, single (Lot number: 045A21A) and on 29Nov2021 as dose 3 (booster), single (Lot number: 013F21A) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "kidney disease" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Jun2022, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=ModernaModerna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: Finished the Paxlovid yesterday. Tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19. with Paxlovid from 25Aug2022 to 30Aug2022.  Clinical course: It was reported that paxlovid completed yesterday and again tested positive today.
the IPOL exposed to an 49.6 Fahrenheit temperature for 12 minutes with no reported adverse event.; the patient received IPOL post excursion with no reported adverse event.; Initial information received on 10-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and reporter reported that the IPV (VERO) [IPOL] was exposed to an 49.6 fahrenheit temperature for 12 minutes with no reported adverse event and the patient received ipol post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect IPV (VERO) for Suspension for injection (with an unknown dosage, frequency, strength, lot: V1A022M, Expiry date: 17-Feb-2024) via unknown route in unknown administration site for immunization (immunization) and the ipol was exposed to an 49.6 fahrenheit temperature for 12 minutes with no reported adverse event. (product storage error) (unknown latency) and the patient received ipol post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.   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 guidelines. 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.