chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIVES ALL OVER UPPER BODY(CHEST, BACK, ARMS, UNDER HER CHIN); VERY TIRED AND SLEPT MOST OF THE DAY; RASH; DEVELOPED ITCHINESS ON HER CHEST AND UNDER HER BREASTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 24-MAR-2021 21:00, the subject experienced developed itchiness on her chest and under her breasts. On 25-MAR-2021, the subject experienced rash. On 25-MAR-2021, the subject experienced very tired and slept most of the day. On 25-MAR-2021 03:00, the subject experienced hives all over upper body (chest, back, arms, under her chin). On 25-MAR-2021 03:30, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very tired and slept most of the day, rash, developed itchiness on her chest and under her breasts, and hives all over upper body(chest, back, arms, under her chin). This report was non-serious.
Runny nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a male 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 medical history reported).    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 73 year old female with rheumatoid arthritis and who may have been immunocompromised who on 30-OCT-2006 at 09:22 AM was vaccinated SC in the "right" with a 0.65 ml dose of Zostavax (lot#653936/0981F). The physician noted that she was vaccinated at another practice. The patient may have been immunosuppressed because she has been on therapy with infliximab (REMICADE) for two years and had her last infliximab (REMICADE) treatment about one month before her vaccination. No symptoms had been noted at the time of the report. A product quality complaint was not involved. Additional information has been received from a physician's office which indicated that there was concern over the use of Zostavax while the patient was using infliximab (REMICADE). The patient was discontinued from infliximab (REMICADE) afterwards as a precaution. The patient's experience was considered to be an other important medical event by the reporter.
Itching rash above her waistline. Started to decrease in about an hour. Taking benadryl to ease symptoms.
Redness, swelling warmth to L thigh, almost to knee measuring about 6x4" irregular bordered, no drainage.  Pt triaged with RN appt.  Enc cool paks or wet cold washcloth to area as much as possible child does not want to allow ice pack.  Enc mom to call for worsening s/s outside area marked, especially if redness is moving to core body, nausea, vomiting, etc...Our Shot record is incomplete for age, unknown if previous doses were given, no other shot record unavailable.  documented previous doses according to our records
Tested positive for COVID-19; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COVID-19 (Tested positive for COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). On 10-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This case concerns a 49-year-old female with nonserious unexpected events of COVID-19, ageusia, and anosmia. Event onset 6 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Same day post vax, the pt developed slight swelling, local soreness. That night it became more red and swollen and his shoulder ached. He developed night sweats and stiff shoulder.
Brain mass - thought to be 2/2 to medication effect (Keppra) vs brain mass. She was admitted for further evaluation with MRI as she required sedation for this; MRI showed interval improvement with decreased edema and cortical enhancement without new findings to suggest disease progression within the brain. Hospital admission within 6 weeks of receiving the COVID vaccine.
States pain and weakness started right after injection on 9/23/22.  Seemed to increase then and has constant pain/dull ache to right upper arm and shoulder. States cannot lift arm without pain, has full ROM, but always with pain. Has tried Ibuprofen and Aleve without relief.  Will be seeking care at her primary MD.
COLD LIKE SYMPTOMS; FELT FATIGUE; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced cold like symptoms. On 12-MAR-2021, the subject experienced felt fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold like symptoms and felt fatigue was not reported. This report was non-serious.
covid arm; extremely painful (arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm) and VACCINATION SITE PAIN (extremely painful (arm)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm) and VACCINATION SITE PAIN (extremely painful (arm)). At the time of the report, VACCINATION COMPLICATION (covid arm) and VACCINATION SITE PAIN (extremely painful (arm)) outcome was unknown. Not Provided          Patient received second dose on March 30th.
Information has been received from a LPN concerning an approximately 77 year old white male with PCN allergy who in 2000 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, per the pt's spouse, the pt developed red left upper arm red and hot to touch. On 10/31/03 at 9:15am the pt was vaccinated with another dose of pneumococcal 23v polysaccharide vaccine (Lot # 647655/0869N, IM in the left deltoid. On 11/01/03 in the AM the pt developed cellulitis described with redness, tenderness, edema to the elbow. The pt was treated with an illegible reported therapy (20mg per day) and acetaminophen (Tylenol, 3 times a day). The pt recovered between 11/05/03 & 11/10/03.  It was also reported that several other pt's had a similar reaction (WAES # 0311USA00334).  No further information is expected.
Extreme pressure in my head which made it nearly impossible to keep my eyes open. Severe sensitivity to light. Profuse sweating followed by chills (this happened for hours). Nausea. Dizziness.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.  No treatment information was reported.   This case was linked to MOD-2021-076762 (Patient Link).
Bullous pemphigoid; his body is reflecting his skin. Very painful.; no longer Walk without assistance; This serious case was reported by a consumer via interactive digital media and described the occurrence of bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bullous pemphigoid (Verbatim: Bullous pemphigoid) (serious criteria GSK medically significant), skin pain (Verbatim: his body is reflecting his skin. Very painful.) and walking difficulty (Verbatim: no longer Walk without assistance). The patient was treated with steroids nos (Steroids). The outcome of the bullous pemphigoid and skin pain were not reported and the outcome of the walking difficulty was not recovered/not resolved.   It was unknown if the reporter considered the bullous pemphigoid, skin pain and walking difficulty to be related to Shingrix.     It was unknown if the company considered the bullous pemphigoid, skin pain and walking difficulty to be related to Shingrix.   Additional Information: GSK Receipt date: 02-Mar-2023. This serious case was reported by a consumer via interactive digital media. The reporter was patient's wife. It was reported that after receiving the 2nd Shingrix vaccine, 2 1/2 years ago, her husband had been suffering with Bullous Pemphigoid. Basically, his body was reflecting his skin. Very painful. Treatment requires high doses of steroids and anti-rejection drugs.  They live isolated because he could not receive the Covid vaccine. The patient could no longer walk without assistance. Apparently this was not rare. Check it out and be very cautious with this vaccination. Follow-up would not possible as no contact details were available
started semi-paraesthesia in the lower and upper limbs as well as muscle weakness; muscle weakness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jun2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. In Jul2021, a month later after the second dose, the patient experienced started semi-paraesthesia in the lower and upper limbs as well as muscle weakness.  The patient has always been healthy. The patient was wondering if it could be a reaction to the vaccine since neurologist and orthopedist were unable to give an explanation after TAC scan and magnetic resonance that excluded possible pathologies. Outcome of events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Large swollen, red area. 4 1/2 x 4 1/2" hot to touch. C/o pain. Patient given Rx for Benadryl and Keflex 250mg for diagnosis of Cellulitis vs.  Allergic Reaction.
Hot feeling in arm that traveled into chest and neck, rash, dizziness/nervousness, trouble swallowing, increased blood pressure (164/98), increased HR 120. Took 2 Benadryl, 1 Claritin and 1 famotidine, 10 mg decadron shot . the reaction started 15 mins after shot took medications and was monitored for an hour.
The pt experienced seizures x 3 approximately 5 hours post vax. The infant was treated with Phenobarbital and was transferred to a tertiary care facility. No neurological abnormalities identified. The pt was discharged to the home with parents.
Information has been received from a pharmacist concerning a 70 year old male who on 14-MAY-2008 was vaccinated with VARIVAX (Merck), 0.5 ml, SC instead of ZOSTAVAX (Merck) (human error, no product quality complaint involved).  The prescribing physician just wrote "Varicella" on the orders.  It was dispensed as a VARIVAX (Merck) dose not ZOSTAVAX (Merck) dose because they failed to look at the patient's age being 70 year old.  No adverse effects reported.  A telephone call to the pharmacist reaffirmed that the wrong vaccine given was human error and did not involve a quality complaint.  Additional information has been requested.
Varicella - low grade temp and red spots, treated with Zovirax ointment.
I woke up the next morning feeling a general muscle soreness throughout my body.  I was also experiencing mild chills and mild dizziness.  I took a 1000mg dose of acetaminophen and a 400mg dose of ibuprofen about an hour after I got up and rested for several hours.  The symptoms started to dissipate at around 1pm but the soreness slightly persisted throughout the day.  Symptoms were gone the next day.
Patient was given a Pfizer COVID-19 vaccine that had expired one day previous to administration on 09/30/2022.  No adverse symptoms noticed by patient or Mother of patient.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 37-year-old male patient who received ENGERIX B pediatric (batch number GX9X5, expiry date 25th February 2021) for prophylaxis. On 19th January 2019, the patient received the 2nd dose of ENGERIX B pediatric .5 ml. On 19th January 2019, unknown after receiving ENGERIX B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown. Additional details were reported as follows: The adult patient inadvertently administered with 0.5 ml dose of ENGERIX B, which led to accidental underdose and adult use of a child product. The reporter consented to follow up. Follow up information were received from pharmacist on 19th February 2019: The patient demographic details were updated. The patient received ENGERIX B pediatric by intramuscular route. In 2019, unknown after receiving ENGERIX B pediatric, the patient experienced injection site reaction. The patient came in to get the 20 mg dose of ENGERIX B adult. The paper was in for 20 mg but 10 mg was typed, reviewed, dispensed and administered to patient, this led to drug prescribing error and drug dispensing error. The patient had been contacted and aware of the situation. No reaction or side effect had occurred due to the result of this besides general localized injection site reaction. The outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to ENGERIX B pediatric. The VAERS details were updated.
* PT TESTED POSITIVE ON 9/1/2021...MILD COLD SYMPTOMS...BUT SHOULD HAVE BEEN ASKED AND NOT RECEIVE A BOOSTER W/I 90 DAYS OF POSITIVE DIAGNOSIS...PATIENT WAS NOT ASKED...ADMINISTERED AT HEALTH DEPT WHO RECEIVES ALL POSITIVE RESULTS.  * PT= 82 YEARS OLD BUT WALKED 2 MILES/DAY AND PERFORMED ON STAGE 34- NIGHTS A WEEK UNTIL 11/16/2021  * HE HAS ALWAYS HAD SUPER QUAD FLU SHOT WITHOUT INCIDENT...  * CALL DAUGHTER WITH QUESTIONS
1st dose 19Jan2022, 2nd not yet received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 19 January 2022 from lot number N4GA4 and expiry date 02nd January 2023).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The reporter was a pharmacy technician. The reporter stated that the patient received first dose of Engerix-B on 19th January 2022 and the patient did not received second dose. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
All around my left armpit area felt scratchy and irritated somewhat at times like a burning feeling, but there were no visible signs of anything.  I looked on-line and read there were some side effects in that area and one suggestion was to use an ice pack.  I applied an ice pack on 4/17/21 and that helped alleviate the irritation considerably.  Nothing that I will be seeking treatment for.  Just thought I would report it for overall tracking.  4/19/21 still some irritation in the left armpit area but not as bad.
Headache; Swollen lymph nodes; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (COMIRNATY; Lot Number: Unknown) via an unspecified route of administration on 08Nov2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 09Nov2021, the patient experienced headache, swollen lymph nodes and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, swollen lymph nodes and body aches was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
My period was due 2 days after I received my second shot and it has yet to come, I am at this point 24 days late.  My cycle is very regular and I have never missed a period like this before.  After some quick research, it appears many women have experienced similar issues.
Extreme swelling of lymph nodes under right arm noted just over 72 hours after vaccination. Swelling lasted about 36 hours, then subsided.
I have been on birth control for 5 months for my adenomyosis and when I got the Covid vaccine 2 days later I started to have my period. I have now been going on 4 weeks with heavy bleeding and clots every time I use the bathroom. I was fine up until I got the Covid shot.
Case number PHEH2014US025077, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 23-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excision. No adverse event was reported following this maladministration.
No adverse reaction patient was given a high dose influenza vaccine and should of received a regular influenza vaccine.
I was told to contact you and let you know that I have been having flu like symptoms since my vaccine Monday afternoon at 3:45. Started yesterday with the headache, body aches and chills. I stayed the day yesterday but i will be leaving early today as I am not feeling any better. Treatment dugs:
At 3 a.m. in the morning following my vaccination, I woke up and could not get back to sleep. By 4 a.m., I was feeling ill - nauseous, chills, achy. I did not get back to sleep until close to 6 a.m. and slept until 7. I felt better and ate something for breakfast, but then was achy and exhausted for the rest of the day - sleeping almost all day. I went to bed at 8 p.m. still feeling exhausted and achy, and slept for 8 hours without waking up. I felt better on May 10. The injection site itched for another two weeks at least.
Patient called 12/30/19 and stated that she has experienced tingling in her left arm ever since she had the flu shot administered.
Patient came to booster clinic < 45 days after receiving 2nd dose. Consent clearly states in bold" I understand I must wait six months from my initial series ".
Felt dizzy immediately after shots. Next AM woke up dizzy and become nauseous. Presented to ER with dizziness and presyncopal symptoms. Received IV fluid boluses, RX for ondansetron, labs and EKG.