chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, hives, aches, chills, nausea  Tylenol PM taken  Started day with aches and chills, at night it became a fever and the nausea and hives started
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age. The patients concurrent condition, medical history and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with multiple unspecified doses of VARIVAX and ZOSTAVAX (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. Additional information has been requested.
hurts; feels kind of strange; discomfort in her arm from the first vaccine/she received the injection in the left arm in which that is the side she is experiencing discomfort; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via medical information team. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient stated that she still has discomfort in her arm from the first vaccine, in which the discomfort has progressed to her hand and felt like some issue with a nerve, like a nerve in her hand. she received the injection in the left arm in which that was the side she was experienced discomfort, she has had this discomfort for 3 weeks, asked if this was ok and why was she experienced this side effect for so long. She stated she has heard some state they experienced the same side effect for a few days or a week, but not as long as she was experiencing the discomfort. Patient described the feeling as she didn't know if it was a nerve, but it felt strange. Sometimes it hurts, but mostly felt kind of strange. She also stated that hand feels like something was not right about left arm and asked if she should receive the second dose. she consulted with the vaccination provider in which they stated she could receive the vaccine in her thigh instead and asked how long people experienced the pain in their arm as noted in the post authorization. Outcome of the events were not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
itchy burning rash on leg and arm; hemorrhoids; Burning rash; softer bowel movements; gas/smelly gas an bowel movements; rash on left arm and right leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements) and FLATULENCE (gas/smelly gas an bowel movements) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastro-intestinal disorder NOS.   On 23-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements), FLATULENCE (gas/smelly gas an bowel movements) and RASH (rash on left arm and right leg). The patient was treated with SIMETICONE (GAS X) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTOBISMOL) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (itchy burning rash on leg and arm), HAEMORRHOIDS (hemorrhoids), BURNING SENSATION (Burning rash), ABDOMINAL DISCOMFORT (softer bowel movements), FLATULENCE (gas/smelly gas an bowel movements) and RASH (rash on left arm and right leg) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-JUN-2021 and contain no new information . On 10-Jun-2021: Follow-up received on 10-JUN-2021 and contain no new information . On 23-Jul-2021: follow up received on 23 JUL 2021 contains no new information
ROUGH TIME; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced rough time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rough time on 12-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210430339.
Given in R arm within 6 hrs experienced pain, swelling, itching at site. Systemic symptoms included malaise, nausea, reduced mental ability. Systemic effects gone within 36 hrs of shot. Local rxn lasted another week. Pain itching and hard lump about size of quarter.
28 YO CAUCASIAN MALE PT C/O R-ARM TINGLING IN A DESCENDING PATTERN ALONG WITH NECK AND TONGUE TINGLING. THIS TINGLING SPREAD TO HIS LEFT DELTOID AND DOWN TOWARDS HIS FOREARM. PT STATES IT FEELS LIKE " CHILLS". PT DENIES BLURRED VISION, CHEST PAIN, AND SOB. PT HAS NEVER EXPERIENCED AN AE TO A VACCINE. W VS @ 9:12 BP  123/74 HR 55 SpO2  90s
Initially I had large red areas around my upper arm which was not painful. This redness lasted several days and finally went away. My arm has remained very sore. After the first injection it was sore for a few days and went away. This soreness has not gone away.  It feels like a very sore muscle and is painful with certain range of motion. It has of today been over 6 weeks since the 2nd injection.
Increased lethargy - extreme fatigue. Slept for 15 hours overnight and was only awake for 5/6 daytime hours next day. Auxillary fever of 101.5 onset midday following the vaccination of Pentacel.
Anterior cervical lymph node enlargement; mobile, non-tender No axillary nodes palpated; slight swelling and tenderness in left axillary Advised follow-up
Wheezing, tightness in chest, sinus congestion and drainage, slight difficult breathing.  Symptoms subsided by 2:30 am, 10/13/2016 and had more or less disappeared by 7:00 am, 10/13/2016.
Information has been received from a physician concerning a 66 year old female with no pertinent medical history who in approximately October 2007, was vaccinated with ZOSTAVAX 0.6ml, SC. On approximately 01-Oct-2008 the patient started experienced pain and developed a rash on her abdomen about 1 week ago. The patient was diagnosed with shingles. The patient was being treated with LYRICA and VALTREX. As of 16-Oct-2008, the patient had not recovered. The patient sought medical attention at the doctor's office. Additional information has been requested.
All of the usual symptoms the day following the shot - nausea, chills, body aches, slept for about 20 hours.  In the following weeks, joint pain (especially noticeable in the hands) was noticed.  Eventually the left hand pain has diminished.  The right hand still has constant pain in knuckles/joints especially in the center of the hand.  The pain has lessened over the weeks, but has remained the same for that last 10-14 days.
I develop body itching; This case was reported by a consumer and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Post vaccination the patient developed body itching. The patient inquired if anyone else also has reported the same event.
Fever 99.2; chills; joint aches & woke up in a sweat; joint aches & woke up in a sweat; Gastric reflux; This is a spontaneous report from a contactable nurse. This 44-year-old female nurse reported for herself. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3248) via intramuscularly in arm right on 08Jan2021 09:30 as dose 2, single (age at Vaccination: 44 years) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL0140) via intramuscularly in arm right on 08Dec2020 10:30 AM as dose 1, single for COVID-19 immunisation. No Covid prior vaccination and did not tested covid post vaccination. On 08Feb2021, fever 99.2, chills, joint aches & woke up in a sweat, then gastric reflux for 3 days post vaccine. Treatment received was antacids & Tylenol. The patient underwent lab tests and procedures which included fever resulted 99.2 on 08Feb2021. The clinical outcome of the event gastric reflux on 11Feb2021 was resolved and the other events on Feb2021 was resolved.  Follow-up attempts completed. No further information expected.
4/1 (starting approx. 12 hrs after receiving): Body aches 4/2 (about 24-36 hours after): Body aches, fever, chills (felt flu-like, equally severe)
Patient received shingrix vaccine 5/13/20. Later in the evening started to get redness to the site and soreness. Next day redness was the size of an orange and body aches. Took tylenol and today felling a little better. Redness remains about the size of a fist. Denied any swelling. No fever at this time but wife had symptoms that were worse. Discussed applying warm or cool compress to area and continue with Tylenol. Advised to call office if redness gets any larger or swelling starts to develop.
AT 1257PM PT REPORTED GENERAL BODY RASH AND ITCHINESS WITH SLIGHT CONGESTION TO NOSE AND CHEST. BENADRYL 25MG PO GIVEN AT 1259PM WITH GOOD EFFECT. VITAL SIGNS WNL. 136/87, 81, 18, O2 100% ON RA @ 1259 PT STATES SHE FEELS FINE AND CAN GO HOME . PT LEFT FACILITY ON HER OWN AT 1316.
Seizure episodes on the next day of vaccination ( Mother is a physician and took care of her at home); This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in the left arm on 17Jun2021 (at the age of 15 years old) as dose 2, single for COVID-19 immunisation in a Pharmacy/drug store. Medical history included Pollen allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the paitent was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in the left arm on 27May2021 (at the age of 15 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient experienced seizure episodes on the next day of vaccination on 18Jun2021. The patient's mother is a physician and took care of her at home. The event resulted to Doctor or other healthcare professional office/clinic visit. Treatment was not given in response to the event. Since the vaccination, the patient had been tested for COVID-19 with RT-PCR salivary test on 25Mar2021 which was negative. The outcome of the event was recovering. The consumer assessed the event as non-serious.
Severe headache and nausea and possible fever (chills in the middle of the night)
This spontaneous report was received from a healthcare worker and refers to a 12 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-SEP-2015, the patient was vaccinated with an improperly stored of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
The MMR had expired 12/4/2021 He had no symptoms or reaction to the shot that day or win next month and no reaciton since. See my printout of note of  my discussion with mom the day of hot pediatric injection  Then see 3/14/2023 visit. Have another MMR on 3/24/23 Had a viral gastrointestinal  see enclosed
Edema, erythema 7 cm x 7 cm inferior to injection site, itching. Treated with ATARAX and hydrocortisone cream.
Tired, headache, swollen injection site (left side) and bruise, muscle aches from left side radiating from neck to arm and hand.
Moderna Covid-19 Vaccine  Tenderness at vaccine injection site progressed to swelling and  hard/firm bump around site that was slightly warm and painful on 2/5/21.
Pts arm was hurting and noticed large redness/swelling around injection site. It is warm to touch.
Possible Guillain-Barre syndrome, requiring vent, plasmapheresis.  12/1/09 Hospital records received, service dates 11/4/2009 to 12/18/09. Assessment: Guillain-Barre Syndrome. Patient c/o back pain/shoulder pain. 5 day hx of pain in shoulder blades. Subjective fever, chills, diaphoresis. Nausea, vomiting, shortness of breath, abdominal pain. Numbness and pain in legs. Morbidly obese. Hypoxic. Bilateral crackles. Pulmonary infiltrates. Hyperglycemia. Gastrostomy tube placement. 1/11/10 D/C summary rec'd for DOS 11/4/09-12/18/09 with D/C DX: GBS.  Acute MI. Acute Respiratory Failure. Hyperglycemia. CAD s/p angioplasty in past. HTN. Hyperlipidemia. s/p Stroke. Hx diverticulosis.  addendum dx: C. diff colitis. Acute posterior wall MI. Nosocomial pneumonia. Acute kidney failure, resolved. Hyponatremia resolved. Pt developed generalized weakness during hospital stay with subsequent respiratory failure requiring mechanical vent. Tx plasmapheresis with no significant improvement. D/C to inpt rehab.
nausea; violent headache; chills/shivering; vomiting; cannot sleep; having vivid dreams; trouble thinking; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. An 80 (units not provided) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 (at the age of 80, units not provided) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking. It was reported that the patient was hospitalized in the ER (emergency room) 45 minutes after receiving the dose. The clinical course was reported as follows: "The patient received her first COVID-19 vaccine and ended up in the ER with a violent headache, nausea, chills, shivering, trouble thinking and even sleep was an enemy because she had vivid dreams." The patient reported that due to these symptoms she was thinking to get the second dose later than 3 weeks. She wanted to know if she should get the second dose. She also wanted to know if she could pass these side effects along (as reported). The clinical outcomes of the events nausea, violent headache, chills/shivering, vomiting, cannot sleep, having vivid dreams and trouble thinking were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Nurse gave vaccine at approximately 9:00 AM in right arm. Patient left vaccination area, then returned at approximately 11:20 AM. Patient with complaint of Right arm pain, radiating down from injection site into right forearm, and across right shoulder into chest and into right upper back. Patient noted to have full range of motion of right arm, right shoulder, right hand, and fingers of right hand. Denies numbness and tingling. The injection site checked and noted to be clean, warm, pink, dry, with no bruising or discoloration. Injection site noted approximately 1 inch below acromion (shoulder joint).  Ice pack applied to area, encouraged patient to see PCP or Health Clinic if pain does not improve.  Phone call made on 9-28-17; patient relates pain is improved. She took Aleve for discomfort on 9-27-17. On 10-13-17, spoke to patient, she relates she went to the doctor on 10-09-17 and that she is doing fine, denies pain, numbness or tingling.
Approximately 10-15 minutes after receiving vaccine, pt. c/o dizziness, headache and shakiness.  BP: 160/60, HR: 70, RR: 24-28, O2 sats: 98%.  No other symptoms noted.  Pt. assessed local EMS. Declines going to emergency room today.  Pt. plans to go to urgent care or call PCP.
Patient was given MMRV (PROQUAD) along with the varicella vaccine.
14 days after 2nd dose severe shortness of breath, fatigue, lightheaded, near syncope.  Diagnosed with bilateral DVT and bilateral PE
inconsolable crying for 1 1/2hrs w/periods of high shrill crying, APAP given q 4hrs; temp ok or nl according to mom;
L deltoid site swollen with 8cm erythema, warm to touch, non tender on 3rd day of Imm. swelling resolving on 4th day.
Started with hives appearing on my face. The next day had chest pain/tightness and shortness of breath. I ended-up leaving work early to go to urgent care. They couldn't find any problem.
Double Vision.  Beginning a little over a week after the shot.  Worsening progressively over subsequent days.    Hospitalized March 17th.  Extensive testing done in hospital.  Eventual Diagnosis Myasthenia Gravis.   By April 19 symptoms had subsided to hardly noticeable.   Symptoms remain hardly noticeable through current date.    No worsening of conditions after second shot.
Began as pain in hands progressed to include left elbow, knees, and feet.  Fever with 100.5 highest.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of Drug ineffective, covid-19 which included Paxlovid from 13May2023 to 18May2023.  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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300203866 Same patient, different product, different event;
Pt had no symptoms. Wrong vaccine given. Pt received Tdap instead of 5th DTaP. No reaction.
Post vaccination patient had the following symptoms: prolonged Left upper arm pain, limited range of motion, itching at shoulder these symptoms have continues since vaccination date. has improved slightly in last four days
Headache; Breastfeeding; A spontaneous report was received from a consumer concerning herself, a 35-year-old breastfeeding mother, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events; breastfeeding/exposure via breastmilk and headache.  The patient's medical history was not provided. Concomitant medication list was not provided by the reporter.  On 24 Feb 2021 the patient received their first of two planned doses of mRNA-1273 (Batch number: 013A21A) via an unknown route in an unspecified arm for the prophylaxis of COVID-19 infection.  On 24 Feb 2021, after receiving mRNA-1273 the patient experienced vaccine exposure while breastfeeding. On 25 Feb 2021, one day after receiving mRNA-1273 the patient experienced headache. Treatment information was not provided.  Action taken with the drug in response to the event; breastfeeding is not applicable. Action taken with the drug in response to the event; headache is unknown.  The outcome of the event; breastfeeding was considered to be recovered/resolved on 24 Feb2021. The outcome of the event; headache was considered to be recovered/resolved on 26 Feb 2021.