chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning her approximately 19 months old grand-daughter, with gastrooesophageal reflux disease and a history of premature birth at 32 weeks of gestation, who on unspecified dates had received three doses of ROTATEQ (Lot # unknown) PO. Concomitant therapy included ranitidine and PREVACID. The nurse reported that on an unspecified date the patient was subsequently diagnosed with rotavirus gastroenteritis. Child was hospitalized for 1 week. The patient had an ELISA performed for identification of rotavirus. The patient was treated with intravenous fluid replacement for vomiting and diarrhea. Patient was discharged and recovered fully on an unspecified date. Additional information has been requested.
Complained of "trouble breathing" Approx 1 hour after receiving nasal mist H1N1 vaccine. Presented with, SOB, increases RR - 36, sub-sternal & intercostal retractions -O2 sat 91% on rm. air - O2@8L transport to ER via ambulance.
Too like Sore for the Arm; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received second dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 09Jun2021( at the age of 16-year-old) as Second dose ,SINGLE DOSE for covid-19 immunisation. The patients Medical history and Concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination. Patient's historical vaccine include first dose of BNT162B2 via intramuscular, administered in Arm Right (It was like 3 weeks before) for COVID-19 immunisation. On 10Jun2021 The patient experienced too like sore for the arm . Reporter stated, I am just calling because this past Wednesday when my son took the second dose of the Pfizer vaccine, but my son is too like Sore for the Arm . Reporter stated, it was started yesterday, and he just called us a little while ago and told that he was still having it in his right arm. Well, it started yesterday, and we noticed that from what he is telling is it is getting worse. he hasn't taken anything. That's why we were calling to see if we could give him some Ibuprofen. Therapeutic measures were not taken as a result of the events. The outcome of the event was reported as not recovered.  Information on Lot/Batch number has been requested.
She recived Gardisil in left arm then Menigitis vaccine in right arm.  Within a mintue of reciveing the second shot she passed out, her body became rigid with her eyes open in a fixed stare, jaw clinched, arms tightened towarsd body, shoulders rolled in towards body, lightly urinated on self, making a low grunting/gurgling sound.  This went on for sveral minutes.  She does not remember anything after the second shot until she woke up on the floor with a fleet of doctors around her. 3/09/09-records received for DOS 3/4/09-After receiving vaccines had a vagal reaction fell to floor lost consciousness and hit forehead. Had some jerking movements of extremities. Now C/O shoulder pain.
Moderna COVID-19 Vaccine  1/4 (Day 1): Approx. 2 cm redness and swelling at injection site. Arm sore. 1/5 (Day 2): Approx. 2 cm redness and swelling at injection site. Arm sore. 1/6 (Day 3): Approx. 2 cm redness. No swelling. Arm sore 1/7 (Day 4): Approx. 2 cm redness (less redness, pink) 1/8 & 9 (Day 5 & 6): No redness, swelling, or soreness. 1/10 (Day 7): Approx. 2 cm redness returns with minimal itching. No swelling or arm soreness. 1/11 (Day 8): @ 0945 3 cm (widest point) redness, swelling, itching and warm to touch. @ 1845 6 cm redness, swelling, itching (increasing) and warm to touch. Applied hydrocortisone cream. No improvement @2042 Same size, itching increasing, 25 mg Benadryl PO.  1/12 (Day 9): No improvement from Benadryl. Awake at 0314 from itching. Applied ice pack. Improved enough to sleep.  @0939 Redness, swelling, itching, and warm, size measures at 10.5 cm. 200 mg ibuprofen PO. @1042 Improvement with ibuprofen. Less itching, size decreased to 10 cm. Continues to be warm and swollen. @2145 220 mg naproxen sodium. Ice packs throughout the day (helps with itching and decreases redness but continues to increase in size). 1/13 (Day 10): Less redness (almost pink), less itching, minimal swelling, continues to be warm and spread. Size 12 cm. Report to Employee Health.  Continuing to monitor, taking NSAIDs, and applying ice packs. Afebrile throughout event (temps range from 96.8 to 98.2). No other systemic effects noted.
11/18 Quarter size knot with red circle. 11/19 golf ball size area of redness - entire thigh swollen. Advised Motrin every 6 hours and Benadryl 1 tsp every 6 (1 1/2 tsp)
Started with high fever 7/22.  Severe Diarrhea and abdominal pain 7/25. Went to Pediatrician 7/27, 7/29, 7/31 given Antibiotic Cipro.  Went to Children?s Hospital VCU on 8/3. Hospital did CT, colonoscopy, endoscopy, MRI. Diagnosis with IBD Crohn?s. On steroids, antibiotic, Humria
Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 13:15 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "mastectomy", start date: 2015, stop date: 2015, notes: Breast cancer resulting in mastectomy 7 years ago; "SVT" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE; ATORVASTATIN; METOPROLOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: EL9269; Anatomical location: Arm Right), administration date: 13Feb2021, for COVID-19 immunization, reaction(s): "Sore arm", "lump in lymph node under arm"; BNT162b2 (DOSE 2, SINGLE; Lot No: EN6204; Anatomical location: Arm Right), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "Sore arm", "lump in lymph node under arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot No: FE3590; Anatomical location: Arm Right), administration date: 09Oct2021, for COVID-19 immunization, reaction(s): "Sore arm", "lump in lymph node under arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Adverse events lasted for a couple of days. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201373782 Same Reporter/Patient, Different AE/Vaccine Dose;US-PFIZER INC-202201373767 Same Reporter/Patient AE; Different Vaccine Dose;
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the local Health Authority at that time. No adverse event was reported. Treatment information was not provided.
Patient was deadly ill for a week, she ran a fever and everything; Patient was deadly ill for a week, she ran a fever and everything; This is a spontaneous report from a contactable consumer and other health professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was deadly ill for a week, she ran a fever and everything (medically significant) on an unspecified date with outcome of recovered after 1 week.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got restless; pain in muscles bones joints; muscles bones joints; muscles bones joints; fever 99.8; skin sensitive; chills; nausea; raging headache; massive thirst; loose stool; significant site pain; This is a spontaneous report from a contactable Nurse (patient) reported that: A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 12:00 PM, (Batch/Lot Number: EL9261) as dose 2 single for covid-19 immunization. The past medical history includes hiv-undetectsble and healthy. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for an unspecified indication, pravastatin taken for an unspecified indication, celecoxib (CELEBREX) taken for an unspecified indication, fluticasone propionate taken for an unspecified indication and azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Feb2021 12hr after the vaccination the patient experienced got restless, pain in muscles bones joints, fever 99.8, skin sensitive, chills, nausea-no emesis, raging headache, massive thirst, loose stool-not diarrhea, and significant site pain-no swelling or redness. The lab test include: body temperature: Result:99.8 on 10Feb2021.The patient is treated with Tylenol, tramadol and massive hydration. The event outcome was recovered on unspecified date 2021.   No further information expected.
Fever 102 Body aches Fatigue Nausea Headache Cough Congestion  Went to clinic, 10/8/2020. Was tested for covid.  Test was negative. Was ill with above symptoms for 5 days. Had lingering cough for 10 days. Treated at home with tylenol and delsym.
The patient experienced prolonged crying, no appetite, a knot in the left leg, redness and soreness.
Mild urticarial lesions on face, head, neck, abdomen, chest, arms and upper legs. Physical exam otherwise normal. Given Benadryl and hives resolved.
Right at injection site was burning, then within an hour or so pain moved to the left side of my neck and shoulder and upper back and then within hrs it spread to the rest of my body I then got a low grade fever of 101 degrees for about 12 hrs and I had extreme exhaustion, weakness and my muscles and joints ached for 2 weeks and my left shoulder still aches in the joint.
8 hours after 2nd vaccine, I started to get goose bumps, then chills. My heard fluttered slightly. Body aches lasted for 24 hours.  I was extremely fatigued and did not feel 100 % until 2 days later
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955) and on 12Apr2021 as dose 2, single (Lot number: EP6955) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient had received paxlovid, oral (lot number: GC4800) for COVID 19 treatment on 27Jul2022 and stop on 27Jul2022.
Pain in small joints, feet, toes, both hands, and her neck; Pain in small joints, feet, toes, both hands, and her neck; Pain in small joints, feet, toes, both hands, and her neck; RA worsened; After receiving the 1st dose of the Moderna vaccine, her pains have came back; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA worsened) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis (Significant worsening of illness once received vaccine) since 09-Dec-2020. Concomitant products included HYDROXYCHLOROQUINE from 22-Jan-2021 to an unknown date for Rheumatoid arthritis, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (After receiving the 1st dose of the Moderna vaccine, her pains have came back). On 09-Apr-2021, the patient experienced RHEUMATOID ARTHRITIS (RA worsened) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in small joints, feet, toes, both hands, and her neck), NECK PAIN (Pain in small joints, feet, toes, both hands, and her neck) and ARTHRALGIA (Pain in small joints, feet, toes, both hands, and her neck). At the time of the report, RHEUMATOID ARTHRITIS (RA worsened), PAIN (After receiving the 1st dose of the Moderna vaccine, her pains have came back), PAIN IN EXTREMITY (Pain in small joints, feet, toes, both hands, and her neck), NECK PAIN (Pain in small joints, feet, toes, both hands, and her neck) and ARTHRALGIA (Pain in small joints, feet, toes, both hands, and her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Additional concomitant medication included unspecified vagina suppository with hormones.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Significant Follow up information was received on 06-JUN-2021  and provided patient and event details.; 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.
onset golf ball size swelling @ inj site;swelling is slowly resolving but redness & soreness in inc LUE laterally;also exp chills daily around noon;pt given med;cellulitis;
Pt presented to Rm 174 from lobby pale/eyes sunken.  When asked what's wrong, pt. replied "I got sick from the H1N1 nasal.  Pt assisted for stretcher to rest.  After 20 minutes color returned. That same afternoon pt seen at STD clinic and was told he was HIV positive. The pt was screened for the inactivated H1N1 Influenza vaccine and was given the live-attenuated H1N1 vaccine. Contact was finally on 03/05/2010 and ask the patient how he was doing after the episode he had with the H1N1 nasal H1N1 vaccine.  Did not acknowledge he had felt. Asked how was he doing - He said he was fine, no problems.  Instructed to see a physician if he felt bad or any probleems.  On 03/19/2010 he was contacted and he stated he was fine and not having any problems.
pt presented with bells palsy 6 days later sent to the hospital had CT scan negative for CVA and was given prednisone and valtrex
Body shaking all over, both arms numb & tingling, headache, chills  03/26/21
Information has been received from a physician concerning a male who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient fainted shortly after vaccination.  Unspecified medical attention was sought.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been requested.
PX HAD PAIN AT TIME OF IMMUNIZATION, THEN ABOUT 9PM ON 3.27.13, PX FELT AS IF AN ALLERGIC REACTION OF THROAT SWELLING, WAIST DOWN HEAVINESS, AND COLD CHILLS. THOSE SYMPTOMS LASTED ABOUT AN HOUR AND SHE USED ELECTRIC BLANKET FOR CHILLS. SHE ALSO HAD REDNESS AT THE INJECTION SITE 1"X4" THAT WENT AROUND TO THE BACK AND CURRENTLY STILL RED. ON 4.3.13 THE PX FELT THROAT SWELLING WAS AGAIN OCCURRING. SHE WAS INSTRUCTED TO VISIT MD WHICH SHE DID, AND HE FELT TO WAIT AND SEE AND THOUGHT SHE WOULD BE FINE.
Patient given MMR and VZV on 10/27/09. Rash all over and whelps that comes and goes appeared 24 hrs after vaccines given.
All day Saturday through today Tuesday, still going on.  Chills, fever reaching up to 103.2, Migraine headache, loss of apatite, Body temperature sky high though out abdomen. Constipation  Occasional vomiting (not too often)   Tylenol regiments might bring fever down but not all the time. Some Ibuprofen to not take too much Tylenol
Patient came in with large red area on right arm.  Area painful and red and swollen.  no drianage.  Pt also had small papula vedicular lesions on truck and arms.  Given RX for keflex and benadyl.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced increase swelling in the arm on an unspecified date about one month before report with outcome of not recovered.
Received moderna vaccine on 3/18/21 and 4/15/21. Presented to ER on 1/24/22 and found to be COVID19 positive.In the ED, patient hemodynamically stable and afebrile.  Patient tested positive for COVID-19.  He is asymptomatic.  He is vaccinated he has not received a booster shot. Admitted for another reason other than COVID19. Discharged on 1/28/22
Patient Complained he was weak and being anxiuos. EMS was called vitals were taken BP 105/75  95% O2 room air HR 68.  He recovered and released to go home.
Within 5-6 hours of getting the vaccine, began having severe abdominal pain at the top of my stomach. Felt like severe hunger pains but got worse when I ate.
On 5/6/09 patient developed hives all over about 20 minutes after vaccines were given.  She was sent for allergy consultation and tested positive for milk and egg allergy.  The allergist recommends skin testing to each of the vaccines to be administered and only one will be given at a time.
Period ended on April 16, 2021.  Missed period since then (usually a 24 day cycle).  No period since moderna first shot on 4/15/2021.
administered 0.25mL due to incorrect reconstitution technique; administered 0.25mL due to incorrect reconstitution technique; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 71-year-old patient who received Herpes zoster (Shingrix) (batch number H7AT2, expiry date 28th August 2023) for prophylaxis.   On 27th July 2022, the patient received Shingrix (intramuscular) .25 ml. On 27th July 2022, unknown after receiving Shingrix, the patient experienced underdose and inappropriate reconstitution technique. On an unknown date, the outcome of the underdose and inappropriate reconstitution technique were unknown.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The health care professional (HCP) reports that 2 patients were administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique. The reporter consented to follow up. Additional Supportive Information: The patient was administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique, which led to under dose and inappropriate reconstitution technique. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111772:Same reporter/Same case
The 4-day old newborn was scheduled to receive her first dose of the Hepatitis B vaccine. The correct vaccine was ordered, but the medical assistant erroneously administered a Hepatitis A vaccine instead.  The error was noted when the medical assistant was entering the vaccine administration information into the patient's chart. The physician and the CDC Clinical Immunization Safety Assessment (CISA) Project were contacted.  The newborn has been closely monitored and returned for a recheck appointment the following day.  She has been afebrile and continues to feed and act well.  No side effects have been noted.
Unsure if related to SHINGRIX or not. I started developing extreme lower jaw gum sensitivity 48 hours after receiving vaccine. I do not have gingivitis and see my dentist for check ups routinely. The next day, I developed right side salivary gland pain and swelling. The following day, I developed left side salivary gland swelling and pain. The gum sensitivity increased and became swollen, red, and inflamed. During this time, I started to develop mouth ulcers to my gum line, tongue and inner lip. Some of the ulcers were red, raised, and inflamed. The other ulcers appeared as flat white spots. The gum swelling has improved at this point although it is still very sensitive. The initial mouth ulcers are improving and others are still appearing mostly as red, inflamed spots at this point. I have done nothing for treatment except comfort measures.  Ibuprofen, soft diet, cold fluids.
2 days p/vax pt became fussy & had high pitch scream intermittently;cold sx w/runny nose;devel t103.6, no vomiting, diarrhea;feeds w/encouragement;APAP for fever;