chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stye on her left eye; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HORDEOLUM (stye on her left eye) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced HORDEOLUM (stye on her left eye). The patient was treated with DOXYCYCLINE on 19-Feb-2021 for Stye, at a dose of UNK dosage form and DEXAMETHASONE, TOBRAMYCIN (TOBRADEX) on 01-Mar-2021 for Stye, at a dose of Tobradex SE drops. On 08-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HORDEOLUM (stye on her left eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded. On 21-Jun-2021: Non-Significant follow up appended; Mailing address and email address are updated
admission date 2/26/2022 had a positive home antigen COVID 19 test on 2/23. She is triply vaccinated. Currently only having URI symptoms. She is a candidate for sotrovimab  3rd vaccine-10/28/2021-Moderna-vaccine, Admin Location (Facility)Home Health Agency
No prior history of acid reflux Extreme onset of acid reflux and GERD degrading quality of life. Endoscopy, Blood Test, and Allergy Test show nothing wrong. April 8th First Shot July 4th First time throwing up from food July 24 serious acid reflux ended up in ER with sensation of something stuck in throat August 4th very severe acid reflux sensation of something stuck in throat did not go away for a week Since then ongoing issues up and down
Information has been received from a healthcare worker concerning an unspecified patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 15-APR-2016, the patient was inadvertently administered an expire dose of PROQUAD (Merck) (dosage not provided, subcutaneous, lot # K014800 with expire date of 12-MAR-2016). No adverse effects were reported. Additional information has been requested.
feel angry/grouchy/mean after the 2nd shot; feel angry/grouchy/mean after the 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (feel angry/grouchy/mean after the 2nd shot) and ANGER (feel angry/grouchy/mean after the 2nd shot) 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, 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 IRRITABILITY (feel angry/grouchy/mean after the 2nd shot) and ANGER (feel angry/grouchy/mean after the 2nd shot). At the time of the report, IRRITABILITY (feel angry/grouchy/mean after the 2nd shot) and ANGER (feel angry/grouchy/mean after the 2nd shot) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
SWEATING PROFUSELY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced sweating profusely. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sweating profusely. This report was non-serious.
24OCT94 pt recvd vax @ this time office visit afebrile & very sl rash on forehead & around chin-not reddened & mom states not itching; mom thought might be allergic react from eating-oatmean w/differnet flavor packets as rash began p/thaty
After shot I began experiencing whole body muscle pain that varies in intensity each day and migrates throughout my body. The pai s change, including a feeling of a sprained ankle, right wrist and hand pain, pain when exerting muscles, and a feeling of being worn out after doing even moderate labor. There is no fatigue at this point.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented fatigue and pain at injection site.
Incorrect storage of drug; dizzy; sweaty; couldnt walk; violent reaction; expired vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AA, expiry date unknown) for prophylaxis.   On 17th June 2019, the patient received Bexsero. On 17th June 2019, unknown after receiving Bexsero, the patient experienced expired vaccine used. On 18th June 2019, the patient experienced dizziness, sweating, unable to walk and violent behavior. On an unknown date, the patient experienced incorrect storage of drug. On 19th June 2019, the outcome of the dizziness, sweating, unable to walk and violent behavior were recovered/resolved. On an unknown date, the outcome of the expired vaccine used and incorrect storage of drug were unknown.   It was unknown if the reporter considered the dizziness, sweating, unable to walk and violent behavior to be related to Bexsero.  Additional details were provided as follows: The pharmacist stated that a patient picked up Bexsero from the pharmacy, and stored the Bexsero at room temperature at home. The patient received the Bexsero at a doctor's office, and this was after the Bexsero was out of range for 72 hours, which led to incorrect storage of drug. One day after vaccination, the patient experienced significant dizziness while standing, and couldn't walk due to this. The patient also felt sweaty and violent reaction. This was early in the morning the day after receiving the vaccine, and the patient felt better by the next day. The reporter did not consent to follow-up. Follow-up was declined.
bilirubin was increased; Chills; Fever; Diarrhea; Dark Urine; itchiness all over; feeling "unwell" or malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 62-year-old male patient who received HAB (Twinrix adult) (batch number X-239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th March 2022, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th March 2022, 1 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced malaise. On 27th March 2022, the patient experienced chills, fever, diarrhea, dark urine and generalized pruritus. On 31st March 2022, the patient experienced bilirubin increased. On 27th March 2022, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the chills, fever, diarrhea and generalized pruritus were recovered/resolved and the outcome of the dark urine and bilirubin increased were not recovered/not resolved.   It was unknown if the reporter considered the malaise, chills, fever, diarrhea, dark urine, generalized pruritus and bilirubin increased to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments:  The patient reported case for himself. On Friday 25th March 2022 patient began feeling unwell or malaise which was lasted until Sunday 27th March 2022. On 27th March 2022 , 3 days after receiving Twinrix adult patient experienced chills, fever, diarrhea and generalized pruritus, dark urine. On 31st March 2022, 7 days after receiving Twinrix adult patient experienced bilirubin increased.    The patient began feeling other symptoms that same day including chills, fever, diarrhea, dark urine and itchiness all over. On 31st March 2022 the reporter was sent to the emergency room by his HCP (health care professional) to check his liver function and he states all his labs were normal except his bilirubin was increased compared to his last bloodwork. The patient was sent home without admission. The only symptom persisting was the dark urine which was not gone away. The reporter consented to follow up.
pt recv vax 20FEB96 & 25FEB95 pt exp a pounding h/a (occipital/parietal) when upright, sensitivity to lights, gen malaise, myalgia spine pain w/walking & a mildly pruritic rash quarter size small papules-non-crusted/vesicular;
diarrhea; fever; leg pain; arm swollen/ swollen arm at injection site; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included peripheral neuropathy. Previously administered products included Shingrix with an associated reaction of pyrexia (for tolerance to the 1st dose refer case id US2020073879).   On 27th April 2020, the patient received the 2nd dose of Shingrix (intramuscular). In April 2020, less than a week after receiving Shingrix, the patient experienced diarrhea, fever, leg pain and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the diarrhea, fever, leg pain and injection site swelling were unknown.   It was unknown if the reporter considered the diarrhea, fever, leg pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in right arm and experienced fever, diarrhea, leg pain, and swollen arm at injection site. The reporter stated that she experienced same event after receiving 1st dose which she received 2 months ago from reporting date but symptoms were more severe after dose 2 than 1st dose. The reporter did not consent to follow up. This case has been linked with US2020073879, reported by same reporter
A physician reported that a female received an injection of tetanus toxoid vaccine (manuf. unknown) "many years ago" and subsequently developed an anaphylactic reaction. The reporter indicated that the pt had the reaction to the horse serum in the vaccine. No further info was available at the date of this report. The anaphylactic reaction in this case was considered medically important.
Swelling of the eyelids & lips 25JUL91 night; w/c cleared up spontaneously 26JUL91;
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Son states that on February 7th his mother developed shingles.  On February 12th developed Bell's Palsy. On May 15th at 9:00 PM his mother had a heart attack.  Is recovering at healthcare facility.
Sweats; Had about a week of Sleeping; Muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches). At the time of the report, HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     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.   No concomitant medications were reported. No treatment related information has been reported.; Reporter'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.
Patient called to report profuse erythema and edema involving the L. arm where vaccine administered. Pt states hot to the touch. Recommended benadryl, and nsaid. Pt stated did not have any benadryl nor NSAIDs at home and is nonambulatory. Pt is unable to attain ride to urgent care or clinic if necessary. Again recommended to seek urgent consultation with physician/arnp/pa-c for further investigation and resolution if condition continues or worsens.
Narrative:  71 yo M with PMH of AAA and CAD. Received bivalent covid-19 booster (Moderna) and quadrivalent influenza vaccines on same day (12/19/22). Pt reports having a balance and walking issue about 3 days after receiving the vaccines. Reports has gradually been able to regain balance. Case evaluated by ID physician who felt symptoms unlikely to be related to vaccines.
Mother states that patient was achy, dizzy, and had a fever.  She also says she was "delirious" and almost took her to the ER.  The symptoms lasted for less than 12 hours and were gone by the next morning.
Information has been received from a RN concerning an 11 year old female pt, who is a twin, with no allergies or pre existing medical conditions, who on 09/12/2000 was vaccinated SQ in the LA with a dose of varicella virus vaccine live. On 08/22/2004 the pt developed a  rash on her stomach which was described as 18-20 lesions. She was afebrile. The RN reported that the pt was treated with Benadryl and calamine as needed. Follow up information received from a RN reported that on 08/03/2004 the pt had  a varicella breakthrough and was described as 18-20 papular lesions on her chest, back and buttocks. There were no laboratory studies performed and she was not ill at the time of vaccination. On an unspecified date the pt recovered. The pt sought unspecified medical attention. The RN also reported that the pt's twin brother developed a varicella breakthrough rash of 18-20 lesions on his stomach following vaccination with varicella virus vaccine live. (WAES0408USA00321). No additonal information is expected.
PREVNAR 13 was given instead of PNEUMOVAX. The 2 doses of PREVNAR were given over 1 year apart.
pt recvd vax & 7 days p/vax exp heat, swelling & pain in middle joint of 2nd & 3rd finger on rt hand only; treated w/Naprosyn;
DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.
arm swelling; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 17th March 2019, the patient received the 1st dose of Shingrix. On 19th March 2019, 2 days after receiving Shingrix, the patient experienced swelling arm. On 21st March 2019, the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: Arm swelling was resolved after about 4 days post injection. The reporter consented to follow up.
large red spot; itches a little bit; a little bit tender; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (large red spot), PRURITUS (itches a little bit) and TENDERNESS (a little bit tender) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (large red spot), PRURITUS (itches a little bit) and TENDERNESS (a little bit tender). At the time of the report, RASH MACULAR (large red spot), PRURITUS (itches a little bit) and TENDERNESS (a little bit tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.   This case was linked to MOD21-017590, MOD21-017606 (E2B Linked Report). This case was linked to MOD-2021-019286 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non-significant follow-up received on 19-Apr-2021, appended in the case on 27-Apr-2021.; Sender's Comments:  MOD21-017590: MOD21-017606:
Office Visit 2/28/202  Pneumonia of both lower lobes due to infectious organism +3 more Dx Shortness of Breath  ? Cough  ? Fatigue ? Generalized Body Aches  ? Chills ? Night Sweats Reason for Visit  Clinical Support 3/3/2021    COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes ? ? Encounter Date: 3/3/2021 ? ? Signed    Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90%   Signs of potential reaction reviewed with patient.   Tolerated IV start and MAB infusion without complication.   Pt has access to pulse oximeter and thermometer (given here) for home monitoring   Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions
Patient arrived back in clinic for evalauation and tx of cellulitis R arm. Pt received Pneumovax on 4/4.  The next day noticed redness and swelling, firmness @ injection site about baseball sized; slowly got better, but presented on 4/8 with red streaks and swelling into his lower forearm. Tx:  PRN Benadryl, elevate arm; Keflex 500 mg tid x5 days.
Patient had a skin reaction after the vaccine. She explained that it was uncomfortable and itchy almost like a rash.
dizziness; nausea; He says the room was spinning around; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EL9264) at the age of 78 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "nausea"; VERTIGO (non-serious) with onset 03Mar2021, outcome "recovering", described as "He says the room was spinning around".  Additional information: Reporter confirmed patient received the first dose on 03Mar2021 and the dizziness began the same day. She said it is resolved now. Patient said the room was spinning around he got nauseous with it too but it got better as the night went on. Reporter said it was after midnight ,so it was on 04Mar2021 when the dizziness recovered completely. Reporter said patient's nausea was recovered now as well. It was just nausea it was not vomiting and that was better now.  No follow-up attempts are possible.  No further information is expected.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Headache. Initial report received from a health are professional on 02 July 2012.
myocarditus some abnormal heart rhythm,  unusual sensation in the heart.  It passes quicklly and I think it is deminshing over time.