chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Office Mngr noticed hives on forehead + neck, chest. Took 3 Allavert Allergy ODT tab, drove home, took Benadryl 50mg + Prednisone 60mg. Severe fatigue Friday Sat + Sun, (01/29 - 01/31/2021), restless, irritable, achy all over, warm + pain @ injection site, + headache  Made my PCP aware. Refill from him on Prednisone always have to premedicate with Benadryl + Prednisone Took 40mg Prednisone 01/30/2021 Took 20mg Prednisone 01/31/2021 Took 20mg Prednisone 02/01/2021 Continue with fatigue + dry hacy cough. (-) Rapid COVID test 02/02/2021 per CDC req'mts for Longterm care facilities
My upper left arm is very painful.  Pain has migrated to left shoulder and left elbow.
HEADACHE; NO SLEEP; BLURRY VISION; CHILLS; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies, no known medical conditions and no known medication usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-SEP-2021, the patient experienced no sleep. On 11-SEP-2021, the patient experienced blurry vision. On 11-SEP-2021, the patient experienced chills. On 12-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chills, no sleep, blurry vision, and headache. This report was non-serious.
Moderna Arm Large red swollen area on arm where vaccine was administered  Itchy  On call allergist suggested antihistamine but not Benadryl.. Took zyzal.  It lasted for several days
- FELT DIZZY & NAUSEA ABOUT TEN MINUTES AFTER RECEIVING VACCINE - DECLINED EMS EVALUATION  - HAD FRIEND DRIVE HIM HOME, AGREES TO GO TO DOCTOR / ER If CONTINUES TO fEEL UNWElL TOMORROW  OR WORSE SYMPTOMS
This spontaneous report as received from a medical assistant refers to 13 years old adolescent, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Headache, Myalgia,  site pain swelling, swollen glands, fatigue, headache  for 1 week
weak; dizzy; had a fast heart beat over 125 BPM; A spontaneous report was received from a Consumer concerning a 75 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy, weakness and increased heartbeat.  The patient's medical history included High blood pressure and High Cholesterol. Concomitant medications included are Tenormin and Laptor.  On Monday 18Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-  (lot/batch: 041620A) on her right Arm.  On 19Jan2021, The patient experienced dizzy, weakness and increased heartbeat.  The patient did not took any medicinal product to treat the symptoms. Action taken with mRNA-1273 in response to the events was not reported.   On 19Jan2021, the outcome of the event- increased heartbeat was resolved. On unknown date dizzy- unknown, weakness-unknown. The reporter assessed the event(s), [dizzy, weakness and increased heartbeat], as related/not related to study drug. {Duplicate causality assessment for each combination of drug and event having different reported causality}. There is no product complaint associated with this case
FEVER 104, NAUSEA, FATIGUE, BODY ACHES NASAL CONGESTION
On 11/09/2017 I received the PPV-23 pneumonia shot. Within 12 hours, I had all of the symptoms listed: headache, low grade fever, lightheadedness (brief), soreness at injection site and towards the elbow 4-5 inches, swollen arm, redness from injection sight to elbow. It has been more than 48 hours since injection and no easing of pain or symptoms.
Pt c/o red, swollen LUE at vaccine site with fever, chills and nausea. Pt also c/o LUE pain. Dx: cellulitis.
2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 22Apr2021/Vaccine administered 38 days from 1st dose) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient has not yet received the booster dose.
3-4 months out from the first dose and have not yet received the second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose.). On 24-Feb-2021, PRODUCT DOSE OMISSION ISSUE (3-4 months out from the first dose and have not yet received the second dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medication information were not provided.   This case was linked to MOD-2021-233605 (Patient Link).
This case is associated with case 2013SA103745. Initial report received from a reporter on 03-Oct-2013. An unknown year old male patient had received an intramuscular dose of FLUZONE intradermal (batch number: unknown, dose number and site of administration not reported) on 30-Sep-2013. The patient's medical history was unknown. Concomitant medication was unknown. On 01-Oct-2013, the patient experienced enlarged lymph nodes in the armpit of the injection site. Laboratory tests and corrective treatments were unknown. Outcome of event was unknown. List of documents held by sender: None.
First night after my shot, my sleep was constantly interrupted as I felt my body was experiencing a slight flu. Next day, I was very fatigued. I had a very faint headache in the afternoon. The strangest symptom was the taste in my mouth. My tongue had an awful taste all day and I felt thirsty. Nothing could take away the bad taste, (tried lots of water and brushing my teeth frequently). Today (7/5/2021), I woke up feeling much better and the strange taste on my tongue is gone.
Mild varicella disease, less than 50 pox, with fever, diagnosed 01/22/09, started 01/20/09 by mother's history. PO Benadryl prn itching
Red knot lt arm about the size of a quarter, hot to touch.Child c/o pain lt arm-symptoms started 10/11/99.Child not feeling well 10/12.
Severe pain in area of injection; fever; malaise (flu-like symptoms); drowsiness; lightheadedness; starting 12 hrs & lasting 48-72 hrs;
The medical history of patients and their concurrent conditions were not reported. On an unknown dates in April 2016 (also reported as from 05-APR-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to first temperature excursion of 47 F for a time frame of 48 hours from 04-APR-2016 to 06-APR-2016. The vaccines were also subjected to second temperature excursion of 47 F for a time frame 72 hours from 19-APR-2016 to 22-APR-2016. The vaccine were also subjected to third temperature excursion of 47 F for a time frame of 24 hours from 25-APR-2016 to 26-APR-2016 and fourth temperature excursion of 47 F for a time frame of 24 hours from 27-APR-2016 to 28-APR-2016. Cumulative temperature excursion was reported as 47 F for a time frame of 168 hours. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Covid treatment; Covid treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 11:00 as dose 1, single (Lot number: EL9269), in left arm, on 01Mar2021 at 11:00 as dose 2, single (Lot number: EN6205), in left arm, on 28Sep2021 at 11:00 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 06May2022 at 11:00 as dose 4 (booster), single (Lot number: F54989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (06Sep2022) Positive, notes: positive antigen test on day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received vaccine but not received any other medication in 2weeks. The patient took Anti-viral medication from 30Aug2022 to 04Sep2022 for treatment of COVID-19. The patient had no other adverse effects from 4 vaccinations.
arm numbness; tingling; sweats; fevers; left arm still hurts; concerns about a stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "concerns about a stroke"; HYPOAESTHESIA (hospitalization), outcome "unknown", described as "arm numbness"; PARAESTHESIA (hospitalization), outcome "unknown", described as "tingling"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats"; PYREXIA (non-serious), outcome "unknown", described as "fevers"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "left arm still hurts". The patient was hospitalized for hypoaesthesia, paraesthesia (start date: Apr2022).  Clinical course: The patient complaints from the first two doses of the Pfizer Covid-19 vaccine (first dose time unknown, second dose in Jan2022 per Caller). She reported that she has complaints of sweats, fevers, left arm still hurts, arm numbness and tingling She reported that she was in the hospital back in Apr2022 due to the complaints with arm numbness and tingling due to concerns about a stroke but was told nothing was wrong with her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 at 10:15 as dose 1, single (Lot number: EL3249), in left arm, on 13Feb2021 at 11:15 as dose 2, single (Lot number: EL 926n), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "had a acending aorta", start date: 2014 (unspecified if ongoing); "Macula degeneration in both eyes." (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC; DOXYCYCLINE; LEVOCETIRIZINE; IRBESARTAN; TEMAZEPAM; ALLOPURINOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Positive; (05Aug2022) negative; (07Aug2022) negative; (10Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment included PAXLOVID from 30Jul2022 to 04Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received BOOSTRIX vaccine 2/26/13 around 3 pm. Patient had miscarriage on 03/06/13.
On an unspecified date, the pt received the first dose of Lymerix.  Subsequently, the pt experienced arthralgias.   The most recent information received on 7/16/99 reports the condition of the pt is unknown.
MUSCLE ACHE, SLIGHT FEVER AFTER THE VACCINES ESPECIALLY THE 2ND DOSE. IN MARCH, I NOTICED I HAD EDEMA ON MY FOOT THEN PROGRESSED UP TO MY UPPER BODY IN MID APRIL. FOAMY URINE, SWOLLEN EYES, SEVERE EDEMA UNTIL I HAD TO TAKE MEDICAL LEAVE IN MID APRIL TO FIGURE OUT WHAT WAS GOING ON. I WENT TO MY PRIMARY DR, THEY DID DIFFERENT KINDS OF TESTING, BLOOD WORKS, AND FINALLY A KIDNEY BIOPSY. I WAS FINALLY DIAGNOSED WITH LUPUS IN MID JUNE. I DID READ AN ARTICLE ABOUT GETTING THE PFIZER OR MODERNA VACCINE BEING LINKED TO CERTAIN KIDNEY DISEASES AS WELL. MY FAMILY (BOTH SIDES) DON'T HAVE ANY KIDNEY PROBLEM HISTORY SO THIS CAME AS A SURPRISE TO ME.
Patient rec'd 2nd covid vaccination and developed ascending numbness and weakness on 07/19/2021.  Has  recently dx'd with MS
Localized reaction. Red, swollen, warm at injection site. Rt arm site of VARIVAX.
Daughter of patient called & reported that there is soreness on the injection site of her mom, inflamed are about 3x3 in & a pea sized bruise on the injection area. It hurts only when the area is touched. I advised them to have it seen also by MD.
fever x 48hrs onset w/in hrs of vax, low grade x 12hrs; lethargic, inc sleeping, irritable when awoke, dec breast feeding x 4 days
Pt was admitted due to cough, muscle weakness, and dizziness.  The patient reports that she received the COVID-19 booster on 11/16  and noted symptoms soon after she was given the shot.   - Decreased sensation in R UE, increased pain in R UE - As of 12/6 continues to have pain in the R UE.   Initial dx: Altered mental status and vaccination reaction.  Neurology note:  Dx of encephalopathy, CVA was ruled out.
02/05/21    6:00PM  total exhausion, chills, headache, joint pain, felt like I had the flu.  Also, my eyes seem to have new floaters, and I felt strange in my head.   10:00pm  the symptoms continued, but when I got in bed I had terrible nauseau so bad that I couldn't sleep.  The next morning my symptoms continued but did not worsen, and then I got so dizzy that I was stumbling.  This all continued for three days.  On 02/09/21 my symptoms subsided, and I felt normal again
Patient's mother contacted on 12/14/2022 to report her child experiencing symptoms of an adverse reaction. Patient's mom stated child had a fever approximately 24 hours after receiving Tdap, HPV, and Meningococcal along with redness and slight swelling to vaccination administration site on left arm. Mom reported that in the early morning of 12/14/22, the patient woke up with swelling and rash to face. Mother stated the rash was flat and itched tremendously per her child's report. Mom denied child having any other s/s related to anaphylaxis at that time. Mother was advised to follow up with PCP and administer Benadryl for rash and itching. On 12/19/22, followed up with mother regarding reaction. Mom states PCP just instructed her to watch child for further symptoms. Mom states swelling was gone by Thursday 12/15 and patient still has a few spots left from rash but it was mostly cleared up by Saturday, 12/17. She states child never developed any other symptoms.
Pt recv vax on 3/12/99; on 3/13/99 pt exp systemic joint swelling, vomiting
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9, lot # N020353, expiry 28-APR-2020 (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute GARDASIL 9 was properly stored. The administered doses of the GARDASIL 9 experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930 US-009507513-1811USA010211: Original Case: 1811USA010211 US-009507513-1811USA010214: Original Case: 1811USA010213 US-009507513-1811USA010213: Original Case: 1811USA010213.
Immediate metallic taste in my mouth, followed by itching of arms neck and throat. About 10 minutes post shot, my tongue felt like it was swelling, that swelling only lasted about 20 seconds. Shortly after that I had an overall feeling of tiredness,lethargic and foggy brain. All of these symptoms lasted about three and a half hours. At about four hours after the shot, I began to have diarrhea.
I had shortness of breath, deep cough, and tiredness for 2 weeks. I still have a cough now and it?s been almost one month. I used to cough up phelm in those two weeks but it was clear. I
Complained of having an asthma attack. Monitored for 30 minutes, gave IM Benedryl 25 mg, then evaluated at ER by physician. Child did not have rescue inhaler with him at school, and parents could not be reached by telephone.
Mild muscle aches starting three hours after receiving the vaccine.  Severe chills beginning seven hours after receiving the vaccine.  Fever of 101.9 which slowly dropped down over the course of four days.  Fatigue- I slept 34 hours, only briefly waking up every 5-6 hours during that time period.  Arm was sore.
15 year old female came into clinic for ordered vaccines, Menveo and HPV (Gardasil).  Patient was monitored for the usual 15 minutes past the vaccine, showing do signs of reaction, the MA that administered the vaccine discharged her with family to the lobby.  The mother of the patient had to stop and make a phone call and remained in the lobby a few minutes longer with her daughter.  The patient started seizing, in a tonic clonic manner.  2 RNs and an MD were called to the lobby. EMS was called, the patient was laid on the floor. The seizing resolved. The patient's VS were a sudden onset temperature of 100.6, BP 76/42, HR 41, RR 24.  98% on RA. Her blood sugar was 108 (taken by paramedics).  The patient was laid on the floor to await the paramedics.  The repeat VS were BP 70/37, HR 48.  the patient was loaded onto the ambulance without further incident.
Unwittnessed seizure activity per pts mother RN, within 10 min after inj. Pt was found to be hypotensive. Pts sxs/v/s stable w/fluids 30 min after incident.
Fever for 48 hours cough tightness in chest  Severe pain from shoulder to wrist ongoing with debilitating pain unable to use arm
That evening (9/9/21) my left arm got pretty sore, but I was expecting this. However, the pain never went away.  I went to my primary care doctor and he diagnosed it as a vax induced tendonitis and sent me to shoulder specialist for cortisone injection.  I saw Dr. on 10/4/21 and he diagnosed it as a vax induced bursitis and put an injection into the shoulder which has not helped yet.  I am still in tremendous pain and cannot dress myself or put my seatbelt on
felt a little sick; Little bit of the chills; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (felt a little sick) and CHILLS (Little bit of the chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     Concomitant products included DULAGLUTIDE (TRULICITY) and LOSARTAN for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, 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 experienced ILLNESS (felt a little sick) and CHILLS (Little bit of the chills). At the time of the report, ILLNESS (felt a little sick) and CHILLS (Little bit of the chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Treatment medications were not provided.   This case was linked to MOD-2022-455789 (Patient Link).
she developed a "sore arm"; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 8th November 2019, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: On the same day of vaccination, the patient developed a sore arm and that resolved two days later. The reporter did not consented to follow up.  The reporter did not have any additional details for this case.  The reporter did not consented to follow up.  This case was linked with case US2020065625, reported by the same reporter.