chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Additional information received. Event was updated.
It started of with a persistent runny nose, coughing, and slight sore throat. I took an at home COVID-19 test and it was positive. I talked to my doctor and we decided not to take Paxlovid. I took robitussin instead.
Patient was under the age of 18 when she received the first dose of Moderna vaccine. Family was called as soon as mistake was realized and informed. No adverse events noted by Mom at that time. Advised Mom to reach out to office if any reactions occur.
3/29 PM 1400 -- vaccine administered 3/29 PM 1415 -- no reaction, left vaccine site 3/29 PM -- mild soreness in vaccination site (upper right arm) 3/29 PM -- in addition to normal dinner, snacks, and at least 32 oz water, drank one glass red wine (~4oz) overnight 3/29-3/30 AM -- feverish, shivering, cold sweats 3/30 AM 0600 -- body aches, headache, shivering, weakness, inability to concentrate, sensitivity to light, confusion, vertigo/dizziness took 600mg ibuprofen, ate banana, drank 16oz water, went back to sleep 3/30 AM 0900 -- less severe body aches, weakness, lethargy, inability to concentrate, vertigo/dizziness 3/30 -- drank ~1 gallon water/herbal tea, took meds as normal, ate at regular times. 3/31 -- AM -- mild body aches
GRANDMOTHER OF CHILD CALLED HEALTH DEPT VIA PHONE . STATES CHILD HAD VACCINES AT CLINIC ON 7/30/2019. REPORTS CHILD WITH FEVER 102.00 SINCE 5 AM ON 7/31/2019. CHILD COMPLAINS OF VOMITING AND DIZZINESS. AT 8 AM GRANDMOTHER REPORTS CHILD HAS FEVER OF 102.00. ASKED HOW TO PROCEED. ADVISED GRANDMOTHER CHILD COULD BE HAVING ADVERSE REACTION TO VACCINES. NEEDS TO FOLLOW UP WITH CHILD PEDIATRICIAN AND OR EMERGENCY ROOM FOR MONITORING ASAP NOW. GRANDMOTHER VERBALIZED UNDERSTANDING. WILL FOLLOW UP ABOUT MONITORING TOOK DOWN PHONE NUMBER.
UPPER ARMS BLEEDING; RED ITCHY SPOTS; INJECTION SITE SENSITIVE; WEAKNESS; LETHARGIC; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced lethargic. On 12-APR-2021, the subject experienced upper arms bleeding. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced red itchy spots. On 12-APR-2021, the subject experienced injection site sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red itchy spots, lethargic, weakness, upper arms bleeding, and injection site sensitive. This report was non-serious.
Given Zoster vaccine L arm on 6-16-10 and redness was noted 6-17-10 and redness is 1/2" x 4" raised and hard. Tender to touch.
Generalized flushing from head to waist, feeling of warmth,  brain fog. no hives or difficulty breathing.  Began while driveing home after 15 min observation period,  Symptoms began to subside around 7pm
Myalgia, Fever METALLIC TASTE IN MOUTH, FATIGUE,CHILLS Narrative:
Rash started day #8 never told site inspectors. Was observed scratching her arm - site inspected plus dried lesions. Seen by physician  20 lesions with pruritus. New lesion on wrist today. Temp on day 8,9,10, to 103F. Diagnosis: Possible generalized vaccinia - very mild.
PATIENT RECEIVED BOOSTER DOSE OF PFIZER VACCINE, AFTER HER WAITING PERIOD PATIENT LEFT, SHE RETURNED BACK A FEW MINUTES LATER AND COMPLAINED OF INCREASED HEART RATE AND SHE FELT LIKE SHE WAS GOING TO PASS OUT. PARAMEDICS CAME TO EVALUATE AND DISCHARGED HER
This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness, headache and vomiting. On an unknown date, the outcome of the sickness, headache and vomiting were unknown. It was unknown if the reporter considered the sickness, headache and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Recently from the reporting date, the patient got the SHINGRIX vaccine for shingles. The patient was very sick, and experienced headache and vomiting. The patient inquired, what will happen if not received the 2nd dose of SHINGRIX.
Patient showed up at the pharmacy on 10/26/2018 in the afternoon and stated her arm has been sore however when she woke up this morning she noticed the welts/rash on her upper left arm.
PAIN, ITCHING, REDNESS AND SWELLING AT SITE OF INJECTION. ALSO EXPERIENCED DIZZINESS, NAUSEA, WEAKNESS, DIARRHEA AND FEVER
Cough; Sinus congestion; Sore throat; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low grade fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced COUGH (Cough), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low grade fever). At the time of the report, COUGH (Cough), SINUS CONGESTION (Sinus congestion), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low grade fever) had resolved. Not Provided          No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up-event outcome updated and declined consent for further FU
Chills, fever, intense body aches, sensitivity to light,  heartburn, headache
Patient had a diagnosed ear infection without fever on day of visit.  Developed a possible febrile seizure later in the evening.  Seen in the emergency room.
Started itching at injection site, feels warm,red blotches on neck, chest. Think from mask. Switched out mask.  Will sit 10 more minutes per EMS. Take benadryl at home
04/09/2021 a day after my 2nd dose. I woke up and started to feel flu like symptoms, nausea, diarrhea, and swollen in hands and extremely fatigued. I waited about two weeks I contacted my doctor to visit, I received blood work. Blood work showed: Antinucleotide activity and Anti RNP. I was then sent to the rheumatologist, who diagnosed me with mixed connective tissue disease. Prescription was given of prednisone, which helped with bringing the symptoms down. I did continue to have flare ups off and on, and after finishing the prednisone I was then prescribed azathioprine, and prednisone in case of flare up. I do still have occasional flare-ups and I am waiting for blood work to see if we will be changing medications. I did have a flare up after receiving my booster however it was not close to comparison to my second shot. Just to note I was already on azathioprine which may have helped with reducing the symptoms/ flare up.
About an hour after vaccination, started with body ache, severe chills, shaking badly. Had low grade fever ranging 99.3 - 100.7.  Patient went to urgent care that evening  and they administer COVID-19 test.  No medications were given but advised to take Tylenol.  Negative test came back on 8/19/20.  Patient went to bed early and woke up with chills again and nausea, took Ibuprofen and felt better a few hours later.  By 11 AM (24 hours after getting the shot), gradually felt better.  Now almost back to normal.
lightheadedness and asthma exacerbation. Tightness in chest, difficult breathing, shortness of breath, fatigue. As of 11/3/2022 doctor prescribed Advair 250/50 BID, Prednisone 40mg PO daily 3 days, Singulair 10mg daily. Symptoms resolved in 4 days with occasional use of albuterol inhaler following. On 11/17/2022 worse asthma exacerbation with difficult breathing, couth, tightness in chest, lightheadedness. Had to leave work after two hours. Doctor prescribed 12-day Prednisone tapering dose. I still required albuterol inhaler 3 times per day until 11/22/22, Albuterol  inhaler 1-2x/day since 11/23/22
Headache, NauseaVomiting, chills, weakness, sweat Narrative:
Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Havrix. On 31st January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
2 in by 3 in ulcer on left deltoid. Localized reaction followed by alteration.
both thumbs went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) 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: HYPOAESTHESIA (non-serious), outcome "recovered", described as "both thumbs went numb".  Additional Information: The reporter (wife) stated that both thumbs went numb immediately after first dose and after a few hours resolved.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Information has been received from a Certified Medical Assistant referring to unspecified number of patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K014191, expiration date 10-MAY-2017, dose and route were unknown). The previous temperature excursion for GARDASIL was 32.4 F for 4 hours and 30.6 F for 20  minutes. The temperature was 18 F and time frame was 30 minutes. It was not because of "data logger". No adverse effects were reported. No PQC was involved. Additional information has been requested.
Approximately 20-25 minutes after receiving the vaccination, it became difficult for me to swallow. My ability to breathe was unaffected, but it was incredibly difficult to swallow, like I could not generate any saliva naturally. Approximately 20 minutes after that, my tongue went numb. The symptoms went away several hours later after taking a couple of doses of Benadryl and Loratadine.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA CARDIOGENIC SHOCK 2/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt recv vax on 9/20/97; on 10/4/97 pt exp headache.
Arthralgia Narrative:  Mild body aches the evening of injection, relieved with Tylenol
I had the fever, sore arm, ear swollen, outside of the ear swollen irritated and itchy. In May outside and inside started itchy and blood in my ear. Had hearing test at the EMT. My balance has been off.
Swelling, hot to touch, feeling off being stung by bee 7 days after shot
Patient developed a hoarsenss of voice and tightness of throat and flushed feeling immediately following vaccination. Epi Pen was administered and 50 mg Benadryl given p.o., EMS transport to ED after administration of solumedrol 125 mg - received Pepcid and Zofran and NS IV in the ED.  Discharged from ED with prednisone 40 mg daily x 4 day with Epi Pen prescription.
every time I take a flu shot, I end up really sick with the flu; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.   This case involves patient (unknown demography) who end up really sick with the flu (influenza) , after receiving INFLUENZA VACCINE.  The patient's past vaccinations included flu shot and end up with flu.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration da not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of sick with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the event influenza.  There will be no information on the batch number for this case.
No adverse event; Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 26-Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 26-Apr-2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 100 microgram. On 26-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 100 microgram. On 26-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 26-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 26-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 27-Oct-2021 and second dose of Moderna vaccine on 26-Apr-2022).    Concomitant medication information was not provided. Treatment information was not reported.   This case was linked to MOD-2023-725187 (Patient Link).
Mother states child was limp, crying before for several hours. No fever. Legs were red and swollen. Was taken to ER on 4/15/02 and put in the hospital for 24 hours for observation and Rx'd with Tylenol. Mother states baby was transferred by EMS from doctor's office on 4/15/02 and states that the child had some seizure activity also.  Mother states child is doing OK now with no problems. Will follow with doctor for future immunizations.
Pink reddish blotch the size of a hand; Half of the blotch is raised and has a border around half of it; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Pink reddish blotch the size of a hand) and PERIPHERAL SWELLING (Half of the blotch is raised and has a border around half of it) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Apr-2021, the patient experienced RASH MACULAR (Pink reddish blotch the size of a hand) and PERIPHERAL SWELLING (Half of the blotch is raised and has a border around half of it). At the time of the report, RASH MACULAR (Pink reddish blotch the size of a hand) and PERIPHERAL SWELLING (Half of the blotch is raised and has a border around half of it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        relevant concomitant products included blood pressure medications, thyroid medications, waterpure. Treatment details not included.
Patient was vaccinated with an adult dose 0.5mL of Moderna Bivalent.
This spontaneous report as received from physician assistant via company representative refers to a 13 year old female patient. on an unknown date of 2013, the patient was vaccinated with first dose of GARDASIL, (strength, dose unit, route, lot# and expiry date unknown). On 09-DEC-2013, patient received second dose of GARDASIL, with recalled lot number J007354 and expiry date 20-FEB-2016 by her mother. No concomitant medications were administered. On same day while injecting, the level of pain felt with second dose was more severe than the first dose of GARDASIL. It was reported that injection site did not appear unusual. On an unknown date of December 2013 (within two weeks), patient had subsided and fully recovered from pain and no treatment was given for events. The outcome of level of pain was more severe than the 1st dose and appearance of the injection site did not appear unusual was reported as recovered/resolved. No further AE information was provided. Additional information has been requested.
Developed a migraine about an hour after shot.  Started feeling very tired and my throat was feeling sore.  Muscle soreness started and is still present 5 days later.  Next day after shot had some bad flu like symptoms; intermittent shivers and feverish.  Could not get out of bed and I was so tired, yet could not get good sleep.  Muscle aches and migraine headaches.  Second day still was extremely tired with migraine and muscle aches with a slight stomach ache.  Lost my appetite going on 5 days post shot.  Took days off of work because of side effects
This spontaneous case, initially received on 27-Jun-2016, was reported by a health professional and concerns a patient of unknown age/gender. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date, the patient received unspecified Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Unspecified allergic reaction (outcome: Not Reported).
Delayed cutaneous hypersensitivity skin reaction Pruritic indurated rash mild, no intervention required
45min past influenza vaccine was admin - Pt began to feel lips swell, hot and dizzy.
A douple days after the vaccine I got COVID arm, it cleared up in about a week. On 4/1/2022 (a month and a half later) I started having really bad shoulder pain in the same vaccinated arm. I went to Urgent Care. I given an X-ray, but nothing was found on the X-ray. The Dr concluded that I had Tendonitis of the shoulder. Was told to take Ibuprophen for the pain and was prescribed  Diclofenac gel to rub on my skin. My condition wasn't getting better, so I saw my PCPs. My Dr showed me exercises to do to help with the healing and pain. When they weren't working I asked to be sent to a PT, hoping that they would be able to advise me better. My Dr. didn't want to give me a a referral so I tried to find some helpful exercises on the internet and they helped a little.
Second dose was horrible / almost killed me; Second dose was horrible / almost killed me; This case was reported by a consumer via other manufacturer and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of near death experience (for tolerance in 1st dose refer case US2021AMR063322).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful (serious criteria life threatening) and near death experience (serious criteria GSK medically significant and life threatening). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feels awful and near death experience were unknown.   The reporter considered the feels awful and near death experience to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient said that experience with Shingrix which almost killed her and when completing Shingrix series second one was horrible. Almost killed her consider for both dose as it was not confirmed 1st or 2nd dose of Shingrix which almost killed her.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063322:1st dose
8/17/2021: Our Medical Assistant mixed the 1.8mL Normal Saline Diluent with the Moderna Vaccine Vial. Thereafter, she had given 0.5mL IM Moderna with Diluent X 1 dose to the patient. Moderna contacted for recommendations. 8/18/2021: Patient contacted, doing well 8/19/2021: Called patient to follow up - mild headache and fatigue, which resolved. Denies any other symptoms DOH also contacted, advised patient to receive one additional dose of Moderna immediately on the opposite arm.  8/24/2021: Called patient - denies any symptoms. Patient notified of plan as discussed above and has an appt on 8/26/2021
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck) (Lot# K003411, Expiry: 06-MAR-2016), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This case is one of the several cases linked with the same reporter link. No additional information provided. Additional information has been requested.
pt recv vax; devel fever 105; persistent screaming > 3 hr; was lethargic; could barely lift her head; fever persisted at about 102 for 48 hr;
Started bleeding the 17th, went to the doctor OB/GYN office and had an Ultrasound - I was supposed to be measuring at 8 weeks and I was measuring at 6 weeks. Miscarried. My due date 9/26/2021 would have been due date; That was my fifth pregnancy. That was my 3rd miscarriage. I have had two full term vaginal deliveries.
Area of warmth, redness and swelling from above elbow to mid arm approx 3"-5".  Mom is RN, didn't want appointment, will just observe.
Itching on legs, arm pits, back, head, arms and groin progressed to a rash in the same areas. The itching and rash was more pronounced the next morning (Sunday) along with small blisters scattered around. Started taking 50mg Benadryl every 4 hours which provided some relief. Itching and blisters very annoying. Going to see doctor Monday morning.