chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 18-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
temp elevation 24FEB98 1PM;APAP given;pediatrician informed 24FEB98 temp elevated 104 & 105 for 24hr;pediatrician visit 25FEB98 10AM;
Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with a 0.5 ml dose of improperly stored (Oka/Merck) VARIVAX subcutaneously in the left arm (lot # L001325, expiration date 13-JAN-2017). No adverse events were reported. Additional information is not expected since the reporter would not like to be contacted.
Janssen COVID-19 Vaccine EUA. Fever at 103.7F (39.7C) at night, fever at 101.7F (38.7C) the second day whole day.  Temperature get back to normal at the second day night. Chill, fever, headache, strong muscle pain at back and both legs, nausea, fast breathe. Still feel very tired on the third day, have to lie down after standing for around 20 minute. Get back to normal on the fourth day.
Red circle around injection site lasting 5 days post injection. Arm soreness for 3 days post injection. Itchy arm onset 4 days post injection.  Benadryl and ibuprofen started 24 hours after injection. Hydrocortisone cream used 3 days post injection.
At about 11pm the evening after receiving the vaccine the patient had fever of about 101* body aches and chills
ONSET OF SICKNESS IMMED.FOLLOWING INJECTION (IM,DELT) HAD FEVER AND FLU-LIKE SYMPTOMS .TESTS FOUND PT WAS NON-RESPONDER.RHEUMATOLOGIST FELT NON-RESPONSE WAS RESULT OF LUPUS.RECVD ADDITIONAL DOSE OF ENGERIX-B ON 3-23-90 RETEST TITER.SIMSYMPS
pt recvd vax;joints painful esp in rt hand causing weakness in grip strength;facial edema & peripheral edema which dec by end of day;facial edema getting progressively worse q day;
Fever, chills, rigors, runny nose, headache, fatigue, cough, shortness of breathe, nausea/vomiting,  and dizziness
After 30 minutes of the shot I experienced burning sensation up to my arms and around my neck. It started triggering my migraines very bad.
really dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (really dry mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DRY MOUTH (really dry mouth). At the time of the report, DRY MOUTH (really dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she did not experience dry mouth before and not for that long time, usually it goes away after brushing teeth. She tried brushing teeth and also spinning water in the mouth and there was no effect. Concomitant medication includes blood pressure and Vertigo medicines. The patient did not receive any treatment medications.
Shoulder pain mimicking a shoulder injury, shoulder pain with movement getting progressively worse over time after the shot. Pain prevalent when moving arm above shoulder level, using arm/hand to apply pressure, and when turning arm.
pt recv vax on 3APR96 & came to office sx w/varicella JAN97;
After getting vaccine, patient said he felt that his "eyes were turning inward" and/or "feel really tired".    He stayed for 30 minutes and his temp was 97.3 F.  He had no fever, redness of eye, or bulging eye.  He could see my 2 fingers from 5 feet.  I told him to monitor symptoms and if it gets worse or not resolve...to speak to MD ASAP.
Information has been received from a registered nurse concerning a patient at an elementary school who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a case of breakthrough varicella with greater than 50 lesions. It was reported that the cases may be classified as serious because there were more than 50 lesions. There was no product quality complaint involved.   Additional information was sought from the school nurse. However, a receptionist indicated that the reporting nurse did not work during the summer while school was out.  Breakthrough varicella was considered to be an other important medical event.  No further details were provided.
Shortly after receiving his vaccine patient alerted pharmacy staff he was feeling light headed. He asked if he could lay on the floor. Patient was laid on his back with and ice pack. He was monitored closely for the next 20 minutes. After 20 minutes patient's symptoms had resolved and was feeling good.
Swelling and rash in upper left arm.  Started a few days after vaccine and lasted about 2 weeks.  Patient used ice and heat and took tylenol.
Around August 13th I Started feeling sharp shooting pain on my right side of my breast it lasted a couple of days and it moved to the left breast it felt like a stabbing pain there was nothing I could do to make it happed it lasted and moved around from side to side. I went to an urgent care on Aug 23rd. because my family doctor had no appointment openings the Urgent care doctor took an X-ray and D-dimer was concern for blood clots but it came out ok. He said it could've been muscular or a virus there's was no definite answer. It has gotten better but it still feels tender.
Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; Headache; Chills; Nausea/Vomiting; Body Aches; Arm Pain - Near Injection Site; Hardness - Near Injection Site; Hot to Touch Sensation - Near Injection Site; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain - near injection site, hardness - near injection site, hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: N A (Not Written on Card)) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 4 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: N A (Not Written on Card)) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) arm pain - near injection site, hardness - near injection site. On 5 Feb 1900, the patient experienced the event(s) hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches.  Treatment details included Benadryl - Advised by HCP to try to alleviate symptoms, Zyrtec - Advised by HCP to try to alleviate symptoms.  Action taken with mRNA-1273 in response to the events was not reported.  On 10 Feb 2021 the outcome of event(s), arm pain - near injection site, hardness - near injection site, hot to touch sensation - near injection site, itchy sensation - near injection site, swelling - near injection site, headache, chills, nausea vomiting, body aches was resolved.
Daily PAC?s & PVC?s such that they kept me awake at night for approx. 13 weeks!
Pt recvd vax & 4-6 days p/vax pt face appeared blue lasting 2 mins & then turned pale lasting 5 mins-later that evening pt appeared pale looking lasting 5 mins; pt never lost consciousness;
No adverse effect, vial was dated today, but had expired in the middle of the night.  Staff had dated the vial 05/06/22.  Vial was opened at 1330 on 05/05/22.  Clinic personal contacted and informed that there is a 12 hour window beyond the 12 hours that the covid vaccine is still good.  No adverse effects for patient.
104 degree fever, vomiting, diarrhea, arm pain, cramps, cold sweats 12 hours after dose, lasting 24 hours. Planned to go to hospital if worsening symptoms by that night. Administered chewable aspirins when when they could be ingested without vomiting. Symptoms lasted over 3 days, 100% after 5 days.
Felt tired and pain in arm. That night drank plenty of fluids. Next afternoon developed some redness on arm but red and itchiness around the  neck.persisting till today. Took over the counter antihistamine pill that works fir 24 hours. Still feel discomfort and itchiness discomfort.
No additional information provided. No additional AE reported. No PQC.; HCP reporting one dose of VARIVAX and one dose of MMR II were administered after a temperature excursion.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 27-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection at a dose 0.5 milliliter (ml) as prophylaxis (lot number W011625 has been verified to be valid; expiration date reported and established as 06-APR-2024) (strength, route of administration, and anatomical location were not provided), and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) subcutaneous injection at a dose of 0.5 ml as prophylaxis (lot number U031359 has been verified to be valid; expiration date reported and established as 07-OCT-2023) (strength, route of administration and anatomical location were not provided). The administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of 30.4 degrees Fahrenheit (F), during a time frame of 1 hour and 15 minutes, and the administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) was stored at a temperature of 53.1 degrees F, during a time frame of 1 hour and 15 minutes. There was not a previous temperature excursion reported. There was no adverse effect reported.
This spontaneous report was received from a 22 year old female patient, regarding herself. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 16-JUN-2015 the patient received one shot (first in booster vaccination) with RECOMBIVAX HB. Concomitant medications were not reported. Patient reported that within 2 hours of receiving RECOMBIVAX HB, she experienced the onset of a sore throat, which progressed to Flu symptoms (Influenza) and respiratory problems (respiratory disorder), neck stiffness/soreness (musculoskeletal stiffness) and a headache. Patient sought medical attention on an unknown date and was seen by nurse int he office. No treatment was given for the adverse event, but the patient had been taking Ibuprofen. Nurse recorded patient's temperature, value of which was not provided. Outcome of the events were unknown. Causality assessment of the events with respect to therapy with RECOMBIVAX HB. Additional information is not expected as no reporter details were provided.
Localized inflammatory reaction at vaccine site on (L) deltoid consistent with localized allergic reaction.
Fever, vomiting 2wk since day of immun, swollen, red, inject site, temp 102 since immun; TC from grand mo 18AMR91 or to DR this day Dx ear infect; MD does not think sx related to immun;
Approximately 9:08AM client rec'd #1 HBV without incident. Approximately 9:09 client amb. to table, and stated to nurse "I feel dizzy" and told to sit down. Client sat in chair and then slumped over. Asst'd per nurses to recline on floor with feet elevated. Client immediately opened eyes and questioned "why am I on the floor" alert to P.P and time. BP110/62, P 70, R 24. 9:14AM BP 112/70 P 78 R 16 ax temp 97.8. Client c/o sore throat that had been present since early AM. 9:20AM BP 108/68 P 80 R 16 recline, 69:20A BP sitting 100/62, standing 82/60 and client c/o feeling dizzy. Asst'd to recline on floor with feet up. Client cont'd alert, oriented to P.P and time. 9:30 BP 98/60 P 80 R 16. 9:35 sit BP 100/60 P 80. 9:40 step mom at school and reported client has fainted before with illness. 9:42 sit BP 102/68 P 76 standing BP 92/68 and c/o weakness, sat down. 9:45 walking about room accomp. by nurse BP 92/64 P 78 R 16. Client denied c/o's. Talked at length with step mom re: need to monitor for weakness, fainting and advised to notify pediatrician office of incident and f/u as needed. 9:53AM client discharged to home with step mom. 3:30PM phoned client's home and spoke with step mom who reports client has had no further c/o weakness, no fainting but continues to c/o sore throat afebrile per step mom. Advised to monitor for cont'd c/o sore throat and to take to pediatrician for check-up especially if develops fever. Instructed to call H D for questions and to report if f/i with MD required. Step mom verbalized understanding.
Infant received vaccines morning of 2/20. At some point overnight between 2/20 and 2/21 the infant expired at home and was found deceased by his mother in the morning. We do not have further details but the death is being investigated by the Coroner's office.
he was experiencing runny nose and soaring eyes; he was experiencing runny nose and soaring eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (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: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", EYE PAIN (non-serious), outcome "unknown" and all described as "he was experiencing runny nose and soaring eyes".  Additional information: Reporter stated that the second dose scheduled on 08Apr2021, which was more than 21 days. The patient was experiencing runny nose and soaring eyes since yesterday. Reporter wanted to know if it was okay to get the second dose today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19 symptoms Per report, employee "got covid 01/24/2020, one day after being vaccinate." Employee reports wife and mother also had COVID.
10/24/03 received vaccine around 10 AM. Had bad asthma attack at 12. At 3 Pm, became nauseous with pains in stomach; had numerous emesis and diarrhea. Lasted 24 hours.
Blood sugar higher than normal at 144; Received vaccine in thigh; blood sugar was elevated at 170; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar was elevated at 170), BLOOD GLUCOSE ABNORMAL (Blood sugar higher than normal at 144) and IMMUNISATION (Received vaccine in thigh) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar was elevated at 170) and IMMUNISATION (Received vaccine in thigh). On 21-Jan-2021, the patient experienced BLOOD GLUCOSE ABNORMAL (Blood sugar higher than normal at 144). On 21-Feb-2021, BLOOD GLUCOSE INCREASED (blood sugar was elevated at 170) was resolving. At the time of the report, BLOOD GLUCOSE ABNORMAL (Blood sugar higher than normal at 144) was resolving and IMMUNISATION (Received vaccine in thigh) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood glucose increased: 170 High. On 21-Jan-2021, Blood glucose increased: 144 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information was added
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medications details were not reported by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment details were not reported by the reporter.  This case was considered for the 106 adult patient out of 190 reported who was received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
I had a Very bad hot flash about 15 minutes after the injection & my Blood pressure shot up , 170/?  and chest pain. Blood pressure was checked every 15 minutes and  was told I could leave after 1/2 hour
KINRIX-PATIENT HAD LOCALIZED SWELLING TO THE RIGHT ARM, RED IN COLOR AND WARM TO THE TOUCH MEASURMENT OF SWELLING IN LENGTH IS 8.5 INCHES AND IN CIRCUMFERENCE 10.75 INCHES LONG. PROQUAD-PATIENT HAD LOCALIZED SWELLING TO THE LEFT ARM, RED IN COLOR MEASURMENT IS 1.5 INCHES IN LENGTH AND 1.5 INCHES IN CURCUMFERENCE.
R side facial paralysis starting 48 hours after second dose of vaccine, diagnosed through ED visit as Bells Palsy
chest discomfort & SOB 15 mins p/receiving the MMR & Td vax; no other meds; cough w/runny nose; BP 110/68, t98; all lung fields presente w/ a mild wheeze upon expiration; airway patent; no rash noted; given DPH; improved in 20 mins;
Limp, dizzy. Fever 104.5, sore legs, bruise (R) thigh.
Patient called on the phone stating that after 24 hours of adminstration of shingrix and prevnar 20 vaccine, patient felt tingling sensation  and pain that was radiating from neck to hips and outward on the right side. She spoke with intern and pharmacist and was advised to call her doctor right away or go to urgent care.
Swollen, red, hot, egg shaped lump. Advised by a pharmacist from pharmacy to ice pack it. Headaches.
Cold hands & feet, internal "nervousness", legs & arms muscle aches, painful walking. Next morning feeling hot, fatigued & mild fever 99.8 degrees. Hearing somewhat impared thru 2nd day.
pt recvd vax & aprpox 5 mins p/vax pt noted to be sitting in chair w/head hyperextended, not responsive placed on floor-not breating was given 3 breaths mouth-to mouth, spontaneous breathing started; pt had sz;
Patient went for 2nd Shingrix on 7/23/21 and while walking in the parking lot, she developed a classic scintillating scotoma on R eye with pounding headache, reminiscent of her prior migraines. She rested when she got home and got a good night sleep; headache abated by the next morning. She has felt fine until this afternoon when she had a scotoma of her L eye, followed by a severe pounding headache to the point of not being able to read. Whenever she has tried to stand up today, the pain has become more severe and she must lie down again. No other neurological deficits. No migraine for years. No prior use of triptans d/t SVT. Vicodin would previously knock it out. PO intake might be less than usual.
big red rash on her arm; big red rash on her arm; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th January 2022, 7 days after receiving Shingrix, the patient experienced red rash and rash. On an unknown date, the outcome of the red rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that she received the first dose of Shingrix and on the day of reporting she noticed a big red rash on her arm. No Lot number or Expiration date was known for the vaccine. The rash had not resolved as she just noticed it on the day of reporting. The patient wanted to know if she should receive the second dose. The patient was referred to her healthcare professional and provided medical disclaimer. The reporter consented to follow up.
swelling (R) thigh (approximately 4 cm with induration) with minimal redness)