chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient reports being quite dizzy and extremely fatigued about an hour after administration of first COVID-19 vaccine dose. She assumed this was normal, however, these symptoms persisted for about 3 weeks after at various times of the day. She felt as if she was intoxicated when symptoms occurred. No other changes in diet or hydration. Patient did not proceed with second dose due to reaction.
Inflammation, erythema, pain, stiffness starting in right elbow, persisted for approx 5 days and then began in left elbow.
Since he had heart Palpitation; He also Shortness of breath with activity but no chest pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (Since he had heart Palpitation) and DYSPNOEA (He also Shortness of breath with activity but no chest pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PALPITATIONS (Since he had heart Palpitation). In 2021, the patient experienced DYSPNOEA (He also Shortness of breath with activity but no chest pain). At the time of the report, PALPITATIONS (Since he had heart Palpitation) and DYSPNOEA (He also Shortness of breath with activity but no chest pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the 2nd dose on 11FEB2021, the lot number is 024M21A. No Concomitant and Treatment medication were reported.
On 2/4/21 a 50y/o Male arrived to recieve a CoVID Vaccine. PT recieved vaccine and after was placed in observation for 15min. After the 15minute pt began to have a c/c of dizziness. Pt was assessed by onsite paramedic with a determination to transport pt to local hospital. PT was transported.
Aching pains started occurring within the heart a few weeks after the 2nd administration of the vaccine. In brief intervals lasting 2-3 minutes each. Slightly to the right of the left breast is where this aching pain occurs.
A report has been received from a Health Professional concerning elementary patients of unknown age. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST (intranasal) and nasal FLUMIST quadrivalent (intranasal) started on an unknown date. The nurse reported that there had been at least 5 elementary aged patients in the past two years and had come into the office to get treated for wheezing after having received the FLUMIST. The outcome of the event of wheezing was unknown. The reporter considered event of wheezing to be non-serious.
Headache, nausea, diarrhea, chills, slight fever, body aches, tiredness - adverse events These symptoms started about 24 hours after my 2nd Moderna vaccine and I took some Tylenol and Sumatriptan (for the headache).  Slept for most of the afternoon and evening on Wednesday, March 10th.   By the next day, Thursday, March 11th was feeling almost back to normal
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 29.36 for dose administered on 03-Apr-2021. No concomitant medications were reported.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40and 5 PM: 41.  On 03-Apr-2021, Excursion time was 09 AM, temperature were 34 and total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  No treatment medications were reported.
resembling shingles; vestibular rash/vesicular rash on one side of the body; This case was reported by a physician via sales rep and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number Y9K7L, expiry date 19th March 2022) and (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included hypertension.   On 19th May 2020, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the dose was an unknown dose. On 23rd May 2020, 4 days after receiving Shingrix, the patient experienced shingles and vesicular rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient developed a unilateral vestibular rash on the right side of the lower trunk, resembling shingles. Till the time of reporting, the rash was persisting. Upon follow up on 27th May 2020, the reporter reported that, the patient developed vesicular rash on one side of his body (3 lesions) along L2-3 through C10 (lower thoracic and lumbar area).  The patent did not report any other symptoms, like pain, fever or sweats-according to the reporter.  The patient was prescribed Valtrex 1 gm three times a day for 7 days. Upon follow up on 28th May 2020, reporter correct address was provided. This case was 1 of 3 linked cases reported by the same reporter.
Patient passed out and fell off the chair on the ground immediately after receiving vaccine. Patient gained consciousness within seconds.
SIDE EFFECT; EXCRUCIATING/PAIN; This spontaneous report received from social media through a patient via a company representative 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. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced side effect, and excruciating/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effect, and the outcome of pain was not reported. This report was non-serious.
Employee recieved the Maderna vaccination at 4pm 1/11/21. Employee was monitored for 30 minutes after vaccination and showed no side effects.  He states that at 5pm he had a scratchy throat, at 8pm he had hives and his throat, chest and mouth started to itch.  At that time he took Benadry and layed down.  He woke up at 10pm with a swollen mouth and throat and was wheezy.  He stated he had a hard time breathing and swollowing.  At that time he took his EPI PEN.  He did not seek medical treatment.  Employee states that on 1/12/21 at 9:30am all symptoms had resolved.
a dose of Menquadfi was administered to a patient that was supposed to receive meningococcal b (Bexsero) with no reported adverse event; a dose of Menquadfi was administered to a patient on 27jun2023, a previous dose of MCV4 was administered to the patient on 21jul2022 with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old male patient to whom a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered who was supposed to receive meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) and a dose of Menquadfi was administered on 27-Jun-2023, a previous dose of mcv4 was administered on 21-Jul-2022 with no reported adverse event.  The patient's past vaccination(s) included Meningococcal vaccine on 21-JUL-2022. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Tetanus Vaccine for Prophylactic vaccination.  On 27-Jun-2023, the patient received 0.5ml  (dose 3) once of suspectmeningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (strength: not reported) (lot U7616AB; Expiration date: 11-APR-2025) via intramuscular route in the left deltoid for Immunization who was supposed to receive meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) with no reported adverse event (wrong product administered) and previous dose of mcv4 was administered to the patient on 21-Jul-2022 with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient called to report that starting shortly after her vaccine, as she was walking home, she developed "intense burning in her stomach" similar to the feeling she gets after taking ibuprofen.  It lasted until Saturday night ( 4/10/21) and was not relieved by cimetidine (which usually works)  She denied eating anything that would cause this effect.  She also denied any nausea or vomiting.
I experienced fevers, chest congestion, body aches, migraines and lumps under my skin.
S: Pt's mom states he woke up this AM with swelling of L thigh and he was unable to walk on it. During the day pain improved, but the swelling has worsened. O: L thigh erythematous lesion L mid thigh edema of upper thigh extending toward knee ROM and patella reflex intact. No warmth noted at thigh.
Approximately 20 minutes after receiving vaccines, pt and guardian building where he passed out hurting face on pavement. Contusions on upper lip bruised chin and hands. Blunt trauma to frontal dentition no signs of breakage follow up 10/6/04. Sent to ER. Left before being seen. BP 105/59 P63.
I felt very dizzy in the afternoon of the vaccine - it went away an hour later. Day 3, itchy rash on my neck and chest and a sandy, itchy feeling in my throat. I took a Claritin and it went away after I woke up. Day 5 - felt very dizzy and had chills and rash came again - all over my chest. It was a burning sensation. Called Dr about 10 PM in evening and she told Claritin and Benadryl for a week. I had lymph node enlarged above my left clavicle on Day 5, as well. Really bad fatigue started occurring - really bad fatigue; headache. Felt horrible. Eventually I started feeling better. Rash went away but I fatigue was still lingering. Lymph node became slowly less enlarged but got the second dose of the vaccine and it enlarged larger than the first time. (Second dose of COVID Vaccine was date was  January 27, 2021 about 3:00 PM.)
63 year old female patient seen on 2/16/17 stated she had not had her zoster vaccination. After administration of ZOSTAVAX, staff member went to enter it in system and noted the patient had it in February of 2014. Immunization Hotline was contacted to ask about any side effects or adverse effects. They stated that any of them that the patient would need to be made aware of are listed of the VIS that the patient already received.
Reported fever of 104F, severe headache, bodyaches, nausea/ vomit x4, couldn't sleep. Symptoms resolved with Excedrin,Motrin, and Tylenol.
This spontaneous report was received from a medical assistance and refers to a 2-month-old patient of unknown gander. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 08-NOV-2017, the patient was vaccinated with one dose of expired ROTATEQ, orally, lot # M025568, expiration date 07-NOV-2017, for prophylaxis. No adverse effects were reported.
Paitent's wife called on 4/15/22 reporting worsening redness swelling and heat at the injection site .  Referred to his PCP, seen same day.  Based on a phone follow up on 4/18/22, He was diagnosed with cellulitis, treated with a course of cephalexin and fully recovered.
Information has been received from a registered nurse concerning a male baby who on 24-MAR-2010 was vaccinated orally with his third dose of ROTATEQ. At the time of vaccination, the baby vomited up his third dose of ROTATEQ. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the baby's outcome was unknown. Follow-up information has been received from the registered nurse concerning a six months old male baby with no illness at the time of vaccination who was vaccinated orally with his third dose of ROTATEQ (lot # 664874/1213Y) at approximately 16:15 on 24-MAR-2010. At the time of the report, the baby's status was unknown. Additional information has been requested.
25 minutes after receiving her 1st dose of Moderna, the patient complained of having a sensation of swollen lips and tasting the vaccine.  Her lips did not appear swollen, she had no shortness of breath, no rash or hives.  The patient has a prior history of allergic reactions to shrimp and other injectables (not specified).    Per the patient, by the time I spoke with her, her symptoms were already resolving.  Her vital signs were recorded and reported to Doctor on duty.  Instructions were received to continue monitoring the patient and she could be discharged when her symptoms were completely resolved.  After an additional 20 minutes, per the patient, her symptoms were all gone and "felt fine".  The patient was discharged to home.  Patient left the clinic by wheelchair accompanied by her family member.  She was instructed to call 911 if her symptoms worsened and/or contact her primary physician.  The patient was asymptomatic upon discharge.
half the sensation of pressure; neck is sore; fingertips are numb / thumbs are the best, ring finger are the worse/ feels like they fell asleep; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (half the sensation of pressure), NECK PAIN (neck is sore) and HYPOAESTHESIA (fingertips are numb / thumbs are the best, ring finger are the worse/ feels like they fell asleep) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PREGABALIN (LYRICA), HYDROMORPHONE HYDROCHLORIDE (DILAUDID), TIZANIDINE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, the patient experienced DISCOMFORT (half the sensation of pressure), NECK PAIN (neck is sore) and HYPOAESTHESIA (fingertips are numb / thumbs are the best, ring finger are the worse/ feels like they fell asleep). At the time of the report, DISCOMFORT (half the sensation of pressure), NECK PAIN (neck is sore) and HYPOAESTHESIA (fingertips are numb / thumbs are the best, ring finger are the worse/ feels like they fell asleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: perfect state (normal) Perfect state.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported being on pain medication protocols already and so he had not changed any medications. Patient stated that he could not tell the texture.
intense itching but before the third shot. Not rash or hives so did not see a dermatologist. Did have blood work done, an ultrasound of my liver. All results normal
Flu-like symptoms; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 07Apr2021 (at the age of 35-year-old) as single dose for COVID-19 immunization. Patient stated that she just had the date of the vaccine but not an expiration date. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated that she was calling to get some information and she was not sure exactly to who was she supposed to be calling. So, she took the Pfizer vaccine (Covid-19 Vaccine) on April 7 (not clarified) and on April 8, she started having side effects and I still have side effects. So, she just wanted to know, how long the side effect will last or is there anything that is given for healthcare professionals (further clarification unknown), is there anything given for side effects. On 08Apr2021 the patient experienced flu-like symptoms. Seriousness of event was not specified. NDC and UPC number was not provided. Further probing could not be initiated as consumer hung up the call abruptly. Hence, other details were unknown and limited information was available over the call. Patient declined to complete the report and stated she was at work. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
A 14 year old male subject experienced syncope on the same day in which he had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject felt weak shortly after receiving vaccination injections and slumped briefly to the ground.  He did not lose consciousness and had no seizure activity or actual syncope.  He denied headache, visual change, dizziness or focal deficits.  The subject remained responsive and oriented.  Motor exam showed 5/5 x 4 and sensation was intact x 4.  The subject feels well now.  He was diagnosed with presyncope.  At the time of this report, the subject had recovered.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 65.97.  Concomitant medications were not provided.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21 and has since receive second dose on 04/16/21.
Pt rec'd MMR and Tdap on 8/24/07; two days later developed herpes zoster.  Likely unrelated, but wanted to report.