chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 68-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death), outcome "fatal", described as "Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest". The patient date of death was 31Oct2022. Reported cause of death: "Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest". No autopsy was performed.  Clinical course details: Patient had no health issues prior to receipt of vaccine and no chronic conditions. No other vaccines were given at that time.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Cardiac arrest leading to death occurred nearly 4 weeks after a single dose of PREVERNA 20 is considered as unrelated to the vaccine use but more likely associated with the old age patient underlying medical condition. Follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results are needed for meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Received Prevnar 20 vaccine dose on 03Oct2022 and died on 31Oct2022/Determined it to be a cardiac arrest
Approximately 12 hours after injection I just felt tired aches and pains joint pain I developed a lump under my left armpit. D adverse effects went away after a day and a half except the lump under my arm it is still there and it still is bothersome
Fainted and Dizziness BP 108/68, Pulse 50/min. Patient felt dizzy and fainted, fell from chair and hit back of head to floor. Patient had no head bleeding or change of consciousness. Noted head to toe assessment done, no bleeding noted. No complaint of any pain. Pulse is 50/min. Patient states this is his normal pulse rate. Patient is advised to go to ER for CT scan of head and for further evaluation. Patient had only fruits for breakfast. Patient refused to go to ER for further evaluation. Vitals rechecked after 15 minutes, BP 127/73, Pulse 54, Patient feels fine and left for home with father.
Not feeling tired but feel winded; My head is hot, like very hot; my body is shivering from being so cold; my body is shivering from being so cold; feel nauseated; my eyes are sore; my entire body is just ache; My fingers are turning ice white and so are my toes; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm right on 11May2021 at 11:45 as DOSE 2, SINGLE (at the age of 29-year-old) for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing (anxiety meds). Historical vaccine included first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced chills. Prior vaccination, the patient had no covid and not tested covid post vaccination. The patient no other vaccine in four weeks. Concomitant medication included unspecified medication for anxiety and paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 11May2021 20:30, the patient experienced not feeling tired but feel winded, head was hot like very hot but my body was shivering from being so cold even though wearing layers and under a blanket. The patient felt nauseated, my eyes are sore, my entire body was just ache. The patient understand aches would come but was not this cold the first time. Just chills from what I can remember and sore arm. The patient's fingers are turning ice white and so are my toes. The patient had not received treatment for the events. On an unspecified date, outcome of the events was recovering. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.
Fever and nausea first day after shot.  Full body rash appeared second day after shot. No rash or any symptoms after first shot and no known allergies.  Currently on day 5 and have a lowered appetite and digestive issues.
The NP injected the Shingrix vaccine too deep on my left arm and for too long . Soon after this vaccination I have a lot of acute, sharp pain near the injection site which caused me to wake up while sleeping. Other times, the sudden pains and spasms will flare up during the day. I also have pain trying to pull up my left shirt sleeve. These pains and spasms have continued to now, which is 3.5 months. I need help to treat this problem, and stop these pain. I do not want this to develop into a handicap.
Initial Sx's started with uncontrollable muscle movements all over my body including my head.  This progressed all weekend long until Monday October 15th when My body started jerking all over the place.  My knees were slapping together, I became unable to walk ( My knees would pop up towards my head.  Speech was very difficult to understand.  I started having Tourette like uncontrollable screaming, twisting movements of my torso and arms.  I was hospitalized at for 5 days.  My d/c diagnosis was touretism as I do not fit DSM criteria for tourettes.  NO one can tell me the cause of this.  It is very coincidental that 17 days after receiving the live flu mist spray I develop these strange unexplainable symptoms.  I am a Registered Nurse Case Manager and Flu shot or mist spray is mandated for employment.  I would like some proof that this is or is not the cause of my symptoms.  My speech remains broken at times with occasional outbursts of screams.  I feel no urge or relief from these sx's.  It is hard for me to cary on my career in these conditions and would like to be back to normal.  After doing my own research there is an aerie similarity between my symptoms and another patient who was diagnosed with Dystonia Disorder after 10 days of the flu vaccine.
1. Cough  2. Sore throat  3. Nasal congestion with rhinorrhea  4. At increased risk of exposure to COVID-19 virus  5. Fever, unspecified fever cause  6. Generalized body aches
Information has been received from a nurse practitioner concerning a 15 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 28-SEP-2009 was vaccinated with the third 0.5ml dose of GARDASIL. There was no concomitant medication. After getting the third dose, the patient developed 103 degree fever. It was reported that the patient didn't experience any adverse effect on first or second dose of GARDASIL. Unspecified medical attention was sought. There were no laboratory diagnostic studies performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
Vaccine was administered in left deltoid on 12 June 2018. Pt reported that there was a scab present at administration site that resolved on 8/6/2018. Pt reported to continue having itchiness at the site. On the evening of 8/10/2018, pt reported having tingling in bilateral feet. It is continuous in nature. Also, currently experiencing tenderness on bilateral oblique areas.
None reported. Patient was given Adacel. Should have received Td Boostrix. Correction Td Boostrix will be given 4 weeks from November 3, 2009 on 12-01-2009. Another Td Boostrix will be given on June 1, 2010.
After child was given vaccine and waited 5 minutes she and mom walked out of clinic. As child was walking down hall mom yelled for help and she got child to chair. Child stayed coherent during episode. Child vomited twice and was very pale. After lying in long chair she sat up and drank a bottle of water. Blood pressure was 80/60 then 10 minutes later it was 104/68. Child stated she felt better and she was able to walk around lobby without dizziness or issues. Child was walked to car and left in care of mom who is a nurse.
have pain when she lifts her arm/ Injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date 25th September 2021) for prophylaxis.   On 5th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 76 years or 77 years. The patient received Shingrix in the left arm. The patient's injected arm was sore and had pain when lift the arm. The pain had gotten better but continued to have pain when lift the arm. The reporter consented to follow up.
injection site redness; Mild swelling around injection site; Arm rash; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and rash. On an unknown date, the outcome of the injection site erythema, injection site swelling and rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness and mild swelling around the injection site but then he also developed a rash that extended from the injection site down past his elbow.
Patient states he has bite-like bumps all over his back and legs that appeared two days after receiving vaccine, but not at the vaccine injection site. Patient wanted to report reaction in case it was vaccine-related.
5 days later I started breaking out in hives. I think I'm having an allergic reaction
Patient reported metallic taste in mouth and nausea 15 minutes after receiving vaccine.  Tingling in lips and tongue  Moved to EMT area-  BP-162/82, pulese-62,   Second set 142/76, pulse 68, O2 sats- 97%
ON 11/10, per parent report on phone,during evening of 11/09, Child displayed gaggy cough, hoarseness, fever, vomiting, lethargy, irregular breathing and rapid heart beat.  MD (child's pediatrician) called. 2 doses of Motrin given during evening.  On 11/10, child is improved, no fever, improved activity.  Phn encouraged increasing fluids and use of motrin. Offered reassurance and praise for Dr. contact. MOC concerned because Dr. doesn't give live vaccines on same day. Phn reassured parent but suggested she obtain MMR #2 separately for future peace of mind. NO further medical f/u was needed.
Pain in (R) arm. Red; swollen. Arm bruised. Asked patient to visit her MD.
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    Concomitant products were not provided. Treatment medication were not reported. This case contains information of 6th patient out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Fever 101.7, nausea, headache, dizziness,extreme weakness, back pain, muscle pain
Injection site was blotchy/red and sore for 2-3 days.   Day 3: small "dots" appeared on right thigh and I later noticed  a small rash (size of coin) on underside of right thigh.   Day 4 all skin irritations became crusty and began receding.   Day 6 they are still present but healing.  I had no reaction from 1st Shingrix injection.
Parent noticed a red spot on the right thigh near the injection site 3 hours after vaccination on 7/16/18. No other rashes were noted that day. Mild fever was reported at 1AM on 7/17/18, 99.2 temporal. Parent gave TYLENOL and symptoms resolved. No additional fevers. When child woke up 7/17/18, parents noticed a rash above the waist which was spreading to upper arms and head. At the time of the office visit, provider noted faint erythematous blanchable patch  about 1 cm. size and 1 inch from injection site on R. thigh and erythematous macules and papules on torso, back, upper arms, head. The provider's impression was that the rash was more likely to be viral versus hives. I called parent to follow-up today to see if symptoms have resolved, changed or worsened but I was unable to reach them.
PREVNAR 13 given in top of (R) thigh erythema, induration surrounding injection site 6/7/13.
Clerical did not pull current record, thought client was new. Did not know Tdap given 8-15-07, so gave one 10-2-12.
Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sweet's syndrome with (R) ankle lesion. Fever, myalgias, beginning approx. 12 July 2008. Rx: oral corticosteroids, NSAIDS
noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and shoulder girdle, diagnosed with parsonage turner syndrome by neurologist, currently taking neurontin for pain as steroids not tolerated
the freezer went too low two weeks ago; expired doses given to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses given to two patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (the freezer went too low two weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 18-May-2022. Reporter was told to record second booster shots that reporter gave on 24-May-2022, but reporter realized that the Moderna vaccines expired on 18-May-2022. Reporter explains that they ordered Moderna in Nov-2021, and the box said frozen. They didn't have a freezer then and found out they can be unfrozen for a month. Then they got a freezer and ordered another supply, which came in on 09-Dec-2021. The HCP called the state department, who referred her to Moderna to check if the doses were viable. The HCP connected the doctor on the line to see if he can provide information on previous excursions. The doctor states that there were fluctuations in the freezer two weeks ago. The freezer went too low.  No concomitant medications was reported. No treatment medications was reported.
CLIENT HAD COMPLETED THE MODERNA SERIES  AND RECEIVED ADDITIONAL PFIZER DOSES  AS FOLLOWS: 1/25/2021: MODERNA LOT# 032L20A 2/24/2021: MODERNA LOT 012A21A 4/26/2021: PFIZER LOT# ER8731 5/18/2021: PFIZER LOT# EW0175
2 days after injection, injection site swollen, bright red and hot.  Full body hives, intense itching and burning with extreme exhaustion and joint pain still active as of 3/4/2021.  Urgent center visit, given a 6 day pack of steroids, told to monitor symptoms and sent home.
pt recv vax 21APR95 10AM no rxn until 28APR95 4AM awoke w/itching & burning; cont during day w/some edema to elbow; ROM WNL welt; raised red fifty cents piece welt w/irregular borders
Cerebral Palsy: DTP vax admin 9/91, devel 105 fever, seizures, turned purple. Diag with cerebral and epilepsy. Child is reportedly disabled, cannot talk, requires diaper, & continuous care.
dizziness, sob, wheezing, chest pain, palpitations, weakness immediately after vaccine
patient rec'd grey cap pfizer vaccine after it was stored in freezer for 22 days- pt will be in at somepoint for replacement dose
Mom States "It was more red today on his leg so I took him to care now today at eleven thirty." "They said I should let you know."
Information has been received concerning a pt who on 03/26/99 was vaccinated with a first dose of varicella vaccine. On 07/07/00 the pt developed a mild case of chicken pox. the pt sought unspecified medical attention. Follow information received indicated that the pt was exposed to varicella on 07/02/00, broke out with 4 -5 vesicles on the clavicular area bilaterally and small papules on the right thumb were noted. It was reported the pt recovered.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 18-Mar-2021, the patient experienced PRURITUS (Itching), VACCINATION SITE RASH (Vaccination site rash) and PYREXIA (fever ). On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itchy, at a dose of 1 dosage form; CORTISONE (topical) for Itchy, at a dose of 1 dosage form and HAMAMELIS VIRGINIANA EXTRACT (WITCH HAZEL [HAMAMELIS VIRGINIANA EXTRACT]) (topical) ongoing since an unknown date for Itchy, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in arm), PRURITUS (Itching), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and PYREXIA (fever ) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 (Inconclusive) 101°F. No relevant concomitant medications were reported. Action taken for Moderna COVID-19 Vaccine was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: No new information was provided.