chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Our office received MMRV  Lot#T036565 on 6/11/21 and entered the information into database (EMR) as "MMR". This was also entered on our "Tally sheet" as MMR and placed in the MMR container. On 6/16/2021, MMR was ordered for patient. The nurse took MMRV vial (that was in the MMR container) and gave the MMRV vaccine to the patient. The patient was also given Varicella vaccine at the same visit. So the patient received #2 doses, for a total of 1.0ml of Varicella vaccine at her 12 month visit.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concurrent medical conditions included tingling (in the head and face started on 15th May 2018). On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and papular rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles and papular rash were unknown. The reporter considered the shingles and papular rash to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient did not mention about tingling in the head and face when she received the SHINGRIX. She filled out that she was feeling well. On 19th May 2018, the patient went back to the pharmacy and stated that she had shingles (bumps appeared). The pharmacist called the on-call physician who prescribed VALTREX for the patient.
Approximately 10 minutes after receiving Hepatitis B injection, the employee returned to the medical office to complain of vomiting times one, that she felt nauseated and hot, was lightheaded, and had abdominal pain. Employee denied dyspnea, itching or tenderness to injection site nor was the injection site red or raised.  Employee spoke with "RN" at Urgent Care and employee stated he recommended that she  should be taken to urgent care for treatment and/or further care.
Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L003855, expiration date 05-FEB-2017) (dose and route unknown). The vaccine was exposed to a temperature described as: "max 47.6F for 10 minutes with three previous excursions of 10 minutes each exposed to a max of 47.6F each time" (cumulative 40 minutes out of recommended). Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Left rotator cuff injury and pain, starting after the shot was administered and continues to date (now two months after the shot).
pt recv vax & devel chickenpox that consisted of approx 27 blisters on back, face & legs;
FEELING AWFUL; TWITCHING EYEBALLS; RANDOM MUSCLE ACHES; DIZZINESS; FELT LIKE THE FLU; COULD NOT WALK; LEG FEELS HEAVY CANNOT LIFT; HANDS, LEGS AND BODY SHAKING; RED FACE; SKIN ON  FACE FELT THICK; COULD NOT RAISE EYEBROWS; THROAT HURT; SORE ARM; FELT TIRED; HOT FACE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:42 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 15:22, the subject experienced red face. On 07-APR-2021 15:22, the subject experienced skin on face felt thick. On 07-APR-2021 15:22, the subject experienced could not raise eyebrows. On 07-APR-2021 15:22, the subject experienced throat hurt. On 07-APR-2021 15:22, the subject experienced hot face. On 07-APR-2021 15:22, the subject experienced sore arm. On 07-APR-2021 15:22, the subject experienced felt tired. On 08-APR-2021, the subject experienced felt like the flu. On 08-APR-2021, the subject experienced could not walk. On 08-APR-2021, the subject experienced leg feels heavy cannot lift. On 08-APR-2021, the subject experienced hands, legs and body shaking. On 08-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced random muscle aches. On 10-APR-2021, the subject experienced twitching eyeballs. On 11-APR-2021, the subject experienced feeling awful. Laboratory data included: Heart rate (NR: not provided) Normal, and Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like the flu on APR-2021, was recovering from dizziness, had not recovered from sore arm, hands, legs and body shaking, feeling awful, and random muscle aches, and the outcome of red face, skin on face felt thick, could not raise eyebrows, throat hurt, felt tired, could not walk, leg feels heavy cannot lift, twitching eyeballs and hot face was not reported. This report was non-serious.
Two weeks after receiving the Jynneous vaccine patient developed a red erythemous, slightly elevated rash on his body. Rash affected skin on arms and legs. Rash also seen on torso but not as sever (pictures taken). The rash was not itchy, or painful. Patient did not have and other side effects. No f/c, body aches, or fatigue. Large patch noted where the injection was given and more confluent.
Corona Virus Concern      Patient was d/c today for NSTEMI, came back to facility and he tested positive. 88% on RA.    HPI This is a 76-year-old male with a history of dementia who presents for facility for concerns of hypoxia and recent COVID diagnosis. Patient was discharged from rehabilitation this morning after being hospitalized for NSTEMI. Troponins have been down trending. Patient tested positive at care facility today. EMS arrival, patient with O2 saturation around 85% on room air. Does not wear oxygen at baseline. No other complaints. Patient is demented.
Extreme heat at neck, Turned bright red on forehead, and moved down body, hives developed, redness, swelling, and extreme itching 4 hours after injection.   Tongue, Face, and lips swelled, numbness in fingers and top of head.    Self administered epipen and one 25 mg benadryl.     at 3am in the morning, administered 2 more 25 mg  benadryl     no more reactions since
menstrual spotting (patient was menopausal and have not had a period in a few years); This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6199) via an unspecified route of administration, administered on the left arm on 12Mar2021 14:00 as dose 1, single for COVID-19 immunisation. The patient's medical history included menopausal (have not had a period in a few years). Concomitant medication included curcuma longa (TURMERIC [CURCUMA LONGA]) and once a day vitamin. Two days after the injection (14Mar2021 at 11:00 AM), patient had some menstrual spotting (patient was menopausal and have not had a period in a few years). It was fairly light and went away in 24 hours. It returned 19 days after the injection and was light again. No treatment was received for the events. The facility where the vaccine was administered was in a pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Pt showed up to the pharmacy and stated that she was given the injection too low in the arm, way under the deltoid muscle, she said she can't move her arm, and that she was referred by her physician to physical therapy.
Approx, 4 hrs after receiving 2nd dose, started c/o pain in the rt shoulder joint.  Pain continues today.  Pt. Cannot even raise his arm.  I want to emphazie the pain is in the shoulder joint not in the muscle
Initial Evaluation: Throat tightening for few seconds only. Swelling on face near eye, tingling on lips Patient is alert and responsive. Refused to call 911, she stated she felt better. BP 149-91 Pulse: 82 02 96%. Given oral benadryl capsule 25 mg. Patient feels better, throat tightening resolved, little swelling on right side of face on right eyelid. Alert and oriented x4, no shortness of breath, no chest pain. Patient advised to go to the ER for further evaluation. Patient agrees to go to the ER but refused to go via nonemergent ambulance or 911. Patient prefers to go by herself to the ER. Refused to call ambulance.
she had diarrhea after the booster dose; after receiving the booster dose in Aug2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 83 year-old female patient received bnt162b2 (COMIRNATY), administration date Aug2021 (Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included COPD (unspecified if ongoing); immune problem (unspecified if ongoing), IgG infusions. The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported DIARRHOEA (non-serious) with onset Aug2021, outcome unknown; IMMUNISATION (non-serious) with onset Aug2021, outcome unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
~ 7-10 vesicles at site of injection of varicella #1 - Occurred ~ 2wks after inj.
knees and elbows were sore and stiff/ I had joint pain all the joints; Pain in arm; can't even drive and pickup anything because of his arm; every so often my right leg is still having some issues; it just slowly got worse; knees and elbows were sore and stiff; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the first dose of vaccine three weeks ago and he mentioned about the side effects that he experienced. On an unspecified date in 2021, the patient experienced his knees and elbows were sore and stiff and he was also experiencing lot of pain in his arm, he believed it was in the injection site. The patient stated that this would be close to almost 5 weeks, when he got the shot very next day it was when he had joint pain, and all the joints felt better now expect for one he got shot in, it never got any better it just slowly got worse and every so often his right leg was still having some issues, it was mainly his right arm. He said that he couldn't even drive and pickup anything because of his arm until today. He also mentioned that he was not able to get the second dose yet. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Boostrix in 20 month old; This case was reported by a consumer via sales rep and described the occurrence of inappropriate age at vaccine administration in a 20-month-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number ZL33B, expiry date 25th November 2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional Information: GSK Receipt Date: 17-Aug-2022. Reporter's comment: The 20 months old patient received Boostrix. Additional Supportive Information: The 20 months old patient received Boostrix, which led to inappropriate age at vaccine administration.
Client observed to have redness with small prickly rash to face-without redness or swelling to injection site without resp distress, wheezing, dizziness or n/v noted-diphenhydramine liquid given po per health dept protocol.
Pounding headache started around 845 am and suddenly nauseated and vomited at 945am. Feeling chills and aches all over the body since then. Placed call to primary doctor's office, the nurse said all of the side effects reported so far were normal for up to  48 hours, push fluids, and to call back if starting to have an allergic reaction
PATIENT REPORTS HAVING ARM PAIN THAT RADIATES FROM INJECTION SITE, UP TO SHOULDER, AND BACK DOWN THE ARM. PATIENT HAS BEEN USING TYLENOL AND ICE. PATIENT STATES THAT THE PAIN STARTED ALMOST IMMEDIATELY AFTER THE INJECTION AND CONTINUES TO THIS DAY. WE ALSO RECOMMENDED THAT PATIENT USE WARM COMPRESS AND FOLLOW UP WITH PHARMACIST IN A FEW DAYS.
Pt is 74 yo female s/p full Moderna vaccination: first dose 2/10, second dose 3/10.  She reports new onset cough, new SOB, fatigue, and known exposure to COVID. COVID test resulted positive on 7/21.  Patient received casirivimab/imdevimab infusion on 7/23.
felt like I had the flu; achy; sweating; Diarrhoea; throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 (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: INFLUENZA LIKE ILLNESS (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "felt like I had the flu"; PAIN (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "achy"; HYPERHIDROSIS (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "sweating"; DIARRHOEA (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "Diarrhoea"; VOMITING (non-serious) with onset 18Apr2021 02:00, outcome "unknown", described as "throwing up".  Additionl Information: Reporter reported that she received her first dose of the Pfizer shot on Saturday. "Last night, (she feel a little be better now) at 2am she was achy, sweating couldn't get comfortable got worse went to the bathroom had diarrhea and throwing up. She couldn't get comfortable. This morning I laid at home and felt like she had the flu. She is on erythromycin antibiotics,  she spoke with someone prior to Pfizer MI and gave information regarding her experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tiredness in the afternoon of the shot (napped from 5-7) then, nausea, vomiting, dry heaves from about 10pm the day of the shot until 3.30 the following morning (so, for about 5-6 hours). Also, one bout of diarrhea at the beginning of all the nausea. sore arm for almost a week Note: I did not file an adverse reaction with the first shot, but the reactions were similar, the only difference being that they came on sooner with the first shot.
note: at approximately 430 pm when she was standing on the front desk she  LOST CONSCIOUSNESS Falling BACKWARDS AND might had HIT HEAD (unwitnessed). Medical assistant imediately came to assist her and WITNESSED UPPER EXTREMITY SHAKING FOR FEW SECONDS.  I arrived to evaluate her less than one minute after the episode: HER BP WAS LOW AND HER HR WAS HIGH. She appeared pale and unresponsive for few seconds, EMS was called while we evaluated her. THEN within 5 MIN SHE REGAINED CONSCIOUSNESS AND COMPLAINED OF A HEADACHE IN THE BACK OF HER HEAD. A repeat BP was normal. WE CARRIED HER TO THE EXAM TABLE. A REPEAT BP WAS NORMAL AND HER HR WAS STILL HIGH. She appeared oriented with a SG of 81 MG. SHE WAS ABLE TO SIT
employees vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, expired product administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that the Moderna COVID-19 vaccine was given out this week with doses from a vial that had been punctured for more than 6 hours instead of being discarded. She stated that the punctured vials were placed in the fridge or on top of an ice pack or in the carton and used beyond 6 hours after it was first punctured. No other specific details were provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# 011J20A; expiration date- unknown), reporting an expired product administered. The event occurred the same day of vaccine administration. The reporter did not provide the causality assessment. The event of expired product administered was assessed as not related to Moderna COVID-19 Vaccine.
Her blood pressure was exacerbated/her blood pressure exacerbated to 200/116 or 200/120; Removed the bandage she noticed a silver metallic discharge on the band aid; Tremendous headaches; had difficulty walking on some days when she had the headaches; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for COVID-19 immunization. The following information was reported: HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "Her blood pressure was exacerbated/her blood pressure exacerbated to 200/116 or 200/120"; VACCINATION SITE DISCHARGE (non-serious) with onset 2021, outcome "unknown", described as "Removed the bandage she noticed a silver metallic discharge on the band aid"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Tremendous headaches"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "had difficulty walking on some days when she had the headaches". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 200/116 or 200/120. Therapeutic measures were taken as a result of hypertension. Clinical course: The patient got her vaccine in Apr or May second dose. Stated that when she removed bandage instead of drop of blood there was silver metallic discharge on the bandaid. Stated that since then she had tremendous headaches. Stated that shortly after her blood pressure exacerbated to 200/116 or 200/120 even after taking her blood pressure medicine. Stated that she has not been to a doctor. She was a nurse. Was concerned about the metallic substance on the bandaid, extreme headaches, blood pressure and it being difficult to really walk on somedays when she had headaches. Patient was scheduled for a MRI on Friday. Wanted to know what was the metallic substance. Stated that she has not gotten the booster and does not want the side effects getting worst. Stated that she has a lot of questions.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Hypertension, vaccination site discharge, headache, gait disturbance and the suspect drug BNT162B2 cannot be excluded.   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.
Pt. reports shortness of breath and aching 2 hours after receiving vaccine. 25mg Benadryl given  Pt. states he went to Urgent care 4-27-21 4-28-21 Pt. reports aching, feeling better overall. Has no follow up appointments at this time
Exactly 24 hrs after shot pt broke out in severe hives, had high fever, and got the flu. For 2 wks he had hive breaking out all over his body, Dr's put him on steroids, because nothing we would use would stop the hives. They told us to just call 911 if he can't breath. He has had a few break out still.
pt notified ER nurse on 21OCt97 that had been exp pain in lt arm since flu vax;pt advised to see MD if pain cont which it did;MD feels this is coincidental & is more likely d/t a pinched nerve;pt is taking physical therapy;x-rays ordered;