chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with unknown improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 14-year-old female patient. On 04-MAR-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 8th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX was P45MN, which was changed to P45M9, as per sales data sheet. The patient received SHINGRIX on the left arm. The patient experienced redness at the injection site, approximately the size of their hand which lasted for five days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 31Jan2021 as dose 2, single (Lot number: E5318), in left arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 15Mar2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: Recurrence of positive Covid antigen test 4 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Recurrence of positive Covid antigen test 4 days after completing Paxlovid and new symptoms (bad nasal congestion, fluctuating fever up and down: normal, fever, normal, fever, sleepiness, headache, tinnitus). No other medication was received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a non-healthcare professional on 24 January 2014. The case was receive on 21 March 2014 at GPV. The two patients had received yellow fever vaccine reconstituted with sterile water. No adverse event was reported. List of documents held by sender: none.
Severe generalized pain throughout entire body. No OTC relieved pain but resolved in 24 hrs
Red painful rash around injection site, encompassing entire upper arm. Pt had to seek ER treatment. Lasted 3 days after vaccine.
Information has been received from a physician concerning a 5 year old female who on 19-AUG-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 659740/0165X) 0.5 ml SQ.  On 19-AUG-2008 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) 0.5 ml SQ in the left thigh.  Concomitant therapy included a dose of DTAP.  On 21-AUG-2008 the patient experienced swelling at the injection site.  On 26-AUG-2008 the patient developed 8 scattered vesicular lesions.  The patient was treated with BENADRYL and ice compresses.  The patient sought medical attention via an office exam.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  This is one of several reports from the same source.  No further information in available.
Hospitalized 8/30 - 9/2 after onset R sided facial droop, not talking and clumsy falling towards her R side - admitted and found to have a L CVA - evaluated by neurology, genetics, hematology - started on 1/2 81 mg aspirin - receiving ST and OT due to persistent speech deficits, motor deficits resolved
Severe dysmenorrhea - caused me to wake up at 4 am , not be able to sleep, could telework from bed, missed choir rehearsal, and had to go to acupuncture on thursday, oct 13 to manage pain and had to take tramadol, increase dose of tizanidine and mexilitine (lidocaine)  to sleep; on friday oct 14, still had severe dysmenorrhea, could not go to second job as a yoga teacher and increased mexilitine to sleep; saturday oct 15 - energy was drained from the severe pain and had to go to acupuncture and missed a choir retreat; dysmenorrhea has continued but is less severe than before
Narrative: COVID infection following COVID vaccine series 03/12, Pfizer, dose #1 04/02, Pfizer #2 05/27 COVID swab, result: not detected 07/30 pt cc: cough , rhinorrhea, nasal congestion exposure: unknow 08/04 COVID swab, result: detected 08/05 pt  cc: cough rhinorrhea, chest congestion worst at night,  08/09 pt cc: chest pain 08/09 clinically resolved 08/12 SARS-COV-2 Variant Sequencing result: pending
Patient received first dose around 0720, within about 10 minutes patient started with slight nausea.  After about 20 minutes he was feeling more lightheaded, dizzy and very tired.  He was transferred to a recliner, feet elevated and initial bp was 124/80 with a pulse of 110.  Patient started to complain of some shortness of breath and oxygen was placed on 2 liters.  His O2 level was 96% at the time.  Local EMS was contacted.  Repeat bp readings were 136/80, 107/70 and 113/74.  His pulses remained tachycardic.  When EMS arrived patient was transported to local ER.
Went to bed at 9:30 pm and woke up at 11:30 with my whole body shaking and pressure on my chest.  Took my blood pressure, it was 226/192. Oxygen level was 79. Took liquid benedryl , got dressed and took blood pressure again after about 10 minutes  and it came down to 139/87 and oxygen was 89. I went to the emergency room. I waited about 20 minutes and then was seen by a nurse.
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 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 4:27 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 27.65. No concomitant medications were reported. Batch number 019B21A administered on 27-Mar-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Immediate lightheadedness and heart fluttering.  Heaviness in head feels like a band around my eyes. Joint popping and soreness in wrists almost immediately.  Blurred vision.
The first day after I received my shot I was running a fever of 102. My side effects passed by May 29th, 2021. On May 21st I went to the hospital due to vaginal bleeding. While at medical center I was told I had a miscarriage. I was showing at 4 weeks when I was supposed to be 7 weeks. I found out I was pregnant on April 30th. I got my first dose on May 5th.  My first shot I just had soreness, but I?ve had a previous successful pregnancy but lost this one between my first and second dose.
Electrical Shocks through out my body. I had the feeling like I had several energy drinks at once, it lasted 2 weeks. it caused me not to sleep.
She had vomiting, low grade fever the night after vaccine. Approx 24 hours after vaccine, mom was alerted by unusual cry after nap and she appeared disoriented, then normal. Similar episode of staring/shivering/mumbling happened briefly that night again. Mom concerned about seizure, but did not seek medical attention because incident did not recur.
extremely tired; sore; sleepy; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration on the left arm on 26Mar2021 at 17:30(at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and endometriosis. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 07:30, the patient experienced extremely tired, sore and sleepy since receiving injection. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extremely tired, sore and sleepy was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
24 hours after injection pt lethargic, w/rash at inj site. Rash increased in size to about size of three 1/2 dollars. No itching, and warmth and sore persisting 48 hours later. Advised ice and BENADRYL.
Developed petechiae and purpura of legs bilaterally several days after the injection. Skin changes lasted around 2 weeks.
On April 9 about 3 or 4 hours after the shot, purple swelling on right ring finger where it connects to palm.  Looked like a bruise color and bulged up  swollen. Looked like maybe blood clotted up inside.  Not painful, but finger kind of numb and cold feeling. April 14 finger all white and kind of numb and cold like no blood circulation. Had teleconference with doctor office and PA seemed unconcerned, just said if it gets worse go to ER. I just tried to keep my hand warm and wore a glove even indoors, and it finally got back to normal.
Muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-Jul-2022 Reporter's comment: The reporter asked whether he/she could take an aspirin or ibuprofen for muscle soreness on 2nd day of first shot. The reporter asked whether he/she could take an aspirin for muscle soreness.
chills,syncope, blood pressure 180/110.  mild fever, headache, flu like symptoms, chest pains, winded, raspy voice, sneezing, runny nose   (dx by ER= viral respiratory infection but tested neg for covudand flu .. rx z pack and prednisone ..  on 8/18  go to see pcp on 8/20 still having chills and symptoms my pcp said Adverse Reaction to Vaccine  said i need to report . pcp advises i do not get the 2nd dose. rx potassium blood pressure medication
had one in 2019, has been over 3 years; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Linked case(s) involving the same patient: US2022AMR154368   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's comment: The case was self-reported by the patient. The patient believed at that time (1st dose), only one shot was advised. The patient reported that now he/she saw GlaxoSmithKline were advising 2 shots within a 6 months period.  The patient asked what he/she should do about the second shot since it had been more than 3 years. The patient reported that his/her primary care would have to contact GlaxoSmithKline. The patient was on daily suppression acyclovir. The patient asked would someone from GlaxoSmithKline contact him/her. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. For the tolerance of acyclovir refer case US2022AMR154368, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR154368:same reporter
Episodic chills; muscle aches and pains; Fever; Pain; Inability to sleep; This is a spontaneous report from a non-contactable consumer (patient) reported for himself. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Feb2021 at 18:00 pm (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma (mild) from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Feb2021 at 12:00 pm, the patient experienced episodic chills, muscle aches and pains, fever and inability to sleep. No treatment was received for the adverse events. The outcome of the events was resolving.   No follow-up attempts are possible. No further information is expected.
muscle aches; chills; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31Mar2021), via an unspecified route of administration on 19Dec2020 19:30 at single dose to prevent Covid. Medical history included COVID-19 from 30Oct2020 to 24Nov2020.  There were no concomitant medications. Eight hours after getting the vaccine (20Dec2020 03:30), she had muscle aches and chills, she also had fatigue on 20Dec2020. She was worried. She was concerned that she had done something crazy. She was through Covid for sure. She wasn't able too much. She was off work that day and didn't have to do anything. She would not have been able to work. The muscle aches were rivaling the worst days of Covid. She had Covid for 3 weeks. Then she had to wait another 10 days to get over the symptoms. She never had to go to the hospital. These muscle aches that she experienced after the injection were as intense as when she had Covid. The Lot on the patient card was difficult read. The information was hand written and squished in. She was unsure if it was EK5B30 or EK5030 or EK5730. The patient underwent lab tests and procedures which included COVID test: positive on 30Oct2020, negative on 24Nov2020. The outcome of muscle aches and chills was recovered on 21Dec2020, fatigue was recovering. The event muscle ache reported as serious, with serious criteria medically significant.   Information about lot/batch number has been requested.; Sender's Comments: The Company considers there is a reasonable possibility that the reported muscle ache is related to the administration of BNT162B2, based on the plausible temporal association and the known safety profile of the suspect.   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 RA, IEC, as appropriate.
Post vax, the pt developed fever, chills, nausea, body aches, swelling at injection site, and soreness at injection site which lasted 3 days.
Severe diarrhea began the day after the vaccine -- multiple times an hour at times, over 10 times a day. It continued for the next few days . The maximum dose of Immodium eventually stopped it, and all bowel movements for two days, then severe diarrhea immediately resumed (on 9/27) . I took 4 Immodium pills in 24 hours, and then didn't eat until just before I would be able to take another Immodium if needed. 2 more days without diarrhea; I went to a mostly unhelpful urgent care appointment. He said take Immodium if I get more diarrhea when I asked what to do if it came back. He said I didn't have the symptoms of a virus (fever, nausea, vomiting, blood in stool). That evening the diarrhea returned.   My stomach does not act like this; I can't remember the last time I had diarrhea before this. I wear an N95 everywhere. I had not eaten at any restaurant for at least 6 weeks before this started, so food poisoning seems unlikely. I'm a vegetarian, so it isn't from meat...
I experienced COVID-19 on 03/07/2023. I had a sore upper back, and but the need of the day it was very sore. I ended feeling foggy, fatigued and had a low grade fever. I felt sick which is one reason I did a test. I took a home COVID-19 test on 03/10/2023 which was positive. I got a prescription for Paxlovid on 03/11/2023 and basically I was very tired this day.  I did not go to see a doctor. I can say I am still recovering. I picked up a cough since my immune system was low. I still have the fatigue by the end of the day and the cough that comes and goes.
Pt presented to Medical Center on 10/6/18 with continuous nonradiating, nonexertional substernal chest pain x 12 hours. S/P smallpox, anthrax, typhoid vaccine on 9/25/18. ECG with some suspicion for pericarditis and had elevated troponin. CXR normal. He received nitroglycerin (which did not alleviate pain which was discontinued). He was also given aspirin, hep drip, PLAVIX, and atorvastatin. Due to elevated trop, pt was transferred to another Medical Center that day. 3 day hospital course was uneventful. Initial bump in trops which started to trend downward.  Dx with myocarditis, started on colchicine and MOTRIN with improvement of symptoms. Discharged on 10/8/18.
hyperlipidemia; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Meniere's Disease", start date: 13Feb2017 (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1), administration date: 19Mar2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: HYPERLIPIDAEMIA (non-serious) with onset 25Jun2021, outcome "not recovered", described as "hyperlipidemia". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.