chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-May-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient was 25 weeks pregnant at the time of vaccination.
Lambert-Eaton myasthenic syndrome (LEMS); vertigo; migraines; postherpetic neuralgia; zoster like rash in the bilateral breasts; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 11-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe vertigo and migraines. The patient was hospitalized and diagnosed with Lambert-Eaton myasthenic syndrome (LEMS). A short time later, the patient experienced a zoster like rash in the bilateral breasts and continued to experience postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX).The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of vertigo, migraines, LEMS, zoster like rash in the bilateral breasts and postherpetic neuralgia were considered to be disabling. Upon internal review, the event of Lambert-Eaton myasthenic syndrome (LEMS) was considered to be medically significant.
12/10/07 Mom reports child has not been acting right since DT on 11/27/07. Tears up during the day and hands jerk at night while asleep. Onset about 24 hours after vacc. Mom things its from DT.
Varicella zoster in right arm. clinical diagnosis. No clinical history of natural varicella. Pt received varicella vaccine one year ago.
Red itchy dots on the forearm and elbow of left arm; red dots on left temple, some on back of neck and between shoulder blades; may be hives; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 62-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) on an unknown date in 2021 (at the age of 62-years-old) both as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced red itchy dots on the forearm and elbow of left arm, red dots on left temple, some on back of neck and between shoulder blades, may be hives, still breaking out 4 weeks after shot, hives in earnest after second shot on 4/9. The events resulted in doctor or other healthcare professional office, clinic visit. Therapeutic measures were taken as a result of events hives and red itchy dots on the forearm and elbow of left arm, red dots on left temple, some on back of neck and between shoulder blades, may be hives, still breaking out 4 weeks after shot. The nurse practitioner looked at rash and treatment included doctor prescribed 1% cortisone cream, however the cream was helping just a little bit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives and red itchy dots on the forearm and elbow of left arm, red dots on left temple, some on back of neck and between shoulder blades, may be hives, still breaking out 4 weeks after shot were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Body flu like symptoms runny nose, and HAS NOT HAD A PERIOD IN OVER A YR, THAT EVENING SHE STARTED TO BLEED, VERY HEAVEY AND WAS VERY FOGGY WITH HER MIND
Temporary paralysis in legs, could not walk; Could not walk; This case was reported by a physician via market research programs and described the occurrence of leg paralysis in a 18-year-old male patient who received Men B NVS (Meningococcal B Recom vaccine + AlOH + OMV) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In July 2017, the patient received Meningococcal B Recom vaccine + AlOH + OMV and Bexsero Pre-Filled Syringe Device. In July 2017, less than a month after receiving Meningococcal B Recom vaccine + AlOH + OMV and Bexsero Pre-Filled Syringe Device, the patient experienced leg paralysis (serious criteria GSK medically significant) and unable to walk. On an unknown date, the outcome of the leg paralysis and unable to walk were recovered/resolved.   The reporter considered the leg paralysis and unable to walk to be possibly related to Meningococcal B Recom vaccine + AlOH + OMV and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Apr-2022 Reporter's Comments: The reporter stated that the patient could not walk, had temporary paralysis in legs The reporter did not consent to follow up. Additional Supportive Information: This case has been linked to US2022AMR064641 and US2022AMR064642, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064641:Same reporter. Patient 2. US-GLAXOSMITHKLINE-US2022AMR064642:Same reporter. Patient 3.
This spontaneous case, initially received on 23-Sep-2016, was reported by a Non-Health Professional and concerns a 35-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 23-SEP-2016 to 23-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52406. No additional suspect drugs. Adverse event description: On 23-Sep-2016, less than full dose of AFLURIA administered (to the patient) as a small amount was expelled when air bubble removed (outcome: unknown, special circumstances: underdose without adverse event). The reporter classified the event as a medication error.
Pt describes daily chest pain starting 2-3 weeks after 2nd dose of Moderna vaccine as well as intermittent left arm tingling. EKG and stress test performed, unremarkable.
Within a few hours of receiving vaccine, patient came down with a bad headache and tiredness. Area of vaccine had become reddened. By the next morning (today) whole right shoulder is swollen, red, warm to touch and itchy with a continued headache. Per Mom, the redness is already improving.
Fever 102.4, Vomiting, Swollen Throat, Hard time breathing, Violent Shaking
patient admitted with COVID on 28 Sept.  Was in ICU shortly after admission, consult obtained due to high oxygen requirement. On NiPPV initially.  Transferred to floor on 1 Oct on NiPPV 15/10 FiO2 80%- transitioned to high flow
Felt bad enough he had to go home from work at 2PM on 10/30/18. He was experiencing chills, aches, and a severe headache. The headache got better with ibuprofen, however when it wore off at 2AM, his severe headache woke him back up again. He finally felt better again at about 10:30 on the 31st.
Dizziness; weakness; Inflammation in body; headaches; pain in joint and muscles; sleeplessness; My eyes would blur if I read, watched TV or looking at I Phone or computer; brain (felt like my body and brain were on fire); This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (BNT162B2, Pfizer-BIONTECH, COVIF-19 Vaccine, Solution for injection, Lot number: EL9267 and expiration date: Not reported),  via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:45 as SINGLE DOSE for COVID-19 IMMUNISATION. The patient medical history included Polymyalgia, Rheumatica, Herpes, Afib, BPH, Sulfa allergy. Covid prior vaccination was No. Concomitant medication included prednisone, hydroxychloroquine silodosin. The patient previously took levofloxacin (LEVAQUIN), statin, metoprolol, fluoxetine, Nortriptyline, pregabalin (LYRICA), propafenone, Zolpidem and had allergies to these drugs. It was reported that the patient had experienced Dizziness, weakness, inflammation in body, brain (felt like my body and brain were on fire),headaches, pain in joints and muscles, sleeplessness. My eyes would blur if I read, watched TV or looking at I Phone or computer all on 12Feb2021 13.00. Covid tested post vaccination was No. Therapeutic measures were taken as a result of events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Child given Dark pink with yellow label (.2ml/10ug) as a first dose instead of the correct dose of Dark blue cap with gray label (.25ml/25ug) as a first dose based on previous vaccination history guidelines.  Phone call to notify mother of error and she reports no adverse events at this time.  Recommendations for vaccination discussed and RN has made steps to address the why the error took place and how to avoid making it again in the future.
Client noticed pain in her neck, left axillary and left shoulder. Had a CT scan two weeks ago that revealed enlarged lymph nodes. Still having pain with enlarged lymph nodes today on 2/19/21. Also stated that she had a metallic taste in her mouth when receiving the first dose of the Pfizer vaccine.
BOTH EYES HAVING PRESSURE-TYPE PAIN, NOW LOCALIZED TO LEFT EYE; HEADACHE; INJECTION SITE PAIN SPREAD IN LEFT ARM; BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes ii, insomnia, neuropathy, tinnitus, vertigo, acne, chronic back pain (bulging discs), seasonal nut allergies, anxiety, smoker, non alcohol user, depression, hearing loss, and cholesterol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, bupropion, lamotrigine, metformin hydrochloride, montelukast, and sertraline. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021 12:00, the subject experienced injection site pain spread in left arm. On 08-APR-2021 15:00, the subject experienced headache. On 09-APR-2021, the subject experienced both eyes having pressure-type pain, now localized to left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain spread in left arm, body aches, chills, headache, and both eyes having pressure-type pain, now localized to left eye. This report was non-serious.
covid-19 test (nasal swab) on 29Jan2021 and the result was positive; covid-19 test (nasal swab) on 29Jan2021 and the result was positive; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, the first dose on 24Dec2020 14:15 (lot number: EKT231) on the left arm, then the second dose on 14Jan2021 (lot number: unknown) on the left deltoid; both at a single dose for COVID-19 immunization. The patient experienced severe abdominal pain, clay colored stool, tea colored urine, intensely burning, exploding headache and productive cough after the first dose was administered on 24Dec2020. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient underwent covid-19 test (nasal swab) on 29Jan2021 and the result was positive. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient called and stated her arm had swelling the day after getting her booster. No other symptoms.
Red bullseye around injection site; Arm started to feel hot and feverish; Incredibly itchy; Sore arm shoulder to elbow; A spontaneous report was received from a consumer concerning a 75 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pruritus/extremely itching, sore arm shoulder to arm/ Pain in arm, injection site warm/hot and feverish  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M20A) for prophylaxis of COVID-19 infection. After receiving the mRNA-1273 vaccine, patient injection site pruritus/extremely itching, sore arm shoulder to arm/ Pain in arm, injection site warm/hot and feverish.  Treatment details for events was anti-itch spray but it didn't work.   Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events, sore arm shoulder to arm/ Pain in arm, injection site warm/hot and feverish were considered to be unknown at the time of this report. The outcome the event, injection site pruritus/extremely itching  was considered to be recovered/resolved.
Reaction after second dose (but not to the first): Headache, fever, nausea, and chills (started the day after the vaccine and lasted 24 hours)  Rash at the injection site 6 days after the injection
no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On unknown dates, patients were vaccinated with improperly stored haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T030706 has been verified to be valid; expiration date reported and established as 02-APR-2023, and lot number U024489 has been verified to be valid; expiration date reported and established as 02-NOV-2023), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742420 has been verified to be valid; expiration date reported and established as 31-JAN-2023), and hepatitis a vaccine, inactivated (VAQTA) (lot number W007371 has been verified to be valid; expiration date reported and established as 13-JUL-2023, lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023, and lot number U012007 has been verified to be valid; expiration date reported and established as 18-JAN-2023) as prophylaxis (product storage error) (doses, vaccination schemes, routes of administration, and anatomical locations were not provided). The administered doses of the vaccines were stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported. In addition, the reporter that she was unsure if any of these vaccines had been administered since the excursion occurred.  Follow-up information has been received from the nurse (previously reported as medical assistant) during a phone call on 25-OCT-2022.   The nurse was able to locate 5 patients that were involved in this temperature excursion (product storage error) and had already collected data on the patients (captured in MARRS # 2210USA009377, 2210USA009378, 2210USA009379, and 2210USA009380).   This spontaneous report refers to a 2-year-old female patient.   On 06-SEP-2022, she was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023 (strength, dose and route of administration were not provided) as prophylaxis.   This is one of 5 reports received from the same reporter.  This case was previously considered non-valid due to lack of patient's identifiers, but upon receipt of follow-up it was determined that the case is now valid. ; Sender's Comments:  US-009507513-2210USA009379:MSD US-009507513-2210USA009377:MSD US-009507513-2210USA009380:MSD US-009507513-2210USA009378:MSD
Tinnitus, had it before but not as bad as this; This case was reported by a consumer via interactive digital media and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included tinnitus.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   The reporter considered the tinnitus to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: This case was reported by consumer (patient) via interactive digital media. The Shingle shot triggered patient's tinnitus the day after the first dose. The patient checked with a doctor for ears last week from reporting.  The patient had tinnitus before but not as bad as this was.  The ear doctor just wrote a paper regarding Covid could cause shingles.  The patient did think the shingles shot triggered tinnitus like 1000 bees in head. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Immediately following 1st dose Pfizer COVID vaccine client turned pale and had a syncopal episode. Client was assisted to a supine position on the floor. Client regained consciousness within 20 seconds of syncopal episode. Client skins were pale for ethnicity, clammy and cool. Vital signs were taken in supine position: BP 121/71, HR: 69, RR 12. Client's mother denied any medication use, stated client was positive for Asperger's syndrome, denied any NKDA or allergies to foods/ environment. Client was assisted to seated position in wheelchair vitals: BP 105/46, HR 60, RR 10, skins returning to normal color for ethnicity, dry and warm. Client was assisted to zero gravity chair without incidence. Client complained of nausea, dizziness and tingling of Left arm and hand. Denied SOB, CP or HA. EMS called. Client care transferred to EMS.  EMS BP: 98/50, 12 lead EKG revealed NSR. Client's mother signed client AMA from EMS care. Client stayed at observation site an additional 30 minutes. Last set of vitals BP 117/69, HR 76 RR: 10. Client stated he felt much better and all symptoms were resolved.  Client's mother instructed on ED protocols and advised to follow up with PCP. Client left observation site with his mother on his own accord and with a steady gait.
Pt w/ history of allergies - on BENADRYL - on TAMAZEPAM X 1 wk for depression - got GARDASIL - kept flat X 15 min - was ok on D/C - when got home - c/o "dizzy", light headed, nausea (4/20) cont. 4/21 with symptoms - went to ER - labs negative EEG negative per dad - 4/22 c/o headache but felt better.
Fever for 2 days, right arm hot, warm and swollen for 4 days with difficulty with abduction.
I have two lumps on my upper right arm between the elbow and the vaccine site. The two lumps appeared on 09/08 and 09/09. They continue to enlarge. This has happened after each COVID-19 vaccine after the same time frame. A surgeon had to drain the previous lumps, but I have not done that with these yet. They did not show any signs on being a bacterial infection. I went to the doctor on 09/22 for the current lumps.
HAD RECEIVED 2ND MODERNA VACCINE ON 03/20/2022, NURSE RANDA ADMINISTER THESE AS 1ST BOOSTER DOSE AT 10 WEEKS INSTEAD OF 5 MONTHS ON 05/31/2022.  NO NOTED REPORTED SIGNS OR SYMPTOMS OR TREATMENT REQUIRED FROM RECEIVING TO EARLY. UNDERSTAND DO NOT NEED TO REPEAT DOSE
This spontaneous report as received from a consumer refers to herself, a 84 year old female patient with shingles. The patient reported no allergies or previous drug reactions. The patient's medical history included orthopedic issues, flu and horse fly bites. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot number were not specified) while she had shingles already and her immunity was compromised because she had the flu and "horse fly bites" in February. Other concomitant medications included unspecified blood pressure medication, ADVIL, unspecified circulation medication, and PRILOSEC. The patient stated that after having ZOSTAVAX, in 2013, she has started to have dry skin and started to use cocoa butter to help soothe this. The patient spoke with her physician. The outcome of dry skin was reported as not recovered/not resolved. No labs were perform. Additional information is not expected.
Swelling of tongue and lips 20 min. after vaccine benadryl was taken.  Day2 flu -like symptoms, fatigue Head-ache, chills day 6, Day 14 still have body aches/ joint pain
p/vax pt exp pain/swelling & irritation @inj site;chickenpox rash; fever;pt had systemic rxn w/mild case of chickenpox;tx:neosporin, somewhat better; short course of antibiotic given;