chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored VAQTA (which had either a lot number of M003011 with expiration date of 15-NOV-2017 or a lot number reported as M021124 with an expiration date of 02-FEB-2018; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions.. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
A fib; Breast cancer; Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A fib) and BREAST CANCER (Breast cancer) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (A fib) (seriousness criterion medically significant), BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and CARDIAC DISORDER (Heart problem). At the time of the report, ATRIAL FIBRILLATION (A fib), BREAST CANCER (Breast cancer) and CARDIAC DISORDER (Heart problem) outcome was unknown.            No concomitant medication information was provided. It was reported that several patient had heart problems. breast cancer and a fib. No treatment medications were provided  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (medically significant) adverse event of special interest Atrial fibrillation and event of Breast cancer in the context of having received a dose of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine.  Onset latency could not be assessed as both the dates of vaccine administration and onset of events were not detailed. Treatment, clinical course, and pertinent investigations were not disclosed. Outcome of the events was noted to be unknown. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (medically significant) adverse event of special interest Atrial fibrillation and event of Breast cancer in the context of having received a dose of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine.  Onset latency could not be assessed as both the dates of vaccine administration and onset of events were not detailed. Treatment, clinical course, and pertinent investigations were not disclosed. Outcome of the events was noted to be unknown. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine is not affected by this report.
pt recv vax 18APR96 & 25APR96 pt exp hives on face & vesicles on back & fever;
Information has been received from a physician concerning an 8 yr old female who on 13Jul98 was vaccinated with a dose of varicella virus vaccine live (lot625372/0057H). On 16Jul05 the pt developed breakthrough varicella with about 10 lesion on the trunk. The pt was also diagnosed with having impetigo. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Pt describes waking the day after her Zoster shot with 3 rows of "blister-like itchy sores", one below left jaw bone, one above left jaw bone, and one row on left eye. Pt went to Dr. was treated with Valtrex. Sores were dried and gone in 2 weeks.
This spontaneous report as received from a registered nurse refers to a currently 5 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB, from lot # M047666, expiration date: 24-OCT-2019 for prophylaxis (dosing details were not reported). The administered dose of the vaccine underwent a temperature excursion of 32 degree Fahrenheit (F) to 35 degree F for 6 hours. No adverse effects were reported. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758.
Shot given 7:45 AM 1-12-14. Reaction to vaccine 10:30 PM 1-12-14. Swelling in throat and difficulty breathing took 25mg BENADRYL, took nebulizer Albuterol treatment every 4 hrs. along with BENADRYL 25mg every 4 hrs. 1-15-14 patient doing better.
Rheumatic fever; Migratory arthritis; Rheumatic heart disease; This is a spontaneous report received from contactable reporter (consumer). The reporter is the parent.  A 14-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 08Oct2021 16:30 (lot number: 30155BA) at the age of 14-years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (batch/lot number: 30130BA, administered in left arm at 14:30 as dose 1, single), administration date: 17Sep2021, when the patient was 14-years-old, for COVID-19 immunisation. The following information was reported: RHEUMATIC FEVER (medically significant) with onset 23Nov2021 06:00, outcome "recovering", described as "Rheumatic fever"; POLYARTHRITIS (medically significant) with onset 23Nov2021 06:00, outcome "recovering", described as "Migratory arthritis"; and RHEUMATIC HEART DISEASE (medically significant) with onset 23Nov2021 06:00, outcome "recovering", described as "Rheumatic heart disease." The events "rheumatic fever", "migratory arthritis" and "rheumatic heart disease" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rheumatic fever, polyarthritis, and rheumatic heart disease and included treatment with monthly penicillin shots and 400 mg ibuprofen. Clinical course: The patient has no known allergies. Prior to vaccination, she was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as other. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.
eyes are burning; buckets of sweating; loss of appetite; not able to cool down; temperature doesn't regulate; tight when deep breathing; migraines; feeling tired; Temp 100.3F; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired), MIGRAINE (migraines), PYREXIA (Temp 100.3F), MYALGIA (body aches) and EYE IRRITATION (eyes are burning) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ELETRIPTAN HYDROBROMIDE (RELPAX AXICORP) for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FATIGUE (feeling tired), MIGRAINE (migraines), PYREXIA (Temp 100.3F), MYALGIA (body aches), EYE IRRITATION (eyes are burning), HYPERHIDROSIS (buckets of sweating), DYSPNOEA (tight when deep breathing), DECREASED APPETITE (loss of appetite), FEELING HOT (not able to cool down) and TEMPERATURE REGULATION DISORDER (temperature doesn't regulate). At the time of the report, FATIGUE (feeling tired), MIGRAINE (migraines), PYREXIA (Temp 100.3F), MYALGIA (body aches), EYE IRRITATION (eyes are burning), HYPERHIDROSIS (buckets of sweating), DYSPNOEA (tight when deep breathing), DECREASED APPETITE (loss of appetite), FEELING HOT (not able to cool down) and TEMPERATURE REGULATION DISORDER (temperature doesn't regulate) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.
Itching at injection site, tingling at site. BPs 156/98 (pulse 126), 127/90 (pulse 92). Ice pack recommended for injection site.
The patient did not report any problem and there was none observed after the shot was given. He said he has had a flu shot last year. The next day however, the patient's mother called an informed us that her son had a reaction to the vaccine late in the night and later on was taken into the hospital. At the time of this report I do not have any additional information.
This spontaneous report was received from a certified medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, lot# and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
paresthesia in hands/arms, feet/legs: 8/20/21 - present slow reflexes
Vomiting 4-5 times around 6-7 hrs after immunizations. Also complained of headache and abdominal pain. No fever.
Evening of 6/23 pt whole body turned red, arms & legs had red spots. Pt had 101 fever - Mother gave child TYLENOL. Pt was taken to ER - temp there 99 - checked over; no labs taken; given DECADRON by mouth & to continue MOTRIN. Clinical impression rash/secondary to imm. FUP w/ PCP 7/1/09.
On the morning of 3/2/2021 I was 27 weeks pregnant and had to complete my glucose screening exam. I drank the entire bottle of glucose and had my blood drawn at 9AM. Around 2pm that same day I had intense pain in my upper right stomach. It lasted for about 2 hours, subsided, and then happened again around 8pm. Once the 2nd round of pain came on, I checked myself into Labor and Delivery to make sure everything was okay with the baby. They ran many tests and could not find an issue. They made me leave without resolving anything. The following day I called my doctor about what happened and she scheduled me to have an ultrasound looking at my gallbladder. The following week we found that I had gallstones so I met with a surgeon and he suggested I have surgery to get my gallbladder removed. I cannot do this until after I give birth. I was out of work for 5 days because of the pain. When talking to my doctor, she thinks the trigger of the gallbladder attack was the glucose drink and not the vaccine.
SOB; throat tightness; abdominal pain; This is a spontaneous report from a non-contactable other healthcare professional reported that a 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809), via intramuscular, administered in right arm on an unspecified date (Age at vaccination was 73 years) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date during his 15 minutes waiting period after the injection the patient began to experienced Shortness of breath (SOB), throat tightness and abdominal pain. No treatment included therapy, follow up response to treatment was excellent. Stable to go home and follow up with PCP. The report assessed as non serious. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No issue until 3 weeks later. Sudden pain in chest. Hurts if any pressure is applied. Worse when lay down or take deep breaths. Seems to be worse right behind sternum.
PT. received Flu vaccine 12/11/08 @ approx 1:45 p.m.- No adverse events noted @ the time of injection.  PT. denied hx of allergies and signed appropriate consent forms.  @ 2037 pt had visit to ER (copies included)
Right upper muscle weakness, which goes to right hand. Reviewed medical record. Please add bilateral arm pain and shoulder stiffness
Patient experienced a localized reaction the following day in his right arm which was red, painful lump.
Developed profuse ? type rash over trunk, extremities and face 11 days after MMR. No fever, cough, or ?
From initial info received on 6/7/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 58 year old male pt received a dose of Menactra, lot U1492AB and a dose of Havrix, lot AHAVB0543BA, administered on 6/2/05. The routes and sites of administration were unknown as per the reporter. The following day, on 6/3/05, the pt developed redness on his face, entire arms and legs. There was no itching and no fever reported. The duration of the redness was 2 days and the symptoms then disappeared. The pt recovered from the event.  Follow up report received on Sept 6, 2005 from a health care professional. It is reported that no previous doses of Havrix was given prior to the June 2m, 2005 injection. No laboratory testing was done. Information was reviewed by the responsible physician and no addiitonal information can be provided at this time. No further information is expected.
During the night I felt like I had a fever, chills and body aches.   And the next morning after I woke up needing to use the restroom, got up but started feeling dizzy and fainted for about 2minutes.  EMT was called and once they arrived I began vomiting and my BP was super low. During the transport to the hospital I vomited again and was given antinausea meds.  At the ER I was given IV fluids, chest xray, EKG and blood was drawn and I was released after a few hours of monitoring
0.5ml Moderna Covid-19 vaccine administered to patient as a booster shot after J & J instead of 0.25ml.
16jul90 pt vax hepta B. pt devel chest pain which persisted for 1-2 dys.
receiving an extra dose with no reported adverse event; Initial information received on 29-Jul-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Media Information (under the reference).  This case involved a 18 years old male patient who had an extra dose with no reported adverse event (extra dose administered) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 28-Jul-2021, the patient received a dose 3 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (o.5 ml, solution for injection, lot U6921AA and expiration date: 17-apr-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  On 28-JUL-2021 the patient developed a non-serious receiving an extra dose with no reported adverse event (extra dose administered) following the administration vaccine.   It was an actual medication error due to extra dose administered.  It was not reported if the patient received a corrective treatment for the event (receiving an extra dose with no reported adverse event).  No laboratory data reported.  At time of reporting, the outcome was Unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills and temperature on the same day but did not get the full effect until the next day with nausea and dry heaving with my whole body hurt and fatigue. This lasted for about 2 ½ days. I had a really bad swollen arm for 11 days with itching. Fatigue had set in and couldn't eat much. I sent an e-mail and didn't get a response back and sought other means by calling pharmacist. I started taking an antihistamine regimen as per suggested by pharmacist. When I saw the doctor they agreed to the regimen. I recovered completely but still have a hard nodule just below where I received the 2nd dose.
I had a terrible rash from the first vaccine.  I had a stroke following the second vaccine.   I could not control my legs, left side of face drooped, was admitted to the hospital for 2 days and administered anti-stroke drugs before being released.
excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Right arm on 06Feb2021 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2000 and ongoing Verbatim: Diabetes. Concomitant medications included metformin taken for diabetes mellitus from 2000 and ongoing insulin glargine (LANTUS) taken for diabetes mellitus from 2011 and ongoing. On Feb2021 the patient experienced numbness in hands, numbness in arms and on 24Feb2021 when she was in the kitchen she had excruciating cramps in her stomach. The patient would receive the second dose this Saturday. The clinical outcome of the events was not recovered except excruciating cramps in stomach was recovered on 24Feb2021.
With first vaccine c/o racing heart rate. 1340 - c/o racing heart; spb 115/69, p 87, rr 22, sats 98 1342 - 50 mg Benadryl given po 1345 - 136/74, 87, 20, 95% 1347 - fanning herself c/o hot flashes 1350 - walked with pt. states feeling better c/o hot flashes 1400 - c/o hot flashes 1405 - 131/69, 82, r 20, 98% 1420 - p 89 1450- 80
RECEIVED SMALLPOX AND ANTHRAX #3 IMMUNIZATIONS ON 21 MAR 2003. ON 23 MAR 2003 DEVELOPED RASH TO FACE, UE, TRUNK (ANTERIOR AND POSTERIOR) AND PROX THIGHS. EVAL BY ME 27 MAR 2003. HAD PAPULAR RASH IN HEAVY CONCENTRATION TO UE (SPARING PALMS), CHEST, BACK, ABDOMEN, PROX THIGHS, AND FACE WITH A FEW PUSTULES TO FOREHEAD. RASH WAS MOST CONCENTRATED ON FOREHEAD AND HANDS. RASH WAS EVAL BY DERM WHO FELT THIS COULD BE AN INCREASED IMMUNE RESPONSE TO THE SMALLPOX VACCINATION. IN APPEARANCE THE RASH WAS SOMEWHAT SIMILAR TO ATOPIC DERM (HEAVY CONCENTRATION OF PAPULES) AS WELL AS ID REACTION AS IT AFFECTED SIDES OF FINGERS/DORSAL HANDS IN INCREASED CONCENTRATION. MILDLY PRURITIC (PRIMARILY WITH SWEATING). NO SYSTEMIC C/O. NO HX OF ATOPIC DERMATITIS. + HX OF PSEUDOFOLLICULITIS BARBAE, CURRENTLY NOT ON MEDS AND IS ON A NO-SHAVE CHIT.
pt recv vax & next day pt mom reported daughter was crying & had a fever of 103.3 & had an inj site rxn characterized by pain & warmth;the pain caused the child to limp;pt irritable & photophobic;inj site red w/red streak to thigh;
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included 3 previous full-term pregnancies. On 21 May 2014, the subject received an unspecified dose of BOOSTRIX (intramuscular, administration site unknown). The last menstrual period was on 3 September 2013 and estimated date of delivery was on 23 June 2014. The subject was exposed to the vaccine during 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 09 July 2014: The pregnancy was not the result of a in-vitro fertilization. The subject was vaccinated when she was 35+2 weeks pregnant. The stop date provided on the source document was different than start date of vaccination. As the date provided was very close to the estimated date of delivery, it could correspond to the delivery date. Clarification has been requested. Follow-up information received on 05 August 2014:  Some of the subject's details were changed. The VAERS info were provided. Follow-up information received on 23 September 2014 from physician: On 28 Jun 2014, after 37 weeks gestation, the subject gave birth to a male live infant, by normal vaginal delivery. The infant had an Apgar score of [8-9], a weight of 4.207 kg.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 05-OCT-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On 06-OCT-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified date in October 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
Adelynn tensed up her legs and began to frown as I was cleaning her thigh with alcohol . After the first injection, she began to scream and cry. I injected the other two and applied band aids. As her mother was comforting her, she began to gag and expelled sme mucus, then threw up. The vomit was thick and a creamy color, with some chunks of fruit (oranges) in it. There was also clear mucus. She threw up twice more over the next five minutes.  She calmed down and stopped crying for about five minutes, then started crying again. Her father took her out of the room. When he returned with her 20 minutes later, he said she had stopped crying almost immediately and was fine. I observed her walking, talking, and not in any apparent distress. Her mother said she had not ever thrown up after previous vaccinations, but that at home she sometimes gets herself worked up when she is upset and does throw up.
Patient received smallpox vaccination on 01 Mar 2013. Adverse reaction occurred with wife on 01 Mar 13 on left eye lid. (accidental inoculation).
1-2 hours after injection pt had redness and hives around injection site. As the day progressed, she was at work, she became more SOB she also felt her heart was beating fast. She went to ER around 8:30pm and was seen. She was treated with Albuterol 2.5mg/0.5ml neb, 80mg Dexamethasone IV, BENADRYL 50mg IM, Ipratropium 0.5mg/2.5 ml neb.