chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received one dose of ROTATEQ following temperature excursions; no adverse event; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No information was provided regarding to the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date, the patient was vaccinated with one improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016790, orally, expiration date 20-APR-2019, for prophylaxis.  The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature excursion below 36° Fahrenheit / 2° Celsius, during a time frame of 3 hours and 1 minute, which was detected by the data logger. There was a previous temperature excursion of below 36° Fahrenheit/2° Celsius (33.8° Fahrenheit) for 29 hours and 38 minutes. No adverse effects were reported.
Vomiting Thurs. night Temp 105 Friday with HA dizziness Temp lasting till seen Tuesday - 100.1 in clinic.
Following my first injection (Pfizer 301308A), I was lightheaded, disoriented, and nauseous. The following two days I ran a fever of over 103. I lost three days of work. Upon my return to work, I was extremely tired and fatigued all the time.  Following my second dose, I began to feel ill that evening. I had a fever the next day, 102-103 degrees, and began to experience sharp chest pains. I felt as though someone was stabbing me through my heart. My chest also felt very tight and I could feel my heart pounding and pulsing throughout my body.   I eventually went to see a Doctor who suspected an adverse reaction to the vaccine but was not permitted to provide me any documentation that my problems were caused by the vaccine based on the instructions they were given. EKG was normal, but my labs were off. The doctor informed me that all my symptoms were indicating pericarditis.   I lost four days of work due to the second vaccine, continued to struggle with extreme fatigue, and my heart rate would jump to 140-150 walking down a flat, short hallway. I also continued to get sharp, stabbing pains in my chest, shortness of breath, and alerts for elevated heart rate while at rest for over ten minutes.   It is now over 14 months later, I still get the spiking heart rate, high heart rate alerts while at rest (even sleep), sharp pains, and tightness in my chest.
3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity to light,  oral sore spots, ( but not open sores ) and a flushed face.  There was no fever.    I took Tylenol for the aches and stayed restful, napping during the day .  By 03/06/21 I felt fine.
office intentionally administered Fluzone HD QIV to this patient because the patient was so close to being 65 with no reported adverse event; Initial information received from on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old female patient who had experienced office intentionally administered fluzone hd qiv to this patient because the patient was so close to being 65 with no reported adverse event while receiving influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received a unknown dose of suspect  influenza quadrival a-b high dose hv vaccine  (strength, frequency,expiration date, route and batch number: unknown) at unknown administration site for Immunization.   On an unknown date the patient developed a non-serious office intentionally administered fluzone hd qiv to this patient because the patient was so close to being 65 with no reported adverse event (off label use) (same day latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of the events  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
pt recvd 2 doses of vax & the day p/2nd dose exp nausea & weakness in arms; pt was seen by MD; sx subsided; pt recvd 1 prev dose of Engerix-B;
shingles, within 2 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles shot and within 2 weeks experienced shingles. The patient said he/she did not want anymore shots. The follow up could not be possible as no contact details were reported.
Patient was diagnosed with covid 19 on 12/28/2020, and received monoclonal antibody infusion on 1/11/2021. Patient had marked yes on questionnaire that she had received monoclonal antibody infusion within 90 days and patient was accidently still given the Modena vaccine on 1/16/2021. Patient was seen by our on call provider, who discussed with patient what had happened and reassured patient that no significant reaction was expected. Doctor discussed with another provider about vaccine series and timeframe. The patient will defer second dose till after 4/11/2021.
Swelling on left arm 10 days after vaccination. Warm, red swelling, spread over next day. Swollen lymph nodes in throat, nausea, headache. Reaction still continuing.  Had mild reaction on day 2 with fatigue, nausea. Felt fine until day 10.
hives all over the body that lasted for 2 to 3 weeks; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (hives all over the body that lasted for 2 to 3 weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives all over the body that lasted for 2 to 3 weeks). At the time of the report, URTICARIA (hives all over the body that lasted for 2 to 3 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was reported that the patient had hives all over the body that lasted for 2 to 3 weeks and eventually completely went away.  No treatment medication information was reported.   Novavax Reference ID was 2022NVX-US-000004257.
Pt exp a large area of erythema & induration @ inject site p/receiving Td;
on/off chills; Patient woke up around 8am with a pounding headache; Had two spoonful of grits and vomited.; He was freezing cold all night; He could not sleep; This is a spontaneous report from a contactable pharmacist. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included hemophilia A. The patient had no known allergies to medications, food or other products. Concomitant medications included emicizumab (HEMLIBRA) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 18Mar2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, the patient could not sleep because he was freezing cold all night. Temp was normal. On 09Apr2021 around 08:00, the patient woke up with pounding headache, the patient had two spoonful of grits and vomited. On 09Apr2021, as of 17:30, the patient was complaining of pounding headache and on/off chills. Therapeutic measures were taken as a result of reported events which included treatment with paracetamol (TYLENOL) on 09Apr2021 at 08:30. The clinical outcome of freezing cold all night, could not sleep, pounding headache, vomited and on/off chills was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt was in usual state of health and received her COVID pfizer booster on 11/20/21. At 8pm that night she had sudden onset vision change and dizziness. She thought it was her sinuses and went to a walk in clinic the next morning where was sent to the ER and diagnosed with acute infarction of the midbrain.
SORE ARM; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimotos disease, and high cholesterol, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A) 1 total, administered on 11-APR-2021 to right deltoid for prophylactic vaccination.  Concomitant medications included levothyroxine sodium for hashimotos disease.  On 17-APR-2021 one week after vaccination patient's blood pressure was elevated. On 18-APR-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 155/90. On 20-APR-2021, the patient was taken to emergency room for high blood pressure of 208/153. Patient was continuously monitoring her blood pressure. Laboratory data included: Blood pressure (NR: not provided) 135/88, 208/153, CBC (complete blood count) (NR: not provided) Normal, CT (computed tomography) scan (NR: not provided) Normal, and EKG (electrocardiography ) (NR: not provided) Normal. On an unspecified date, the patient experienced sore arm. Laboratory data (dates unspecified) included: Stress test (NR: not provided) Normal.  On 21-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 180/110.  Treatment medications (dates unspecified) included: clonidine, losartan, and amlodipine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure, and sore arm. This report was serious (Other Medically Important Condition).  Additional information was received via on 11-MAY-2021. The following information was updated and incorporated into the case narrative: Laboratory data was updated.; Sender's Comments: V0. 20210518309-COVID-19 VACCINE AD26.COV2.S-ELEVATED BLOOD PRESSURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY -  hashimoto's disease, high cholesterol
shoulder is hurting; fever of 100.8F; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder is hurting), PYREXIA (fever of 100.8F) and CHILLS (CHILLS) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Supplementation therapy.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ARTHRALGIA (shoulder is hurting), PYREXIA (fever of 100.8F) and CHILLS (CHILLS). At the time of the report, ARTHRALGIA (shoulder is hurting), PYREXIA (fever of 100.8F) and CHILLS (CHILLS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.8 (High) 100.8F.         Treatment was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I am a breastfeeding mother. I got my second Covid vaccine on Wednesday in my left arm. Within 24 hours I experienced very tender left axillary lymphadenopathy. Within 48 hours I experienced the worst clogged breast ducts of my entire life in my left breast (extensive, almost 50% of my breast, exquisitely painful). In my breastfeeding doctor group many docs are writing that they are seeing this too. Please consider recommending nursing mamas get vaccine in their thigh.
Patient developed significant rash on same arm as injection site. Patient was told to contact her provider and was seen by primary physician. MD said it was bad local reaction.
fatigue, chills, body aches, brain fog, difficulty concentrating, chest pains, earlier menstruation, pain at injection site into arm, back and chest. Sought treatment due to chest pains.
The patient had a localized reaction.  Bilateral legs with inflammation at the injection sites.  Left leg with increased erythema 3-4 cm a Prevnar injection site.  Treatment: ice and tylenol - mother is aware swelling will decrease.
Tuesday (day of vaccine) 8:30 pm -headache (rate it a 6/10) 9pm- chills shower and heating pad 10:30pm Took a Cold Plus tablet 11pm began warming up but still a headache Arm is very sore  Wednesday 1:30 am diarrhea vomiting and disoriented (fell off of toilet) can't sleep chills and body aches 7am- Tylenol headache (8 out of 10) 10 am soup and crackers Tylenol and shower 1pm headache (2 out of 10) congested washed sheets and made the bed  Thursday Headache (1 out of 10) neck hurts got up to sweep floor 1:30 pm Tylenol Eyes hurt
Herpes outbreak, cold sore & genital.  Still have outbreak as of  3/22.   I don't have a doctor, so I notified the clinic, made an appt. for 3/30/21.  Couldn't get an earlier appointment.
No adverse reactions noted at this time. Pt did not know she was pregnant the time she received the vaccine.
I had a mild drainage runny nose situation. I also had sinus pressure which led to headache. I also had body aches for 2 days but no fever. I had a general feeling of malaise. I took a COVID-19 Home test  on August 24, 2022 and it was negative. I still had symptoms on the 25th and it was positive. I contacted my physician and he indicated that I should take Tylenol. He prescribed Paxlovid but I did not take it due to the interaction with my other medication. It took about 3 days to recover and it took another week to get a negative. I went to the office on September 1st and had a blood panel drawn and it was normal.
Three days following first dose I had a rash on upper right buttock that lasted three weeks, and muscle twitching began 3 days after first dose, continues daily still. I informed the School Nurse at the school I am employed with, she told me to contact my PCP, he looked at rash, he noticed the muscles twitching, he did extensive blood work.
LEFT ARM  SWOLLEN; LEFT ARM HURTS; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes mellitus, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1865031 expiry: 20-MAR-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left arm swollen. On 13-MAR-2021, the subject experienced left arm hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm swollen, and left arm hurts. This report was non-serious.
Breakthrough case admission after 3 vaccines Moderna 2/16/21 Lot# 013M20A;  MOderna 3/16/21 Lot# 030A21A;  Moderna 11/4/21 lot# 033F21A
Twinrix was administered on September 23rd 2023 and had expired on September 22nd; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 23-SEP-2023, the patient received Twinrix. On 23-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix was administered on September 23rd 2023 and had expired on September 22nd). The outcome of the expired vaccine used was unknown.   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: 25-SEP-2023 The reporter was a pharmacy technician. The reporter wanted to know was the dose valid. The vaccine administration facility was the same as primary reporter. The pharmacist reported the administration of expired Twinrix vaccine to patient, which led to expired vaccine used. The reporter did not consent to follow up.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was in observation area and fainted while seated in chair. Patient recovered and stated that she forgot to inform us that sh faints after injections or drawing blood.. Patient stated she was afraid of needles.  EMSwas called  Patient left with husband before EMS arrived.
Severe pain in arm.  Limited movement. Difficulty raising sideways after 3 days.  Greenish streaks down arm (veins?).
Flu vaccine may be ineffective due to temperature excursion with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient who stated flu vaccine may be ineffective due to temperature excursion with no reported adverse event while receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient had no medical history, concomitant disease or risk factor. The patient's medical treatment(s) and family history were not provided.  On 17-Oct-2022, the patient received an unknown dose of suspect  influenza quadrival A-B vaccine (Suspension for injection) (lot: UT7680NA) (expiry date, strength, frequency was unknown) via intramuscular route in an unknown administration site for prophylactic vaccination.  On 17-Oct-2022 the patient had a non-serious event flu vaccine may be ineffective due to temperature excursion with no reported adverse event (product storage error) (latency: same day) following the administration of influenza quadrival A-B vaccine.   Action taken: not applicable.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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.
2JAN97 exp sore throat, earache, fever 101-broke out in 5-6 small chicken pox;