chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact; 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.
73 y/o male with c/o developing fever after receiving Td shot. States he has had Td in the past with no ill effects. This patient received Tetanus Toxoid at 11:27am. At around 14:10, patient went back to clinic c/o uncontrollable chills and vomit x2. Prochlorperazine 5 mg once, ranitidine 50 mg once, acetaminophen 1300 mg once.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-AUG-2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 31-OCT-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
By 1700 "feels really bad" c/o sore throat, difficulty swallowing, flu like symptoms, body aches, chills and nausea. Taken to ED and given Epinephrine sq, benadry and ibuprofen.
chest pains; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9263), via an unspecified route of administration in the left arm on 14Feb2021 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included piroxicam (PAXIL). The patient was not pregnant at the time of vaccination. The patient had not had COVID-19 prior to vaccination. The patient had no known allergies. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 24Jan2021 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. On 14Feb2021 22:00, after the second vaccine, the patient began having chest pains, which she had never experienced before. The pain has lasted, and she was now being checked by a cardiologist. Treatment was received for the event. The patient had a chest X-ray and EKG on an unspecified date. The outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information about lot number has been requested.
Information has been received from a 63 year old female registered nurse with drug hypersensitivity to CECLOR, high cholesterol and osteoporosis who on 17-SEP-2008 was vaccinated with a first dose of PNEUMOVAX. Concomitant therapy included BONIVA and CRESTOR. On 18-SEP-2008, the patient experienced a local site reaction after she received what her physician told her was PNEUMOVAX. However, she got a red vaccine instead of a clear, colorless solution, so she suspects it was not PNEUMOVAX. She was concerned since her husband is immunocompromised and she dose not want to pass anything to him. Follow-up information from the consumer. She spoke with the physician's office and they confirmed that she received PNEUMOVAX. They informed her that the hub of the needles are red. The injection site reaction with redness, warmth and swelling at the injection site started on 18-SEP-2008. At the time of this report, the patient had not recovered. No product quality complaint was involved. Follow-up information was received from the patient. Administering physician's name was provided. Follow up information was received from a health professional at the physician's office. The patient had no illness at the time of being vaccinated. It was reported the patient was vaccinated intramuscularly 0.5 mL on 18-SEP-2008 at 11:00 am (previously reported as 17-SEP-2008) with PNEUMOVAX (lot # 659487/1960U). At 11:03 am on 18-SEP-2008, the patient experienced an injection site reaction with redness and swelling. The reporter offered the patient to come if worse, but the patient did not call back. On unknown date, the patient recovered. No further information was available.
Redness, swelling, a knot at the site of the injection.  4-5 cm bullseye.
completed series, developed shingles/ Suspected vaccination failure; shingles rash on ear; pain radiating to side of head; Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on back).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On an unknown date, between 5 and 7 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), radiating pain and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, radiating pain and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, radiating pain and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: This case was self-reported by the patient.  The patient had completed two doses of Shingrix series about six to twelve months ago from reporting. The patient received 2nd dose of Shingrix on arm. About five or six months after completing the series the patient developed a shingles rash on his ear that was recovered. The patient also had pain radiating to the side of head at that time that was recovered. After recovering, the patient again developed pain and shingles rash on ear that was recovered.  The dermatologist saw and diagnosed shingles.  The patient had nothing else to report.  This report consented to follow up.  Additional Supportive Information: This case was considered as vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.
VERY painful headache  about 7 days after vaccination that will not go away. I have been taking 350mg Aspirin every 6 hrs to make the headache bearable. Shortness of breath started today.
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICANTION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Pt presented to the ED with complaints of a non-productive cough and shortness of breath for the last few days. She has been out of her inhalers and therefore has not been able to use them. The patient states it is hard for her to differentiate a COPD versus CHF exacerbation. She has been taking her Lasix daily as prescribed. The patient does not weight herself reguarly, but denies recent weight gain and her clothes feel the same. She denies leg swelling. The patient denies fever and chills. She denies congestion. The patient has intermittent chest pain that is not abnormal for her and occasionally takes Nitroglycerin for her chest pain. Cardio consulted. 11/16 BC sent 11/17 repeat COVID came back positive, she was started on decadron and Tessalon pearls.   Pt was seen and is not in apparent distress sometimes decline meds. Denies any current CP with intermittent exertional SOB. She was discharged in stable condition on 11/27/2021
approx 15 minutes after receiving shot pt became very dizzy with severe headache. pt reports inability to drive since, and iattempted to go to work but was sent home due to inability to perform normal tasks at work. pt reports unable to get up from lying or sitting with out significant help, an once standing she is so dizzy she must instantly sit back down
went unconscious for 2.5 days; deaf in one ear; vomiting; permanent nerve damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization, reaction(s): "spells of dizziness after the first dose". The following information was reported: After two weeks of second dose of vaccination, VOMITING (non-serious), outcome "unknown", described as "vomiting"; and then LOSS OF CONSCIOUSNESS (medically significant), outcome "recovered", described as "went unconscious for 2.5 days". When patient woke DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "deaf in one ear". The doctor informed that, the patient had NERVE INJURY (non-serious), outcome "unknown", described as "permanent nerve damage". The events "vomiting", "went unconscious for 2.5 days", "deaf in one ear" and "permanent nerve damage" were evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On January 23, 2021 was experiencing abdominal pain took ibuprofen because she thought it was menstrual pain  went outside to play in the snow she fell and hurt her leg and she woke up the next day and the abdominal pain got worse went to urgent care doctor did a physical exam and the doctor told her she needed to go to the emergency room. She went to ER the next day they ran some test saw that her appendix was ruptured and did surgery the next three hours after they got the test results.
Area around vaccine site is inflamed and red. Nursing is monitoring for increase on size, warmth, fever.
Patient had a grand mal seizure hours after receiving the second dose of the vaccine. Patient had tried to get medically exempt after the first vaccine due to exhibiting pre-seizure symptoms (staring spells, lethargy, jerks of extremities, dazed feeling) but her neurologist refused the exemption.
(L) deltoid area was swollen, hot to touch and painful. MD prescribed antibiotics for cellulitis.
Fever (103), shaking, chills, rash, photophobia. All resolved with Motrin in 24 hours.
Light headed, stomachache, nausea. Vaccine given 7:50AM and symptoms reported at 10:30 AM. Employer to return him to clinic if treatment desired.
neurologic reaction; weakness; numbness; paresthesia; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurologic reaction), ASTHENIA (weakness), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurologic reaction), ASTHENIA (weakness), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and MYALGIA (muscle pain). At the time of the report, NEUROLOGICAL SYMPTOM (neurologic reaction), ASTHENIA (weakness), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
10/15/2022 Swelling of left neck and left axillia. Faint light red rash above left clavicle. 10/16/2022 Rash resolved, swelling improved 10/17/2022 continued improvement
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Rt deltoid swollen almost to elbow swelling in arm pit and chest. All areas are red and warm to touch.
Chest Pain SOB Feeling hot 30 min- numbness to mouth Tingling to hands/fingers  Rest and recovered.
Mild nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received Shingrix. On 3rd July 2019, 2 days after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix immunization and experienced mild nausea. The patient asked how long the side effect would last.
Headache; Really tired; Sore arm; Maternal exposure; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure), HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2-3 drinks/week) in November 2004. Concurrent medical conditions included Sulfonamide allergy, Melanoma in January 2017 and Hashimoto's thyroiditis since April 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, LEVOTHYROXINE for Thyroid disorder NOS, PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Aug-2020 and the estimated date of delivery was 20-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure). On 06-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Really tired) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, Pregnancy test: positive (Positive) Positive. On 21-Dec-2020, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception reported was 25-Aug-2020.  Previous pregnancy was reported as live full term birth as outcome on 26-Feb-2019. No treatment information was reported.; Sender's Comments: .
Experinced runs diarrhea after second dose.; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Experinced runs diarrhea after second dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Experinced runs diarrhea after second dose.). At the time of the report, DIARRHOEA (Experinced runs diarrhea after second dose.) outcome was unknown.            Concomitant and treatment information provided.   Reporter did not allow further contact
No additional AE; patient received only 2 of 3 doses in 2017. Nurse called in today because she learned of administration of third/final dose of GARDASIL 9 on 3/20/2023.; This spontaneous report as received from an other health professional refers to a patient of unknown age and gender. No information on patient medical history, current condition and concomitant medication was provided.  In 2017, patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 20-MAR-2023 the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route of administration, lot# and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).
pt recv vax 20OCT95 & MAY96 pt devel 20 to 30 papular lesions;
became febrile, not on room air. So she was tested for COVID, which was positive on 6/16.
L deltoid pain. No localized reaction other than pain. Self treated with Motrin. Dizziness & Nausea, worse in AM, diminishing throughout the day.
Patient's spouse stopped by the pharmacy in the morning one day following the vaccination. He reported that patient developed one hive on the back of her neck that they had noticed in the morning. No other hives reported at this time. Recommended for her to take some BENADRYL, 25 to 50mg 4 times a day or ZYRTEC 5mg twice daily. Also instructed not to rub the hive and to not apply any pressure or heat to the hive as this can sometimes potentiate the reaction and make it even worse. Also instructed them to keep a close eye on it and take pictures of the area a couple times a day to make sure it is not getting worse and if so to call the primary doctor right away.
No known adverse events. Pt received Novartis brand of influenza vaccine - Novartis is recommended for children ages 4 yrs & above.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 12-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006949: US-009507513-1903USA006950.
Pt recv vax on 10/26/98; on 10/30/98 pt exp autoimmune rx of sore throat, fever, stomach pain, joint pain, blood in urine; serum sick;
Received vaccine at about 11:00am.  At 6:00pm,  I began getting hoarse which cleared up about 12:30 or sometime after midnight.
exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 Nurse reported that patient was administered with Havrix vaccine. On 15Jun2023 vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit. The reporter was not sure on which date vaccine was administered. According to reporter it was administered between 15Jun2023 and 21Jun2023. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The patient was administered with vaccine, which was stored at low temperature which led to, Incorrect storage of drug. The reporter consented to follow up. This is 1 of 8 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2023105926:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105927:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105917:same reporter