chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Negative serology testing for Hep A and Hep B; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included risankizumab (Skyrizi).   On an unknown date, the patient received Twinrix. On an unknown date, more than 2 years after receiving Twinrix, the patient experienced therapy non-responder (Verbatim: Negative serology testing for Hep A and Hep B). The outcome of the therapy non-responder 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: 20-OCT-2023 The retired physician noted that his wife completed the Twinrix series about 8 to 10 years ago. His wife was currently taking Skyrizi and recent serology testing for Hep A and Hep B came back negative so she had been given an extra dose of the Twinrix. The reporter consented to follow up via email, not postal mail. No further details provided at time of call.
the above patient received the above 2 shots but these were intended were a different patient apparently sitting in the waiting room.  The above patient was here to get her 2nd pfizer shot but received a half dose of Moderna  and a high dose flu shot instead.  The mistake was realized while the patient was here and didn't seem upset.  After filing discrepancy with my company, I was contacted and told to tell patient to still comeback and get a 2nd Pfizer shot.  Upon leaving her a voicemail about a week ago, no contact has been made and patient has not comeback.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with VAQTA (lot # L045713 with expiration date 14-JAN-2017, strength, dose and route were unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
Feeling groggy; Really tired; Achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy). At the time of the report, SOMNOLENCE (Feeling groggy), FATIGUE (Really tired) and MYALGIA (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Treatment medications were not provided by the reporter.
Patient is a 66 year old female who presents with redness and pain left upper arm at site of SHINGRIX vaccine, received 2d ago. Redness started within 30 min. of receiving it. She marked it yesterday and it expanded about 5mm outside that area today. Took a dose of ibuprofen 200mg and it did help. No itching. Had left side body tingling immediately after vaccine, lasted 15 min. and resolved. Otherwise feels well. No fever, chills, H/A, dizziness, body aches, CP, dyspnea, arthralgias, N/V.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012717 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
A few hours after injection, I began having discomfort in my left shoulder, the location of the injection.  Over the following next few hours I began to have overall body aches and pains in my joints.  My skin became extremely sensitive to the touch, a very strange hard to describe sensation.  I then began to get the chills, and running a fever.  Ultimately my fever spiked at 104 degrees.   I took a cold bath to bring the fever down, and for the rest of the night seesawed back and forth with fever using cold compresses and no sheets on my bed to keep my fever down.  I also took one 200 Mg Ib-Profen.  At roughly 26 hours after the injection, I no longer have a fever, but the body aches persist.
Information has been received from a medical assistant referring to an unspecific number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered improperly stored doses of PROQUAD (Merck) (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the 3 reports by the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild.
Brought to the ER as a code blue, 50 minutes down. CBC, CMP, and HIV screen completed. Deceased despite attempts of revival. Wife reports patient reported not feeling well, c/o feeling short of breath, started having foaming at the mouth, loss consciousness. He had pink sputum on arrival.
WAS GIVEN FLU SHOT & PNEUMOCOCCAL VACCINE AT A CLINIC STAFFED BY STUDENT NURSES.  VACCINES WERE GIVEN IN THE SAME ARM.  THE NEXT DAY THE ARM WAS SWOLLEN, RED & HOT TO THE TOUCH.  2ND DAY PATIENT COMPLAINED OF FEELING VERY ILL - LETHARGIC, FEVER, MALAISE.  BY DAY 3, THE PATIENT HAD FULLY RECOVERED
product storage error; This spontaneous report was received from a physician regarding to a patient of unknown age and gender.    Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot # T021302, expiration date 19-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not provided).  The improperly stored suspect vaccine experienced a temperature of -5 degree Celsius (°C) for 20 hours with no previous temperature excursion.   The call was made due to a digital data logger.
Left red, swollen, inflamed warm, itchy. Rxn 10x8 15cm. Pt will f/u.
This spontaneous report as received from clinical medical assistant refers to a patient of unknown age and gender. On 16-JAN-2014 the patient was vaccinated with VARIVAX (SDV, MDV OR ADDITIVE) (EA), lot # J003539 and 25-MAR-2015 (strength, dose and dose number was unknown) subcutaneously. On 16-JAN-2014, reconstituted VARIVAX was exposed to 42 F for 25 hours before being given to patient. No known adverse effects. The outcome of the exposed to 42F for 25 and no adverse event was unknown. No further information provided. Additional information has been requested.
Rash on L arm covering about 3sq." that is feverish and painful to the touch.
Client received 1st COVID vaccine of Pfizer (Lot# EW0182, expiration 06/28/2021). At 1653, Client states that she is dizzy and has "hot flashes". At 1654, RN, RN, and RN responded to this event and transferred Client to the anti-gravity chair. At 1654, RN and PHN responded and began assessment. At 1654, vital signs are blood pressure is 180/100, heart rate 74, oxygen saturation 99%. Client reports the dizziness and hot flashes resolved in seconds. Client reports being recently diagnosed with hypertension two months ago, but is not on medication. Client states "I refuse to take medication". At 1656, blood pressure was rechecked on opposite arm and is 182/104. At 1657, blood pressure is 182/110. At 1701, PHN and RN educate Client on hypertension, ED precautions, and common adverse effects of the COVID vaccine. At this time, PHN offers Client emergency services, but Client declines. PHN and RN advises Client to follow up with primary care provider. At 1710, vital signs are blood pressure 182/102, heart rate 75, oxygen saturation 98%. At 1711, Client stood up with no complains and with resolved symptoms. Client left against medical advise to stay in observation for an addition 30 minutes. Client walked out of facility with a steady gait at 1711, and states "I will make an appointment with my provider tomorrow".
This spontaneous report as received from a medical assistant refers to six patients of unknown age and gender. The patient's medical histories, concurrent condirions and concomitant medications were not reported. On unknown dates six patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route of adminsitration, lot number were not reported). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient became extremely dizzy 7 to 8 hours after the vaccine. He fell down and hit his head after 10 hours. He slept and woke up feeling dizzy. Then later on that day, the dizziness went away and he was fine.
Sleepy; Aches; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (Sleepy), MYALGIA (Aches) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced SOMNOLENCE (Sleepy), MYALGIA (Aches) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleepy), MYALGIA (Aches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Local tenderness at vaccination site (left deltoid) developed 7 days after vaccine. She developed red, raised, warm area 8 days after the vaccination. Symptoms resolved within 3 days
Pain at sight of injection (thigh), increasing fever (101), and abnormal onset of fatigue and lethargy.
Patient waited the mandatory 15 minutes and felt fine.  Left for a few minutes and then came back in to the vaccine clinic with symptoms of lips tingling and possible her tongue swelling.  She was given 50mg of PO Benadryl (Diphenhydramine) and was taken to the emergency department.  Patient was monitored for 4 hours in the emergency department with no additional symptoms noted.  Spoke with patient this morning, was still having some tingling of the lips but was being controlled with Benadryl.  No problems breathing or swallowing
Headache- intense Flu-like symptoms w/ fever- coughing- nasal congestion- ending in a visit to ER.  Lung, blood and urine samples seemed o.k. Came home and had  temp for over a week (low grade) still had cough-
Patient started to experience body ache, chills and fever at midnight on 07/03/19 and then at 5 am she woke up with upper body (neck, arms, torso, back) covered in hives. She started taking Benadryl and under this medication the rash went away only on 07/06/19.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Jan-2022 at 11:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 11:11 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as booster dose.  The patient received vaccine past its 30-day expiry date on 31-Jan-2022 at 11:11 AM.  Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment information was not provided.
Hypotonic Hyporesponsive Episode -  2 x episodes of loss of consciousness with inability to arouse.
Sore arm at injection site on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site on left arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    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 VACCINATION SITE PAIN (Sore arm at injection site on left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The treatment information was not provided.  The patient enquired about the immunity time period of the vaccine and also about any tests she can take to test the immunity.
Heart palpitations, fluttering, extreme fatigue, elevated BP, heart rate jumping to 200bpm
I received the vaccine Apr2021 and then diagnosed with autoimmune disease Jul2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset Jul2021, outcome "unknown", described as "I received the vaccine Apr2021 and then diagnosed with autoimmune disease Jul2021". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered vaccine to 15 year old unknowingly, patient reported passing out two days following the vaccination. Patient got the vaccine on Friday and reports loss of hearing and vision blacking out the Sunday after getting the vaccine. After questioning, the patient said she had very little to eat the day before passing out and nothing the day she passed out. After drinking a soda, her blood sugar was found to be 100 so EMT assumed she passed out due to low blood sugar unrelated to vaccination. No other further adverse events/symptoms
On that day I woke up with hearing loss in my right ear, feeling of fullness and pulsatile tinnitus.   I was seen by my Primary doctors office and given Amoxicillen for  days with a Medrol dose pak.  After 5 days this did not improve and was seen by ENT.  Audiology testing was done and I was diagnosed with Sudden Sensorineural Hearing Loss of my right ear of moderate degree.   MRI testing was done on 3/12/2021 and revealed no reason for these symptoms.   Prednisone 30 mg was taken for 7 days tapering to 20 mg for 3  days and then to  10 mg for 3 days.   Follow up is on April 6 to ENT.   Hearing may not return and pulsatile tinnitus may remain.
testosterone plummeted; They said his testosterone plummeted and had no B12; right hand is swollen severely and could barely make a fist.; suspected carpa tunnel.; he has been very sick with his joints, severely hurting, not able to get out of bed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12), PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.), CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 prophylaxis.     The patient had no known allergies and no covid diagnose.  Concurrent medical conditions included Blood pressure high (since teenager).    On 13-Sep-2022, 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. In February 2023, the patient experienced ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12), PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.), CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed). At the time of the report, ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed) had not resolved and PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.) and CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2023, Blood testosterone: plummeted. In February 2023, Vitamin B12: no B12 in blood.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The last dose was given at store to the patient.  No concomitant medications were reported.  The patient received two times booster vaccine.  The doctor started him on testosterone and B12 injections. They were 12 weeks in. Caller reports her husband's right hand is swollen severely and could barely make a fist. They went to an orthopedic doctor and suspected carpatunnel. Now his joints were extremely painful and they did not know if it was an autoimmune disorder. Today the patient was suppose to get his fourth testosterone injection. Doctor told him not to get anymore covid vaccines.
This spontaneous report as received from an other health professional refers to a 72 year old patient of unknown gender. The patient was vaccinated with PNEUMOVAX 23 injection, 25/.025 Y (dose, route and lot@ were unknown) on 08-OCT-2014 and 29-OCT-2014 respectively. No adverse symptoms reported. Additional information has been requested.
AFTER FLU SHOT WAS GIVEN PATIENTS REPORTS NERVE PAIN IN HIS ARM AND OVER THE WEEKEND THE NERVE PAIN TRAVELED TO HIS LOWER LEGS AND FEET. HE ALSO REPORTED NIGHT SWEATS FOR TWO NIGHTS.
chest pain, shortness of breath, tremors, abdominal pain, back pain, vomiting.
This spontaneous report as received from a licensed practical nurse refers to a 19 month old patient. On 17-APR-2018, the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB(route unknown by reporter) lot # N034006 expiry date 01-FEB-2020 for prophylaxis (Product storage error). Temperature was reported as 9°C to 25°C. Time frame was reported as 1 hour and 15 minutes. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved.This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1804USA010519: US-009507513-1804USA010520.
Pt fainted after Hep B vax. Ammonia was used to revive her, and she had a seizure. Pt was lowered to the floor and had a second seizure. Her pulse was 40, and her skin was pale. Pt revived after her feet were elevated. She recovered well after about 60 seconds.
Patient fainted after vaccination near front of store. Hit arm on fixture and was bleeding. We bandaged the patient.
itchiness; Hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jul2021 10:30 (Lot number: EW0186) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no known allergies and other medical history. There were no concomitant medications.  The following information was reported: PRURITUS (non-serious) with onset 23Jul2021 22:00, outcome "not recovered", described as "itchiness"; ALOPECIA (non-serious) with onset 23Jul2021 22:00, outcome "not recovered", described as "Hair loss". The events "itchiness" and "hair loss" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, alopecia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date in 2014 (reported as after 24-NOV-2014), the patients were vaccinated with doses of improperly stored GARDASIL (lot#, expiry date, dose, frequency unspecified). No adverse events were reported. No PQC involved. This is one of several reports received from same source. Additional information has been requested.