chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information provided by facility director.  Resident told medical provider on 3/3/21 at routine visit that he had not felt right since receiving vaccine on 2/11/21. No specific complaints and no findings reported by provider. No specific complaints reported prior to  nurse at facility finding resident unresponsive and breathing at approximately 6AM on 3/5/21. 911 initiated. EMS, police and coroner responded.
1st dose on 2022, did not come for their second or third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix received in June or July 2022) and Twinrix (2nd dose received on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 17-FEB-2023 Reporter's comment: The pharmacist had several patients who received first and second dose of Twinrix back in June or July 2022 and most of them did not came for their third dose. No further details about patients were provided. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patients did not receive the 3rd dose, which led to incomplete course of vaccination. This case had been linked with US2023027430, reported by same reporter.; Sender's Comments:  US-GSK-US2023027430:same reporter
In patient reported "nausea and hot face". EMT evaluated. Pt's symtoms resolved after 23 minutes. No emesis, no facial flushing, no respiratory distress. Pt was released at 3:09 pm. RN
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate Free. In 2022, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown. Concomitant medications were not reported. It was unknown if patient was enrolled in COVID-19 Vaccine trial.   The reporter's causality for the event(s) of COVID with Adalimumab Solution for Injection was Not Provided. Treatment medications were not reported.
Patient states she had rash and soreness at injection site 1 month after 1st dose of vaccine.
Information has been received from a Registered Nurse concerning a 12 month old female patient who on 30-AUG-2010 was vaccinated SQ with a 0.5 ml dose of MMR II (Lot# 663511/0443Z) (Expiration date: 25-MAR-2012) and a dose of VARIVAX (Lot#: 667257/0610Z) (Expiration date: 23-APR-2012). The nurse reported that on 31-AUG-2010, the patient experienced body rash and a seizure. Patient went to the emergency room. At the time of the report, the patient was recovering. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Within 24 hours of vaccine, got severe (R) deltoid pain, temp to 103.5, redness overlying injection site.
No adverse event; TE evaluation states vaccines have been administered; This spontaneous report was received from a medical assistant regarding a 5-year-old male patient.    There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 23-MAR-2022, a temperature excursion occurred. On 25-APR-2022, the patient was vaccinated with second dose at private doctor's office/hospital; vaccine as purchased by public funds by a health care professional (1 previous administrated dose) of varicella virus vaccine live (oka/merck) (VARIVAX) administrated subcutaneously (SQ) (formulation, strength, dose, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U025790 or U029496, which had been verified to be valid, expiration dates reported and validated as 19-AUG-2023 and 21-SEP-2023 respectively), as prophylaxis (Improper storage of product in use). The vaccine administered was stored at temperatures that went, from -14 degrees Celsius (C) up to -10 C for a time frame of 3 hours, and from -10 C up to 8 C for 1 hours 30 minutes, as recorded by a data logger. There was no previous temperature excursion. No additional AE details were reported. No PQC. Additionally, the vaccine was not available for evaluation because it was given to the patient; usage for device was initial use.    This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Patient was administered incorrect vaccine by medical assistant staff from what was ordered by doctor. No adverse events have been reported by patient's mother.
The day after my 3rd Moderna vaccine whenever I started to move my right arm I had a pain that radiated down my arm to my fingers causing me to grab my arm in agony and tears.  On Monday, 11/22/2021,  morning I called out of work  and  I made an appointment to see a doctor because I couldn't take the pain anymore.  They told me that I had a local reaction to the vaccine due to the swelling, heat and redness in my upper right arm at the injection site and that the swelling was pushing on a nerve in my arm which when moving my arm is what was causing the pain that ran down my arm.  I was given gabapentin to help with the nerve pain until the swelling in my arm went down.  I'm still having pain in my arm tuesday, 11/23/2021.
Day after on 10/4/18 patient had bad headache and soreness on arm. On the weekend so 10/6/18 she experienced redness at injection site and is warm to touch. On 10/8/18 I was informed of this on 10/8/18 suggested this is normal adverse event but contacted her physician who agreed but would like to see her just in case.
Mom noted swelling (L) arm day after vaccines. 11/20/13 (L) upper arm was swollen, red and warm to touch. Advised cold pack to arm. 11/22/13 phone call to mom - she states it is improving.
Patient became dizzy, pale, clammy & sweaty lethargic stated his very tired.  Pulse droped into the 50's - oxygen @ 3 liters had patient lie down checked vitals 97/51.  68 pulse ox 99% 911 called and was further assessed.
I received the 2nd dose of vaccine around 2pm on 01/02/21, was feeling fine until around midnight/1 am I felt chills and feverish but had a temp of 98.8 at that time, woke up around 4am with body aches, chills, fatigue, and a temp of 102.3. I was fine with these symptoms as I knew they were common side effects until my heart rate spiked from about 60 to the 160s and I began to have a throbbing headache. I could not get my heart rate to come down, I was calm and knew it was not anxiety so I went to the ER where they did blood tests, EKG, UA and gave me fluids. Everything came back normal but my heart rate continued to be elevated around 130s for a couple more hours, finally came down to about 100-110, HR is still slightly elevated and I still have a fever of 100.4 and migraine
No additional information was provided; back in April we had a delivery of GARDASIL 9 that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported.     Back in April 2021 the reporter had a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days. When the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator. It was discovered on 16-JUN-2021 that 5 bad doses were given, and 6 potential patients were involved, including that on 13-MAY-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (one time dose; lot # T026168, expiration date 04-DEC-2022; route and strength unknown) for prophylaxis (product storage error). The reporter could not confirm if this was a valid dose or bad dose. No additional adverse event. The temperature and time frame of the vaccine was unknown. There was no previous temperature excursion. The call was not because of a data logger.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA005004: US-009507513-2106USA005001: US-009507513-2106USA005005: US-009507513-2106USA005047: US-009507513-2106USA005150:
rash at injection site, R leg "hundred-ish tiny bumps with white pink tips"; later rash appeared on face and neck; T max 102 F; diarrhea. the night of 6/25/09 parent reports pt experienced body jerking/twitching/mouth movements; poor appetite. parent tx with tylenol, ibuprofen. patient referred for MRI and EEG
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was provided.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case( Same reporter)
Day 8 after vaccination, oozing and itching at injection site. Currently using ointment and taking Benadryl.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: Patient has a history of fainting when receiving vaccinations.  She fainted roughly 1-3 minutes after vaccine was administered, while sitting in her chair.  Her mother was present and helped pharmacist lie patient on the ground and elevate her legs on a chair.  Patient was given a lollipop and water while she recovered from the event.  She left the pharmacy around 30 minutes after event with her mother stating that she no longer felt faint and was okay to leave.
Patient reported feeling abrupt onset at about 5 minutes after injection of a sensation of 1/2 of her head feeling hot like she was in a hot shower and a flushed feeling.  No other sx that would suggest anaphylaxis.  40 minutes in while still experiencing above affected side ear was flushed.  Given 50mg of benadryl at that time and all symptoms resolved by 65minutes
MD Called 1/25/22, medication error Adult Pfizer Dose given to patient Inform guardian/father of medication error Patient is doing well, NAD Patient monitored for at least 30 minutes Called, spoke to (privacy), refer to CDC   Appt scheduled the next day to follow up with Pediatrician.  Precaution Advised
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, and ERYTHEMA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FEELING ABNORMAL, FEELING COLD, MYALGIA, and CHILLS. On 30-Oct-2021, the patient experienced SWELLING FACE, ERYTHEMA, RASH MACULAR, PRESYNCOPE, and NAUSEA. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN, and DISCOMFORT. The patient was treated with CLONAZEPAM for Adverse event, at a dose of 1 and a half pills; ASPIRIN for Adverse event, at an unspecified dose and frequency and OSCILLOCOCCINUM for Aches & pains in legs, Headache, Fever, Chills, Fatigue, and Flu like symptoms, at an unspecified dose and frequency. On 30-Oct-2021, CHILLS had resolved. At the time of the report, FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, ERYTHEMA, RASH MACULAR, PAIN, PRESYNCOPE, DISCOMFORT, MYALGIA, and NAUSEA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. She used hemp oil sav on the arm and it took a lot of the pain and discomfort away. drank some Pepsi, because sometimes when she has gas she feels like fainting. She had three big burps afterwards and felt better.   This case was linked to MOD-2021-255333, MOD-2021-255328 (Patient Link).
13aug84 to MD persistent pain in lt buttocks,hip,thigh x2 mo& TMJ pain x2wk;paresthesia in lower limbs;7sep84 swelling of ankles,feet &hx of hip pain since Jun;RF-arthritis rt ankle,arthralgia of hips cont;23Oct84 dx:psoriatic arthritis;
expired vaccine given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-365967, MOD-2021-365701 (Patient Link).
Mild headache, fever, chills, body ache, lack of energy. I still have a very strong pain in my left arm where I received the vaccine.
COLD NIGHT SWEATS LASTING FOR WEEKS AFTER FIRST DOSE. These started the second night after receiving the first dose, and lasted for approximately five weeks. Two nights after the second dose, the cold night sweats started again. These kept me up most of the night for weeks the first time, and again last night when they started again. Along with the cold night sweats, I have had transient but severe  muscle and joint aches and pains, with extreme pain in right shoulder, radiating down right arm.
My tongue and mouth became swollen and sore. .I still have no taste after 3 weeks.
A pediatrician reported that post vax pt developed fever, diarrhea and crankiness. No addtl info was available as of the date of this report.
Post vaccination patient reports feeling light headed. Patient was transferred for observation. AT 1145am vitals BP 99/69 Pulse 65 R18 SPO2 99%. Patient is alert and verbally responsive vitals at 1150am P 70 BP 103/78 R 18. Responsive to verbal stimuli speech is clear. Fluids were given and tolerated. Vitals are stable and patient sits up independently and voiced improvement. Patient refused to be transfer to ERB for further evaluation. No other symptoms reported, patient was released from facility by self
This spontaneous report was received from a Registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis . No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Right upper medial arm with 6 cm diam of redness, warmth and pain. (R) deltoid (injection site) was not involved with these changes.
Pt devel arthralgia sx following vax w//rubella virus vax live; No further details were provided;
Pt recv vax on 11/20/98; on 11/22/98 pt exp nausea, cramping & RA bruised
ANXIETY/NERVOUSNESS; DIFFICULTY SLEEPING; BODY ACHING. IT IS IMPROVING TODAY WHICH IS ABOUT 48 HOURS AFTER VACCINE WAS GIVEN.
Received Tdap on 3/24/08. On 3/25/08 face and eyes swelled x 5 days. States she took Motrin and Benadryl.
About 6 days after the shot, pain slightly left and lower of center of chest.  Shortness of breath a few days later and heart would beat really fast for a few seconds after.  These would occur not together, but sometimes 3 times a day to 3 days between.  Slightly right upper side of center of chest had a kind of tightness feeling a couple of weeks later.   Searching online showed you people have this (myocarditis) from second shot and anti-infamitories (ibuprofen) is usually prescribed for this.  Taking it 4-6 times a day for about 9 days fixed the shortness of breath and left side pain.  The cardiologist recommended taking it for longer.  About 8 more days and the right pain is gone.  Now just have fast heart rate for 5-15 seconds every once in a while.
Pt recv'd her immunizations on 10/14/99.On 11/15/1999, pt returned to have her 2nd dose of Varivax;at that time she admitted she was pregnant but the nurse gave her the vax in error. Later she came back and stated that she had been pregnant
This literature marketed report as received from the authors in a published article refers to 18 patients of unknown gender under 70 months of age. The article described the result of follow-up epidemiological study which was conducted to determine the circulation genotypes during 2011 season and whether the increase in rotavirus (RV) diarrhea was caused by replacement genotypes. Similar proportions of RV genotypes were found among vaccinated and unvaccinated children. The local data suggested that 5 years after the introduction of RV vaccination there was no genotype replacement. This report refers to the 18 patients who on unknown dates were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral (dose and lot number not reported). The patients received at least one dose of RV vaccine at least 14 days prior to presentation, as determined from the hospital records or after querying the state registry. The patients presented to the emergency department during the RV season of 2011 and were diagnosed as having RV diarrhea. Stool samples analysis confirmed RV using polymerase chain reaction (PCR). The outcome of the event was unknown. The reporter considered the event to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (manufacturer unknown). Additional information has been requested.
Menstrual period was off and crazy for 3 months after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER (Menstrual period was off and crazy for 3 months after vaccination) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstrual period was off and crazy for 3 months after vaccination). At the time of the report, MENSTRUAL DISORDER (Menstrual period was off and crazy for 3 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow up received contain no new information.