chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became white, began screaming-which lasted for hours, she began running a fever of 103.  I called the pediatrician and reported this event, and was "blown off" concerning it.  I was treated as an "over reacting" parent.  Patient began with ear infections and respiratory infections within days of this vaccine, the DTaP.  This child was PERFECTLY healthy until this vaccine was given.  Her illnesses with ear infections and respiratory infections has continued her whole life-the last 12+ years!  She has had ear tubes, adenoids and tonsils removed, she has episodes of severe blisters in her mouth, on her face hands and feet.  She has not made antibiodies to some vaccines that have been forced upon us. She was diagnosed with an IgA deficiency around age 3.  This child's illnesses have wreaked havoc on her life, and that of our family, and on our financial health, as well. I have NO doubt, after completing extensive research that the DTaP is the cause of my child's health issues.
Probably 6-8 weeks, and yes it went away/suspected vaccination failure; had the vaccine for them, or they would have been a lot worse; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had shingles for probably 6 to 8 weeks, and it went away. The patient had the Shingles vaccine and was thankful as shingles would have been a lot worse. The patient's doctor gave the patient something for the pain and it really helped. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
7 or 8 red spots around the injection site, they are just like red blotches; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 Vaccine and developed 7 or 8 red spots around the injection site, they are just like red blotches/Vaccination site erythema.  The patient's medical history was not provided. Concomitant medications included levothyroxine and simvastatin.  The patient received her first of two planned doses of mRNA-1273 (Lot number 011L20A) on 04 Jan 2021 intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, two days post first dose of the COVID  19 vaccine the patient developed 7 or 8 red spots around the injection site. The red spots did not itch and were not found anywhere else on her body.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event 7 or 8 red spots around the injection site, they are just like red blotches was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received and experienced slight injection site pain refer linked case US2018158689). In June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 2 doses of SHINGRIX. Approximately in June 2018, the patient received 2nd dose of SHINGRIX. The patient experienced deep muscle pain and soreness that although somewhat improved, was still present 2 months after the injection at the date of reporting.
This is a 80 year old female with a PMH/PSH as noted below. The patient was recently hospitalized with N/V/D as acute gastroenteritis, was treated and discharged back to facility. Her rapid Covid at that time was negative. Patient was home with her aide and stated that she felt "sick". She was tested for Covid on 1/11 and was positive. She was sent to ED today for MCA infusion but was found to have a low saturation in the high 80s prompting further evaluation and admission. Patient denies any SOB or distress, states she is just "tired". In the ED, she was placed on 3l/m with sats of 94% and appears comfortable at rest
Patient became light headed shortly after receiving the vaccine. She briefly fainted, but quickly became responsive. She was sweating profusely, but had no chest tightness, shortness of breath, or swelling of the throat. She laid down for 20-30 minutes while we called 911. When the ambulance was slow to arrive, she made the decision to have her friend drive her to the emergency room. She was able to walk out of the store with her friend's assistance.
Initial report received from a healthcare professional on 09 January 2014. A 25-year-old female patient had received first dose of FLUZONE ID, (batch number UT4721BA) intradermally in left arm on 08 January 2014. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions includes epilepsy, seizure free 21 years. On 09 January 2014, one day after vaccination, the patient reported of pins and needles feeling going down her left arm and her arm was red and swollen at the injection site, about the size of a small pancake. Pharmacist advised her to take a BENADRYL and if no improvement to go to urgent care. Laboratory tests were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Swelling in the injection site, pt had a tight chest/throat with nausea and light headed. BENADRYL 50 mg IM
Abdomen pain; chest pain; back pain; He got sick; Early this morning, he started feeling nauseous; Yesterday, his lymph nodes on left side were swollen; By next day, pain radiated to the entire arm, Today, the pain is in his left arm; After receiving 2nd dose, on same day, he started with pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick) and VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No historical conditions were reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-May-2021, the patient experienced VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site). On 17-May-2021, the patient experienced MYALGIA (By next day, pain radiated to the entire arm, Today, the pain is in his left arm). On 19-May-2021, the patient experienced LYMPHADENOPATHY (Yesterday, his lymph nodes on left side were swollen). On 20-May-2021, the patient experienced ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick) and NAUSEA (Early this morning, he started feeling nauseous). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Abdomen pain), CHEST PAIN (chest pain), BACK PAIN (back pain), ILLNESS (He got sick), VACCINATION SITE PAIN (After receiving 2nd dose, on same day, he started with pain at injection site), MYALGIA (By next day, pain radiated to the entire arm, Today, the pain is in his left arm), LYMPHADENOPATHY (Yesterday, his lymph nodes on left side were swollen) and NAUSEA (Early this morning, he started feeling nauseous) outcome was unknown.            No concomitant drugs were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Arm pain and dizziness; Arm pin and dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 04Aug2021 at 10:15 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included aciclovir (ACYCLOVIR) for cold sores from unknown date and unknown if ongoing and fluticasone propionate (FLONASE), ketotifen fumarate (ZADITOR) and fexofenadine hydrochloride (ALLEGRA); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Aug2021 at 10:45, the patient experienced arm pain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of arm pain and included treatment with Advil. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain and dizziness was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Patient age 17 at time of Moderna vaccine, not-approved for this age-group at this time.  reviewed cautions with mother and patient, no adverse effects reported.  Will return for 2nd dose at 4 weeks
Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.
Migraine headaches after second dose for 2 weeks; flu like symptoms for a week to a week and a week and a half; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine headaches after second dose for 2 weeks) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week to a week and a week and a half) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus operation NOS in 1989. Concurrent medical conditions included Sinusitis (The patient typically has sinus attacks annually in April).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced MIGRAINE (Migraine headaches after second dose for 2 weeks) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week to a week and a week and a half). The patient was treated with CYCLOBENZAPRINE at a dose of 5 milligram once a day and PREDNISONE at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine headaches after second dose for 2 weeks) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week to a week and a week and a half) had resolved.            No concomitant medication was reported. A non -smoker patient typically has sinus attacks annually in April. These attacks were so bad that the patient had a sinus surgery in 1989. About 7 years ago the patient started getting sinus attacks again each April. The patient reported that in year 2022 the patient had no sinus attack.  The patient reported no side effect from first dose of Moderna COVID -19 vaccine. Further he reported about the visit to urgent care for migraine headache. He received medication for the migraine headaches. The patient went to urgent care over the flu symptoms. Urgent care gave the patient cyclobenzaprine 5mg once daily. The patient was also given Prednisone on a tapering schedule.   This case was linked to MOD-2022-539871 (Patient Link).
1st dose March2022, no 2nd dose yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter called to report that a patient went to the facility to get a second dose of Shingrix. The professional did not administer the second dose yet. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Got pneumonia vaccine Oct 22nd. By evening my hand on that arm was puffed out on top and arm was aching. Next day swelling on hand had gone down some and knuckles were black and blue. Pain in arm and elbow lasted 4 days. On 6th day hand is still discolored.
Her temperature was 99.7; She felt nauseated; Next day after receiving 2nd dose, patient didn't feel very good on her feet; Her husband had to walk with her so she couldn't fall/She fell once on next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Next day after receiving 2nd dose, patient didn't feel very good on her feet), FALL (Her husband had to walk with her so she couldn't fall/She fell once on next day), PYREXIA (Her temperature was 99.7) and NAUSEA (She felt nauseated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Librium, Lexapro, dilaudid, Levofloxacin, Zofran, Requip, Zyrtec-D and Iodine) and Allergy (Alcoholic beverages). Concomitant products included THYROID (ARMOUR THYROID), VALSARTAN, LORAZEPAM, OMEPRAZOLE, GABAPENTIN, DESVENLAFAXINE, FLUOXETINE, METOPROLOL, PROMETHAZINE, MELATONIN, RISPERIDONE and MIRTAZAPINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Next day after receiving 2nd dose, patient didn't feel very good on her feet) and FALL (Her husband had to walk with her so she couldn't fall/She fell once on next day). On 19-Mar-2021, the patient experienced PYREXIA (Her temperature was 99.7) and NAUSEA (She felt nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CALCIUM CHLORIDE, GLUCOSE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE (PEDIALYTE [CALCIUM CHLORIDE;GLUCOSE;MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE;SODIUM CHLORIDE;SODIUM LACTATE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Next day after receiving 2nd dose, patient didn't feel very good on her feet), FALL (Her husband had to walk with her so she couldn't fall/She fell once on next day), PYREXIA (Her temperature was 99.7) and NAUSEA (She felt nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10/12/21 Was my 3rd vac.  Last was a booster.  at 11:00 AM this morning, my entire body felt like it was on fire.  Within 3 minutes, a rash broke out on arms, face, neck, legs, stomach.  Within 3 minutes, rash turned to hives.  2 minutes later, welts were all over body and swelling.  Everything disappeared within 50 minutes after starting.    $ other people I know have this happed from 9 months to a years after last vac.  happens to them monthly now.  one was my daughter as well.
Narrative: COVID infection following COVID vaccine series 03/21, Pfizer, dose #1 NON AGENCY 05/03, Pfizer, dose #2 NON AGENCY 08/16 pt cc: cough, rhinorrhea exposure: unknown 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending 09/28 COVID swab, result: detected 09/28 pt admit to medicine cc: hyperglycemia dx: pending LOS: undetermine, currently hospitalized 09/28 CXR impression: No active pulmonary process. 09/28 FIBRINOGEN result: 308 09/28 DDIMER result: 0.46 09/28 TROPONIN I result: <0.016 09/28 CRP result: 0.814 H
exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment: The reporter reported that the patient received Shingrix vaccine. The pharmacist stated that the Shingrix vaccine was exposed down to 28 Fahrenheit for 8 hours, the reporter stated that there was no prior excursions. The reporter reported that the 8 patients were administered temperature exposed Shingrix vaccines. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide patient details. The reporter did not consent to follow up. Additional supportive information: The Shingrix vaccine temperature was exposed upto 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022140241:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140236:Same reporter
Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received as non-significant information.
Patient started having severe body aches about 6 to 8 hours after administered the Moderna booster vaccine, then had fever (exact temperature didn't get recorded) for at least 8 hours. Patient took aspirin to help, and felt better with fever and body aches after 2 days. Patient reported cold/chill feeling after couple of days.
Patient had reaction to vaccine after administered. Pt described having pain and tingling down arm and became pale and diaphoretic. Patient stated feeling dizzy and nauseous. Patient was given water and granola bar and instructed to lay down on exam table. Vitals and blood sugar checked. Blood sugar was 120, BP 112/72, pulse 57, and O2 100. Provider recommended ER and patient declined. Patient remained in office until dizziness, nausea, and sweating stopped.
From initial information received on 8/6/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 35 year old male patient received a RABIES vaccine, administered at 8:30am on 3/31/04. The lot number, route, site, and dose number information was not provided for the product administered. Sometime after the administration of the Rabies product the patient experienced a pre-syncope episode, chest pain, and a ventricular ectopy. The patient's recovery status was reported as recovered.  Follow up on 09/28/04 states: "From additional information received through a telephone call on 09/22/04 from a physician, it was reported that the pt received IMOVAX RABIES on 03/31/04.  The physician did not have the lot #, but stated that she would call back with this information, as well as the route of administration. The pt received the vaccine as part of a post-exposure series.  He is a veterinarian, who was exposed to bull saliva during intubation. The bull was a suspected carrier of rabies.  The pt's last rabies vaccination was in 1999 with no prior reactions reported. His diagnosis of ventricular arrhythmia was based on cardiac monitor rhythm strips, as well as by pt's symptoms. He has since recovered from these events without sequelae." From additional information received on 29Sep04 from a healthcare professional, it was reported that the pt received the Imovax Rabies vaccine from a recalled lot, lot number W14192 administered IM. Reportedly the pt has fully recovered from the event.