chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R013858, expiry date 12-JUN-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
patient received typhoid po vaccine on 8-24-07. Last dose was on the 30th. Developed fever, chills, stomach upset, lost appetite and severe headaches on 9/6/07. Headaches bothered her the most. Did not see a doctor and rested. Was sick for 7 days and now has recovered completely.
This is a solicited report from a marketing program 'Facilitated Collect' based on the information received by Pfizer (Mfr. Control No. 21K-163-4068186-00). A contactable consumer (patient) reported that a 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 1, single, and intramuscular on 02Mar2021 (Batch/Lot number was not reported) (at the age of 59-years-old) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis and moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. In 2021, patient received the 1st dose and on 02Mar2021, patient received the 2nd dose of Pfizer COVID-19 vaccine. In Aug2021, the patient experienced COVID-19. The outcome of the event COVID-19 was recovering/resolving. The reporter's causality for the events of COVID-19 with Humira (Adalimumab) was no reasonable possibility, while for BNT162b2 was possible. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and suspected covid-19 cannot be totally excluded
Abcess following HIB lot #1136L. Fever 99.1, loss of appetite, goopy eyes.
tendinopathy of left rotator cuff.  advised to start physical therapy.  intense pain in tendon when moving arm.  barely able to raise arm due to pain.
Pt began experiencing chest pain shortly after being administered 2 dose of Pfizer vacc. Pt notes she had the same reaction when given the 1st dose.
Case number PHEH2016US029896 is an initial spontaneous report received from consumer (Novartis employee) on 10 Nov 2016. This case refers to 52 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185285, expiry date: Apr 2017) at dose of 0.5 ml intramuscular on 06 Nov 2016. On 08 Nov 2016, the patient experienced itching all over. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious by the consumer. The causality of the events was not reported.
At 12:15 pm pt. felt dizzy (6/30/09) and cont to do so. 4:30 AM 7/1/09 oral temp of 101 degrees F. TYLENOL administered. Incoherent and fatigued all day on 7/1/09, slept all day. Came in to PMP at 4pm.
Narrative:  She relates having experienced dry throat that started about 40 minutes after the initial vaccination and lasted for about 2-3 hours. During that time, she felt very thirsty (much more than normal) - causing her to drink more water than normal. The increase in water intake a/w feelings of dry throat. She did not have difficulty drinking water/eating. She denied difficulty breathing or swallowing itchiness, urticaria, flushing, swelling of any part of body including face, confusion/disorientation, dizziness/lightheadedness, weakness, shortness of breath, palpitations, nausea, abdominal cramping, or feeling the need to vomit/have diarrhea.
The patient developed a fever of 104F, irritability and a small red papular rash on his face a few hours after the vaccines were given.
"Moderna COVID-19 Vaccine  Small rash around injection.  Rash blistered and is itchy.
CHEST PAIN; FATIGUE; FEELS WEAK; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 75 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: exercise induced asthma, gout, blood pressure, anxiety, alcohol user, asthma, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not a drug abuse or illicit drug user. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-AUG-2021 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety, mometasone furoate for asthma, salmeterol xinafoate for asthma, verapamil for blood pressure, and allopurinol for gout.  On 15-AUG-2021, after receiving the vaccine, the patient started having post nasal drip from the nose. It was clear, but it was very heavy and everywhere then there was mucus.  On 16-AUG-2021, the patient experienced chest pain and the patient thought it was because of anxiety and took lorazepam which did not work, and was hospitalized and had to stay in emergency room for observation. The patient stated that lots of scans were done, received IV and then was released on 17-Aug-2021. The laboratory result for lots of scan was unknown. The Consumer stated that they tested him for Covid-19 and it came back negative. . On an unspecified date, the patient experienced fatigue, and feels weak, the patient was asked if the symptoms were gone the patient stated that the patient was feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain and post nasal drip on 17-AUG-2021, the patient  had not recovered from feels weak, and the outcome of fatigue was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837701-covid-19 vaccine ad26.cov2.s -Chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
4/8/21:  I receive the injection at 1:50pm on my left arm.  8pm: I begin experiencing normal side effects: soreness, body aches, and headache.  9pm: In addition to the soreness, body aches, and headache, I start having chills, which last on and off throughout the night. 4/9/21:  7am: I feel fatigued, with headache and body aches throughout the morning and afternoon. 3pm: I begin to have some itchiness on my forehead and both ears. My right knee cap feels hot and bruised, but there is no mark. 5pm: Visible hives appear on my forehead and right knee cap, and my ears are red. All of these spots are very itchy and uncomfortable.  9pm: The hives begin to be much more noticeable and itchier. I take one Benadryl before going to bed which helps the itchiness somewhat. 4/10/21  3:30am: I am woken up by pain in my ears and they have gotten incredible swollen, red, and hot. They are very tender to the touch. I take another tablet of Benadryl.  7am: There are more hives on my forehead and cheeks, as well as my knee and now on two of my fingers. A few spots also appear on my feet and on one toe. My ears are less swollen but still not back to normal, and they are still red, hot and tender.  9am: I have a video call with a Physician?s Assistant who determines it is most likely not an anaphylactic reaction (no swelling in my throat or eyes or any of the other red flag symptoms. I also take my blood pressure with a home monitor and it is normal). He prescribes me a steroid pack.  12pm: The hives begin to be less and less itchy and red.  8pm: The hives are almost completely gone, save for a few spots on my feet. As I am breastfeeding my 14-month-old daughter, I had waited to begin the steroid pack until after our last nursing session of the day (around 7:30pm). As the hives seemed to be going away on their own, I decide to not take the medication. I do take one dose of Zyrtec. 4/11/21:  7am: the hives are completely gone
Patient experienced nausea, and rash all over body. Couldn't lift arm for 2 days. Rash lasted for 2 days.
Pharmacy negligently administered an Adult Pfizer Covid-19 vaccine to my son who is 10 years of age and required the Pfizer Covid-19 vaccine dose.
Nausea; Headaches; Reduced stamina and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Reduced stamina and fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Reduced stamina and fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Reduced stamina and fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
pt started feeling bad 6NOV, 7NOV, 8NOV acute sinusitis 11NOV went to MD rx Vantin; 14NOV started feeling bad, chills, cough, phlegm, body ache, light sensitive
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter..; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003542: US-009507513-2105USA003543:
Extreme exhaustion; Nausea; Feverish; Minor aches; Horrible headache; This is a spontaneous report from a contactable consumer (the patient). A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202) via an unspecified route of administration in the Right Arm on 03Mar2021 at 20:15 PM as a single dose for COVID-19 immunisation. The patients medical history includes Diabetes, Obesity, High Blood Pressure and Migraines. The patient was allergic to medications such as Leveler, Lisinopril and Doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021, after administration of the vaccine (within 24 hours at 15:00 PM), the patient experienced extreme exhaustion, nausea, felt feverish, minor aches, and a horrible headache. The headache lasted for several days and the other events resolved within 10 to 12 hours. The clinical outcome of the events such as extreme exhaustion, nausea, feverish and minor aches was recovered on 05Mar2021 and for headache, the outcome was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, CoughWheeze, Rash, felt warm and had alittle chest tightness. Cough, no wheeze. Narrative:  Employee felt ill in the evening. Took Zyrtec for itching. Followed up next day with Zyrtec. Felt fine after the third day. proceeded with second dose which was uneventful  Other Relevant History:
Information has been received from a physician concerning a 5 yr old southeast Asian male with mild sensorineural hearing loss and no known drug allergies, who on 09Jan01 at 10:00AM was vaccinated with a first dose in the left thigh of varicella virus vaccine live (lot634478/0091K). Concomitant therapy included tuberculin purified protein derivative (PPD tine test) and poliovirus vaccine. There was no illness at the time of vaccination, no adverse events following prior vaccination, and no other concomitant medications. On 20Sep05 the pt experienced breakthrough varicella with approx 100 lesions. Subsequently, the pt recovered on 27Sep05. There were no lab or diagnostic tests performed. Follow up information from a health professional indicated that the pt's parent scheduled an appt to evaluate the rash that had a one week duration. It was noted that there were no complications. Additional information is not expected.
Quadrivalent Flu Vaccine.....debilitating headache, (couldn't get up-lasted 30 hours), muscle and body aches,(back especially), temperature, sweats(entire body!), chills ( entire body shaking), couldn't eat, dry heaves, shallow short breathes. Lasted about 30 hours....still feeling weak and nauseated. Afraid to ever get the double dose again!
Pt recieved ADACEL, FLUZONE, MENVEO starting at 1150 in the left deltoid. Nurse then moved to the rt side and administered HAVRIX in the rt deltoid. At this point, 1153, pt stated that he was beginning to feel lightheaded and asked if he could take a minute. He then immediately stated that he was feeling extremely lightheaded at which point he passed out. Pt went completely limp and was observed to begin to snore. At this point this nurse was joined by BSN and another BSN. Pt was moved from the chair to the bed, legs were elevated. Vital signs were 96.7, 61 bpm, RR 23 100/60 left arm, 100/62 rt arm. 1157 HOB was raised to 30 degrees BP 90/48, temp 96.4. 1200 cool cloth was applied to the forehead and HOB was lowered back down 1206 BP 100/70. 1213 BP 120/70, 70 BPM, 98% RA. 1219 HOB was raised to 30 degrees, BP 124/74. 1224 HOB was raised to 75 degrees BP 118/68 rt arm, 83 BPM, 98% RA. 1230 Pt at 90%, dangled legs, sips of water. 1234 BP 94/60, Pt reported to be feeling lightheaded, granola bar was given and HOB was returned to 30 degrees. 1240 BP 118/70. 1245 HOB 90 degrees, dangled legs BP 120/76 on LT arm 80 bpm, 97% RA. 1250 BP 118/80 rt arm. 1302 BP 118/82, 62 BPM, pt standing leaning on bed. 1305 91% RA, 81 BPM, 1308 BP 100/76, pt is standing and walks. 1310 BP 118/76, 67 BPM, and 91% RA. 1312 Pt states he feels well enough to leave, he is able to walk on his own. He is escorted by his mother.
late second dose on  4/25/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 1st January 2023) 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 received on 27th October 2021, batch number DK23D, expiry date 8th February 2022).   On 25th April 2022, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 25th April 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: 5-May-2022 Reporter's comments: The pharmacist inquired how to proceed with the third dose of Twinrix. The patient received late second dose. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to which led to lengthening of interval between vaccine doses.
Pt came into pediatrics center to receive a Tdap. After she had left M.A. realized that she had given a DTaP. Dr was contacted and he did not think another injection was needed.
Dizziness & Headache Narrative: Employee reports felt light-headed, fatigued, and had headaches, as well as injection site pain/discomfort/soreness. Reports using Tylenol for symptom relief.
Headache, muscle aches, nausea, general fatigue. Headache, which was a medium headache, lasted about 3 hours. Muscle aches, nausea, and fatigue lasted for two days. I didn't take any medicine or anything for the reactions. I rested and ate light meals for the two days.
pt recvd vax; pt devel tremors; pt taken to ER & dx as infantile myoclonic sz; devel delay;
Pt. received extra dose of age appropriate Moderna Covid-19 2023-2024 vaccine.  Patient did not appear to have any adverse reactions as she was monitered for approximately 15 minutes following vaccination.  She was talkative, moving around without difficulty, and engaging with the people around here. Patient encouraged to hydrate and use the arms normally.
BODY ACHES; WEAKNESS; CHILLS; HEADACHE; NAUSEA; FATIGUE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included mononucleosis, and thyroidectomy, and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 11-MAR-2021, and was recovering from headache, nausea, weakness, fatigue, and injection site pain. This report was non-serious.
Received 2nd covid vaccine on 2/9/21 and 1st shingrix on 3/3/21. Reported the following "I had the same reaction to the 1st shingles shot as I had to the 2nd Covid  shot.  I believe I have correctly diagnosed this reaction.  It has a photograph of one cluster of bleeding  capillaries (petechiae) and discussions regarding immune thrombocytopenia (ITP)  with respect to vaccines. "
Patient reports burning in chest, arm pain, headache, chills that have lasted 3 days after vaccine.   Also with diarrhea
Client phoned and stated that after taking Oral Typhoid (Vivotif) 2nd capsule on 12-12-07, he started having a headache, abdominal pain, fever in the morning of 12-13-07.  Client went to see PMD on 12-14-07 for headache and abdominal pain.  PMD told client to stop all his medicine, and drew blood for test.  Client went back to see PMD on 12-17-07 for same symptoms.  Client was told that his blood test showed elevation of enzymes in liver, stop drinking for 1 week, just take BP medicine, not to take Tylenol and follow up in 1 week.
Female revaccinee with a non-specific generalized rash.  She was vaccinated on February 21.  On February 26, she started to develop a flat, macular, continuous, very erythematous rash in the creases of her axilla, neck, pubic area, and under her breasts.  The rash slowly extended in area throughout the following day when she visited her physician.  The rash was nonpruritic and nonpapular/nonvesicular, and the only other symptoms she had were a mild headache and mild malaise.  On physical examination, the physician also noted a singular small ?almost?-vesicle on the back of her soft-palate.  Her vaccination site showed a major reaction without complications.  Observation but no further treatment was recommended.