chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed clinical social worker referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have been administered improperly stored RECOMBIVAX HB (lot # L007558, expiration date 10-NOV-2016; dose and route were unknown). The vaccine were stored under temperature 11 Celsius degree for 17 days. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.01.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 9 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Thirty years ago, we were told to get the swine flu shot as there would be a pandemic. After I had it, my legs were paralyzed for 2 days. The person behind me who got it developed Guillain Barre syndrome was paralyzed for life. I figured I had a miracle as I was the mother of 4 teens. In 2010, I did not have an appt with my Dr, so I went to a pharmacy. I told the pharmacist I just wanted the regular flu shot & he agreed I should never ever get one for swine flu again. On this Oct. 4, 2010, I had an appt. My Dr. said it should not bother me and I must have a flu shot. Our gov't gave no warning it would be combined & it was too early to hear of any feedback from you or TV. In fact, there has been nothing in the media. Both another Dr. & insurance company suggested I report my symptoms. CDC said leave your # & will call you back. No one ever did. I called again in Dec. & got recordings. Hence, this form. For 10 days I got symptoms, could hardly get around, & had to hire a GNA. On the 3rd day I had bronchitis symptoms 2 nights, then I felt like my digestive tract was paralyzed & couldn't eat, just used liquids and lost 5 lbs. I went from 116 to 111 lbs. I still can't eat much at a time. After that, I had episodes of losing my breath. My lungs are clear, & have no congestive heart failure. In 3 months, I walk very slowly, use a walker & cane. Since I have experienced this, I have found out all my symptoms are the pattern Guillain-Barre takes, the diaphragm being last. I guess I can never get my regular flu shot again. I don't expect you to do anything but I thought, you should know. It has decreased the quality of my life. I had enough problems as it was. It's a full time job taking care of my diabetes. I live alone, & have some part-time help.
Patient complained of dizziness, felt "flushed". O2 sat was 99% no DIB, asked patient to lie down, no hives noted, face and neck became flushed. Blood pressure was 180/92, c/o facial "tingling" 50mg IM Benadryl given. Vital signs returned to normal after 8 minutes, PCP and family notified. All redness and "tingling" gone-released to family and instructed to f/u with PCP.
Symptoms began within approximately 12 hours of vaccination with body aches and soreness, weakness and malaise, mental fogginess, chills and sweats, loss of appetite, slight nausea, needed assistance to walk.  Symptoms subsided after two days, therefore did not seek medical attention.
LEG PAIN; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, and fever. This report was non-serious.
some symptoms I have and I'm having; A spontaneous report was received from a consumer, concerning herself a female patient of unknown age, who had to receive her first dose on (9-02-2021) Moderna's COVID-19 vaccine would like to some information regarding vaccine  The patient's medical history was not provided, concomitant medication was not provided by reporter.  On unknow date patient had to received their first dose of two planned doses of mRNA-1273 (lot number not provided) via unknown route for COVID-19 infection prophylaxis but she had some previous medical history so she want to take advice from safety regarding vaccine   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was not resolved at the time of this report
Initial report received from a health care professional on 01 September 2010. A 27-year-old female patient with no medical history, takes no medications, no illness at the time of vaccination and had no other vaccinations within 4 weeks, received on 31 August 2010 an intramuscular (IM) deltoid injection of FLUZONE, lot number U3651AA. On 31 August 2010, the patient complained of having numbness and tingling from the injection site at the deltoid all the way down the arm to the fingers. The deltoid area was red, swollen and warm to touch. The patient complained of having fatigue and a headache. The outcome was reported as not recovered. Documents held by sender: None.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On an unspecified date, the patient received an improperly stored dose of ROTATEQ (dose not provided; lot # L029615, expiration date: 15-MAY-2017) orally. The administered dose of vaccine was exposed to a temperature of 33.3 Fahrenheit for 24 hours. No previous temperature excursions were reported. The temperature excursion was detected by a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
a little worse than the last time I had it; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (a little worse than the last time I had it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.  No Medical History information was reported.On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (a little worse than the last time I had it). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (a little worse than the last time I had it) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were provided.This case was linked to MOD-2021-382988 (Patient Link).
COVID; COVID; Crohns disease flare up; Psoriasis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID"; CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohns disease flare up"; PSORIASIS (non-serious), outcome "recovered", described as "Psoriasis". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the DRUG INEFFECTIVE, COVID-19, CROHN'S DISEASE, PSORIASIS  with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of psoriasis and crohns disease flare up was not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and CROHN'S DISEASE, PSORIASIS. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received other vaccine and medication in 2 weeks. 4 days after stopping Paxlovid, the patient started experiencing symptoms of Covid again. Paxlovid was given as treatment for COVID-19 from 24Jul2023 to 29Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Flu like symptoms for 24hrs. High fever.  Chills and body ache. Lump under arm pit
Site: Pain at Injection Site-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Pharmacist monitored patient. Patient was give orange juice after experincing small seizure and vomiting twice. Color came back into skin shortly after. Patient came to pharmacy day after to report incident.
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 10-Oct-2014. It was reported that the nurse didn't remove the clip so only 1/2 dose was administered. Did not receive the other 1/2 of dose. The outcome of the event of 1/2 dose FLUMIST QUADRIVALENT administered for dose is unknown. The report was considered to be non-serious.
unable to sleep; severe decrease of body temperature; Shortness of breath and difficulty breathing; heart was racing; could not move arm, felt like it was broken; Legs wobbly; no strength in legs for three days/ weak legs; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath and difficulty breathing), PALPITATIONS (heart was racing), INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature) and TREMOR (Legs wobbly) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nodule on extremity. Concurrent medical conditions included Blood pressure increased (high blood pressure) and Nasal cavity mass. Concomitant products included VITAMIN D3 for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath and difficulty breathing), PALPITATIONS (heart was racing) and LIMB DISCOMFORT (could not move arm, felt like it was broken). On an unknown date, the patient experienced INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature), TREMOR (Legs wobbly) and MUSCULAR WEAKNESS (no strength in legs for three days/ weak legs). At the time of the report, DYSPNOEA (Shortness of breath and difficulty breathing), INSOMNIA (unable to sleep), BODY TEMPERATURE DECREASED (severe decrease of body temperature) and LIMB DISCOMFORT (could not move arm, felt like it was broken) outcome was unknown and PALPITATIONS (heart was racing), TREMOR (Legs wobbly) and MUSCULAR WEAKNESS (no strength in legs for three days/ weak legs) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. No treatment information was provided.
?Patient without significant medical history presenting with complaint of discomfort in his central chest described as an aching like "bricks on my chest" since Saturday 2 days ago.  Pain has been intermittent.  Denies pleuritic pain or hemoptysis.  Patient denies cough, sore throat, fever, shortness of breath, diarrhea, loss of smell or taste or any known exposure to somebody positive for coronavirus.  Patient states onset of symptoms after his second coronavirus vaccination.  Denies leg pain or swelling.  No abdominal pain or vomiting.  No history of similar problem in the past.  No DVT/PE or ACS risk factors.?
Information has been received from a physician concerning a 5 year old male who on 10-AUG-2007 was vaccinated with the second SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (No lot number was given). Concomitant vaccinations included the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). On 13-AUG-2007, the patient developed injection site reaction that was swollen and warm to the touch. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
I went to bed at night feeling off, I woke up the next day felt worse, everything was spinning I threw up and I called 911 and went to the emergency room in an ambulance. At the the emergency room they diagnosed me with peripheral vertigo. I started experiencing hearing loss so the ER directed me to see an ENT who diagnosed me with Sensorineural hearing loss.
Patient was nervous before the vaccination. After vaccination she started to feel hot and cold. Her hearing started to fade in and out. She sought help and was directed to lay flat on the floor and breathe. She started feeling light headed and that her vision was tunneling. Her appearance was pale and her hands were clammy. Her blood pressure was taken via wrist and was normal for her (112/72). The medical professional tending to her had her continue talking, asked her to state her DOB, name, age, the date, etc.  After about 5 minutes she started to feel better- she sat up and had some water and M&Ms. She then laid back down but continued to converse with us. This took place over about10 minutes from first symptoms. She remained laying down for about 10 minutes after and then slowly sat up, and when she felt comfortable sitting she tried standing up. She then went home for the day (was an employee of the store).
Mom states that 5-6 days after her child received Varicella vaccine. She broke out in chicken pox which lasted for 6 weeks. She had few on face but the rest of her body was covered with chicken pox with fever.
Patient received Moderna covid-19 vacine today first dose at approximately 1256.  Patient reported very mild sensation of numbing near mouth and mild sensation numbing in face.  Denied shortness of breath or difficulty breathing, or numbing of tongue or throat closing, any rash or swelling.  Patient reported slow progression of numb feeling in face, and very mild sensation of numbness in throat.  Rapid response team called around 1330.  Per rapid response team RN, administered diphenhydramine 25 mg PO at 1351.  Pt tolerated well.  Patient escorted to ER with rapid response team at approx 1400.  RN.
Received flu shot on Oct. 30, 2008 - got bad head-ache on Nov.1, 2008 -experienced sudden and violent vomiting. Headache and body aches for 5 more days.
the vaccine was administered after temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 29-APR-2022, the patient was vaccinated with an improperly stored dose (administered after temperature excursion) of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U026207 with expiration date of 24-AUG-2023 or lot # U029496 21-SEP-2023, for prophylaxis (dose, route of administration and frequency were not reported).         Temperature excursion -9 C; Time frame 1 hour 45 minutes; no temperature excursion  No further information provide.
Pt reported not feeling well in less than 5 minutes after shot. Initially he was sweating, followed by dizziness. In few seconds, he started convulsing. I administer Epi-pen 0.3 mg, 1 adult dose in his left thigh. His convulsion stopped at very moment, paramedics took over from there. His vitals were checked and monitored by paramedics for few minutes. He did not require hospitalization at this moment, however advise to seek medical attention if he feels something abnormal. He was able to walk himself to his car, where his family member drove him to home.
COMPLAINED HE FELT DIZZY UPON WAKING, THEN LOSS OF CONSCIOUSNESS MORNING AFTER VACCINE.
No adverse event occurred with the patient, however, she was pregnant at the time and the pregnancy was not yet known to her or the provider.
1/18/2021 Neck felt tight- Lymph node was very swollen and it stay a couple of weeks and then it stop. Mass on my neck/ Spoke with Specialist and I was informed that he did not think that it was related to the vaccination
Pentacel administered to a 63 year old stem transplant patient, no AE; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old male patient received 0.5 ml  first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ067AAA, Exp. Date 13-Jun-2020) via intramuscular route in the left deltoid on 11-Jul-2019.  The patient's past medical history included Stem cell transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Narrative:  The patient received three doses of Pfizer COVID 19 vaccine in Jan/Sep 2021. The patient tested positive for COVID 19 on 21 Jan 2022. The patient presented to the ED with generalized weakness that was getting worse. The patient also had a mild sore throat. The patient was admitted on 21 Jan with a diagnosis of COVID 19. The patient was treated with dexamethasone and discharged on 25 Jan 2022 in stable condition.