chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a male patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. On an unknown date in 2012, the patient was vaccinated with a dose of an unspecified pneumococcal vaccine (manufacturer unknown), reported as a "booster pneumonia shot" (dose, route of administration, lot # and expiry date not provided). On an unknown date in 2012, the patient experienced pneumonia. The consumer reported the patient was admitted to an unspecified hospital in 2012 due to pneumonia. The relatedness between the event of pneumonia and unspecified pneumococcal vaccine was not reported. Upon internal review, the event of pneumonia was determined to be medically significant. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA001825.
administration of FLUBLOK to a patient younger than indicated with no reported adverse event; Initial information was receivedon 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who stated administration of influenza quadrivalent recombinant vaccine [Flublok] to a patient younger than indicated with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza quadrivalent recombinant vaccine lot number not reported via unknown route in unknown administration site (formulation, dose, frequency, expiry date and strength: unknown) for Immunization and stated administration of influenza quadrivalent recombinant vaccine to a patient younger than indicated with no reported adverse event (off label use) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
Meningococcal Vaccine, Menomune, was given IM instead of SQ.
This non-serious spontaneous case, initially received from pharmacist on 14-Mar-2018 and concerns an 18-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 05-Feb-2018, the patient was administered with AFLURIA (TIV) dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT33908 and expiry date: 30-Jun-2018) with foreign particles floating in syringe (explicitly coded as product contamination particulate matter and drug administration error). This case was associated with PTC (product technical complaint) with PTC reference number: PR485504. It was reported that, no adverse effects were noted after the vaccination. Follow-up report received from Pharmacist on 16-Apr-2018: The reporter confirmed the age of the patient (18-year-old) and date of vaccination (05-Feb-2018). Narrative amended accordingly. Case correction received with IRD 14-Mar-2018: The LLT of the event 'Particles in the AFLURIA pre-filled syringe' was changed from 'product contamination particulate matter' to 'particle present in liquid product' in the event tab. The narrative was amended accordingly.
Arm sore at injection site.  No tenderness, no redness - just slightly sore to the touch
Narrative: Patient reports that she started her period the day she got the J&J Vaccine (9/10) and this was 2 weeks early for her. Also has an IUD and often doesn't even get periods. She had been bleeding through 9/22/21 which is when she notified the primary care clinic of the reaction. By then she called it " spotting. Blood was dark brown.
01/28/22 presents to Birth Center Triage for "induction of labor". PMHx of "Anemia, Depression, Fibroid, uterine"
Per patient's mom 3-5 days after receiving PCV13, DTaP patient would have staring episodes with muscle twitching. This would occur 2x per day for 3 days.
7-18-19 Got rash at inj site (R) side 1/2 way down arm, pt did not tell mother until 7-20-19 mother states rash as raised bumps. Spoke to pts mother @ 938AM 7-22-19 pt still had rash, no fever, no swelling, no SOB, no pain. Mother states pt resisted any treatment of Antihistamine oral or topical cream. I did call Merck vaccine dept to report pts syptoms on 7-22-19 as well. Mother informed to give pt benadryl come in if symptoms worsen go to ER for SOB/breathing problems.
Infant rec'd DTP/OPV on 22APR91 no adverse rxn noted; In next 48hrs-infant went to slep 11MAY91 & appeared well; found dead in bed p/nap;
crying for 4-5hr p/shot & acting different;t101-102;would lie still & cry instead of moving about but had no unusual movements & no inc tone;
Sore arm Fever Muscle aches Chills Headache Tiredness  Symptoms have lasted for 4+ hours so far
Arm was hurting/When patient press it hurts/pain the hand; Pain in the right side of throat; Could not lift arm very high; Vomiting; Chills; Fatigue did not bother much; Slight headache; Fever unknown after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting/When patient press it hurts/pain the hand), OROPHARYNGEAL PAIN (Pain in the right side of throat), MOBILITY DECREASED (Could not lift arm very high), VOMITING (Vomiting) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (cancer survivor.).   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was hurting/When patient press it hurts/pain the hand), OROPHARYNGEAL PAIN (Pain in the right side of throat), MOBILITY DECREASED (Could not lift arm very high), VOMITING (Vomiting), CHILLS (Chills), FATIGUE (Fatigue did not bother much), HEADACHE (Slight headache) and PYREXIA (Fever unknown after second dose). The patient was treated with BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was hurting/When patient press it hurts/pain the hand), OROPHARYNGEAL PAIN (Pain in the right side of throat), MOBILITY DECREASED (Could not lift arm very high), VOMITING (Vomiting), CHILLS (Chills), FATIGUE (Fatigue did not bother much), HEADACHE (Slight headache) and PYREXIA (Fever unknown after second dose) outcome was unknown.            Concomitant medication included blood pressure tablets. It was reported that the healthcare professional recommended the patient to take Advil.   This case was linked to MOD-2021-283816 (Patient Link).
Bumps in legs/thighs due to vaccine at injection site x 3 days.
This is a spontaneous report from a contactable consumer. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2016 as a single dose as a pneumonia shot. The patient had unspecified medical conditions and concomitant medications. The consumer stated that she got the shot last year in March or April and she broke out all over; itching and stuff and scratching the blood out of herself and she was messed up. Her hair came out and her eyes were stuck and she broke out all over. She had to pull layers of skin off and she wanted to know who she could talk to about it. The consumer stated that this got her eyes "running" and she would wake up and they will be stuck together. She also stated that she broke all over and she got "Jet leg"; they were sun spots, she got light spots and it's from her feet to all way up to her head which broke out all over. She received the shot around 5-6 of March last year in the hospital and two days later, she broke out ever since. The consumer further stated that as soon as she got the shot, she started to hurt the next day and the next day it swelled all over and then she got the breaking out turning all over the stuff; rashes all over her, all over her head; took her hair off. The consumer mentioned that she had consulted with a physician and they have been treating it ever since last year but they did not get rid of it. It had not improved and were not getting any better. She stated that she got to try to get these people because somebody got to help her as it broke her out; itching, scratching, burn all the time, and her eyes were messed up. Outcome of the event "Had to pull layers of skin off" was unknown; while for the rest of the events was not recovered.
Diagnoses  1. Cough (R05) 2. Exposure to COVID-19 virus (Z20.822) 3. Reactive airway disease with wheezing (J45.909)  Patient with cough with reactive airways with wheezing and rhonchi, with possible left upper lobe early infiltrate. Will start patient on doxycycline to cover for possible bacterial infiltrate. Also will be placed on albuterol inhaler and prednisone to deal with inflammatory aspect of her disease. Recommend she follow back up with her primary care provider in the next 1 week, return to urgent care for any worsening symptoms. See urgent care discharge summary for plan.  She was also swabbed for Covid, though quite unlikely since she has received both vaccines already. Advised to self isolate at home and not return to work or school until COVID results available. Advised results may take 2 to 3 days for to be available, and all results will show up on medical records. We will call you with any positive results. Tylenol or ibuprofen as needed for fevers, body aches. Over-the-counter cough and cold medication as needed. If any increasing shortness of breath, or other concerning or worsening symptoms, go to the emergency room for further evaluation.
STATES SHE DEVELOPED INTENSE ITCHING. SHE AND HER DOCTOR THINK IT IS FROM THE VACCINE. STARTED ON STEROIDS TODAY.
Headache, Myalgia, sore arm, body aches and tension headache for 2 days Narrative:  Other Relevant History:
High fever of 105 , chills, muscle soreness , fatigue and swollen lymph node under left arm.
This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included low potassium and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medication within two weeks of vaccination. The patient previously received ampicillin (AMPICILLIN), levofloxacin (LEVAQUIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER872) via an unspecified route of administration in the right arm on 23Mar2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021, at 12:30 after the second dose, in morning the patient got out of the shower and found two bruises. One on right thigh over three inches in length. A second bruise on left thigh that was smaller the patient husband check and found none. He took photos of those bruises. A few minutes later, actually watched a third bruise appear. We went to the ER. The patient can share photos and blood work had other symptoms, such as fever and aches, but am reporting this due to the bruising. The bruises are still present today. The patient underwent lab tests and procedures, which included blood test on 16Apr2021 and resulted platelets were within normal range. The events resulted in emergency room/department visit or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the event found two bruises, fever and aches was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Night sweats; Sense of dehydration; Back pain; swollen lymph nodes under armpit; Fever; Terrible headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 10:30 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included borderline for Sjogren's Syndrome and COVID-19 with pneumonia. The patient was allergic to yeast and corn (but patient consume).  The patient previously took prochlorperazine maleate (COMPAZINE) and levofloxacin (LEVAQUIN) for an unknown indication on an unknown date and experienced drug allergy. Concomitant medication included unspecified vitamins only from an unknown indication from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 20:30, the patient experienced fever, swollen lymph nodes under armpit (same side of body as injection), night sweats, terrible headache, sense of dehydration, back pain and nausea began after 10 hours of vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Symptoms mostly abated 48 hrs later. The clinical outcome of events fever, swollen lymph nodes under armpit (same side of body as injection), night sweats, terrible headache, sense of dehydration, back pain and nausea were recovered on 10 Apr2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, nausea, fatigue and injection site pain. On an unknown date, the outcome of the fever, nausea, fatigue and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, nausea, fatigue and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, nausea, fatigue and injection site pain post vaccination. All the symptoms listed, required the patient to take 2 days of sick leave from work. The patient fully recovered after 3 to 4 days with no prolonged symptoms. This case has been linked to case US2019GSK023610, US2019GSK023609, US2019GSK023611 and US2019GSK023600, reported by same reporter.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
only the liquid component / was administered; only the liquid component / was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva466a, expiry date 31st March 2022) for prophylaxis.   In August 2021, the patient received the 1st dose of Menveo. In August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, only the liquid component of Menveo was administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
extremely tired; metallic taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "moderately high blood pressure" (ongoing), notes: diagnosed when she was about 40 years old. There were no concomitant medications. Vaccination history included: Bnt162b2 (all her prior doses are by Pfizer, dose number unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 23Oct2023, outcome "not recovered", described as "extremely tired"; DYSGEUSIA (non-serious) with onset 23Oct2023, outcome "recovering", described as "metallic taste". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Since patient felt at her age and got all the other vaccines and should have the new COVID vaccine, injection in upper left arm. She does not know the name of the COVID shot she got today, just knows that it was by Pfizer since all her prior doses are by Pfizer. She has her old vaccine cards but they did not give her a new vaccine card for today's COVID shot. Patient received the most recent Pfizer COVID-19 vaccine on 23Oct2023. Patient reported that she had a metallic taste after receiving the vaccine and wanted to know if that was a normal side effect to experience? Patient also reported that she was extremely tired 2 hours after the vaccine, and asked if that was a normal side effect? She had an adverse effect from the COVID shot she just had. She is not sure but it is definitely not life threatening, clarifies the adverse effect is that she got a very strong metallic taste in her mouth within 15 minutes of getting the shot, it was immediate. Outcome for metallic taste in her mouth: still ongoing but not as bad as it was. She is also insanely tired, which started about 2 hours after the shot, outcome is the same. She does not think she is going to die, feels like she has to go to sleep now. The metallic taste will eventually go away, it has to go away and will not stay with her forever. It is unpleasant. She does not know if it has ever been reported or if it is coincidental.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Crohn's disease aggravated; This is a solicited report from non-Pfizer sponsored program, received from a contactable consumer, the patient, based on information received by Pfizer (21K-163-4051022-00). A 62-year-old adult female received the first dose of intramuscular BNT162b2 (TOZINAMERAN, solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 06Apr2021 (at 62-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, solution for injection in pre-filled pen, citrate free; batch/lot and expiry information not provided) unspecified dose at an unspecified frequency from an unspecified date for moderate to severe adult Crohn's disease. There was no medical history or concomitant medications reported. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (TOZINAMERAN, solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 16Mar2021 (at 62-years-old). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Apr2021, the patient experienced Crohn's disease aggravated. The action taken with adalimumab was unknown. The outcome of the event Crohn's disease aggravated was recovered on an unspecified date in 2021.   The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 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.  The reporter's causality for the event(s) of CROHN'S DISEASE FLARE UP AFTER COVID 19 VACCINE with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, the event chron's disease aggrevated is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.
rash; This is a spontaneous report from a contactable consumer or other non- healthcare professional (patient's sister). A 55-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced rash. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Reporter (female, aged 57) mentioned that she received second dose on 23Apr2021, then on Monday she developed little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs. Reporter also mentioned that her sister who lived with her aged 56, also developed a similar rash after developing symptoms.
Flush, Itchy. chills, with fever,  Tongue burnt, Burnt feeling,  when  you tongue drinking "Hot" coffee.   No Tasting sensation for "One" week.   Tongue still has this "Burnt" feeling.
69-year-old female presents for evaluation due to allergic reaction. She received her second Covid vaccination at approximately 12:00. Approximately 15 minutes afterwards, notes that her skin was itchy. She alerted staff and EMS was called. She was given Benadryl. She was given epinephrine IM by EMS at approximately 1307 hrs. she notes at that time, felt like her throat was closing, her voice changes and was mildly short of breath.