chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (left shoulder), administration date 11Mar2021 (Lot number: EN6207, Expiration Date: 06Jun2021) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Therapeutic measures were taken as a result of headache. Treatment included Tylenol 500 mg.  Additional information: Patient received his first Pfizer BioNTech covid-19 vaccine on 11Mar2021, approximately 4 days later after the vaccine he experienced headache that had continued. Patient's second Pfizer BioNTech Covid 19 vaccine was scheduled for 01Apr2021. The patient was concerned about the side effect, headaches. When he took it he didn't have it right away, but now he was having headaches. Investigation Assessment was not provided.   No follow-up attempts are possible. No further information is expected.
patient had swelling, redness on the injected site.  she also had rashes on her back.  patient was advised to use icepack (or clean cool wet washcloth) over the affected area and take benadryl for couple days, if no relief to contact physician office
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: after previously testing negative in two different days; Negative, notes: after previously testing negative in two different days; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Vaccine received: Yes, Other medication in 2weeks: Yes, Other medication details other medication in 2weeks product: Sertraline  No follow-up attempts are possible. No further information is expected.
Presented with cough/congestion; + Covid in ED; dx Covid PNA;  treated with zinc, antibiotics, steroids, low dose O2; discharged home on room air
sore shoulder; my foots swell; I got all in groin area kind of sore; rash and skinfold in groin; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got bnt162b2 yesterday (reported on 31Mar2021) and had sore shoulder little, foots swell and today the patient was driving car for an hour got all in groin area kind of sore and the patient had a rash and skinfold in groin. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
04/14/19: GOT 1ST SHINGRIX DOSE. PT CAME IN ON 04/20/19 SAYING THAT AFTER HER SHOT SHE NOTICED THE AREA GETTING RED AND HOT TO THE TOUCH. BY WEDNESDAY THE 17TH, SHE WENT TO THE DR AND THEY DIAGNOSED HER WITH CELLULITIS AND PUT HER ON CEPHALEXIN. SHE SAID AT ITS GREATEST SIZE 4 INCHES AROUND. SHE WILL TALK TO HER DR ABOUT WHETHER OR NOT SHE SHOULD GET THE 2ND DOSE. SHE TRIED TO REPORT IT TO VAERS,  DEPT OF HEALTH, AND THE CDC WITH NO LUCK (SHE SAID SHE KEPT GETTING HUNG UP ON). EMPLOYEE WILL REPORT TO VAERS AND SHE WAS HAPPY WITH THAT.
Pain felt at the injection site within the hour of getting vaccine. Heavy tiredness felt that evening. Next morning, around 9 am body aches began. Muscle and joint pain not felt in previous Moderna injections. The pain was very debilitating. Ibuprofen taken with minimal relief. Right arm became very painful with lymph nodes in armpit and neck swelling. Pain lasted for approximately 2 days after injection. As of this writing (4 days after injection), swelling has gone down in lymph nodes but is still tender in right armpit.
Patient called 4/23/21 reporting unilateral (left nostril) nosebleeds occurring each day since receiving the vaccine.  She saw PCP and had blood pressure medications adjusted to control hypertension, however, nosebleeds have persisted.  I have given her my personal cell phone number to call me immediately  and to go to Emergency Room if bleeding worsens or other problems arise such as sudden, severe headache.  (Patient states that blood flow contained clots for the first day or two, but has been flowing without clots each day at least and sometimes twice per day.  She is able to stop blood flow within 5 minutes by packing nostril each time.)  I have instructed patient to make appointment with ENT (Ear, Nose, Throat) Dr.
Information has been received from a nurse practitioner concerning a 13 year old white female student with asthma and allergic rhinitis who on 04-MAY-2007 was vaccinated with the first dose of GARDASIL, injection. On 09-NOV-2007 the patient received the third dose of GARDASIL (lot# 659435/1265U), intramuscularly. On 10-NOV-2007 the patient experienced red blotches and red bumps over her entire face, the morning after receiving the third dose. The patient went to the urgent care for treatment and was given clindamycin gel and hydroxyzine hydrochloride 25 mg oral with good relief of symptoms. No additional information is expected.
Begining on Thursday 10/28 he had unusually strong neck pain which developed into a headache and continued to get worse over the course of a few days.  By the morning of 10/31 he was having problems chewing, but was able to hide the effects.  by 10/31 evening, one side of his face was starting to not move and his tongue was affected.  This is when we we went to the ER.  Over the course of several days his condition worsened until his entire face lost all motion.  He ultimately developed bilateral facial paralysis that involved his 7th and 5th cranial nerves.  One of his eye lids could not close completely.  When he tried to blink, his eyes appeared to roll in different directions.  His cheeks, eye brows, lips, were unable to move, and his tongue was affected somewhat.  His hearing was also affected eventually.  Upon discharge from the hospital, he noticed that somewhat loud sounds became deafening and hurt his eardrums.  However, by the time he was discharged, he was showing signs of improvement as IVIG had been administered for 5 days.
yawning; the Johnson and Johnson 2 doses; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Left heart failure" (ongoing); "Mild kidney disease" (ongoing). There were no concomitant medications. Vaccination history included: janssen coviD-19 vaccine (Dose: 01, Lot number: 1805029), administration date: 26Mar2021, when the patient was 79-year-old, for COVID-19 Immunization; janssen coviD-19 vaccine (Dose: 02, Lot number: 1822811), administration date: 11Nov2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "tiredness"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Sep2022, outcome "unknown", described as "the Johnson and Johnson 2 doses"; YAWNING (non-serious) with onset Oct2022, outcome "not recovered". The events "the johnson and johnson 2 doses" required physician office visit.  Additional information: The patient was at the doctor for a check-up and he got the shot sometime in Sep2022 and about a month later he noticed he was yawning. Caller states he listens to his body, and he would go lay down and then get up and take care of his responsibilities, but he was just tired and yawning and he has never had that before. Prior Vaccinations (within 4 weeks) was reported as none.  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.
approx 4 hrs p/vax pt began screaming & could not settle down; screaming episode lasted around 3 hrs; ice applied to leg & APAP given; pt fully recovered w/in 24 hrs p/initial 3 hrs; pt was irritable & fussy;
30yo Male client reported dizziness and had a syncopal episode after receiving Janssen vaccine. LOC returned without assist. Client alert and oriented post syncope. BP 100/60 Client reported not eating for over 12hrs Gatorade given to client No EMS called Client ambulatory upon leave
had first dose of Bexsero last July / second dose last week; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in last July 2020).   In July 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. In July 2021, unknown after receiving Bexsero and Bexsero 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 details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported The patient had 1st dose of Bexsero last July and the second dose last week which led to lengthening of vaccination schedule. The reporter said they were not aware it needed to be done closer together also asked should she need a booster. The follow up would not be possible as no contact details were available.
About 11 hours after shot:  severe vomiting for over an hour,  severe chills, fever 99.6 18 hours after shot continuing through the next day,  sore left shoulder
A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received FLUMIST QUADRIVALENT (intranasal) 0.2 ml unknown, via nasal route, on an unknown date. On an unknown date, the patient experienced sniffles. Treatment with FLUMIST QUADRIVALENT (intranasal) was not changed. The outcome of the event was unknown. The event was considered non-serious.
Headache, Sedation, Myaglia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:
This case was reported by a nurse and described the occurrence of fever in a 2 month old female pt who received Infanrix. On 7/26/04, the pt received the 1st dose of Infanrix. At an unspecified time following the administration of Infanrix, on 7/26/04, the pt experienced fever and fussiness. The pt was treated with Tylenol. The outcome of the events is unknown.
Patient has been experiencing numbness or tingling in his thighs since two days after receiving Fluvirin. Symptom seems worse at night while trying to sleep.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults.  The HCP had asked if the patients need an additional 0.25ml dose now.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.     No adverse events were reported.  No treatment medication reported by reporter.
Hair loss; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa. Concomitant medications included natalizumab (TYSABRI) taken for an unspecified indication from 31Mar2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 09:00AM patient experienced hair loss. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are needed; No further information expected.
Inflammation, itching, redness extending from just above injection site to elbow and about 5" wide. Advised cool compresses and BENADRYL 25mg Q6H.
has not experienced any adverse effects; inadvertently administered after its labeled expiry date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-AUG-2023, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, administered for prophylaxis (lot# U039721, expiration date: 10-AUG-2023; strength and route of administration were not provided) after its labeled expiry date (expired product administered). The patient had not experienced any adverse effects. The health care professional confirmed there was no temperature excursion.
Couple of episodes of feeling  like i was getting sick. lasting a hour or so. (run down, warm). Had a rash brake out. Mainly on torso, some on other body areas. Have been on for 6 days now.
This case was reported by a healthcare professional via sales representative and described the occurrence of facial rash in a 4-year-old subject of unspecified gender who was vaccinated with KINRIX (Glaxosmithkline). The subject's medical history included gastrointestinal disorder that resolved prior to KINRIX administration. On an unspecified date the subject received unspecified dose of KINRIX (unknown, left thigh). Approximately two weeks after vaccination with KINRIX, the subject experienced "rash build up on face", swelling of face and "starting to talk in circles". At the time of reporting the outcome of the facial rash, swelling of face and speaking disorder was unspecified.
Red, itchy hives started developing on abdomen, arms, legs 24 hours after injection.
PATIENT IS HAVING PAIN IN ARM. SHE REPORTS IT STARTED FOLLOWING MORNING BUT HAS LINGERED ON FOR A WEEK. SHE SAYS IT IS A NAGGING ACHE FROM SHOULDER TO ELBOW. SHE BELIEVES IT TO BE BURSITIS CAUSED FROM VACCINE. NO TESTS HAVE BEEN COMPLETED. PATIENT IS TREATING AT HOME WITH OTC MEASURES, SUCH AS ICE AND ANTI-INFLAMMATORIES.
It started with a headache, and then general achiness in my joints and a persistent cough. I did a home COVID-19 test and it was positive. I went to the doctor, and they prescribed me PAXLOVID. I took it one and the morning and one at night. Most of the symptoms went away after a week except the cough. I took some over the counter cough medicine and then it worked for after a week.
the patient's mother claimed that the patient had 2 doses of the "HPV vaccine", 1st dose at 13 years of age and 2nd dose at 15 years of age.; HCP provided patient history of abnormal Pap smear in 2019 that was positive for HPV and "ASCUS./HCP reported the patient came back to their office in July 2020 for another Pap smear which was again positive for HPV; in July 2020 for another Pap smear which was again positive for HPV and "ASCUS"/in September 2020 and results showed a "low grade squamous intra-epithelial lesion CIN 1 on all 3 biopsies."; This spontaneous report was received from a medical assistant, referring to a 26-year-old female patient. The patient's pertinent medical history and concomitant medications were not reported. Her current conditions included "heavy smoker, 20-39 cigarettes per day", and the patient has no known drug allergies.   On unknown dates, at the age of 13 and 14-year-old the patient was vaccinated with the first and second dose, respectively of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), both vaccines were administered as prophylaxis (formulations, strengths, doses, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported) (inappropriate schedule of product administration).   The reporter stated that, the patient had history of abnormal Papanicolaou (PAP) smear in 2019, it was positive for human papilloma virus infection (HPV) and atypical squamous cells of undetermined significance (ASCUS) (papilloma viral infection and cervical dysplasia), and negative for 16, 18 and 45 genotype. The medical assistant reported that, the patent did not return for further testing as recommended after this result.   In July 2020, the patient came back to their office for another PAP smear, which was again positive for HPV and ASCUS (papilloma viral infection and cervical dysplasia), and negative for 16, 18 and 45 genotype.   In September 2020, the patient was underwent a colposcopy and the results showed "a "low grade squamous intra-epithelial lesion CIN 1 on all 3 biopsies."  The outcome of papilloma viral infection and cervical dysplasia, was not recovered. The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with the aforementioned events were not reported.
the day following vax pt exp a decrease in appetite, persisting as of 4/26; pt also devel diarrhea (6 stools per day)
This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L013827, expiry date: 21-APR-2017). Healthcare worker reported that the vaccine underwent temperature excursion at 6 degree Fahrenheit for 196 hours. There were no previous excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Patient experienced shooting pain down arm soon after receiving vaccination. 10 minutes later, everything returned to normal.
Patient/customer reports hives on back of left leg, rash on right upper arm and rash on back (below left shoulder blade) began about 24 hours after receiving her second dose of Shingrix vaccine. Patient advised she may take benadryl for the itching.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of GARDASIL 9 (lot# M023169, expiry date: 13-JUN-2018) that was exposed to 52.2F for 3.5 hours (incorrect product storage). No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Dad reports on the evening he received shots, he stopped eating and had diarrhea and fever. He was taken to ER and was admitted to the hospital. Call to pediatrician, states not related to shots.  Diagnosed with acute gastroenteritis and dehyration.
This spontaneous report as received from an approximately 30 year old female patient regarding herself. On an unknown date in August 2014 the patient was vaccinated with PNEUMOVAX 23 (lot number and expiry date unknown) (dosing regimen and frequency unknown) at her place of employment. No concomitant medications were reported. On an unknown date approximately in 2014 (also reported as two weeks later) the patient experienced bronchitis. The patient stated that since she was vaccinated she has bronchitis four times. No lab diagnostic studies were performed. The patient did not seek professional medical attention. The patient self treated the bronchitis with Z-Pak. The outcome of bronchitis was reported as not recovered. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of the event bronchitis was not recovered. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. There was no product quality complaint reported. Additional information has been requested.
Administered 3 vaccines total. This was the 3rd one, given accidentally  Narrative:  Patient was erroneously scheduled for a 3rd vaccine and was administered it. No acute ADRs noted. No delayed ADRs noted per days: chart review on 3/16/21
dollar size red area around injection site    having patient put ice on it.  patient spoke to md and md said to apply ice packs and if not better by monday then call md again monday