chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a headache, pretty severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (not ongoing), notes: had ulcerative colitis prior to getting any of the vaccines. There were no concomitant medications. Past drug history included: Levofloxacin, reaction(s): "Drug allergy", notes: Brand name Levaquin; allergic to whatever is active in both the generic and brand name of the medication. Vaccination history included: BNT162b2 (Dose 1, single, Only says Pfizer COVID-19 vaccine purple cap., NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 23Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Only says Pfizer COVID-19 vaccine purple cap., NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 13Apr2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Had a headache, pretty severe headache". Therapeutic measures were taken as a result of headache.  Additional information: Other conditions was noted as no. For the first and second boosters patient received, the reason for those doses was because patient had ulcerative colitis, which is an autoimmune condition. It was confirmed that patient had ulcerative colitis prior to getting any of the vaccines. Family medical history relevant to adverse event was noted as no. Patient only had one known drug allergy, that was to an antibiotic with the generic name levofloxacin, brand name Levaquin, patient was allergic to whatever was active in both the generic and brand name of the medication. Anatomical location of suspect dose was noted as upper left arm. Vaccination facility type was noted as other (medical facility). Vaccine administered at military facility was noted as no. Other products was noted as no. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was noted as no. List all vaccines administered on same date with the Pfizer vaccine considered as suspect noted as no. It was reported that patient had a headache, pretty severe headache, after the first booster but that was really it and the headache only lasted on and off for a day, took an Excedrin or caffeine acetaminophen aspirin combination drug for his headache. The event did not required emergency room or physician office visit. Investigations was noted as no. Relevant tests was noted as none.  The lot number for BNT162b2 was not provided and will be requested during follow up.
She began to notice blurred vision; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2022, the patient received the 1st dose of Shingrix. On 23rd June 2022, 1 days after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was not recovered/not resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter stated that, she received Shingrix and the following day after the vaccination she began to experience blurred vision.  The reporter reported that symptoms was not resolved yet. The reporter was provided medical advise disclaimer and referred to healthcare professional. The reporter did not consent to follow up.
Pt recv vax on 11/24/97; within 1 wk post vax pt exp myalgia, sweats & hepatitis
Woke up this morning w/"red spots" all over - more on trunk - few on face, arms and legs. Had fever 2 nights ago. Given Benadryl for itching.
Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep quality at night after vaccine. Chills, Fever and scratchy dry throat began about 10 hours post vaccine.   Fever of 100.4 lasted about 18 hours.  Loose stools after about  24 hours. Ear ache and tender neck lymph nodes began after 24 hours. dry throat lasted 48 to 72 hours.
Left upper thigh swollen 24 hours, post vax, in that area. No redness or increased warmth in area.
I was in bed for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shots a few years ago and he/she was in bed for a few days from the side effects.
arm was sore for a couple days; We got a full dose (100 mcg shot) as opposed to a half dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for a couple days) and INCORRECT DOSE ADMINISTERED (We got a full dose (100 mcg shot) as opposed to a half dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 006B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 15-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (We got a full dose (100 mcg shot) as opposed to a half dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for a couple days). On 15-Oct-2021, INCORRECT DOSE ADMINISTERED (We got a full dose (100 mcg shot) as opposed to a half dose) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore for a couple days) had resolved.      No treatment and concomitant medications were provided.   This case was linked to MOD-2021-363657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: follow up received contains, Patient information, Dose information, event and reporter contact details updated.
mom called 17OCT95 & stated pt hadn run temp all noc up to 104.4 R, mom instructed to take pt to pvt MD, also to cont the APAP q 4-6hrs for the temp as instructed the day a/as per protocol; MD talked w/mom & also referred to pvt MD;
LETHARGY; NAUSEA; MINIMAL BODY ACHES/SHOOTING PAIN  FROM THE FRONT  OF  HEAD TO BACK OF EARS; FEVER; PAIN IN HANDS AND FEET; This spontaneous report received from a patient concerned a female of unspecified age. 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: 042A21A and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced pain in hands and feet. Laboratory data included: Body temperature (NR: not provided) 102. On 07-APR-2021 23:00, the subject experienced minimal body aches/shooting pain from the front of head to back of ears. On 07-APR-2021 23:00, the subject experienced fever. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101-102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, minimal body aches/shooting pain from the front of head to back of ears, nausea, lethargy, and pain in hands and feet. This report was non-serious. This case, from the same reporter is linked to 20210417239.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 11-OCT-2012 23:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt was given 1st dose of covid Pfizer vaccine.  vaccine expired from refrigerator 2/26/2023, given 3/3/23.  father informed clinic that he received a letter stating that the vaccine was expired and that he had been "sick ever since then".  pt has had nausea vomiting and diarrhea that started on 3/17/2023-seen at pcp and told had viral illness.
This spontaneous report was received fro a 53 year old female patient, who was reporting on herself. The patient was in remission of breast cancer and had allergies to BENADRYL, VALIUM, ZOLOFT, TAXOL and NEUPOGEN. On 19-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX, lot # L028280, expiration date: 28-OCT-2016, 0.65 ml, subcutaneously for shingles prevention. There was no concomitant medication. On 03-MAR-2016, the patient developed shingles. She sought medical attention and went to the emergency room (ER) on 03-MAR-2016 was prescribed with VALTREX to treat her shingles outbreak. She was then released from the ER on the same day, hence she was not admitted to the hospital. The patient also mentioned that she felt very tired and she got sores around her "lower middle section" area of her body and she felt pain on an unknown date in 2016. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
I had a sinus infection that may have been totally unrelated to the vaccine, but it required an antibiotic and steroid shot. Prior to my vaccine, I had not needed any antibiotics for an extended period during the pandemic. My allergist examined me and prescribe medicine.
Fifteen minutes post vaccination, patient complained of metallic taste in her mouth and headache. Patient was provided with a glass of water and was assessed by RN. Vital signs were taken and monitored by RN. Blood pressure was 160/70, heart rate was 87, and oxygen 97%. Patient denied history of high blood pressure, but stated she had a busy stressful day. Blood pressure was repeated about 5 minutes later and read 148/72. Patient denied any shortness of breath, chest pain, palpitations, rash or itchiness. Patient reported feeling better after finishing her glass of water, and taking a few deep breaths. Patient reported feeling less anxious after this. Patient was advised to seek immediate medical attention at Emergency Department if symptoms return, or any new symptoms arise in the next few hours or days. Patient left vaccine clinic alert, oriented, and stable with her husband around 2:35PM. All symptoms resolved prior to patient leaving vaccine clinic.
Info has been received from a health professional concerning a female pt, who in approx Oct 2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot 3643251/0445M). Additional therapy given at the same time, in the opposite arm included a dose of influenza vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently in approx Oct 2002, the pt developed "severe" pain, "very" swollen armpit with throbbing, "sore to the bone" and she could not raise her hand. It was noted the soreness lasted for 2 days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested. The health professional mentioned 13 other pts who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02249, 0211USA02250 and 0211USA02251).
Immediate onset LLE pain, elbow. Employee concerned vaccination given "too high" given incorrectly.  LUE pain, decreased ROM, weakness developed. Seen at Employee Health. MRI. Referral to Ortho. Dx: Parsonage Turner Syndrome associated with vaccination.
Severe pain in shoulder and difficulty moving arm/shoulder. Ice applied, OTC MOTRIN administered. Slightly elevated temp also (99.4 up from 97 at time of admin).
Patient was seen on 5/19/21 complaining of numbness and tingling in both of his hands, face, and mouth, and stated that it started three days prior. He was not having any fevers and there was no known injuries. Dr. ordered a CBC w/ diff, CMP, ferritin, Hemoglobin A1C, iron and TIBC, and TSH, all of which came back normal.  Patients' mom called hospital on 5/22/21 stating that he had an incident during a game on 5/21/21 where he became disoriented and felt like he became less alert. He went to the Emergency Department on 5/23/21 with numbness and tingling that was present for one week and a headache for one day. After evaluation it was decided that neurology would see him outpatient. Neurology saw him on 5/25/21 and he said he has had difficulty concentrating and maintaining attention. He has also had memory issues. They ordered an MRI and EEG which have not occurred yet.
Arm pain, pins and needles in vaccine arm, chest pin, tachycardia, palpitations, night sweats,
Symptom of lupus returned after three year span of remission; all major joints painful, extreme fatigue, anorexia; mouth ulcer; ANA elevated.
Flu vaccine given 10-27-2004.  Started feeling itchy morning of 10-28-2004 and as the day progressed she became worse.  As of 10-29-2004 she presents to the clinic with urticarial rash scattered over entire body, has been taking Benadryl since 7pm on 10-28-2004.  Woke up on 10-29-2004 at 0130 with numbness and inflammation on lower lip.  She has been taking soda baths to relieve the itching.  Her lower lip is quite edematous and red.    Benadryl 50mg every 6 hours - was ordered by provider.  Patient instructed to call ER if symptoms worsen or persist.
Mild adverse reaction in clinic, delayed recovery lasting longer than 15 minutes.  Patient vaccinated at 10:50 am, reported feeling dizzy. Patient ate fruit gummies pouch and drank some fruit juice, MOC reports this as only food intake this morning. Patient laid down on mat from 10:58 until 11:20 am, lights off, drank additional juice, and smelled ammonia inhalant. Patient sat up at 11:25 on mat, at 11:30 sat up in chair. Explained to parents possibility of calling EMS. Additional RN's present, HR 80bpm, respirations normal, walked around clinic space with nurses at side. Patient reports feeling better. Discharged to home, sent with additional fruit juice and pretzels. Advised parents to continue monitoring and seek medical attention for warning signs (loss of consciousness, pain to injection sites worsening). Parents verbalized understanding.
no additional adverse symptoms were reported; a patient received a dose of properly stored PROQUAD after its labeled expiration date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, concomitant medication, drug allergy/reaction was not reported.  On 03-JAN-2020, the patient was vaccinated with a properly stored, expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) albumin status:recombinant Human albumin (rHA), lot # R015746, expiration date:02-DEC-2019 (strength, dose number, route, anatomical location was not reported) for prophylaxis (expired product administered). Other suspect therapies included sterile diluent (strength, dose, dose number, route, anatomical location, lot/batch #, expiration date was not reported). No additional adverse events were reported. No product quality complaint was involved.
Tired; This case was reported by a consumer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 20th October 2017, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1127 days after receiving Shingrix, the patient experienced tiredness. On 20th November 2020, the outcome of the tiredness was recovered/resolved.   The reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced tiredness. This case has been linked with US2020AMR233686, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR233686:same reporter
he has had severe stomach pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 08May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 09May2021, outcome "not recovered", described as "he has had severe stomach pain".  Additional information: Patient's sister (reporter) reported the age as 38 or 39 years old. Stomach ache was unbearable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was sitting in her chair when the RN noticed that the patient started to lean forward and proceed to fall forward out of the chair.  The pt hit her head on the floor and lost consciousness.  The RN rolled the pt onto her side and the pt woke up.  Paramedics responded BP 90/69,  HR 49, glucose 95.  The paramedics recommended that the pt go to the hospital, pt refused. Pt was monitored for an additional 30 minutes.
extreme fatigue, pain at injection site, muscle aches, extreme chills, lymph node swelling size of a lemon that lasted 7 days with pain on a scale of 1-10 at 10, bruising at injection site, bruising around lymph nodes and underside of arm.
Rebound of symptoms and positive antigen test; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), on 20Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety/ADHD" (unspecified if ongoing); "Anxiety/ADHD" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered", described as "Rebound of symptoms and positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2022) Positive, notes: Positive antigen test; (Aug2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical information: The patient had no known allergies. The patient received vaccine and other medication were received in 2 weeks. Anti-viral details included; Product was COVID 19 Treatment. Brand was Pfizer. Treatment start date was 17Aug2022 and treatment stop date was 22Aug2022. Indication was for Treatment of COVID-19.  No follow-up attempts possible. No further information expected.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were 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 provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.
mom states pt recv vax 27MAR95, pt had elevated t104 & chills @ 930PM on 27MAR95 & was taken to ER for tx;
Information has been received from a nurse practitioner concerning a 14 year old female who on 31-JAN-2008 was vaccinated with the first dose of GRADSIL, 0.5 mL, IM. Concomitant medication was not reported. On an unspecified date in 2008, the patient had "periods of blacking out" after she received the vaccination. It was also reported that the patient was having migraine headaches. The reporting nurse practitioner stated that the neurologist felt that the symptoms were not related to GARDASIL. The patient will not complete the series of vaccinations. Additional information is not expected.
Pain at site of injection. Has not abated after 2 weeks and 2 days. No treatment until today. Hurts to abduct arm.