chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache, pain in the back of my head, neck pain redness at the site of vaccination arm swelling all the way down to the hand, dizziness lightheaded pain in the left ear overall feeling tired weak and horrible.
Left arm redness and hives one week later after injection. At injection site, Warm to touch.  Slight itch.  Redness grew double in size after first day of reaction.
This spontaneous report as received from a Doctor of pharmacy refers to a 50 year old female patient. No known pertinent medical history or drug reactions/allergies. On 27-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J001008., exp. date: 24-APR-2014), 0.65 ml, subcutaneous. Concomitant therapies included nortriptylene and losartan potassium (manufacturer unknown). On an unknown date, the patient developed an injection site reaction. The immediate area was red and raised and the size of a quarter. Surrounding the area was an area 3 inches in diameter that was swollen and pink. The injection site area was sore to the touch. The patient sought medical attention by pharmacy visit. The pharmacist told the patient to treat the area with ice and to take ibuprofen (manufacturer unknown). No laboratory tests were performed. On 01-JUL-2013, the patient said she was feeling better. The patient outcome was reported as recovering. Additional information has been requested.
Dizziness lead to loss of balance and patient fell on the floor after setting up appointment for 2nd dose. She was ok. She stayed on the ground to recover. No additional injury was reported.  She left with her family member once she recovered
On an unspecified date, this 5 year old female received her fourth dose of vax in series. One day later she developed an area on the deltoid of erythema and induration. The induration was approximately 2 inches with some slight ecchymosis. The pt complained that her arm was sore. She was instructed on cool compresses and Tylenol. The most recent information received on 10/21 reports the condition of the pt is ongoing.
NEPHROPATHY; RIGHT SIDED OCCIPITAL NEURALGIA; PLATELET ISSUES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced nephropathy, right sided occipital neuralgia, and platelet issues. Treatment medications (dates unspecified) included: propranolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nephropathy, right sided occipital neuralgia, and platelet issues. This report was non-serious.
Information has been received from a Registered Nurse concerning a 2 month old male who on 30-APR-2009 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot number was not provided).  On 04-MAY-2009 the patient experienced blood in the stool and diarrhea.  Unspecified medical attention was sought.  Tests for blood and rotavirus were performed.  On an unspecified date the patient recovered.  Upon internal review, blood in the stool was determined to be an other important medical event.  Additional information has been requested.
Had seizure 7/25/09. Had Mri & Ct scan & blood work. In August diagnosed with Hashimoto Thyroiditis & compensated hypothyroidism.  10/6/09 PCP medical records received DOS 7/30/08 to 8/27/08. Assessment: Syncope Follow up from ER. Seizure?. Eyes rolled back, twitching, then limp. Lasted 30 seconds.
Left arm red, hard, warm to touch.  Dr. assessed arm and gave Keflex.
Pain/redness raised area on left arm. Symptoms occurred 12-24 hours after vaccine. Raised bump.
Information has been received from a certified Medical assistant concerning a 29 month old female, previously reported as adolescent, with no known drug allergies and no past medical history who on 25Oct2001 was vaccinated in the leg with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 10Apr2003 the pt presented to dr's office with a moderate case of chickenpox. Unspecified medical information was sought. Follow up information indicated that on 10Apr2003 the pt was seen in the office and was diagnosed with varicella. Itchy pustules were found on her chest and legs. The reporter indicated that the pt's sister was vaccinated with a dose of varicella virus vaccine live and developed a moderate case of chickenpox. Additional information has been requested.
This spontaneous report was received from a medical assistant, refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered RECOMBIVAX HB (strength, dose, route, lot# were not reported) which were exposed to temperatures of 10 degrees Celsius for 7 hours and 45 minutes. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
patient suddenly felt sick - dizzy and nauseous -  complained of dry mouth - gave a bottle of water and also checked blood pressure  117/84 HR 90   - no sign of breathing difficulty
Fiance reports 24 hrs after receiving the COVID-19 J&J vaccine pt passed away
Arm swelling, hardness, hot, redness. Continued for 9 days, 7th day was the worst.
flu like symptoms; fever; chills; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix and Shingrix, the patient experienced influenza-like symptoms, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and chills to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter had noticed the flu like symptoms (fever and chills) with a number of patients that started about 10 to 12 hours after 1st or 2nd dose and lasted for about 10 to 12 hours. The reporter gave consent to follow up via mail. This case has been linked with case US2019AMR209590, reported by same reporter.
Product storage error; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) (batch number MG92G, expiry date 3rd May 2021) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the PFS Pediarix vaccine was activated one day ago, which led to incorrect storage of drug. The reporter wanted to know if the vaccine can still be use a day after the activation.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) who received from a consumer regarding a 41 year old female pt who experienced nasal congestion.  At 41 years of age, the pt received a dose on 12/04/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/04/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion) on 12/05/03.  As of that date, the event had not resolved.  No additional information was available at the date of this report.
arm was sore; she couldn't lift it; redness; swelling /area became huge, puffy/swelled up to the size of a tennis ball; itchy; enlarged lymph node / swelled up; vertigo; could not get out of bed for two to three days; puffy; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in January 2020 refer case the US2020156578).   On 1st July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo, activities of daily living impaired and tissue puffing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo and tissue puffing were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo, activities of daily living impaired and tissue puffing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In July, the patient arm was sore within a few hours and she couldn't lift it the next day. The swelling and redness didn't develop until a few days later.  On the third days, the area became huge, puffy and itchy. An enlarged lymph node developed in the arm pit of her left arm and swelled up to the size of a tennis ball.  Four days after the shot, she had vertigo and could not get out of bed for two to three days which was how long it lasted. She did see her primary physician.  All side effects were resolved around seven days after the injection. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156578:same reporter
We were informed by EMS that the patient was found deceased on 2/11/2021 at her home.  EMS states she was dead for some time, no medical care given.
Rash, redness, hardness in the area of shot injection, crossing of eyes/ eyes rolling back, difficulty breathing, loss of ability to stand or walk around, muscle weakness, fever of 104, and restlessness.
Approx 5 minutes after injection, injection site arm shoulder began to have a burning sensation, progressed to neck back of head burning sensation and pain. Then progressed to all over body shakiness, confusion, high blood pressure 220/120 , tachycardia , unable to stand without falling.
Shingles rash; rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with antibiotics nos and steroids nos (Steroids). On 15th July 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. About a week after receiving the dose, she developed a shingles rash in her right ear that lasted amonth and a half.  The patient was treated with antibiotics and steroids. The patient received the injection in her right arm.  The reporter did not consent to follow up.
Colon operation; Sleepy; Vomited; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4438481-00 (Agency).  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. , Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: COLON OPERATION (medically significant), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleepy"; VOMITING (non-serious), outcome "unknown", described as "Vomited". The action taken for adalimumab was unknown.  Clinical course: Reporter also reported as an adult female with events of Colon surgery and non-serious sleepy after Covid Vaccine/slept 15 hours and Vomited after Covid booster with humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced colon surgery, sleepy after covid vaccine/slept 15 hours and vomited after covid booster.   Causality assessment: The reporter's assessment of the causal relationship of "colon operation", "sleepy" and "vomited" with the suspect product(s) 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 causality for the event(s) of colon surgery with humira (Adalimumab was no reasonable possibility) Not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of sleepy and vomited  were assessed as related to the  Comirnaty vaccine. Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  event colon operation.
Testicular pain; Pain with urination; sweating; Hives; Macular rash on his back; Dizziness; vomiting; chills; muscle aches/sores on his arms; fever; severe pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives) and RASH MACULAR (Macular rash on his back) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 059721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, TESTICULAR PAIN (Testicular pain), DYSURIA (Pain with urination), HYPERHIDROSIS (sweating), URTICARIA (Hives), RASH MACULAR (Macular rash on his back), DIZZINESS (Dizziness), VOMITING (vomiting), CHILLS (chills), MYALGIA (muscle aches/sores on his arms), PYREXIA (fever) and VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-324016 (Patient Link).
Vaccine site, L upper arm, with erythema mild swelling & vesicular erupting 4 x 4 cm area.
Patient exhibited seizures 2 days after shot (DTaP, HIB, and Pneumococcal). Patient diagnosed with idiopathic infantile spasms and is being treated with 6 weeks ACTH therapy. Per follow up report-Patient is currently taking 250mg of Sabril and will need to continue taking the medication for 1 year.  The medication is currently stopping her seizures.  However, it gives her significant reflux and may cause loss of peripheral vision.  We are unsure of her outcome once she tapers off of the medication in 11 months.  Her condition is still termed as idiopathic.  No genetic or other cause (other than the vaccination) has been linked to her condition. 1/13/06 Review of D/C summary confirms admission diagnosis of febrile convulsions and discharge diagnosis of infantile spasms.  Treatment with ACTH was documented. D/C on ACTH & Zantac. Review of ER admission note (medical record) states diagnosis as seizures. Increased fussiness noted. Abnormal EEG with hypsarrythmia noted. Head CT & brain MRI WNL. Platelets were 520 (150-400 norm). In spite of an elevated Taurine level of 240.2, there was no evidence of a disorder of amino acid metabolism. 12/31/09 Patient is currently tapering off the medication she has been taking for 11 months. She has been seizure-free since 10/05. Her long term seizure activity is unclear. SHe has no evidence of a cause for her sizure activity CT scan and MRI show no cause for infantile spasms. EEG has now normalized. Vaccination is our only suspect thus far.
Fever, chills, muscle/body aches, headaches, and fatigue. Onset 1 hour after vaccination. Cleared 10 days later.
approximately 40 patients over the age of 64 have received ADACEL with no reported adverse event; Initial information received on 15-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves elderly and unknown gender approximately 40 patients over the age of 64 have received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2018 the patient developed a non-serious approximately 40 patients over the age of 64 have received Adacel at (unknown: formulation, strength, dose, frequency, route, administration site, batch number) for prophylactic vaccination with no reported adverse event (product use issue, unknown latency).  It was reported that "Pharmacist did not have any individual patient information available currently. Pharmacist states that she is compiling this information and agreed to follow-up to provide this information. Pharmacist states that email is the best method to communicate with her. No additional information provided by the reporter."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Father called today reporting that his daughter had vaccines on 9/15/22 and began having a headache, body aches, and fatigue on 9/17/22, then went to school yesterday and vomited. He said he took her to doctor and they said her symptoms were related to vaccines more than likely.  He said that today she has developed a rash all over but other symptoms have resolved.
Information has been received from a registered nurse (RN) concerning a 6 month old patient who on 09-MAY-2008 was vaccinated PO with the first dose of ROTATEQ and was in the office on 09-SEP-2008 to receive the second dose ROTATEQ. The RN reported that there were no problems. It is unknown if the patient sought medical attention. A product quality complaint was not involved. Follow-up information was received on 29-SEP-2008 from a registered nurse who reported that there no adverse reactions or problems when the patient was vaccinated on 09-SEP-2008 with the second dose of ROTATEQ. No further information to be provided.
Area around ZOSTAVAX injection site reddened and warm to touch. Tender/red area approximately 2 1/2 inches in diameter. Treated with cold compress & ibuprofen. Referred patient to PCP for evaluation.
20 year old female given expired Tenivac vaccine; Initial information received on 19-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 20 years old female patient who was vaccinated with 0.5 ml first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U5525AA and expiry date: 07-Apr-2019) in the right deltoid on 19-Apr-2019.  The patient's past vaccination(s) included first dose of TDAP.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was reported that all the other expired vaccines in the refrigerator were removed except the Tenivac and there were a total of 4 including the one given.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.   Documents held by the sender: None.
Heart problems; This is a spontaneous report from a contactable consumer (patient). A 71-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly administered in left arm on 04Mar2021 13:00 (Batch/Lot Number: EN6204) as dose 1, single for COVID-19 immunisation. Medical history included diabetes from May1994 and ongoing. Concomitant medication included dulaglutide (TRULICITY) taken for diabetes. The patient reported the heart problems started after 1st vaccination on an unspecified date in 2021. The event heart problems was considered serious by the patient due to Life-threatening, Persistent / Significant disability / Incapacity and Important medical event. The event required visit to physician office. Therapeutic measures were taken as a result of heart problems which included ongoing 5 MOS (as reported) and cardiology SVT medicine. The event outcome was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101013907 same patient/reporter/product, different dose, similar event