chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Distal injection site with area of reddened induration 6 cm (width) x 3.5 cm (length). Proximal injection site with small area of yellow resolving bruising. Dad states patient has been limping off and on and denies noticing patient actively itching site. MD revied and stated it was a local reaction and not an infection. MD advised to apply ice pack PRN to site on 10/26/23.  Seen in clinic 10/27/23: "Large local reaction to immunization.  This is not uncommon and will resolve with conservative cares.  Advised to continue to apply ice.  No difficulty walking during exam today.  No present concern for cellulitis however we should continue to monitor.  I drew an outline around the rash with parental consent so that we can continue to monitor over the weekend.  In light of the upcoming weekend, I sent a prescription for Keflex 25 mg/kg/day for 7 days which I instructed the parent to start should there be any concern for significant worsening of the rash beyond the marked outline.  At this time the antibiotic is not yet needed.  Father is agreeable with this plan." from MD
Fever, chills, headache, body aches, abdominal pain, nausea,
5 DAYS AFTER VACCINE, STARTED DEVELOPING SYMPTOMS INCLUDING HEADACHES, VISION LOSS AND RASH
5.5 hours after the sore arm. Next morning I was cold but about noon chills started till 7pm with extreme exhaustion.
Dizzy, shaky, hives, shortness of breath like (asthma) joint pain, headache (bad) vision change (blurry) back, neck pain, fever and ER they found no other reason than immunization. She sleeps sometimes 19-20 hrs a day. Joints hurt now.
itching like a mosquito bite; injection site reaction; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of unknown age who experienced injection site reaction (injection site reaction) and itching like a mosquito bite (injection site itching), while she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE injection lot number not reported  via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious injection site reaction (injection site reaction) and itching like a mosquito bite (injection site itching) unknown latency following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Other lab data was not reported.  Final diagnosis was injection site reaction (injection site reaction) and itching like a mosquito bite (injection site itching).  It was not reported if the patient received a corrective treatment.  Outcome of event was unknown.  Information on the batch number was requested.
Rashes/Hives all over the lower back, legs, hands, arms, elbow and small rashes and hives in the area where vaccinated (pictures available, if requested).  Doctor's diagnosis was "Urticaria, unspecified"   Taking Benadryl, applying cortizone cream, and received prescription called Hydroxyzine 25 mg
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    This case contains information for the 65 out of 77 adult patients described by the reporter. No concomitant information was reported. It was reported that, Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
Lymph node Inflammation under injection arm; Rash; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lymph node Inflammation under injection arm), RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph node Inflammation under injection arm), RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 27-Mar-2021, VACCINATION SITE LYMPHADENOPATHY (Lymph node Inflammation under injection arm), RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  Concomitant medications were provided   This case was linked to MOD-2021-089699 (Patient Link).
Home test antigen COVID test performed today July 10, 2022 was positive; Home test antigen COVID test performed today July 10, 2022 was positive; Decrease appetite; Hoarseness; Nausea; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 29Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 10Jul2022, outcome "unknown"; DYSPHONIA (non-serious) with onset 10Jul2022, outcome "unknown", described as "Hoarseness"; NAUSEA (non-serious) with onset 10Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Home test antigen COVID test performed today July 10, 2022 was positive"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Decrease appetite". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: Home test antigen COVID test performed today July 10, 2022 was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The 15 year girl who was vaccinated with pfizer COVID vaccine 2 doses in May and Jun2021 and a booster dose in 29Jan2022 who woke up today Sunday 10Jul with hoarseness and later in the day developed nausea and dizziness. She also developed some decrease appetite. Home test antigen COVID test performed today 10Jul2022 was positive. Optional Information already mentioned in the description of the event. Nothing else to add. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Significant fatigue that starts every afternoon usually with a headache until I go to bed.  Then wake up fine to only the fatigue starting over again in the afternoon.  Usually take naproxen for the headache.  This has occurred everyday since the day after getting the vaccine.
This spontaneous report as received from a healthcare worker refers to 4 patients of unknown ages and genders. On an unknown dates the patients were vaccinated with MMR II albumin status unknown (route, dose number and dosage unknown; lot # J003791 EXP 28-MAR-2015). It was reported that the vaccine was given to 4 patients after the vaccines were exposed to temperatures outside of recommended condition. No adverse events were reported. Additional information has been requested.
Child inadvertently received the second dose of MMR just 2 weeks after the last dose (verses 28 days)
severe abdominal cramping that started on 6/19 and still continuing on 6/22 when reported
Tingling and flushing in arm  Of vaccine. Followed by tightening of throat And rapid heart rate. Is followed by uncontrollable shaking of the legs. Blochi skin.
Pt recvd vax on 22OCT91 & mom reported pt up all night, screaming (130-430PM), t103, chapped lips, inject site tender but not inflammed; seen by MD 23OCT, t102.5; fatigue, some tremors;
DID NOT CONTINUE THE VIVOTIF AFTER TAKING FIRST DOSE; A spontaneous case report was received from a nurse on 25-Oct-2019 for two consumers.  Based on the information obtained from the nurse two individual case safety report PVX201910-000826 (PVX2019-2664; first consumer) and PVX201910-000829 (PVX2019-2665; second consumer) were created and cross-linked in the database.  This case (PVX2019-2665) described a female consumer who "did not continue the Vivotif after taking first dose" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-Oct-2019. It was reported that she was traveling on 29-Oct-2019, so she will be receiving the injectable typhoid vaccine instead and not continuing the Vivotif.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not continue the Vivotif after taking first dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not continue the Vivotif after taking first dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000826:
Legs swelling, trouble writing, disoriented and can't find words, trouble with speech, unsteady gait, dizziness.
This case was reported by a nurse via call center representative and described the occurrence of chills in a 50-year-old female patient who received SHINGRIX. On 8th April 2018, the patient received the 1st dose of SHINGRIX. On 8th April 2018, 9 hrs after receiving SHINGRIX, the patient experienced chills, headache and pain. On an unknown date, the outcome of the chills, headache and pain were not recovered/not resolved. It was unknown if the reporter considered the chills, headache and pain to be related to SHINGRIX. Additional details were provided as follows: On 8th April 2018 at 14.00, the patient received SHINGRIX. Limited information was provided.
Patient presented to emergency department on 11/2/2021 with shortness of breath, hypoxia, and cough. He had tested positive for COVID-19 on 10/26/2021. He was given monoclonal antibodies. Patient's condition continued to worsen. He was treated with dexamethasone, baricitinib, and supplemental oxygen. He was transferred to the ICU on 11/15/2021 and required intubation. Patient was changed to comfort measures only on 12/19/2021 and expired on 12/19/2021.
give a TENIVAC dose today after it expired, with no reported adverse event; Initial information received on 18-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 60 years old female patient who was given a tenivac dose today after it expired, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  On 18-May-2022, the patient received dose of  0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, ( lot:  U6603AA ; expiry date: 05-Mar-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that the patient was given a tenivac dose that day after it expired, with no reported adverse event (expired product administered)  (onset date: 18-May-2022; latency: same day) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event give a tenivac dose today after it expired, with no adverse 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.
I developed a pain in my left arm. I went into the doctor he thought it was a hematoma. He thought I was acting positively. It was painful but I could still move it. I took Tylenol and Ibuprofen as instructed by my PCP. I dealt with the pain and continued to get my booster dose.
Rapid heart rate; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1053) via an unspecified route of administration in the left arm on 12Apr2021 at 17:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19.The patient did not receive any concomitant medications  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced rapid heart rate. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rapid heart rate was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Left arm bruised and sore, but not an issue. About a week after vaccine, I had shooting pain in left ear, left neck and throat, and my head on left side at various places. I first thought it might be a sinus infection or throat infection, but doctor examined me and concluded the pain was probably a result of the vaccine. She prescribed Gabapentin and extra-strength Tylenol for the neuralgia or pain.
The patient received her 2nd dose of SHINGRIX on 11/7/18, and the next night she developed two small spots of shingles, perhaps 1/2 inch in diameter. She had received her 1st dose on 07/01/2018 and developed shingles on 10/3/18. She stated she no longer had the rash present from her October shingles outbreak, so it was determined ok to give the 2nd shot based on recommendations. She went to the doctor and was treated with valacyclovir 1 gram tid for 7 days for both shingles episodes. Keep in mind she is being treated for chronic leukemia with SPRYCEL. It appears she did receive a quadrivalent influenza vaccine on 10/27/2018. She did not receive it at our facility but I was able to look it up in a statewide vaccination database.
Dizziness and some nausea (almost ran off road in my car); sore arm.
Site of injection remained swollen for 8 days. On day 8, site become red, hot, and itchy. Area of swelling and redness increased throughout the day, about 11 cm.
HARD NIGHT SLEEP; HAD GOOD LUCK WITH IT / HELPED WITH NEUROPATHY AND FEET DID A LITTLE BETTER / HAD PAIN IN LEFT KNEE AND THAT WENT AWAY ALSO; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: neuropathy (pain in left knee). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported that he was happy with getting the vaccines and did not want to receive Moderna's. Per the consumer, he had good luck with it. He mentioned the Vaccine helped with his neuropathy and feet did a little better. He state he had pain in his left knee and that went away also (coded as unexpected therapeutic benefit) (dose number in series 2). The patient stated when he got the booster he had a hard night's sleep but his feet were still doing better (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had good luck with it / helped with neuropathy and feet did a little better / had pain in left knee and that went away also and hard night sleep was not reported. This report was non-serious.
Vomit/extreme chills and headache for 24 hours muscle ache and joints almost like a sever Flu.
tiredness; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PYREXIA (fever) and NAUSEA (nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 040821A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's thyroiditis on 09-May-2003. Concurrent medical conditions included Allergy to antibiotic (tetracycline), Penicillin allergy and Cosmetic allergy (allergic to some skin care products.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, VITAMIN B [VITAMIN B NOS], ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS, PROBIOTICS NOS and MAGNESIUM for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, FATIGUE (tiredness), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            treatment to the events not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-071125 (Patient Link).
Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP's for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation, elevated lipoprotein and hemocystine line.  05/21/2007 MR received form treating hospital.  Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing.  The pain radiated to the Right shoulder.  Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP.  Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct.  Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Patient developed severe pain in shoulder that has persisted. Vaccine site indicated by patient was into the deltoid ligament and not in the muscle. Continues to have limited range of motion and pain.