chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Had red rash on the lower part of the right arm/Had red rash on right beast) and PRURITUS (Had itchiness on the lower part of the right arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Had red rash on the lower part of the right arm/Had red rash on right beast) and PRURITUS (Had itchiness on the lower part of the right arm). At the time of the report, RASH ERYTHEMATOUS (Had red rash on the lower part of the right arm/Had red rash on right beast) and PRURITUS (Had itchiness on the lower part of the right arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: TCR: Gave HCP follow Up consent. No email address/fax number to send ADR.Received new document, No New Information
minor body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 24Jan2021 at 12:00 as dose 1, single (Lot number: EL8982) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: ZOLOFT oral taken for anxiety, start date: 2003 (ongoing). The following information was reported: PAIN (non-serious) with onset 24Jan2021, outcome "recovered" (25Jan2021), described as "minor body aches". Therapeutic measures were not taken as a result of pain.  Additional information: The first 2 vaccines resulted in minor body aches that lasted about 24 hours. Not serious, no medical attention was required. Relevant tests and specific relevant tests for thromboembolic events with thrombocytopenia were none.
Vaccines given on 12-13-07 in afternoon.  Mom called Dr. Friday 12-14-07 in evening.  Pt. C/O redness, warmth, pain at injection site L leg.
Received a dose of GARDASIL 9 on 22-5-20 after previously receiving 2 doses of GARDASIL  on unspecified dates "about 2 to 3 years ago"; Received a dose of GARDASIL 9 on 22-5-20 after previously receiving 2 doses of GARDASIL  on unspecified dates "about 2 to 3 years ago"; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant therapies were not reported. On an unknown date in 2017 (reported as 2 or 3 years ago), the patient was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and then on an unspecified date, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (routes, anatomical positions, lot numbers and expiration dates were not reported) as prophylaxis. On 22-MAY-2020, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, anatomical position, lot number and expiration date were not reported) as prophylaxis (interchange of vaccine products and inappropriate schedule of product administration). The outcome of the events was unknown. Causality assessment for the event of interchange of vaccine products was not reported. No additional information was provided. No product quality complaint was involved.
This is a spontaneous report obtained from a non-contactable nurse through a Pfizer sales representative. A 85 year-old male patient received, on an unspecified date, in Jul2015, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jul2015, the patient experienced rash all over his body, fever, and cellulitis. Clinical outcome of the events was unknown and causality was not available at time of this report.
experienced arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. After receiving the vaccine the patient experienced arm soreness.  The reporter did not consent to follow up. This case is linked to the case US2020240882, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020240882:same reporter
Onset of fever, chills, myalgia on 11/3/07 at approx. 11:00am.  Left upper arm painful, red & swollen.  Ibuprofen 400 mg prn fever, myalgias & hot packs to area.  Rociphin 1000 mg IM on 11-5-07, Bactrim DS 900 mg BID x10 days.
Gums & Lips swelled up drastically.  Was so swelled up I was on straw diet for 10 days, benadryl helped.  For second vaccine an EpiPen was called in for possible anaphylactic reaction.
Rash breakout with red bumps all over body, mostly under arms and things; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash breakout with red bumps all over body, mostly under arms and things) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Antidepressant therapy.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Rash breakout with red bumps all over body, mostly under arms and things). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Rash breakout with red bumps all over body, mostly under arms and things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Arm started hurting, heat up to shoulder joint, down both sides, into left breast. Went to ER the next day. Then saw Dr. orthopedist.
As of 4/4 swollen lymph node in armpit on same side as injection in arm. Still swollen on 4/6.  4/6 evening, noticed itchiness at injection site and slight rash.
Diarrhea; Experienced fever of 101 degrees F; Started vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Experienced fever of 101 degrees F) and VOMITING (Started vomiting) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Oct-2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Experienced fever of 101 degrees F) and VOMITING (Started vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (Experienced fever of 101 degrees F) and VOMITING (Started vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101 degrees f (High) 101 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB lot # K008879 exp. 30-MAR-2017, lot# K019701 exp. 17-JUL-2017, K026533 exp. 07-AUG-2017 (dose, route of administration not reported). The LIQUID PEDVAXHIB was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Information has been received from a registered nurse concerning an 11 year old female who on 11-MAR-2009 was vaccinated with GARDASIL (lot number, route and site not reported). Concomitant therapy included DAPTACEL and LUPRON. The patient was to receive DAPTACEL and MENACTRA. It was not product confusion. It was a human error on the part of the nurse. Based on child's age the nurse thought GARDASIL was to be given. The patient's mother did not want the child to get GARDASIL. No adverse effects noted. The patient sought medical attention. Follow up information was received from consumer concerning her daughter. The mother stated her daughter would not continue with the 2nd  or 3rd dose of GARDASIL. Follow-up information has been received from a health professional concerning the 11 year old female who on 11-MAR-2009 was vaccinated with the first dose of GARDASIL (lot number 661846/1312X, route not reported) into her right deltoids. Concomitant therapy included her first dose of DAPTACEL, (lot number AC52B030AA, route not reported) into her left deltoid. The patient has two siblings. Additional information is not expected.
pt passed out & was assisted to the floor;pt had some sz activity lasting a few seconds;pt found out from mom that is allergic to diphtheria in Td;
On 10/21/2000, the patient's mother noticed a rash on her left buttocks and took her to an urgent care facility. The patient was treated with steroids. The patient was seen on 10/23/2000 and was diagnosed with greater than 60 clusters of lesions in the left S1 dermatome. The steroids were discontinued and the patient was then treated with acyclovir and atarax. The reporter believed that the patient's symptoms were worsened with the treatment of steroids. The PA also reported another patient's symptoms.
PATIENT'S ARM WAS SWOLLEN, HOT AND RED THE MORNING AFTER RECEIVING THE IMMUNIZATION. PATIENT ICED THE ARM AND USED OVER-THE-COUNTER ANALGESICS FOR RELIEF.
Information has been received from an office medical assistant concerning an approximately 14 year old female who "sometime last year 2009", in 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). It was reported that the patient after receiving the first dose of series of GARDASIL, sometime last year 2009, the patient experienced migraines, dizziness and vomiting for two days and then they went away. The patient sought unspecified medical attention. The AEs improved on therapy. On an unspecified date the patient recovered. The patient was not going to receive second or third dose of GARDASIL. Follow up information was received from office medical assistant who was told by the patient's mother concerning this 13 year old (previously reported as approximately 14 year old) female with no illness at the time of the vaccination and no known drug allergies who on 17-DEC-2008 (previously reported as sometime last year 2009) was vaccinated with a dose of GARDASIL at another office. After the vaccination was given the following 24 hours, on approximately 18-DEC-2008, the patient had vomiting, dizziness and bad migraines. At the time of the report, the patient recovered from the symptoms. No further information is available.
After giving the Typhoid inj. & Tdap in patient's left arm, I gave the Hep A in his right deltoid. Immediately after receiving the Hep A, patient went unconscious & had a seizure. Was unconscious for less than 1 minute. Fully recovered.
Patient reports fatigue, joint pains, joint stiffness and joint warmth for 1 month
fatigue, hand and feet tremors, nausea, dizziness, heart pounding sensation, h/a, tingling to  hands and feet, heart pounding when lying down, "shock wave" sensation that would occur suddenly and travel up her body.
NASAL CONGESTION; MUCUS; CHILLS; PAIN AT THE INJECTION SITE; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 13-MAR-2021 15:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced nasal congestion. On 13-MAR-2021, the subject experienced mucus. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain at the injection site. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, fatigue, nasal congestion, mucus and pain at the injection site was not reported. This report was non-serious.
underwent a stem cell transplant; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: (004756).  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "organ transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation. The following information was reported: STEM CELL TRANSPLANT (medically significant), outcome "unknown", described as "underwent a stem cell transplant". Therapeutic measures were taken as a result of stem cell transplant. The caller wanted to know the timeframe for a patient, who underwent stem cell surgery, to get a Pfizer bivalent COVID vaccine. Further explained that the patient had his primary series and booster doses of the Pfizer BioNTech COVID-19 vaccine. He then underwent stem cell transplant and got the primary series of the Pfizer BioNTech COVID-19, monovalent vaccine again on 08Mar2023 and 30Mar2023 respectively. The caller asked if all the vaccines prior to the stem cell transplant are invalid. The caller specifically requests information regarding the bivalent Pfizer BioNTech COVID-19 vaccine. The caller also asked if the patient could receive a second dose of Pfizer BioNTech COVID-19 bivalent vaccine 4 months after the first one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported event STEM CELL TRANSPLANT assessed as unrelated to suspect drug  and more likely related to intercurrent/ underlying medical condition,Linked Report(s) : US-PFIZER INC-202300214458 same patient, different drug, dose and event;US-PFIZER INC-202300214459 same patient, different drug, dose and event;
This spontaneous case was initially received on 13-Jan-2016. The case report was received from a Health Professional and concerns an adult female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Start date: Nov-2014 or Dec-2014. No additional drugs suspected. In 2014, after starting treatment with AFLURIA the patient experienced Hives. She went to her OT the following day and was told it was not a reaction to the vaccine. She was treated with diphenhydramine. She had an allergic reaction to diphenhydramine and was then placed on prednisone which helped. For relevant test results see appropriate report section. Linked case: 2016057883 (same patient). Follow-up information received from HCP on 16-Mar-2016: The patient's medical history included reactions to penicillin/amoxicillin allergy and sulfa with tingly hands and slight puffiness, diphenhydramine allergy, migraine, hypertension, and globus. She had no history of asthma, sinusitis, or reactions to food. Her medications included pravastatin, nebivolol for hypertension, and vitamin D. Last year, less than 24 hours after receiving influenza vaccine, the patient developed a generalized rash with enlarging patches of erythema, minimal itch, and no palpable lesions. The eruption cleared after about 2 weeks and a course of prednisolone.
Pulled needle out too quickly; Vaccine ran down her arm; A spontaneous report was received from a consumer concerning a 38-year-old female consumer, who received Moderna's COVID-19 Vaccine (mRNA-1273) where needle was pulled out too quickly and vaccine ran down arm.  The patient's medical history was not provided. Relevant concomitant medications included seizure medications.  On 13-FEB-2021,The patient received the first of the two planned doses of mRNA-1273  (Batch# 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13-FEB-2021, while receving vaccination, the needle was pulled out too quickly and vaccine ran down arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event(s) the needle was pulled out too quickly and vaccine ran down arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient relates sudden onset of left-sided upper arm pain centered over the deltoid insertion and biceps that started approximately 2 to 3 hours after her COVID booster.  Has been unrelenting ever since.  She has seen multiple doctors had multiple imaging and continues to have pain with any kind of range of motion.  She is undergone steroid injection x2 without relief.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot number, Expiry date, dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 6hrs after shots, fever T-102 degrees followed by increased HR and vomiting x 3. Shots given on 9/8/10. Fever continues on 9/10/10. Acetaminophen alternating with ibuprofen prn.
Reports rt shoulder pain following injection with subsequent increased pain and reduced mobility to right shoulder/trouble raising arm above head.
Pt was to have Menveo vaccine, but was given Bexsero.  No adverse reaction noted.
10 days later, I developed generalized uticaria-type rash. Painful, itching. I developed swelling to joints, and pain. I developed throat pain and Shortness of breath. My HR was fast, at 150. I had to be hospitalized and placed on IV Solumedrol and Benadryl for 4 days.  I was then discharged on Oral Prednisone, Atarax, and Singulair.
Pt called to let us know yesterday 5/14/15 she noticed her right thigh where she got the Pneumococcal vaccine was swollen. Pt states she left work early due to her leg feeling stiff/swollen. Pt got home and her temperature was 101. Pt followed up with her PCP and was given a antibiotic injection. Pt states she is unable to put weight on her leg at all due to pain. Pt is taking ibuprofen PRN for pain and ZYRTEC for inflammation. Pt is concerned due to the high fever she has been experiencing and the diameter of the swollen spot from the vaccine. Spoke with Dr and he is going to call the pt to FU. Called patient to check on her status this morning. She is on AVONEX in the Vaccine Study. Reviewed the sequence of events with patient. On 5/13/15 noted mild pain and redness the size of a dime at the PNEUMOVAX injection site on right lateral thigh. She reports the pain increased and she was very uncomfortable sitting down at work, so went home. She took her temperature and it was 101 degrees and at that time the area was greater than a quarter size. She took ADVIL, TYLENOL and hydrated. She was evaluated by her PCP on 5/15/15 and the injection reaction area grew to 3-4 inches in diameter. Her PCP told her to take BENADRYL 50mg and continue ADVIL and elevate the right leg. She was advised if the area grew larger to call back. She started KEFLEX 500mg po BID for 10 days. Her fever then went up to 102.6 and grew larger. Then 2 hours later went back to PCP and was given ROCEPHIN IM (5/15/15). The next day (5/16/15) the injection site area grew larger, increasing in redness, swelling and pain. She noted ecchymosis in the center of the reaction and her PCP advised  her to go to ER. She was given Vancomycin IV 350 over 2 hours. She reports labs were done and WBC were slightly elevated. She started a Rx of BACTRIM DS one po bid(5/16/15) and then discharged home. Spoke to her this AM and she reports it has grown a bit larger with a "funky bruise" color; however, no fever, less painful and mildly swollen. Advised to follow up with PCP for evaluation and follow up with me afterwards.
group of kids" were administered the adult dose of Havrix; group of kids" were administered the adult dose of Havrix; This case was reported by a physician via call center representative and described the occurrence of overdose in a patient who received HAV (Havrix adult) (batch number S002507 ?, expiry date unknown), (batch number 94J24, expiry date unknown), (batch number G99R4, expiry date unknown) and (batch number J95H7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The physician reported that a group of kids were administered the adult dose of Havrix starting about a month ago to date, which led to overdose and inappropriate age at vaccine administration. There was no reports of symptomatic adverse event at the time of reporting. The reporter consented to follow up. The reporter provided Lot numbers but did not have expiration dates to provide for vaccines. The batch number of Havrix vaccine was reported as S002507. As per sales data, this number did not match with any Gsk lot. The batch number of Havrix vaccine was reported as 944J24, which was not available in sales datasheet, hence updated to 94J24.
Previously healthy 22 yr old male with 6 days of chest pain, nl toponin, ECHO, CRP and ESR and mild abnormal ECG, patient given clinical diagnosis of pericarditis which seems correct.