chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a rash on the back and legs and it itches; Little red bumps appeared and itches like crazy, severely on the back and top of the tights; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Had a rash on the back and legs and it itches), RASH ERYTHEMATOUS (Little red bumps appeared and itches like crazy, severely on the back and top of the tights) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 05-Mar-2021, the patient experienced RASH PRURITIC (Had a rash on the back and legs and it itches) and RASH ERYTHEMATOUS (Little red bumps appeared and itches like crazy, severely on the back and top of the tights). On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved. At the time of the report, RASH PRURITIC (Had a rash on the back and legs and it itches) and RASH ERYTHEMATOUS (Little red bumps appeared and itches like crazy, severely on the back and top of the tights) outcome was unknown.            No concomitant medication reported. Treatment medications included diphenhydramine.  On 01-Jun-2021, the patient reported they visited a doctor and dermatologist for their rash and itching. These events are now thought to be caused by psoriasis, and the patient is now being treated for psoriasis (unknown treatment).  Company Comment: Based on 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.   This case was linked to MOD-2021-070522, MOD-2021-070522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: TCR added. Event information updated.; Sender's Comments: Based on 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.
- Fever to 101.6F,  resolved after 12 hours and  ibuprofen - Body aches, resolved after 24 hours - Chills, resolved after 12 hours - Fatigue, resolved after 48 hours
H1N1 mass immun clinic at local school. This employee took injection stated within minutes finger on both hands tingly and numb - 1 hr later - still numb - no other c/o injection site fine - went to ER bold reaction - no meds given. Better now but finger "stiff" when tries to bend.
Pfizer Dose 1 2/11/21 (EN6201) Pfizer Dose 2 3/11/21 (EN6204) COVID Positive 8/7/21 Hospitalized 8/5/21-8/9/21 Presented to and discharged to home from ED 8/10/21  8/12/21: Patient is a 75 yo female with medical history of breast cancer on chemotherapy , HLD, HTN, Hypothyroidism , Depression , Obesity  She is presenting after a syncopal episode at home. She states since yesterday she has not been feeling very well , she had an episode of non bloody emesis and passed out hitting her head. She was able to get 911 to bring her to the hospital. Of note she was recently admitted 8/5-8/9 for Neutropenic fever for which she received one dose of neupogen with improved counts . During that admission she tested positive for COVID. She was supposed to visit her PCP today about plans for possible monoclonal antibody infusion but she got admitted to the hospital. She follows Dr her last chemotherapy was 3 weeks ago and it was halted because she was hospitalized  She has not had a BM in the past 2 days. Denies abdominal pain , SOB, chestpain. She lives alone and ambulates with a walker. In the ER her vitals were stable. Labwork was remarkable for Hb 3.7 (last Hb was 8.8 on 8/10)  , wbc 1.4 , normal platelet , UA negative , normal coagulation profile, potassium 3.1 , normal lactate, elevated LDH and haptoglobulin , normal pro BNP. She was transfused 1 unit pRBC in the ER  Discussed with Dr who recommended starting her on neupogen 480mg SQ for 5 days until wbc > 15000.  8/15/21: The patient known to have metastatic breast cancer on chemotherapy, presented to the hospital with episodes of syncope and she found to be dehydrated and initially her hemoglobin was 3.7 and thoughts that was the cause of the syncope and she received 2 unit of packed red blood cell with hemoglobin improved to 10.9, most likely the initial hemoglobin result was hemodiluted.  She had fever with chills and cough, her COVID 19 test is positive.  She had chest CT angiogram show no pulmonary embolism and show bilateral pneumonitis. She did not had hypoxia and she was not candidate for steroids or IV antiviral therapy. Continue her supportive therapy with vitamins and IV fluid and Tylenol.  Initially she presented with severe leukopenia, the oncologist consulted and he recommend neupogen subcu and she received it with improvement in her leukopenia.  Patient initially started on vancomycin and Zosyn due to sepsis with leukopenia and neutropenia/immunocompromised due to chemotherapy.  Blood culture are negative so antibiotic stopped. Discussed with the oncologist, the workup for DIC and acute coagulopathy is negative, okay to discharge the patient with supportive therapy and follow-up with him at the clinic with repeated labs.  The patient had hypokalemia and hypomagnesemia which replaced p.o. and IV.  The patient feel depressed without suicidal ideation, started on mirtazapine 15 mg HS. Patient is not candidate for nursing home.  Discussed with the patient, will discharge the patient home, take Tylenol and vitamins and improved p.o. intake, will send the patient home with nurses and COVID-19 safe home program and follow-up with her oncologist.
Extreme Fatigue; Felt Heavy; Severe Headache; Chills; Nausea; Red Injection Site Spread 3.5"; Severe Side Effect; Not Feeling Well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe Side Effect), MALAISE (Not Feeling Well), HEADACHE (Severe Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Severe Side Effect) and MALAISE (Not Feeling Well). On 03-Mar-2021, the patient experienced HEADACHE (Severe Headache), CHILLS (Chills), NAUSEA (Nausea) and INJECTION SITE ERYTHEMA (Red Injection Site Spread 3.5"). On 05-Mar-2021, the patient experienced FATIGUE (Extreme Fatigue) and FEELING ABNORMAL (Felt Heavy). On 06-Mar-2021, VACCINATION COMPLICATION (Severe Side Effect), MALAISE (Not Feeling Well), HEADACHE (Severe Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site Spread 3.5"), FATIGUE (Extreme Fatigue) and FEELING ABNORMAL (Felt Heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Patient presented to emergency department on 11/17/2021 for worsening shortness of breath, cough, fever, chills, and body aches. She was found to be COVID-19 positive and admitted for further management. She was treated with supplemental oxygen and dexamethasone. Patient was discharged home on 11/20/2021.
Child complained of his left arm being itchy where he received flu shot. Mother noticed arm around site of vaccination was red & swollen & feels "hard". Denies respiratory problems or itching anywhere else on body. Able to move arm without difficulty. Did not give any medication. Refer to PMD for assessment. Recommend ice to site.
No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE; This spontaneous report has been received from a medical tech and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 15-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once time (valid lot number W024333 [expiration date 01-AUG-2024]) (dose, dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error).   No further adverse events (AEs) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007438:
Flu and pneumonia shots 4pm Wednesday 23rd January. 7pm Thursday 24th temperature of 102.9, rash? and tenderness.  Treated with Theraflu and ginger tea.  Major night sweat - fine in morning.
Information has been received from a doctor's office staff concerning a 19-26 year old female patient who on an unspecified date was vaccinated with 0.5 ml of a dose of GARDASIL (Lot not reported) intramuscularly. Subsequently, the patient had an adverse reaction to GARDASIL and had to go to the hospital. It was not reported whether the patient was admitted or which hospital she went to. The office staff mentioned a spinal tap, but it was not confirmed if the spinal tap was done on the patient. At the time of reporting the patient's status was unknown. Additional information has been requested.
Pt advised and completed consent to get 2nd pfizer. After completion of injection, and inputting information into data base pt received Moderna as first dose on 06/29/2021 and not pfizer.
Splotchy red rash appeared at injection site 1 week post injection. No pain. Visibly swollen and warm to the touch.  rash is 2x3 inches
felt terrible; This is a spontaneous report via contactable other HCP (patient). A 70-year-old female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient received tofacitinib citrate (XELJANZ XR Prolonged-release tablet), oral from unknown date of 2017 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient stated stopping xeljanz for 4 to 5 days before and 4 to 5 days after received covid vaccine. The patient felt terrible on an unspecified date after receiving the vaccine and was unsure if it was related to the vaccine or stopping xeljanz. The patient stated she did not have any joint inflammation during the time she stopped xeljanz and unsure if MD aware. The action taken in response to the event for tofacitinib citrate was dose not changed. The outcome of event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
CHEST PAINS , VOMITING, EXTREME FEVER, MASSIVE HEADACHE BODY PAINS AND ACHES , MINOR CONVULSING , INTERNAL PAIN ALLOVER
This literature marketed report was received from the authors of a published article, and refers to an elderly patient of unknown gender. The objective of this retrospective study was to examine a large cohort of adults age 65 years and older for evidence of increased risk of adverse events (AEs) requiring medical attention following vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) as compared with vaccination with of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown; PPSV23). On an unknown date, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown), hepatitis B vaccine (recombinant) (manufacturer unknown), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, typhoid vaccine (unspecified) and pneumococcal 13v conj vaccine (CRM197) (exact dose, route of administration, lot# and expiration date were not provided for all). Within 15 minutes of immunization, the patient felt the tongue swollen/thick and experienced mild difficulty in breathing and swallowing, which was confirmed as anaphylaxis. The patient had no rash hives or facial swelling, no nausea or abdominal pain, and no confusion. The patient had a history of anaphylaxis to other agents such as eggs and intravenous contrast and experienced the same symptoms. The outcome of anaphylaxis was not reported. The author considered the event to be related to the vaccines. Upon internal review, the event of anaphylaxis after vaccination was determined to be medically significant.
Arm hurt from shoulder to the hand after MOTRIN for a few days, it was better but now comes & goes. Fold arms at waist if cannot lift without strong pain.
Face is kind of a little bit swollen, more like in the down area below the nose like her mouth and her chin that's where the most swelling is; This is a spontaneous report from a non-contactable consumer or other non-health care professional. This consumer reported for a female patient (Aunt of reporter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported) via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that the patient had the Pfizer vaccine two days before the time of reporting, and she was having a lot of the side effects. On 11Mar2021, the day of reporting, the patient experienced "face was kind of a little bit swollen, more like in the down area below the nose like her mouth and her chin that's where the most swelling was". The reporter read that it was normal, but the patient wanted to make sure that it was okay. The reporter further stated that the swelling was more like in the down area, below the nose like her mouth and her chins that's where the most swelling was, just a little bit". The patient was worried that whether she should get the second dose. The reporter wanted to know whether experienced people in Pfizer recommend something to make this feel better with symptoms that the patient was experiencing. The clinical outcome for the events was unknown. Limited information was available over the call.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
After approx. 15 sec. of flu administration pt. looked pale. Mom was by her side. She fainted briefly for 5-10 secs then came back to alertness. But her hands were stiff and cold. Complained of tingling sensations.
contact dermatitis; balance problems; postherpetic neuralgia; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. Patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), patient suffered of contact dermatitis, balance problems and, postherpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events of contact dermatitis, balance problems and, postherpetic neuralgia  were considered to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a nurse practitioner and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that an improper dose of PROQUAD lot number: M034692, expiration date: 24-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided), was administered for prophylaxis. The vaccine was reconstituted with a sterile diluent lot number: M015992, expiration date: 26-NOV-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided). The vaccine was exposed to a temperature of 15.8 Fahrenheit (F) for 2 hours and 25 minutes. The call was not because of a data logger issue and there was no previous temperature of excursion. No adverse effects reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004548:
22-years patient administered  FLUZONE QUADRIVALENT HIGH-DOSE /no AE; 22-years patient administered  FLUZONE QUADRIVALENT HIGH-DOSE /no AE; receiving FLUZONE QUADRIVALENT HIGH-DOSE on accident due to the administrator not verifying the product prior to administration, original order was not for a high dose but a standard flu vaccine with no adverse event; Initial information received on 01-Dec-2021 regarding an unsolicited valid non-serious case from other health professional via Agency (under the reference: 00880548).  This case involves a 22-year-old female patient receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on accident due to the administrator not verifying the product prior to administration, original order was not for a high dose but a standard flu vaccine with no adverse event (wrong product administered, product administered to patient of inappropriate age, overdose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Dec-2021, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, strength: high dose, lot UJ763AA, expiry date: 30-Jun-2022] via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administered, overdose (latency same day).  At the time of report, no adverse event reported.  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.
suspected blood clot; When walking experiences traumatic pain in legs; her legs went numb while at store; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (suspected blood clot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (When walking experiences traumatic pain in legs) and HYPOAESTHESIA (her legs went numb while at store). On an unknown date, the patient experienced THROMBOSIS (suspected blood clot) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of unknown. On 16-Apr-2021, HYPOAESTHESIA (her legs went numb while at store) had resolved. At the time of the report, THROMBOSIS (suspected blood clot) outcome was unknown and PAIN IN EXTREMITY (When walking experiences traumatic pain in legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Several adverse events have occurred since 3rd dose (Moderna)-Lot number 039d21A) on 10/28/21- March 2022 Heart attack. March 2022, Stroke 3 weeks after heart attack. On 10/18/22 received the Pfizer BV-lot number6J6665 at  Pharmacy.  On 10/29/22 Arrived at the Emergency Department at Hospital with an admission to Hospital. Discharge date 11/1/2022 medical determination of Renal Infarction. Doses received  1st Moderna-027A21A on 3/5/21 2nd Moderna- 039A21A on 4/2/21 3rd Moderna- 039d21A on 10/28/22 4th Pfizer- 6J6665 on 10/18/22
on the left side of her face / red; Mild Swelling; itching (AE) on the left side of her face; This case was reported by a consumer and described the occurrence of red face in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included prednisone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix, the patient experienced red face, swelling and pruritus. On an unknown date, the outcome of the red face, swelling and pruritus were recovered/resolved.   It was unknown if the reporter considered the red face, swelling and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that about a year ago she had her 1st dose of Shingrix vaccine in her left arm. The patient stated that she had it at 4 PM and at 2 AM in the morning she had a lot of itching on the left side of her face like a circle shape from her forehead, cheek, and down to her neck. It was very red. The patient reported mild swelling. The patient reported it last for 2 to 3 weeks. The patient was prescribed a regimen of Prednisone and health care professional recommended not to get the 2nd dose. The patient reported that it did not affect her breathing. The patient did not consent to follow up with her health care professional because he had moved to another state. The lot and expiration date were unknown.