chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, intramuscularly in the right arm on 08Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to peanuts and shellfish, COVID-19 on an unspecified date (reported as a COVID-19 diagnosis prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Jan2021 (reported as 3 minutes after receiving the vaccine), the patient experienced itching. The patient was treated with diphenhydramine (BENADRYL) 50 mg for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "itching" was not resolved.
Reaction 1: sore left shoulder at the injection site next day for one day only Reaction 2: 5 days after vaccine, noticed blood on my shirt where I had been itching, left upper arm between injection site and elbow. Appearance of skin is rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to my dermatologist 3 days after itching started. Diagnosed as Allergic Contact Dermatitis due to Covid 19 vaccine. Given Rx anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset.
Fever and headaches began 2 days after vaccination. Over next few days had body aches, orange urine, nausea, sore throat, congestion, and shortness of breath. Hospitalized 7/14/03.
Patient noted multiple red lesions, pruritic, over upper and lower limbs and chest.  Treat with Benadryl and observation.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 2:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:39 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.79 and 41.89.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM  temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively,  9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Aprox 24 hours after vaccine, headache developed and lasted aprox 24 hors. 7 days after vaccine, swollen, tender lymph node in armpit of same arm that received vaccine.
S: Mom states pt has redness and swelling on right leg where pt got his vaccines. Pt complained on pain x 2 day. Right let lateral aspect around injection site. Erythematous. No  induration. Plan: 1. Besadeye 12.5/5 7.5 ml q 8 hours x 3 days. 2. Keflex 280/5 po 7.5 q 8 days. Seen by doctor.
pt awoke morning p/vax parents reported pt was sluggish & eyes were glazed so they were suspicious;pt had had sz during the noc;pt was dx w/sz disorder 6mo ago but parents never told contraindication for DTP;mom stated no prior problems;
20-30 mins after booster shot got itchy all over,  next day arm at injection site red and sore, itchy all over body no rash, every day after red spot on arm grows is kinda hard and hurts is warm to the touch, all over intermittent body itching gets worse
COVID19 booster vaccine vial not discarded from previous day, incorrectly use to vaccinate patient d/t communication error between medical staff. Notified HCP Dr., as well as manager, CMA. No follow up treatment necessary d/t vaccine still being viable. CMA contacted Agency & spoke with staff for direction toward how to handle situation. CMA also contacted Pfizer manufacturer and was instructed that a punctured vial is good for 24 hours between degrees of 35 F and 86 F.  Going forward officer closer will discard open vial, as well as a double check of morning opener will double check that old vial has been discarded & new vial has been opened. Dr. was advised regarding situation and per Dr. no further action is necessary.
pt recvd vax & approx 1 wk later pt died; COD SIDS; no details available from reporter; family hx of SIDS;
Pain in arm after first dose; redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm after first dose), ERYTHEMA (redness) and RASH (Rash) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm after first dose), ERYTHEMA (redness) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (Pain in arm after first dose), ERYTHEMA (redness) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided No concomitant medications were reported.
no other AE occurred; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUN-2022, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (dose: 1 dose, lot #: U039948, expiration date: 16-DEC-2023; route and strength were unknown) for prophylaxis (Product storage error).   The vaccine underwent temperature excursion of -2.5 Celsius for 5 hours and 6 minutes.  There was no previous temperature excursion. No other adverse event (AE) occurred.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2206USA005711: US-009507513-2206USA005697: US-009507513-2206USA005588: US-009507513-2206USA005579:
Red rash and terrible itching. Saw doctor today started medrol steroid pack and taking Benadryl
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, concomitant therapies and drug reactions or allergies were not reported. From 14-NOV-2017 through 07-DEC-2017, the patients were administered improperly stored doses of PROQUAD injection, lot# N021726 with expiration date on 06-FEB-2019 (doses and routes of administration were not reported) and VARIVAX injection, lot# M010485 with expiration date on 01-MAR-2018 (doses and routes of administration were not reported). Administered doses of vaccines underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour. There was a previous temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours. A digital data logger was involved in recording the excursions. There were no adverse effects reported. Follow-up information has been received from the vaccine coordinator on 15-FEB-2018. It was reported that a 12 months old male patient received a dose of the PROQUAD on 07-DEC-2017, lot # N021726 with expiration date 06-FEB-2019. The patient did not experience any adverse events following administration of PROQUAD. There was no information available regarding VARIVAX. Additional information has been requested.
Information has been received from a physician's assistant concerning a 17 year old female who has had "multiple sexual partners and engages in high risk behavior".  Her first pregnancy resulted in a spontaneous abortion in March 2006.  On 06-FEB-2007, the patient had pelvic inflammatory disease from which she recovered.  On 28-FEB-2007, the patient had an ultrasound which revealed a complex ovarian cyst.  Also on 28-FEB-2007, urine and ultrasound tests confirmed that the patient was not pregnant.  She was referred to a gynecologist for evaluation of her ovarian cyst.  On 12-MAR-2007, the patient was vaccinated with the first dose of GARDASIL (lot #653736/0014U), 0.5 ml.  On 30-MAR-2007, the patient presented to the gynecologist for evaluation of her existing ovarian cyst.  It was determined via ultrasound that the patient was 6 weeks and 4 days pregnant.  Her last menstrual period (LMP) was estimated to be late January/early February (estimated delivery date 08-NOV-2007).  In the end of April 2007, the patient had a spontaneous abortion followed by a dilation & curettage (D & C).  Subsequently (date unknown), the patient was diagnosed at the ER with a urinary tract infection (UTI) status post spontaneous abortion and D & C.  On 08-MAY-2007, the patient was vaccinated with the second dose of GARDASIL (lot #657005/0314U).  She was fully recovered from the spontaneous abortion at that time.  On 07-SEP-2007, the patient was vaccinated with the third dose of GARDASIL (lot #657872/0515U).  Subsequently, the patient recovered from the UTI.  In the follow-up phone call of 07-FEB-2008, the PA reported that she did not consider the spontaneous abortion or UTI as disabling or life threatening.  She was unsure if the patient had been hospitalized at all.  Upon internal review, spontaneous abortion was considered to be an other important medical event.  No further information is available.
Per parent: Patient began having hand and feet swelling, which progressed to facial and full body redness and swelling, as well as raspy breathing. Noted to have an axillary fever of 102F. Went to ED, and swelling self-resolved within 2 hours. Fever treated with TYLENOL suppository. Patient remained fussy for a few days afterward, but no recurrence of fever or swelling.
Flushing; chest tightness; slightly short of breath; itching of palms and soles of feet; fine red rash on inside forearms. Received Benadryl 50mg PO at approx. 1210 pm; in 1 hour, patient's rash had resolved and only slight itching sensation remained. Patient was released to go home.
Approx. 20 min. after getting vaccine, the pt. noticed swelling in (R) forearm. I then notified the RN. RN note indicates no pain reported, but long w/ swelling. Pt. complained of weakness and blurred vision.
Does not feel good; Face is cold; Headache; Muscles hurt; Got confused, lost/disorientation; Left side of face and body went numb; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of got confused, lost, disoriented, left side of body went numb, left side of face was still numb, does not feel good, headache, muscles hurt, face is numb and cold.  The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown).   On 29 Dec 2021, the same day following vaccination, the patient experienced events, got confused, lost, disoriented, and left side of body went numb. She was taken to the emergency room (ER) and observed for a potential stroke. The reporter stated, all labs came out fine and she was discharged the same day.  On 30 Dec 2020, the patient experienced events, left side of face was still numb, does not feel good, headache, muscles hurt, and face is numb and cold. The treatment information reported included diphenhydramine.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, got confused, lost, disoriented, was considered as unknown.  The outcome for the events, left side of body went numb, left side of face was still numb, does not feel good, headache, muscles hurt, and face is numb and cold, was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. Since an unknown date in November 2012, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot#, expiration date and route not reported). No adverse event reported. This is one of several reports from the same source. Additional information is not expected.
She began to have the memory issues and are progressively getting worse; And I cannot think ,I do not want to think; She began to have the memory issues and are progressively getting worse; I have a problem with my attention, cannot pay attention; This is a spontaneous report received from Pfizer sponsored program Support from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported, NDC number was not reported) dose 2 via an unspecified route of administration on 19Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. No other product was given. No investigation assessment was reported. On Jul2021 the patient experienced she began to have the memory issues and are progressively getting worse, and I cannot think, I do not want to think, I have a problem with my attention, cannot pay attention. No PQC was present. The Patient stated that after the second dose, for the last 4 weeks, she had been having memory issues and attention issues. She can't not think and does not want to think but she has lots to do. On her own she did a study where she spoke to 2 friends who are having similar issues. One was a friend and the other was a young healthcare provider. They reported memory issues but not attention problems. These are things she was ashamed of, that she cannot remember what she was supposed to do or not do. She wants us to know there are more side effects other than physical ones. She wanted Pfizer to know that there are other things going on. She never had memory issue until the vaccine. The caller disconnected prior to the conference of the call: Agent explains the caller was reluctant to provide any information on herself for the report, she declined her last name and address. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Next morning had flu like symptoms that last day and a half. I had similar reaction to first shot.  I participate in class with classmates of similar age. Many of them reported similar reaction to first SHINGRIX shot. My neighbor had yesterday and she is experiencing similar reactions today.
I contracted COVID-19 on 05/30/2022 with symptoms of cough, congestion, and fatigue. I was prescribed PAXLOVID on 05/31/2022. I was ill for 3 days before my symptoms began to resolve. I have fully recovered with no lingering symptoms.
Generalized (pt presents with COVID, has Stage 4 lung cancer. doctor recommended pt come to ER and get the antibody infusion. only complaining of mild weakness.)
Came to ER for confusion and possible low blood sugar on 7/29/21. Blood sugar 124 on arrival. Patient was lethargic and tested positive for COVID. Stable vitals temperature 99.7° 0 blood pressure 137/64 below pulse of 93 and 98% on room air. Also found to have acute metabolic encephaloprathy likely secondary to UTI and COVID19. Placed on ceftriaxone for UTI . During her stay she developed acute hypoxic respiratory failure, requiring opti-flow 90% and 60L. Likely from COVID pneumonia. Placed on dexamethasone and remdesivir. Required precedex for BP. Patient went comfort and passed away on 8/25/2021
Injection site became painful, bruised and warm to touch on 11-15-09. So painful that it prevented sleep. Painfulness at site lasted approximately 24 hours. Patient treated with ADVIL and hot/cold compresses.
Sore throat; Swollen glands; Tiredness; Chills; Fever; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with IBUPROFEN (ADVIL 12 HOUR) on 14-Jan-2021 for Fever, at a dose of 500 mg.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.; Sender'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. Further information has been requested
This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
slightly raise; discoloration; looks like muscle tissue; pain at the site; red; itches; slightly swollen; 3.5 inches wide and 7 inches long; This spontaneous case was reported by a consumer and describes the occurrence of MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site) and VACCINATION SITE ERYTHEMA (red) in a 49-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 was provided by the reporter.     On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE RASH (3.5 inches wide and 7 inches long). At the time of the report, MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE RASH (3.5 inches wide and 7 inches long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications were not provided.
Hard, red knot on left arm near injection site.  Extremely tender to touch. Redness is moving down arm from injection site and swelling is  growing.  Area is "warm" to the touch.
Herpes Zoster diagnosis in a varicella vaccine recipient. Painful unilateral rash. Given antiviral treatment.
Information has been received from a Registered Nurse referring to a 17 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection site reactions.  The area was red; Injection site reactions / Hot to touch; Arm was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site warmth and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received her 1st dose sometime last year (in 2019). She experienced injection site reactions. The area was red, hot to touch and the arm was sore for several days.  She received her 2nd dose and did not experience any reactions. The reporter did not consent to follow-up. This case has been linked with case US2020244406, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244406:same reporter