chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After a mosquito bite on 4-7  a few hours later, I broke out in hives over my entire body except my face and neck. in addition to highs over my body I currently have a swollen lip. I never had hives before.  On Thursday morning I went to an urgent care clinic.  Doctor prescribed prednisone and a anti-histamines.  I am taking the prednisone and Benadryl. It seems like the Benadryl really helps after it kicks in.
Extreme muscle pain, headache, stomach pain, chills to the point of teeth chattering, weakness/fatigue, lightheaded From 10 pm until next day 2pm
thought to be allergic reaction; redness at injection site; Vaccines administered after temperature excursion; Information has been received from the reporting registered nurse referring to a child of unknown age and gender. The patient was reported as no illness at time of vaccine after wellness exam. And the patient was reported with no current medical condition and no known allergies.   On an unknown date, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # T013537, expiration date 17-OCT-2021) (strength and dose were not reported) subcutaneously on the left thigh for prophylaxis. On an unspecified date, the door of freezer was left ajar and the vaccine underwent temperature excursion to 15 degrees Fahrenheit for less than 15 minutes without any previous temperature excursion; The digital data logger which was involved in recording excursion details. And the child returned the next day with redness at injection site. It was thought to be an allergic reaction. The child was sent home with instruction to take diphenhydramine hydrochloride (BENADRYL). The reaction on its arm was reported as resolved. The causality between both events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA011529:
10 DAYS POST RECEIVING VACCINE, DEVELOPED RASH, SELF DESCRIBED AS SHINGLES. RASH LOCATED ON LEFT LOWER BACK. ABOUT 17 DAYS POST-VACCINATION, DEVELOPED ADDITIONAL RASH ON LEFT LOWER BACK.  CLIENT HAS HAD FRREQUENT BOUTS WITH SHINGLES, "EVERY 3 MONTHS" OR SO.  HAD PREVIOUSLY TAKEN VALTRREX DAILY TO PREVENT SHINGLES.  HAD BEEN OFF MED FOR "AT LEAST 6 WEEKS TO 2 MONTHS"
got around the vaccine area a circle of 3 inches really really red; Vaccine area was slightly itchy; pain in the arm to the touch for two days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm to the touch for two days), VACCINATION SITE ERYTHEMA (got around the vaccine area a circle of 3 inches really really red) and VACCINATION SITE PRURITUS (Vaccine area was slightly itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, SIMVASTATIN, CALCIUM and VITAMIN D NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm to the touch for two days). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (got around the vaccine area a circle of 3 inches really really red) and VACCINATION SITE PRURITUS (Vaccine area was slightly itchy). At the time of the report, PAIN IN EXTREMITY (pain in the arm to the touch for two days), VACCINATION SITE ERYTHEMA (got around the vaccine area a circle of 3 inches really really red) and VACCINATION SITE PRURITUS (Vaccine area was slightly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medications.
Strong, pulsing tinnitus (both ears) Constant since mid March 2021.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 09-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports from the same reporter. Additional information has been requested.
A Few hives on my neck and left eye. Started 1/24/21. Slowly subsiding.  Sinus congestion and pain from back of right side of head into my shoulder. My vaccine was given in the left arm.
01Aug90 pt vax w/ hepta B. Pt exp right inguinal adenitis and right-sided pelvic pain.  04Sep90 pt vax w/ 2nd hepta B.  3 wks later pt exp more prominent reaction accom. by more widespread lymphadenopathy. TOR pt sx improved - under tx.
pt recv vax 29NOV96 & that same day pt exp site pain that radiates down arm & into fingers;persistent for 5wk in duration;no numbness or tingling;
Flare up of Arthritic conditions Heart issues, cold left arm when left above the head for over a minute. confusion, swimming head
Patient got large splotchy rashes on both upper arms after the covid vaccine. They do not itch, doesn't feel them. She didn't report it to anyone. She is seeing her dermatologist next month. The splotches cover a large portion of both her upper. arms.  They cover mostly the back of her upper arms  have not faded or changed. Large red splotches have remained the same since right after the vaccine Per pt sometime the splotches get more reddish.
Extreme Fatigue Muscle Aches Chills and night sweats Nausea
This spontaneous report was received from the patient's father referring to her daughter, an approximately 1-year-old female patient, with milk allergy as concurrent condition. The patient had no pertinent medical history or concomitant medications. On an unknown date towards the end of June 2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, route of administration and frequency were unspecified) for prophylaxis, along with four other unspecified routine vaccinations during an office visit. On an unknown date in June 2017 (reported as since getting the vaccines administered) the patient had been tired and her leg hurt where she got the vaccines administered (pain in extremity). Additionally, it was reported that she had a body rash on an unspecified date (rash generalized). It was reported that the patient was not hospitalized because of the adverse events. At the time of the report, the outcome of pain in extremity, rash generalized and fatigue was unknown. The relatedness assessment between PNEUMOVAX 23 and pain in extremity, rash generalized and fatigue was not reported.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown demography. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with PROQUAD (Merck) (dose and route unknown) lot # L041629 with expiration date of 22-APR-2016 which was improperly stored. The vaccine was exposed to a temperature of -7.1 degree Celsius for 3 hours and 18 minutes, and the data logger was involved. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Cough  Fatigue  Sore throat Muscle or body aches Headache  Congestion or running nose
This case was reported by a physician and described the occurrence of urticaria in a 3-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline).  In September 2007 the subject received 2nd dose of Engerix B at 720 elisa units.  Approximately 8 to 20 hours after vaccination with Engerix B, the subject developed urticaria over her body.  She was treated with Benadryl and the urticaria resolved.  Two to three days later, she developed hives, which again resolved with additional Benadryl.  Follow-up received on 15 October 2007 from a physician indicated that the subject received Havrix instead of Engerix-B.  The subject had previously received the first dose of Havrix in August 2006 and had no problems after receiving the first dose.  Further information was not provided.  Follow-up was received by a physician who is an allergist, via Merck Research Laboratories.  Medical conditions were notable for no drug reactions or allergies and no pertinent medical history.  The subject did not have any problems with the 1st dose of hepatitis A vaccine.  The subject received no concurrent medication.  The subject received the 2nd dose of Havrix (GlaxoSmithKline) and developed urticaria all over her body the following morning.  The physician estimated that the onset of the urticaria was 8 to 15 hours after receiving the 2nd dose of Havrix.  The subject's parents called the subject's primary care physician who instructed that the subject take Benadryl.  The hives appeared to a lesser extent each day and resolved without sequelae.
Patient reported right shoulder injury that started shortly after vaccination. She states she went to an ortho specialist after about two months and was told her injury was from the vaccine.
Pain at injection site Swelling at injection site Redness at injection site Itching at injection site General malais Dizziness
DAPTACEL being administered to a patient over 7 years old instead of ADACEL. with no reported adverse event; DAPTACEL being administered to a patient over 7 years old instead of ADACEL. with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] being administered instead of Adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 16-Dec-2022, the patient administered with a Booster dose 1 at dosage 0.5mL of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, (lot number: C5828AA and Expiry date: 30-Mar-2023) (strength, frequency: not reported) via intramuscular route in the right deltoid for immunization over 7 years old instead of Adacel with no reported adverse event (product administered to patient of inappropriate age), (wrong product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Arm soreness; chills; body ache; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Lot number: FH8020) at the age of 45 years as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 IMMUNIZATION; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 IMMUNIZATION. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Arm soreness"; CHILLS (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "chills"; PAIN (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "body ache"; NAUSEA (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "nausea". Therapeutic measures were not taken as a result of pain in extremity, chills, pain, nausea.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any medications within 42weeks prior to the COVID vaccine. Patient did not received treatment for AE.   No follow-up attempts are possible. No further information is expected.
Within minutes of receiving my first vaccination, I developed a metallic type taste in my mouth. Currently experiencing altered smell and greatly reduced or altered taste.
dizziness; tiredness; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (tiredness) and CHILLS (chills). On 24-Mar-2021, DIZZINESS (dizziness), FATIGUE (tiredness) and CHILLS (chills) had resolved.        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.   No concomitant medication details were reported. No Treatment Medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-086271 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086271:2nd dose
Received shot at 6:00 am.  At 4pm started to experience chills, then fever and body aches.   Gone by  7 am the next day.
10 days after receiving Varivax vaccine in right thigh, parent noticed redness and red bumps on injection site on right thigh. Physician noted round area of redness with 3-4 papules inside the red area.  No treatment was required.
Vaccine administered on 2/11/21. Presented to emergency department on 2/18/21 following an episode of syncope and collapse at home. Patient reports becoming dizzy and diaphoretic at home and passed out in bathroom. Presented with left-side rib pain and headache attributed to hitting door and ground during fall. Was checked for COVID19 prior to transferring to observation unit and was found to be positive. Patient was discharged home in stable condition from observation on 2/19/21.
This spontaneous report as received from a pharmacist refers to a 52 years old female patient. The patient was vaccinated with dose 1 PNEUMOVAX23 on AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 16Nov2012 after getting the PNEUMOVAX23, the patient called her physician to find out if she had ever had one before and he told her she was administered a PNEUMOVAX23 3 months ago in August 2012. She was not experiencing any adverse reactions. It was unknown if there was any relevant laboratory data. On 16Nov2012, it was unknown if she will ever have a PNEUMOVAX23 again, and she was not experiencing any adverse reactions from having 2 PNEUMOVAX23injections in 3 months. Additional information has been requested.
This case was considered medically important. Additional information has been received regarding Prevnar lot number. laboratory testing and onset date change of event. Information regarding Prevnar was received from a healthcare professional regarding a 2-year-old male patient who experienced an afebrile convulsion. The patient received the fifth dose on 11-Aug-2005. The patient has a history of ear infection. The patient received 4 doses of Prevenar vaccine doses in past. Concomitant medications were not reported. The patient experienced an afebrile convulsion on 30-May-2006. The patient was referred to a neurologist; an electroencephalogram (EEG) was performed (results unknown). The patient's outcome was not specified. See related case (s): HQWYE550225JAN07 (non-expedited) and HQWYE024130JAN07 (expedited). No additional information was available at the time of this report.
71/2 INCH BY 3 1/2 INCH RASH. Painful at site and also area of rash, muscle aches, also large hematoma at injection site
Red arm; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, fever and chills. On an unknown date, the outcome of the erythema of extremities, fever and chills were unknown.   It was unknown if the reporter considered the erythema of extremities, fever and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced red arm. The reporter declined to provide information for safety reporting. The reporter did not consent to follow-up.
itching at the injection site; swelling at the injection site; rash at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-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 VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.Consumer stated that his wife got the 1st shot on 24Feb2021 and developed itching, swelling, and rash at the injection site.   This case was linked to MOD-2021-108935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Medical report contains information on Dose 2 and its events
Received vaccines, passed out while checking out and hit head on floor about 15 minutes later. Ice applied and observed x 20min. Did have brief LOC immediately after fall. Released to home, where began to experience episodes of vomiting and seemed "out of it" per dad about 1 1/2 after vaccine given. Sent per squad to MC-ER. Was evaluated and admitted. 2/4/08-records received for DOS 7/10-7/11/07-DC DX: Left frontal contusions secondary to fall. Experienced a vasovagal event after receiving vaccinations producing a fall to floor. Momentary loss of consciousness then recurrent emesis and confusion. C/O headache and waning nausea. Left-sided neck pain.
An 11 year old patient was administered Daptacel instead of Adacel, no AE; An 11 year old patient was administered Daptacel instead of Adacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professionals (2 reporters) via inbound (reference number- 00493320).  This case involves an 11 year old male patient who was administered 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number: C5624AA; expiry date: 10-Jun-2021) via intramuscular route in left deltoid for prophylactic vaccination on 22-Feb-2021, instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]  (wrong product administered) (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  The reporter would like to know when it would be safe to have the patient return to receive the Adacel  At the time of this report, it was unknown if the patient experienced any adverse events.  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. 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.
This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Three weeks after vaccination, the patient experienced bell's palsy. The emergency visit was required. The reporter consented to follow up.
Redness at site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness at site of injection".  Additional Information: Consumer stated," I am calling about my side effect, I had my 2 dose of Pfizer yesterday at 10:16 that I when to give me for my first dose, when had 24 hours redness at site of injection so calling what to do. "Consumer was informed about the Medical Information Department and provided the number. Consumer stated, "Why do you need this information? I called for Medical advise, I need medical help I don't need information and put my experience frog vaccine. QR Comment: As consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.