chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling, soreness and redness at the site of injection; swelling, soreness and redness at the site of injection; swelling, soreness and redness at the site of injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Jan2022 15:00 (Lot number: FL 3197) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Jan2022, outcome "unknown" and all described as "swelling, soreness and redness at the site of injection".  Additional information: 35 year old female patient received booster Pfizer-BioNTech Covid-19 vaccine around 3pm Friday 14Jan. The day after she experienced swelling, soreness and redness at the site of injection. No fever and site was not warm to the touch. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 5th August 2014. The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information: The last menstrual period, the due date and the number of gestational weeks were not reported. This is one of the 17 cases reported by the same reporter for the same vaccine.
no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/ frequency: 1,  lot # T010310, expiration date 24-MAR-2022, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.   This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483
Upon vaccinating child with MMR, inserted needle into arm, began administration, needle and syringe separated and contents spilled onto patient. Uncertain if any amount was administered. Received order from physician to re-vaccinate.
Experienced a witness arrest at home on 1/27/21 while watching TV. Wife performed CPR prior to EMS arrival. Pt intubated using King Airway due to edema and bleeding. Admitted to ICU on Vent
Right side of upper and lower lip tingling and numb. Resolved an hour or so after onset.
Information has been received from a physician concerning a female (demographics not provided) who, on an unspecified date was vaccinated with Gardasil (Lot # not provided).  Subsequently the patient developed eosinophilic fascitis.  The reporting physician was not the treating physician.  The reporter received the information through a phone call from a pediatrician.  No specified information regarding the patient was given.  No further information was provided.  Additional information has been requested. Follow-up received 4/16/2008. No further information was provided due to confidentiality concerns, as the parents of the patient were pursuing litigation against the pediatrician. Additional information is not expected.
No additional AE/PQC; HCP called to report patient was given a dose of PROQUAD that was stored outside of prescribing information temperatures. Product TE outcome was supported( case 02370482); This spontaneous report has been received from a nurse, regarding a unknown number of patients of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 12-APR-2023, the patien was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number: W036931, which was determined to be valid as syringe formulation, with an expiration date on 19-MAY-2024).  The administered dose underwent a temperature excursion of 9.8 degrees Fahrenheit (F) for 1 hour and 42 minutes as it was stored outside of prescribing information temperatures. There was not any previous temperature excursion reported. (Product storage error)  No additional adverse event was reported, and no further information provided.   This case was determined to be non-valid, due to the lack of the patient's identifiers.  Follow-up information has been received from a health care professional on 01-MAY-2023. The patient's demographic information was updated. This case was regarding a 1-years-old male patient. The reported administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection was performed subcutaneously in the left thigh on a private doctor's office/hospital with public funds. It was reported that the temperature excursion occurred as a result of a reading from a data logger, because the power blipped, and the temperature went up to 9.8 degrees Fahrenheit (F) for 1 hour and 43 minutes.  This case is one of two reports from the same reporter.
28FEB92 1010AM DTP recvd; 12MN t103.5; 29FEB92 MD called prescribed DPH; late PM pt OK;
Numbness in toes,uderside toes,both feet; chills; really tired,very fatigued; developed fever; COVID-19; COVID-19 positive after second dose; slight cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), COUGH (slight cough), NASAL CONGESTION (nasal congestion) and DRUG INEFFECTIVE (COVID-19 positive after second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COUGH (slight cough) and NASAL CONGESTION (nasal congestion). On 13-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (COVID-19 positive after second dose). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), CHILLS (chills), FATIGUE (really tired,very fatigued) and PYREXIA (developed fever). At the time of the report, COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), COUGH (slight cough), NASAL CONGESTION (nasal congestion), DRUG INEFFECTIVE (COVID-19 positive after second dose), CHILLS (chills), FATIGUE (really tired,very fatigued) and PYREXIA (developed fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) Caught delta variant and tested positive for covid.         Treatment medications were not reported.   This case was linked to MOD-2021-292464 (Patient Link).
Patient received the 1st COVID vaccine (Pfizer, Lot #: EW0173, and expiration date: 08/2021) at 2:55 PM. Patient received the vaccine while sitting in the zero gravity chair, due to a history of feeling lightheaded and passing out with needles. After a few minutes in the zero gravity chair, patient expressed that she was feeling good and wanted to sit in the observation area next to her boyfriend. She got up and walked to another chair without assistance and with a steady gait.  EMT made contact with the patient at 3:12 PM, while she was sitting in the observation area. Patient was conscious, alert, and oriented to person, place, time, and situation but complained of "lightheadedness." EMT grabbed a wheelchair and patient was then transferred to wheelchair, without assistance. At 3:15 PM, baseline vital signs were taken, while patient was sitting: blood pressure: 136/82, heart rate: 108, respiratory rate: 18. Skin was cold, dry, and normal for ethnicity. Patient claimed to have anxiety and explained that fainting and lightheadedness was "common" for her after receiving a shot. Patient denied taking any medications or having any allergies. A second set of vital signs were taken at 3:20 PM: blood pressure: 136/86, heart rate: 108, respiratory rate: 18. Skin was moist, warm, and normal for ethnicity. Patient was negative for orthostatic pressures. EMT advised patient to stay an additional 30 minutes for further observation. Around 3:50 PM, patient was asked how she was feeling and she stated "good." EMT educated the client on what to do if additional signs and symptoms developed and when to contact her provider. EMT also explained the use of V- safe to the patient. Patient then left the vaccination site, unassisted and with a steady gait.
This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced weakness of arms and pain in arm. On an unknown date, the outcome of the weakness of arms and pain in arm were recovered/resolved. It was unknown if the reporter considered the weakness of arms and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced arm weakness and soreness for months after receiving a flu vaccine (unsure of brand) in the past. This case has been linked with US2018124862, reported by same reporter.
This case was reported by a consumer via call center representative and described the occurrence of addison's disease in a 70-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. Concurrent medical conditions included sodium decreased. On 3rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th January 2019, 1 days after receiving SHINGRIX, the patient experienced feeling unwell and fever. On 16th February 2019, the patient experienced addison's disease (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the addison's disease was unknown and the outcome of the feeling unwell and fever were recovered/resolved. It was unknown if the reporter considered the addison's disease, feeling unwell and fever to be related to SHINGRIX. Additional details reported as follows: The next day after vaccination, the patient did not feel well and had a fever, which was 101 F. The patient felt very sick for 2 weeks prior to the hospitalization and had very low sodium. The patient was treated for low sodium for 18 months at the time of reporting and was sick for a while. The patient was not sure if SHINGRIX was what sent her over the edge and caused her to be hospitalized. The patient thought, the patient had Addison's disease prior to getting SHINGRIX but it just was not diagnosed yet. The emergency room visit required. The reporter did not consent to follow-up.
After receiving the vaccination I went to bed had fever, chills, and a very bad headache. I started to drink tea and realized the tea was spilling down the left side of my mouth. My face was drooping and I could not close my left eye. I was not able to smile and had lost full sensation on the left side of the face.  I phoned my physician and was placed on antiviral and steroid medications. Both Valacyclovir 1 gram 3xs per day. and Prednisone 60mg per day.  I also was referred to an eye physician for further follow up and a Neurologist of whom referred me to Physical therapy and Acupuncture.
The Pfizer dose I received in October was my booster shot, after doing a full series of Moderna. I started experiencing Covid symptoms on December 16 and tested positive on December 18.
Patient came in for an appointment and asked for the Johnson and Johnson COVID vaccine. I let the provider know about the patient wanting the vaccine and the provider said it was okay to give the patient the COVID vaccine. Patient received vaccine at 4:20pm on July 2nd 2021 and patient tolerated vaccine well.
Consistent Cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Consistent Cough) and PYREXIA (Fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004B21A) for COVID-19 vaccination.     Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]), LOSARTAN, MEMANTINE, BRIMONIDINE and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Consistent Cough) and PYREXIA (Fever). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; ASCORBIC ACID (VITAMINS C) at an unspecified dose and frequency and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at an unspecified dose and frequency. At the time of the report, COUGH (Consistent Cough) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, SARS-CoV-2 test: positive positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medication included Mulit Vitamins.  Treatment information included CPACK Citromiacin for 5 days.; 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. However, based on the mechanism of action of mRNA-1273, causal association between the event of COVID-19 infection  and mRNA-1273 is assessed as not applicable.
Patients arm is very red. she says she has been experiencing pain in her body on the side that the vaccine was administered and she her arm is very sore
Pt was administered the pneumococcal polysaccharide vaccine in her (R) deltoid and developed a site reaction within 24 hours - 48 and worsened after a week with an infection and cellulitis with ulceration which required an antibiotic and 2 office visits.
Patient developed a rash (blisters) on injection site after 7 days - put on BENADRYL cream.
She received 0.5ml of H1N1 monovalent shot inadvertently instead of 0.25ml.
Patient returned to clinic at 2:20pm said that he had woke up with a headache, had soreness and swelling at injection site that morning. Examined by physician, no fever or swelling noted.  Still c/o of soreness. Advised to take NSAID, rest, ice.  Return to clinic if not resolved in a few days or if more symtoms present.
Patient received the Moderna COVID19 vaccine on 12/28/2020 approximately 10:00 AM.  By approximately 1830 patient noticed she was beginning to have some peripheral vision disturbances.  Patient noted to have slight head ache at the time.  Two mornings, on Wednesday, patient reports being unable to see when entering a lighted room.  Vision limitations being able to see minimally and what was able to be seen was very blurry with dark circles when squinting.  This visual disturbance improved after 30 seconds to a few minutes of being in dim light.  This occurred on Wednesday with headache developing later in the day.  Ibuprofen helped headache.  Has continued to have daily headaches since injection.  Patient states headaches seem to be improving some as the week has gone on.
Redness + itching at site, has persisted for several days. After 8 days after immunizationn rash and itching is dissipating, approx size 1inch by 1inch, only at injection site.
Pt reported that 3 days after receiving Flu shot she experienced feeling hearing loss on Rt side feeling off balance and dizzy.
One day post vaccine, the patient felt spaced out, like in a different reality. Patient noted that he takes about 15 vitamin pills.
First dose on 08Oct2021, Second on 02Nov2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3SE27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 2nd November 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an early second dose of Fluarix 2021-2022, which led to shortening of vaccination schedule. Both vaccines had the same lot number and expiration date. The reporter consented to follow up.
redness around injection site; chills/ chills; FAtigue; aching in joints; aching in joints and throughout his whole body / body aches; shakes; aching in back muscles; fever up to 101 degrees/ fever; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol) and ibuprofen (Advil).   On 20th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache. On 23rd November 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, chills, joint pain, general body pain, muscular back pain, fever and headache were not recovered/not resolved and the outcome of the fatigue and tremor were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, chills, fatigue, joint pain, general body pain, tremor, muscular back pain, fever and headache to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix vaccine on 20th November 2020 friday afternoon. On friday night he had chills.  On 21st November 2020, saturday morning he had fatigue, aching in joints throughout his whole body, chills, shakes, aching in back muscles and fever up to 101 degree F. On 23rd November 2020, 3 days after vaccination the patient had injection site erythema. In less than a week the patient experienced headache. Patient took Tylenol and Advil on Saturday.  The patient had body aches, headache, fever and chills at the time of repoting. The patient had redness around the injection site and just above or below the injection site as well. No further information was available. The reporter consented to follow up.
On the day of, fever, body aches, and severe headache. Recurring after 14 days: fevers of at least 99.4 F every few days accompanied by headaches. Has been happening for months no approximately 2-3 times a week.  It interferes with work and now have been prescribed with Meloxicam  for the head and neck pains. Nothing for fevers. Please help me figure this out. I must work to pay my bills.
a patient received a dose of Kinrix subcutaneously instead of intramuscularly; Inappropriate age at vaccine administration; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   Concomitant products included MEASLES MUMPS RUBELLA VACCINE.   On 26-JUL-2023, the patient received Kinrix (subcutaneous). On 26-JUL-2023, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: a patient received a dose of Kinrix subcutaneously instead of intramuscularly) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the intramuscular formulation administered by other route and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jul-2023 The physician told that such dose was administered on the same leg as an MMR vaccine dose (brand was not specified). The reporter consented to follow-up. The patient received a dose of Kinrix subcutaneously instead of intramuscularly at an inappropriate age, which led intramuscular formulation administered by other route and inappropriate age at vaccine administration.