chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness/erythema; red/itchy eyes; Rash across the stomach; Cold chills; Tremendously itchy skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Tremendously itchy skin), ERYTHEMA (redness/erythema), EYE PRURITUS (red/itchy eyes), RASH (Rash across the stomach) and CHILLS (Cold chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRURITUS (Tremendously itchy skin) and CHILLS (Cold chills). On 27-Feb-2021 at 8:00 AM, the patient experienced RASH (Rash across the stomach). On an unknown date, the patient experienced ERYTHEMA (redness/erythema) and EYE PRURITUS (red/itchy eyes). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) from 27-Feb-2021 to 03-Mar-2021 at an unspecified dose and frequency. On 03-Mar-2021, PRURITUS (Tremendously itchy skin) was resolving. On 03-Mar-2021 at 9:00 AM, RASH (Rash across the stomach) had resolved. At the time of the report, ERYTHEMA (redness/erythema) and EYE PRURITUS (red/itchy eyes) outcome was unknown and CHILLS (Cold chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.     This case was linked to MOD-2021-169853 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Updated reporter information. On 01-Jul-2021: significant follow up appended
Pt was given Pfizer as his second dose and had received the Moderna vaccine on 05/02/2021 as his first dose. Pt was given incorrect vaccine as second dose.
MUSCLE PAIN; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle pain. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, and fever. This report was non-serious.
Immediately after vaccination an overpowering metallic taste was present in my mouth; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at the age of 39 years, administered in Arm Left on 27Mar2021 12:45 (Lot Number: EP6955) at single dose for covid-19 immunisation.  Medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. Reported that Immediately after vaccination an overpowering metallic taste was present in my mouth. Even after eating, drinking and brushing teeth the taste remained. Food and drink still tasted the same but immediately after swallowing my mouth tasted like I was sucking on a roll of pennies. By the following morning it was gone on 28Mar2021. Adverse event started on 27Mar2021 12:45. No treatment received for the adverse event. Outcome of events was recovered on 28Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Sep2023 at 10:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (BOOSTER); Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 4 (BOOSTER); Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 5 (BOOSTER); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was treated with COVID 19 antiviral treatment from 27Sep2023 to 02Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via a field representative refers to a 57 year old female patient. The pertinent medical history was not reported. On an unknown date the physician vaccinated the patient with PROQUAD (Merck) (dose and route unspecified) in error. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 26-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, expiry date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiry unknown). The vaccine was stored between -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. During previous temperature excursion vaccine was exposed to a temperature range of -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006809: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006819: US-009507513-1709USA006820.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-APR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (rHA, lot # L024265, expiration date 01-JAN-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for four times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of -13 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the third time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the fourth time was 16 hours with the lowest recorded temperature of 8.5 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Headache,Fever of 102.7, chills, abdominal, pain with bloating, nausea
Moderna Booster was erroneously administered in our office  and pt is 5 months short of being 18 y/o.  NO symptoms or adverse effects.  Just reporting error since she should have gotten Pfizer booster
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date May 2016). On 12th October 2015, the patient received FLULAVAL QUADRIVALENT. On 12th October 2015, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: On 12th October 2015, less than a day after receiving the vaccine, the patient experienced injection site burning. It was so painful that it woke her from sleep on the 2nd day after the vaccination and it was sore at the time of reporting. In October 2015, less than a week after receiving the vaccine, the patient subsequently experienced swelling at the injection site (right deltoid). This case has been linked to 3 other cases US2015150874, US2015150886 and US2015150875, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL QUADRIVALENT and or lot number of the vaccine.
1 1/2 days after shots, noticed severe swelling in leg that shots were given. Swelling was from top of thigh to below the knee. Difficulty walking due to severe swelling. Gave her tylenol and used ice. Leg was hot at the knee.
After the second dose of Moderna  she reports bruising developed in the legs in multiple locations, and could not walk, dizziness, weakness. She was  hot  then cold multiple times. Dr prescribed meclizine which helped the dizziness-. has been taking tylenol and ibuprofen alternating as well. At the time of this writing 03/13/2021 patient states she is mostly recovered but not complete.  Dr did not run any test to see what might be causing the bruising?
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U002539, was verified to be a valid lot number with an expiration date reported and established as 24-JUL-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 12-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Pt reports pain in both shoulders 2+ months following vaccinations. Sometimes it results in lack of hand strength or arm reach limitations.
became hot and dizzy and stated she had some facial pain.  further assessment determined the response to be a vasovagal response.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021 at 2:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 1:52 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.80 for dose administered on 07-Jan-2021 and 76.62 for dose administered on 03-Nov-2021.   No concomitant medications were reported.  Batch number 025L20A underwent temperature excursion on 07-JAN-2021 with temperature 34 degrees Fahrenheit at 09:00 AM to 10.00 AM. This vial was moved to fridge on 05-JAN-2021 and beyond use date for the vial was reported as 27-JAN-2021. Product moved to clinic on 07-JAN-2021. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
11/03/2020: Patient to urgent care, patient states pain  started later that day of injection, pain continues. C-Reactive, CBC, and melovicam given. 12/21/2020: Presents to urgent care with muscle weakness, arthalgia/joint pain. Suggested physical therapy and a referral to orthopedics done.
Moderate swelling, redness & pain at injection site, warm to touch for  just over 24 hours. Moderate muscle & joint pain continuing over 48 hours. Dull headache more than 48 hours. Moderate fatigue continuing more than 48 hours. Alternating taking Tylenol & Motrin since vaccination with little relief.
On 08/24/98, immediately following vax, the pt's mother noted that the child felt warm and was fussy and irritable. Approximately 2 hours post vax, the child developed an erythematous bumpy red rash all over her body. The rash did not seem to irritate her or to be itchy and the bumps were more pinpoint rather than welt-like. At 9 PM that evening, the pt developed a temperature of 102.4 degrees F and was then referred to the ER for further evaluation. Upon arrival to the ER, the pt was hospitalized. A physical exam revealed 'impressive' diaper rash which consisted of an erythematous plaque in her groin with multiple excoriated regions and satellite lesions. A 68 hour regime of a septic work-up and cefotaxime treatment were initiated. The child's rash and fever subsequently resolved without sequelae. It was recommended that she not receive varicella virus vax at the age of one year because of the above experience. No further information is available.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is the 4th of 14 reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Severe Itching and Rash on Back and Lower Abdomen...also feel itchy on other parts of body.
This spontaneous report was received from a nurse and refers to a 17 weeks and 5 days old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-FEB-2019, the patient was inadvertently vaccinated with ROTATEQ orally (dose was not reported, lot # R021650, expiration date 27-MAY-2020) for prophylaxis. The vaccine was administered to patient of inappropriate age. No adverse effects reported.
She was week, fell, wouldn't eat, drink or get out of bed.  Died after being sent to hospital 3 times and ended up on hospice
Red welt, approximately 3/4 cm and itchy about 45minutes to 1 hr after receiving. Informed to take some oral BENADRYL and apply ice.
Irregular heartbeat, resting heart rate at least 20 bpm higher than normal; Severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in; Severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: El3302), dose 1 via an unspecified route of administration, administered in arm left on 17Mar2021 at 10:00 as (at the age of 33-years-old) single for COVID-19 immunisation. Medical history included rheumatoid arthritis and known allergies: coconut. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021 at 08:00, the patient experienced irregular heartbeat, resting heart rate at least 20 bpm higher than normal and severe fluctuations in oxygen levels, feeling out of breath and unable to take a deep breath in. The patient did not receive any treatment for the events. The patient assessed the events as non-serious. The outcome of all the events was resolved.  Follow-up attempts completed. No further information expected.
Patient was inadvertently administered the Pfizer bivalent COVID-19 immunization instead of the monovalent formulation. Patient had not received the primary COVID-19 vaccination series.
Memory not good; Throwing up on and off for two weeks; Nauseous; Lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot of pain), MEMORY IMPAIRMENT (Memory not good), VOMITING (Throwing up on and off for two weeks) and NAUSEA (Nauseous) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Lot of pain). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory not good), VOMITING (Throwing up on and off for two weeks) and NAUSEA (Nauseous). At the time of the report, PAIN (Lot of pain) and MEMORY IMPAIRMENT (Memory not good) had not resolved and VOMITING (Throwing up on and off for two weeks) and NAUSEA (Nauseous) had resolved.            Concomitant product use was not provided by the reporter.  The patient had lot of pain due to being without Rinvoq almost a month, did not remember the last time when patient had medication. Patient's memory was not good. After second Covid-19 vaccine, patient was nauseous and throwing up on and off for two weeks. Patient's first and third vaccine had no issues. Patient had started back on Rinvoq in last week in Dec-2021.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter's causality for the events of lot of pain with Rinvoq was reported as a reasonable possibility, for event of memory not good was not provided and for the events of throwing up on and off for two weeks and nauseous was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Reactions that cleared within 24 hrs of injection: Fever of 100.7 Chills Congestion Fatigue  Achy muscles  Continuing symptoms: No menstrual cycle in 6 weeks (first dose was 4/3/2021) Injection sight swollen, hard, hot, and red Headache