chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 AND 1/2 CM OF ERYTHEMA AT SHOT SITE WITH 2 VESICLES. ONE VESICLE CRUSTED.
Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Other- multiple falls-Severe
Increased temperature 108 after received flu vaccine, mom gave Motrin.  Increased fluids.  Pedialyte and used cool compreses to decrease temperature.  Temperature decreased to 102.  About 1 hour after child taken to see MD that same night, mother was instructed to carry Motrin and to push fluids.  Mother was told that child has increased temperature due to flu vaccine, child continue with temperature 100-101 x2 day.  After this was fine.
This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a female patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). In September 2015, the patient received FLUARIX QUADRIVALENT. In September 2015, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was recovered/resolved. It was unknown if the reporter considered the palpitation to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: The reporter stated that, the patient went to the hospital on 30th September 2015 with heart palpitations and below normal plasma levels (unspecified laboratory test). On 5th October 2015, the patient was doing fine. The reported expiry date 16th June 2106 with lot number 7994K was updated to 16th June 2016 according to the sales database.
Received vaccine from a vial that had been punctured over 23 hours ago; Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been punctured over 23 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 31H21A and 040C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Jul-2021 at 10:25 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022 at 10:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been punctured over 23 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been punctured over 23 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. The vial initially stored in refrigerator 28-Jun-2022, vial first punctured on 11-Jul-2022 at 14:10. Vial was stored under Room temperature post puncture and Vial did not undergo any temperature excursion issue. No treatment medication reported.
she's not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) via the Pfizer-sponsored program. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 26Jan2021, at single dose, for covid-19 immunization. Medical history included covid-19 - the patient has been tested positive on an unspecified date but it's 2 months now, and they said that it's still in her. Concomitant medications were not reported. The patient had the first shot yesterday 26Jan2021 and she's not feeling well on Jan2021. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
pt stated her whole arm swelled up and she had a fever of 104F for 36hrs. She was very sick and tired for 2 weeks
pt recv vax 1DEC95 & 15min later pt became pale,dizzy & BP was 112/60;pt was given saltines & juice;555PM BP was 138/80;pt stated that felt better,color was improved;
This spontaneous report as received from a nurse refers to 34 unspecified patients of unknown age. On an unknown date, 34 unspecified patients was vaccinated with improperly stored GARDASIL (lot#, expiry date unknown) exposed to 32F for 33 days. It was also reported that one unspecified patient received improperly stored PEDVAXHIB exposed to 32F for 33 days. There was no product quality complaint. No adverse effects were reported. Outcome of the reported event was unknown. Additional information has been requested.
17AUG94 approx 2 hrs p/shots very abruptly c/o of severe h/a, stomachache-very sleepy-vomited 1x-called MD-2x's was seen inMD office; was instructed to wake q 2 hrs-Mortin q 4 hrrs-cool bath;18AUG94 pt still has t102;
Autoimmune hepatitis; This case was reported by a nurse and described the occurrence of autoimmune hepatitis in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced autoimmune hepatitis (serious criteria hospitalization and GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the autoimmune hepatitis was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune hepatitis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was given the first dose of the shingrix vaccine and 1 week later he developed autoimmune hepatitis. He had to be hospitalized for several days and get a liver biopsy. The nurse did not know exactly how long he was hospitalized. While in the hospital he was treated with prednisone. The reporter consented to follow up.
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 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 12:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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 reported as 30.97 on 14-Feb-2021 and 31.06 on 21-Mar-2021.  Concomitant products were not provided.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM, 32 degrees Fahrenheit at 10:00 AM, 32 degrees Fahrenheit at 11:00 AM, 35 degrees Fahrenheit at 02:00 PM and 35 degrees Fahrenheit at 03:00 PM. These vials were moved to fridge on 09-Feb-2021.The vaccines moved to clinic on 13-Jan-2021. BUD date for the vials was reported as 10-Mar-2021.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature of 34, 32 and 34 degrees Fahrenheit at 09:00 AM, 10:00 AM, 11:00 AM. These vials were moved to fridge on 16-Mar-2021. Product moved to clinic on 21-Mar-2021. Vaccine BUD date was 15-Apr-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 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.   This case was linked to MOD-2022-566976 (Patient Link).
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 26 of 84 patients. It was reported that, the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported) between 25-Oct-2017 to 27-Oct-2017 (as reported). The vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C) and was administered to the patient. The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Follow-up report received on 09-Nov-2017: It was reported that, the vaccine was administered between 25-Oct-2017 to 27-Oct-2017 (as reported). The reporter stated that, no adverse effects after vaccination were reported. Temperature was not monitored on 24-Oct-17 (could have been between 2-8C, but not certain). Vaccine has since been discarded. Amended narrative accordingly.
Patient is a 2 year old male who was given a single adult dose of VAQTA.; This spontaneous report has been received from a laboratory medical technician, referring a 2-year-old male patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 16-DEC-2022, the patient was vaccinated with a single adult dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection 0.5 milliliter (lot number W008110 has been verified to be a valid lot number, expiry date 27-OCT-2023) indicated as prophylaxis (strength was not reported) (product administered to patient of inappropriate age).
Chills,  fever, body aches and head ache that lasted 24 hours. Small rash near injection site and a slight arm pit pain. Patients took Ibuprofen 200mg  x 4 tablets
Administered Spikevax 12+ 23-24 to patient.  After receiving patient stated she felt dizzy.  She felt like she might pass out.  She started to twitch/jerk a few times.  She was pale, clammy, warm, and had visual disturbance.  Got paper towels with cool water applied and placed on the back of her neck and her forehead.  She asked to lay down, so placed her on the floor in recovery position with her head on father's leg.  Continued to leave cooled paper towel on back of neck and forehead.  After several minutes she stated she was feeling better.  We slowly sat her up and let her sit for several minutes.  The dizziness had passed.  After several minutes of sitting upright she was feeling better.  She was then placed on chair in the IMZ room.  Color had returned to her face.  She was no longer hot or clammy.  Vision was normal.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced. On 18-Nov-2021, had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication details reported.
Some facial numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Some facial numbness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Some facial numbness). At the time of the report, HYPOAESTHESIA (Some facial numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided by reporter. No treatment medications are provided by reporter.   Reporter did not allow further contact
Had Bronchitis it was a bad 3 month; Got the normal flu; down immunity wise; Got so sick it lasted close to 2 weeks; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp from social media.  This case involves a 67 years old patient (gender not reported) who got so sick (malaise), down immunity wise (decreased immune responsiveness), had bronchitis (bronchitis) and got the normal flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was reported that, on an unknown date, the patient got so sick (malaise) that lasted close to 2 weeks then the patient was down immunity wise (decreased immune responsiveness) and a month later had Bronchitis (latency unknown for all). The patient reported that it was a bad 3 month. The patient had not taken shots since and got the normal flu (influenza) for 4.5 hours (unknown latency) following vaccination.  Additional information: No C19 (probable abbreviation is Covid 19, request for clarification not possible). The patient had been eating right fruits mostly, multiple Vitamins, zinc and eating C Vitamins and minerals.  Laboratory data not reported.  It was not reported if the patient received any corrective treatment or not for reported events.  The patient had recovered from got so sick and normal flu on an unknown date and outcome of other events was unknown at the time of reporting.  There will be no information on the batch number for this case.
Local (faint) redness and induration 6.5 cm x 8cm. 4 days post vaccination.
swelling on my penis along with a series of small bump; swelling on my penis along with a series of small bump; This is a spontaneous report from a contactable consumer (Patient). An elderly male patient (Age: 74 unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EL 9261), via an unspecified route of administration, administered in left arm on 05Feb2021 11:30 as single for COVID-19 immunisation at Hospital. Patient had known medications, food and pollen allergies and hay fever. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications in two weeks, the list was approximately 30 items long. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 05Feb2021, later in evening, patient experienced a swelling on penis along with a series of small bump. The swelling was approximately 25-30mm in length and 5mm in width. The site ran parallel to the glands, were it complete, it would had been a ring around the shaft. The swelling lessening and the bumps are diminishing in size. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovering.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Mom noticed a hard spot on left thigh on 2/28/2008.  On 3/01/2008 pt. experienced tenderness and taken to Dr.  Given Ceftriaxone and follow-up on 3-03-2008.  Today left thigh with 4 x 3 cm indurated area with tenderness, not fluctuant.  No culture obtained.  Treated with Bactrim to cover CA-MRSA.  Suspect not all 4 injections were given in left lateral thigh, as listed below.  Will clarify sites and if MMR was IM.
Passed away; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, approximately 2 hours prior to the onset of the event, the patient received a dose of mRNA-1273 intramuscularly in the for prophylaxis of COVID-19 infection. They were not feeling sick or experiencing any adverse events. Vital signs included temperature 98 degrees Fahrenheit. Approximately two hours after receiving the vaccine, the patient passed away. No treatment information was provided.  Action taken with the drug in response to the event was not applicable.  The patient died on an undisclosed date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately two hours after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Flu like symptoms; Wound at injection site; Wound at injection site; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, injection site reaction and wound. On an unknown date, the outcome of the influenza-like symptoms, injection site reaction and wound were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site reaction and wound to be related to Shingrix.  Additional details were provided as follows: The reporting pharmacist was the spouse of the patient. The age at vaccination was not reported but it could be 61 years or 62 years. The patient received dose of Shingrix in the unknown arm. The patient experienced wound at injection site. The reporter consented to follow up.
Narrative: COVID infection following COVID vaccine series 01/26, Pfizer, dose #1 02/17, Pfizer, dose #2 08/16 pt cc: cough, headache, myalgias, rhinorrhea, sore throat exposure: unknown 08/17 SARS-COV-2 Variant Sequencing RESULT: pending 08/17 COVID swab, result: detected
Constant ringing in ears; Hips and legs feel very heavy; Hips and legs feel very heavy; Minor rash on wrists; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Sep2021 10:00 (Lot number: EW0187) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics; "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "known allergies", notes: known allergies: demerol; Dilaudid, reaction(s): "known allergies", notes: known allergies: dilaudid. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EW0187, lot unknown=False, administration date=30Aug2021, administration time=10:00 AM, dose number=1, vaccine location=Right arm), administration date: 30Aug2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 21Sep2021 08:00, outcome "not recovered", described as "Constant ringing in ears"; MUSCULOSKELETAL DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious) all with onset 21Sep2021 08:00, outcome "not recovered" and all described as "Hips and legs feel very heavy"; RASH (non-serious) with onset 21Sep2021 08:00, outcome "not recovered", described as "Minor rash on wrists". Therapeutic measures were not taken as a result of tinnitus, musculoskeletal discomfort, limb discomfort, rash.  Follow-up (24Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Approx 5 min /p injection noted rash & redness up & down both arms, Evaluated by clinic MD orders for Benedryl
Diagnosed with COVID; A spontaneous report was received from a female consumer of an unknown age concerning herself, She received Moderna's COVID-19 Vaccine and was diagnosed with COVID.  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 (Lot number not provided) on 24 Dec 2020 via unknown route at unknown anatomical region for prophylaxis of COVID-19 infection.   On 03 Jan 2021, after receiving the first dose of mRNA-1273, the patient was diagnosed with COVID. The patient would like to know if she can receive the second dose, which is scheduled for 21 Jan 2021.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome for the event of diagnosed with COVID was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 diagnosis after vaccination, this event is assessed as unlikely related to mRNA-1273.