chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, PYREXIA, and HEADACHE in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Arrhythmia.    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 CHILLS, PYREXIA, and HEADACHE. At the time of the report, CHILLS, PYREXIA, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Blood pressure measurement 173/84 (High). On an unknown date, Heart rate (abnormal), Heart rate irregular.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included Antihypertensive pills. No treatment drugs were reported. Blood Pressure unit showed heartbeat was irregular the day after the Moderna vaccine.   This case was linked to MOD-2021-380721 (Patient Link).   Reporter did not allow further contact
pt recvd vax & 1-2 hrs p/vax exp itching & hives on extremities; pt took DPH;
lt arm swelling shoulder to elbow, red, warm to touch to see PMD 7MAY97;MD office visit dx severe reaction on clinical eval;
Raised red bump, about 2 inches wide. Warm and tender to touch. Not itchy.
11/13/08 Called EH office complaining of redness, pain and swelling in right upper arm from a Pneumoccal injection given 11/12/08. Advised warm compress and tylenol or advil and notify if becomes worse.11/14/08 AM called EH office again, states right upper arm worse with redness and pain and swelling extending down past elbow, advised to come and let us see it. She came into EH office (10am)noted redness and swelling extending down arm past elbow, complaining of pain on bending elbow. Advised to go see her personal physician.
Varicella given 3/15/12. Onset of localized redness/itch on 3/15/12 pm. Improved when seen 3/19/12 with some residual erythema (L) upper arm.
Continuous pain (R) upper arm since Flu vaccine 9/23/14. Body aches x 3 weeks.
Numbness in left leg, pain in the administered area, difficulty to lift the leg, dizziness, double vision.
COVID19 Pfizer on 8/27/21 (EW0187), 2/14/21 (EL9261), 1/24/21 (EL9262) in Left deltoid for each, administered at Hospital Hospitalized for new acute bilateral PEs showering, unprovoked.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 30-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N017833, with expiration date of 16-NOV-2019, by  intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. On 25-JAN-2018, the patient received the second dose of GARDASIL 9 lot # M035486, expiration date of 05-JUN-2019, by intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. Then on 22-MAR-2018, the patient was vaccinated with the third dose of GARDASIL 9 lot # N020139, expiration date of 14-FEB-2020, by intramuscular route (strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the digital data loggers and freezers expired before they were re-calibrated. The reporter was aware in some of the freezers there was a temperature excursion that the data logs showed. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they have paper logs to monitor those temperatures.   The reporter wanted to know whether need to take any action since the vaccines stored in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021.  No treatment medications were reported.
Massive hair loss; migraines came back; menstrual cycle all messed up; vaccine is administered on the same date; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: WG10190, Expiration date: Not reported), via unspecified route, administered in left arm on 31Mar2021 (at the age of 45-year-old) as dose 2, single; and first dose of BNT162B2  (Lot Number: WG10190) via an unspecified route of administration, administered in  left arm on 31Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Chronic migraines. And patient had known allergies to Sulfur. No other vaccine 4 weeks prior to covid vaccine. Concomitant medications were not reported but Patient received few mediations within 2 weeks of vaccination and details unknown. Prior and post vaccination, patient was not diagnosed and tested with covid 19. On 15Apr2021, after the vaccination, the patient experienced Massive hair loss, migraines came back, and menstrual cycle all messed up. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the events is not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
CoughWheeze DRY THROAT, COUGH, FLUSHING Narrative: 10 minutes after administration of 2nd covid vaccine, he felt hot, diaphoretic, and c/o dry mouth. Employees was escorted to ED for evaluation, declined exam at this time. Will wait to see if symptoms improve. Employees was advised to be evaluated, he still declined evaluation. He was encouraged to return to the ER for worsening symptoms. Pt was able to drink w/o any difficulty. Remained flush in appearance,
I STARTED SEEING DIFFERENT COLORS AND I HAD A HARD TIME FOCUSING ON OBJECTS. IT LASTED FOR ABOUT 15 MINUTES. THE NEXT DAY, MY BLOOD PRESSURE HAD SPIKED.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-395985 (Patient Link).
Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021.  The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.
HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Heart disease, unspecified (Heart disease), Cholesterosis (Cholesterol) and Blood pressure high (Blood pressure). Concomitant products included LISINOPRIL for Blood pressure high, ROSUVASTATIN for Cholesterolosis NOS, INSULIN, EMPAGLIFLOZIN (JARDIANCE) and METFORMIN for Diabetes, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The storage condition of the vial at the time of the excursion was refrigerated. Maximum or minimum temperatures reached in by the vial was in between 2-8 Celsius degrees. Excursion duration was almost 24 to 30 hours and one vial of vaccine was impacted. Treatment medication was not provided by the reporter.
Severe back pain, migraine, unable to concentrate, fatigue, fever, chills - these have resolved except the fatigue Extreme sensitivity to foods - starting 3 week after 2nd shot - ongoing Shortness of breath - starting 3 week after 2nd shot - ongoing, intermittent.
Fever, chills, insomnia, dizziness, fatigue, headache, nausea, disorientation
Patient developed squamous cell carcinoma at injection site.  Patient is scheduled for a consult for excision.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 07-APR-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # J009723, expiry date 30-JAN-2015), 0.5 ml, intramuscular. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
had 2 shots and still get the Shingles/Suspected Vaccination Failure; get shingles; very painfull; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 28-FEB-2023 Reporter's comment: The case  was received from the patient via interactive digital media. The patient had 2 shots of Shingles vaccine and still got the shingles and it was very uncomfortable. The reporter stated that never know where they would be next and wherever there was a nerve ending and they were very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Couldn't get out of bed the next day, or move her arm and lost taste and smell; Couldn't get out of bed the next day, or move her arm and lost taste and smell; Couldn't get out of bed the next day, or move her arm and lost taste and smell; This is a spontaneous report from a contactable consumer. An adult female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 20Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient experienced COVID-19 prior to vaccination. It was unknown if patient was pregnant and it was unknown if patient was pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient couldn't get out of bed the next day, or move her arm and lost taste and smell on 21Aug2021 with outcome of recovering. It was unknown if treatment was received. It was unknown if patient tested for COVID-19 after vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
I had pain on my lower left thigh where I have Shingles rashes a few hours following the Pfizer injection. The following day I broke out with Shingles.  No forewarning several days ahead like I usually have.  I had had 2 doses of the preventative  Shindrix vaccination with the final  dose  in October 2020.
Pt received dose of saline only in left arm.  Repeated dose of Pfizer in right arm. Treatment - repeated dose of Pfizer in right arm symptoms - Pt reported saline injection stung  Signs - immediately Time Course - 1 hour.  pt chose to go lunch before receiving replacement dose  Outcome - pt received pfizer dose in right arm
C/O dry throat and mouth. C/O headache and nausea. C/O dizziness. C/O arm weakness. ER visit 8-3-15 said gave 3 injections for nausea, migraine and steroid. States rested a little and just feeling a little better 8-3-15 at 3:45 PM.
This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a 83-year-old female patient who received SHINGRIX (batch number D3L5G, expiry date 29th November 2020) for prophylaxis. On 16th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th May 2018, 3 hrs 42 min after receiving SHINGRIX, the patient experienced general body pain (serious criteria disability). On 21st May 2018, the patient experienced rectal bleeding (serious criteria disability and GSK medically significant) and blood in stool (serious criteria disability and GSK medically significant). On 25th May 2018, the outcome of the rectal bleeding and blood in stool were recovered/resolved. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain, rectal bleeding and blood in stool to be related to SHINGRIX. Additional details were provided as follows: This case was reported by Certified Medical Assistant (CMA). At 11:18 hours, the patient received SHINGRIX in the left deltoid. At 03:00 in afternoon, the patient experienced body aches. The patient spent the next three days at home recovering and she felt better by the weekend (unknown date in May 2018). On 21st May 2018, 5 days after vaccination the patient had rectal bleeding and also it was described as blood in stool. On 23rd May 2018 Wednesday, the patient visited the office. On 1st June 2018, the patient underwent colonoscopy that showed no cause for the bleeding.
Patient reported that his left leg started to swell on 7/22/23, the whole calf, tender to touch, painful, little redness. He applied cold compress for an hour but no help.  He took ibuprofen today in the morning before calling pharmacy.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (lot # L045676, expiration date 09-MAY_2017), (lot# L046509, expiration date 19-MAY-2018), (lot# L051100, expiration date 17-JUN-2017) (dose and route were not reported). Concomitant drug was not reported. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
PT HAD A RED CIRCULAR RASH THE DAY AFTER GETTING THE FLU SHOT WHICH WAS VERY LIGHT AND WARM TO THE TOUCH, THE NEXT COUPLE OF DAYS THE RED SPOT PUFFED UP AND WAS HOT TO THE TOUCH AND VERY RED. TOLD PATIENT SHE NEEDED TO TRY ANTIHISTAMINES AND MAYBE ICE IT. IF IT CONTINUES FOR LONGER THAN 5-7 DAYS TO LET ME KNOW.
About 28 hours after 2nd varicella vaccine developed shingles-like rash R wrist area. Very pruritic, also painful.