chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced INFLUENZA (flu). At the time of the report, INFLUENZA (flu) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient mentioned that she needed to be checked for an urgent care because she felt like she had a flu and she wanted to confirm if it was COVID.  Patient confirmed that she previously received COVID-19 Vaccine.  No treatment information was provided.   Reporter did not allow further contact
Given Hepatitis B vaccination - 3rd dose on 2/13/2017. Next day developed malaise, weakness, fatigue, fever up to 104.7 and mild sore throat.
After arriving at home after getting the shot, I began to have flu-like symptoms. This included an extremely sore throat with very swollen glans. My throat is/has been red with pus-like pockets on the inside of my throat. In addition to the throat issues, I have been extremely lethargic, with sensitivity to light and sound. I have had all of these symptoms for 6 days now. I also have had lots of diarrhea but that cleared up after 3 or 4 days.
Pt mom reports that pt felt her throat was getting tight 20 minutes after vaccine, then experienced tachycardia. Mom reports gave Benadryl and symptoms subsided.
Local swelling, redness and itching on left upper arm. Was improving when seen in office on 7/1/05.
Severely enlarged lymph nodes at clavicle, neck, and axillary. Unable to wear clothing due to tenderness in enlarged lymph nodes, unable to work at hospital x2 days. Lymphatic drainage massage did not resolve. Swollen nodes very painful.
RASH Headache Pain in arm Welt in L arm @ injection site (pain) Itchy throat Fever of 101 degrees ACHY feeling Symptoms started about 6:00pm I did take Benadryl and tylenol was taken upon my arrival home. Symptoms continued to 9/24/19. Additional benadryl taken and symptoms resolved 9/25/19
Neglected to take the final two doses; A spontaneous report was received from other healthcare professional on 20NOV2023 regarding a male patient of unknown age who "neglected to take the final two doses" (PT: Intentional dose omission). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.   The patient's medical history, concomitant medications, or allergies were not reported.   It was reported that patient took the first two doses of Vivotif on 12NOV2023 and 14NOV2023 and then neglected to take the final two doses.  The outcome of the reported events not applicable.    The action taken with Vivotif with respect to the reported event was not applicable.    No additional information was reported.  Company comment: It was reported that a consumer took the first two doses of Vivotif on 12NOV2023 and 14NOV2023 and then neglected to take the final two doses (intentional dose omission). The causality of intentional dose omission is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer took the first two doses of Vivotif on 12NOV2023 and 14NOV2023 and then neglected to take the final two doses (intentional dose omission). The causality of intentional dose omission is assessed as not applicable to Vivotif considering the nature of the event.
At approximately 12 noon, felt sleepy , then 12:30 lips were edematous, red rash all over body.  Denies any shortness of breath. She had had no meds./ food that day because she was having lab work done. Gave herself Epi pen injection and Bendaryl (25mg). She is allergic to bee stings so keeps Epi on hand.
Headache, chills and body aches at night the same day that I got it and after two days many head itch.
On evening of dose, experienced arm swelling, hardness, and redness.  Fatigues, chills, fever, nausea, and muscles aches started day after till 3 days after.  Those symptoms started on Friday, but then on Friday started to feel dizzy, with vasodilation and tachycardia.  Felt like was going to pass out. - lasting an multiple hours.  Felt tachycardia (measured by Fitbit) which started Friday evening and has lasted to this day of reporting.  Tachycardia is slowly improving.
Bruising 2" x 2" with redden hot area around injection site. Redness and heat remained 3-4 days, pain from inflammation for 3-4 days.
DAY AFTER VACCINE I FELT VERY TIRED CHILLS, FELT LIKE I HAD A FEVER. NO FEVER REGISTERED WITH THERMOMETER. RIGHT ARM VERY SORE, PAINFUL TO LIFT UP.  2ND DAY I NOTICE REDNESS AND SORENESS BELOW THE INJECTION SITE . SKIN IS WARM TO TOUCH.
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fall on an unspecified date with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA with lot number M011116 and expiration date of 17-JUN-2017 (strength, route of administration, anatomical location and dose were unknown), which were stored at a maximum of 60 Fahrenheit degrees (F) for 24 hours and a minimum of 29.3 degree F for 1.5 hours (14 cycles below 32 degree F). There was previous temperature excursion described as below 32 degree F off and on for a week, several occasions stated as 50 minutes, 45 minutes, 40 minutes, 55 minutes, 1 hour and 15 minutes, 50 minutes, 35 minutes, 35 minutes, 1 hour and 35 minutes, 2 hours and 15 minutes, 45 minutes, 30 minutes and 55 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
suspected vaccination failure/had both shingle shots and got the shingles; shingles/Got shingles just over it; 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: This case was received from the patient via  interactive digital media. The patient had both shingles shots and got the shingles just got over them. 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.
Information has been received from a healthcare worker concerning a female patient of unknown age. On 17-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (lot #, dose and route were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date in the last year, in 2011, the patient received the first dose of GARDASIL and on 17-AUG-2012, she got the second dose. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Headache 1 hour after vaccine. Chills the next morning at 6:00am, followed by headache and periods of being hot after taking Advil
Cellulitis; Sinus drainage due to the weather; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), SINUS OPERATION (Sinus drainage due to the weather) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, CELLULITIS (Cellulitis) had resolved and SINUS OPERATION (Sinus drainage due to the weather) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            Concomitant medications were not reported.  Patient reported non-serious events of Flu-like symptoms, sinus drainage due to the weather and cellulitis with SKYRIZI(RISANKIZUMAB).  On unknown dates, the patient experienced Flu-like symptoms, sinus drainage due to the weather and cellulitis. On an unknown date, CELLULITIS was resolved. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  Patient reported that she got cellulitis from her second dose of covid vaccine.  She was down with flulike symptoms for a couple days after her covid vaccines and also lots of sinus drainage due to the weather.  Treatment information was not 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.  Company Comment: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Cellulitis, after receiving the second dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Cellulitis, after receiving the second dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a registered nurse refers to a 12 months old patient of unknown gender. On 08-MAY-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2014) that on 03/03/2014 was exposed at an unsupported temperature excursion temperature range 45F, time frame: 24h). No adverse effect ws reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER). At the time of the report, VACCINATION COMPLICATION (severe reaction that landed me in the ER and medical bills/had a vaccine reaction that landed me in the ER) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant and treatment drugs were not provided  Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Followup Recived on 24-AUG-2021, dose no. of the suspect vaccine added.
Information has beenr eceived from a registered nurse concerning a patient who on 12/4/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Subsequently on 12/6/01, the patient called the office complaining that her left arm where she received the injection was red, edematous and painful. The patient was seen in the office on 12/7/01 and her arm was fine. The RN reported that there was nothing there. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is expected. The RN also reported that another patient experienced cellulitis and SOB and was hospitalized after vaccination with pneumococcal vaccine 23 polyvalent (see WAES01120796).
High temp fever (102.5), body aches, headache, possible loss of consciousness (momentarily- unverified - I wasn't there) temp responded to acetaminophen/cold compresses but lasted thru night. In AM temp down to <=101 for another 12 hours, slept all day After 18 hours, temp resolved (still achy for another 12 hours)  NO chills, NO nausea, only mild injection site swelling Note - the pharmacy suggested I create this report because of the possible loss of consciousness (was non-responsive to sibling when arrived home)
Local reaction to DTAP swelling right leg - vastus lateral. Mom to monitor decrease, use warm compresses.
Community Member recieved 2nd dose within 17 days of 1st dose of Pfizer
per Cardiology, patient developed Myopericarditis from covid vaccine. Patient received 2nd shot of Pfizer on 9/30/21 and within 24h developed chest pain in left upper chest radiating towards his back, sharp and burning in nature. Admitted to hospital on 10/2. Still admitted as of today 10/4.
PT STATES SHE RECEIVED FLUAD MONDAY 9-28-20. SYMPTOMS APPEARD THE FOLLOWING DAY AND CONTINUED TO TODAY 10-01-20. SYMPTOMS INCLUDED PAIN AT INJECTION SITE, PAIN TO THE TOUCH, REDNESS(APPX 2INCHES IN DIAMETER), ITCHING, SKIN HARDNESS IN AREA, MILD BRUISING ABOVE INJECTION SITE.
Pt developed a 12.5 x 10 cm area of redness, a 6.5 x 5 cm area of swelling and tenderness to touch on left lateral thigh. Pt was able to ambulate. Pt was treated with cool compresses for 24 hrs and then warm compresses and with Motrin. Pt was to follow up in 2-3 days.
Complete exhaustion, no energy, soreness of trunk, loss of appetite, rapid weight loss.  No appetite.
Rash to arm. Received injection 2/20/14. Arm rashed, red, sore, warm. No fever.
Patient presented at home with vomiting two times. No appetite for food or fluid intake. Irritability, decreased sleep and bruising of the arms
Swollen lymph nodes under right arm; A spontaneous report (United States) was received from a consumer concerning herself a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen lymph nodes under right arm/ vaccination site lymphadenopathy.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem and bupropion hydrochloride.   On 20 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced swollen lymph nodes under right arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, swollen lymph nodes under right arm was unknown.
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. ON an unkown dates, the patients were vaccinated with improperly store doses of VAQTA (lot # L009445, expiration date: 01-JUN-2017 and lot # L002717, expiration date: 02-JUN-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was expired for 20  days. Given inadvertently due to confusion in extended dates. vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and PRODUCT TEMPERATURE EXCURSION ISSUE (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and PRODUCT TEMPERATURE EXCURSION ISSUE (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and PRODUCT TEMPERATURE EXCURSION ISSUE (possible administration of invalid dose to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data (between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Face and neck became extremely hot and red.  Redness lasted 4 days, disappearing a little bit each day.  I noticed rough skin similar to a rash as well as swelling on my face the next day.  Should I get the second vaccine?
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 4:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 3:47 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   The age of patient was provided as 56.61.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  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. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).