chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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.   The age of patient was provided as 73.84.  Concomitant products were not provided.  On 03-Nov-2021, At excursion time 10:00 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021 for batch number 035C21A.  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 Fisherbrand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
SWELLING IN ARMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included does the patient have any allergies? :: no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On APR-2021, the subject experienced swelling in arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in arms. This report was non-serious.
COVID+ 12/26/2021 Sxs: sneezing, loss smell, coughing, itchy throat,
pt recv vax & 1hr later exp SOB, heart palpitations & a sl raised & itchy rash;upon exam EKG nl, lungs were clear & there were no other skin eruptions;tx w/Zyrtec;pt went home & indicated will report to the hosp if the SOB inc;
Patient received the second dose of the Pfizer COVID-19 vaccine on 30APR2021. Within 72 hours (03MAY2021), the patient developed hives and her right eye was swollen. 08MAY2021- patient experienced a swollen lip and a metal taste in her mouth. 12MAY2021- Patient was seen at an urgent care with throat swelling and received a steroid shot. Her primary care provider recommended she add Singulair and Zyrtec to her medications. The patient is to be seen by an allergist. Physicians did recommend changing her amlodipine to another blood pressure medication even though it is noted that a reaction to this medication is unlikely to be causing the patient's symptoms. The patient continues to have recurrent hives to this date.
5:36  complaint of tingling sensation  to face and lips; no swelling observed, no other complaints. 5:45 patient drove self home
I woke up Monday morning after receiving vaccine on Sunday with a severe headache and cold sweats.  The cold sweats have subsided however I am still having a headache.  Its not as severe as it was on Monday but i have kept a headache since Monday even taking Tylenol and ibuprofen doesn't make it completely go away.
Started with painful swollen glands at base of skull, moved to neck and base of ears, next day stiff swollen foot and ankle then the next day stiff swollen knee (while foot improved), next day both knees swollen. The next day both knees were improving and elbow was stiff and swollen and it ended with stiff wrists and hands for several days. Symptoms lasted altogether about 9 days.
Bell's palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included Prednisone 50 mg/day and Advair 550 breathing treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Significant and pronounced flu-like symptoms, fever (100.9), weakness, aches/pains in joints and muscles throughout body (in addition to injection site). Could not continue work after 1/2 day and went home sick.
Days 3 through 10: ipsilateral axillary lymphadenopathy and tenderness as well as tenderness over left chest well inferior to the axilla. No treatment. Day 8: Sudden onset of a localized 3 cm cutaneous rash (erythema, pruritis, induration) at injection site in shoulder. Rash lasted for 24 hours. No treatment. Day 11: Deltoid exercise induced 2cm cutaneous rash (erythema, pruritis) at injection site in shoulder. Rash lasted 10 minutes.
Few minutes after patient received COVID Pfizer #2 dose patient's cheeks became flushed and she reports tightness/itchiness of throat. Patient received Benadryl 25mg IM R arm and after few minutes tightness and itchiness of throat resolved.
Less than 24 hours after receiving the second vaccine dose, I woke up in the middle of the night to go to the bathroom. I was fine getting out of bed, walking to the bathroom, using the toilet, and getting to the sink. As soon as I turned on the faucet to wash my hands, I was hit with vertigo. The entire room started to spin. I lost my vision and tried to make my way back to the bedroom to wake my husband. Once I got in the bedroom I not only could not see but my hearing became muffled like I was under water. My husband was speaking to me but sounded like he was far away. After about 30 seconds, my vision came back as did my hearing. The vertigo spinning lasted about half that amount of time (15 seconds). I have never had vertigo before in my entire life.
No other issues or concerns noted; a 3 year old female patient was accidently administered GARDASIL 9; This spontaneous report was received from an office manager (reported also as customer) and refers to a 3-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-MAR-2022, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No other issues or concerns were noted (no adverse event).
Patient experienced swelling, hotness in upper arm, tightness from swelling. Advised to get antihistamine.
Febrile seizure Seemed well in morning except felt warm and was given ibuprofen.  At 4 PM suddenly had seizure that lasted a few minutes.  When squad arrived fever was 104.  Was also found to have one red eardrum on physician evaluation after seizure.
07/01/22 presents to Birth Center Triage for "scheduled repeat C-section".  PMHx of "CESAREAN SECTION" "CONIZATION, CERVIX"
Booster dose administered >12 hours post puncture/what are the protocols if an expired dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered >12 hours post puncture/what are the protocols if an expired dose was administered) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered >12 hours post puncture/what are the protocols if an expired dose was administered). On 23-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose administered >12 hours post puncture/what are the protocols if an expired dose was administered) 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.  The dose was drawn out of a vial which was punctured more than 12 hours. No other AEs reported by HCP on behalf of patient.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non significant Follow-up received
Flu shot given left arm, approximately 2 hours later, developed urticaria, itching, severe pain at site radiating to left arm, neck and shoulder. Site bruised and erythematous. Developed edema of hands, paleness with nausea.
Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016209502) on 18-Apr-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Tetanus Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Severe nasal congestion within hours. Loss of smell and taste. Following day of vaccine received my Positive PCR test results  for Covid 19. Tested negative 12 days prior.
After getting a shot, my son was fussy then slept all day. He developed an earache and become feverish. In the middle of the night (10/11 pm) my husband and I were awakened by our son groaning and gnashing his teeth, moving his body in strange ways, grinding his teeth and growling as if he was possessed. He was sweating and feverish. I brought him into bed with me and he stopped making the scary sounds. I looked it up online and this type of growling, teeth gnashing is a symptom of encephalitis, which is one of the potential side effects of the DTap shot he'd received that morning.
Client received flu vaccine 11/8/06. Mother noted RT. deltoid become redden and swelling Thursday pm. Friday morning redness had increased with swelling. Child seen by pvt md and dx with cellulitis at injection site and placed on keflex. Monday  11/13/06 mother states his arm is improving. Client is being followed up by pvt md.
Swelling, redness and pain at the injection site, extreme neck pain,  muscle fatigue all over,  nausea and lethargy.
Initial report received from a health care professional on 03 Dec 2009: This three year old child received FLUVIRIN (batch no: 102126P1A) intramuscularly on an unspecified date inadvertently (dose not reported).
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 24-JUN-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (lot # expiration date and dose were not reported) which had been improperly stored during 24 hours at 9.50 degrees C and 144 hours stored at temperatures between 8.01 degrees C to 8.11 degrees C. Concomitant medications were not reported. There was not previous temperature excursion and the call was made because of a data logger. No adverse effects were reported and there was no PQC involved. This is one of several cases from the same source (MARRS # 1607USA004298 and 1607USA006955). Additional information has been requested.
MEDICATION ERROR.   RN mixed TIXAGEVIMAB and CILGAVIMAB in the same syringe against manufacturing instructions for use and against instructions on pharmacy dispense label. Patient received the full dose of EVUSHELD (300mg/3ml TIXAGEVIMAB and CILBAVIMAB 300mg/3ml) patient was observed for 1 hour.  patient discharged to home without any adverse reaction to medication
I noticed that I was out of breath. I was having trouble walking. I thought I was just out of shape. About a month ago, I noticed I was out of breath walking 15-20ft. I went to the Dr where a chest XRAY was clear and a STRESS TEST came back clear as well. As of right now, I am not out of breath anymore. It has completely gone away with no medication or any changes.
I took annual physical and 29 days later blood tests results were abnormally low (WBC 3.5; RBC 3.21; PLT 42K; etc.). For the next 3 months blood continued to drop until I was diagnosed with Aplastic Anemia I spent 6 days in hospital and I am still taking treatments.
patient had seen pmd. dx. with allergic reaction gave benedryl and prednizone. came to HD and the rash was jagged circular red areas on lower 1/2 of body. no itching temp 98. had mmv combination 12 days prior.encouraged to see ER if respiratory problems arise.
Swelling of the right arm noted by mom the next day but no fever. Patient given DIPHENHYDRAMINE x ROCEPHIN by injection and 10 day course of KEFLEX and 5 day of HYDROXYZINE. Labs: CBC done in office.
Developed shortness of breath, heart palpitations, lightheadedness with wheezing approx 48 hours after vaccine administration.
Information has been received from a consumer, concerning her daughter who in October 2008 and December 2008, was vaccinated with her first and second dose of GARDASIL IM (lot number and site not reported) respectively.  Since the patient got her second dose vaccine, she experienced light headedness, headaches and stomach pain.  The patient's adverse events were recovering.  Additional information has been requested.
Information has been received from a registered nurse concerning a 2 month old female who on 13-DEC-2006 was vaccinated with Pneumovax 23 (lot # 655588/0883F), instead of PREVNAR.  The nurse confirmed that this was not product confusion, but a staff error.  Unspecified medical attention was sought.  Additional information has been requested.
Sore arm where the shot was administered; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporter's comments: The patient said just a sore arm where the shot of Shingles vaccine was administered.  The event was recovered after a few days.
Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot
I was sick to my stomach within 12 hours after the vaccine. I was bedridden from exhaustion for 3 days. I have had chronic shoulder pain ever since. I assumed the pain would get better. Then, because of Coronavirus, I didn't want to bother anyone about it. But recently, the pain has intensified and extended down my arm into my forearm, elbow and wrist. There is still a yellow bruise where the vaccine was injected.
muscle cramps; chills; I now have a headache; fever 100.4; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (muscle cramps), CHILLS (chills), HEADACHE (I now have a headache) and PYREXIA (fever 100.4) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps), CHILLS (chills), HEADACHE (I now have a headache) and PYREXIA (fever 100.4). At the time of the report, MUSCLE SPASMS (muscle cramps), CHILLS (chills), HEADACHE (I now have a headache) and PYREXIA (fever 100.4) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.4 (High) fever 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Severe non-stop migraine everyday, all day, dizziness, skin rashes, acne, ringing in the ears, back pain (spine and tailbone), lack of energy, chronic fatigue, muscle pain and weakness, confusion. Memory loss, comprehension issues, depression, burning or prickling sensation in most parts of her body, temperature sensitivity in her hands and feet, color changes in her hand and feet, numbing feeling in different places of her body, including her face, uncontrollable laughing, fainting.
Unknown which vaccine patient received.  Patient states soon after vaccine he began having dizziness off and on.  He states 2 weeks ago that he began having associated dizziness and shortness of breath.  Prior to coming to ER he had severe chest pain and shortness of breath that was worsening.  He was found to have left lower extremity DVT with extensive bilateral pulmonary emboli.  He is currently stable.  He has no risk factors associated with developing DVT/PE.  He is active, does not smoke, and has no history of cancer.  **Unsure of which vaccine patient received***
(R) upper arm red and warm to touch. Area slightly swollen. Started evening of 5/15/17. No pain. Arrived at clinic 5/16/17 at 10:20.
PATIENTS FACE WAS DRAWN TO ONE SIDE, HE HAD SLURRED SPEECH, STILL HAVING RIGHT SIDE OF FACE STILL DRAWN ANDCOULDN'T CLOSE HIS MOUTH HAD NO STRENGTH, HAD NO CONTROL WHEN DRINKING OUT OF STRAW.  CARDOLOGIST AT THE TIME GAVE STEROID FOR TREATMENT AND MASSGAING OF THE SIDE OF MOUTH TO TRY AND LOOSEN UP THE MUSCLES.
flu-like symptoms; muscle aches; stomachache; back pain; skin sensitivity; headache; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband.   The reporter did not know for sure if the patient experienced a fever or not.  The reporter did not consent to follow-up.
1/31/2023 - redness at vaccine site 2/1/2023 - red, swollen, hot to touch, bigger in size at vaccine site
I woke up because of an uncomfortable level of heat at 6 am and could not move my body until 11 am. Could not check my temperature until 2 pm, when it was 101 F, but I know I was much hotter earlier in the day, to where my bed felt like my heated blanket was on. Heart was pumping extremely fast, somewhere around 110 bpm. Experienced sore eyes and blurry vision?felt like there was pressure behind my eyes. Light sensitivity and felt like I was being overloaded just by watching a movie.  No appetite. Could barely drink water. Fever of 101 persisted even after an Advil, did not let up until the next morning with a temperature of 99.
I began to have severe blurred vision around 12 PM today, 9/17/21. This lasted about 2 hours.
No adverse effects were reported; the patient was administered an improperly stored VAQTA vaccine / temperature: 32.1 degree Fahrenheit; This spontaneous report was received from a certified medical assistant and refers to a 21 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 32.1 degree Fahrenheit (F) for 4 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No adverse event (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
devel of facial & body rash-pruritus @ 1500;exam reveals gen wheals;tx w/DPH & prelone;
Severe muscle pain in both legs and lower back. The next morning the pain was so intense it hurt to even walk or sit.