chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to a 14 year old patient of unknown gendfer. No concurrent condition and medical history was reported. On 10-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# K006117, expiry date: 14-JAN-2017, intramuscularl in the left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Headache, Arthralgia, chills, injection site pain, fatigue, sensitivity to light Narrative:
vaccinated about 12 noon on 2/25/10. pt reports itching and tiny bumps on arms, eyes, ears, neck in evening hours.
The day after the vaccine was administered (9/18/18) patient experienced muscle soreness at the site of the injection, overall "great weakness, exhaustion, and chills". All of which subsided within 1-2 days after symptoms appeared.
small hives on lower arms, near my wrist, upper legs, and one small hive on my cheeks, neck and chest. I also felt horrible fatigue, malaise. I had COVID over Thanksgiving and was reported to my local health department. I also had a bad headache and horrible muscle tightness. The hives lasted on and off for 32 hours. The malaise was overnight and the fatigue and pain at the injection site lasted 72 hours.
Afew days after recieving the vaccine the pt developed runny nose and swelling in the rt side of her neck. No fever at that time.  On June 10(22 days after dose) pt noted a "pimple on her face" followed on June 11th by 3 vesicles on her left arm, no fever.  She was seen by PMD and was treated with ibuprofen and augementin at that time.  By 6/15/08 lesions had spead to legs, trunk and face.  On 6/17/08 she developed a fever to 102 and was seen at ER.  She was started on acyclovir and her Mycophenolate was stopped that that time.  ON 6/19/08 she was again seen in the ER for worsening lesions including swelling of right eye.  She was admitted for IV acyclovir treatmetn at this time. 7/3/08-records received for DOS 6/19-6/25/08-DC DX: Varicella. SLE with nephritis. C/O generalized vesicles, pustules, fever, rash macular, right eyelid swelling, mild conjunctival injection. Vaccine administered on 5/24/08 and first presented on 6/17/08.
child had dizziness and fatigue the same day a few hours after, mother stated child was fine the next day.
Developed small red, hot raised blisters close to the site of injection. This developed into one fluid filled blister that drained clear liquid.
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 20-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti-viral Paxlovid as COVID 19 Treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx 2yrs p/vax pt exp chickenpox consisting of raised bumps, mild fever, & itching. 12/16/98 dx w/chickenpox
I had my vaccination on 10/03/2022. I started to experience extreme muscle and joint aches and pains on 02/19/2023. I tested COVID-19 Positive on 02/22/2023. I contacted my physician on 02/24/2023 and was stated because my case was mild.  I was not prescribed Paxlovid.
Localized reaction left deltoid with 5-7 cm redness. Warm to the touch. Child voices no complaints of pain. Normal ROM. Advised Tylenol x warm compresses QID, RTC if no improvement.
Diarrhea & NauseaVomiting Narrative:  took tylenol
Signs/Symptoms: itchy, fine red lacy rash (near injection site), NO Respiratory Issues. Treatment: (Individual took personal dose of Benadryl @ 15:50).
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with live ZOSTAVAX (lot # not reported). The patient developed shingles within two weeks. It was unspecified whether the patient sought for medical attention. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, route, and frequency were not reported) (lot # reported as N008007 and expiration date: 09-MAR-2019) for prophylaxis. The vaccine was administered with sterile diluent (MERCK STERILE DILUENT) (lot # N006806 and expiration date: 12-AUG-2018) which was properly stored.  There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit (°F) (18.5 °F) for 3 hours and 15 minutes. Data logger was involved and there were no previous excursions reported. Lot number N008007 is an invalid lot number for varicella virus vaccine live.
severe fatigue, sore throat, low grade temp off and on post-72 hours, ear pain, lymph nodes swollen under left jaw area, chest tightness and pain upon inspiration for the past 3 days. Reeived Janssen on 4/3/2021. Have white pus pocket on left tonsil for approximately five days
blisters at the injection site; itching at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: moderna covid-19 vaccine (DOSE 1, SINGLE), administration date: 06Feb2021, when the patient was 74-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 2, SINGLE), administration date: 06Mar2021, when the patient was 74-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 3, (BOOSTER) SINGLE), administration date: 27Oct2021, when the patient was 75-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 4, (BOOSTER) SINGLE), administration date: 12Apr2022, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 24Oct2023, outcome "unknown", described as "itching at the injection site"; VACCINATION SITE VESICLES (non-serious) with onset 25Oct2023, outcome "unknown", described as "blisters at the injection site". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site vesicles.  Additional information: The caller (patient's wife) wanted to know if itching and blisters at the injection site is normal or have been reported after receiving the Pfizer COVID vaccine. Her husband went on Tuesday to (institution name withheld) to get the COVID-19 shot and he got Pfizer.  The next morning when he woke up he had a blister. When he went to take bandage off, the blister popped, it was a clear fluid and that was Wednesday. The injection site itched all night long and when he woke up on 25Oct2023 to take the band-aid off, the blister popped. Her husband also had blisters at the injection site today, 26Oct2023, but caller didn't look because she didn't want to have to pop it again.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
(L) deltoid area swollen with erythema 3 cm x 3 cm patch with warmth.
2:50PM- DT Booster was given. 3:05PM-became diaphoretic, no BP, unable to see HR. 3:07PM-0.3 ml Idronlir 1:1000 given. 3:10PM-became GHT, BP 72/50 P=92.
This spontaneous report was received from a healthcare professional and consumer via Pfizer concerning a female patient of unknown age. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately 2015, the patient started therapy with pregabalin (LYRICA), 225 mg daily for an unknown indication (route, lot# and expiry date unknown). On an unspecified date in the end of December 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose number, dose, unit, route, anatomical location, lot# and expiry date not reported). On the same day after vaccination, the patient had a reaction. The following day, the patient went to the emergency room (ER) for having hives (urticaria). She was advised that she had cellulitis and acquired bronchitis. On an unknown date, the patient experienced burning mouth sensation (oral discomfort) due to which the physician added 100 mg of pregabalin (LYRICA) making it to a total dose of 325 mg and that 100 mg was making her drowsy in the morning (somnolence). On 16-APR-2018 (reported as "this morning"), the patient woke up with half of her body feeling more tingly than normal (paraesthesia). Action taken with pregabalin (LYRICA) for the event "burning mouth sensation" was dose increased and for all other events it was unknown. Outcome of all the events was unknown. The reporter's causality assessment was not provided. Upon internal review, the event "cellulitis" was determined to be medically significant.
Extreme paranoia; insomnia for 72+ hours; hallucinations; hospitalized in mood disorders; This is a spontaneous report from a contactable consumer. This 24-year-old female consumer(patient) reported for herself (patient).   A 24-years-old non pregnant female adult patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 26Jan2021 as dose 1, single for covid-19 immunisation (at the age of 24-year-old). The patient medical history was not reported and concomitant medications were none. Facility type vaccine was workplace clinic. The patient did not received any other vaccines within 4 weeks prior to the Covid 19 vaccine. The patient did not received any other medications within the 2 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient had been tested for Covid 19 post vaccination through nasal swab test. On 29Jan2021, 03 days after vaccination, the patient experienced extreme paranoia, insomnia for 72+ hours, hallucinations, hospitalized in mood disorders unit for 10 days with no previous symptoms or hospitalizations. The events resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 10 days. The patient received treatment medications for the events. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test): results were unknown. The clinical outcome of the events was Resolved with Sequel on an unspecified date on 2021.  Follow-up attempts are completed. No further information is expected.
Later that evening, at bedtime noticed that arm was very sore. The next afternoon she noticed that arm was very red and hot. Unable to raised arm. Went to ER and was given Prednisone PO and oral antibxs. Much better today.
Systemic: Nausea-Severe, Systemic: Vomiting-Medium
Left shoulder soreness began a couple of hours after injection. Right shoulder sore after 5 days. Pain continueing 3 weeks after injection. Left arm cannot be raised above shoulder level. Wrist and fingers stiff and achy. Shoulder pain on both arms. Left is worse. Wrists and fingers ache on both hands.
Sudden nausea,  diaphoresis, lightheaded, shortness of breath, injection site pain for approx 10 min
Right side lower pain ever since. It comes and goes very frequently; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 27 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: 301558A) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cherry allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Right side lower pain ever since. It comes and goes very frequently". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain. Additional information: The first dose of Pfizer COVID-19 vaccine (Batch/Lot No: FJ1611) was reported as administered on 17Nov2021 02:00PM in arm. The second dose of Pfizer COVID-19 vaccine  (Batch/Lot No: 301558A) was reported as administered on 26Oct2021 in left arm. The case was reported as non-serious. It was reported as not resulting in death, no life threatening, not causing/ prolonging hospitalization, no disabling/ incapacitation or no congenital anomaly/ birth defect.  No follow-up attempts are possible. No further information is expected.
Body redness, hives and itchiness upon cold exposure (pool, ice, cold drinks) 1 week after shots (HPV/MENVEO/TDaP).
sneezing, red swelling below lt eyes given Epi 11OCT95 @ 210 same day vax was given, given DPH;
Sore Arm Injection Site; Headache; A spontaneous report was received from a consumer concerning himself of 66 years old male patient who experienced sore arm injection Site/injection site pain, headache/headache.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) on 30 Jan 2021, intramuscularly at upper arm for prophylaxis of COVID-19 infection.    On 30 Jan 2021 the patient experienced sore arm at injection site and headache. She took 3 Advil tablets before receiving the vaccine. She took two more Advil tablet after the event. Treatment of the event included Advil.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events sore arm injection site and headache was considered resolved.
Fainted two times, fast heart rate, dizzy, light headed  Sought treatment from doctor.
Patient received 2nd dose of Moderna vaccine 21 days after first dose making 2nd dose invalid.  Patient will be revaccinated on 2/24/2022 per current CDC guidlines outlined in the COVID 19 vaccine administration errors revaccination guidance of 12.01.2021
Patient was nervous about receiving Pfizer vaccine. As soon as the needle was injected, patient began crying and was pointing to her mouth. I told her to remove her mask and breathe, which she did, she stated that her chest felt tight. I asked if her throat felt ok she stated yes and continued to talk. We instructed the patient to take deep breaths and she said her chest felt better but she felt dizzy. I gave her apple juice and instructed her to put her feet up. We repeatedly offered for her to lay down to which she refused. Patient continued to cry and state she felt "like everything is spinning and like I don't have control over my body". We called a code white and called emergency services. Patient continued to state she did not feel well, was shaking on and off, and was uncontrollably emotional. Patient was taken to hospital by EMT (Reaction may have been a panic attack)
Severe Headache, Painful and very swollen area on arm, Red area on arm approximately 4-5 inches long and 3 inches side.  For two days could hardly move I was so exhausted.
Received a 3rd vaccine (Pfizer) dose after previously receiving 2 Moderna doses (last dose given 3/5/21).  Low grade fever on 3/16/21 of 100.2 following vaccine.  Acetaminophen administered.  Temperature had returned to normal of 97 on 3/17/21.  First two doses of Moderna vaccine given by Medical Center  at  Country Club.
Headache, Sedation, Myalgia, Arthralgia, Chills, pain at injection site Narrative:
mom says AM 9APR92 got DTP/OPV/HIB & was OK until 3AM during nite had fever 102 R & was fussy; 10APR92 2PM fever 105 R mom took to MD dx ear infection; ? if fever was due to ear infect or vax;
Hot to Touch Sensation - Near Injection Site; Itchy Sensation - Near Injection Site; Arm Pain - Near Injection Site; Swelling - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
On June 22, 2022, pt. arrived around 9:00AM with mother and 2 siblings for immunization visit. Pt did not receive any immunizations until age 12 due to mother's beliefs against vaccines. Mother reports they have moved and he needs all his vaccines to enroll in school. Mother desires pt. to receive all  vaccines that he is due for. Nurse attempted to reduce cost to patient by suggesting combination vaccine MMRV proquad without checking age range for vaccine. Patient was checked in around 9:30 AM and Nurse began preparing vaccines for both children.  After counseling, mother agreed for vaccines and signed for them around 9:45AM. Vaccination of pt. began around 9:50AM and MMRV proquad was given in right arm subcutaneous. Nurse realized error at 10:00AM and patient stayed in office until 10:15AM. Pt denies SOB, swelling of throat or tongue. Pt reports only heavy, sore arm feeling due to multiple vaccines.
I had tinnitus before but now it is louder. Gingko Biloboa was helping to keep it manageable but that doesnt seem to have any effect now.
Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Loose stool / and had all he could do to get to the bathroom in time; threw up; began with chills and sweats/Chills; began with chills and sweats/Sweating; stomach hurt so bad; Feeling unwell; Hot flashes; arm was sore; This is a spontaneous report from a contactable consumer (patient's husband). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL0142, Expiration 31Mar2021, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:20 (at the age of 69-years-old) at 0.3 mL single dose for COVID-19 vaccination. Medical history included coronary heart disease, aneurysm in his stomach area, quadruple heart bypass in the 1990. There were no concomitant medications. Historical vaccine included flu shot and experienced arm was sore. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 at 21:30, the patient experienced his arm was sore. On 08Feb2021, the patient experienced loose stool/and had all he could do to get to the bathroom in time, threw up, began with chills and sweats, stomach hurt so bad, feeling unwell, hot flashes. On 09Feb2021, now, he was extremely tired and weak, just sleepy. There was no emergency room or physician office for the events. No treatment was provided for the events pain in arm, threw up, chills, sweats, tired, weak, hot flashes, sleepy, stomach hurt so bad, feeling unwell. Unspecified treatment was provided for the even loose stool. The outcome of the events pain in arm, threw up was recovered in Feb2021. The outcome of the events loose stool, tired, weak, sleepy, stomach hurt so bad was unknown. The outcome of the events chills, sweats, hot flashes was recovering. The outcome of the event feeling unwell was not recovered.
Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 20 Oct 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 20 Oct 2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 20 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and Placed in refrigerator on 20 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that the vial was initially stored in the refrigerator on 29 Oct 2021. Patient did not experienced any adverse event. Vial does not undergo temperature excursions. No treatment medications were provided.
starting 12 hours after vaccine, patient was fatigued, lightheaded, headache, body aches, low fever for 24 hours
14 cm local reaction with induration and erythema.  Fever of 105 degrees F,  24 hours after immunization with temps resolving after 48 hours.