chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pounding Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (ongoing), notes: Verbatim: Pre-diabetic, Diagnosed about 6 years ago.; "Overweight" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Covid Vaccine, Batch/Lot number:ER8732, Dose; Left Arm), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 13Apr2021, outcome "not recovered", described as "Pounding Headache".  Additional information: Caller states his 16 yr old took his second shot yesterday and he has a pounding headache. States he wants to know what his son can take for his headache. States he sees it listed as a side effect but doesn't see anything about what he can or can't take. Doesn't know if he can give him aspirin or what.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around March 8th I started to feel strange pain in my head. I felt bumps on my scalp. I went to a dr on March 10th and was dx with shingles. On the morning of March 12th I woke up with partial facial paralysis and went to urgent care and was diagnosed with Bells Palsy. March 15th I saw neurologist, who confirmed I had bells palsy.  I continue to feel lingering symptoms including facial nerve pain, twitching, and continue to feel stressed by my face no longer being symmetrical
Achy; Chills; Fever; Fatigue; This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously received unspecified vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 for immunisation. On an unknown date in Apr2021, the patient experienced achy, chills, fever and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events achy, chills, fever and fatigue were resolved on an unknown date in Apr-2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 13 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Client presented at PH office on 05/17/04. Received adult td on 04/28/04 right deltoid. C/o sharp shooting pain right arm/ shoulder area, approx 2 weeks post injection. No redness, pain, drainage, post injection. No muscle  atrophy noted on 05/17/2004.
This spontaneous report was received from a Nurse Practitioner and refers to a 15 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. At 03:21 PM on 04-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the right arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Pt recvd 3 doses of Engerix-B & 11NOV91 it was determined that pt did not respond to the vax series;
Vaccination given at approximately 2 pm. Patient stated racing heart and dizziness at 3:37 pm. Pulse was 72 and respirations 14. Patient was taken to nearby hospital.
Resident coded and expired; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and coded and expired.  The patient's medical history was not provided. No concomitant product use was reported.  On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On undisclosed date, the patient coded and expired.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on an undisclosed date. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: MEDICAL COMMENT: MOD 2021 009822 DEATH NOS This case concerns a patient of unknown age and gender who received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection and had died.  Very limited information regarding this event has been provided at this time to make a proper medical assessment, therefore, the causality is unlikely related to the vaccine in this case of death not otherwise specified. No contact information provided. Follow up is not expected.; Reported Cause(s) of Death: Unknown cause of death
Approximately 18 minutes after vaccine was administered I felt dizzy, lightheaded, heart racing, flushed, tongue felt thick. Blood pressure immediately elevated along with heart rate. I was taken to the emergency room. They performed a EKG and gave me IV decadron and Benadryl.
Patient had a rash and pain in left deltoid following vaccination. No systemic symptoms, just localized pain in arm since vaccines.
no additional AE/PQC reported; caller reports vaqta administered after a temperature excursion; This spontaneous report was received from an medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not reported.  On 17-AUG-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot #T023913, expiration date 31-MAR-2022 for prophylaxis (dose #, exact dose, route, and anatomical location were not reported). A vaccine undergo temperature excursion in temperature 9 Celsius degrees for 5 min. It was unknown if a digital data logger was involved. No additional adverse events was reported. Case information does not suggest a causal association with the device or device constituent
Sore throat began 12/12/2022.  The pain increased so I went to the urgent care clinic on 12/16/2022.  The pain became excruciating so I went back to the urgent care clinic on 12/18/2022.  My neck began to look swollen on the left side and the pain began shooting up my neck from my throat to my jaw and left ear and I was unable to swallow food without pain.  On 21/21/2022 my left eye stopped blinking and the left side of my mouth was crooked so I went to the Emergency Room.  I was diagnosed with Bell's Palsy. I lost the ability to speak clearly or swallow food properly.  As the paralysis in the left side of my face increased, my hearing diminished and sounds were delayed and off.  On 2/22/2022 I woke up with total hearing loss, extreme vertigo, and vomiting.  Due to the inability to swallow and the vomiting, I lost over 30 lbs from December 2021 to May 2022 dropping from 175lbs to 138 lbs.
EMPLOYEE WAS AMBULATING DOWN THE HALLWAY WHEN HE EMMITED ALOUD SHOUT BEFORE FALLING INTO THE WALL AND EVENTUALLY TO THE FLOOR. EMPLOYEE WAS RIDGID AND APPEARED TO BE HAVING SIEZURE LIKE ACTIVITY. EMPLOYEE HAD A BLOOD TINGED SPUTUM. EVENT LASTED APPROX 35-45 SECOND BEFORE RELAXING AND BEGINNIG SNORING RESP.  EMPLOYEE APPEARED TO BE IN POSTICTAL PHASE. EMPLOYEE EVENTUALLY BEGAN TO ROUSE,HOWEVER, WAS VERY CONFUSED. DURING EVENT EMPLOYEE WAS PLACED LEFT LATERAL POSITION AND AIRWAY IS MONITORED . 911 WAS NOTIFIED. ON EMS ARRIVAL EMPLOYEE WAS BECOMING MORE COHERENT WITH NO RECOLLECTION OF EVENTS AND NO OBVIOUS INJURIES NOTED. EMPLOYEE IS PLACED ON STRETCHER IN POC AND TRANSPORTED TO HOSPITAL.
10 days and I still feel poorly after this vaccine... last night was scary. Back left under ribs back pain...then chest pain left / same spot on the front left... felt like a cardiac event. Then I saw the large inflamed rash on my left arm and I collapsed in the shower. I took my medicine and went to sleep and felt ok for a little this morning and now the pain is back - this time with heartburn. I?ve been sick to my stomach on and off since the vaccine, weird taste and feeling in the back of my throat, place where they gave me the shot swelled up half the size of a baseball within an hour of the vax - it?s still a bit bigger than my other side. Could it be allergic reaction to this?
Pain, temp, swelling, occasional tingling, less range of motion, hard areas, inflammatory response.
Left arm the patient couldnt lift it. It was red and swollen. On 8/13/2020 it was itching and a little red
(+) swelling, Redness and pain of left forearm approximately 5 x 5 cm - given Rx for antihistamine and pain (Atarax ; Motrin ); ice pack elevate arm
Red and swollen at site of injection, approximately 2.5in x 1in. Tylenol given for pain. Injection administration technique questionable, RN injected too low, possibly missing the deltoid. Reported this information to our primary care provider's office.
no adverse event; the patient was accidentally administered VARIVAX instead of VAXELIS; 11 month old patient was accidentally administered VARIVAX; This spontaneous report was received from a consumer via representative and refers to an 11-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-AUG-2021, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (formulation, route of administration, lot#, expiry date were not reported) for prophylaxis instead of intended diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS). It was reported that there was no further adverse event.
Extreme nausea dizziness vertigo headache fever aches  that lasted six days.
15APR92 pt devel mild hives the prior evening 14APR92, took DPH, hives have inc in size had episode of chills, aching in joints; hx of working in woods & field on 14APR92 MD out of town; Seldane, Pred ordered & stop Tagamet;
This spontaneous report was received from a healthcare worker reporting an unspecified number of patients of unknown age and genders. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported). 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that (Oka/Merck) VARIVAX that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect reported. Additional information has been requested.
Patient was previously seen in the ED on 11/12/22 for abdominal pain. During this visit, she tested positive for COVID-19 by PCR.   She returned to the ED on 11/18/22 with continued abdominal pain along with a productive cough. While in the ED, the provider noted that she was intermittently hypoxic, so patient was placed on 2L O2 by nasal cannula. Ultimately patient admitted 11/18/22  - 11/21/22. Discharge diagnosis included acute hypoxic respiratory failure due to COVID-19 pneumonia. Patient was weaned to room air 11/20.
Patient stated that she had excessive sneezing since the vaccination. Warm at site of vaccine. 3 inch diameter of hardness and redness around site of vaccination. Experienced dry, itchy eyes. No fever, runny nose or cough. 3 days later, redness was subsiding.
Information has been received from a pharmacist concerning his 12 year old son who was vaccinated at school with one dose of Hepatitis B IM. Approximately one hour following vaccination, the child's arm became swollen and red at the injection site. The school nurse placed ice on his arm and the swelling subsided. No further information is available.
Nausea, muscle pain, weakness, tired, headache, shivering as fever came up, fever (101-102). Diarrhea, redness/swelling at site. Started Sat. 10-13-18 afternoon - in bed all day Sunday - felt better Mon. - didn't feel good until Sat. 10-20-2018. I am fine now! Should I take the second SHINGRIX?
Shivers, headache, agitation, malaise,  Can?t function -feels like I have the flu
Unable to work 1/22, fatigue, HA, Chills, Fever, symptoms resolved on day 2
Pt face turned red and was warm no other problems. Was red face and warm 4-6 hr. No other problem.
Developed sneezing and hives within minutes. Swelling of face, lips, eyes, hands, feet. No wheezing; given epinephrin, Benadryl and steroids. Observed for 12.5 hours. Did well.
Fatigue; Weakness; Rash on the upper abdomen; Rash on the upper abdomen / felt like burning; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tremor, arrhythmia and fibromyalgia. Concurrent medical conditions included arthritis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced fatigue and weakness. On an unknown date, the patient experienced rash and burning sensation. On an unknown date, the outcome of the fatigue, weakness, rash and burning sensation were recovered/resolved.   It was unknown if the reporter considered the fatigue, weakness, rash and burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 62 years or 63 years. The patient received dose of Shingrix in the left arm. Within 12 hours after vaccination, the patient experienced fatigue and weakness, lasted for about a day and then resolved. One week after the injection, the patient developed a rash on the upper abdomen that felt like burning. It lasted for about a week and then resolved. The reporter did not consent to follow up.
Initial information regarding an unsolicited valid serious case received on 26-Sep-2018 from a consumer. This case involves a 75 years old female patient who experienced recurrence of arrhythmia, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Arrhythmia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 16-Sep-2018, the patient received a 0.5 first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a serious recurrence of arrhythmia (arrhythmia), one day (reported as next day) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. Other relevant tests included no lab data. Final diagnosis was recurrence of arrhythmia. It was not reported if the patient received a corrective treatment. The patient was not recovered from the event. List of documents held by sender: none.; Sender's Comments: This case involves a 75 years old patient with history of arrhythmia who developed recurrence of arrhythmia one-day post vaccination with FLUZONE HIGH DOSE. Time to onset is compatible. This could have multiple causes viz. other preexisting medical conditions, any other drug treatment, stress etc. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations and therapies, lab test ruling out other etiology is missing for further assessment of the case. Based on limited information reported assessment cannot be done.
I have a swollen lymph node in my right arm pit.It's a bit tender to the touch and hurts if i lay on my left side with my upper arm pressed against my body but if i hug my pillow its fine.
Rash, nonspecific skin erruption beginning on right hip, spreading to lower back and abdomen. Symtpoms began one day after vaccination and have been spreading for 4 days. Patient prescribed Zyrtec and Prednisone.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 18-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Painful; Wrong injection technique; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain and wrong injection technique. On an unknown date, the outcome of the pain and wrong injection technique were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient received vaccine in unknown deltoid. The pharmacist stated she administered the first dose of Shingrix to patient who asked why the pharmacist was giving the injection in the deltoid muscle, which led to wrong injection technique. The reported stated she was researching this further, and was not sure whether the Shingrix was given subcutaneously. The pharmacist was not in the pharmacy at the time of this call, so limited details were available. The reporter consented to follow up. This case had been linked to the case US2019162813, reported by same reporter.
0300 10/6/2020 woke with high grade fever (102.4), muscle and body aches, chills. Fever responsive to ibuprofen 600 mg.  Fever returned 3 hours after ibuprofen dose. Continuing to have fevers, alternating between acetaminophen and ibuprofen q4h.   Pt does have hx of reacting similarly to flu vaccine on the past, but this year is especially severe.
Moderna COVID-19 Vaccine EUA   This lot # is for the first injection.  I have since received my second dose on 3/11/21 and my booster - also Moderna - on 11/22/21.  With each successive dose, the tinnitus seems to have become much worse.  It seemed to get a little better as time went on after the first 2 doses, but with the booster it has come back ringing at even higher volume.  Most distressing/
large whelps on arms, leg, and at one time I had one appear on my face.  They come and stay for several days and then go away. This happened for regularly for several months and then quit.  I got the virus in August and right before I tested positive, I broke out again.