chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within days after the MMR vaccination we noticed a change in our son's behavior. He was very quiet and irritable. There was an unwillingness on his part to socialize with friends and relatives. This same behavior continued during a long vacation, through the summer and into the fall of 2003. In October 2003 his hearing was tested and he was diagnosed to have bi-lateral sensorineural hearing loss. Our son was fitted with hearing aids in January 2004 and to date (3/2005) has not lost any more of his hearing. He is no longer exhibiting the same behaviors described above. Per Follow up report received 05/09/2005:  Nearly two years after the vacination patient still has bilateral hearing loss (30-40% in both ears).  This amount of hearing loss has, so far, remained consistant. Per follow up report- patient has moderate to severe sensorincural hearingloss in both ears. The degree of loss is the same as was originally reported.
After napping, infant received first and only vaccine, Infanrix DTaP. Baby cried for 15 seconds after vaccine and was quiet afterwards. Mother secured baby in car seat and drove three minutes to store. When she picked up baby she was limp and not responding to stimulation for about a minute. Baby opened her eyes slightly but was still limp. Mother immediately drove to doctor's and stimulated baby to wake again. She was alert when nurse saw her. Mom was told this is not a typical response but that baby appeared alert and OK now.
a mild headache; some red spots on the tops of her hands; it's a little bit tingly; sore upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore upper arm), HEADACHE (a mild headache), ERYTHEMA (some red spots on the tops of her hands) and PARAESTHESIA (it's a little bit tingly) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore upper arm), ERYTHEMA (some red spots on the tops of her hands) and PARAESTHESIA (it's a little bit tingly). On 21-Apr-2021, the patient experienced HEADACHE (a mild headache). At the time of the report, PAIN IN EXTREMITY (sore upper arm), HEADACHE (a mild headache), ERYTHEMA (some red spots on the tops of her hands) and PARAESTHESIA (it's a little bit tingly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-083707, US-MODERNATX, INC.-MOD-2021-083552 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Added TCR-patient refuse further follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083707:Reporter(Caller) case US-MODERNATX, INC.-MOD-2021-083552:Caller Wife case
Patient has history of vasovagal syncopy / seizure and told us in advance. When he was administered the vaccine, he passed out for just a short period of time and had a minor seizure (approx. 5 seconds).
Rash varying from urticaria type to maculopapular per doctor's office nurse administering vaccine and pt's sister in-law respectively. Pt died due to CVA in brain stem. Dx of rhabdomyolysis given also. F/UP report on 3/28/03: Cause of death was complications of dehydration.
Initial report received from a healthcare professional on 30 August 2013. A 26-years-old female patient had received an intramuscular  dose 1 of ADACLE vaccine; lot number C4432AB (anatomical site of administration was not reported) on 30 August 2013. The patient was pregnant at the time of vaccination. Date of last menstrual period was 16 January 2013. The estimated date of delivery was on 23 October 201. At the time of the report, the patient had not experienced any adverse events. Patient's health during pregnancy, specify risk factors (e.g.: alcohol, tobacco or recreational drugs) and treatment for infertility, specific risk factors were reported as not applicable. Concomitant medications and past medical history was not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
No adverse event; Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st bivalent vaccine) on 28-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Blood pressure high and Blood cholesterol abnormal.    On 07-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023) 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 EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccines 1st bivalent vaccine Pfizer on 28-Sep-2022 and 2nd bivalent vaccine Moderna on 07-Mar-2023).    Concomitant medication was not provided.   Treatment information was not provided.
Parasthesia Extreme fatigue Burning in entire body Muscle twitching Chest pains Lower leg pain Low blood pressure High heart rate
Death. Questionable SIDS.  Autopsy Report received which stated patient experienced reaction unevaluable.
Since May I have not been able to smell anything, I do have a cough, I have to go to the ER again on last Friday because I had a really bad cough, and I was diagnosed with Pneumonia. I have had 9 Covid tests but they have been negative. When I went to the ER they said my lungs look like someone who have had Covid but I have not. They did a CT CAT scan with contrast and a breathing treatment and blood work. Last August before getting the vaccine I went to the ER and I had been diagnosed with pneumonia as well. They thought it was Covid but it was not. I have a referral with a pulmonologist specialist and I still have a cough and can't smell anything.
her hands and feet were so cold; 101 temperature; Tired; Little Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (her hands and feet were so cold), PYREXIA (101 temperature), FATIGUE (Tired), HEADACHE (Little Headache) and CHILLS (Chills) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL COLDNESS (her hands and feet were so cold), PYREXIA (101 temperature), FATIGUE (Tired), HEADACHE (Little Headache) and CHILLS (Chills). At the time of the report, PERIPHERAL COLDNESS (her hands and feet were so cold), PYREXIA (101 temperature), FATIGUE (Tired), HEADACHE (Little Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101 (Inconclusive) 101 temperature. On 10-Mar-2021, Granulocyte count: high (High) high. On 10-Mar-2021, Monocyte count: high (High) high.         No Concomitant medications was reported Treatment information was not provided
Redness, swelling, warmth at injection site, hair loss. Nno treatment needed.
C/O measles like rash covering entire body, except face on 5/7/06.  c/o intense itching not relieved by Benadryl.  Saw MD 5/8/06 and was given Prednisone and Zantac.  Also taking Aveno Baths.  Off work 5/8 and 5/9.  Back to work 5/10, continues to have rash, but she states much improved with less itching.
Immunizations: Pediarix and Prevnar given in (R) thigh on 1/30/08. On 2/2/08 2 firm lumps noted in thigh with erythema - warm to touch. Advised cool compresses and Tylenol.
This case was reported by a physician and described the occurrence of unable to get up in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unknown date in September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). On an unspecified date in September 2011, within 2 weeks of vaccination with FLULAVAL, the subject experienced unable to get up. The subject laid on the floor all night and her husband could not get her up off the floor until the next day. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLULAVAL. The physician reported administering over 100 flu vaccinations and had 8 subjects report very unusual adverse events. This case 3 of 8 (see case IDs A0946057A, A0946060A, A0946073-A0946077A for details of the other reports).
Patient has experienced significant swelling and discoloration at injection site of right deltoid, extending to the lower forearm. Patient also experienced pain, especially in the region of the elbow. Referred to health care provider for possible cellulitis.
Information has been received from a nurse through the Merck pregnancy registry concerning an 18 year old female with attention deficit/hyperactivity disorder and allergies to codeine and ULTRAM who 26-JAN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot 3 654741/0013U). On 02-APR-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL vaccines (Lot # 657617/0384U). On 03-JUL-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 658100/0525U). On 18-SEP-2007, it was reported that the patient was at 13 weeks gestation (LMP=19-JUN-2007). There was no adverse experienced related to this event. The nurse reported information based on information provided by the patient's grandmother during a telephone conversation. "The baby was born in March 2008 and is doing fine. Only has a little bit of gas/GI Issues but is fine. As far as they know the baby is healthy and normal with no congenital anomalies." No additional information is expected.
Blisters / swollen tongue and lips, sensitive gums, symptoms of a yeast infection in vaginal area
Drug allergy NEC on 2013-09-25, clinician comment: local skin reaction.
Pt. had a sore shoulder for 2 weeks, but after using a heating pad the shoulder pain resolved.
Patient came back day after shot given saying his throat was burning and he was having trouble breathing but did not seek medical attention the night of admin.
Patient presented to the ED and was subsequently hospitalized on 3/25/2021 for 7 days.
Patient reported arm stiffness, muscle aches, general malaise. Patient also reported pain and lack of movement.
Infant had DTaP #4 on 06/17/02. Seen Rx PMD on 06/19/2002. child had approximately 10 cm med raised area on left anterior thigh. Area warm to touch with several small blisters. child seen today by dr, immunizations given at 2:00 pm. Edema/ Redness, noted 8:00 pm on 06/17/02.
(1) Patient presented to triage on 1/7/11 w/a one day hx of "flu-like" symptoms; body aches, chills; nasal drainage. Findings: fever. Maternal/fetal tachycardia. Elevated BP. (2) Pt (1) starting TAMIFLU; CXR; IV fluids; HTN eval; anticipate SVD - Resp isolation.  Vaccine failure.
PT GOT A DIME-SIZED RED RASH AROUND THE INJECTION SITE. SHE STATED THAT IS NOT TENDER OR ITCHY JUST "FELS HARD" WHEN TOUCHING.
REDNESS, SWELLING AND ITCHING OVER BICEP AREA OF ARM. PATIENT REPORTED SYMPTOMS STARTED SEVERAL HOURS AFTER THE SHOT AND REPORTED TO PHARMACY THE NEXT DAY WITH MILDER SYMPTOMS. THE PHARMACIST CALLED PATIENT ON THE SECOND DAY AFTER THE SHOT AND PATIENT REPORTED THE SAME SYMPTOMS BUT THAT THEY WERE STARTING TO GO AWAY. THE PATIENT HAS NOT TAKEN ANY MEDICATIONS FOR THE PROBLEM BUT SHE SAID SHE MAY TAKE A BENADRYL FOR THE ITCHING.
30JUL97 noticed a very heavy hair loss-more than ever;recv last hep b shot of 3 series shot on 22JUL97;
Sore arm all day today. Small headache. Starting around 5pm, I became dizzy, nauseated, and feverish.
My wife's arm is starting to get red where the injection site was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My wife's arm is starting to get red where the injection site was) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (My wife's arm is starting to get red where the injection site was). At the time of the report, VACCINATION SITE ERYTHEMA (My wife's arm is starting to get red where the injection site was) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of ROTATEQ (lot number L033693 with expiration date 31-MAY-2017 and lot number L035510 with expiration date 13-MAY-2017). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA005724: US-009507513-1704USA006552: US-009507513-1704USA006550: US-009507513-1704USA006551.
(Vasovagal Response and Mild Urticaria) ? Felt faint, had very mild rash on both arms. Pt said he saw a flash of ?blue light?.  Possible to d/t laying out in the sun. Mom noted possible allergic reaction to cats at home. (Initial BP 100/62  ? 10 mins 118/68).  Treatment:  Diphenhydramine 50mg/ml injection on right arm.
App. 10 mins after 3 vaccines were given, pt. passed out and hit (L) side of head, VSS, BP 110/70, alert and oriented x 3 - after several attempts to have her sit up - she was dizzy - MD had pt. transferred to hospital via ambulance with Mom.
Ringing in ears/head - Tingling/numbness on (L) side of face.
Itch and red oval/circular rash at injection site.  Began less than an hour after injection and has continued for 3 days as of now. Still ongoing.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MAGNESIUM; ZYRTEC; NEXIUM; ESTRADIOL. Vaccination history included: Comirnaty (Dose 1), for COVID-19 Immunization. The following information was reported: BASOSQUAMOUS CARCINOMA (medically significant), outcome "unknown", described as "squamous basal cell"; NEOPLASM PROGRESSION (non-serious), outcome "unknown", described as "Basal cell also diagnosed on nose that was not previously detected. Another basal cell carcinoma has now been diagnosed on opposite shoulder that was not detected in March"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "bump on arm near injection site that was painful to the touch". Additional information: Patient experienced bump on arm near injection site that was painful to the touch. Approximately 3 months after 2nd dose of Comirnaty. Diagnosed as squamous basal cell 8 months later upon skin check by dermatologist in March. Basal cell also diagnosed on nose that was not previously detected or being watched. Another basal cell carcinoma has now been diagnosed on opposite shoulder that was not detected in March during skin check-just appeared. Patient does not have any underlying medical conditions. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arthritis due to the cold; headache; Joint pain; Chills; Tired, fatigue; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis due to the cold), HEADACHE (headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Tired, fatigue) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20/A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Medical history reported as arthritis), Joint pain (Medical history reported as joint pain) and Memory loss (Medical history reported as amnesia). Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE (MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]) for Arthritis and Joint pain, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for Energy Levels, APOAEQUORIN (PREVAGEN [APOAEQUORIN]) for Memory loss.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (headache), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired, fatigue) and MYALGIA (Muscle pain). On an unknown date, the patient experienced ARTHRITIS (Arthritis due to the cold). On 06-Feb-2021, HEADACHE (headache), CHILLS (Chills), FATIGUE (Tired, fatigue) and MYALGIA (Muscle pain) had resolved, ARTHRALGIA (Joint pain) outcome was unknown. At the time of the report, ARTHRITIS (Arthritis due to the cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
She received vaccine on Fri.  She did not experience any adverse effects until waking up the next day.  She was dizzy, had some episodes of rapid heartrate, and vomited bile one time.  She went to the doctor and he thought it was related to the vaccine.  She started feeling better Monday night.
This spontaneous report as received from a practice manager refers to 10 patients of unknown age and gender. The patients' relevant medical histories, concomitant medications and past drug histories are unknown. The patients were vaccinated with VAQTA (lot #M036057, expiration date 18-MAY-2019) and PEDVAXHIB (lot #M007762, expiration date 07-DEC-2018) on unknown dates between 05-Apr-2017 to 28-Jun-2017 for unknown indication (unknown routes, doses and frequencies) that had experienced temperature excursion on 05-Apr-2017. On unknown dates between 14-Mar-2017 to 28-Jun-2017 these patients received PROQUAD (Lot # M038227 and expiration date 06-Mar-2018) for unknown indication (unknown route, dose and frequency) that had experienced temperature excursion. It is unknown if the patients continue to take VAQTA, PEDVAXHIB, or PROQUAD, and the outcome is unknown. Additional information has been requested.
After pt's Kinrix and MMRV vaccine he had localized redness and swelling and a little pustule that developed.  He was treated with clindamycin with resolution of symptoms.
A 12 year girl received first dose of vaccine as Off label; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year girl received first dose of vaccine as Off label) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year girl received first dose of vaccine as Off label). On 04-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 12 year girl received first dose of vaccine as Off label) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.  No concomitant medications reported by reporter.
Information has been received from a medical assistant concerning a 14 year old female, who on 15-OCT-2007 was vaccinated in the arm with a dose of Gardasil. Concomitant vaccinations included MENACTRA and Dtap, administered in the other arm. On 15-OCT-2007, as the medical assistant was pulling the needle out of the patient's arm, the patient fainted. the patient was on top of the exam table and she fell forward onto the medical assistant and then hit her face on the floor. The patient got cut right below her chin. The patient went to the hospital to get stitches. It was reported that the patient was out for 30 seconds. At the time of the report, the patient's outcome was unknown. Additional information has been requested.