chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning her 5 year old Caucasian daughter with no prior medical history and no known allergies who on 8/10/99 (also reported as 8/14/99) was vaccinated SC in the left arm with a 0.5ml dose of varicella virus vaccine live (lot # 631072/0449J). There were no concomitant medications. There was no history of chicken pox and no recent exposure to chicken pox or herpes zoster. On 9/11/02 (also reported as 9/10/02), the patient developed a low grade fever and a patch of vesicular lesions on her temple on one side of her head that seemed consistent with shingles. It was also noted that the patient developed a headache. It was reported that the distribution was noted on the trigeminal nerve with less than 50 lesions. It took 5 days until all vesicles had broken and no new lesions. The virus was cultured as varicella zoster on 9/11/02. The physician collected a sample for VZV analysis and identified on 10/2/02 as wild type strain. Medical attention was sought and the patient was given acyclovir. Subsequently, the patient recovered. The patient's experience were considered to be an other important medical event (OMIC). Additional information is not expected.
mouth, tongue, and throat itching and swelling. patient was treated in the ED and sent to urgent care for evaluation. Care given is unknown.
Headache, muscle aches, arthritic aches, low fever, fatigue came on 6 hours after the shot and is continuing the next day. I am less than 24 hours after the shot at this point.
Soar arm.  Soar lower back.  Tired and general blah feeling.
swollen lymph nodes; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; DULOXETINE; KYLEENA; IUD NOS. Vaccination history included: Bnt162b2 (Lot unknown: True, Lot unknown reason: Misplaced/discarded, Administration time: 12:00 PM, Administrator route: Intramuscular, Vaccine location: Right arm, Dose number: 1), administration date: 14Dec2020, when the patient was 23 years old, for covid-19 immunisation, reaction(s): "nausea", "headache", "chills", "sweats". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccines given 05/12/2003. Patient developed systemic hives (over whole body) on 05/13/2003. He was on Augmentin as well.
received a 5th booster by mistake/received 5th Moderna dose as a booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (received a 5th booster by mistake/received 5th Moderna dose as a booster) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 014M20A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 23-Jun-2022, the patient experienced EXTRA DOSE ADMINISTERED (received a 5th booster by mistake/received 5th Moderna dose as a booster). At the time of the report, EXTRA DOSE ADMINISTERED (received a 5th booster by mistake/received 5th Moderna dose as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient had received 4 Moderna vaccines and she received a fifth Moderna dose as a booster by mistake on 23-Jun-2022. No treatment drug details was reported.
Face "looked weird" according to Aunt. Child was taken to ER and dx with Bells Palsy.
severe stomach aches; missed work for 2 days; nausea; vomiting; muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach aches), IMPAIRED WORK ABILITY (missed work for 2 days), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C1A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach aches), IMPAIRED WORK ABILITY (missed work for 2 days), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches). On 08-May-2021, ABDOMINAL PAIN UPPER (severe stomach aches), IMPAIRED WORK ABILITY (missed work for 2 days), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs and treatment medications were reported.
I had cold-like symptoms on 12/5/2023; I had sneezing, productive cough, and runny nose. I took two home antigen tests on the morning of 12/6/2023 and got a positive result on both. I went to the NP that afternoon and got a prescription for molnupiravir and cough medicine, which I started taking that evening. I also took OTC DAYQUIL to manage the symptoms. My symptoms lasted for maybe a week to ten days. I have COPD and use an albuterol inhaler and nebulizer every day. After the COVID-19, I felt like my lungs were a little worse than before and that I had to use the nebulizer more often on a daily basis during the first couple of weeks in January 2023. I developed bronchitis around 3/12/2023, and I was prescribed 500mg of cefalexin. When I had bronchitis, I had nasal congestion and difficulty breathing. Later during the illness, the mucus became a neon green color. I contacted my NP and got another round of the same antibiotic. At the time of this writing, the bronchitis is gone, but I still don't feel like my lungs are what they should be. I now get winded more easily. I normally use a nebulizer once a day, but since I've had bronchitis, I sometimes have to use it twice a day.
this morning the patient woke up and noted that her right upper arm was sore and there was a red patch surrounding the vaccine site, no fevers, no meds given, pt came to clinic for eval
Exactly 9 days following this vaccine my daughter experienced her first seizure. These continued periodically for about one year.
I began to throw up and have diarrhea. On 2/24/2023, I took a home antigen test and got a positive result. I called a telemedicine number, and I was prescribed PAXLOVID and an anti-nausea medicine. I also took OTC guaifenesin. The anti-nausea medicine worked right away. At the time of this writing, I have general malaise, cough, headaches, and altered sense of taste. I've lost my appetite, so I have also lost 8 lbs. I now weigh 104 or 105 lbs. My doctor suggested that I possibly had long COVID-19. I was due to undergo eye surgery on 3/15/2023. I was not able to undergo the surgery, because I took a COVID-19 test and got a positive result.
Same problem/continue to have diarrheal now into 9 months; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Same problem/continue to have diarrheal now into 9 months) in a 74-year-old female patient 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 DIARRHOEA (Same problem/continue to have diarrheal now into 9 months). At the time of the report, DIARRHOEA (Same problem/continue to have diarrheal now into 9 months) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided It was reported that women in her mid to late 70s had the same problem after receiving booster dose. Treatment medications were not provided.   This case was linked to MOD-2021-356678, MOD-2021-355994, MOD-2021-355923 (Patient Link).
w/in 48 hrs p/vax pt exp an inject site reaction which was described as red, raised rash (size of a softball), on lt leg by the 4th day, center started to turn purple, very hot to the touch & painful; rx w/cold compresses; no v,d; afebrile
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # H013949 and exp date 31-OCT-2013) subcutaneous (dose not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patient experienced developed cellulitis-like reactions after receiving ZOSTAVAX. The patient was treated by an unspecified physician by telephone. The patient received unspecified oral biotics. The outcome of developed cellulitis-like reactions after receiving ZOSTAVAX was unknown. It was reported that other two patients had cellulitis with ZOSTAVAX and was seen by a physician (MARRS 1305USA004281). This is one of several reports from the same reporter. Additional information has been requested.
SEVERAL MINUTES AFTER RECEIVING HIS VACCINATION, PATIENT STARTED TO EXPERIENCE LIGHTHEADEDNESS AND A RACING HEARTBEAT.  HE PUT HIS HEAD BETWEEN HIS KNEES, APPLIED AN ICE PACK TO THE BACK OF HIS NECK,  AND DRANK SOME GATORADE.  HE FELT BETTER AFTER ABOUT 10 TO 15 MINUTES.
Pt recv vax on 11/5/98; on 11/7/98 pt exp fever (101), hives on legs & arms
L-deltoid continues to be sore two weeks after injection. After five weeks, soreness has decreased, but is still tender and difficult to move. Instructed the mother to call or bring her back to the office if symptoms did not improve or to call back and inform us of her progress in one month.
PATIENT DEVELOPED A RED, SWOLLEN, ITCHY UPPER ARM AT THE ADMINISTRATION SITE WITHIN 12 HOURS OF ADMINISTRATION. PATIENT TREATED WITH STAT ORAL DIPHENYDRAMINE PRESCRIBED BY PHYSICIAN. ALSO PRESCRIBED FOR THE ADVERSE REACTION WAS ATARAX 25MG PO Q 6 HRS PRN X 3 DAYS.
I am experiencing severe tinnitus. I suffer from tinnitus anyway, but it became much worse after the first shot and has not subsided. I received the second shot 04/24/2021 at 1:00 p.m. and it seems to have gotten worse still. I have not sought treatment. Maybe the tinnitus is not related to the vaccine, or this is inconsequential, but I feel I have a responsibility to report it.
administered Fluzone High Dose to seven patients ranging from age 36-54/ no adverse event; administered Fluzone High Dose to seven patients ranging from age 36-54/ no adverse event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 43 years old female patient who accidently received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ285AA via intramuscular route in the left arm on 21-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to overdose and product administered to patient of inappropriate age.  it was reported that a Medical assistant accidentally administered Fluzone High Dose to 7 patient's between the ages of 36-54.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt said he started having stomach pain on 9/25/16 (10 days after flu shot) Went to Hospital on 9/26/16 and claimed they refused to see him. He stated he has Kidney and Liver damage from the flu shot. I asked for test results and records but pt has nothing to give me.
Fever 101. Nausea, Headache, and body aches per pt states symptoms started at night and states still continued to this morning 02/21/2019. Pt advised to continue to Tylenol and Motrin and push fluids if symptoms worsen please call office.
After second dose of Pfizer Covid-19 vaccine he received two days ago on Wednesday June 2nd around 5pm. Felt tired that night and into the next day with some local swelling and pain to the right arm at site of injection, and also into right armpit. Thursday evening, he was resting sitting on the couch and developed some mild chest pain. Can't really describe the location or severity very well. Did seem to be worse with inspiration. Hasn't reoccurred since that time. Still feels somewhat tired today with mildly sore right arm. No fevers. No chest pain today.    IR showed second dose of Pfizer Covid-19 vaccine was given to the left arm but confirmed with CVS that it was given to the right arm.
Patient received first dose of Moderna on 04/08/2021, second dose on 05/06/21. Patient was taking prednisone. She stopped taking prednisone on 6/6/21. On 6/8/21, her hands and feet were swollen. She consulted a physician and he diagnosed her with rheumatoid arthritis. Pt stated before she received vaccines, she was given an RF test and the results were negative for any rheumatoid factors.
Red rash at the injection site; Red rash at the injection site; Received full booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash at the injection site), VACCINATION SITE RASH (Red rash at the injection site) and ACCIDENTAL OVERDOSE (Received full booster dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21, 029L20A and 011L20A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu vaccine (3 weeks after the booster dose). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Patient had many allergies to medicines and products but did not specify which ones.), Aortic valve stenosis (Patient had a cardiac aortic valve stenosis prior vaccination and After vaccination she went to her Doctor and noticed that her valve stenosis went from minor to moderate/severe condition. Her doctor said that it happens with age and did not attribute it to the vaccine.) and Thyroid disorder NOS.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and PRAVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter.   On 06-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full booster dose). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red rash at the injection site) and VACCINATION SITE RASH (Red rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red rash at the injection site), VACCINATION SITE RASH (Red rash at the injection site) and ACCIDENTAL OVERDOSE (Received full booster dose) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not immunocompromised but received full dose of booster dose.   Patient did not tested positive for Covid-19.   No treatment medications were reported.   This case was linked to MOD-2022-536019 (Patient Link).
PATIENT DEVELOPED ABOUT 9CM REDNESS SWELLING WITH MODERATE ITCHING TO RIGHT DELTOID AND HOT TO THE TOUCH. MOTHER GAVE PATIENT BENADRYL AND BY THE 4TH DAY THE SWELLING HAD GONE DOWN AND ONLY HAD REDNESS AND MILD ITCHING TO AREA. DR. INSTRUCTED PARENT TO CONTINUE GIVING BENADRYL AND MOTRIN FOR DISCOMFORT.
rash to red breast; rash to red breast; tenderness; swollen; heat and rash to red breast; Covid booster; Off-label use; This is a spontaneous report from a contactable physician received via a sales representative. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as Dose 3 (Booster), Single for Covid-19 immunization and influenza vaccine (FLU VACCINE VII, Lot number and expiry date: Not reported), via an unspecified route of administration from an unspecified date as Unknown dose, single for an unspecified indication. The patient's medical history included Type 1 diabetic, high blood pressure and a breast cancer survivor since 2020. The patient's concomitant medications were not reported. The patient previously received the past drugs BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown, Age at vaccination:49-year-old at vaccination) via an unspecified route of administration on an unspecified date as Dose 1, Single and Dose 2, Single for COVID-19 immunization. On an unspecified date, the patient experienced with tenderness, swollen, heat and rash to red breast. It was reported that she received both flu vaccine and Pfizer COVID-19 booster on the same day 12 prior to her symptoms. Event took place after use of product. It was suspected that it could be an inflammatory response to the 4th vaccine but wasn't certain, to be held reported seeing that on a rare occasion on other vaccinated individuals. The patient was prescribed and received treatment with 500 mg of Cephalexin capsules once a day for 7 days. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
SHINGLES; painful under right armpit; This case was reported by a consumer and described the occurrence of shingles in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles and axillary pain. On an unknown date, the outcome of the shingles and axillary pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and axillary pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported, but it could be 67 or 68 year. After receiving 2nd dose of Shingrix, the patient experienced shingles and not really bad but very painful under right armpit. The reporter reported that idea how much longer this will last.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2022 at 13:00 as dose 3 (booster), single (Lot number: FK9896), 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 was not reported. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Head ache for 7 days.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache for 7 days.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Head ache for 7 days.). At the time of the report, HEADACHE (Head ache for 7 days.) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
17 yo F with history of hypermobility syndrome and chronic pain, autonomic instability here for possible vaccine reaction. Was seen 12/12/17 for impetigo, on left upper outer thigh on antibiotics for this. Seems to be getting better less drainage. Did have a new spot come up at back of neck. She is taking cephalexin as prescribed 500 mg TID and applying mupirocin. Got MCV vaccine at that appointment into left upper arm. Felt achy following day. On Friday ached up arm and face/neck, seemed to have difficulty keeping eye on that side open/droopy eyelid. Called and referred to urgent care (notes not available), felt likely adverse reaction to vaccination, told to follow-up if difficulty breathing or other signs of allergy so returned for feeling of lump in her throat, had a negative strep test at that time. She is feeling pins and needles now on arm, neck, burning feeling as well. Has been distracting her and keeping her from normal activities. She is using strategies learned at her away camp at Clinic including distraction and staying busy and deep breathing but these sensations are different. Otherwise she is eating and drinking normally, breathing without difficulty, no nausea/vomiting/diarrhea.
A report has been received from a Health Professional concerning an 11 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 07-Jan-2014. The patient was inadvertently given an expired dose of FLUMIST QUADRIVALENT. The patient experienced expired dose of FLUMIST QUADRIVALENT which started on 07-Jan-2014. The outcome of the event of expired dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
A red, itchy rash that started on my stomach on Sunday evening 02/07/2021 and now has slowly spread all over my upper body within the last three days. I get the chills with it, but otherwise fine.