chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 17Oct2023 to 21Oct2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351191 same patient, different drug and AE;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JUL-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 17-MAY-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt recvd vax 3AUG92  had pain in lt hip & was listless; pt indicated thought had a kidney stone; pt seen by MD & worked up for kidney stone; pain in the lt flank & hip; 14AUG92 devel herpes zoster;
ANAPHALAXIS, TONGUE SWELLING FOLLOWING INJECTION, REPEATED TONGUE, FACE, NECK CHEST ABDOMIN SWELLING, REPEATED LY HOURLY THROUGH  sEPTEMBER 11, 2021, NOW  CONSTANT ABDOMINAL SWELLING WITH HUGE SWELLS AND INTERMITTANT TONGUE SWELLS., FACE SWELLS, NECK AND CHEST SWELLS. Roof of mouth swells, causing loose teeth. Swelling made the patient unrecognizable. Patient began 150mg Orladeyo for type 3 HAE on  September 3, 2021, which has slowed the swells and slightly lessened severity, but not eliminated them. High doses of Prednison, benedryl, and Pepsid did nothing to reduce or eliminate the swelling, anaphalaxis.
On 10/15/02 at time of next immunization, mother reports that 7-15 days after last shots, child had a seizure while sitting in high chair. Was taken to ER; was told it was afebrile seizure. Temperature was 102 at that time. On 7/9/02 child had received the IPV, MMR and Varivax. Incident occurred on 7/24/02.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a male 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment History was provided.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA013755: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358.
Developed axillary pain in same arm as injection, and developed small swelling on chest wall, same side as injection. This site previously had mastectomy.  It looked like 8x8x2cm swelling. Pain in axilla went away after 6 days, and so did swelling.
Still have bad pain in left arm. Can?t raise my arm all the way up before more pain
Seizure with loss of consciousness, but without passing out,  lasting shorter than 2 minutes with no prior history of seizures. Other present symptoms included: aura including heightened fear, visual and auditory abnormalities, loss of awareness, loss of muscle control in face and neck, staring episode, breathing difficulties/gurgling, and loss of bladder control. All symptoms subsided upon regaining consciousness/awareness.
Expired vaccine used; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication provided. no treatment information provided.
Patient had left arm soreness, redness, and swelling in the middle of her upper arm shortly after receiving the flu vaccine and symptoms continued into the next day. Patient monitored site and was advised to contact Primary Care Physician if symptoms continued or worsened.
Swollen lymph node under left armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Lot number: GH9697), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE , lot number: ER2613, vaccine location=Left arm), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE , lot number: ER2613, vaccine location=Left arm), administration date: Mar2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph node under left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
5 MINUTES AFTER INJECTION, PATIENT NOTED TO SIGH AND LEAN HIS HEAD BACK.  PALLOR NOTED WITH EYES ROLLING TO BACK OF HEAD.  PATIENT UNABLE TO VERBALLY RESPOND FOR APPROXIMATELY 1 1/2 MINUTES.  DIAPHORETIC.
per patient  after 72 hours  from getting the vaccine on 1/19  she experienced    severe itchiness all over her body , no sign of hives or redness , no fever   , it lasted almost the whole day  , pt called me on 1/20  to report the reaction  the itchiness  was  getting better ,
DIED; This spontaneous report received from a patient via a company representative via Social Media concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "I know people that had every jab and booster and still died!" On an unspecified date, the patient died from unknown cause of death (dose number in series 1). It was unspecified if an autopsy was performed . The patient received additional covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date. This report was serious (Death).; Sender's Comments: V0:20220231899-Covid-19 vaccine ad26.cov2.s-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
6 HRs after vaccine: I began to feel nausea, weak, tired, mild headache.  I had a few random sharp stabbing pains in my L. hand.  Took 325mg Tylonol with water and went to bed.  7 1/2 HRs after vac: I woke to my hands seizing.  For the next 2 1/2 HRs: Starting with the muscles in scalp and my hands and moving toward my neck and then down through my torso; my muscles would seize and shudder violently for 1 to 3 minutes, subside for maybe 10 seconds and seize again.  I didn't loose consciensness. My teeth clenched and chattered so violently that I thought they would break. It was nearly impossible to open my mouth. I felt very cold even thouhg my husband said my skin temp was normal and I had 5 blankets over me. 9 1/2
AdVerse Reporting for FIRST DOSE Moderna Vaccine recieved 1/22/21: 1-2 days after usual sore arm.  However 13th day after receiving injection  I developed severe fatigue, fevers as high as 101.9, shaking, nausea, severe itching.  overall feeling of sick.  3 days later it passed. Due to my preexisting conditions I have isolated myself for almost 1 year, followed all protocols, and very rarely out in public. I also recieved flu vaccine.  So doubt the symptoms I had could be contributed to flu bug. So since it seemed very odd I am reporting this to CDC. Note: I had 2nd dose 02/19/21. So far only reaction is sore injection site. Should I develop symptoms after several days like the ones I reported after 1st dose, I will report these to this site.
After my second vaccine, I developed severe right earache. It was inflamed and by the night my left wrist  had a rash that looked like shingles. I told my doctor about my symptoms and he suspected cellulitis. My doctor gave me ear drops and placed me on antibiotics. So my rash was still present and by the next day I experienced headaches and nausea and felt out of place. I called into work since I did not feel good. On Thursday 01-14-2021, I went back to work but now the same rash I developed on my left wrist was in my right ear. My ENT doctor did lab work and a culture test to check for herpes or shingles, both of these exams were negative and these symptoms lasted one week then they resolved.
After vaccine that night-L thigh red in small area, firm, Itching.  Not painful. Next day-markedly more spread out, red. Looked well otherwise.  When got home day after vaccine, around entire thigh, red, firm, itchy.  TO UC- Ultrasound of area completed-no fluid, cephalexin abx due to possible cellulitis, but more likely a large local reaction, Non-tender.   No fevers.  Not systemically ill.  Redness gone, not spreading, Darker red color now, still appearing well.
Patient presented to pharmacy on 09/15/2012 with red, swollen, warm to touch bump at site of injection. He was told to apply ice and take diphenhydramine and call MD or pharmacist if it wasn't better in a few days.
No treatment sought or provided. I always react to vaccinations, with redness, fever, swelling around the injection site that can linger for as much as 2-3 weeks, a few days of flu-like achiness, headaches and discomfort,  so I haven?t thought anything about the similar symptoms I?m experiencing now. Until last night. Nine days after receiving the injection I started having deep itchiness in the muscular area around the injection site. When the site appeared more red and inflamed again this morning, I thought I might have scratched it in my sleep. I?ve taken nothing to reduce the reaction, I?ve avoided scratching the area, and this evening the area appears slightly redder and warmer. I?ve decided to seek medical attention in the morning if it hasn?t subsided, I?ve emailed the poc at the clinic that administered the vaccination, and I have an epipen in my home if I need it.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included eczema. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The reporter who is a physician was reporting a case for himself. In 2018 after vaccination, the patient experienced pain at the injection site. The contact details of the physician was provided. The reporter consented to follow up. For tolerance to next dose, refer case US2019004267.
Low fever ranging 99.7-100.7 beginning about 12 hours after shot and lasted about 14 hours. Body aches and headache beginning about 16 hours after shot until taking acetaminophen at about 26 hours after shot.
During my vacation I was with a party of 4 I caught it and after a health kit returned a negitive at first but my symptoms went worse with cold like symptoms and I took another home test which turned out positive. That is when my cough got worse on 2/14, so I called my doctor and he prescribed a cough medicine Benzonatate. This turned out to help me but the cough still persisted.  I contacted my doctor again and was prescribed a cough syrup promethazine w\codeine. Again, it helped but it still persisted. Third, time called my doctor and prescribed two inhalers, Symbicort and Albuterol Sulfate,  and was advised if these don't work a chest X-ray will be ordered.
Extreme fatigue and dizziness lasted 5 days.  Constant metal taste in mouth, from 04/03/2021- currently.  Sense on smell is now sensitive as in everything smells bad like b old burnt coffee, from 04/03/2021- currently
A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.). At the time of the report, RASH PRURITIC (A minor kind of rash which was itchy after getting the Moderna COVID-19 vaccine on January 19th , 2021.) outcome was unknown. Not Provided      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.
Fever, vomiting, rash from 11/3/96 through and beyond 11/10/96. From video tapes, development (speech, socialization) slowed greatly from this time forward. Diagnosed with autistic spectrum disorder with generalized anxiety disorder. Full blown autism.
inadvertently administered the Arexvy diluent only without the lyophilized component; inadvertently administered the Arexvy diluent only without the lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B945F, expiry date 01-FEB-2025) for prophylaxis.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Arexvy diluent only without the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Arexvy diluent only without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Oct-2023 Clinic operations manager called to inquired that when the patient could come back for a full dose of the Arexvy. The reporter did not consent to follow-up. The patient was inadvertently administered the Arexvy diluent only without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Headache & Fever Narrative: All s/s less than 48 hours after vaccination; no known exposure to COVID-19.
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 16May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Oct2021, outcome "recovered" and all described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Oct2021) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FEELS LIKE GETTING STUNG BY A SCORPION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced feels like getting stung by a scorpion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels like getting stung by a scorpion was not reported. This report was non-serious.
The pt had seizure activity for about a minute, then she was drowsy until she was brought to the ER.
Decreased vision, mild heart palpitations.  I had an eye exam in September and it was the same as it has been for the last several years.  I had another one in March and it changed drastically and my vision has continued to decline.  I have also had some mild heart palpitations but they are not regular.
Received Menactra 3/24/06. About 4/6/06, developed tingling in feet. Seen in our office on 4/13/06 with c/o numbness of hands and feet. On 4/14/06, began c/o pain and numbness on upper extremity from elbow to tip of fingers and from up to mid-shin. Also numbness in feet and a sensation of having lump in throat. Sent to neurology for eval. As of 5/28/06, not recovered. 2/5/09-GBS per CISA
headaches; sore arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arms".  Additional information: Was speaking to my sister today and learned that she and my brother-in-law both recently were vaccinated for COVID-19. She mentioned they both received the Pfizer vaccine at their doctors office. She said that on their first shots they both experienced headaches the next day but not that bad and that they both had sort of sore arms where the injection had taken place. They both received 1st shots on same day a few weeks ago  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial and follow up information has been received from a health professional concerning a 39 year old whit female patient with NKDA and with HPV and with a family history of breast cancer (mother) who on 07, Nov 2006 was vaccinated with a second IM dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654540/0800F) into the left deltoid. It was reported that the patient jerked her arm away and the needle came out of the patient's arm and did not received a full dose of the vaccine. It was reported that it was "hard to tell how much of the injection was lost." "A 1/3 of the injection came out of the patient's arm and what is left in the vial." It was recommended that the patient get re-vaccinated with dose number 2. The patient was "upset for the inconvenience" and the patient decided to discontinue the injection because she had a "bad experience", she already had HPV and she had trouble getting to the office. No symptoms were noted. A first dose of HPB rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0696F) was given IM into the deltoid on 05, Sep 2006. Additional information is not expected.
Subarachnoid Brain Hemorrhage   MEDICAL EMERGENCY  9 days in ICU