chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information; was administered a 4th dose; the patient received a dose at 10 years old and then two doses at 13 years old; This spontaneous report has been received from a nurse, concerning a 13-years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   In approximately 2014 (reported as "at 10 years old"), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis, later in approximately 2017 ("reported as at 13 years") the patient received the consequent two additional doses (inappropriate schedule of product administration) (strengths, doses, routes of administration, anatomical locations, lot numbers, and expiration dates were not provided). Moreover, on 26-JAN-2023, the patient was administered a 4th dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (extra dose administered) at a dose of 0.5 milliliter intramuscularly as prophylaxis (lot number W011264 has been verified to be valid; expiration date reported as 16-JUN-2024 but upon internal validation established as 05-SEP-2024) (strength and anatomical location were not provided).
Started having headaches 10 days after influenza vaccine administration. Patient went on a business trip 10/1 and returned feeling worse on 10/4. On 10/5 wife found patient grunting and drooling, unable to get out of bed. Developed tonic-clonic seizures soon after arriving to the ED. Urine drug screen was negative. Patient developed refractory status epilepticus and was intubated and sedated on propofol/midazolam/ketamine, lacosamide, levetiracetam, clobazam, valproic acid. Was empirically treated for viral encephalitis and bacterial meningitis. All cultures (CSF, Blood, urine, sputum) were negative. MRI with no structural abnormalities. Autoimmune work up negative so far. Was given a 5 day course of high dose methylprednisolone, IVIG and PLEX.
Pt felt faint immediately after injection; pain, soreness at injection site continued for several hours; the following morning pt complains of pain in eyes especially upon looking up  (T-daP and Hep A given at same time of HPV vaccine)
Tremors for 5 hours without a fever. Once the tremors stopped, I had a fever (highest of 102.1), and that time my entire body had the sensation of being on fire inside and out. This lasted for another 5 hours.
Immediate symptoms consisted mainly of swelling throughout the body. A visit to the doctor resulted in a course of prednisone and Claritin, however the long term effects were not yet realized.
admitted with CKD with volume overload, acute metabolic encephalopathy due to hypoxia; admitted for diuresis for acute on chronic CHF; condition worsened; placed in ICU and on a ventilator; pt improved and was moved to medical floor; extubated; respiratory status stabilized; found to be positive for COVID while in the hospital; bilateral pneumonia; started on antibiotics; guarded prognosis with severe hypoxia; intubated again and moved to ICU; status changed to DNR; pt's condition worsened and he was found deceased in the hospital
12/27/2020  intense pain at injection site. 12/28/2020 bumpy rash, very itchy both arms and hand, chest, stomach, under the armpits, shoulders, both legs. Triamcinolone Acetonide Cream, some relief to rash; rash still persists.
Pt came to ED with shortness of breath and a productive cough. Pt has a PMH of COPD with emphysema but is not on home oxygen. Pt is admitted with COVID-19 with pneumonia with acute hypoxic respiratory failure.
Tiredness set in about three hours later.  Went to bed later and slept for 16 hours.  Second day still tired but did not nap although tired by dinner time Shivering and chills started at bedtime, and reoccurred several times Severe headache morning after injection and went away after 24 hours Sore arm began within an hour of injection Took Tylenol at bedtime
This spontaneous report as received from a physician via a company representative, refers to a female patient on approximately in her 60's. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were unknown) for prophylaxis. It was reported that, on an unknown date about 10 years later, the patient experienced a case of shingles (herpes zoster). It was unknown if a treatment was given for the event as well as if laboratory diagnostics/studies were performed. The outcome of herpes zoster was unknown. The causality between ZOSTAVAX and the event was not provided.
neuropathy tingling sensation and aches in both feet had almost gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): INT-20600 (BioNTech SE).  A 78-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ6738, Expiration Date: 31Jul2023) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II", start date: 1997 (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; HYDROCHLOROTHIAZIDE; LOSARTAN; AMLODIPINE; METFORMIN; CARVEDILOL. Vaccination history included: BNT162b2 (dose 3 (booster), Lot number: unknown), administration date: 20Dec2021, for COVID-19 immunization, reaction(s): "neuropathy tingling sensation and aches in both feet had almost gone away"; Covid-19 janssen (dose 1, Lot number: 202A21A), for COVID-19 Immunization; Covid-19 janssen (dose 2 (booster), Lot number: 202A21A), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Nov2022, outcome "unknown", described as "neuropathy tingling sensation and aches in both feet had almost gone away".  Additional information: Patient has been diagnosed with diabetes II for the past twenty-five years. The neuropathy has become more and more pronounced over the years. It was a constant tingling along with aches and sometimes constriction in the toes. The soles of feet were where the tingling and aches occurred every day and continued to a lesser degree throughout the day. The patient noticed that after two-three days after the Pfizer covid vaccine booster injections that the neuropathy tingling sensation and aches in both feet had almost gone away. This cessation had also occurred after the previous Pfizer COVID booster on 20Dec2021. The previous cessation gradually diminished after six months and the neuropathy symptoms returned. The patient has other health issues (not further specified). NDC: 59267-0304-02.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201362450 same patient/event, different drug;
1/19/2021 @ 2:00p am minor body ache and headache for x days.
Systemic: Fainting / Unresponsive-Mild, Systemic: Patient fainted and exhibited seizure-like symptoms for a few seconds, then appeared to be okay-Mild, Systemic: Seizure-Mild, Additional Details: Patient fainted after administration of vaccine, and appeared to start seizing for a few seconds.
(L) arm with 14 x 9 cm erythema and approx 11 x 8 induration around central scab. (+) warmth. (1) Cold compresses and KEFLEX 250/5 1 tsp TID x 10 days (2) Tylenol/Motrin prn pain/fever (3) Benadryl prn for itching (4) if fevers persist > f/up 4 days or worsening rash
Patient complained that his stomach hurt at 8 PM on 1/25/12, went to bed, got up at midnight on 1/26/12 continuing to report stomach pain. He then vomited at 1:30 am. After vomiting, he appeared better and slept the remainder of the night. He was able to drink water after vomiting.
Fever, chills, headache body aches, scab local redness bump, local itching
Pt states she had stomach flu in early October and shortly after (10/4/14) she collapsed and was taken to hospital. By the time she arrived at hospital she was experiencing near full paralysis which was later diagnosed as being consistent with Guillain Barre. She spent a total of 5 months in the hospital and rehabilitation facility. She is now home and walking with assistance of walker.
Got really uncomfortable around 5-6 pm and gave tylenol Around 8 pm started having full body spasms They occurred every 30-45 seconds It slowed down to every 2 minutes and was able to fall asleep around 2-3 am Alert throughout, no eye deviation, no color change or weakness Could not breastfeed due to spasms Parents called on call Nurse and spoke with on Call Doctor, given option to  monitor at home or go to ER. Parents chose to monitor at home over night
Swelling and rash was noticed on morning of 12/29/20, a day after injection was given, on injection site. There was alot of pain to site and some itching late the same day. Went to urgent care to have arm looked at since rash looked bigger on 12/30/20. PA took a look and diagnosed me with "cellulitis of left upper limb" and "adverse effect of other viral vaccine, initial encounter". She prescribed Keflex 500mg and Cetirizine 10mg treating it as an infection. Redness went away on 1/3/21
postherpetic neuralgia; hearing issues; balance problems; herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, hearing issues and balance problems. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of the report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of herpes zoster, postherpetic neuralgia, hearing issues and balance problems to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster, postherpetic neuralgia, hearing issues and balance problems were considered to be disabling.
I noticed a side affect that I have not seen anywhere. On the foot on the side of my injection I started getting shooting/shock-like pain. I noticed this too after my first dose but thought maybe it was another cause. Now that I am getting the same reaction with my second dose, I am confident it is related to the vaccine. It lasted less than 24 hours on the first shot. I only got the second dose a few hours ago.
Felt extremely exhausted. The next few days, was abnormally tired, even three days after. No fever chills or body aches. Soar arm starting 12 hours after, went away after 3 days.
Information has been received from a 22 year old female with no pertinent medical history, who on 14-JUN-2007 was vaccinated with a first dose of GARDASIL.  Concomitant therapy included ORTHO TRI-CYCLEN.  On 17-JUN-2007 the patient fainted.  The patient went to the emergency room and was later released.  Subsequently, the patient recovered.  In August 2007, the patient was vaccinated with a second dose of GARDASIL.  In August 2007 2 weeks after vaccination, the patient experienced fainted.  Subsequently, the patient recovered.  In March 2008, the patient was vaccinated with a second dose of GARDASIL.  In approximately March 2008, 3 weeks after vaccination, the patient experienced fainted.  The patient was seen by a physician.  Unspecified blood tests and computed axial tomography were performed (results not reported).  At the time of the report, the patient was recovering.  She reported that she "still feels like fainting and dizzy."  Additional information has been requested.
Pt vaccinated 9/20. The next day he was eating at church & had a seizure. TC generalized approximately <5 min. Upon arrival to ER temperature was 104 degrees F. Dx: febrile seizure. Sun. at hospital.
Irregular menstrual cycle. I'm having periods every 11-14 days vs. normal 21-23 day cycle.
Received multiple doses of vaccine; The patient recieved multiple vaccinations with different companies; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Received multiple doses of vaccine) and INTERCHANGE OF VACCINE PRODUCTS (The patient recieved multiple vaccinations with different companies) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and Janssen COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On 29-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 19-Apr-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient started Janssen COVID-19 VACCINE (unknown route) at an unspecified dose. On 21-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, Janssen COVID-19 VACCINE (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received multiple doses of vaccine) and INTERCHANGE OF VACCINE PRODUCTS (The patient recieved multiple vaccinations with different companies). At the time of the report, EXTRA DOSE ADMINISTERED (Received multiple doses of vaccine) and INTERCHANGE OF VACCINE PRODUCTS (The patient recieved multiple vaccinations with different companies) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient received multiple Moderna, Pfizer, and Janssen Covid-19 vaccines.  No treatment information was provided.
Ongoing, wide spread muscle twitches. Injection sites (muscles) are STILL sore, occasional numbness in hands. My urine has a very strong smell and a cloudy appearance, which is ongoing. I went to Urgent Care concerning this issue and was told I needed to see a Urologist. I am unable to do so financially, as I am a student with no health insurance.
Day of - after injection he complained of soreness (to be expected) he did not have an appetite (unusual) Day after - complained of soreness (to be expected) 2nd day after - complaining underarm of injection site now painful, I felt both arms and injection site on left arm feels considerably warmer to touch than right arm/same location.  Says he is cold . . . don't know if related.
tired; headache; This is a spontaneous report from a contactable female consumer (patient, she is a therapist) reported for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12May2021 at 10:00 (at the age of 61 years old), as 1st dose, single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date (she takes thyroid medicine and has been taking it for over 10 years). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported. The patient previously took dupixent for rash (She states her last dose was the 1st week of May2021). The patient experienced tired, headache on 12May2021. The reporter stated, she got her 1st dose 12May2021 and had side effects of massive headache and very tired that started the same day in the evening. The outcome of the events were unknown.   Information about the Lot/batch number has been requested.
High blood pressure; Rash on the injection site; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEADACHE (Headache) and VACCINATION SITE RASH (Rash on the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced HYPERTENSION (High blood pressure) and VACCINATION SITE RASH (Rash on the injection site). At the time of the report, HYPERTENSION (High blood pressure), HEADACHE (Headache) and VACCINATION SITE RASH (Rash on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood pressure measurement: high (High) High.     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.   The concomitant medication was provided as ibuprofen. The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   It is unclear if the increased blood pressure is being reported as an underlying condition or an event; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   It is unclear if the increased blood pressure is being reported as an underlying condition or an event
It was reported that a pt (7 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
A report has been received from a Physician concerning a child, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced RED EYES. The patient recovered from the event of RED EYES on an unspecified date. The report was considered to be non-serious.
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am     Hospitalized on  2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm      Primary Care visit @ 3:30 pm on 2/5/2021
I had my 2nd vaccine yesterday and today experience chills; vomiting; and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (I had my 2nd vaccine yesterday and today experience chills), VOMITING (vomiting) and DIARRHOEA (and diarrhea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (I had my 2nd vaccine yesterday and today experience chills), VOMITING (vomiting) and DIARRHOEA (and diarrhea). At the time of the report, CHILLS (I had my 2nd vaccine yesterday and today experience chills), VOMITING (vomiting) and DIARRHOEA (and diarrhea) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
headache; muscle aches; fifth shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 04, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 03, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 02, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 01, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 20Sep2022, outcome "unknown", described as "fifth shot"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches". Additional information: The reporter said that she got her Pfizer shot yesterday. It's her fifth shot and she has a headache and muscle aches and whatnot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed rash on whole body, itchy, cranky, and low grade fever on 8-20-2009.  Saw family physician on 8-25-2009  Dx MMR vaccine reaction and allergoc rhinitis.  No treatment given.  Spoke with grandma on 9-3-09 who states the fever is gone and the rash is fading.
Right arm started to itch  the afternoon of 1/7/2021 . I thought the itch was related to start of eczema flare in area near injection site.  Itched for several hours but then by evening no longer itchy. This morning (1/8/2021) noticed 2x3 inch red area on upper right arm. Area seemed "fuller" than left arm.  No itch, no pain, just red today. Still same redness and size at 300pm as was this morning at 800 am.
family tested negative for COVID-19 but he was positive; This case was reported by a physician via call center representative and described the occurrence of coronavirus test positive in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included exposure to communicable disease (positive for Covid 19).   On 14th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced coronavirus test positive. On an unknown date, the outcome of the coronavirus test positive was unknown.   It was unknown if the reporter considered the coronavirus test positive to be related to Shingrix.  Additional information was provided as follows: The patient's complete family tested negative for COVID-19 but he was positive. The patient wanted to know if as he received Shingrix on 14th August 2020, that should be related to test positive to COVID 19 or to have a false positive. No further information were provided. The reporter consented to follow up.