chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 26-MAR-2009, the patient was inoculated with ZOSTAVAX 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 condition of herpes zoster. On or about 14-SEP-2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster. She was prescribed VALTREX and tramadol for management of her painful symptoms and chronic pain. As a direct and proximate result of the 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.
2 - 3 DAYS POST VACCINATION PATIENT DEVELOPED ITCHY RASH ON UPPER EXTREMITIES WHICH HAS SINCE SPREAD TO TRUNK, LOWER EXTREMITIES, BACK AND HEAD. SYMPTOMS CONTINUE AS OF THIS DATE.
Initial information has been received from an 86 year old male physician with no illness at the time of vaccination or pertinent medical history or allergies, who is also the patient and follow-up information was received from a physician.  On 10-JUN-2008 at 9:25 AM the patient was vaccinated into the left deltoid with the first dose of ZOSTAVAX (Merck) (lot # 659407/0295X).  Concomitant therapy included NORVASC.  On 25-AUG-2008 the patient developed erythematous papular lesions on his chest.  The patient further stated that the above lesions were confined to one dermatome.  The physician reported in follow up that the patient called to report that he had developed shingles rash.  The patient was treating with VALTREX.  The outcome was unknown.  Additional information is not expected.
DEAD; This spontaneous report received from a consumer via a company representative through social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health. The patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, after 3 days of receiving booster the patient died from an unknown cause of death (Dose number in series 2). It was unknown if an autopsy was performed or not. It was reported as "I think this vaccine is from hell. Recently knew someone in perfect health got booster and about three days later was dead".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221222480.; Sender's Comments: V0-20221222470-Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Numbness L anterior chest.  Numbness/tingling R groin radiating down R inner thigh.  Intermittent onset night after vaccine.  BP 152/92.
This spontaneous case was reported by a consumer and describes the occurrence of GASTRITIS (the infection is going into my stomach) and LABYRINTHITIS (inner ear infection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced GASTRITIS (the infection is going into my stomach) and LABYRINTHITIS (inner ear infection). At the time of the report, GASTRITIS (the infection is going into my stomach) and LABYRINTHITIS (inner ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient stated he knows he has an inner ear infection based on his symptoms (symptoms not provided).  He also stated he could tell "the infection is going into my stomach". Treatment information was not provided. The second dose of mRNA-1273 (Moderna Covid-19 vaccine) was scheduled for 20 Apr 2021. The patient was scheduled to see his doctor on 21 Apr 2021.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This is a 66-year-old African American female with past medical history of hypertension, multiple sclerosis, dementia, functional quadriplegia secondary to multiple sclerosis.     She came to the hospital with a chief complaint of right-sided facial droop which was noticed it 1:30 p.m. by the patient's daughter.  All the symptoms where going on a little bit earlier as well.  It was noted that the patient was more sluggish than usual baseline.   Other than that the patient cannot talk much due to advanced multiple sclerosis and bedbound status with functional quadriplegia.  History taking was limited from the patient.  It was reported that the patient's daughter was tested positive for COVID-19 and she was quarantine Ng by herself.  Patient was being cared for by home health nurses, PT and occupational therapist.  They have been testing the patient almost every day for COVID-19.  Today finally her test came back positive for COVID-19 at home.  Before all the previous tests were negative for COVID-19.
Rash/hives on palms of hands, bumps on you get, rashes on body, swollen lips, yeast infection
she had a left sore arm/the big red spot is hurting/injection site reaction of pain; Stated that she has a big red spot on it now. Stated that it  was an injection site reaction/redness 5cmX 10cm in size; injection site swelling; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: SD0809) at the age of 53 years as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021 01:00, outcome "not recovered", described as "she had a left sore arm/the big red spot is hurting/injection site reaction of pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Dec2021 01:00, outcome "not recovered", described as "Stated that she has a big red spot on it now. Stated that it  was an injection site reaction/redness 5cmX 10cm in size"; VACCINATION SITE SWELLING (non-serious) with onset 13Dec2021 01:00, outcome "unknown", described as "injection site swelling". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling.  Clinical course: Report not related to study or programme. No investigation assessment.  Follow-up attempts are completed. No further information is expected.
Headache, Myalgia, NauseaVomiting, pain in injection arm Narrative:
Moderna COVID-19 Vaccine EUA: Approx 12 hours after receiving injection I first got a severe headache, for which I took ASA with some moderate relief. I then noticed body aches & chills. After about 45 minutes I went to bed, still chilled. After lying down the chills became rather violent, more like spasms or seizures and lasted about 15 minutes. Finally they stopped and I had a fitful nights sleep due to body aches & headache. On awakening I still had discomfort, took Ibuprofen, and it is still ongoing at this time (2:30 pm) but seems to be going away. Primary feeling is now weakness & fatigue
2 hours post vax, the guardian of the pt reported that the pt was not "acting right" and that she seemed quiet. She was instructed to call pediatrician or go to ER.
Pt noticed itch and then rash on arm. Pt explains rash spread to chest and abd over the next 24hrs. Rash continued to lower ext.
About 3 pm receive Hepatitis B shot.  About 4:30 began to feel ill.  By 5pm she was reporting a severe headache across the back of her head and into her neck (throbbing).  Her neck was very painful.  Also dizzy, weak, achy, cold sweat, hot and cold, elevated temperature.  Spoke to the after-hours nurse who said we should take pt to emergency.  Went to Hospital.  There her symptoms continued to worsen (she was in tears from the headache).  She also had some shortness of breath and found it difficult to stand up (complained her legs were weak and sore).  A minor rash developed on her face (nothing was visible on her arm at the site of the shot).  Symptoms peaked around 7pm.  By the time she was seen by a doctor, she was already improving.  She was given 500 mg Tylenol and felt almost well by 8:30pm.  She woke up around midnight with a headache again and we gave her more Tylenol.  She slept through the night, until late the next AM.  Throughout the following day she continued to have a minor headache, neckache and complained about her legs feeling stiff and sore.  She was also fatigued and slept during part of the day.  After about 24 hr she was largely back to normal.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported similar events for 3 patients. This is first of three reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lightheadedness/dizziness on an unspecified date with outcome of recovered, weakness on an unspecified date with outcome of recovered. Event was described as lightheadedness, dizziness and weakness lasting 2-3 minutes after injection, resolved by lying down, given fluids and glucose tablet. occurred in 3 patients of Pakistani Indian descent.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017379977 different patient, same product, same event; US-PFIZER INC-2017379978 different patient, same product, same event.
Normal labor and c-section delivery. Hospital admission within 6 weeks of receiving the COVID vaccine.
Swollen lymph node in injection arm continues in day 3 following injection, headache, fatigue
had a headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 14:50 (Lot number: EN6198) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "fainted", notes: As a child many decades ago, she fainted after a Penicillin shot. Vaccination history included: Bnt162b2 (Dose 1), administration date: 23Feb2021, for Covid-immunization. The following information was reported: HEADACHE (non-serious) with onset 16Mar2021, outcome "not recovered", described as "had a headache". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that the patient received both doses of the Pfizer Covid Vaccine. The patient reported that she was reporting it because the headache lasted so long and the Nurse Practitioner had not heard of it lasting like that. The patient stated that she was a little aware of the headache before 16Mar2021. The headache kept on and kept on and right now it was a slight pressure. She also stated that sometimes it progressed through the day, like during the day when she was distracted it was not as bad and then at night she was aware of it. The patient started taking Naproxen because the Ibuprofen was not helping.  No follow-up attempts are possible. No further information is expected.
fatigue?began about 6 hours after receiving the vaccine. Took a 3 hour nap in the evening and then slept for 12 hours overnight.
Redness, slight swelling, hot to touch of entire upper left arm. Approximately 4" x 4"
pain in his left armpit; expected pain in his arm; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves an 11 years old male patient who experienced pain in his left armpit (axillary pain)  and expected pain in his arm (vaccination site pain), while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported.  On 16-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a pain in his left armpit (axillary pain) and  expected pain in his arm (vaccination site pain) ( latency unknown) following the administration of INFLUENZA VACCINE.  Details of lab data not reported.  Final diagnosis was expected pain in his arm and pain in his left armpit.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported at the time of reporting.  Information on the batch number was requested
Shortly after administration of the Moderna #2 dose, patient experienced really dry throat.  Her tongue felt weird but no swelling of throat, tongue, nor lips. She felt really dry, kept on drinking.. Said her throat was so dry that it felt like she couldn't swallow.
Patient received vaccine on 4/5/21.  She presented to her PCP on 4/22 with swelling and redness in the inside upper area of her right arm.  Determined to be a superficial thrombosis.  Patient has not history of VTE, but does smoke.  Uses a Mirena IUD for contraception as well.  Platelet count remained normal during this time, and was never affected.
March 9, 2021: 3:30am:  Woke up with chills and feeling very cold 7:00am:  Woke up with fever of up to 103F and extreme fatigue and headache which lasted during the day.  To ease the symptoms I took Tylenol every 6 hours. 10:00am:  Started noticing hives, first on my left shin and continued to manifest in my torso/back as well as forearms.  I called my physician via telehealth and I was advised to take Benadryl as needed.  Took Benadryl twice (6 hours apart) and the hives calmed down and eventually went away during the course of the day.  March 14, 2021 1.30am:  Woke up with itchy hives on my torso and back.  Took Benadryl once again.  I called my physician and was instructed to take Cetirizine for the next couple of days (10mg at 1x per day).  Symptoms subsided.  March 23, 2021 4:00am:  Woke up with itchy hives on the left side of my torso and across my back and my groin area and upper thighs.  Called my physician once again who instructed to take Cetirizine for a course of 2 weeks.  No symptoms while taking Cetirizine.  Stopped taking Cetirizine on April 2.  April 6, 2021 6:00am. Woke up with itchy red patches (with very small bumps) in localized areas of the body (ie on my hand, on my right leg, and areas near my armpits.  These lasted a little while with intense itchiness...would subside to just having red patches, and another area of the body would manifest red itchy patches.    The above lasted several days as I wanted to see if this would go away on its own.   On April 9th, called my physician to advise of the continued itchy patches which seem to come and go in different areas.  Advised to take Cetirizine once again for another 2 weeks once a day.
Flu like symptoms next day.  Vomiting and diarrhea.  Body aches.  Hot and cold sweats and chills.  Night cold sweats during brief sleeping periods.  Third day was the same.  Loss of appetite and dehydrated.  Severe itching on my back.  Today is the fourth day and I broke out with a rash on my back.  Cortisone has relieved it thus far.  My appetite is back.  I did not vomit but still experiencing diarrhea.
She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown.  Information about lot number has been requested.
macular, papular area; injection site is still bruised; injection site itchy; injection site is red; injection site is swollen; This spontaneous case was reported by a physician and describes the occurrence of RASH MACULO-PAPULAR (macular, papular area), VACCINATION SITE BRUISING (injection site is still bruised), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH MACULO-PAPULAR (macular, papular area), VACCINATION SITE BRUISING (injection site is still bruised), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen). At the time of the report, RASH MACULO-PAPULAR (macular, papular area), VACCINATION SITE BRUISING (injection site is still bruised), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact.
Immunization hep A#2 on 10/10/05. On 10/12/05 awakened with area of erythema on right cheek with some itching, no pain. Slight erythema left cheek more blotchy. No other rash found. No insect bite found.
This case was reported by a other health professional via sales rep and described the occurrence of skin warmth in a 5-year-old female patient who received KINRIX (batch number G35ZK, expiry date 2nd December 2017). Concomitant products included PROQUAD. On 18th April 2017 14:30, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 20th April 2017, 2 days after receiving KINRIX, the patient experienced skin warm and injection site swelling. On an unknown date, the outcome of the skin warm and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the skin warm and injection site swelling to be related to KINRIX. Additional details were reported as follows: The patient received a dose of KINRIX on left deltoid. On 19th April 2017, the patient received 1st does of PROQUAD (batch number: M032497, expiry date: 2nd January 2018) on left arm. The health care provider reported that the patient arm was warm to the touch with mild swelling of the skin.
Verified patient's name/DOB/allergies. nurse administered the vaccines correctly and sent patient to observation because he received the meningitis vaccine which causes some patients to become dizzy, nauseated.  When I went to check on the patient 5 mins later, he looked pale and was having cold sweats. The patient said he sees "white" and did not feel well at all. Patient stated that he was not having any difficulty breathing but he did feel like vomiting. I assisted the patient to vomit, but only spit. Patient's vitals were monitored and patient was given water to sip on.  Vitals:  09:35a BP @ 89/55 | O2 @ 99% | P @ 81 09:45a BP @ 106/74 | O2 @ 99% | P @ 81 09:55 BP @ 108/73 | O2 @ 99% | P @ 70  Patient was taken to school principal's office to lie down and speak with his father, which made him feel better. Patient pallor returned to normal and patient verbally stated that he felt good. Patient was then sent back to class.
numbness and tingling in arm and hand.  Extreme joint pain in left hand.  Coughing and difficulty breathing. Decreased mobility and strength in left arm.
Information has been received from a health professional concerning a female in the 5th grade who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. The patient was not hospitalized. There was no product quality complaint involved. Additional information has been requested.