chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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, the very virus that ZOSTAVAX is intended to prevent. In 2013, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. 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.
Blood clot in her left leg; Has been sick ever since; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her left leg) and ILLNESS (Has been sick ever since) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in her left leg) (seriousness criteria hospitalization, medically significant and life threatening) and ILLNESS (Has been sick ever since) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 27-Jun-2021 due to ILLNESS and THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO VASCULAR) for Thrombosis, at a dose of 15 milligram twice a day and RIVAROXABAN (XARELTO VASCULAR) for Thrombosis, at a dose of 20 milligram once a day. At the time of the report, THROMBOSIS (Blood clot in her left leg) and ILLNESS (Has been sick ever since) outcome was unknown.            On 27-JUN-2021 patient went to the emergency room and was hospitalized overnight due to the blood clot in her left leg  currently patient is on blood thinner treatment  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.; 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.
PHN; residual nerve damage; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On 22-SEP-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided) On an unknown date in 2009, reported as less than one month after receiving zoster vaccine live (ZOSTAVAX), the patient suffered debilitating injuries including painful and debilitating outbreaks of shingles as well as postherpetic neuralgia (PHN), significant throbbing pain, itching and residual nerve damage, which continued at the reporting time and have required medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, the patient suffered serious, progressive, 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 of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events of herpes zoster, postherpetic neuralgia (PHN) and residual nerve damage was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster, postherpetic neuralgia (PHN) and residual nerve damage were considered to be disabling.
Headache; joint pain; intense muscle aches; very sore injection site; sinus pressure; nausea; vaccine received same date: Influenza Quadrivalent; vaccine received same date: Influenza Quadrivalent; Pfizer Bivalent - Dose Number: 3 / Moderna - Dose Number: 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 at 15:00 as dose 3 (booster), single (Lot number: 6H9097) at the age of 30 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 20Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "transgender" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: elasomeran (dose 1, lot number: 025B21A, vaccine location: Left arm), administration date: 07Apr2021, for covid-19 immunisation; elasomeran (dose 2, lot number: 039B21A, vaccine location: Left arm), administration date: 07May2021, for covid-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Nov2022, outcome "unknown", described as "Pfizer Bivalent - Dose Number: 3 / Moderna - Dose Number: 2"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Nov2022, outcome "unknown" and all described as "vaccine received same date: Influenza Quadrivalent"; HEADACHE (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered"; MYALGIA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "intense muscle aches"; ARTHRALGIA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "joint pain"; NAUSEA (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "sinus pressure"; VACCINATION SITE PAIN (non-serious) with onset 21Nov2022 at 10:30, outcome "not recovered", described as "very sore injection site". The events "headache", "joint pain", "intense muscle aches", "very sore injection site", "sinus pressure" and "nausea" required emergency room visit. Therapeutic measures were not taken as a result of headache, arthralgia, myalgia, vaccination site pain, paranasal sinus discomfort, nausea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies  No follow-up attempts are possible. No further information is expected.
Warm at the injection site; Itches at the injection site; Redness at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itches at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itches at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itches at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doss of ROTATEQ (lot # L004456, expiration date 07-AUG-2016, exact doses were not reported), orally. It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Local rxn to MMRV (at site MMRV given) - red and firm 6 x 6 cm.
Took Moderna vaccine, had warm sensation all over my body immediately,  had to pull over on the way home, felt faint. When I got home the side effects got worse, started having chills, difficulty breathing, bad taste in my mouth, fever, extreme dizziness, fatigue. These symptoms went on for 2 days. Started feeling better on Sunday, still felt fatigued on and off for a week, it's now April 27, and I still feel dizzy often and bad taste in my mouth.
Terrible burning sensation immediately after injection; Weird taste in mouth; Fatigue; Very thirsty; Mouth was dry; a little weak; Has a little anxiety every now and then; This is a spontaneous report from a contactable consumer (patient). A 69 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263, expiration date:May2021), via an unspecified route of administration (on left arm) on 31Jan2021 09:15 (at the age of 69 -years-old), single dose for COVID-19 immunization. Medical history included ongoing chronic kidney disease and asthma. The patient's concomitant medications were not reported. Patient had Sore arm, left arm. Confirmed left arm received the COVID-19 Vaccine. Arm is still sore, but not as bad as the first and second day. Terrible burning sensation immediately after injection. Asked if that was normal. Felt injection going in. Patient had weird taste in mouth, very thirsty, mouth was dry. Could have been nerves because has a little anxiety every now and then. Today can taste blueberries and oatmeal. Almost like taste buds are back to normal. Patient had fatigue after he got home from the injection. Felt a little weak. Subsided for the most part and felt better yesterday afternoon. All the events started 31Jan2021. The outcome of the event vaccination site burning was not recovered, other events are unknown. No prior vaccination within 4 weeks, no adverse events following prior vaccinations.
Since receiving vaccine, i get sudden flushing of face, arms, legs, and torso.  I feel like I am on fire and I get a bright red rash everywhere.  It burns a lot and mildly itchy.  It lasts for about an hour  to an hour and a half and then will dissipate.  I have never had anything like this prior to receiving the  vaccine.  It has happened many times since receiving the vaccine.   I took a benedryl the first time it happened because I thought I was having an allergic reaction.
Sore throat; Fever; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and HEADACHE (Headache) 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.   No concomitant medication information was provided. No treatment medication information was provided.    Reporter did not allow further contact
Sick with flu-like symptoms; Sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's family member. The age at vaccination was not reported. The patient was sick with flu like symptoms for 1 week. The caller declined to provide further information. For tolerances of 2nd dose refer case US2020AMR025580, reported by same reporter for the same patient.
COVID Arm, red, itchy, raised blotch about 2 inches in diameter around the injection site.  lasted about 2-3 days
pt recv vax; was found not breathing; brought to hosp; pt pronounced dead on arrival; presumed SIDS 6 days posy vax;
This is a prospective pregnancy case. This 26-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 29 December 2014. The subject's past medical history included human papilloma virus infection and miscarriage. Concurrent medical conditions included gestational diabetes. The subject's last menstrual period was on 16th June 2014 and estimated date of delivery was 23rd March 2015. The subject received BOOSTRIX at week 28 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Got very bad rxn pneumonia shot. 11-25-13 around 7 PM inj site became itchy and swelled up like a balloon and rash developed underneath her arm. She visited her Dr. next day and Dr. said he never saw a reaction like this before and Dr. gave her Rx's for BENADRYL and erythromycin.
PATIENT RECIEVED SECOND DOSE OF PFIZER COVID VACCINE AT 2 WEEK INTERVAL INSTEAD OF 3 WEEKS. PATIENT WAS MADE AWARE OF MISTAKE. SO FAR, HAS REPORTED NO ADVERSE EVENTS BUT SHE JUST RECIEVED THE VACCINE TODAY. 6/26/21
One week and one hour after receiving the injection my arm began to itch, and I noticed redness at the injection site.  This was not severe.  It lasted two days (48 hours).
This spontaneous report was received from a Licensed Practical Nurse and refers to a 19-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) lot # N013276 with expiration date on 21-JAN-2020. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA001308.
Patient experienced severe swelling, redness, and warmth at vaccine site. Patient also described itchiness. Symptoms lasted for about 5 days and were treated with OTC Ibuprofen.
initially c/o pain in rt arm 27FEB98;couldn't lift arm while taking shower & when shown to mom 5 inch swelling deltoid area of vax;black needle stick area, very red & hot;called ER & told to come in;
"Pt w/ hx of allergies to salmon, milk, eggs, shrimp. No other medical info available at the time of vaccination. P/t c/o hives on bilateral legs and itchy throat 10mins post vaccination. Vitals @15:45 BP 130/78, HR 76, RR 16, SpO2 100% -- > 16:55 122/78, 87, 16, 100% -- > @17:16 124/79, 88, 16, 100% Pt given Benadryl 50mg PO @16:53 and 0.3mg Epi into the Left Thigh @17:17.  911 was called @17:18 and the patient was taken to the Emergency Room.  Disposition is unknown to this writer.  Allergy noted in pt chart and 2nd dose Pfizer vaccine appt canceled."
Pt got mild case of shingles 3 weeks after getting 2nd dose of SHINGRIX vaccine. After the vaccine, her arm was sore, but the soreness went away. Then a 2-3 inch rash developed under her left breast.  Visited doctor's office, they evaluated her and will be monitoring for improvement over the next 3 weeks. No additional drugs prescribed.
pt presented 6/9/99 w/moderate swelling of anterior lt thigh w/mild redness;pt had DTAP vax IM lt thigh on 6/8/99;
Slight swelling, significant itching, large reddened area around injection site. Resolved after 2 days of BENADRYL.
This spontaneous report as received from a Licensed Vocational Nurse regarding an 1 patient of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 09-SEP-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot# L005299 and expiry date: 17-FEB-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
the rash went down my legs but mostly on my arm; the same relaxation and feeling in her tongue which lasted an hour; rash on both arms; on the opposite arm of her vaccinated arm, she had a rash that itched and that went away; relaxation which felt like my blood vessels open; slight tongue enlargement; This spontaneous case was reported by a consumer and describes the occurrence of VASODILATATION (relaxation which felt like my blood vessels open), SWOLLEN TONGUE (slight tongue enlargement), RASH PRURITIC (on the opposite arm of her vaccinated arm, she had a rash that itched and that went away), RASH (rash on both arms) and RASH (the rash went down my legs but mostly on my arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical information provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VASODILATATION (relaxation which felt like my blood vessels open) and SWOLLEN TONGUE (slight tongue enlargement). On 24-Jan-2021, the patient experienced RASH PRURITIC (on the opposite arm of her vaccinated arm, she had a rash that itched and that went away). On 25-Jan-2021, the patient experienced RASH (rash on both arms) and FEELING OF RELAXATION (the same relaxation and feeling in her tongue which lasted an hour). On 28-Jan-2021, the patient experienced RASH (the rash went down my legs but mostly on my arm). On 29-Jan-2021, RASH PRURITIC (on the opposite arm of her vaccinated arm, she had a rash that itched and that went away), RASH (rash on both arms), RASH (the rash went down my legs but mostly on my arm) and FEELING OF RELAXATION (the same relaxation and feeling in her tongue which lasted an hour) outcome was unknown. At the time of the report, VASODILATATION (relaxation which felt like my blood vessels open) and SWOLLEN TONGUE (slight tongue enlargement) 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.   No medical history provided. No concomitant medications provided. No treatment information provided
This spontaneous case reported by a consumer, describes the occurrence of adverse event (taking IV-antibiotics daily) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced adverse event (taking IV-antibiotics daily). At the time of the report, adverse event (taking IV-antibiotics daily) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (Lot number unknown). The registered nurse reported that the patient received her second dose of Gardasil (Lot number unknown) approximately in MARCH of 2007 at the college health clinic and experienced a temperature of 103 degrees. Medical attention was sought. At the time of reporting the patient recovered from the temperature of 103 degrees. The nurse reported that they are unsure about giving the patient her third dose of Gardasil due to the patient's experience with the second dose. No further information was provided. Additional information has been requested.
Patient developed rash on his lip, chin, and cheek. Was described as itchy and burning. Appearance looked like a cold sore on lip which also appeared to be swollen. On 06/11/2021 follow-up with the patient occurred. Patient stated that the rash was resolving. He was advised by myself to see his healthcare provider if rash does not continue to resolve. He stated he has not seen a provider at this time as it appears to be improving
Feb 22  started to get some pimples in the left ear Feb 26  started to get some pain in left ear Feb 27  diagnosed as shingles at NYU urgent care .