chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 09-FEB-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was diagnosed with shingles and suffered post-herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); 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; also suffered serious, progressive, permanent and incurable injuries; as well as 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 pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles and post-herpetic neuralgia was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the events were considered as disabling.
Presented 2 weeks after the vaccination with evolving urticarial rash and low grade fever consistent with Serum sickness like reaction. He is currently in the hospital as an inpatient under monitoring.
24 hours later very fatigued and weak; 24 hours later very fatigued and weak; 10 minutes after being vaccinated got a bad taste in mouth.; This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 26Feb2021 at 16:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, anxiety, Meniere's disease, asthma, migraine and allergies to sulpha and opiates. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included estradiol (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), celecoxib (CELEBREX), losartan (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing.  The patient previously received povidone-iodine (BETADINE) on unknown date for unknown indication and experienced drug allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 16:40, 10 minutes after vaccination, the patient experienced a bad taste in her mouth. On 27Feb2021, 24 hours later, the patient experienced very fatigued and weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bad taste in mouth, very fatigued and weak was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hard area with blistering, clear liquid noted/drainage from site x 2 days, chills.
RASH ON THE BACK, UNDERARM AND LEGS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced rash on the back, underarm and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on the back, underarm and legs was not reported. This report was non-serious.
A report was received from a health care professional on 3/22/04 concerning a 65 year old female vaccinee who experienced on 11/21/03 a sore throat, productive cough, and nasal drainage after receiving Fluvirin on 11/12/03. On 11/21/03, the vaccinee experienced a sore throat, productive cough and nasal drainage. The vaccinee recovered from all events on 11/26/03. There was insufficient information to determine the reporter's causality assessment. No follow up pending. All information received.
AE: patient had shortness of breath 15 minutes post vaccine administration. Treatment: no medication was given. patient was under observation.  laying down improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
Initially after injection client experienced lightheadedness and some chest tightness that resolved end of the day. The chest tightness quickly resolved and the lightheadedness resolved at some later time. Body aches, fever, chills developed x 2 days and then resolved.  Left shoulder pain and back pain adjacent to arm 9/10 with movement at 10 days after vaccination. Arm is difficult to lift up and client needs to move elbow forward to lift arm.
This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to GARDASIL 9. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
(L) arm swelling & red & warm to touch. Advised guardian to take client to doctor. Received 2 shots to the (L) arm.
Sore arm at site of injection, chills, nausea, headache, vomiting
Pain as a pressure in the center of chest, rated # 5 on scale of 1-10, associated with SOB, and diaphoresis approx 2 wks post vaccination. He denied nausea. Symptoms: Pain, chest NEC, Shortness of breath.
pt recvd vax 20APR94 & called 22APR94 c/o pain & swelling in the lt shoulder w/o redness; seen 23APR94; had swollen lymphadenopathy, very tender in axilla in the supraclavicular area & upper trapezius area lt side; CBC was nl;
Symptoms include fever (102 F degree), runny nose, headache and body ache occurred. Treated with Tylenol cold medicine.
I had no problem with the vaccination, but did test positive for Covid-19 just over three months later (4/27/2022). I started Paxlovid the same day I tested positive with the breakthrough infection and then unfortunately had a rebound infection starting 5/4/2022. I finally tested negative again on 5/13/2022.  My initial symptoms were loss of voice, sore throat, cough, sneezing, congestion, minor fever/elevated temp, headache, dizziness, fatigue, loss of coordination, nausea, swollen glands. Once Paxlovid kicked in I had a horrible bitter/metallic taste in my mouth (dysgeusia). I had debilitating fatigue for about a month after infection. It took me ~6 weeks to feel like I was recovered from Covid.
aug-patient could not stand/walk well screaming and very clingy from morning to bedtime. Stopped speaking immediately. Began to not listen/ pay attention. Lost muscle tone.
Patient developed erythematous, papular, nonpruritic rash a few hours after receiving vaccinations. Father also reported fever to 101.2 F. Rash still present 8/13.
Patient with complaint of headache. Patient assessed by NP and EMS. Headache rated as 3/10. Elevated BP of 176/100 on assessment. Pulse 87, O2 saturation 100% on room air. Pt denies history of high blood pressure. Patient denies chest pain, dizziness.
Headaches that lasted 10 days, I am not sure if this is a side effect but a black floater appeared in my right eye. I have an appointment with an ophthalmologist because it is not going away. The floater did not happen immediately after the shot but it seemed to feel like it was headache related. It?s hard to describe and I have never had eye issues in my life I am still getting headaches but they appear to be getting further apart in the last two weeks.
This spontaneous report as received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug allergies were not reported.  The registered nurse reported that on 10-MAY-2017 the patient was inadvertently vaccinated with expired dose of PROQUAD Human serum albumin (HSA)(lot # L024497, expiry date : 01-JAN-2017), for prophylaxis (expired product administered). Concomitant therapies included sterile diluent(Manufacturer Unknown) (Lot# and expiration date was unknown by the reporter). There was no previous temperature excursions . No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Client called Clinic 3/3/10 & left upper arm: Tricep area swollen w/3-4 " red area, hot & hard. Also with red rash starting @ both hands & progressing up the arms. Client went to ER/Dx=Allergic Reaction to Varicella Vac. Meds: "BENADRYL, Steroids & PEPCID".
Patient received her COVID-19 vaccine at 1400 on 12/29/2020. At 1515 she complained of a headache, sinus pressure and numbness under her right eye. She denied any blurred vision, SOB, or any other symptoms.
Joint pain. Most severe around hips and lower back.  Fever of 100.7.  Chills.
Student reported to school office complaining of blurry vision, dizziness, and his head appeared to be weaving. Parent called to pick student up and he walked down the hall with the parent bumping into her as they walked. He was unable to locate the door handle as he tried to open the car door.
Found blood clots on 03.14.2022 put me on injectable blood thinner while I was in the hospital. Once I was released from the hospital they started me on ELIQUIS for 14 days I took 10mg twice a day and after that I took 5mg twice a day and that is what I am currently taking. They also took me off of my birth control and I can no longer take estrogen birth control so I had an IUD that is not estrogen based put in. I have a follow up appointment with my hematologist in September to discuss how I need to proceed.
Upper substernal chest pain with exertion and deep inspiration and when lying down. Began approximately 36 hours after the 2nd dose of the Pfizer COVID 19 vaccine. No fever, shortness of breath, palpitations, cough, sick contacts. Pain is described as dull and does not radiate. No medications were given by mother for the pain. Patient came to ED with mother 4 days after the onset of the chest pain since the severity of the pain had not changed.
3/12/21 2nd day after first shot: Extreme pain in arm; fatigue and weakness  *3rd Day: weak  *4th Day: slow recovery 4/8/21 1st day after 2nd shot: pain in arm;  *2nd Day: pain in arm, allergic reaction/skin rash, late in day extreme chills and fever 102.5 degree; *3rd Day: continued temperature regulated by Tylenol;  *4th Day: Fever breaks, minor dry coughing;  *5th Day: no fever, continued coughing;   *6th Day: increased cough becomes difficult to manage; return of fever fluctuates between 99 and 101.6 degrees, fatigue;  *7th day: continued fatigue, fever, and severe dry coughing
High Fever (Body temperature went up to 102 F.) Weakness and Body aches. Shortness of Breath starting Thursday 12/30 and continued till 1/3. Taking Wixela and Albuterol but did not seem to have helped. Set up appointment with local Care facility for 12/31 evening. Took Spiriva on Friday Night and DuoNeb on Saturday Morning per recommendation. They seemed to have helped but shortness of breath was still there. Visited Urgent Care (but had a virtual visit) on 1/1 and was suggested to wait until Fever goes down. Asked me to continue on Wixela and Albuterol only. On Sunday 1/2. the fever seemed to have gone down but was feeling weak. 1/3- Was still feeling weak so did not log in for work (remote). 1/4- Was feeling much better and was able to log in and work.
patient complains of a swollen area where the injection was administered.  She stated that the injection hurt when administered.  She claims the area is very sore to the touch 1 month after the injection was given.
On 10/26/00, ER visit with 90 second seizure while febrile. Treated with Tylenol and Motrin. On 11/15/00, office visit with seizure with temperature of 101.8F.
Breakthrough case admission after three vaccines Moderna 2/24/21 Lot# 038K20A;  Moderna 3/24/21 LOt# 002B21A;  Moderna 12/17/21 Lot# 060H21A
Pt became almost unresponsive, pulse present but low blood pressure. Pt became responsive and complained about nausea and lower abdominal pain.  No throat swelling, chest tightness or trouble breathing. Ems came less than 10 min and took patient to hospital.
Rash All Over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash All Over) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced RASH (Rash All Over). On 31-Dec-2020, RASH (Rash All Over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event one hour later after vaccination, a causal relationship cannot be excluded; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event one hour later after vaccination, a causal relationship cannot be excluded
Information has been received from a RN concerning a 5 yr old white male with seasonal allergies and no other medical history who on 11Dec02 was vaccinated SC with a first dose of varicella virus vaccine live (lot 641148/0791M). Concomitant vaccines that day included a fifth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot C0948AA) given IM and a fourth dose of poliovirus vaccine inactivated (Ipol) (lot W0010) given SC. Concomitant therapy included cetirizine hydrochloride (Zyrtec). On 18Oct04 the pt developed 15 lesions on his back and face with more appearing. The pt was seen for a doctor's visit and the lesions were classified as modified varicella. The pt was treated with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) and diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered from the modified varicella. There was no product quality complaint involved. Additional information has been requested.
4x2 inch Red Itchy Patch at injection site at day 9. She will take some BENADRYL and contact her doctor.
Sinus infection start Sunday night 12/12, went to clinic on 12/15, got antibiotics, zyrtec, and sudafed
Fever, headache, chills, malaise, pt couldn't get out of bed for a day.
States she felt ache and itchy "all over" felt sweaty, had buzzing in her ears, felt her mouth and throat were swelling. Stated this was her first influenza vaccine ever. State this reaction occurred at other times, but could not be specific about what may have caused it. Took Benadryl, self-prescribed, on her own with relief.
approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was bradycardic at 56, diaphoretic, hot, and altered. Patient continued to deteriorate in mental status.  Patient indicated yes by nodding and clutching throat to airway constriction. Patient given .3mg epi via auto injector in the left thigh. Patient status improved markedly after adminstration. Patient taken to Er for observation and EKG. Patient was discharged without incident.
administered 4 doses of an affected vial; received dose of Moderna vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No medical history is reported by reporter.     On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered 4 doses of an affected vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Headache, Myalgia, DIZZINESS, TINNITUS Narrative: Employee claimed that she experienced dizziness, headache and fatigue the day of the vaccination and the day after. there after she felt better. Employee got the second dose 1/21/21 Employee claimed that she experienced intermittent tinnitus , that started 2 weeks after the second dose, that became persistent after April first. Employee had not seek medical evaluation
Keloid formation following a robust primary reaction to initial vaccinia vaccination on 4/2/02.
Havrix adult administered to child; Havrix administered to a 1-week-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-day-old male patient who received HAV (Havrix adult) (batch number 95DB2, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th November 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 18th November 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter gave consented to follow-up via phone. Additional supportive information: An adult dose of Havrix had been given to a child patient, which led to overdose and inappropriate age at vaccine administration.
Fever over 103, severe headache, Blurred vision, nausea, vomitting, stomach pains, loss of appetite, Fainted and was sent to the ER after being released from hospital. Still having mild to severe headaches.
HPI:  PT  GOT SHINGRIX VACCINE #2  11/13,  FELT GENERAL MALAISE FOR A DAY OR TWO THEN DEVLOPED COLD SORE ON LIP, NOW FEEING THE SORES IN HER NOSE, NASAL PASSAGES.  AREA FEEL IRRITATED .  NO FEVER.  HAS HAD SOME INTERMITTENT GENERALIZED ICHING  W/O AND SKIN  RASH- NO NEW SOAPS, DETERGENTS, ETC.
Resident noted in bed without pulse/respiration at 4:40 am on 8/29/22. CPR was initiated per nursing home staff. EMS arrived to take over care and transferred to the hospital, however resident expired at hospital ED.
Shingles-like itchy, burning, rash with pus-filled blisters on the right side of my abdomen and trunk
2 days later I begin experiencing moderate nerve problems in my right hand, which have progressively worsened since, to the point that using my right hand is very difficult.
Pt given PEDIARIX and Hep B on the same visit. (2 doses of Hep B vaccine.
Started cramping about an hour after. Then 2 hours later started having bright red breakthrough vaginal  bleeding. I am not sure for my chucks for another 8 days and was not bleeding prior to vaccine not cramping.
Rash at injection site.  Very itchy on days 9-10 (March 6-7).  The rash is approximately 3" x 4" in a rectangular shape.  Today is day 13, and the red patch remains but is not itchy.
localized redness, pt would not bear weight on leg; tx ice compresses x 15mins/qid; to be seen if unable to bear weight in AM;
This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 06Apr2021 13:00 at single dose for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 06APR2021 at around 1PM. She woke up in the middle of night (she usually does so). When she woke up this morning and had a cup of tea, noticed that she was "somewhat sensitive to caffeine" which is unusual because she liked drinking coffee. On 07APR2021, her heart rate (HR) is 96 beats per minute (BPM), which is high because her usual HR is 60 BPM. Her oxygen levels are normal (98%). She asked about this possible side effect to the vaccine, aside from her sore arm. She asked if she could take Ibuprofen. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021389552 Same reporter/drug/AE, different patient
Granuloma annulare after receiving the second shot; This spontaneous case was reported by a patient and describes the occurrence of GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 033C21A) for COVID-19 vaccination.     Patient did not had any acute and chronic illnesses at the time of vaccination. Patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy (Outdoor allergy) and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE and HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot). At the time of the report, GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) outcome was unknown.            Patient started taking prescribed medication after taking the vaccine. He started Escitalopram Oxalate before the booster due to family death. HCP (Health care professional) and Dermatologist were aware of the side effects.  In Dec-2021 patient went to see a dermatologist. Patient was diagnosed with granuloma annulare after receiving the second shot and before the booster.   No treatment information was reported.   This case was linked to MOD-2022-643706.