chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lichen planus; Information has been received from a lawyer concerning a case in litigation and refers to a male patient of unknown age. The patient's medical history, historical drugs and concomitant therapies were not reported.  On or about 05-NOV-2014, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered painful rashes, scarring and lesions on the soles of this feet, his ankles, his lower back and around his eyes. He also lost his fingernails and toenails, and was diagnosed with lichen planus.   The symptoms had resulted in physical limitations, mental and emotional distress. The patient sustained severe and permanent personal injuries. He 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. The outcome of the event was not recovered.  The causal relationship between the event and Zoster Vaccine Live (ZOSTAVAX) was related.   The event was considered to be a disabling event.
Fevers to 104 starting several hours after vaccine administration, erythematous, painful, indurated skin reaction starting the following day and persisting for several days.
receiving the two-shot application of vaccine and both times. She took extremely ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (hospitalization) with onset 08Sep2022, outcome "unknown", described as "receiving the two-shot application of vaccine and both times. She took extremely ill".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SWOLLEN TINY RED LUMP AT SITE OF INJECTION; SORE ARM AT THE SITE OF INJECTION; MUSCLE ACHES (DOWN FROM THIGHS); UNABLE TO SLEEP DUE TO MUSCLE PAIN; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism.  On JUN-2021, the patient experienced unable to sleep due to muscle pain. On 01-JUN-2021, the patient experienced muscle aches (down from thighs). On an unspecified date, the patient experienced swollen tiny red lump at site of injection, and sore arm at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep due to pain, swollen tiny red lump at site of injection, and muscle aches (down from thighs), and the outcome of sore arm at the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124984.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 9:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.03 for dose administered on 27-Feb-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit at 09:00 AM, 35-degree Fahrenheit at 11:00 AM to 02:00 PM, 34-degree Fahrenheit at 03:00 PM to 04:00 PM and 35 degree Fahrenheit at 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Severe armpit pain.  Knee pain.  Fatigue. Sole of feet very tender.  Irritability.  Runny nose.
Pt c/o dizziness, but reports vertigo at baseline time of arrival. Pt reports she did not take her prescribed meclizine PTA. Brought to med obs #1 via w/c, reporting she is back to baseline vertigo symptoms at time of transfer. Pt refused to assume trendelenburg position, stating, "I will not lie down," despite education on benefits of positioning. Pt did report she needed to use restroom prior to vaccination but was told to "hold it." Pt escorted to bathroom via w/c by staff per her request. Ambulated from w/c to restroom without difficulty, gait steady. Pt reports resolution of symptoms. BP elevated and rechecked WDL upon recheck. Denies hx of HTN. No s/s of distress noted at time of d/c to home. Escorted to exit via w/c per protocol. Pt spouse to drive pt home. VS are as follows: 1039: BP 188/95, HR 79, RR 18, O2 sat 100% on RA 1044: BP 167/11, HR 75, RR 17, O2 sat 100% on RA 1100: BP 157/88, HR 66, RR 17, O2 sat 100% on RA.
Developed rash on arms, legs, trunk, knees swollen, c/o itchiness. Per advise of his physician, he took OTC antihistimine as treatement of symptoms.
PT WAS BEING MONITORED AFTER VACCINATION. I HAD A SMALL CONVERSATION WITH PT AROUND 3 TO5 MINUTES AFTER RECEIVING DOSE. I CHECKED ON HIM AT THE 7 TO 10 MINUTE MARK AND HE WAS FOUND NON-RESPONSIVE . PT WAS WARM TO THE TOUCH AND DID NOT RESPOND TO VERBAL COMMANDS OR PHYSICAL STIMULI. PT WAS ADMINISTERED 0.3MG EPINEPHRINE AND 100MG DIPHENHYDRAMINE.
Red rash 2" wide x 4" long extending down inner arm from injection area and very sore.  Reddened skin 3" wide x 6" long extending down inner arm starting below rash almost to elbow, and very hot to the touch.  Symptoms subsided after 7 to 8 days.
Pt called - stated hives and itching over entire body - 6 hrs after injection. PO BENADRYL taken.
Rash on one leg, then next day larger, then opposite leg, then up both thighs. No pain, no itching or pustules. did NOT respond to Benadryl or topical treatments for poison ivy/Gold Bond etc.
2nd Dose received Hep B vaccine 40mg IM 5-21-07 and patient contacted me (nurse) 5-23-07 and stated evening of 5-21 she got a film over her right eye. Went to eye doctor 5-22-07 and he stated it was her cornea and is sending her to cornea transplant doctor 6-5-07.
sensory disturbances- vision changes, loss of hearing and balance- did not receive dose #2 with us
Right arm pt has redness, no fever, no pain and warmth. 15 x 10 cm. No induration.
pregnant and received first dose of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received first dose of vaccine) in a 29-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in 2016. Concurrent medical conditions included Gestational diabetes and Type 2 diabetes mellitus in 2016. Concomitant products included INSULIN for Diabetes mellitus, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2021 to an unknown date for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Nov-2020 and the estimated date of delivery was 21-Aug-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received first dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received first dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2020, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception 01-Nov-2020. On 01-Jan-2021 ultrasound done results -not provided. Previous pregnancy end date included 01-Apr-2019 with live birth. No treatment information provided.
Liquid has accumulated at the bicep area, it's just sitting there.; right arm is all swollen from the bicep to the crrok of the arm; right arm is all red; Was really tired; Had no energy; No appetite; That night arm started itching/It was still itching; This spontaneous case was reported by a patient and describes the occurrence of EDEMA PERIPHERAL (Liquid has accumulated at the bicep area, it's just sitting there.), ASTHENIA (Had no energy), DECREASED APPETITE (No appetite), VACCINATION SITE PRURITUS (That night arm started itching/It was still itching) and FATIGUE (Was really tired) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concurrent medical conditions included Prostate cancer and HIV disease (HIV positive, was tested in 1985) since 1985.    On 15-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (That night arm started itching/It was still itching). On 16-Oct-2022, the patient experienced ASTHENIA (Had no energy), DECREASED APPETITE (No appetite) and FATIGUE (Was really tired). On 17-Oct-2022, the patient experienced EDEMA PERIPHERAL (Liquid has accumulated at the bicep area, it's just sitting there.), VACCINATION SITE SWELLING (right arm is all swollen from the bicep to the crook of the arm) and VACCINATION SITE ERYTHEMA (right arm is all red). The patient was treated with HYDROCORTISONE for Itching, at a dose of 1 % percent w aloe. At the time of the report, EDEMA PERIPHERAL (Liquid has accumulated at the bicep area, it's just sitting there.) and VACCINATION SITE PRURITUS (That night arm started itching/It was still itching) had not resolved and ASTHENIA (Had no energy), DECREASED APPETITE (No appetite), FATIGUE (Was really tired), VACCINATION SITE SWELLING (right arm is all swollen from the bicep to the crook of the arm) and VACCINATION SITE ERYTHEMA (right arm is all red) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 1985, HIV test: (Positive) Positive. No concomitant medications were reported. Patient's previous vaccination includes 1st Dose on 12-Jan-2021 with lot no. 039K20A, 2nd Dose on 09-Feb-2021 with lot no. 012M20A, 1st Booster dose on 28-Oct-2021 with lot no. 071F21A and 2nd Booster dose on 08-Apr-2022 with lot no. 033K2-2A. Treatment medication was Hydrocortisone cream 1% w Aloe.
On the evening of the 9th day after receiving my first dose of the Covid19 vaccine, the injection site was painful and felt bruised and made it hard to sleep on that side of my body.  By the morning of the 10th day, my upper left arm, site of the injection was very red, itchy and hot to the touch. It wasn't painful, just irritated and concerning. We marked around the red part to keep an eye on it and make sure it wasn't spreading.  It continued to be red and warm to the touch for three more days.  The redness did spread slightly downward to the base of my bicep area.  All of the redness was finally gone by day 15 after receiving the vaccine.
Pt recvd vax & 1 wk following vax exp an inc in SGOT levels; @ the time of the report had recovered; No further details were provided;
I got a Moderna booster after Pfizer vaccine in March and April. My period normally lasts four days. Currently, however, I have been getting extremely heavy flow since 12/5/21. It is now 12/14/21 and it shows no sign of stopping. I also had menstrual changes with the  Pfizer vaccine (heavy flow, very tender breasts) that took three months to wear off but were not as dramatic as this.
Patient is complaining of prolonged shoulder pain. Patient states that there was a "lump" at the injection site (now gone), and that her shoulder continues to ache to this day. Patient states that she saw a chiropractor, who diagnosed her with "Shoulder Injury Related To Immunization." Patient states a family friend's daughter, who is a doctor, suggested that a nerve may have been struck during immunization.
Flu like, severely limited my activities, achy body,  headache, very sore arm, exhaustion continues till today. Some days are better than others.  This is extreme.  When I had my first oral herpes outbreak some 20 years ago it was very extreme as well. My dentist said he had never seen anything like my outbreak.
Constant ringing in the ear. Dr. at local facility said it was tinnitus and he wanted to start treatment with cortisone.
This is a spontaneous report from a contactable other hcp (patient). A 69-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9810), via an unspecified route of administration in arm left on 03Mar2021 at 15:30 (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included RA, Waldenstrom Macroglobulinemia, osteoporosis, scoliosis, glaucoma, osteoarthritis, nerve damage, herpes, atherosclerosis. The patient known allergies were reported as Cipro family of antibiotics. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9819), via an unspecified route of administration in arm left on 10Feb2021 at 13:15 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 08Mar2021 at 00:00, the patient experienced serious itching on my torso, stomach, neck, face, head, armpits, and back. / some kind of pruritus, rash/harsher rash, red dots and this has lasted and gotten worse since the shot. The patient reported that went to dermatologist, who said to use Cerave cream for 2 weeks, then Triamcinolone 2 weeks, plus hydroxozine. Some kind of pruritus, she said. Nothing had helped (it's not shingles, and skin has a red tinge, like mild rash, sometimes red dots and harsher rash, sometimes not). She knew the mast cells are working overtime with a hystamine response, but her oncologist doesn't know if the vaccine kicked it off. But this had lasted and gotten worse since the shot. The events resulted in physician office visit. The outcome of the events was reported as not resolved.  Follow-Up (20Aug2021): Follow-up attempts are completed. No further information is expected.
FLUZONE Influenza High dose immunization Expiration Date 04/09/2018 given to patient in the left deltoid. Provider in charge notified, Health Care administered notified, Lead MD notified and patient notified. Patient has no reaction. Will continue to follow up with patient.
Patient developed severe pain by shoulder bone area in the middle of the night. Patient also experienced redness. Site of reaction was 3 inches from injection site.
Adverse side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse side effects). At the time of the report, VACCINATION COMPLICATION (Adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse side effects). At the time of the report, VACCINATION COMPLICATION (Adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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, a causal relationship cannot be excluded.
This is a spontaneous case, initially received from a pharmacist (the initial and follow-up received on 26-Oct-2018 are being processed together) on 15-Oct-2018, concerns an 81-year-old, elderly female patient. It was reported that, the patient had no chronic medical illness. On 15-Oct-2018, the patient was administered high dose of FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250805 and expiry date: 30-Jun-2019] and the patient accidentally received non-company suspect product FLUZONE [dose, route of administration, anatomical location, batch number and expiry date: not reported]. The patient had no complaints or side effects after the vaccination. The reporter assessed the case as non-serious. Follow-up received from a pharmacist on 20-Nov-2018: The patient had no chronic medical illness. The reporter confirmed that, the FLUAD dose given was 0.5 ml. The reporter also confirmed that, the patient had no complaints or side effects after the vaccination. Upon internal review, it was realized that, the event coding was incorrectly done for the event. Hence, the event coding was changed from 'extra dose administered' to 'overdose'. The narrative was amended accordingly.
The patient did not have adverse events but because he was 18 years old at the time of administration, he should have gotten the pediatric formulation rather than the adult formulation of HAVRIX. He had no side effects from this vaccine based on our phone conversation on 6/15/18 at 9:56 am.
104+ Degree fever, Headache, severe muscle pain, chills, nausea, tired for 3 days.
had vision issues; seeing dots; burning sensation around/near sternum; my heart skipped; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN9581, expiration date: May2021), via an unspecified route of administration on arm left on 23FEB2021 17:45 age at vaccination: 57 years as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included SVT heart condition tachycardia and not had any other recent vaccinations or started any new medications. The patient Concomitant medications she takes VITAMIN D pills and hormone therapy progesterone and estrogen, but she has for a while. No further details provided about these. On 25Feb2021, the patient experienced seeing dots and had vision issues. It was reported that she received the first dose of the Pfizer vaccine 2 days ago and had vision issues, when she saw white surface and bright light she saw dime sized blue dot changed to pink which wouldn't go away for a minute. She reported While she was closing the garage door, when you go into the sun flare of vision and it goes away as she was going to the bathroom, everywhere that was white. She saw blue dots and there was a continuous pattern to it blue changed to pink and remained pink. Same color as in the bathroom, for a minute up to longer than a minute that concerned me. I have no medical conditions. If I see pink dots it that retina detachment. Wondering if it's causing any damage. I have SVT heart condition tachycardia. I was concerned about it because the night I took it I had a circular burning sensation around/near sternum and my heart skipped, and it scared me, just the first night. I got the vaccine at 5:45pm this happened about 11pm. I don't know if it was gas or anxiousness. When I was signing up they asked if I had/was COPD, smoker, and clicked yes, since I have a heart issue but no one was concerned about it. I heard about a new strain which is more deadlier than the others. What I'm concerned about is the 2nd dose and needing the another variant dose. She was concerned about if there could be damage to the retina in her eye, whether she should seek treatment, and what if she decides not to take the second dose and goes with another vaccine, what are her options about what she can do. The lab test included Weight increased 15lbs (Weight: Caller says after a year being inactive after COVID, clarified that she did not have COVID-19, she was inactive in her home and has gained 15lbs it's terrible) on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
16MAY96 pt had 1x episode of a febrile sz;transported to ER t104.7;sl ear infect dx, ATB prescribed;17MAY96 no inc temp today but pt is listless/pale