chrisvoncsefalvay/vaers-outcomes huggingface dataset:
postherpetic neuralgia; shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On 14-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving defendants' zoster vaccine live (ZOSTAVAX) vaccine, on 18-OCT-2014, the patient was diagnosed with shingles after experiencing extreme pain, a rash and an outbreak of blisters on her back, spine, breast and ribcage resulting in medical treatment. This outbreak lasted for months and resulted in post-herpetic neuralgia. Zoster vaccine live (ZOSTAVAX) caused these injuries and the need for medical treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work. 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. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result 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 shingles and post-herpetic neuralgia were considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the events of shingles and post-herpetic neuralgia to be disability.
Muscle aches, headache for 2 days following vaccine.  Diagnosed with Shingles yesterday.  Rash on right flank, burning pain radiating to just above navel all on right side.  Aside from vaccine side effects, have not been sick, sleeping well, eating well, normal level of stress.
sensation of a tingling feeling from behind my knees and down each leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (sensation of a tingling feeling from behind my knees and down each leg) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Demarol).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PARAESTHESIA (sensation of a tingling feeling from behind my knees and down each leg). At the time of the report, PARAESTHESIA (sensation of a tingling feeling from behind my knees and down each leg) outcome was unknown.            Action taken wit mRNA-1273 in response to the events was not applicable.  Concomitant medications and Treatment information were not provided.   This case was linked to MOD-2021-074946 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Patient demographics updated, allergy to demarol added, dose details added.
High fevers, rigors, severe  headache, body aches,  not able to go to work severe
acute celiac artery dissection, splenic  dissection with splenic artery thrombosis found upon presentation to ER, was admitted 5/14/21-5/18/21 vascular surgery consulted no surgical intervention needed, started on anticoagulation for 4-6mo *uncertain if related to covid 19 moderna vaccination prior*
Chills and fever within 24 hours. After 48 hours inability to sleep due to pain in left arm at injection site. Burning stinging pain continues today along with a slight itchiness and a very pronounced red spot. At first you couldn?t tell where I had gotten the shot and daily the red spot grows bigger and feels hot in temperature. It also feels swollen.  The red spot  has grown to the size of 5 inches  in diameter. Slight nausea the first day of injection. Along with genera malaise.
This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with (Oka/Merck) PROQUAD (lot #, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information.  No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US003638 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that this patient under 13-years-of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Pain, redness, and swelling at the injection site; Pain, redness, and swelling at the injection site; Swelling at the injection site; Stayed in bed for 24 hours; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 23rd October 2020, refer linked case US2021AMR002675) and PNEUMONIA VACCINE (patient received on 23rd October 2020, refer linked case US2021AMR002675).   On 4th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, weakness generalized, muscle pain, tiredness, headache, shivering, fever and upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were not recovered/not resolved and the outcome of the weakness generalized was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, weakness generalized, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient had received second dose of Shingrix at the MD office. The batch number and expiry date of Shingrix was unknown. After the second Shingrix shot, the patient had to stay in bed for 24 hours and then felt better.  The patient experienced all the side effects listed on the website such as pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002675:Same suspect, same reporter, same patient, different dose (1st dose)
My daughter felt warm to touch. Took her temperature with a digital thermometer. Read 101.1. Gave her 2 Acetaminophen tablets.
Information has been received from a pharmacist concerning a female patient of unknown age, who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. NO concomitant medications were reported. On 02-NOV-2012 the patient experienced redness, swelling and "hard knot" in the arm that the ZOSTAVAX was administered. No treatment was given for the events. At the time of reporting the outcome of the events was unknown. Patient did not seek medical assistance. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
DTP inject caused erythema & swelling (larger than size of an orange) in 15 pts;
I take continuous birth control to not have my period. I haven't had my period in months. Approximately 2 hours after receiving my first dose of Moderna, I got my period. I googled and saw other reports of other women having this issue- so thought I better report it as it may effect menstrual cycles.
Developed fever 101, local rxn at inject site - 3cm indurated area; splotchy, maculopapular rash on face, abd, back, chest, diaper area & legs following DTP/OPV immun lasted 2 days.
No additional AE reported; a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 12-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) 0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022 (strength, and route of administration were not provided) for prophylaxis, after a temperature excursion (product storage error). The temperature excursion was 12.4 degrees Fahrenheit (F) for 20 minutes. The previous temperature excursion was 6 F to 14 F (11.6F) for 25 minutes. No additional adverse event (AE) reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA010794: US-009507513-2203USA010696: US-009507513-2203USA010795: US-009507513-2203USA010654: US-009507513-2203USA010652: US-009507513-2203USA010658: US-009507513-2203USA010686:
12-18 vACCINATIJON 12-20 0100 LEFT EYE BEGAN TO SWELL,  ALSO NOTICE 2 SMALL RAISED BUMPS, NOT FLUID FILLED. RINSED EYE WITH COOL WATER, THEN APPLIED WARM COMPRESS. 12-20 IN MORNING WHEN SHE GOT OUT OF BED BOTH EYES WERE SWOLLEN W/ DARK CIRCLE BELOW. 12-20 LATE MORNING, EDEMA SUBSIDED, EYES NORMAL. 12-20 LATER IN DAY, TOOK BENEDRYL FOR SEASONAL ALLERGIES. 12-21 NO ISSUES 12-22 1300 BOTH EYES BEGINNING TO SWELL AGAIN, L MORE THAN RIGHT.
Burst blood vessel in her eye; Really bad headache/Her head was throbbing; Chills; Sinus headache; Her ear hurt; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9266, expiration date: 31May2021, via an unspecified route of administration at left arm on 17Feb2021 at a single dose for Covid-19 immunisation. Medical history included migraine diagnosed 35-40 years ago, aneurysm from 01Aug2018 and lung cancer. There were no concomitant medications. The patient reported that she had a really bad headache the next day on 18Feb2021, after getting her first dose of the vaccine on Wednesday, 17Feb2021. She sated that on the 18th she had chills and the really bad headache, and she has a history of migraines and also has an aneurysm in her brain which she doesn't know how long that has been there. She says she also looked in the mirror this morning 19Feb2021, while putting her make up on and saw that a blood vessel had burst in her eye, which could have been from the pressure she had from the headache. She says her second dose is scheduled on 10Mar2021. She says that she had a little headache the afternoon she got the vaccine that went away, then the next morning at 04:00 am her head was throbbing, and she suffers from migraines but this felt like a sinus headache. Her ear hurt and she thought it was more sinus then, and nothing she took for it would alleviate the pain. She says when she got up then she got chills. She says that nothing she did like she normally does helped, like she tried heat and cold it was not going to give. She says that she used ice packs then put heat on her shoulder, and also did a Neti pot, maybe that caused her eye have blood vessel burst in it, she doesn't know. She says that the blood vessel burst in her right eye, which seems to have gotten better since this morning, it is not quite as red. She says it could be that she rubbed it. She says her headache is gone now and her chills are gone. The patient recovered from the events really bad headache/Her head was throbbing and chills on 19Feb2021, for the event burst blood vessel in her eye was recovering. The outcome of the event Sinus headache was not recovered while the outcome of the event ear hurt was unknown.
Approximately 3 weeks after my 3rd dose - Started with the right side of my neck (Pain went through my ear through my shoulder) and sore throat. I called my doctor and was prescribed with an antibiotic assuming it was an ear infection. Then a week after I developed a rash  and called my doctor again and was prescribed an anti viral, then my thyroid was physically swollen and I went to the ER to have it checked and they did a CAT scan and recommended that I have a follow up regarding my thyroid. I was sent to Dr. (ENT doctor) and she ordered an ultrasound with the biopsy and blood work. The blood work came and they might think I have Hashimoto Disease and as of today I am still not treated for anything because they are waiting for my biopsy result.
p/vax pt to MD for fever 102.5, red & swollen arm, 2nd sl wheezing;
pt exp fussiness, shaky, eyes rolling, sleepy 6-8 hrs p/vax;
fever - duration 24 hours body aches - duration 4 days fatigue - duration 4 days under arm lymph node pain - duration 5 days
Angioedema occurred primarily around the eyes. It presented with redness, itching, and significant swelling in this area but mouth, throat, and tongue were unaffected. It began the night of 4/10/21 after I had dinner and had red wine. While drinking the wine my face began to itch horribly. Over the course of the night my face became red and swelled. I went to the urgent care the following morning and was given prescription steroids to reduce the swelling and redness. The swelling and redness went down over the course of the day. However, I had another angioedema episode on June 19 with the same symptoms. However, they seemed slightly less severe and itching was mild.
FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20211144727.
1600-1700 9-30-14 red area 10cm. Denies fever. No swelling. Painful to touch. C/O slight numbness to left ring finger. C/O itching to injection site.
This spontaneous report as received from a consumer's mother regarding her 15 year daughter. On 16-AUG-2012, the patient was vaccinated with a first dose of GARDASIL (lot number was reported as H063645, expiry date was not reported) 0.5 milliliter (ml), intramuscular. On 19-OCT-2012, the patient was vaccinated with a second dose of GARDASIL (Lot # H012973, expiry date was not reported), 0.5 ml, intramuscular. Approximately on an unknown date in 2012, the patient experienced pain at the injection site following administration of GARDASIL, but the pain has since subsided. Patient sought medical attention. No treatment was given. No lab diagnostic test was performed. On an unknown date, the event pain was recovered. The reporter stated that the patient was late in receiving her third dose in the series of GARDASIL, which is other-than-indicated. The patient was scheduled to receive her third injection of GARDASIL on 19-SEP-2013 at an unspecified physician's office. Additional information has been requested.
evening p/vax child became fussy w/temp of 106.0 R given APAP;
Information has been received from a pharmacist concerning a 67 year old female patient, with tetracycline allergy and a medical history  of chicken pox, mumps and measles, who on 13-Feb-2008 was vaccinated with ZOSTAVAX (lot#659323/01613U) in the left arm deltoid. Concomitant therapy included PRILOSEC 20mg (2 capsules, once daily), atenolol, and amitriptyline  hydrochloride. The pharmacist reported that the patient received the vaccine and developed PHN. The timing was not known. Two days after vaccination, on 15-Feb-2008, the patient experienced rash at the site of vaccination (3 inches diameter, raised red area, hard and hot with no pustules. The patient did not have fever. There was no recent exposure to chickenpox or shingles noted. In mid April 2008, the patient experienced daily left sided headaches and in mid June, the patient experienced daily left sided headaches and in mid June, the patient experienced pulsing sensation in the left eye. At the time of the headaches and in mid June, the patient experienced pulsing sensation in the left eye. At the time of the report, headaches and eye sensation and visual distortion continue and were diminishing. The patient was seen in the physician's office. A specimen was not collected for PCR. Additional information is not expected.
Initial soreness at injection site - dissipated in 2-3 days.  About a week later, started feeling numbness in left arm (injection arm).  Arm feels heavy and half asleep.  No loss of strength.  Also aches from shoulder through fingers.
33 year old female with no prior existing conditions began experiencing paresthesia in all 4 extremities a few days following the seasonal flu vaccine. Numbness and extreme fatigue continued to increase over several days. One week after the vaccine when she was unable to function or grasp properly she reported to the emergency room and was admitted with suspected GBS or MS following an enhancing lesion shown on an MRI. Patient was hospitalized for three days and given IV steroids. Patient had a lumbar puncture that revealed oligoclonal bands. Patient was released and referred to neurology to determine guillain-barré or multiple sclerosis.
Day after second vaccine woke to complete loss of hearing in left ear. Next day balance was off and still is-and hearing in left ear is still gone.
high pitched crying & fever 103.5 ax to 104 R; devel several hrs p/recvd vax;
Lipoma in arm, then in glands in neck on left side. Now she has a CSVT affecting both sides of her brain and a LOT of neurological problems. They are giving her drugs to dissolve the clot.
No adverse events reported by client. Tubersol (PPD solution) .5 cc administered IM in left deltoid.
Sore/achy arm.; This is a spontaneous report from a contactable consumer (patient). An 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination was 55 years), solution for injection, lot number: EN6207 and expiry date was not provided), via an unspecified route of administration in the left arm, on 25Mar2021 at 10:00, as single dose for COVID-19 immunisation. Medical history included allergy with penicillin. Patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Mar2021 at 15:30, the patient had sore and achy arm. Treatment mediations were not reported. Outcome of the event recovered in Mar2021.
Breakthrough case admission after 2 vaccines Pfizer 7/30/21 lot# Ew0198;  Pfizer 8/20/21 Lot# FC3183
TIA (transient ischemic attack) - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
bone pain, lasting 10 days; Tooth pain, lasting 10 days; This non-serious case was reported by a other health professional and described the occurrence of bone pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone pain (Verbatim: bone pain, lasting 10 days) and toothache (Verbatim: Tooth pain, lasting 10 days).  The outcome of the bone pain and toothache were not resolved.   It was unknown if the reporter considered the bone pain and toothache to be related to Shingrix.     It was unknown if the company considered the bone pain and toothache to be related to Shingrix.   Additional Information: GSK receipt date: 10-Oct-2023 This report was submitted via the online direct entry reporting system The patient experienced tooth and bone pain, lasting 10 days. The symptoms were treated. The reporter consented to follow up.
Diarrhea; Everything hurts in her body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MYALGIA (Everything hurts in her body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included VITAMINS NOS for Supplementation therapy, LISINOPRIL, METOPROLOL, SERTRALINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced MYALGIA (Everything hurts in her body). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown and MYALGIA (Everything hurts in her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
child devel a full case of chickenpox p/exposure;pt recv vax @ age 1yr 2 1/2yr prior to developing the chickenpox;
left me with blockages in my left leg; left arm has been in severe pain; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 27Jan2022, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "left me with blockages in my left leg"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left arm has been in severe pain".  The patient's left arm has been in severe pain since he got the vaccine. On 27Jan2022, the patient stated, "left me with blockages in my left leg".  The lot number for bnt162b2 was not provided and will be requested during follow up.