chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 3 days of flu like symptoms (fever, chills, muscle aches) patient (myself) developed a rash on hand which spread  up arm, along with intense nerve pain. Visited Urgent Care on 06/08/2021 and was diagnosed with Shingles. Treated with Valtrex.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 17 year old female patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dosing details, lot # and expiry date unknown) for prophylaxis. On an unknown date, the patient developed a fever and fatigue. The outcome of fatigue and pyrexia was unknown. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
LEFT ARM SORE (INJECTION SITE); This spontaneous report received from a patient concerned a female 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: 1805022 expiry: UNKNOWN) 1 in total, dose was not reported, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced left arm sore (injection site). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm sore (injection site). This report was non-serious.
Patient states she has been experiencing migraines after the shot and she does not have a history of migraines. States she has a history of seizures, and she feels like she felt before she had seizures. We recommended she see a physician.
Pain is Left arm, with fever and chills. Within two more hours the arm was immobilized with pain. I couldn't lift my arm or move it without pain. I took 2 ibuprofen which didn't help. Six hours later an Aleve did not help.  I tried an ice pack which made no difference in the pain. I wasn't able to sleep that night due to the overwhelming pain. I still have only limited use of my arm due to excrutiating pain.
Moderna COVID 19  Vertigo lasting 24 hours, dizziness for another 12 hours
About a month after my first Moderna dose (1 day after second dose), I woke up with unbearably burning and gritty feeling eyes ad eyelids. This was on April 28th, 2021. I had tried to put my contact lenses in and it hurt so bad, they would not stay in my eyes. As the day progressed I began to have blurry, hazy vision with blue and red lines around every object that I would look at. I went to the emergency room but they did not find anything wrong with my eyes. I have been to multiple eye doctors appointments, including an ophthalmologist, and no doctors can find anything wrong with my eyes. Certain treatments give me some relief, but the symptoms never fully go away. I have tried Cequa eye drops as well as Restasis eye drops for severe dry eye syndrome. I also have to use artificial tears about five times a day. Zaditor and Pataday allergy eye drops work somewhat. I can no longer wear contact lenses and I'm stuck in glasses. I cannot wear makeup or cosmetics any longer because they burn my eyes. I have swollen blood vessels in my eyes along with a swollen eyelid on my left eye as well as a swollen lacrimal caruncle in that eye. I still hope that one day I can find something to help me with this vaccine injury. This was definitely caused by the vaccine because of the timeline after which I received both my first and second dose. I cannot find any other reason that I would have just woken up with this eye pain one day. I am suffering every day. I need help. One optometrist did tell me that he thought this might be autoimmune in nature. I have had many blood tests done and now have significantly elevated rheumatoid factor along with sudden high blood pressure. I always used to have low blood pressure. I have telangiectasias in my eyes. (In my chart.)
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 04-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown.    Additional information has been requested.
hard at the injection site; my arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard at the injection site) and VACCINATION SITE PAIN (my arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard at the injection site) and VACCINATION SITE PAIN (my arm was sore). At the time of the report, VACCINATION SITE INDURATION (hard at the injection site) and VACCINATION SITE PAIN (my arm was sore) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-160993, MOD-2021-044414, MOD-2021-044414 (Patient Link).
Tingling and numbness of tongue about 2 hrs after injection; Tingling and numbness of tongue about 2 hrs after injection; Soreness at site of injection for 1 day; This is a spontaneous report from a contactable consumer reported for an adult male patient of an unspecified age that he started to receive bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration from 26Jan2021 to 26Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Jan2021 the patient experienced tingling and numbness of tongue about 2 hrs after injection (paraesthesia oral), tingling and numbness of tongue about 2 hrs after injection (hypoaesthesia oral), soreness at site of injection for 1 day (vaccination site pain). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as recovered.  Information on the lot/batch number has been requested.
RINGING IN EAR; HEAD COLD; DIGESTIVE ISSUE; COVID POSITIVE; SHAKES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced covid positive. On 20-MAR-2021, the subject experienced shakes. On 21-MAR-2021, the subject experienced digestive issue. On 22-MAR-2021, the subject experienced ringing in ear. On 22-MAR-2021, the subject experienced head cold. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes on 21-MAR-2021, and digestive issue on 23-MAR-2021, and had not recovered from head cold, covid positive, and ringing in ear. This report was non-serious. ; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Had first vaccination on 1/6/21.  After second injection, severe pain under her right arm with swelling that has not subsided after 24 hours.
Patient received tetanus booster in ER after cat bite. Had nausea, weakness 24 hours after. Then right deltoid site red and hot. Came to PCP's office. 6/15/06 Follow up via phone: not as red or swollen; itchy and peeling but better.
Patient was seen 4/8/03 and rechecked in office 4/9/03 for a rash; was diagnosed with Chicken pox.
4 hrs p/DTP/OPV/HIB seen 1 hrs p/episode brief period of unresponsiness, limp & perioral cyanosis;
itching; erythema; feeling hot; arm still rashy; arm still rashy and tender; Night sweats; Face is flushed; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), FLUSHING (Face is flushed), PRURITUS (itching), ERYTHEMA (erythema) and FEELING HOT (feeling hot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  The patient's past medical history included Celiac sprue (Pain In stomach and rash on face feel sick gluten free) in 2008 and Pulmonary valve replacement in 2021. Concurrent medical conditions included Drug allergy (Swollen face ,red and hot flashes), Penicillin allergy (S Itchy back hives) since 1977, CLL since 2012, Celiac disease (Diet) since 2012 and Osteoporosis (Recasts once a yr). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, FUROSEMIDE (LASIX [FUROSEMIDE]) from August 2021 to an unknown date, METOPROLOL from August 2021 to an unknown date, CALCIUM ASCORBATE, TOCOPHERYL ACETATE (VITAMIN E+C [CALCIUM ASCORBATE;TOCOPHERYL ACETATE]), VITAMIN D [VITAMIN D NOS] and ZINC for an unknown indication.    On 29-Oct-2021 at 4:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced NIGHT SWEATS (Night sweats) and FLUSHING (Face is flushed). On an unknown date, the patient experienced PRURITUS (itching), ERYTHEMA (erythema), FEELING HOT (feeling hot), RASH (arm still rashy) and PAIN IN EXTREMITY (arm still rashy and tender). At the time of the report, NIGHT SWEATS (Night sweats), FLUSHING (Face is flushed), PRURITUS (itching), ERYTHEMA (erythema) and FEELING HOT (feeling hot) outcome was unknown and RASH (arm still rashy) and PAIN IN EXTREMITY (arm still rashy and tender) had not resolved. Not Provided          Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: reporter information, allergies and medical histories, concomitant medications and events added.
On January 20th I got shingles on my left abdomen.  second moderna given on 1/28/21.  Rash began to heal, but then had another outbreak in the same location February 15th with nerve pain. Treated with valtrex.  Two weeks later I had one more small outbreak. Still with continued pain and tiny dots on stomach though seeing improvement.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 26-JUN-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
SOB, hoarseness approx 2-3 hrs post vaccine. Scalp sores, increased LFT, uncontrolled blood sugars, severe fatigue, diplopia, neck pain, numbness head and face.
Information has been received through the Merck pregnancy registry from a Registered Nurse concerning a 23 year old female who on 24-APR-2007 was vaccinated with GARDASIL (Lot #654535/0960F). Concomitant vaccinations on 24-APR-2007 included MENACTRA, (manufacturer unspecified) and hepatitis A virus vaccine (manufacturer unspecified). The patient received the second dose of GARDASIL (Lot #657006/0188U) on 18-SEP-2007 and then experienced a miscarriage on 06-JAN-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient received the third dose of GARDASIL on 06-FEB-2008. The patient's estimated delivery date was 16-APR-2008. The patient became pregnant prior to receiving the second dose. Upon internal review, miscarriage is considered to be an other important medical event. Additional information has been requested.
Pt called today, 9/6/18 reporting  that his advrese effects be reported to the VAERS: Myalgia, severe pain in injection site that kept patient up all night (he even had to take an opioid), malaise, nausea, firm/tender hand, swelling at injection site.
Subject in pneumococcal vaccine trial, with severe COPD, was admitted to the hospital for Pneumonia and COPD exacerbation. Vaccination took place on 1/28/2008 and admission was on 7/29/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request. Subject ID is H105098.
Information has been received from a office administrator concerning her daughter, a 20 year old female who on an unknown date, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # not available). The patient experienced dizziness and nausea the same day after receiving GARDASIL vaccine (yeast). The patient did not seek medical attention. Patient recovered the following day. Additional information is not expected.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year old trainees and among others were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 17-19-year-old male patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 5 months after vaccination developed meningococcal meningitis, year reported as 2008 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
1/14/21 - 1/15/21 - Chills, fever of 99.7, body aches, pain in all my joints, fatigue, headache Around 9pm on 1/14/21 I developed hives that covered my entire body. I took an off brand Benadryl that did not help. The hives continued for a couple of days.  On 1/15/21 I noticed dark red blotches covering my throat area spreading on each side. As of 1/24/21 it is still there but much less noticeable.
This case was reported by a consumer, the subject's grandmother, and described the occurrence of seizure in an infant female subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject had no concurrent medications or relevant medical history. On an unspecified date in 2008 and 20 January 2009 at 16:30 the subject received 1st dose and 2nd dose of INFANRIX (unknown). She received the second dose when she was four months old. On an unspecified date in November 2008, around the time the subject received her two month INFANRIX dose (but the grandmother does not recall very well), the subject experienced projectile vomiting which resolved on an unspecified date. On 22 January 2009, two days after vaccination with the second dose of INFANRIX, the subject experienced seizure accompanied by projectile vomiting while she was sleeping. The subject was not febrile when the seizure occurred. The subject's mother called a physician, but did not take the subject to be seen because the physician stated it was not necessary. The subject has not been seen since this seizure occurred. The seizure resolved on an unspecified date. Outcome of the projectile vomiting was unspecified. This case was assessed as medically serious by GSK. Follow-up information was received from a physician on 30 March 2009. The subject had no relevant medical history or allergies. On 11 March 2009, electroencephalogram (EEG) was normal. The physician reported that no further DTaP vaccine would be administered for now. The physician reported that the events resolved. The physician considered that the events were unlikely related to vaccination with INFANRIX. The physician reported that the events could have been associated with the following: The subject's mother reported a ten minute staring spell which occurred one to two days after DTaP administration. No spontaneous movement was noted. There was no vomiting per the physician's records.
Redness and swelling at injection site. Started about the size of an egg, and now 2 days after vaccination (Sep. 3 2022) almost entire underside of forearm is red (approx. 8? in length, 4? wide oval shape spreading from injection site). There is also some firmness at injection site. Itchiness has occasionally accompanied this as well. Topical hydrocortisone and topical diphenhydramine were trialed but no improvement in symptoms were noted.
Nerve damage to arms and hands resulting in atrophy, loss of coordination and strength, and twitches down arms.
0600: Extreme fatigue-difficulty raising head off pillow, diarrhea, rt hot, severe swelling, red & painful, 1700: fever-started at 99.4, increased to 100.1 @ 2100, severe finger swelling at the joints, painful & stiff, knees became swollen, stiff & painful -evening. Took ibuprofen 800mg BID. (last dose @ 2100. Went to bed, next morning: all but slight stiffness & discomfort to right fingers was gone.
Thu 4/5 pm got flu-like symptoms, Fri woke up with body aches, slight fever, headache, vision pulses, slowly went away, by Sun felt normal.
was sick/ very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: was sick/ very sick). The outcome of the sickness was resolved (duration 3 weeks).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-JUN-2023 This case was reported by a patient via interactive digital media. The patient was very sick after the shingles shot and had to go to urgent care. The reporter reported that to contact him/her.
Pt recvd vax & exp serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous test for collagen vascular diseases, & been non-diagnostic;
Staff pulled the DTAP/IPV combination KINRIX, had the provider verify the vaccine, and then administered it to pt. Pt. stayed for 15 minutes to see if any reactions were noted. None were so the mother was given a VIS and was told to call if any reactions came about. Staff then realized KINRIX was 4-6 years of age and notified the provider of the mistake. The provider reassured staff that the patient would more than likely be okay and that there should not be any adverse effects from giving the KINRIX. We have been in contact with the family since the incident and no reactions/adverse effects have been noted.
After administration of the vaccine, pt stood up and fainted. He regained conscious quickly. Emergency service was called but he refused service and was fine later to go home. He stated that he got anxious getting vaccinations in general anyway.
C/o lightheadedness 151/86 84 97% O2 12:45  patient stated feels much better and given apple juice : 134/83, 71 98% O2
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 328 hours, with the recorded temperature of -1.66 degrees Celsius The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 5 year old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 18-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine:  VARIVAX, lot # R018780  and expiration date 01-JUL-2020(strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored was reported on the sterile diluent used. The vaccines were exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011480; US-009507513-1903USA011572; US-009507513-1903USA011571; US-009507513-1903USA011574; US-009507513-1903USA011570.