chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; Trigeminal neuralgia; Can not tolerate loud noises; Jaw still hurts; Double vision in right eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), TRIGEMINAL NEURALGIA (Trigeminal neuralgia), HYPERACUSIS (Can not tolerate loud noises), PAIN IN JAW (Jaw still hurts) and DIPLOPIA (Double vision in right eyes). At the time of the report, BELL'S PALSY (Bell's palsy), TRIGEMINAL NEURALGIA (Trigeminal neuralgia), HYPERACUSIS (Can not tolerate loud noises), PAIN IN JAW (Jaw still hurts) and DIPLOPIA (Double vision in right eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown.  The patient went to the emergency room twice. She was put on a steroid by her doctor.  She is undergoing treatment with a neurologist.  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.; Sender'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.
Friday, day after 1st injection. Flu-like symptoms, stomach ache, fatigue. Sent home from school, went to bed. Called Dr. told to bring her in if still feeling bad on Monday.
12:15 a.m.  Horrific headache,  horrible body shakes and chills High fever, extreme fatigue, sore throat, extreme pain in armpit  Fluids, advil, lots of sleep. Still fatigued
Moderna dose 2 received at 1605. Patient reported funny taste and throat tightness. Oral diphenhydramine liquid 25mg was given. Tongue swelling and mild stridor were noted, prompting administration of an epinephrine pen and EMS was called. SpO2 noted to be in high 70s, along with persistent symptoms, so she was given an additional epinephrine pen as well as 100mg IM hydrocortisone. She was started on a 15L non-rebreather mask, IV was placed in the left antecubital space, and intubation kit was pulled from cart. Tongue and stridor improved after these doses of epinephrine and hydrocortisone. Blood pressure 190s systolic from 170s systolic after first epinephrine dose, with HR 116 at this point, and SpO2 99%. As EMS arrived, diphenhydramine 25mg IV was administered. At that point, tongue size and stridor were noted to have worsened again, so a third epinephrine pen was administered prior to EMS transport. Patient received racemic epinephrine inhalation nebulizer in EMS. Further treatment administered in ED: LR, dexamethasone and famotidine. Patient admitted later that day for further monitoring given hypertensive status. Put on scheduled cetirizine, famotidine, and dexamethasone and PRN albuterol and racemic epinephrine. Throughout her stay, patient continued to improve with stable vital signs and normal breathing. She was monitored for a total of 2 days and discharged home on 1/29.
Lymph node swelling and pain under left arm lasting for 5 days and injection site tenderness.  Treated with warm compresses.
Patient received FLUVIRIN 2013-2014 and PNEUMOVAX shots on same day in same arm. Patient reports swelling from shoulder to elbow accompanied with pain and redness.
Patient admitted on 4/25/22 with chest discomfort.  Patient had booster on 4/14/22.
Had the 2-shot series several years ago, developed shingles over the weekend/suspected vaccination failure; just developed shingles over the weekend; It is miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In October 2022, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was told that not good enough and so he/she had the 2-shot series several years ago and just developed shingles over the weekend and it was miserable. The patient asked that what the hell was happened. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient passed out and fell to the floor shortly after receiving the immunzation. She received a cold compress and quickly felt better.
Moderna, several health issues since the booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Moderna, several health issues since the booster) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Moderna, several health issues since the booster). At the time of the report, IMMUNISATION REACTION (Moderna, several health issues since the booster) outcome was unknown.            No concomitant medication was reported.  The dose patient received was booster.  No treatment medication was reported.   This case was linked to MOD-2023-695939 (Patient Link).
This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
The pt developed respiratory distress, wheezing, urticaria on the same day as vax. Skin color was red and skin was warm. Treated with epinephrine. Transferred to ER for observation and possible admission.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cancer. Concomitant products included ASA, acyclovir, Calcium (Unknown), dexamethasone, omeprazole, LANTUS, NINLARO, Cranberry Pill and TOPROL. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site pain and fatigue to be related to SHINGRIX. Additional details reported as follows: The patient received vaccine on left, upper arm on outside area. The patient experienced pain, soreness, fatigue which lasted for two days. The pain and soreness from the first shot were located at the location of the injection. The caller did not report to any healthcare professional and did not seek any medical attention after either shot. The patient had denied permission to contact their physician. No additional information was available. This case has been linked with US2018GSK118633, reported by the same reporter for same patient.
COLD SYMPTOMS; FLU SYMPTOMS; SICKNESS FOR 48 HRS; This spontaneous report received from contact via a company representative concerned a male patient 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: unknown) dose, start therapy date were not reported for prophylactic vaccination.   The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced cold symptoms. On APR-2021, the subject experienced flu symptoms. On APR-2021, the subject experienced sickness for 48 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, flu symptoms, and sickness for 48 hrs. This report was non-serious.
On 9/14/16 patient had received BEXSERO left deltoid immediately after she passed out since vaccine given she also has had dizziness nausea, HA's and severe pain left arm.
COVID infection (diagnosed 12/30, fully vaccinated with booster) who presents with fever.
Initial report received on 13 February 2008 from a health care professional. A 13-year-old female patient with no past medical history, and no known allergies, had received a first, intramuscular right deltoid dose of MENACTRA (lot number U2551AA); and a second, intramuscular "left" dose of GARDASIL (manufacturer Merck, lot number 0802U) on 05 February 2008. Approximately three days later, the patient complained of discomfort in her hips bilaterally; and had developed petechiae in the hip and buttock area bilaterally. No treatment was required. Reportedly, blood work was within normal limits. At the time of this report, the patient was slightly improving, but was not considered to be recovered. Follow-up information was received from the reporter on 18 March 2008. The Gardasil was given in the left deltoid. The patient's father was a physician, and ordered a CBC which was reported as "normal". Per the health professional, the form was "complete".
Acute onset of fever (same day vaccines administered) no other symptoms except for "breathing funny" & hard knot on thighs.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-SEP-2012, at age 62, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider at a county health department. On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Expired dose of Moderna was administered/2nd dose administered 1 day after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna was administered/2nd dose administered 1 day after use by date) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus NOS.   On 19-Aug-2021 at 10:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021 at 10:53 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna was administered/2nd dose administered 1 day after use by date). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna was administered/2nd dose administered 1 day after use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up document received contains non-significant information as it is similar to initial source documents. On 05-Oct-2021: Non-Significant follow-up received on 05-OCT-2021 contains no new information.
Fever of 101.7 F noted in the office, also had fever at home, but not documented with a thermometer. Urticaria rash all over the body a day after the immunization were given.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 12-MAR-2014, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about March 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Chief Complaint: chest wall pain s/p fall.  Recently exposed to Covid. Continue oxygen to maintain adequate oxygenation.  BiPAP  Intravenous steroids.  body was released to the funeral home
I returned from a cruise on 10/13/2022 and I began to have symptoms on 10/17/2022. When I woke up that morning, I didn't feel sick or feverish but did feel under the weather. As the day progressed, I had to make a visit to the health care facility for a pre surgery appointment. I called them ahead of time to inform them that my wife had tested positive for COVID-19 and that I had been exposed. They wanted me to keep my appointment, so I went with a mask on. When I arrived, they interviewed me and then sent me to a different location to be tested for COVID-19, where I tested positive. They sent me straight home. When I returned home, I started feeling more of the COVID-19 symptoms. I was starting to get a headache and some body aches but still was not having any fever. The physician's office called me later that afternoon to prescribe me PAXLOVID. After the recommended five days of the medication, I felt 100% better.
Hands and arms were hot and itchy/Feel like itchy on my knees and my elbow; Feeling like my ears are hot/Hands and arms were hot and itchy; 3-4 dots almost as if something had bit me; This is a spontaneous report from a contactable consumer(Patient). A 38-year-old female patient received bnt162b2 (Pfizer-bioNtech COVID-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 16Mar2021 at 3:15 as Dose number Unknown, Single for COVID-19 immunization(at the age of 38 year-old).The patient medical history and concomitant medications were not reported. On 16Mar2021, the patient had experienced 3-4 dots almost as if something had bit her and on 16Mar2021 at 18:00 the patient had experienced that her ear started to warm and hot and eventually her elbows were itchy, and then when hands were itchy, she checked the time that was about 1:40 in the morning and it stop itching maybe an hour ago or 7 o'clock and my ears had stopped feeling warm. I did not feel that at night but now I am feeling it again. The outcome of the events were unknown.    No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
pain at the injection site; tiredness; headache; chills; feeling unwell; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 10Feb2021 at 13:15 (01:15 PM) (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included known allergies: penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm right on 20Jan2021 at 12:15 PM (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. On 10Feb2021 at 20:00 (08:00 PM), the patient experienced pain at the injection site, tiredness, headache, chills, feeling unwell, muscle aches. The patient did not receive treatment for the events. Outcome of the events was recovering.  Follow-up (PRD/SRD 12May2021): Follow-up attempts completed. No further information expected.
Received second Moderna June 2021,  acute vision loss Left eye  August 2021.
Grandmother, reports after patient had second dose of HPV she developed POTS (postural orthostatic tachycardia syndrome). She has been to ER multiple times She required cardiac ablation for SVT in 2018. POTS has interfered with her ability to do physical therapy. Previous provider was informed by grandmother but nothing reported.
Patient received the first dose of Moderna COVID vaccine on 1-3-2021. The redness, heat, itchiness, induration at the site of the Moderna COVID vaccine, left deltoid,  started on 1/6/2021 and getting worse. The area measures 6 cm X 6 cm. Patient states the redness and induration is getting larger.  Patient instructed to apply ice and take Benadryl.  The patient was referred to her primary care provider.
Seizure like activity with fever around 4:30 am on 8/16/14. Lasted for 2 minutes
Woke up at 4:40am I had this tapping/fluttering sound in my ear like it was opening and closing a door in my ear and super loud, and it continued throughout the day. It persisted for 3 days and then I called my PCP and she said for me to come in. She checked my ear and she said I didn't have inflammation or drainage. I wasn't prescribed any medication. She prescribed an MRI, and that showed that there was nothing significant. So, I followed up with ENT doctor, and he said he couldn't see anything that was wrong. And he prescribed me with a nasal spray, Flonase etc. I didn't use either one of them. This has been happening for a month and it lessened over time. And that's usually when I wake up in the morning and it subsides throughout the day.
4/10/2021 - Arrived in ED with weakness reported in R arm and Bilateral legs, Admitted into facility.  4/11/2021 - Neurology consulted expressed concern for AIDP, various neurological tests performed (MRI Brain, CT head and Lumbar Puncture). CVC placed for plasma exchange treatment 1/5                                                                                                                                 4/12/2021 - CT no acute abnormality, L.P. high protein.           4/13/2021 - Continued ascending Paresis.  Monitored closely for Respiratory distress plasma exchange treatment 2/5            4/14/2021 - Plasmapheresis 3/5 performed. decreasing GCS intubated.