chrisvoncsefalvay/vaers-outcomes huggingface dataset:
and has developed neuropathy in both her feet.; This serious case was reported by a other health professional via sales rep and described the occurrence of peripheral neuropathy in a female 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 peripheral neuropathy (Verbatim: and has developed neuropathy in both her feet.) (serious criteria GSK medically significant). The outcome of the peripheral neuropathy was not resolved.   The reporter considered the peripheral neuropathy to be related to Shingrix.     The company considered the peripheral neuropathy to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2023. The reporter reported that individual reporter know from the gym approached him last night at the gym in and began to tell reporter about an adverse event that had occurred to his mother.  The patient received the Shingrix vaccine a few months back and had developed neuropathy in both her feet.  The patient had been to the doctor's office and was currently dealing with the issue, the patient believed it was from the Shingrix vaccine.  The reporter did give his phone number and agreed to follow up from GSK.
I experience nausea within 2-3 after my Dose 3 Moderna 01/12/2022. I self medicated and had to go to the hospital on 03/25/2022 because the nausea was to the point that I was not able to function. I went to the Hospital for observation and they took Blood samples, x-ray and provided nausea medication. I was only there for few hours observation, evaluation and treatment. I am still scheduled for additional treatment and follow-up with my primary provider.
Headache injection site pain, chills, fatigue, 1 week later injection site itching/redness/swelling, congestion  Narrative:
Tested positive in the community on 1/9/22, fully vaccinated with booster-Moderna.
Hard 1 cm once sub q and mild erythema around. No pain. No tenderness. No discharge. (L) lateral femoral side.
At 4:26pm patient reported that she has itchy eyes and nose and also a runny nose. Vital signs taken. Patient given Diphenhydramine by mouth at 4:33pm. Patient was discharged to go home.
A patient was given an incorrect additional dose of flu vaccine this year. At this time the patient has no side effects or reactions.
Male caller stating he was vaccinated on 3/6/2021 administered 1st dose of Moderna vaccine in his (LA) Lot# 036A21A. Two days later he had increased injection site pain which led to left arm tingling and numbness, began to radiate up the left side of his neck and then to his face. He also began having tingling down his left hip and to his left leg. He went to the ED on 3/11/2021 complaining all the symptoms and worsening. Hospital ED recommended a neurology consult. He went home and attempted to get an appt with a neurologist and could not schedule until June 2021. Called Health clinic today 3/14/2021 stating his concerns with worsening symptoms and was recommended he return to the ED for further medical Manag
Patient states she has an itchy rash on both her lower legs since the day after receiving the Pfizer vaccine. It was advised she take Benadryl and to see her adult provider to assess if this could be related to the vaccine and/or if she needs any further treatment for the rash.
Developed intense brain fog, confusion, memory loss, diarrhea, sleeping 10-12 hrs per day plus 2 naps per day. Was to the point that I was reaching out to touch my family members to make sure they were really standing in front of me. As an RN myself, I was very worried. Lasted for a total of 5-6 days and then completely went away. No history of mental illness other than anxiety. Was seen by PCP on day 2 of symptoms. Scheduled for MRI of the brain and complete lab work collected. No signs of inflammation or infection. If symptoms continued then would have prescribed course of steroids but symptoms went away on June 7th. 2nd dose of vaccine was on June 1st.
Had a very high, huge local reaction that went from his shoulder to almost his elbow. Red, swollen and warm. (It is notable that his older brother had the identical response). Report was file for him, too.
The vial was left out from the night before and a dose was given to the patient. The manufacturer was contacted and informed us we had given the vaccine within the allotted time frame for effectiveness to not be questionable. The patient was also notified of the incident and did not seem upset.
nurse inadvertently administered Pfizer COVID-19 vaccine beyoind use date (past 6 hours after dilutiion) parent notified dose needed to be repeated after contacting Pfizer
pt recv vax dec appetite & inc sleep x 2 days; wt dec by 1/2 oz; no sz, high fever;
Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's.  That resulted in cervical C3 thru C7 epidural mass.  Hemilaminectomy for evacuation of hematoma on 3-17-2021.  C5-C6 discectomy anterior cervical w/ fusion 3-18-2021.  Resulting complications were unexplained atrial fibrillation 3-21-2021, Ongoing rehab appointments for right arm and leg numbness.
Sore  arm; Fatigue; A little bit of nausea; A little headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore  arm), FATIGUE (Fatigue), NAUSEA (A little bit of nausea) and HEADACHE (A little headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore  arm), FATIGUE (Fatigue), NAUSEA (A little bit of nausea) and HEADACHE (A little headache). At the time of the report, PAIN IN EXTREMITY (Sore  arm), FATIGUE (Fatigue) and NAUSEA (A little bit of nausea) outcome was unknown and HEADACHE (A little headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-245602 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received included no new information.
mild myocarditis with fevers +constitutional symptoms, trop and BNP elevation (without other cause), ekg abnormalities, EF wl
Pt had an episode in the middle of the night following his vaccine. He couldn't sleep and went to the bathroom where he had very loud, forceful vomiting. He then fell backwards and appeared to have a mild seizure that lasted a very short time. He has never had a seizure in his life prior to this. He did not know where he was or who his care giver was for a short time. His care giver then got him back into bed and then he had uncontrollable rigor for approx 45 minutes. He was fine when he went to bed and is fine now other than some dizziness. (this was all reported information from his caregiver).
No adverse event; 35 patients received a 0.25 ml dose as booster instead of 0.5 ml.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster instead of 0.5 ml.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster instead of 0.5 ml.).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
Patient got ill approximately on 5/1/10 with headache; then started fever 38.1 C and more; no jaundice; boring observed in the ED for 3 days. He received vancomycin, acyclovir. He was stable and no transferred to ICU, nor intubated. He denied any bleeding or reduced amount of urine. No recent hx of traveling, so far. Patient & friend (no name given) traveled to several cities in a foreign country from 5/14-5/28/10. Friend got similar illness light headache, chest/back/spine pain for 2 days ("mild meningitis"); no MD/hospital/tests.
Patient was given expired dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No known drug allergies were reported. Patient did not have acute illnesses at time of vaccination or 1 month before vaccination. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient never had adverse event following any previous vaccines.  Concurrent medical conditions included Hypertension.  On 23-Mar-2022 at 1:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2022 at 1:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired dose of Moderna vaccine) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial did not undergo any temperature excursions. The patient did not experience any adverse event. No treatment medication were provided.
Following injections, child's arm became clonic and eyes rolled back, put child on the floor with legs elevated, diaphoretic.  Child jumped up and stated does this, passes out. Sat child down on the bench and he became clonic again with arms and stared ahead.  Eased child back down to the floor and the back of the childs head hit the floor.  Resulted in a small elevated area on the posterior head.  Vitals at 9:24AM were blood pressure  left arm 120/40,Pulse 80, Respirations,  child warm to touch, diaphoretic, face pale.  Elevated legs, ice pack on the back of the head and cold compress on forehead.  9:35AM Vitals blood pressure 102/50, Pulse 78, Resp.  24, c/o being  hot then cold.  sat up the child and become lightheaded so layed back down at 9:40AM,  Lips pale.  9:50AM blood pressure 94/30 pulse 72, Respirations 10 States not lightheaded, skin dry to touch and not hot.  States feels better so was sitting and then would lay down in front of a fan.  10:01AM, blood pressure 120/72, Pulse 80, Resp. 12, states feeling better, lips red, skin warm to touch sitting up.  Tried standing up and stated weak and sat back down on the bench.  10:04 AM  blood pressure 120/70, Pulse 82, Resp 12,  While sitting observed involuntary shaking of legs and arms.  Child stated feeling better.  at 10:15AM walked child to vehicle.  Recommended to the adult with child that the child should rest the rest of this day.
I felt my heart racing like it was going to get out of my chest; my mouth got very dry at that moment I thought I was having a panic attack.; my mouth got very dry at that moment I thought I was having a panic attack.; I try to calm myself got a bottle of water and drank the whole bottle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 32030BD) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 29Mar2021, when the patient was 58-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 08Mar2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "I felt my heart racing like it was going to get out of my chest"; DRY MOUTH (non-serious), PANIC ATTACK (non-serious), outcome "not recovered" and all described as "my mouth got very dry at that moment I thought I was having a panic attack."; THIRST (non-serious), outcome "not recovered", described as "I try to calm myself got a bottle of water and drank the whole bottle". Therapeutic measures were not taken as a result of palpitations, dry mouth, panic attack, thirst.  Additional information: Patient reported that, I felt my heart racing like it was going to get out of my chest crazy, my mouth got very dry at that moment I thought I was having a panic attack. I try to calm myself got a bottle of water and drank the whole bottle. No covid prior vaccination, yes covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337169 same patient/drug, different dose/event;
Received shots on Wednesday, 3-14-07, started getting a little red and sore to touch on Thursday.  By Friday the right upper arm red, swollen, hot to touch down to the elbow.  Took child to MD at ER.  Child has cellulitis of right arm.  Treated with antibiotic Keflex by mouth
The patients are not having any side effects that I am aware of; temperature excursion/ the GARDASIL 9 was given to 3 different patients./ ABOVE 47 degrees Fahrenheit (54.2F) for 0 hours 30 minutes; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-NOV-2020, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # 1637648 with expiration date 19-JUN-2022 (route of administration and anatomical localization was not reported) for prophylaxis. Administered vaccine underwent temperature excursion of 54.2 Fahrenheit degrees for 30 minutes. Digital data logger was involved. No previous excursions occurred.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA009526: US-009507513-2011USA009052:
Chills, temperature up to 101.4, body aches.  Lasted less than 24 hours. Temperature went down with Tylenol.
Patient states she had severe muscle weakness and inability to move from bed for 2 days. States it was severe all over muscle weakness as well as flu-like symptoms. Muscle weakness seems more severe than typical adverse event.
I woke up at 4am on 9/2/2021 with a severe headache. Over the next 2-3 hours I developed head to toe, global body aches. I also suffered extreme fatigue and spent 21 of the next 24 hrs in bed, sleeping.
Left arm is stiff and sensible, forearm swollen on the inside near the elbow under the bicep, I can clearly feel some swelling (a lump under my skin). Put ice yesterday night but still there this morning. I don't feel any other discomfort.
she started to experience a headache; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (herself as patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021, it was reported that she started to experience a headache after receiving the 1st dose of the vaccine today 09Apr2021. Her headache started one hour after she received the vaccine and she wanted to know if she could take Tylenol as she might experience migraines. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received vaccines 2/1/11. Fever 103 degrees AM 2/2/11 PM 2/2/11 - fever 105 degrees - chills, malaise, vomiting. Child to hospital.
It was reported that a female received Fluzone SV '99-'00 on 10/5/99. On the same day, she experienced a mild local site reaction. The pt has recovered completely. "Reviewed, no additional information at this time, 11/17/99."
rash around vax inject site appeared p/24 hrs; course of Augmentin was prescribed along w/topical bactroban; sx dec p/3 days;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 06-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Started as headache. Headache increased and sinus pain and tingling skin sensations in upper left face area after 24-36 hours. Symptoms steadily increased until 4/13, visited ED on a doctor friends advice. Small lesions had s started to appear at hairline Was diagnosed with shingles, prescribed 7 days acyclovir. Now 1 day into acyclovir treatment, progressing as expected, shingles symptoms increasing. Follow up PCP appointment planned for 4/15.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 01-NOV-2011, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
RASH APPEARED APPROXIMATELY 1 1/2 HOURS AFTER RECEIVING VACCINES.  RASH FIRST APPEARED ON HEAD AND HAIRLINE AND SPREAD OVER BODY BY 10/24/04.  RASH FULLY SUBSIDED BY 10/25/04.
This is a spontaneous report from a contactable consumer (patient's mother). A 3-year-old female patient received PREVNAR 13, via an unspecified route of administration in the leg, on 12Aug2014, at single dose. Relevant medical history included ear infection until a week before (she had never been on antibiotics) and house dust allergy. Concomitant medications were not reported. No vaccines given on the same day or eight weeks prior to PREVNAR 13. Before vaccination the doctor did a basic language test and all looked great, so patient got the vaccine. On 17Aug2014 the patient started stuttering and experienced trouble moving legs. On an unspecified date she experienced a reaction to vaccine, would throw her head forward trying to get the words out, didn't eat for 2 days and started screaming for two days. In Apr2015 she experienced ear infection. Clinical course was as follows: four to five days after vaccination the patient started stuttering. For a few weeks it seemed the stuttering was getting worse. As she was trying to speak, she would throw her head forward trying to get the words out. The patient's mother went back to the doctor and was referred for language therapy. Since Sep2014 her daughter has been going to a center, stuttering lasted 6 months and recovered completely a month and a half before. The patient underwent lab tests and procedures which included hearing and language test done on an unspecified date which showed it wasn't a hearing issue. The patient was hospitalized for the events would throw her head forward trying to get the words out/stuttering to the point of throwing her head forward and she received speech therapy. The patient recovered from stuttering in 2015; recovered from didn't eat for 2 days, trouble moving  legs, screaming for two days and would throw her head forward trying to get the words out an unspecified date. Outcome of event ear infection was recovered. Patient's mother stated that this was not the first time she had a reaction to vaccines. The patient's doctor considered stuttering and would throw her head forward trying to get the words out as unrelated to PREVNAR 13. Follow-up (10Jul2015): new information received from a contactable consumer (patient's mother) includes: event "started stuttering/stuttering to the point of throwing her head forward" start date updated. Follow-up (10Sep2015): Follow-up attempts completed. No further information expected. Follow-up (14Sep2015): New information obtained from a contactable consumer includes: hospitalization for would throw her head forward trying to get the words out/stuttering to the point of throwing her head forward, treatment, outcome updated for ear infection. Follow-up attempts completed. No further information expected.
Left deltoid area with jagged redness, slight swelling and slight warm. Area measures 6" long 5" wide. 1st night pt took Tylenol. Area itches and burns from time to time. On 03/16/2002 first notices small red patch that grew. Pt visited the doctor and was given Zyrtec and hydroxocine and a shot.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXIA
Hives and itching on upper torso and back to just below breast and to where the shot was given. Patient has taken sponge baths using aveno oatmeal which has helped the itching but not the hives. She has also taken benadryl during the day but it did not help.