chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took shot for shingles it gave her shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took shot for shingles it gave her shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had a friend working with him/her for years when the covid struck all of them unfortunately. The friend experienced Covid and then she received Shingles vaccine and the vaccine gave her the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Child is Ex P.T. with dev. delays - midst neurological w/u including EEG. Foster mother states child started to have twitching of mouth to left - in hours after vaccines, continued with tapering medicine in days later.
I had body ache, fatigue and fever for 3 days. Then, I started having serve headache. Then, I started having a rash on my forehead and my eyes were swollen for 2 weeks. I went to my doctor and I was diagnosed with shingles. I went to a eye specialist to make sure my eye's were not damage.
Approximately 1 week after my 1st dose I began have numbness and tingling in both lower arms and hands (left greater than right). It continued until approximately 2 months after the 2nd dose. I saw my PCP on 3/2/21 regarding my symptoms and she diagnosed it as carpal tunnel. I received no treatment. The symptoms have completely gone away.
red, warm bump at the injection location for few days. low pain. 1.5 inch.
Itchy rash in both armpits, groin left and right, isolated itchiness in small areas in some parts of the body; hives in both armpits; This is a spontaneous report from a contactable consumer reported for himself. A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in right arm on 18Jan2021 14:00 (at the age of 73-years-old) as 1st dose, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine administered was other. The patient's medical history and concomitant medications were not reported. The patient was allergic to medications, food, or other products, shellfish and iodine in CT Scan dye were reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any vaccines within four weeks prior to the vaccination. On 23Jan2021 15:00 (5 days after the vaccine), the patient experienced developed delayed allergic reaction Itchy rash and hives in both armpits, Itchy rash in groin left and right, isolated itchiness in small areas in some parts of the body. The patient received treatment for the events was benadryl 25mg tab, 2% diphenhydramine cream, clari. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
SOB; chest pain; vomited; tachycardia/ 49 point increase in heart rate; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Sep2021 (at the age of 15 years old) (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. Medical history included autism, visceral hyperalgesia, and Tourette's syndrome from an unknown date and unknown if ongoing. Concomitant medications included guanfacine hydrochloride (TENEX); lamotrigine (LAMICTAL); magnesium; and sertraline hydrochloride (ZOLOFT); Probiotic; and Vitamins; all were taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took OMNICEF [cefdinir] and experienced drug hypersensitivity and flu vaccine VII and experienced allergy to vaccine. The patient experienced SOB, chest pain, vomited, and tachycardia/ 49 point increase in heart rate on 24Sep2021. SOB and chest pain getting out of shower 24Sep, then vomited. Woke with chest pain two nights in a row (morning of 27Sep, 28Sep), worsening. Normal EKG and lab work, but advised to push fluids and check pulse. Noticed tachycardia on standing. 49 point increase in heart rate from laying down to standing. Patient took betablocker (Propanolol) for his treatment received. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient underwent lab tests and procedures which included electrocardiogram: normal in Sep2021, heart rate: 49 point increase on 24Sep2021, lab work: normal in Sep2021. Treatment was received for the events included PRN Medication. The outcome of the events was not recovered.
This spontaneous report as received from a physician assistant refers to a female patient in her early 70's. In December 2013 ("before Christmas 2013") the patient was vaccinated with a dose of ZOSTAVAX in the left arm (lot#, route unspecified) given by an unspecified pharmacy and experienced terrible pain in both shoulders, the back of the neck and back of the head within 24 hours of vaccination. The pain started on the left side of the top of the shoulder then to the neck and head and then migrated to the right side. No treatment was given for the events, and patient visited emergency room for medical attention. The outcome of the events was reported as recovered/resolved on an unknown date. Additional information has been requested.
This spontaneous report was received from a pharmacy intern and refers to a patient of unknown gender and age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On 22-NOV-2016, upon insertion of the needle, the patient experienced pain and jerked arm away. Only a partial amount of vaccine was administered. The outcome of the event was unknown. The patient sought medical attention by an office visit. The relatedness between the event and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Two days following the vaccine, I had a miscarriage . I was 8 weeks pregnant.
This spontaneous report as received from a consumer refers to a 71 years old female patient. The patient was vaccinated (route not reported) with ZOSTAVAX (lot number and expiry date not reported) on July 2012. No other co-suspects were reported. Concomitant medications included: vitamin B complex). On 14-NOV-2012 the patient developed shingles on her tailbone. The clustered bumps itched and hurt so bad that she had to cover them to avoid irritation. No treatment information was reported. The outcome of shingles on tailbone was unknown. The relatedness for shingles on tailbone was unknown for ZOSTAVAX. Additional information has been requested.
1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021  Complained Right arm hurt, dizzy 1-4-2021  Felt better - did laundry, daughter found her deceased at 3:30 pm.                        Dr. at hospital said it was "cardiac event" according to death certificate.
Within three hours of receiving the vaccine, the injection site was erythemetous, swollen, and warm to touch. I began having shaking chills, HA, general myalgias and arthralgias, and abdominal cramping. This continued daily with worsening of symptoms to the point that I was unable to eat. On 11/4/2021, I developed severe vertigo and vomiting along with all the other symptoms and sought care at a local ED. I was given fluids, meclizine, and zofran and discharged home. The vertigo improved, but the other symptoms continued including a severe HA for which I was reseen in the ED on 11/6/2021. Treatment included fluids, pain medication, and anti-emetics. I was once again discharged home. I continued to have profound weakness, nausea, anorexia and was barely able to ambulate.   November 11,2021- I awakened with a significant visual defect in my left eye-multiple shadows in the medial inferior visual field. I was subsequently evaluated by an optometrist where retinal photographs reveal optic nerve swelling. I was immediately referred to a retinal specialist who diagnosed me with optic neuritis- probably vaccine related. I was placed on prednisone 20 mgs daily and valcyclovir 1000 mgs BID.  November 24,2021- recheck with retinal specialist- minimal change in optic neuritis OS-continued on prednisone and valcyclovir at same dosages.  My generalized weakness is gradually improving. I lost nearly 10 lbs during this entire illness, but my appetite has improved. The optic neurutus is presently the major issue. I am an emergency physician and unfortunately have been unable to work since November secondary to these issues. I am regularly being followed by my retinal specialist and internist.
poison Ivy eruption on her face; shingles; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (poison Ivy eruption on her face) and HERPES ZOSTER (shingles) in a 23-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DERMATITIS CONTACT (poison Ivy eruption on her face) and HERPES ZOSTER (shingles). At the time of the report, DERMATITIS CONTACT (poison Ivy eruption on her face) and HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
couldnot sleep; Confusion; Itching with a rash; Itching with a rash; she is having a hard time remembering things sometimes since having the vaccine; her heart is beating faster; This is a spontaneous report was received from a contactable consumer (patient).   A 68-year-old female patient of weight 68.04 kilograms and height 165 centimetres received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL8982, Expire Date: 31May2021) via unspecified route of administration in left arm on 22Jan2021 at 2-2:15pm as single dose for covid-19 immunisation. The patient's medical history included diabetes mellitus. The patient had no thyroid, and she does not have any allergies to medication but trees and caffeine, she has been taking allegra for most of her life. There were no concomitant medications. Previously patient took Flu vaccine (she had in Nov2020 or Dec2020 the Flu vaccine, but it was more than a month ago). Reporter states she just came back from her regular doctor because she had the vaccine on 22Jan2021 and the day after she started scratching her arm and her body some. The reporter also explained she had been having confusing and it was bothering her, so she needed to see her doctor about this. Her doctor gave her a shot. The reporter explained the confusion, she was having a hard time remembering things sometimes since having the vaccine. The reporter does not know what kind of shot her doctor gave her for the itching. She then confirmed she had only had the itching and explained it was with a rash and the confusion. Her heart was beating faster she thought since having the vaccine but maybe because it was because of her worry, she was very sensitive person. When she couldn't sleep, she takes a Xanax. When asked if the caller was having trouble sleeping after the vaccine, she clarifies that she was sleeping ok, she had been taking Benadryl due to the itching. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient had no adverse events following prior vaccinations. The patient had no family medical history relevant to adverse event and no relevant tests were done. In Jan2021, the patient had undergone lab tests which included heart rate and the result was faster. Adverse event resulted in physician's office visit. The outcome of events memory impaired, heartbeats increased was unknown, whereas not recovered for confusion, itching with a rash and was recovering from the event could not sleep.  Follow-up attempts are completed. No further information is expected.
extra dose Engerix-B accidentally administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   Previously administered products included Engerix-B (received primary immunization of Engerix-B on an unknown date).   On 06-JUN-2023, the patient received the 4th dose of Engerix B. On 06-JUN-2023, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: extra dose Engerix-B accidentally administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 7-Jun-2023 The nurse stated that in the system it looked as though the patient needed her third and final dose, but then after the dose was given it was realized the patient had already finished the series. No further information provided at the time of the call. The reporter was initially hesitant to provide details due to privacy concerns, but consented to safety follow up. The patient received fourth dose of Engerix-B, which led to extra dose administered.
Patient received first Pfizer shot on 12-22-2020. Patient arrived at the same clinic to get the 2nd pfizer vaccine on 01-12-2021. However, patient get Moderna instead of Pfizer (Lot 041L20A, Exp 12-31-2069)
1 week post administration, fever/chills, chest pain with EKG changes, and mildly positive troponins.
Within minutes of immunization, I experienced tingling on chin which then became swollen and painful. A blister formed, which broke open during the night. I was told it was herpes simplex virus, a fever blister.
flu like symptoms; pain in the right arm; received the COVID 19 Booster; This is a spontaneous report from a contactable consumer (patient). This consumer reported for self that: A patient of an unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number were not reported) via unspecified route of administration, in right arm on 11Oct2021 09:12 as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number were not reported), both via unspecified route of administration, on an unspecified date as a dose 1 and dose 2, single for COVID-19 immunization. On an unspecified date the patient experienced flu like symptoms, pain in the right arm and patient received the COVID 19 booster on 11Oct2021 09:12. The right arm was the injection arm. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No other AE reported; administration of improperly stored RECOMBIVAX HB; This spontaneous report was received from a nurse referring to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was provided.  On 23-NOV-2021, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) (0.5 ml ;lot number T032918 has been verified to be a valid lot number, expiration date reported and established as 12-NOV-2022; route and anatomical location of administration were not reported) for prophylaxis (product storage error).   The involved vaccine was exposed to a temperature excursion of below 36 grades Fahrenheit (F) (34.8 F) for 45 minutes with previous temperature excursions of 34.8 F for 13 hours 55 minutes and 33.9 F for 26 hours 30 minutes. No additional adverse event was reported.
Fever, Chills, Muscle Aches, Cough and Itchy Throat...all symptoms lasted 9 hours
I did not have an adverse reaction to the vaccine. I have had issues with my back for several years. Normally if I throw my back out, I will go for an adjustment, and I would be ok. My back went out and now I have muscle spasms on top of pain. I see pain specialist and get steroid injections into my back. I would occasionally take Advil or Tylenol to help with the pain.
Few second after given Menactra vaccine. Patient tried to stand up and walk but suddenly passed out and according to mother patient developed shaking of extremities and eyes rolling to the back, skin pulled for almost one minutes. When paramedic came patient already awake alert and oriented. Subsequently patient was brought to E.R.
Arm reactions; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm reactions) and PAIN IN EXTREMITY (Arm soreness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm reactions) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, LIMB DISCOMFORT (Arm reactions) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were given. No treatment information were given.
Fever; Headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ZINC, Black elderberry, VITAMINS NOS, TERBINAFINE and LANSOPRAZOLE for an unknown indication.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up received on 09-APR-2021 contains significant information include Reporter's details.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
319 patients who received the expired dose.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose.). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (319 patients who received the expired dose.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 5/7/2021 No concomitant and treatment medication reported.
Soreness started Saturday. Pt did not see rash until today. Red, itchy rash, hot to the touch, swollen. Rash measures approximately 4 inches east to west and 4 inches north to south.
Extreme body aches, cold chills, unbearable headache, nausea  Increases menstrual bleeding and intense cramping Chest tightness
This spontaneous report was received from a registered nurse and refers to a 10 month old male patient. The patient's pertinent medical history included umbilical hernia and cardiac murmur functional (reported as: "PPF functional heart murmur"). The patient did not have any concomitant medications and drug reactions or allergies. On 08-JAN-2018, the patient was vaccinated with a first dose of ROTATEQ vial, orally, lot # N014980; expiry date 16-NOV-2018 (dose was not reported) for prevention of rotavirus. On 08-JAN-2018, the patient was vaccinated with the second dose of ROTATEQ vial, orally, lot # N009962; expiry date 15-NOV-2018 (dose was not reported) for prevention of rotavirus. On 17-JAN-2018, the patient was admitted to the hospital with a diagnosis of intussusception. Unspecified treatment was given for the event. On an unknown date, intussusception was reduced but re-occurred at the time of the report. Unspecified lab diagnostic and studies were performed (reported as: " whatever was completed in the hospital"). At the time of the report, the patient was hospitalized. Re-reduction of intussusception was being attempt. The outcome of the event was reported as not recovered. The relatedness between the event and ROTATEQ was not reported. The reported considered the event to be life threatening and causing the patient a significant disability or incapacity. Upon internal review, the event of intussusception was considered to be medically significant.
This spontaneous report as received from a registered nurse refers to a 19 year old male patient. Patient's medical history was not provided. On 02-AUG-2012, the patient was vaccinated with VAQTA injection 50/1.0 U/ML, dose 1, 0.5 ml, intramuscular. On 10-DEC-2013, the patient was vaccinated with VAQTA dose 2, 0.5 ml, intramuscular. Patient's concomitant medications were not reported. On 10-DEC-2013, the patient was administered a second dose of pediatric dose instead of the indicated adult dose. No adverse effects reported. No further information provided. The outcome of patient was administered a second dose of pediatric dose instead of the indicated adult dose and no adverse event was unknown. Additional information has been requested.