chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got my shot/ got shingles\Suspected Vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The patient received shingles shot 3 years before reporting. The patient experienced shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were not provided.
Missed menstrual cycle (my menstrual cycle has always been very regular and was due April 27; still has not arrived). Confirmed not pregnant.
Heart attack; Lost alot of weight; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WEIGHT DECREASED (Lost alot of weight). The patient was hospitalized from 22-Mar-2021 to 26-Mar-2021 due to MYOCARDIAL INFARCTION. The patient was treated with Rehabilitation therapy (On 01 Apr 2021, the patient was put in cardiac pulmonary rehab, currently in sixth week.) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and WEIGHT DECREASED (Lost alot of weight) outcome was unknown.            No concomitant medications reported.  The patient had a heart attack following stents. The patient had a cardiac catheterization on 22 Mar2021 and then was admitted to the (hospital) critical care unit (CCU) for 1 night, and then went home on 26 Mar2021. The patient may possibly have to do a total of 12 weeks of cardiac pulmonary rehab, but the patient would not know until he has his cardiologist appointment on 14 May2021.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Bell's Palsy occurred. Paralysis on left side of face. Unable to completely close left eye and metallic taste in mouth. Prescribed steroids and Acyclovir.
1st shot 3/20/21 and 2nd shot 4/10/21.  My period is typically about 5 days and very regular.  I started my period on April 1 and today is April 13 and I am still bleeding and I have been extremely bloated.  Other side effects that I have been experiencing were more typical  arm pain and diarrhea the day after the 2nd shot. Also today   I noticed a rash or hives that have started on the arm that I received the shot in.
This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 17-year-old female patient who received Havrix (batch number B2JH7, expiry date 6th June 2020) for prophylaxis. On 22nd May 2018, the patient received Havrix .5 ml. In May 2018, 4 days after receiving Havrix, the patient experienced neck pain, fatigue, fever, general body pain, lymph node pain and headache. On an unknown date, the outcome of the neck pain, fatigue, fever, general body pain, lymph node pain and headache were recovering/resolving. It was unknown if the reporter considered the neck pain, fatigue, fever, general body pain, lymph node pain and headache to be related to Havrix. Additional details were provided as follows: The reporter is the patient's father. The patient received Havrix in the right deltoid. On the same day, the patient also received Meningococcal vaccine (unspecified) concomitantly. The reporter noted, the patient received three additional vaccines two days after receiving Havrix. Vaccine names were not provided. Adverse events were improving since they began. The patient was taken to her doctor's office and tested for mono (mononucleosis), test results were negative. The patient was not hospitalized for treatment of any of the reported events. The contact details of the physician were provided. No additional information was provided. No further information would be available for the reported suspect vaccine and adverse event 'off label use'. The reported suspect vaccine (Twinrix) was changed to Havrix as per the batch number B2JH7. Lab Comments: On an unknown date, the patient underwent Mononucleosis (mono) test, which found as negative.
DEVELOPED RASH AND TINGLING AROUND LIPS AND TOUNGUE. TOOK ORAL BENADRYL AND THIS SUBSIDED WITHOUT INCIDENT.
Pt recvd 3rd hep B vac 22OCT90 & exp pain @ inject site which lasted 2 weeks.
Note: Any requests for follow-up information on this case should be send directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 19 November 2014. A 25 year-old male subject whose past medical was reported as no was found to have acute pericarditis unspecified 23 days after the subject had received on 08 July 2014 an injection of ACAM2000 (lot number, route and site of administration not reported) and on 26 June 2014 he received Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 19 July 2014 and an abnormal Echocardiogram on 19 July 2014. Results of an ECG were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Deltoid, glutes, calves lactaid acid. Muscle weakness. Went to doctors. Did blood work. Things ruled out.  Test showed imflamation. Currently on pregnezone. Future doctor visits scheduled.
Information has been received from a registered nurse concerning her 22 year old daughter with no allergies who on 24-JAN-2007 was vaccinated with HPV VLP vaccine (yeast). Concomitant therapy included methylphenidate HCl (RITALIN) and "pregnancy shot" (name unknown). On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot."  Later that evening her "fingers turned white and blue."  She then went back to the physician who instructed her to "wrap it in warm packs." The patient also took diphenhydramine HCl (BENADRYL).  The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area.  At the time of the report, the patient was recovering.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a registered nurse concerning her 22 year old "healthy" daughter with no medical history and no allergies who on 24-JAN-2007 was vaccinated with GARDASIL.  Concomitant therapy included RITALIN and "pregnancy shot"(name unknown).  There was no illness at the time of vaccination.  On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot."  Later that evening her "fingers turned white and blue."  She then went back to the physician who instructed her to "wrap it in warm packs."  The patient also took BENADRYL.  The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area.  Follow-up information reported that the patient stated that "her arm stung became hot at time of injection, tingled down to her fingers", same arm shot given in deltoid.  Later hand and fingers (that arm) swollen, white across knuckles.  She put warm packs on it at home, next day felt better difficult to left arm above shoulder height.  The patient recovered 2-3 days later.  It was noted that the patient had no adverse events following previous vaccinations.  Additional information is not expected.
numbing a little on her face; redness on her eyes; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Her face was numbing a little on her face and there was redness on her eyes. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd 3 doses of Engerix-B vax & exp no adverse rxn; HBSAB was neg p/completing the series; pt recvd a booster dose of Engerix-B 7DEC91 & titer not drawn as of 10FEB92;
Right sided facial numbness and swelling, Treated with Benadryl, lasted 9 hours. Symptoms disappeared on Friday, returned on Saturday, Retreated with Benadryl, Symptoms went away on Sunday, Tingling and itching of right side of the face returned on Monday. Treated with Claritin in the evening.
vaccine was administered subcutaneously versus the recommended intramuscularly, pt did not report any adverse effects
Large soft as well as  hard swollen lymph glands and nodes in neck and clavicular region and severe muscle aches and pains in upper body and neck.
5-10 minutes following influenza A monovalent vaccine (H1N1) tightness in throat, lasting approx 5 min. Itching over body w/itching in throat starting at approx 1300. sent for medical evaluation at clinic.
Case PHEH2016US027158 is an initial spontaneous report received from nurse on 17 Oct 2016. This report refers to a 52 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) at a dose of 0.5 ml intramuscular on 17 Oct 2016. On the same day, it was reported that temperature excursion occurred with FLUCELVAX prefilled syringe (PFS) in a closed refrigerator. The vaccines were cool to touch upon discovery. She estimates the time of excursion was 2 to 3 days, max temperature was estimated to be less than 77 degrees Fahrenheit (F). This was first excursion (vaccination error). No adverse event was reported following this medication error (incorrect storage of drug).
PATIENT SAID THE FIRST DOSE THEY HAD SOME VERTIGO/HEADACHE BUT TOOK SOME MEDICINE AND THEY WERE OK.  I TOLD THEM TO PURCHASE SOME MECLIZINE AND SHE DID.  I DID WARN HER THE SECOND SHOT COULD CAUSE MORE SIDE EFFECTS.  THE PATIENT SAID THE EVENING OF THE SHOT SHE HAD CHILLS AND WAS FEELING UNWELL.  THE NEXT MORNING WHEN SHE GOT UP FROM THE BED SHE FAINTED AND HIT HER FACE ON THE GROUND AND IT CAUSED A BLACK EYE ON HER RIGHT EYE
14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender 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 01-Dec-2022, 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 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No concomitant drug information was provided.  It was reported that 14 patient had received the vaccine which was in refrigerator past 30 days.  the vaccine used by date was 26-Nov-2022 however vaccine was administered on 01-Dec-2022.  No treatment drug details were provided.  The case contains the details of one of the 14 adult patients who had received an expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-685141 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter
Approximately 24 hrs after vaccination, patient's left arm swelled up and turned red. A tennis ball sized lump appeared about 3 inches below the injection site. Patient also experienced full body myalgia. He was able to go to work the following day. But was still pretty sore. The lump and redness had decreased.
left arm was cold and numb; left arm was cold; pain on the right side of the neck; had headache; right and left shoulders sore; Left foot and left knee are sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache) and ARTHRALGIA (right and left shoulders sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache), ARTHRALGIA (right and left shoulders sore) and MYALGIA (Left foot and left knee are sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (left arm was cold and numb), PERIPHERAL COLDNESS (left arm was cold), NECK PAIN (pain on the right side of the neck), HEADACHE (had headache), ARTHRALGIA (right and left shoulders sore) and MYALGIA (Left foot and left knee are sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
woke up on 4/7/2021 unable to hear at all in right ear, after having NO symptoms since original vaccine on 3/11/2021 except for a dull headache on most days, which subsided on 4/3/2021.  There were no prior indication that hearing loss was imminent, such as pain, ringing in the ear, redness, itching, fever, crackling, popping, muffled hearing, etc.  I saw my primary doctor on 4/7/2021 to rule out ear wax or infection.  She started me on Prednisone and referred me to ENT.  Appointment with ENT is on 4/8/2021 for his evaluation.
Developed a rash on the palms/side of both hands. Subcutaneous bumps that were mildly itchy. Disappeared after about a week. Used Benadryl to alleviate but did not seem to have any effect on diminishing the rash.
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported dizziness, diplopia, headache, and difficulty with answering questions. Denies chest and abdominal pain and shortness of breath. Patient transported to the emergency department where initial vital signs within normal ranges except blood pressure 170/119 mmHg. Physical and neurlogical exam noted above symptoms with cranial nerves, sensation, and extremty strength intact/normal. Patient's symptoms rapidly resolved without intervention. Repeat vital signs within normal ranges except blood pressure 134/91 mmHg. Determined patient experienced a vasovagal episode. Patient discharged to home stable.
Pain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica; ain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 26-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered pain throughout her entire body, headaches, fatigue, stiff and painful joints, hips and legs. Pt was diagnosed with inflammatory polyarthritis and polymyalgia rheumatica. It was also specified that the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not provided. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, polyarthritis and polymyalgia rheumatica were considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
I had pain and soreness in my right breast for about 1 week.  It was continuous.
Adverse Event:  Client reports severe headache, left flank pain, copious amounts of emesis observed, diaphoresis, change in level of consciousness, audible wheezing, beginning phases of posturing. Client spouse  reports this is how she presents with previous episodes of anaphylaxis  and seizure episodes.   Treatment: Interventions were assisting guest to the medical area via wheel chair, cold packs, emesis bags, EMS activated. hydration with water, therapeutic conversation, epic pen administered x1, unable to obtain vital signs due to posturing.  Outcomes: Wheezing  resolved, increased LOC,  consented to being transferred to Medical Center. Spouse at her side and daughter left  together.
No immediate adverse reaction when first got the shot. It was sore for a couple of days, then it felt fine. After 8 days a swollen, red rash, appeared around the vaccination site about the size of a baseball or so. It is/was slightly sore. I believe it to be "Covid arm." After 4 days the rash was almost gone, but now on day 5 (today), it is back just like it was initially. I was wondering if others had "Covid arm" appear, then mostly go away, then have it return.
Fever, body ache, chills, pulmonary embolism, dvt , cough, ? this continued until mid July. I have continued to have a fever in the evening currently
REDNESS, SWELLING, IRRITATION IN ARM INJECTION WAS ADMINISTERED. PCP CONTACTED - RX ORDERED FOR BENADRYL & HYDROCORTISONE. PT INSTRUCTED TO MONITOR FOR WORSENING OF SYMPTOMS OR UNRESOLVED REACTION.
Red blotches with dots: legs, feet, belly, back and neck. No fever, no breathing problems 10/12/02. 10/14/02 Monday disappeared. Phoned doctor; reported doctor said it was vaccine related.
Patient was observed after 15 minutes of vaccination, appeared to be well. 5 minutes after observation person, patient was in the waiting room and stated he was feeling dizzy and lightheaded
On December 1st, Patient had a stroke that involved a low speed multi vehicle collision. A CT of the head demonstrated a subacute right MCA stroke.  Follow-up CTA demonstrated extensive occlusive thrombus involving the left ICA, right ICA, right vertebral arteries.
cold; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After giving immunizations at 12:10 mother noticed a hole at 12:15pm on R arm by varicella shot. Also a sm hive noted outside the injection site of the MMR. MD notified. Zyrtec 10mg given per MD. Called mother and checked on pt-mother stated it went away-has had no other problems.