chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syringe had been activated with a needle attached for 40 minutes prior to administration of the dose/ no AE; Initial information was received on 11-Nov-2021 regarding an unsolicited valid non-serious case from an Other healthcare professional via Media Information (under reference- 00853459) and transmitted to Sanofi on 11-Nov-2021.   This case involves a male patient (unknown age) while receiving TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] syringe had been activated with a needle attached for 40 minutes prior to administration of the dose with no adverse event (Device defective).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On 09-Nov-2021, the patient received once dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of Device defective (latency was on same day).  It was reported "Two days ago, Typhim Vi was administered to a patient from a manufacturer's prefilled syringes. It was not realized until after it was administered that the syringe had been activated with a needle attached for 40 minutes prior to administration of the dose".  Product used: Used. Still using product: No.  At the time of reporting, patient had no adverse event.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Re-occurance of shingles (had it ~18 years ago) lesions, extreme pain, etc...
A few hours after my vaccination I began to have searing joint pain in my fingers (right hand). The pain is like a sharp stab which lasts for a few minutes then it goes away. The pain comes and goes every few hours. I have never experienced anything like this in the past nor my family.  Note: The only other symptom I had was a sore arm which I felt with both my vaccinations. No flu like symptoms or anything else I am aware of.
PATIENT RECEIVED VACCINE EARLIER THAN RECOMMENDED GUIDELINE PER CDC. 2ND DOSE WAS ON 8/24/21 AND ONLY 16 YEARS OLD. DOSE WAS GIVEN YESTERDAY AND PATIENT HAD NOT REPORTED ANY ADVERSE REACTION YET.
Redness and swelling at injection site measuring 10cm. Pt complained of pain at injection site
Seizure x 2 7/10/08-records received for DOS 6/18-6/20/08-DX: seizures.Presented to ED after erratic breathing, shaking whole body. Crying.
Inappropriate schedule of vaccine administered; Severe itching on my back, legs, buttocks, hands; This is a spontaneous report received from a contactable consumer, the patient. A 53-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration in left arm the 18Mar2021, as single dose for COVID-19 immunisation (at the age of 53-years old). Medical history included blood pressure high. Concomitant medication included Diphenhydramine HCL (BENADRYL) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 04Mar2021 at 11:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the 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 other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food, or other products. On 18Mar2021, the patient experienced severe itching on my back, legs, buttocks, hands. The vaccine was administered outside the range of 19-42 days after the first dose (Inappropriate schedule of vaccine administered). No therapeutic measures were taken as result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event itching was not recovered and inappropriate schedule of vaccine administered was unknown at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Received VARIVAX vaccine #2 on 11-30-12. On 12-3-12 patient stated, "My arm is red, hard and hot. That started on 12-1-12." Golf ball sized area of redness and induration around vaccine site. No fever or rash.
Noticeable fatigue several hours (3-4) after receiving 2nd shot (on 4/5/21).  The morning of 4/6/21 has the following:  headache, muscle aches, chills, joint pain, not hungry.
Patient with fever and chills for 1 day after vaccination, syncopal episode 4 days after vaccination
DTaP adult given 07/12/2006. Illness 07/19/2006 ear pain, swollen glands in neck, rash on face, temperature 100 degree.  07/21/2006 urticarial like rash on forehead, scalp sore.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 27-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Upper left arm at injection site because red, inflamed, hot to the tough. arm swollen and large hard bump in center. Could not lift arm above head. Cellulitis infection that spread over several days encompassing most of upper arm.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 10-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    Concomitant product use was not provided by the reporter.  Patient of 6 months of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.  Patient was given with appropriate vaccine or scheduled as per CDC.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
i had my second pfizer shot on 3/5/21 and on 4/1/21 i awoke to terrible muscle contractions in my mid to low back, hips and right leg.  over the next few days the symptoms increased to 10 out of 10 pain with searing, burning nerve pain in these areas and greatly reduced function.  after two weeks and no change i went to urgent care and they presctibed prednisone and flexaril which had no effect at all.  trying to work i ate handfuls of ibuprophen and wore multiple pain patches just for parttime work until i couldn't work any longer, and as of now i haven't been able to work for 10 months.  i developed constant tinnitus, my energy remains low (i used to be a skier and a biker and now i struggle to take my dog for... long walks.  in october '21 and again in january '22 i took two courses of medication presctibed by a long haul covid specialist, even though i don't have long covid but rather an adverse reaction and i have been treated in much the same way in this case with prednisone, ivermectin, fluvoxamine and aspirin, and some other supplements. i got covid in dec '20 and since then my smell and taste have not returned to normal.  i often can't smell or taste things or they have strange chemical overtones to them.  other than that i was fine until after my second pfizer shot.  after the adverse event started, nothing i could do would quell the pain for long. now after the two more recent courses of medication, along with acupuncture, massage and chiropractic sessions, i can get through most days without pain medication and just have a low level of nearly constant discomfort, with occasional times of increased pain.  but my activity is very limited, my back is very weak, can't handle weight and vigorous activity.  it feels as if the tissues on the right side of my lower spine are permanently damaged and my spine doesn't want to stay in alignment.
weeks of lethargy, tiredness, suicidal thoughts and actions extreme depression, not willing to leave bed
Swelling of eyes and lips. Not sure of time. I haven't called doctor yet. It is 745 and they open at 9. She has no other symptoms that I know of.
12 hours after booster was given, I developed a bad headache, all over body ache. I was also freezing for about an hour. The symptoms subsided by morning but I was lethargic most of that day.
Pt recvd 1st HIB/DTP/OPV on 13FEB91; 2nd HIB/DTP/OPV on 17MAY91 & on 30JUN91 pt seen in office & dx w/otitis, had fever the preceeding evening; On 2JUL91 hospitalized for H. Flu Meningitis; tx Rocephin & Decadron;
p/vax pt devel rash under arms next day lasted until 2nd hep b vax given 9/22/99;on 9/23/99 rash underarms worsened & spread across chest & up neck;went to MD 9/27/99;given Stera-prep dose pack w/no improvement;
Temperature of 101, chills, body aches, swelling of wrists, pain in the back, pain where spine meets skull, headache, rash on torso, tenderness at injection, extreme heat where injection was given.
expired dose of act-hib was administered with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2023, the patient received unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ796AA; expiry date: 12-Aug-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of act-hib was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient presented to the ED on 10/6/2021 with cough and shortness of breath post COVID-19 exposure.  Pulse ox was 80%  and he was started on oxygen (4 L nasal cannula), dexamethasone PO daily x 10 days, and remdesivir x 1, then  daily x 4 days.  As of 10/11/2021, patient is still in the hospital on oxygen.
Staff member reported left arm felt heavy and was very nervous with sweaty palms 13 minutes after vaccination. He received Benadryl 25mg IM to his right deltoid and he reported symptoms subsided 1 hour after Benadryl and was symptom free for 6 hours. He reported body aches and HA the next day through 12/27/20 and then complete resolution of symptoms.
Pt recvd 3 doses of Heptavax-B vax in 1988; JUL to AUG91 pt exp non-response; Booster dose of Engerix-B given;
This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (lymphoma in remission). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient broke out with lumbar distribution zoster, 2 weeks after receiving SHINGRIX. The reporter asked should the patient get second immunization of SHINGRIX, and if yes what should be the timing and the results studies in potentially immunosuppressed patients. The patient had already reported to centers for disease control (self-reported). The reporter did not agree to be contacted for follow up.
Arm hurt; arm hurt and felt like a weight; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm hurt) and heaviness in arm (Verbatim: arm hurt and felt like a weight).The outcome of the pain in arm was unknown and the outcome of the heaviness in arm was resolved (duration 3 months).   It was unknown if the reporter considered the pain in arm and heaviness in arm to be related to Shingrix.  It was unknown if the company considered the pain in arm and heaviness in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter did not want to provide any patient demographics. The reporter stated that she had her Shingrix vaccination in the left arm. After the vaccination the patient stated that her arm hurt and felt like a weight was on it when she moved or lifted it for 3 months.  No further information was known. The reporter did not consent to follow-up.
Low grade fever, stiff/sore muscles, tightness in spine; feels like in a constant hard bear hug. Painful to move about, reach or lift any objects over 4 lbs.  Diagnosed with an L2 closed fracture on 5/9/23 after initial MMR was given on 5/5/2023. Had second MMR given on 6/28/23 and now having same symptoms and to include diarrhea.
Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140, expiry date unknown) intramuscular at the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunization. The patient received Covid vaccine in a hospital. Medical history included high blood pressure, penicillin allergies. Concomitant medications included clonidine, bupropion hydrochloride (WELLBUTRIN XL), pantoprazole, topiramate, alprazolam (XANAX), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ascorbic acid (VIT C), fish oil, lactobacillus nos (CULTURELLE), ox bile; all from unspecified date for unspecified indication. The patient previously took ceftriaxone and experienced allergies. The patient did not receive other vaccine in four weeks. The patient has no diagnosis of Covid-19 prior to vaccination. On 22Dec2020 07:00 AM, the patient experienced diarrhea. The patient was not Covid tested post vaccination. No treatment was administered due to diarrhea. The outcome of the event diarrhea was not recovered. The reporter considered the event non-serious.
Reported difficulty breathing and lips swelling. 911 called. epi administered and oxygen applied. taken by ambulance to hospital. remained alert but not  fully coherent.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concurrent conditions was not provided. On 17-JAN-2019, the patient was vaccinated with improperly stored doses of VARIVAX, lot # R017639, expiry date 20-JUN-2020, for prophylaxis (dose, strength, dose number, vaccination site and route of administration not provided). Concomitant therapies included sterile diluent which was properly stored. Multiple temperature excursions were reported as 6 degrees Fahrenheit to 14 degrees Fahrenheit for cumulative time frame of 7 hours. Previous multiple temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the Product storage error was not reported.
Information has been received from a doctor of pharmacy concerning a male patient who on 23-OCT-2010 was vaccinated IM with a dose of PNEUMOVAX 23 0.5ml. A pharmacist reported that a patient received a dose of PNEUMOVAX 23 and experienced a sore arm at the injection site. At the time of reporting, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
left eyelid swollen; redness in right eye; right eyelid swollen; Headache; Nausea; She rubbed it and saw that it was puffy; Later on her right eye was sore like she had a shot in it; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0151 and expiration date :not reported) via an unspecified route of administration, administered in left arm on 20Apr2021 at 10:00 (Age at vaccination 56 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus and high blood pressure from 1999 to ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to AE(s) was None. Concomitant medication(s) included metformin (METFORMIN) 1000mg daily from Apr2021 to ongoing, insulin detemir (LEVEMIR) 46 units in the morning50 units in the evening from Dec2014 to ongoing, liraglutide (VICTOZA) 1.8units daily from 2019 to ongoing, glipizide (GLIPIZIDE) 10mg by mouth daily from 2019 to ongoing taken for diabetes mellitus, lisinopril (LISINOPRIL) 10mg by mouth daily from an unspecified start date to ongoing for blood pressure and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25mg by mouth daily from an unspecified start date to ongoing taken for water pill. On 20Apr2021, patient experienced headache, nausea. On 22Apr2021, right eyelid swollen and redness in right eye. On 23Apr2021 patient experienced left eyelid swollen. In Apr2021, she rubbed it and saw that it was puffy and later on her right eye was sore like she had a shot in it. The right eye was red and more swollen than the left. When asked details about the swelling, she states she didn't pay attention to her face yesterday. She wiped her face and went on about her day. Later on her right eye was sore like she had a shot in it. She rubbed it and saw that it was puffy. On the day of reporting her left eyelid was swollen. The patient inquired what should she do. If it worsens should she go see a doctor. AE(s) did not require any visit to Emergency Room/ Physician Office. Relevant test was reported as none. The outcome of events Headache and Nausea was recovered in 20Apr2021, right eyelid swollen, left eyelid swollen and redness in right eye was not recovered, she rubbed it and saw that it was puffy and later on her right eye was sore like she had a shot in it was unknown.  No follow-up attempts are possible. No further information is expected.
WAVE OF NAUSEOUSNESS AND WARMTH, "FEVERISH", UPSET STOMACH.
Soreness at injection site - started approximately 5 hours post vaccine - no treatments required   Generalized fatigue - started approximately 12 hours post vaccine - no treatments required
Itchy Rash; fever; debilitating joint pain; nausea; fatigue; headache; inj site pain; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date was not provided), intramuscular (left arm) first dose on 14Jan2021 12:30 at single dose for covid-19 immunisation. The patient's medical history Asthma, adrenal insufficiency, hypokalemia, chronic migraine, Vit D deficiency, Known allergies: IV Contrast dye, and Covid. The patient was not pregnant at time of vaccination. The patient's concomitant medication includes unspecified drug. On 14Jan2021 13:00, the patient experienced itchy rash, fever, debilitating joint pain, nausea, fatigue, headache, and injection site pain. The patient did not received treatment for the events. The outcome of the events was recovering.
Pt's husband came in today (6/26/2021) and reported that ten days after receiving the shot (6/15/21), his wife (the patient) started feeling weak and felt numbness in her legs. She is currently in the ICU being treated. They believe it may have been because of the shot. Blood clot has not been confirmed.
non- itching rash covering entire body about 24 hours after administration only marginally responded to benadryl after 3 days patient started on steroids and it did respond to that