chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies. It was unknown if patient ever diagnosed for COVID-19. It was unknown if patient had any acute illness or chronic long lasting condition.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant product reported by reporter.  Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergone temperature excursion.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up information included fax number.
A report has been received from a Health Professional concerning a Child, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced Influenza A which started on 21-Dec-2012. The patient recovered from the event of Influenza A on an unspecified date. The report was considered to be non-serious.
Sore muscles began soon after vaccination. In the night woke up dizzy. Then had intense chills and became nauseated. After several bouts of chills finally fell asleep again. Next morning woke up with fever of 101 F (usually body temp is around 97.5) and headache. Stayed in bed all day with fever and headache. In evening symptoms began to disappear.
Two doses were then inadvertently administered on 13-JUN-2023.; experiencing chills; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of chills in a adolescent female patient who received Herpes zoster (Shingrix) (batch number 577BF, expiry date 30-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th February2023).   On 13-JUN-2023, the patient received Shingrix (unknown arm) and Shingrix (unknown arm). On 13-JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced accidental overdose (Verbatim: Two doses were then inadvertently administered on 13-JUN-2023.). In JUN-2023, the patient experienced chills (Verbatim: experiencing chills). The outcome of the chills was not reported and the outcome of the accidental overdose was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix and Shingrix.     It was unknown if the company considered the chills to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter stated that patient received first dose o Shingrix and then inadvertently administered the two doses of Shingrix in different arms. The patient reportedly started experiencing chills.  The reporter declined to provide the additional patient information. The reporter declined the consent to follow up. The patient received 2 dose of Shingrix on same day in different arms, which led to accidental overdose.; Sender's Comments:  US-GSK-US2023083877:Same reporter
Really weird; Weak back of legs; Dizziness/ light headed like a fog; Hard to concentrate; Arm pain at injection site; Hot & cold flashes; Hot & cold flashes; Had exactly 40 hours of feeling warm; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot & cold flashes), FEELING COLD (Hot & cold flashes), FEELING HOT (Had exactly 40 hours of feeling warm), FEELING ABNORMAL (Really weird) and MUSCULAR WEAKNESS (Weak back of legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation, Blood pressure high, High cholesterol, Sugar blood decreased (Low sugar level at times, but does not have a glucometer to access) and Blood pressure high.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HOT FLUSH (Hot & cold flashes), FEELING COLD (Hot & cold flashes), FEELING HOT (Had exactly 40 hours of feeling warm) and VACCINATION SITE PAIN (Arm pain at injection site). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Really weird), MUSCULAR WEAKNESS (Weak back of legs), DIZZINESS (Dizziness/ light headed like a fog) and DISTURBANCE IN ATTENTION (Hard to concentrate). On 10-Mar-2021, HOT FLUSH (Hot & cold flashes), FEELING COLD (Hot & cold flashes), FEELING HOT (Had exactly 40 hours of feeling warm) and VACCINATION SITE PAIN (Arm pain at injection site) had resolved. At the time of the report, FEELING ABNORMAL (Really weird), MUSCULAR WEAKNESS (Weak back of legs), DIZZINESS (Dizziness/ light headed like a fog) and DISTURBANCE IN ATTENTION (Hard to concentrate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was given. No treatment information was provided.
Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest.    The patient's medical history was not provided Concomitant product use was not provided by the reporter.  On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol.   Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died.   The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches.  The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest
Pt was admitted on 8/10/2021 with c/o sob, cough and body aches, fever. Pt wears 6L NC at home.  Pt was discharged 8/11/2021.
No concerns following vaccine until 7-8 days later when it started to itch, had a large reddened area at the injection site, warm to the touch, hard and tender. Also had swollen lymph nodes on left side of neck. Reported her whole left side felt "heavy." Spoke with her provider and was prescribed prednisone and diagnosed virtually with serum sickness level 3.
Reports local RXN RUA 2/2 BEXSERO vaccine which was administered 8/31/2017. Area became swollen and then 7 welts or hives appeared. Area was sore and very tender to touch beginning the next day. Welts resolved by Sunday evening. Better now but remains swollen.
This spontaneous case, initially received on 12-Sep-2016, was reported by a health professional and concerns a 56-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 10-SEP-2016 to 10-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52305. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Sep-2016, the patient experienced welting, bruising, painful, heat (outcome: not recovered/not resolved) and swelling (outcome: recovering/resolving) 3-4 inches below the injection site within 1 hour after received AFLURIA. On 12-Sep-2016, the swelling has gone down now, improving, much better today. Reporter's assessment: The reporter considered the events bruising 3-4 inches below the injection site, heat 3-4 inches below the injection site, painful 3-4 inches below the injection site, swelling 3-4 inches below the injection site and welting 3-4 inches below the injection site as non-serious and related to the administration of AFLURIA. The reporter did not know the cause of the event, but speculated that the needle may not have been deep into the muscle tissue.
C/o 1-2 wk hx of numbness/tingling of (L) arm 1 day after receiving HPV#1. No redness/swelling pain. Completely resolved by about 2 wks post-injection.
My adverse event was not related to the vaccine. It happened 10 months latter. I contracted COVID while on vacation.  I had a 102 F. temp, chills, fatigue, and cough.
Unwitnessed death approximately 3 weeks later (estimated by date of last communication).  Decedent discovered 6/1/21.  Postmortem done 6/2/21 at Facility .  Vaccination history 4/22/21 was not known at the time of partial autopsy or before cremation.  Report lists negative toxicology, no microscopic exam done.
On 04/26/16, 65 yo F was seen in clinic for annual wellness exam. During this visit, pt was ordered to receive Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) [IMM78 Custom]. At 1118, pt was administered 0.5 mL IM in right deltoid (Mfg: Wyeth-Ayerst, NDC #0005-1971-01, lot #M51194, exp: 5/1/2017). Pt tolerated injection without incident and was discharged home. On 05/03, pt returned to clinic for an unrelated complaint. During this visit, the pt was noted to have a rash on her right upper arm. Pt denied any pain and there was no warmth to the area. Pt reported that the rash was "getting better". Pt was evaluated by MD and rash was diagnosed as an "Injection site reaction....secondary to Prevnar - resolving reaction". The pt was advised to apply cool compresses, take benadryl prn and return to clinic for any worsening symptoms. Pt was then discharged in stable condition.
soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist also reported the patient did have some soreness in her arm after the first injection. The vaccine administration facility was the same as primary reporter. For tolerances of 2nd dose of Shingrix, refer case US2019209798.
Received Moderna Covid Vax Lot# 011J20A Moderna on 12/26 . Hives came on 1/7 and have flared every night since. Patient spoke with  her rheumatologist (being treated for RA post covid) and her PCP about urticaria. Patient MD started her on high doses of Benadryl and 2 full strength 24 hr Allegras also continue on methylprednisone  prev taking for RA but was tapering off as she was increasing methotrexate but stopped taper to keep hives at bay.  Patient started on low dose birth control by her PCP and today is day 1 without a outbreak of hives. This AM she woke up without the hives.
red blood blisters raised on her stomach; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (red blood blisters raised on her stomach) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BLISTER (red blood blisters raised on her stomach). At the time of the report, BLISTER (red blood blisters raised on her stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data :  blood tests done along with the platelets count  No concomitant product reported by the reporter No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-05-2021,contains non-significant information.
This spontaneous report was received from a nurse practitioner concerning an approximately 12 year old female patient with asthma, environmental and food allergies, shellfish allergy, tree nuts allergy and peanuts allergy. On 05-SEP-2013, the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date were reported as UH898AA and 30-JUN-2014 respectively), intramuscularly. Concomitant therapy included ADVAIR. On 05-SEP-2013, the patient developed widespread hives 2 hours after administration of the first dose of GARDASIL. The patient sought medical attention (office visit). She was treated by her unspecified primary care provider with unspecified antihistamines and topical cream. No lab tests were performed. At the time of the report, the event was not resolved. The reporter stated that the GARDASIL series would not be continued. The relatedness for widespread hives was unknown for GARDASIL. Additional information has been requested.
pt recv vax;reported allergic rxn;tongue swelled,felt faint&reported rapid heart beat;rescue called,vital signs monitored,some hypertension;exp episodes of feeling faint&somewhat more rapid heartbeat;
redness, warmth, and hardness at injection site getting worse over last 4 days. 10 post injection. No fevers or chills. Approximate 6cm area of redness. Started on Keflex
Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Shingrix stored in the freezer, used in patients; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 9CR25, expiry date 24th September 2023) and (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The registered nurse reported that Shingrix that had been stored in the freezer from shipment.  The Shingrix had been used in patients.  The reporter did not know exactly how many patients had been administered the Shingrix. The reporter stated that there were 3 boxes of Shingrix stored in freezer (1 with same lot).  The reporter reported that unknown patients had been administered Shingrix, no additional patient demographics available or dates of administration.  The shipment date was unknown. The reporter consented to follow-up. Additional supportive information: The patients received Shingrix that had been stored in the freezer, which led to incorrect storage of drug.
Nausea, bloated, stomach pain, headache, dizziness, racing heart, hands feet go numb, comprehension and memory problems, extreme fatigue, chronic all over pain, sharp shooting pains into groin, vision blurred, swollen optic nerves, bladder spams, day and night sweats, absence periods, weight gain, mouth sores, hip pain, back pain, racing heart, quick to anger, lag out seizures.
rash; All over rash with some itching; This is a spontaneous report from a contactable Nurse reported for self. This 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan 2021 12:50 on right arm at single dose (Lot # EK4176, Expiration Date: Mar2021) for covid-19 immunisation. Medical history was not provided. Concomitant medications were none. Past drug history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 16:00 at age of 34 year old at single dose (Lot # EH9899) for covid-19 immunisation. About 30 minutes after being administered (05Jan2021 13:20) that second dose she developed all over rash with some itching. She took Benadryl and Pepcid in response. Today the all over rash with some itching came back at the same persistent level. She wants to know what kind of timeframe she can expect with the continued allergic reaction of all over rash with some itching. She was made to check into the emergency room for observation, but did not have any testing/lab work/investigations done and was not admitted to the hospital. Outcome of the events was not recovered. Reporter seriousness for All over rash with some itching was Medically significant. Drug result was related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rash and Itching cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
when i received the first two doses, i didnt encounter any problems beside arm pain on the injection side. However, when i received my booster 3 days ago, i experienced lip swelling/ blisters extreme body aches that prevented me from sleeping and reporting to work. i also felt shooting pain on my entire left arm all the way to my wrist and fingers. Today i feel so weak and joint pain in my knee. Additionally, armpit is extremely painful and i also feel so weak.
Body shaking (thought it was my vehicle) 45 mins. After injection. Stopped Shaking 9:30 pm, same day. Injection site was sore for 2 days
Moderna COVID-19 Vaccine EUA Shot was given 11/1/2021. Experienced tingling and soreness of the body starting 11/02/2021. On 11/04/2021 my tongue felt like it had been burned by scalded coffed. By 11/05/2021 my upper lip felt different and by 11/07/2021 I had facial paralysis on my right side, affecting the eye, cheek, and lip areas.
My sister received a PREVNAR 13 shot which has totally compromised her immune system. Within 2 hours she got sick on her stomach and began to shake all over. She didn't know if she was going to make it home she was shaking so badly. Then she got ulcers on both tonsils and on her tongue. She lost her sense of taste. As time has progressed she continually was having breakouts with rashes and hives all over her body. There was much pain and suffering involved with this process with horrific itching. Her thighs, calves and feet began to cramp and break out as well. The skin began to become hot and would peel from her feet and hands. The latest malady is that she has spent 4 weeks in critical care in Medical Center and is now in Rehabilitation Hospital. She is no longer able to walk and has no feeling in her hands and feet. At one point in Medical Center they were thinking they may have to intubate her because of oxygen issues and they were afraid that it may paralyze her lungs as it had her feet and hands. They did not have to intubate her. They have been unable to diagnose any problems so they are treating symptoms. She is taking a chemo drug and has been on steroids trying to slow down the breakouts and to help the nerves in her hands and feet. Her spleen is enlarged and her liver and kidney counts have been affected. At one point she had to be catheterized because she couldn't even pee. That seems to have corrected itself. She is having to take Occupational, Physical and Group Therapies trying to get the use of her body back. She was very healthy and had not missed 1 day of work for 30 years prior to this shot. She has documented reports from Rheumatologists, Neurologists, Nephrologists, Immunologists, Oncologist/Hematologists, and Allergists. All of their testing has found nothing. The insurance company has been good so far about her treatment but the lack of a diagnosis may soon be a problem. They have thought she had Guillain-Barre Syndrome and then Churg-Strauss Syndrome. None of those panned out either. She broke out on her right foot before entering the hospital and losing the ability to walk. Since being in Hospital she lost the "wiggling of toes" movement and any kind of movement in her ankles. Her feet continue to swell. The outbreak on the foot continues to develop blisters. The foot continues to ooze. Because of taking the CYTOXAN (chemo drug) they are concerned about the lowered immune system and her weakened ability to fight infections. They are treating her with a chemo drug not even knowing exactly why. The bottom of her lungs have collapsed due to being in bed most of the time. They continue to watch her oxygen as it fluctuates. She is no longer on oxygen, though.
He tested positive for Covid- 3 days without symptoms; He tested positive for Covid- 3 days without symptoms; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, by a contactable consumer (patient).  This male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 22Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jan2021, the patient tested positive for Covid, 3 days without symptoms with outcome of unknown. He asked if it's okay to get the second dose. The patient underwent lab tests and procedures which included Sars CoV-2 test: positive on 06Jan2021.    Information on the lot/batch number has been requested.