chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain in the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain in the site of the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 VACCINATION SITE PAIN (Arm pain in the site of the injection). At the time of the report, VACCINATION SITE PAIN (Arm pain in the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reported.
shingles; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 17-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or around 06-SEP-2013, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently,  the patient was treated by a healthcare provider for the following injuries resulting from patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. At the reporting time, the outcome of shingles was not provided. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Information was received from a healthcare professional regarding temperature stability issue of VARIVAX. Information on administration of the vaccine or about the patients was not reported. No adverse event was reports. This is one of the two reports. Additional information has been requested.
This spontaneous report as received from a consumer refers to his 62 years old wife with drug reaction/allergy to sulfa and no pertinent medical history, who on 27-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose not reported and route not reported) (lot # 0562AE - in validation process). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on 27-JUL-2012 his wife developed redness in her hands and feet. She also had tingling and she broke out in sweats after getting ZOSTAVAX. No treatment was given for an AE. At the time of the report the events did not improve. There were no laboratory diagnostic studies performed. The patient did not seek medical attention. Additional information is not expected.
Developed rash on legs and forearms within a few hours.  Spread to chest within two days.
Information has been received from a pharmacist concerning a male pt who in April 1993 was vaccinated with a dose of hep B vaccine recombinant. (lot number 15560 reported, invalid for the product). Subsequently, the pt developed learning disabilities.. The pt sought unspecified medical attention. Upon internal review, learning disabilities were determined to be an other important medical event. Additional info is not expected.
Patient came to hospital with reports of numness, tingling, & loss of sensation to bilateral hands. Patient also reported sharp/stabing chest pains. All symptoms ongoing for 1 week before she came to the ER
arm pain/ sore arm; Their arm is sore and hard to lift up; patients states that they felt the injection burning; Initial information regarding this unsolicited valid non-serious case received from an physician assistant and transmitted to Sanofi on 14-Nov-2019.  This case involves a 67 years old female patient who experienced arm pain [Pain in extremity], their arm is sore and hard to lift up [Injected limb mobility decreased] and patients states that they felt the injection burning [vaccination site pain], while she received vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019, the patient received a dose of suspect Influenza 0.5 ml Usp Trival A-B High Dose Subvirion Vaccine (lot UJ285AB and Exp. Date 02-Jun-2020) via unknown route in arm NOS.  On an unknown date, the patient developed a non-serious arm pain [Pain in extremity], their arm is sore and hard to lift up [Injected limb mobility decreased] and patients states that the felt the injection burning [Injection site pain], (a month) following the administration of Usp Trival A-B High Dose Subvirion Vaccine.  Corrective treatment was unknown for all events.  At the time of reporting, outcome was Not Recovered / Not Resolved for all events.
Fever 100 F; Muscle Aches; A spontaneous report was received from a consumer concerning a 48-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever 100 F (Fahrenheit) and muscle aches.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient developed a fever 100 F and muscle aches and the symptoms were still going on. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, fever and muscle aches, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Petechial rash. Self limited, took 2 weeks to clear. Happened after dose 1 in August, was gone faster.
Pt had a rash just above the elbow going halfway up the arm and 3/4 around the arm shortly after the shot. Pt also had pustules. Pt states she went to the doctor and was told she had an allergic reaction. They gave her a steroid patch.
Case number PHEH2014US021825 is an initial spontaneous report received from a nurse on 29 OCT 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413101) via intradermal route on 28 OCT 2014. It was reported that on 28 OCT 2014 after vaccination, she had a red bump at the injection site. The event outcome was unknown. The seriousness and causality was not reported.
Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not provided) for prophylaxis. On 12-OCT-2018 (2 weeks after receiving first dose of GARDASIL 9, the patient vaccinated with a second dose of GARDASIL 9 (lot # R008163, expiration date:18-NOV-2020, dose and route were unknown) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. This is one of two linked cases due to same reporter. Sender's Comments: US-009507513-1810USA008238.
Patient felt a tingling up and down her arm and into her fingers as soon as the shot was administered.  Started feeling nauseous and light headed. Patient was given crackers and drink and she sat down for about 30 minutes. She started to feel better and said the tingling got better, then left.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours, 20 min. On 26-OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
soreness in arm, hard knot at injection site, itchy rash spread roughly 3 inches around injection site, bruising area slightly smaller than rash area
Swelling immediately after vaccine was administered, also rash.  Ice pack was applied for 5 minutes and swelling decreases.  Rash was still visible, but cream was applied. This is in follow-up report(s) previously submitted on 8/10/2006. Information has been received from a physician concerning a 17 year old female who on an unspecified date was vaccinated with 0.5 ml dose of GARDASIL. Subsequently, the patient experienced painful, swelling "the size of a golf balll" at the injection site. Unspecified medical attention was sought. No diagnostic laboratory studied were performed. The patient recovered by "the next day." Additional information has been requested.
PENTACEL and IPOL administered, thus double doses of polio. No adverse events in patient reported.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), on 12Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 21May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; ARMOUR THYROID. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDS"; Hydrocodone, reaction(s): "known allergies: hydrocodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. If vaccine received was yes, Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 02Jun2022. Treatment stop date: 06Jun2022, Indication: Treatment of COVID-19. Rebound of COVID 5 days after finishing Paxlovid. Adverse events start date: 11Jun2022, if patient recovered was recovering, If treatment ae was no.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
8 hours after my TWINRIX and rabies second vaccine. I started having Starburst open eyed visuals then got sick. Progressively sicker for 5 days then at day six I think I almost died. Hr was at 120+ body temperature high, extreme anger, difficulty walking, thinking, and talking. I figured my body went through the throws of almost dying from rabies. Figured it would be a one time thing. However, since then. It happens about once a month or more frequently recently. Accompanied with the same metallic taste in my mouth that I feel as burning pain especially where I have severed and exposed tongue nerves in my inner gumline through to my tongue. The degree of pain, discomfort, anger, and paranoia it brings with it is almost completely unbearable. Occasionally I will have small seizures at the worst point. If I did not grow up in abuse. I do not think I could have survived the anger, paranoia, and emotional stress of feeling like your dying. I have to use to much ibuprofen. I think I would have died without it a few times. Especially, the first week. So, getting proper medicine is impossible. I should have 500mgib prophen/20mgoxycodone x20 and 60 VALIUM 10mg.
Local erythema, induration, itching, myalgias, fever. Follow up states missing lot numbers are unavailable.
client had Right side severe joint and muscle pain. barely able to move. large bruise on leg; lasted 7-10 days; saw her provider who thought she should not take the 2nd dose of the vaccine
big painful lump on her left knee, the lump is still there but the pain is going down; Swollen knee like an abscess; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of KNEE DEFORMITY (big painful lump on her left knee, the lump is still there but the pain is going down) and JOINT SWELLING (Swollen knee like an abscess) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced KNEE DEFORMITY (big painful lump on her left knee, the lump is still there but the pain is going down) and JOINT SWELLING (Swollen knee like an abscess). At the time of the report, KNEE DEFORMITY (big painful lump on her left knee, the lump is still there but the pain is going down) and JOINT SWELLING (Swollen knee like an abscess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided.
Received Varivax vaccine #2 11/16/2005. Redness started 11/16/05 evening. Awoke this am with enlarging redness induration, warmth at site of injection area enlarging at 3:15 pm 2.75 inches x 3 inches. Also r shoulder pain, headache, left eye pain with pressure.
At 12 hrs muscle ache and joint pain. At 24 hrs. symptoms continue  with increasing muscle,joints and back pain. Increasing fatigue and virus type(flu like) symptoms resulting in bed confinement.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of ROTATEQ (lot # not reported) that were exposed to 33.6 F for 1 hour. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Digestive tract inflammation - mouth sores, throat swelling, esophagitis for months. 2022 esophagitis, gastroparesis (ongoing)
Vertigo, fatigue, sudden increase in hearing loss in right ear accompanied by tinnitus and reverberation.  Occurred about 24 hours after 1st injection in January.   Patient seen by audiologist on Monday, Jan. 25th and then referred to and  treated by ENT with course of steroids soon after with no improvement.   Fatigue lasted a few days.   Hearing loss and tinnitus continue.
patient's tongue started to feel a strange numbness; metallic taste; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 19:30 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included allergies to Band-aide adhesive. The patient received dose 1 of the vaccine on 27Jan2021 07:30 PM, lot number: EN5318, Left arm. The patient is not pregnant at the time of vaccination.  Th patient did not have COVID-19 prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (DYAZIDE) taken for an unspecified indication, start and stop date were not reported; ezetimibe (ZETIA) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  On 17Feb2021 19:50, within 20 minutes of vaccine shot the patient's tongue started to feel a strange numbness from the tip to approximately an 3/4 of an inch. Then the patient developed a metallic taste. Thee outcome of the event was not recovered. The patient was not tested for COVID post vaccination. No treatment was received for the medication.
This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-month-old patient who received KINRIX. On 2nd December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: Physician reported that a patient that is younger than 4 years old was given a KINRIX vaccine. Patient did not have any symptoms.
Pt experienced limited mobility of fingers and upper hand exactly five weeks post immunization. MD walk in visit r/o TIA, CVA. Orthopedic MD visit on 12/5 diagnosed problem as peripheral nerve palsy.
I received my second Pfizer booster for COVID-19 on 4/15/2022. On 7/29/2022, I was at a rehabilitation session and felt too fatigued to do the exercises; I ended up going home early, because I couldn't even last for 3 minutes. They gave an antigen test, which yielded a negative result. Then on 7/30/22, at about midnight or so, I woke up with a fever, a cough, and a headache on the right side of my head and neck. By the time I woke up later in the morning, I was barely able to get out of bed and shuffle to the bathroom. I took another antigen test and got another negative result. I kept taking antigen tests over the weekend and getting negative results each time. It wasn't until 8/1/2022 or 8/2/2022 that I finally got a positive result. I ended up being sick for 3 weeks. I normally go to rehabilitation sessions 2 days a week, but I was unable to go to my sessions during those 3 weeks that I was sick. I had a fever that would break and then come back. For a whole week, I had a deep-bone body ache from head to toe, and I couldn't shake it. When I had the headache, my eyes also ached. I spent most of the time sleeping for 10-16 hours at a stretch, because I was so fatigued. I had a terrible cough. I treated my symptoms with OTC medicines like NYQUIL, DAYQUIL, ibuprofen, and TYLENOL. The medicines didn't help much with the deep-bone ache, but they did help break the fever. During my illness, I was under the guidance of an RN, who advised me regarding what actions to take. I'm normally very active and walk 5+ miles a day, but during my illness, I was barely able to shuffle around my apartment. My kids and their spouses brought food and drinks, but I spent most of the time sleeping. I did the bare minimum with regard to movements, eating, drinking, medicating, and toileting. My recovery was very slow. I didn't leave my apartment except to go to the patio to get some sunlight, and even that was exhausting. I didn't begin to really feel like I was recovering until the last week of August and the first week of September 2022. I'm doing much better now, but my energy and stamina levels aren't what they were prior to the illness. On good days, I can walk a mile and a half. I was able to gradually work my way back up to 15 minutes max on the exercise bike at the rehab facility. Even now, though, I don't feel like I have completely recovered, because I can overexert myself without realizing it, and I'll be down for about 2-3 days afterwards. This often seems to happen after the rehab sessions, because I do have to work during those sessions.
Prior to vaccine administration, patient stated that needles make her queasy. Within 1 minute of administering FLUBLOK, patient began to feel lightheaded and slightly nauseous. Patient sat forward in chair with head on knees for approximately 5 minutes until symptoms resolved. Patient denied feeling like she was about to faint and did not lose consciousness at any point. Patient stated a short period of partial hearing loss for less than a minute. Once symptoms resolved patient waited a couple more minutes before leaving. She states that her husband is a physician and can monitor her if symptoms return.