chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a huge, painful warm mass inmy left axilla; tenderness topalpation of injection site; This is a spontaneous report from a contactable health care professional, the patient. A 38-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730,) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included endometriosis and anxiety and had allergies to IVP (intravenous pyelogram) dye. The concomitant medications received within two weeks of vaccination included loratadine (CLARITIN), guaifenesin (MUCINEX), norgestimate and ethinyl estradiol (ESTRELLA), venlafaxine (EFFEXOR), and alprazolam (Xanax) all for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202 via unspecified route of administration in the left arm on 24Feb2021 (at the age 38-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced axillary mass which was a huge, painful and warm mass in the left axilla which appeared less than 12 hours after injection and it was also visible and also there was tenderness to palpation of the injection site (vaccination site tenderness). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of axillary mass and vaccination site tenderness was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax; swelling & redness from elbow to shoulder occurring w/in hrs;seen in ofc; instructed to tx w/ ice & dph;
Chills; Swollen/tender lymph nodes underarm on the side of the injection site; Bruising at injection site; Cold sweats; Sore arm/body ache; Fatigue; Nausea; Headache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruising at injection site), COLD SWEAT (Cold sweats), LYMPHADENOPATHY (Swollen/tender lymph nodes underarm on the side of the injection site), MYALGIA (Sore arm/body ache) and FATIGUE (Fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism and Anxiety depression. Concurrent medical conditions included Bee sting and Penicillin allergy. Concomitant products included BUSPIRONE for Anxiety, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Depression, LEVOTHYROXINE for Hypothyroidism, MELATONIN for Sleep problem.   On 21-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (Sore arm/body ache), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at injection site). On 23-Apr-2021 at 5:00 PM, the patient experienced COLD SWEAT (Cold sweats). On 24-Apr-2021, the patient experienced INJECTION SITE BRUISING (Bruising at injection site). On 25-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen/tender lymph nodes underarm on the side of the injection site). On an unknown date, the patient experienced CHILLS (Chills). On 25-Apr-2021, COLD SWEAT (Cold sweats), MYALGIA (Sore arm/body ache), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at injection site) had resolved. On 30-Apr-2021, LYMPHADENOPATHY (Swollen/tender lymph nodes underarm on the side of the injection site) had resolved. On 03-May-2021, INJECTION SITE BRUISING (Bruising at injection site) had resolved. At the time of the report, CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Birth control medication were also included in concomitant products. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics, reporter information, vaccination facility details, medical history, concomitant medication, dose details added. Events updated. On 19-Jul-2021: Follow up received that contains NNI. Dosage regimen information and Vaccination site pain event were added from initial follow up.
didnt feel well; arm inflammation; pain all night in my neck and my back; pain all night in my neck and my back; I could not sleep; terrible fever; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. She started having side effects 4 days later. On 16May2021, the patient did not felt well, had arm inflammation, pain all night in her neck and her back, she could not sleep, had terrible fever. She asked if she need to get tested for corona virus. Outcome of the event terrible fever was not resolved and outcome of rest all events were unknown.  Follow-up attempts completed. No further information expected.
Immediately following vaccine patient became pale and diaphoretic lost consciousness apprx. 20-30 seconds. Patient was helped to floor placed on 100% NRB mask for 15 mins. Given p o fluids and recovered. No signs of allergic reaction noted. Injection site was benign. Patient returned to duty within 1 hr of event. Vital signs stable and after event.
Knee joint pain and stiffness, difficulty walking and climbing stairs. Some swelling in the knees.
fever 103 & virus was hospitalized for this on 30NOV93 @ 445PM;
Rash (8cm x 10cm), soreness. Redness. Hot to touch.
The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The vaccines was stored in freezer, take out one to two vials and place in fridge each day as needed) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Red around bicep area, swollen, hot and painful to touch. Patient took Tylenol and put ice on area. 3 days later, swelling subsided, still some redness, not hot.
burned going in; This is a spontaneous report from a contactable other hcp.   A 18-months-old female patient received the fourth dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number not provided) intramuscular in the thigh right on 02Aug2019 13:30 at single dose for immunisation. The patient medical history was none. On 02Aug2019 the patient received also the first dose of influenza vaccine (FLU VACCINE VII, Sanofi Lot number: UT6647JA expiry date: 30Jun2020) intramuscular in the left thigh, and the fourth dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL, Sanofi, Lot number: UJ017AAA expiry date: 26Oct2020) intramuscular in the left thigh both for immunisation. The patient previously received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (Lot number: W09943; Expiration: 30Apr2020) intramuscular in the right thigh on 02Aug2018 (a little over 2 months), the second dose (Lot number: W51762; expiry date: 30Jun2020) intramuscular in the left thigh on 03Oct2018 at 4 months old, the third dose (Lot number: X11327; expiry date: 30Sep2020) intramuscular in the right thigh on 03Dec2018 at 6 months old all at single dose; on the same dates she received also diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid all at single doses for immunisation. The medical assistant reported that a first product (Batch/lot number: AG8356, NDC number: 0005197101), Expiry Date: May2021), was not administered as the product needle was injected into the patient's leg but the whole top of the syringe was cracked so the medication shot all over the bed and the patient didn't get any of it. Reporter went to administer the vaccine, while in the child leg, whole top of syringe was cracked, defective vial, and by vial the reporter means prefilled syringe, where the needle attaches on to the top of the syringe was cracked. Reporter did not notice before placing the needle on because they have to push up to get air out, the crack must've been farther up in the syringe. The patient was successfully re-dosed and the successful dose of pneumococcal 13-val conj vac (dipht crm197 protein) burned going in. The outcome of the event was not reported. Information on the batch number has been requested.
very sore arm, nausea, headaches, high temperature (99.4), felt like a zombie, felt sick, stayed in bed, unable to concentrate
Patient reports she is currently on birth control and had her period on 3/29/2021 and after receiving the vaccine she started her period again and it was a much heavier period then the previous ones since starting her Junel birth control.
This spontaneous report as received from a consumer refers to a female patient (the reporter's mother) of unknown age. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose, dose number, route of administration, lot/batch number, expiration date and indication were not reported). No adverse event symptoms were reported. No product quality complaint was reported. Additional information is not expected as the reporter declined to provide any contact information.
Initial unsolicited report received from a consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016247853) on 18-May-2016. This case was linked to 2016SA098087 (same reporter, same event). This case involves a male patient (age not reported) who was vaccinated with a dose of Meningitis Vaccine (batch number, expiry date, route and site of administration: not reported) on 25-Apr-2016. Other medical conditions was reported as none. Concomitant medications included VYVANSE and CYMBALTA. On an unspecified date (reported as four days ago), following the vaccination, patient experienced blisters and "broke out in little red itchy dots". Laboratory investigations and corrective treatment were not reported. The outcome of the event blisters was not recovered and the outcome of the event little red itchy dots was not reported. List of documents held by sender: none.
swollen lymph node on their neck; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on their neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node on their neck). At the time of the report, LYMPHADENOPATHY (swollen lymph node on their neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not received any treatment medications.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt reported to ER complaining of soreness, aching and inflamed "blotches" all around upper arm, near vaccination site. ER treatment: 1.5g Aricef, Bactrumps and Bactroban ointment to cellulitis. Health department treatment: Ibuprofen 800 mg tid, Keflex 500mg tid.
PRODUCT LOT WAS VERY SLOPPY AND HARD TO READ (PRODUCT LABEL ISSUE); DIZZY AND FELT LIKE FAINTING; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included feeling faint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: OU1A71A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:03, the subject experienced dizzy and felt like fainting. On an unspecified date, the subject experienced product lot was very sloppy and hard to read (product label issue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and felt like fainting on 08-APR-2021, and the outcome of product lot was very sloppy and hard to read (product label issue) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
devel pain, swelling, redness in inj site-lt deltoid area;the next day devel fever, gen body aches & chills;limitation ROM of the lt arm;
itching in general; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in general) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (itching in general). At the time of the report, PRURITUS (itching in general) was resolving.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I could not find the store like I was confused; I didn't remember/ I just forgot; I couldn't read; I got into a car accident; fatigue/the vaccine somehow made me tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I could not find the store like I was confused"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "I didn't remember/ I just forgot"; READING DISORDER (non-serious), outcome "unknown", described as "I couldn't read"; ROAD TRAFFIC ACCIDENT (non-serious), outcome "unknown", described as "I got into a car accident"; FATIGUE (non-serious), outcome "unknown", described as "fatigue/the vaccine somehow made me tired".  Additional information: The patient felt fine, but the pharmacist did not give the patient a list of any of the side effects that could happen and they did not make the patient to sit and wait 15 minutes. The patient went home for few minutes, and felt fine. So, then the patient drove to the store and couldn't find the store like the patient was confused, to how to get there and then the patient does not go to that store very often. So, the patient just said maybe just forgot or something and then when came out of the store. The patient was fine in the store, felt okay and put all the groceries in the car and then got into a car accident in the parking lot of the store. Then after that the police came and the patient could not figure out how did, could not find and figure how to get in driver's license registration and insurance like the patient could not read, the patient did not remember. The patient was wondering if the vaccine somehow made the patient tired or confused that either it caused to have an accident or not to be unable to figure out how to get to the store and how to find ID that was needed or whatever. Does it caused confusion or fatigue or something or not at all.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
rash; itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd July 2019, 1 days after receiving Shingrix, the patient experienced rash and pruritus. The patient was treated with methylprednisolone. On an unknown date, the outcome of the rash was unknown and the outcome of the pruritus was recovering/resolving.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The registered pharmacist stated that the patient developed rash and itching the next day after receiving Shingrix or the day after that.  He started on methylprednisolone and before the date of reporting he was doing much better. He was experiencing only a little itching. The status of the rash was unknown. The reporter consented to follow up.
Episode of super ventricular tachycardia (SVT) lasting 10-15 minutes with near syncope, pallor, weakness which started unexpectedly at rest. The SVT episode was @  4 weeks after my 2nd COVID19 vaccination.  I was able to self regulate after many attempts at Valsalva maneuver. My cardio exercise regimen (typically 5 day/week for 30-40 min) was impacted with limited exercise tolerance for @ 4 weeks after SVT episode.
got the flu shot and have had it twice; Initial information was received on 08-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional via Social Media.  This case involves Adult and unknown gender patient who got the flu shot and have had it twice after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On an unknown date the patient got the flu shot and have had it twice (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 11-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously (lot number S032355, expiration date 14-OCT-2021) (exact dose and anatomical location were not reported), as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot number S032591, expiration date 16-AUG-2022). The vaccine experienced temperature excursions from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.6 F) for 12 hours (multiple excursions) and from 15 degrees Fahrenheit to 46 degrees Fahrenheit (16.0 F) for 30 minutes. Digital data logger was involved. There was no previous temperature excursion. The outcome of the event was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001739: US-009507513-2009USA001283:
No adverse event; one male patient received improperly stored ROTATEQ; Information has been received from an office manager referring to a 6-week-old male patient. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 25-JUL-2019, the patient was vaccinated with received improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot S000945, expiration date: 13-JUL-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The call was because of data logger. Total time and lowest temperature below 2 degrees Celsius ("-0.2 C") for 1 hour and 12 minutes and total time and highest temperature above 9 degrees Celsius ("11 C") for 2 hours and 44 minutes. There was no previous temperature excursion. No adverse effect reported.
The patient had like insect bites on her arms. The patient took CLARITIN at home and said they stop coming out. We recommended BENADRYL.
States received first covid vaccine early 4/2021 and soon afterwards developed chest pain. She went to her PCP at that time and he treated her for possible anxiety related to insomnia. She went to ER on 5/5/21 with negative workup and was told that it was likely anxiety related. She presented to my office on 6/1/21 for second opinion for continued chest pain. CT PE study was done finding multiple PEs.
This spontaneous report was received from a registered nurse via a company representative refers to a three female patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patients were vaccinates with GARDASIL 9. On an unknown date the patient experienced tonic clonic movements was unknown. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information has been requested.