chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. is a 38 year old male complaining of chest tightness, itchy throat.  Noted to have a dry cough.  Encouraged pt. to remain calm, relax, take a deep breath.   Fire Rescue arrived at scene for further evaluation.  Vital signs rendered.  Patient declined hospitalization at this time.  Patient recovered from adverse event.  Encouraged, educated to patient to contact emergency services or drive to the nearest emergency room in the event another adverse reaction occurs.  Patient acknowledged and left observation area at 11:58am.
Headache, Myalgia, righ t arm/neck/shoulder/chest pain, chills
Extreme pain in stomach with continued diarrhea 4/15/21-5/1/21. Visited Dr. 4/26/21 who ordered CT scan. Visited DR. 4/28/21. Dr. admitted me to Hospitalon 4/28/21. Dr. performed Colonoscopy with Biopsy and Endoscopy on4/30/21. Diagnosis with Enteritis inflammation of the small intestine.
Exposed to Covid by co-worker wk of 5/17/21. On 5/23/2021 I woke up broken out from head to toe in a rash/hives/itching. Went to clinic for Covid test. Negative, they prescribed Prednisone. By 5/25/2021 it was worse. I went to my family physician. He immediately sent me for an antibody test. I am one out of 20 that the vaccine did not work. No antibodies. Detergent, medicine was ruled out. On 6/10/11 I was sent to hospital by my dcotor for fever, shortness of breath an rash/hives. They prescribed Dexamethasone 6MG, 2X a day. Referred me to an allergist. Allergist took me off cholesterol med an prescribed a non-steroid for itch.
Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022; Achy with all doses; Chills with all doses; Exhaustion have had this happen with all doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy with all doses), CHILLS (Chills with all doses), FATIGUE (Exhaustion have had this happen with all doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch nos. 004M21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2022, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced PAIN (Achy with all doses), CHILLS (Chills with all doses) and FATIGUE (Exhaustion have had this happen with all doses). On 27-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022). On 09-Mar-2022, PAIN (Achy with all doses), CHILLS (Chills with all doses) and FATIGUE (Exhaustion have had this happen with all doses) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 02-Mar-2022 and second dose on 27-May-2022) outcome was unknown.            No concomitant medication information was provided. Patient experienced achy, chills, exhaustion and have had this happen with all doses. Patient took Paxlovid for COVID-19 treatment from 30 Sep 2023 to 05 Oct 2023. Patient had medication drugs include Prednisone from 23 Sep 2023 to 28 Sep 2023, Rabeprazole on 24 Mar 2023, Clonazepam on an unknown date, DULOXETINE HCL DR 20 MG CAP CAPSULE,DELAYED RELEASE(DR/EC) on an unknown date. No treatment medication was reported.   This case was linked to MOD-2023-746343 (Patient Link).
Information has been received from a registered nurse concerning a 72 year old female who on 14-JAN-2008 was inadvertently vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (lot number: /0109U). No other information. Unspecified medical attention was sought in the office. There was no product quality complaint. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.74. Concomitant products were not provided. On 13-Feb-2021, Excursion time was 09 AM, with temperature as 32. Total doses given for the day was 152 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 09-Feb-2021 and. Vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 13-Feb-2021 no hourly temperature recordings available. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
On Monday I was informed that I had been exposed to COVID-19 over the weekend. I tested for COVID-19 with an at home kit and it was positive. My symptoms included a head cold, congestion, nasal drainage, and runny nose. I felt I was going towards developing an ear infection, so I consulted with my physician. They did not prescribe any medications. I am feeling better today.
Patient received the covid vaccine on 12/28/2020.   con 12/29/2020 c/o new onset neck pain.  She described it as "shooting pain at the base of the neck". No hx of neck pain or headache. Neck pain persists until 1/4/2021.  Her PCP at the urgent care started her on Baclofen and gabapentin for pain controlled.  Covid test on 12/29/2020 was negative.
Vaccine was expired on 5/30/22 and administered.  No adverse reactions. Provider notified
Started having slight soreness in the vaccinated armpit/lymph nodes region about 48 hours ago. Has slowly gotten a bit worse over time. No visible swelling, only pain. Taking Advil to alleviate symptoms; no other issues.
p/vax pt felt like muscular cramping in inj site; constantly sore & throbbing; pain @ inj site so severe pt couldn't concentrate @ work; MD tx ibuprofen & physical therapy;
received her first dose of Shingrix in November-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on November 2020, 0.5 ml intramuscular in unknown deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was the pharmacist, the patient was female at her pharmacy.  It was reported that the second dose was planned, but was not administered at the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details reported for 1st dose of shingrix.
ANXIETY; INJECTION SITE PAIN; NAUSEA; JOINT PAIN; TACHYCARDIA; PALPITATION; MUSCLE ACHES; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 133 pounds, and height was 62 inches. The patient's concurrent conditions included narcolepsy, hashimoto's disease, migraine headaches, non-alcohol user, non-smoker, amoxicillin and erythromycin allergy, dust mite allergy, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced tachycardia. On 06-APR-2021, the subject experienced palpitation. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Laboratory data included: Chest X-ray (NR: not provided) unknown, Echocardiogram (NR: not provided) Normal, and Urinalysis (NR: not provided) Urinalysis showed moderate blood. On an unspecified date, the subject experienced anxiety, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, and palpitation on 08-APR-2021, chills, and fever on 07-APR-2021, and headache on 09-APR-2021, was recovering from nausea, fatigue, joint pain, and muscle aches, and the outcome of injection site pain and anxiety was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Narrative:  92yo male had 2 visits to the ED on 10/20/21 and on 11/16/21 for unexplained weakness. Pt then was taken back to the ER on 11/17/21 for a fall and had a CVA. Pt then was transferred to another hospital and facility was notified on 12/6/21 that pt passed on 12/5/21 at hospital from CVA. Pt had received covid vaccines on 2/3/21 & 3/4/21. This death is not related to covid vaccines.
DUE TO A CLERICAL ERROR, PATIENT RECEIVED DOSES OF DTAP, IPV, HEPATITIS A & HEPATITIS B   15 DAYS AFTER RECEIVING THE SAME VACCINES AT ANOTHER CLINIC
PATIENT DEVELOPED REDNESS ON LEFT ARM, ABOUT 3 INCHES BELOW SITE OF ADMINISTRATION, STARTING ABOUT A WEEK AFTER VACCINATION. THERE IS NO RASH, NO ITCHING, NO PAIN OR NO FEVER. PATIENT WENT TO URGENT CARE TO HAVE TREATMENT (NOT SURE WHICH MEDICATION GIVEN). REDNESS HAS GOTTEN WORSE, THEN ALSO APPEARS ON RIGHT ARM (SPOTS), RIGHT SIDE OF BELLY.
Moderna COVID-19 Vaccine EUA  My arm was sore starting approximately 3 hours after receiving the shot. The injection site was not sore, but my bicep. The soreness is worse today, again, not at injection site. When I move my arm, the bicep is very sore.
Large lymph nodes in my right armpit and my neck; Lost 7 pounds; Still not myself; Diarrhea; This spontaneous case was received on 26-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04239) and concerned a female patient of unreported age.  The patient's historical vaccine included unspecified influenza virus vaccine with unspecified adverse reaction. The patient's medical history and concomitant medications were not provided.  On 01-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location: right arm, dose and route of administration: not reported) for flu prevention. The batch number reported was 276571 and expiration date: 30-Jun-2021.  On 02-Oct-2020, one day after vaccination with Flucelvax QIV, the patient experienced large lymph nodes in the right armpit and her neck.   On an unknown date in Oct-2020, the patient experienced severe diarrhoea for five days and was treated with unspecified antibiotics and probiotics. The patient also lost seven pounds and she was not herself, as reported.  On an unknown the in Oct-2020, the patient recovered from the event of diarrhoea.  At the time of initial reporting on 26-Oct-2020, the patient had not recovered from the event of 'feeling abnormal'.   The outcome of the events 'lymph nodes enlarged' and 'weight loss' was not reported.  The reporter assessed the case as non-serious.  This case is linked to the cases 202005553 (the same patient) and 202005556 (the same reporter).  Company comment: A female patient of unreported age, was vaccinated with Flucelvax QIV. One day after vaccination with Flucelvax QIV, the patient experienced lymphadenopathy. On an unknown date in Oct-2020, the patient experienced severe diarrhoea for five days and was treated with unspecified antibiotics and probiotics. The patient also lost seven pounds and she was not herself (feeling abnormal), as reported. Causality is assessed as possibly related for lymphadenopathy. Treating diarrhoea with antibiotics confounds causality, and weight loss was likely associated with it. Temporal relationship was unclear. For diarrhoea, weight loss and feeling abnormal, causality is also unassesable due to lack of information.; Sender's Comments: A female patient of unreported age, was vaccinated with Flucelvax QIV. One day after vaccination with Flucelvax QIV, the patient experienced lymphadenopathy. On an unknown date in Oct-2020, the patient experienced severe diarrhoea for five days and was treated with unspecified antibiotics and probiotics. The patient also lost seven pounds and she was not herself (feeling abnormal), as reported. Causality is assessed as possibly related for lymphadenopathy. Treating diarrhoea with antibiotics confounds causality, and weight loss was likely associated with it. Temporal relationship was unclear. For diarrhoea, weight loss and feeling abnormal, causality is also unassesable due to lack of information.
Patient returned to pharmacy shortly after she received flu vaccine, reported allergic reaction, itching all over body without rash or hives. I recommended to take 10 mls of BENADRYL syrup, and went over pt's allergies. She reported that she is slightly allergic to eggs which she found out not too long ago. She said she is not allergic to anything else and did not have flu vaccine for years.
Headache, Leg weakness, facial and periorbital puffiness, fever 102 x 1d, nausea and dizziness.
right leg feels numb; right leg feels tingly; right leg feels tingly, numb, and achy; red rash; covid arm on left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (right leg feels numb), PARAESTHESIA (right leg feels tingly), PAIN IN EXTREMITY (right leg feels tingly, numb, and achy), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE REACTION (covid arm on left arm) in a 25-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) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (right leg feels numb), PARAESTHESIA (right leg feels tingly), PAIN IN EXTREMITY (right leg feels tingly, numb, and achy), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE REACTION (covid arm on left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (right leg feels numb), PARAESTHESIA (right leg feels tingly), PAIN IN EXTREMITY (right leg feels tingly, numb, and achy), RASH ERYTHEMATOUS (red rash) and VACCINATION SITE REACTION (covid arm on left arm) outcome was unknown.            No concomitant medication was reported by the reporter. The patient had right leg has been feeling tingly, numb and achy.
Patient reported that her arm still has a red mark where the shot was given, that she can still feel a lump inside of her arm, and that a piece of skin where the vaccine was given had fallen off of her skin.
The spontaneous report as received from a healthcare professional refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L023587, expiration date 26-JUN-2017 (dose, and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
pregnant pt recv vax & later pt exp fetal demise @ hosp;pt felt that may have been caused by flu shot;
10x14 Maculopopular rash at injection site on right arm with warmth.
Patient reported a large significant rash on abdomen in addition to fever and chills.  The fever and chills have subsided but the rash persists.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (ongoing). Concomitant medication(s) included: HUMIRA, start date: 08Dec2022, stop date: 09Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The COVID-19 was treated with Paxlovid. Treatment start date: 22Feb2023 and treatment stop date: 26Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300094071 same patient, different drug/different event;
On 1/19/2021 the patient developed a large round area measuring 8.5 cm x 12 cm below area of vaccine injection. The area was erythematous, itchy, with mild swelling. At the beginning it was mildly tender but the tenderness was short living. Patient was initially treated on 1/20/2021 with arm elevation, ice compress and antihistamines. On 1/25/2021 patient symptoms not better yet and oral prednisone added to treatment.
Shingles break out 10 days after first injection, pain and pox on neck and head
Chest started hurting, and went to the ER. Had an EKG and it was negative. Tested positive for COVID-19. Was given Celebrex and went home.
Manufacturers expiration date of 11/6/2021, but upon moving to the inpatient hospital pharmacy department the refrigerated expiration date was modified to 9/30/2021.  Therefore, the dose was considered to be expired.  No adverse events were associated with this administration.
March 12, 2021 @ 12:01 am. Developed Severe headache, nausea, body aches. Headache worsened when laying down.  Self treated with over the counter Dimenhydrinate  3 times. For nausea. Tylenol 1. Headache did not go away after 4 hours. Took a Butalb/asa/caff/codeine 30mg at 4am. (PRN order for migraines)  Headache eased up a lot.  Felt flushed through the night.  March 12, 2021- About mid afternoon on started a painful swelling under left armpit. (Injection was in left arm). Treated with  Ice packs.  March 13, 2021- swelling under left armpit worsening. Cannot put my arm down. Treating with ice packs.  Nausea, headache are better. Body aches are reduced.
80 year old patient was given Vaxelis vaccine but should have been given Tdap. Patient had no reaction or adverse outcome to vaccine.
He could barely walk for the first two days; Extreme fatigue; Swelling; Dizziness; Arm pain at vaccine site; Fingertips pain; Headache up the back; Nauseous; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller reports that he received second dose Tuesday of vaccine. Caller reports that he could barely walk for the first two days, he has experienced swelling, extreme fatigue, dizziness, arm pain at vaccine site, finger tips pain, headache up the back and nauseous. Caller reports that he is still suffering side effects today and would like to know how long they will last. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm was sore, and had a small lump at injection site. The lump never went away, and about a week later, lump got harder and bigger,  about 1.5 inches diameter, and started to itch, then turned red.
Patient presented to pharmacy this morning around 930am stating she woke up on day 2 with her lymph node under her left arm totally swollen and uncomfortable along with a headache in the back of her head on the right side.  She said the swelling had continued into today along with the headache.  The swelling is on the side where the covid shot was given...NOT the other two shots.  I recommended she go to her dr or urgent care to follow up but she is visiting  and has no insurance here and didn't want to go in.  She wanted to know if lymphadenopathy was an adverse effect of the shot.  It shows less than 2% however I still recommended she go be checked out due to her history and headache.  She said she had taken Motrin and/or APAP for headache.  Told her if she won't go in then if symptoms worsen or she gets fever she definitely needs to go in.  She wished to just monitor at this time due to insurance being in another country and she is supposed to be heading back and she can see her Dr. at that time.
Hip pain; sweats, fever of 100.4, chills, joint pain. These symptoms lasted 12 hours. After that I had a headache and 99 degree fever that persisted for a day. No other symptoms after 2 days.
Information has been received from a health professional concerning a 62 yr old white female pt with right leg cellulitis who on 08Nov05 was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). Concomitant therapy included esomeprazole magnesium (Nexium), citalopram hydrobromide (Celexa), alprazolam, furosemide (Lasix), albuterol, and amoxicillin/clavulanate potassium (Augmentin). On 08Nov05 the pt developed 7 cm erythema, heat, and pain at injection site. The pt's outcome was unk. No further information is available.