chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was barely sore; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) (age at the time of vaccination was 63-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "knee pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was barely sore"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional Information: The patient got both of the PFIZER COVID-19 vaccine injections and the last one was on Monday. He had a history of knee pain for which he periodically got a steroid injection and he will eventually have surgery.He had a doctor appointment coming up and wonders if he can get the steroid injection in his knee. After his first PFIZER COVID-19 vaccine injection, his arm was barely sore and after the second one, his arm was sore for 24 hours and he got a little headache. In the past, he was on oral steroids and got the flu vaccine and he got sick as a dog.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 033f21a), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient did not receive other medication in 2 weeks. No known allergies.
MI on 14 OCT while performing vigorous physical exertion as an patient in 80 degree heat for several hours.  Complained of CP and SOB and presented to the field aid station.  No cardiovascular findings on PE but sent to ER for eval after reported "previous heart surgery."  PMH of WPW ablation in 2009.  Sent to hospital with pos ECG and elevated Troponins and D-Dimer.  Evacuated to Hospital for cardiac cath on 14 OCT.  Released on 15 OCT
1st shot: intense swelling at/around injection site, immediately, persisted for one week 2nd shot: intense swelling at/around injection site and red painful rash on entirety of my back, immediately, persisted for one week, along with rash for 10 days, attended professional clinic, prescribed medicine to control
On 9/10/2013 at 9:30 PM I went to bed but began to feel bad, heart rate was elevated. I got up to watch TV but felt worse. At 10:00 PM I took my blood pressure which was 168/89, pulse 85. (My normal BP is about 128/72.) I took my temperature which was 97.6. I got up and walked around for awhile then tried to distract myself by again watching TV. At 11:15 PM I felt worse, got dressed and told my husband that he might have to take me to the ER. I again got up and walked around for awhile. At 12:30 AM on 9/11/2013 I took my BP again and it was 143/84 and pulse was 71. Since I was beginning to feel better, I went to bed and slept uneventfully until 6:30 AM. At 7:00 AM I took my BP and it was 111/72 and pulse was 71. The adverse reaction lasted about 3 hours. Today, 9/11/2013, I feel fine but tired.
Injection administered to right arm of male, within 30 seconds exhibited a vasovagal response. Pulse 56 B/P 90 Palpitations. cooled layed down. vitals began to normalize and was able to ambulate to the waiting area.
The patient reported muscle weakness that began about 24  hours after the first dose of the moderna vaccine.  He also had high sensitivity nerve pain.  He slept for 16 hours and then the side effects resolved after one day.
severe headache; This is a spontaneous report from a non-contactable consumer (patient husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about lot/batch cannot be obtained.
Patient developed pain/stiffness and itching in L arm the night of vaccine admin. The next morning it was more severe and she went to ER. They administered a steroid shot.
Expired Pediarixadministered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th July 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 28th July 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  This report was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 28-Jul-2022. Reporter's Comments: The nurse reported that a patient was administered a dose of Pediarix on 28th July 2022, which had an expiration date of 8th May 2022. This was the patient's third dose in the series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix on 28th July 2022, which was already expired in 8th May 2022, which led to Expired vaccine used.
nausea; joint pain; fatigue; shingles; redness and swelling at the site of the injection; redness and swelling at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness and swelling at the site of the injection), VACCINATION SITE SWELLING (redness and swelling at the site of the injection), NAUSEA (nausea), ARTHRALGIA (joint pain) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling at the site of the injection) and VACCINATION SITE SWELLING (redness and swelling at the site of the injection). On 22-Jan-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced NAUSEA (nausea), ARTHRALGIA (joint pain) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (redness and swelling at the site of the injection), VACCINATION SITE SWELLING (redness and swelling at the site of the injection), NAUSEA (nausea), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. Treatment included Topical steroid cream
severe headache; diarrhea; generalized aches and pains; flu-like symptoms; nausea; face is on fire; has a rash/has a rash to her upper thighs, abdomen, chest, and right arm above the elbow; This is a spontaneous report from a contactable pharmacist.  A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number: X91013, expiration date: Jan2021, NDC: 00005-1971-01), via an unspecified route of administration in the left arm on 03Jun2019 at a single dose for immunization. Medical history included non-cancerous brain tumor that was removed a year ago on 02May2018. The patient's concomitant medications were not reported. The patient experienced headache, diarrhea, generalized aches and pains, flu-like symptoms, nausea, and her face is not red but feels like face is on fire in Jun2019. The patient also reported she has a rash to her upper thighs, abdomen, chest, and right arm above the elbow in Jun2019. The patient did not report a rash to her left arm which was the arm the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was administered in. The outcome of the adverse events was not recovered.
No adverse event; Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022; Administered the vaccine to patient after the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 09-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Severe palsy, with pain eating my nerves , both upper extremities,  mainly right dominate arm and hand , severe muscle atrophy, and loss of use of right hand.
Administration error Moderna Monovalent was given as a booster instead of the Bivalent No adverse reaction
Night sweats; Fatigue; Chills; Injection site pain; Cold; Injection site itching; Device misfire; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE MALFUNCTION (Device misfire), NIGHT SWEATS (Night sweats), NASOPHARYNGITIS (Cold), INJECTION SITE PRURITUS (Injection site itching) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21E. and 046b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-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) 1 dosage form. In 2021, the patient experienced DEVICE MALFUNCTION (Device misfire), NASOPHARYNGITIS (Cold), INJECTION SITE PRURITUS (Injection site itching), CHILLS (Chills) and INJECTION SITE PAIN (Injection site pain). In November 2021, the patient experienced NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue). In 2021, DEVICE MALFUNCTION (Device misfire), INJECTION SITE PRURITUS (Injection site itching), CHILLS (Chills) and INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, NIGHT SWEATS (Night sweats), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FATIGUE, NIGHT SWEATS and COLD was not provided. The reporter's causality for the event(s) of CHILLS with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of DEVICE MISFIRE, INJECTION SITE ITCHINESS and INJECTION SITE PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication information was provided.  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
Manufacture's package: Measles + Mumps + Rubella + Varicella (ProQuad) is for children 12 months to 12yrs of age. Vaccine administered to a child older than 12yrs.
pt recv vax & approx 30min post vax pt exp dizziness;VS were nl;MD indicated that 8 other pt had similar exp (WAES97100694, 97100696 through 97100701 & 97100703);
4 days after 2nd injection I experienced sudden sharp pain in left heel when knee is straight and toes flex up. I experience this pain each time I make this motion. About a week later I noticed persistent numbness in the same area, left heel around outside and back of heel. After a week I called my PA for appointment and on May 25 I saw her and got a full blood panel and an xray.  She referred me to a podiatrist but also mentioned it might be connected to the vaccine, as other cases of neuralgia have been noted.
Rash with redness and no blistering at location of vaccine administration site. Size is approximately 3.5 inches in diameter and round. The patient mentioned it wasn't very painful.
This spontaneous report was received from a nurse who referred to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M033335, expiration date 11-OCT-2017 (dose, anatomical location and route of administration were not mentioned) for prophylaxis. No adverse effects were reported. The nurse was able to add that the patient has a history of high blood pressure. The nurse was also able to share that the patient was showing no adverse reactions in regards to receiving expired vaccine. The patient has been contacted by the nurse to schedule a re-vaccination. The patient declined at this time and preferred to what until the holidays would be over.
p/recv vax pt briefly went unconscious & fell hitting upper lip;vasovagal syncope;FSBS 120mg/dL;dizziness, feeling tired, fell out;shaky;
This spontaneous report as received from a nurse refers to a unknown numbers of patients of unknown age and gender. Medical history and concomitant conditions were not reported.  On an unknown date the patients were vaccinated with M-M-R II, lot # J015503, expiration date 05-DEC-2014, lot # J000154, expiration date 04-JAN-2015, lot J004204, Exp 12-APR-2014, lot J007929, Exp 28-JUN-2015 and lot J0109993, Exp 06-SEP-2015. Dose and route were not reported. The nurse reported an excursion of 13.64F for 1h 15 minutes affecting M-M-R II. Nurse reported that there have been multiple excursions to this product over the past two years, potentially over 15F. The product had been administered post excursion. There have been no reports of adverse effects to any patient. Patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
On 7/15/13 I was given Rabies Immune Globulin and the rabies vaccine. Within 48 hours psoriasis (lesions) erupted across my upper thighs, ankle, arms, and scalp and back. Treated unsuccessfully with KENALOG and LIDEX. Biopsy psoriasis vs psoriasis derm. Clobetasol gave temporary relief. Continues to spread. Starting x TRAX treatment 3/18/14.
Nausea; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included Factor V Leiden. The patient previously received fentanyl (MANUFACTURER UNKNOWN) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 19:00, the patient experienced nausea, headache and diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea and headache were recovered on 31Mar2021, after the duration of 36 hours diarrhea was recovered on 02Apr2021, after the duration of 4 days.   No follow-up attempts are needed. No further information is expected.
Immediate complaint of Ringing in the ears, Dizziness, and Nausea BP 120/82, HR 100, R 22 Ox 98, 99  Child recovered and vitals stabilized, but mother reports her nausea continued, and Vomited dinner. Child then developed swelling of her injection site.
Pt. hospitalized from 8/5/21-8/7/21 for DVT Right lower extremity and  Pulmonary embolism
SICK; MIND HAS GONE DOWN THE TUBE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer (wife) via a company representative through social media concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 07-NOV-2022. The patient's weight, height, and medical history were not reported. The patient received 2 doses of series 1 covid-19 vaccine ad26.cov2 s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got sick, and was hospitalized. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. Also reported that the patient's mind has gone down the tube. It was reported as "How bad were you sued from your poisonous Vax for covid. And how much do you have to pay out. My husband got sick from taking your Vax. And he has not been the same again. He ended up in the hospital twice with both of your jabs. He has not taken the boosters and has yet gotten sick, but his mind has gone down the tube. He is not the same man I married 30+ years ago." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, mind has gone down the tube, and off label dosing frequency was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be not voided and this customer preference case has been assessed and does not represent a product quality complaint. The disposition and root cause determination were documented properly based on the PQC evaluation/investigation performed.; Sender's Comments: V0: sick. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
pediatric dose was administered to an adult; pediatric dose was administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 34-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was medical assistant. The reporter reported that a pediatric dose of Engerix-B was administered to an adult , which led to adult use of a child product and underdose. The reporter given permission to follow up via e-mail. Note: The consent to follow up granted was captured in general tab conservatively due to discrepant information in narrative about follow up granted or not.
Tickle high up in nose- right eye swelled- and face got puffy and bright red- occurred about 20 minutes after vaccine.  Took Benadryl  and puffiness remained or about two hours.