chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild swelling of face and lips; Mild swelling of face and lips; This is a spontaneous report from a contactable physician. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 11:00 at a single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 16Jan2021, the patient experienced mild swelling of face and lips. Both the events resulted in emergency room visit. Therapeutic measures were taken as a result of mild swelling of face and lips which included steroid shot, told to take ZYRTEC and PEPCID. Outcome of the events was unknown.
Pt. states immediately after vaccination in left deltoid, she had penetrating, burning pain from the shoulder to the wrist.  She felt the arm to be limp and just hanging as if paralyzed.  She also complained of muscle soreness, and a hematoma which resolved within one week.  She still continues with weakness, burning, and shooting pains in the left deltoid muscle.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB06BA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 13th April 2022, unknown after receiving Bexsero and Bexsero 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 is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14th Apr 2022 Reporter's Comments: The nurse reports male patient was administered an expired dose of Bexsero. At the time of reporting, a repeat dose had not been administered. The reported consented to follow up. Additional Supportive Information: The patient received Bexsero which was already expired which led to expired vaccine used.
Patient complained of excessive irritation at the injection site. Patient has redness and some swelling around injection site.
intermittent dizziness; chills; swollen lymph nodes in her neck; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "intermittent dizziness"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "swollen lymph nodes in her neck".  Additional information:No seriousness was reported. A patient asked what to do after experiencing intermittent dizziness, chills, and swollen lymph nodes in her neck after receiving her first dose of the Pfizer-BioNTech COVID-19 vaccine on 28Mar2021. The dizziness is so severe that he had to come home early from work one day this week. She was not sure if the next dose should be given.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-DEC-2010, the patient was vaccinated with a dose of PNEUMOVAX 23. On 13-APR-2015, the patient was vaccinated with a dose of  PREVNAR 13. There was no adverse event reported.
Excessive crying for 30 minutes, but stops with mother's soothing. Temp: 97.4 rectal. Site injection areas are soft, no swelling or redness.
Patient was waiting for 15 mins after the 2nd Janssen booster vaccine in the waiting room.   She started feeling dizzy and slowly fell over the chair she was currently sitting and down to the ground.  Pharmacist and technician came out to check on her, helped her up and gave her water/juice/lolipop.   She was alert and responsive but still look pale.  Pharmacist called 911 and when the paramedic came, they check her blood pressure/pulse/HR and everything was normal.  They recommended her to go to the hospital for a thorough check up but she refused.  She called her neighbor and he came over to pick her up at about 12:50 pm.
Sleepy; Painful joints; Pain in arm; Shoulder fracture; Broken knee cap; Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall), SOMNOLENCE (Sleepy), UPPER LIMB FRACTURE (Shoulder fracture), PATELLA FRACTURE (Broken knee cap) and ARTHRALGIA (Painful joints) in a 66-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.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Dec-2021, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced FALL (Fall), UPPER LIMB FRACTURE (Shoulder fracture) and PATELLA FRACTURE (Broken knee cap). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), ARTHRALGIA (Painful joints) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FALL (Fall), UPPER LIMB FRACTURE (Shoulder fracture) and PATELLA FRACTURE (Broken knee cap) was resolving, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (Pain in arm) had not resolved and ARTHRALGIA (Painful joints) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.   Concomitant Drugs Not Reported.  It was reported that the patient experienced joint pain and reported going to physical therapy for knee pain and shoulder pain. Patient had arm pain. Patient fell and broke left shoulder and right knee cap in Jan 2022 and also stated that got really sleepy and had joint pain for four days after Covid-19 vaccination.   It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the events of Painful joints and arm pain was a reasonable possibility. The reporter's causality for the events of fall, Sleepy, Shoulder fracture and Broken knee cap was not reported with Rinvoq (upadacitinib) and Janssen Covid-19 Vaccine.   No treatment medication were provided.
1 Expired moderna covid-19 dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired moderna covid-19 dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired moderna covid-19 dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired moderna covid-19 dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccine was supposed to expire on 12-FEB-2022 (30 BUD) and was administered on 14-FEB-2022;  Concomitant medication information was not reported Treatment information was not reported
Tiredness; Slightly feverish; This is a spontaneous report received from a non-contactable consumer, the patient. A male (adult) patient of unknown age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) via unspecified route of administration on an unknown date (at an unknown age) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17Mar2021, the patient experienced tiredness and was slightly feverish. No therapeutic measures were taken for the events. The clinical outcome of the events tiredness and slightly feverish was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Swelling to (R) and (L) leg. Right thigh 10 cm across. Left thigh 6 cm across. Warm to touch. MOTRIN, BENADRYL, TYLENOL, Ice pack.
administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022; Nurse states that they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse states that they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022) and PRODUCT STORAGE ERROR (administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse states that they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse states that they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022) and PRODUCT STORAGE ERROR (administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  The vial was initially stored in the refrigerator on 11-Mar-2022.  The booster dose was administered on 22-Apr-2022.  The vial did not undergo any temperature excursions.  No treatment drug was reported.
Arm swelling the size of a golf ball within 6 hours of injection. Arm extremely painful, could barely move arm 2 days. Deep bruising. Swelling of arm lasted 8 days, pain gradually lessened. Then swelling in armpit lasting 6 days, before swelling in armpit went away arm swelling and itching at injection site again lasting 3-4 days. Pain in neck and shoulder blade noticed. Dizziness lasting half a day after injection. Months later still get pain every once in a while at injection site, neck and shoulder blade.
I saw him for well check up at 09:30. He had history of mild cough and normal exam. He had vaccines and went home. He took a nap and awoke with bark-like cough and respiratory distress.  8/31/09 Hospital medical records received for 8/19-8/20/2009.   FINAL DX: croup Records reveal patient experienced mild cough & rhinorrhea prior to office visit but had slept well.  No abnormal findings on office exam when received vaccines including initial dose of Flumist.  After nap at home, awoke w/stridor & respiratory distress.  ENT consult & laryngoscopy done which revealed an abnormally shaped epiglottis but no edema.  Had stridor & agitation upon awakening from anesthesia & admitted for observation.  Tx w/steroids & epi.  Responded well to tx & d/c to home. ICD-9 codes for DC 464.0, 786.1
Fever 99 with 2 ADVIL. Chills, sweats, tachycardia. Symptoms started the evening after the shot was administered and lasted approx 24 hours.
Continuous, high pitched cry - x 7 hrs; Give DT instead of DTP in future.
9*9 AREA REDNESS/TENDER/WARM (R)THIGH.
Headache, nausea, fatigue  and triggered Behcet?s Disease Flare manifested in genital ulcers
Breakthrough case admission after 3 vaccines Moderna 3/4/21 Lot# 029A21A;  Moderna 4/1/21 Lot# 028A21A ; Moderna 11/26/21 Lot# 012H21B
While the Menactra was being administered IM in the left deltoid the patient fainted and had a mild clonic tonic seizure. Patient also urinated on herself during seizure.
I do not recall the exact time of how long after the vaccines my child developed bumps on her arms and legs. It was after the vaccinations done on 11/29/2007. I took her to the doctor on 12/20/2007 and was told that she had Eczema. I was not told that this could be a reaction from the vaccines. Until recently, I was unaware that I could file a report.
This case meets criteria for vaccine breakthrough review.  Known exposure to family. Sx include SOB, cough, chest pain.
PT HAD SUDDEN ONSET OF FEVER OF 103 AND WAS VERY LETHARGIC FOR 24-36 HOURS WENT TO ER. WAS ADVISED TO CONTINUE TYLENOL AND FLUIDS. THEY DID LABS WHICH WERE NORMAL. FOLLOWED UP WITH DR. THE NEXT DAY. WAS GIVEN ROCEPHIN IM AND DID BLOOD CULTURES.
Swollen left lymph node in armpit. Node portruding from arm, tender, slightly painful.
On the night of the shot, I had trouble sleeping, my heart would stop so I was awake most of the night in fear of not waking up, when I did get some sleep, I was having nightmares, I also had a metallic taste in my mouth and could smell it.   My Dr. is having me take 600 mg Ibuprofen, and 650 mg in Tylenol rotating them.
Case number PHEH2014US011539 is an initial spontaneous report from the nurse received on 05 Jun 2014 with a follow up information received from a nurse on 11 Jul 2014. This report refers to a 16 years old female patient. Her medical history included bipolar disorder. Her concomitant medications included LAMICTAL, RISPERDAL and Birth Control Pills (BCP). Her vaccination history included administration of MENVEO in the past which was well tolerated. On 05 Jun 2014, she was inadvertently vaccinated with a booster dose of MENVEO (batch number: M12098) via subcutaneous route in the left arm post laterally. No adverse event reported following this medication error (wrong route of vaccination).  Follow up information received from a nurse on 11 Jul 2014: Patient demographics (initials, date of birth, age and gender), medical history, concomitant medications, vaccination history, vaccination date and site updated.
Presented with SOB x 6 days: + covid PTA 6 days; Admitted to tele with Covid PNA; tx with maxipime, steroids, remdesivir, vanc, Vit D, doxycycline, singulair, zinc, clindamycin; intially LF O2; HF O2; 9/15 increasing O2 needs to HF O2; + GI bleed 9/16; 9/20 tx to PCU due to increasing hypoxia and need for further HF O2 and possible intubation; 9/22 back to tele; 9/23 back to HF O2; 9/24 pt desired DNR order then changed back to full resuscitation status; 9/25 pt on HF o2; desat with repositioning; emergency intubation; after intubation, pt became bradycardic/hypotensive; multiple Cardiac arrests with ultimately asystole and death
I inadvertently gave patient a partial dose (a few drops) of the Rotavirus vaccine, but she wasn't due for it because she was 20 weeks old and had not had any previous doses. As soon as I realized I did not need to give her the dose, I removed the syringe from her mouth and wasted the remainder and explained to parents why she did not need it. They asked what "Rotavirus" was and I explained how the virus affects the body and since she technically is past the age of receiving the vaccine, I gave them the symptoms to watch for, and to call our office if she should come down with them.  They verbalized understanding.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 12:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Mar-2022 at 12:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
COVID-19; PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM) and COVID-19 (COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In March 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In April 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced PSORIASIS (PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM). In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, PSORIASIS (PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM) and COVID-19 (COVID-19) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM and COVID was not provided. No concomitant drug reported. No treatment information was provided by the reporter.  Company comment: This is a spontaneous case concerning 38 years old male, with no relevant medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose (reported as booster dose) of mRNA-1273 vaccine. The patient was noted to have received two doses with TOZINAMERAN (Interchange of vaccine products). Outcome of the event is unknown. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning 38 years old male, with no medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose (reported as booster dose) of mRNA-1273 vaccine. The patient was noted to have received two doses with TOZINAMERAN (Interchange of vaccine products). Outcome of the event is unknown. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This case was reported by a physician and described the occurrence of diarrhea in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline).  Concurrent medical conditions included gastro esophageal reflux.  Concurrent medications included ZANTAC.  On 26 June 2009 the subject received 1st dose of ROTARIX (oral).  On 27 May 2009, 1 day after vaccination with ROTARIX, the subject experienced diarrhea.  At the time of reporting the event was unresolved.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;
Pain at injection site right arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site right arm), PYREXIA (fever) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site right arm), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at injection site right arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided          No treatment information provided  No concomitant medication listed