chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of vaccines stored at 22F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number ABX29BA, expiry date 30th May 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, Men ACWY-CRM NVS (Menveo) (batch number AMVA586A, expiry date 30th August 2022) for prophylaxis, DTPa-IPV (Kinrix) (batch number 2NT2N, expiry date 7th May 2023) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 5S945, expiry date 6th April 2023) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 5-JUL-2022 Reporter's Comments: The medical assistant reported that the 12 patients had  Bexsero, Menveo Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B which were stored at 22 Fahrenheit for 30 minutes. Excursion occurred on  6th April 2022 and vaccines were administered until MAY 2022. The reporter gave consent to follow up. Additional supportive Information: The vaccine were stored at 22 Fahrenheit in to 30 minutes which lead to Incorrect storage of drug. This was 1 of the 12 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022102741:Same reporter US-GLAXOSMITHKLINE-US2022AMR103705:Same reporter US-GLAXOSMITHKLINE-US2022AMR103707:Same reporter US-GLAXOSMITHKLINE-US2022AMR103708:Same reporter US-GLAXOSMITHKLINE-US2022AMR103709:Same reporter US-GLAXOSMITHKLINE-US2022AMR103710:Same reporter US-GLAXOSMITHKLINE-US2022AMR103711:Same reporter US-GLAXOSMITHKLINE-US2022AMR103712:Same reporter US-GLAXOSMITHKLINE-US2022AMR103713:Same reporter US-GLAXOSMITHKLINE-US2022AMR103714:Same reporter US-GLAXOSMITHKLINE-US2022AMR103715:Same reporter
Swelling; Itching; Welts; Discoloration; Headaches; Nausea.
I have a breakthrough case of Covid. I was prescribed PAXLOVID. I had headache, body ache, fever, chills.
2/5/2021, headache, rapid heartbeat at 8:30 pm, resulting in insomnia, .moderate inje tin site pain 2/6/2021  fever and chills at 3:30 pm with extreme fatigue, pain upon moving arm 2/72021 back to normal
MOTHER REPORTS DAUGHTER COMPLAINED OF PAIN UNDER HER ARM FOR A COUPLE DAYS. MOTHER THOUGHT IT WAS JSUT EHR ARM BUT WHEN SHE LOOKED AT HER LEFT UNDERARM, THE CHILDS UNDERARM/ARMPIT AREA WAS SIGNIFICANTLY SWOLLEN. THE MOTHER ALSO NOTICED THE CHILDS LEFT BREAST WAS SWOLLEN AS WELL AND WAS NOTICABLY LARGER THAN HER OTHER BREAST. 2 WEEKS HAVE PAST AND THE CHILDS ARM HAS IMPROVED HOWEVER THE BREAST STILL IS SWOLLEN AND TENDER. WRITER ADVISED THE MOTHER CALL THE CHILDS PROVIDER BEFORE SCHEDULING A 2ND DOSE. MOTHER AGREED TO CALL.
Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.; Her left thumb is almost swollen with constant pain.; After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks; She started with joint pain.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.), PAIN IN EXTREMITY (Her left thumb is almost swollen with constant pain.), RASH (After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks) and ARTHRALGIA (She started with joint pain.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.), PAIN IN EXTREMITY (Her left thumb is almost swollen with constant pain.), RASH (After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks) and ARTHRALGIA (She started with joint pain.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Rheumatoid arthritis, at an unspecified dose and frequency; IBUPROFEN for Rheumatoid arthritis, at an unspecified dose and frequency and MELOXICAM for Rheumatoid arthritis, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.) and PAIN IN EXTREMITY (Her left thumb is almost swollen with constant pain.) had not resolved, RASH (After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks) was resolving and ARTHRALGIA (She started with joint pain.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant- Supplements , Allergy Medicine. Patient treated with X-ray & MRI   This case was linked to MOD-2021-351143 (Patient Link).
MMR vaccine given 1-29-15. No prior MMR vaccination. 9 days later pt developed extensive rash over entire body with splotches on face. Mild fever, pain in knee/leg at injection site but no swelling or redness at the site. Rash now improved, still with pruritus.
Soreness at injection site immediately after dose.  About 9 hours after dose chills, headache, neck aches, and leg aches began.  Fever was noticed around 1am pushing 101F.  By morning, most were better.
This spontaneous report has been received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date in 2015, a few weeks ago, (Oka/Merck) VARIVAX [lot # J013728, Expiry: 30-OCT-2015] was improperly exposed to 54 degree Fahrenheit for 8 hours. On 21-OCT-2015 the patient received a dose of the improperly stored (Oka/Merck) VARIVAX via the subcutaneous route. No adverse effects were reported. Outcome of the improperly stored vaccine was not known. Additional information has been requested.
pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years); pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 65-year-old patient who received HBV (Engerix B 10 mcg) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 20-JUL-2023, the patient received the 3rd dose of Engerix B 10 mcg. On 20-JUL-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years)) and adult use of a child product (Verbatim: pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years)). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 24-Jul-2023 The reporter consented to follow-up. An adult patient received a pediatric dose of Engerix-B (10 mcg), which led to underdose and adult use of a child product.
After #2 dose Pain in joints including ankles, knees, arms; Large red area under blister remained; Blisters below left ankle bone lateral side; This spontaneous case was reported by a nurse and describes the occurrence of BLISTER (Blisters below left ankle bone lateral side), ARTHRALGIA (After #2 dose Pain in joints including ankles, knees, arms) and ERYTHEMA (Large red area under blister remained) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced BLISTER (Blisters below left ankle bone lateral side). On 09-Apr-2021, the patient experienced ERYTHEMA (Large red area under blister remained). On an unknown date, the patient experienced ARTHRALGIA (After #2 dose Pain in joints including ankles, knees, arms). At the time of the report, BLISTER (Blisters below left ankle bone lateral side) and ERYTHEMA (Large red area under blister remained) outcome was unknown and ARTHRALGIA (After #2 dose Pain in joints including ankles, knees, arms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   18 days later developed large blister below left ankle bone lateral side which drained clear liquid , med redness after blister drained. No obvious injury to foot or ankle.  The reported stated that patient received treatment medication of Antibiotic for blister, but didn't state what Antibiotic was used.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information received on 17-Jun-2021, ethnicity, race, occupation and event updated
Patient is a 70yo F who presented to the ER on 11/23 for worsening shortness of breath and chest pain after testing positive for COVID on 11/22. Symptoms onset 11/18. Chest pain workup reassuring (negative CT PE, EKG sinus rhythm with no ST or T wave elevations, CXR consistent with interstitial lung disease, labs WNL). While initially on RA, her oxygen requirements increased to 3L, so remdesivir and dexamethasone started. Oxygen was weaned as tolerated. Tessalon Perles given for cough. Patient weaned to room air. Oxygen walk test passed, no supplemental oxygen required. Overnight blood sugars elevated, no AG, negative BOB. Likely 2/2 dexamethasone and poor intake (crab salad). Recommend diabetes management with PCP. F/u with PCP within 1 week.
I was at home in bed and I was very lucky to wake up. I told my wife I needed medical attention right away because I could not breathe. We got in the car and drove to the hospital. They did a whole bunch of tests. MRI, CAT scan, blood work, Covid test. I do not know the results of the tests, only the Covid test, which was positive. Once I was admitted they did 2 treatments through IV.  I was only there for one day and a half. They gave me a steroid for 5 days.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4109906-00. A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (1 in 2 wk) (citrate free)) for psoriasis. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Sep2021, outcome "unknown", COVID-19 (medically significant) with onset 16Sep2021, outcome "recovered" (2021) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Sep2021) positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter's causality for the event(s) of Covid with BNT162B2 (Drug/Vaccine): was possible. The reporter's causality for the event(s) of Covid with Humira (Adalimumab) was no reasonable possibility.  The lot number for vaccine (BNT162B2) was not provided and will be requested during follow up.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency. Consideration should also be given to the contribution from the co-suspect medication adalimumab
Patient started filling dizzy about 10 minutes after vaccine.  He felt weak and tired and also started sweating profusely.  Skin was cold and clammy to the touch. I checked his BP and it was 89/53. I called 911 as precautionary and ems arrived within 5 minutes.  Patient had stopped sweating by then and was able to stand and walk with EMS to another area of the store to be evaluated further and monitored.
Felt nauseous about 2 hours after Pneumovax, went to sleep (hadn't eaten all day, diabetes). Woke up about 4 hours later, felt weak, feel to ground, felt diaphoretic, SM BG 270.
Two days later of the vaccination the glands of my throat were hurting and had sinus congestion.
Inflamed nerves beginning in upper legs, then going to lower extremities, severe nerve pain, followed by body weKNESS,
no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 15-month-old female patient.  The patient's medical history, concurrent conditions and previous drugs reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with an unproperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) lot number U029794, expiration date reported as 23-SEP-2023, administered subcutaneously on the right thigh as  prophylaxis (strength, and lot # were not provided) (product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008838: US-009507513-2209USA008836: US-009507513-2209USA008837: US-009507513-2209USA008834: US-009507513-2209USA008835:
Patient had cardiac arrest secondary to MI less than 24 hours from receiving the vaccine. Now on 3 pressors.   Although due to the patient's health condition, this may not have been attributed to the vaccine.
Mom reports swelling of throat when she looked down her throat last p.m. at 10:00. Temperature of 101.1, arm sore, and tiredness.
Headache, Sedation, Myalgia, Arthralgia, Fever,  Diarrhea, NauseaVomiting,  Chills Narrative:
104°F fever, nausea, impaired vision, dizziness, migraine and body pains.
Herpes zoster with complication; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a male patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles.  After the vaccination, the patient suffered a painful persistent rash, which was diagnosed as herpes zoster with complication. The patient continued to suffer the effect of herpes zoster; the outcome of the event was not recovered.  The causality between event and zoster vaccine live (ZOSTAVAX) was not provided.
Facial swelling L side nontender, nonerythematous. No respiratory distress. Follow up received 1/4/2010. Impression: Large mass occupying the nasal cavity, sphenoid sinus, extending minimally into the left orbit, and extending prominently through the left pterygopalatine fossa into the infratemporal and temporal fossa. The location is highly suggestive of a juvenile angiofibroma, though the enhancement pattern is somewhat aytpical. The location is atypical for an inverted papilloma, although the enhancement pattern is more suggestive of this diagnosis, this is thought unlikely. Other possiblilites including esthesioneuroblastoma, lyphoma and rhabdomyosarcoma merit consideration but the lack of intracranial extension, but there are features which are atypical for each of these diagnoses. Overall, a juvenile angiofibroma is most likely.
Has about five percent Psoriasis/small amount of Psoriasis; COVID vaccine issues; left hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Has about five percent Psoriasis/small amount of Psoriasis), IMMUNISATION REACTION (COVID vaccine issues) and ARTHRALGIA (left hip pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   In February 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) Dose 1. In March 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to Dose 2. In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced ARTHRALGIA (left hip pain). On an unknown date, the patient experienced PSORIASIS (Has about five percent Psoriasis/small amount of Psoriasis) and IMMUNISATION REACTION (COVID vaccine issues). At the time of the report, PSORIASIS (Has about five percent Psoriasis/small amount of Psoriasis) had not resolved and IMMUNISATION REACTION (COVID vaccine issues) and ARTHRALGIA (left hip pain) had resolved.            No relevant concomitant medications were reported. The COVID vaccine issue left hip pain for two months following vaccine. Small amount pf psoriaisis stated that she still had about five percent psoriasis. No treatment medication reported. It was unknown if patient was enrolled in a Covid-19 Vaccine trial.  The reporters causality for the events left hip pain, COVID vaccine issues and Has about five percent Psoriasis/small amount of Psoriasis with SKYRIZI was not provided. The reporters causality for the events left hip pain, COVID vaccine issues and Has about five percent Psoriasis/small amount of Psoriasis with Pfizer was provided as possible.  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.
she gave a 17 year old female an extra dose of IPOL by accident with no reported adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional via Nurse.  This case involves a 17 years old female adolescent patient who was given an extra dose of ipol by accident with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications includes unspecified Tuberculosis vaccines for Prophylactic vaccination.    On 23-Mar-2022, the patient received 0.5 ml (fifth dose) of suspect IPV (POLIOMYELITIS VACCINE INACTIVATED) (lot U1A452M) (strength: unknown; expiry date: 20-FEB-2023) via subcutaneous route in the left arm for Immunization. 4 other doses were administered subcutaneously at 8 weeks, 4 months, 7 months and 4 years on unknown dates for suspect IPV (VERO).  On 23-MAR-2022 the patient received an extra dose of ipol by accident with no reported adverse event (extra dose administered) following the administration of IPV (VERO).  It was reported, Pregnancy: none and Last menstrual period was on 28-Feb-2022 Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test- 0.5ML. Strength is standard except for Fluzone HD-STANDARD  Indications: Immunization or TB skin test-TB Test/Immunization.    Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness in the torso; Feeling sick; probably had a fever; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema in a elderly female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine and COVID-19 VACCINE. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced erythema (Verbatim: Redness in the torso), sickness (Verbatim: Feeling sick) and fever (Verbatim: probably had a fever). The outcome of the erythema, sickness and fever were not reported.   It was unknown if the reporter considered the erythema, sickness and fever to be related to Influenza vaccine.     It was unknown if the company considered the erythema, sickness and fever to be related to Influenza vaccine.   Linked case(s) involving the same patient:  US2023138520   Additional Information: GSK receipt date: 10-Oct-2023 The reporter was a pharmacist. The patient got both covid-19 and Influenza vaccine last year in 2022 and  developed a redness in the torso only, up to her neck, not affecting legs, arms or back.  The reporter stated she felt a little bit sick, and she probably had fever but she was not sure. The reporter did not consent to follow-up.
Received vaccine at 9 am and was slightly fatigued throughout the day - mainly started around 1/2PM.  Body aches and dizziness started around 6PM, aches ran from my lower back down to my toes. Headache (when standing), fever  (between 99.8, up to 100.4) and chills started around 9/930PM.   All symptoms lasted throughout the night. Body aches subsided around 10am. 1/29 - body is sore, pain at injection site, severe headache.