chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered frozen Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis.   In March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: The nurse administered frozen Shingrix vaccine to the patient within 7th March 2022 to 31st March 2022. The healthcare professional provided consent to follow up. Information within adverse event report was all the healthcare professional provided at this time. Additional Supportive Information: The patient received frozen Shingrix vaccine which led incorrect storage of drug. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061860:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter.
Patient has severe arm tenderness at vaccine injection site and limited motility in arm vaccine was administered.  Patient stated was improving each day.
Information has been received from a nurse practitioner concerning an 18 year old female who on 08 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. Within one week the patient developed facial acne. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Immediately after receiving the immunization she had swelling at the injection site and approximately a 1 inch tall bump. It was purple in color. She was treated with an ice pack and diphenhydramine. She was monitored for 30 minutes. The swelling seemed to subside some after the 30 minutes by using the ice pack, but was still a little swollen.
Diarrhea; Nausea; felt very tired and achy whole day; Body Ache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), DIARRHOEA (Diarrhea), MYALGIA (Body Ache), NAUSEA (Nausea) and FATIGUE (felt very tired and achy whole day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body Ache) and FATIGUE (felt very tired and achy whole day). On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore Arm), DIARRHOEA (Diarrhea), MYALGIA (Body Ache), NAUSEA (Nausea) and FATIGUE (felt very tired and achy whole day) outcome was unknown.            She was taking concomitant medication. She did not take any medicine for treatment.
he received 2 out of 3 doses / last dose / in 2007; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received in 2007).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided are as follows: The case was reported by patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. Could not asked any questions regarding adverse event and very limited information was collected as the reporter was getting ready to get off the call.  The reporter refused to provide phone number and zip code due to privacy. The reporter did not consent to follow up.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (administration of an expired dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 048F21A) for COVID-19 immunization. No medical history reported. On Oct 3, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 3, 2021, patient administered expired product (administration of an expired dose). On Oct 3, 2021, administered expired product (administration of an expired dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated the dose administered after 30-day use by date or after manufacturer date of expiry. Storage details provide by reporter included: Date the vial was initially stored in the refrigerator: Sep 1, 2021 with a use by date of Oct 1, 2021. This case linked to MOD-2021-339392 (patient link).
Patient states that a few days after vaccine, administration site became very painful and pain radiated up to ear. On 10/14, patient said large black bruise developed mid-arm.
felt a little tired after the first dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (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: FATIGUE (non-serious), outcome "unknown", described as "felt a little tired after the first dose of the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that her other son who is 16 only felt a little tired after the first dose of the vaccine and he tested negative for Covid. She asked if the vaccines given to 16 year olds is the same as the ones given to adults. She called in for her two sons. Both sons had their first dose of the vaccine last 02Apr2021 and scheduled to have the second dose on 25Apr2021.  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-2021392131 same reporter/drug, different patient/AE
Swelling, redness near injection site 5 inches by 5 inches, bruising and injection site discomfort, flu-like symptoms, joint aches, eye pain.
Provider ordered a DTAP for a 14 year old patient. The MA never caught the mistake & gave the patient the DTAP. The patient is protected & will not require a 2nd dose. Private office. DTAP. GSK DTAP - INFANRIX. 0.5cc I found the error when I was loading the patient information into XXXX [a state immunization registry]. At this point I am at a loss at how to prevent this from happening. We have the DTAP/TDAP/TD guide hanging on the fridge. We have had the nurse from the health dept. in to do immunization training. I have sent out many, many memos about this. We now have EMR & on the screen where the order was filled it clearly states that the DTAP that was ordered is only for children under the age of 7 years. It seems to me that the nurses are just not taking the time to read!!!! The patient is protected & will not require a 2nd dose.
This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. On 15-JUN-2013, the patient was vaccinated with a dose of M-M-R II (lot # 0597AA, expiry: 28-APR-2013). No adverse effect reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 15 year old female who on an unspecified date was vaccinated with a dose of GARDASIL 0.5 ml IM. 30 to 40 minutes after the vaccination, the patient passed out and vomited in her car. Subsequently, the patient recovered from passing out and vomiting. The patient sought unspecified medical attention. Additional information has been requested.
Pulmonary embolism of right lung. Required hospitalization x1 overnight. Was started on enoxaparin inpatient, then transitioned to Eliquis 10mg twice daily with intent to drop down to 5mg daily. Presented to ER on 3/3/21 with chest pain. Patient continues to follow up in clinic.
My daughter is breastfeeding.  10 days after I took the covid vaccine she spiked a fever of 101 and her heart rate was over 150 bpm. I took her to the ER. They completely dismissed this is possible by the vaccine even though in a study it happens 1% of the time.  She was tested for covid, flu, and RSV to be negative.  She was diagnosed with unknown febrile fever.  I am reporting in case this is a trend with other breast feeding mothers.  We took her to the doctor two days later and they also dismissed the possibility.  The fever lasted 24 hours and she seems healthy now.
I had 99.5F on 7/31/2020. 0n 8/1/2020, my fever spiked to 101.5F. I went to Urgent Care. The prescribed Keflex and Doxycycline and Tylenol. My fever came down but the swelling in my arm got worse. It was about the diameter of a baseball and red and hot. I contacted my PCP on 8/3/2020 and she told me to continue the antibiotics. The fever dropped but the redness and swelling continued. By 8/6, I had more red patches appearing near the injection site. The original site grew as well. Mt PCP took me off of the antibiotics and now has me on Prednisone and Benadryl since last night. By this morning it faded a little bit.
Swelling of arm around injection site, pain, bruising. FLUZONE HD vaccination administered in other arm.
SICK ON 1-31-22 WITH SORE THROAT, SOB, CHEST PAIN, COUGH, NASEL CONGESTION, PNEUMONIA. TESTED POSITIVE FOR COVID-19 IN THE ER BY PCR ON 2-4-22. ADMITTED TO HOSPITAL 2-4-22. DIED 2-20-22 AT 0150 HOURS.  C.O.D.  CARDIOPULMONARY ARREST, SEVER ADULY RESPIRATORY SYNDROME, COVID-19 INFECTION
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-MAY-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed VALTREX and prednisone for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Myalgia, Arthralgia, Fever, Lymphedema Right Axillae area, Temp 101.3 Narrative:
clumsy; he had trouble with coordination; Hand Eye Coordination issues; basically felt drunk; it has gotten worse; motor actions are overactive and uncontrollable; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (age at vaccination: 66-years-old) as dose 2, single for covid-19 immunization. Medical history included diabetes from 1983, musculoskeletal disorder he was a ortho patient. Concomitant medication(s) included insulin glargine (LANTUS) taken for diabetes mellitus and insulin lispro (HUMALOG) taken for diabetes mellitus, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Patient received second dose on 04Mar2021 (about 2pm) and had a sore arm. patient said, on 06Mar2021, about 9:30pm. Patient experienced the clumsy, off kilter, stumbling around, hand-eye coordination involved. On Thursday 04Mar2021. Patient had no issues with the first dose of the vaccination, but on Friday 05Mar2021 about 9pm patient had trouble with coordination. Patient had trouble putting his foot down and said continuously having trouble with his hand eye coordination issues. Patient felt drunk but he was not dizzy and thought it was minor thought, but it has gotten worse. Patient stated reported, used a cane for his balance. Patient clarified it was Saturday 06Mar2021 not Friday 05Mar2021 between 9pm and 9:30 pm he started having issues with coordination. He states about 59 hours after second vaccination. Patient drove a short distance and states his fine motor skills on his feet are not what they should be, he said with his hands and texting he was hitting all the buttons but was able to call DSU on his own. Caller also reports he will not be driving any more until he was better. When putting pants on the caller reports he has to lean against something while putting pants on, he states his balance and everything are interconnected, that its almost neurological. he says its like his brain was not connected with his limbs it is ahead time of time or behind time, its more behind time. He read about a brain fog but was unsure if that is what he is feeling. Cane was taken as treatment received for event basically felt drunk. The outcome for event trouble with coordination, hand eye coordination issue and motor actions are overactive and uncontrollable was not recovered and unknown for other.  No follow-up attempts are possible. No further information is expected.
Vomiting, fevers, sweating, headaches, and bone pain. 12:15am- 1:00pm
2/19/21 1200: received second dose of COVID-19 vaccine (Moderna, lot 016M20A) 2/19/21 1800: experienced fever (102.3 on acetaminophen) and chills; took acetaminophen 500 mg PO Q6h x 2 doses 2/20/21 am: fever and chills resolved; experienced fine rash on back of thighs and upper buttocks; took loratadine 10mg PO x 1, and topical hydrocortisone cream x 3 days 2/20/21 pm: experienced vaginal yeast infection; took miconazole 1200 vaginal ovule x 1 2/23/21: rash and yeast infection resolved
Provider summary "96-yr old female with a past medical history significant for HFpEF and aortic valve stenosis who presented after a syncopal episode. The paitent was admitted and later found to be COVID(+). Echo was done while inpatient but not resulted prior to discharge. The patient was found to be mildly dehydrated and responded to 500cc bolus. Suspected the syncopal episode was secondary to dehydration as the patient had mild shortness of breath and states she felt weak but vitals were stable during hospitalization. CXR was notable for possible left-sided pneumonia but likely symptoms were secondary to COVID, antibiotics were discontinued without evidence of secondary bacterial infection. "
Information has been received from a 17 year old female patient, for  VARIVAX (Merck), a Pregnancy Registry product who on 28-DEC-2012 was vaccinated with VARIVAX (Merck) (therapy dose, route and site unknown). She had no relevant past medical history, relevant concomitant drugs or relevant past drug history. On 18-FEB-2011 she had a pregnancy test and she discovered that she was pregnant with an estimated due date of 23-NOV-2011. No other relevant laboratory testing had been performed. She would not receive any more VARIVAX (Merck) and she was currently not experiencing any adverse effects from this event. Addiitonal informaton is not expected.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 21.1 C, time frame: 16 hours) doses of PROQUAD of lot/batch # L046507 with expiry date 17-MAY-2017, lot/batch # L033696 with expiry date 28-FEB-2017, lot/batch # L050908 with expiry date 14-JUN-2017 and lot/batch # L009210 with expiry date 17-SEP-2016 (Dose, dose number, vaccination site and route of administration not provided) since 01-MAR-2016. There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from same reporter link. Additional information has been requested.
shortly after receiving vaccination developed flushing/redness of neck and chest; consumed 10 mg of Loratidine. Was discharged to home from vaccination site 30 minutes later with improvement of symptoms.
pt recv vax 29MAY96 & 5JUN96 lab eval revealed elevated AST 357, ALT 268 & LDH 1740;other lab eval included total protein 6.4, albumin 4.1 & triglycerides 111;hgb, PB, alk phos & serum bilirubin nl;21JUN96 AST 457, ALT 378 & LDH 2100;
Dry cough; Second dose received 24-JUN-2021/Booster received 27-JUL-2021; Left arm sore after receiving covid booster; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), VACCINATION SITE PAIN (Left arm sore after receiving covid booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24-JUN-2021/Booster received 27-JUL-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, received third 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) Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE PAIN (Left arm sore after receiving covid booster). On an unknown date, the patient experienced COUGH (Dry cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24-JUN-2021/Booster received 27-JUL-2021). At the time of the report, COUGH (Dry cough), VACCINATION SITE PAIN (Left arm sore after receiving covid booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received 24-JUN-2021/Booster received 27-JUL-2021) outcome was unknown.            The concomitant medication was not reported by reporter It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter. On an unknown date patient had a CAT scan and results not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recv vax 30AUG96 & 19JAN98 devel h/a, fatigue & a papular pustular rash on trunk, arms, axilla & labia which spread for 2 days w/several crusting over & itching & less than 30 lesions;the following day devel fever 101;
sleep more during the day; scarring from the rash; skin feels like sandpaper now where the rash appeared; rash hurt/ rash that covered my arm, stomach and legs; rash was red; could not sleep at night; Still itches; rash burned when tried to put anti itch cream; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash was red), INSOMNIA (could not sleep at night), RASH PRURITIC (Still itches), BURNING SENSATION (rash burned when tried to put anti itch cream) and SOMNOLENCE (sleep more during the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced RASH ERYTHEMATOUS (rash was red), INSOMNIA (could not sleep at night), RASH PRURITIC (Still itches), BURNING SENSATION (rash burned when tried to put anti itch cream) and RASH (rash hurt/ rash that covered my arm, stomach and legs). On an unknown date, the patient experienced SOMNOLENCE (sleep more during the day), SCAR (scarring from the rash) and SKIN TEXTURE ABNORMAL (skin feels like sandpaper now where the rash appeared). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) ongoing since an unknown date for Adverse event, at a dose of 25 milligram and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 20 milligram twice a day. At the time of the report, RASH ERYTHEMATOUS (rash was red), RASH PRURITIC (Still itches), SCAR (scarring from the rash), SKIN TEXTURE ABNORMAL (skin feels like sandpaper now where the rash appeared) and RASH (rash hurt/ rash that covered my arm, stomach and legs) had not resolved and INSOMNIA (could not sleep at night), BURNING SENSATION (rash burned when tried to put anti itch cream) and SOMNOLENCE (sleep more during the day) outcome was unknown.            No concomitant drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-May-2021 and event verbatim updated. On 14-Jun-2021: Follow-up received on 14-Jun-2021, included additional events of scar and skin texture abnormal. On 20-Jul-2021: Follow up received on 21-Jul-2021 and contains no new information