chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (We had patients who were administered the vaccine that underwent temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (We had patients who were administered the vaccine that underwent temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (We had patients who were administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the patient was administered the vaccine that underwent temperature excursion.The vaccine was stored in an ultra cold freezer at minus 82 degrees Fahrenheit.The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit.The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19 Nov 2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator.The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.No vaccine state changes were noticed. The vaccine was never refrozen.None of the vials were punctured. No previous temperature excursions were reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
MMR, VARICELLA and HEP A @ 12 months - 8 days later - patient had febrile seizure. DTAP #4 and HEP A @ 18 months - 8 days later patient had seizure - without fever.
Initial unsolicited case received from a Physician on 22 Nov 2016. This case involves an 80 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI704AA , Expiry date: 17 May 2017, dose and site of administration was not reported) intramuscularly on 12 Oct 2016. The patient medical history includes cardiac, HTN (hypertension), history of cardiac arrhythmias, overactive bladder, A Fib (atrial fibrillation) and the patient illness at the time of vaccination was reported as unknown as per reporter and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 12 Oct 2016, same day after vaccination the patient developed hypertension, tachycardia, and was febrile with elevated WBC. On an unknown date the patient was evaluated in Emergency department and admitted to hospital overnight for observation. On an unknown date, patient was diagnosed with sepsis. The patient lab test include blood cultures negative, CT scan negative. The patient was treated with antibiotics for diagnosis of sepsis. The outcome of the events were reported as recovered on an unknown date and the patient was discharged from hospital on 13 Oct 2016. It was reported as the Cardiologist determined this was a reaction to the flu shot. List of documents held by sender: none. Sender's Comments: This case concerns 80 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and developed sepsis, hypertension, tachycardia and was febrile with elevated WBC. Time to onset is compatible with the role of vaccination. Patients medical include hypertension, hypothyroidism, cardiac arrhythmia, overactive bladder and A Fib. Hypertension, tachycardia can be attributed to preexisting condition. Further information regarding etiological work up, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
raised small red lump on right shoulder, a bit itchy; raised small red lump on right shoulder, a bit itchy; raised small red lump on right shoulder, a bit itchy; patient felt a little tired after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy), PRURITUS (raised small red lump on right shoulder, a bit itchy) and FATIGUE (patient felt a little tired after second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U7A21A and 0U5B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Osteoporosis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, IBANDRONATE SODIUM for Osteoporosis.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (patient felt a little tired after second dose). In November 2021, the patient experienced ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy) and PRURITUS (raised small red lump on right shoulder, a bit itchy). On 10-Apr-2021, FATIGUE (patient felt a little tired after second dose) had resolved. At the time of the report, ERYTHEMA (raised small red lump on right shoulder, a bit itchy), MASS (raised small red lump on right shoulder, a bit itchy) and PRURITUS (raised small red lump on right shoulder, a bit itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Biopsy: results not available (Inconclusive) Results not available. On 16-Dec-2021, CD4 lymphocytes increased: high (High) increased.         No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PEDVAXHIB (doses and routes were not reported) lot # K002747, expiration date 09-DEC-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L024129, expiry date: 17-JAN-2017 (route of administration, anatomical location and dose were not reported). No adverse effects were reported. Additional information has been requested.
continued pain in the area of the arm where shot was given when the arm is moved, or when lifting
Vaccinated 8 PM 11/30/2001. Retired at 10 PM. Slept until 9 AM December 1. Felt very tired and needed more sleep. Managed to get around very wobbly, light headed and sleepy. Had lunch at 12 noon, still tired and sleepy. Finally went to bed and slept soundly until 4:30 PM. After rising I felt better and was fine for remainder of night.
Presented with questions concerning egg and receipt of influenza vaccine. Advised she was told by her mother that when she was 10 years of age she had issues where her chest broke out in hives and her face swelled for 2-3 hours but resolved on its own. She did not require any medical intervention. The family rarely ate eggs so it wasn't until 2 years later when she ate mayo/egg breakfast she had similar symptoms and the family assumed it was the egg. She has never ben officially tested for egg allergy. She was unaware of above rx until she mentioned a skin reaction following her 9/30/2015 flu vaccine to her mom. Following this IM flu vaccine she advised her upper chest (above breasts) broke out in fine red dots 1 hour after IM flu vaccine. These symptoms lasted about 2-3 hours and self resolved. Advised she is VEGAN so doesn't eat eggs or items made with eggs. She did not received any flu vaccines for 2016 season until arriving at Immunization clinic who just administered FLUBLOK 2/7/2017 and referred to clinic for reported egg allergy.
This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 10-month-old female patient who received ENGERIX B pediatric (batch number 97Y27, expiry date 5th February 2021) for prophylaxis. On 30th May 2018 14:00, the patient received ENGERIX B pediatric (intramuscular) .5 ml. On 2nd June 2018, 3 days after receiving ENGERIX B pediatric, the patient experienced erythematous rash. On 9th June 2018, the patient experienced genital rash. The patient was treated with antibiotics nos. On 8th June 2018, the outcome of the erythematous rash was recovered/resolved. On an unknown date, the outcome of the genital rash was unknown. The reporter considered the erythematous rash and genital rash to be possibly related to ENGERIX B pediatric. Additional details were provided as follows: The patient received either 2nd or 3rd dose of ENGERIX B. The patient developed rash on face that consisted of red bumps. By Sunday, the rash was on her back. On Tuesday, the reporter took patient to the pediatrician and she was prescribed a steroid cream. The reporter was only able to apply cream to the patient's back. By Friday, the rash was started to resolve. The redness was going away but the bumps were still there. On Saturday, the reporter was started to break out again although her face had never fully resolved, but at the time of reporting the patient was started rash appearing on her hairline, chest, stomach, extending down into pubic area. The patient's back was almost all clear, had only two bumps left. The reporter took the patient back to her pediatrician and was prescribed a new antibiotic and was referred to a dermatologist. The reporter gave permission for the patient's physician to be contacted.
Received Expired Vaccine beyond MFG Expiry Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond MFG Expiry Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond MFG Expiry Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond MFG Expiry 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.     The vial did not undergo any temperature excursions. The vaccine administered on 02-DEC-2021 involved only 1 patient.  No treatment information was reported.
Itching and swelling and warmth of mid-triceps area on injected arm and redness and slight swelling of left lower eyelid.
2/29/12 pt had inflammation at the site that night along w/ redness, itching, hot to the touch, hard to the touch (size of a small saucer plate) body aches & painful.
Sneezing, coughing, nasal congestion, fever-Dr. has her on nebulizer treatment.
Intense ringing sound in left ear associated with a pounding headache lasting about ten hours. Patient self-medicated once with Motrin 800 mg. Ringing in ear and headache has not returned.
Several days after first dose of Covid-19 vaccine, she developed shingles of her left frontal face.
Cutaneous lesions following anthrax vaccine #2 consistent with delayed hypersensitivity reaction - see attached clinical summary. Developed dry, pruritic, raised rash that started on his feet, and later spread to his groin, axilla and wrists approx 2 weeks later. Treated with Calamine lotion with minimum relief. After he contacted clinic on 12/12/03, he started taking Benadryl prn, which has helped with the itching. Local: red, swollen, with minimal tenderness x 2-3 days; small knot under skin x 1 week.
Pt took ibuprofen after vax. By 9 pm fever started. In morning woke up with no fever. Went to nurse because of local irritation at injection site including redness, rash, warm to touch. Nurse recommended BENADRYL and ibuprofen. Per nurse doesn't look like cellulitis. Pt feels lethargic and has flu-like symptoms on last check/call by pharmacist.
Severe headache, malaise, arm tenderness, new joint pain in right middle finger, right second toe, right lateral ankle, with increased pain in left hip.
Patient reported that she came and got the vaccine but after several days noticed her arm swelling , redness , soreness , and hard to touch . Patient then reports all those symptoms worsening  with streaking down her arm . Patient stated she went to ER and they said it was allergic reaction and needed to have a report done
Itchy left arm; Swollen face; Red face; Head pressure; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure) and MYALGIA (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, 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 started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PRURITUS (Itchy left arm), SWELLING FACE (Swollen face), ERYTHEMA (Red face), HEAD DISCOMFORT (Head pressure), MYALGIA (Body aches) and HEADACHE (Headache) had not resolved. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
subcutaneous administration of Arexvy to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-AUG-2023, the patient received Arexvy (subcutaneous). On 28-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: subcutaneous administration of Arexvy to a patient).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 31-Aug-2023 A doctor of medicine asked how to proceed with this patient. The reporter did not provide information about Arexvy dose (lot number, expiration day). During the call permission to follow up was not requested. The patient received a dose of Arexvy vaccine subcutaneous which led to intramuscular formulation administered by other route.
Developed shingles 3 days after vaccination same side of body, different site. Treated with acyclovir.
Case previously recorded as MA2009-4186. Initial case report received from non-health care professional, via Novartis Medical Communication on 12 NOV 2009. An 18 month-old patient was vaccinated with 0.5ml of S-OIV FLUVIRIN (batch no. 1402123P1) i.m. 12 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-008108.
pt recv vax; later same day, fever &  cough became worse & v one time;
Around 6pm I started to get a really bad headache and all I wanted to do was lay down because I was getting very tired. About an hour later my entire body was aching and I couldn't stop shaking with chills. I couldn't move or turn in my bed without my entire body just hurting. Even the blankets and clothes I had on were hurting my body. I tossed and turned throughout the night. At midnight I woke up to use the bathroom and my face and eyes were hurting. Once I got into my bathroom and looked in the mirror, my face was a little swollen and my eyes were a little puffy. My forehead and cheeks were a little red so I took my temperature and I was running a fever of 102.
I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/28/2023 HTN (HYPERTENSION) I95.9 HYPOTENSION 4/27/2023 HTN (HYPERTENSION) I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/28/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I95.9 HYPOTENSION 4/27/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
after second vaccine: significant aches, pain in all joints unaided by naproxen. chills, significant headache and nausea
Information has been received from a nurse practitioner concerning an adult pt/medical center employee who on approximately 08/21/2001 was vaccinated with varicella vaccine. On approx. 08/21/2001, within 24 hrs of vaccination, the pt experienced three lesions. It was noted that the lesions were not the typical varicella, but that the lesions were vesicular. Additional info has been requested.
Balance issues: Vaccine was received Friday afternoon. On Saturday, approximately 23 hours after I received the vaccine I started occasionally  losing my balance when I went to reach for something.  This kept getting worse throughout the afternoon. I did take a nap for a couple of hours, but then on awakening (I think around 9pm the day after my vaccine (Saturday)) I could barely walk straight. As I was walking I would just start falling over and I'd have to put my hand out to catch me so I didn't fall to the ground. By Sunday morning it was mostly resolved, though I did have some occasional incidents that day (Sunday) and the next (Monday). For example I would be doing exercise at home (working out to a fitness game), and when moving my hands and feet all of a sudden I would start tipping over. If I planted my feet and just moved my hands I was okay. It is now Wednesday morning and I haven't had any balance issues since Monday night. Note that I didn't really feel dizzy, I just unexpectedly started falling over when this happened.
He got diarrhea; fever; He lost his taste, the sense of taste; the sense of smell; He has been having fever chills; body ache; headache; He has been having fever chills; body ache; headache; He lost his taste, the sense of taste; the sense of smell; his body is going weak; He is been having cough; This is a spontaneous report from a contactable consumer (patient wife). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Right on 05May2021 (at the age of 35-year-old) as dose number unknown, single for covid-19 immunization. The patient had no medical history and concomitant medications. The patient got Pfizer vaccine a week ago, so that's last Wednesday (05May2021) and he had been having fever since Monday (10May2021), so he was been having for almost four days now, he was been his body was going weak, he was been having a cough and today (13May2021) he got diarrhea, so they inquired if they should go to the hospital or what they should be doing in this case. The reporter stated that the patient had no inflammation, but he just had some, he had been having fever chills, body ache headache and he said he lost his taste, the sense of taste and the sense of smell in May2021. The reporter felt like it's still the same, It was the same, not improving at all. The patient had no other medication, but just right now for the pain, he was taking Tylenol. For fever Tylenol (Treatment). When probed if patient took any other medication other than Tylenol for treatment, reporter stated, He was been taking Pedialyte and just Tylenol at 500 mg, he only took one. Outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Leakage out of the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (Leakage out of the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (Leakage out of the injection site). At the time of the report, VACCINATION SITE DISCHARGE (Leakage out of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
As at 1:00 Am I woke up with a tremor all over my body, I couldn't get up, I had a lot of headaches, in the morning I could get up but I had almost no strength and so it lasted all day and also the next day (they were 2 days with symptoms), sore throat, temperature ,, dry cough were the same symptoms as when I got COVID but all the symptoms in 2 days, on the third day I went to the doctor prescribed me paracetamol 750, loratadine and salmeterol / Fluticasone powder, on Friday (it can be said that the vaccine was on Monday) I had the COVID test and it came out negative
Had measles after MMR vaccine Feb 13th fever to 102 and shortness of breath, 2/16, Admitted to hospital w/bilateral pneumonia, SOB got worse, fever to 101.2 cough, WBC on admission 2.6; Rash onset on 2/18, fever to 103 and rash worsens on 2/19, on 2/20 ARDS, patient was intubated, as of 2/21 patient is stable but no improvement after intubation; 2/23.
About 30 hours after receiving third dose of the Moderna vaccine I had a seizure. I had juvenile epilepsy when I was 17-21 and no seizures or any neurological events in 14 years and then had a violent seizure unlike any other that I previously had.