chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Uveitis flare up/ eye flare; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis flare up/ eye flare) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE) and Panuveitis (NON-INFECTIOUS INTERMEDIATE, POSTERIOR AND PANUVEITIS). Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced UVEITIS (Uveitis flare up/ eye flare) (seriousness criterion medically significant). At the time of the report, UVEITIS (Uveitis flare up/ eye flare) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an adult female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was not resolved. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was not resolved. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Had Covid19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had Covid19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (got covid on a cruise). Concurrent medical conditions included Blood pressure abnormal.   On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Had Covid19). At the time of the report, COVID-19 (Had Covid19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication included blood presure medication.  Patient's height was reported as 5 foot 1 inch.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred 7 months 18 days after the third dose of mRNA-1273 vaccine. There is Inappropriate schedule of product administration was noted in the case with dose interval of 38 days (interval between dose 1 and dose 2 longer than 35 days). SARS-CoV-2 test was positive after 7 months 18 days after the current vaccination. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement   This case was linked to MOD-2021-025671 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred 7 months 18 days after the third dose of mRNA-1273 vaccine. There is Inappropriate schedule of product administration was noted in the case with dose interval of 38 days (interval between dose 1 and dose 2 longer than 35 days). SARS-CoV-2 test was positive after 7 months 18 days after the current vaccination. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Follow up information received from the reporter on 01-Mar-2003 provided patient's date of birth and lot number. Information regarding FluMist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a 49-year-old male who received a dose of the vaccine and subsequently developed the "flu." Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on an unspecified date. Dose regiment was not provide. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced the "flu" (influenza). No additional information was available at the time of this report.
Varivax Vaccine (Lot #0786R) given 6/6/06 @HD. Patient developed Acute Varicella (Mild) on 6/16/06. No complications.
Site of injection had blisters small and large extending over 1"oval area. Swelling and redness and firm area 2 1/2" diameter. Lesser erythema of he (Rt) upperarm Posterior lateral aspect. increased temp and pain 2/10. 6/21/07 follow up -The swelling decreased
Injection-site pain/soreness/tenderness. Myalgia. Cellulitis. Treatment-antibiotic/NSAIDs.
4AM temp 105.2 27AUG91 APAP given; Fever & APAP only also 1 tsp of Phenabarb @ 4AM (hx fever sz); 101.5 p/initial tx until p/Wed PM;
9-21-21 Sore, swelling and red shoulder at nite; 9-22-21 posterior neck soreness with profuse sweating there and into chest and back (temp 97.3 F), weakness thru out esp sore, hot knees with pain in joints, and lateral esp right greater trochanter with  hot pain . Difficult to walk. Some blacking out at computer when reporting to doctor.  Much tossing and turning at nite. Poor sleep. Went back to bed after plant watering and slept until 3p. Took 2 Ibuprofen 400mg x2 in afternoon and pm. Somewhat better that evening . Better on 9-23-21. This reaction was worse than my 1st COVID19 vaccination
Received the Seasonal Influenza Vaccine around 11am and around 4pm states that she began having chills, shaking all over (states she shook so bad she thought she would fall out of the bed), and vomitted x 1. States she then went to bed at 5pm and woke up at 8am the next morning and symptoms had resolved.
Patient had a reaction from the Tdap shot, she had swelling and pain at site (site was hard and numb) then pain started to radiate to her whole arm and then to her neck (neck was stiff), she went to urgent care and they gave her pain medication and she was also prescribed prednisone 50 mg daily for 5 days. This all happened over a course of a week. Patient states she is getting better.
He has complained of muscle pain in his left arm since October. Motion aggravates the pain, slightly relieved with NSAID use.
Patient was vaccinated around 10:55 AM. Within a couple of minutes she started feeling lightheaded, sweaty, and had blurry vision while sitting. She reported no history of blood sugar issues, but she said she only had some donut to eat today. I initially gave her three glucose tablets and a bottle of water, which she sipped. She reported feeling better within a few minutes. I checked her blood pressure at 10:59 AM. It read low at 81/44 with a pulse of 73. But, I checked again since I doubted the accuracy of the reading. The second reading was 101/56, with a pulse of 79. Patient said she was feeling better, but continued to sit. I gave her one more glucose tablet to equal a total of 16 g of carbs given. She sat for at least fifteen minutes until she felt well enough to get up and shop. She checked back after shopping and said she was fine.
Woke up 12/3/09 with itchy raised rash. Rash on L deltoid, L side of face, L side of abdomen and around to back, L leg and foot. No fever. Used Benadryl topical and then later Benadryl po. Rash resolved on 12/4/09.
hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 31-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 5th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season .5 ml. On 5th October 2020, 8 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2020-2021 season in left arm. Approximately 8 hours after receiving the Fluarix Quadrivalent 2020-2021 season, the patient experienced hives.  The patient took children's Benadryl and the symptoms resolved. The reporter consented to follow up.
Nurse had a topical exposure to the vaccine, the content reached her skin for a couple of minutes; Case reference number US-BN-2022-003828 is a spontaneous case received from other health professional on 04-Oct-2022 via  Communication (reference number: USBAV22-1621) and concerns a patient of unknown demographic.  The patient's relevant medical history and medication details were not provided.  On an unspecified date, nurse had topical exposure to the vaccine (explicitly coded as Occupational exposure via skin contact with product). The content reached her skin for a couple of minutes, with no open areas of the skin. The patient washed hands for ten minutes. There are no more details if this was related to the product issue.   At the time of this report, it was unknown if the patient experienced any adverse event.  As reported, it was deemed it not to be a PQC after all since there is no identified product quality defect.  Additional information received on 05-Oct-2022 form Bavarian Nordic included confirmation that this is not PQC report.  Additional information received on 05-Oct-2022 form Bavarian Nordic included local BN case ID.; Reporter's Comments: A patient of unknown demographics was about to be vaccinated with Jynneos vaccine, and as reported, nurse had topical exposure to the vaccine, which is considered as occupational exposure via skin contact with product. The content reached her skin for a couple of minutes, with no open areas of the skin. At the time of this report, it was unknown if the patient experienced any adverse event. Occupational exposure to product is considered as listed per company convention. The patient's relevant medical history and medication details were not provided. Occupational exposure to product has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was about to be vaccinated with Jynneos vaccine, and as reported, nurse had topical exposure to the vaccine, which is considered as occupational exposure via skin contact with product. The content reached her skin for a couple of minutes, with no open areas of the skin. At the time of this report, it was unknown if the patient experienced any adverse event. Occupational exposure to product is considered as listed per company convention. The patient's relevant medical history and medication details were not provided. Occupational exposure to product has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
My son developed fever of 100.4, rigors and vomiting (twice). We gave him Tylenol. The next day (11/7/2010) he developed hematuria (gross) by 4:00 PM. We gave him fluids and on 11/8/2010, we took him to the ER. The fever and vomiting subsided at this time and he received 1L saline IV in the ER. Urine dipstick was positive for RBCs (moderate) and for a proteinuria > 300 mg. No WBCs, bacteria or casts were found in the urine. Urine cultures were negative. Liver functions were overall normal with only a very slight elevation in AST. He also was found to be severly neutropenic with a WBC; 1.1 and an absolute neutrophilic count of 300. Platelets and hemoglobin were within normal limits. The next day, the hematuria start to resolve (RBCs by urine dipstick was found to be 10-11) and disappears within 3 days. We were left with persistent proteinuria in the range of 1-2+ (10-20 mg/ dL) for 2 weeks (resolved on 11/24/2010). At the same time, repeated labs shows: WBC improved to 3.1 and ANC to 900. All work-up (C3, ESR, BUN and creatinine) were normal.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received SHINGRIX. On 18th May 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 18th May 2018, the patient experienced shivering, feeling cold, headache, nausea, stomach pain, cold and sweating. On 21st May 2018, the patient experienced difficulty breathing. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the shivering, feeling cold, headache, nausea, stomach pain, cold and sweating were recovered/resolved and the outcome of the difficulty breathing was unknown. The reporter considered the pain in arm, shivering, feeling cold, headache, nausea, stomach pain, cold and sweating to be related to SHINGRIX. It was unknown if the reporter considered the difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At around 6:00pm or 7:00pm on the night of less than a day after receiving the vaccination, the patient started feeling cold, shivering, and freezing and at night the patient woke up soaking wet and reported that he had to change his t-shirt three times during the night. Then he began to feel nauseous, stomach pain, and developed a violent headache which would not go away. On 21st May 2018, 3 days after vaccination the patient could not take a deep breath last night, because he would get stabbing pain in his abdomen. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient also reported having a sore arm from the vaccination which still had not resolved. It felts like someone had punched him in the arm. The patient gave consent to contact the physician and provided contact details for the same.
This patient received her MMR, HIB, and Varivax vaccines on 02/12/01. On 03/07/01, she developed a low grade fever, parotid swelling without erythema, and her stenosis ductus was slightly swollen. Resolved after 4 days.
After vaccination patient experienced soreness and and small bump at injection site for approximately 1 month. Now the pain comes and and goes sometimes. Advised patient to see a physician. According to pt still has a small bump, can't be seem but she can feel it. Pt did not report this until 6wks post vaccination (today).
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. From 14-APR-2016 until 02-DEC-2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # K016966, expiration date: 10-MAY-2017 and lot # L040460, expiration date: 27-MAY-2017 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The vaccine doses were exposed a temperature of 1 °C for 68 cycles for a time frame of 12 hours each time; data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006775: US-009507513-1701USA007900.
Scratchy throat, extreme soreness and reduction of movement in left arm that spread to entire left side of body. Low grade fever. Reported to facility who prescribed Prednisone which causes heart rate to speed up. Decided not to take because of high blood pressure. Took Ibuprofen instead. Extreme pain subsided on Saturday late in the day, 4/5/12. Sunday developed dry cough which worsened through Monday morning and throughout the day. Monday night threw up mucous after several bouts of coughing. Lungs feel inflamed. In process of contacting Dr. again to receive antibiotics or Vitamin D, C.
5 to 7 days after receiving vaccines, began breaking out, worse than normal and continued to get worse. (Face) Typically only 1 to 2 pimples. Breakout continued to worsen and at 1 mouth is grouped in individuals pimples with pustules that ooze at times. Appears to be grouped to left side of face near hairline above ear to face, head and between brows.
About 2 days after my 2nd dose, I started feeling really tired and had a dry cough and that progressed, and I started getting pressure in my lung area, so I got more concerned because my cough got worse. I went into my doctor's office and when she listened to my lungs, she could hear a wheeze. She sent me for lung x-ray, but it didn't come back that I had pneumonia and they didn't think it was COVID at that time, but my breathing got harder and harder, and the wheeze got more and more. I was just on albuterol at first, but within 2 weeks after doctor's appointment, they called me back in because it was harder to breathe. I got another lung x-ray, but it looked the same, and they called it bronchitis and could see irritation. They put me on Budesonide and Albuterol, and it was like that for another 6 weeks and I had to increase it and had to use a nebulizer and I started using both formulas and that took about 4 weeks doing 4x a day. I went to pulmonologist at that point, and she took me off Albuterol and put me on Symbicort 2 puffs 2x a day and I'm still on that and I'm breathing a lot better, and my lungs look better but there is still irritation. It's still ongoing but it's not as bad. It's under control and I am coughing up gooey yucky stuff from my lungs and I am doing that when I wake up and I've never been a smoker. I do have a history of asthma, but I haven't had any episodes of it in 5 years until the vaccine. There was also crushing fatigue and days that I would get out of bed, and I just couldn't seem to do anything and the brain fog and absolute exhaustion and that could be that I wasn't getting a lot of oxygen and that lasted until about a month ago and little by little it has gotten better.
She had throbbing pain radiating from the back of her neck to the elbow in the arm that she received the injection; chills; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "She had throbbing pain radiating from the back of her neck to the elbow in the arm that she received the injection"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Therapeutic measures were taken as a result of pain. Additional information: It was reported that patient had an adverse reaction. She had throbbing pain radiating from the back of her neck to the elbow in the arm that she received the injection and it was getting worse after 3 days. ES TYLENOL did not help with the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in shoulder which has been ongoing since the vaccine.  Limiting the mobility of my left arm.
Patient was administered ZOSTAVAX in error when the VARIVAX vaccine was ordered. No adverse reaction noted and clinical follow up via phone call the next day with father who reported no adverse reactions.
Patient was very nervous about receiving the vaccine and has a fear of needles, dad confirmed and was with patient the whole time. About 15 minutes later, patient was complaining of a tingling left hand and arm, and tingling tongue. She said she could breath without any issues, but was feeling light headed. 911 was called with moms and dads consent. With moms consent, patient got one dose of benadryl 25mg tablet. Paramedics came and took the patient.
Information has been received from a health professional concerning a 11 year old male patient with NKDA and type I diabetes mellitus who on 07/06/01, at 4:00 pm was vaccinated SQ in the left arm with a first dose of varicella virus vaccine live. concomitant vaccine therapy that day at 4:00 pm included MMRII and  hepatitis be vaccine, recombinant. Other concomitant medication included insulin and mometasone furoate (Nasonex). There was no illness at the time of vaccination. It was noted that the patient had no recent exposure to chickenpox or shingles and there was no rash at the injection site post vaccination. It was also noted that there was no immunosuppression. On 07/11/01, the patient developed a rash of approximately 50 lesions on his head, trunk, upper arms and legs. the rash was described as discrete erythematous papules and a few pustules ("not clear fluid"). He was afebrile and had no other systematic symptoms. The rash was described by the patient's mother. It was noted that the child had not yet been seen by the doctor's office. Follow up information has been received from a health professional who reports a skin culture  was done of a pustule  and grew a gram negative rod that was not a soeudomonas. A vesicle and papule were sent  for VZV analysis. The specimen was adequete and there was no VZV identified. It was confirmed by Columbia University that the specimen was negative for VZV. It was noted by the reporter that he thought the patient "had a folliculitis and this rash was unrelated to the vaccine".  The patient has recovered.
Itching red skin larger than half dollar at shot injection  site began Day 8 after shot.