chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight reaction / pain in her right arm (at the injection site); felt tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Prior outbreak of shingles near her eye in last september). Previously administered products included Zostavax (receivied about 5 to 6 years before reporting).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 68 or 69 years old. The patient received her first and second dose of Shingrix at the same pharmacy. She always gets her shots in her right arm.. The patient had a slight reaction, She said that she had pain in her right arm (at the injection site) and also felt tired. Both of these events resolved after a couple days. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020AMR230563; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230563:same patient (2nd dose
Runny nose began very soon after my 2 year 2 weeks old daughter received the Nasal Flu Spray. It is still an ongoing problem along with wheezing as of today, nearly 6 months later.
Headache Grade 2. Improved with ibuprofen. Lasted 24 hours.
1 week after vaccination, the delayed  severe skin rush and soreness similar to this article(https://www.verywellhealth.com/skin-reaction-moderna-covid-19-vaccine-5115699). And long lasting psoriasis like skin dryness.
Large swelling occupying most of the left thigh which developed 1-2 days, post vax. Skin erythematous with a few vesicular eruptions. Swelling lasted 5-6 days but redness and oozing vesicles lasted 7-8 days and subsided. Indurated, dark pigmentated  10cm X 10cm patchy area. Itching lasted 2 weeks.
Patient stated he started to feel sick the day after he received his vaccination with chills and fever. Patient got progressively worse with sob, coughing up yellow phlegm. He went to the ED with worsening SOB. Preliminary eval in ED documented extensive pulmonary interstitial lung changes suggesting possible early ARDS vs pulmonary edema. Pt admitted to ICU with acute on likely chronic respiratory distress with associated hypoxia. He does not present with hypotension, fever despite findings of leukocytosis and increased lactic acid. BIPAP, breathing treatments, systemic steroids, empiric antibiotic treatment.
Case number PHEH2013US026252 is an initial spontaneous report received from a medical assistant on 20 Dec 2013 with a follow-up received on 31 Jan 2014. This report refers to an 11-year-old male patient. Examination showed that he was a well-child. His concomitant medications were not reported. He received only Men A lyophilized conjugate component of MENVEO, (batch number: M12127), reconstituted with a sterile diluent instead of MenCYW-135 liquid component intramuscularly in to the left deltoid on 17 Dec 2013. No adverse reaction reported following this administration error. Follow-up received from the medical assistant on 31 Jan 2014: Updated patient demographics (weight and height), medical history and site of MENVEO application.
Severe stomach cramps, severe diarrhea, feverish, nauseated, weak,  started Saturday night okay Sunday Monday, Tuesday morning severe stomach cramping, stabbing pain, severe diarrhea, hot cold flashes, very nauseated unable to eat. Sips of water.
administered the YF-Vax vaccine mixed with sterile diluent water instead of sodium chloride with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other health professional.  This case involved a 24-year old male patient who experienced administered the YELLOW FEVER VACCINE - US [YF-VAX] mixed with sterile diluent water instead of sodium chloride with no adverse event (Product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient had ongoing typhoid.  On 17-Dec-2020, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ091AA, expiry date: unknown) via an unknown route of administration in the right arm for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique.  On an unknown date, it was reported that reporter noticed that there was a vial of the diluent saline from the Yellow Fever Vaccine. Reporter became aware that the sterile water was used as a diluent with the Yellow Fever instead of the normal saline and yellow fever (Product preparation issue). No adverse events were reported. No treatments were needed. Prescriptions were not written in these cases.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Patient presents, hx of cardiomyopathy, squamous cell carcinoma- not currently being treeated-- COVID positive dx Tuesday c/o with body aches, SOB, denies fevers/chills. Patient was treated with antiviral yesterday. Patient denies CP.
Pain & swelling - left deltoid & tricep, left arm warm to the touch at injection site, headache - all symptoms started at 8:00 PM on date of injection. Symptoms worsened to moderate level by 9:00 AM on 8/23.
Swelling and redness to site within 45 minutes. Treated with 50 mg of Benadryl IV push.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of VAQTA 25/0.5 (Lot # M015290, expiration date 20-SEP-2017 and Lot 3 reported as M022924, expiration date 24-JAN-2018) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were 9 degree C for 1 hour 24 minutes. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Developed a rash on my body from kind of like head to toe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. After Pfizer Covid vaccine shot, patient developed a rash on body from kind of like head to toe and patient went to dermatologist, she does not think, because they did two biopsy, both of which showed that patient had an allergic reaction to something but she did not feel like it was related to the vaccine and has encouraged me to get the second shot and patient just thought to call her to get a little more information about this side effect that might be a rash. Outcome of the event was unknown.  Information about lot/batch was requested. Follow-up attempts are completed. No further information is expected.
Large welts on both legs, both elbows, back of neck, and buttocks. Benadryl given. Lasted approximately 24 hours.
felt achy; severe pain across her neck and back; severe pain across her neck and back; Initial information received on 01-Mar-2023 regarding an unsolicited valid non-serious case received via Patient.   This case involves an unknown age female patient who experienced felt achy, severe pain across her neck and back after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date in October 2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at (unknown: formulation, strength, dose, lot number, route, administration site) for immunization.  On an unknown date, the patient developed a non-serious event felt achy (pain), severe pain across her neck and back (neck pain, back pain) at unknown latency following the administration of FLUZONE HIGH-DOSE QUADRIVALENT.  It was reported that "Patient reporting, she went to her local pharmacy and was administered the product FLUZONE HD QIV back in OCT2022. Patient states she experienced some adverse reactions after receiving the vaccine. Patient felt achy, severe pain across her neck and back that lasted about 5 days. Patient said she used ice packs for the pain and states she did not have a temperature or any other signs. Patient was curious if the FLUZONE QIV NP also had traces of formaldehyde in it and informed patient there was also traces of it in that product as well. Patient satisfied with information provided. Patient gave consent for a callback to follow up if needed."    Action taken with FLUZONE HIGH-DOSE QUADRIVALENT was not applicable.  Corrective treatment:  used ice packs was received for all events.  At time of reporting, the outcome was Recovered on an unknown date for all the event lasted about 5 days.
Initial case was received from a consumer on 13 November 2012. A 62-year-old male patient, after fasting in the morning, received dose one of a right arm intramuscular injection of ADACEL, sanofi pasteur Ltd., lot number unknown, on 06 November 2012 at 10:30AM. The patient ate lunch. At 1:30pm on 06 November 2012, three hours post vaccination; the patient developed intestinal cramping and then passed out for four minutes. His wife, a registered nurse (RN) took care of him at home and he did not go to the emergency room (ER); however, the patient did contact his physician. The arm of the injection had soreness for one week. Laboratory, diagnostic tests or treatments were not reported. The patient past medical history included allergies to shellfish, iodine, and questionably thimerosal. Illness at time of vaccination was reported as none. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Arm swelling and warm; Warm; Chest pain; Dizzy; Tinnitus; Chills; Nausea; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Arm swelling and warm), FEELING HOT (Warm), CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and TINNITUS (Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced SWELLING (Arm swelling and warm), FEELING HOT (Warm), CHEST PAIN (Chest pain), DIZZINESS (Dizzy), TINNITUS (Tinnitus), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body ache). On 29-Apr-2021, SWELLING (Arm swelling and warm), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. At the time of the report, FEELING HOT (Warm) had resolved and CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and TINNITUS (Tinnitus) was resolving.            No relevant concomitant medications were reported. No treatment information was reported.
Pt devel seizures 2 mon after DTP. Shortly after the onset was dx with epilepsy
Kinrix was administered to a patient 3 months before the 4-years-old minimum recommended age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 30-AUG-2023, the patient received Kinrix. On 30-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a patient 3 months before the 4-years-old minimum recommended age).  The outcome of the inappropriate age at vaccine administration 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: 30-AUG-2023 The medical assistant called to report Kinrix was administered to a patient 3 months before the 4th years old minimum recommended age.  The facility was planning on administering Dtap alone and patient had 3 doses of Dtap and IPV before today´s (on the day of reporting) dose. The vaccine administration facility was the same as primary reporter The patient received Kinrix below the scheduled age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Chest pain for 2 days with EKG changes, elevated troponin and CRP consistent with myocarditis
Vaccine given 6/12/19. Patient seen 6/14/19 complaining of leg aches, tiredness, easy fatigability. Patient with history of anxiety and mom with hx of vaccine refusal.
Jitteriness in the evening, total insomnia that night, but no fatigue the next day.
PATIENT REFERS THAT INMEDIATLY AFTER VACCINATION HE STARTED FEELING NOT WELL WITH CHEST PAIN, TACHYCARDIA AND WEAKNESS. TOOK ADVIL AND LEFT FOR WORK. AT AROUND 4PM HE COLLAPSED IN HIS WORK. HE WOKE UP 8HRS LATER FEELING CONFUSED, COULDN'T MOVE THE LEGS, DESORIENTED, WITH CHEST PAIN AND WEAKNESS. HE WAS HOSPITALIZED.    11/17/09 Medical; records recieved for DOS 10/28/09-11/5/09. Final DX: Suspects viral syndrome, systemic erythematous lupus, rule out meningitis, Diabetes Mellitus di novo, Syncope .  C/o LOC at home. HA, weakness, somnolence, malaise x6 hours s/p vaccine. Looked ill. Immunosupressed. LE weakness. Possible conversion reaction suspected. Facial rash. Steroid therapy. Patient left hospital AMA after 8 days. Flu A/B neg. No neuro cause for sx detected.  ICD9 Codes: 780.2, 079.77, 322.7, 250.0
16SEP96 t103.104 next day red spots all over chest, achey, periods of uncomfortable & screaming p/nap approx 45min-1hr;achey & irritable dx by MD-MMR rx measles like dec appetite;
Pt developed attenuated varicella disease with approximately 15 lesions on 03/10/2001
27MAR96 1PM c/o not feeling well, flushed, broke out in hives;also became drowsy;brought to clinic @ 2PM given cola to drink;pt had not eaten lunch-became more alert;
Patient previous receiving the vaccine shot he alerted the medical staff and nurses since he almost every time he undergoes an injection he develops vasovagal syncope. Medical staff was prepared to deliver attention. Approximately two minutes after having the vaccine, patient developed lightheaded and faint. He had  self-limited systemic hypotension , which promptly resolved as well patient mentation and alertness once he regain consciousness. Afterwards patient only complained of mild nauseas that as well resolved previous leaving the observation area of the clinic. Patient previous leaving the vaccination clinic recover himself completely denied any constitutional symptom including chest pain, headaches, nauseas or vomiting. Blood pressures returned to normal limits. No medication nor further test were needed, only vital signs monitoring.
Pt had SOB for the past week. He recently had the stomach flu 2 weeks prior (he and family tested negative for COVID-19). He had fever, vomiting NBNB, diarrhea for several days which then improved. He however did not improve all the way to his baseline and started to feel short of breath with exertion moving around the house. He was unable to lie down flat and had to sleep semi-upright. He was seen by his PCP and prescribed prednisone and azithromycin on 3/1. He did not improve and came to town for his covid booster shot and decided to come in to the EC.  He states noncompliant with lovenox because he left it at home and did not expect to stay in town for more than 24 hrs. Patient is on O2 at home and has been having increased need 4L-- >5L. Patient also states he feels his "afib is all over the place." Patient also states rue arm pain. In ED, went into Afrib with RVR.
Developed a nodule at the injection site; Experienced soreness; This case was reported by a consumer and described the occurrence of injection site nodule in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th November 2021, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 20th November 2021, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site nodule and pain in arm. On an unknown date, the outcome of the injection site nodule and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site nodule and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 as follows: The reporter was the mother of the patient The reporter stated that the patient received his first dose of Bexsero intramuscularly into his left arm and immediately following the injection, he experienced soreness in the arm and developed a nodule at the injection site. The nodule and soreness took 30 days to resolve. The reporter did not have the lot or expiration date of the administered vaccine. The reporter did not consent to follow-up.
Information has been received from a physician concerning an 8 year old female who on 27-MAY-1999 was vaccinated SC on right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 629263/0308J). It was reported that the patient developed less than 50 lesions. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a 1-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004460: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.
8/7/09- 4 y.o. Received immunization Booster at medical center. Returned 8/12/09 for mild irritation vs cellulitis (L) arm at site for varicella. AUGMENTIN prescribed - Seen 8/18/09 at medical center. Dx'd torticollis seen 8/19/09 with difficulty walking. Referred to ER Hosp. D/C'd 8/24/09. Was informed MRI was negative, D/C diagnosis arthritis. S/P vaccination- plan to F/U to Rheumatology in Sept received a call 8/24/09-readmitted to clinic- difficulty walking unable to turn head.  10/5/09 Hospital records, DC summary received, DOS 8/19/09 to 8/21/09. Assessment: Post-Vaccination Arthralgia. After vaccination large erythematous area on arm. Bump on right upper extremity. Patient presents with 2 day h/o neck pain, back pain, and leg pain. Difficulty moving neck. Difficulty in walking. Wide-based gate, shuffling. Difficulty getting up to stand. Stiff gait. Ataxia.
Pt was given a "double" dose of booster. She received .5mL instead of .25mL.
Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 29 year old female patient. On 13-APR-2017, she was vaccinated with VARIVAX lot # M041513, expiration date 11-OCT-2018, which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received.; Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008915: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008922: