chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose number=3; Sore arm muscles / arm/muscle extremely sore; Sore arm muscles / arm/muscle extremely sore; Extreme fatigue; Nausea; Lethargic; Headache; arm/muscle extremely sore/rash.; arm/muscle extremely sore/rash.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female non-pregnant patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: FF2587, Expiration date was not reported), via intramuscular in arm left on 05Oct2021 at 15:30 (at the age of 73-year-old) as a dose 3 (booster), single for COVID-19 immunization. The patient's medical history included Lupus. The patient had known allergies were reported as none. Past drug events included corticosteroids, high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, rituximab, etanercept and experienced weakened immune system. The patient's concomitant medications in two weeks included hydroxychloroquine, citalopram, methotrexate, Atvo, all were taken for an unspecified indication. The patient had received other vaccines within four weeks prior to the COVID-19 vaccine that included influenza vaccine inact sag 4v (FLUAD QUAD, Batch/Lot number: 70461-0121-03), via an unspecified route of administration in arm left on 16Sep2021 as a dose 1, single for an unspecified indication. Historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL9262, Expiration date was not reported), via intramuscular in arm left on 28Jan2021 (reported as at noon) as a dose 1, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EN6200, Expiration date was not reported), via intramuscular in arm left on 18Feb2021 at 11:30 AM as a dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Oct2021, the patient experienced sore arm muscles / arm/muscle extremely sore, extreme fatigue, lethargic, nausea, headache, arm/muscle extremely sore/rash. Stated that, on an unspecified date in Oct2021, the patient experienced side effects of booster shot 3-4 days, lethargic, headache, arm/muscle extremely sore/rash and dose number=3, nausea on 05Oct2021. Stated that, weakened immune system, use of medications that suppress the immune system (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine and biologic therapies like rituximab and etanercept). Treatment was not received for the events. The specific relevant test for thromboembolic events with thrombocytopenia was reported as none. The outcome of the events sore arm muscles / arm/muscle extremely sore, extreme fatigue, nausea was recovered on an unspecified date in Oct2021 and for lethargic, headache, arm/muscle extremely sore/rash was recovered on an unspecified date in 2021 while for the other event was unknown.  Follow-up attempts are completed. No further information is expected.
Patient received regeneron on 12/2 around 3:15 pm in the thighs as well as abdomen and reports yesterday around 7pm she develped red blotchy and itchy rash on the front of her neck as well as behind her left ear. She tried not to scratch it and the rash had resolved spontaneously. When she woke up in the morning. Patient states today (12/3) she  developed red blotchy and itchy rash between her right middle and ring finger as well as on her right calf. She denies facial swellig, wheeze, difficulty breathing or talking, sensation of throat swelling.
heart palpitations; skin rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 76 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 17Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 4 (Booster), single, Lot: FK9893, Anatomical location: right arm), administration date: 13Oct2022, when the patient was 76-year-old, for Covid-19 immunization; bnt162b2 (Dose 3 (Booster), single, Lot: FF2593, Anatomical location: right arm), administration date: 21Oct2021, when the patient was 75-year-old, for Covid-19 immunization; bnt162b2 (Dose 2, single, Lot: EN6205, Anatomical location: right arm), administration date: 08Mar2021, when the patient was 74-year-old, for Covid-19 immunization; bnt162b2 (Dose 1, single, Lot: EN6201, Anatomical location: right arm), administration date: 13Feb2021, when the patient was 74-year-old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset Sep2022, outcome "not recovered", described as "heart palpitations"; RASH (non-serious) with onset Sep2022, outcome "not recovered", described as "skin rash". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, rash.  Additional information: Patient does not take any medications, was just an old lady. She had blood tests done every 6 months. Patient had Flu shot same day as Covid booster. Previous doses of Covid vaccine were all Pfizer. Patient got heart palpitations that didn't last a long time. Heart palpitations came and went quickly, maybe 30 seconds, a minute and, will pass. Heart pounds rapidly, 30 seconds, a minute, then stops. It had been waking her up at night. It was usually later in afternoon, when she starts getting tired during the day. She noticed more when it wakes her up at night. Got the shot, within 1 or 2 weeks after the shot, this  has been reoccurring. First thought, whatever then, it kept going and had rash in both arms, and lower part of legs. It had been reoccurring since then, daily, nightly. She also had gotten rash on arm, was persistent, comes and goes. Size of rash varies, will come out red then, goes away then, new ones come out and, are reoccurring. Rash started same time as heart palpitations, within 1 or 2 weeks after the shot. Patient wanted to know how long they will last. It was definitely a reaction the shot. She was wondering if this will ever go away. It had been months, nothing has changed. She did not know if it there was a bad batch there or what. Treatment: Nothing because, nobody knows why it is, is definitely from the Covid shots. It is kind of uncharted territory.
Employee told employee health "got fever on Wednesday evening was off and on till Friday at 3pm, and Wednesday evening got: really tired, bad body aches, chills and headache and those all lasted till Friday at 3pm. I got the vaccine Wednesday morning/midday."
Initially admitted for CAP with documented low suspicion for COVID.COVID + 7/20. Completed vaccine Jan 2021. Treated w/ O2, remdesivir, steroids, zinc, vit-c. Improved and discharged home.
Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22-03395) and concerned a 67-years-old female patient.  The patient's concurrent condition included diabetes. The patient's concomitant medications were not reported.  On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. The batch number reported was 346341, and expiration date 28-Apr-2023. The reporter stated that the vaccination went normal as always.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient developed nausea and diarrhoea. It was reported that the patient was given 7up and acid and couple of them received anti-diarrhoea pills as treatment.   On the same date, the patient recovered from the events of nausea and diarrhea. The patient no longer had these symptoms.   The reporter did not provide casualty assessment.   The reporter assessed the case as non-serious.  This case is linked to the cases 202204733, 202204734, 202204735, 202204737, 202204738, 202204739 and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Information has been received from a Licensed Visiting Nurse (L.V.N) concerning a 68 year old female patient with intravenous (IV) iodine allergy, codeine allergy, allergic to "TALWIN", sulfonamide allergy and allergic reaction to antibiotic "CEFTIN" and allergic to steroids who on 13-SEP-2007 was vaccinated IM with a dose of PNEUMOVAX 23 lot #657525/0554U. On 13-SEP-2007 the nurse reported that patient developed a "cellulitis like" injection site reaction after receiving a dose of PNEUMOVAX 23. The patient reported that on the day of the vaccination, the injection site was red, so she took some BENADRYL, the next day, she noticed that the injection site was swollen and inflamed. The inflammation eventually spread from deltoid down to her elbow. The patient was sent to an emergency room and released. Caller was requesting a lot check of this vaccine due to the patient having adverse experiences. No further information is available. The patient was recovering. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information is not expected.
vaccine gave me shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient stated that, Shingles vaccine gave him/her shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Face and lip swelling. Tightness in throat under jaw. Went to Urgent Care 3 days later, prescribed Steroids.
Pt called to report her symptoms. States she received her first dose of the Moderna vaccine on 03/09/2021 and that she had mild symptoms, but then starting 03/16/2021 she developed a "hard bump" that was red, swollen, and itchy, and that her whole right arm feels achy and numb and she cannot hardly use it. States she went to urgent care for it on 03/18/2021, but they didn't do anything except tell her to take some Benadryl. When pt called, advised her to alternate between heat and ice for her arm to help with swelling and pain, and to take some Benadryl tonight when she goes to bed to see if that helps for tomorrow morning. Also advised her to call her PCP to see what their recommendation would be.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Initial report received on 25 September 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 4 year old, male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of PENTACEL: lot number C3199AA on 10 October 2008, lot number C3183AA on 11 December 2008, and lot number C3180AA on 12 February 2009; and 1 dose of DAPTACEL (lot number C2999AA) received on 12 August 2009. Approximately 3 years after the last dose, on 05 August 2012, the subject developed cold-like symptoms followed by a cough that began on 08 August 2012. He then developed a paroxysmal cough without a whoop on 13 August 2012. He also experienced posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 22 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 22 August 2012. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
The patient was vaccinated on 08/25/2003.  2 days after he presents rash on trunk and extremities.  He received Benadryl 08/27/2003 and hydrocortisione cream.
rash on front of body in about 24hrs afrer 1st shot.   Chills and achy body after 2nd shot along with rash on front of body again.
No other AE details; TE vaccine; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 09-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 5 milliliter once, lot # W025273 and expiration date 10-AUG-2024 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 70 degree fahrenheit  for 9 minutes on 02-MAR-2023; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2306USA008333: US-009507513-2306USA008772: US-009507513-2306USA008590: US-009507513-2306USA008760: US-009507513-2306USA008606: US-009507513-2306USA008802: US-009507513-2306USA008793: US-009507513-2306USA008746: US-009507513-2306USA008019: US-009507513-2306USA008077: US-009507513-2306USA007917: US-009507513-2306USA008479: US-009507513-2306USA008071: US-009507513-2306USA008567: US-009507513-2306USA008784: US-009507513-2306USA008836: US-009507513-2306USA008267: US-009507513-2306USA007844: US-009507513-2306USA007881: US-009507513-2306USA007905: US-009507513-2306USA008075: US-009507513-2306USA008108: US-009507513-2306USA008171: US-009507513-2306USA008487: US-009507513-2306USA008508: US-009507513-2306USA008515: US-009507513-2306USA008543: US-009507513-2306USA008829: US-009507513-2306USA008388: US-009507513-2306USA008400: US-009507513-2306USA008402:
Information has been received from a health professional, who was contacted by a school nurse, concerning a 5 year old female with no past medical history who on 09/10/2001 at approximately 11am was vaccinated with the first dose of varicella vaccine in the left leg. There was no illness at the time of vaccination. On 09/17/2001 at 7:30am, the pt developed a varicella like rash on the neck and shoulder which was noted to be a rash of four spots on the back of neck-suprascapular area. The pt's mother noted that the rash was weeping. the areas were not clustered there were singular raised scabbec centers. The pt was not seen by a physician. On 09/19/2001, the pt recovered. It was reported that the pt's brother also developed a varicella like rash following vaccination with varicella vaccine. The initial report indicated that three children developed the reaction; however, follow-up revealed that only these two children were affected. No further info is expected.
night sweats, chills, severe headache, body aches, fever (temp not taken)
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms of 50% or more.  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 12 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case patient 1
Patient called pharmacy on 6/5/2019 and reported developing a shingles rash out break.
This case was reported by a other health professional via call center representative and described the occurrence of gianotti-crosti syndrome in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included nebivolol hydrochloride (Bystolic) and mometasone furoate (Nasonex Nasal Spray). In June 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, less than a week after receiving SHINGRIX, the patient experienced gianotti-crosti syndrome, papular rash, painful rash and blister. On an unknown date, the outcome of the gianotti-crosti syndrome, papular rash, painful rash and blister were not recovered/not resolved. The reporter considered the gianotti-crosti syndrome to be related to SHINGRIX. It was unknown if the reporter considered the papular rash, painful rash and blister to be related to SHINGRIX. Additional details were provided as follows: Within 3 to 5 days after receiving vaccine, the patient experienced papular painful rash with blisters which was formally diagnosed as a rare skin condition (Gianotti Crosti Syndrome). The patient's symptoms required an office visit to his primary care physician as well as the dermatologist but did not require an emergency room visit. The patient would not be receiving the 2nd dose in the series due to the symptoms. The patient was receiving treatment from both his dermatologist and primary care physician as well as the reporter thought that the symptoms and subsequent syndrome diagnosis due to the SHINGRIX. No further information beyond what was documented above.
I caught an allergic reaction when I got my first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I caught an allergic reaction when I got my first vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (I caught an allergic reaction when I got my first vaccine). At the time of the report, ALLERGY TO VACCINE (I caught an allergic reaction when I got my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Body aches; fever - 100.8 degrees; chills; nausea; tired; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9263) on his left arm, via an unspecified route of administration on 25Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and covid. The patient's concomitant medications were not reported. The patient experienced Body aches, fever - 100.8 degrees, chills, nausea, tired; all on 26Jan2021 06:30 AM. No treatment was received for the events. The outcome of the events was recovered on unspecified dates.  No follow up attempts are possible. No further information is expected.