chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"still sick today"; couldn't get out of bed; left arm swelling; joint pain; muscle pain; chills; nausea; vomiting; fever; fatigue; headache; felt a "sharp pain" during the vaccination; Painful arm; felt like they "stuck it in the bone"; felt like the vaccine "went to her heart; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed) and VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Osteoarthritis and Seafood allergy (Shellfish). Concomitant products included PARACETAMOL (TYLENOL) for Fever, IBUPROFEN and NAPROXEN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (MOTRIN [IBUPROFEN]) (unknown route) dosage form. On 17-Apr-2021, the patient experienced BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination) and VACCINATION SITE PAIN (Painful arm). On 18-Apr-2021, the patient experienced BEDRIDDEN (couldn't get out of bed), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). On 19-Apr-2021, the patient experienced ILLNESS ("still sick today"). At the time of the report, BONE PAIN (felt like they "stuck it in the bone"), DISCOMFORT (felt like the vaccine "went to her heart), ILLNESS ("still sick today"), BEDRIDDEN (couldn't get out of bed), VACCINATION SITE PAIN (felt a "sharp pain" during the vaccination), VACCINATION SITE PAIN (Painful arm), VACCINATION SITE SWELLING (left arm swelling), ARTHRALGIA (joint pain), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had recovered, recently had a physical examination which went well, and reported adverse events had subsided. Patient had nothing further to report.  No treatment drug information are reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow up received. TCR attached, updated outcome of all events as recovered.
left arm swollen; left arm redness; left arm hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and skin warm. On an unknown date, the outcome of the swelling arm, erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid. The patient's left arm was swollen, red, and hot to the touch.  The reporter did not provide any additional details.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Lymphadenopathy of OPPOSITE side of body (of vaccine given)--- occipital, cervical and axillary. Onset within 24hrs. Improved within 72hrs. No additional symptoms; remaining ROS and physical exam NORMAL.
A pt experienced a 3 day course of diffuse vesicular lesions with some macropapular lesions. (n<50)
swollen lymph nodes armpit; itchy skin; mild headache; mild chills; This is a spontaneous report from a contactable consumer.  A 67-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 16Feb2021 09:00 AM (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus and Chronic lymphocytic leukaemia from an unknown onset and unknown ongoing and concomitant medications include Insulin Glargine (TOUJEO), Metformin, Dapagliflozin Propanediol Monohydrate (FARXIGA), Simvastatin. On 21Feb2021 06:00 AM, after the vaccination, the patient experienced swollen lymph nodes armpit, itchy skin, mild headache, mild chills. Patient received treatment with antihistamine and Tylenol. The events assessed as non-serious. No other vaccines were taken in four weeks. Patient was not found covid prior vaccination. Patient was not tested covid post vaccination. The outcome of the events was recovering at the time of this report.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Moderna vial had been punctured for around 50 hours when vaccine was administered. Vaccine was not expired and had been kept in a refrigerator the entire time it had been opened up until it was administered. The patient did not experience any adverse outcomes and said she "felt the same as when her first two shots of Moderna were given".
This literature marketed report as received from a physician refers to 7 patients of unknown demography. The patient's current condition included STAT3 deficient hyper IgE syndrome. On an unknown date, the 7 patients were vaccinated with PNEUMOVAX 23. On an unknown date, 7 patients experienced large local cellulitis-like reactions. The outcome of the event was unknown. The reporter assessed the causality of the event to be related to the suspect therapy. A copy of the published article is attached as further documentation of the patient's experience. This case is linked to MARRS case # 1502USA008276 and case # 1502USA008320 linked from the same literature. Additional information is expected.
Recieved booster anthrax on 2/2/09.  On 2/3/09 soldier presented with injection site erythema and itching. Treated with antihistimine.  On 2/4/09, symptoms became severe, and was therefore give burst dose steroids: prednisone 60 mg PO for 4 days.   Sxs abated.  Soldier now recalls that he had similar reaction at last annual booster. RECOMMEND PERMANENT EXEMPTION FROM ANTHRAX.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: (unspecified date) 98.5, notes: My fever on first day was 98.5 or something menial like that and then never had another one; SARS-CoV-2 test: (unspecified date) Positive, notes: after day ten after i tested positive and had completed paxlovid on day twelve my symptoms came back worse; (28Jul2022) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Jul2022 to 25Jul2022.  Clinical course: It was reported that after day ten she tested positive and had completed paxlovid on day twelve her symptoms came back worse. She had not yet even tested negative but had completed her ten day isolation and was testing regular. There was never a negative test but symptoms came back. She also never had a fever and still have not. Her fever on first day was 98.5 or something menial like that and then never had another one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I started experiencing symptoms around 9 pm.  Headache, nausea, dizziness,  fatigue, generalized body pain, soreness/redness, and swelling at the injection site, moderate to severe pain lasted 3-4 days. Today is the 4th day,  the headache,  fatigue, and generalized body pain are subsiding, but the blurry vision from my second shot returned yesterday 05/05/2022.  I called a friend of mine who is a doctor and he instructed me to take Tylenol or Advil, then if symptoms worsen to call my doctor or go to the emergency room.   Treatment Tylenol 500mg  ( 2 cap) every 4-6hours cold compressor for injection site  Consumed lots of water and getorade Rest
Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age female patient who experienced rash, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date, dose, route and site of administration were not reported). On an unknown date the patient developed a non-serious rash, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the patient had rash for days after receiving Flu shot.  Relevant tests were not reported.   Final diagnosis was rash.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  List of documents held by sender: None.
received dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 33-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacy technician reported that, the patient received a dose of Twinrix that had expired on 8th February 2022, which led to expired vaccine used. The reporter consented to follow up.
PT here for 1st dose of Pfizer, received at 1324. At 1328, PT stood from chair in observation area and then collapsed. PT presented with pallor, diaphoresis. VS at 1331 were: BP laying 98/62, HR 56, SPO2 95% RA. It is unclear whether PT lost consciousness completely; PT reports that he had felt anxious, SOB, and over-heated and that he had stood up to get the attention of nurses. He said that he knew he was going to pass out and tried to grab a chair, but missed it and fell to ground. PT reported that he doesn?t believe he hit his head or injured himself. PT was assisted to elevate legs, remained laying. At 1333, PT?s color had already begun to improve. PT accepted and consumed offered juice and water, ate a small snack. VS at this time: BP 116/68 laying, HR 58, SPO2 97%. Pulse at 1336 was 70. PT reported that he was anxious about the vaccination and had not had anything to eat all day aside from some nuts. At 1340, PT reported that he felt ?okay?. At 1341, PT was able to sit up on floor without assistance, reported that he was a little dizzy but ?not like before.? VS at this time: BP sitting 112/70, HR 69, SPO2 97% RA. PT?s head was assessed for any signs of injury, none noted. PT educated on vasovagal responses, safety, what to expect throughout day, and to report this incident when he presents for 2nd dose. PT continued with slight s/s, reporting at 1343 that he felt okay, but things were a ?little echo-y?. PT was sitting while drinking water and declined to lie back down. At 1346, PT reported that s/s and improved and was able to stand up from the floor without assistance in order to sit on chair. PT?s pallor and diaphoresis were resolved; although PT reports that he was feeling cold. PT put coats back on and reported that feeling was better. By 1349, PT stated ?I feel okay, maybe a little bit distant.? At 1403, PT was able to stand without difficulty, reported that he felt no changes from sitting position, denied dizziness, vision changes, hearing changes. VS at 1403: BP 116/70 standing, HR 78, SPO2 97%. PT reports that this is in line with his normal BP. PT walked short distance in facility, moved without difficulty or pain, full ROM and steady gait noted. PT reported that he felt ready to leave facility, that he will be monitored by family at home. PT exited facility at 1410.
Child seen 8/20/04 with wheals on right upper arm x 2 left lower arm, small pink papule right chest. Rough texture to wheal at administration of Hib vaccine.
Systemic: Dizziness/Lightheadedness-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Additional Details: Some bleeding at injection site indicating that needle hit capillary. This compounds injection difficulty with heart complications as some portion of injection is not completely IM but IV (via capillary) also. This moves the vaccine more rapidly into the volume of distribution of the patient. Aspiration of the syringe at the injection site is not required for COVID-19 vaccinations, perhaps it should be.
blacked out; nauseated; dizzy; cold sweat; fell to the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: pistachio nuts" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Past drug history included: Isoniazide, reaction(s): "Known allergies: isoniazide". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "blacked out"; NAUSEA (non-serious), outcome "unknown", described as "nauseated"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; COLD SWEAT (non-serious), outcome "unknown"; FALL (non-serious), outcome "unknown", described as "fell to the floor". The patient underwent the following laboratory tests and procedures: tests: Unknown results.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195599 Same patient, same events, different dose;
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Cold; Upset stomach; Shaking; Chills; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), CHILLS (Chills) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), CHILLS (Chills) and MYALGIA (Muscle ache).   At the time of the report, NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), CHILLS (Chills) and MYALGIA (Muscle ache) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI
Patient experienced fever, chills, headache, nausea and cellulitis. She was treated in ER and sent home on cephalexin, prednisone, and cetirizine.
Ill feeling; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill feeling) and PSORIASIS (Psoriasis flare-up) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concomitant products included CYANOCOBALAMIN (B-12) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Ill feeling) and PSORIASIS (Psoriasis flare-up). At the time of the report, MALAISE (Ill feeling) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved.            The patient had flare up. She had surface rash at bottom of scalp, She had itches when she was sweating. Her second dose of moderna vaccine caused feeling of being ill.  She was taking supplement of B-12 injections. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt Father noticied rash around injection site on left leg / father stated " rash was raised with a few hives" one day after injection. 4-7 days after injection father stated rash was all over body, trunk, arms, legs. The same rash was concentrated around the injection site. pt was brought to Urgent Care on 14 Aug 2015 by parents.  Pt was given hydroxyzine and rash cleared up, no other symptoms reported.
Facial numbness/challenge to move  (Bells Palsey) and Tingling in left arm
Rash at sight immediately after injection.  Severe pain in arm, shoulder, collar bone, armpit area and up neck. Some pain that radiates down to pinky and ring ring and some numbness down arm to pinky and ring finger at times, numbness was happening more often in the first 2 weeks after shot.  Hard to move arm due to pain and probably frozen from lack of use, arm feels weak.  On day 24 and still in severe pain, especially in armpit and shoulder collar bone.
It started the day I got my booster. The pain was a 8 and it felt like a charley horse and then I woke up to the pain and charley horse traveling to my left thigh. This pain lasted 20 min. It happened 2-3 time a day lasting 15-20min at a time. This would happen 2-3 time a day and lasted until February 28. Then the episode would happen once a day lasting 5-10. I had one on the 3/1/21, 3/05/21 and the 8th.
Shingles vx ,I have a break out at least once a month/ suspected vaccination failure; Break out at least once a month, just a small patch; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had this since patient was 20 years age).   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that he/she just found out that he/she had to have the Shingles vaccine again. The patient had a breakout at least once a month luckily it was just a small patch, but it sits directly on the patient's butt bone. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient states that "a couple hours after the injection she started running a fever and for the next couple of days had vomiting and pain at injection site". She said that even now, 20 days after injection she still has nausea and has not been able to eat a full meal.
Arm area swollen - formed a red spot size of 50 cent raised - painful - some itching.  Do not feel well - no energy.  Contacted doctors office.  Keeping close watch on it.
Reddened area noted on (L) post. arm approx. 4 cm in diameter.