chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Five hours after vaccination I began to feel very weak. During the same evening I could not eat, my muscle and bone joints became extremely sore and I could not sleep that evening. It felt like I had the Flu but without symptoms like sore throat, diarrhrea, or barfing.
pt recvd vax;24 hrs later,exp wrist/knee swelling & pain, and knee effusions;resolving
(L) arm where PNEUMOVAX 23 given has a 3 cms round cellulitis, tender. Warm compresses & PO AUGMENTIN 875mg PO BID x 10.
Was informed by the husband on Thursday May 27, 2021 that his wife had passed away 10 days after the first moderna vaccine and that her physician said it was contributing factor to her death.  The husband was waiting for the death certificate.
This case was reported by a nurse via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that a patient experienced a fever of 102.8 degree F. No additional information could be obtained. The health care professional ended the click to chat prior to providing patient, product and adverse event details.
"COVID arm"; arm swollen red and achy, bump at injection site; arm swollen red and achy, bump at injection site; fatigue; fever 100.7; arm swollen red and achy, bump at injection site; arm swollen red and achy, bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue) and PYREXIA (fever 100.7) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue), PYREXIA (fever 100.7), INJECTION SITE SWELLING (arm swollen red and achy, bump at injection site) and INJECTION SITE ERYTHEMA (arm swollen red and achy, bump at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION ("COVID arm"), INJECTION SITE URTICARIA (arm swollen red and achy, bump at injection site), VACCINATION SITE PAIN (arm swollen red and achy, bump at injection site), FATIGUE (fatigue), PYREXIA (fever 100.7), INJECTION SITE SWELLING (arm swollen red and achy, bump at injection site) and INJECTION SITE ERYTHEMA (arm swollen red and achy, bump at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: inconclusive (Inconclusive) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
flu like symptoms; extremely fatigued; headache; I could do nothing; ached all over/aching; This is a spontaneous report from a consumer (patient). An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown; expiry date: not known), first dose via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. After the 2nd shot of the Pfizer covid 19 vaccine, she had 48 hours of flu like symptoms, aching, extremely fatigued, headache that went away, just like someone opened the blinds, very quickly, 5 weeks from last shot, and got the same symptoms and they lasted for 7 days. she could do nothing, went from the couch to the bed, ached all over. The patient had went to urgent care, had two swabs in 48 hours, negative for covid, swabs one done at drugstore on Thursday and Saturday went to urgent care and both were negative. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The first day, I was in a lot of pain all over my body, the normal aches and flu-like symptoms. I was in so much pain that I cried. Because I have fibromyalgia, my doctor advised that I go to the hospital because it hurt to touch my skin. I was sent to the ER a week later because my symptoms had lasted so long, I had a persistent headache, and they wanted to check for thrombosis.
6 x 7 cm firm, swollen, reddened area at site of injection. Headache.
It was 3 to 4 days after the vaccine, around 9/19/2022, it increased the symptoms of my interstitial cystitis. it created pain for my interstitial cystitis pains. I see my doctor on a weekly basis and we were trying to extend my treatments. and I had to go back to weekly treatments for the pain.
Patient had influenza vaccine on 1/27/21 - interval between vaccines -less than 14 days. Patient completed screening form and answered no to this question. Error was noted during documentation after vaccine administered during vaccine clinic.
My symptoms started on the January 7, 2023, but I didn't test until the 9th. I had a head cold, sore throat, and heavy fatigue for about two to three days. I never ran a fever. The symptoms went away after about five or six days, but my head cold came back after that. I started taking Paxlovid on January 10th, 2023. I tested negative on the January 25, 2023.
mom states arm became very swollen down to elbow & pt cried excessively; devel URI & severe cough next day, seen by MD recovered w/in 24 hrs from swelling;
1APR98 tenderness only;2APR98 erythema, tenderness swelling @ inj site;seen in office @ 4PM 2APR98 erythema progressing 6cm diameter w/vesicle formation;
shingles after 2nd dose /Suspected vaccination failure; possible episode of shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 14th September 2022, unknown after receiving Shingrix and Shingrix, 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: The Sales rep had submitted a medical information request on behalf of a healthcare provider, which contains a potential adverse event related to a possible episode of shingles after the 2nd dose of Shingrix. The reporter had consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Due to discrepancy in source document outcome date 14th September 2022 was captured.
11:43 shortness of breath, pain on left, side tingling, throat swelling, 12:14 hives, numbness in face -returned to urgent care with severe headach, anaphylactic symptoms, extreme flashing pain in upper back, left arm and shoulders-ekg indicated a cardiac event and was sent to Hospital.  Tested and treated, released at 11pm. Next morning (10/1/2021) 08:30 anaphylaxis, went to Hospital -treated and released at 3pm
Tachycardia up to 160  with exertion; Shortness of breath; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia up to 160  with exertion), DYSPNOEA (Shortness of breath) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 25-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Tachycardia (History of tachycardia with previous pregnancy.). Concurrent medical conditions included Bee sting hypersensitivity.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 29-Dec-2020, the patient experienced TACHYCARDIA (Tachycardia up to 160  with exertion) and DYSPNOEA (Shortness of breath). On 28-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, TACHYCARDIA (Tachycardia up to 160  with exertion) and DYSPNOEA (Shortness of breath) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.    Cardiac monitor, CXR, CBC, TSH, CMP in the Emergency Department and physician evaluation.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs of tachycardia and dyspnea  for this 25-year-old female.   Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
COVID-19 and pneumonia; Extended time after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 and pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended time after 1st dose). On 06-May-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 and pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (COVID-19 and pneumonia) and PRODUCT DOSE OMISSION ISSUE (Extended time after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. The patient reported that he was treated with steroids, antibiotics and inhaler for the pneumonia. Patient was scheduled to receive the second dose of the Moderna Covid19 vaccine 05June2021 however the patient was diagnosed with double pneumonia  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 pneumonia  and mRNA-1273 is assessed as not applicable. For the event product dose omission causality is assessed as not applicable too.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 pneumonia  and mRNA-1273 is assessed as not applicable. For the event product dose omission causality is assessed as not aplicable too.
This spontaneous report was received from a medical assistant regarding 2 patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Patient received Pfizer COVID vaccine on 3/8/21 (lot # EN6199), 4/3/21 (lot # ER8737), and 2/4/22 (lot # FK9895). On 6/10/22, patient admitted to our inpatient facility (med/surg unit) with hypoxia related to COVID-19 infection, COPD, and atrial fibrillation. Patient was discharged home on 6/14/22.
Arm began to itch where at the injection site, a few hours later the site became red and hot and slightly raised. Went away after two days. 4 days later woke up to a much larger red itchy area, takes up entire upper portion of my left arm (only on the front, does not wrap around my arm).
On 7/21/22, after the patient received the Moderna booster, the injection site started to swell. It was a golf ball size. When she stopped by the pharmacy on 7/23/22, the injection site was bigger than a palm size. Patient also has pressure headache and some sinus symptoms. She was using ice packs and antihistamine. She was advice to continue doing those and follow up with the doctor on Monday. I called and checked on the patient on 7/24/22, the injection site swelling didn't get bigger, and her sinus symptoms were also improved. Still advice patient to continue doing ice packs and antihistamine and call her doctor on Monday.
This is the short version: As soon as she administered the shot I felt severe pain. When I tried to move it is was very heavy. She said it was normal. When I left the store, I had no strength to push open the door. I was heading to dinner with my boss and co-worker. They asked me what was wrong as soon as they saw me. I also began feeling feverish. I ended up being sick for weeks. The pain in my arm continued to get worse. I did Physical Therapy, went to a Chiropractor and then my Orthopedic Doc requested I get surgery. The needle nicked my bursa sac.
Patient developed low grade fever, body aches, axillary lymphadenopathy, and a diffuse macular rash to the torso; treated with Motrin 800mg TID and Tylenol prn; reaction may be allergic in nature or may respresnet mild diffuse vaccinia; symptomatic management with close patient follow up.
3 of her staff members tested positive after taking the 1stdose/3 of her workers tested positive for Covid; 3 of her staff members tested positive after taking the 1stdose/3 of her workers tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect.  A contactable nurse reported same events for 3 patients. This is second of 3 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after taking the first dose on 11Jan2021. The event was reported as non-serious. The patient underwent lab tests and procedures which included Covid: positive on an unspecified date. The outcome of events was unknown. Got the first shot on the 05Jan2021 for all of the 50 employees and 70 residents. On 11Jan2021, they got a result for asymptomatic 3 employees that tested positive with COVID 19. Health professional had questions about 2nd dose guidelines.   Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and COVID-19 test positive on 11Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-2021049693 same reporter/ drug/ event, different patients;US-PFIZER INC-2021049695 same reporter/ drug/ event, different patients
Approximately 1 1/2 - 2 hours after receiving the vax, the pt broke out in hives on the face and neck. On 9/1/00 Dad reports hives & fever have resolved. no new sxs.
Wednesday i had vomiting This time i had diarrhea and like i had cold symptoms we gone by Friday.
Initial unsolicited report received from a pharmacist on 27-Oct-2017. This case involves 87-year-old male patient who was vaccinated with dose of FLUZONE HD 0.5 ml via intra muscular route, (batch number: UI883AB, expiry date: unknown, dose in series and site of administration were not reported) in the left deltoid on 25-Oct-2017. Patient's medical history and concomitant medications were not reported. Stated patient did not receive any other vaccines that day. Stated that patient had no known allergies. On 25-Oct-2017, same day following the vaccination, patient experienced severe pain from shoulder to shoulder and extending down the back. Stated patient reported he also felt funny. Lab data and corrective treatment were unknown. The event outcome was recovered at the time of reporting. List of documents held by sender: none.
had shingles, even had the shingles shots/ suspected vaccination failure; shingles 4 times; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Shingles shots and had shingles 4 times. The patient stated that shingles was very painful. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
arm slightly red the next day & a  little itchy.  Seem to clear up & on day 7 on 1/11  arm was very red & itchy as well as swollen. Used Benadryl ointment & took a claritin  to help with allergic type reaction.  Today arm much worse.  Red swollen & warm to touch.  Does not apprear to be infected
1)  Developed significant vertigo on day 2 post vax. Ongoing 2) Vax Brain Fog- sluggish thinking and memory issues
Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an 18 months old male patient who was vaccinated with an expired dose of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation; and Hepatitis A vaccine for Immunisation. On 09-Jul-2018, the patient received a 0.5 mL expired dose of suspect HIB (PRP/T) Vaccine lot YU802AA, expiry date: 08-Jul-2018, in left thigh. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. 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. Documents held by sender: none.
patient received first Moderna vaccine dose on Saturday 4/3/21 @ 11:30 am and on Sunday night she woke up at night in hives on her chest and legs. She took Benadryl and was better. She also mentioned that she gets hives from seasonal allergies and that on Thursday 4/1 (2 days before the vaccine) she also had hives due to seasonal allergies.