chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness on the arm; did not feel good; headaches characterized as shooting pain, instantaneous from the forehead to behind the ear; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on the arm), VACCINATION COMPLICATION (did not feel good) and HEADACHE (headaches characterized as shooting pain, instantaneous from the forehead to behind the ear) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on the arm), VACCINATION COMPLICATION (did not feel good) and HEADACHE (headaches characterized as shooting pain, instantaneous from the forehead to behind the ear). At the time of the report, PAIN IN EXTREMITY (soreness on the arm) and VACCINATION COMPLICATION (did not feel good) outcome was unknown and HEADACHE (headaches characterized as shooting pain, instantaneous from the forehead to behind the ear) had resolved.            No concomitant medication information was provided by the reporter.  The patient experienced headaches characterized as shooting pain, instantaneous from the forehead to behind the ear which lasted for a day and a half.  No treatment information was provided by the reporter.
Patient has pain down the arm intermittently. Severe pain in tricept area especially when arm lifted  above her head.
PER PT: 4-5 DAYS AFTER SHE RECEIVED HER VACCINE IN THE RIGHT DELTOID SHE DEVELOPED A RED RASH. AFTER TWO ADDITIONAL DAYS WHEN HER RASH HAD INCREASED IN SIZE PT SOUGHT TREATMENT FROM DR WHO DIAGNOSED THE RASH AS A SKIN INFECTION/CELLULITIS AND PRESCRIBED CEPHALEXIN 500MG 4 TIMES DAILY FOR 10 DAYS.
Day one: (by the time I got home from receiving the vaccination, Gardasil) Headache, Dizzy, Weak, fluttering in chest, and that night swelling in my feet. (Fluttering in chest continued into days 2-6). Day 4: Dirrhea. Day 5: Nausea.
Dry cough; Loss of taste and smell; Loss of taste and smell; Weakness/felt like no energy; Headache; Fever; Chills; Fatigue; Tested positive for Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for Covid-19), COUGH (Dry cough), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell) and ASTHENIA (Weakness/felt like no energy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history information was reported.  Concomitant products included PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid-19). On an unknown date, the patient experienced COUGH (Dry cough), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), ASTHENIA (Weakness/felt like no energy), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, COVID-19 (Tested positive for Covid-19), COUGH (Dry cough), AGEUSIA (Loss of taste and smell), ANOSMIA (Loss of taste and smell), ASTHENIA (Weakness/felt like no energy), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included cough medicine  Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Contactable Nurse. This Nurse reported for a 94-year-old female patient (consumer's grandmother). A 94-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 at single dose of second dose, on 29Dec2020 at single dose of first dose for covid-19 immunisation. Medical history included dementia, hip fracture from 19Nov2020 the patient was admitted for a broken hip on 19Nov2020, on 16Jan2021, she had a fall in the rehab facility. No Prior Vaccinations (within 4 weeks). Concomitant medication included levofloxacin (LOVENOX [LEVOFLOXACIN]) to 18Jan2021 and restarted in Jan2021, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient experienced tested positive for covid-19 on 28Jan2021. The patient was swabbed for the COVID-19 PCR test on 26Jan2021, her results came back as positive. She had a rapid COVID-19 test on 28Jan2021 that came back positive as well. The patient underwent lab tests and procedures which included chest x-ray: unknown results on 28Jan2021, COVID-19 PCR test: positive on 26Jan2021, COVID-19 Rapid Test: negative on 19Nov2020, COVID-19 Rapid Test: positive on 28Jan2021. The patient was asymptomatic. She had no fever, lungs sounded clear. The event outcome was unknown.  No follow-up attempts are possible; Information on Lot/Batch number can not be obtained.
3rd shot made me and my father almost commit suicide; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete, Manufacturer Unknown), for COVID-19 IMMUNISATION. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "3rd shot made me and my father almost commit suicide". Clinical course: The reporter and his father (patient) went to the hospital because reporter honestly wanted to die to the fact that Pfizer truly made a big disaster. Getting the Pfizer 3d shot made the reporter and his father almost committed suicide.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event SUICIDAL IDEATION cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; manufacturer unknown), for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "developed a DVT one month after receiving the Pfizer Booster". Clinical Information: The patient developed a DVT one month after receiving the Pfizer Booster. No previous history and no identified reason. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states she developed rash on her left arm and experienced swelling that went down after about 3 days. She did get prescribed a MEDROL DOSE PACK to help with swelling. Says she is okay.
Approximately 2 hours after vaccine he experienced tightness of chest, heavy breathing, itchy, puffy eyes and anxiousness. He went to the local emergency room.
Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient taken to emergency medical facility.
Stomach hurt; continuous diarrhea; muscle pain; chills; tired; severe sweating; Feel warm; Body pain; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, couple of hours after receiving Shingrix, the patient experienced chills, tiredness, sweating, feeling of warmth and general body pain. On an unknown date, the patient experienced stomach pain, diarrhea and muscle pain. Shingrix was discontinued. On an unknown date, the outcome of the stomach pain, diarrhea, muscle pain, chills, tiredness, sweating, feeling of warmth and general body pain were recovered/resolved.   The reporter considered the stomach pain, diarrhea, muscle pain, chills, tiredness, sweating, feeling of warmth and general body pain to be related to Shingrix.  Additional details were reported as follows: The reporter stated that he received 1st dose of the Shingrix about 3 weeks ago and within few hours of receiving the vaccine in his right arm, he started to feel warm and had severe sweating, felt tired, then started to have chills with body pain. The patient's stomach hurt with continuous diarrhea for about 4 days.  After about 4 to 5 days, all the adverse events resolved The healthcare professional ordered a covid 19 test and it was negative. The healthcare professional has advised patient to not get the second dose of the Shingrix vaccine due to these adverse events. The patient wanted to get a refund because he was only entitled to one shot and his doctor told him to definitely not get the second shot so patient did not get the full benefit of the shot. But they informed patient that no refunds were going to be given to him. The reporter consented to follow up.
Patient recieved an Hep-A vaccine. Did well ok'd to go with father to waiting room to wait another 20 minutes. Observed his father with LOC. Patient himself had LOC with petite type seizure, was brought to floor safely by self and assistants from others in waiting room. LOC x30 seconds. He was also sent back to room. Given cool packs & apple juice. Vital sign checked and was WNL. Patient recovered within 10 minutes. Doing better. Had some sore muscle pain to left ankle. He was advised also to seek medical evaluation. Patient stated that he had no breakfast or lunch prior to visit. Family members arrived with a lunch. Left clinic at 3:45 PM with father and a family driver.
Patient received their first Pfizer Covid vaccine and while his sibling was receiving her vaccine approximately two minutes later the patient fainted and fell on the floor and hit his head.
My wife had IPF and passed away. We have an Oximeter Plus here at home. I began to feel extremely tired and decided to check my O2 sat. I was roughly 2 hours following my shot. My O2 sat is normally 97-98. When I checked it it had dropped to 84. This is abnormal for me. It remained at this level until about 4 hours after my shot when I checked it had returned to my normal level. This does give m some concern about my follow up vaccine.
Local reaction occurred at injection site 24 hours after administration.  Redness on right thigh extended around to posterior aspect.  No abscess palpated, warm to the touch, induration not well demarcated.  Ordered Motrin prn and parent instructed to seek medical attention if high fever and/or change in behavior.
Moderna booster dose. Should have been 0.25mL. Nurse drew-up and gave 0.02mL. Patient (notified by phone) will return to clinic for booster dose on 12/28/2021.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, administered on 24-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-DEC-2021, the patient experienced confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) 2 time resulted Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were intramuscularly vaccinated with GARDASIL (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Aches; Chills; Nose bleeds that last 20 minutes to 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), EPISTAXIS (Nose bleeds that last 20 minutes to 4 hours) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Apr-2021, the patient experienced EPISTAXIS (Nose bleeds that last 20 minutes to 4 hours). On an unknown date, the patient experienced PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches), EPISTAXIS (Nose bleeds that last 20 minutes to 4 hours) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Muscle/joint soreness to the extent that the patient is unable to dress herself/complete basic activities of daily living without assistance. ***Patient is an RN. Injection site appears to have been given outside of the deltoid muscle (too high)
Narrative:  Pt reported nausea/vomiting/diarrhea/fever/fatigue & muscle pain on day after had received first dose of covid vaccine. Pt reported SE to facility. RN informed pt these were common SEs.
15 mon. pt /w hx of OM & pharyngitis, vax /w MMRII dev fever, macular rash, WBC dec to 2800, dev stiffness legs, lethargy, irritability.  Has severe dev delay w/ poor speech, fluct. muscle tone, po6r motor & head control, spacticity.
Diagnosed with myocarditis 4 days after injection. Hospitalized for 1 day.
The vaccine was expired 9/1/2021, it was administered to the patient in the left deltoid. It was discovered to be expired after administration. Manufacturer was called. Did not have data to support the potency of the vaccine post expiration date. Hospital was given the following recommendations from the representative " ACIP/CDC recommendation for administration of expired none live vaccines is to repeat the dose as soon as possible." The patient and provider notified of the incident. The patient stated that she would return 10/09/2021 @ 10 AM to receive the dose of pneumococcal 23 vaccine.
Pt suffered a TIA. She had right sided weakness and difficulty speaking. She was taken to the ER, CT waa preformed and no abnormalities were detected. The symptoms resolved in 24 hours.
This spontaneous report as received from a consumer refers to a 60 year old male patient with medical history of "toe nail fungus" and with no drug reactions/allergies. The patient stated about a year ago (about August 2012) he was diagnosed with the shingles. His doctor recommended he got a ZOSTAVAX vaccine after the shingles went away 6-7 weeks ago (about in June 2013) he got the ZOSTAVAX shot (1 injection, under the skin of the right arm, lot #, dose were unspecified) . There was no concomitant therapy. And then a few weeks after (on 08-AUG-2013), he broke out with the shingles and still had some of the rash present. He went to the doctor and started taking Acyclovir and "a cream of some kind" on 09-AUG-2013. No lab diagnostics studies was performed. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Rash at injection site on day 10, continued increase in size of rash and swelling for the next week with bruising.  Three random lesions on trunk and one on scalp.  No eruptions noted.
Information has been received from a physician via company concerning a 19 year old female patient who on an unknown date was vaccinated with a dose of GARDASIL (lot number, route were not reported). The physician reported that the patient fainted and vomited after receiving GARDASIL. At the time of the report, the patient outcome was not provided. Additional information has been requested. This report is linked to MARRS case 1308USA011581, same reporter.
tiniest soreness in arm; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (Patient) reported that: A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date were not reported) dose 2 via unspecified route of administration, on 31Jan2021 (at the age of 68-year-old) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the tiniest soreness in her arm following vaccination. The patient asked if no reaction to the vaccine indicates that the vaccine is not effective. She explained reading in several different places that "when people get a reaction to the vaccine, it means that the body is working". She then asked if there any tests that indicate if she has build up an immunity after receiving the COVID-19 vaccine and also stated being "very disappointed with Pfizer" and would have expected a precise recommendation on what test to take to asses her immunity after vaccination and added she understands that a reaction would be the body's response to it working with the vaccine, she is worried about the vaccine not being effective, her arm was not her concern, it is so minute and she declines to complete a report. She was asking how will she know if it is effective in fighting off the virus if she did not have any real reaction to the vaccine. The outcome of event is unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): 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.
soreness in knees and legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in knees and legs) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LOSARTAN, SIMVASTATIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in knees and legs). At the time of the report, PAIN IN EXTREMITY (soreness in knees and legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
About 12 hours after injection, fever of 102.5F, intense chills. Fever lasted 48 hours total, lessening over time.
Product expired on 09-Nov-2021 and administered on 10-Nov-2021/ Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Product expired on 09-Nov-2021 and administered on 10-Nov-2021/ Administer expired vaccine to patients, after the manufacture date of expiration) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Product expired on 09-Nov-2021 and administered on 10-Nov-2021/ Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Product expired on 09-Nov-2021 and administered on 10-Nov-2021/ Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. It was unknown when vial placed into refrigerator. Vial did not undergone any temperature excursion issue. 168 doses were administered from Lot number 048C21A. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant follow up received contains Primary Reporter address updated
PATIENT WITH RHEUMATOID ARTHRITIS NOTICED AFTER IMMUNIZATION STIFFNESS IN JOINTS ALONG WITH FATIGUE
First COVID-19 vaccination given on 4/21/2021, second dose given after recommended interval. Both doses were Moderna
I had some numbness and tingling while I was at work, and I almost fainted on 2/4/2021. My blood pressure was extremely high. I was referred to a neurologist.
Injection 10/20/14 at 0900. 1030 hacking cough, non-productive. 1115 eyes became blood red, scratchy. Cough lasted 10 hours. Red eyes 30+ hours.
pt was mistakenly given an undiluted vial of vaccine. No immediate physical reaction noted. Pt informed of error.  Dr., medical director, contacted and informed. OK to monitor pt for a total of 30 min to watch for adverse reaction. If feeling well, may go home after. Recommended at this point to receive 2nd dose.  After 45 min from receiving dose, no adverse events noted.
Patient had Small pericardial effusion. noted as an incidental finding on a CT heart score
Patient received dose of fluzone quad HD on 9/6/23 and then was immunized with the same product again on 9/27/23. Patient did not report any adverse reaction but received his Spikevax on 9/27/23 and reported localized pain in the injection site. He could not confirm which arm he received the flu vs the spikevax in on 9/27/23
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO (batch number unknown, expiry date unknown). On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced swelling in the arm like an abscess for one week. The patient received the second dose. This case is one of the 3 cases reported by the same reporter for 3 different patients.