chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Janssen product on 03/31/2021. They tested positive for COVID-19 on 10/14/2021 at the nursing home at which they were a resident. The individual died on 10/19/2021 after a rapid decline in health. The individual was on hospice care at the nursing home for underlying medical conditions.
CHEST PAIN; CHILLS; MILD AND SEVERE HEADACHE; MILD SORE THROAT; BODY ACHE; PAIN BEHIND THE KNEES; NAUSEA; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced pain behind the knees. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021 17:30, the subject experienced mild sore throat. On 07-APR-2021 17:30, the subject experienced mild and severe headache. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild sore throat, body ache, chest pain, pain behind the knees, mild and severe headache, and chills, and nausea on 09-APR-2021. This report was non-serious.
Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactive salivary glands, light-headed.  States speech was affected due to tongue swelling.  No respiratory distress.  Took Benadryl 25mg approx. 45 minutes after symptom onset.  Symptoms improved 1 hour after taking Benadryl dose.  Does NOT plan to receive 2nd dose due to immediate allergic reaction.
On the evening of the 27th day (02/11/21) after the first Moderna shot, I had an ischemic stroke on my Right Middle Cerebral Artery and was hospitalized
Patient called into Services on April 6 to report a suspected "allergic reaction related to his Covid19 Vaccine received March 30.  He said that beginning 24-48 hours after his vaccine he began to experience "a sore throat, swollen lips, conjunctivis in both eyes, pain and muscle aches, and hives/boils all over his body.  He asked if he should go to an urgent care center.  His mother had suggested an urgent care.  He wanted us to complete  the form and was going to the Urgent Care.  Couldn't find his vaccine card, so called him with Lot # and expiration of dose.  Advised to call us back after being seen to update his condition.
chills; piercing headache; fatigue; vertigo; This is a spontaneous report from a contactable Nurse (patient) A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 at 13:15 at single dose in left arm for COVID-19 immunisation at the age of 32-year-old. Lot number was ek9231. Medical history included alpha thalassemia, chronic anemia, lactose intolerant, attention deficit disorder (ADD). The patient was not pregnant. Concomitant medications included colecalciferol (VITAMIN D) supplement, multivitamin, escitalopram oxalate (LEXAPRO). The patient had chills, piercing headache, fatigue, and vertigo with first vaccine administration on unknown date. The outcome of the events was unknown. The patient did not have COVID-19 prior to vaccination, and the patient was not COVID-19 test positive post vaccination.
Patient was given his 2nd Pfizer vaccine 5 days before the recommended time between the 1st and 2nd dose.
Experienced Covid Arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 14:45 (Lot number: 59267-1000-1) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; CHLOROPHYLL; SELENIUM.  The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 14Jun2021 09:00, outcome "recovered" (16Jun2021), described as "Experienced Covid Arm at the injection site". Therapeutic measures were not taken as a result of vaccination site discomfort.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19, Patient had not taken any vaccine within 4 weeks prior to the COVID vaccine, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
feel fatigued for one full day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feel fatigued for one full day) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 FATIGUE (feel fatigued for one full day). At the time of the report, FATIGUE (feel fatigued for one full day) had resolved. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-516385 (Patient Link).
He had an influenza vaccine on the right arm on 10/13/06 and a Pneumovax on the left arm. He had a previous pneumovax in 994 without any difficulty. The day following this injection, his left arm became more swollen over the posterior medial aspect extending down to the forearm. The arm was itchy. he did not have any face or throat itchiness or rashes. He called the ER and they advised him just to monitor the situation. Today he fells the arm is better and the swelling is going down. Itching is slight, but resolving. The pt as outlined before had a fall with a fracture of the left clavicle, which has been treated conservatively. He has no other specific complaints.
Patient experiencing substantial bruising about 4 inches below the vaccination site....a large band of bruising (purple/red).
Fever; Chills; Body Aches; Sweating; Fatigue; Insomnia; Sensation of pounding heart (could feel heart beat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot Number: ER8727) via an unspecified route, administered in Left Arm on 23Mar2021 at 10:15 AM (34-year-old at vaccination) as single dose for covid-19 immunization. The patient's medical history included heart murmur and occasional anemia. Allergies to medications, food, or other products was reported as none. The patient's concomitant medications were reported as none within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 22:30, the patient experienced fever, chills, body aches, sweating, fatigue, insomnia, sensation of pounding heart (could feel heartbeat), lethargy. The events began 12hrs after 1st dose, and latest for 3 days, but still battling fatigue even after mild activity. Since the vaccination, has the patient was not been tested for COVID-19. No treatment received for resulted adverse events. The outcome of the event fatigue was not recovered, and the outcome of other events was resolving.  Follow-up activities closed. No Further information is expected.
Received MMR vaccine 3/4/08, started having night sweats, leg achiness and headaches week of 3/9/08. 3/13/08 Flat red rash over anterior and posterior trunk and both arms with mild itchiness. Rash gone in 4 days. 3/14/08 Increase in arthralgia with swollen hands and wrists with stiffness and pain, also hips and legs painful at joints. 4/1/08 Arthritis milder but headaches have been frequent and severe. Arthritis and H.A. persists at time of this report.
pt recvd vax & devel t 101; rash noted; irritable but alert; diff macular rash & koplik's spots;
Pt c/o dizziness immediately after receiving 2nd dose of Pfizer.  Pt had one episode of syncope.  Father was present and assisted pt to the ground.  No falls.  Pt reports feeling nervous. A&Ox3.  pt speaks in full complete sentences.  No facial/mandible/tongue swelling.  No stridor.  Pt ambulatory to  med bay, refusing to sit in w/c, w/ steady gait. Pt refusing pulse oximeter.  Resp regular/deep.  BP stable 149/50, HR 88, RR 16.  Pt tol PO.  Pt stable and released from the vaccination site.   Recommended that the patient follow up w/ their healthcare provider.
Body hives at back of neck/lower hairline at 0500 on 12/3/21. spread to full body. cetirizine stopped itchiness, but not hive spread. benadryl taken 50mg/day since 12/3/21 (stops itch and prevents generation/spread of hives).
Symptoms first occurred the next morning around 5am.  Symptoms have been intermittent (everyday for a few days and now just every few days), but consistent in location and type of pain. Pain has been 10/10 in the bilateral, distal biceps and between the scapulas.  NSAIDS have dealt with the pain issues to date.  Occurrence has fallen off to every few days. There was never any fever, nausea, weakness, or numbness.
This spontaneous report as received from a physician via a field representative refers to an 11 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, 0.5 ml, (lot # was not provided). Other suspect therapies included unspecified meningococcal vaccine (lot #, dose, manufacturer and route were not reported) and BOOSTRIX vaccine (lot #, dose and route were not reported) given during the same vaccination session. The patient's concomitant medications were not reported. On the same day (30-OCT-2015), the patient started to faint. The physician had turned to speak with the child's parent, and when she turned back to the patient, the patient was beginning to fall towards the floor. The physician reported that she caught the patient on her way down to the floor. The next day, it was reported by the patient's parent that the patient's nose was swollen and sore. The physician speculated that the patient's nose must have "bumped into her" when she caught the patient to keep her from falling onto the floor. The outcome of the events was unknown. There were no product quality complaints (PQC) involved. These adverse events have not been reported to Vaccine Adverse Event Reporting System (VAERS). The reporter's causality assessment was not provided. No further information was available. This is one of the two reports from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 10th April 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, diarrhea, pain in arm and chills. On an unknown date, the outcome of the nausea, vomiting, diarrhea, pain in arm and chills were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, diarrhea, pain in arm and chills to be related to SHINGRIX. Additional details were provided as follows: The patient reported having nausea, vomiting once and diarrhea the evening of getting the 1st dose of SHINGRIX. The patient also noted sore arm and chills. These issues resolved after 1 day, she planned to get the next shot. The patient was very upset about 2nd shot not being available. All questions were not asked as the report was not her priority of the call. She had not reported these issues to her physician but provided physician's name.
I began to experience common symptoms about 24 hours after the shot. On Friday or Saturday night (4/30 or 4/31) - I think it was Friday but am not sure, I began experiencing extreme chest pain and possibly esophageal pain and shortness of breath. It was difficult to breathe, the pain was so intense I was crying out and crying, I began profusely sweating, lost color and experienced ringing in my ears as I was close to passing out (had made it to the bed at this point). I asked my husband to call for an ambulance but w waited to do so. These intense pains and shortness of breath passed after about an hour. I also experienced headaches that would not go away for days. I ultimately went to an emergency walk-in clinic Sunday, May 1 and talked to them about my chest pains and headaches. They wrote off my chest/upper back pains as an anxiety attack, which I have never had in my life, and recommended a different OTC medication for the headaches which ultimately  went away. I am not one to seek emergency medical care, I do not have heart or anxiety problems but the chest and upper back pains were excruciating but short lived. Very scary!
Tight chest, cough, itchy neck about 30 mins after shot. Took 25mg Benadryl and symptoms were mostly alleviated within 40mins.  Took another 25mg Benadryl and symptoms went away in about 30mins
had the shots/ had Shingles 3 times, suspected vaccination failure; had Shingles 3 times; This case was reported by a consumer via 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 1st dose of Shingles vaccine and the 2nd 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) 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 Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The case was reported by the patient for himself/herself. The age at vaccination was not reported.  The patient got vaccinated with the Shingles shots but also experienced shingles 3 times.  This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.
On 10/04/10 the site was slightly dark 1 1/2 by 1 1/2. Parent states that the area was hot, pink and swollen at home.
56 doses administered after temperature excursion; Vaccines went out of range high 3x for a total of 47 minutes and reached a high of 48.7; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 doses administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines went out of range high 3x for a total of 47 minutes and reached a high of 48.7) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 doses administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines went out of range high 3x for a total of 47 minutes and reached a high of 48.7). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 doses administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines went out of range high 3x for a total of 47 minutes and reached a high of 48.7) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccines were not punctured at the time of temperature excursion. The beyond use date (BUD) for the vaccine was on 14-Nov-2021.  Vaccine was administered on unknown date Nov-2021. Start date for the events was on unknown date  Nov-2021 and was recovered on Nov-2021.  No concomitant medications were reported No treatment medications were reported.
Narrative: COVID infection following COVID vaccine series 04/08 Janssen, dose #1 05/14 COVID swab, result: not detected 05/14 lactoferrin result: positive 05/14 CRP result: 0.113 05/14 ESR result: <1 08/01 pt cc: cough, chest congestion, diarrhea, vomiting, nausea exposure: unknown 08/10 COVID swab, result: detected 08/10/ED admit dx: post covid GI syndrome LOS: 1 day 08/10 ABDOMEN, 2-VIEW u/s impression: Nonobstructive bowel gas pattern. 08/13 clinically resolved
Received her booster dose of the Moderna Covid-19 vaccine; her injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her injection site arm was sore) and EXTRA DOSE ADMINISTERED (Received her booster dose of the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 001B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (her injection site arm was sore). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received her booster dose of the Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (her injection site arm was sore) and EXTRA DOSE ADMINISTERED (Received her booster dose of the Moderna Covid-19 vaccine) outcome was unknown.            Patient Date of Birth was mentioned as 13May (declined yr) Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-291045.
severe migraine; felt fatigued like having the flu; felt dizzy; redness; bruise on the injection site; rash in face; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (dull headache), MIGRAINE (severe migraine), INFLUENZA LIKE ILLNESS (felt fatigued like having the flu), DIZZINESS (felt dizzy) and ERYTHEMA (redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (dull headache), MIGRAINE (severe migraine), INFLUENZA LIKE ILLNESS (felt fatigued like having the flu), DIZZINESS (felt dizzy), ERYTHEMA (redness), RASH (rash in face) and CONTUSION (bruise on the injection site). On 17-Feb-2021, ERYTHEMA (redness) had resolved. At the time of the report, HEADACHE (dull headache), MIGRAINE (severe migraine), INFLUENZA LIKE ILLNESS (felt fatigued like having the flu), DIZZINESS (felt dizzy), RASH (rash in face) and CONTUSION (bruise on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
possible cellulitis on injection arm.; swelling and redness with possible cellulitis on injection arm./ Shoulder to elbow; swelling and redness with possible cellulitis on injection arm.; This case was reported by a physician via sales rep and described the occurrence of cellulitis of arm in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant), extensive swelling of vaccinated limb and erythema of extremities. The patient was treated with medication unknown (Patch) and antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the cellulitis of arm, extensive swelling of vaccinated limb and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the cellulitis of arm, extensive swelling of vaccinated limb and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day after administration of Shingrix, the patient had swelling, redness with possible cellulitis on injection arm from shoulder to elbow. The patient sought treatment at local emergency department. The patient was given patch and antibiotics. The symptoms resolved. No additional information known at the time of reporting. The reporter did not consent to follow up.
Headache; A spontaneous report was received from a consumer concerning a unknown aged male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown)  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date, the outcome of event headache was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Patient complained of a rush of feeling hot.   Patient was laid supine, VS monitored.   Patient was transferred to the ED.
patient received 2nd dose of Pfizer vaccine on 6/5/21. On the evening of 6/7/21 patient developed chest pain. When she woke up at 0530 on 6/8/21 her chest pain was still there. At this time patient developed nausea and was brought to the emergency room. In the emergency room she was found to have a troponin of 1155. She was started on indomethacin and colchicine for myocarditis.
Racing Heart, Short of Breath, Sweats, Dizzy, Blurry Vision
Diahrea. nausea, severe pain at every site I ever had surgery or a procedure. Severe pain in both feet, pain in my midsection , pain in my back, pai n in my legs.   weakness and tired ness from the day of vaccine in January 24th until around March 10th.   I felt like I wanted to die.
pt recvd vax 3JAN95 & fever started on 4JAN95 t105.1 R & lethargic, loss of appetite; will not put weight on legs; seen in ER on 4JAN95; No relief of fever w/APAP; seen by MD on 11JAN95; t100.2-still lethargic;