chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.).    The case was reported for 4th out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant drug information was provided.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  Treatment drug information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Red rash around injection site, itchy, painful, warm to the touch.  Patient to contact primary care provider.
Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730, expiry date: unknown), intramuscular on the right arm on 16Dec2020 11:00 to at a single dose for an COVID-19 immunization. Medical history included hypertension, obesity, lymphadenopathy, and migraines. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan, clonazepam (KLONOPIN), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX), and zinc. The patient experienced right arm soreness, kinda like nerve pain and can't lift her arm up or reach the back on 16Dec2020. Outcome of the events was not recovered. No treatment was received for the events. The patient underwent lab test which included COVID test (nasal swab) on 19Dec2020 and 26Dec2020: both negative. The reporter considered the events non-serious.
Headache, chills, shaking, nausea, vomiting, diarrhea, lightheadedness, through 4/16/2021. Low BP, Lightheadedness, diarrhea, fainting. Till 4/22/2021. Still have light headedness as of today.
Grunting with respirations, respiratory rate 44, heart rate 138, one bloody stool. CBC, CMP, UA and x-ray reported below. Patient showed clinical improvement by 5:50pm. Reported labs the next morning were normal and lungs sounded clear. That day (22nd) the patient had multiple loose stools without abdominal tenderness or distension, and he was given PEDIALYTE. Complete recovery in 24 hours with no intervention.
3-5 days post-vaccine he developed intermittent fevers up to 102 degrees, burning pain in legs,  and headache/neck pain . Then developed profound AMS a few days later
Nausea and tightness in chest next day. Tightness is felt when relaxing and worsens when breathing deeper.
Vaccine had expired the day before. Expiration date noted during documenting. Family notified, no side effects noted or expected.
Gland swelling next to her neck; Swelling close to she had the vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated, "My niece (patient) got Pfizer Covid vaccine after the first dose and she was complaining about her Gland swelling next to her neck and swelling close to she had the vaccine. She had already swollen and then after she had second dose vaccination she wondering if someone have report that as a side effect, she didn't have it before the vaccine." The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patients' medical history and concurrent conditions were not reported. On 28-MAY-2015, first patient was vaccinated with a dose of improperly stored M-M-R II lot number reported as 002528 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid  lot number for stored M-M-R II. Additional information has been requested.
A few days after taking the shot, I woke up to extreme unexplained pain in the right inside of my left knee.  It persisted and I called my physician after 2 weeks.  I made an appointment with the earliest being available 2 weeks later.  The knee still is difficult to walk on 5 weeks later though somewhat improved.
Patient endorses feelings of ?tired? approx. 30 minutes after vaccine.  Patient reports he went home after his work day and reported feeling more and more tired.  Patient reports he ordered dinner with his girlfriend and at approx. 20:00/21:00 reported bilateral swelling to lymph nodes in neck, and feelings of his ?throat closing up.?  Patient endorses, ?I felt like I was having a panic attack.?  At approx. 22:00 patient took 3 tabs of Benadryl and 2 tabs of acetaminophen and noticed improvement and then went to bed.  Patient reports improvements in symptoms but persistent bilateral lymph node swelling in neck throughout the weekend.  Today (12/21):  Patient endorses increased lethargy, persistent bilateral lymph node swelling in neck and + sore throat.  Patient denies fever.  Patient took 2 tabs of Benadryl at 10:00 today while at work.  Patient called PCP today while at work describing symptoms and advised to leave work and to get COVID tested.  During call with RN, patient is awake/alert and in NAD acute respiratory distress.  Pt endorses able to move air freely, no SOB, and difficulty breathing.  Patient reports scheduled telemedicine appointment tmw am.  Patient denies recent travel of self or girlfriend, and denies known covid exposure in community or workplace.
Headache lasting 17 hours, nausea, intense itching at vaccination site, large red rash at vaccination site and loss of hearing acuity for 6 days.
he was just tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US074707_NS.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "he was just tired".  Additional information: Patient Slates he got his second COVID vaccine on 26Mar2021. States after getting the vaccine he was just feeling out of it (clarified he meant he was just tired).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 22-MAY-2014 the patient was inadvertently vaccinated with unspecified dose of ZOSTAVAX intramuscularly rather than subcutaneously (lot#, expiration date, anatomical location not reported). Concomitant medications were not reported. No adverse effects reported. Product quality complaint (PQC) was involved. Additional information has been requested.
S & S began approximately 24 hrs after receiving vaccine. Pt had requested both vacc in left arm although provider stated better in separate. Pt declined this suggestion. Redness & swelling distal to pneum vacc, hot, swelling. Unable to sleep secondary temp & chills last noc, worsening thru today. Temp 100.4, BP 140/98, P86, R 20, Tx with MEDROL dose pack. KEFLEX 500 TID x 10 BENADRYL 25-50 mg q 4-6 ice packs.
injection site area remains warm to the touch; Vaccination site pain; hard to sleep on the left side; red patches; There were red patches that were kind of itchy.; injection site area remains swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site area remains warm to the touch), VACCINATION SITE PAIN (Vaccination site pain), SLEEP DISORDER (hard to sleep on the left side), ERYTHEMA (red patches) and PRURITUS (There were red patches that were kind of itchy.) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (amoxicillin) and Allergy to antibiotic (cefzil). Concomitant products included MINERALS NOS, VITAMINS NOS (EQUATE ONE DAILY WOMEN'S HEALTH) from 01-Jan-2017 to an unknown date for an unknown indication.    On 28-Mar-2021 at 7:55 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site area remains warm to the touch), VACCINATION SITE PAIN (Vaccination site pain), SLEEP DISORDER (hard to sleep on the left side) and VACCINATION SITE SWELLING (injection site area remains swollen). 28-Mar-2021, the patient experienced ERYTHEMA (red patches) and PRURITUS (There were red patches that were kind of itchy.). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain), PRURITUS (There were red patches that were kind of itchy.) and VACCINATION SITE SWELLING (injection site area remains swollen) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site area remains warm to the touch), SLEEP DISORDER (hard to sleep on the left side) and ERYTHEMA (red patches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was recommended to take ibuprofen and antihistamines for treatment. Symptoms lasted a total of eleven days.   This case was linked to MOD-2021-244797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up: events added, event outcomes, treatment and concomitant medications, and medical history.
Vaccine administered to 17 year old patient; A spontaneous report was received from a healthcare facility staff member concerning a 17-years old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and experienced product administered to patient of inappropriate age. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, product administered to patient of inappropriate age, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Approximately 10 hours s/p 2nd dose COVID vaccine #2 for me, I felt very tired.  About hour 11 s/p vaccine I felt like I got hit by a semi truck.  Chills so bad my teeth were chattering uncontrollably, body aches all over, joint pain, my skin hurt to be touched everywhere, and a mild headache.  I did not sleep all night due to being unable to get comfortable.  Tylenol did not help.  I never call out sick to work, but I did the next day because I felt so awful, and hadn't slept a wink all night.  around noon on 02/02/2021 the symptoms were more tolerable, and by the end of 02/02/2021 they were mostly gone except mild lingering HA.  by 02/03/2021 I was able to return to work.  Still didn't feel quite myself, but the worst of the symptoms had subsided.
Symptom onset 13 days post vaccination. Patient presents with fever and scattered red bumps on torso. Right lower eyelid sore and puffy. Right side of neck is sore.
No other issues or concerns noted; Varivax had a temperature excursion and had been administered; This spontaneous report was received from an office manager, referring to a patient of 4 year old of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 07-APR-2022, a temperature excursion was of -6.9 Centigrade degrees (°C), during 9 minutes occurred. A previous temperature excursion was not reported.   On 08-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# U022320, expiration date 15-JUL-2023, for prophylaxis (strength, dose, route and frequency were not reported). No other issues or concerns noted.  This is one of 4 reports received from the same reporter.
arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant medication not reported. The Patient was vaccinated with the Moderna COVID-19 vaccine sometime between February 2021 and January 2022, and experienced symptom of arm soreness for an undisclosed period of time after taking the vaccine. Unknown whether the event caused the patient to seek medical care. Treatment medication not reported.
no adverse event; expired vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about medical history, concomitant therapy and concurrent condition was not provided.   On 07-DEC-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # s039316 was evaluated and changed to the valid Lot # S039316, expiration date 04-DEC-2021; strength, dose detail and route was not reported) for prophylaxis (expired vaccine used). The product did not have any temperature excursions prior to administration. No other adverse event (AE). The outcome of expired vaccine used was unknown.
ITCH AT INJECTION SITE. REDNESS. THEN HIVES. HIVES SPREAD ABOUT ACROSS ARM TO APPROX 4X5 PATCH. INCREASED INFLAMMATION & REDNESS ACCOMPANIED WITH TIGHTNESS AND L ARM PAIN OVER THE NEXT COUPLE HOURS. ASTHMATIC SYMPTOMS BEGAN, EG WHEEZING. REACHED OUT TO MD VIA EMAIL. THEN WENT TO ER WITHIN ANOTHER HOUR AT MD'S INSTRUCTIONS.
I had sore throat, congestive, headache, and fatigue. These lasted for about 5 or 6 days. On Feb 9th, I tested positive for COVID-19.
Loose stool/diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 2, single for COVID-19 immunization. Patient medical history included cholesterol and constipation (patient was mostly a constipated person). The concomitant medication included Simvastatin at a dose of 20 mg taken for cholesterol from 20 years ago. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had a reaction from taking Lipitor and simvastatin. Adverse event did not result in hospitalization and no treatment was received for the adverse events. First shot just fatigue for 2 days. Second diarrhea. I am usually a constipated person but now have more loose stool and diarrhea. Patient was now taking probiotics and anti-diarrheal pills will have colonoscopy beginning of 2022. If anything was shown on the colon he will contact us. He did think there was any problem with shot and simvastatin for cholesterol. The outcome of the event was unknown.   Follow-up attempts are needed; Information on the lot/batch number has been requested.
Severe Headache (that kept me up at night), nausea, shivering, slight fever, sore shoulder. Taking 400 mg ADVIL every 3 hours - helps a little.
Pt developed a rash on both arms, tops of shoulders, and collar bone and complained of soreness to left arm. Pt was given BENADRYL and rash resolved after one day.
Received MMR #1 12/13/10, right deltoid 1/3/11 Rt arm swelling began 1/3/11 with joint pain in elbow, wrist & hand. No shoulder pain, only Rt upper extremity. Is right hand dominant. 5 x 5 cm area at fleshy area of triceps tender to touch.
Patient received an additional dose of Shingrix approximately 14 months after completion of the  2 dose series in 2018.
When getting dressed before school on 10/18/2019, mother noticed patient's arms was red and swollen.  Mother brings child to health department/school nurse's office at 10:00 AM on 10/18/2019 for assessment.  Local reaction to flu shot noted: area of redness, warm to touch, swelling.  Edges of redness marked with ballpoint pen.  Measured 2.25 inches across/horizontally, 1.25 inches vertically/up and down arm.  Mother reports that they applied hydrocortisone cream once, but that swelling and redness had reduced by the afternoon/evening of 10/19/2019 and was completely resolved by 10/20/2019.  No oral antihistamines were administered.
Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left on 26Mar2021 at 14:15 (at the age of 48-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food or other products. Historical vaccine included tetanus (TETANUS VACCINE, Lot number: 5), via an unspecified route of administration on 17Feb2021 as a fifth dose for immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 15:00, the patient experienced headache and nausea. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events for headache and nausea was not recovered.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine facility information was added. Concomitant therapy was left as blank since case contain concomitant medication. TETANUS VACCINE was removed from concomitant drug and updated as Historical vaccine as it was administration outside the 4 week interval.
Severe chest pain after echocardiogram found fluid building up around my heart, this Continued and worsened over the next three months becoming so severe and painful that I could not even get a hug from my Children.  I prayed nightly that god grant me just one more day.  I could not Eat, I was slowly dying and I was forced to get this vaccine. My financial situation is horrible right now, I was not supported by my employer through this situation as  I was promised, only pressured to return to work despite my declining health status and my financial situation worsening
Getting COVID in August after having the vaccines; Getting COVID in August after having the vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Getting COVID in August after having the vaccines".  Clinical Information: Female consumer states that she had the first COVID 19 booster dose a year ago.She also mentions getting COVID in August after having the vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 11/23/99, the pt received her first dose of Lymerix for prevention of Lyme disease. Three days later, on 11/26/99, the pt experienced an 8cm local reaction. No treatment was given.  The most recent information received on 1/5/00, reports the condition of the pt as resolved.