chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100.9 temp; vomiting; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 13-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right (reported as right arm) on 11Jun2021 at 10:00 (at the age of 13-year-old) as dose 2, single for covid-19 immunization. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and women's multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 14May2021 10:00 (at the age of 13-year-old) as dose 1, single for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021 at 02:00, the patient experienced 100.9 temperature and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature resulted as 100.9 (unspecified units) on 12Jun2021. Therapeutic measures were not taken as a result of the events. Outcome of the events 100.9 temperature and vomiting was resolved on an unspecified date in Jun2021.  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.
Extreme irritability that began within 24 hours of her vaccine with a hive like rash as well. Odd obsessive thoughts that are not her nature at all, day and night, waking her. Of note per her first DTP she had notable startling for 1 wk and very loose freq. stool mucusy for 3 wks.
Started < 48 hours after vaccination with small hives with central blisters, very itchy; first in hands, then shoulder, neck, thorax, feet, mouth, not genitalia.
Provider hospital summary: "Patient was admitted with Covid pneumonia and associated acute on chronic respiratory failure with hypoxia and AKI on CKDs 4. She appeared to be improving with improvement in her respiratory status and renal function however on 11/16 she began to c/o of lower lumbar back pain. Clinical dx at that time was chronic LS back pain with hx of LS ORIF with acute muscle spasms. She continued to have pain with an unremarkable neurologic exam and unremarkable abdominal exam. Testing including abdominal US ( AAA), MRI Lspine, lab follow up testing all were unremarkable. Patient continue to c/o back pain in communication with family they were inclined to think she was passing away as patient brother had a similar response prior to death from endstage kidney ds. Aggressive management was continued without change in her clinical status she then worsened with hypotension initially fluid sensitive. Re-assessment did not reveal an explanation for the hypotension. She continued to clinically decline with fewer periods of responsive and further hypotension Decision was made for comfort care in family meetings.  She passed away with family present. She was found to have thick yellow secretions suctioned on the day of her death this may have been related to worsening covid pneumonia/secondary bacterial pneumonia although the decline was not respiratory symptoms."
No adverse effects; he administered a pediatric dose of VAQTA [...] instead of an adult dose; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 10-OCT-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), lot # S002506, expiration date 04-APR-2020 (exact dose and route of administration were not reported) for prophylaxis. The pharmacist reported that he administered the pediatric dose of hepatitis a vaccine, inactivated (VAQTA) instead of an adult dose. No adverse effects reported.
About two weeks after the first Moderna shot, a small growth, about the size of a grain of rice, developed on the floor of the left side of my mouth.   About two weeks after the second Moderna shot the growth started rapidly growing larger to about the size of an olive,  and three weeks after that it had to be surgically removed.  The growth was malignant and required a second surgery and radiation.  When I asked the oncologist if the shot could have triggered the growth of the tumor they said it was possible.
12/27/21 presents to ED for "acute onset shortness of breath". PMHx of "chronic diastolic CHF, CKD stage III, permanent atrial fibrillation on Eliquis, Bronchiectasis, diverticulitis, recurrent left pleural effusion, diffuse alveolar hemorrhage while on Coumadin (2/2021), pulmonary embolism (2017) on Eliquis,  hyperlipidemia, rectal prolapse"
Patient received Pfizer dose #1 Sept 1st and dose #2 Sept 20th. He reported noticing a rash on his skin around 9/9 but did not pay much attention to it. Patient is fairly confident he noticed rash in between 1st and 2nd dose. Admitted to local Hospital 9/21 with rash, prelim pathology results concerning for pemphigus vulgaris.  No clear triggers.
Patient received covid-19 vaccine at 1745 and began experiencing cough and shortness of breath at 1800 and was given 3 puffs of albuterol. Patient was transported to the ED and was satting 100% on room air.  Patient was given oral diphenhydramine and prednisone in the ED and discharged home on 4 more days of prednisone.
itching + rash all over Dr. prescribed: Betamethasone 5% DP + hydroxyzine HCl 25mg 3x daily + Pepcid 40mg.  When continued on Hydroxyzine continued to  get worse, for 2 weeks. Went off  Hydroxyzine then in about 5 days later  began to get better. Now about 1 wk. later  it is almost gone.
pt recv vax 7MAY98 & 4 days p/vax 11MAY98 pt exp pain, redness, & hardness @ the inj site;
Raised, itchy bumps (like mosquito bites).  These first appeared on her knees, then spread to hands and feet, and seem to be arising on other parts of her body now as well.
pt recvd vax & w/in hrs post vax exp a fever of 101.8;sx cont
BLURRED VISION; KIDNEY PAIN; UNEXPECTED THERAPEUTIC BENEFIT; UNABLE TO WALK; CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 03:45 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced unexpected therapeutic benefit. On 08-MAR-2021, the subject experienced unable to walk. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced mild headache. On 09-MAR-2021, the subject experienced blurred vision. On 09-MAR-2021, the subject experienced kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, mild headache, blurred vision, kidney pain, and unable to walk, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
chills, Bilateral Axillary lymphadenopathy, Headache, Pain at injection site..... all symptoms lasted approximately 48 hours with pain at injection site still present as of today
I received the Moderna COVID-19 Vaccine EUA on Thursday, May 13 at 2:30 pm.  I did have a rash on my stomach the next day, but it soon went away.  Then on Saturday, May 15, I awoke to an achy stiff right leg.  I went to take a bath and it was difficult to get my right leg to bend at the joint in order to sit down.  My right leg continued to feel stiff and achy especially at the back of my knee joint.  This discomfort has continued and I am still experiencing it today, Monday, May 17.  I feel this could possibly be a side-effect of the vaccine due to the fact that symptoms occurred soon after the shot, and also because I did not have any joint or leg discomfort or stiffness prior to the shot.
Case number PHEH2014US020321, is an initial spontaneous report from a pharmacist received on 07 OCT 2014. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2014/2015 (batch number:  not reported) intramuscularly that was stored at room temperature for three days on 06 OCT 2014. The reporter was not aware of any side effects/complaints by the patient. No adverse event was reported following the medication error (incorrect storage of drug).
pt says she has extreme pain both of her hands from the top of her knuckle, down the wrist to her finger tips. She says they are very sensitive and have a purple color.  She says her hands having a very painful stabbing pains that feels like bee stings with like a burning sensation. She has had these symptoms for over a month.  She is using lidocaine cream for this pain.  Pt will see her PCP next week for a regular scheduled appt so she will discuss with them.  She took the 2nd vax dose on 3/19/2021 and her symptoms have remained.
POST VACCINE, PATIENT DEVELOPED DIZZINESS, DIAPHORESIS, AND NAUSEA. BROUGHT BACK  TO OBS VIA WC, PLACED IN TRENDELENBERG ON STRETCHER, VSS, HR RETURNED TO NORMAL AFTER A FEW MINUTES. ONCE S/S IMPROVED, SAT UP AND PROVIDED SNACK AND WATER, ONCE S/S RESOLVED, ESCORTED TO EXIT WITH NO ISSUES AT 1830. 1807 INITIAL BP 124/67 HR 45 SATS 98% RA 1812 BP 147/84 HR 72 SATS 100% RA 1825 STANDING BP 123/77 HR 68 SATS 100% RA
Moderna COVID-19 Vaccine EUA: (P.S.: I'm reporting it more because I started having below symptoms a day after I got the vaccine and later on I tested positive for COVID-19) - Chills (Had it for 3 consecutive days after the vaccine) - Headache (Have been having it every single day since Jan 1st) - Mild Fever for 2 days (Jan 2nd and 3rd) - Nasal congestion (stuffy and runny nose) - Cough - Fatigue / SOB - Tiredness  - Body aches  - Photophobia (Still have it at night) - Sore eyes (moderate for a whole day, mild after)  - Sound/noise sensitivity (Still have it at night) - Loss of smell/taste - Joint pain
Swollen neck; Rash on neck; Red neck; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and penicillin allergy. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 03:00, the patient experienced rash on neck and swollen and red neck. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash on neck and swollen and red neck and included treatment with Benadryl at the time of event. The clinical outcome of the events rash on neck and swollen and red neck was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 5 minutes after the injection, the site burned. I didn't give it much thought until about 8 PM that same evening, when it really burned and my arm felt tight. By the next morning, there was a very red swollen patch approximately 2 inches by 3 inches, which was very hot to the touch. I could not completely bend my arm because it was so swollen. Almost 48 hours later and my arm is still quite warm and has some swelling.
reaction to it was a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site) outcome was unknown.            Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-294926, MOD-2021-294965 (Patient Link).
Doctor placed an order for a Pediatric Hep A vaccine on this patient whom is an adult. CMA gave pediatric vaccine instead of adult vaccine. Vaccine was second checked by another LPN but neither nurse caught that it was a pediatric dose for an adult.
chills; headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache and Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: NNI; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
12/20/22 presents to ED for "Change in mental status, agitations, decrease PO intake". PMHx of "HTN, cardiomyopathy (EF 25%), LBBB, HLD, CAD s/p PCI/LAD"
headache that would come and go; a little bit of chest pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on Apr2021 as dose 1, single for covid-19 immunisation and experienced headache. On an unspecified date in 2021, the patient experienced headache and chest pain. It was reported that after shot 1 Patient experienced headache that would come and go After shot 2 Patient also experienced a headache that would come and go and a little bit of chest pain after the second shot. Event took place after use of product. She received both shots in Apr2021. The outcome of the event headache was not recovered while the outcome of the other event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Child seen right after immunization series for a rash that presented 11 days after MMR vacc. Rash began on face and has traveled to trunk and UE/LE. Child does scratch. No fever. No decrease in appetite. No difficulty breathing. Twin brother with same vaccine with same problems. Rash began 24 hours after day at park where child had sunscreen on and exposed to water at theme park. Mom has given 3 doses of Benadryl with resolution of sx.
I was vaccinated with ZOSTAVAX for shingles in 2009 and I have just had another breakout of shingles....Should there be a 2nd. Vaccine given when this happens?
Within minutes: brain fog, disorientation, needed walked out to car so could be driven home. Lasted 3 days. Day 9 post vaccine: Covid arm (red swollen area about 2x4 inches); Covid throat on left side  swelled to size of tennis ball. Treated with allergy meds, ice; no impact on breathing / swallowing. Throat swelling gone by a.m., arm swelling lasted 7 days. LOTS of nerve pain: hit every place my body has been injured / had surgery. Worst with wrists, hands, mouth, and left hip (replaced in 2010). Also impacted arthritis in hands and feet causing painful flare ups. Other than arthritis have no more nerve pain or brain fog since 4/30/21. Also experienced emotional lability and sense of overwhelm: lasted 3 weeks.
Didn't feel right in the car on the way home - body tingling, felt like she couldn't keep her head straight, headache, stomach upset, couldn't move arm.
Began intractable migraine type headache five (5) days post injection. Lasted almost 3 weeks. Treated with Ibuprofen, Ultram, Ketoralac, and Benadryl x 3 days per neurologist instructions along with Zomig and ergotamine.
Post-Vaccine Lymphadenopathy   occurred 2 days after 2nd dose
acute hypoxic respiratory failure; Sepsis; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPSIS (Sepsis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Characteristics and outcomes of adverse events after COVID-19 vaccination. 2021;2:e12565     Concurrent medical conditions included Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome.    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 ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure and Sepsis. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) and SEPSIS (Sepsis) to be possibly related.    Concomitant medications were not provided Treatment medications were not reported  Company Comment: This case concerns a 79-year-old, male patient with a history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome, who experienced the fatal unexpected serious events of ACUTE RESPIRATORY FAILURE (AESI) and SEPSIS. The events occurred at within 10 days after a dose of Moderna COVID-19 vaccine. The rechallenge was not applicable due to the nature of the events. The medical history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371540, MOD-2021-371541, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from the team and  contains significant information.; Sender's Comments: This case concerns a 79-year-old, male patient with a history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome, who experienced the fatal unexpected serious events of ACUTE RESPIRATORY FAILURE (AESI) and SEPSIS. The events occurred at within 10 days after a dose of Moderna COVID-19 vaccine. The rechallenge was not applicable due to the nature of the events. The medical history of Cerebrovascular accident, Type 2 diabetes mellitus and Obstructive sleep apnea syndrome remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure; Sepsis
Eye swollen closed, throat scratchy and swollen. Per ED MD, severe allergic reaction consistent with anaphylaxis. Also has allergy to ibuprofen and reports took some earlier today; mistook the brand name for acetaminophen.
Myalgia, Arthralgia, Fever, Chills, fatigue  Narrative:
My neck is stiff.  my legs are in pain.  my arm that received the shot is swollen.  I have a bruise to the entire site of the shot.  shooting pain that radiates to both shoulder blades.  I have a salty taste in my mouth.
This case was reported by a healthcare professional via a representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The sales representative reported that there has been 4 cases of cellulitis at this doctor's office recently. They have increased their doses of KINRIX during this time and were questioning whether it may have been a cause. The sales representative had no additional information.
This spontaneous report as received from a lab technician to a 12 month old female patient. The patient did not have pertinent medical history or drug allergy. On 20-SEP-2013 the patient was vaccinated with M-M-R II lot # H018947, exp 18-OCT-2014, 0.5 ml, subcutaneous. There was no concomitant therapy. On 20-SEP-2013, patient had an allergic reaction within 5 minutes of receiving M-M-R II on 20-SEP-2013. Patient developed redness and welts around injection site and was given 4ml BENADRYL for treatment and reaction subsided quickly. Patient was sent to an allergist (name unspecified), allergy test was done, and patient was diagnosed with an egg allergy. Patient recovered on 20-SEP-2013. Additional information has been requested.