chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave vaccine to 17 year olds; A spontaneous report was received from a healthcare professional concerning a 17-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient received the vaccine resulting in the event of inappropriate age of dose of administration.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, inappropriate age of dose of administration, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Batch number: unknown), where the product was administered to inappropriate age. There were no associated AEs.
I have a fever of 102.5 degrees; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I have a fever of 102.5 degrees) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have a fever of 102.5 degrees). At the time of the report, PYREXIA (I have a fever of 102.5 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 c (High) 102.5 C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant drugs were provided.  No Treatment information was provided.   Reporter did not allow further contact
8 x 11 cm erythema on left arm which is 2 cm bigger than right circumferentially, with underlying 5 x 5 cm induration; slightly tender, warm, no axillary node increased with noted last night.
Drug interaction; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Drug interaction) in a 22-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In January 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen,Citrate free. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). At the time of the report, DRUG INTERACTION (Drug interaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Lack of drug effect reported after humira with start date as on unknown date in 2022 Booster dose received by patient via intramuscular route. No treatment medication was reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a adult male patient who received BOOSTRIX. On 13th MAY 2015, the patient received BOOSTRIX. On 13th MAY 2015, an unknown time after receiving BOOSTRIX, the patient experienced wrong injection technique. In MAY 2015, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage and wrong injection technique were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to BOOSTRIX. Additional details were reported as follows. The pharmacist administered BOOSTRIX with a 18 G needle (vs a 25 G). Subsequently, less than a week after vaccination, the patient bled and  he felt the vaccine leaked out.
Pt experienced about 1 inch of redness, induration, heat, pain and itching to injection site within 24 hours of vaccination.
TEMPORARY BLINDNESS/EVERYTHING WENT DARK; This spontaneous report received from a consumer concerned an 18 year old male of unknown race and ethnicity.  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: 042A21A, expiry: UNKNOWN) dose was not reported,1 total administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced temporary blindness/everything went dark. The reporter stated that his son received the vaccine the same day that is 10-APR-2022 as him and his son received the dose from the same vial, he had temporary blindness, everything went dark, he told the pharmacist and was told that it was a normal side effect, no issues after, it resolved after about 15 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporary blindness/everything went dark on 10-APR-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220204276.; Sender's Comments: V0: 20220227808-covid-19 vaccine ad26.cov2.s - temporary blindness/everything went dark. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Fever of 102.6 for 48 hours, then 101.9 for 12 hours, severe headache, shaking chills, body aches, extreme fatigue
Swelling of injection site, intense itching, muscular pain, swelling of upper arm spreading to the rest of the arm
This case was reported by a consumer via patient support programs and described the occurrence of lung congestion in a 63-year-old male patient who received Flu Seasonal QIV Dresden. Co-suspect products included LOVAZA capsule for cholesterol and ADVAIR inhalation powder for chronic obstructive pulmonary disease. On 30th October 2017, the patient received Influenza vaccine. On January 2001, the patient started LOVAZA 1 g at an unknown frequency and ADVAIR at an unknown dose and frequency. On an unknown date, less than a month after receiving Influenza vaccine and unknown after starting LOVAZA and ADVAIR, the patient experienced lung congestion (serious criteria GSK medically significant), cold, dry cough and feeling unwell. The action taken with LOVAZA was unknown (Dechallenge was unknown). Rechallenge with LOVAZA was unknown. The action taken with ADVAIR was unknown (Dechallenge was unknown). Rechallenge with ADVAIR was unknown. On an unknown date, the outcome of the lung congestion, cold, dry cough and feeling unwell were unknown. It was unknown if the reporter considered the lung congestion, cold, dry cough and feeling unwell to be related to Influenza vaccine, LOVAZA and ADVAIR. Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. On 1st January 2001, the patient started ADVAIR 250/50 at an unknown dose and frequency. The patient reported to get refills on his medications. On 30th October 2017, the patient received flu shot at the hospital (doctors office) and when he got home he started feeling ill. The reporter described the adverse event as being a cold, congestion on the chest and a dry hacking cough.
Patient experienced itching and tingliness... some redness and her blood pressure rose to 170/98. Administered 50mg of benadryl generic and she waited for over 30 minutes. Her blood pressure dropped to in the 140's over 90's and she was able to leave and return home on her own,
Left upper arm swollen about 2" x 3" red and slight warm to touch and tender. Ice packs to site 10-15 minutes every 3-4 hours for two days. Keflex tsp bid for 10 days. Motrin for pain.
Moderna COVID-19 Vaccine EUA Severe body chills(started at 7pm to 10am)) body aches (8pm to 10am)) headache (10pm to 8pm next night) Lethargy 10pm to present)
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/23/2023 ACUTE EXACERBATION OF COPD
GOT SLEEPY AND THEN FELL ASLEEP; HEART PALPITATIONS; KIDNEY PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for kidney pain.  On 30-AUG-2021, the patient experienced got sleepy and then fell asleep. On 30-AUG-2021, the patient experienced heart palpitations. On 30-AUG-2021, the patient experienced kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got sleepy and then fell asleep, heart palpitations and kidney pain was not reported. This report was non-serious.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of ROTATEQ orally (dose and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Swelling in (R) leg fever 104 degrees fine pinpoint rash torso. Fever, lethargic, rash, pulling at ears.
vaccinated on 3/16/21 & 4/8/21 and diagnosed with Covid on 8/5/21 U07.1 - COVID-19
2 1/2 to 3 inch area at injection site that is red firm and warm to touch , no fever or other problems
Patient complained of pain in arm where vaccine was given, and saw MD on 2/15/17 for left shoulder pan. MD aspirated fluid 2/16/17 and informed pt to make apt f/u as needed.
pt came in requesting a flu shot and received a pfizer covid booster.  she was previously vaccinated with moderna,  a flu shot was then also given, pt was monitored for adverse reactions. none reported.
did not show any antibodies after the first shot; injection site was very very swelling; injection site very uncomfortable; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (did not show any antibodies after the first shot), VACCINATION SITE SWELLING (injection site was very very swelling) and VACCINATION SITE PAIN (injection site very uncomfortable) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (did not show any antibodies after the first shot), VACCINATION SITE SWELLING (injection site was very very swelling) and VACCINATION SITE PAIN (injection site very uncomfortable). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (did not show any antibodies after the first shot), VACCINATION SITE SWELLING (injection site was very very swelling) and VACCINATION SITE PAIN (injection site very uncomfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: negative. In January 2021, White blood cell count: okay, no infection Okay, no infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant therapy included heart pills. The reporter stated very very scary episode after two weeks of received the vaccine. Doctor put patient on antibiotic but really did not help, so patient was put on more stronger penicillin.
Headaches started the following day (1 May 21) treated with Advil. On May 18th developed numbness in the left side of mouth. On May 19th developed paralysis on the left side of face. Went to ER, where they diagnosed it as Bell's Palsy. Treatment given Valacyclovir 1 gram tablet 3 times per day for 7 days. Prednisone 20mg 3 tablets once a day for 7 days. After those next treatment was methylprednisolone 4 MG DSPK pack with 40mg Pepcid twice a day and Benadryl at night
syncope and collapse, called 911, paramedics evaluated vitals, low blood pressure on arrival, rechecked it after a few minutes and it was back to normal, did not go to hospital
My resting heart rate has increased significantly.  I work out 4-5 times per week so noticed it almost immediately.   I am otherwise very healthy
This case was reported by a physician (subject's mother) and described the occurrence of fever in a 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination on the same date as suspect product included meningococcal acwy vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2000; tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed; manufacturer unspecified; unknown; unknown given in 2000; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given in 2000. Medical history included: the subject "had swelling as an infant to DTwP." In 2000 or 2001, the subject received 1st dose of CERVARIX (1 dose, unknown route, right arm). Per the physician, the subject received CERVARIX 2 to 3 years ago. Less than one day ("within 24 hours") after vaccination with CERVARIX, the subject experienced fever and lymphadenopathy. The subject received other vaccinations on the same date, but the physician was attributing the reaction to CERVARIX. At the time of reporting the outcome of the events were unspecified.
Pt returned to clinic for evaluation of RUE. Per Dr. notes pt had cellulitis of RUE. Prescribed BACTRIM D/S 800-160 mg. one table BID times 7 days. Pt had redness swelling, fever, pain with  movement. Pt returned 7-17-17 Abx discontinued-did not help with cellulitis, symptoms improving per Dr. Symptoms were more persistent with allergic reaction per Dr.
Patient receive 2nd Moderna vaccine on 02/11/21 at 12:55pm. Patient experienced elevated heart rate of 120 within 15 minutes of receiving 2nd Moderna vaccine injections. Patient had complaints of dizziness and weakness. Blood pressure elevated at 180/87, 02 sat - 99%.  1:26pm Blood pressure 174/71, heart rate 98, O2 sat - 98%.  1:30pm  Blood pressure 146/73, heart rate 89. Patient stated she was feeling better, no dizziness or weakness. Patient decline ER transport.
Pt. completed full observation without event and arrived at checkout complaining of dizziness, lightheadedness and tingling sensation. Returned to observation and laid down. Cleared by EMS to exit facility.
received both doses of the Covid vaccine. Patient was currently 38 weeks pregnant and was going to deliver on Monday 22Feb2021; Patient had both doses with only a sore injection site; This is a spontaneous report from a contactable consumer, the patient. A pregnant female patient of an unspecified age received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration, on an unspecified date Dose 1,Single  for COVID-19 immunization and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration, on an unspecified date Dose 1,Single  for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient recently received both doses of the Covid vaccine. Patient was currently 38 weeks pregnant and was going to deliver on Monday Feb2021. Patient was hoping she could help with blood testing for antibodies from baby id that would help. Patient had both doses with only a sore injection site. No other complications. Outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Flu-like symptoms: weakness, fatigue, soreness, headache. Began 16 hours after vaccine and lasted approximately 36 hours. Treated with bedrest.  However, tiredness/fatigue still continue 12 days after vaccination, and have not subsided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 01-MAR-2018 the patient was inadvertently vaccinated with expired dose of VARIVAX lot # M000998, expiry date: 07-JAN-2018) for prophylaxis. Other suspect therapies included sterile diluent. No adverse effects reported. No product quality complaint involved.
Shoulder sore immediately and increasingly (11:00 AM).  Flu symptoms began within a couple hours.  First, skin/scalp soreness.  In the evening, I began to feel feverish, had a headache, chills, and dizzy/delirious sensations.  At midnight, I had a fever of 101.6.  At 7:20 AM (following day), temp. was down to 99.8.  At 8:15 I broke into a sweat and felt faint.  I had to hurry to the bathroom, where I had a bowel movement that began firm but then turned very soft.  At 8:30, temp was down to 99.1.  I had no energy, so i rested/napped for a couple hours.  By 11:30 I had eaten and remaining symptoms were mild--muscle and scalp soreness, slight headache.  By mid-afternoon, I was again drained of energy and napped for about two hours, very uncommon for me.  Spent a quiet evening, and the next morning, I was feeling almost normal again.
Left deltoid redness, sore, hard (at) site, warm, swollen, itching at site. Injection given 2 days ago. Notice area within 24 hrs after injection.
Moderna COVID-19 Vaccine EUA Patient presented to Pharmacy around 3:30pm on 3/24/21 complaining of anxiety, confusion, bilater lower leg edema and erythema, and dizziness. Her blood pressure was WNL and her heart rate was >100bpm (I did not record BP and HR so I am not reporting exact numbers). I monitored her for about an hour, after which she stated she was feeling better. I instructed her to seek medical attention should any of her symptoms worsen or return. On the evening of 3/24/21 she presented to Hospital ER department. The provider that treated her reports erythematous rash involving bilateral lower legs and ankles as well as her face. Also reports lightheadedness.
Caller states they experienced a sore arm for a few days; slight pressure headache; her husband had fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for patient (Husband). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. The caller reported that she and her husband received the second dose of the vaccine 4 weeks from the first dose of the vaccine. Caller also stated she and her husband had normal reactions to the vaccine. The "caller states they experienced a sore arm for a few days" and a "slight pressure headache" on an unspecified date. The caller stated, "her husband had fatigue" on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Information has been received from a registered nurse concerning a 19 year old female patient with idiopathic thrombocytopenia and no drug reactions/allergies, who on 29-MAY-2008 was vaccinated intramuscularly on her arm with the first 0.5 mL dose of GARDASIL vaccine. On the same day the patient experienced severe muscle pain and spasm in her back and buttocks. There was no concomitant medication. On 28-JUL-2008 was vaccinated intramuscularly on her arm with the second 0.5 mL dose of GARDASIL vaccine and experienced severe muscle pain and spasm in her back and buttocks several hours later. All symptoms resolved within few days after the vaccination. The patient did not seek medical attention. The patient had not received the third dose. Additional information has been requested. Follow up information received from a registered nurse on 26-JAN-2009. It was reported that the 19 year old female patient with idiopathic thrombocytopenia diagnosed since age 2, no problem within childhood or adolescence, no current problems now, on 28-JUL-2008 was vaccinated intramuscularly into the right deltoid with the second 0.5 mL dose of GARDASIL (Lot # 659184/0843X) at approximately 16:00. The patient reported that on 07-AUG-2008 she developed "waves" of sharp muscle spasms in back, buttocks, upper thighs and side of buttocks. The patient stated it started within a few days to a week from injection. The patient described the pains in her muscles as bad, very painful, when it first happened, but they would become less severe as time went on. The patient saw family physician and was given muscle relaxers, and it helped some. The duration of symptoms lasted on approximately off for a month or so. On approximately 28-AUG-2008, the patient recovered. The patient states she had the same symptoms after the first injection on 29-MAY-2008, but did not put it together that it was from vaccine until she received the second injection and symptoms repeated themselves. She was doing OK at this time, but declined to receive the third dose of GARDASIL. Additional information is not expected.
24 hrs after shot headache and fatigue. 14 days after shot I developed ?Covid arm?
Approximately 10 days post vax, pt experienced 2 positive lesions described as vesicles at the injection site, mild erythema and itching at the injection site.
1/19/2022 pt admitted to hosp after being found laying in feces x 7days with maggots; acute metabolic/infectious encephalopathy secondary to pneumonia from gram positive cocci and COVID 19; positive COVID test on 1/20/22; DNR; developed melena, endoscopic evaluation offered but pt refused; experienced change in mental status and fever; IV ABX; MRSA bacteremia and pneumonia; poor kidney function; condition worsened; became hypoxic and nonresponsive; transitioned to inpatient hospice where he passed away
Fever rose to 105 (R)- was taken to ER. Mom states was given APAP
HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210350883.