chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received booster on Sunday, 10/3 at 3:00 PM (3rd dose), by Monday at 2:00 AM began to feel normal symptoms such as nausea, headache, dizziness, but by Tuesday, 10/5 at 10 PM had significant stomach pains at a 10 out of 10  (similar to feeling food poisoning). I also had chest pain. I felt dizzy and lightheaded as well.  I then began to have violent diarrhea that would not stop (15+ times per day) and ended up in the emergency room on Thursday, 10/7, where I received fluids, and they monitored my heart. I was still having diarrhea at that time. They saw on EKG that I now had Long QT (at 500), which I've only had in the past secondary to medication.  I did not have Long QT again prior to this event as I had an EKG in May 2021 and it did not show Long QT.  They also tested me for everything including my fecal, COVID PCR test, influenza A, B, and all was negative. The ER doctor informed me that he thought it was related to the vaccine. I'm filing this report to make others aware that this could potentially happen, and there could be an impact on the QT/QTC for the heart.
I came down with Covid; I came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I came down with Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: Patient's family follows the guidelines set, have had their vaccines thru Pfizer and boosted. Now just recently, patient came down with covid, it has been so very mild.
It was back in May, a month after the shot, I started having joint pain in my hip. As far as walking, it wasn't bad, but any time I sat down it was pretty intense. I went to orthopedic doctor, and he sent me to physical therapy. I went and after 2 or 3 sessions they told me they couldn't do anything with me because I was having balance and gait issues, and they recommended I see a neurologist. It took me several months to get in to see them, and I think it was December but I'm not sure. My short term memory has gotten bad, and I don't remember sentences and times. But even now, when I stand up my legs start shaking and they said I have orthostatic tremors. They said it was pretty rare but is pretty sure it's what I have. Now, recently, I've noticed other little tremors and my mind seems to be getting worse by the day, but that may be from some medicine he has prescribed to help. I now walk with a cane and a limp because my hip still bothers me. I've worn hearing aids for years and they said my speech recognition in my ears is worse. I went to ENT and they said I had acoustic neuroma (but this was before I got my second shot).
Hello,  Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM.  The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home.  Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects.  Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days.  Then I also started with a slight fever, which of the times checked, reached about 101.  Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch.  I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again.  That went on all day.  When laying down that night the cramping would subside enough to sleep a little on and off during the night.  The calf muscle cramping started to gradually subside, but took about 17 days to go completely away.  The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended.  Best regards,
Developed a large, red, slightly raised area around the injection site on my upper right arm.  Area is tender.
Pt's arm was red and sore around the spot of the shot for about 24 hours. She complained of pain in that arm but was able to do normal activities. After 24 hours, the redness and swollenness spread and grew to cover most of her upper arm, from below her shoulder to above her elbow. She said it itched really bad. It was hot to the touch.
mom reports pt recvd vax 6OCT93 1030AM; w/in 1-2 hrs pt appeared to wheeze, cough & stated throat felt tight; pt is an asthmatic but has never had tightening of throat a/;
Respiratory   Acute non-recurrent frontal sinusitis - Primary   Relevant Medications   azithromycin (ZITHROMAX) 250 mg tablet   Cough   Relevant Medications   albuterol HFA (VENTOLIN HFA) 90 mcg/actuation inhaler   azithromycin (ZITHROMAX) 250 mg tablet   Other Relevant Orders   COVID-19 PCR  Strongly suspect COVID-19 viral infection versus other respiratory viral illness.  Swab sent for laboratory confirmation. Concern for development of pneumonia, will treat with azithromycin. Patient did have first COVID shot two days ago.  Patient was advised on over-the-counter remedies including Tylenol, NSAIDs, Robitussin or Mucinex, plenty of fluids and rest.  Should quarantine for 14 days and remain separated from any other household members as much as possible.  If any other household contacts display any symptoms, they should be evaluated and tested as appropriate.  Advised to contact any person who had close contact in the 48 hours prior to symptom onset as well as anyone while patient was having symptoms.  Advised if any difficulty breathing, worsening shortness of breath, fever uncontrolled by Tylenol or ibuprofen, or changes in level of consciousness, patient should go to the emergency room immediately for evaluation.
Information has been received from a RN concerning a 2 year old male who was vaccinated SC with a dose of varicella virus vaccine live. The reporter indicated that approximately two to three months ago the pt came into the office with chickenpox. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Body aches, fever, nausea, headache. Lasting for21 hours. Stayed in bed whole time
A red, itchy, growing lump at the injection site; A red, itchy, growing lump at the injection site; A red, itchy, growing lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A red, itchy, growing lump at the injection site), VACCINATION SITE PRURITUS (A red, itchy, growing lump at the injection site) and VACCINATION SITE ERYTHEMA (A red, itchy, growing lump at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (A red, itchy, growing lump at the injection site), VACCINATION SITE PRURITUS (A red, itchy, growing lump at the injection site) and VACCINATION SITE ERYTHEMA (A red, itchy, growing lump at the injection site). At the time of the report, VACCINATION SITE MASS (A red, itchy, growing lump at the injection site), VACCINATION SITE PRURITUS (A red, itchy, growing lump at the injection site) and VACCINATION SITE ERYTHEMA (A red, itchy, growing lump at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since; no adverse event; Expired vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since) and NO ADVERSE EVENT (no adverse event) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 06/23/23 and was stored in the refrigerator since).    Concomitant medication details not reported by the reporter. Dosage text was reported as Unknown. Treatment details was not reported by the reporter.
Experienced severe pressure and pain all around her heart, severe rapid heart beat, felt like she was going to have a heart attack; High blood pressure for almost 3 weeks; Severe rapid heart beat; This is a spontaneous report from a contactable consumer reporting for herself  A 61 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe pressure and pain all around her heart, severe rapid heart beat, and high blood pressure for almost 3 weeks. She felt like she was going to have a heart attack. She is now on prednisone.  AT the time of the reporting event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
- Ringing in ears began about 2 hours after the injection and has persisted constantly for last 24 hours and is ongoing (most annoying) - Significantly swollen lymph nodes near injection arm -  Low grade fever started around 18 hour point post injection - Headache overnight and until around lunch time - subsided now with Tylenol - Body aches began at 24 hour post injection
pt recvd vax 16AUG94 lt deltoid; father noted inflammation on 17AUG94 while was getting pt ready for bed; area sl edematous & red to elbow; had iced it; sentto MD no treatment; suggest DTAP be used @ preschool 22AUG94 mom says pt OK now;
no adverse event related to the vaccine, but patient was admitted to the Adult Care Unit for COVID-related issues on 10/15/2023.   Presented to the ED the same day for chief complaints of nausea, vomiting, diarrhea that began the night before.  From ED physician note:  This is a 62-year-old female with a history of borderline diabetes and obesity who is presenting with nausea, vomiting and diarrhea starting last night, as well as shortness of breath which she states is actually more of a chronic issue.  She was found to be hypoxic to the mid 80s on room air, COVID-positive.  X-ray shows no evidence of lobar pneumonia.  She does not appear to be systemically ill or toxic.  She has a completely benign abdominal examination with no major metabolic or hematologic abnormalities.  I do not suspect an acute intra-abdominal process that would warrant a CT scan at this time.  Likewise I do not suspect an alternative acute cardiac or pulmonary process.  As mentioned above she was placed on 2 L nasal cannula, with oxygen saturations now in the mid 90s.  Given her COVID?19 and hypoxia she will need to be admitted to the hospital for further care.
QUITE ANXIOUS ABOUT THE SYMPTOMS; HIVES; HALF OF LIP SWOLLEN; ITCHY ABOVE THE HIPS; NIGHT SWEATS; WOKE UP A FEW TIMES DURING THE NIGHT; This spontaneous report received from a patient concerned a female 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: 0418Z1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced night sweats. On 06-APR-2021, the subject experienced woke up a few times during the night. On 07-APR-2021 07:00, the subject experienced half of lip swollen. On 07-APR-2021 07:00, the subject experienced itchy above the hips. On 07-APR-2021 07:00, the subject experienced hives. On an unspecified date, the subject experienced quite anxious about the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up a few times during the night on 07-APR-2021, was recovering from night sweats, had not recovered from half of lip swollen, hives, and itchy above the hips, and the outcome of quite anxious about the symptoms was not reported. This report was non-serious.
Child received 6 mo imms and flu#1 on 1/4/21 am. About 6pm child had fever, chills and a seizure-like epside. He returned to baseline shortly after the event. He was taken by ambulance to MC ER and discharged with diagnosis of suspected febrile seizure. A follow-up phone visit on 1/5/21 was done. Baby continued to have borderline fever (T99) but was otherwise doing well.
Patient stated had trouble moving her arm since the shot. She wasn't able to lift anything or use her arm for 1-2 days. Arm extremely sore since then.
Why did they give me the 1st shot being under 50; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: The patient self-reported this case. The patient got his/her first dose of Shingrix 2 months ago from the date of reporting. The patient stated that the pharmacist refused to give him/her second Shingrix shot. The patient also stated the pharmacist said him/her that the computer told him he could not give the second dose but did not say why.  The patient assumed it was his/her age. The patient asked why they gave him/her the first shot. The patient reported that he would be turn 50 in July. Additional supportive information: The 49 years old patient received dose of Shingrix vaccine, which led to inappropriate age at vaccine administration.
On 1/21/23 10:20 am, client received a Pfizer Bivalent in the right arm. At 11 am, a member came to the nurse table and stated the client is not feeling well. Client stated about 30 minutes after she received the vaccine while cleaning in kitchen felt the dizziness, nausea, headache, and flushed feeling all over the body. So, she sat and put her head down. Client does not know how long she was resting. Client stated she was starting to feel better when she was woken up and the dizziness, nausea, headache, and flushed feeling started all over again. Client also stated she did not have anything to eat for breakfast. Client was given snacks and drinks.  Vitals recorded: 11:05 am BP= 154/84 HR 84, 11:10 am BP=148/93 HR 80, 11:20 am BP=145/76 HR 75. Client has a history of anxiety and obesity but denies taking any medications. Client denies any allergies or other medical history. At 11:30 am, client continued to eat and drink and reported feeling better. At 11:40 am last vitals BP=140/72 HR 70.  At 11:45 am, client was walking around the hall with a mop. Client was advised to take it easy for the day and will be receiving a call from the nurse for a follow-up.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 05-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for approximately 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 6 of several reports from same reporter. Additional information has been requested.
Taken 4 full doses of Moderna COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Taken 4 full doses of Moderna COVID vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (Taken 4 full doses of Moderna COVID vaccine). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (Taken 4 full doses of Moderna COVID vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-422785 (Patient Link).
PAIN AND INFLAMMATION AND REDNESS INITIALLY, NOW JUST PAIN AND INFLAMMATION AT INJECTION SITE. ALSO HAVE PAIN IN THE NECK AND UPPER BACK AND LEFT SHOULDER. CANNOT SLEEP SINCE VACCINE WAS ADMINISTERED.
This spontaneous report as received from a medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different date: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot number, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 6 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
June 14, I had the vaccine. June 25, I started having muscle aches, severe headache and sore throat. This continued through the next week along with being extremely tired. July 5, I went to the ER due to severe chest pains (I have NEVER had chest pains before). They sent me home that same day. By July 7th, I felt like my heart was seizing and went back to the ER this time also with shortness of breath and a fever. I was admitted on July 7th and discharge on July 9th, with diagnosis of Pericarditis--a SIDE EFFECT OF THE VACCINE. I am now currently on sick leave as I cannot work. I was told by medical staff to report this so that is what I am doing.
Patient presented to office 10/3 complaining of itchiness with redness on bilateral legs, neck, and chest that started 10/2/19 at night. Mom states she had flu shot on Tuesday (Oct. 1) and a child she sits for has impetigo.  Physician notes include: A blanching macular rash throughout the body in small areas- a few appear more urticarial. Suspect reaction to the flu vaccine.
Case number PHEH2014US025060, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 83 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 07 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
From telephone contact with reporting nurse practitioner, it was reported that a 27 month old patient received a TriHibit (combination Tripedia and ActHIB) vaccination on 08/21/01. Reportedly the patient developed a local reaction 7.5 cm X 9 cm at the injection site. From additional correspondence received on 11/20/01 it was reported that the pt also received a MMR and a hep B vaccination on 8/21/01. Reportedly the pt recovered from this experience. This case is closed.
sick; Initial information was received on 17-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got sick while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for influenza Immunization.  On an unknown date the patient had a non-serious event of sick (illness) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.