chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was "sick for a while"; Can't get over the tiredness / still exhausted; This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and exhaustion. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the exhaustion was not recovered/not resolved.   The reporter considered the sickness and exhaustion to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The patient was non-diabetic (negative for diabetes) and she was healthy, active, exercised and had healthy diet. The patient was in her late 70's/early 80's. It was unknown if the reaction occurred after 1st or 2nd  shot of Shingrix. The age at vaccination was not reported.  The patient was not on lots of medicine. The patient was sick for a while and sickness has resolved but she could not get over the tiredness. The patient was still exhausted. The reporter provided limited information.  The consent to follow-up was requested. This was 1 of the 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021017003:Same reporter US-GLAXOSMITHKLINE-US2021017037:Same reporter US-GLAXOSMITHKLINE-US2021AMR018312:Same reporter. Case for friend 2 of 2.
Patient received his first dose of the Pfizer Covid-19 vaccine on 7/2/21. Later that day the tip of his tongue had no taste. About 72 hours later, patient experienced numbness/tingling  down the side of his face. He went into the emergency room and had workup/CT scan. Patient was diagnosed with Bell's Palsy.
diff breathing, asthmatic coughing, tearing red eyes, chills;DPH, Pred had nof effect;
Symptoms: Severe generalized abdominal pain, severe vomiting.  No diarrhea.  Tx: ER visit per hepatology phone consult  Outcome: calmed down after 6 hours after ER Tx began; released home. 24 hours of rest resolved condition.
muscle aches/ severe muscle aches; fever; chills; worse fatigue/ exhaustion/ tired; mostly slept; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the right deltoid on 21Jan2021, at 10:00 (Batch/Lot Number: EL9261, Expiration Date: May2021, at the age of 49 years old) as dose 2, single for COVID-19 immunisation. Since early Apr2020, the patient spent 4-6 hours/day face-to-face with COVID patients for months. After starting work on COVID unit, she previously had mild illness, sore throat, fatigue, achey, but no cough, and fever not over 99 from 09Apr2020 to 17Apr2021. Unknown if she had COVID. She kept working in the COVID unit per requirements at that time. On 29Dec2020, she had COVID antibody test: negative. The patient's concomitant medications were not reported. She did not have prior vaccinations. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EJ1685, Expiration Date: Mar2021), intramuscular, administered in the right deltoid on 31Dec2020 (at the age of 49 years old) for COVID-19 immunisation. On 21Jan2021, at 14:00, the patient experienced muscle aches (also reported as severe muscle aches), fever for 3-4 days, chills, worse fatigue/exhaustion, mostly slept for 2-3 days, sore arm, and tired- 1 week. No therapeutic measures were taken as a result of the events and the patient just rested. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Area red, hot, swollen. Spreading over shoulder onto back. Another child had some reaction 2 wks prior same lot.
Patient admitted with symptomatic hypercalcemia. Gave calcitonin and IV fluids. Patient was appropriate for discharge and close outpatient follow-up. ED visit 10 days later for the same problem. Treated and released. ED visit and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
Within 15 minutes I felt really lightheaded, which went away after about 1/2 hr. That night about 9pm my R arm was aching SO bad, like I've never felt. Also I got a horrible headache and lower backache, could not sleep. Felt horrible till about noon the next day started to feel better slowly.
3 days p/vax pt felt dizzy & nauseated lasted several hr;5th day p/vax s/s came back & pt started to have nausea, dizziness again w/cramping & diarrhea & really abd vomiting;it lasted 24hr;pain;can't sleep
Headache; Woozy feeling; feeling like you have been drinking the alcohol; Feeling of unwell; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: not reported) via an unspecified route of administration on 28May2021 at 3:00 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that I just had Pfizer vaccine yesterday (28May2021) at 3 and I pretty much felt okay yesterday (28May2021) but today (29May2021) I was feeling very strange and I knew all of this is side effects. The one I had maybe like was a little bit of headache. I thought I should hydrate more and I did try to do that but the weirdest feeling was like a woozy feeling like it just came and went. It was kind of a feeling like you have been drinking the alcohol and all. That's a weird feeling I was getting that concerned me. I was really concerned about that. And I know that the symptoms are the feeling of unwell. So, it feels really strange to me. When the patient was asked for medical help, the patient reported that I mean, it's not severe enough. I was just resting in my bed right now. I did not drive anywhere because I thought it would not be a good idea. I just thought it was a good idea to tell you what was going on. I know we were supposed to contact the pharmacy, but the pharmacy was closed right now where I had the vaccine. I do not know, I just thought I would tell someone what is going on because I was concerned. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Patient was tested positive for COVID-19 infection 2 days prior to admission.  He was admitted under Hospital Medicine Service for further evaluation and management.  Cardiology has evaluated this patient for elevated high sensitivity troponin which was suspected secondary to demand ischemia in the setting of acute hypoxic respiratory failure because of COVID-19 infection.  Patient was evaluated with an echocardiogram that showed mild concentric left ventricular hypertrophy and normal LV function.   He was diagnosed, Acute hypoxic respiratory failure secondary to COVID-19 infection with underlying bacterial pneumonia:  Patient is now saturating well on room air.  Acute hypoxic respiratory failure resolved.  He received antibiotics, Remdesivir, dexamethasone .
PT HAD HIVES AND ANGIOEDEMA. DID NOT STATE TREATMENT. PT IS CURRENTLY HEALTHY
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 70-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) and (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th January 2019, the 2nd dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were reported as follows: The patient received 2nd dose of SHINGRIX in mid January, intramuscularly on right deltoid. The event bruising was still present at the injection site. The patient did not take any blood thinning medications, no pain, no issues, just bruising. The reporter did not consent to follow-up.
90yo M hx COPD, pulmonary fibrosis with chronic hypoxic respiratory failure on O2 4L NC cont, prednisone dep 10mg daily, GERD, OA, HLD, BPH, aortic stenosis,, otherwise active (ambulates without walker, learned to ski at age 65) with previous exposure to COVID19 on 7/7/2021 (son in law also admitted to hospital currently with COVID19), who presented to hospital with fever, cough, sob, diarrhea on 7/19/2021 and had SARSCOV2 nasopharyngeal swab positive at that time but was tolerating his home O2 need at 4L NC and opted to be discharged to home  presented back to hospital today (7/24/2021) with worsening shortness of breath and hypoxia into 70s despite 4L NC while at rest occurring last evening. Patient required 12L High flow nasal NC respiratory support. Patient complete a 5 day course of Remdesivir and a 10 day course of Decadron. Patient was able to be discharge a week after admission on his baseline O2 requirements.
gen clonic tonic sz 2hr p/vax w/hypotonia & poor responsiveness for 2hr p/the event;needed fluid resuscitation & 02 therapy;t103.4 R;recovered w/in 12hr of event & f/u as out patient;
petechiae w/thrombocytopenia initial platelets 7.000 went to ER w/small hematoma in cut fossc. platelets then 1.000, few w/hem/once;
COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a male 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-JUL-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000187269.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Chills and sweats, aches beginning during sleep Nausea and Vomiting and diarrhea persisted until about 8am next day Next day fatigue and lack of appetite, resolved within 24 hours with slight residual Epigastric pain
Patient started to have bilateral numbness in hands 15 minutes after vaccine. He was monitored for approx 30 minutes and never developed other symptoms.
Pfizer COVID-19 (5-11 yr old) vaccine 0.2 ml given instead of the Pfizer COVID-19 (12+).
Bell's palsy/droopiness on the left side of her face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 28-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she had drooping on the left side of her face. On the 25th, she went to the ER and it was Bell's Palsy. Her second dose will be on Thursday, 29Apr2021, and is wondering if she should get the second dose. On 27Apr2021, she reported the droopiness in her face is staying about the same. She had blood work done in the emergency department and her bloodwork was all normal. The patient underwent lab tests and procedures which included blood test: normal on 25Apr2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Patient called the pharmacy to report some reactions that she believe from receiving the Moderna Vaccine. Patient got her first Moderna Covid-19 Vaccine on 07/25/2021 @ 10:35am and called the pharmacy on 08/07/2021 evening to report that she had allergic reaction from getting the vaccine. She complained about pain in the other arm rather than the one she got the shot at. Also she reported back pain, headache and contractions. She also stated that all the symptoms started after one week of getting the vaccine. I advised the patient to take some pain meds like motrin or tylenol and to seek medical help by visiting the nearest urgent care or emergency room. I also told her that we here at pharmacy are going to follow up with her to check on the progress of the case and offer medical advice as needed.
fully vaccinated (moderna, 3/5/21, 4/9/21); onset of symptoms 8/2/2021
Tested positive for COVID after being fully vaccinated. Symptom onset 8/7/21.
This case was reported by a pharmacist and described the occurrence of arthritis aggravated in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 27th June 2018, the patient received SHINGRIX 50 mcg/mg. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthritis aggravated and injection site pain. On an unknown date, the outcome of the arthritis aggravated and injection site pain were unknown. It was unknown if the reporter considered the arthritis aggravated and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the staff pharmacist who himself was patient. In 2018, the patient experienced increase in arthritis; he had increase in pain in several joints that already had arthritis. The patient also had severe pain at the injection site, but that was a known side effect. The patient had not read that the arthritis pain increase was a known side effect.
On approximately April 1, 2021, I began to develop progressive left shoulder pain.  The symptoms are those of adhesive capsulitis.  The pain limits some use of my left upper extremity.  There is no weakness.  There is no history of trauma, illness or other antecedent occurrence associated with the development of the symptoms.   (I have been a physician for many years.)  I think that it might be related to the vaccination.
Within an hour of getting the flu shot, my arm became very sore and painful, with severe pain when I even tried to lift the arm, move it or even grasp anything. I took ibruprofen, which TBH hasnt helped much.
Developed urticarial rash over the face within  5 minutes of the vaccination.No difficulty breathing, fainting or cough noted. Exam revealed an erythematous wheal-like urticaria over the face. Lung auscultation was clear. Capillary refill was normal. He continued to be alert and well oriented.
pt recvd vax; began to itch on lt deltoid that pm;devel knot;did not get med eval until 16dec then redness & swelling; induration size  50 cents;
syncope, seizure. patient recovered after less than 1 minute. patient was assessed by EMS and declined transport to hospital
100.5 Fever started 8 hours after injection. Soreness and stiffness of whole arm started 4 hours after injection and lasted 24 hours. Body aches and light-headedness started 8 hours after injection and lasted 36 hours.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium
Temp 101-103 degrees x2 days.  Loose stool x2.  Flatulence x2 days-present.  Sibling became ill w/ same sx - ? virus.
Anaphylaxis reaction; A spontaneous report was received from a consumer concerning a 77 year old, female patient who developed Anaphylaxis reaction.    The patient's medical history included allergies. Concomitant product use was not provided by the reporter.     Vaccination details are not provided by the reporter. After she received vaccine developed Anaphylaxis reaction.  Treatment for the event included steroid shot. Now her doctor says the shot is ineffective and she can't get the second shot. She wants to know whether that information true and she is willing to take second shot despite her doctors advice.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event Anaphylaxis reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
profuse sweating; Shortness of breath; weakness; This is a spontaneous report from a contactable physician. An 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 0810, Expiration date: Not reported), via intramuscular route in right arm on 14Oct2021 at 13:00 (at the age of 83-years-old) as dose 3 (booster), single for COVID-19 immunization in a pharmacy/drug store. The patient's other medical history included cardiomyopathy and esophagitis. The patient was allergic to shellfish and other fish. Concomitant medications/any other medications received by the patient within 2 weeks of vaccination included carvedilol, furosemide, methylprednisolone and sertraline. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route in right arm on 13Mar2021 at 13:00 (Lot number: 9266, Expiration date: Not reported) as dose 2, single and in Feb2021 at 13:00 (Lot number: Unknown, Expiration date: Not reported) as dose 1, single for COVID-19 immunization (at the age of 83-years-old). The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 14Oct2021 at 23:00, the patient experienced shortness of breath, weakness and profuse sweating. The patient was hospitalized for these events on 14Oct2021 and received treatment with steroids, nutritional support and mycophenolic acid (MYFORTIC) which led to emergency room/department or urgent care, hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization) and disability or permanent damage. Since the vaccination (post vaccination), the patient had been tested for COVID-19 by nasal swab with COVID polymerase chain reaction (PCR) and ribonucleic acid (RNA) rapid nucleic acid amplification (NAA) test on 15Oct2021 with negative result. The patient was discharged from the hospital on 30Oct2021 with 16 days of hospitalization. The outcome of these events was not recovered at the time of report.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt recv vax on 8/16/95; on 2/25/99 pt exp chicken pox rash, fever (100.8); tx=Tylenol
Appendicitis 12 days after first dose. Reporting because I see online it?s been noted as a side effect for another type of covid vaccine.
"Covid Arm" - Swollen, itchy, red patch just below mildly bruised injection site. Approximately 3.5 inches long by 3 inches wide.
administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered after the date of expiry on 02Dec2022 to 1 adult patient. Vaccine expired on 27Nov2022).    No concomitant and treatment medications are reported.
Patient is a nurse and decided to self-administer. She did not read the instructions and drew up and gave herself the adjuvant only. Therefore, she did not get any antigen. She had a sore arm, but this is expected from the vaccine.
No further adverse events reported; MMRlI given had expired on 12/17/2020; This spontaneous report was received from a pharmacist concerning to a 24-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 31-DEC-2020, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) for prophylaxis, lot number reported as R036581, expiration date reported and validated as 17-DEC-2020 (vaccination scheme, route of administration, and anatomical site of vaccination were not provided). It was reported that the vaccine did not experienced temperature excursion. No further adverse events were reported.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a first grade male pt who on 03/20/98 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information was received from the registered nurse who indicated that the patient was vaccinated at an unknown location and not at her facility. Chickenpox was diagnosed on or about 17-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience.  (WAES # 0403USA02088, 0403USA02109, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115).
The morning following my vaccination, I started to notice visible blood in my urine. This continued for about a week before clearing up. I sought medical care from my primary care provider. I was referred to a urologist, who performed a cystoscopy in July 2021. The results showed no abnormalities, so I was referred to a nephrologist for further treatment. A biopsy of one of my kidneys was performed in July 2021. The results led to my diagnosis of IgA nephropathy.
pt recv vax 9MAY95 & devel a high fever & was more sleepy; No further details were provided;