chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverese effects; A dose of PROQUAD was given to an unspecified "53 year old patient"; This spontaneous report has been received from a medical assistant referring to a 53 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided      On 03-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), subcutaneously (strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Has CLL, chronic lymphocytic leukemia, stage 0; She is producing very few antibodies; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. She received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had CLL (chronic lymphocytic leukaemia stage 0) after received the both doses of the Pfizer-BioNTech COVID-19 vaccine. She explained she took antibody tests and her haematologist explained that she must act as if she had not been vaccinated. She asked if a third dose of the vaccine is recommended for immunocompromised patients. FAQ-Pfizer stated the need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. Failed to explain that the study excluded participants who were immunocompromised from section "18.1 Efficacy in Participants 16 Years of Age and Older" of the Full EUA PI, LAB#, revised: 19May2021. She was encouraged for HCP consultation. The patient underwent lab tests and procedures which included antibody test with unknown results. The outcome of both events was unknown.
11/15/22 presents to EC ED for "low back pain". PMHx of "CVA, hypertension, diabetes"
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/6/2021 and 2/27/2021. Patient presented to ED with generalized weakness for several days prior to admission. Patient noticed difficulty walking and progressed to being unable to stand/get out of chair. In the ED, temp 99.9, vitals stable.  Labs with normal WBC, procalcitonin 0.51, lactate wnl, Cr 2.06, BNP 604 and trop 0.1.  UA with rare bact, 3+LE, 20-50 WBCs. Patient was admitted for acute hypoxic respiratory failure, due to covid 19. He was treated with steroids for 10 days and cefepime.  He had acute CHF, renal failure.  He eventually developed spontaneous PTX and had chest tube placed by pulmonary.  Goals of care addressed with family who eventually elected comfort measures and hospice. Patient expired at 1600 on 9/17/21.
1st shot 2 years ago, 2nd yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st first shingles shot 2 years ago).   On 1st October 2022, the patient received the 2nd dose of Shingles vaccine. On 1st October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received 1st dose of shingles vaccine 2 years ago.  The patient stated that, they did not tell him/her that, he/she needed a second shot of shingles vaccine. The day before reporting he/she got another shot of shingles vaccine. .  The patient wanted to know if he/she should get another in a few months. Additional Supportive Information: The patient received 2nd dose of shingles vaccine later than the recommended schedule which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.
Pt developed worsening rhinorrhea after receiving FLUMIST. On 1/7/16 developed crusted lesions around nose that spread down to lip. Clear runny nose turned to think green nasal discharge. No fever. Diagnosed with impetigo by MD on 1/8/16.
Information has been received from a registered nurse concerning her 1 year old daughter who on an unspecified date was vaccinated SC with a single 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  Ten days after vaccination, the patient developed 25-300 skin lesions.  She also had a low grade temperature.  No further information was available.  There was no product quality complaint involved.  The patient is one of triplets whose sisters (WAES#0608USA05091 and 0608usa05188) also had adverse experiences after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.   Additional information has been requested.
Patient was given the COVID vaccine instead of the Fluarix vaccine. Patient was told after COVID vaccination was given. Then patient received the Fluarix after patient was spoken too about the wrong initial vaccination was given.  No Adverse event after patient was consulted by the pharmacy manager.
After 1st dose, she skipped 2 menstrual periods; She had swelling of the face; Had one week of migraine with emergency visit at UCST; She had severe headache for a week; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (After 1st dose, she skipped 2 menstrual periods), SWELLING FACE (She had swelling of the face), MIGRAINE (Had one week of migraine with emergency visit at UCST) and HEADACHE (She had severe headache for a week) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease. Concurrent medical conditions included Asthma, Hay fever, Hives (Hives/Urticaria) and Endometriosis.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MENSTRUATION IRREGULAR (After 1st dose, she skipped 2 menstrual periods), SWELLING FACE (She had swelling of the face), MIGRAINE (Had one week of migraine with emergency visit at UCST) and HEADACHE (She had severe headache for a week). The patient was treated with PROGESTERONE for Uterine haemorrhage, at an unspecified dose and frequency and EPINEPHRINE for Adverse event, at an unspecified dose and frequency. At the time of the report, MENSTRUATION IRREGULAR (After 1st dose, she skipped 2 menstrual periods) outcome was unknown and SWELLING FACE (She had swelling of the face), MIGRAINE (Had one week of migraine with emergency visit at UCST) and HEADACHE (She had severe headache for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Epinephrine, Steroids, anti-histamine and oxygen used as treatment medication for adverse events.  Two days later, the patient experienced severe swelling of the face, cause was unknown.   This case was linked to MOD-2021-278942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received: Updated patient information including height, weight, race and pregnancy status, added patient allergic conditions and current conditions, addition of new event - Migraine, Epinephrine, Steroids, anti-histamine and oxygen used as treatment medication for adverse events were updated in I narrative supplement.
pt came to pharmacy and said she is getting her second dose of moderna, her card also had one moderna sticker from HCF, I gave her 0.5ml for second dose. after administration she said she already had a J&J shot and her dr told her to do this, and she said never mind I told you and  just erase what I said, I had already given the shot so I made her sign paper for what she did and  I thought I should report it , this is outside our protocol
Information has been received from a physician concerning a 6 year old female patient with no pertinent medical history and no known allergies who on an unspecified date was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (lot number not reported). There was no concomitant medication. In mid January, 2010 the patient come back in the office with a very mild chickenpox like rash around the head and shoulder area. The physician stated she asked the patient to call back in a couple days with an update but the patient never did so the physician was unsure of the patient's status at this point. There was no lab studies performed. Additional information has been requested.
Patient received vaccine at 11:25AM, then sat down in our lobby for 15-minute observation. Patient was accompanied by brother-in-law and sister.   11:30AM - patient began to have seizures, patient's arms were both visibly flailing and head was jerking. Patient's family members explained that patient has history of seizures. This happens 5-6 times a year. The lights were dimmed and patient's family was caring for patient.   11:45AM - patient's seizures stopped and patient came to.   11:52 AM - patient and family left. ER precautions were given but refused by the family. They stated they believe it was unrelated to the vaccine. We explained the stress caused by received a vaccine could potentially trigger a seizure and they should let PCP know next follow up if they do not want to go to ER.   Upon follow up call, patient's family said patient is doing fine and no other reportable symptoms except sore arm.
14 hours after the vaccination my son began to feel short of breath, warmth in the chest, very fast heartbeat, and chest pain. We immediately went to an emergency room and they detected pericarditis. Followed with a little milder symptoms. He will continue to visit his doctor.
Headache, Myalgia, Arthralgia, Chills Narrative: Chills, body aches, headache. Face "felt funny".
No adverse event; Patient received 0.25 ml of vaccine instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) 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 assessment was provided for UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml).    The patient had their monovalent and a previous booster dose of bivalent vaccine.  The patient was over 65 years old.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 15 of 20th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
Breakthrough case after three vaccines; patient expired  Pfizer 1/16/21 Lot# EL0142;  Pfizer 2/6/21 Lot# EL9261;  Pfizer 10/11/21 Lot# EW0183;
Fatigue; Joint aches like flu; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ARTHRALGIA (Joint aches like flu) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 11-Feb-2021, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Joint aches like flu) and CHILLS (Chills). On 11-Feb-2021, FATIGUE (Fatigue), ARTHRALGIA (Joint aches like flu) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient began having acute epigastric pain and pain in the middle of her back between her shoulders. It started four days (4-17-21) after her second COVID19 vaccine, 4-13-2021. She visited Urgent Care on 4-2021, and the Murphy's sign was positive, where she had pain in her right upper abdominal quadrant. The pain was constant after she ate anything, especially foods high in fat or fried. Patient is thin at 120 lbs and 5 ft 4 in. She is in good health and exercised regularly.  Urgent Care ordered a HIDA scan, RUQ abdominal ultrasound, and bloodwork to evaluate the liver and acute inflammation. The bloodwork and ultrasound were normal. The HIDA scan was completed at Medical Imaging on May 6, 2021.  The report showed Biliary Dyskinesia with an ejection fraction of 23%. "Homogeneous uptake of the radiopharmaceutical is noted within the liver. Gallbladder activity is noted at 20 minutes. Small bowel activity is noted at 48 minutes. Gallbladder ejection fraction is 23 % (normal is greater than 35%). No bile reflux. No evidence of cystic duct obstruction. Diminished gallbladder ejection fraction. Findings consistent with gallbladder dyskinesia. No symptoms recreated with CCK injection." (Not sure if this will cause permanent removal of gallbladder. Patient chose to keep it in for now.)
Vaccine administered after the 31 day refrigerated beyond use date but before the 45 day excursion date.
"within the last 2 days" on an unspecified date the patient started to experience jaundice; an unspecified patient received his first dose of RECOMBIVAX and "two days later" had a second dose of RECOMBIVAX on an unspecified date; an unspecified patient received his first dose of RECOMBIVAX and "two days later" had a second dose of RECOMBIVAX on an unspecified date; This spontaneous report was received from a pharmacist referring to a neonate male patient of unknown age. The patient had no pertinent medical history, drug reactions/allergies or concomitant therapies.     On an unknown date in October 2019, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (vaccine dosage detail, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis. And two days later, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (vaccine dosage detail, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered and inappropriate schedule of vaccine administered). On an unspecified date in October 2019, within the last 2 days, the patient started to experience jaundice and was taken to the emergency room on 09-OCT-2019. It could not be confirmed when the jaundice started. Lab diagnostics or studies included bilirubin, aspartate transaminase (AST)/ alanine transaminase (ALT) and albumin. No treatment was given for the jaundice and no intervention was given to prevent serious criteria. There was no product quality complaint (PQC). The outcome of jaundice was not recovered. The causality between the event of jaundice and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not provided.
PT GOT 2 IMMUNIZATIONS ON RIGHT THIGH 2 DAYS AGO.  LAST NIGHT PT STARTED GETTING SWELLING AND PRURITUS IN THE AREA.
Cellulitis with lymphangiitis, increase drainage, left axilla lymphadenopathy on day 9 of vaccine administration. Pt prescribed five day of Levaquin 500 mg.
sx started 10/24/99 h/a, cough, diarrhea, muscle aches;no fever;
28 year old female patient, who about 10 years ago, in approximately 1995, was vaccinated with a first dose of hepatitis B virus vaccine.  After the vaccination in approximately 1995, she developed an injection site reaction that has since resolved completely.  It was reported that the patient never received the last 2 doses to complete the series.  No other information regarding the adverse event was provided.  There was no product quality complaint reported.  The patient sought unspecified medical attention. Additional information has been requested.
Bad headache, fatigue, chills, slight nausea.  Did not test for fever.
Janssen on 3/10. Positive on 8/21 admitted 8/28 to current
muscle aches; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 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 muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingrix and experienced muscle pain and fever . The patient enquired how long does the side effect last. No other information was provided.
Itchy on arms and trunk, dizziness started 15 minutes after dose.  Vital signs stable.
O.V. Left upper arm deltoid area reddish, warm to touch, with knot about size of small marble. Reddish area about size of 2 fifty cent pieces. Advised warm compresses 4x daily for 20 minutes. Childrens Ibuprofen or Tylenol per package directions. Will take time for knot to go away, area may bruise. If no improvement or reason to call.  4/10/03 improving.
Pt recv vax on 12/8/98; on 12/10/98 pt dx=Guillain Barre syndrome
Tired, weak, muscle aches, ears ringing, light headed, headache, chills
This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with dose 2 of VARIVAX 2 weeks early. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation.  Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago.   No follow-up attempts are needed. No further information is expected.
I started out being hoarse, nausea, achy, headache, head congestion, and chills. I tested positive for COVID-19 and my doctor prescribed me Promethazine DM. I have a cough, head congestion, and nausea.
patient is fully vaccinated with 1st dose on Dec 26, 2020 / 2nd dose on Jan 15, 2021.  patient tested positive for Covid 19 in clinic on July 7, 2021.