chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 11/05/2002, concerning a female vaccinee in her 40s who experienced joint pain 1 week after receiving virus influenza on an unreported date in 2001. On an unreported date in 2001 the vaccinee experienced joint pain 1 week after receiving virus influenza. No treatment was administered and the joint pain resolved after a few days. The reporter has assessed the relationship of the vaccine to the event as unclassifiable.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 12-AUG-2013, one patient was vaccinated with an improperly stored dose of ROTATEQ (lot # reported as H012979 expiration date 06-FEB-2014) (dose and route not specified), that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA008790), another patient was vaccinated with improperly stored PEDVAX (MARRS 1308USA009657), another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA009656), and another one was vaccinated with improperly stored GARDASIL (MARRS 1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
Mother reported redness and swelling to bilateral arms, deltoid areas (8 hours after immunizations). The child was afebrile, skin was soft to touch, no drainage from sites, positive measurement taken, (+) gm check, (+) mvt of cxt. Recheck in 2 days.
Information has been received from a physician's assistant concerning a 12 month old patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, 5 days after receiving the vaccine, the patient experienced swelling to the neck. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I felt like I was going to pass out; There was no way I could stand up without passing out; I had two more episodes like that; My heart rate was probably, it instantly, probably tripled; Skin tingling; Face was numb; Hands and feet were numb; I felt like I was having a heart attack; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration in left arm on an unspecified date, at 44 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Seventeen minutes after he received his first shot, he had "his heart rate was probably, it instantly, probably tripled and he felt like he was going to pass out, skin tingling, hands and feet were numb, face was numb. There was no way he could stand up without passing out, they picked him up at pharmacy and he had two more episodes like that within the next 15 minutes but they were not quite as intense, but he felt like he was having a heart attack". The patient asked if he could take the second vaccine dose. The patient stated he just took paracetamol (TYLENOL) the first two days and 'then he was good, afterwards". The reported events resolved on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
24 hours after vaccine developed redness and pruritus below the sight. Child has a history of allergy especially nuts. Had previous DTap in same (left) arm.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/1/2022 AORTIC VALVE STENOSIS  ACUTE ON CHRONIC RESPIRATORY FAILURE 12/17/2022 AORTIC VALVE STENOSIS  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/31/2022 AORTIC VALVE STENOSIS  HYPOXEMIA 12/31/2022 AORTIC VALVE STENOSIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/1/2022 MIXED ACID BASE BALANCE DISORDER W HYPERCAPNIA  ACUTE ON CHRONIC RESPIRATORY FAILURE 12/17/2022 MIXED ACID BASE BALANCE DISORDER W HYPERCAPNIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/31/2022 MIXED ACID BASE BALANCE DISORDER W HYPERCAPNIA  HYPOXEMIA 12/31/2022 MIXED ACID BASE BALANCE DISORDER W HYPERCAPNIA
Symptoms presented on the 19th and sustained until the 24th.  On the 24th, symptoms started to wane and were highly diminished by the 25th.  Symptoms: Lethargy and fatigue. Congestion. Dizziness Headache Fever: 100.0 (Only present on the 19th)  Treated symptoms successfully with over the counter cold medications. Acetaminophen Ibuprofen  Dextromethorphan Guaifenesin
This case was reported by a other health professional via call center representative and described the occurrence of lower extremities weakness of in a 68-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). The patient's past medical history included colonic polyp, diverticulitis, hemorrhoids, frozen shoulder (Periarthritis), scoliosis and spinal column stenosis. Concurrent medical conditions included incompetent cervix, drug exposure in utero (exposed to Diethylstilbestrol in utero), heart murmur, glucose tolerance impaired, cholesterol, vitamin D deficiency and osteopenia (allergies). Concomitant products included Aspirin, calcium carbonate, fish oil, PRESERVISION and PREVENAR. On an unknown date, the patient received SHINGRIX (intramuscular). On 11th April 2018, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On 12th April 2018, the patient experienced lower extremities weakness of, taste metallic, swelling, injection site pain and fatigue. On an unknown date, the outcome of the lower extremities weakness of, taste metallic, swelling, injection site pain, fatigue and pain in arm were unknown. The reporter considered the lower extremities weakness of, taste metallic, swelling, injection site pain and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's concomitant medications included Probiotics and Vitamin D. The patient received SHINGRIX in left deltoid and experienced jelly like legs, metallic taste, pain at injection site, swelling, fatigue and arm was sore.
Soreness and swelling at injection site beginning next day after shot Day 3 a  redness and itching began on left arm wear injection was given. Each day the redness, and itchiness increase in area. Day 6 ( today) I woke to see that it had advanced down to just above the inside of the elbow and around slightly to back of arm.   The doctor prescribes prednisone RX plus said to apply hydrocortisone cream twice daily.
After my second shot, the next morning I began to get very fatigued, more than the first shot.  As the day went on, my feet began to hurt.  The pain was similar to a very strong neuropathy pain.  By the end of the day, I had to crawl around my house as my feet were unbearable.  Today, 6 weeks later I am still fighting the pain.
Red, painful rash several inches below where the shot was. Is persisting. Reminds me of a sun burn.
Vaccinating nurse, RN accidentally gave a pediatric dose of Pfizer to patient who is 16 years of age.
Patient had severe pain in his legs on Friday April 8th. He woke early in the morning, and could not walk for a few hours. The pain subsided by afternoon, though mild soreness persisted for the day. He was ok, and relaxed for the weekend and stayed off his legs for the most part. On Monday April 11th, patient woke up with a facial droop like that of Bells palsy. His face was swollen on his right side. His right eye was pink, tearing up and felt irritated. His face both mildly hurt and felt numb in some places. This persisted all day. The next day patient experienced the same symptoms, but to a lesser degree. On April 13th, patient woke more umcomfortable and swollen. His left eye had a pink stripe across it, and both eyes felt irritated. Today is April 14th. The swelling had gone down and he is experiencing less discomfort, but is not symptom free yet. Patient has never experienced any of these symptoms before, including the pain in his legs. He did not do any strenuous activities that week, and he had no illnesses for months prior to this event.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown gender that was over 50 years old. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Dose, route and lot number were not reported. No co-suspect and concurrent therapies were reported. On an unknown date the patient developed shingles. The patient recently went to the pharmacy on an unspecified date stating that their unspecified physician had prescribed for them to be administered another dose of ZOSTAVAX. A second dose of ZOSTAVAX was not administered. At the time of this report the outcome of shingles was unknown. The patient sought medical attention, went to see unspecified physician. The causality was not reported. Additional information has been requested.
dizzy; Whole body got hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Time of vaccination: 14:30, Anatomical Site of injection: Left upper arm, Batch/Lot number: EW0151, Route of administration: Intramuscular), administration date: 06Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; bnt162b2 (DOSE 2, SINGLE, Time of vaccination: 14:30, Anatomical Site of injection: Left upper arm, Batch/Lot number: EW0151, Route of administration: Intramuscular), administration date: 27Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Time of vaccination: 16:00, Anatomical Site of injection: Left upper arm, Batch/Lot number: FL3197, Route of administration: Intramuscular), administration date: 29Nov2021, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; FEELING HOT (non-serious), outcome "unknown", described as "Whole body got hot".  Additional Information: After receiving dose 4, patient was not asked to wait. She had no adverse reactions to doses 1-3. As she walked away she got dizzy and her whole body got hot, starting at the top, rolly down to my legs. She stopped and talked to the nurse about it but he didn't know what it was. He just printed her to a chair and said sit. No one checked on her about 15 mins later left fine so she feft that was the only time she had any reaction to the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296335 same patient/drug, different doses/AE (LOE);
Myalgia, Fever, CHILLS, FATIGUE Narrative:  Other Relevant History:
Case number PHEH2015US026894, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 63 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 08 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse event was reported following this medication errors. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.23.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Ran a high fever for 48 hours. Lots of body ache for 48 hours.
I am the epidemiologist reporting on behalf of 62 year-old male patient.  Patient received one dose of the Pfizer vaccine on 3/15/2021, according to immunization records.  The patient passed away on 3/17/2021 (2 days post first dose, hospital inpatient). The death certificate lists ?Cardiac Arrest? as the immediate cause of death due to or as a consequence of esophageal cancer, possible bowel ischemia and colon cancer. No additional information regarding underlying conditions that may have contributed to this death is available.
Patient developed faint red rash on lower front of calf on left leg, Rash on right side of stomach and between breast.
Circular red rash at vaccination site; it has been extremely itchy. It began to fade after about day 10 post vaccine.  It is still fading on day 14 but is still itchy.  i' putting lidocane lotion on it at night.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
3:45pm pt received pfizer covid-19 vaccine in L deltoid. denies any allergies other than penicillin.  4pm c/o slight pressure in throat, chills, oriented x3, sitting in chair 4:05 diphenhydramine 50mg/ml administered to pt @ 1ml IM in right deltoid HR 70 R 18 non-labored, non audible, no wheezing, BP 114/78 4:15 HR 70, R 18 non-labored/non audible/ says pressure om throat is gone, still feels a little cold, HR 105/74 4:30 feels abou the same, resp not labored, sitting in chair relaxed, HR 68 BP 117/78 (last ate at 1:30 pm) 4:35 feels tired, relaxed, sitting calmly in chair, no new sx BP 106/73 4:40 relaxed and tired. taken home by father via car. HR 68 non-labored breathing. no new sx
Patient experienced hives on legs (bilateral) about 2 hours after receiving MENVEO vaccine. Pt contacted MD and was instructed to take BENADRYL.
Pt complained of rash around injection site "looked infected", according to the doctor. States other areas of rash on body were "big, red splotchy areas". Seen by PMD on 8/24/01 and treated as infection and reaction. On 8/27/01, rash subsided except for some on extremities at injection site only.
Patient developed pain and swelling at the injection site that radiate to her back and find it difficult to move left arm up and pain when turning or coughing.
No adverse symptoms reported; Patient inadvertently received a dose of PROQUAD and a dose of VARIVAX during the same office visit; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 24-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S017265 with expiration date of 01-DEC-2020 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. On the same date, the patient also received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019460 with expiration date of 24-JUN-2021 (strength,  dose, route, frequency, and anatomical location were not provided) for prophylaxis (accidental overdose).      This is one of two cases from the same reporter.     ; Sender's Comments:  US-009507513-2008USA012800:
Expired vials were used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  No vial had undergone any temperature excursions. There were no adverse reactions to the vaccine as reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received on 19-Nov-21, included secondary reporter details
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGIRX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGIRX (intramuscular). On an unknown date, less than a year after receiving SHINGIRX, the patient experienced pain in arm and feeling bad. The action taken with SHINGIRX was unknown. On an unknown date, the outcome of the pain in arm and feeling bad were recovered/resolved. It was unknown if the reporter considered the pain in arm and feeling bad to be related to SHINGIRX. Additional information was provided as follows: The age at vaccination was not reported. The patient received first dose of SHINGIRX in early October 2018 and experienced sore arm and felt bad for 4 to 5 days. The events were resolved. The patient did not ask for doctor information or permission to follow up.
pt recvd vax;mom relates sore leg,will not walk on it,is edematous;mom states fever of 103.9;pt started crying at 6pm 2MAR95, would not eat or cry,was shrill;settled down about 2am 3MAR95;
Pt recvd 1st dose of Hep B vax; approx 2 days following vax pt devel severe h/a & was noted to have papilledema; pt hospitalized eval neg; dx aseptic meningitis; double vision w/deviation of lt eye; lateral rectus muscle palsy;
Information has been received from a nurse concerning a "12 year old" female who was vaccinated with her 1st dose of GARDASIL, 0.5ml, IM.  The patient also received another 4 different vaccines (unspecified) and a few hours later the mother called and reported her daughter had a seizure.  The patient had sought medical attention.  The outcome was unknown.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Reported she has an absence right above her uterus that kept getting larger ... it has cleared but no she has a knot on her stomach that appeared 07/13/2021
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) Positive, notes: initial positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: No other medication in 2 weeks. Treatment included Paxlovid from 04Aug2023 to 09Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse practitioner refers of unknown age and gender. On 24-SEP-2014 the patient was inadvertently vaccinated with expired PNEUMOVAX23, injection, 0.5 ml, intramuscular (IM), lot # J009827 that had expired on 10-AUG-2014. Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Peristent headache, pain in lower abdomen, tightness of skin in left leg, consistent fatigue, and brain fog. Loss of appetite.