chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hypertension; 1 nosebleed; slight headache; This is a spontaneous report from a contactable nurse. A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0140, expiry date not reported), via an unspecified route of administration on 09Jan2021 09:45 at a single dose in the right arm for COVID-19 immunization. Medical history included known allergies on penicillin as child. The patient had no COVID prior to vaccination. The patient's concomitant medications were not reported. Patient had the first dose of BNT162B2 (Pfizer brand, Lot number: EH9899) on 21Dec2020 08:45 AM in the left arm for COVID-19 immunization. The patient had no other vaccine in four weeks. Patient received second dose 09Jan2021 and for the last 4 days, started on 12Jan2021, the have had hypertension with 1 nosebleed and slight headache with no history of hypertension. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events hypertension, nosebleed and slight headache was not recovered.
Started crying @ 530PM & continued to cry x 2 1/2 - 3 hrs; Taken to ER; Tx Pediaprophen & APAP; Also noted lymph nodes in groin;
Had fever of 102.7, & chills and went to ER. Was checked for Flu, strep and other respiratory diseases.
Pt had episode of decreased awareness, increased dizziness, spaced-out appearance and wheeze after getting hep A and Varicella. Oral rehydration solution did not resolve issue. Pt's vital signs were normal but continued to stare blankly into space. Able to answer questions, but with delay. Episode followed vaccines within minutes.
Fours hours after receiving Pfizer vaccination on9/24/21 patient began to have constant left sided chest pain, "foggy headed since 10/1/21. The chest pain worsens in evenings.
Patient reported abnormally long period of muscle soreness after receiving influenza immunization that persisted for over 1 week. Patient said she saw her physician 1 week after the immunization and he said it may have been administered to being administered too high in the deltoid muscle.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date in 2009 (unknown date 5 years ago), the patient was vaccinated with ZOSTAVAX vial, (lot number and expiration date was unspecified), dose and frequency were unspecified. Concomitant medication was unspecified. The patient had transported the ZOSTAVAX from the pharmacy to the unspecified physician's office were it was administered. The patient stated that the ZOSTAVAX was at room temperature, approximately 70 Fahrenheit (F), for 1 and a half hours. On an unknown date in 2009, the patient was administered the improperly stored dose of ZOSTAVAX. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Site: Bruising at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient came in with severe bruising. this is 5 days after she got the vaccine. the circle around the injection site is at least 3 inches in diameter.
SEVERE HEADACHE, AND EYE PAIN- OTC IBUPROFEN TAKEN, AND PATIENT SLEPT. SYMPTOMS DECREASED 11:00 PM, 9/27/12. PATIENT OUT OF WORK 9/26/12. NAUSEA- ATE CRACKERS, AND PATIENT SLEPT. SYMPTOMS RESOLVED IN 2 HOURS.  RASH-FLAT, RED, ON UPPER CHEST, BETWEEN AND UNDER BILATERAL; BREASTS DISCOVERED BY PATIENT ON 9/28/12 AT 6:00 AM. NO PAIN, DISCHARGE, OR ITCHING. RASH RESOLVED 9/29/12 8:00 PM. NO TREATMENT.
A report was received from a regulatory authority on 11/25/02, concerning a 63 year old male vaccinee who experienced a frozen shoulder which was considered to be disabling or incapacitating and required hospitalization 2 days after receiving the Fluvirin vaccine on 10/04/02. The vaccinee was receiving lisinopril concomitantly. On 10/6/02 the vaccinee experienced a frozen shoulder which lasted for 5 days and required hospitalization. The vaccinee recovered on 10/14/02. There was insufficient information to determine the reporters causality assessment.
poor sleep; nausea; pain; This spontaneous case was reported by a patient and describes the occurrence of POOR QUALITY SLEEP (poor sleep), PAIN (pain) and NAUSEA (nausea) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L02A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (pain). On 20-Jan-2021, the patient experienced POOR QUALITY SLEEP (poor sleep) and NAUSEA (nausea). At the time of the report, POOR QUALITY SLEEP (poor sleep), PAIN (pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.    Reporter did not allow further contact
sore arm; injection site rash; 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 Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and injection site rash. On an unknown date, the outcome of the pain in arm and injection site rash were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient received dose of Shingrix and later developed a sore arm and an injection site rash that lasted a week. The reporter consented to follow up. The reporter declined to provide any further information for this adverse event.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: patient reported a benign metallic taste in mouth
headache; fever; nausea; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and FATIGUE (fatigue) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information received on 21-JAN-2022. 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced omicron (coded as suspected covid-19 infection and suspected clinical vaccination failure), and  and was hospitalized (date unspecified) for 3 days. (Dose number in series 1) Laboratory data (dates unspecified) included: Oxygen (NR: not provided) low. It was reported as "I take your vaccine and booster 4 days after I got my booster I was sick, I was in the hospital with omicron for 3 days"  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This case was associated with product quality complaint number 90000213232. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220145043 (dose number in series 2). This case, from the same reporter is linked to 20220139924.; Sender's Comments: V0: 20220139342-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20220139342-COVID-19 VACCINE AD26.COV2.S- Suspected covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Headache, Myalgia, SWEATY , L ARM PAIN AT INJECTION SITE, CHILLS Narrative:
unable to swallow after 6 hours of dermal filler injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (unable to swallow after 6 hours of dermal filler injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0116/2/LZ0A and 012L/626A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection in 2014.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPHAGIA (unable to swallow after 6 hours of dermal filler injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, DYSPHAGIA (unable to swallow after 6 hours of dermal filler injection) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949322, 20210949808, 20210949974, 20210950004, 20210950006 and 20210950120.
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Indication for use in the case: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid from 17Jun2022 to 21Jun2022 for treatment of COVID-19. The patient had rebound covid symptoms after 4 days of finishing Paxlovid and positive rapid test after 5 days from 25Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information in the case narrative, a causal association between reported events and suspect cannot be excluded. case will be reassessed upon receipt of further information.
pt recv vax; exp apnea; to er; given CPR by grandma;examined by PMD & will receive no more pertussis per PMD;
Fever, fatigue, injection sight pain, join pain, rapid pulse, headache, feel unwell
mild leg muscle pain; difficult to walk; legs feel heavy; stability problems; couldn't walk; leg pain has gotten worse over time; became a disability; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (became a disability) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (The patient underwent 2 knee replacements.).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain has gotten worse over time). 04-Mar-2021, the patient experienced DISABILITY (became a disability) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced WALKING DISABILITY (couldn't walk). On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy) and BALANCE DISORDER (stability problems). On an unknown date, the patient experienced MYALGIA (mild leg muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (leg pain has gotten worse over time), WALKING DISABILITY (couldn't walk), GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy), BALANCE DISORDER (stability problems), DISABILITY (became a disability) and MYALGIA (mild leg muscle pain) outcome was unknown.            No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had vaccine at 1430. At 1600, patient returned to vaccine clinic complaining of swollen glands and feeling of potential throat swelling, asking for benadryl. Patient states she has had an anaphylactic reaction in the past, but never to a vaccine or medication. Vital signs taken - BP 166/90, pulse 103, SpO2 100%. Patient monitored for few minutes and continued to feel additional tightness in her throat. Crisis nurse called and patient transported to ED for further evaluation. diphenhydramine 25mg PO given in ED at 1838. Pt reports self taking ibuporfen 600mg at 1535. She has had anaphylaxis in the past 5 years ago to food (treated with solumedrol and benadryl) and once walking thorugh the park>25 years ago an
Big post nasal drip, followed by soreness at and around injection site. Light fever about 6 hours after shot; fever continued through the night and next morning.
Slight fever on Thursday night. Friday put to sleep on stomach for 2 hours and mother found him deceased.
Headache started 02/24/05. Headache is forehead and down both sides continued through 2/28/05. 3/1/05 slightly improved. Tylenol 500mg given orally relieved headache for 30min. Sudafed cold tried with  no relief.
I had a sore throat on Tuesday May 24, then Wednesday May 25, a severe headache late in the day.  My COVID-19 home test was instantly positive.  I went in to see my primary on May 27 and by then I had chills and fever and my throat was very sore, she put me on Paxlovid, which I started on May 27.  I took all 10 doses and on the 4th day I decided I was gonna be just fine.
On 12/13/22, 12 Pfizer Bivalent boosters were administered at two vaccine sites.  The two loose unpunctured vials had expiration dates of 12/09/22.  The vaccine had expired 4 days earlier, expirations are on the boxes and not vials so nurse was unaware.  Call to HCF, told to complete VAERS and call manufacturer. If not viable: follow CDC guidelines which is to notify client and re-vaccinate in 8 weeks.  Pfizer requested data logger temps and calibration certificate as well as event details. Per Pfizer, we are within the 75 days of stability assessment.
Vaccine was left out of the refrigerator since 10/15/21  and I did not notice until after the shot was given to the patient.
13 weeks and 5 days pregnant. Local injection site reaction, slightly itchy, site is firmer to the touch when compared to other arm, slightly red
This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 43-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 22nd June 2017). On 3rd October 2016 08:00, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016 10:00, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue and taste metallic to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient did not mention the severity of the side effects he experienced. The reporter did no have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patients. This is one of the 4 cases reported by the same reporter.
Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling as well. 4 days after injection I developed a rash to feet, legs, groin and parts of torso with associated swelling.  No shortness of breath but do have some slight burning to hands and legs with mild pain.
Patient received flu vaccine for the 1st time 2/11/08 and varicella #2 on same date.  On 2/12/08 she developed urticaria all over the body.  She ate Cheerios 2/11/08 night & 2/12/08 ate chicken, mac & cheese, apple & corn.  No egg allergy.  Treatment: Benadryl elixir, prednisolone.
the day after the shot, started feeling unwell (approx 24 hours post shot). Slurring words, stumbling around and general unwell feeling with a fluttery feeling in chest. No previous heart issues of any kind. After it continued for an hour or so, I took him to the ER and it was discovered that he was in AFIB. 2 rounds of meds and tests, but stayed in that rhythm. They ended up doing a cardio version and it went back into normal sinus rhythm. Follow up with dr, placed on Eliquis, EKG, stress test and sleep study have found no other contributing factors atthis point.
1.15.20 Child came with swelling Left arm Pain Redness aFter vaccination x 2 days.
Blister around the injection site. Dr verified that it is a bacterial infection and given an antibiotic, all within 3 days.
Information has been received from a physician concerning a 15 month old female with no known drug allergies, no significant medical history and immunocompetent who on 10/8/02, was vaccinated with MR II (lot 642179/0348W). Concomitant therapy administered on the same day included varicella virus vaccine live and HIB conjugate vaccine. On 10/11/02, the pt developed diarrhea, a low grade fever and conjunctivitis. The symptoms worsened to fevers of 103 degrees F. the pt was rechecked on 10/16/02 and some blood work was done. The physician said that it looked like a viral process. The child started to become dehydrated and presented with a whole body rash that was itchy. On 10/17/02 the pt was admitted to the hospital for dehydration with a one-pound weight loss. The physician reported Coxsackie virus was ruled out. The physician reported that the rash looked like pictures of a classic, full-blown measles rash in medical textbooks. The physician reported that as soon as the child received fluid replacement, the rash looked even more like classic measles. The pt had been released from the hospital and was improving. Follow up information was received from the physician who indicated by 10/17/02, the rash was consistent with measles. The physician also reported that the patient was hospitalization for two days. The physician reported that no test could be indentified to confirmed measles. Subsequently, the patient recovered. No further information is available.
Hives on mid to lower body. Benadryl seemed to help.  In evening
Patient states she was vaccinated with the 3rd dose of Pfizer on 11/30/31. On Wednesday 12/1/21 the patient developed chills, fatigue, and low grade temp. By 12/2/21 she felt better. She reports never previously having a vaccination reaction.
The patient reports swelling , redness, and pain in the injection arm. I observed the patients arm and she has swelling above the elbow to the shoulder with redness. The patient reports having taken Tylenol, Benadryl, and applying cool compresses.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil. Subsequently, following vaccination, the patient experienced pain and a burning sensation in the arm. Unspecified medical attention was sought. At the time of this report, the patient's pain and burning sensation in the arm persisted. Additional information has been requested.
Covid vaccine on 11/09/2021, 03/01/2021, 01/28/2021. Patient came in for syncope and recieved IV hydration. She presented with acute encephalopaty and weakness on admission.
Sore arm then below injection site got bright, red, swollen, warm in area as big as palm of hand. Went to ER by midnight because redness spreading down arm. Given Benadryl. Next day doctor prescribed prednisone and Benadryl, alright. Today feeling much better but there is still some swelling and redness.