chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; She is coughing up a lot of stuff and blowing out stuff; congested; hoarse; having a hard time talking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Impaired immune system" (unspecified if ongoing), notes: she has an impaired immune system. There were no concomitant medications. Vaccination history included: moderna (DOSE 1, SINGLE, Lot number: 030L20A,, EXP: 16Jul2021, Dose and Route: Unknown dose; route is left arm , Time: Believes 20:00 because she cashed out of the pharmacy at 20:15), administration date: 26Jan2021, when the patient was 60-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE, LOT: 013M20A, EXP: 31Jul2021, Dose and Route: Unknown dose; route is left arm , Time: About 18:30-18:45), administration date: 23Feb2021, when the patient was 60-year-old, for Covid-19 Immunization; Flu vaccine (Previous Fall had to get flu); Pneumonia vaccine (second pneumonia). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; COUGH (non-serious), outcome "unknown", described as "She is coughing up a lot of stuff and blowing out stuff"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congested"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarse"; SPEECH DISORDER (non-serious), outcome "unknown", described as "having a hard time talking".
Information has been received from a physician concerning a 15 year old female who in February 2007, was vaccinated with a first dose of Gardasil. The physician reported that the patient developed muscle pain, headache and dizziness after receiving the first dose. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Patient felt lightheaded, turned pale and passed out.  Patient then began having seizure activity which lasted about 5 seconds.  Patients arms stiffened and shook to the left.  Patient also had staring episode where both eyes were focused to the left side.
Vaccine brand=Other, Vaccine brand other=Moderna; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and on 06Oct2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "migraine" (unspecified if ongoing); "asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "sub clinical hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Oct2023 at 12:00, outcome "unknown", described as "Vaccine brand=Other, Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 29Oct2023 to 03Nov2023. Patient had no known allergies. Patient's LMP was 03Jun2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356874 same patient, different drug/event;
VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. 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: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). This event(s) is considered unassessable. The event(s) 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(s).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Was prepared incorrectly- mixed with the sterile diluent intended for merck varicella/mmr/mmrv vaccines, and then .5mL of the solution was administered.
Wrong immunization given. Lot # did not match what was given. No temp, swelling or adverse event. Mom and Dr. aware. Dr. will decide what/when to be given to catch up.
scheduled for their third dose; Body aches; Chills; Low grade fever; Headache; Second dose received on day 96; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose received on day 96), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Jan-2021. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), AMLODIPINE BESILATE (NORVASC), PROGESTERONE, CLONAZEPAM, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced OFF LABEL USE (Second dose received on day 96). 13-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Second dose received on day 96), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose), PAIN (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.         This case was linked to MOD-2021-083078, MOD-2021-083092 (E2B Linked Report). This case was linked to MOD-2021-083104 (Patient Link).; Sender's Comments:  MOD-2021-083078:husband 1st dose case MOD-2021-083092:husband 2nd dose case
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 7th October 2018, the patient received the 1st dose of SHINGRIX. On 8th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, erythema, chest pain and injection site warmth. On an unknown date, the outcome of the injection site pain, erythema, chest pain and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, erythema, chest pain and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at right deltoid at 14:00. The patient was experiencing pain at the injection site that extends to her hand and the site was hot.
Chronic Hives more frequent and more severe than normal (including itching and burning, hives covering more of body than usual)
This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of unidentified Merck hpv vaccine (reported as "either GARDASIL or GARDASIL 9") (name, strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced symptoms described as postural orthostatic tachycardia syndrome (POTS). The outcome of POTS was unknown. The causality assessment between POTS and unidentified Merck hpv vaccine was not reported.
fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
My son has developed a rash of tiny red bumps on his lower back and stomach. This is the first I have noticed it. He is also rather cranky and has loss of appetite.
more than 35 days since received first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (more than 35 days since received first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (more than 35 days since received first dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (more than 35 days since received first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported . No treatment medication was reported .
L shoulder tightness and throbbing, light headedness, tightness in hand / jaw / shoulder
Pt recvd 3 doses of Engerix-B 8MAY91, 5JUN91, & 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
Very warm sensation on inner right lower leg that comes and goes. It moves down the leg like a liquid was going down the leg. This happens several times a day, whether sitting, laying down or standing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 09Apr2021 at 14:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin, sulfur drugs and seasonal pollen. Concomitant medications included probiotics (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced very warm sensation on inner right lower leg that comes and goes. It moved down the leg like a liquid was going down the leg. This happened several times a day, whether sitting, laying down or standing (sensation of warmth). The clinical outcome of the event sensation of warmth was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
with in 12 hours had a headache that progressively became intense. Headache resulting in sensitivity to light and noise. Had to rest from head pain. However, more distressing symptom was onset of low back pain. The low back pain started as body aches. This low back pain has become constant, significant and unrelenting. It has effected sleep and standing. No history of low back pain prior to injection. The low back has remained constant and significant now for 2.5 weeks.
Within minutes: tachycardia, nausea and lightheadedness. Tachycardia episodes continued for three weeks. Onset two days later: extreme flushing, hot flashes, lightheadedness, severe brain fog, nausea and fatigue. Lasted approximately six months. Increased sensitivity to chemicals, fragrance, which triggered headaches, sore throat, fatigue and heart palpitations. Change in rate of time for skin to heal. Extreme flushing and skin irritation still occurring but not as frequent. Recently had allergic reaction to amoxicillin. No prior allergic reaction to penicillin products as and adult or child.
Information has been received from a nurse practitioner concerning a 13 yr old female who on 22Aug95 was vaccinated SC with a 0.5mL dose of varicella virus vaccine. The NP reported that in June 2005, the pt developed a case of breakthrough chickenpox characterized by about 80 lesions on her back. It was noted that the lesions were also all over her body including her ears. Unspecified medical attention was sought. At the time of this report, the pt's breakthrough chickenpox persisted. No further information is available.
Soreness in arm, treated with Tylenol.  duration of adverse event approx. 36 hours
Pt experienced fever of 101.6 about 1.5 days later, along with arm swelling 6 inches across and 5 inces down on the night of vaccine, the area is red, hot and hard, chills, sweating, bloody nose, swollen lymph node - tender and visible, and nightmares.
This was his first time receiving Hep A vaccine; he had received doses of the other two vaccines before at his previous well checks.  Afternoon of shots he was very calm and weirdly still when awake. During his 2 naps he slept more than usual.  Evening of shots he had thrown up in his bed some point over night (he sleeps from 7p-7a so not sure when in course). On Tuesday (shot was on Monday morning) he had no appetite. Would barely touch food or liquids. Again slept more than usual for naps. Threw up around 5pm the small amount of food he had eaten. Overnight he had diarrhea.. he woke up in middle of night upset and I changed him, his clothes, and bedding. By morning he had more diarrhea in diaper.  Wednesday still no change in appetite. Still diarrhea that I was having to either bathe him after or change entire clothes and sheets. Was up in middle of night upset again with diarrhea. (Mind you; he has been sleeping through the night from 7p-7a since almost 3 months old with no problem unless sick).  Thursday I am concerned for dehydration. I leave a message for nurse on call to help me diagnose symptoms of dehydration. I ask if this could be vaccine related and she said no most likely not - because it had lasted. (Side note: we have a toddler and two adults in the household as well who have still yet to get the said virus). His lips have been cherry red I guess from either not drinking enough or not feeling well.  Thursday night he woke up inconsolable. When I picked him up it was as if he didn?t realize I was there to comfort him and was just crying nearly inconsolably. I realized more diarrhea and changed everything. Got him some milk and got him calm and down.  Friday still no change. A little more appetite at dinner but then quickly out of blue was inconsolably crying for over 30 mins. I tried bathing, singing, toys, walking outside, etc all thE tricks but wouldn?t ?snap out?. Only had one pee diaper today and still diarrhea.  Increasingly more irritable to no avail.
Mom states pt c/o stomachache & irritable 15AUG91 in late PM vomited, c/o nausea continued emesis & t104.4; 16AUG91 mom gave pt APAP & "threw it up"; Mom called MD who said probably had the flu;
This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not reported. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient details other than gender, lot number, expiry date, date of administration or dose number of SHINGRIX were unknown. The pharmacist reported that the patient received the SHINGRIX dose at the Medical Doctor's Office (MDO) and not at their pharmacy.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) lot # L013068 with expiration date on 14-APR-2017 and PROQUAD lot# L031602 with expiration date on 18-FEB-2017 (dose, strength and anatomical site were nor reported). No adverse events were reported and no product quality complaint was involved. Additional information has been requested.
I woke up two days later with Vertigo. I could not turn fast or bend forward without Vertigo.  I tried my chiropractor first, times two different sessions. I then found myself dizzy even during sleep Aug 30th into the 31st. On the 31st of August I sought the help from my Doctor. Doctor B was unavailable, so I saw Doctor T. She placed me on a new medication Meclizine for my Verito
Patient called pharmacy from shore house stating itchy rash had formed at injection site and wanted to know if it was safe to use Benadryl cream to relieve the itch. I asked patient if rash was spreading or staying the same. She stated she thought rash was spreading. I suggested that she lightly trace the rash on her arm with pen so she would be able to determine if the rash was in fact spreading and told her if it does continue to spread, to contact her physician immediately. She stated she was going to call her doctor the following morning to discuss it with her. I asked the patient to keep me posted of the results. I called patient at home on 11/11/2015 at 9:00am to find out how she was feeling. Patient stated rash had spread to her elbow and was seeing the doctor this morning. I asked the patient again to please contact me regarding results of doctor visit. 11/11/2015 2:07 pm received call from Dr's office stating doctor believes patient had an allergic reaction to ingredient in the Prevnar-13 vaccine administered (lot# M06899 exp 03/2017). Doctor ordered prednisone and antibiotic.
During the 15 minute waiting period right after getting the vaccine, for 5 minutes I had experienced ringing in my ears, sweating, and complete loss of vision. These symptoms only lasted those 5 minutes and never came back.
This is an e-mail that was sent from pt.  As we discussed previously, I have been having shortness of breath and some chest discomfort since about two months after I received the smallpox vaccination.  Of course, I did not at first think of the vaccination as cardiac complications were not mentioned prior to vaccination that I noted. I decided to stop smoking and did that by 8/03 but that did not help and by December 2003 I was more concerned. I mentioned the symptoms including shortness of breath, chest pressure, and pain radiating to my chin to Dr. Again, I did not think of the vaccination, however, the symptoms were significant enough to warrant a cardiac referral. Fortunately, the stress echo only showed mitral valve prolapse with mild mitral regurgitation. This is something very new for me and I then tried to figure out why this had suddenly happened.    When I called you earlier you advised that I let Dr. and the cardiologist know of my concern. Plans are for me to have a yearly repeat cardiac evaluation with stress echo. My symptoms continue and I want to be sure that I fill out any forms required to report what I feel is a side effect from the smallpox vaccination.  I am OK now but if symptoms get worse and it really was the vaccination, I want to be sure it is reported appropriately.
Localized skin reaction at the injection site?itchy, hot to touch + felt like a bump under skin. Lasted about 4-5 days.
Handhurt for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Handhurt for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Handhurt for a day). At the time of the report, PAIN IN EXTREMITY (Handhurt for a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
No adverse event was reported. When processing the vaccination, patient stated multiple times that they were receiving the 2nd dose of the vaccine. After processing through insurance and after administration I logged the dose in the vaccine database and they received their second dose in February of 2021.
Fever Body Pain, Headache Chest congestion, like pneumonia,  Nose congestion,