chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; COULD NOT HOLD BODY WEIGHT; COULD NOT OPEN EYES; URINATED; LETHARGIC; LOW BLOOD PRESSURE; FELT FREEZING COLD; FELT SICK AND DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included little alcohol user, and non-smoker. The patient had no known allergies. She was not pregnant at the time of report. She had no drug abuse or illicit drug usage. The patient was healthy and not taking any medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202/ZA21A, expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 at left arm for prophylactic vaccination. (The patient was not sure about 3rd letter of batch number as 2' or Z'). No concomitant medications were reported.  On 28-JUN-2021, within 30 second after receiving vaccine the patient did not feel good. She asked for water to her son while waiting she fainted. She urinated. She woke up after a while, felt confused or could not figure out what was going on. She was lethargic. She felt so hot' for 30 minutes. She was sweating profusely.  She sat down on the floor and felt sick, retching several times and finally vomiting/ puke. She could not hold her body weight and could not open eyes. Patient was taken to the hospital via ambulance. In ambulance patient received IV anti-nausea medication. In emergency room (ER) bloodwork up and electrocardiogram (ECG) was done and both were normal and she had really low blood pressure (did not recall the exact measurements). She felt freezing cold and needed warm blankets until her body temperature finally regulated, an hour later. After 3-4 hours she felt better and went home. She has not sought any further medical care after this occurrence. She was hospitalized for 3 hours. She was feeling better at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, puke/ vomiting, retching, confused or could not figure out, felt hot, sweating profusely, could not hold body weight, could not open eyes, urinated, low blood pressure, felt freezing cold, and felt sick and did not feel good on 28-JUN-2021, and lethargic on 29-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210708856-COVID-19 VACCINE AD26.COV2.S-Fainted, Puke / vomiting, Retching. 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).
Vaccination site pain; Pain; Swelling; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), COVID-19 (COVID-19) and VACCINATION SITE PAIN (Vaccination site pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Mar-2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In 2021, the patient experienced COVID-19 (COVID-19). On 14-Aug-2021, the patient experienced PAIN (Pain) and SWELLING (Swelling). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN (Pain) and SWELLING (Swelling) had not resolved and COVID-19 (COVID-19) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  The patient was still experiencing pain and swelling on regular basis. He experienced severe arm pain for two days after covid vaccine shot. The patient was contracted to covid-19 in spring 2021.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was not available.  The reporter's causality for the event(s) of PAIN, SWELLING, CONTRACTED COVID-19 and HAD SEVERE ARM PAIN AFTER COVID VACCINE SHOT was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Treatment Drugs Not Reported.   Reporter did not allow further contact
Redness, swelling, warmth, itching around the injection site lasting 48-72 hours, symptoms subsided then returned on 1/2/201; Employee advised use of oral or topical antihistamine .
received the adult dose instead of a pediatric dose; received the adult dose instead of a pediatric dose; received his fourth dose of engerix-B; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 17-year-old male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 4th dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced adult product administered to child, overdose and extra dose administered. On an unknown date, the outcome of the adult product administered to child, overdose and extra dose administered were unknown.  Additional details were provided as follows:  The patient received 4th dose of adult Engerix-B, instead of a pediatric dose, which led to adult product administered to child, overdose and extra dose administered. The reporter consent to follow up. This case has been linked with US2021122656, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122656:Same Reporter
Information was received from a pharmacist via a company representative concerning an unspecified number of patients (demographics not provided). On unknown dates, the pharmacist reported that he administered subcutaneous injections of foamy ZOSTAVAX 19400 PFU (lot # unknown) to unspecified patients. Because of the foamy ZOSTAVAX, the patients may not have received a full dose of ZOSTAVAX although the pharmacist reported giving the patients single 0.65 ml injections. No adverse effect reported. No further information provided. Product quality complaint was filed. Additional information has been requested.
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider at physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider at a hospital for shingles (herpes zoster). On an unknown date, she was admitted to the hospital due to the event. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Injection site is red; Injection site is swollen; Injection site is sore; Fatigue; Muscle aches around waist; Feeling down; Patient noticed 2 drops leaking from the injection site,after receiving the vaccine; Recieved 0.25mL but is unsure if it was 0.25ml; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSED MOOD (Feeling down), VACCINATION SITE DISCHARGE (Patient noticed 2 drops leaking from the injection site,after receiving the vaccine), UNDERDOSE (Recieved 0.25mL but is unsure if it was 0.25ml), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) in a 30-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 16-Dec-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2022, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 07-Sep-2022, the patient experienced UNDERDOSE (Recieved 0.25mL but is unsure if it was 0.25ml). On an unknown date, the patient experienced DEPRESSED MOOD (Feeling down), VACCINATION SITE DISCHARGE (Patient noticed 2 drops leaking from the injection site,after receiving the vaccine), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE PAIN (Injection site is sore), FATIGUE (Fatigue) and MYALGIA (Muscle aches around waist). At the time of the report, DEPRESSED MOOD (Feeling down), VACCINATION SITE DISCHARGE (Patient noticed 2 drops leaking from the injection site,after receiving the vaccine), UNDERDOSE (Recieved 0.25mL but is unsure if it was 0.25ml), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE PAIN (Injection site is sore), FATIGUE (Fatigue) and MYALGIA (Muscle aches around waist) outcome was unknown.            Patient had no allergies. No concomitant medications were reported. Patient never had COVID positive test or diagnosis. Patient Received Bivalent on 07-Sep-2022, she received 0.25mL stated that it was the standard dose for all boosters, believed that was what it stated in the news, but it was unsure if it was 0.25ml. After receiving the vaccine, she noticed after noticed 2 drops leaking from the injection site, and wanted to know if she was under dosed, did she had full protection or adequate antibodies.  No treatment information was provided.
Patient called to report she received the pneumovax yesterday and when she left the office she felt fine and then 2 hours later she was at a store and she suddenly felt like she was going to pass out and then she was unable to lift her entire left arm up. She immediately asked a pharmacist if this was a normal reaction and pharmacist said no. She went home right away and sat on the sofa and applied a heating pad to her arm. She took Tylenol and alternated it with Advil. Today her arm feels some better, but her spine feels painful and she feels exhausted.
Weird taste; extremely tired; other_vaccine_same_date_vaccine_date=28Jan2021; other_vaccine_same_date_vaccine_date=28Jan2021; This is a spontaneous report from a contactable consumer who reported for the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:30 at single dose for COVID-19 immunisation. The patient was vaccinated at Health  facility. Age at vaccination was 79 years. On the same date (28Jan2021) the patient receive another Pfizer vaccine for immunization. It was reported the patient receive other Pfizer vaccines within 4 weeks prior to the COVID vaccine in Jan2021. On 28Jan2021 at 17:15 the patient experienced weird taste and was extremely tired. No treatment was received for the adverse events. The events had resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Had knot left antecubital swollen and sore. Appeared after first vaccine and worsened after sevond.  I developed sudden tinnitus in left ear and both symptoms still present.
He also mentioned having neuropathy in both ankles and feet; After getting the shot, the itchiness on the back and chest is so severe; he can hardly walk due to the excruciating pain; excruciating pain; dizziness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunization. Medical history included he is experiencing headache and sinus infection (from unknown date and ongoing) that has been going on for about 6 months and was not managed despite getting scanned. He added that he was a smoker for over 60 years, and that when his oncologist discovered he has cancer he was given 2-6 months, but that was back in 2017. Concomitant medication was not reported. Caller would like to report his experience with the Pfizer covid vaccine he received yesterday. He stated that a callback may be given in case more information is needed. Caller mentioned taking chemotherapy every two weeks for his cancer, and one of the expected side effects is itching. After getting the shot, the itchiness on the back and chest is so severe that he only managed to sleep for 45 minutes (Jan2021). He also mentioned having neuropathy in both ankles and feet, the shot may have messed with his nerves and he can hardly walk due to the excruciating pain. Additionally, he experienced dizziness, described as "drinking a 12-pack and standing too quick". Outcome of the event was unknown.   Information about lot/batch number has been requested.
Employee was tested positive for COVID-19 on 9/13/21. Employee was removed from work 9/13-9/22.
Pt was sitting in the waiting area in a chair with arms.  Patient was in the chair less than 5 minutes and fainted. She fell from the chair and hit her head on the floor. A pharmacist and technician were immediately there. Patient struggled to maintain consciousness and EMS was contacted and arrived at pharmacy.  Pt declined to go with EMS and waited in the pharmacy for several minutes after EMS left before leaving.
Pt had rash for four days.  Only 4 bumps on her body.  Her daycare did have an outbreak of pox.  Slight fever of 101 degrees by ear.  Tempra given for 1 day.  Child was not in bed or lethargic.
Patient felt like she was "breathing in cold air" 2 hours after vaccine given. Notified our office next day as had continued.
it was rpt from nurse concerning pt who was vax & subsequently devel severe diarrhea;
rash that started 7/27/2021 to R arm and bilateral lower legs - redness, itching, papules
Occuld Respiratory: Sclera very injected Lids with edema, sore, scratch throat. chills cough onset 5 hrs after FLUZONE
headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 11:00 am (age at vaccination was 77 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included atrial fibrillation and high blood pressure. The patient did not have any allergies. Concomitant medication patient received within 2 weeks of vaccination included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), atorvastatin and amlodipine besilate, olmesartan medoxomil (OLMESARTAN E AMLODIPINA EG). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EI9265, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 am (age at vaccination was 77 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. On 27Feb2021 at 19:00 pm, the patient experienced headache, low energy and body aches. Today on 01Mar2021, 3 days after second dose patient was still experiencing headache, low energy, and body aches. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date. The patient received treatment with Tylenol Extra Strength. The outcome of events was not resolved.  No follow-up attempts are needed. No further information is expected.
patient was under observation post vaccination when he passed out in his chair/slumped over. Patient was somewhat responsive within 10 seconds. We called 911 immediately. The EMT tested patient's blood pressure and heart rate. Both came back WNL. We monitored the patient for an additional 30 minutes in the pharmacy counseling room. We also got patient an orange Gatorade from the store to help restore his electrolytes as he was profusely sweating. Patient refused the EMS take him to the hospital and wanted to drive himself home from the pharmacy.
Paient who was only administered the 1st dose from an unknown HPV vaccine dose series at age 10 years and had missed the remaining corresponding HPV vaccine doses for completing the series; Had missed the remaining corresponding HPV vaccine doses necesary for completing HPV vaccine dose series; No additional AE; Product origin unknown; This spontaneous report was received from a physician referring to a 23-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.     On an unknown date at the patient's age of 10 years old, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported).       The patient was only administered the 1st dose and had missed the remaining corresponding HPV vaccine doses necessary for completing the HPV vaccine dose series (inappropriate schedule of product administration, product origin unknown and product dose omission).  No adverse events were reported.
Information has been received from a physician concerning a male pt who on 7/26/99 was vaccinated with varicella. On 1/3/00, the pt experienced a rash with many lesions and a low-grade fever not exceeding 101F. The physician reported "many cases" of chickenpox in the community; however, the pt's mother is not aware of any exposure to the pt. Unspecified medical attention was sought. Additional information has been requested.
On June 10, 1999 the pt developed chickenpox and was hospitalized. The pt was treated with acyclovir and a vesicular specimen was collected for analysis via polymerase chain reaction. Hospitalized due to severity of rash. Follow-up information from an RN confirmed that the pt was hositalized due to the severity of the varicella rash and indicated that the pt subsequently recovered.
Initial report received on 14 February 2007 from a health care provider who has acquired the information from a newspaper article. Per the newspaper article, it has been reported by the state department of health that an eight year old child, who had received a flu vaccination and had unspecified underlying health problems, died from the disease influenza on 12 February 2007. Additional information was not provided related to this case. (The firefighter that was also reported in the title of the article had not been vaccinated.
No additional AE/No PQC; HCP called to report TE with PROQUAD.  PROQUAD was administered to 3 patients after the most recent prior excursion on 4/11/2023 and before the current excursion on 5/4/2023. Date of administration was unknown at time of call. Consent to contact is y; This spontaneous report was received from the Medical Assistant referring to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date in 2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) injection, 0.5 milliliter, lot #W012728, expiration date: 16-OCT-2023, administered for prophylaxis (anatomical location, strength, and route of administration were not provided) after the "most recent prior" excursion on 11-APR-2023, and before the current excursion on 04-MAY-2023 (product storage error). No additional adverse events.  The causality between events and suspect therapy was not provided.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-2305USA003128: US-009507513-2305USA003072:
Injection site rash: varicella - Information has been received from a registered nurse concerning a 27 year Caucasian female patient who on 12 Apr 2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 632384/1728J) On 25 Apr 2000 the patient developed a mild case of chickenpox with amild low grade fever and pox lesions covering small portion of her back, arms and legs.  It was also noted that the patient developed an injection site rash.  Unspecified medical attention was sought.  Follow up information from a registered nurse reported that on an unspecified date the patient recovered.  No further information is expected.