chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother reports child had screaming, increased temp and stiff neck after immunization. They went to ER. Test were negative for meningitis. ER physician told them the reaction was to Prevnar.
Patient had 10x10 cm erythema on left upper arm where vaccine was given. No anaphylaxis. Hydroxyzine 10mg tabs given for 3-5 days. Desonide 0.05% BID x 10 days.
arm turned red and streaky within a minute or two of the injection. Watched closely for 15 minutes, but no swelling or further irritation occurred. Did apply instant ice bag to help reduce the chance of further reaction
Swelling of uvula (required emergency treatment); tachycardia (required medical treatment).; This is a spontaneous report from a contactable consumer (Patient) reported that: A 55- years-old Female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8729 and expiration date: Not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 10:45 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 55 years). The patient Medical history was none. The concomitant medications were not reported. The patient historical Vaccine include PFIZER-BIONTECH COVID-19 VACCINE (1st dose via right arm) (Batch/Lot Number: ER2613) for covid-19 immunization on unspecified date in Mar2021 at 10:00 AM. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. The patient experienced Swelling of uvula (required emergency treatment) and tachycardia (required medical treatment) on 06Apr2021 at01:00 AM. The seriousness criteria are medically significant. The events result in emergency room/department or urgent care. The patient is treated with IV Benadryl and epinephrine nebulizer. The event outcome was recovered on unspecified date in Apr2021.  Follow-up attempts are completed. No further information is expected.
pt had rash around injection site and itched for 24 hours, then redness remained.. no swelling, or warm to the touch
Upper intestinal aches - on a scale of 1-10 I would give it a 4. It was bothersome but I was able to do normal activities.  It lasted for about 4 days and I began to take Pepto Bismol to help with the aches.  This was not a normal gassy event from food, the ache was different and not in a normal location.  I never had diarrhea or constipation and my appetite never went away. However, I did cut my food consumption in half.
Severe headache causing mild nausea due to pain. Continues  ongoing from 4hrs after dose  to present. Itching all over they body from morning after the dose to present. Trouble concentrating, brain fog since morning after the dose to present. Restless from morning after the dose to present. Numbness around mouth, since the morning after the dose to  present. Fatigue since morning after the dose to present.
I received my 4th dose of Moderna Bivalent on 12/02/2022. My COVID-19 symptoms started on 12/27/2022 at round 08:00AM. I had a severe headache, cough, and stuffy head. I did a COVID-19 home test on the same day which was positive by the evening my symptoms got worse. I started vomiting and I was dehydrated so my husband took me to the Emergency Room. I received intravenous fluids and nausea medication  Ondansetron ODT 4 milligrams as per needed.
1. April 10-13: 3 days of sickness, chills, fever 102, arm extremely painful, all over body aches, nausea, SVT heart racing 120 bpm. 2. Later in April and May had 3 episodes of SVT: heart racing up to 220 bpm 3. Late May: Great fatigue, too tired to drive safely, sleeping mid-day naps for hours, VERY unusual for me. 4. DIZZY, lightheaded, headaches, head foggy, nausea
Patient accidently received third dose of Shingix vaccine. Patient presented to pharmacy and asked for Shingrix vaccine to be given, review of system did not find any history of Shingrix vaccines being given in past. Vaccine was processed successfully through insurance. First vaccine in series was given 3/26/22. Patient returned 5/4/22 for Moderna booster and asked when he would be due for his Shingrix booster and when he would need the vaccine series again, mentioned that this was his second time getting the series and he had received it once already in 2020 from another pharmacy. Review of Vaccine Registry found two doses of Shingrix given in 2020. Informed patient to not return for an additional dose of Shingrix and that third dose should not have been given.
Patient walked in on 9/29/18 at approximately 1:45pm. She had light red, swelling on the injection arm (Right) from the injection site down ~4 inches and toward her bicep. She described the swelling as warm and slightly painful starting soon after her injection on 9/28/18. I recommended she take loratadine (OTC) for a couple days to help with the swelling and to contact either her physician or this pharmacy if swelling does not go down.
This spontaneous report as received from a physician refers to a 1 year old female patient with no pertinent medical history and no drug reactions/allergies. On 24-FEB-2014, the patient was vaccinated with the first dose of PROQUAD (lot # J010597; expiration date 28-FEB-2015) (route not provided). Concomitant therapies included the second dose of FLUZONE, administered on 24-FEB-2014, separate site. No co-suspect therapies were reported. On 27-MAR-2014, the patient developed shingles following vaccination with PROQUAD. The physician reported that the patient developed shingles like rash that followed a dermatome on the upper left back. The physician reported that when she saw the rash it was described as crusted papules. The outcome of the event was reported as recovering/resolving. A physician was contacted. The patient received treatment with cephalexin and mupirocin ointment. A lab diagnostic test was performed for Varicella-Zoster Virus Antibodies, IgG and IgM on 03-APR-2014, and the result was negative antibodies detected to IgG and IgM. Additional information has been requested.
This patient is a pleasant 40-year-old lady has ESRD and is on hemodialysis.  Patient was diagnosed with COVID-19 a week ago, and was tested  because she was symptomatic with slight cough and loss of smell, she was told not to go to the usual center she goes for hemodialysis.   therefore she missed 2 of her dialysis days.  and yesterday she went to another center where they accept COVID patients.  And from there she was sent to the emergency room probably because of abnormal labs.  In the ED patient was found to have hyperkalemia .  Hemodialysis stat has been ordered by Nephrology and patient is admitted for further treatment.
Information has been received from a male concerning himself who on an unspecified date was vaccinated with an expired dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). No adverse event (AE) was reported. At the time of reporting, the patient's status was not provided. Follow-up information was received from the male patient who reported that on 21-FEB-2011, he was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not reported, lot # 664444/0722Y, expired date 21-NOV-2010). On 22-FEB-2011, he developed a fever of 99.5F and body aches. The patient consulted by phone with doctor who advised him to take TYLENOL. The patient had recovered. Follow-up information was received from the male patient who reported that it was in the evening of 21-FEB-2011 (previously reported as 22-FEB-2011) he experienced fever and body aches. Follow-up information was received from the physician who reported that a 75 year old male pharmacy associate with no known allergies on 21-FEB-2011 at 15:30 was vaccinated subcutaneously on the arm with an expired first dose of ZOSTAVAX (Merck) (lot # 664444/0722Y). On 22-FEB-2011 (previously reported as 21-FEB-2011) the patient experienced soreness at site of injection and mild fever. The reporter mentioned that he did not know if the patient had siblings. There was no illness at time of vaccination. No lab diagnostics studies were performed. On 23-FEB-2011 patient recovered. Additional information is not expected.
PT HUSBAND SAID HER LEFT ARM WAS RED AND SWOLLEN AFTER SHE GOT VACCINATED AND LASTED FOR 3 DAYS AND FROM 4TH DAY ONWARDS SWELLING GOT REDUCED AND NOW SHE IS DOING FINE AFTER TAKING IBUPROFEN.
The patient told that she fainted after she got the first dose of pfizer vaccine. she cautioned us that it may happen again. the patient dad is with her. After 5 minutes getting the vaccine she felt dizzy and she started crying and we called 911 and before the paramedics came the patient recovered and refused to go to the hospital.
Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 37 years and 2 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code. No treatment medication was provided.
Diarrhea-like soft stool 2.5 hours after inoculation; fatigue and general malaise for more than 36 hours after inoculation; sore left arm for more than 36 hours and soreness at the injection site.
sustained a minute long seizure; temperature of 101.5 Fahrenheit; during the injection the liquid squirted out of the syringe where the needle was attached all over the patients arm and floor; during the injection the liquid squirted out of the syringe where the needle was attached all over the patients arm and floor; Initial information regarding an unsolicited valid serious case was received from other health care professional via Medical Information (Reference number- 00711792) and transmitted to Sanofi on 05-Aug-2021.  This case involves a six-year-old female patient who had sustained a minute long seizure (seizure), temperature of 101.5 Fahrenheit (pyrexia) after receiving IPV (VERO) [IPOL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) received on 04-Aug-2021 for prophylactic vaccination.  On 04-Aug-2021, the patient received a dose three (0.5 mL) of suspect IPV (VERO) (lot T1D481M, expiry date: 25-Jul-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  It was also the case of exposure via skin contact and syringe leak (syringe issue) on 04-Aug-2021 (latency: same day).  The reporter stated that a dose of IPOL was given and during the injection the liquid squirted out of the syringe where the needle was attached all over the patient's arm and floor. The reporter then gave the patient a second injection of IPOL in the other arm. The reporter was reporting the event and wanting to know if the second shot given would cause a problem.  On 04-AUG-2021 the patient developed a serious event reported as sustained a minute long seizure (seizure) on the same day in the evening following the administration of IPV (VERO). This event was assessed as medically significant.  On 04-AUG-2021 the patient developed a non-serious event reported as temperature of 101.5 Fahrenheit (pyrexia) on the same day in the evening following the administration of IPV (VERO).  It was reported, the patient's mom took the patient to the ED (emergency department) that evening due to having a temperature of 101.5 Fahrenheit and the child sustained a minute long seizure.  Other relevant laboratory test were not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovering from events.; Sender's Comments: This case concerns a six-year-old female patient who seizure and pyrexia after receiving IPOL. It was also the case of exposure via skin contact and needle issue. the patient's body temperature was 101.5 degree Fahrenheit. The time to onset is compatible with the role of the vaccine. Concomitant medications included VARICELLA ZOSTER VACCINE for prophylactic vaccination. Additional information regarding medical history, past medical treatment(s), vaccination(s), condition at the time of vaccination and other laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed
Hospitalization day 3 first vaccine 1/9/2021.  92-year-old comes in with change in mental status.  Per the daughter, patient was able to follow commands about a week ago and was eating on her own.  She states she was able to identify where she was, identify family members, and the time and the date; but she states about a week ago she was diagnosed COVID positive, and she has not eaten anything for the last 4 or 5 days and felt very weak.  Normally she can, per the daughter, with assistance use a walker, but she has not gotten out of bed in the last 5 days.  Patient's daughter states she has been coughing, productive of whitish phlegm.
He suffered three febrile seizures. 1600, 1800, 1900 followed by 11 hours of sleep that was so deep he did not move or nurse. Seizures included trunk spams and shaking of the hands and becoming straight like a board followed by "passing out". His temp was 101 for most of the day, shot up to 103 for less than a half hour. (Using hospital grade temporal lobe thermometer) He cried harder than he had with colic and I could not get him calm. No nursing for this period.
pt recv vax & 17MAR97 pt devel a rash; then devel brusies and petechiae; hospitalized with multiple bruises - pt dx with immune thrombocytopenic purpura
CLIENT IN FOR FLU VACCINE SITE REDNESS, SITE WARM TO TOUCH. CLIENT SEEN BY DR. IN OFFICE AT TIME OF VISIT. CLIENT TOLD TO WATCH AND COME BACK BY IF PROBLEMS PERSIST.
PT CAME IN FOR THE 1ST OF HEPATITIS A SHOT. IMMEDIATELY AFTER THE INJECTION, THE PT'S EXPRESSION CHANGED & FELT SHE HAD TO SIT DOWN. SHE WAS LEANING AGAINST A WALL & SLID DOWN TO THE FLOOR. SHE SAID SHE FELT NAUSEOUS. SHE ASKED FOR & RECEIVED SOME COLD WATER. SHE WAS THEN HELPED TO A CHAIR & HAD HER FEET ELEVATED. OCCASIONALLY SHE FELT SWEATY. MENTIONED THAT HISTORY OF PASSING OUT WHEN RECEIVING SHOTS WAS COMMON. AFTER 20 MINS OR SO SHE DECIDED THAT A RIDE HOME WAS NECESSARY. SHE CONTACTED HER FAMILY. RIGHT BEFORE HER PARENTS ARRIVED, SHE VOMITTED A LITTLE, MOSTLY LIQUID, SOME COLOR, BUT NO BLOOD. SHE WAS ABLE TO WALK OUT ON HER OWN & WAS IN THE PHARMACY AREA FOR ABOUT 45 MINS.
Dose administered after exposure to room temperature >24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours). On 11-Nov-2021, PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reported that 1 vial of the Moderna vaccine was placed at room temperature at 9 am on 10-Nov-2021, left at room temperature overnight, and then, 24 hours later, on 11-Nov-2021 9am, 1 booster dose was administered and, after an additional 6 hours, at 3pm 11Nov2021, 2 doses were administered from the same vial as booster doses. No concomitant medications were reported. No treatment medications were reported.
1 week following vax, whole body hives. persisted for 1 week despite oral benadryl + tagamet, topical steroid cream. facial rash developed at tail end of hives, persisted for 4+ weeks. menstrual cycle as well seems affected -- from 25 day cycle (+- 3 days) to 35-50 day cycle for multiple cycles post-vax.
patient given pediarix, prevnar, hib, and rotarix. Localized rash on left thigh immediately after pediarix administration.After 7 minutes of monitoring patient rash has spread over trunk, back, and neck. After 25 minutes of monitoring patient well appearing, no  respiratory distress, and localized rash still present but improving in redness.
Blueish and red discoloration in legs that looked like the start of a severe hive break out or other rash.  Rash was noticed about 5 minutes after injection. Pharmacist administered 5ml of liquid Benadryl about 5-7 minutes post vaccine injection.  The symptoms dissipated about 25-30 minutes later.
Arm kind of sore; Arm red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm kind of sore) and VACCINATION SITE ERYTHEMA (Arm red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm kind of sore) and VACCINATION SITE ERYTHEMA (Arm red). On 06-Jan-2021, VACCINATION SITE PAIN (Arm kind of sore) and VACCINATION SITE ERYTHEMA (Arm red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; 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 ended up with facial weakness 9/26/2013 was seen by MD 9/27/13 diagnosed with Bell's Palsy.
Headache, SOB but 99% O2, vitals okay, talked to NP and told to monitor. Felt better the next day. COVID + in the past
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 16-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 expiration date: 10-AUG-2014 (dose, lot # and route of administration were not reported). It was unknown if the patient had been received another dose of PNEUMOVAX23 at the time of this report. Additional information is not expected due to the reporter declined to provide any additional information for this report.
Felt light headed about 10 minute after vaccine administration.  He then passed out for a few seconds.  He was still light headed 24 hours after vaccine administration and was sent home on quarters (sick leave) for 24 hours.
Near syncopal episode. Pt. fell forward off of exam table, hitting head. Evaluated immediately by provider. BP 110/70 O2 Sat 99% P-62.
arm very swollen, very warm and a redness appeared on it; arm very swollen, very warm and a redness appeared on it; arm very swollen, very warm and a redness appeared on it; a little bit of muscle pain; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 12-Jan-2021.    This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (a little bit of muscle pain), PAIN (body aches), PERIPHERAL SWELLING (arm very swollen, very warm and a redness appeared on it), ERYTHEMA (arm very swollen, very warm and a redness appeared on it) and SKIN WARM (arm very swollen, very warm and a redness appeared on it) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (a little bit of muscle pain) and PAIN (body aches). On 08-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm very swollen, very warm and a redness appeared on it), ERYTHEMA (arm very swollen, very warm and a redness appeared on it) and SKIN WARM (arm very swollen, very warm and a redness appeared on it). At the time of the report, MYALGIA (a little bit of muscle pain), PAIN (body aches), PERIPHERAL SWELLING (arm very swollen, very warm and a redness appeared on it), ERYTHEMA (arm very swollen, very warm and a redness appeared on it) and SKIN WARM (arm very swollen, very warm and a redness appeared on it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication includes Colesterol Meds and Antibiotics A doctor marked her arm to see and to measure how the condition of her arm evolved, and prescribed antibiotics; 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.
Information has been received from a RN concerning a healthy nine year old female pt, who on 09Jun00 was vaccinated with a dose of varicella virus vaccine live (lot630678/0426J). On 02Jun05 the pt developed a rash on her abdomen and legs, which then spread to her lower extremities. The rash was described as water filled vesicles and itchy. The suggested treatments were avena (AVEENO bath), diphenhydramine (Benadryl), and calamine lotion. At the time of this report the pt's outcome is recovering. There was no product quality complaint reported. The pt sought medical attention. Additional information has been requested.
ErythemaMultiform Narrative: One week after vaccination developed redness, heat and swelling @ site. Took benadryl and applied cool compresses, reports site is "better."