chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; No energy; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), ASTHENIA (No energy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea), ASTHENIA (No energy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, DIARRHA (Diarrhea), ASTHENIA (No energy), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details were provided.
Information has been received from a consumer concerning her husband, a 76 year old male with no pertinent medical history, drug reaction or allergies who "about three months ago" approximately NOV 2007 was vaccinated with Zostavax (Oka/Merck). There was no concomitant medication. In approximately 2007, "shortly after receiving the vaccine", the patient developed a rash on his face; and blister like lesions on his neck and back. At the time of reporting the patient had not yet recovered from the rash on his face and the blister like lesions on his neck and back. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient received a 3rd dose of VARIVAX today; wasn't realized that PROQUAD was given last year . No adverse event at this time.
Nurse was giving vaccines, Pulled the needle out, then pushed to retract needle and vaccine squirted in to patients left eye
kidney transplant; slight headache; mouth dry; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL TRANSPLANT (medically significant), outcome "unknown", described as "kidney transplant"; HEADACHE (non-serious), outcome "unknown", described as "slight headache"; DRY MOUTH (non-serious), outcome "unknown", described as "mouth dry". Patient got his first dose already and was experiencing a slight headache and mouth dry. And he also had his kidney transplant. Therapeutic measures were taken as a result of renal transplant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received the 1st COVID vaccine of Pfizer (Lot#EW0185 expiration 05/22/21) At 4:28PM client reported dizziness, lightheaded, headache, no blurred vision, no chest pain, no shortness of breath. Client has been waiting for 20 minutes in the observation area. at 4:33PM RN responded to event. Vital signs are blood pressure 100/62, hear rate 73, oxygen saturation 99%. Client reports slight headache towards the frontal lobe. Per client and client's father, there is a history of asthma and no known allergies. At 4:38PM EMT obtain vital signs that are blood pressure 110/60, heart rate 74, oxygen saturation 99%. Client reported feeling weak, no dizziness, and no lightheaded. Provided supplemental nutrition and fluids to client. Client accepted. RN educated client and father about ED precautions and common adverse effects of COVID vaccine. At 4:47PM vital signs are blood pressure 100/60, heart rate 82, oxygen saturation 99%. Client reports not feeling symptoms. All symptoms had resolved. Client has steady gate and is waiting for other siblings to complete observation time.
A few minutes after the patient received both immunizations, the patient felt dizzy and fell on the floor, and fainted for about 10 seconds. 911 was called and the EMT came and took him to the hospital. His friend informed me that he has skull fracture and some Internal bleeding. And they were told that he need to rest at home for a month, then see his primary care provider after that.
HEADACHE; MUSCLE  ACHES; NAUSEA; LOW-GRADE FEVER; BODY ACHE; CHILLS; SO SICK AFTER INJECTION; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, non smoker, Addison's disease, hypothyroidism, and osteoporosis, and other pre-existing medical conditions included patient was not pregnant at the time of event. patient have no drug allergies/drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 13:15 to Left Arm for prophylactic vaccination. Concomitant medications included fludrocortisone for Addison's disease, hydrocortisone for Addison's disease, levothyroxine for hypothyroidism, calcium citrate for osteoporosis, amino acids nos, ascorbic acid, ergocalciferol, and tocopherol. On MAR-2021, the subject experienced so sick after injection. On 05-MAR-2021, the subject experienced body ache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced muscle aches. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from muscle aches, chills, nausea, low-grade fever, and body ache, and the outcome of so sick after injection was not reported. This report was non-serious.
Development of fever and localized rash within one day of vaccination, progressing to full body rash and joint pain in hands, feet, knees and hips by 2/17/16. Painful gait. Pain unrelieved by TYLENOL. Doctor's office visit on 2/20/16; advised to switch from TYLENOL to ibuprofen for joint pain and ongoing fever. Advised to return for course of Prednisone if not resolved within one week. Pain and fever resolved without follow up visit.
Vaccine went under temperature excursion; No adverse event; Vaccine went tempearture excursion  and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion  and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion  and was administered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion  and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion  and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the day after power was lost in the middle of the day at 12:00 pm and had to placed all vaccine in a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. This case is reported for patient 21 out of 26 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:
Patient was administered expired MMR vaccination SQ on Left Upper Arm at 2:50 PM (date of expiration: 4/23/23).
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received via social media from a 65 year old patient of unspecified sex, race and 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: Unknown, Expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (reported as 3 months after getting vaccinated), the patient got the virus (suspected clinical vaccination failure) and because of the vaccine, patient didn't end up in the hospital. The patient reported of having mild symptoms (suspected covid-19 infection).  Laboratory data (dates unspecified) included: Oxygen saturation (not provided) never below 96. 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 (Other Medically Important Condition).; Sender's Comments: V0. 20210946648-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
I noticed on Thursday and Friday that my blood sugar levels were elevated. I didn't eat anything unusual and my increased blood sugars did not respond to my insulin as I would expect. The highest my blood sugar got to was 250. Wasn't a huge deal and today is Saturday and my blood sugar is back to normal.
Localized bruising for 1 week, subcutaneous lump lasting for 6 weeks, localized itching and numbness lasting for 4 weeks.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unspecified date the patient was vaccinated intramuscularly with a dose of GARDASIL (Lot# and dose not reported). Concomitant medications included influenza virus vaccine (unspecified) and MENACTRA. On an unknown date the patient experienced seizure after having GARDASIL. The patient did not seek for medical attention. No treatment was give. At the time of this report the patient had recovered from seizure. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Hives/Rash on most of body, treated with Benadryl and cortisone cream every 4 hours since onset of symptoms
6 weeks pregnant at the time of vaccination. Estimated due date 04/15/2022. 4 days after vaccination bleeding and cramping began and lasted 10 days, resulting in a miscarriage.  2 normal and healthy pregnancies in 2012 and 2014.
Moderna COVID-19 Vaccine EUA - I had swelling, itching and redness from the upper L arm to just above the elbow on the outside of the arm. There was no pain and the symptoms subsided by the next day around midday.  I had no other issues that I could discern.
Unable to lift arm, Chills fever 100.5, unable to sleep , Headache Dysequilibrium, slow to answer questions, Unable to text phone #s for help, couldn't spell properly. 11/10 lethargy , fever 101.5 .  11/11 lacking energy and body aches
Vaccinator went to check on pt at the end of the 15 mins wait post-Pfizer COVID vaccine 3rd dose. Pt reported "tingling" in throat, but denied swelling, itching, difficulty breathing. HR 74. O2 98%.  Had pt wait for full 30 mins. Pt reported symptoms resolved, denied any other symptoms, and he went home. Advised to go to ED for any worsening symptoms.
Patient had Regeneron infusion on 8/13/2021 and was vaccinated with her first dose of Pfizer on 10/13/21.  This error was caught we the patient came into clinic for her second dose of Pfizer.  The 2nd dose of Pfizer was not given.  Patient states she had severe flu like symptoms and was in bed for several days due to symptoms.
Product temperature excursion issue; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication was provided by reporter.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, fever, nausea, injection site rash and injection site erythema. In June 2018, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the injection site swelling, fever and injection site erythema were unknown and the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, fever, nausea, injection site rash and injection site erythema to be related to SHINGRIX. Additional detail were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received vaccine on Thursday and experienced swollen red arm with rash at injection site, a fever of 101 degrees F and was nauseated for one day. The reporter stated that rash did not go away and was getting larger. No other details were provided. The callback was attempted to patient without success and limited report was filed.
Swollen lips, numbness on chin, shaky. "Not feeling well". Saw Primary and was given cetirizine 20mg one Daily, Methylprednisolone dose pak 6 day.
Stomach pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, ENALAPRIL MALEATE (ENAPRIL), OMEPRAZOLE, EZETIMIBE, LORATADINE (LORATADIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided.  No treatment information was provided.
Second dose given 46 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 46 days after first dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Hip surgery. Concurrent medical conditions included Blood pressure management and Hypercholesterolaemia.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 46 days after first dose). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 46 days after first dose) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug included blood pressure and cholesterol medications. Treatment medication was not reported.
"lightening-like" sensation in back of neck, up into back of head upon injection. 12 hours out..feeling abnormal... chills shortly thereafter, throughout the night. also nausea, headache. Next day, mental confusion, fog.. .lymph glands under arm on  right side very tender, some swelling...this continued for at least 3 days.
No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 22-MAR-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U022819 with expiration date 14-JAN-2023 (dose, route, and anatomical location were not reported) for prophylaxis. The vaccination occurred after the temperature excursion occurred (product storage error). The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was exposed to 1.4 degrees Celsius during 48 hours and it was reported that there were a previous temperature excursion. No additional adverse events were reported. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007094: US-009507513-2206USA006674: US-009507513-2206USA007098: US-009507513-2206USA007068:
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 7-year-old male patient who experienced nasal congestion, sore throat, fever and nausea. At 7 years of age, the patient received the first dose on 12-Dec-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 12-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 14-Dec-2003, 2 days post-immunization, the child developed nasal congestion and a sore throat. On 16-Dec-2003 he experienced a fever and nausea. Phenergan (promethazine hydrochloride) (manufacturer unknown) was prescribed for the nausea. No additional information was available at the time of this report.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe
ADVERSE EVENT: Approximately 6 hours after the shot, I began feeling feverish, although my temperature remained at its usual level of 97.6 degrees. I also began experiencing joint and muscular pain. The following morning, (10/14/21) the joint and muscle pain was intense and my temperature was beginning to go up. My first check was around 9 a.m. and it was 99.8. At approximately 7 p.m. it reached it peak level of 101.2 and began to slowly decrease. At 10 p.m. it was 100.6; at 11 p.m. it was 100; at midnight it was 99.2. The next day, Friday, Oct. 15, I felt much better; the joint and muscle pain was almost completely gone, I didn't feel feverish anymore, and at 9 a.m., my temp was 99.3. it continued to decline and by 1 p.m. it was back at my normal level of 97.6.  TREATMENT: I treated the fever, aches, and pain with 650 mg acetaminophen every 6 hours, beginning at 9 a.m. 10/14/21. OUTCOME: Recovered after=effects of booster shot in approximately 36 hours.
large local react w/swelling; 7.5cm x 7.5 cm got larger the next day, warm to touch & very tender;
syncope recurrent etiol. r/o supraventricular tachycardia, r/o neurodepressive syncope; peds cardiologist prescribed meds, further testing being done; 30OCT92 pt dizzy & passed out in band; dx by ER MD hyperventilation;
Case number PHEH2014US011235 is an initial spontaneous report received from a physician on 02 Jun 2014. This report refers to a 04 year old male patient. His medical history and concomitant medication were not reported. He was vaccinate with a dose of MENVEO (batch number: not reported) via subcutaneous route on an unknown date in May 2014. Vaccination was performed using 5/8 inch needle. No adverse event was reported following this medication error.
Kinrix dose was given by accident, should have been pediarix,  pt family informed, baby is doing well.
No reactions reported. Vaccine error of receiving repeat 2 month vaccinations 3 weeks after the first dose.