chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I pregnant when receiving the first dose of the Covid vaccine. Est due date of November 12th. This was my first pregnancy. Early April (1-2 weeks later) I started experiencing some bleeding and has a miscarriage within a week from the first symptoms.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies were reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced shaking. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced tiredness. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of shaking, vomiting, tiredness and body aches was not reported. This report was non-serious.
Covid-19 Vaccine booster; Lupus; Felt incredibly sick after the booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (Covid-19 Vaccine booster) (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1,MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose:2,MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Covid-19 Vaccine booster"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "Lupus"; ILLNESS (non-serious), outcome "unknown", described as "Felt incredibly sick after the booster". Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 30OCT97 & 5min p/vax pt exp h/a;10min p/vax pt exp nausea;40min p/pt exp sniffling & congestion;tx consisted of APAP & fluids;
PATIENT SAID HE HAD SEVERE NAUSEA DIARRHEA AND NOW HAS ABDOMINAL PAIN/CRAMPING. HAS NOT SEEN A MEDICAL DOCTOR TOLD HIM IF IT CONTINUED HE SOULD SEE ONE.
PATIENT RECEIVED MONOVALENT PFIZER VACCINE INSTEAD OF BIVALENT-- PT IS FINE
5 inch diameter itching pain swelling and feaver. Feels like my arm is full of bees.
Client reported rash on left side of neck and facial tingling/slight swelling about 4 hours after vaccine; HR 88, BP 130/90 RR 18. Assessed by Medical Director - urticaria most consistent with an allergic reaction.  Patient offered Benadryl and  encouraged to stay at clinic for observation, but chose to go home - explained risks and danger signs to be aware of that would require immediate visit to ED. Client took 25mg Benadryl at 5pm and MD spoke with her at 6pm - she indicated there was improvement with her rash after the initial dose.
Within 12 hours after injection, the patient developed the usual symptoms of fatigue, myalgia, headache. However, she also developed a dry cough, mild dyspnea and flexion of fingers in both hands, which eventually returned to normal. The fingers were flexed and could not be straightened up for several hours.  This is not reported in the PI
Mom states child had seizure at daycare on 3/5/03 at 10 a.m. Child was transferred to a medical center via ambulance. Private MD stated that she gave wrong dosage of Motrin. Stated she gave 3/4 tsp when she should have given 1 tsp. This caused increased temperature (unknown deg).
On 6/12/2021 around 2pm I noticed the redness around my arm. The right arm was extremely sore which stopped me from being able to use it during daily/normal activities.
patient discovered with slow respirations, poorly arousable, diaphoretic and pale with blue lips. Pt.   transferred to stretcher, vs at 2:20 pm - 159/100 with HR of 50. VS at 2:30 pm 130/82 with HR of 79 and 2:40 p   126/91 with HR of 73 and O2 sat 100% on RA.  Patient given po ginger ale, water, and granoal bar.  Patient   released to mom and dad's care. Patient ambulatedand stable, alert and oriented x4.
No adverse event; Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    Concomitant product use was not provided by the reporter. It was reported that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. Treatment information was not provided.
The Patient was unintentionally provided an expired  dose of this vaccine. The patient had no symptoms or adverse reactions. The patient was notified of the error and plans to return in 8 weeks to be revaccinated per CDC and the manufacturer guidelines.
This spontaneous report as received from a licensed practical nurse refers to a 57 year old patient. On 06-JAN-2017 the patient was vaccinated with a pediatric dose of VAQTA lot # M022531, expiration 23-FEB-2018 intramuscular for prophylaxis.  No adverse effect was reported. This is one of several reports from the same reporter.   Additional information has been requested.
A report was received from a health care professional on 12/16/03 concerning a group of 5 vaccinees aged less than 4 years of age and of unknown gender who were inadvertently administered Fluvirin on an unknown date. On an unknown date, a group of 5 vaccinees aged less than 4 years of age and of unknown gender were inadvertently administered Fluvirin. No adverse events have occurred as a result of this at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/26/04: A follow up report was received from a health care professional indicating that a 2 year old male vaccinee inadvertently received 0.25ml Fluvirin on 12/2/03. The vaccinee did not experience any adverse symptoms as a result. Follow up pending.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 subject experienced not responding to therapy (please see case numbers A0962820-22A for the other 3 subjects).
Sharp chest pain; Shortness of breath; Multiple occlusive thrombus in right leg(distal femoral, and popliteal vein with nonocclusive in right mid femoral vein); Right leg swelling; This is a spontaneous report from a contactable Other Health Professional. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation. Medical history included Acute cholecystitis without obstruction from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had not been diagnosed with covid-19 prior vaccination. It was unknown if patient had been tested for covid-19 post vaccination. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple occlusive thrombus in right leg(distal femoral, and popliteal vein with nonocclusive in right mid femoral vein) and right leg swelling on 13Apr2021; shortness of breath on 17Apr2021 and sharp chest pain on 18Apr2021, all with outcome of Recovered/Resolved with Sequel. Further events description stated that on 13Apr2021 the patient developed right leg swelling; on 17Apr2021 developed shortness of breath; on 18Apr2021 he woke with sharp chest pain. He went to ER and found to have multiple occlusive thrombus in right leg (distal femoral, and popliteal vein with nonocclusive in right mid femoral vein). CT Chest in Apr2021 revealed emboli in bilateral lower lobes, right middle and right upper lobes. The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events. The patient had heparin drip and ELIQUIS. The events resulted to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The events recovered with lasting effects on an unspecified date.  Information about Lot/Batch number has been requested.
Severe diarrhea for three days, Extreme swelling of stomach. Extreme abdominal pain. Additional swollen area on left side of intestines. Shingles like pain in  abdominal skin and flesh.
I've noticed an out of breath feeling when doing activities that do not normally cause an issues such as going upstairs or walking uphill for a short distance.
13AUG93 pt recvd vax & was enroute to home when mom observed hands turn inward, knuckles clenched, eyes rolled up in head; pt was very pale, dazed look on face, diaphoretic & urinated in pants. sx lasted about 2 1/2 mins;
She got her vaccine, everything seemed pretty good.  On the 7th she was so tired out that she could barely walk.  She did not have any energy to do anything, and so weak, and feeling so bad that she was ready to die, and has been feeling bad ever since.  She felt terrible, also had a rash that is over her forearms, and down her other arm, her fingers and her face.  She also has sores in her hair because of it, and her body itches all over and also her head.  She does not scratch it but the medicine that she was given does not work.  One of the prescriptions that she was prescribed was over $500.00 and her insurance denied it.  She has been to UC about every week, and they tell her to go to her PCP, which at the last visit she did not want to talk to her.  She also went to a rheumatologist who told her it was from her lupus, and she also went to a dermatologist.  She has never been this sick before.   She is still very weak and can hardly go anymore, and feels that everybody is out having fun and she can't do anything anymore.    She forced Dr. to see her and he did not want her to not say anything and that the 4th shot was giving a lot of people reactions.  She told him that she needed some help, total disability and he told her they were not talking about that.
Was feeling ill within 10 minutes of the immunization. (Nausea, Malaise, felt heavy and tired)  He had an area on his left cheek after the shot that was described as an "inflamed zit" that swelled to the size of a golf ball and was tender to touch all around the area.  He felt ill for three days but was able to play football the evening of 10-20-2006.  The vaccine was given 10-19-2006
pt recvd vax; pt devel sore throat, adenopathy, & fever; lab evaluation revealed anemia & elevated liver func tests; pt dx w/ acute infectious mononucleosis; MD felt that pt exp was not an adverse rx to the vax;
Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter reported that Last one was in the refrigerator with a label on it (not to be used in patients). Date the vial was initially stored in the refrigerator was 2Aug2021. On 03-SEP-2021 4 doses were administered. On 20-SEP-2021 4 doses were administered. On 01-OCT-2021 7 doses were administered. On 18-OCT-2021 4 doses were administered. On 25-OCT-2021 19 booster doses were administered. On 26-OCT-2021 14 booster doses were administered. On 27-OCT-2021 19 booster doses were administered.
Per Mom, developed diffuse papular rash about 3/1/02 on trunk and extremities, went away 3/6/02. On 3/6/02, developed redness and blisters left anterior thigh at site of Varivax injection.
7 people who turned up with appendicitis; 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 APPENDICITIS (7 people who turned up with appendicitis) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (7 people who turned up with appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (7 people who turned up with appendicitis) 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.   Reporter also mentioned that there was 7 people who turned up with appendicitis in a research group who received the vaccine (unknown which vaccine).  Concomitant product use was not provided by reporter.  Treatment information was not provided.  Company Comment - This case concerns a patient of unknown age and gender who experienced the serious unexpected event of Appendicitis. The event occurred an unknown time after a COVID-19 vaccine of unknown manufacturer. Re-challenge is unknown as no information about the dose(s) is reported. The Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-313517 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender who experienced the serious unexpected event of Appendicitis. The event occurred an unknown time after a COVID-19 vaccine of unknown manufacturer. Re-challenge is unknown as no information about the dose(s) is reported. The Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
administered reconstituted with non approved diluent; administered reconstituted with non approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent .  They were trying to figure out which patients received an incomplete dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, the patient was administered Shingrix reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter
Narrative:  Developed an Atypical Parkinson's Syndrome within one month after receiving 3rd dose (booster) Moderna COVID vaccine without other explanation for development of sub acute Atypical Parkinson's Syndrome.
had 2 seizures; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on an unknown date at 2nd dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on an unknown date at 1st dose, single for COVID-19 immunization. The patient had 2 seizures after receiving his 2nd dose of the Pfizer vaccine. The seizures occurred approximately 15 hours after the vaccine was given. He has no underlying seizure condition. The event was reported as serious for Life-threatening. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Additional Details: numbess- arm and fingertips, tingling - arm
Patient stated that 5 days after shot she had about and 8 X 8 area that felt like sandpaper on back and it itched. However, it was not red. The symptoms lasted for about 10-14 days and then disappeared.
Fever in excess of 103F. Chills. Muscle aches. Headache. Sore arm.
I received my 3rd dose on 10/15/2021 and my adverse event started 04/05/2022   at mid day on  the right side of my face  was numb.; itching and painful. The whole right side was  numb I felt like I couldn't swallow.   I had sore on my cheek, chin, and my mouth. By the time  I went to see my doctor on 04/11/2022  my face blown out. I had a syndrome called  Ramsey hunt syndrome.  I had headache;  itching and numbness.  I felt like I had a sore throat .  My doctor  gave me  anti viral   ( Valtrex) Acyclovir for  7 days and prednisone for few days. I  went back to the doctor after a week  04/25/2022  she prescribed gabapentin. I still take it now   for pain.  I still have itching and numbness  on my right side of the face but not severe like before. Am still taking medications.
Chest Pain, myalgias, headache.  Received ibuprofen for headache.  Discharged home on metoprolol succinate 25 mg/day (new).
My son got his Varicella booster on 10-14-20.  He cried upon injection and was irritable a bit. All was ok until Monday 10/19/20. He started becoming super irritable. His stool changed to be softer and liquid. No fever but he kept pointing at his head,  mainly forehead and temples. I have him ibuprofen because I suspected headaches. He since started hitting himself in the head and nose. To the point of bruises on temples and nose bone. He looks like he is in pain all the time. I suspect  Encephalitis, he has been rubbing his eyes a lot.  The severe side effects list "brain reactions" as  a severe side effect. What does that entail? How general! My son is non verbal (mostly) and can't really tell me what's going on. He has  never attacked himself like this to leave such visible marks and bruises. Teachers and family alike are deeply concerned.   Due to covid I am reluctant to make it all worse by going to the hospital. Especially with the lack of attention we get as parents of a ASD child, but if it continues we can't have him keep injuring himself.
Pfizer vial was diluted with 0.8ml of diluent instead of 1.8ml, so only one three 0.3ml doses were able to be drawn from the Pfizer vial instead of six.  Patient ended up with a bigger dose of Pfizer than what is recommended. Attempted phone call to the patient to inform them of receiving the incorrect dosage.  Patient has not called back- had to leave a message.