chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a representative and described the occurrence of hepatitis B antibody negative in a 9-year-old subject of unspecified gender who was vaccinated with HEPATITIS B VACCINE. On a unspecified date the subject received 3rd dose of Hepatitis B vaccine at 0.5ml to complete the primary Hepatitis B series. At an unspecified time after completion of the Hepatitis B series, the subject was tested and did not show immunity. The subject was hepatitis B antibody negative. At the time of reporting the event was unresolved.
Injection was given to right arm.  Two weeks later, my upper arm and shoulder have deep aching.  No noticeable swelling or heat in the upper arm, but there is a small (3mm) purple weal (regular edges)  at the injection site.
but ended up getting the covid-19; but ended up getting the covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "but ended up getting the covid-19". Clinical course: Caller mentioned that she already got the COVID-19 vaccine, but ended up getting the covid-19. She would like to know how long she had to wait before getting the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female patient of unknown age, who was also a pharmacist, concerning to herself. The patient's pertinent medical history and concurred conditions were not provided. The patient reported that on 31-JUL-2016 she was vaccinated with ZOSTAVAX (lot #, dose, route and expiration date were not provided). Concomitant therapies were not provided. It was also reported that on 01-AUG-2016, 2 days after onset date of therapy with ZOSTAVAX, her arm became swollen 5 inches around, red and she was in pain. The patient said that she "generally did not feel well". The patient stated that she needed to order brochures. The outcomes of arm swollen 5 inches around, red, pain, and generally did not feel well were unknown at the time of the report. There was no product quality complaint (PQC) involved. Additional information has been requested.
Severe generalized soreness of muscles and joints, impairing movement due to pain, extreme headache, extreme fatigue. Unable to sleep night after administration due to soreness, focused pain to bilateral calves, heating pad applied with little relief, 600mg of Ibuprofen around the clock seemed to take edge off. Symptoms remain an issue. Worst is subsiding.
Swollen red knot on arm that vaccine was administered in. Hot to the touch. Intense pain in arm vaccine was administered in. Swollen lymph nodes on the same side of the body that the vaccine was given in.
COVID vaccine expired on 4/4/22.  Patient was administered Pediatric Pfizer vaccine on 4/11/22. No adverse reaction noted.  Patient's parent notified that patient needs to be revaccinated.
Immediate swelling, redness around injection site - large.  Treatment - given diphenhydramine 50mg/ml intramuscular right deltoid.
Pt developed itching, mild rash around injection site several minutes after injection. She also reported some itching to face bilaterally. No evidence of anaphylaxis. Symptoms improved after 1/2 hour. She refused EMS services. Band-Aid was removed and new band aid was placed on other arm where the pt then developed mild rash there as well. Suspect new allergy to bandaid adhesive. Doubt this was a reaction to the vaccine. Pt was counseled to follow up with PCP for further guidance regarding 2nd dose.
Information has been received from a pharmacist concerning a HIV patient who was vaccinated with PNEUMOVAX 23 and had more of a swollen arm and fever than normal. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. This is one of several reports from the same source. On 23-SEP-2009 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
t102, high pitched cry for 3 hrs or more; pain not relieved by APAP;
first dose on 27Feb2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose and missed 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. VAERS details reported for 1st dose of shingrix. The reporter consented to follow up.
pt recvd vax  @ 430PM & @ 7PM had emesis x 2 lips turned blue was cranky a/emesis; went to ER had temp 103.1; very letharic that noc;
One day after vaccines, was noted to be crying and shivering "as if cold". Given warm bath and swaddled and went to sleep. Now with leg R limb swollen and tense; pulse (+), edematous upper leg and into groin.
A non-serious spontaneous report of several patients received expired FLUMIST was received from a health professional concerning female children ages 2-years-old to 18-years-old. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 06-Dec-2010. The patients received expired FLUMIST from 07-Dec-2010 through 03-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
problems with joints in elbows, knee and ankles they are horribly stiff; can barely move, can't move knees and arm; does not feel active as before; completely knocked off after 2nd dos; Right arm red to the touch; Right arm itches; 102.9 fever; Right arm bruised; Right arm has bumps all over; Right arm completely swollen; She can't work with her arm like this; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this) and JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.     On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 17-Jul-2021, the patient experienced CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever). On an unknown date, the patient experienced JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before) and VACCINATION COMPLICATION (completely knocked off after 2nd dos). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (Right arm bruised), SKIN MASS (Right arm has bumps all over), PERIPHERAL SWELLING (Right arm completely swollen), LIMB DISCOMFORT (She can't work with her arm like this), JOINT STIFFNESS (problems with joints in elbows, knee and ankles they are horribly stiff), HYPOKINESIA (can barely move, can't move knees and arm), ASTHENIA (does not feel active as before), VACCINATION COMPLICATION (completely knocked off after 2nd dos), ERYTHEMA (Right arm red to the touch), PRURITUS (Right arm itches) and PYREXIA (102.9 fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow-up : New event added
Very Dizzy, headache, dry mouth, cramps and abdominal pain, body aches, nausea, slept most of the day.
high pitched crying for at almost 12 hours interspersed with extreme sleepiness and difficulty rousing from sleep, fever of 102+, red, hot site of injection.
Pt thought the shot was too high, needle in too deep. Mentioned the above statements to his wife the same evening as receiving the shot.
Prolonged joint pain; prolonged muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Prolonged joint pain) and MYALGIA (prolonged muscle pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Prolonged joint pain) and MYALGIA (prolonged muscle pain). At the time of the report, ARTHRALGIA (Prolonged joint pain) and MYALGIA (prolonged muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sore arm radiating to shoulder and neck, CHILLS, headaches, groggy mind
I had really bad cough that lasted for three weeks. I went to the doctor after one week, my doctor prescribed Tessalon Perles and albuterol inhaler to help with coughing. I followed up with my doctor three weeks later as the coughing still had not subsided. My primary care physician referred me to a pulmonologist who did ran a lung capacity test that came back normal. The allergist ran allergy test that came back positive for environmental allergies. I was advised to continue with my daily inhaler and to follow up with my allergist.
Minutes after the vaccine, developed perioral numbness, tingling, mild difficulty swallowing.  Complained of SOB and had marked diaphoresis.  BP dropped to 87/50.  Maintained sats 100%RA, lungs were clear.  Has a hx of a vagal response after blood donation
Patient had documented her DOB on web site for the appointment. When pt came into appt she had a temporary driver's permit and the DOB on the permit was different. During check-in process, the DOB was not properly matched to the DOB stated on the database, and the patient was vaccinated. We had discovered the patient was underage after billing the vaccine upon further review of documents.
Information has been received from a registered pharmacist concerning a patient who on an unspecified date was supposed to receive ZOSTAVAX (Merck) and was inadvertently vaccinated with VARIVAX (Merck) (lot #, expire date and route not reported) instead. No adverse effect reported. Additional information has been requested.
spontaneous pneumothorax; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 01-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 06-AUG-2017, reported as approximately five days after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute shortness of breath, collapsed lungs and respiratory failure. The patient was diagnosed with spontaneous pneumothorax. The patient's injuries resulted in prolonged hospitalizations As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event spontaneous pneumothorax was not recovered and causal relationship was assessed as related.   The lawyer considered the event spontaneous pneumothorax to be disability.   Upon internal review the event spontaneous pneumothorax were determined to be medically significant.
Nurse attempted to draw up Shingrix vaccine after diluent was mixed. The nurse reported that about half of the vaccine leaked around the seal where the needle was inserted. She reports that this has occurred more than once in the last three weeks, but not previous to that time.
Pt developed red area approximately 2 cm diameter on right deltoid. Follow up information received indicates no further redness developed and the area is fading in color.
COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid from 12May2022 to 16May2022 as treatment of COVID-19. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322260 same patient, different drug/event;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI  ACUTE CORONARY SYNDROME, UNSPECIFIED
2 days after varicella immuniz. 9x9 cm area of erythema & tenderness.
Fever 100.2 for 4 nights, joint aches, headache nightly.  One incident, 3 hours of diarrhea. No congestion, loss of taste or smell. Lungs feel tight but no blue lips or fingers. 11/9, spiked fever 100.2 again and headaches, joint aches continue. No explaination for what is happening to me. I am a healthy active person who cannot function physically w/o pain now.
No additional adverse events reported. No product quality complaints reported. No further details provided.; Medical Assistant reports the administration of improperly stored VAQTA.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-DEC-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T031202, expiration date 14-JUN-2022) 0.5 milliliter (anatomical location and route of administration were not reported) for prophylaxis (product storage error). The vaccine was stored at 50.5 degrees Fahrenheit (F) for 57 minutes. No previous temperature excursions were reported and it was not reported if a digital data logger was involved. No previous temperature excursion reported.  No additional adverse events were reported (no adverse event).
General malaise on evening of vaccination (29APR2021).  Fatigue and malaise increase over next 3 days culminating in witnessed syncopal episode while lying supine at home on  2MAY2021.  EMS contacted and SM declined transport.  Reported to ED on 03MAY2021 by POV and evaluated, tested for COVID-19 which was negative.  SM denies any sick contacts in weeks prior to incident
Information has been received from agency (mfr. no 236874K06USA) from a 34 year old female consumer with multiple sclerosis who in October 2006, was vaccinated with Pneumovax 23. Concomitant suspect therapy included REBIF and influenza virus vaccine (unspecified). In October 2006, the patient experienced fever and bruising with injection site during administration of interferon beta-1a. Therapy with interferon beta-1a continued. The outcome of the fever and injection site bruising was not reported. Additional information is not expected.
leg started hurting and had difficulty walking; He can barely walk; Couldn't sleep last night; Left knee is in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg started hurting and had difficulty walking), GAIT DISTURBANCE (He can barely walk), INSOMNIA (Couldn't sleep last night) and ARTHRALGIA (Left knee is in pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (3 years ago).    On 17-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep last night) and ARTHRALGIA (Left knee is in pain). On 17-Feb-2021 at 7:00 PM, the patient experienced PAIN IN EXTREMITY (leg started hurting and had difficulty walking) and GAIT DISTURBANCE (He can barely walk). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 17-Feb-2021, INSOMNIA (Couldn't sleep last night) had resolved. At the time of the report, PAIN IN EXTREMITY (leg started hurting and had difficulty walking), GAIT DISTURBANCE (He can barely walk) and ARTHRALGIA (Left knee is in pain) 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 included an unspecified blood pressure medication.
Have been a well controlled insulin diabetic for 30 years without medical issues. In Feb 2021 gradual onset of significant discomfort left thumb proximal joint. Diagnosed with De Quervain's tenosynovitis left thumb in March 2021.  Rec'd cortisone injection which decreased pain, Left thumb now with mild contracture. April 2021 right large toe proximal joint pain gradually increasing. Diagnosed in July 2021 with joint inflammation & arthritis. Currently receiving Physical Therapy . July 2021 inflammation of right gums and tooth. Dentist initial diagnosis of potential Autoimmune inflammation. Gum biopsy by specialist is scheduled for 8/16/21.
HEART PALPITATIONS, INCREASED HEART RATE, CHEST PAIN. BEEN TO EMERGENCY ROOM, SEEN CARDIOLOGIST. ADVISED HAVE NEVER HAD UNTIL I RECEIVED THE VACCINE. DIAGNOSED AS TACHYCARDIA
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. Of the 55,989 patients exposed, 1 patient experienced ACUTE PERICARDITIS. Of the 55,989 patients unexposed, 3 patients experienced ACUTE PERICARDITIS. The exposed patient was in the age group 19-24, male. The 3 unexposed patients were from age group 19-24. Sex: 3 males.
facial drooping symptoms similar to Bell's Palsy on an unspecified side of the face; moderate to severe pain behind his left eye; unequal pupils-one is a 2 and 1 is a 3; This spontaneous report has been received from a pharmacist referring to a 51 years old male patient. The patient had no pertinent medical history or concomitant medications. Drug reaction or allergies included diphenhydramine hydrochloride (BENADRYL) allergy. Concurrent condition included hospitalization (reported as inpatient).  On 30-SEP-2019, during hospitalization, he was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (lot #, expiration date and dose were not provided) for prophylaxis.   On the morning of 01-OCT-2019, the patient woke up experiencing moderate to severe pain behind his left eye (eye pain), facial drooping symptoms similar to Bell's Palsy on an unspecified side of the face (facial paralysis) and unequal pupils-one was a 2 and 1 was a 3 (unspecified test). Medical attention was sought. There was no intervention to prevent serious criteria. On the same day, a non-contrast computed tomography (CT) (unspecified body part) was performed with a negative result. He was being treated with amoxicillin 1440 mg every 8 hours orally, erythromycin ophthalmic ointment 4 times a day and methylprednisolone sodium succinate (SOLU-MEDROL) 125 mg intramuscularly-one time dose, and prednisone 60 mg daily. The events were not resolved.  The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.  Upon internal review, facial paralysis was determined to be medically significant.