chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started with maculapapular rash in varying stages, starting 10 days after vaccine administration, clinically has chickenpox. There is no fever on day 3 of rash. Still with spots, case seemed mild so far.
After the flu shot was administer, she stand up to leave and fell to the floor.  On the floor she was unresponsive and her body was jerking.  The seizure lasted 30 seconds.  She felt nauseous afterward.  The pharmacist who administered the shot monitor her for 10 minutes before releasing her back to her mother's care.  No other adverse event noted after this incident.
patient was administered Trumenba yesterday from another pharmacy but was supposed to receive Menactra for school; Initial information received on 03-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (age unknown) who received vaccines TRUMENBA instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site instead of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site..  It was an actual medication error due to wrong vaccine administered.  It was reported that patient was administered Trumenba yesterday from another pharmacy but was supposed to receive Menactra for school.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none. Information on batch number was requested for this case.
Patient reported while at home to have developed body aches, rash to neck area, itchy throat, headache and vomiting. Patient sought care at an urgent care where they reportedly received Solumedrol and a steroid taper pack. Patient reports that the rash is improving, has scheduled follow up with Urgent care tomorrow.  Verbalized they will call 911 if symptoms acutely worsen.
injection spot itchy; injection spot to still be slightly red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection spot itchy) and VACCINATION SITE ERYTHEMA (injection spot to still be slightly red) 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 VACCINATION SITE PRURITUS (injection spot itchy) and VACCINATION SITE ERYTHEMA (injection spot to still be slightly red). At the time of the report, VACCINATION SITE PRURITUS (injection spot itchy) and VACCINATION SITE ERYTHEMA (injection spot to still be slightly red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not reported.  Treatment information was not provided by the reporter.
Fever w chills, aches & pain, Knot on left arm at vaccine site, Advil Tylenol IVF Fluids
Started my menstrual cycle on the evening I received the vaccine. Since I am on the Norethindrone, this was unusual but could have been unrelated. My cycle went from the 4/21-4/26. I then started another menstrual cycle on 5/2 which went until 5/7. I then started another cycle on 5/12-5/16. In the last 27 days, I have been on my period for 16 of them. I went to donate blood on 4/29 and my hemoglobin was 1.5 pts lower than usual, and I've had two periods since then.
Information has been received from a licensed practical nurse concerning a 7 years old female with penicillin allergy and medical history of dermatitis atopic in 2009. Who on 18-MAY-2005, was vaccinated with VARIVAX (Merck), first dose (lot # 648315/0072R expiration date January 2007). On 29-OCT-2008, patient received the second dose of VARIVAX (Merck) (Lot# 661666/1192X expiration date 20-AUG-2010) 0.5 ml subcutaneously. There was no concomitant medication. On approximately 26-FEB-2011, the patient started with pink bump that turned into a lesion. The areas affected were chest, face and arms. The patient was seen in the office on 01-MAR-2011 and diagnosed with chicken pox. No labs or tests were done. No treatment given for the adverse event. At the time of the report, the patient still had lesions (lesions were not crusting over or scabbing over but not blistering). Also, a licensed practical nurse mentioned that the patient's mother told her there were two other children on the block that had similar rashes, and one child had seen their physician and the other child will be seeing their physician. Additional information has been requested.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves male patient who had an expired 0.5 ml dose of MENACTRA IM in the left arm today to a patient, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Nov-2018, the patient received a 0.5 ml  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5746AC, expiry date- 14-Oct-2018 Intramuscularly in left arm. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for an expired 0.5 ml dose of menactra im in the left arm today to a patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse event; Received expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture).    This case contains information for the 1st of 3 patients described by the reporter.  No concomitant medication was reported.  It was unknown when the vial was initially stored in the refrigerator.  On 08-Aug-2022, the vial was first punctured.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-627651, US-MODERNATX, INC.-MOD-2022-627652 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627651:case for patient 2 US-MODERNATX, INC.-MOD-2022-627652:case for patient 3
Pt developed nerve pain/tingles in legs--has not subsided at this time--Dr.  thinks it could be a peripheral neuropathy.
pt recvd vax & 1/2 hr p/inject exp a visual disturbance: rt eye 1/2 way blurred, now completely blurry; pt getting worse;
THE FOLLOWING DAY AT 5;00 PM AFTER VACCINATION, I WAS COUGHING UP BLOOD AND WENT TO THE ER. AT THE ER THINGS GOT PROGRESSIVELY WORSE AND I WAS LOSING QUITE A BIT OF BLOOD AND MY OXYGEN DROPPED INTO THE 70'S. I WAS ABOUT TO BE INTUBATED, BUT THE ER DOCTOR TRIED A  BREATHING TREATMENT AND ATIVAN FOR ANXIETY WHICH SLOWED THE COUGHING DOWN. I WAS ADMITTED TO THE HOSPITAL AND MONITORED FOR THREE DAYS. I AM HOME NOW AND I STILL COUGHING UP RESIDUAL BLOOD CLOTS. IWAS GIVEN ANTIBIOTICS AS WELL.
I had a severe sore throat and a low-grade fever. I went to the doctor on 14th and he said that there was lot going on in my throat, and he gave me 10 day course of amoxicillin. Also had swollen lymph nodes, on my left side. On June 18th, the fever had stopped but the throat was still horrible. I have a lot of fatigue. I called clinic, televisit, told me take ibuprofen for the severe sore throat and the throat got better. But I was still sick, only better because of the medicine. Went to doctor on 24th, clindamycin, 10-day treatment, sore throat went away; I was able to get off ibuprofen, but I still have very swollen lymph nodes on my left side neck; but now my hearing is affected, it's not clear on my left side. It feels like I'm in a deep well on that side, it's like an echo or like it's stopped up. The hearing issue just started on the 6th of this month (July). No new treatment at this time, rest and rest. The fatigue is better now then it was, I am getting my strength back but I'm still quite bushed at the end of the day.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. It was unknown if patient received any other vaccine s in the 4 weeks prior to COVID-19 vaccine. Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available. No treatment medication was reported.
Moderna vaccine 1st dose  received on 3/4/2021 around 10 am .  At noon patient experienced chills  Symptoms: redness in her head/face Hives /wheels  Itching  Patient described event as something that gave her anxiety , she felt "desperate" Patient states it lasted 1.5 hr .   Patient took advil , she feels better.  Only symptoms today is Left arm pain
Flu like symptoms. Nausea, chills, diarrhea, fatigue, weakness. Felt back to normal by next morning.
Patient was administered vaccine in left arm, soreness and weakness started immediately and has persisted for approximately 2 months.
Information has been received from a CMA and physician's assistant concerning a 38 year old female smoker with hypertension, penicillin allergy, condyloma and fibromyalgia and a history of cervical dysplasia with conization who in approximately July 2008, was vaccinated with MMR II (HSA) (Lot # 657118/0865U). Concomitant therapy included lisinopril and hydrochlorothiazide. The patient received her first dose of MMR II as a child in the 1970's. A titer for MMR II in June 2008 showed immunity to rubella, but not mumps or measles. The patient was revaccinated with 0.5 ml of IM MMR II (HSA) (Lot # 657118/0865U) (date not reported) and a titer was again done on 25-JUL-2008. This titer again showed no immunity to measles. Medical attention was sought as the patient was seen in the office. The patient was considered to be not recovered. There was no product quality complaint. Additional information was received on 29-SEP-2008 from the physician's assistant who indicated that on 10-JUN-2008, the patient's rubella antibodies were 71 (immune), rubeola (Measles) antibodies were <0.91 (negative) and mumps antibodies were <0.91 (negative). The patient was vaccinated on 17-JUN-2008 with her second dose of MMR II (Expiration date 30-MAY-2009). On 25-JUL-2008, the patient's rubella antibodies were >400 (immune), rubeola (Measles) antibodies were <0.91 (negative) and mumps antibodies were 1.86H (positive). The patient was still not rubeola (measles) immune after second dose of MMR II. No further information is expected.
Information has been received from Merck pregnancy registry through a 15 year old female consumer with cardiac murmur, asthma, and an allergic reaction to Penicillin, Augmentin, and c-Chlor who in October 2007, was vaccinated with the first dose of GARDASIL (lot# not provided). At the time of reporting the patient was approximately 16 weeks pregnant. No adverse side effects were reported. Unknown medical attention was sought. An ultrasound showed that the baby was okay at this point. The patient's outcome is unknown. No product quality complaint was involved. Follow-up information was received from the patient's mother which reported that in March 2008, the patient gave birth to a female baby at 23 weeks. The baby was born alive, her organs were well developed and had a strong heart beat. The baby weighed 11lb 8oz. Eight hours after birth, the baby died. According to the patient's mother, the doctors could do nothing for it because the baby was too premature. The patient's mother reported that the patient had even attempted suicide. Upon internal review, premature baby, birth weight low and suicide attempt were considered to be other important medical events. Additional information is not expected.
11:10 Pfizer COVID 19 EUA vaccine given in R deltoid.  11:30 Pt fainted, hitting L side of forehead on wall. 11:30 1st RN and 2nd RN arrived in room.  Pt helped to R lateral position on mat on floor.  Pt was complaining of stomach pain and head ache on L side of head.  Assessed client?s head, no bump, redness or trauma noted. Client alert and oriented x 3. Cool cloth was applied to forehead and juice was given after nausea resolved. 11:42 Pt reported feeling better and was helped to sitting position, continued to sip juice. 12:00 PM Pt was alert and oriented x 3 and denied headache or stomach ache.  Pt's father pulled car to entrance and pt walked to family car. Pt and her mother were advised to contact PCP with any concerns.   Pt and her mother were informed that VAERS report would be filed and information for VAERS was given to them in English and native language.
I am pregnant and at the time of vsafe check in, I am just 78 weeks  4 days pregnant. On 09-29-2021 I had a complex migraine. I went to the hospital , I had episode where I could not speak, my right arm arm went numb and had a blind spot in the middle of my eyes. They ruled that it was a complex migraine.  They did lab work, did an MRI of the brain with contrast.  EDD: 10/16/2021.
Right lower extremity. Nickel size erythematous patch around injection site of varicella.
This spontaneous report was received from a female patient of an unknown age and refers to herself. No information on the patient's concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date in approximately 2012 (reported as "about 4 years ago") the patient was vaccinated with GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (reported as "recently"), the patient had an unusual Papanicolaou smear (PAP). The outcome of the event was unknown. The relatedness between the event and the GARDASIL was not reported. Additional information has been requested.
Chills, headache, body aches, nauseous, possibly a fever, bad taste in mouth
muscle pain; fever; tiredness; headache; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in leg left, administration date 07Sep2021 09:00 (Lot number: FC3184) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: MYALGIA (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "muscle pain"; PYREXIA (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021 09:00, outcome "not recovered", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, pyrexia, fatigue, headache, vaccination site pain.  Additional information: No other vaccine in four weeks. No other medications in two weeks. Adverse event: muscle pain, fever, tiredness, headache, injection site pain. COVID prior vaccination. COVID tested post vaccination.Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=RT-PCR Priority, Covid test date=01Sep2021,Covid test result=Negative. No Known allergies. No other medical history.  Follow-up attempts are completed. No further information is expected.
Provider summary "Urology was consulted and the patient had a Foley placed with bladder irrigation.  The patient will need to see Urology in close follow-up; nursing facility has been instructed to help arrange this appointment further transportation schedule.  Plavix is still on hold given risks of hematuria, this can be restarted as needed for PCP or nursing home staff.  Blood pressure well controlled, calcium channel blocker held, lisinopril restarted. The patient was found to be incidentally COVID positive, and has completed his quarantine.. The patient did have an abnormal urinalysis, but the sample was taken from an indwelling Foley catheter and thus likely highly contaminated.  He has finished a 3 day course of Zosyn.  After discussion with Infectious Disease and his urologist, all are in agreement that this does not require treatment, especially in the absence of fevers or other symptoms."
Diffuse erythematous rash on lateral (L) upper arm with central clearing. Mild scaling at border. Hydrocortisone apply twice a day prn.
sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) 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 OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
I received the 2nd Covid 19 shot on 09/10/2022, around 2:pm. At 8:00pm I have called the on call nurse to report high blood pressure and high heart rate, with pounding heart, as my only concern.  Despite having fever and chills, which I have had with my first Covid 19 shot. The Dr. on call I spoke with,  said that I don't have to worry,  he never admitted  patients with those symptoms. In October I start having chest pain, but I ignored.  I had a CT scan done in October,  and I was told that I have pericardial effusion 10mm. I was having trouble breathing, my heart rate was very high (118-126)my voice has changed,  I was dizzy and coughing.  After 2 months I was able to gave an echo radiography,  and they said that everything it is normal now. I still have high heart rate and feeling dizzy.
10 days after receiving H1N1-develope lymphadenopathy in L axilla, Injection given in left deltoid on 10/21/09. Nodes were not painful and have subsided. Pt saw his physician.
full body pruritic rash, given prednisone 20mg QD x 5 days, improved by 50%, currently on Ranitidine & Cetirizine, referral given to Allergist
Pacemaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown", described as "Pacemaker". Clinical course: There have been five of us on one floor that have had heart issues after receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 15 year old male patient who on 06-AUG-2010 was inadvertently vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 664628/1018Y). It was mentioned that the patient received his first dose of VARIVAX (Merck) at one year old. He returned today (06-AUG-2010) for his second dose and inadvertently received ZOSTAVAX (Merck). No adverse effects were reported. Additional information has been requested.