chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent conditions included COPD (chronic obstructive pulmonary disease). The patient's pertinent medical history or concomitant medications were not reported. On 07-JUN-2017, the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On an unspecified date in June 2017, the patient experienced shortness of breath, redness at the site, itching and pain. The patient went to the physician's office, where she was advised not to worry about the vaccination. Additionally, it was reported that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of dyspnea, pain, pruritus and vaccination site erythema was unknown. The relatedness assessment between ZOSTAVAX and the aforementioned adverse events was not provided.
Guillian Barre syndrome; numbing in hands and feet; psoriasis to legs; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 15Sep2021 (Batch/Lot Number: 301308A) as dose 2, single (at the age of 35-years-old) for Covid-19 immunisation. There were no medical history and no concomitant medications. The patient had no known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 25Aug2021 (Batch/Lot Number: FC3184) as dose 1, single (at the age of 35-years-old) for Covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced numbing in hands and feet - progressed to psoriasis to legs - currently in hospital being treated for Guillian Barre syndrome, on 07Oct2021. The patient's hospitalization was prolonged as a result of guillian barre syndrome, numbing in hands and feet and psoriasis to legs. The patient underwent lab tests and procedures which included SARS-COV-2 test via nasal swab: negative on 23Oct2021. Therapeutic measures were taken as a result of the events which included IVIG - and therapy. The outcome of the events was not resolved. This report is serious (caused/prolonged hospitalization). The events resulted in: Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization).
DIARRHEA; UPSET STOMACH; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on MAY-2021, and the outcome of upset stomach was not reported. This report was non-serious.
pt exp onset of short, clinical seizures approx 5 hrs p/recvd DTP vax; had 2nd short, similar seizure @ approx 18-20 hrs post vax; pt adm to hosp for observation;
Dose received:3; Low grade fever; Soreness at injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 44-year-old male patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Lot number: FF2587) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP6955, Route of administration: unknown), administration date: 22Mar2021, when the patient was 43 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EP6955, Route of administration: unknown), administration date: 12Apr2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose received:3"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Low grade fever"; VACCINATION SITE PAIN (non-serious) with onset an unknown date in Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Soreness at injection site".  No follow-up attempts are possible. No further information is expected.
Cellulitis - injectoin site - started with rash, redness & pain in the area. Prescribed Cephalexin 500 mg 1 TID x 10 days. Also had feverish feeling the day after injection.
This spontaneous report as received from a healthcare worker refers to a 70 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. None drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). On an unknown date, the patient developed a knot in her arm (unspecified which one) after receiving ZOSTAVAX. The outcome of knot in arm was unknown. The relatedness between the knot in arm and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
She is here complaining of electrifying pain and numbness in her left axilla, underneath the arm to the elbow, sometimes traveling down to the hand. She received her 2nd COVID vaccine on 1/27/21 in the left arm. She was fatigued on Saturday and Sunday was feeling better. Her arm pain started on Monday 2/1/21. She is unable to abduct her arm past 90 degrees. She is having trouble lifting and moving her arm. Her strength is equal in BUE. She has taken ibuprofen, tried warm packs and ice packs without relief. She is not having any neck pain, chest pain, SOB or pain that radiates to her jaw. There is no swelling in LUE/axilla. There is no rash present.
Petechiae developed first on face-spread to abd & then head-to-toe w/exception of scalp-started to fade by 3rd day. Md told mom that petechiae probably result of rubella component of MMR vax.
I am still having COVID-19 symptoms. It started with dry scratchy eyes. I felt feverish and my temp was mid 96's, my normal is 96.8. Scratchy throat, congestion and a lot of cough. I still have the cough from the first COVID-19 I had. The Dr gave me Paxlovid. I started getting a fever and fatigue.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Since 06-NOV-2014 the patients were vaccinate with doses of PEDVAXHIB (lot #, expiration date, dose and route unspecified) that were improperly stored. No adverse effects were known. This is one of several reports received from same source. Additional information has been requested.
Woke up in the middle of the night following vaccination with a racing heart. Unable to sleep remainder of night. Ran a 102.5 degree fever most of the following day accompanied by extreme lethargy.  On day four following vaccination woke up with fullness in both ears. This condition resolved, but developed into bilateral tinnitus. This tinnitus has remained a chronic condition.
experiencing pain and in shoulder area after injection. advised to take acetaminophen or ibuprofen to help relieve pain, ice and rest. if does not get better advised to see doctor for further examination. On 10/8 he still had pan, on 10/9 he noticed an improvement and able to move arm with less notable pain
Whole arm was sore the next day, pain swelling and itching at the injection area for two weeks menstrual was due 10/19/2010 caused delayed menstrual cycle.
No noted difficulty after injection. Pt stayed in the clinic for 5 min. after inject. - pt. was in her car, passenger seat. A friend came into clinic saying pt passed out and was having a seizure - nurse checked pt. - pt was awake, alert, pallor, vital signs stable. Pt stated she always faints/seizures when any type of inject given - pt brought into the clinic - given a Coke, laid down for approx. 20 min. Pt left with partner without problem.
While patient was in observation, he started complaining of itching at the injection site. He was offered diphenhydramine but refused. Observation was extended for an additional 20 minutes and symptom resolved. Patient was discharged home without complaints of any other symptoms.
Chills, fever of 103, felt as if their was a hot rod going through spine and teeth, nausea, vomiting, unbearable pains throughout body
Mother called 3 days later and said that her son had swelling in arm, face, and penis the day after vaccine administered. She gave him Benadryl and it went down. She did not want to bring him in to be seen.
Breakthrough case admission after three vaccines Moderna 2/12/21 Lot# 013M20A;  Moderna 3/12/21 Lot# 044A21A;  Moderna 1/6/22 Lot# 028L21A
Pain at injection site and rash on that arm mostly, and less so on rest of body. Start about 4hours post vaccine; and next day symptoms were improving, but still there.
Horrible body aches/all over body pain; extreme pain in both hips; severe migraine; nausea; diarrhea; no appetite; Fever; exhaustion; nightmares; skin sensitivity; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 at 14:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN), 112 mg, from unknown date for unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6199), via unspecified route of administration in the left arm on 04Mar2021 at 14:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation and clarithromycin (BIAXIN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced horrible body aches, extreme pain in both hips, severe migraine, nausea, diarrhea, no appetite, fever, exhaustion, nightmares, skin sensitivity, literal all over body pain. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, pain in both hips, migraine, nausea, diarrhea, no appetite, fever, exhaustion, nightmares and skin sensitivity was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe kidney pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 16:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), LEXUS PRO and ethinylestradiol/etonogestrel (NUVARING); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 16:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021, the patient experienced severe kidney pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe kidney pain was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022; Patient received expired vaccine, beyond 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine, beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine, beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine, beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (The vaccine was stored in the refrigerator 03-Mar-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The vaccines placed in refrigerator on 03-Mar-2022, and doses administered to patient after 30-day use by date on 04-Apr-2022 around 9AM . The patient received first booster dose.  Treatment information was not provided.
I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I was vaxxed and boosted ( Moderna ), and I just got Covid on a plane) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was provided.  It was reported that the patient  took Paxlovid and felt so much better but 4 days after treatment experiencing all Covid Symptoms.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history. Patient experienced the unexpected non-serious AESI event of Covid-19. On unknown date, patient received unknown dose number and booster dose of mRNA-1273 vaccine. On unknown date patient experienced Covid-19. Allegedly, the event was described as, "I was "vaxxed " and boosted (Moderna), and I just got Covid on a plane. Patient took Nirmatrelvir + Ritonavir (Paxlovid) and felt better. However, 4 days after treatment it was reported that the patient experienced "all" Covid-19 symptoms and was tested positive. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history. Patient experienced the unexpected non-serious AESI event of Covid-19. On unknown date, patient received unknown dose number and booster dose of mRNA-1273 vaccine. On unknown date patient experienced Covid-19. Allegedly, the event was described as, "I was "vaxxed " and boosted (Moderna), and I just got Covid on a plane. Patient took Nirmatrelvir + Ritonavir (Paxlovid) and felt better. However, 4 days after treatment it was reported that the patient experienced "all" Covid-19 symptoms and was tested positive. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient inadvertently received vaccine at age 49 instead of the recommended 50, no reported side effects at this time.
Vomiting 3:30 pm followed by headache and tiredness through 1/18/2022
Severe pain in left shoulder developing approximately 24 hours after injection.  Treated with ibuprofen 600mg TID x 2 days.
Acute onset of frontal lobe encephalitis with seizures within 24 hours of flu vaccination.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient was vaccinated with GARDASIL (confirmed not GARDASIL 9) on 06-AUG-2012, 11-OCT-2012, 18-FEB-2013 and 14-APR-2015. No adverse symptoms reported. Additional information has been requested.
adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event) 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 ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was using profane language multiple times and would not give any further information. Limited AE Report. Concomitant medication use was unknown Treatment information was unknown
Information has been received from a licensed practical nurse concerning a 11 year old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) dose and routed not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading
Injection site pain/Stinging/burning with injections; Flu symptoms; Generalized aching/Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), PAIN (Generalized aching/Body Aches) and INJECTION SITE PAIN (Injection site pain/Stinging/burning with injections) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, INFLUENZA VACCINE for an unknown indication and ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced INFLUENZA (Flu symptoms) and PAIN (Generalized aching/Body Aches). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain/Stinging/burning with injections). At the time of the report, INFLUENZA (Flu symptoms), PAIN (Generalized aching/Body Aches) and INJECTION SITE PAIN (Injection site pain/Stinging/burning with injections) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
58F w/o significant PMHx presenting to ER with arteriolar thrombosis. Two weeks prior, pt developed swelling and pain in left foot (~1 week post vaccine #2). She went toto urgent care and was prescribed ketoconazole cream. She then developed multiple ulcers on her left foot. She presented to ED on 5/12/21. Arterial duplex reviewed complete occlusion of mid-distal SFA into the popliteal and posterior tibial arteries. Pt now returned and ready to be admitted. Of note, pt is a 20 year smoker, half pack a day. Denies any personal or family hx of previous clots. Arterial duplex reviewed complete occlusion of mid-distal SFA into the popliteal and posterior tibial arteries
Pt had swelling, erythema and bruising after injection. Erythema was approximately 10 inches area, small bruise about 2 cm (1 inch).
Breakthrough COVID case: both ears ache, significant cough, headache, and exhaustion from coughing. Zero energy, brain fog.
2.19.06 Patient received vaccines. 2.20.06 Patient seen at hospital ER for acute medicine shot reaction right thigh swollen, red, hot, tender to touch. Treated with Prelone 15 mg 15ml 1 tab PO every day for 5 days plus Benadryl 12.5 mg/5ml 1/2 tsp PO every six hours.