chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT REPORTED DIZZINESS AND SEEING SPOTS SO PHARMACIST WAS CALLED TO HELP PATIENT.  UPON ARRIVAL TO PATIENT, PHARMACIST ASKED PATIENT IF SHE KNOW WHERE SHE WAS AND PATIENT REPORTED A DIFFERENT LOCATION THAN FACILITY SHE WAS IN.  AT THIS POINT, CALLED FOR MEDICAL PROVIDERS AND NURSES TO HELP ASSESS PATIENT.  PATIENT'S VITALS WERE NORMAL, BUT THEN PATIENT STOPPED VERBALLY RESPONDING TO HEALTHCARE PROVIDERS FOR ABOUT 10-15 SECONDS.  SHE THEN STARTED RESPONDING AND ACTING NORMAL.  PATIENT WAS BROUGHT INTO EXAM ROOM WHERE PHYSICIAN PROCEEDED TO EVALUATE HER AND DO NEUROLOGICAL TESTS.  SHE COULD NOT COMPLETE THE NEUROLOGICAL EXAM AND THEN BEGAN TO BE VERBALLY UNRESPONSIVE.  SHE COULD ANSWER QUESTIONS BY BLINKING HER EYES, BUT COULDN'T MOVE OR TALK.  EMS WAS CALLED AT THIS POINT.   EMS TOOK PATIENT FROM CLINIC.  PATIENT WAS CALLED A FEW DAYS LATER TO CHECK IN AND PATIENT REPORTED "Medical services released me to drive home since no other episodes occurred, only flu-like symptoms and I did not go to the ER."
droopy eye; had eye discharge after vaccine; eye was swollen; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 21 year old male patient who experienced droopy eye (eyelid ptosis), had discharge after vaccine (eye discharge) and eye was swollen (eye swelling), after he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past vaccination included influenza vaccine (He had similar symptoms last year).  Medical history, medical treatment and family history were not provided.  No concomitant medication or no other vaccines administered to the patient.  On an unknown date, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious droopy eye (eyelid ptosis) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, the patient had discharge after vaccine (eye discharge) and eye was swollen (eye swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Pharmacist called to report that a patient called after hours about possible side effects from FLUZONE QUAD.  Details of laboratory data not reported.    corrective treatment: patient was prescribed with some antibiotic eye drop.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a 21 year old male patient who had eyelid ptosis, eye discharge and eye swelling, after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Had flu like symptoms; Mild headache; Just felt run down; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu like symptoms), HEADACHE (Mild headache) and FATIGUE (Just felt run down) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Had flu like symptoms), HEADACHE (Mild headache) and FATIGUE (Just felt run down). At the time of the report, INFLUENZA LIKE ILLNESS (Had flu like symptoms), HEADACHE (Mild headache) and FATIGUE (Just felt run down) had resolved.            Patient was taking medication for Crohn's disease. Treatment information was not provided.
Information has been received from a physician concerning a 60 year old female patient with penicillin allergy, cephalosporins allergy and VICODIN allergy and with no pertinent medical history who on 12-FEB-2010 was vaccinated IM with her first 0.5 ml dose of PNEUMOVAX 23 (Lot # 665401/1320Y). Concomitant therapies included LEXAPRO, DIOVAN, hydrochlorothiazide (manufacturer unknown), LIPITOR and KLONOPIN. On 13-FEB-2010 the patient experienced cellulitis at the injection site. On 14-FEB-2010 the patient was evaluated in the emergency department but released on the same day. There were no lab diagnostic tests performed. She was treated with IV antibiotics. The physician requested a lot check. At the time of report the patient's status was not recovered. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released.
Patient came to employee health for her 2nd hep b vaccine. After receiving the injection.  she felt a little nausea. A few minutes later she became unresponsive, diaphoretic, and vomited. It did take a few minutes to become alert and able to respond to respond to questions. Team member escorted to the ED to be evaluated and treated.
Positive COVID-19 test on 09Aug2021. Fully vaccinated on 19Mar2021; Positive COVID-19 test on 09Aug2021. Fully vaccinated on 19Mar2021; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), dose 2 via an unspecified route of administration on 19Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications was not reported. Device Date was reported as 10Aug2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as (at the age of 44-year-old) single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Aug2021 the patient experienced positive covid-19. It was reported that Positive COVID-19 test on 09Aug2021. fully vaccinated on 19mar2021. AE resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. The outcome of event was Not recovered.  No follow-up attempts are needed. No further information is expected.
She says she woke up the next morning with a bad headache, stomach ache, vomiting, fever, chills, body aches and no appetite. She reports having had no energy through 6/8/16.
Patient began with arm pain immediately after injection.  Same night began with fevers of 102.  Patient took MOTRIN she noticed some redness and swelling in both arm near elbow the following day, applied ice on 08/03/2006.  Fevers still present with swelling, instructed to take BENADRYL came into office on 08/04/2006, given samples of ZYRTEC 10mg and prescription for cephalexin. Patient not recovered at this time.
Dark bruise a few hours after, about 24 hours later experienced redness, arm became very swollen and painful with red streaks on third day. Also, experienced purple reddish toes.
red, swollen, itchy, warm area of 5cm x 4.7 cm at injection site. Discomfort began the day after the vaccine and the skin changes noticed the morning after (2 days after vaccine administration) It is unclear which vaccine site it is
Red spot with hard lump under surface slightly swollen started itching on 7-12-2021
A vial that has been opened for 9 days was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A vial that has been opened for 9 days was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported No Treatment information was reported
The patient is a 83 y.o. male who presented from home on 1/15/2023 with weakness and fall and was found to have COVID-19 and hypoxia.          Assessment and Plan   Acute hypoxemic respiratory failure COVID-19 - Presented with: weakness - Symptom onset: 1/12/23 - Positive COVID-19: 1/15/23 at hospital - Vaccination status: Vaccinated with 2 boosters. - CXR on admission showed no acute findings - Oxygen status: RA - Decadron: Yes. Expected end date 1/25/23 - Remdesivir: Yes. Expected end date 1/20/23 - DVT prophylaxis:Subcutaneous heparin - Serial COVID labs ordered: Yes - Case Management/Social Services consulted: No    Acute UTI with bacteremia  History of left kidney stone s/p ureteral stent and lithotripsy -Recent diagnosis of left sided kidney stone (1.4 cm) s/p left ureteral stent placement and lithotripsy (1/4/23) per Dr., follow up scheduled 1/18/23.  -Frequency and abnormal UA noted on admission.  CT shows stent in position, possible posterior subcapsular hematoma.  Patient without left flank pain. -Urine and blood cultures growing pan-sensitive klebsiella -cont rocephin, will transition to keflex or omnicef at discharge for total of 14 wks   -discussed with Dr.(urology), plan OP follow up with Dr. once UTI resolved.    Acute kidney injury -Likely prerenal in setting of illness above.   -resolved with IVF's. Encouraged po fluids   Weakness Fall -Without significant injury -PT/OT rec HHC    Type 2 diabetes with neuropathy -No marked hyperglycemia on admission, but now on steroids.  On metformin and glipizide at home. -Hold oral agents.  Lantus 10 units nightly with sliding scale coverage ordered.   -cont gabapentin    Essential hypertension -cont home meds   Elevated troponin -Without delta in setting of AKI.  EKG unremarkable. -No further work-up indicated.   OSA -By history, does not use CPAP.   BPH -Continue Flomax and finasteride.   Hyperlipidemia -Continue statin.   History of lung cancer -Stage I adenocarcinoma of RUL. -Completed course of radiation treatment without evidence of recurrence
Patient fainted after receiving Tdap, MCV4 and Varicella vaccine. Patient fainted and hit his front head. Patient was bleeding from his nose. Paramedics were called to evaluated patient. Patient was taken by mother to hospital to be evaluated by MD.
Lump in neck 2 weeks after that I still have today. Fever 103. Weakness x 2 days
This happened after both vaccine doses: I had an incident of BPPV  7 after the first dose, 10 days after the second.
At roughly 9:00pm I was scrolling through my phone when it became very difficult to focus and I felt nauseous.  I got up to go to the bathroom and became extremely dizzy and my heart felt like it was going to beat out of my chest.  I was having difficulty breathing  and felt disorientated.  I crawled up the stairs and when I reached the top I stood up to walk and promptly fainted/passed out.  According to my husband I was out for roughly 30 seconds.  He described my body as completely tense (formed fists, shaking). I don't have any recollection of passing out.  When I came to I was overwhelmed with nausea and immediately vomited.  I was sweating profusely and struggling to breath.  After I vomited, within minutes (less than three) I felt fine.  My heart rate returned to normal and I wasn't dizzy or nauseous.
pt recvd vax & had irritability w/ t 104; taken to hosp;
PATIENT FELT FAINT AND DIZZY AND NEEDED ASSISTANCE TO STAY UPRIGHT. STATED THAT IT ALWAYS HAPPENS WHEN THEY GET A VACCINE
- Arm pain after initial injection for 2 days - Significantly swollen lymph nodes on Monday after shot.  Lymph nodes visible on left side of neck.
Patient received Moderna as first dose at age 16.  Received second dose Moderna on 5/12/21 in accordance with CDC guidance.  No AE.
Redness; itching; Poor sleep; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itching), POOR QUALITY SLEEP (Poor sleep) and INJECTION SITE PAIN (Pain at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site). On 24-Jan-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (itching) and POOR QUALITY SLEEP (Poor sleep). On 19-Jan-2021, INJECTION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ERYTHEMA (Redness), PRURITUS (itching) and POOR QUALITY SLEEP (Poor sleep) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
#2 shot Feb 28th - March 2 headaches,pain in lungs, extreme fatigue-went to bed for a few days then I was able to walk around but chills,fatigue for 3 weeks
Narrative:  COVID infection following COVID vaccine series 12/29/2020, Pfizer, dose #1 01/22/2021, Pfizer, dose #2 09/23/2021, Pfizer, dose #3 08/27 COVID swab, result: detected 08/27 SARS-COV-2 Variant Sequencing result: pending 08/29 pt cc: No symptoms exposure: unknown 08/31 TROPONIN I 0.156 08/31 pt admit to Medicine cc: Generalized weakness dx: COVID19 Mil LOS: 4 08/31 ESR 10 09/01 FIBRINOGEN result: 258 09/01 DDIMER result: 0.41 09/01 ESR 10 09/02 FIBRINOGEN result: 261 09/02 DDIMER result: 0.35 09/02 ESR 9 09/03 FIBRINOGEN result: 235 09/03DDIMER result: <0.22 09/03 ESR 13
Moderna booster received same day/time as seasonal flu shot. Have received flu shots in the past without any adverse reactions. Prior to Moderna booster, received Pfizer SARS-COV2 vaccine dose 1 on 4/17/2021 and Pfizer  SARS-COV2 vaccine dose 2 on 5/8/2021 without any adverse side effects. This leads me to believe Moderna is the issue. Hives on mid-section of body, extending from hips to chest, front and back. Not overly itchy or red. Hives are small and do not touch (relatively spaced out). Took Benadryl.
Information has been received from a consumer (the patient's friend) referring to a male patient of unknown age. The patient had polio years ago. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength and route unknown). In 2015 (reported as sometime last year) the patient experienced a shingles rash all over his back. The patient sought medical attention by physician visit. The outcome of the event was unknown. Causality was not provided. Additional information is not expected as no contact details were provided.
sore throat; Mouth sore; Mouth Red; Roof of Mouth swollen; Headache; feverish; Night sweats; Didn't feel well; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), PYREXIA (feverish), NIGHT SWEATS (Night sweats), MALAISE (Didn't feel well) and OROPHARYNGEAL PAIN (sore throat) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (Sore arm). On 03-Jun-2021, the patient experienced PYREXIA (feverish), NIGHT SWEATS (Night sweats), MALAISE (Didn't feel well) and HEADACHE (Headache). On 05-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (Mouth sore), MOUTH ULCERATION (Mouth Red) and MOUTH SWELLING (Roof of Mouth swollen). On 09-May-2021, MYALGIA (Sore arm) had resolved. On 03-Jun-2021, PYREXIA (feverish) had resolved. On 04-Jun-2021, NIGHT SWEATS (Night sweats) had resolved. At the time of the report, MALAISE (Didn't feel well), OROPHARYNGEAL PAIN (sore throat), HEADACHE (Headache), ORAL PAIN (Mouth sore), MOUTH ULCERATION (Mouth Red) and MOUTH SWELLING (Roof of Mouth swollen) 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.
since vaccine adm R wrist and hand pain continunig since now day 28 since vaccine adm.
Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain at the injection site".   Additional information: Caller, 72 y/o male consumer, stated, "I got my first shot (Pfizer Covid-19 Vaccine) at the (Facility name withheld) yesterday, 03Mar2021. Caller stated his second vaccination is scheduled on 24Mar2021. Caller stated he has two appointments scheduled on the 24th and need help rescheduling. Caller stated the only contact information he has is a website on the back of the vaccination card that was given to him after receiving his vaccination. However, caller stated he did not have a computer. Caller asked, "how long is your arm supposed to stay sore?" Caller confirmed that he was experiencing pain at the injection, above and beneath the site.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My son had a swollen lymph node in his left clavicle area. It was very painful and lasted for 5 days. Our doctor ran blood tests and a chest x Ray to rule out other possible causes. It was determined to be a side effect from his second shot.
This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with an improperly stored oral, ROTATEQ, lot # L008996, expiration date 01-DEC-2016, (strength and dose number were not reported). No adverse effects reported. The reporter stated that the vaccine was exposed to a temperature of 34F during 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Patient noted visual disturbance 30 minutes s/p vaccination..described difficulty reading and the floor tiles moving. No headache, fever, syncope, GI, GU, CV symptoms. Full resolution after 2 hours.
This case was reported by a other health professional via call center representative and described the occurrence of viral conjunctivitis in a 70-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 18th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 30 days after receiving SHINGRIX, the patient experienced viral conjunctivitis. On an unknown date, the outcome of the viral conjunctivitis was resolved with sequelae. It was unknown if the reporter considered the viral conjunctivitis to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that patient experienced viral pink eye. It was not resolved with treatment. The reported batch number 9A539 for SHINGRIX did not exist and was updated to 9AS39 as per the sales database.
mild headache; mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732), via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 73-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included atenolol (MANUFACTURER UNKNOWN), amlodipine besylate (MANUFACTURER UNKNOWN), budesonide (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates. 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. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced mild headache and mild fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of mild headache and mild fatigue was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
During visit patient signed consent form denying any prior reaction or issue with any vaccine. Vaccine administered at 16:30. At approximately 16:45 provider was packing up things to leave and patient states she needs to call her neighbor because she was feeling like she was going to faint. She then got diaphoretic and clammy with ashen appearance. At approximately 16:49 patient became unconscious yet still breathing. O2 sats dropped to 66%. 911 contacted by provider. At 16:50 patient received 0.3mg epinephrine and 16:55 received 50mg diphenhydramine. Patient was in and out of consciousness after receiving medication. Paramedics arrived at 17:05 and patient had regained full consciousness by that time. She was then taken to the nearest hospital for further evaluation.
Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included IBANDRONATE SODIUM (BONIVA) for Bone density abnormal.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm). At the time of the report, VACCINATION SITE PAIN (Sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medication.