chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient states he received covid booster shot and flu shot 8 days ago, "I ended up going to the emergency room in hospital due to headache and double vision in my right eye. They did a CT scan, drew some lab work, did an EKG - everything came back okay, so set me up to see an eye doctor on 11/18/ 2021." Patient states he is still experiencing a headache and double vision - "hasn't let up at all." Rating headache "2"/10 at this time. + subjective low grade fever, body aches. + Mild cough/chest congestion, + nausea. Some intermittent diarrhea, "none the past 2 days." States he was having some mild symptoms when he went to ER, did not mention these symptoms to ER physician while there. ***States patient's son has covid now, "and we were around him." They were notified that the eye doctor he has been set up with, most likely will not let him in clinic while he is experiencing covid symptoms (told them to call). Recommended he return to local ER, states he will return to hospital at this time, wife states she will work on encouraging him to go.
A couple of hours after the flu shot on 10/11/17, I was unable to eat. I had not appetite. I felt suddenly very down and depressed. Mood changes. I went to bed early because I didn't want to do anything. I could not sleep well and I woke up at 5 AM. I went to work, I was still very depressed and down and I had no desire to do anything, then I stared to get anxious. I had no appetite at lunch. Ate something light. Went home after work, and same thing, anxious, down and depressed. And I started to have some little bit of itching/tingling on my face. I have been anxious since with mood changes. The appetite is a little better today 10/17/17, but I still have some anxiety. I had flu shots before, but it is the first time I feel anxious and down after a flu shot. I went to see my doctor yesterday, 10/16/17 because I was not feeling good. The doctor told me to rest and drink water.
hard of hearing; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (086396).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "kidney stones" (unspecified if ongoing); "gastric issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Feb2022, outcome "unknown" and all described as "tested positive for COVID"; HYPOACUSIS (non-serious), outcome "unknown", described as "hard of hearing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Feb2022) positive.  Additional information: The reporter was taking encorafenib (Braftovi) and she was tested positive for COVID-19 with home test and at the clinic she also tested positive. It was also reported that her husband had also had the vaccine and had showed all the little symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Injection site reaction; Warm at injection site; Itchy at the injection site; Redness at injection site; Painful at injection site/tender at injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE PRURITUS (Itchy at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Painful at injection site/tender at injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced INJECTION SITE REACTION (Injection site reaction), INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE PRURITUS (Itchy at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Painful at injection site/tender at injection site). At the time of the report, INJECTION SITE REACTION (Injection site reaction), INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE PRURITUS (Itchy at the injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Painful at injection site/tender at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A spontaneous case was received from a Pharmacist on 20-JAN-2021 which refers to a Female  who developed the following events injection site reaction(PT: Vaccination site reaction ,itchy at injection site(PT: Vaccination site pruritus),redness at injection site(PT: Vaccination site erythema),warm at injection site(PT: Vaccination site warmth) and tender at injection site(PT: Vaccination site tenderness) The patients past medical history and concomitant medications list were not reported. No lab data were reported. The patient received their first of two planned doses of mRNA-1273 (Batch No 011J20A) on 28-DEC-2020, intramuscularly.  The outcome of all the events were reported as resolved. The action taken for Moderna COVID-19 Vaccine was Unknown.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre- existing disease); there is no plausible mechanism to implicate the drug.  Concomitant product use was not provided by the reporter. No treatment information was provided.
01/12/2021 Veteran called to report the following sx  that started in AM: - blurred vision - dizziness, slight - muscle fatigue/soreness - slight dry cough (no wheezing) - sore throat - tingling feeling in head/lips/extremities
Headache, radiating pain in lower back upwards towards shoulder blades and downwards into legs. Over all tiredness/fatigue and aches.
I got the Pfizer Covid booster shot and I have had terrible side effects from it that lasted 8 days and I still have fatigue.   It included High fever, chills, major sweats, body aches and horrible headaches.  It would comes and go for 8 days everyday getting worse in evening.   I was barely able to get out of bed some days.   I would start to feel better then it would come around again.   Had loss of appetite.  Lost approximately 8-10 Lbs.   I drank plenty of fluids and rest and took advil.  The advil did nothing for the headaches.   On the 8th day the side effects mostly went away but I still am very fatigued, not great appetite and occasional headache.    Everything I read and doctor I talked with said most side effects go away in a day or two.   I had zero side effects with the first two Pfizer covid shots.    My doctor thinks I has plenty of antibodies from me having covid before plus with the two Pfizer shots that maybe my body is fighting the booster.  I don?t have any underlying conditions and am healthy.  I I would think for healthy people they should do an antibody test first to see if you actually need the booster.   Because if i knew how sick it was going to make me I would not have gotten it and I?m very pro-vaccines.
From initial information received on 11/07/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 19 year old female pt received a dose of Menomune, Lot # UB335AB, administered SC in the left arm on 10/31/03.  Two days later, the pt complained of headache, malaise, low grade temperature, photophobia, and nausea.  The pt also experienced these symptoms on the third and fourth days after vaccination.  She did not have any vomiting, but did complain of photophobia.  The pt was examined by a physician on 11/05/03.  At that time the pt felt slightly better, but the symptoms persisted.  The pt denied shortness of breath, chest pain and stiff neck.  She returned to school on 11/07/03.  Reportedly, the events were still resolving at the time of this report.
Approx. 7 hours after injection, pt. developed symptoms of headache. chills, tight muscles.
I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.; One of my symptoms was canker sores in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.) and APHTHOUS ULCER (One of my symptoms was canker sores in my mouth) 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 COVID-19 (I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.) and APHTHOUS ULCER (One of my symptoms was canker sores in my mouth). At the time of the report, COVID-19 (I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.) and APHTHOUS ULCER (One of my symptoms was canker sores in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Arm is sore, redness and swelling in upper area of arm, between injection and elbow.
2/14 large, red, hot blotch - 10 days after receiving vaccine 2/15 treated at convenient care for cellulitis, prescribed Doxycyline 2/19 primary care physician said no cellulitis, just a vaccination reaction/rash rash is fading
PT WOKE UP WEDNESDAY MORNING WITH THROBBING IN ARM AND TINGLING WITH SEVERE PRESSURE FEELING LIKE A BLOOD PRESSURE CUFF WAS ON HER ARM SQUEEZING IT TIGHT...MAKING IT GO NUMB...IT IS MORE OF A PRESSURE AND DISCOMFORT THAN PAIN...TOLD PT TO APPLY ICE PACK IF SWOLLEN OR PAIN, TAKE APAP OR MOTRIN (ANALGESIC), AND TO GO TO MD TO BE CHECKED OUT...I NEVER SAW THE ARM JUST SPOKE WITH PT OVER THE PHONE...PT STATED IF CONDITION WORSENS SHE WILL GO IN AND SHE WILL DEFINITELY TAKE AN ANALGESIC.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Other medical history was none. Other vaccine received. No other medication in 2 weeks.
This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered VAQTA (lot: L046953; expiry: 14-JAN-2017) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger.  This is one of the several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1612USA010325:same reporter.
Received Pfizer vaccines on 10/26/21 and 11/16/21. Came to hospital on 1/14/22 to deliver her baby. Coincidentally found to be COVID positive. Pregnancy complicated by COVID + on admission  Pt does note normal fetal movement. She denies LOF or VB. Delivery went well without any issues. Dishcarged on 1/18/22
Having difficulty sleeping; Soreness; Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Stiffness), INSOMNIA (Having difficulty sleeping) and VACCINATION SITE PAIN (Soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Stiffness) and VACCINATION SITE PAIN (Soreness). On an unknown date, the patient experienced INSOMNIA (Having difficulty sleeping). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Stiffness), INSOMNIA (Having difficulty sleeping) and VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Chronic cough, congestion & wheezing at night, currently taking on Montelukast
I just didn't feel like myself I was foggy light headed which went on for a couple of weeks so I took my blood pressure and that's when I noticed my heart rate was very low so I went to doctor.
Had anaphylactic reaction to Flu shot. Received shot on (L) arm at 1545. Went to ED with itching of (L) arm and later all over. Respiratory distress, throat swelling, and hives on face and upper chest. Arrived to ED approx 1120. (Provided by patient)
1635-Itching of back of throat 25mg  Benadryl given. 1640- Clearing throat ,itching "slowing down" Pepcid 20mg po Given. Vitals  97% HR 75 1645 Throat clearing ceased. Feels symptoms are improving. 1653 Throat soar not tight feels normal.NO SOB mild itching L wrist 1700 Discharge home. Feeling well. Symptoms resolved ER precaution discussed.
about 1 1/2 hour after receiving it I felt a pain and numbness down left arm into pinky and ring finger. That only last about 2 minutes. Then the pain radiated to left side of neck and head and headache is still there at 1pm.
Booster gave too soon. we gave bivalent booster on 4/1/2023, pharmacy 9/7/2022 then clinic again on 11/25/2022.  Patient did not have reaction
Bp became elevated. ?High normal? hives tingly arm terrible headache. Happened with both vaccines. Treatment tylonal and benedryl. Happened immediately after shot.
Information has been received from a female nurse who on 13-FEB-2007 vaccinated herself with a first dose of GARDASIL into the buttocks. On approximately 20-FEB-2007 the patient developed a bad rash which were "raised bumps on her arms, legs, her trunk and everywhere else besides her face." She went to a dermatologist who took a biopsy of the bumps and told her it was an auto immune response to the vaccine. In April 2007, the patient recovered. Additional information has been requested.
This patient was provided 0.2 cc of an adult Pfizer vaccine in error, as they should have been provided a 0.3 mg dose instead.    Staff member was previously drawing up pediatric Pfizer vaccine which requires different types of re-constitution than the adult Pfizer vaccine. While the correct amount of saline was used to dilute the vaccine, the incorrect drawn up dose was given to the patient.   Patient has been contacted and scheduled to receive appropriate replacement dose.
Reaction from Prevnar was very tired and very sore. Mom treated pt with Tylenol PRN. (Recommended Tylenol prior to shot.)
Pain like a knot I couldn't lift my arm only half way. I started physical therapy. I have frozen shoulder. It hurt hot and cold put on shoulder.
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included General medications for an unknown indication  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PAIN IN EXTREMITY (SORE ARM). At the time of the report, PAIN IN EXTREMITY (SORE ARM) outcome was unknown. Not Provided    Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable..    This case was linked to US-MODERNATX, INC.-MOD-2021-109761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109761:WIFE CASE
Patient became lightheaded about 5 minutes after vaccine administration. She then started to sweat and turn white and finally fainted. After lying her on the floor she woke up almost immediately. No further complications after that
A 19 month old female pt exposed to a bat, developed a fever following treatment with RabAvert. On day 0, the pt received one immunization in the buttock and one in the arm. On day three, she received another vaccination in the buttock. Both vaccinations were Imovax. RabAvert was initiated on day 7 and the pt developed a fever of 102 degrees F. The next day, the mother reported that the pt was fine. Follow Up received 10May04: The pt had no symptoms or complaints from previous vaccines or the possible exposure. She received her third rabies vaccine with RabAvert, 1mL, Im on the right thigh on 09Apr04. She became febrile, tired and lethargic. Twenty four hours later, she recovered.
Initial unsolicited report received from a other non-healthcare professional on 06-Sep-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (Batch number, expiry date, route and site of administration was not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced very large welt that lasted a few days and was warm to the touch and a rash. The patient not sure if from the shot but did need to see a doctor for it. The patient's laboratory data and corrective treatment were not reported. On an unknown day, the patient was recovered from event (lasted a few days). List of documents held by sender: none.
Pain, swelling & tenderness at injection site, Fatigue, Muscle Pain, Joint Pain, Chills, Nausea and Fever
This infant had a rash on his face and entire body. He had a fever the day of his immunization and the day after. No fever since 07/04/01. The rash started the day 07/04/01. No reactions. Referred to CMC.
Break out on the skin/ spread as a rash under the ribcage and back; Break out on the skin that looked like poison ivy; Itchy; In some spots oozing.; Bad headache; Chills; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 00:00, the patient experienced break out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events breaks out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations was resolving 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.