chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a contactable consumer reported for herself in response to Non-HCP letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart rate increased, blood cholesterol increased, hypertension from an unknown date and unknown if ongoing. Concomitant medications included ongoing metoprolol 25mg, twice daily, lisinopril 5mg once daily from Jun2020 for hypertension, ongoing atorvastatin (LIPITOR (ATORVASTATIN) 20 mg once daily from Jun2020 for blood cholesterol increased, ongoing levothyroxine, diphenhydramine hydrochloride (BENADRYL) from an unknown date to unknown date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Lot number: EL9261) as SINGLE DOSE for covid-19 immunisation causes rapid heartbeat was monitored, it keep going up and down/went to the emergency room. The patient only has a little pain on my arm where i was given the shot on an unspecified date. Drank a lot of water before after shot, Nurse suggested taking Benadryl after the shot which I did and had no reaction. The patient underwent lab tests and procedures which included heart rate increased: 135-120-110 bpm (Normal BPM 55-65 was up to 135-120-110 etc after vaccine (1st shot)), heart rate normal: 55-65 bpm (Normal BPM 55-65). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  Information about batch/lot number has been requested.
Patient scheduled, arrived and consented to receive the first dose of the Pfizer Covid vaccine on Thursday Feb 4,2021 around noon. Patient received his vaccine and was directed to an observation seating area, accompanied by his wife and completed at least 15 minutes of observation prior to being released home.  When patient stood up from his chair to exit the clinic , he fell and hit his head on the floor which caused substantial bleeding.   He was immediately attended to and transported to the Emergency Dept on the campus of this vaccination site for treatment.
Resident reported she didn't feel well. She started running a fever of 103.  Resident complained her stomach and genitals were burning and pain in her legs. Resident has been vomiting today and diarrhea.  EMS was called and resident transported to Hospital today 1/19/21
12/22/17 - left shoulder Swelling & pain then Neck pain after shoulder pain moved to neck x 3 weeks. 1/4/18 - Seen in Urgent Care - starting a week ago right shoulder pain and neck pain. Decreased ROM & has tried shoulder exercises. Taking Motrin & Norco for pain. Referred to Orthopedic physician. 1/8/18 - Seen in Orthopedics - Frozen shoulder (neck & right shoulder pain) - Weakness at right shoulder (xray was normal). Referred to Neurology for EMG study. 1/11/18 - Seen in Neurology - for right arm weakness. Referred to Physical Therapy before EMG study conducted. 1/23/18 - Seen in Physical Therapy - will be seen 1-2 times per week for 12 weeks.
report a possible side effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (report a possible side effect) 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 COMPLICATION (report a possible side effect). At the time of the report, VACCINATION COMPLICATION (report a possible side effect) 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.   No Concomitant medication were provided by the reporter  No treatment medications were provided by the reporter    Reporter did not allow further contact
approx 15min p/vax pt returned w/swelling @ site of inj itching, redness of eyes, severe congestion f nose, productive cough, extreme anxiety;adrenalin & DPH given;sx subsided w/in hr;monitored during noc;no dx on 10/14/99;
On the evening of December 1st I woke up with chills early morning and every couple hours with thirst, headache I took some TYLENOL to help with fever I slept on the airplane I got home about 4PM. I was running a fever and got up to 101.5 degrees. I dragged myself to bed and slept. I went to emergency room with extreme coughing and trouble breathing. I received an albuterol inhalation treatment and oral steroid. After about two days I declined and then was prescribed a long dose oral steroid. Right now I have a lingering cough.
I've got tinnitus like I've never known before. It's been going on for about a year.  Also, much lower energy.
Patient reports a burning sensation in her chest, weakness, and fatigue.  States this started Wednesday following the vaccine.
product leaked out between the tip and the needle and seemed to be pressurized.; due to the reconstituted product being foamy.; Initial information received on 18-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00816465.  This case involves an unknown age female patient who was experienced RABIES (HDC) VACCINE [IMOVAX RABIES]  (needle issue) and (product preparation issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 18-Oct-2021, the patient received a 1 ml dose of suspect RABIES (HDC) VACCINE lot number: T1B813M and expiry date: 07-DEC-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate reconstitution technique and needle leak (latency: same day).  At the time of reporting, no adverse event was reported.   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 the 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.
Fever 102 lasting about 10 hours. Stiffness in neck to wrist area on injection side. Severe headache.
Pt recvd series of Hep-B & 13NOV91 recvd 5th inject; 17NOV91 pt devel vertigo; no tx was given as of 19NOV91 vertigo was persisting;
31Jul90 pt vax;  31Jul90 devel axillary temp of 102.5F & 3 convulsions.
Started with mucousy foul smelling diarrhea shortly after rotavirus vaccine. 2 days later developed few episodes of vomiting. Stools 8-10/day currently day 5 of diarrhea.
Patient had arm soreness without swelling that started the evening she received the 4th dose.  Entire arm was sore for about 5 days.  Patient was fatigued and no energy for 5 days.  No fever.  Pt called doctor, and she took a COVID test, and tested negative.  She was unable to sleep the first night due to soreness, and discomfort.
Rash, erythema Multiform, urticarial pruritus and abscess around injection site.
Information has been received from a licensed practical nurse referring to a 14 year old patient of unknown gender. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; dosage, frequency and route of administration were unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA009046.
The day after vaccination of 4th dose, I started having itching, tingling and pain to left arm. It began to swell up to the size of a nickel. It continued to swell in size. The next day, all of these symptoms increased. I began having trouble walking and was lightheaded. The swelling began moving down my left arm. I decided to go to the ER at the Hospital on 5-22-2022. They gave me a prescription for hydrocortisone ointment 1% tid, hydroxyzine 25mg, cefalexin 500mg q8hrs, famotidine 40 mg twice daily as needed, and methylpred 4mg dose pack. They told me that I could get Claritin over the counter and take as directed as well as use warm packs as needed. My arm is starting to feel much better. I still have some slight swelling, itching and pain.
Neck stiffness, started on (R) side 24 hours after injection went around neck. Dec. ROM of neck.
Rash ,nausea ,vomiting  body aches  tiredness ,extreme itching
Fatigue  Diarrhea Cough  Muscle or body aches  Headache
PMH significant for ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD.  10mins post vaccination pt c/o feeling faint w/ blurred vision and is visibly pale. Writer transferred pt from observation to triage area via w/c. Pt is present with mother and brother.    Pt received 2nd dose Pfizer today. Pt appears pale, slight perspiration noted on forehead. Offered and provided water for hydration. Pt stated that he felt lightheadedness and stuffy ear, which had resolved soon after being placed in triage.   V/S @ 100PM: BP - 83/48, HR - 60   Continued to monitor pt for add'l 30 min. Provided juices and water. Pt verbalized improvement to sx.   V/S @ 1:30PM: BP - 130/60, HR: 66   Pt verbalized resolution of sxs, stated OK to go home. Per NP, pt OK to be released from clinic. Pt denied experiencing any more abnormal/new sxs. Pt left with family, steady gait, AxOx4.
Feeling nauseous, no appetite, headache and low grade fever after 24 hrs.  Took 400 mg Ibuprofen and 500 mg Acetaminophen  Itchy rash on face and torso after 48 hours.  Took  two Benadryl capsules in addition to Ibuprofen and Acetaminophen  Swelling on face and eyes after 72 hours.  Still taking Benadryl and  Ibuprofen  with Acetaminophen.  Still have rash and slight fever.
This spontaneous report was received from a social media regarding a female patient of unknown age. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with GARDASIL (batch #, lot #, dose, frequency, route, indication not reported). No concomitant medications were reported. On an unknown date the patient experienced seizures (medically significant). The outcome of seizures was unknown. The causality of the event was not specified by the reporter. This is one of the two reports received from the same reporter (sibling case # 1406USA006887). Additional information has been requested.
Administered with expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Received vaccine within 5-10 minutes shortness of breath, tightness of chest, labored breathing. Primarily in the diaphragm area. Chest wall symptoms bilaterally. Currently still getting worked up for that. Physician put me on a prednisone taper to reduce inflammation. I was evaluated yesterday and they said with everything taken into account and if my chest wall improves to my comfort level she will have me get a CAT scan of the chest next week. I have not ever in my life had chest wall stiffness like this. I was advised due to the circumstances do not get the 2nd dose.
Received the new Zoster vaccine at doctors office and 6 hours later had severe headache, malaise, myalgia to the point that I couldn't get out of bed and missed work the following day. No fever or respiratory symptoms. Treated with acetaminophen. Cleared in 48 hours. No local reaction.
Quarter size red mark presented at MMRV injection site within 24 hours, with considerable soreness. Swelling around red mark spread to a peak diameter of 4.5 inches about 48 hours after injection, then slowly subsided. The area was warm to the touch and itchy. No fever and no rash, only considerable localized redness, swelling, and pain. DTaP injection site was unremarkable.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: el9263), in left arm, on 13Feb2021 as dose 2, single (Lot number: el7267), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "hay fever" (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 Jun2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2023) negative, notes: Tested negative; (20Jun2023) negative, notes: Tested negative; (22Jun2023) positive, notes: tested and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid from 12Jun2023 to 17Jun2023 for the treatment of COVID-19.
This case was reported by a consumer and described the occurrence of facial flushing in a 78-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Baby aspirin, Vitamins, Calcium, Fish oil, STRESS TAB and Biotin. There were no other medical conditions. On 13 October 2010 at 08:30 the subject received unspecified dose of FLULAVAL (unknown, left arm). The subject also reported that after a previous influenza vaccine (unknown manufacturer) on an unspecified date, she experienced local injection site pain and redness. On 13 October 2010, almost immediately after vaccination with FLULAVAL the subject experienced flushing of her face. On 14 October 2010, one day after vaccination with FLULAVAL, she experienced lightheadedness. On an unspecified date, several days after the FLULAVAL vaccination, she experienced reflux and pain in eyes. The subject visited her internist and he performed a cardiogram, which showed no change. She also visited her gastroenterologist, who scheduled her for a colonoscopy and her cardiologist, who scheduled a stress test. The results of the colonoscopy and stress test were unspecified. The subject felt that all of these symptoms occurred as a result of the flu vaccination. The events resolved on 31 October 2010. No other information was available at the time of reporting.
vaccine went into the subcutaneous layer rather than the muscle layer; arm was not sore, just a little bit of inflammation; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine went into the subcutaneous layer rather than the muscle layer) and VACCINATION SITE INFLAMMATION (arm was not sore, just a little bit of inflammation) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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)) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine went into the subcutaneous layer rather than the muscle layer) and VACCINATION SITE INFLAMMATION (arm was not sore, just a little bit of inflammation). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine went into the subcutaneous layer rather than the muscle layer) and VACCINATION SITE INFLAMMATION (arm was not sore, just a little bit of inflammation) outcome was unknown.            Concomitant medication was not provided. It was reported that the patient got the bivalent booster dose and the vaccine provider used a 5/8 inch needle to administer the vaccine to them. The vaccine provider grabbed the arm to form a muscle (patient was 120 lbs) but did not use the whole depth of the needle and patient thought that the vaccine went into the subcutaneous layer rather than the muscle layer. The arm was not sore - just a little bit of inflammation and not the usual. There was no fever. As per patient it could be a vaccine failure.  Treatment information was not provided.   Reporter did not allow further contact
It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose..He did not know that there was a limited amount of time to receive the second dose) had resolved.            Patient date of birth given as 1971.  Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received, contains no new information. Corrected: event start date removed, event outcome updated to resolved and action taken updated to not applicable from initial.
Headache, Myalgia, Arthralgia, CoughWheeze, NauseaVomiting, chills, fatigue, brain fogg Narrative:
1) Severe chills for about an hour on first evening, starting around 9pm, required blankets to warm up 2) Muscle pain in arm at location of shot made it difficult to raise arm over head, starting about same time as chills and lasted about 24 hours. 3) Elevated temp of 99 on second evening around 8:30pm (I usually am about 97)
Completed vaccine series on 1/19/21. In early March 2021 developed bilateral submandibular lymphadenopathy associated with diffuse oral and tongue pain and inflammation, consisting of dry mouth, erythema, fissuring of  tongue, lichenoid changes, and 2 raised mucosal lesions. This has been associated with swelling and inflammation of the lips with cracking at the corners of the mouth, currently being managed as angular cheilitis with topical steroids and nystatin ointment. I has seen my PCP, ENT, and oral medicine for these symptoms. Labs were unremarkable and ultimately underwent oral biopsy which showed chronic inflammation and granulomatous inflammatory reaction with C3 deposition. These findings are non-specific and I do not have a diagnosis at this time. All symptoms persist to date. Oral symptoms are being managed with dexamethasone mouthwash and lips are being treated with topical steroids and nystatin as noted above.
Narrative:  COVID infection following COVID vaccine series 05/12, Pfizer,  dose #1 04/21, Pfizer, dose #2 12/21 COVID swab, result: detected 12/18 pt cc: sore throat, chills, diarrhea, fatigue, myalgias exposure: unknown 12/28 clinically resolved
Felt dizziness and lightheaded about two minutes after receiving shot. I passed out and when I woke up I was struggling to regain consciousness control of my body as I was having a seizure.
The pt developed swelling (2 x normal size) in left leg. He was evaluated at ER and put on antibiotics. Site was red and hot as well. At the time, he  was put on cephalexine every six hours for seven days.
Completed 2 Doses and Titers Does Not Show Protective Immunity; Initial Report Received on 08-Aug-2019  A reporter reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not get immunity after two doses of Heplisav.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC #, route, and site not reported).   On an unspecified date, the patient was reported to not get immunity after two doses of Heplisav.   No additional information was reported.    Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed as the dosing, time to titer and results of the titers are not available.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed as the dosing, time to titer and results of the titers are not available.