chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 17-Jan-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a male patient (under 65 years of age) who was tested positive of Influenza A virus after he got flu post receiving vaccine, FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapies were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unknown date, the patient developed flu and after tested of having rapid flu, it came back positive for A-strain (Influenza) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Patient was in the hospital and tested by nasal swab for the flu A strain. Patient was on droplet precautions at the facility and reportedly could be reached from 10-6 (unspecified unit).  Final diagnosis was Influenza A virus infection. The patient was treated with oseltamivir phosphate (Tamiflu) and an unknown antiviral. Outcome of the event was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns an adult patient who was tested positive for Influenza A after and despite vaccination with a Influenza containing vaccine. The time to onset is not known. Moreover, there is no information regarding patient's condition at time of vaccination, immune status, predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Arm soreness; Left eye sealed up with yellowgunk; left side of her face was turning yellow and was swollen / some swelling at the jaw line; skin discoloration; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix. On 6th November 2019, 2 days after receiving Shingrix, the patient experienced pain in arm, eye discharge, facial swelling and skin discoloration. On an unknown date, the outcome of the pain in arm, facial swelling and skin discoloration were unknown and the outcome of the eye discharge was recovered/resolved.   It was unknown if the reporter considered the pain in arm, eye discharge, facial swelling and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 4th November 2019, the patient receive the 1st dose of Shingrix vaccine and two days later when she got up in the morning she noted her left eye was sealed up with yellow gunk on it, and the left side of her face was turning yellow and was swollen. She also experienced arm soreness and states there was still some swelling present at her jawline. The reporter was requested to provide consent to follow up.
Received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Date the vial was initially stored in the refrigerator was 25 March 2022. It was reported that vial did not undergo any temperature excursions.      No treatment medication was provided by the reporter.
High fever, increased to as high as 102.4 F Severe body aches, muscles, joint pain, headache Nausea, fatigue, stomach pain
Pt had hives all over body 2 hours after vaccine.  Did have Tylenol after vaccine.  Saw MD.  Given Benadryl.  Pt recovered without problems.  He did have a red arm at DTaP injection site for 4-5 days.  Mother states child had diarrhea and vomiting 3/27 and 3/28.
Severe pain, swelling (3x size of left arm) inside above and below elbow. Also serious itching, especially in the AM. Incident lasted 10-11 days.
Patient fainted right after receiving her shot.  She woke up immediately after, though very pale and shaky.  Patient stayed laying down for 15 minutes until she felt better and left under her own power with no problems.
didn't feel good; woke up itching really bad; raise her right arm which hurt; Nausea; Sweating; felt hot but didn't have  a fever; Diarrhea; This is a spontaneous report from a contactable other hcp. A 54-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fatty liver disease and hypothyroid from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller is calling about the Pfizer covid vaccine. The caller tried to get on VSAFE and wanted to report her side effects but was unable to. On 03Sep2021 the caller has experienced the sweating and things like that. The caller started itching and having whelps come up. The caller has taken Benadryl and its helped, but she still has it. It feels like it's not bad like it was before the Benadryl, but the caller feels like a sensation like she wants to scratch. The caller woke up the second night with this itching. Friday morning the caller had sweating, and she felt hot but didn't have a fever, had diarrhea and didn't feel good. Saturday the caller woke up and went to raise her right arm which hurt to lift it, but she got her shot in the left arm and she had nausea. Sunday the caller was better. Monday morning the caller woke up itching bad and took Benadryl. Then last night this happened again early in the morning, she woke-up itching. The outcome of the event raise her right arm which hurt, woke up itching really bad was not recovered and outcome of the event didn't feel good was unknown and outcome for other events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Chest pain, left side weakness, cold in extremities, lightheaded, pale complexion.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EWO162), in left arm, on 29Apr2021 as dose 2, single (Lot number: EWO165), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 32 years, in right arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "exercise-induced asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. Concomitant medication(s) included: SERTRALINE, start date: Jul2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks of vaccination, Sertraline, brand: Au-robindo, start date: Jul2018. Rebound case of Covid-19 5 days after completion of Paxlovid course. Anti-viral for COVID 19 Treatment was Paxlovid, Treatment start date was 19Jun2022 and Treat-ment stop date was 24Jun2022. Patient known allergies: sulfa drugs and other medical history: de-pression, anxiety, exercise-induced asthma, high cholesterol.  No follow-up attempts are possible. No further information is expected.
The pt developed hyperesthesias and pruritis fllowing JEV #3 onset within a few hours post vaccination. Symptoms have decreased but not resolved.
Later that night, the patient had symptoms of myalgia on both of her arms; "it went from one arm to the other."; The patient had "upper body pain above her belly button".; This spontaneous report was received from a pharmacist and refers to a 57-year-old female patient. The patient concurrent conditions included COVID-19. She had "a ton" of an unspecified allergies. The patient had no concomitant medications. No information regarding the patient's medical history was provided.  On 25-JUL-2020, the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml, intramuscularly(anatomical location was not reported) (lot# S024808 with expiration date 02-JUN-2021). A reason for vaccination was that "the patient had COVID-19 and her doctor wanted her to get the vaccine for breathing and pneumonia" (prophylaxis).  On the same day at night, she began to have symptoms of myalgia on both of her arms, reported as "it went from one arm to the other". On that day (25-JUL-2020, reported as "then"), the patient had "upper body pain above her belly button". She did not sought any medical attention. The patient took a diphenhydramine (BENADRYL) but it was not prescribed treatment for her symptoms. No laboratory tests were performed. The outcome of the events was reported as recovering.  The relatedness between the aforementioned events and PNEUMOVAX 23 was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
severe pain at the site of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (severe pain at the site of the vaccine) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022 at 7:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Nov-2022, the patient experienced VACCINATION SITE PAIN (severe pain at the site of the vaccine). At the time of the report, VACCINATION SITE PAIN (severe pain at the site of the vaccine) had not resolved.            Concomitant medications were not reported.  Patient arm did not hurt as patient was receiving the vaccine or even shortly after. It hurt more than any other vaccine patient received and was still painful to the touch at 5:19 pm on 24Nov2022. Treatment medications were not reported.
PT FAINTED THE NEXT MORNING AFTER VACCINATION. REQUIRED GLUE ON FACIAL LACERTAION.
Migraines daily, inflammation of joint, excessive weight gain, return of menopause symptoms , muscular pain, fatigue,   Acupuncture to treat side effects, minimal relief of symptoms Primary care provider for exam  and labs- all exam and labs within normal limits
Patient received Moderna dose #2 on September 23 (first dose received 8/24/2021). The following day he reports developing a fever. Three days post-vaccine (9/26) the patient reported chest tightness while getting ready to exercise. This pain did resolved. The following night the patient was awakened by crushing chest pain that radiated to his jaw and shortness of breath. EMS was called and the patient presented at Hospital emergency department. Upon arrival, the patient had diffuse, minimal ST elevations on EKG and an elevated troponin. His chest discomfort was partially alleviated. He was given aspirin 81 mg and colchicine 0.6 mg twice daily was initiated. The patient also received (see continuation)  40 mEq of potassium to replete electrolytes (potassium level upon arrival 3.4 mmol/L). The patient received 600 mg ibuprofen three times daily and 2 fentanyl 25 mcg injections to alleviate pain. Care was supportive in nature. A cardiac MRI was performed (results summarized in Item 19). As a result, the patient was prescribed metoprolol succinate 12.5 mg twice daily, ibuprofen was discontinued, and colchicine was continued. On the morning of 9/29, the patient felt symptom-free and was discharged with metoprolol succinate 12.5 mg twice daily and will be following closely with cardiology for follow-up.
pt had t102, screaming x 7hrs & inc sleepiness x 2 days & swelling @ inj site;fed well throughout & was treated w/APAP only;did require an extra visit to the office
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX (batch number Z9RR4, expiry date unknown) for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. The reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional information reported as follows: The reporter provided the name of the nurse who had given the vaccine, for follow up communication. The patient was called on the day of reporting, with complaints of redness at the injection site approximately 4 inches in diameter, and warm to the touch. They were evaluating whether to had the patient come in for appointment. They (reporter) think it was due to the vaccine.
After 3 days of vaccination, patient complained of generalized itching and has hives (red spots).
Within 1 hour after injection, very sore arm. At 4:30am on 11/4/21 woke with pain in arm and under the arm near breast area.  Sore and achy legs, arm. At 11:00am on 11/4/21 started running fever - 99.5, nausea, vomiting, diarrhea, chills. On 11/5/21at 2am, still fever of 99.5. Left arm still swollen, red and very painful at injection site and under arm. On 11/7/21, arm still red and very sore, and all joints still achy. The soreness in left arm at injection site has remained tender to this day - 12/10/21. Not sure if the pain is directly related to the vaccine, or a result of sleeping in a different position due to the soreness of the arm.
lymphadenopathy (swollen lymph nodes); feeling pain on the injection site; feel some swelling on the right portion (same side with the injection site) above the clavicle "collar bone"; This is a spontaneous report from a contactable consumer reported for herself.  A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Aug2021, same evening, the patient started feeling pain on the injection site and just slept on it during the night. About 2 or 3 days, she started to feel some swelling on the right portion (same side with the injection site) above the clavicle collar bone. Up until now she still has the swelling. reporter also stated that others had it too" but she was just getting a bit concerned about the prolonged duration of the swelling. Caller wanted to know if lymphadenopathy (swollen lymph nodes) is a reported adverse event after getting the Pfizer BioNTech Covid-19 Vaccine. At the time of this report feel some swelling on the right portion was not recovered and other event outcome was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Itchy raised pinkish red 2 cm diameter patch on left arm at site of injection occurring on the 8th day after injection. Patch expanded to 5cm long by 9th day. Two Benadryl tablets reduced color and itchiness.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Mild
Unknown if Adverse reaction occurred. Patient received a second dose for Fluzone-HD within a two week period , So far no adverse reaction reported
Information has been received from a RN concerning a female pt with a history of chickenpox who in approximately 2003 was vaccinated with a dose of varicella virus vaccine live (Lot # not provided). The pt subsequently developed shingles. It was not known what treatment was provided or if the pt recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated a similar experience with another pt (WAES # 0308USA00822).  No further information is available.
Patient called office to report 3-15-12, 12:44 pm. Reported Rec'd Shingles and Tdap vaccines on 3-13-12. Patient believes he had a reaction to vaccine. Incident reported - Patient woke up in middle of night for two hours had extreme stomach upset and diarrhea followed by chills. Symptoms subsided. No fever. VIS stated to call provider to report reaction.
CHIEF COMPLAINT:   Covid symptoms about 2 wks ago +home test 9 days ago Has underlying disease  including leukemia. Past few days worsening cough ,fatigue weakness & SOB   HISTORY OF PRESENT ILLNESS:     81-year-old male past medical history CLL, Ramsay Hunt syndrome with loss, BPH presenting the hospital due to shortness of breath.  He reports that he has been having symptoms for approximately 2 weeks.  He also has associated cough productive of white sputum.  He had a positive home test approximately 9 days ago.  Does have a sick contact he reports that his nephew had Covid and was working with him and he became sick shortly afterwards.  He did receive the Covid vaccine last February received 2 doses of mRNA vaccine.  He was set to get his booster until he became sick.  He denies any other acute symptoms.  He has been following with oncologist and has been treated with chemotherapy for his CLL in the past but has been told there recently this past month his white cell counts was elevated again he was being monitored for further treatment.  In the ER, he was afebrile stable vital signs.  He was requiring 5 L of oxygen via nasal cannula to maintain saturation above 90%.  Chest x-ray revealed Covid pneumonia.  Lab work was notable for hyperkalemia 5.7, elevated CRP, elevated D-dimer, white blood cell count of 184, and platelet count of 135.  Covid PCR was positive.  He was given ceftriaxone, doxycycline, dexamethasone in the ED.
Itchy throat; Hives on right arm at injection site; Red patch at injection site (gotten worse); This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat), VACCINATION SITE URTICARIA (Hives on right arm at injection site) and VACCINATION SITE ERYTHEMA (Red patch at injection site (gotten worse)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Itchy throat), VACCINATION SITE URTICARIA (Hives on right arm at injection site) and VACCINATION SITE ERYTHEMA (Red patch at injection site (gotten worse)). At the time of the report, THROAT IRRITATION (Itchy throat), VACCINATION SITE URTICARIA (Hives on right arm at injection site) and VACCINATION SITE ERYTHEMA (Red patch at injection site (gotten worse)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that the events started a week and a half after the vaccine dose. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up was received on 19-APR-2021. All reported events' outcome was updated to recovered/resolved.
symptoms with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms with the first 2 doses) in a 53-year-old female patient 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 VACCINATION COMPLICATION (symptoms with the first 2 doses). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (symptoms with the first 2 doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.   This case was linked to MOD-2021-398464, MOD-2021-398524 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received about 4 to 5 years ago.). In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, pain and feeling unwell. On an unknown date, the outcome of the headache, pain and feeling unwell were unknown. It was unknown if the reporter considered the headache, pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX in June 2018, and experienced response. The patient wouldn't call it, a reaction. He experienced headache and felt achy and didn't feel good for a couple days following the 1st dose of SHINGRIX.
I have been experiencing very significant autoimmune reactions to mosquito bites since receiving the Covid vaccine. Most recently, in July I had to go to urgent care and was diagnosed with cellulitis due to one (mosquito) bug bite. On 08/10/2021, I got 17 mosquito bites and all have significant reactions that did not happen previous to receiving the vaccine.
Left deltoid erythema in circular pattern apply cool compress every 1-2 hrs. for next 2-3 days watch for fever or changes in behavior - call if worse call with any concerns, questions, or new/worsening symptoms.
5 x 2 local red warm tender area around vaccine site DTaP (L) thigh given yest. 8/28/17. Onset last night worse today.
Client stated she developed throat swelling and difficulties swallowing, headache, exhaustion. Client went to the ER for evaluation, was given BENADRYL and Prednisone for five days.