chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-4573. Case report received from a physician via MedCom, on 17 NOV 2009. Patient 3-year-old or younger was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m. on 13 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008308.
arm is still a little red and warm to the touch; arm is still a little red and warm to the touch; 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 78-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset Apr2022, outcome "recovered" (Apr2022) and all described as "arm is still a little red and warm to the touch". Additional information: The patient reported that she had Prevnar 20 last Wednesday, 06Apr2022. Her arm is still a little red and warm to the touch, she looked on the internet and it said that this would last up to three days. The patient was wondering if there is any problem but did state that she felt ok and just wanted to ask.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician via a company representative, referring to a 12 year old non-pregnant female patient with no pertinent medical history or drug reactions/allergies. On 02-MAR-2016 the patient was vaccinated with 1 shot of GARDASIL 9 (lot# and expiration date were not reported) via subcutaneous route. There was no concomitant medication. On the same day, after receiving GARDASIL 9, the patient passed out. The patient was kept for about 25 minutes for observation and recovered. Her blood pressure was checked (result and unit were not reported) and she was given "PEDIALITE" before being sent home. It was reported that the patient had received two other vaccines, but GARDASIL 9 could not be ruled out as the cause. Additional information has been requested.
Syncope episode, lightheaded, nausea, dizzy, seeing black fuzzy spots, flu-like symptoms (sweaty, chills). Pt rest for 15 mins. and got better.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMUAL INSEAD OF 0.2ML OF THE 10MCG FORMULA.
Patient DID NOT have any adverse reactions. Patient felt fine and still feeling good.  Patient received the Bi-valent as a initial dose. CDC was called and they recommended that the patient receive a 2nd dose of Mono-Valent for 2 months later with another Bivalent dose.
Headaches, fever, swelling under the armpit of the left arm. swollen ganglion.
Patient experienced a rash on her right arm that was warm to the touch, swollen, and tender that was noticed the following day. Patient went to urgent care on 10/22/2019 and was prescribed triamcinolone and doxycycline but the patient did not take the doxycycline.
Symptomatic since 12/20/21, tested positive on 12/21/21. Isolation for 10 days until 12/30/21. She will follow up  Covid hotline for further guidance and antibody testing after isolation ends.
inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 42-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 25-JUL-2023 It was given in error and was supposed to be administered to a different patient. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.  The patient received Shingrix at inappropriate age, which led to inappropriate age at vaccine administration
PATIENT HAD RED SPOTS, ITCHINESS, AND PIN-PRICK FEELING ON ARMS, AND CHEST TIGHTNESS ABOUT 15 MINUTES AFTER SHOT WAS GIVEN.  ONE DOSE OF EPINEPHRINE (GENERIC EPIPEN) WAS GIVEN TO PATIENT, AND PATIENT ALSO TOOK A PUFF FROM HER ALBUTEROL INHALER.  AFTER SEVERAL MINUTES, SHE FELT HER CHEST TIGHTNESS SUBSIDE.  PATIENT WENT TO URGENT CARE CLINIC NEXT DOOR.
PFIZER COVID-19 VACCINE WAS ADMINISTERED AFTER THE 30 DAY PERIOD THAT THE VACCINE IS ALLOWED TO BE STORED IN THE REFRIGERATOR.  PATIENT DID NOT REPORT ANY ADVERSE EVENT TO THE VACCINE THAT HE RECEIVED.
Tingling in left arm radiating to hand, little finger. BP 110/80 HR 90 @ 1139. Injection site has no redness or swelling. BP 120/80 HR 70 @ 1150. Tingling better, feels ok to leave.
fever, chills, body aches, joint pain, lymph node pain, vomiting, mood changes
About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching.  The stomach issues resolved after a couple  of  days, but the severe itching continued and is  especially bad wherever my clothing  comes in  contact  with my skin.  Over  the next several  weeks, I tried hydrocortisone cream, Benadryl gel, Benadryl tablets, Calamine  lotion, corn starch, menthol itch  cream,  but  nothing  has helped for very long.  I don't have much of a rash...just a bit  of raised redness when the itching is particularly bad.  I have been miserable with it.  I  visited my neurologist for  Botox injections  and asked her about  it and she said she  thinks I'm having a  histamine reaction  to the Covid vaccine.  The severity of the itching  is getting slightly better,  but  it's  now  been almost 6 weeks of unrelenting itching.  I'm  not taking Benadryl 3 times a day.
81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5.  His wife noticed on Sunday, he started acting strangely, more confused.  He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.
A patient complained of numbness/tingling in the Right Arm after receiving 2nd dose of Moderna at 09:11 AM. She told the observation nurse it didn't happen with her 1st dose. Vitals were taken B/P: 159/84, HR: 60, Resp: 16, Temp: 96.6, O2: 98%. The patient stated the feeling in her right arm radiated from the injection site down her right arm. The charge nurse spoke with the patient and informed to inform him if the situation got worse or she required further attention. The patient left with her husband without any further complaints. She registered for V-safe to track any future symptoms.
Guest reported a tightness and soreness at her left armpit approximately 10 minutes following administration of the vaccine.  EMS was called. Reported the discomfort as a 5 out of 10 to EMS. There was no evidence of rash or swelling.  The guest stated "I am feeling fine, just sore". Guest accepted water. Guest was sitting up ; breathing was steady; skin color pink .
Developed rash (few bumps on chest & rt deltoid) 30 min post vax, itching upper body;
pt recvd vax & began screaming & could not be comforted; redness at inject site; settled down after 3 hrs;
it is very itchy,; red at vaccination site; at the time her arm hurt/painful for two days; today it hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (at the time her arm hurt/painful for two days), VACCINATION SITE PAIN (today it hurts), VACCINATION SITE PRURITUS (it is very itchy,) and VACCINATION SITE ERYTHEMA (red at vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (at the time her arm hurt/painful for two days) and VACCINATION SITE PAIN (today it hurts). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (it is very itchy,) and VACCINATION SITE ERYTHEMA (red at vaccination site). At the time of the report, PAIN IN EXTREMITY (at the time her arm hurt/painful for two days), VACCINATION SITE PAIN (today it hurts), VACCINATION SITE PRURITUS (it is very itchy,) and VACCINATION SITE ERYTHEMA (red at vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow up
Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
Patient has a mild case of shingles outbreak. She reports numbness and tingling in her face around the eye. She has one pustule on her nose. Her provider prescribed Valtrex therapy, which she began taking on 03/06/2019.
chills; nausea; This case was reported by a consumer and described the occurrence of chills in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced chills and nausea. On an unknown date, the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the chills and nausea to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient had nasty reaction to vaccine chills and nausea. This case has been linked to another case reported by the same reporter US2019AMR211876.
Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 16-FEB-2012, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-OCT-2014, the patient was treated by a physician for a painful rash that was diagnosed as shingles. The patient has been prescribed Acyclovir to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Mom states child had wheezing, croup-like cough and pounding fast heart rate. Still has some wheezing and coughing.
urticaria rash; This case was reported by a physician and described the occurrence of urticarial rash in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 weeks after receiving Shingrix, the patient experienced urticarial rash. On an unknown date, the outcome of the urticarial rash was recovered/resolved.   It was unknown if the reporter considered the urticarial rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that 2 to 2 and half week's post vaccination, developed an urticaria rash over the entire body lasting about 2 weeks. The patient's physician was unsure if it was due to the vaccine or not but some other cause. The reporter asked if 2nd dose could be taken. The reporter did not consent to follow up.
This spontaneous report as received from a certificated medical assistant refers to about 6 patients of unknown ages and genders. The reporter stated that on unspecified dates, since 02-APR-2013, about six patients received a dose of GARDASIL (dose, route application site were unspecified) (lot# H010123; exp date: 16-JAN-2015), and two to three patients received ROTATEQ: MARRS#1305USA002896. The reporter stated that the GARDASIL were exposed to an unsupported temperature excursion. These vaccines were exposed multiple times into the freezing range, the lowest temperature being 23F; the total time frame being 1 month. The number of excursions into the freezing range exceeded 5 times. The exact number of times these entered the freezing range was unspecified. No known adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Client received Dtap/IPV instead of Tdap, client was here with her sister who was to get Dtap/IPV.
Patient was sitting in observation area c/o dizziness. Patient was taken to EMS room and laid on cot. States she feels better and that she got overwhelmed by the crowd.
This is a spontaneous case, initially received from other non-health professional on 13-Dec-2017, concerns a 71-year-old elderly male patient. The patient's current conditions included dizziness, hyperlipidaemia, benign prostatic hyperplasia (BPH), nocturia, microscopic haematuria, hypertension (HTN), atrial fibrillation and dry eyes (since an unspecified dates). The patient's concomitant medications included SYSTANE GEL for dry eyes, NTG for chest pain, ASA, B12, doxycycline, finasteride, HCTZ, fluorometholone (eye drops), XIIDRA 5%, magnesium, PRILOSEC, pravastatin, BETAPACE, ZANAFLEX, tramadol, trazodone and valsartan for unknown indications. On 13-Sep-2017, the patient was administered with FLUARIX vaccine. On 12-Dec-2017, after two months of FLUARIX vaccination, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 179403, expiry date: 30-Jun-2018) (explicitly coded as inappropriate schedule of drug administration). It was reported that, patient had not experienced any adverse events after both the vaccination. The reporter assessed this case as non-serious. Non-significant follow up received on 25-Jan-2018: The reporter confirmed that, patient had not experienced any adverse events after the vaccination.
Soon after injection, left deltoid (site of injection) has been very sore, and has been chronically sore in the months since.
Sore throat; shortness of breath after walking short distance in home; Headache; Tiredness/ fatigued; Chills; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and had abatacept (ORENCIA) infusion monthly. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alendronate sodium (FOSAMAX) and levothyroxine sodium (SYNTHROID) for unknown indications from unknown dates. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 23Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The clinical outcomes of the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient called office on 5/2/11 with complaints of her arm hurting and having a hard time raising her arm due to the pain. At the the time the patient was on vacation and was not seen by this provider for this problem. She stated she had been swimming, but had a hard time raising her arm (left) and that it hurt. She stated that there was no lump or red spot on her arm. She did have a bruise from the injection, but it was resolving. She was advised to take Motrin for the pain and ice the area. She was also advised to seek medical care if she was in increasing pain. She called on 5/3/11 with the same complaints and was given the same advice. She was not due home until 5/9/11 and was advised that she could be seen then at the office. She did not make an appointment. When attempted to contact the patient on 5/10/11 there was no answer at her given phone number. It is not know if she sought care for this arm pain.
Patient has redness on her stomach and arms. She reports that the redness has improved some. She will continue to monitor and will follow-up with her primary care doctor on Monday 3/15/21.
This spontaneous report has been received from a registered nurse. The reporter stated that improperly stored doses of GARDASIL 9 (strength, dose number, route not reported, lot number L025737 expiration date 280JUL-2017) were administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects were reported. No further information was provided. This is one of several reports from the same source. Additional information has been requested.
At 1450 patient approached Paramedic with concern regarding left wrist pain and vein protruding more than right. This occurred approximately 10 minutes into her 15 minute observation period following a 1st dose Pfizer (Lot # EW0162, Exp: 07/31/2021). Client denied any other symptoms. Paramedic  noted that client was able to ambulate to chair in observation without assistance and with a steady gait. Client rated the pain as 2/10 on a 0-10 pain scale and was non-radiating. Paramedic observed there was no asymmetry between left and right wrists, there was mild distention of left radial vein, negative for pain on palpation, negative for temperature difference between right and left extremity. At 1502 client began to complain of neck discomfort, then a headache on forehead which she rated a 5/10. Client reported a history of epilepsy and stated she has a headache aura prior to seizures. Paramedic advised client to sit in the zero gravity chair for further assessment and noted client was able to ambulate to chair on her own accord and with a steady gait. Client denied complaints of dizziness, shortness of breath, blurry vision.  At 1508  client stated left radial pain was gone, headache was now rated a 3/10. Client was given a bottle of water. At 1510 vitals were taken with client sitting in zero gravity chair: blood pressure 110/80, respiratory rate: 14, heartrate: 78, client was alert and oriented to time, space, situation and person (CAOx4). Client stated symptoms were diminishing. At 1520 a second set of vitals were taken: Blood pressure: 112/82, Respiratory rate: 14, Heartrate: 78, CAOx4. Client stated she had no complaints. Client was advised to stay an additional 15 minutes. At 1540 client released from observation and she left the observation site on her own accord with a steady gait.
Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPNOEA (Difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
At 15 minutes post vaccination right leg felt "heavy" followed by tingling of right side of face  and tongue.  Mostly, but not completely resolved at 24 hours post vaccination.
Constipation, daughter was screaming and straining to move her bowels for at least twenty minutes several times over the weekend.