chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost two weeks after the shot, i noticed itching on my left arm.  After showering the next day I noticed a red area about 4 inches wide and 8 inches long with slight swelling and itching.  The swelling and itching was not noticed in the days immediately following the shot.  I will contact my doctor about the situation and follow up with them if the condition gets worse or does not go away.
Subject is enrolled on a clinical trial that is evaluating the nonavalent HPV vaccine in cancer survivors and received HPV Vaccine Dose 1-3 on 5/24/17, 7/21/17 and 11/29/17. On 5/24/18 subject was diagnosed with a secondary malignancy, cancer therapy-related acute myeloid leukemia. The event has been deemed by the responsible site physician (MD) and by the overall responsible physician for the study (MD) as unrelated to HPV vaccine and definitely related to prior cancer therapy (chemotherapy) that the patient received for treatment of his primary cancer.
This case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema and swelling. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain, erythema and swelling were recovered/resolved. It was unknown if the reporter considered the pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient's age was above 65 years. The age at vaccination was not reported. The provider stated that she had patient who complained of pain, redness and swelling. The provider recommended TYLENOL and warm compress and issues resolved. No additional details were available. The reporter did not agree to be contacted for follow up. This case has been linked with case US2018GSK167498, reported by the same reporter.
Starting late February : increased blood pressure diastolic upto 100. Headaches,  Started Toprol xl and prn Norvasc.. poor control.  Lasted overall for about  5 months.  BP improved over time in supine position.  Now : orthostatic hypertension. example   standing 130-145 systolic, diastolic 90-95   and pulse 80-90 -- > supine immediately usually 120-130/ 77-84 diastolic   pulse 72 -80 occasional BP now 115 /75 for day or 2.   (not taking any medication due to attempt led to dizziness with very small dose of losartan 12.5) Also started with hives at times around august /.September - food allergy panel showed significant elevation of IGE level to 12 out of 13 food substances.. new (except eggs)
Myalgia, Arthralgia, Fever, NauseaVomiting, chills, fatigue, , pain arm Narrative:
I developed shingles on my right leg right under my knee. They started  around 2 days after vaccination.
Temperature starting within 24 hours of injections with lack of appetite & fatigue.  Cough developed within 24 hours with positive strep (rapid test) 3/31/09.  Pt given script for AMOXICILLIN.
Chills, fever of 101.7F, nausea, & headache.  This symptoms lasted approx. 36 hours.  We visited our physician the next morning.  Tested negative for the flu.  Rotated over the counter pain meds. to counter the symptoms listed above.
My only reactions to the shot were a siege of muscle pain throughout my entire body. On March 14th, one week later, I awoke in the night with either afib or a very rapid heartbeat. I have CAD and one stent but have never experienced this.  We drove to clinic. My troponin level was 69 - a count pertaining to heart muscle involvement.  After 7 hours, I was released.  However, two days later, I awoke in the night unable to speak or think clearly. I was taken by ambulance to Hospital where I was diagnosed with a heart attack - the first I've ever had.   the troponin level was now 76. Since the heart is a muscle, and the shot affects muscles, could there be a co-relation? I didn't have the second shot.  Should I have one?
Pt R/arm became swollen from shoulder to wrist, was red, hot, lasting almost 1 wk. w/fever. Consulted w/PMD, who advised continuing to observe & come in if > problems. On 10/12, arm still slightly swollen & red.
Day 44 of missed menstrual cycle. Before vaccine,  cycle was never later, nor missed.
UTI;  Severed upper arm shoulder started approx 6 weeks post second dose; tightness in chest; humming in ears (slight)
After 7 days of first shot of Moderna, my arm around the shot location got very swollen and very ichy.  A red rush around the area.  Treating it with Benadryl and ice
In public school 8:45 - to administer Tdap and received call from mother that child came home 3:30 p.m. and arm and hand was all swollen and child told her that she felt dizzy like she was going to faint after going back to class and her throat was swelling. She said she told her teacher. Instruct mom to call Ped. or take to urgent care. Unable to reach mom until today. States took to ER and said allergic reaction and give BENADRYL and she did and all resolved now.
Information has been received from a registered pharmacist concerning a 78 year old male with no pertinent medical history who on 30-MAY-2009 was vaccinated subcutaneously with a 0.5ml dose of ZOSTAVAX (Merck) (lot# unknown). On 05-JUN-2009, the patient was hospitalized due to severe pain caused by shingles. Unspecified lab diagnostics studies performed. The patient was hospitalized for a day and a half. On unspecified date the patient recovered. Severe pain caused by the shingles was considered to be disabling by the reporter. Additional information has been requested.
Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning); vaccine administered after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date) and PRODUCT STORAGE ERROR (Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after the expiration date) and PRODUCT STORAGE ERROR (Puncture expiration date: 12-May2022 at 11:00pm (kept in refrigerator through following morning)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Refrigerator expiration date was  05-Jun-2022 and vaccine was removed from refrigerator on 06-May-2022.  Puncture expiration date was reported as 12-May-2022  at 11:00pm (first punctured on 12-May-2022 at 11:00 am-kept in refrigerator through following morning)  On 13-May-2022 vaccine was administered to patient in the morning.  No treatment information was provided.
Right after receiving the covid-19 vaccine today at 1:00pm patient passed out in vaccine chair less than 30 seconds after receiving the vaccination. He remained passed out for about 30 seconds and came to but was sweating and seemed disoriented. Gave the patient a cold water and some paper towels to help cool off and had to sit in monitoring area for 30 minutes. At this time the patient seemed fine and well recovered stating that he has a fear of needles but has never passed out before when receiving a vaccine
pt recv vax; exp arthritis & arthralgia;f/u info stated sx not related to vax; pt had sustained an arm injury "on the job" resulting in persistent arm pain;
tested positive  after the 1st dose; tested positive  after the 1st dose; This is a spontaneous from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive after his 1st dose of vaccine. The consumer already received 2 doses of the vaccine; she received her 2nd dose last Saturday (unspecified date). She inquired if she needed to be quarantined from the patient or if she could go to work. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
~1 wk after injection   big red itchy rash appear on injection arm below injection site.  Thought maybe a bite UNTIL a same thing happened to a friend.  Physician friend asked if I used anything like Miralax.  I do.  POSSIBLY MORE IMPORTANT, however, is that I had a colonoscopy 2 days before injection with Miralax prep - 14 doses in a 12 hourr period.
EXPIRED VACCINE ADMINISTERED (EXP 6/30/22). NO ADVERSE REACTIONS REPORTED.
Hurts to move or raise her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Hurts to move or raise her arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Hurts to move or raise her arm). At the time of the report, VACCINATION SITE PAIN (Hurts to move or raise her arm) 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.   Treatment medication not provided. Concomitant medication 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.
Pt emailed  health department on 3/27 in regards to a red, itchy, rash on her arm that was warm to touch. Pt reported the injection site used for the COVID19 Moderna vaccine was given too low based on the opinion of her mother in law who is a nurse and other peers who are nurses. Pt agreed to contact her PCP asap for evaluation at public health nurses request. Rash appeared more than 1 week after injection  however pt reported experiencing a lot of discomfort in her arm the day of her vaccine and moving forward.  Public health RN called Moderna, they do not recommend another 1st dose, they do recommend pt proceed with her 2nd dose as scheduled.
After I received the vaccine I noticed there seemed to be a knot where I was stuck. Over the next week that small knot seemed to turn to a red  welt that has gotten bigger, starting to look more pale in the middle and itchy.
3RD DOSE OF PFIZER COVID VACCINE GIVEN 9/29/21, LOT #FF2588;  7/23/22 pt to ED after bx taken by ENT of throat on 7/21/22 with c/o worsening sore throat, poor oral intake; bx showed no malignancy or dysplasia; while pt in hospital, he tested positive for COVID on 8/8/22; given Remdesivir, 1 dose of dexamethasone; pt's condition worsened, experienced hypoxic respiratory failure; required NRB; CXR negative; US of right upper extremity showed occlusive DVT in subclavian and axillary veins; given Lovenox; respiratory culture showed Klebsiella and MRSA; pt's condition deteriorated; required intubation; things continued to worsen; family transitioned pt to comfort measures; he was extubated and passed away in the hospital
Knot in her left arm; arm is warm to touch; itching; injection site  (left deltoid) swelling; chills; injection site pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site  (left deltoid) swelling), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (arm is warm to touch), CHILLS (chills) and VACCINATION SITE MASS (Knot in her left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021 at 4:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site  (left deltoid) swelling), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (arm is warm to touch), CHILLS (chills), VACCINATION SITE MASS (Knot in her left arm) and VACCINATION SITE PAIN (injection site pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (injection site  (left deltoid) swelling), VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (arm is warm to touch), CHILLS (chills), VACCINATION SITE MASS (Knot in her left arm) and VACCINATION SITE PAIN (injection site pain) 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 considered VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (arm is warm to touch) and VACCINATION SITE PAIN (injection site pain) to be possibly related. No further causality assessments were provided for VACCINATION SITE SWELLING (injection site  (left deltoid) swelling), CHILLS (chills) and VACCINATION SITE MASS (Knot in her left arm).    No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Chills, Knot in her left arm and injection site pain were added as event. Birth date of patient was updated. Causality had been updated for the events Injection site pain/itching/warm to touch.
A 30 year old female pt experienced nausea and dizziness on the evening of 29-DEC-2000 following her vaccination with RabAvert that day. On 19-DEC-2000, the pt had been working in a veterinarian's office when she received approximately 6 wounds to her hand from a dog bite. the dog had terminal cancer and was euthanized at another location before tissue samples for rabies analysis were obtained. The dog owner had refused to quarantine the dog for the required 10 days after the bite despite being informed of his obligations. The pt received her first dose of RabAvert on friday, 29-DEC-2000. She also received human rabies immune globulin. That evening, she had complaints of nausea, dizziness and was unable to stand. She also experienced severe abdominal pain at approximately 0100 Saturday morning. All events resolved that evening. The pt discovered that she was pregnant on approximately 01-JAN-2001. This is her third pregnancy. Her pregnancy due date is 10-SEP-2001. On Tuesday, 02-JAN-2001, the pt received her second dose of RabAvert. She again experienced dizziness which resolved on Wednesday morning. On Friday, 05-JAN-2001, the pt received her third dose of RabAvert with no adverse events experienced. She stated that she will be seen soon for prenatal care.
itching is bothering; itched  for about 6 days before going away; allergic reaction on arm; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction on arm), PRURITUS (itched  for about 6 days before going away) and PRURITUS (itching is bothering) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included IBANDRONATE SODIUM (IBANDRONATE), ROSUVASTATIN and FLUDROCORTISONE.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction on arm). On 04-May-2021, the patient experienced PRURITUS (itched  for about 6 days before going away). On 23-May-2021, the patient experienced PRURITUS (itching is bothering). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. On 10-Feb-2021, ALLERGY TO VACCINE (allergic reaction on arm) had resolved. On 10-May-2021, PRURITUS (itched  for about 6 days before going away) had resolved. At the time of the report, PRURITUS (itching is bothering) outcome was unknown.            Patient reported to have used an expired cortisone cream and triamcinolone cream that had been prescribed previously for something else as treatment.
12 post vaccination-awoke from sound sleep "unable to breathe" progressed to coughing disorientation, blurred vision, vomiting.
red around injection site; warm around injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received the 1st dose of Shingles vaccine. On 29th June 2022, 5 days after receiving Shingles vaccine, 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 not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient received 1st shot on unknown arm at doctor's office last Friday and on in the morning of reporting day, he/she noticed that the arm was red and warm around injection site. The patient asked if this was normal. Follow-up would not be possible as no contact details available.
big blisters; Initial information was received on 08-Feb-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the big blisters (blister), after the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had big blisters (blister) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient cannot take the flu shot as the patient break out in big blisters.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
On 9/15/16, patient had redness on left upper arm, fever of 99.9.
The first night I had severe chills and an intense headache but that went away the next morning. Then four days later I broke out in hives all over my body.  Still have hives on day 6.
No additional AEs were reported; Nurse called to report that a pediatric dose of RECOMBIVAX was given to an adult on 12/16/2022; Nurse called to report that a pediatric dose of RECOMBIVAX was given to an adult on 12/16/2022; This spontaneous report was received from a Registered Nurse concerning to an adult patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 16-DEC-2022, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) pre-filled syringe, 0.5 milliliter once, lot #W022795, expiration date: 19-MAY-2025, (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product administered to patient of inappropriate age) (incorrect dose administered).  No additional adverse events were reported.
Red, swollen, itchy, painful, raised spot around injection site approximately 2? wide by 1? long - warm to the touch.
blood sugar went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up). The patient was treated with METFORMIN for Blood sugar increased, at a dose of 1 dosage form. At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Blood glucose: 340 (High) high. On an unknown date, Blood glucose: 100 (Inconclusive) usually in 100s.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  On 06-FEB-2021, the patient's blood sugar went up to 340 when it is usually was in the 100s. To treat this elevated blood sugar, his doctor doubled dose of metformin. Patient stated that doubling his dose of metformin had caused  to have diarrhea.
Patient called 2 days after vaccines and said arm really sore and red, came in day 4 and arm red, warm to touch, swollen, itchy and sore with whitish patch, suggested to see dr. Dr prescribed antibiotic and steroid.
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, MALAISE, PAIN, VACCINATION SITE MOVEMENT IMPAIRMENT, and VACCINATION SITE SWELLING in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication JANSSEN COVID-19 VACCINE (Primary dose). Past adverse reactions to the above products included No adverse reaction with JANSSEN COVID-19 VACCINE.    On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 19-Dec-2021, the patient experienced SOMNOLENCE, MALAISE, PAIN, VACCINATION SITE MOVEMENT IMPAIRMENT, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, CHILLS, FATIGUE, and PYREXIA. On 18-Dec-2021, EXPIRED PRODUCT ADMINISTERED had resolved. At the time of the report, SOMNOLENCE, MALAISE, PAIN, VACCINATION SITE MOVEMENT IMPAIRMENT, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, CHILLS, and FATIGUE had not resolved and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 19-Dec-2021, Body temperature 101-102.6 (High).         No concomitant medications were provided by reporter. No treatment medications were reported.