chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after receiving my booster shot I began to experience full body hives and dermatographism (skin writing). I was prescribed steroids on the 3rd day which helped alleviate symptoms over the 4 day course but then the hives, which are painful and extremely itchy came back worse than ever. It was recommended by my dermatologist that I begin taking Allegra and pecid in addition to my regular Benadryl. This has helped lessen the severity but the hives have not gone away and any pressure on my skin leads to an outbreak. I have been experiencing this everyday since November 8th (1 month and 11 days). It has shown no signs of lessening or going away.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 05-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion fifteen times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (216, 29.3); (24, 33.6); (52, 33.1); (28, 30); (104, 29.1); (48, 32.9); (36, 31.1); (24, 34.5); (24, 32.4); (96, 34.2). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received an additional dose of Meningococcal and TdaP. This vaccine had been given in 2019 but was reported in system under an incorrect birthday that the mother had given on the consent form at that time. I pulled up the patients records in system on the correct birthday and gave the vaccines, only to find out that there were two accounts involved and the patient had already received these doses. Patient and mother has been  informed and no negative outcomes at this time.
Information has been received from a mother concerning her 16 year son who on 18-FEB-2008 at 19:00 was vaccinated in the deltoid with a 0.65 mL first dose of zoster vaccine live (Oka/Merck) instead of dose of varicella virus vaccine live (Oka/Merck) (MSD). No further information was provided. Additional information has been received from a health professional. It was reported that the patient had no reaction and "recovered." Additional information has been requested.
Stroke; Heart attack; had experienced pain in Caller's Right Arm which feels like 'Shingles inside arm' with corresponding pain radiating down Caller's arm and up Caller's shoulder on unknown, previous date; Caller confirm pain was due to 'post-herpetic neuralgia'; This spontaneous report was received from a patient concerning herself, a 65-years-old female patient. Patient current conditions included penicillin allergy. Information regarding the patient's concomitant therapies, medical history and historical drug was not provided.   On 09-APR-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) 0.65 milliliters subcutaneous route, lot number K020802 (expiration date was not provided) as prophylaxis.  On the same date, the patient experienced pain radiating up her shoulder and down; she reported to feel like "shingles inside arm", later it was confirmed that the pain was due to post-herpetic neuralgia.  On approximately October of 2015 (6 months after vaccine administration), patient confirmed to having experienced a stroke (cerebrovascular accident) and a heart attack (myocardial infarction.)  The outcome of the events was reported as not recovered. Causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the events was not reported.  Upon internal review the events of myocardial infarction and cerebrovascular accident were considered to be medically significant.
Felt sore throat and tachycardia; Felt sore throat and tachycardia; COVID test came back positive; COVID test came back positive; This is a spontaneous report from a contactable physician, the patient.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Dec2020, as a single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020, the patient felt sore throat and tachycardia. The patient also reported that on an unspecified date, in Dec2020, the COVID test came back positive (the Sepheid test, not the rapid test). The events were reported as non-serious. The patient underwent lab tests, which included COVID-19 test: positive on an unspecified date in Dec2020. It was unknown if the patient received treatment for the COVID test came back positive, felt sore throat and tachycardia. The clinical outcome of the events the COVID test came back positive, felt sore throat and tachycardia was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19, Oropharyngeal pain and tachycardia, based on temporal relationship.  There is very limited information provided in this report.   This case will be reassessed upon receipt of follow-up information.
bubble at injection site; This spontaneous report was received from a pharmacist via vaccine employee regarding a patient of unknown demographics. Information on patient's pertinent medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2018 (over one year ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) in the deltoid via intramuscularly (dose, strength, lot #, expiry date unknown) for prophylaxis (the pharmacist did not remember which product it was). On an unknown date, the patient developed a bubble at the injection site (injection site reaction). The outcome of injection site reaction was unknown. Causality assessment was not provided.
Intense soreness post shot and day after(vaccine received at 12:30pm), at 6:00 am this morning I was unable to stand due to intense throbbing in left arm. It took about 15 minutes to get my body used to changing from a lying position to standing.   Upon getting out of bed nausea set in. I dry heaved for a few minutes.   Muscle/body cramps all over (more intense than my Covid aches)  Headache   Chills  It is currently 11:27 am, I took an Advil over an hour ago that has alleviated some of the symptoms.
Patient developed a rash on her elbow the day after immunization.  She states it is warm to the touch and itches.
AFTER THE SECOND DOSE ON SEPTEMBER 27, 2021, ABOUT A WEEK LATER I BEGAN HAVING TROUBLE WALKING, THEN MY LEGS  BEGAN GIVING OUT ON ME, I COULD NO LONGER WALK AS I DID PRIOR TO THE VACCINE. ABOUT 2 WEEKS AFTER THE SECOND DOSE, I COULD NOT FEEL MY FEET ANYMORE! i WENT TO A DOCTOR AND SHE TOLD ME THAT I HAD BLOOD CLOTS IN MY LEGS AND THAT WAS THE REASON I WAS HAVING PROBLEMS. SHE ALSO TOLD ME THAT THOSE WERE SOME OF THE SIDE EFFECTS CAUSED BY THE MODERNA VACCINE.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a eight-year-old patient. Neither the patient's medical history nor the concomitant medications have been reported for this patient. The product expired on 11-Dec-2011. The patient received the expired FLUMIST 12-Dec-2011. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. There was no late occurring adverse event reported.
Per patient phone call: solid pink blotch 1" x 3" rash/lump on left arm that doesn't hurt unless pushed on, no itching; "flu-like" symptoms (vomiting, sick to stomach, no temp); had doctor appt on 11/14/14 and no treatment required per pt discussion with doctor; pt was feeling better on 11/14/14 when she came into pharmacy.
Guillain-Barre. Loss of feeling all over body. Plasma treatment and therapy.
Patient called to report that her arm was a little swollen, and hot to touch, the day after the vaccine. She has had flushots in the past and has never had a problem. It has gone down today, She did not have any pain or a fever at any time. And did not report any hives or itchy skin. She was just a little concerned, I told her that it can happen to some patients. She was putting ice on the area and took Tylenol. I told her to continue to put ice on it and try ibuprofen instead of Tylenol. She will follow up with her doctor.
Fatigue with first 24 arms, arm soreness 8 days later developed red patch at injection site- skin slightly raised and warm to the touch. Was a red blotch not itchy, not relieved by allergy medication. Resolved within 24 hrs
Arm with induration and erythema down to elbow, with pain for 3 days Treated with heat packs and Tylenol
Severe drop in blood pressure, dizziness nausea.. 48 hours after tingling in tongue, roof of mouth,gums..itching on back and legs..
ears-capillary reddness, general malaise, achyness, weakness, t104.2, chills;
Skin allergies but a little more intensive; Injection site itchiness; Injection site Redness; Blotchiness; Skin allergies but a little more intensive; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchiness), DERMATITIS ALLERGIC (Skin allergies but a little more intensive), CONDITION AGGRAVATED (Skin allergies but a little more intensive), INJECTION SITE PRURITUS (Injection site itchiness) and INJECTION SITE ERYTHEMA (Injection site Redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G07M2CA) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH MACULAR (Blotchiness), DERMATITIS ALLERGIC (Skin allergies but a little more intensive), INJECTION SITE PRURITUS (Injection site itchiness) and INJECTION SITE ERYTHEMA (Injection site Redness). On an unknown date, the patient experienced CONDITION AGGRAVATED (Skin allergies but a little more intensive). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Blotchiness), DERMATITIS ALLERGIC (Skin allergies but a little more intensive), INJECTION SITE PRURITUS (Injection site itchiness) and INJECTION SITE ERYTHEMA (Injection site Redness) had resolved and CONDITION AGGRAVATED (Skin allergies but a little more intensive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional event added, skin allergies but a little more intensive.
Patient reported to ER on 4/23/21 with complaint of chest pain.  Symptoms started that morning.  Felt fine the evening before.  No fevers, chills or productive cough.  He also had associated shortness of breath.
Very sore arm, hard to lift, hot to the touch red raised area near the site of injection. noticed it after going to bed and laying on it. (figure roughly 12 hours after injection).
Patient currently admitted at (5) days inpatient starting on 11/21/2021. Patient is a 79 y.o. male who presents today with weakness and diarrhea. The patient has a history of renal transplant, diabetes, CKD 3, HTN, HLD, COPD. The patient speaks another language and his son at bedside assists with translation. The patient is fully vaccinated for COVID and he was getting his booster shot on 11/18. Later that day he developed symptoms of fatigue and weakness. He then developed diarrhea and abdominal pain, fever and cough. He has some shortness of breath with activity. He came to the ER for evaluation.    In the ER the patient was COVID positive. He was found to be hypoxic requiring 2L NC. His CXR was negative for any acute abnormalities. He had labs showing AKI and hypokalemia. He was given decadron and potassium supplement. The hospitalist team was contacted for admission and further management.   ASSESSMENT / PLAN: * Acute hypoxemic respiratory failure Assessment & Plan Secondary to COVID, no infiltrates noted on CXR at this time Symptom onset: 11/18 Isolation: Severe Respiratory, if improved/afebrile antipyretics consider deescalation on 12/8 due to immune compromised status  Vaccination Status: Fully vaccinated, got his booster shot on the day of symptom onset  Continue supplemental O2, Titrate/wean to maintain SpO2>92% Continue Dexamethasone 1/10 Continue Remdesivir 1/5 Encourage Self Prone, IS, deep breathing and ambulation as tolerated  Symptomatic Treatment: Anti Tussives, Anti Emetics, Analgesics VTE PPx: Lovenox 40mg SQ q24 Daily CBC, CMP, CRP, D-Dimer Monitor I/O, daily weight, creatinine Maintain net neutral to negative fluid balance q24 Code Status: Full      AKI (acute kidney injury) Assessment & Plan Likely due to dehydration with poor PO intake and diarrhea  History of renal transplant Monitor renal function closely  Hold home lasix and lisinopril    COVID-19 virus infection Assessment & Plan Tested positive 11/21 Fully vaccinated, got booster the same day as symptom onset See plan above    COPD (chronic obstructive pulmonary disease) Assessment & Plan Continue inhalers  No wheezing on exam   Chronic kidney disease (CKD), stage III (moderate) Assessment & Plan Now with AKI Continue to monitor renal function closely    Dyslipidemia Assessment & Plan Continue statin    HTN (hypertension) Assessment & Plan BP stable Continue home metoprolol and hydralazine, hold home lisinopril and lasix with AKI   History of renal transplant Assessment & Plan Continue home tacrolimus, mycophenolate  Renal function worse than baseline, monitor closely    Type 2 diabetes mellitus  Assessment & Plan Last A1c 7.2, repeat pending Transition home levemir to lantus  Monitor blood sugars and adjust insulin as needed, anticipate hyperglycemia with steroid use
Headache, Fever, Rash, RASH NOT AT INJECTION SITE Narrative:
Starting about 2 hrs after receiving the shot, muscle pain throughout left arm, spreading through all muscles of body by 5am. Sever periods of chills followed by sweating and feeling hot. Nausea, headache. Took Excedrin, Aleve and tums. Worst of the symptoms subsided by 24 hrs post vaccine administration. Slight nausea and headache still persists at time of filling this report out. I feel it's important to note that I had COVID in December and feel the adverse reactions were due to having sufficient antibodies against COVID. Perhaps it shpuld be recommended that people get antibody titers to determine if the vaccine is necessary as is done to determine if HepB boosters are necessary.
On the night of 10/22/20 patient sat up suddenly and had  what she reports as, "75% dimming of the right eye," that lasted for about 5 minutes. Vitals at that time were BP 122/82,  p 72, o2 sat 97% on RA, and temp 97.8. (Patient is a CRNA) After confirming no other neurological deficits, patient laid down and experienced blurring of her left eye with left eye pain. No treatment given. Today she has no vision deficit or pain.
Febrile seizure (104.5 F) one day after immunization. 1 episode, received TYLENOL and MOTRIN after admission, physical exam was positive for an erythematous throat, no exudates, no vesicles.
Redness, itching, hives on and around injection site; Redness, itching, hives on and around injection site; hives on and around injection site approximately 5 hours; This is a spontaneous report from a contactable nurse who reported for herself, a 37-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown) at the Workplace clinic, intramuscular in the right arm on 08Jan2021 at 16:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Patient had no COVID prior to vaccination, and was not COVID tested post vaccination. The patient was not pregnant. There were no concomitant medications. The patient previously took and had known allergies to morphine and Hep B vaccine preservative. The patient previously received the first dose of BNT162B2 (unknown lot number) on 18Dec2020 at 11:45 AM, at 36 years of age, via intramuscular in the right arm for COVID-19 immunization. On 08Jan2021 at 21:15, the patient experienced redness, itching, hives on and around injection site approximately 5 hours after 2nd dose, still present 2 days later. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; Information on lot/batch cannot be obtained. No further information is expected.
Reported: After receiving HPV #3, patient began to walk toward elevator. Passed out and reportedly hit head on the carpet. Came to. Was put in a chair and given water, felt ok and wanted to leave went down elevator and began to feel dizzy again. Pt. brought to Exam Room 20 to lay down, water, cool compress and a lollipop given to pt. Was requested by mom to examine pt. Per Dr., pulse 70, pt. alert and interactive. Was advised to remain horizontal for 10 minutes, then sit up for 5 mins, then ok to leave if feeling better. Nurses were advised to check on pt. at intervals described.
INSOMNIA; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that a patient of unspecified age and sex (subject number and site number were not reported) experienced grade 2 insomnia. The event occurred unknown days after COVID-19 vaccine  Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with study vaccine was not applicable. The outcome was recovered.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported.   On 20-JUL-2021, the subject experienced insomnia.  On 24-JUL-2021, the subject recovered from insomnia.  Investigator's causality assessment:  The event of insomnia was possible to the study vaccine.  Company causality assessment: The event of insomnia was possible to the study vaccine.
I administered the Pfizer Covid 19 Booster vaccine to this patient four months after her second covid vaccine instead of six months. I verified the vaccination card after I administered this vaccine. Before I gave the shot, I did ask the patient if she had the vaccine 6 months ago and she told my yes. I did not verify on the card that it was 6 months ago before I gave the shot.
lt anterior thigh swelled w/approx 3in induration; area was reddened & hard;
Fainted , fever of 102.5 and ached all over for 24 hours
Patient complains of localized "tightness" to right arm where she received the vaccine.  Patient states she experiences the tightness when she keeps her arm up for extended periods of time. Patient states that when she keeps it up for extended periods of time, it also goes numb.  Patient does not report tightness, numbness, pain, or other discomfort while using her arm for other activities. When the symptoms occur, the patient states that putting her arm down or moving her arm around relieves her of her symptoms.
Fatigue on 12/28/2020, Fever (101.4F) on 12/30/2020, positive COVID test results on 01/2/2021, loss of smell on 1/2/2021.
Crazy itching; Shingles started on Wednesday, but was really bad on Saturday and sunday; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles started on Wednesday, but was really bad on Saturday and sunday) and PRURITUS (Crazy itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A 4/10/63) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HERPES ZOSTER (Shingles started on Wednesday, but was really bad on Saturday and sunday). On 10-Apr-2021, the patient experienced PRURITUS (Crazy itching). At the time of the report, HERPES ZOSTER (Shingles started on Wednesday, but was really bad on Saturday and sunday) and PRURITUS (Crazy itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received anti-viral and a cream as a treatment. No concomitant medications were reported.
Information has been received from a female consumer of unknown age via Pfizer Inc. referring to herself. No concurrent conditions or medical histories were mentioned. In back of June 2015 (exact date not available) the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route unspecified). In 2015, the vaccine made her back sore hurt, she had ache in her back and one of her shoulder, her back was bothering and when she looked her back one day before reporting day (exact date not available) it was swelled. There was no product complaint reported. The outcome of events was unknown. Additional information is not expected because the consumer was not willing to share further information.
I had pain in both arms. I had light sensitivity hat lasted for a while. I had a headache. I had bad pain in my neck and head between my eyes. I am having chronic abdominal pain when I go to the bathroom that started happening at the end of May. I went to a doctor about my abdominal pain. I been trying to get into a Neurologist for the light sensitivity issues.
Fever, achy, decreased energy, rash (measle like rash) x 2 weeks after PROQUAD vaccine.
Extreme mood swings, depression,  back pain, fatigue, extreme cramping, heavy spotting between periods with clots, brain fog . Spotting stopped yesterday on its own 4/30/21
Dizziness and localized right posterior headache, pain scale 7/10. Observation for 20 mins (patient fasting, last meal and fluids 10pm last night. Patient preferred not to take anything by mouth unless necessary). Vitals were taken twice, stable. Still had dizziness and headache after 20min of observation, ambulace was called at 10:41am for observation. Exam WNL.  BP: 150/83 P 48 Oxigen 98% (laying down) BP: 144/94 P 62 Oxigen 98% (sitting) At 2:45pm Patient was called by phone for f/u on status of patient, was told by patient that he decided not to go to hospital and stayed at home and rest. He said he was given an option on way to hospital weather he wants to go to hospital or go home. Patient decided on his own to go home and rest. He said he is no more dizzy, still had HA generalized more localized on right posterior. Slept 2 hours after vaccine, wife observing at home, will rest today and tomorrow and wants a work note for today. will email work note today.
Starting one week AFTER vaccination: red, hot swelling (about 2" across) at injection site and quite itchy for about a week; can still see traces of swelling 2-3 weeks later, but less itchy.
PATIENT STARTED WITH ITCHY SKIN ON THURSDAY 11/5/20,  ITCHY SKIN PROGRESSED TO BLOTCHY SKIN DESCRIBED AS HIVES.  PATIENT WENT TO URGENT CARE CLINIC ON SATURDAY MORNING AND ORAL STEROIDS WERE PRESCRIBED.  PATIENT IS CURRENTLY TAKING ORAL PREDNISONE AND MONITORING THE RESOLUTION OF THE RASH