chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increase blood sugar; This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received Shingrix. On 12th November 2019, 1 days after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was unknown.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient took the vaccine last night from day of reporting and on day of reporting patient sugar in the morning showed to be 295. Normally the patient morning sugar around 150. The patient enquired whether Shingrix vaccine shot cause to increase blood sugar level. The permission to follow up was denied.      Lab Comments: On an unknown date, the patient did lab test.
Injection at 12:30pm; 20-25 mins post injection, tingling starting in neck on right side, traveled up right side of face/cheek into hairline. The same happened with first dose, remaining tingly all day and started itching at night. After 2nd dose, the symptoms still occurred but more mild and not as long lasting. Still feels tingly now.
Fever, chills, nausea, headache, bodyaches, rash on chest, itchiness   Fever headache and bodyaches started 12 hours after vaccine and rash started over a day after the vaccine.
Information has been received from a female with sulfa allergy who on 10/29/01 was vaccinated with pneumococcal vaccine 23 polyvalent in her right arm. Concomitant therapy included Norvasc, methotrexate, Toprol XL Tablets and Premarin. Subsequently, the pt experienced large raised red area in her right arm pit that itches and pain at the injection site. Unspecified medical attention was sought. In follow-up, the physician reported that the pt did have redness and heat at the site of the pneumococcal vaccination and it resolved spontaneously, 4 days later. The physician felt that it was "not clear to him that this was any sort of significant reaction". Additional information is not expected.
Fever; severe headache; body aches; sore throat; cough; severe fatigue; dizziness; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 19Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had history of allergy to ibuprofen and amoxicillin. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation within four weeks prior to the second dose. On 19Mar2021, the patient had experienced fever, severe headache, body aches, sore throat, cough, severe fatigue and dizziness. The patient did not receive treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, severe headache, body aches, sore throat, cough, severe fatigue and dizziness was resolving.    No follow-up attempts are needed; information about lot/batch number cannot be obtained
Patient was diagnosed with shingles in his ear by PCP on 2/18/15.
Vaccine 7/23. 7/26-noticed lymph node (L) cervical enlargement. 7/30-started AUGMENTIN for cervical lymphadenitis. 8/3-Lymph enlarging (L) cervical.
In mid/late June 2021, I had a high heart rate/tightness in chest for a few days. I dismissed it as stress/anxiety. Again a high heart rate/tightness in chest occurred in late July/early August and again i dismissed as stress/anxiety. In late September (approx. 9/19) the high heart rate and chest tightness reoccurred. It would not subside so went to the ER. They diagnosed cardiac tamponade, pericarditis and myocarditis. I was flown to a HCF to have fluid drained (pericardiocentesis). The high heart rate returned about a week later but I was told that is common in the 2-3 month recovery period.
The evening after receiving these vaccines, the patient stated that she developed swelling in her left arm and it was warm to the touch. The swelling traveled down her arm. She stated that she took Benadryl and the swelling went down some and by Monday when she called, it had not worsened. Consulted patient to follow up with PCP to determine if further action was needed.
Vaccination administered to patient who was outside of the approved age guidelines for the vaccine. Contacted manufacturer, who advised us to check on patient and have parent monitor for any adverse side effects. Advised by manufacturer to not give patient the second dose.
Child was ok before vaccination. We don't know the exact time of reaction onset, but after a few hours he had difficulty breathing, hoarseness and wheezing and a fast heart beat. He was like this for about 3 days.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vicodin allergy, reaction(s): "known allergies: Vicodin allergy", notes: known allergies: Vicodin allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medication vitamins with iron in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First couple of days, the  injection site was sore (which is a "normal reaction").  By day 3, injection site became itchy, warm, red, and swollen.  I also had pressured pain in the armpit.  I contacted my primary care physician whom has placed me on antibiotics; Sulfamethoxazol and Caphalexin
Mother of patient reported that son developed sudden rash and swelling during the night which was 9 days after receiving vaccines. Rash was red, pea-sized, and spread from trunk to extremities within 8 hours. No dyspnea or elevated temperature occurred. Itching was present for two days, then stopped. Mother reports patient was taken to ER within 12 hours of rash onset and treated with Prednisone & Benadryl IM. Patient was released from ER and continued treatment of Bendryl PO for 1 day & Prednisone PO on tapered schedule. Swelling disappeared after 24 hours, rash continued to spread into 6 inch "spots", but mother denies any dx of hives fron ER MD. Rash recessed over next two weeks, but continued to recur intermittently although patient felt well and was able to go on family vacation for 1 week. On day 16 from onset of symptoms, patient was seen by doctor for intermittent recurrence of rash. Mother states results of exam included kidney function test and CBC which were with normal range. Parvovirus was suspected, but tested negative. No diagnosis was made. Patient left for trip on day 18 from onset and still had some recurring "spots".
Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023; No adverse event; Dose administered after 30-day Use By Date (patient 1); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 2.5 mL.Vial was initially stored in the refrigerator on 10-Feb-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
Patient in 2.9.17 for CPE. Per staff provider gave okay to administer vaccine for 10 yrs. 11 months age. Age of patient at time of event: 10 years 11 months. Type of Event: Wrong age (patient not correct age for vaccine given).
Lips and tongue tingling and numbing. Tongue starts to swell. Epinephrine IM given. All signs/symptoms resolved.
Information has been received from a healthcare student concerning a female "in her sixties" who "about 3 weeks ago" was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included ZOLOFT and XANAX. "About a week after receiving ZOSTAVAX (Merck)" the patient developed tingling and "prickly" sensation from her waist down. The patient also reported to the healthcare student that she was experiencing loss of sensation to her buttock and the bottom of her feet when she was sitting on the toilet. The patient had called the pharmacy for medical attention. At the time of the reporting, the patient had not recovered. No further information is available.
September 16, 2021 onset of vomiting sent my husband to the Urgent Care who sent him to the Emergency Room -- CT Scan shows likely cancerous nodules growing on Colon, Liver, and Lung -- he has been referred to Oncologist for next steps
Lightreaction same day. After 6 days, symptoms worsened: nausea, diarrhea, vomitting (wouldn't hold anything) , headache, sore throat, bruising all over the arm where shot was given, and fever . Patient was admitted twice to the hospital ( on 4/12/2021 and on 4/15/2021)
Initial report received on 21 November 2008 from a Nurse Practitioner.   A female patient (demographics not provided), who had no concurrent illnesses, and "unknown" past medical history, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009 (lot number U2840AA) on 17 November 2008.  Approximately five hours post-vaccination, the patient experienced shortness of breath, cough, congestion in her lungs, and her eyes became red, swollen and watery, similar to conjunctivitis.  Later that evening, the patient reported having generalized body aches and soreness, and she felt very tired.  The patient was not medically evaluated.  No relevant diagnostic tests or laboratory data were collected.  The following morning, all of the patient's symptoms had "cleared".  Documents held by sender: None.
About 15 minutes after getting it I had a strange bitter taste in my mouth. Also a lot of fatigue afterwards.
Left arm red after pneumonia shot on Thursday. Pneumonia vaccine is painful, red and swollen. Patient was diagnosed with localized cellulitis and dermatitis of the left upper arm, also localized reaction to vaccine. Treated with Cephalexin and ice for pain and swelling.
approx 10 hrs p/vax pt devel high fever (not measured), sweats, followed by vomiting x 3 progressing to shaking all over, diarrhea x 2;
-Right arm with swollen with a round warm red rash measuring 6m x 5.5.  -Left arm with same reaction but smaller measuring 5x 4.5cm
Right arm swelled to size of egg. On 10/02 experienced numbness in left hand, tongue, and left side of mouth. On 10/4, experienced numbness in left foot and headache. Admitted to hospital on 10/4 for possible stroke. Doctor diagnosed GBS. I am having problems with eyes double vision at close range. Information from Discharge summary states GBS disproved, did show Trancent ischemic attack. msv
Information has been received from a licensed practical nurse concerning a 18 months old patient of unknown gender. On 03-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
I am very ill; weak; cannot concentrate; I may have to go out on short term disability since i cannot do my job in patient care at the hospital; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported i am very ill, weak, cannot concentrate and i may have to go out on short term disability since i cannot do my job in patient care at the hospital. Prior to the vaccine i was in great shape, but now cannot function. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Over the weekend after receiving my vaccine on 01/15 I had swollen lymph node in my right armpit, I was prescribed a Z-Pak for that. My doctor did blood work showing elevated liver enzymes. Multiple blood draws after that. Since then, I have had an ultrasound, MRI and FibroScan on my liver, results came back normal but I still have elevated liver enzymes. I did get a rash around my mouth and petechiae (broken blood vessels) on my hands after the vaccine.
This spontaneous report was received from a pharmacist, concerning a 54 year-old female. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, frequency and route of administration were not reported) lot # N009167 with expiration date of 02-FEB--2018, for prophylaxis. The temperature excursion of the ZOSTAVAX was of 41°F for a time frame of 8 hours. No previous temperature excursion occurred. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA000712.
No additional adverse events; patient was inadvertently administered a dose Varivax, that was improperly stored; This spontaneous report has been received from a research coordinator (physician) referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, and drug allergies were not reported.  On 14-NOV-2019 the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection,  lot number S005084, expiration date 19-FEB-2021 for prophylaxis (concentration, frequency, and  administration route were not reported), that had been improperly stored in a temperature of -13.8C for a time frame of 51minutes. The vaccine was reconstituted with properly stored sterile diluent. No adverse events were reported. Additionally it was reported that a data logger was involved.  The outcome of the event was unknown.
Information has been received from a registered nurse concerning a patient who on 18-AUG-2009 was mistakenly vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect was reported. It was unknown if the patient sought medical attention. Follow-up information was received from the registered nurse. She mentioned the patient was 66 year old. The wrong vaccine was administered due to human error and computer error. She noted that the computer system was new within the last coupe of months. The nurse indicated that the provider "heard shingles" but it "came through" as VARIVAX (Merck). She said that the provider selected VARIVAX in error. The nurse added that the label intact and that it was not due to a label error. She also reported that the patient returned 2 days after receiving the vaccination with an adverse experience of injection site redness and warm to touch. She indicated the red area measured 2.5in x 3in. The patient had recovered from the events. Additional information has been requested.
Skin rash, I search it and it looks similar to seborrheic dermatitis, I have never had this breakout, consequently I attribute it to the Covid vaccine, I get relief with Tar soap but it is not a cure
Night sweats; This is a spontaneous report from a non-contactable consumer reporting for herself.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced night sweats on 13Jan2021. The outcome was unknown  No follow-up attempts are possible. Information on batch number cannot be obtained
Got 2nd vaccine and redness keeps spreading R arm. 4/10/21 at 1130p. Noticed 4/11/21 that redness expanded past bandaid. Got 2nd pfizer vaccine. States it itches. A little tender to touch. Moving does not hurt. Took an OTC off brand of zyrtec today. Does have clobetosol at home placed on it this morning- no better or worse. States woke up this morning and felt like it was still getting bigger. Thinks has gotten bigger still.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 20-MAY-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. The medical assistant reported that the patient was administered the second dose of GARDASIL on 18-MAR-2014 and the third dose of GARDASIL on 20-MAY-2014. No adverse effects were reported. It was reported that therapy with GARDASIL was not discontinued. the outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Case number PHEH2014US025146, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 45 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
16AUG96 phone call from om rt arm swollen size of baseball @ site of shot;advised to put warm compresses & check w/FMD;23AUG96 arm turned a brownish color;did not go to MD-arm OK;
period - 1 week earlier than expected.; Aching and pain in right wrist; feels bruised and hurt to move; Extreme fatigue; arm pain/aches; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727) via an unspecified route of administration in the right arm on 23Mar2021 at 20:00 (at the age of 39-years-old) for COVID-19 immunisation. The patient medical history was not reported. The patient reported there were no allergies to medications, food or other products. The patient concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), vit-d (MANUFACTURER UNKNOWN)  (MANUFACTURER UNKNOWN, Org bound minerals (MANUFACTURER UNKNOWN. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, within an hour of receiving the vaccine the patient got her period - 1 week earlier than expected. Within 20 hours, the patient began experiencing aching and pain in right wrist which feels bruised and hurts to move and is a bit swollen. No injury has been reported. Also, the patient experienced extreme fatigue immediately following the vaccine and through today and arm pain/aches as expected. It was reported that there were no treatment medications taken for the reported events. The clinical outcome of the events irregular periods, wrist pain, extreme fatigue, pain in arm, feels bruised hurt to move the wrist was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Red/hot/hard/itchy/lump with swelling diffuse 10x9cm.
She got tinnitus after each of her two Covid vaccines. The first time lasted  about a week and then thankfully went away. After the second one, she once again got tinnitus. This time lasted about a week and a half. Mosty in the right ear both times, but occasional in the left, as well. Thankfully it went away again as a more full-time thing, but she does still get twinges of it.