chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness in the arm; high blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "tenderness in the arm"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high blood sugar". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the patient got her first vaccine shot and the next day, she had a funny thing happen "but it was not the shot". She is experiencing a high blood sugar and tenderness in the arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately following the administration of MCV & HPV vaccine child appeared to have petit mal seizure - eyes rolled back, pale skin tone, arched back, arms & legs extended. Child became coherent approximately 45-60 seconds after event commenced.
Pt recvd MMR vax as a child; pt currently wxhibited a lack of response to mumps; no further details were provided;
Notes reaction after Tdap vaccine, received in office 7/16/18. Reports her arm is itchy and hurts, warm to touch in the area of injection. Also notes swelling at site of injection and body aches.  Reports having a low grade temp. States she took off work yesterday. Today at work. Reviewed above with Physician. Can apply ice to site of injection. Patient is Gravida 2, para1001.
A few hours after injection my tongue started to feel sore, almost as if I had scorched it.  The following day it continued to be sore but only on the side the injection was given (right), it also developed a purplish blister in the area where it is sore.  I had my injection on 03/16/2021 today is  03/18/2021 and the blister and soreness is still there.  I can still eat and drink normally, it is just uncomfortable to do so.
Palpitations started approximately 24 hours after injection.  Captured arrhythmia on iwatch later that day as bigeminy PVCs.  No heart history or arrythmias prior to this day.  Symptoms continued several episodes a day for 2 months, increasing in frequency and duration after the second shot on 1/11/21.
Approximately 2 hours after receiving the immunizations patient began feeling  feverish (hot, sweaty, chills), he also had onset of headache and dizziness with reported near syncope in shower.
COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
In March 2000, the pt developed a mild case of chickenpox consisting of approximately 40 lesions. It was also noted that the pt had a mild fever and not ill. Follow-up information from a nurse practitioner reported that on approximately 03/10/2000 the pt recovered.
Information has been received from a licensed practical nurse concerning a 12 year old male who on 10-JUN-2010 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (LOT# not reported) with no adverse symptoms reported. The nurse reported that the patient was intended to receive his second dose of VARIVAX (Merck); was inadvertently administered the ZOSTAVAX (Merck). Follow-up information has been received from the licensed practical nurse concerning the 12 year old male with no illness at time of vaccination (school physical) and no drug allergies and no medical history who on 10-JUN-2010 at 16:34 was vaccinated subcutaneously in left deltoid with a single dose of ZOSTAVAX (Merck) (LOT# 664671/0149Z). Concomitant therapy/vaccination received at the same time at 16:34 included the fifth dose of ADACEL (LOT# C3446AA, IM, at right deltoid) and a dose of APLISOL (lot number 94775, left forearm, intraderm). The patient didn't experience any adverse event. No further information is available.
tip and sides of tongue felt numb approximately 30 minutes after dose. left side upper and bottom lip gradually became numb as well over the course of the afternoon and evening. approx. 24 hours after dose, numbing sensation started presenting around left eye and eyelid.
This spontaneous report as received from a registered pharmacist refers to a an approximately 59 year old female patient with penicillin allergy and no pertinent medical history. On 20-AUG-2012, the patient was vaccinated subcutaneously in the left arm with, 0.65 ml ZOSTAVAX lot: 0071AE exp: 03-APR-2012. No concomitant medications were reported. Pharmacist stated a patient received ZOSTAVAX and at the injection site it looked like a "bee sting". The size was 2.5 inch diameter across at the injection site. Within the 2.5 inch diameter across at the injection site, the middle portion was red, raised and 1.5 to 2 inches in diameter surrounded by another 1/2 inch diameter that was lighter in color. The patient also was not feeling perfect. The patient sought medical attention by visiting the pharmacy. Labs were not performed. No treatment for the event was given. At the time of the report, the patient was recovering. Additional information has been requested.
Every muscle and joint in my body hurt, and I was coughing constantly.  It lasted all day, the day after the shot.  I slept a lot during the day, it still hurt when I went to bed for the night, and I woke up feeling fine the next day.
Rash noted on Left arm about 4 days after vaccine. Raised rash has now spread to chest. Temperature currently 37.5. Contacted PCP today via telehealth.
Rapid heart beat; Stomach issues; Develop a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), ABDOMINAL DISCOMFORT (Stomach issues) and VACCINATION SITE RASH (Develop a rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), ABDOMINAL DISCOMFORT (Stomach issues) and VACCINATION SITE RASH (Develop a rash at the injection site). At the time of the report, HEART RATE INCREASED (Rapid heart beat), ABDOMINAL DISCOMFORT (Stomach issues) and VACCINATION SITE RASH (Develop a rash at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided.
Lymph node in my neck, same side as I got the injection, became swollen one week after first shot.   It wiggles, pea size and no discoloration on my skin
PATIENT RECEIVED IN ERROR PFIZER MONOVALENT VACCINE FOR FIFTH DOSE SHOULD HAVE BEEN PFIZER BIVALENT
Fever of 102.4, treated with ibuprofen and acetaminophen since vaccination.  Started on 3/6 Bone, joint, and muscle pain.  Started on 3/6 Sore throat, swollen lymph nodes in neck, ear ache (left). Started on 3/7 Cough and chest pressure, breathing difficulty. Started on 3/7
Complained of dizziness within 5 minutes of vaccine administration, then numbness in left arm from shoulder to fingers about 10 minutes later, then complaining that numbness of left side of face began within 5 minutes of arm numbness.  Taken to ED via wheelchair and placed directly in room for treatment.  Given Benadryl 50mg PO and observed.  Discharged home at 3:39pm.
generalized fatigue, weakness, mild "flulike symptoms"  Date and time of vaccination: (list both if they received both shots): 1st 1/12/2021, 2nd 2/3/2021 at 0730  Brand and lot of vaccine: pfizer 1st #eh9899, 2nd #el8982
Employee stated she had racing heart within 30 mins to receiving the flu shot. Was seen in the ER and they stated it was anxiety per the employee. Seen by cardiologist who could only come up with severe reaction to flu vaccine. No previous history when flu shot given in past years.
Patient was given the incorrect vaccine ordered by the PCP  Patient's parents reported no side effects and no abnormal s/s
Upper arm became swollen and hard and hurt. Then a day later it became red. Now soft - reaction about gone.
For 2 days after receiving vaccine he stated he couldn't move. He was in bed other than to go to the bathroom with severe body aches. Stated his thinking was foggy "in la la land". After starting to get his strength back, about 4 days later, he felt so terrible that he started having thoughts of suicide. "I could have gotten a gun and shot myself" He stated he even looked at the glass patio door and wondered how hard he would have to hit it to finish himself off. Stated he was eating right, some grains and protein as well as drinking extra fluids.
Three days after vaccination, I developed a 2-inch radius slightly raised, mildly red, itchy rash that lasted for approximately 7 days. The itchiness and redness were variable in intensity throughout the day and resolved 95% after a week. 3 weeks later, there is still a hint of itchiness but no redness or visible signs of a rash.
This spontaneous report was received from a pharmacy intern concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 09-JUN-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot number L012482 and expiration date 10-APR-2017), subcutaneously for prophylaxis (dose was not reported). No adverse effects were reported.    Additional information has been requested.
POSITIVE COVID-19 HOSPITALIZATION, SHORTNESS OF BREATH AND HYPOXIA
Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.) 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 assessment was provided for PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.).    No concomitant medication details was reported. No treatment medication details was reported.
Pt began experiencing aches, dizziness while walking, chills, and headache on 03/11/2021 at bedtime. Pt began experiencing nausea on 03/12/2021 morning. Pt took Tylenol for symptoms, but received mild relief. Pt was advised to continue taking Tylenol as directed, and if the symptoms worsen or do not resolve in 1-2 days to seek medical care. SPI was consulted and Dr. was notified.
Immunocompromised patient did not received 3rd dose before 1st booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient did not received 3rd dose before 1st booster shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient did not received 3rd dose before 1st booster shot). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient did not received 3rd dose before 1st booster shot) outcome was unknown.            No Concomitant product use was reported.  It was reported that the Immunocompromised patient received first and second shot of the primary series, and the first booster dose of the Moderna COVID-19 Vaccine. The patient stated they recently discovered there was a third primary series dose for immunocompromised patients, but the patient not received it before first booster shot.  The vaccination date, lot number and expiration date were unknown.  No treatment information was provided.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and unknown sex. The nurse reported that on an unknown date, unspecified number of patients were vaccinated with the dose 2 of GARDASIL (lot#, dose/frequency and route unknown) approximately one year after receiving dose 1. No symptom required. Additional information has been requested.
Patient received 2nd dose of Jynneos vaccine at 9:52am to the right forearm, slight redness and rash noted around injection site at the end of patients 15 minute observation at 10:07 am. Patient stated that he had applied pressure to the injection site, prior to the MA and Nurse observing the site. No complaints of pain or itchiness noted. No anaphylaxis symptoms noted. Patient released and he left the facility in no distress. Patient instructed by Nurse to monitor injection site for the redness and irritation, along with being instructed to antihistamines of choice if needed. VIS reviewed with patient prior and post vaccination.
I experienced moderate pain in calves beginning evening of 3/18/21, & sporadically since then.  I began having moderate lower abdominal pain on 3/19/21, lasting approximately 24 hrs.
Pt became weal after receiving HPV injection and was assisted to supine position on examining table. Immediately reported feeling better. Recommended meningitis be with held today. Pt and mother stated pt. needs meningitis for college. Requested immunization today. Meningitis given. Pt then became weak and pale. No improvement. Pt became cold, clammy c/o abd. pain. 911 called. Pt declined stated going to her own private MD. Ambulated out of clinic assisted by her mother. Initial B/P 150/98 P 60 T 96.7 when paramedics arrived B/P 110/59 P 56.
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of red spot at injection site in a 36-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. On 1 October 2013 the subject received a dose of FLUARIX Quadrivalent (.5 cc, unknown route, left arm). On 2 October 2013, 1 day after vaccination with FLUARIX Quadrivalent, the subject experienced red spot at injection site. The vaccination was administered at a "flu shot clinic." The red spot was described as an "8 by 10 centimeters red spot on lower left bicep adjacent to injection site." Diagnostic results included vital signs measurement on 3 October 2013. Per the nurse practitioner, the subject "is currently stable with good vitals." At the time of reporting the event was improved. The nurse practitioner reported that medical attention was not required but the subject did consult a healthcare professional regarding the event. The healthcare professional considered the event was possibly related to vaccination with FLUARIX Quadrivalent. Follow up was received on 21 October 2013 from nurse practitioner. The reporter did not consider this case serious. The event was not life-threatening, did not involve severe of permanent disability, did not involve hospitalization, did not involve a congenital anomaly, and did not jeopardize the patient or require intervention. It was unknown if there were other details that could have been associated with the event. A biopsy was not performed. The reporter indicated that the subject had received the suspect drug before; however, provided no additional details.
One week ago I had the vaccine and had pain at the injection site that night which improved and disappeared in next couple days. Around 7pm one week later, I noticed a small red itchy spot on the injection site. It has grown and is slightly raised now with a two inch diameter. Only this local reaction has occurred.
This spontaneous report was received from a nurse and refers to a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 10-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
Pt received 1st Moderna vaccine at 1428. Was waiting for 30 minutes per protocol d/t hx of allergies (non-COVID meds). At 1521, I (site supervisor) was called in, as patient was being to report sx of adverse rx. Pt A&Ox4, reporting tightness in throat, mild numbness in lips, light-headedness, and pressure "behind eyes". V/S assessed q2min: BP: 145/76, HR: 83,  Sats: 98% on RA, RR: 18. V/S remained stable throughout event. RR called at 1531 - pt had continued to be A&Ox4 able to report symptoms were improving except for light-headedness. Began to demonstrate unusual behavior including slow, vague responses, staring off into space, feeling "weird". 2nd floor clinic staff arrived on scene, assumed immediate care of pt. Doctor assessed pt's V/S, reporte without adventitious sounds. No medications administered. Pt refused to lay supine on floor, stated she was well enough to sit. BP stable, rising slightly - increased to 172/83, HR 89. Increased RR, with shallow breaths, 911 called. Paramedics arrived, pt still in stable condition with what appeared to be disassociative moments - able to answer questions, no loss of consciousness at any  time. Reported swallowing was "easier". At 1546, with paramedics present, pt appeared to "snap out of it" - focused and alert, stating she "feels better" and opted out of going to hospital. Paramedics left, 2nd floor staff returned to clinic, offered to provide taxi voucher to patient. Pt reported she hadn't eaten anything prior to receiving vaccine. At 1600, pt stated "it's coming back" - began having unfocused, disassociative symptoms again. Requested to be sent to the hospital, as she lives alone and was concerned about being by herself. No other change in condition, V/S remained stable, pt responsive at all times, no emergency meds administered. AMR arrived at 1622 and took pt to medical facility via stretcher.
Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice prior to vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. It was reported that the patient was involved in a discussion as to how advisable it was for individuals who have had lung transplants to have the shingrix shots.  The patient incurred muscle pain after the first and no side effect after the second.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252443:Same reporter
Woke up coughing up flim.  It has never stopped.  Still do it daily.  Did not cough up flim before the 2nd vaccine. Went to doctor got steroid shot but it did not help.
Pt recvd 1st dose of recomb on 13DEC90 w/no adverse rxn; On 11JAN91 pt recvd 2nd dose of vax & 2 days later devel generalized urticaria w/pruritis; later recovered & advised not to receive further doses of recomb;