chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; dizzy; sweaty; lethargic; difficulty standing; weak leg muscles; sore arm,; jittery; low grade fever; aches and pains; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic) and DYSSTASIA (difficulty standing) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), PAIN IN EXTREMITY (sore arm,), FEELING JITTERY (jittery), PYREXIA (low grade fever), MYALGIA (aches and pains) and FATIGUE (fatigue). On 21-Mar-2021, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), MYALGIA (aches and pains) and FATIGUE (fatigue) had resolved, PAIN IN EXTREMITY (sore arm,) outcome was unknown. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown. Not Provided          Treatment medication included Ibuprofen and Tylenol. Concomitant  medication were not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079100:1st dose vaccine
felt like a bee sting, barely could feel it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 (Lot number: EN6201) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "depression" (ongoing), notes: diagnosed 32 years ago; "bipolar" (ongoing), notes: diagnosed 32 years ago; "asthma" (ongoing), notes: diagnosed 32 years ago; "high blood pressure" (ongoing), notes: diagnosed 5 years ago; "anaphylaxis to MRI contrast " (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX taken for bipolar disorder (ongoing); GABAPENTIN taken for depression (ongoing); PROZAC taken for depression (ongoing); LISINOPRIL taken for hypertension (ongoing); EPIPEN taken for anaphylactic reaction; VENTOLIN ACCUHALER (ongoing). Vaccination history included: Bnt162b2 (First dose: , LOT: EN6201, Injection, right upper arm, unknown dosage, Verbatim: right arm got sore (From: 12Feb2021 To: 13Feb2021)), administration date: 12Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "right arm got sore". The following information was reported: PROCEDURAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "felt like a bee sting, barely could feel it".  Additional information: It was reported that the patient taking Pfizer Covid 19 Vaccine because she believes in it and because she has asthma and wanted to get it early. Concomitant Products was ongoing Daily vitamins and Ventolin Inhaler. Caller states she also carries an EpiPen because she had anaphylaxis to MRI contrast and before she even had the vaccine, she talked to Pfizer and the FDA to make sure there was no matching ingredients and none of the ingredients were the same so she went ahead with it. First dose on 12Feb2021 with sore arm started within about 2 hours then it was gone within 24 hours. Confirms started 12Feb2021, ended 13Feb2021, and has recovered completely. Reporter seriousness for Second dose for felt like a bee sting, barely could feel it was Unspecified.  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Pt reports she had allergy induced asthma. Evening after vaccination, had wheezing, cough, SOB. Called her Dr. and her placed her on steroids.
This case was reported by a consumer via call center representative and described the occurrence of upper back pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 26th September 2018, the patient received SHINGRIX .5 ml and Influenza vaccine Quadrivalent 2018-2019 season. In September 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced upper back pain. On an unknown date, the outcome of the upper back pain was not recovered/not resolved. It was unknown if the reporter considered the upper back pain to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The reported stated that she was having a lot of pain in her upper back. The pain started after she received the SHINGRIX and flu shot in the right arm 50 mcg the day before reporting. Flu shot received in left arm at the same time. The reporter was unsure of which flu vaccine was received. The reporter given permission to contact physician.
Same day post vax, the pt experienced pain in his leg. The pain persisted and on 12/16/99, the pt was seen by the physician.
40 mins after receiving MMR, pt returned with c/o twitching right leg, hot flashes feeling of tongue swelling and difficulty swallowing taken to ER.
Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of VARIVAX (Merck) (strength, frequency and route unknown, Lot# L017998 with Exp. date 19-MAY-2017, Lot# L007224 with Exp. date 30-MAR-2017, Lot# L009205 with Exp. date 17-MAR-2017). The vaccines were expose to 30.9F for 11 hours and 50 minutes at first excursion; and then exposed to 9 F for 3 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red,blotchy generalized rash and lethargy noted day after vaccine. Evaluated in Urgent Care, and sent for consult with allergist. Dr. prescribed course of prednisone and recommends employee not receive second dose. Dr. notes that employee has had positive COVID titers in the past.
Received TIV (IM) on 11-18-10. On 11-20-10, while deer hunting developed SOB, profuse sweating, muscle cramps in both arm & hands. "Could hardly stand up to walk" weakness. Hx of DM - states blood sugar OK. States my heart is OK. Went home - took BENADRYL. Subsided.
NO ADR, timing ERROR Narrative: 57 days between 1st and second dose.
On April 27th, I went to local ER with acute shortness of breath.  X-ray and CT scan showed possible fluid build up in lungs.  I was admitted to hospital on April 28.  Echocardiogram diagnosed heart failure, ejection fraction was 25%.  Pulse was also quite high (120-135), and blood oxygen was low (88-90%).  Cardiac catheterization showed no blockages in coronary arteries.  Echocardiogram, EKG, and bloodwork were negative for heart attack.  Ultimate diagnosis from doctor was idiopathic cardiomyopathy.  Currently taking several medications and under care from primary care physician and cardiologist.  At follow up appointment with primary care following discharge, she suggested I report the incident out of an abundance of caution.
Significant stiffness in finger joints, wrists, both hands.  Intermittent swelling of finger joints , especially thumb. Stiffness worse in morning and night.  Being treated via physical therapy. On going from 4/2/2021 to present.
employee woke up at 430 am on 02/05 with report of difficulty swallowing , swelling of left side of face m neck and left upper extremity. Left arm also with numbness and tingling. Also with report of difficulty swallowing as she felt her throat was swollen  Reports " a big ball like mass" on left armpit and left neck .  Self administered epipen , Benadryl and Motrin
Five patients experienced fever, chills, nausea and vomiting within 48 hrs after immunization.  All pt received immunizations from the same vial between 6/1/89 & 6/15/89. One of the five pts treated w/tylenol & compazine.
Information has been received from a physician concerning a 64 year old female with no pre-existing allergies or medical conditions who on 02-OCT-2007 in the A.M., received a single dose series subcutaneous in the right arm of Zostavax (Oka/Merck) (lot#658082/1744U). There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. On 03-OCT-2007, the patient developed reddness, swollen, hot, and itchiness at the injection site. The patient sought medical attention by a physician. No lab or diagnostics studies were performed. On an unspecified date the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
red rash on neck/chest; hives on arms/feet; Tingling sensation in tongue (swelling); Feeling hot and flushed facial area; Dizziness; Burning in feet; Increased blood pressure; Tingling sensation in tongue (swelling); This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6208) via an unspecified route of administration on 02Apr2021 at 09:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were none. The patient had unspecified allergies. On 03Apr2021 at 10:00 the patient experienced dizziness, burning in feet, red rash on neck and chest, hives on arms and feet, "tingling sensation in tongue (swelling)," feeling hot and flushed facial area, and increased blood pressure. She had no history of hypertension. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited an emergency department or urgent care as a result of the events. The patient received treatment with steroids and antihistamines. The outcomes of dizziness, burning in feet, red rash on neck and chest, hives on arms and feet, "tingling sensation in tongue (swelling)," feeling hot and flushed facial area, and increased blood pressure were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
High fever 102.8  Chills No heard ace no body pain. Lasted12.5 hours
No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; Information has been received from a nurse prescriber referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 17-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S028920 with expiration date 16-SEP-2021 for prophylaxis (dose number, exact dose and route of administration were not provided) (product storage error). The sterile diluent (STERILE DILUENT) ( (lot number and expiration date were not reported) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly.  The temperature excursion was not reported and was for a time frame of 1 second. There was previous temperature excursion reported: the temperature excursions were from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes. The digital data logger was involved. No adverse effect was reported.
Left arm is red, swollen, warm to touch. Following up with PCP on 10/10/17.
Pt recvd 1st dose of vax 11FEB91 & the following day exp severe local pain secondary to reflex sympathetic dystrophy; pt devel swelling of lt hand; Pt exp necessitated a visit to MD; pt was given meds & recovered;
start to have fever, chill, and body ache after 8 hours later (99-102) , last for 36 hours
I developed Bell's Palsy, paralysis on my left side of my face. This occur 3 weeks after I receive my first dose of the Pfizer vaccine. I could not close my left eye, inability of smile, drooling, facial distoration,  difficulties in eating.
She has experienced no adverse event.   This patient was evaluated in clinic yesterday (12/7/22).  We had a discussion regarding her COVID vaccination status.  During the course of that conversation, there apparently was a miscommunication between myself and the husband (patient is cognitively impaired and unable to provide a reliable history).  I understood that she had received a second dose of the primary series at an outside facility and this is why there was no record of it in our electronic medical record.  As such, I recommended she receive a Moderna booster.  She was subsequently given a bivalent booster at the time of her visit.  It later came to my attention that she had never received the second dose of her primary series.  After researching this particular scenario on the CDC website and discussing this with our clinical pharmacist, I think the most appropriate course of action would be to administer an additional primary dose sometime within the next 8 weeks.  There appears to be some discrepancy between when it is advised to administer this dose, but nonetheless I did recommend she receive a another dose of the primary series.  To further complicate the picture, the patient did contract COVID approximately 3 months ago, which from an antibody production standpoint would result in a similar outcome as a second primary dose.  However, as this is considered a vaccine administration error and reporting is strongly encouraged, I did report it to the vaccine adverse event reporting system (VAERS).
Developed sudden onset of severe abdominal pain late morning on 1/23/2021. Diagnosed in the ED early afternoon.  Received palliative care due to DNR status. Died around 5 am on 1/24/21. Death due to thrombosis of the superior mesenteric artery.  Also multiple clots in both lungs and also in the gut. Clot in heart.
Patient received the first dose of Shingrix in 2018 and did not receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a unk patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 2018 prior before reporting).   On an unknown date patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On 23rd June 2022, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date :23rd June 2022 Reporters comment: The reporter did not consent for follow-up and did not provide adverse event details by the health care professional. The health care professional does not consent to follow up by safety team. Adverse event contained all information provided by the reporter. Additional Supportive information: The patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination
generalized weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (generalized weakness) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ASTHENIA (generalized weakness) and PYREXIA (Fever). At the time of the report, ASTHENIA (generalized weakness) and PYREXIA (Fever) had resolved.            Treatment drugs were not provided
"welt" at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient received a dose of Shingrix and developed a welt at the injection site.  The reporter did not consent to follow-up. The healthcare professional declined to provide any further information at this time.  The healthcare professional stated that she would call back later when she had more time.
patient had syncopal episode at work the day after recieveing Moderna booster covid-19 vaccine. patient rested and took day off work and now has no symptoms.
Pt vaccinated with Recombivax developed weeping rash scalp, face around hairline, sides of neck,lower arms & hands. Began 12OCT90 cleared in approx. 2 wks. Severe itching.
At the injection site I developed a red patch about 2 inches in diameter, an itching developed at the site, and it became warm to the touch, with slight swelling  and soreness. Within 48 hours all symptoms were decreasing. As of right now, about 51 hours after first noticing this I feel it is resolving.
4/2/21 pt c/o tingling in hands bilat. pt was moved to exam room and monitored for a total of 25 mins post vaccination. During that time pt was lying down the whole time, no other symptoms or signs were noted. 4/29/21 the day before her 2nd dose Pt called stating that she experienced hives, swollen throat, and itching after receiving her first covid vaccine for about 3 hours while at home, from 4/2-4/5/21 she states she had loose stool, nausea, and loss of appetite. Pt stated symptoms improved with benadryl.
Extreme soreness in sholder.  Dull pain when rotating left arm clockwise or counterclockwise, when lifting arm. Ache arm wakes me up at night when I roll from side to side.
1 week after vaccination developed shingles. Pt had flu vaccination at the same time. I do not have the information about which flu vaccination he had.
4/9/21 Vaccination Center At approximately 1115 while observing people post vaccination I was summoned by companion to assist pt who was ?feeling faint?. On arrival person was conscious and responsive, pale, diaphoretic, with eyes closed, verbalizing he felt like he was going to faint. BP measured at 77/41, HR via O2 Sat device 39-44. Person coached to take deep breaths, able to transfer with assist of one to wheelchair, transported to observation room, self transferred to stretcher and placed in supine position with HOB approximately 20 degrees. BP 91/54, HR 51. Person verbalized immediate relief when positioned on stretcher. Monitored for 20 minutes, BP 133/61, HR 64. Assisted to sitting position on stretcher, tolerated cranberry juice and graham cracker. Self transferred to wheelchair where he was transported to main waiting room, observed for 20 minutes. Person reported return to baseline, ambulated independently out of vaccination center. Person remained conscious throughout.
Tongue & toes tingled, Weak all over the body, & sharp pain in the head. Took Benadryl at 7:00 and symptoms subsided.
Eyes were red, swelling and itching. Rash on eyelids. Mildly dizzy. Injection site mildly red and swollen.
Patient received her vaccine and was being observed in the observation area upon becoming diaphoretic, pale, clammy and not looking well. RN approached asked if she was having difficulty breathing and pt reported yes. initially unable to obtain pulse or 02 reading. BP 58/38 and Epi injection was administered to the right outer thigh. Patient color and vitals started to improve and breathing was better. patient also was placed on cot in supine position initially. Last set of vitals prior to EMS arriving was BP 84/72, p-71, 02-99% and respirations are 22.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-FEB-2018 the first patient was vaccinated with 2 doses of expired PNEUMOVAX 23 (dose, frequency, lot # and route were not reported) (expiry date: 04-FEB-2018) for prophylaxis. No adverse event reported. Product quality issue was not involved. The outcome of events was not provided. The relationship between the events and PNEUMOVAX 23 was not provided.
Lightheadedness, severe dizzy spells, upset stomach (constant), eyes hurt. Given script for: meclizine 12.5 mg tabs.
Double Vision(sideways), Was diagnosed as 6th nerve palsy, later resolved on its own after 4-6 weeks Severe Headaches with distinct feeling from normal headaches Headaches ongoing, being managed with gabapentin 300 mg/3 times a day  Reading or looking at screens triggers the headaches in short duration despite the medicine  As a result of the adverse event, the patient was forced to apply for short term disability at work.(The job requires constant use of computers)
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, fever and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, fever and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the pain in arm, fever and influenza-like symptoms to be related to Shingrix. Additional information was received as follows: The age at vaccination was not reported. The patient felt soreness up and down her arm. The reporter stated that additionally, it felt like a fever blister on mouth coming but it never came. The patient felt better 4th day after adverse events. The patient would like for someone to call as she was very concerned about taking the 2nd dose of Shingrix.
I had a lot of coughing. I went to bed then I had shivering, chills, and fever of over 100 off and on. I went to the clinic and tested positive and they prescibed me Paxlvoid. These symptoms lasted for 5days.
Initially had some warmth and redness on the injection site which as now resolved. <1cm subcutaneous nodule palpable in (L) anterior thigh remains.
Slight headache, chills, fever of up to 101.6 for 3-4 days & very painful underarm !