chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left side of her face felt swollen and numb; left side face swollen; shoulder pain, like a muscle ache at the site of the injection; shoulder pain, like a muscle ache at the site of the injection; headache; funny feeling in her face; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6207 and expiry date was unknown), via an unspecified route of administration, administered in Left arm on 19Mar2021 at 15:30 as dose 1, single (at the age of 44-years-old), for covid-19 immunization. Medical history included ongoing chronic migraine (had chronic migraines for 25 years) and ongoing bipolar disorder (had a diagnosis of Bipolar for 25 years) and Vitamin D low. There was no family history. Concomitant medications included lamotrigine (LAMICTAL ODT) taken for bipolar, oxcarbazepine (TRILEPTAL) taken for chronic migraine and topiramate (TOPAMAX) taken for migraine or bipolar, all 3 were ongoing since unknown dates over 10 years and another concomitant medication ergocalciferol (VIT D) taken for vitamin d low over two months. There were no prior vaccinations (within 4 weeks). There were no additional vaccines administered on same date of the Pfizer suspect. It was stated that the patient got the first dose of the Pfizer vaccine on 19Mar2021 (Friday) at 15:30 in the left arm and reported that she sat for the 15 minutes and right away she got shoulder pain, like a muscle ache at the site of the injection, headache; and on her drive home her left side of her face felt swollen and numb and the sensation went away but it came back. The patient had funny feeling in her face on 19Mar2021. At the time of reporting everything was gone except a slight funny feeling in her face. She was asking should she get the next dose of the vaccine. The patient was not visited to emergency room and physician office for the events. Relevant tests were none. The outcome for the events left side of her face felt swollen and numb was recovered in Mar2021; events of shoulder pain, like a muscle ache at the site of the injection, headache was recovered on 21Mar2021 and event of funny feeling in her face was not recovered.  No follow-up attempts are possible. No further information is expected.
Headache, Body aches, Chills/trouble regulating body temperature, nauseous. Unsure how long it lasted because it was in the middle of the night. I was able to fall back to sleep and felt okay the next morning. I am still feeling a little nauseous and I am very tired because I didn't sleep well as a result of the symptoms but I felt fine enough to go to work.
Initial report received on 07 October 2011 from a healthcare professional. This case involves 1 of a cluster of 2 patients with the same reporter, same vaccine FLUZONE and same lot number UH477AB. Information regarding the other patient is captured in case number 2011-09783. A female patient with NKA (No known allergies) had received an intramuscular injection of FLUZONE on 05 October 2011 and within approximately 6 hours later complained of chills and also noticed a rash on her torso which subsequently spread to her neck, arms, back and thigh requiring evaluated by her physician. Per the reporter, more information will be provided on follow-up. At the time of this report, the patient had not recovered. Follow-up information was received on 09 January 2012 from a health care professional. The patient was a 47-year-old female. The patient had received the injection in the left deltoid. The patient was seen at a doctor's office on 07 October 2011. The patient had no illness at the time of vaccination and took no concomitant medications. The patient's outcome was reported as recovered. Follow-up information was received on 23 February 2012 from a health care professional. The patient had no adverse events after previous flu shots. The patient's outcome remained recovered. Documents held by sender: None.
No motivation; Severe fatigue/always felt tired and it keep coming back; Some tiredness; trouble sleeping; Felt quite sick; Chills; she keeps falling asleep; This is a spontaneous report received from contactable consumer (patient). This 67-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced chills, some tiredness, felt quite sick. This was resolved short after. She had experienced severe fatigue after a couple of weeks after getting her second dose. She exercised regularly 5 days a week but right now she just sat down and kept falling asleep. Sometimes she also had some trouble sleeping. She also had no motivation, always felt tired and it kept coming back and was "driving her crazy." The outcomes of chills, some tiredness, and felt quite sick were resolved. The outcomes of severe fatigue, kept falling asleep, trouble sleeping, no motivation and felt tired were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Vaccine was administered to patient after temperature excursion occurred; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Parkinson's disease, Hypertension and Hyperlipidemia.    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 TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred).    No concomitant medication was reported.  HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within that time line. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
"Moderna Covid-19 Vaccine EUA."  Adverse Effects  were  Fatigue and Body Aches.  after  sleeping the body aches and fatigue went away after 24 hours.
Information has been received from a pharmacist and a medical assistant concerning an 81 year old female who on 08-DEC-2008 was vaccinated subcutaneously with a dose of ZOSTER vaccine live (Oka/Merck) (lot # 663196/1417X).  Concomitant therapy included NORVASC, HYDROCHLOROTHIAZIDE (unspecified), LEVOTHYROXINE SODIUM and LOSARTAN POTASSIUM (MSD).  It was reported that the patient complained of severe itching on her back and she had small lesions on the one side of her back that look like bites started from 25-JAN-2009 to 26-JAN-2009.  It was reported that the patient developed shingles rash.  The patient was recommended to see a dermatologist.  The dermatologist had prescribed a steroid cream and FLUOCINONIDE on 27-JAN-2009, VALTREX on 28-JAN-2009, and BACTROBAN on either 27-JAN-2009 or 30-JAN-2009 to treat the patient's symptoms.  The patient's shingles rash persisted.  As of 02-FEB-2009, the patient was not recovered.  Follow-up information was received which reported that the patient's drug allergies included CODEINE, CORTISONE and PENICILLIN.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain.  The sample of the lesion was collected on 28-JAN-2009.  The sample was taken from a punch excision of skin on the left posterior shoulder.  The findings are suggestive of toxic dermatitis.  The possibility of a drug eruption could be considered, if the clinical picture allows.  The PCR results for the specimen from a punch excision of skin on the left posterior shoulder was negative.  Additional information has been requested. 06/24/09 This is in follow-up to report(s) previously submitted on 3/27/2009. Follow-up information was received which reported that the patient presented on 28-JAN-2009 with a rash on the left shoulder, papulovesicles in a linear distribution. Culture taken was negative. On 02-FEB-2009 a biopsy was performed, results were drug eruption. The patient treated with BACTROBAN and ELOCON compound. Additional information has been requested.
shortness of breath/dyspnea; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0171) via an unspecified route of administration (age at vaccination 57-year) in Left Arm on 22Jun2021 14:45 PM as dose 1, single for COVID-19 immunization. The reported vaccination Facility Type was pharmacy. Medical history included congestive heart failure and COVID-19 from 25Dec2020 to an unknown date. The patient's concomitant medications were not reported. There was no history was reported of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). On 23Jun2021 the patient experienced shortness of breath/dyspnea. The patient states she got Pfizer COVID 19 vaccine at (withheld), Clarified she had the first dose; The next day in the morning she noticed the shortness breath. It gets worse on and off. Today it is worse. Reports today when the aid got here, by the time she got to the shower and tried to get in shower, she couldn't get in the shower, that is how short of breath she was. The patient reports she has been short of breath and can hardly breath. She went to the hospital last night; mentions she already has CHF, congestive heart failure; and she had COVID last year; she had caught COVID in 25Dec2020; but when she got to the doctor, she was not having congestive heart failure; there was no fluid; and no pneumonia. Clarifies she was seen in the emergency room on Wednesday night 30Jun2021 but not admitted to the hospital. While providing family history, caller mentions her sister had the COVID 19 vaccination and also had shortness of breath. A clone report is created to document the sister's experience. This is report one of two. The patient underwent lab tests and procedures which included chest X-ray: negative and electrocardiogram: negative on 30Jun2021. The clinical outcome of the event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021832272 same reporter/drug/event, different patient
This spontaneous report as received from a licensed practical nurse refers to a 11 year old female patient. In approximately 29-JUL-2013 the patient was vaccinated with her first dose of GARDASIL 0.l5 ml, lot # unknown, intramuscularly. In approximately 29-JUL-2013, the patient experienced fever, feeling bad, joint pain and a hard time getting down the stairs. The patient sought unspecified medical attention. No treatment was given for the events. The outcome of the events was unknown. Additional information has been requested.
The next morning after the shot I had a sore arm with mild or moderate pain, redness and swelling where I got the shot. Later in the day around 4:00 PM I began to feel tired, my body ached all over kind of like when you have the flu. (Which I Do Not Have) muscle pain, 99.4 fever, some stomach pain, and a shooting pain in my right big toe that began about 5:00 PM this evening. My body felt light and also like it had a led weight attached to it, just not feeling well.
pt recvd 2 doses of Engerix-B & following 2nd dose, devel inflamed rash on face & scalp on 16JUN92; tx w/DPH for 2.5 days & cortisone cream on face; seen by staff MD, will be seeing a dermatologist;
Severe swelling, discoloration, and soreness around injection site (left shoulder). Symptoms persist seven (7) days after injection.
Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in right deltoid. Per dad in phone call on 1-18-2013 she is doing fine with no reactions.
Patient fainted a few minutes after receiving the vaccine. She was fine after a couple minutes and declined to have ambulance
Pt called clinic today and stated that she had MMR vaccine last 01/16/2002. Yesterday she noticed red rashe on her face, truck, and back area. Pt denied temperature and stated that she had mile joint pain in legs and arms.
Coughing, wheezing, rash on cheeks, decreased pulse ox (92-94%), vomiting x2, gave epi pen jr 0.15 mg. Oxygen saturation increased. 911 was called took to hospital.
14y/o M was in a sitting position and right after the HPV vaccine, fell forward hitting his head on the floor.   Ice pack applied to forehead VS WNL  O2 99-100 % RA, BP 113/71, P 81 at this time.  Vaccines given at 3:45pm. Bump noted to left forehead. Pt stated he did not eat all day. Never fainted from vaccines in the past.
Rapid HR with ringing in ears, dizzy, high blood pressure, approx., 10 minutes after injection.  Symptoms went away without intervention at 30 minutes post injection. Became short of breath with elevated heart rate and blood pressure again approx. 45 min.  post injection tat worsened when standing, walking or talking, HR 143 BP 229/127 I was sent to the ED to monitor had a EKG, Benadryl, Pepcid, Then I  had sinus tachycardia  in ED, stayed until approx. 4 hours past injection. Symptoms resolved at time of DC
MEDICATION ERROR (ADMINISTERED 1 CC); OFF LABEL USE; This spontaneous report received from a health care professional concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 30/DEC/2069) dose was not reported, administered on 22-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject had medication error (administered 1 cc) and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error (administered 1 cc) and off label use was not reported. This report was non-serious.
About a week after first vaccine developed swelling in her left foot.  About a week after the second vaccine  she experience vaginal bleeding (blood clots).  Subsequently was placed in home hospice, given opioids and died
1st dose really sore at injection site 2nd dose:  3-4 hours after receiving shot felt lightheaded for a few minutes, 8 hours later left arm, shoulder and face was very sore and stiff, chills but no fever, body aches, joint pains, lethargic for 2-3 days after the shot.
12/13/2021 Vaccine administered 12/21/2021 Unusual headache, dull and persistent, located around the ear, jaw, temple 12/22/2021 Continued severe headache, ear pain, jaw pain 12/23/2021 Loss of feeling in tongue 12/24/2021 Visit to urgent care, prescribed Amoxicillin, diagnosed for possible sinus infection, severe headache overnight, discovery of paralysis of right side of face, most noticeably right eye. 12/25/2021 Visit to ER, diagnosed with Bells Palsy, prescribed steroids, anti virals 12/26/2021 (current) headaches have subsided, medications taken, paralysis continues but has not spread
approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like hamstrings were "pulled" and shins and ankles in pain as well.  In addition, overall body fatigue, feeling exhausted.  All symptoms continued for approx 36 hours, gradually ending after 48 hours
Two issues after the vaccine: 1. Right arm pain started after the second dose and continue for six months, but it started after all boosters  2. After third dose I got the Tinnitus and it continues till today
Shaking chills, severe frontal headache, severe neck pain, body aches.  Shaking chills lasted approx. 2 hrs. Headache still present next morning.
I went to the ER at Clinic where I had the kidney transplant done on August 6, 2021. In January 2022 I had caught COVID. I had a fever, runny nose, and a cough. I had the monoclonal antibody infusion on January 14, 2022.
Patient was vaccinated and reports systemic side effects of muscle and body aches for about 1 week post vaccination. Patient was admitted for a broken hip and heart failure was incidentally found with an echocardiogram that was previously normal in 2017.
Stated, "5 hrs after injection arm extremely sore, made it difficult to sleep at night, 2nd day after injection had to use R hand to lift L arm above head, ran fever off and on for 3 days. Used Motrin daily for last 3 days. No c/o redness but had a very small bump at injection site. Rcd injection is same arm dislocated 17 years ago. Feel there might be some decrease in pain today" Client referred to Dr. if doesn't continue to see improvement.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for an unknown indication.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medication were reported No treatment medication were reported.   This case was linked to MOD-2021-395985.
Fever, chills, generalized body malaise, blurry vision, facial break outs (blemishes), localized soft tissue pain, induration and swelling at injection site. Admitted to hospital for observation. Pt recovered. 10/16/09 Hospital records received for dates 9/24/09 to 10/3/09. Pt seen in ER 9/24 DX: Contact Dermatitis. Presenting SX: vision changes, HA, sweating, itching after receiving Flu vaccine same day. Assessment: some burry vision noted, facial rash on forehead. tx and dc. Pt seen in ER on 9/25/09 with c/o achiness, chills, fever, decrease weight. DX: Acute URI. Assessment: WNL except erythematous rash on forehead. tx and dc. ER visits on 9/26/09 Presenting  SX: c/o right limb pain, swelling, painful lump on right pectoral area, right shoulder pain. Pt was admitted to hospital for observation and r/o testing. DX: Acute URI, myositis, asthma. Assessment: (+)right deltoid swelling, (+)induration. Pt treated and stable at time of dc. Diagnostics/Labs: CXR(-), right shoulder xray(-), EKG(-), UA (+)blood, WBC 13.6(H), PTT 24.9(L), platelets 142(L), neutrophils% 69.2(H), lymphocytes% 18.1(L),  WR CRP 27.36(H) PMH: smoker, appendectomy at age 14, dental implants at age 37. ICD9 codes: 995.3, 692.9, 465.8, 728.0, 493.90
Received vaccine at 12pm on 12/23/20. I had severe back pain on 12/24/20 and on 12/25/20 I woke up with itching all over body  but did not pay much attention, that night at around 8 pm I noticed hives on my face. Took some OTC Benadryl and went to sleep.  The next day on 12/26/20, I woke up and my body was completely covered in hives, took some more Benadryl without improvement. I took a nap after taking benadryl, woke up and hives started progressing, had chest pain, chest tightness and hand swelling so I decided to go to Urgent Care. I was given a steroid injection and was sent home w/ prednisone, epipen and Diphenhydramine.
34 months old male inadvertently received the second dose of expired Moderna infant at around 9:30 AM on 9/6/22. The vaccine expired 34 hours from the manufacturer's recommendation date on 9/4/22.
Restriction of movement in left arm and severe pain in deltoid muscle beside bicep where the shot was administered.  When I move my arm in certain motions such as putting on a shirt/jacket, it feels like I am tearing/pulling the deltoid muscle. This only started filling the 2nd jab. Initially thought it was just sore from injection and would fade after a couple of days. It gradually got worse and still experiencing the pain nearly 6 months later. Now visiting a chiropractor who told me there are aware of about 15 other similar cases locally and the Covid shot seems to be the common denominator. I am only submitting this report now because I initially thought the pain was coincidental but it seems there may be a connection.
Had stinging in arm upon injection. Had a softball sized lump on injection site and had red layer around injection site as a hotspot. Put hydrocortisone on bump for itching. Has had cellulitis before. Moderna second dose, still has bump, red spot as big as 2 ½ inches. Has a fever of 99.7.  Doctor has asked her to continue with cortisone and has prescribed steroids.
High fever; Headache; Vomiting; This is a spontaneous report from a contactable Nurse via Pfizer Sales Representative. This Nurse reported same events for 4 patients. This is report 4 of 4. A 16-year-old patient received meningococcal group b rlp2086 (TRUMENBA, injection) on an unknown date via Intramuscular in one arm at single dose (Batch/lot number: Unknown) for Meningitis serogroup B vaccine and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Injection) via intramuscular injection in the other arm at the same time with trumenba at unknown dose for vaccine. The patient experienced the symptoms included high fever, headache and vomiting. Outcome of the events was unknown. Seriousness and causality between with events and trumenba and menactra were not provided.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020279270 same reporter, same drug, same event, different patients.