chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients were administered the Moderna Covid 19 Monovalent booster instead of the bivalent). No concomitant medications were provided. HCP stated that they accidentally administered 4 patients with Monovalent booster doses instead of bivalent doses. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650927, US-MODERNATX, INC.-MOD-2022-650934 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650934:Same reporter US-MODERNATX, INC.-MOD-2022-650927:Same reporter
Patient had flu vaccine injection 10/12/05 between 1-2:00 p.m. at work.  Had no symptoms of current illness.  Experienced a seizure that evening approx. 6-7:00 p.m. while at the dinner table.  Body became rigid, LOC, and pt. bit her tongue.  No loss of urine.  No report available of extremity motions. Seen in Emergency department. In ICU for 24 hours then medical floor for another 24  hours.  CT -cranial was negative.  Lab work showed mild elevation of TSH Medical records state cerebral edema. msv
Patient appeared anxious when he came in to get vaccinated. He complained of not really wanting  to get the vaccine, but was compelled by his employer. About 15 minutes after vaccination, he started sweating profusely, complained of dehydration, looked pale and asked to lay down. Ice pack was given to the patient and 911 was called.  EMT checked his blood glucose and was found to be hypoglycemic. He was later transported to the ER by the EMT.
High fever of 104F with vomiting and URI symptoms. This occurred 1 day after F/u vaccine administered. Has had fever for three days. Seen Monday 11-5-01, afebrile.
Blanching red rash, diffuse, spreading out from injection site. Began approx 2 hrs from injection. Treated with OTC Benadryl. Occasional tingling, angioderma around mouth. Disssapated after Benadryl.  Rash is gradually fading and requires less Benadryl to keep in check.  Had similar reaction to Shrinyx vaccine 2 years ago.  Rash lasted 1-2 weeks without Benadryl treatment.
Worsening headache all day starting when she got up. At times the headache would get much worse and then slack off some. Eventually by late afternoon her headache reached a point where she felt like she was getting hit "with a sledge hammer" wich led her to get very dizzy and nauseous. She had dry heaves once. The pain would also make her tramble and sweat.  These continued through the night of 12/22 but had eased some some by the next morning (12/23)returning to a dull headache level again.  Her dizziness had disappeared by the next morning (12/23) but the headache remained to a lesser degree and body aches were added on to the reaction. She did not run a fever.  She remained not feeling well until the morning of 12/24 when she woke up in better condition.  She was treated with Aleve and Tylenol, cool cloths on forehead, and pressure against her head with our hands when the pain was most severe.
Tachycardia; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jan2021 (at age of 79-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included melanoma, high blood pressure, 2 Bad heart valves, aortic insufficiency, pancreatitis, brain tumor, stage 1 Bronchioloalveolar carcinoma/ stage 4 Bronchioloalveolar carcinoma, metastasis into both lungs, atrial fibrillation, hysterectomy, high triglycerides, thyroid obliterated, irregular heart beat, appendix removed, lung cancer surgery, benign meningioma surgery. Concomitant medication included erlotinib hydrochloride (TARCEVA) taken for an unspecified indication, start and stop date were not reported. The patient previously took synthroid and experienced drug hypersensitivity. The patient experienced tachycardia on an unspecified date. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sudden on set severe fatigue lasting 3 hrs - better after drinking bottle of mountain dew.
Flu Vaccine was given with pneumoning without any problems. Noted, about 15min patient came and stated her back hurt. Blood pressure 150/80, Pulse-60 regular rhythm rate. No other signs and symptoms went shopping after.
Passed out within 5 minutes of receiving the vaccine.  Dizziness, skin pale, b/p 80/48.  Transported to Hospital for treatment.
Information has been received from a registered nurse concerning a 57 year old female with no drug reactions/allergies, who on 06-SEP-2007 was vaccinated SC with a 0.65mL dose of ZOSTAVAX (Oka/Merck) (lot number: 658085/0882U).  Concomitant therapy included losartan potassium (MSD) and simvastatin (MSD) and doxycycline (manufacturer unknown).  Subsequently the patient experienced a three inch area of redness and swelling shortly after receiving the vaccination.  When the redness faded the area looked discolored and bruised and then cleared.  Approximately one week ago the patient experienced a red rash with blisters that the patient described as looking like a shingles rash.  The patient also noted that the rash looked like a burn.  The rash had progressively worsened since it started.  The patient was not seen by the physician and the rash had not been confirmed to be a shingles rash.  No lab diagnostics studies were performed.  The outcome was reported as not resolved.  Unspecified medical attention was sought through a telephone call to the office.  No further information was available.  There was no product quality complaint.  On 01-NOV-2007 follow-up information was received from a health professional in the physician office who indicated that the physician did not believe the patient had shingles or any adverse experience related to the vaccination.  The physician felt the patient had a contact dermatitis and referred her to a dermatologist.  Additional information has been requested.
Developed diffuse rash on abdomen of small, pin size red dots within 24 hours of vaccine.; Also developed stiff neck on right side.; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:15 (Lot number: Ff2593) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Eczema-not currently active; "ulcers" (unspecified if ongoing), notes: ulcers 37 years ago; "gall bladder removal" (unspecified if ongoing), notes: gall bladder removal 35 years ago; "facial filler", start date: Jul2020 (unspecified if ongoing), notes: facial filler. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; BIOTIN; VITAMIN C [ASCORBIC ACID]; TURMEE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0171, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 23Apr2021, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0183, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 54 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 09:15, outcome "unknown", described as "Dose number 3"; RASH ERYTHEMATOUS (non-serious) with onset 18Nov2021 11:30, outcome "recovered" (Nov2021), described as "Developed diffuse rash on abdomen of small, pin size red dots within 24 hours of vaccine."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 18Nov2021 11:30, outcome "recovered" (Nov2021), described as "Also developed stiff neck on right side.". Therapeutic measures were not taken as a result of rash erythematous, musculoskeletal stiffness.  Additional information: Was not itchy or painful. Second day the rash was light pink in color. Third day rash disappeared. Also developed stiff neck on right side. Had vaccine in left arm. Neck stiffness continued for about 32 hoursPrior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Follow-up attempts are completed. No further information is expected.
Arm is still sore - right arm; Wiped out; Had fever of 99.3; No appetite; Achy; Lethargic; Felt like crap; Can barely lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Can barely lift my arm), PAIN (Achy), LETHARGY (Lethargic), FEELING ABNORMAL (Felt like crap) and DECREASED APPETITE (No appetite) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Hypertension (High Blood Pressure), Cholesterol, Atrial fibrillation (Afib), Drug allergy (Toredal) and Drug allergy (Cumadin). Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN and LOSARTAN for an unknown indication.   On 11-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced LIMB DISCOMFORT (Can barely lift my arm). On 14-Mar-2021, the patient experienced PAIN (Achy), LETHARGY (Lethargic) and FEELING ABNORMAL (Felt like crap). On 16-Mar-2021, the patient experienced DECREASED APPETITE (No appetite) and PYREXIA (Had fever of 99.3). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is still sore - right arm) and FATIGUE (Wiped out). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Mar-2021, PYREXIA (Had fever of 99.3) had resolved. On 17-Mar-2021, LIMB DISCOMFORT (Can barely lift my arm), PAIN (Achy), LETHARGY (Lethargic), FEELING ABNORMAL (Felt like crap) and DECREASED APPETITE (No appetite) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is still sore - right arm) and FATIGUE (Wiped out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 99.3 (Inconclusive) fever 99.3 for half hour.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021 and contains updated patient demographic details, medical history, concomitant medications, vaccine information, action taken with suspect product, outcome of events limb discomfort, pain, lethargy, feeling abnormal, decreased appetite from unknown to recovered.
Patient described the adverse reaction as starting immediately, symptoms included: Nausea, Vomiting, Diarrhea, GI cramping, Migraine, Dizziness.
Dizziness starting  3 days after vaccination, progressively got worse. During first 2 months, feeling unsteady, like he may fall when getting up from bed or chair, learned to raise body very slowly while bracing, walk with legs wide apart and holding to walls, lightheaded, nauseous, head pressure, headaches, swollen sinuses. PCP had recently left at that time so was unable to be evaluated. Symptoms have gradually improved since, now 6 months later still has intermittent mild dizziness. Had history of intermittent dizziness but last incident prior to vaccine was in 2018.  High blood pressure (up to 140/90) for 6 weeks after vaccine. Relatively elevated for him.  Diffuse erythematous rash that lasted for 2 weeks after vaccine, has since resolved.
Shoulder pain, extreme pain at site, body aches, exhaustion, fever (99.2) weakness, nausea.
Initial report was received from a health care professional staff member on 25 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal injection (lot number, route and site of administration not reported). On an unspecified date, the patient was having trouble lifting her arm. She developed a large red circle, very hot and painful. The pain radiates up into her neck and unable to turn it. The patient neck feels a little better but has other symptoms still ongoing. She was advice to put a cool cloth or ice on the site and see if it would help and after the patient was able to fall asleep. No further informational was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Shingles vaccine given 12/31/2008.  Onset of painful genital ulcerations- two total- on approximately 1/14.  Evaluation in office revealed two isolated well- circumscribed genital ulcerations.  Pt has been married for 40+ years, no sexual activity for over 12 years, no h/o HSV infection - oral or genital-.  Unsure if this lesion could have been related to vaccine.
This is a spontaneous report received from a Pfizer from a contactable consumer, the patient. This 71-year-old female patient reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunization. Medical history included degenerative disc disease, always have pain in lower back and down lower hip and legs, for which once in a while she gets a shot. She stated that she always has the pain, it just acts up sometimes. Concomitant medication was not specified (reported as medication for her disease). The patient reported that she was experiencing terrible pain right now (unspecified date) and asked if she can take pain reliever. The patient is scheduled for the second dose of the BNT162b2 vaccine on 23Mar2021. The clinical outcome of terrible pain was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.
Swelling, sore, redness at site of injection. Had chills for first two days but not currently. Not febrile.
Initial unsolicited report received from a consumer (patient's son) on 17 March 2016. This case involves female patient (age not reported) who was vaccinated with a dose FLUZONE HD (batch number: U5016BA, expiry date: not reported), by intramuscular route in left deltoid on October 2014 and the patient also received a dose of Flu Vaccine (batch number, dose, expiry date, route and site of administration: not reported) on an unspecified date after receiving FLUZONE HD. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as allergies: none as per reporter. Medical history included history of diabetes, elevated blood pressure and illness at time of vaccination was reported as none. Patient was previously vaccinated with flu vaccines several times (batch number, manufacturer, expiry date route and site of administration: not reported) on unspecified dates. Concomitant medications were not reported. On unspecified date, following the vaccination, the patient had developed red area at injection site of left arm and itches at injection site, and repeated scab over, the patient also states that the scabs came off and also experienced shooting type pain in her left arm. At the time of reporting the patient still presented all the events. It was reported that the patient required doctor visit (unspecified date). Laboratory data was not reported. Patient had not received corrective treatment. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
June 2017 Developed uncontrollable rage, headaches, dizziness Persisted for 2 weeks.   July 4th, 2017: Extreme dizziness, loss of appetite,  bedridden for 4 -5 days with flu like symptoms   Following Sunday was hospitalized for 4 days for uncontrollable high Blood Pressure 230/120
10 days after receiving his 2nd shot his right leg from around the knee lost all feeling.  He could not stand nor walk.
Numbness traveling down left arm to palm and fingers (left ring & pinkie finger).  Tingling, heavy feeling in palm and underside of arm.  Intermittent pain rated 5 out of 10.   Blood pressure was 98/54 and pulse was 67 which is normally where it runs.
Patient states she has nerve pain in the arm she  received the injection.  The pain has decreased but it is still present. The pain started shortly after receving the injection.
Unilateral Vestibular Hypofunction in her right ear; Equilibrium Instability; quite sick; Hadn't been well; dizziness; Hadn't been well and didn't get second shot; Nerve Damage; Full episode of vertigo/Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve Damage), VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick) and VACCINATION COMPLICATION (Hadn't been well) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced NERVE INJURY (Nerve Damage) and VERTIGO (Full episode of vertigo/Vertigo). On an unknown date, the patient experienced VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick), VACCINATION COMPLICATION (Hadn't been well), DIZZINESS (dizziness) and INTENTIONAL DOSE OMISSION (Hadn't been well and didn't get second shot). At the time of the report, NERVE INJURY (Nerve Damage), VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick), VACCINATION COMPLICATION (Hadn't been well) and DIZZINESS (dizziness) outcome was unknown and VERTIGO (Full episode of vertigo/Vertigo) and INTENTIONAL DOSE OMISSION (Hadn't been well and didn't get second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported
Information has been received from a physician assistant via a company representative referring to a 16 year old female patient. The patient was not pregnant. The patient had previous history of hives and irritable bowel syndrome. The patient's drug reactions/allergies and concomitant medication were unknown. On 11-AUG-2016, the patient was vaccinated with GARDASIL 9 (intramuscular; dose, lot # and expiration date were unknown). On 12-AUG-2016, the patient developed hives. The patient visited her doctor to seek medical attention. Unspecified treatments were given. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
A) 1 week F/U on knee pain B) 1 week F/U on R-shoulder pain C) Med refills D) Recheck spot on R-hand E) toes and fingers went numb after shots on 11-30-07 6-8 hours later, Felt good next morning, about all day. Sunday pretty bad, coming back Monday, gone by Tuesday wierd deal. Both hands and feet. (Hands and feet all circ went out); Patient also indicates he had trouble breathing next day After shot "like the Flu".
Went to ER with really bad lower GI pain in August. After having a CT done they determined I had diverticulitis. I was put on antibiotics and followed up with my regular doctor but pain has continued (on a much lesser scale) on and off since then. Honestly, I'm not really thinking it's related to the vaccine at all but I received a voicemail after doing my vsafe check-in where I had noted it and was told to either call or fill out this form. I should also note that I had my first shingles shot on July 24th of this year and my mother, who had the Pfizer vaccine, was also diagnosed with diverticulitis 2 months prior to me.
Began with swelling at injection site...initially approximately the size of a golf ball, progressing over next 2 days to approximately the size of a baseball...site was hot to the touch and red and painful.  Swelling began to dissipate on 5th day and after approximately 10 days was pretty much back to normal with the exception of minor itching.
Patient in to receive Yellow Fever vaccination. Patient left clinic room with mother to go to check out. Patient was in check out for five minutes, when per patient hit and slid down the check out door. Elevated patient's feet on chair, and applied cold compress to the back of patient's neck while patient remained on floor. After ten minutes we then let patient sit up and drink some water for five minutes before she stood up. Patient left with mother without any more incidence.
Approximately 24 hours after pneumonia injection in left deltoid, the arm became very red, hot and swollen. Patient described swelling as cottage cheese-like lumps in upper arm muscle. Took aspirin, arms less red and swollen today. Area is not hot to touch.
Day 1 (3/7/21): sever ice-pick like headache right back toward the left front of the head.  Then sever flu-like symptoms including: fever, chills, fatigue, and body aches and pains. Flu symptoms lasted 3 days.  Day 6 (3/12/21): severe head pain like an ice-pick in the back right radiated to the front left, heard a loud humming inside my head, it felt like my head was gyrating, AND my vision in my right eye became distorted and I couldn't move my legs I couldn't feel them - I thought I was having a seizure. After the Day6 event I have had persistent tremors, muscle twitches, weakness in legs, phantom sensations on my left side hand/arm or left leg,  forgetfulness, memory problems, word retrieval problems, constant ringing in ears and nausea.
C/O feeling warm all over and developed a red lacy rash on trunk and extremities.  Benadryl 25 mg tablet PO was given.  BP taken.
CHILLS, MYALGIA Narrative:  symptoms lasted 24 hrs  Other Relevant History:
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.