chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anxiety prior to scheduled appointment for 2nd shot; Dizziness; vision seems off; tightness in throat; head feels tingly; Heart pumping fast; Anxiety after first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly) and PALPITATIONS (Heart pumping fast) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and VACCINATION COMPLICATION (Anxiety after first shot). On 03-Sep-2021, the patient experienced ANXIETY (Anxiety prior to scheduled appointment for 2nd shot). On 07-Aug-2021, VACCINATION COMPLICATION (Anxiety after first shot) had resolved. At the time of the report, DIZZINESS (Dizziness), VISUAL IMPAIRMENT (vision seems off), THROAT TIGHTNESS (tightness in throat), PARAESTHESIA (head feels tingly), PALPITATIONS (Heart pumping fast) and ANXIETY (Anxiety prior to scheduled appointment for 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Heart rate: high (High) Heart pumping fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant Follow-up include event of Anxiety .
Patient stated her vaccine was given high up on her shoulder and she experienced arm pain for about 2 months
19 year old female with a history of tachycardia syndrome (on carvedilol) presented to ER with acute chest pain radiating to jaw and bilateral arms. Episode occurred 3 days after second shot of Pfizer COVID vaccine.
12 hrs after vaccination I developed flulike symptoms- chills, aches, fatigue, headache. It was over 24 hrs later.
couldn't even walk from kitchen to living room; almost collapsed in the kitchen; extremely fatigue; Joint pains; Fever around 100; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't even walk from kitchen to living room), FALL (almost collapsed in the kitchen), FATIGUE (extremely fatigue), ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FATIGUE (extremely fatigue), ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100). On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't even walk from kitchen to living room) and FALL (almost collapsed in the kitchen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Apr-2021, ARTHRALGIA (Joint pains) and PYREXIA (Fever around 100) had resolved. At the time of the report, GAIT DISTURBANCE (couldn't even walk from kitchen to living room) and FALL (almost collapsed in the kitchen) outcome was unknown and FATIGUE (extremely fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-083581 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083581:
So, on the night of November 10, 2021 I had severe reactions to the COVID Vaccine for 2.5 Days. After (7) hours of receiving the Vaccine, I work up at midnight in my bed freezing cold, shaking, teeth rattling. I had severe pain & pressure in my neck (spinal cord and head). I felt like I went into a paralysis for 30 minutes to an hour. I was crying and had to bite down on my comforter to prevent myself from breaking teeth. I had body aches, stomache ache, no energy, head ache, back ache, neck ache, for 2.5 days. I had fever and chills. I had a sore arm for 5 days.  Had headache, body pain, chills, fever, back ache, neck ache, no energy, etc. for 2.5 to 3.0 days.
I had an incidental finding of a small asymptomatic pericardial effusion on a CT scan in the ER due to abdominal pain.  (Abdominal pain was of unknown origin and the pericardial effusion was incidental and asymptomatic).
ON 12/24/20 AT 11:30AM DEVELOPED SORE ARM AND MINOR HEADACHE LASTING 2 DAYS.
Given incorrectly as 2nd dose of primary series. Initial dose was given on 10/8/22 of the Pfizer 5-11y vaccine. There are no adverse symptoms to report.
Dizziness, Headache, Myalgia, NauseaVomiting, ACHING PAIN AMONG ALL INSIDE ORGANS (HEART, LUNGS, KIDNEYS, LIVER, STOMACH, INTESTINES), MUSCHLES AND SKIN. STABBING PAIN AMONG EYEBALLS, HEAD AND INSIDE EAR CANALS. NAUSEA, TIREDNESS, AND DZZINESS. LOWER BACK PAIN Narrative:
improperly stored VARIVAX were administered to patients.; No additional AE reported; This spontaneous report was received from a registered nurse and referring to a 4 year and 5-month-old male patient. The patients' medical history was not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX). Current condition included allergic rhinitis.    On 10-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on right thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. No complications, no reactions, no complaints Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error).  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA007314:
Pt's mother called 1/16/01 to report her daughter received Varivax 1/11/1. She developed facial and neck rash on 1/14/2001, which resolved. She developed trunk rash on 1/15/01, which resolved by 1/16/01.She called family MD who told her to report to health department. Rash was red/raised but not pustules or drainage. None at injection site.
Narrative: Patient was hospitalized on 10/06/22 shortly after receiving the COVID-19 bivalent booster with initial documentation noting pt. feeling unwell after vaccine on 10/04/22 and concern for dehydration. Note indicated that pt. had fever and altered mental status. Further documentation from 10/7/22 by PCP who reviewed outside records indicates that pt. was hypotensive on presentation, had tachypnea, AMS, chest Xray with acute infiltrate in RLL pt. likely with pneumonia. Pt. was intubated with differential: septic shock, sepsis, PNA, UTI, dehydration. If infection, presentation would unlikely be d/t vaccine, but reporting due to timing of vaccine and initial documentation.
Large, itchy and aching rash at injection site that started 6.5 days later and is getting worse.
Started with pain to back shingle like rash from back to left nipple on chest no blistering pain (in arm left) crippling shooting pains loss of feeling to left side caused to fall with additional injury etc as of mid June still active pain. Internal organ issues.
Chills, very high fever of 101.7, headache, arm very sore, fatigue, could not function, had to go to bed.  It started the day after the vaccine, and I was sick all day and all night, woke up the next day with no fever.
Inappropriate schedule of vaccine administered; Arm  was sore; Can't lift anything; Can't lay on it to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  was sore), MOVEMENT DISORDER (Can't lift anything), SLEEP DISORDER (Can't lay on it to sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Acid reflux (esophageal). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm  was sore), MOVEMENT DISORDER (Can't lift anything) and SLEEP DISORDER (Can't lay on it to sleep). On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 25-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm  was sore), MOVEMENT DISORDER (Can't lift anything) and SLEEP DISORDER (Can't lay on it to sleep) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant medication also included cholesterol meds and acid reflux meds.  Treatment information was not provided.
after administering vaccine patient fainted and was found on the floor of observation area. She was conscious when i ran to her.She said she usually feels nausea after vaccines and feels like this was just her normal reaction. She refused an ambulance and felt like she was ok. We gave her ice water and and ice pack as she bruised her head when she fainted. We continued to monitor her and she kept refusing medical assistance. She had a friend come to drive her home.
Low grade fever 99.6 , Headache, body aches, chills, nausea for approx. 28 hrs
This spontaneous report as received from a registered nurse, refers to an unspecified patients of unknown ages and genders. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1707USA011936.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided          No treatment and concomitant medications were provided.   This case was linked to MOD-2021-406420, MOD-2021-406419 (Patient Link).
The pt developed shingles (herpes zoster) with lesion involving left side of body, chest, arm pit, and back wit clustered herpetic lesions.
No additional AE/PQC reported.; administered the GARDASIL 9 vaccine at 0, 2, and 4 months.; This spontaneous report was received from the consumer and referred to a female patient of unknown age. The medical history, current conditions and concomitant medications were not provided.  Approximately in March 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, lot# and expiration date were unknown) for prophylaxis. Approximately in May 2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, lot# and expiration date were unknown) for prophylaxis.  On 21-JUL-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route, lot# and expiration date were unknown) for prophylaxis (Inappropriate schedule of product administration). The patient was administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at 0, 2, and 4 months. The patient wanted to know if receiving the third dose early would create a need to get another dose at a later time? No further information provided. No additional adverse event (AE) or product quality compliant (PQC) reported.
Patient got high fever ten days after administered, stopped talking, when started to talk again he stuttered and continues to, irritability.
:Took vaccine at 1:15pm March 9 then 12 hours later at 1:15 am March  she started shivering and threw up once. Felt lousy. Headache No rashes, injection site clear. No fever Took Tylenol 9:30 am for headache
fever; chills; muscle aches; nausea; fatigue; cough; very sick; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Mar2021 04:00 as single dose for covid-19 immunisation. Within 30 minutes of receiving the vaccine, on 19Mar2021 16:30, patient got very sick: fever, chills, muscle aches, nausea, fatigue, cough. The fever broke early the next morning but the other symptoms remained for 2 more days. At that point, he continued having fatigue, cough, nausea and chills for a further 5-6 days. At that point, and continuing now, he still have low level nausea, fatigue and a cough. It's very slowly getting better but it has take 2 weeks to not feel completely sick. The patient underwent lab tests and procedures which included viral test (Nasal Swab, Aegis PCR): negative on 01Mar2021. No treatment. Outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tiredness, faintness, headaches.  I was feeling bad enough that my family doctor had me into the office for an in-person consultation and blood work.  The blood work on Nov. 5, showed an anomaly in the D dimer section of 940 ng/mL FEU    I was sent for a CT scan on Friday, November 5th at the Clinic.
Pt immediately after receiving vaccine HPV appeared to have fainted, also appeared to have brief (20 sec) seizure activity.  Non responsive, posturing with arms, eye rolling back.  Completely responsive within one minute.  After juice and 5 min was "back to himself".  Observed for a continued 30 min.
Initial information received on 23-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a female patient (unknown demographics) who experienced cellulitis, nausea, and left arm was very sore and red and there were all over joint pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 05-Oct-2018 at 12:45, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UJ011AG, exp date: 30 June 2019 via unknown route in the upper left arm. On 06-Oct-2018, the patient developed a serious cellulitis, left arm was very sore and red and there were all over joint pain one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE . It was reported that reporter believes that the Vaccine was contaminated with bacteria. This was assessed as serious due to medically significant event. On 06-Oct-2018, the patient developed a non-serious nausea one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was an actual medication error case due to Inadequate aseptic technique in use of product. It was reported that the nurse opened the refrigerated package, and put it on a dirty and unsterilized sink prior to administering. (Other relevant tests included no lab data.) Final diagnosis was cellulitis, nausea. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none; Sender's Comments: This case involves a female patient (unknown demographics) who presented with nausea, redness, sore arm with joint pain and was diagnosed with cellulitis one day post vaccination with FLUZONE QUADRIVALENT. Time to onset is compatible. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, and lab tests ruling out alternate etiologies. Moreover, it was reported as adequate aseptic measures were not taken during vaccination (opened the refrigerated package, and put it on a dirty and unsterilized sink prior to administering). Hence there is a possibility that the cellulitis is due to introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Pt recv vax in 1994; in 1995 pt exp fibromyalgia.
Feeling very tired, achey, and sore, and the next morning (Oct 14) felt very dizzy and fainted.
like her heart wanted to go out; almost could not speak; tired legs; tongue a bit heavy; mouth started to be heavy; confusion, a bit; vaccine burned a bit; felt very tired; forehead a bit heavy too; chills; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy) and ORAL DISCOMFORT (mouth started to be heavy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.  On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy), ORAL DISCOMFORT (mouth started to be heavy), CONFUSIONAL STATE (confusion, a bit), VACCINATION SITE PAIN (vaccine burned a bit), FATIGUE (felt very tired), HEADACHE (forehead a bit heavy too) and CHILLS (chills). On 19-Apr-2021, VACCINATION SITE PAIN (vaccine burned a bit) had resolved. At the time of the report, CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy), ORAL DISCOMFORT (mouth started to be heavy), CONFUSIONAL STATE (confusion, a bit), FATIGUE (felt very tired), HEADACHE (forehead a bit heavy too) and CHILLS (chills) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication was not reported.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
extreme fatigue, headaches, low grade fever, stomach pain, rash, tinnitus, bradycardia, breathing difficulties following the booster.  There were no reactions to the first injection and only minor symptoms following the second injection.  Patient has long-term Covid symptoms following her prolonged bout with Covid in late 2020.  Rest, physician referral to dermatologist, cardiologist, and abdominal ultrasound.  Over time (2-3 weeks), the symptoms lessened and present no significant issues at the current time.  However, patient is hesitant about having further Covid injections.
Myalgia, Arthralgia, tingling sensation in roof of mouth, thick tongue feeling "tonsils touching my throat"....occured 6 minutes after injection. Flushed feeling and aches and pains started 90 minutes after injection, and flushed feeling continues through 6 hours. Narrative:  tingling sensation in roof of mouth, thick tongue feeling "tonsils touching my throat"....occured 6 minutes after injection. Flushed feeling and aches and pains started 90 minutes after injection, and flushed feeling continues through 6 hours (has not gone away).
Red, swelling, itching in left arm for approx. 6 days, low grade fever for approx. 3 days, red rough skin on top lip next morning that lingered for more than 1 month.
pt recvd vax 20NOV93 & mother-in-law reports pt hospitalized 25JAN94 dx of GBS made;pt has been hospitalized several times since then;
This is a spontaneous report from a contactable consumer, reporting for her cousin's wife. This consumer reported similar event for 3 patients. This is one of 3 reports. A female patient, of unspecified age, received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), on an unspecified date, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced shingles on an unknown date, with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Linked report(s): PFIZER INC-202101473111 same reporter/drug/event, different patient; PFIZER INC-202101473796 same reporter/drug/event, different patient.
Fever, headache, face numb - started the evening he got the Tdap vaccine. Improved the next day.