chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9266), on 10Mar2021 as dose 2, single (Lot number: EL3246) and on 23Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Excessive daytime sleepiness" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing). Concomitant medication(s) included: MIRAPEX; HORIZANT; TAMSULOSIN; OMEPRAZOLE; MODAFINIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITINE; FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 30Jun2022 to 04Jul2022.
Vaccine given 11-28, symptoms started evening 11-29 presented to clinic 11-30. Area distal to vaccine administration site warm, pink, indurated.
c/o chest tightiness (midline) w/ h/o asthma & 4 CABG.  HR 68-80 Reg  Resp 16/unlabored;   SpO2 97%   152/95  h/o HTN;  self medicated with own ventolin 2 puffs & NTG 0.4ml SL with increase in symptoms.   Asymptomatic after additional 15 mins.
pt recvd vax; hives 12 hrs after vax; tx w/ DPH;
extreme fatigue within 4 hrs., arm/shoulder pain during hs, approx 24 hrs. later redness measuring  approx. 5 cm noted approx. 2 inches down from injection site, still quite painful to touch,48 hrs. later area is red, hot to touch, swollen with hive appearance, still painful,size increased to 10 cm in size
Patient General Malaise unknown cause . Onsite EMS was called vitals were taken BP 124/78  99% O2 room air HR 74. Patient refused evaluation/care. Left against medical advice.
Client received zoster and Influenza at 2:00 pm. Went home, then to the lodge. Noticed slight SOB at 5:00 pm. Taken to Urgent Care; upon arrival; symptoms worsened and client lost consciousness. O2, EPI x 2 doses, and BENADRYL were given. Pt transferred via ambulance to hospital where steroids and PEPCID given. D/C from ER at approximately 10:00 pm. Nothing consumed at lodge. Had anaphylaxis approximately 12 years ago after contrast dye given. This reaction was delayed a few hours also.
4 weeks later contracted Covid. CDC called to follow up on my weekly vaccine report and told me to come here and record my infection and positive home test on and nasal lab results, both taken on 11-6-2022.
tired; sleep all day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and SOMNOLENCE (sleep all day) in a female patient of an unknown age who received mRNA-1273 (batch nos. 014M42A and 028A21A) for COVID-19 vaccine.     Concurrent medical conditions included High cholesterol and Heart disorder.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired) and SOMNOLENCE (sleep all day). At the time of the report, FATIGUE (tired) and SOMNOLENCE (sleep all day) had resolved.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-101495 (Patient Link).
Woke at 4:30 AM on 12/30/21 with headache, fever, body aches, sore arm, redness and swelling at site, vomiting. Took tylenol for fever and stayed in bed. The next morning I felt fine just tired. I was given full dose on 12/29/20.
On 8th day injection site became red, deeply itchy and tender to touch.  Extreme fatigue, no appetite
31 y/o female received vaccine at 18:00-  pt. received 8727. pt. had left and came back to vaccine site stating she felt dizzy and tingling. pt. states she has anxiety and psych hx. pt. is evaluated by Dr and she is advised to follow up PCP and allergist to see if she is able to receive Johnson & Johnson vaccine. Pt. is advised by DR. not to come to state site for further doses. Pt states she will follow up and is refusing transport to hospital for further evalauation. Pt. signs refusal.
Pt. seen in office on 01/13/2010 in the evening with a urticarial rash, no fever, not pruritic, Benadryl helps.
Swollen, red skin on left deltoid within 4 to 6 hours after immunization. At time of visit, had grown to approximately 8cm x 4cm. Mother instructed to observe & return to clinic if no improvement.
Patient also received first dose  of Covid- 19 on 7/31/23 and second dose on 8/11/23.  Second dose not needed this early.  Patient received Typhoid vaccine on 7/31/23 and was reordered and given on 8/11/23.  Patient received MMR-II on 7/31/23 and received dose on 8/11/23.
This spontaneous report was received from a physician refers to a pediatric patient of unknown age. On an unknown date in April-2013, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
38 y/o male who received his 3rd anthrax vaccine high in his right upper arm on 24 APR 2015. That was the only vaccine he received that day. He experienced almost immediate pain near his right shoulder and in his upper arm. The pain was significant. He reports pain intensity was initially 8/10 and later, 5-6/10 using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). The pain hurt to the point patient significantly limited use of his right arm x 24 hours. He reports pain increased with movement and from clothing touching the affected area. His pain resolved within 2-3 days, without recurrence. Patient denies recent RUE trauma or injury, but did have right rotator cuff repair in 2010. He denies RUE numbness or weakness. The first day post-vaccination, patient also reports tenderness and swelling surrounding vaccination site (<2" area), which lasted 2-3 days. He denies redness and warmth at vaccination site, but does report a pea-sized knot around that time that resolved at 2 days. Patient denies similar reactions following previous anthrax vaccines. Patient experienced the onset of a headache within 4 hours of vaccine receipt. Patient self-treated with ALEVE with little resolution, but he was able to sleep through the night. The following morning, he woke up with a headache. He self-treated with ALEVE that day and was able to carry out his ADLs and work duties, and sleep through the night. The next morning, patient again awoke with a headache accompanied by blurred vision, stiff neck, fever (maximum temperature was 100 degrees F) and chills, and lightheadedness. He denies photophobia, nausea and vomiting, but experienced phonophobia. Patient sought evaluation at a local emergency room. [Name and location of ER and hospital where admitted is unknown to reporter]. He was treated with IV fluids and pain medication, with no significant decrease in his headache. After an evaluation to rule out meningitis was begun, he was admitted for observation and treatment for 3 days. He had a normal head CT and normal CSF analysis post-lumbar puncture. His headache resolved after treatment with TORADOL. All of patient's symptoms subsided by time of discharge. Patient has been symptom-free for about 3 months.
Very red and swollen, hot to touch at site of DTaP. Patient very uncomfortable and cried all night with pain from it.
feeling muscle tension in the back of her neck that spread up to her eyebrows; it was like a tension headache; discomfort; This is a spontaneous report received from a contactable consumer from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 07Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset Mar2021, outcome "unknown", described as "feeling muscle tension in the back of her neck that spread up to her eyebrows"; TENSION HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "it was like a tension headache"; DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "discomfort".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335314 Same reporter, suspect drug and events; different patient
Woke up during night 10-29-12 with fever, chills & sweating. Reported swollen node under Rt arm this morning (10-30-12) and muscle aches. 10-31-12 spoke with client is better but some muscle tenderness.
Seizure activity documented within two hours after administration of vaccine. Loaded with anti-seizure med.
Patient's husband called 1/5/23 to report the patient had broken out in hives after receiving the Pfizer Bivalent Covid booster vaccine. I counseled him to give the patient two 25 mg Benadryl tablets to alleviate the hives and to go the the emergency room if symptoms worsen.
This case was reported by a lawyer and described the occurrence of mercury poisoning in a 7 year old female patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and pertussis vaccine absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified this report. At an unknown time after receiving Hepatitis B vaccine, DTP/DTaP vaccine, Haemophilus vaccine, and/or MMR II vaccine, the patient experienced neurotoxic effects resulting in severe neurodevelopmental injuries. The events were attributed to mercury overdose and poisoning resulting from the thimerosol component of the vaccines. The multiple symptoms of the patient's injuries occurred and were first manifest no later than 1/1/01. According to the attorney, the patient incurred medical expenses and will continue to incur medical expenses in the future as a result of her injuries. The attorney also alleged that the patient suffered significant impairments in her ability to enjoy life, faces significant obstacles to performing the tasks and activities of everyday living, and suffers ongoing physical and mental distress. This case was assessed as medically serious (OMIC).
doses administered after more than 1 temperature excursion during 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during 33 weeks on 2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 11:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:33 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 79.48 for dose administered on 31-Mar-2021 and 79.40 for dose administered on 03-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021. Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range 51 to 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Localized injection reaction, small red blisters on left thigh.  Symptomatic tx w/ ice.
1 week after vaccination client noted weakness in L) side of face, arm, and hand.  Also slurred speech.  Presented in ER and given tPA medication and flown to a specialty hospital .  she was placed in ICU for 24 hours and then moved to general floor for another 12 hours and then released.
This spontaneous report was received from a pharmacist concerning her daughter who might have been between 9 and 11 years old. It was reported that the patient was not receiving any concomitant therapies and did not receive concomitant vaccinations at the time of vaccination. The patient's relevant medical history and concurrent conditions were unknown by reporter. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 1 dosage form, for human papilloma virus (HPV) prevention (strength, route of administration, frequency, lot# and expiration date were not reported). On an unknown date, after the first dose, the patient experienced syncope, and in the week that followed, experienced bad dizziness and headaches lasting 2 to 3 weeks. It was reported that the pharmacist was contacted and that no treatment was given for the adverse events but the patient was currently taking an unspecified medication for headaches. It was reported that the patient refused completing series. The outcome of syncope, headache and dizziness was reported as recovered on its own on an unknown date. Causal relationship between GARDASIL 9 and the events syncope, headache and dizziness was not reported. Upon internal review, the event syncope was determined to be medically significant.
A high dose vaccine was accidentally given to a 44 year old woman. This occurred during an offsite clinic where we forgot to bring the portal we use to scan in vaccines. If we would have had this, the error would have been caught before being given to the patient.
L arm soreness; neck/shoulder ache; neck/shoulder ache; fatigue; Pregnant at the time of vaccination? Yes; This is a spontaneous report from a contactable other Health care professional (patient). A 34-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 at 10:15 (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation in public health clinic. Medical history included fetal distress from an unknown date and unknown if ongoing (Hx of emergency c-section with 1st pregnancy due to fetal distress). Concomitant medications included PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE] taken for an unspecified indication, start and stop date were not reported; calcium gummies taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have COVID prior vaccination and not COVID tested post vaccination The patient was pregnant on 20Jan2021 at the time of vaccination. On 20Jan2021 at 15:00, the patient experienced L arm soreness, neck/shoulder ache, fatigue on. The mother reported she became pregnant while taking bnt162b2. The patient was 9 Weeks pregnant at the onset of the event. The patient was due to deliver on 18Sep2021 and last menstrual date on 12Dec2020. The patient did not receive any treatment for the events. The outcome was events was reported as resolved on an unknown date.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 026C21A) for COVID-19 vaccination.     Concomitant products included CLARITHROMYCIN, OMEPRAZOLE and AMOXICILLIN for Helicobacter pylori infection.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of took Tylenol two times in total. At the time of the report, MYALGIA (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 98 (High) 98. had gone to 100 before.. On 27-May-2021, Heart rate: 111-113 heart beats per minute (High) 111-113. On 28-May-2021, Heart rate: 85-103 heart beats per minute (High) 85-103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Dizziness, Headache, Myalgia, Fever, Diarrhea, Chills Narrative:
My husband an I took the BOOSTRIX injection,0.5 ml in our arms at Pharmacy. In less than 24 hours we suffered from extreme muscle ache, confusion and physical fatigue. We we unable to perform daily activities of activity like walking to restroom and minimal sitting upright. We also experienced severe headaches and lack of appetite. The symptoms resembled a flu. We both were tested and flu came back negative. We are heading to second week after the injection and my husband's symptoms have only worsen. He has periods of weakness and lack of energy.
Presented to ED w/cough, fever, wkness x 5 days; admitted for COVID pna; tx w/ abx; tx to acute care facility for IR needs.
left arm was sore; tired and drained after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore) and FATIGUE (tired and drained after first dose of vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE, LOSARTAN and METFORMIN for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore) and FATIGUE (tired and drained after first dose of vaccine). At the time of the report, PAIN IN EXTREMITY (left arm was sore) and FATIGUE (tired and drained after first dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-406739 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Aug2021 as dose 3, (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 as dose 4, (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: STELARA, start date: 20May2022; BENICAR HCT, start date: 01Jul2022, stop date: 19Jul2022; ZOVIRAX [ACICLOVIR], start date: 11Jul2022, stop date: 15Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Day 39 and still have not gotten their second dose; A spontaneous report was received from a healthcare professional concerning a 63-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and on day 39 and still have not gotten their second dose(missed dose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001M20A) for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient experienced the event, day 39 and still have not gotten their second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, day 39 and still have not gotten their second dose (Missed dose ) was unknown.; Reporter's Comments: This refers to a 63-year patient who missed their second dose administration appointment. No associated AE/SAEs reported.
Received vaccine at about 3:30 p.m., chest cavity began aching around 8:00 p.m. By the next morning, it was difficult to breathe and was painful. Hurt to stand up. Had a fever of 99.5.
Initial misuse report received from a health care professional (nurse) on 26 September 2013 and the case was received on 21 March 2014 at GPV. Four patient (age and under 18 years) had received a dose of FLUZONE ID (batch number, route, dose in series and site of administration was not reported) on an unspecified date. The 4 patient (age was under 18 years) received FLUZONE ID vaccine  and it was reported that the vaccine should  not be administered to patient less than 18 years or 65 and over. No adverse event was reported. List of documents held by sender: none