chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected COVID-19 infection/ got COVID-19; Revaccination with different covid-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Suspected COVID-19 infection/ got COVID-19), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Kidney transplant.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Suspected COVID-19 infection/ got COVID-19), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Suspected COVID-19 infection/ got COVID-19), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Not developed any antibodies.         No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. The reporter stated "I got JJ first shot then the moderna, got tested for antibodies because I have had a kidney transplant found out I didn´t develop any antibodies. One week later I got COVID-19. Lucky it was a mild case so I was ok.
Patient received shot then developed shingles within the week after; no previous history is shingles or any other current conditions.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe
fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (they had COVID diagnosis, testing and symptoms on 01Dec2020) on 01-Dec-2020.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Jan-2021, the patient experienced PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive.         No concomitant medications were provided.  No treatment information provided
Woke up 7/11/07 with increased temp 101.4, c/o H/A, nausea, dry mouth, dizziness
Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 13:30 (Lot number: ER2613) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Allergic to penicillin; "Accident" (unspecified if ongoing), notes: auto accident in 97; "Neck pain" (unspecified if ongoing), notes: Chronic neck pain due to auto accident in 97. The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021 13:35, outcome "recovered" (2021), described as "Dizzy". Therapeutic measures were not taken as a result of dizziness.  Additional information: The patient received unspecified medication within two weeks of vaccination. Prior 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. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
I ached from my knees to the top of my head for almost a day. I had headaches, severe congestion with excessive phlegm, voice change, and no energy.
This is a spontaneous report from a contactable consumer (Patient, self-reported). A 42-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: not reported) dose 2 via an unspecified route of administration in left arm on 27Apr2021 (age at the time 42-year-old) as unknown, single dose for COVID-19 immunization in the pharmacy or drugstore. The patient's medical history and concomitant medications were not reported. The patient was allergic to Tylenol 3D. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: not reported) dose 1 via an unspecified route of administration in left arm on 27Apr2021 at 12:00 (age at the time 42-year-old) as unknown, single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On 29May2021 at 16:45, the patient experienced hives all over my body, it looks like chicken pox. The device date was 04Jun2021. All events are non-serious. The outcome of the event was reported as recovering. Information on Lot/Batch number was available. Additional information has been requested.
GI upset, severe muscle spasms, light headedness, tachycardia, chest tightness/SOB; tx 02 by facemask, DPH, Epi, Solu cortef IV, Toridol IV w/lactated ringers solution; febrile beginning 10PM day of event; hospitalized x 3 days & recovered
After the first shot, I began menstruating immediately and heavily for two day. I had already finished my period the week prior. I was have extreme anxiety, headaches, and dizziness.  Following the second injection: I got extremely sick requiring medical treatment. I have struggled with ongoing vertigo that is now impacting daily life and requiring medical tests, treatment with specialists, and medications. I have had consistently had heart palpitations, racing heart, and irregular heart beat requiring being seen by a cardiologist.
Cold sweats 64.5 hours later, causing fainting, followed by vomiting 6 times and diarrhea once.  Recovered after 1 hour.
7cmx9cm red, slightly warm, but non-tender area all over left deltoid. No fluctrime. Afebrile. Marked area and recommended recheck in 24 hours.
swollen and tender lymph nodes; swollen and tender lymph nodes; coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age (reported age: 62; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after first vaccine, the patient experienced swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms. With second dose, she had similar symptoms, but not the swollen and tender lymph nodes, no chills or fever. She stated that she felt like she was going all over this again. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient with difficulty breathing, itching in throat, and hive like reaction to scalp.  Patient never given flu shot in our clinic but reported having it in prior years without problems.
one week after the Covid-19 vaccination- my arm became very itchy, hot and a bit swollen. By Saturday my upper arm skin was firm not soft and there were two red marks.  The itching and heat persisted.  This is Monday afternoon- my arm is still itchy, has two red blotches but the heat is less and the skin isn't has firm to the touch.
3 hrs after injection got real tired and took a nap for 20mints. 12 hours after injection got fever of 101, chills, body aches, pain from left arm up to my neck down to my hips and into my artificial knee-rt side. Fever came down to 99 after taking 600mg motrin. Injection site still painful.
01/18/22 presents to ED for "Dyspnea on exertion". PMHx of "CAD, CABG x 1 and stents, AVR replacement and DM A1C 6.1 x 1mo, GERD with Barret's"
Client states he started feeling bad around 9:30pm on 4/10/03. States R arm hurt from shoulder on down. States neck felt stiff and had numbness to R hand. States he went to bed but woke up at 2:30am and had temp of 103.1 deg F. States he took four Motrin. RTC 4/11/03 for f/u.
increased fatigue; headache; body ache; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01, Batch/lot number: Unknown), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "increased fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports low neutrophil count so md lowered Ibrance to 100 mg/daily. feeling a bit better with some energy but lethargic at times, mouth sore, headaches/migraines at times, chills with low temperature and low blood pressure on occasion, small weight gain, constipation at end of cycle, hip/arm pain. Increased fatigue/headache/body ache after covid vaccine number 2 on 28Feb2021 but much improved. Patient states md aware of cycle which has been 14 days on, 7 off since start and was not per order of 21 days on, 7 off. md aware of all symptoms. seeing md 24Mar2021 and will review. Patient began medication 08Jan2021 and was taking Ibrance 125 mg/daily for 14 days on, 7 off until dose lowered 05Mar2021 (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented w/ SOB, tested Covid +. Tx w/ O2, Remdesivir, steroids, abx
Suddenly, my eyes felt gritty, had a sore throat, slight tightness in chest. Both eyes became totally bloodshot and very red beneath my eyes. I felt tired and had a headache. My bloodshot eyes lasted for 2 1/2 days. My arm was red and swollen from upper right where shot was given to elbow which lasted for 3 days. I was alarmed that my eyes were so red.
Had fatigue and fever of 102 the two days immediately after the shot (somewhat expected). Starting on that Friday/Saturday April 30/May 1st started feeling allergic with watery eyes, runny nose, headache, extremely tired and low grade fever of 101 with GI issues. It's been almost 5 weeks now and I still have a low grade fever, consistently around 99.8 - 100.8. Today as of the time of this writing (5/27/21) my temp is 101.4. My normal/baseline temperature historically is around 98.5. Along with this consistent fever, I'm now experiencing random muscle spasms and nerve pain throughout my body, something I have never experienced before. This started 2 weeks ago with back pain that turned into roaming muscle/nerve spasms. Last week I started having abdominal pain that lasted for 3 days. Yesterday, the injection site on my right arm started throbbing and continued throbbing until this morning.   I've seen a doctor and am having some tests done, but largely this remains a mystery. Before the 2nd shot I was fine, no fever, no muscle/nerve pain, and wasn't nearly as fatigued as I am now.
Positive Covid test on August 7; Positive Covid test on August 7; Pain in back of right rib; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; Had sinus congestion. Nasal drip. Chest congestions with wet cough.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Lot Number: EN6202) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Lot Number: EN6207) as single dose, both at the age of 58-years-old for COVID-19 immunization. The patient had no other medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had positive Covid test on 07Aug2021. The patient had sinus congestion, nasal drip, chest congestions with wet cough, pain in back of right rib since 07Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Jul2021; Covid test: positive on 07Aug2021. Outcome of the events was recovering.
Client given expired Rotavirus; waited in clinic for 15 min after meds given; no problem noted. Inform doctor & supervisor. Will call or send letter to revaccinate.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-MAY-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was snot reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Havrix dose was accidentally given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 09-MAY-2023, the patient received the 1st dose of Havrix. On 09-MAY-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix dose was accidentally given to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was a medical assistant. The reporter reported that an expired Havrix dose was accidentally given to a patient.  They provided information about the vaccination, patient and vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter reported that an expired Havrix dose was accidentally given to a patient, which led to expired vaccine used.
Progressive symmetric lower extremity motor weakness extending to the upper extremities (power 2/5 both upper and lower extremities) with gradual loss of deep tendon reflexes till they were absent. Clinical diagnosis of GUILLAIN-BARRE syndrome. Transferred to intensive care unit on 10/28/06. Did not require intubation. Developed autonomic dysfunction with variable blood pressure and intermittent sinus tachycardia. Started on plasmapheresis (total 6 sessions) on 10/28/06 and responded with recovery of motor strength.
No additional AEs; temperature excursion on GARDASIL 9/ temperature above 47 F; This spontaneous report as received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 02-NOV-2020 (reported as today), the patient was vaccinated with an improperly storage dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S033308 with expiration date 08-APR-2022 (dose, frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse events reported.  The vaccine was stored at a temperature of above 47 Fahrenheit degrees, time frame of 1 hour and with not previous temperature excursion. Digital Data logger was not involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
or has a little cold/he's a little cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (or has a little cold/he's a little cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (or has a little cold/he's a little cold). At the time of the report, NASOPHARYNGITIS (or has a little cold/he's a little cold) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported.  The patient reported that, He doesn't know if he's immunocompromised and said he's a little bit immunocompromised   Reporter did not allow further contact
no additional adverse events reported; Improperly stored dose administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T031202, expiration date 14-JUN-2022) 0.5 milliliter (frequency and route not reported) for prophylaxis (product storage error). The vaccine was stored at 50.5 fahrenheit (F) for 57 minutes. No previous temperature excursions were reported and it was not reported if a digital data logger was involved. No additional adverse events were reported.
Currently dealing with pain in my left arm, mainly where the injection was done. I only had pain the first day after receiving the vaccine then no other symptoms until today
Patient came to clinic requesting vaccination for work with patient registration patient received vaccination, no known side effects Director called to confirm patient did receive vaccination Provider  called Parent New preventive measures introduced
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no pertinent medical history, concurrent therapies and drug reactions or allergies. On 29-DEC-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU), subcutaneously, lot # N014942, expiration date 02-FEB-2018 (reported as 20-FEB-2018) (frequency and dose were not reported). Other suspect therapies included administered on the same day sterile diluent (STERILE DILUENT), subcutaneously, lot# N006324, expiration date 24-JUL-2019. On 30-DEC-2017, the patient experienced localized reaction at the injection site, which was swollen and itchy as well as rash. The patient came to the pharmacy on 05-JAN-2018 to report these events. The patient took an unspecified dose of diphenhydramine hydrochloride (BENADRYL) on recommendation of unspecified pharmacist after calling the pharmacy. No laboratory diagnostics were performed. The patient sought medical attention. The outcome of injection site swelling, rash and injection site pruritus was reported as recovering on 05-JAN-2018 (reported as rash was 75% gone). The causality assessment was not provided.
Moderna COVID-19 Vaccine EUA Soreness, bruise redness radiating down arm after 9 days from vaccination
Rx technician administered the vaccine and reported that a tine amount of vaccine leaked out of patient's arm. Patient was concerned that she did not get the full dose
Day 1 of vaccine 1/4/21 - No symptoms. Day 2 - 1/5/21 site of vaccine red, circular area about the size of a .10C piece that by the end of an 8 hour day had spread to 35mm long by 15mm wide and was slightly raised and warm to touch. Let side of neck and shoulder were sore and painful and c/o headache, she did take Motrin and Benadryl on this day. No fever or chills.  By Day 3-1/6/21 experiencing no symptoms and all of the above have gone away.
6 hrs after Anthrax vaccine pt reported palpitation, generalized joint pains, fatigue, Nasoocular pruritus, nausea, vomiting, memory loss, difficulty concentrating. Symptoms gradually improved over course of 6-7 days.
Starting having staring spells on 06/14/19, er visit on 06/15/19, er visit on 06/16/19 and admitted to hospital on 06/16/19.  06/16/19 diagnosed with Focal seizures Multiple seizures a day anywhere from 10-20 07/10/19 admitted to hospital again and diagnosed with infantile spasms
Hives on upper left arm, not at the same spot as injection site, about 27 hours after vaccine administration. Hives on face and ears about in addition to hives on arm about 30 hours after vaccine administration. 44-48 hours after vaccine administration, still experiencing hives on face in addition to nausea, dizziness when moving and standing, fatigue, and feeling feverish (but do not actually have a fever).
Unsteady on feet, loss of balance, loss of bladder control by weekend; loss of feeling in hands and arms by end of following week and constant falling.
Some muscle tightness in injected arm, followed by vision disturbance. Initial visual disturbance was left lateral (left eye) blur followed by increasing blurring and then flashing lights in a semicircle, left lateral field of view. This was ongoing and increasing in intensity for approximately 2 hours. Eventually at its worst the flashing lights covered approximately 30-40% of the left lateral visual field of the left eye. The issue resolved without any treatment after the two, to two and half hours.