chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Has Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Has Covid-19). At the time of the report, COVID-19 (Has Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were mentioned.  The patient had the vaccine series in January and February.  No treatment details were reported.
First dose / 22 months before this report / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 22 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No more information was provided.
This spontaneous report was received from a physician concerning a 5 month old patient of unknown gender. On an unknown date at 5 months of age, the patient was vaccinated with their first dose of oral, ROTATEQ (dose and lot# not provided). No adverse experiences was reported. Additional information has been requested.
HCP said she already administered the Pfizer-BioNTech Covid-19 Vaccine to this patient before she even knew she already received the Cansino.; HCP said she already administered the Pfizer-BioNTech Covid-19 Vaccine to this patient before she even knew she already received the Cansino.; has difficulty ambulating or walking; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable nurse reported for female patient. A 72-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, FH8020; Expiration Date: Feb2022) via an unspecified route of administration, administered in arm left on 19Oct2021 (age at vaccination: 72-year-old) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's medical history included bionic knee which was part of the alteration in the way she walks. The patient's concomitant medications were not reported. The patient previously received cansino COVID-19 vaccine via an unspecified route of administration, on unspecified date as dose 1, single for covid-19 immunisation. The patient received Cansino However, reporter said she already administered the Pfizer-BioNTech Covid-19 Vaccine On 19Oct2021, to this patient before she even knew she already received the Cansino. Reporter said this patient had difficulty ambulating or walking, and said she was unsure about Cansino's efficacy. Reporter said that patient heard of symptoms of COVID toe or inflamed toe associated from the vaccine. Reporter doesn't later provide any further details for this. Reporter wants to know if it was okay that she gave the Pfizer-BioNTech Covid-19 Vaccine to this patient considering she already received a different Covid-19 Vaccine. Reporter says patient didn't know about Cansino being a COVID vaccine until then, she didn't know the patient had been vaccinated prior, then realized it after she had already been vaccinated with the Pfizer-BioNTech COVID-19 vaccine. Reporter clarifies that the patient had just received the Pfizer-BioNTech COVID-19 vaccine yesterday. She says she wouldn't have vaccinated the patient with that dose if she knew ahead of time, but she didn't know the names of all of the COVID vaccines. patient doesn't know about the Cansino vaccine, she was trying to be cautious. The outcome of events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
mild moderate case of chickenpox vesicles on chest, waist, face;afeb;
Joint pain; Severe muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe muscle pain) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myotonia congenital. Concomitant products included TRAMADOL for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Severe muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Severe muscle pain) and ARTHRALGIA (Joint pain) had not resolved.            Treatment information provided mentioned Tramadol and Tylenol. 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.
approx 10 minutes p/vax, pt c/o not feeling good, became clammy, flushed & BP dropped; episode lasted 15-20 minutes; pt was given liquid pop & fully recovered; pt had breakfast prior to vax;
Uncontrollable shaking/shivering/tremors for about 1-2 hours. It finally went away after time, no medication was taken.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Expiration Date for the lot 070H21A was reported as 07-Apr-2021 with total of 173 doses. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was reported as unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains reporter address updated.
Sore arm - same arm where the vaccine was administered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 12Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) for unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 23Mar2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. 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. On 13Apr2021 at 07:00, the patient experienced sore arm - same arm where the vaccine was administered. No therapeutic measures were taken as a result of the event. The clinical outcome of the event sore arm - same arm where the vaccine was administered was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On November 16, 2022, I was experiencing brain fog, and a scratchy dry and cold throat. I was having issues thinking and teaching my class. The next morning getting ready for school at 08:30 AM, I had a stuffy nose, sore throat, I felt like I had a temperature, I was fatigued and tired with diarrhea. I also had a headache. I took a rapid COVID-19 test at home and it came back positive. I have been quarantining and staying in home drinking liquids. I contacted my PCP that same day and told me I did not qualify to receive the antiviral medications. As of today I have a headache and alternating from a stuffy nose to runny nose depending on my position. I have some mild coughing. I still feel tired and achy but not as bad as the other day. I have been drinking bone broth, so my throat is feeling a bit better.
No adverse event; administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border; Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1) on 03-Mar-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.    On 28-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 28-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (administered 0.2 ml from the pink cap. Nurse realized that per the new guidance patient should have received 0.25 mL from dark blue cap with grey border) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the monovalent 3-Mar-2023 and on 28-Apr-2023 received bivalent vaccine as second dose.).    No concomitant information was reported. No treatment information was provided.
Reaction/Event: significant discomfort for several days with much suffering; Case Narrative: Initial unsolicited report received from a Non-healthcare professional on 02 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (batch number, dose, dose in series, route and site of administration was not reported) on an unspecified date. It was reported that patient was allergic to chicken feathers. Patient was not allergic to eggs. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had Extreme allergic reaction: lymph nodes very swollen in neck/upper body with hives and significant discomfort for several days with much suffering. Lab data and corrective treatments were not reported. Outcome of events was not reported. List of documents held by sender: none.
This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Not feeling strong), FEELING ABNORMAL (Not feeling herself), DECREASED ACTIVITY (For 3-4 days not able to carry on normal activity) and FATIGUE (Fatigue) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Blood pressure). Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 LETHARGY (Lethargic), ASTHENIA (Not feeling strong), FEELING ABNORMAL (Not feeling herself), DECREASED ACTIVITY (For 3-4 days not able to carry on normal activity) and FATIGUE (Fatigue). At the time of the report, LETHARGY (Lethargic), ASTHENIA (Not feeling strong), FEELING ABNORMAL (Not feeling herself), DECREASED ACTIVITY (For 3-4 days not able to carry on normal activity) and FATIGUE (Fatigue) had not resolved. Not Provided          Treatment information was not provided.  Concomitant medication include pill for blood pressure
Immediately following injection, she reported onset of nausea and headache.  Had several episodes of vomiting.  The following day 4/11/21, woke up with numbness in bilateral hands and feet that was new.  Numbness has resolved as of 4/12/21.  Continues to have nausea and fatigue
The next day after my second dose of vaccine I developed: -gross hematuria x3 days -tremors / shakes for about 5 weeks -chest discomfort when taking a deep breath -palpitations for about 5 weeks -high blood pressure for about 5 weeks -headache for about 1 week Findings: -abnormal EKG - seen by Cardiologist -urine test showing hematuria, proterinuria - seen by Nephrologist - diagnosis of IgA Nephropaty
Information has been received from a certified medical assistant (CMA) referring to a patient (7) of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown. The vaccines were stored under 34.5 F (min) and 27-9 F (Max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
The symptoms started two hours after the injection, with red face and neck, red bumps on  face, burning sensation, numbing feeling  around the mouth.. I took my Epi-Pen waited about and hour, still had the burning and numbing around mouth, red bumps. I headed to the Emergency. The staff gave me prednisone, different brand Diphenhydramine 50mg
no adverse effects; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant medications included sterile diluent. Information about the patient's pertinent medical history, previous drug reactions and allergies was not provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot number R035221 and expiration date 04-DEC-2019 (strength and route of administration was not provided) (product storage error).   No adverse effects were reported.  The temperature of the vaccine administered was reported as from 15-degree Fahrenheit to 46-degree Fahrenheit (29.1-degree Fahrenheit) and the time frame as for 3 hours.  There was no previous temperature excursion. No data logger involved.
inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient (unknown if pregnant) received meningococcal group b rlp2086 (TRUMENBA) administered in arm (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days".  No follow-up attempts are possible. No further information is expected.
Tinnitus (both ears worse in left ear); This spontaneous case from the was retrieved on 16-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1833078-1), reported by other healthcare professional and concerned a 66-year-old, female patient.  The patient's concurrent conditions included asthma, hypertension and allergiy to sulfonamides, nonsteroidal anti-inflammatory drugs (NSAIDs), nitrofurans, azithromycin and verapamil. The patient 's concomitant medications included bisoprolol, Breo ellipta (fluticasone furoate, vilanterol trifenatate), senior multivitamin (vitamins NOS), magnesium oxide and B12 (cyanocobalamin), all used for unreported indications.  On 26-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported). The batch number reported was 312869.  On the same day the patient was also vaccinated with a non-company co-suspect Covid-19 Moderna vaccine (elasomeran; route of administration: intramuscular, anatomical location: left arm, dose: reported as '3' and indication: not reported). The batch number was 088D21A.   On 31-Oct-2021, in the evening, five days after receiving Fluad Quadrivalent and Covid-19 vaccine Moderna , the patient experienced tinnitus.  At the time of initial reporting, the patient had not recovered from the event. Tinnitus was worsening in both ears and it was worse in left ear.  The reporter did not provide a causality assessment.  The event was assessed as non-serious.  Company comment: A patient was vaccinated with the suspect product Fluad Quadrivalent and non-company co-suspect Covid-19 Moderna vaccine. Five days after vaccination the patient developed tinnitus. Causality is confounded by concurrent administration of co-suspect vaccine. Causality is additionally confounded by therapy with concomitant drug bisoprolol. Based on plausible time relationship, causality is assessed as possibly related. Sender's Comments: A patient was vaccinated with the suspect product Fluad Quadrivalent and non-company co-suspect Covid-19 Moderna vaccine. Five days after vaccination the patient developed tinnitus. Causality is confounded by concurrent administration of co-suspect vaccine. Causality is additionally confounded by therapy with concomitant drug bisoprolol. Based on plausible time relationship, causality is assessed as possibly related.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "82-year-old gentleman with past medical history significant for chronic obstructive pulmonary disease, coronary artery disease, CVA, ventricular tachycardia status post ICD, hypertension, OSA on oxygen at night as well as orthostatic hypotension.  He presented to the emergency department on 01/01/2023 with a chief complaint of worsening shortness of Breath.  Patient was recently in the emergency department and was diagnosed with COVID, he was not hypoxic so he was sent home nebulizers.  He states over last couple days his symptoms have gotten progressively worse so they decided to return to the emergency department.  Wife and daughter are at bedside.  He admits to a cough which is nonproductive.  He denies any chest pain, abdominal pain, nausea or vomiting.  He does admit to a few episodes of diarrhea this morning.  On arrival to the emergency department he was noted to be fluid overloaded as well as COVID positive and was given a dose of Lasix.  He will be admitted to the floor for further monitoring.   Patient was given a couple doses of lasix with minimal improvement and an increase in his creatinine levels which resulted in patient undergoing a thoracentesis from which he received tremendous benefit. Patient was kept an additional day for observation as he had returned to his baseline O2 requirement of 1-2L NC. The following day patient was discharged after working with therapies. While there was some discussion on possible rehab prior to discharge home, family and patient reported good support at home and deferred option. Patient further continued to have a stable mild AKI with Cr. 1.3 and a repeat BMP for 1 week from discharge was ordered. "
p/vax pt presented to office w/poss chickenpox;a varicella titer was drawn pt did not seroconvert;a few days  later the spots went away;
Information has been received from an office manager concerning a female who was vaccinated in the physician's office with a second dose of GARDASIL and experienced an episode of syncope "right after the 2nd dose". It was not specified if the patient sought medical attention. Additional information has been requested.
Warmth, itching & redness at (R) deltoid vaccine site. onset 6 days after injection.  Pepcid 20mg PO daily Loratidine 10mg PO daily doxycycline 100mg PO BID x 10day
Patient c/o tingling in left face and neck and lump in throat 20 minutes after vaccine given. She was given benadryl 50 mg IM and stated symptoms were gone after 15 minutes. O2 sats 100%