chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; Felt flu-like; Injection site pain; Headache; Muscle aches; Chills; Joint pain; Fever of 101 F; Fatigue; Swollen lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), INFLUENZA LIKE ILLNESS (Felt flu-like), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache) and MYALGIA (Muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021 at 7:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), INFLUENZA LIKE ILLNESS (Felt flu-like), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), MYALGIA (Muscle aches), CHILLS (Chills), ARTHRALGIA (Joint pain), PYREXIA (Fever of 101 F), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes). In February 2021, DYSPNOEA (Shortness of breath) outcome was unknown, INFLUENZA LIKE ILLNESS (Felt flu-like), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), MYALGIA (Muscle aches), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, ARTHRALGIA (Joint pain) and PYREXIA (Fever of 101 F) had resolved and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
light rash on my chest,sides and neck.  i had chills ON AND OFF ALL DAY and joint aches. THE rash was going away by evening after taking benadryl. chills and joint pain last 2 or 3 days after second shot..
Patients were administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 048B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The vial was initially stored in the refrigerator on 22-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up contains significant information of dose 1 and dose 2 information  and patient demographics updated. On 27-Oct-2021: Follow up received on 28-Oct-2021 contains alternative phone number for reporter, report's address and facility details
Medication was given in wrong area. Was placed into shoulder joint hitting bone. I know have extreme pain. unable to lift/ move my shoulder. If I try to move my arm/ shoulder I have shooting pain into my neck and down my arm. I also had fever chills
Left calf pain. US completed. Blood clot in left great saphenous vein and branches. Patient is being treated with Lovenox 60 mg BID. Outcome is unknown at this time.
an hr or an hr & half p/vax pt became glassy eyed & shook all over;pt then fell asleep for 15min;when awoke was lethargic & had a fever for 3 days;
pt states about a week after she took her 2nd covid vax the skin above her eyes turned red and itchy.   Her eyelids and ears are itchy, red, skin is very dry and scaly.    Pt is taking Benadryl and also using Vaseline and zinc oxide.  She is still having these symptoms and will contact her PCP if they do not subside.
No adverse event; Dose 1 and dose 2 are administered in 2021 and 2023 respetively; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 are administered in 2021 and 2023 respetively) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No known allergies were reported. It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before.  Concomitant products included VITAMIN D3, MULTIVITAMINS [VITAMINS NOS], HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE), ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 are administered in 2021 and 2023 respetively). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 are administered in 2021 and 2023 respetively) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 are administered in 2021 and 2023 respetively).    It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to MOD-2023-723962 (Patient Link).
PASSED OUT; VACCINATION ADVERSE REACTION; DROP IN BLOOD PRESSURE; INJECTION SITE BLEEDING; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 66 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) (citrate free), dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis.  No concomitant medications were reported.  On unspecified dates, the patient experienced covid-19 vaccine reaction, drop in blood pressure, passed out three times and injection pain and bleeding with previous presentation of Humira. On an unspecified date, covid-19 vaccine reaction, drop in blood pressure and passed out three times resolved. The patient had injection pain and bleeding with previous presentation of Humira before switching to citrate free Humira. Patient had a reaction to the covid-19 Johnson & Johnson vaccine. It was reported that it caused blood pressure to drop and patient passed out three times. Patient went to emergency room. The patient agreed to have physician contacted. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Drop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn; and action taken with adalimumab was not reported. The patient recovered from passed out, vaccination adverse reaction, and drop in blood pressure, and had not recovered from injection site pain, and injection site bleeding. The reporter considered the causality between the covid-19 vaccine ad26.cov2.s, injection site pain, and injection site bleeding as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220402232-covid-19 vaccine ad26.cov2.s -Passed out. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Numbness hands and feet, tingling. EMG 05/15/2012. Neurology Consult 05/16/2012. IVIG x 5 days. Outpatient.
Fever of 102 degrees, headache lasting for 12 hours. Tylenol taken.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 48 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor was Product Quality Complaint (PQC) involved. This is one of several cases received from the same reporter. Additional information has been requested.
recently cut herself with a piece of metal which led to some bleeding; recently cut herself with a piece of metal; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 07Mar2021 (lot number/expiration date: unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine last Sunday (07Mar2021) and reported no side effects post-vaccination. On an unspecified date, the patient recently cut herself with a piece of metal which led to some bleeding. She hasn't had her tetanus shot in the last 20 years and she wanted to know if she can get it. The event outcome was unknown.  Information on the batch/lot number has been requested.
A pt (age and gender unspecified) experienced urticaria after treatment with RabAvert. The pt received RabAvert on 02Aug04, 09Aug04 and 12Aug04. Following the 2nd dose of RabAvert, the pt developed urticaria. The pt reportedly received previous doses in the gluteal muscle and had not maintained compliance with the recommended timing.
Had several hours of chills/shivering, followed by several hours of being extremely hot with some hallucinations.  Fever with body aches from head to toe.  Extremely lethargic for 24 hours or so.  Still not back to 100% energy level, but getting close.
"Covid Arm".  Delay skin reaction on left arm, slightly below the injection site started on 9th day post injection.  Itchy swollen patch approximately 6-8 inches in diameter.
tenivac that expired on march 2022, exact date unsure, was administered to patient with no adverse event; Initial information received on 14-Apr-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age female patient who experienced tenivac that expired on march 2022, exact date unsure, was administered to patient with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Tenivac).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Apr-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (dose, route, lot number and administration site: unknown) expiry date: Mar-2022 for Immunization (expired product administered) (latency: same day).  Reportedly asking if the patient needs another dose or if there are any advice for reactions.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (tenivac that expired on march 2022, exact date unsure, was administered to patient with no adverse event).  At time of reporting, the outcome was Unknown for the event tenivac that expired on march 2022, exact date unsure, was administered to patient with no adverse event.  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 the Directive 2001/83/EC 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.
I experienced arm soreness and for approximately 24-hours a very intense/constant headache. I continue to experience headaches but they are not as frequent as before. I also experienced lockjaw and clicking. My DDS advised that a mouth guard would help to alleviated the pain in my jaws that I was experiencing.
still fatigued; a little nauseous; temperature was 99.8; vomiting; third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose; malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),; hard to climb stairs; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose), MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),), GAIT DISTURBANCE (hard to climb stairs), PYREXIA (temperature was 99.8) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose), MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),) and GAIT DISTURBANCE (hard to climb stairs). On 05-May-2021, the patient experienced PYREXIA (temperature was 99.8) and VOMITING (vomiting). On 06-May-2021, the patient experienced FATIGUE (still fatigued) and NAUSEA (a little nauseous). On 05-May-2021, VOMITING (vomiting) had resolved. On 06-May-2021, PYREXIA (temperature was 99.8) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose) had resolved and MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),), GAIT DISTURBANCE (hard to climb stairs), FATIGUE (still fatigued) and NAUSEA (a little nauseous) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) temperature-99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       This case was linked to MOD-2021-044878, MOD-2021-044878 (Patient Link).   Reporter did not allow further contact
15 mins, dizzy, faint feeling, weakness, nausea and given toast, juice, cold pack behind neck, elevated lower extremities. BP 140/88, metallic taste that left mouth after 10 min. Went back to work. Presented to ER around 1 PM.
Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left arm on 06Feb2021 at 12:00 as dose 2, single for COVID-19 immunisation. The medical history of the patient included gastritis and arthritis. The concomitant medications of the patient included calcium (CALCIUM), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and amitriptyline (AMITRIPTYLINE) all taken for an unspecified indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 13Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 07Feb2021 at 01:00, the patient experienced joint pain. Therapeutic measures were not taken as a result of event. The patient recovered from the event on an unspecified date in 2021.  Information about Batch/Lot number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Had shots Mon. pm- mom noticed his arm was swollen this pm- child said arm itched this am. No fever at hospital today.
client was given HPV immunization on right arm, immediately told mother that she felt dizzy and weak- client stood up from chair and gradually slumped down to floor- (vaccine administator, medical aide)supported client's head from hitting floor-no apparent injuries noted-rested and aware of surroundings-after 45 minutes client left with mother ,ambulating and with instructions of any further episode to go to er- comfort measures explained
a patient was administered a third dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (a patient was administered a third dose of the Moderna Covid-19 vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (a patient was administered a third dose of the Moderna Covid-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (a patient was administered a third dose of the Moderna Covid-19 vaccine) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from a pharmacist via a physician, referring to a 27-year-old female patient, who had no children but "did had intercourse". The patient's pertinet medical history, drug reactions/allergies and concomitant medications were not reported. On 06-NOV-2009, the patient was vaccinated with the first dose of GARDASIL, then on 21-JAN-2010 and 26-MAY-2010, she received the second and the third dose of GARDASIL injection (dose, route of administration, lot # and expiration date were not provided for all). On an unknown date, the patient became positive for human papilloma virus (HPV) with 2 abnormal Papanicolaou (Pap) Smear. It was unknown if a treatment was given for the events. The outcome of the events was not recovered, as the patient's events persisted at the time of the report. The relatedness between the patient's being positive for HPV with 2 abnormal Pap Smear and quadrivalent human GARDASIL was unknown.
Tremors in left arm occasionally; Blurred vision; Area above the injection site hurt when took a deep breath, felt an occasional stabbing pain in that area (4/10 pain scale); Arm also hurts; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 17:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient previously received acetylsalicylic acid (ASPIRIN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if it was ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she felt tremors in left arm occasionally. It happened when she pressed it against the edge of my laptop while it was on her lap today, on 19Apr2021 (day 2). Also, on the first day, 18Apr2021, the area above the injection site hurt when she took a deep breath, and she felt an occasional stabbing pain in that area (4/10 pain scale). This was no longer happening. Today, 19Apr2021(day 2), the patient was  experiencing some blurred vision, but might be unrelated (e.g. tired) and she was  able to blink it away. Her arm also hurts but nothing unbearable or strange. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events arm also hurts, area above the injection site hurt when she took a deep breath, felt an occasional stabbing pain in that area (4/10 pain scale), tremors in left arm occasionally and blurred vision. The clinical outcome of events area above the injection site hurt when she took a deep breath, felt an occasional stabbing pain in that area (4/10 pain scale) was recovered on an unknown date in Apr2021, while the clinical outcome of the events arm also hurts, tremors in left arm occasionally and blurred vision were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.