chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Metallic taste in my mouth; I stagger when I walk. Walking is difficult. I feel like I am losing balance; My heart was racing right after I got the vaccine, My heart speeds up and then settles down; Headaches; I do not feel the same since I received the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.), DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance) and PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FC-014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (I do not feel the same since I received the Moderna Covid-19 vaccine.) had not resolved and DIARRHOEA (Diarrhea), DYSGEUSIA (Metallic taste in my mouth), GAIT DISTURBANCE (I stagger when I walk. Walking is difficult. I feel like I am losing balance), PALPITATIONS (My heart was racing right after I got the vaccine, My heart speeds up and then settles down) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received the vaccine in her left arm shoulder deltoid muscle.   No concomitant medication was provided.  No treatment medication was provided.
None - no reaction reported patient received 2 flu vaccinations: 1) 10-28-2010 FLUVIRIN (.5ml) 2) 11-5-2010 FLUVIRIN (.5ml).
1/3/21 noted a red lump/hive looking mark on the injection site. Mark was warm to touch.
9 days after injection, subject developed a localized, prominent red rash around the injection site approximately 3-4 inches in diameter. No/minimal swelling, no pain, and no itching. Rash has persisted without improvement for ~12 hours. Subject experienced moderate arm soreness from approximately 3-30 hours after injection (i.e. more severe than most other vaccines previously received), but has had no symptoms in the intervening period and has not been febrile.
Less than 1 minute after administration  of Pneumovax pt's face turned bright read and complained of swelling tongue and throat. Pt given 2 dose of Epi pen 0.3mg. Pt was taken by EMS to emergency room for observation. She was discharged shortly later.
took one flu shot and it almost killed me, five weeks and I've never been sick in my life; Initial information was received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer via social media (under reference number: US-SA-SAC20211006000097).  This case involves an unknown gender adult patient who experienced a non-serious event took one flu shot and it almost killed me, five weeks and I had never been sick in my life (malaise) while receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event took one flu shot and it almost killed me, five weeks and I had never been sick in my life (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, at time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
sore around site; sleepless night; bad headache; legs sore ; flu like symptoms ( not runny nose)   tylenol not helping -
Norming feeling; Extreme pain in arm; Loss of complete function of epsilateral arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Norming feeling), PAIN IN EXTREMITY (arm), and HYPOKINESIA (Loss of complete function of epsilateral arm) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Norming feeling), PAIN IN EXTREMITY and HYPOKINESIA (Loss of complete function of epsilateral arm). At the time of the report, HYPOAESTHESIA (Norming feeling), PAIN IN EXTREMITY (arm) and HYPOKINESIA (Loss of complete function of epsilateral arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The treatment information was not given.   This case was linked to MOD21-083908, MOD-2021-097544, MOD-2021-097588.
Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to change the company causality from "Unclassified" to "Possible". Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to add modifier for the company drug 'Praluent' and to add the labelling for this product in event to product assessment screen. Initial unsolicited report received from a healthcare professional on 10 November 2015. This case involves a 62-year-old female patient who was vaccinated with a dose of Flu vaccine (batch number, expiration date, dose number, dose, site and route were not reported) on or around 15 October 2015. The patient also received a dose of Praluent 75mg for treatment of cholesterol on or around 15 October 2015. On 29 October 2015 (fourteen days later) the patient received her second Praluent dose 75mg. The treating physician discontinued Praluent on 29 November 2015. The patient's medical history and Concomitant medications were not reported. On unspecified date following the vaccination the patient experienced flu like symptoms, nausea, fever, chills and body aches. After second dose of Praluent, the patient again experienced the same flu like symptoms, nausea, fever, chills and body ache. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. The treating physician was uncertain if the symptoms could be attributed to Praluent, the flu vaccine or illness. List of documents held by sender: none. Addendum on 9 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to add modifier for the company drug 'Praluent' and to add the labelling for this product in event to product assessment screen. Addendum on 9 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to change the company causality from "Unclassified" to "Possible".
A few days after receiving the flu vaccine the patient started experiencing dry mouth and burning tongue syndrome. She does not know if it is related to the vaccine but wanted to report it.
LOST VOICE; VOMIT; HARD TO FOCUS; HEADACHE; LITTLE FEVER; FEELING UNCOMFORTABLE; DIZZY; SWEATING; WEAKNESS; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-APR-2021, the subject experienced feeling uncomfortable. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced lost voice. On 11-APR-2021, the subject experienced vomit. On 11-APR-2021, the subject experienced hard to focus. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on APR-2021, had not recovered from dizzy, lost voice, hard to focus, and feeling uncomfortable, and the outcome of sweating, weakness, headache and vomit was not reported. This report was non-serious.
Chills, fever (100.7), fatigue, local injection site reaction that lasted about 3 days
Manager was notified that the employee had suffered a stoke-like "serious medical event" hours after the end of her shift, while at home.
Coldness, chills, queasy stomach, nauseated, tiredness and no energy.
a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.; big red patches; it looks like hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.), ERYTHEMA (big red patches) and URTICARIA (it looks like hives) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced RASH (a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.), ERYTHEMA (big red patches) and URTICARIA (it looks like hives). At the time of the report, RASH (a rash on her both thighs / now is on her arm, chest, stomach, back, which she still has.), ERYTHEMA (big red patches) and URTICARIA (it looks like hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A serious adverse event report of bacterial pneumonia and non-serious adverse event report of achy, temperature, and cough has been received from a registered nurse concerning a 39-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 18-Sep-2009. The patient received a total of one dose of FLUMIST before the onset of the event. The patient felt achy several days after receiving FLUMIST. Then he had a temperature and cough that  progressed. The patient was hospitalized with bacterial pneumonia on an unknown date. The events were resolved on 10/05/2009.
vaccine was expired, no temperature excursion occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V-2 virus at the time of administration".  Patient reported no adverse reactions.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The reporter reported that the patient, who was intended to receive ZOSTAVAX, was inadvertently administered 0.5 ml VARIVAX (merck)(subcutaneously) (lot # was unknown, SC)on 25-SEP-2012. No adverse effects reported. Additional information is not expected.
severe h/a, sweating, dizziness, fatigue onset 6PM 16APR94; 17APR 8AM transported to hosp;
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Pt. states that after receiving the 1st dose of Moderna 04/04/2021, started experiencing symptoms 04/04/2021 of severe anxiety and panic attacks. No noted Primary visit/communications. Pt. still continuing to experience symptoms/ Received 2nd dose of Moderna 04/30/2021 017B21A (Experienced similar symptoms)
This is a spontaneous report from a Pfizer sponsored program. A 17-year-old male patient received his first dose of TRUMENBA (NDC # 0005-0100-10, Lot # M13065, Expiry Date Sep2016), intramuscular in the left arm on 02May2016 at 0.5 ml, single. Medical history included ongoing acne (diagnosed a few years ago, probably in 2013 when EPIDUO was started), ongoing chronic allergies (multiple allergies since he was an infant), ongoing asthma (since he was an infant, he had asthma when he exercised), coeliac disease from 22MAY2008 and ongoing, food and environmental  allergies. Concomitant medications included EPIDUO gel from 07Oct2013 and ongoing PROAIR HFA from 30 Mar2009 and ongoing, ongoing EPIPEN. The patient experienced headaches, fever, malaise, body aches all over his body, it was generalized, swollen painful left upper arm/the left arm pain was at the injection site, myalgia, decreased range of motion in the left arm, all on 02May2016 with outcome of unknown. Since 02May2016, the patient had headaches, fever, malaise, myalgia and a swollen, painful left upper arm with decreased range of motion in the left arm. She further described the malaise as body aches all over his body; it was generalized. The left arm pain was at the injection site. The patient also had a fever for 48  hours. The temperature was not taken at home due to the mom did not have a thermometer but patient's mother reported he was hot. In the office, his temperature was normal, 97.4 degrees Fahrenheit on 04May2016. He had fever control medicine, MOTRIN 400 mg, before coming to the office. He did not receive treatment at the office. The patient was evaluated by physician and discharged home without being prescribed any medicine. Follow-up (29JUN2016): Follow-up attempts are completed. No further information is expected.
Shooting pain down right arm. Right shoulder and upper arm stiffness and pain, decreased ROM, numbness and tingling.
1/9/2021 fever of 101.3, chills, 1/10/2021 fever 99.6, diarrhea,  pain in injection site slight.  Tylenol
arthritis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. This female patient of unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient received her first dose of vaccine on 23Jan2021 (reported as "today") and would get Remicade on Monday for her arthritis. The patient asked if it was safe and if it would affect the vaccine. Outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Pain and itching at injection site after about 2-4 hours lasted to the next day approximately 24 hrs  Face flushing started about 2-4 hours after vaccine and lasted only about 4 hours.  Nausea  started  about 6 hours after vaccine and lasted about 10 hours
Eyes started feeling "gravely" about 10 when he was going to bed. Eyes were almost swollen shut, had swelling under tongue (not throat) Wife called nurse line. He had taken a dose of Dayquil, she had visit with pharmacist and said to give him Benadryl and to go to ER if not better in 1 hr. He was better and did not have to go to ER. Never had difficulty swallowing. C/O bad taste in mouth, eyes puffy until Sun.
Shakes; chills; fever; headache; neck pain; arm pain; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 11:15 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included FLU, administration date 2021. Vaccination history included Bnt162b2 (Dose Number: 1), administration date: 03May2021, when the patient was 36 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 24May2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 06Dec2021 11:15, outcome unknown; TREMOR (non-serious) with onset 06Dec2021 20:30, outcome recovering; CHILLS (non-serious) with onset 06Dec2021 20:30, outcome recovering; PYREXIA (non-serious) with onset 06Dec2021 20:30, outcome recovering; HEADACHE (non-serious) with onset 06Dec2021 20:30, outcome recovering; NECK PAIN (non-serious) with onset 06Dec2021 20:30, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 20:30, outcome recovering. Therapeutic measures were not taken as a result of tremor, chills, pyrexia, headache, neck pain, and pain in extremity. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported as 08Dec2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Severe fatigue, joint pain, scrotum swelling, left armpit pain, aggravated tremors, aggravated tinnitis, chills/sweats
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter  No Treatment Information were provided by the Reporter
INTENSE PAIN AT VACCINATION SITE. REDNESS, SWELLING, HEAT, INFLAMATION AT SITE. FEVER OVER 101 FOR 48 HOURS.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot/batch # L048849, expiry date 04-FEB-2018 (dose, strength, vaccination site and route unspecified). The temperature excursion was reported as 34F for 48 hours. No adverse effect were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Child was inadvertently given 0.5 ml of FLUZONE when dose should have been 0.25 ml because of child's age. Mother notified within 30 minutes of administration of error.
Starting day 4 site began with intense itching, and some redness.  On day 5 welts started breaking out at site, redness and itching continued.
Rash to skin fold (axilla, groin, and abdomen) began about 3/31/2021.  Diagnosed with biopsy as eczema on 4/21/2021.  Additional rash to extremities and trunk began about 4/5/2021 and continues to worsen. Diagnosed as PUPPPS on 4/17/2021.  Currently pregnant with EDD 5/16/2021
(R) Lateral upper arm is indurated 8 x 5 cm with mild warmth/redness afebrile- patients mother said reaction lasted several days but he made a full recovery
Pt. developed redness at site of injection and itching. 2 days later developed 3 dime size spots in line on upper arm of injection. Tender and itchy.
Patient complained of itching on back of neck and behind ears. Denied shortness of breath, difficulty breathing, rash or sweating. 25 MG IM Benadryl administered at 1019. Patient watched for 15 minutes following Benadryl administration. Patient denied any symptoms following.
The child had an episode of dizziness after receiving GARDASIL and VARIVAX #2 fainted for <1 minute (20 seconds) but recovered well right away.
Skin Lesion: Fever; Pruritus - Information has been received from a registered nurse concerning a 5 year old caucasion female who on 26 Jul 1996 was vaccinated with one dose of varicella virus vaccine live sc in the left arm.  Concomitant therapy included one dose of mealses-mumps-rrubella vaccine (msd) adinistered sc in the right arm.  On 01 mar 2000 the patient experienced 10-15 itchy lesions and a slight low grade temperature.  it was noted the mother to start colloid oatmeal (aveeno) baths and diphenydramine HCL (Benadryl - subsequently, the patient recovered.
Patient had lip numbness and mild swelling for 5 hours and then complete resolution of symptoms. No Shortness of breath or itchiness