chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I had my shots I was sick 3days both times.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (When I had my shots I was sick 3days both times.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ILLNESS (When I had my shots I was sick 3days both times.). At the time of the report, ILLNESS (When I had my shots I was sick 3days both times.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication information was provided. No concomitant medication information was provided.
Chills,  really bad headache, nausea, rash on face (lasted 3 days).  Antibody test came back negative (no coverage listed).
Breakthrough case after three vaccines  Moderna 4/27/21 Lot# 044B21A;  Moderna 5/25/21 Lot# 023C21A;  Moderna 12/21/21 Lot# 013F21A
Low grade pain; Sore above it and below it; little bump underneath left armpit area; Lipoma (fatty cyst); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Low grade pain), PAIN IN EXTREMITY (Sore above it and below it), AXILLARY PAIN (little bump underneath left armpit area) and LIPOMA (Lipoma (fatty cyst)) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, 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 experienced PAIN (Low grade pain), PAIN IN EXTREMITY (Sore above it and below it), AXILLARY PAIN (little bump underneath left armpit area) and LIPOMA (Lipoma (fatty cyst)). At the time of the report, PAIN (Low grade pain), PAIN IN EXTREMITY (Sore above it and below it), AXILLARY PAIN (little bump underneath left armpit area) and LIPOMA (Lipoma (fatty cyst)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (Negative) Patient authorized an ultrasound which came back negative for anything cancerous/tumor..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced aggravated low grade pain and sore above it and below it when he works out.  Patient tried physical therapy, massages, ice and heat to treat the pain.  Treatment product information was not provided. Concomitant product use was not provided.
7 days post vaccine dose #1 - armpit pain on side of injection and small rash and swelling at injection site
This spontaneous report as received from a Pharmacy Technician refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with M-M-R II (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The pharmacy technician reported that 7 doses of improperly stored M-M-R II may had been administered. No adverse events reported. Additional information is not expected.
Patient went to ER cause his arm was red. Er states its a reaction to the booster and possible infection. Patient was given antibiotic and pain medications.
Intense ringing in the ears, headache, and vivid dreams. Will make a doctor appointment to address adverse events in the coming days.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccination for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 23-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
died; Guillain Barre syndrome; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient's grandmother) via media.  This case involves a male patient (age unspecified) who had Guillain-Barre syndrome and died (death) after he received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain-Barre syndrome and died (death) (unknown latency for both the events), following the administration of INFLUENZA VACCINE.  The event Guillain-Barre syndrome was assessed as medically significant.  Details of laboratory data was not reported.   It was not reported if the patient received a corrective treatment before death.  At the time of report, the outcome of event Guillain-Barre syndrome was unknown.   It is unknown if an autopsy was done. The cause of death was not reported.  The information on batch number was requested for this case.; Sender's Comments: This poorly document case received from media concerns a male patient who had Guillain barre syndrome and died after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab/radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: died
Achy arm; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy arm) and ARTHRALGIA (Joint pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Achy arm) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Achy arm) and ARTHRALGIA (Joint pain) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No Concomitant medications were provided. No Treatment information was reported.   This case was linked to MOD-2021-039133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: A follow up was received on 23-JUL-2021, The outcome of the event was updated.
Denies any flu-like symptoms or GI problems. Reports hoarsness but no sore throat. Reports progressive pain and swelling of joints of hands, knees and ankles.  Initially just achiness but progressed to severe throbbing pain mostly in hands and wrists.  Unable to make a fist at the worst point.  Accompanied by burning and numbness of lower extemities and fatigue.  Pain not relieved with advil alternating with Tylenol or by hot/cold.  Improving with prednisone.
This spontaneous report was received from a medical assistant concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.     On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M037011, expiration date:21-FEB-2018, lot # M031943, expiration date: 27-DEC-2017 and lot # M035145, expiration date: 30-JAN-2018, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion between 5 and 14 Fahrenheit degrees for 48 hours. No previous temperature excursions were reported. Data logger was not involved. No adverse effects were reported. A phone call was placed on 22-MAR-2017 to the medical assistant, who reported that, she was waiting for the office manager to download the information and then she would fax it in. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US0095075131701USA005974. The WWID US009507513 1701USA005974 refers to the linked report (and therefore not being nullified).. The correct WWID is now referenced in this safety report (US0095075131704USA006957). Additional information has been requested.; Sender's Comments: US-009507513-1701USA005974: US-009507513-1704USA006956: US-009507513-1704USA006958:
SHORTNESS OF BREATH; STOMACH ISSUES; NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shortness of breath, stomach issues, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, not feeling well and stomach issues was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/06/2021. PATIENT FULLY VACCINATED ON 03/19/2021.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments:  US-009507513-1611USA004113:
Patient went to multiple locations throughout county receiving multiple vaccinations. He utilized different names, addresses, and  other information. No medical adverse events have been reported.
I was woken up from sleep at 11:30 with swelling of my tongue.  It was getting hard to breath, so I got ice and sucked on it for awhile, then I put a cold cloth on my face, tried to relax and the swelling seemed ok.  I stayed up all night because I was afraid that it would get worse, At about 9:30a.m. it seemed to be getting back to normal with just a little swelling in the back of my tongue.  I felt terrible for the next three days and still don't feel great. Sore joints, got chills, headache.  I am not going in for the second shot.
This case was reported by a pharmacist via call center representative and described the occurrence of cramp in hand in a adult patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cramp in hand. On an unknown date, the outcome of the cramp in hand was unknown. It was unknown if the reporter considered the cramp in hand to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, a patient experienced cramping in one hand. The healthcare professional asked a general question over chat and reported that he heard things like this but did not recall any specific details on the patient affected. No patient details were provided. This case has been linked with case US2018158105, reported by same reporter.
I received the first shot March 6, 2021. I was sick the whole next day. I received my second shot on April 3, 2021. I was sick for 3 days after that one. I had swollen glands that lasted for 2-3  weeks. I got my third shot on September 29, 2021 and I was sick for just over 3 days. I had severe muscle aches starting in early morning after the shot that lasted about 2 days. I had swollen glands on the collarbone on the  injection side. I had chills , fevers and weakness for almost 4 days during that time I slept in my winter coat under my bedcovers. When I got out of bed I felt dizzy. I couldn?t eat for the first 3 days. I had severe headaches for the first 2 days after the shot.
HEADACHE, LOSS OF TASTE/SMELL, NASAL CONGESTION, SORE THROAT, DRY COUGH, GENERAL MALAISE MAB INFUSION
Dizziness within 10 minutes of shot; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Aug2021 at 13:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The medical history included allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 17Aug2021 at 14:00, the patient experienced dizziness within 10 minutes of shot. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of dizziness which included treatment with water and observation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a female (age unknown), who on 29-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Subsequently, a few hours after receiving the vaccination the patient developed widespread hives. The patient self treated with Benadryl and the symptoms resolved within 24 hours. The patient sought unspecified medical attention. On 30-MAY-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Tightness in throat,  difficulty swallowing. I took 1 or 2 capsules of benadryl 25mg and symptoms gradually subsided.
Redness, warmth, pain, swelling from LEFT lateral neck to wrist. Significant pain in arm. Palpitations.
Pt started having cardiac issues 5 days after second vaccine.  Ended up having to have pacemaker placed and now on many cardiac medications.  Had no prior history of any cardiac events or issues prior to vaccine.
pt became unconscious;had dilated pupils;rapid tongue movement;circumoral cyanosis;no resp x 10 sec; BP 118/66; P 142 irregular;gasped for air, than shallow R 14;conscious but lethargic;N/V undigested food;pale;Dx poss sz;hosp
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992: US-009507513-1802USA012204: US-009507513-1802USA012205: US-009507513-1802USA012206: US-009507513-1802USA012207: US-009507513-1802USA012208: US-009507513-1802USA012209: US-009507513-1802USA012210: US-009507513-1802USA012211: US-009507513-1802USA012212: US-009507513-1802USA012213: US-009507513-1802USA012214: US-009507513-1802USA012215: US-009507513-1802USA012216: US-009507513-1802USA012217: US-009507513-1802USA012218: US-009507513-1802USA012219: US-009507513-1802USA012220: US-009507513-1802USA012221: US-009507513-1802USA012222: US-009507513-1802USA012223: US-009507513-1802USA012224: US-009507513-1802USA012225: US-009507513-1802USA012226: US-009507513-1802USA012227: US-009507513-1802USA012228: US-009507513-1802USA012229: US-009507513-1802USA012230: US-009507513-1802USA012231: US-009507513-1802USA012232: US-009507513-1802USA012233: US-009507513-1802USA012234: US-009507513-1802USA012235: US-009507513-1802USA012236: US-009507513-1802USA012237: US-009507513-1802USA012238: US-009507513-1802USA012239: US-009507513-1802USA012240: US-009507513-1802USA012241: US-009507513-1802USA012242: US-009507513-1802USA012243: US-009507513-1802USA012244: US-009507513-1802USA012245: US-009507513-1802USA012246: US-009507513-1802USA012247: US-009507513-1802USA012248: US-009507513-1802USA012249: US-009507513-1802USA012250: US-009507513-1802USA012251: US-009507513-1802USA012252: US-009507513-1802USA012253: US-009507513-1802USA012254: US-009507513-1802USA012255: US-009507513-1802USA012256: US-009507513-1802USA012257: US-009507513-1802USA012258: US-009507513-1802USA012259: US-009507513-1802USA012260: US-009507513-1802USA012261: US-009507513-1802USA012262: US-009507513-1802USA012263: US-009507513-1802USA012264: US-009507513-1802USA012265: US-009507513-1802USA012266: US-009507513-1802USA012267: US-009507513-1802USA012268: US-009507513-1802USA012269: US-009507513-1802USA012270: US-009507513-1802USA012271.
Leg DVT; This literature-non-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (Leg DVT) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       Concurrent medical conditions included Cardiovascular disease, unspecified.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Leg DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Leg DVT) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Total 330 patients were included in the study, with mean age of 70 years. Out of which, total 221 patients received Moderna vaccine.  Side effects were reported in 50% of patients who received the Moderna vaccine. The most common symptoms were local site skin reaction, fatigue, and muscle pain.  The patient was diagnosed with leg DVT after receiving Moderna vaccine and was treated outpatient.  Authors concluded that COVID Vaccines are safe in patients with cardiovascular disease with infrequent serious side effects.  Company comment: This is a literature non-study case concerning of unknown gender and sex patient with reported medical history of cardiovascular disease (not specified), who experienced the serious (due to medically significant), unexpected, AESI event of Deep vein thrombosis (Leg DVT). The event occurred after mRNA-1273 vaccine (unknown dose). The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-715852 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Live follow up received by safety on 16-Mar-2023 has email with full text article and contains reporter information, literature information and event details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715852:Case for remaning patient who developed DVT
1 Week after Varivax vaccine administered - pateint noticed redness at site. Then developed to inflammation, redness, warmth and tenderness to touch - local reaction no systemic response.
HEART HURT; FINGERS NUMB ON LEFT SIDE; HEADACHE; This spontaneous report received from a physician via a company representative concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced heart hurt, fingers numb on left side, and headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the heart hurt, fingers numb on left side and headache was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
I experienced pain in my left clavicle. I took a Tylenol and the pain went away.
cannot smell; cannot taste; began smelling "smokiness"; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (began smelling "smokiness"), ANOSMIA (cannot smell) and AGEUSIA (cannot taste) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAROSMIA (began smelling "smokiness"). On 08-Apr-2021, the patient experienced ANOSMIA (cannot smell) and AGEUSIA (cannot taste). On 08-Apr-2021, PAROSMIA (began smelling "smokiness") had resolved. At the time of the report, ANOSMIA (cannot smell) and AGEUSIA (cannot taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment was unknown.
Right thigh erythema, mild tenderness, 10 cm x 9 cm. Normal activity. H/o fever. Clezdamycin, Zyrtec.
Adult Covid vaccine given. Vomiting, fever, tired the following day (11/9)