chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hemorrhaging stroke/ brain bleed; in a coma for nine days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (hemorrhaging stroke/ brain bleed) and COMA (in a coma for nine days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Heart disorder (Heart problems). Concomitant products included LISINOPRIL for an unknown indication.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced HAEMORRHAGIC STROKE (hemorrhaging stroke/ brain bleed) (seriousness criteria death, hospitalization prolonged and medically significant) and COMA (in a coma for nine days) (seriousness criteria death, hospitalization prolonged and medically significant). The patient was hospitalized on 28-Aug-2021 due to COMA and HAEMORRHAGIC STROKE. The patient died on 08-Sep-2021. The reported cause of death was hemorrhaging stroke. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient found her husband lying on the floor. Reporter was unsure that whether patient was taking concomitant drug daily. No treatment information were provided.  Company Comment: This case concerns a 66-year-old, male patient with relevant medical history of Blood pressure high and Heart disorder, who experienced, serious unlisted AESI of hemorrhagic stroke and serious unlisted event of coma, both had a fatal oucome. The event occurred after unspecified duration from  second dose of Moderna COVID-19 Vaccine.  The rechallenge was not applicable as the events occurred after second dose of Moderna COVID-19 Vaccine. The exact cause of death was not provided. However, the medical history of Blood pressure high and Heart disorder remains as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-year-old, male patient with relevant medical history of Blood pressure high and Heart disorder, who experienced, serious unlisted AESI of hemorrhagic stroke and serious unlisted event of coma, both had a fatal oucome. The event occurred after unspecified duration from  second dose of Moderna COVID-19 Vaccine.  The rechallenge was not applicable as the events occurred after second dose of Moderna COVID-19 Vaccine. The exact cause of death was not provided. However, the medical history of Blood pressure high and Heart disorder remains as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: Hemorrhaging stroke
FELT LIKE HAD THE FLU; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) 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 felt like had the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like had the flu was not reported. This report was non-serious.
9/17-9/19 shortness of breath (difficulty in talking on the phone for more than 1 minute) 9/19-9/22 shortness of breath fading. Tightness in left chest area when breathing deeply 9/23 Inability to get a full deep breath(when seated & not out of breath).  When laying down later, pressure/tightness in left chest area with every inhale. Felt as though I would pass out.  1 burst of diarrhea- called on call physician and was instructed to call for an ambulance. When vitals were checked by EMT, blood pressure was approx 155/97.
I was having eight to ten loose stools a day accompanied with a lot of gas pain. I called the doctor who prescribed some medication and asked for a stool sample. Once the results of the sample came back it showed positive for C-diff and Norovirus. I was given a prescription of vancomycin for 10 days. I will be giving another stool sample on April 5, 2023, to ensure that the medication has cleared up the C-diff.
Arm swelled up; Patch; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up), RASH (Patch), CHILLS (Chills) and PYREXIA (fever) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up), RASH (Patch), CHILLS (Chills) and PYREXIA (fever). On 25-Jan-2021, CHILLS (Chills) and PYREXIA (fever) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm swelled up) and RASH (Patch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Patient presented on day  3 from vaccination date with  erythemic/edemic swelling surround the insertion site on her rt thigh. Mother of child states the swelling was noticed the following am from the vaccination date. Swelling has not decreased since onset and states she has used over the counter diphenhydramine x1 to assist with swelling. Mother of child states patient has had recations prior to this though never greater than a half-dollar size surrounding injection site from  prior vaccinations. Area of edema/erythema measured horizontally 5in./12.7cm and vertically 2.75in./6.9cm.  Rx prescribed of Prednisolone suspension @ 2mg/kg/day, 7ml/21mg BID x 5 days with use of OTC diphenhydramine  6.25mg BID to QD for the next 2-3 days for improvement in patient comfort. Patient directed to return to facility in 1 week. +++++patient did not follow up for 1 week evaluation+++
Initial information has been received from nurse practitioner as part of pregnancy registered  for GARDASIL, concerning an approximately 16 years old female patient with an unspecified pertinent medical history or drug reactions/allergies, who on 06-SEP-2012, was vaccinated with the first 0.5 ml dose of GARDASIL (lot reported as 1860AA) and on 06-NOV-2012, was vaccinated with the second 0.5 ml dose of GARDASIL (lot reported as H010123) (route was not reported). No other co-suspected were reported. Concomitant medications included: FLOVENT. Subsequently, the patient became pregnant with an last menstrual period (LMP) of 14-SEP-2012 and an estimated delivery date (EDD) of approximately 21-JUN-2013. No treatment information was reported. A urine pregnancy test was performed. It was reported that the patient sought medical attention by contacting the nurse practitioner. The patient's outcome was unknown. Follow up information was received from the same nurse practitioner on 28-OCT-2013. The reporter stated that the patient had an elective termination on an unspecified date for reasons other than the GARDASIL exposure. The reporter did not have additional information because they no longer see the patient. Upon internal review induced abortion was considered medically significant. No further information is available. Additional information is not expected.
patient is getting a morning glucose level of 137 and before it used to be 120; This non-serious case was reported by a consumer via call center representative and described the occurrence of glucose increased in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-SEP-2023, the patient received the 1st dose of Arexvy (right arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced glucose increased (Verbatim: patient is getting a morning glucose level of 137 and before it used to be 120).  The outcome of the glucose increased was not reported.   It was unknown if the reporter considered the glucose increased to be related to Arexvy.     It was unknown if the company considered the glucose increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient self-reported this case. The patient received Arexvy vaccine last Friday, after receiving the vaccine the patient was getting a morning glucose level of 137 and before it used to be 120. The reporter did not consent to follow-up.
Moderna COVID?19 Vaccine EUA.   Red, sore, warm and itching skin around injection point. It is roundish, with a diameter of about 4 inches
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 16-MAY-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L002424 with expiration date 23-APR-2016, subcutaneous, dose unknown). No adverse effects reported. Additional information has been requested.
5 MINS POST VACCINE, PT COMPLAINED OF HEART RACING AND MILD DIZZINESS. TAKEN TO OBS VIA WC, S/S RESOLVED UPPON ARRIVAL. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1055. 1040 INITIAL BP 142/77 HR 87 RR 18 SATS 97% RA 1050 BP 134/84 HR 85 RR 20 SATS 97%
Stiff neck, severe headache one day after Menactra vaccine. Headache continued x 3 days. Admitted to hospital, labs done - normal results. records received 10/10/07-10/10/07-records received from facility for DOS 9/19/07-ER visit-Assessment:Viral Syndrome. Presented with cough and cold symptoms but most concerned over headache and neck pain in addition to fever. Temp 99.3. Symptoms began on 9/17/07-with abrupt onset of significant bifrontal headache assoicated with the feeling of eye strain. Muscle aches, malaise and fatigue.
Client felt dizzy after given .5mL FLUZONE. Observed for one hour, assessment completed, released at 12:20pm.
Site of injection became inflamed 1 day after injection. Patient took 1 aspirin tab and rubbed cocoa butter on the skin. Next day - redness completely disappeared.
Pt complaining of severe pain in left upper arm around area of injection site. States it is  "hot to touch".
I have started having an involuntary, uncontrollable tremor/spasm in my right hand.  It shakes and stops me from being able to control my hand or use my hand as I was (for instance, if I am writing, I usually have to wait out the tremor before continuing writing).  It seems to be getting worse with time - with originally happening, maybe, once a day.  Now it happens several times a day and throughout the night - even waking me, at times.    I do not know if it is related, but I have developed a mild stutter, as well.
Information has been received from a male physician and a nurse concerning physician's 70 year old female wife with diabetes. On an unspecified date in 2008 (reported as "7 years ago"), the patient received her first dose of PNEUMOVAX 23. On 28-JAN-2015 the patient was vaccinated with her second dose of PNEUMOVAX 23 (strength: 25/0.5 (unit not provided) dose, route not reported, lot# K005957/ expiration date: 08-MAR-2015) for routine vaccination. The nurse reported that since 28-JAN-2015, the patient experienced pain, redness, swollenness, and tenderness throughout her whole arm and patient's arm was "twice the size of her husband". The physician stated he would rate his wife's injection site reaction with PNEUMOVAX 23 as severe. He also reported that his wife's arm was tender up to her shoulder and down to her elbow and was "swollen to double its normal size". The physician was requested lot check for this lot of PNEUMOVAX 23. ADVIL and ice were given as treatment for the events. The patient had seen the physician for medical attention. There was no lab diagnostic studies performed. The outcome of all the adverse events was reported as not recovered. This report was one of the two reports received from the same reporter (MARRS# 1502USA000317). Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) and NAUSEA (Nausea) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm Pain) and NAUSEA (Nausea) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided by reporter. Reporter did not allow further contact.
Into about 10 minutes after receiving  the Pfizer COVID-19 vaccine, patient fell on the floor and  passed out briefly for about 5 seconds, EMS called immediately, V/S at 1030 BP 111/70 HR 52  O2 SAT 99%  RA. At 1032, V?S BP 123/74 HR 57 O2 SAT 99% RA, at 1035 V/S 117/81 HR 60 O2 SAT 99@ RA, at 10/40 V/S 108/76 HR 60 O2 SAT 99% RA, EMS arrived 1042, patient passed out again briefly for about 5 seconds, BP was 129/73. ER Doctor was on site from the beginning of the incident. Patient transported to Hospital ER for further evaluation.
severe chills; got very hot and started to sweat; got very hot and started to sweat; Arm was sore; fever; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 08:15 (at the age of 43 years), as Dose 1, single for COVID-19 immunisation, at workplace clinic. The patient's medical history included ongoing blood pressure and cholesterol. Patient had no known allergies. The patient received other medications (Concomitant medications) in two weeks as Blood pressure/ Cholesterol Meds. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021 13:00 AM, About 16-18 hours after shot, started getting severe chills that lasted about 2 hours, then got very hot and started to sweat. Lasted for about 3 more hours, Arm was sore during this time. He was better with no fever by 05:00 hours, the next day. The patient did not receive any treatment for the adverse events. The clinical outcome of the event severe chills was recovered on 10Feb2021 at 15:00 am and fever recovered on 10Feb2021 at 17:00 am and rest all the events was recovered on unspecified date in 2021.   Information on the lot/batch number has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly stored PROQUAD (Merck) (lot number and expiration date were not reported). No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Rash, hives that spread up back and buttock - Has hard knot at injection site.
trouble sleeping; feeling irritable; red eyes; ear pain; blood pressure was way up; fever; but she does not think she received the right product; she is really upset and confused; she is really upset and confused; This spontaneous report was received from a 69-year-old female patient, who refers to herself. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On 20-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided) or with the second dose of zoster rge vaccine (mammalian) (SHINGRIX), 50 micrograms, intramuscularly, (lot# and expiration date were not provided) for prophylaxis.  On 22-MAY-2019 (reported as 2 or 3 days after vaccination), the patient had trouble sleeping, red eyes, ear pain, fever, she was feeling irritable and thought that her blood pressure was way up. Since an unknown date in May 2019, the patient was really upset and confused. The patient stated, that she thought she was dying. She was taking an antibiotic to treat her symptoms. The outcome of trouble sleeping, irritability, red eyes, ear pain, fever and increased blood pressure was unknown. The outcome of feeling upset and confused was reported as not recovered.  The relatedness between the events and the suspect vaccines was not provided.  The reporter considered the events of trouble sleeping, irritability, red eyes, ear pain, fever and increased blood pressure to be life threatening.
Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 03:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis (reported as sinus) and reflux. The patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), pantoprazole sodium sesquihydrate (PROTONIX) and loratadine (CLARITIN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 10:00 the patient experienced low grade fever 100.2 (units unspecified) and chills also sore arm at injection site. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade fever 100.2 and chills also sore arm at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
45 minutes after receiving injection I got generalized large hives all over my body, my chest started to feel tight, and under my chin up to my bottom lip felt numb and tingly. Took 50mg Benadryl, Zyrtec, and Pepcid, symptoms subsided. Went to ER for follow up and they prescribed me 18 days of tapering prednisone and an epi pen, advised me to not get 2nd dose.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, while administering a ZOSTAVAX subcutaneously (lot # and dose were not reported) it was reported that it was difficult inserting the needle and penetrating the patients "elderly skin". It was unknown if the patient received the full dose of the ZOSTAVAX. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
pt reports on 30MAR97 pt awoke afeb, fatigued & w/profound systemic joint aches, dizzy & lightheaded;sx lasted for 24hr;fatigue & lightheadedness 3APR97;diarrhea on & off 3APR97;
Chills, low grade fever, migraine, nausea, vomiting, aches all over body, redness and swelling at and around  injection site (?Covid arm?). Fatigue, lightheadedness, lasted about two days, then very tired for about a week.
She got bruise on the injection site about the size of a half dollar; Headache; This is a spontaneous report from a contactable consumer.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 07Jan2021 at single dose for COVID-19 immunisation. About lot, the reporter doesn't know if it is an L or a C, 3249, and thinks it is a C. Age at vaccination was 80-years-old. Medical history included blood pressure high. Concomitant medications included lisinopril for blood pressure high plus an unspecified long list. When she got the shot, she got bruise on the injection site about the size of a half dollar. She has headache too, first two days. Onset of headache was reported as 8th or 9th day after vaccination (Jan2021). The patient is supposed to go back on the 29th. The patient was still experiencing headache, slightly but not as bad, while outcome of bruise on the injection site was unknown. Information on the lot/batch number has been requested.
DIFFUSE ERYTHEMATOUS ERUPTION INVOLVING ABD, BACK, CHEST  AND EXTREMITIES
3/23-3/24 fussy, runny nose 3/25 thurs. - lethargy, fever vomit, temperature 102-103 3/28 rash began on face, ears, spread to trunk, legs - arms. eyes red 3/28 to ER 3/30. fever continues rash persists, to family Dr, CBC and 4A; appetite poor, lethargic. improved by 4/1/04
Migraine like feeling; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine like feeling), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache). On 17-Feb-2021, the patient experienced FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced MIGRAINE (Migraine like feeling) and NAUSEA (Nausea). At the time of the report, MIGRAINE (Migraine like feeling), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Post vaccine, pt became pale and dizzy. No nausea, no vomiting, and no diapherisis. She stated that she "feel as though I'm going to faint" with blurred vision. Pt admits to being fearful of needles.
Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves a patient of unknown demographics who got sick since patient stopped getting the shots (Illness), while the getting Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  Since an unknown date (unknown latency), the patient did not have a flu shot in over 30 years and got sick (illness) since patient stopped getting the shots.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Diarreah. Chills/hot. Fatigued. Headache. Joints hurt. Injection site hurts.