chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RESIDENT STATES THAT HIS RIGHT ARM ITCHES FROM VACCINE SITE TO FOREARM AREA.  AREA HAS RED DISCOLORATION.  DENIES ANY PAIN AT THIS TIME.
stroke; was on blood thinner; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; BLOOD DISORDER (non-serious), outcome "unknown", described as "was on blood thinner". Therapeutic measures were taken as a result of blood disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Sunday 11/7/2021 I woke up not feeling well. I felt very chilled and fatigued. I had a headache and body aches but no fever. I just felt very cold. I later found out that I was in direct contact with someone on Friday who tested positive for COVID-19. I also found out a few days later that I was in contact with someone else who tested positive for COVID-19 as well. I took two COVID-19 test but they were both negative. I had a cough, congestion, runny nose, and a sore throat. I haven't loss sense of smell or taste.
This spontaneous report as received from a physician refers to a 16-month-old patient of unknown gender. Information about concurrent conditions and medical history was not provided. On 23-DEC-2014 the patient was supposed to receive an unspecified flu vaccine, which was placed on a counter next to GARDASIL (strength, dose and lot# not provided). The physician inadvertently picked up and administered a dose of GARDASIL intramuscularly to the 16-month-old patient instead of the intended flu vaccine. When physician realized the error, she additionally administered the intended flu vaccine. No adverse effect reported. Additional information has been requested.
Post vax the patient was unconsolable, screaming for 2-2 1/2 hours then arching, unresponsive, staring for 20 minutes than asleep for 6 hours. Then back to her previous good state of health.
Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised) in a 74-year-old male patient 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 OFF LABEL USE (Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised). At the time of the report, OFF LABEL USE (Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   It was reported that patient was doing fine.  Treatment information was not provided.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 05-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Papular, targetoid eruption over limbs. Pruritic. 1 week after Anthrax #3 and 2 weeks after smallpox.
Didnt have any energy; Light sensitivity; It put me down for 24 hours; Splitting headache like a migraine; Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not get out of bed), ASTHENIA (Didnt have any energy), PHOTOSENSITIVITY REACTION (Light sensitivity), FEELING ABNORMAL (It put me down for 24 hours) and HEADACHE (Splitting headache like a migraine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (screwed up patient's sleeping pattern).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MOBILITY DECREASED (Could not get out of bed), PHOTOSENSITIVITY REACTION (Light sensitivity), FEELING ABNORMAL (It put me down for 24 hours) and HEADACHE (Splitting headache like a migraine). On an unknown date, the patient experienced ASTHENIA (Didnt have any energy). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. In April 2021, FEELING ABNORMAL (It put me down for 24 hours) had resolved. At the time of the report, MOBILITY DECREASED (Could not get out of bed) and ASTHENIA (Didnt have any energy) outcome was unknown and PHOTOSENSITIVITY REACTION (Light sensitivity) and HEADACHE (Splitting headache like a migraine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication reported. Patient reported that she might have taken an aspirin for her symptoms, but does not remember.
A body rash on my back, stomach, trunk, arms, and legs, rash itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A body rash on my back, stomach, trunk, arms, and legs, rash itches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH PRURITIC (A body rash on my back, stomach, trunk, arms, and legs, rash itches). At the time of the report, RASH PRURITIC (A body rash on my back, stomach, trunk, arms, and legs, rash itches) outcome was unknown. Not Provided          Concomitant information not provided. Treatment information not provided
This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received  FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT.  Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Racing thoughts, rapid and complex motor tics, heightened state of fear, obsessive thoughts, licking of objects in the home as well licking of people at school, inability to remain in a location for even a minute at a time, running around and flailing of his limbs, running into people, inappropriately touching people, rapid and constant touching of objects for no purpose, complex motor tics with his arms and legs, periodic growling vocal tic, and an inability to execute simple academic tasks. Symptoms came on rapidly in the early morning hours of 2/21/14 and have progressively worsened.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: After waiting 15 minutes patient stated a rash had occured on same arm as injection. I called the minute clinic nurse practitioner in store and she examined the patient, gave her a prescription of 3 days of hydroxyzine 50mg, and instructed her to go to the ER if symptoms got worse.
This spontaneous report was received from a nurse and refers to a 2 year old patient of unknown gender. The patient's medical history included mosquito bites and exaggerated swelling response to them. The patient did not have any other known allergies. On 08-SEP-2015, the patient was vaccinated with a dose of M-M-R II, lot # K021952, expiration date 10-NOV-2015 (dose and route of administration were not provided). The patient took no concomitant medications. On 10-SEP-2015, the patient developed "eye swelling". On an unknown date in September 2015, the patient was examined by the physician who documented that the patient had "no discharge and no fever". The physician believed that the patient might had been bitten by mosquito as the patient had a history of an exaggerated swelling response to mosquito bites in the past. The physician diagnosed the patient's eye swelling as cellulitis of the face. The physician prescribed BACTRIM, solution, 6 ml, orally, every 12 hours for 7 days and amoxicillin, 250 mg/5ml orally, every 12 hours for 7 days to the patient as the treatment of the event. No lab diagnostics were performed. At the time of reporting (reported as "currently"), the patient was recovering from the event. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
pt recv vax 13APR96 & 20APR96 pt exp a typical varicella rash;rash began on the abd & spread quickly to involve the entire body;Md stated that this was the worst case  ever seen;tx w/med;
Pt recvd vax & was dx w/pyrexia-unk etiology; pt woke up leg was stiff & was not alert & active & would just sit & stare; pt was running a fever (105-106) R & was shaky & movements were jerky; pt was vomiting; pt feverish & lethargic;
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 6-month-old male patient who experienced runny nose after being in close contact with his brother, who had received the Flumist. Medical history: Relevant medical history was noT provided. Product details: Additional suspect medication included influenza virus vaccine injection (manufacturer unknown), which he received on 06-Nov-2003. Concomitant therapy: Concomitant medications were not reported. Event details: The patient experienced runny nose (rhinorrhea) on 11-Nov-2003, after being in close contact with his brother who had been vaccinated with Flumist (accidental exposure). The infant had also received an influenza virus vaccine injection (manufacturer unknown) on 06-Nov-2003. Related case(s): The patient's brother developed the cold symptoms of a runny nose and fever following receipt of Flumist on 06-Nov-2003 (see MCN HQWYE0195). No additional information was available at the date of this report.
This spontaneous report as received from a registered nurse refers to an 18 days old female patient. The patient did not have pertinent medical history and drug reactions or allergies. On the day of birth, the patient was vaccinated with the first dose of RECOMBIVAX HB (strength 2.5microgram/0.5ml, dose, lot#, expiration date and route were unknown). There were no concomitant therapies. On 02-OCT-2014 the patient was inadvertently administered a second dose of RECOMBIVAX HB (strength 2.5microgram/0.5ml, dose, lot#, expiration date and route were unknown). The nurse stated that later that day on 02-OCT-2014 (also reported as 03-OCT-2014), the patient had a fever and was "fussy". The patient was admitted to hospital to rule out sepsis on 02-OCT-2014. A "Septic Workup" with a spinal tap was performed. She stated that the "septic workup" was negative and it was determined that the patient had a viral illness. No treatment was given, only "supportive measures". She stated that the patient was discharged from the hospital on 05-OCT-2014. The nurse stated that the patient was "still running a low fever" but was no longer "fussy". The outcome of the event was not recovered. Additional information has been requested.
Right side of throat soar & nostral on right side (opposite of shot), chills,  tired, nausea
Caller states she got her first Pfizer Covid vaccine on 20Apr2021 and has since had trouble focusing and reports she is "hearing things that aren't there."; trouble focusing; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that that the female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced caller states she got her first pfizer covid vaccine on 20apr2021 and has since had trouble focusing and reports she is "hearing things that aren't there." on an unspecified date with outcome of unknown, trouble focusing on an unspecified date with outcome of unknown.    The clinical course was reported as follows: Caller states she got her first Pfizer Covid vaccine on 20Apr2021 and has since had trouble focusing and reports she is "hearing things that aren't there." She wants to know with these side effects, should she proceed with the second dose. Agent states the caller on the line received her first vaccine and after that she had some strange side effects, she had trouble focusing and hearing things that were not there, agent states the caller has her second vaccine scheduled for tomorrow and wants to know if she should get it. Caller confirmed details provided. Confirms she received the first dose of the Pfizer Covid vaccine on 20 APR 2021, caller declines to provide further information for a report at this time, states she has to get back to work.   Follow-up needed. Information about batch/lot number has been requested.
36 hours post 1st shot: Immediate onset of severe neck pain, chills, body aches, headache 101 fever, red circle and knot at injection site, felt strange. The following day, I developed a severe rash on my upper abdomen, chest, back and face. On 04/10/21, my arm at injection site turned raised and red; freezing cold hand, tips of my fingers were numb for 45 minutes, itching, fast heart rate, extreme pain in left shoulder blade.  On 4/26/21 I had a mammogram which showed 2 small masses (5 mm x 5 mm) and prominent lymph node left arm pit. Biopsies are scheduled on 5/6/21.
Patient reported body aches, flu-like symptoms, redness, pain and swelling at injection site, joint pain/aches in opposite side of body that injection was given. Severe body aches.
pt recvd vax 27DEC93 & rash worse afterwards; dry scabed rasied rash;
I have all the symptoms of Guillain-Barre Syndrome from the Johnson & Johnson shot.   The symptoms started on June 18th with massive muscle pain in my left side upper back, left shoulder, and left arm. Very painful nerve pain down my arm that has persisted for over 3 weeks. Partial loss of feeling in my arm and loss of strength in my left arm. My arm is substantially weaker and I cannot use my arm in the manner I use too.  As if today's date of 7/12/2021 I have muscle weakness, nerve pain from my upper back and all the way down my right arm.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date place in refrigerator: 03-Nov-2021 No temperature excursion of product reported. No adverse events were reported.  No concomitant drug information was provided.
Pt was given the Dtap injection in the left thigh on 4/2/13. Patient's mom brought him in on 4/3/13 complaining of emesis x 3-4 from 12 pm to time of visit with erythema and increased warmth at injection site.
This spontaneous report as received from a other health professional refers to a 63 year old female patient. The patient had a history of unknown reaction to codeine and penicillin. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant therapies included aspirin, ascorbic acid, RESTASIS, OS-CAL CALCIUM CARBONATE, vitamins (unspecified), lisinopril (unknown manufacturer) and estradiol (unknown manufacturer). ON 11-SEP-2014 the patient experienced redness at the injection site and fever. The patient sought medical attention by calling the physician's office. As treatment over the counter BENADRYL was taken and ice was put over the reaction site. The outcome of redness at the injection site and fever was reported as recovering/resolving. Additional information has been requested.
Pt noticed the 2 gland swell at left subclavicular area up few days after the first vaccine. Per pt, it had gone down but the it still there, and it has been 3 weeks already
The day following my first dose of the Moderna shot, I experienced fatigue, slight chills, and a low grade fever. The day after I also experienced a higher than normal arm pain at the site injection.
Information has been received from a published article, title as stated above concerning a 20 weeks old previously healthy female who presented to the emergency room, with low grade fever, hematochezia and non-bloody emesis that lasted for about 48 hours. She had received her second set of immunizations; including oral ROTATEQ one week prior to presentation. Physical exam revealed multiple petechiae over her entire body but no visceromegaly. Barium enema was negative for intussusception, although stool enzyme immunoassay was positive for rotavirus. Platelet count was found to be 19,000/cmm, hemoglobin was 6.4 g/dl, and white blood cell count was 8,300/cmm with normal differentials. On peripheral blood smear she had normochromic, normocytic  red blood cells with polychromasia and occasional schistocytes, giant platelets and no blasts. Direct coomb's test was negative, blood urea nitrogen, serum creatinine, coagulation studies, compliment factors, liver functions and immunoglobulin levels were all within normal limits, lactate dehydrogenase was 399 U/L; serologies for HIV, Epstein-Barr virus, cytomegalovirus and parvovirus B-19 were negative. Her bone marrow showed normal cellularity with increased number of megakaryocytes. She was stabilized with packed red blood cell transfusion and intravenous fluids, but the platelet count dropped down to 3,000/cmm. Thrombotic Thrombocytopenic purpura was ruled out with normal ADAMTS-13 levels, though fresh frozen plasma was given prior to this. Patient was given 1g/kg body weight, infusion of IVIG in two divided doses and platelet counts rose up to 32,000/cmm within the next 2 days. She was discharged home with recommendations for close follow up. She required three more doses of IVIG for recurrent drop in platelet counts, over the next 2 months, with a good response each time; while no bleeding was reported. Following the fourth dose of IVIG her platelet count increased to 192,000/cmm and subsequently remained over 150,000/cmm without intervention. After 4 months of follow up, she continued to do well and her hemoglobin had remained stable. She was advised not to receive the third dose of ROTATEQ. The development of serious rotavirus gastroenteritis in a partially vaccinated infant was rare but was known to occur. The development of immune thrombocytopenic purpura in this infant might have been associated with rotavirus infection, although this could have been an incidental finding. The prevalence of rotavirus infection was very high worldwide and it would be of interest to perform analysis examining platelet counts and hemoglobin in infants diagnosed with acute rotavirus infections. Additional information has been requested.