chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25 minutes after I had pain going up my right side neck up carotid, then numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away; 25 minutes after I had pain going up my right side neck up carotid, then numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away; 25 minutes after I had pain going up my right side neck up carotid, then numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 15Apr2021 at 17:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and high cholesterol. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included losartan potassium 25 milligram (MANUFACTURER UNKNOWN) for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 18:10, 25 minutes after, the patient had pain going up her right side neck up carotid, then at 18:30, numbness right face cheek, and lips. Lasted about 20 -30 minutes then went away. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events 25 minutes after had pain going up right side neck up carotid, then numbness right face cheek, and lips; lasted about 20 -30 minutes then went away was resolved on 15Apr2021.   No follow-up attempts are needed. No further information is expected.
Guillain Barre Syndrome - rapidly progressive weakness in upper and lower extremities; numbness; tingling; unable to walk on own.  Treatment consisted of a 5-day course of IVIG.
Moderna COVID-19 Vaccine EUA inadvertently given instead of Pfizer BioNTech COVID-19 Vaccine EUA. No symptoms appeared during the 15 minute wait time after vaccine administered and currently no other symptoms at this time.
This spontaneous report was received from a pharmacist refers to a 56 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not specified. The pharmacist reported that, on 10-NOV-2015, the patient was vaccinated with ZOSTAVAX, intramuscularly in the right deltoid instead of subcutaneously (dose, strength, dose number, # lot, expiry date unspecified). But the pharmacist was not sure. Following the administration, the patient experienced an inch and a half in diameter raised, redness, painful, hot area around the injection site on an unspecified date (approximately in 2015). Rash was not reported. The patient sought the medical attention (unspecified). Product quality complaint was not reported. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. No further information was provided. Additional information has been requested.
small red pimples; 10 small bumps located on mid sternum; red hot skin on upper chest from decolletage to sternal notch; red hot skin on upper chest from decolletage to sternal notch; This is a spontaneous report from a contactable physician. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via intramuscular route of administration in the left arm on 24Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to petroleum products. Concomitant medications included sertraline hydrochloride (ZOLOFT) and colecalciferol (VIT D3); taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced red hot skin on her upper chest from decolletage to sternal notch. On 25Mar2021, the patient experienced 10 small bumps located on her mid sternum. On 08Apr2021, the patient experienced small red pimples. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event red hot skin on upper chest from decolletage to sternal notch was recovered on an unknown date in 2021 while the event small red pimples was recovered on an unknown date Apr2021. The clinical outcome of the event 10 small bumps located on mid sternum was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe shivering 2 hours/ headache, nausea, severe arthralgia and myalgia for 18 hours/burning hands, freezing feet 2 hours. Severe fatigue for 7 days. Moderate fatigue and nausea  through the 2nd week as well as general malaise.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 25-AUG-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
The pt was nervous about getting a vaccine, and stated that they normally get nervous or light headed after blood draws or shots - 2 shots were requested (Covid and Flu) after the Covid Shot was administered the pt experienced a brief episode of light headedness followed by a brief loss of consciousness (less than 5 seconds) - when he awoke he experienced nausea and vomiting for about 5 to 10 minutes. Dad was in the room with us and we offered to call emergency services but was refused. After about 10 minutes pt did feel better, and mom came to pick him up and take him home while dad and the rest of the children proceeded to get their vaccines.  Dad states that lightheadedness is something that nearly always accompanies shots or blood draws, but the nausea was new, the patient states that he had not yet eaten today and came straight in after waking up.  Emergency services were declined, but we did counsel the father of what to watch out for in case of major allergic or life threatening reactions over the course of the next few days, and even if the patient is feeling better some sort of follow up care would be advised since nausea and vomiting was new for the patient.
Information provided by patient as follows:  Slight throat tightening within first 20 minutes and then after an hour had some amount of numbness in left side of face only. About after 4 hours, I had complete numbness of the left side of my face. The numbness persisted through the rest of the day. The day following the vaccine, the numbness still persisted in areas by my left eye and upper cheek area. After over a week, those areas are still affected. My left eye feels weak, photosensitive, and strained. I am experiencing frequent headaches and pain around/above my eye. I am also noticing intermitted numbness/tingling in my upper extremities and hands.   Scheduled to see provider on 2/24/21 regarding if 2nd dose should be given (findings from that visit unknown)
Pt was very sleepy, hard to arouse, slept from time left the office until about 445 that PM;
fever like 101; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 24May2021 (at age of 22-year-old) as dose 2 single for COVID-19 immunization. Medical history and Concomitant medication were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 03May2021 (at age of 22-year-old) for COVID-19 immunization. It was reported that patient had been having a fever like 101 on 25May2021 and she gave him Ibuprofen and Advil and today he will work. She stated she was not sure if he has a fever or not. She confirmed her son received the Pfizer Covid vaccine for both doses. Caller states she was thinking maybe he needs another one. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Moderna COVID-19 Vaccine EUA Within 8 hours of receiving the 2nd Moderna dose in right upper arm, I was experiencing 9/10 sharp upper arm pain (00:30 2/10/2021). The pain was so intense I almost vomited and was not able to sleep. My range of motion was severely limited, and I had to use my left arm to help move my right arm.  This continued through 2/10/2021. At 1300 took 1000 mg Tylenol and had minor relief for an hour. Tried to stay hydrated and move my right arm as I could, which was still very limited. Woke up at 01:30 early morning 2/11/2021 with intense pain in right upper arm still, not able to sleep. Range of motion continues to be severely limited due to pain. Made an appointment with PCP office first thing. I was concerned I could have SIRVA and wanted to get a medical professional?s opinion. She said it is probably a combination of the Moderna vaccine and a ?bad injection,? meaning the nurse administering my vaccine at facility was very high on my deltoid (almost to my joint). I was told to call back if my arm pain or range of motion worsens.
Rash above the right ankle up to six inches that is tender and hot to touch; Tenderness, Rash above the right ankle up to six inches that is tender and hot to touch; Diarrhea; Muscle pain; Rash above the right ankle up to six inches that is tender and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Rash above the right ankle up to six inches that is tender and hot to touch), TENDERNESS (Tenderness, Rash above the right ankle up to six inches that is tender and hot to touch), DIARRHOEA (Diarrhea), MYALGIA (Muscle pain) and RASH (Rash above the right ankle up to six inches that is tender and hot to touch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING HOT (Rash above the right ankle up to six inches that is tender and hot to touch), TENDERNESS (Tenderness, Rash above the right ankle up to six inches that is tender and hot to touch), DIARRHOEA (Diarrhea), MYALGIA (Muscle pain) and RASH (Rash above the right ankle up to six inches that is tender and hot to touch). At the time of the report, FEELING HOT (Rash above the right ankle up to six inches that is tender and hot to touch), TENDERNESS (Tenderness, Rash above the right ankle up to six inches that is tender and hot to touch), DIARRHOEA (Diarrhea), MYALGIA (Muscle pain) and RASH (Rash above the right ankle up to six inches that is tender and hot to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided. Treatment information was not provided.
Wrong Pfizer vaccine administered to a patient, received Pfizer tris-sucrose instead of Pfizer 5-11 formulation. The patient tolerated the vaccine well, with no complaints. The patient's parent informed that the patient accidentally received Pfizer tris-sucrose instead of Pfizer 5-11.
Gastrointestinal bloating and gas, mild stomach pain, slight nausea within 10 to 12 hours post vaccine.  By the next morning, pain progessed to substernum (like heartburn) so pt took OTC Pepcid x 3 days.  On day 4, pt ate evening snack and started vomiting.  Pain intensified on day 5 so pt went to emergency department at hospital. 11/19/09  DC Summary and Hospital records received for DOS 11/15-11/18/09. Pt.presented with h/o intermittent substernal abdominal pain, nausea.  Treated with Omeprazole and IV fluid.  Continued to improve without nausea, vomiting or diarrhea.Slight low-grade fever. DC DX: viral gastroenteritis, diabetes mellitus type 2, hypertension, hyperlipidemia, nasal allergies
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M041514, Exp. 11-OCT-2018; Lot# N021315, exp. 07-AUG-2019; N017395, exp. 07-JUN-2019; and PROQUAD, Lot# N024563, exp 06-MAR-2019; Lot# N0199825, exp. 19-JAN-2019, Lot# N013270, exp. 25-OCT-2018, Lot# N010867, exp. 01-OCT-2018, Lot# M041083, exp. 04-APR-2018, both for prophylaxis, which had a temperature excursion of 15F to 46F (17.2F) for 2 hours. It was reported that no the vaccines did not have previous temperature excursion and it was detected by a data logger. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. Concurrent conditions included diabetes mellitus and hypertension. There was no allergy/drug reaction. The medical history was not reported. On 07-APR-2016, the patient was vaccinated with ZOSTAVAX (lot#L039096, expiry: January 2017) 0.65 ml subcutaneously. The patient took several unspecified concomitant medications. Approximately on 08-APR-2016 (reported as a day after" receiving ZOSTAVAX, the patient experienced numbness in the opposite arm. The patient went to the hospital on an unspecified date for the numbness and the patient was "kept under observation for a day but was not admitted and then sent home and referred to neurology". The pharmacist stated that while the patient was under observation at the hospital, the patient had an unspecified CT scan. No treatment was given for the event. The outcome of 'numbness in the opposite arm' was reported as not recovered. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
1 1/2 hr p/receiving vax felt cramping in lt jaw & lt side of face from forehead to jaw line stated had pulling sensation & sl indentation under lt zygomatic arch; seen by MD 16JUL; MD felt was side effect from immunization;
12/23/22 I woke up with body aches and a headache, took ibuprofen and felt better for the rest of the day. On 12/24/22 I tested positive for COVID with a home COVID test. I called a local clinic and prescribed PAXLOVID. I started taking it that day. I never felt that bad, it just felt like a minor cold. I tested yesterday and am still positive for COVID. I have recovered.
Red patch the size of silver dollar around site of injection.  Itchy. Hard. Warm to the touch.
None Stated Medical records state agitation, weight gain, retarded development. msv. Information received from the 60 day follow-up states he did get better with medication and alot of hard work, he still has autism and is now in a special school. But with therapy & medication he is better after 4 years
Pt. here today for TBST reading C0838. Nurse noted that pt's (L) deltoid area 2 1/4" x 2 1/2" slightly firm swelling reddened  areas with injection site noted in between area. No drainage nor blisters noted at site, slightly warm to touch. Pt stated she developed headaches 1 hour after receiving shot on 7/28/09 #7 on 1-10 pain scale - took med. for it today pain at #3 on 1-10 pain scale. Denies fever. Pulses (L) arm/wrist present & strong on palpation. Inst pt to call PCP.
Went down hill after receiving the 2nd shot and stopped breathing; Went down hill after receiving the 2nd shot and stopped breathing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 22-Mar-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing). On 24-Mar-2021, the patient experienced RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) (seriousness criteria death and medically significant).   On 24-Mar-2021, GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing) outcome was unknown. The patient died on 24-Mar-2021. The reported cause of death was stopped breathing. It is unknown if an autopsy was performed.      Reporter wasn't sure if patient received Pfizer or Moderna vaccine.  The patient was in hospice care and reporter thought the patient received the vaccination from a local pharmacy.  Concomitant medications and treatment medications were not provided.; Reported Cause(s) of Death: Stopped breathing
Severe headache and muscle pain when I woke up. By 10 am I started itching on my face, forehead, and back of neck. By evening the aches were much less, but I had hives on my face and neck. The aches subsided but the hives continued with itching in various areas on my body. The following day I had the hives and my lips would get itchy and numb intermittantly and I had some facial swelling. The following day I decided to go to urgent care since it was not responding to cortisone cream and antihistamines. I was given a cortisone injectone around 1100 am and continued antihistamines. The following day the rash is still present on my forehead and back of my neck but is less red and raised.
Hospitalization 11/7-11/15/21 for COVID pneumonia. Treated with baricitinib 11/7-11/5;dexamethasone IV; Remdesivir
Janssen COVID-19 Vaccine EUA Sunday night 3/7/2021 to 3/9/2021: Fever,  weakness, dizziness, swelling left upper arm (where I got my shot) 3/9/2021: difficulty breathing, fast heartbeat
Became septic and was hospitalized/It was reported the patient had a 104F fever; This spontaneous case was reported by a physician and describes the occurrence of SEPSIS (Became septic and was hospitalized/It was reported the patient had a 104F fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced SEPSIS (Became septic and was hospitalized/It was reported the patient had a 104F fever) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in September 2022 to sometime in September 2022 due to SEPSIS. At the time of the report, SEPSIS (Became septic and was hospitalized/It was reported the patient had a 104F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Body temperature: 104 F.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  Patient got the vaccine, dose number not specified. It was reported the patient had a 104F fever and was hospitalized and became septic and was hospitalized 48 hours after taking the vaccine.  No treatment information mentioned.  Company Comment: This is a Spontaneous case reported by a physician, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Sepsis, which occurred 2 days after an unspecified dose of mRNA-1273 vaccine. Patient had a 104 F fever and was hospitalized. He became septic. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a physician, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Sepsis, which occurred 2 days after an unspecified dose of mRNA-1273 vaccine. Patient had a 104 F fever and was hospitalized. He became septic. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Pain and redness at injection site after 3 hrs. Treated with Ibuprofen. Lasted about 48 hrs Flu-like symptoms, alternating chills, fever after 24 hrs. On and off for about 24 hrs. All subsided by the third day.
zero outbreaks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 06Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "herpes", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose no=1), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "zero outbreaks". Additional information The caller  contracted "herpes" in 2018. The caller stated that he is embarrassed about this but since getting the 2nd dose of the Pfizer COVID 19 Vaccine him nor his wife have had a herpes outbreak. They received their 2nd dose of the vaccine 06Jun2021. The caller stated that he generally has 3 outbreaks a year. he had since had zero outbreaks. Caller wanted to know if we have seen this correlation before or if he had gotten "lucky." He would like to report this possible positive event to Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101548714 Same Reporter/Drug/AE, Different Patient