chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot.; experiencing extreme fatigue and weakness in the muscles; he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot.; experiencing extreme fatigue and weakness in the muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in Jul2022 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: Bnt162b2 (Primary Immunization series complete, He had received all the COVID vaccines from Pfizer), for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), FATIGUE (non-serious) all with onset Jul2022, outcome "not recovered" and all described as "experiencing extreme fatigue and weakness in the muscles"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), ILL-DEFINED DISORDER (non-serious) all with onset Jul2022, outcome "not recovered" and all described as "he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot.". The events "he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot." and "experiencing extreme fatigue and weakness in the muscles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the reporter assessed the events as non-serious. They have consulted doctors but hadn't found the cure. They had made tests and RMIs, but the brain looks normal. She wanted to know if Pfizer recommends a treatment or a specialist to consult this case. The patient was older than 12 years. She described that they are almost sure that this was caused by the vaccine because the symptoms started the next day after vaccination. Now he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot. The patient took the last booster dose from Pfizer and he had taken all the COVID vaccines from Pfizer and it was the bivalent grey cap formulation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHF; lymphedema; did not receive 2nd Dose within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (CHF) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (CHF) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days). The patient was hospitalized from 10-Mar-2021 to 07-Apr-2021 due to CARDIAC FAILURE CONGESTIVE. At the time of the report, CARDIAC FAILURE CONGESTIVE (CHF) and LYMPHOEDEMA (lymphedema) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.; Sender's Comments: This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.
Patient is a 79 y.o. female patient of a MD with history of CAD s/p CABG x3, DM 2, HTN, hyperlipidemia presented to the Hospital with myalgias.   On 4/16 she is feeling much better. Lungs clear, abd soft and non tender, no diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 4/10 Symptoms present on admission: malaise, cough Date of covid positive test: 4/13 Vaccination status: vaccinated Imaging: CXR negative Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: Paxlovid started 4/13, continue at discharge Consultants following: none Anticipated special isolation end date: 4/23    ESBL Klebsiella pneumonia bacteriuria Diagnosed 4/6/2023, initially treated with Keflex and transition to levofloxacin once results known on 4/8/2023, Pt states she did not take levaquin Previously treated with Macrobid x2 rounds prior to 4/6/2023 Follows with urology office, has been on vaginal cream in past Changed to Cipro on 4/13, continue at discharge   Wide complex tachycardia CAD s/p CABG x3 Continue Plavix, aspirin, metoprolol, statin Asymptomatic K is 3.7 Mg is 1.5 on 4/14, TSH 2.3, echo with LVEF 50%, mild valve disease Suspect related to COVID infection, continue to monitor as outpatient, continues to be asymptomatic Increased toprol to 75mg daily Follow up with cardiology as outpatient   Diabetes mellitus type 2 with hyperglycemia insulin-dependent Resume home regimen   Lactic acidosis  Lactic acid 4.2 Stop metformin Repeat lactic acid normal   HTN, essential Cr 1.18 Continue lisinopril, metoprolol  Hyperlipidemia Continue rosuvastatin
bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bells palsy) 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 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced BELL'S PALSY (bells palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (bells palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown.  On 29-Oct-2021, the patient went to emergency room  because the right side of her face was paralyzed and she was having slurred speech and they diagnosed her with bells palsy.  Treatment information was unknown.  Company Comment: This case concerns a female patient of an unknown age with no reported medical history who experienced expected event of Bell's palsy.  The event occurred 1 month 21 days after an unspecified dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as the recent administered dose prior to the event was not specified.  Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The event is an important medical event and an adverse event of special interest.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history who experienced expected event of Bell's palsy.  The event occurred 1 mont 21 days after an unspecified dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as the recent administered dose prior to the event was not specified.  Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The event is an important medical event and an adverse event of special interest.
Patient reported nausea, chills, and all over body aching starting the morning after receiving the vaccine (about 8:00 am on 12/13/18). Patient reported starting to feel better, but not fully recovered at 4:15pm on 12/13/18.
atrial  fibrillation at a rate of 144 for 1hr&30 min; BNT162B2 (lot number ewoke 8) on 22Apr2021 as 2nd dose; This is a spontaneous report from a contactable healthcare professional (patient himself). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 22Apr2021 (Batch/Lot Number: ewoke 8) as 2nd dose, single; and via intramuscular route administered in right arm on 22Apr2021 11:00 (Batch/Lot Number: ep7553) as 1st dose, single for COVID-19 immunisation. Medical history included known allergies: PCN. The patient's concomitant medications were not reported. Patient was not diagnosed with COVID prior vaccination. The patient experienced atrial fibrillation at a rate of 144 for 1hr&30 min on 14May2021 18:30. Event resulted in emergency room/ department or urgent care. Treatment included EKG x3, Chest x-ray, Blood work, Aspiran. Outcome of the event was recovering. Patient was not COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event atrial fibrillation and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was hospitalized on 7/9/22 for unrelated reason. Patient began having hypoxia and increased cough beginning 7/27/22 with a low grade temperature as well. COVID positive on 7/28/22
Muscle Spasms, Nerve Pain, Pain and weakness in left side of face, pain around my eyes, Pain at the base of the skull, face twitching, confusion, dizziness, memory loss, mixing up letters and numbers, slurred speech, brain fog, extreme fatigue, nausea. This was very very intense for about 4 weeks.  (At 3.5 weeks started taking 40 milligrams of loratadine daily). I am still experiencing symptoms but less intense than the first month. I am very concerned about my health and well-being. Scared and deeply saddened.
lump @ site areas of legs, gland swelling of neck; 1 day unable to move legs, arms, head; took to ER;
Patient turned pale, and started tipping over, nurse laid her down and raised her legs, she came back to with in a few seconds
Extreme fatigue, headache, muscle aches. Currently 24 hours of fatigue and aches.
50 minutes after being vaccinated I felt very painful stabbing sensation like someone was sticking needles in my brain all over mostly the left side of my head. The needle pricking sensation lasted  on and off fir 5 DAYS straight. While relaxed, calm, fully hydrated and not stressed On the 6th day my heart felt fluttery in the morning.  Day 6 or 7 my heart started MASSIVELY skipping BEATS REPEATEDLY FOR 1-2 beats making my blood pressure drop suddenly over and over and over my sister who is a NURSE told me to go to the ER. The ER told my the electrical signals from my brain to my heart are not functioning properly ever since I took the vaccine. They told me it was not heart failure and suggested that I do not take the second dose of the Covid vaccine sing it appears I had a bad allergic brain reaction to the 1st shot which is not effected my HEART SKIPS A BEAT OR SEVERAL BEATS every single day since I took the vaccine my heart stops anywhere from. 5 - 12 times A DAY EVERY DAY!  May 28 had a level 9 tightness / pain back left of my scull three inches from my heat towards the left back of my head lasted 20 seconds.   A lot of tingling  in my brain mostly the left side ever since I took the vaccine.  AFYER SEEING A CARDIOLOGIST I WAS DIAGNOSED WITH THE VACCINE CAUSING ME TO NOW HAVE ?SINUS BRADYCARDIA? which means I could go into cardiac arrest. I know for a FACT the vaccine did this to me because symptoms started 50 minutes after me ig vaccinated. I had NO PRIOR HEART ISSUES BEFORE TAKIBG THE VACCINE. I?m only 46. This happened to someone else I know and I read a bunch of other people online are having the SAME ISSUE 5-7 days AFTER being VACCINATED all of a sudden having Heart ISSUES.  Therefore, TAKE THIS SERIOUSLY and STOP HIDING THIS INFORMATION TO THE PUBLIC. this is not an isolated situation.
Headache, NauseaVomiting, fatigue, hand sweating, got/cold flashes, dizzy Narrative:  Headache, nausea, fatigue, hand sweating, hot/cold flashes, dizzy. Afebrile.
Signs and symptoms since 4/27/17. Presented with an intense burning on the pelvis, strong jabs, and severe pain in the right waist all the way to the sciatic nerve. There are no signs of external blisters. Doctor specifies internal shingles. Treatment:  ZOVIRAX 800, NEURONTIN 300 and 100 mg, Amitriptyline 50, BACLOFEN and vitamin B12 1000mg IM.
11/12 - stiff neck and mild headache; took 2 Advil before bed around 9pm.  to ward off more aggressive headache 11/13 - woke up with violent headache and dry heave vomiting approximately every 15 min.  I shut myself in my dark, quiet bedroom                    tried to sleep and diminish the effects. 11/14 - still had violent headache but vomiting was down to every 1/2 hour.  Drank lots of water to hydrate but kept vomiting.  Had                    my husband take me to the ER. 11-18 - Discharged home. 11-20 - Extremely violent headache ranking 9 on a scale of 10 with vomiting.  Returned to ER 11-21 - Transferred  .
Patient is a 27 year old male with PMH of autism, intellectual functioning disability, and seizures who presents to ED s/p 4 seizure-like episodes. Patient is autistic, lethargic, and unable to provide any history. The patient lives in a group home. As per ED record patient had 2 episodes that were 2 hours apart and then the second 2 were within 30 minutes of arrival. Patient is normally nonverbal at baseline.
Hives, Sore Muscles, Acid Reflux, Headaches, and Earache.
still experiencing crippled hands, corset feeling around mid section, numbness in hands and feet and not nomal feeling of skin
Vestibular neuronitis; ringing in the ears; myalgia; fever 102.9; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR NEURONITIS (Vestibular neuronitis), TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9) and HEADACHE (headache) in a  patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR NEURONITIS (Vestibular neuronitis). an unknown date, the patient experienced TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, VESTIBULAR NEURONITIS (Vestibular neuronitis), TINNITUS (ringing in the ears), MYALGIA (myalgia), PYREXIA (fever 102.9), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.9 (High) High.         No Concomitant and treatment medications were reported.
Swelling, redness, warmth to area evening of vaccination; itching next day. Treated with CLARITIN, BENADRYL, cortisone cream.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with no previous medical history and no known allergies who on 05-DEC-2007 was vaccinated with her first dose of GARDASIL (Lot# not reported). On 14-MAY-2008, the patient was vaccinated with her second dose of GARDASIL (Lot# not reported) and tested as pregnant with an office pregnancy test. The patient stated that her LMP was last week (estimated LMP = 07-May-2008). LMP or gestation was uncertain. There was no concomitant medication. There were no problems reported. Unknown medical attention was sought in the office. The patient's outcome is unknown. Follow up information was received from registered nurse and phone call. It was reported the patient's last menstrual period (LMP) was 20-MAR-2008 (previously reported as "estimated LMP = 07-May-2008") and estimated delivery date (EDD) was 02-JAN-2009. On 20-AUG-2008 the patient had serum alpha-fetoprotein test (MSAFP) done and the result was negative. The mother declined amnio testing. On 20-AUG-2008 (at 14 weeks gestation) ultrasound did show sonographic markers for trisomy however the repeat ultrasound in 18-DEC-2008 was normal. On 24-DEC-2008 the patient delivered a 7 pounds 7 ounces male baby without complication during pregnancy or labor/delivery and without infection or illnesses during pregnancy. It had been a vaginal delivery and there were no congenital anomalies. The baby had spent one week in the hospital with fever of unknown origin and received unspecified antibiotics but was otherwise healthy and normal. The patient had returned for postpartum visit since. Her baby was "fine". No further information was available.
pt recv vax initial report sent 13MAR95 & f/u info from MD indicated that pt was only inquiring about the incidence of diminished antibody titer levels several years following vax & that there was no patient involved;WAES94100026 is deleted
Within about 10 seconds after administering vacine, patient seemed very sleepy.  I talked to him through the entire incident which lasted approximately 5 minutes.  Patient did not lose consciousness.  He stated that he felt flushing all over his body, but did not feel light headed or nauseous.  The flushing was the only symptom reported, although the patient appeared to be close to losing consciousness.
Discolored rash at the area of the vaccine; Arm felt a bit sore; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (Discolored rash at the area of the vaccine) and INJECTION SITE PAIN (Arm felt a bit sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE RASH (Discolored rash at the area of the vaccine) and INJECTION SITE PAIN (Arm felt a bit sore). At the time of the report, INJECTION SITE RASH (Discolored rash at the area of the vaccine) and INJECTION SITE PAIN (Arm felt a bit sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's medical history was not provided. No relevant concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
she started noticing on 4/17 new onset of numbness and as though her left arm at the injection site feels "heavy and weighed down". stated her pain level is moderate with a scale of 5 out of 10. she hasn't taken any medications to treat and is pending seeing her PCP.
Expired vaccine administered to patient; She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours). On 24-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 24-Aug-2021, PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was unknown. The treatment information was not provided by the reporter.  Dose was administered using the expired punctured vial beyond 12 hours.  Injected the expired Moderna COVID-19 vaccine to 7 patients.  Number of doses/vials.  7 doses/ 1 vial; Total amount of time the vial was exposed to Refrigerator temperature: Greater than 12 hours in the refrigerator.
Patient received Zostavax vaccine on 9/3/14 6:15 pm, had no adverse reaction on injection site, left and went home. On 9/5/14 pt returned to phcy around 4:41 pm to fill rx for other meds and noticed the rash while talking to pharmacy tech, she then reported the rash to RPH who assess the local rash and determined that it had occurred almost 2 days later. The rash wasn't raised and didn't feel warmth to touch. Pt doesn't feel faint or lightheaded, aside from the rash, she feels fine. Rph advised pt to take Benadryl to reduce the incidence of rash or injection site reaction. No ice pack needed as there is no swelling involved. MD notified by fax about local site rash at the injection site.
Started with funny feeling in throat at 1640hrs, then at 1730 hrs started itching, then at 1745hrs: knew "something was not right". Then took Benadryl, Claritin and Pepcid.  Face getting red, and started swelling, hives on chest, hands swollen, hives proceeded to cover body, then seen in ED: Diminished breath sounds, O2Sat: 91%, Pressure in throat and chest, not able to take deep breath. Treatment in ED: Solumedrol 125mg IV, Benadryl IV to total 50mg, Albuterol Nebulizer, and Pepcid IV. Discharge Meds:  Prednisone, and albuterol inhaler, and Epi-Pen.