chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This morning, she complains of feeling nervous; jittery; chills; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 74 years as single dose for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NERVOUSNESS (non-serious), outcome "unknown", described as "This morning, she complains of feeling nervous"; AGITATION (non-serious), outcome "unknown", described as "jittery"; CHILLS (non-serious), outcome "unknown", described as "chills"; COLD SWEAT (non-serious), HYPERHIDROSIS (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "this morning she had the cold sweat, she was sweaty and in her mouth, she had dry mouth.". Therapeutic measures were not taken as a result of nervousness, agitation, chills, cold sweat, hyperhidrosis, dry mouth. The patient said she was hurrying to try to get her phone number, the patient did not know she would need it. The patient was calling to find out, she took the first shot last Thursday and it had gone okay but this morning the patient had this jitteriness, like she feels nervous. The patient did not know if it was a coincidence but she had a little chill late at night but it had been cool there so that could had caused it. The patient tried to find out from the other lady the patient talked to how important was the second shot, because the patient might not take the second shot so she wanted to know how protected she was with one shot. The patient clarifies she was calling about the Pfizer COVID 19 vaccine. The patient sees Pfizer on the card, if the patient can make out the writing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event report.  I'm report this form due to the fact that the patient is 17yo.  Pfizer vaccine is approved for 18yo and over.
This case was reported by consumer (subject's mother) and described the occurrence of hive in a child male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Hepatitis B vaccine (details unknown). On 18 June 2012, at an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced hive. At the time of reporting the outcome of the event was unspecified. The vaccination course with Hepatitis B vaccine was discontinued. The subject's mother called because her now 18-year-old son had headache and tiredness lasting 4 days and still ongoing at the time of the report after receiving HAVRIX. See case A0982384A for details. She reported the hives with Hepatitis B vaccine when asked about previous vaccinations. Denied permission to contact physician.
DIZZINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1803618 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 07:30 to right arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
started the next morning with a tensional head ache; A spontaneous report was received from a Consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  the headache starting next morning with a tensional head ache.  The patient's medical history was not provided. Concomitant medications reported were Doxycycline 20 mg, Oxydutynin 5 mg for  for unknown indication.  On 24 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Jan 2021 morning, the patient experienced tensional head ache. The patient also reported that she woke up every morning with the same ache but on that day it was like a tension head ache and it felt it all day. The patient reported that she never had a head ache in the entire life.  Treatment details included Tylenol, Advil (Ibuprofen)  The seriousness criteria of event headache was other as per source document.  Action taken with mRNA-1273 in response to the events was not reported.   On 01 Feb 2021, the outcome of the event tensional headache was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of headache, a causal relationship cannot be excluded
Itching all over; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 03Mar2021 11:30 (at the age of 50 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and pseudo tumor cerebi. The patient is not pregnant at the time of vaccination. Concomitant medications included azithromycin and prednisone. The patient did not receive other vaccine in four weeks and had no COVID prior to vaccination. The patient experienced itching all over on 03Mar2021 11:30. No treatment was given in response to the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Swollen lymph node under left armpit into chest and neck. Tingling in left hand. Headache. Severe chest pain on left side. Extreme fatigue.
The location of the injection has turned into a knot about an inch in diameter with another half inch around that area being red. The entire site has fever in it. It is still this way 48 hours after the injection. Dr. is prescribing KENALOG.
I (the patient) received the Varicella vaccine on 01/08/03 and have now come down with a full blown case of Chicken Pox.  I keep being told by doctors that this is unheard of, that most reactions are minimal (2-5 lesions at most).  I (the patient) currently have about 500 lesions (after having a fever of just under 102 degrees for 3 days).    I have been told that there is no data available on adults receiving this vaccine and that my reaction to it should be reported.  I am not sure if the doctor who gave me the vaccination will report it or not, so I am doing it myself. Please feel free to call me with any questions.
(L) anterior thigh swelling, redness, pain. No treatment prescribed at this time. Symptoms started 2 days after immunization.
Approximately 8 hours after vaccine was administered adverse reactions occured- Chills, fever, extreme muscular and joint pain, dry mouth, severe headache, fatigue  Symptoms lasted approximately 10-12 hours, after symptoms stopped, feeling very fatigued and muscle soreness in neck.
COVID-19; very mild symptoms; tested positive for 2 weeks; Pfizer; Moderna; COVID-19; tested positive for 2 weeks; Sniffles; Had received the COVID-19 vaccine off label; 2nd booster dose; Congestion; This serious initial spontaneous safety report was received on 26-JAN-2023 from a consumer via the contact center.   A female of 20 year-old was vaccinated with intramuscular Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose (reported as a second booster) on 04-AUG-2022 in the upper arm at a health department vaccination site.  The following secondary suspect medications were reported: Pfizer Biontech Covid-19 Vaccine (tozinameran) dose 1 and dose 2 on unspecified dates in 2021, and Moderna Covid-19 Vaccine (elasomeran) dose 3 (first booster dose) on an unspecified date in 2021.  Medical history included Influenza like illness and Vaccination site pain after receiving Pfizer BioNTech COVID-19 vaccine (tozinameran)(on unspecified dates in 2021 for couple of days). It was reported the individual had no additional medical history or known allergies to report.  No concomitant medications were known by the reporter.  On 04-AUG-2022, the individual received her first dose as a second booster dose, after 3 previous doses of different COVID-19 vaccines (PT: Off label use) (PT: COVID-19 immunisation). Additionally, after vaccination, the individual experienced vaccination failure (PT: Vaccination failure) (Serious: Medically Significant). On 04-JAN-2023, 5 months 1 day after vaccination, the individual got COVID-19 (PT: Breakthrough COVID-19) with very mild symptoms, no fever; just congestion (PT: Unevaluable event) and the sniffles (PT: Rhinorrhoea). She reportedly continued to test positive for about 2 weeks.   Relevant lab tests included: SARS-CoV-2 test (Result: Positive; Unspecified date in JAN-2023).  At the time of reporting, the event outcomes of Off label use, COVID-19 immunization, and Vaccination failure were recovered/resolved and event stop dates were 04-AUG-2022, and Breakthrough COVID-19, Unevaluable event, and Rhinorrhoea were recovered/resolved on unspecified dated in JAN-2023.; Sender's Comments: This 20 year-old female experienced: Vaccination failure, COVID-19 immunisation, Off label use, Breakthrough COVID-19, Rhinorrhoea and Unevaluable event after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events COVID-19 immunisation, Off label use, Breakthrough COVID-19, Rhinorrhoea and Unevaluable event were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted and the reported event of Vaccination failure is considered Related and Covid-19 Vaccine, Adjuvanted and the other reported events is considered Possible.
1st dose 3 years ago, never had the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: The case was reported via interactive digital media. The patient had a Shingrix shot 3 years ago but he/she never had the 2nd shot.  The patient asked if get the second shot now then he/she need a 3rd dose. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
yesterday she had a tooth pulled; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot# unknown), via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 19Apr2021, patient got her tooth pulled. The dentist prescribed her with antibiotic Z-Pak for five days. The patient was scheduled to receive the second dose on 23Apr2021 and wanted to know if this could interfere with the vaccination. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Fever - 2 days Chest pain - 3 months Peripheral neuropathy - ongoing
Redness, sore, swelling - all occur 24 hours later (at site of injection).
Brief fluttering of heart many times throughout the day, no other symptoms, ongoing but with less frequency
severe pain in extremities; could not get out of bed due to pain in her bones; overall feeling of heaviness; discomfort; severe pain in all her muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in extremities), BONE PAIN (could not get out of bed due to pain in her bones), LIMB DISCOMFORT (overall feeling of heaviness), DISCOMFORT (discomfort) and MYALGIA (severe pain in all her muscles) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-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 02-May-2021, the patient experienced PAIN IN EXTREMITY (severe pain in extremities), BONE PAIN (could not get out of bed due to pain in her bones), LIMB DISCOMFORT (overall feeling of heaviness), DISCOMFORT (discomfort) and MYALGIA (severe pain in all her muscles). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and BARIUM SULFATE (FLUID) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (severe pain in extremities), BONE PAIN (could not get out of bed due to pain in her bones), LIMB DISCOMFORT (overall feeling of heaviness), DISCOMFORT (discomfort) and MYALGIA (severe pain in all her muscles) outcome was unknown.            The patient had severe pain in all muscles and extremities over the last 48 hours. Patient had lots of fluids and ibuprofen because she could not get out of bed due to the pain in bones and muscles. She has an overall feeling of heaviness and discomfort.   Action taken with mRNA-1273 in response to the event was Not Applicable . No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up received contains Reporter e-mail.
SLURRED SPEECH DIZZINESS DRY MOUTH  LOSS OF TASTE LEG PAIM AMD NUMBNESS LOSS OF COGNITION FEAR OF NOT GETTING BETTER
Information has been received from a Registered Pharmacist concerning a 64 year old female patient who "about a week ago" on approximately 06-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient experienced redness and warmth in her arm. The pharmacist stated that the patient still had redness and a little warmth in her arm. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Patient presented with possible seizure activity. Patient has a long known history of seizures but when she had the placement of a vagal nerve simulator seizures have subsided for 2 years. Patient also takes THC/CBD gummies for treatment of her epilepsy. Patient states she had the moderna covid vaccine yesterday and has had symptoms of an oncoming seizure today. Patient states she has also had increased anxiety and depression over the last week. Patient currently has tremors and is very anxious and tearful.
Local reaction left thigh 6x5 cm induration with erythema, non tender, no warmth to palpation, no streaking or spreading erythema.
Few hours after receiving shot - swelling, redness, heat around the whole upper arm, pain.
Erythremia and swelling localized to L thigh area around 5 cm around vaccination site.
This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cough since an unknown date. Concurrent medical conditions included COPD and Diabetes.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and life threatening) and BACK PAIN (Back ache). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) to be possibly related.    Treatment includes 3 stents placed to right coronary artery. Blood sugar was over 500 and patient was put on insulin.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Patient complaining of discomfort on the site of arm administration, the day the vaccine was administered (08/17/2023). Patient indicates that he bled a lot when withdrawing the needle. On August 20, 2023, patient noted hardness, swelling, and redness in the site of administration area. On August 23, 2023, it indicates that the site area began to turn purple, more hardened, more inflamed and the area felt hot. Patient has not presented generalized fever only in the area of ??vaccine administration. It was suggested to visit a doctor for review and treatment.
Pt received vaccine 9/26/16 - in the next 3 weeks he experienced weakness, dizziness, disorientation and palpitations. He is on COREG for cardio-myopathy and thought it may have conflicted. Still feels ill. No treatment from MD.
Patient seen in the emergency department on 5/30 via EMS for evaluation of a fall due to weakness. Patient was subsequently admitted. Patient also reported a cough and was found to be COVID-19 positive via PCR on 5/30. Was discharged on 6/2.
each dose gave her 'a rush of energy not felt since childhood' within about 15 minutes, and in the days that followed her chronic back pain went away, food irritations, and other complications eased.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: fe3590) at the age of 36 years as dose 3 (booster), single, administration date 27Apr2021 (Lot number: er7533) as dose 2, single and administration date 06Apr2021 (Lot number: er8734) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 4  (booster), single. Relevant medical history included: "Known allergies: allergic to penicillin" (unspecified if ongoing), notes: Known allergies: allergic to penicillin; "adrenal insufficiency" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life.; "convulsions" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life.; "neuropathy" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life.; "migraines" (unspecified if ongoing), notes: patient has mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life. Concomitant medication(s) included: TOPAMAX; AYGESTIN; CBD OIL; NAC [ACETYLCYSTEINE]. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "each dose gave her 'a rush of energy not felt since childhood' within about 15 minutes, and in the days that followed her chronic back pain went away, food irritations, and other complications eased.". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior to vaccination. Patient had mixed adrenal insufficiency (prior to vaccines) and suffered from convulsions, neuropathy, migraines, and more for most of her life. each dose gave her 'a rush of energy not felt since childhood' within about 15 minutes, and in the days that followed her chronic back pain went away, food irritations, and other complications eased.   No follow-up attempts are possible. No further information is expected.
A report was received from a healthcare professional on 11/20/2002 concerning a female vaccinee who was inadvertently administered 0.1ml Fluvirin subcutaneously on 11/20/2002.  On 11/20/2002 the vaccinee was inadvertently administered 0.1ml Fluvirin subcutaneously instead of a PPD test.  No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment.
Itching and Headache initially with persistence of itching to current day. New onset fatigue.
Bell's palsy; Information has been received regarding a case in litigation from a lawyer and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around December 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event Bell's palsy was considered as not recovered. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the event Bell's palsy to be disability. Upon internal review, Bell's palsy was determined to be medically significant.
Gastrointestinal hemorrhage with hematemesis; Evaluated by GI, EGD performed which showed oozing gastric ulcer with a visible vessel, with clips placed.  Treated with Protonix drip and transition to p.o. twice daily PPI.  Patient hemoglobin stabilized, and patient hemodynamically ready for discharge at this time. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.