chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches) and HEADACHE (headache). At the time of the report, PAIN (body aches) and HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This case was reported in a literature article and described the occurrence of fatal exacerbation of glomerulonephritis in an adult male subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). At the age of 12 years, the subject was diagnosed with PR3-ANCA-associated glomerulonephritis due to Wegener's granulomatosis. He was treated with CYCLOPHOSPHAMIDE, METHYLPREDNISONE and AZATHIOPRINE. During the follow-up from 1999 to 2004, the subject suffered from several relapses that were treated with CYCLOPHOSPHAMIDE or METHOTREXATE in combination with CORTICOSTEROIDS. In 2004, the subject developed a biopsy-proven renal relapse. DEOXYSPERIGUALIN, an antiproliferative drug with effects on lymphocytes and macrophage function and neutrophil production, was started in combination with high doses of steroids. During the 1st three cycles, a partial remission was induced. Because hematuria and proteinuria persisted, the kidney was re-biopsied and showed persistently active glomerulonephritis with new necrotizing and and crescentic lesions. The 4th and 5th cycles went uncomplicated. In the 6th cycle, the subject received unspecified dose of Influenza virus vaccine (unknown route and injection site), lot number not provided. Shortly after vaccination, a severe relapse occurred with purpura, arthralgias, new nodular lung lesions and active glomerulonephritis. DEOXYSPERGUALIN was stopped and MYCOPHENOLATE MOFETIL in combination with high-dose CORTICOSTEROIDS and plasma exchange was given. Despite this therapy, the subject developed a severe ulceration of the legs, abdominal pain with bloody diarrhea and intercerebral haemorrhage due to cerebral vasculitis, resulting in death. The vaccination was done while the subject had an active glomerulonephritis suggestion that activation of the vasculitic process after influenza vaccination was caused by so-called bystander activation in which the vaccination resulted in activation of antigen presenting cells expressing the autoantigen proteinase 3. The author considered the events were possibly related to vaccination with Influenza virus vaccine. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.
MOC called stating pt. school nurse told to report vaccine reaction. MOC states child has temp of 101, severe migraine, vomiting, muscle rigidity. MOC called 9/7/07 MOC advised to go to ER-pt not seen at this clinic for symptoms
Patient came in for her 18 month well child check. Patient received two vaccines. The Hep A (Vaqta) vaccine had expired in March 2023.  Parent & provider were notified immediately of expired vaccine administration. Pediatric Director was also called and informed of situation. Patient is scheduled to receive repeat Hep A vaccine at next visit. No adverse outcomes reported.
Felt Hot; Fatigue; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), FEELING HOT (Felt Hot) and FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.   No Medical History information was reported.  On 11-Apr-2021 at 10:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021 at 10:30 PM, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). On an unknown date, the patient experienced FEELING HOT (Felt Hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at a dose of 25 mg. At the time of the report, DIZZINESS (Dizziness), FEELING HOT (Felt Hot) and FATIGUE (Fatigue) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced dizziness and fatigue approximately 30 minutes after the injection. He was treated with Diphenhydramine 25 mg per oral and was monitored by a registered nurse for additional 30 minutes.   This case was linked to MOD-2021-079489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding patient's demographics, dosage details of Moderna vaccination, treatment details, and additional event felt hot was added.
Pt. received MMR and Varicella (separate doses) 9/1. On 9/10 fever 102.5. 9/14 - rash on face/trunk/arms. Rash has continued and now had scabs on rash.
inconsolable crying (not high pitched) refusal to eat;local rxn lt thigh @ inj site-redness, induration, tenderness, edema;gen mottling-ashen grey skin color w/pink mucous membranes;atypical urticarial rash progressing up from leg;
Patient not experiencing any signs/symptoms of adverse effects / No additional AE; PROQUAD administered to patient after undergoing a temperature excursion that wasn't supported; This spontaneous report was received from a registered nurse and refers to a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumn (rHa) (PROQUAD) injection,lot #X002296, expiration date was estimated as: 21-JUL-2024, administered for prophylaxis (strength and route of administration were not provided). This vaccine was administered to patient after undergoing a temperature excursion (Product storage error). No additional adverse event was reported.
I have been experiencing chronic urticaria since getting the Moderna COVID booster shot. I have been treated regularly by an allergist and dermatologist. I've been breaking out in severe hives since 12/13/21 to present 12/15/2022. I am controlling the symptoms with cetirizine and montelukast. When I don't take these medications, the hives are excruciatingly painful.
Varicella Information has been received from a registered nurse concerning a 10 year old female patient, who on an unspecified date, "years prior" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In early November 2005, the patient developed chicken pox. The patient recovered on an unspecified date. The registered nurse mention that the patient's two siblings, a seven year old female (0601ISA0321) and a five year old male (0511USA01986) experienced similar events following vaccination with varicella vaccine live (Oka/Merck) No additional information has been requested.
Diarrhea; joint pain; This is a spontaneous report from a contactable consumer (patient)   A 40-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0158) via an unspecified route of administration on 07Apr2021 at 09:30 am on the left arm as single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0167) via an unspecified route of administration on 28Apr2021 at 09:20 am on the left arm as single dose for COVID-19 immunisation. Medical history included IBS, Pencillin and Sulpha allergy. The patient's concomitant medications were not reported. Patient's other vaccine within four weeks prior the vaccination was none. Other medications in two weeks prior vaccination was none. Covid prior vaccination was none. The patient was not tested for Covid post vaccination. The patient developed diarrhoea two days after receiving her first vaccine. It did not improve by the time of the second vaccine and continued. Only other reaction was joint pain that lasted 24 hours. The patient stated that she had no other symptoms and noticed the diarrhoea started after consuming dairy. The patient stated that the diarrhoea continued with no other symptoms. The patient stated that she noticed that diarrhoea was worse after certain foods. The patient stated that she cut out dairy and gluten and only have diarrhoea when she ate those things. The patient stated that she had stopped dairy, but still had some diarrhoea and removed gluten. The patient stated that she did not had diarrhoea since removal of gluten. The patient did not take any treatment medication for the events. The outcome of the events was resolving.  Follow-up (15Jun2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: second dose information obtained, Event diarrhoea clinical information was obtained.  Follow-up attempts were completed. No further information is expected
Still feeling it, ears and head / Suspected vaccination failure; It gets in your ears / it's in your ears and head; Still feeling it, ears and head; Head buzz; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Still feeling it, ears and head / Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: It gets in your ears / it's in your ears and head) (serious criteria GSK medically significant), shingles (Verbatim: Still feeling it, ears and head) and noises in head (Verbatim: Head buzz). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa and shingles were not recovered/not resolved and the outcome of the noises in head was not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles and noises in head to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, shingles and noises in head to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 07-MAR-2023  This case was reported by the patient via interactive digital media.  The patient had asked if it gets in your ears and makes your head buzz. He/She was still feeling it even after the shot and did not knew, what to do with the physician who were useless, no luck, oh my, he/she did not find any relief, if it was in your ears and head. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Dizziness, Nausea, Fatigue, Muscle aches and Headache symptoms severe for 1 day and mild on day 2. Advil and anti-nausea medication.
A white ring between the colored part of my eye and the white part; Cholesterol build up; Sore arm; Fatigue; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), EYE DISORDER (A white ring between the colored part of my eye and the white part), EYE DISORDER (Cholesterol build up), LIMB DISCOMFORT (Sore arm) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 10-Feb-2021, the patient experienced EYE DISORDER (A white ring between the colored part of my eye and the white part), EYE DISORDER (Cholesterol build up), LIMB DISCOMFORT (Sore arm) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), EYE DISORDER (A white ring between the colored part of my eye and the white part), EYE DISORDER (Cholesterol build up), LIMB DISCOMFORT (Sore arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
shortness of breath; heart seemed to be beating fast/thumping; dizziness; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Sep2021 20:00 (at the age of 42 years) (Batch/Lot Number: PC3182) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included venlafaxine hydrochloride (VENLAFAXINE ER); losartan taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. 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. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Aug2021 08:00 PM (at the age of 42 years) (Batch/Lot Number: FD8448) for covid-19 immunisation. On 07Sep2021 09:00 the patient experienced, approximately 5 days after receiving the second dose of the vaccine began to have shortness of breath, heart seemed to be beating fast/thumping, dizziness, and extreme fatigue. This was still occurring as of 21Sep2021. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included heart rate increased: fast on an unspecified date. The patient received treatment was unknown. The clinical outcome of events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
cellulitis; arm felt warm; arm was red; arm was swollen; A spontaneous report was received from a consumer who was also a female patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, arm felt warm/ vaccination site warmth, arm was red/ vaccination site erythema,  and arm was swollen/ vaccination site swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date in Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient received their first dose of vaccine in Feb 2021. During the week of 14 Feb 2021, the patient's arm felt warm, was red and swollen, and the swelling started to go down to the upper arm. On 19 Feb 2021, the patient went to urgent care and the doctor said it was cellulitis. Treatment for the events included antibiotics.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was not resolved or reported at the time of event.; 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.
Little red spots on her hand; Little red spots on  hand; Rash; This spontaneous case was reported by a physician and describes the occurrence of PAPULE (Little red spots on her hand), ERYTHEMA (Little red spots on  hand) and RASH (Rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis (Atopic dermatitis - chronic recurrent).   On 19-Mar-2021 at 11:33 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAPULE (Little red spots on her hand), ERYTHEMA (Little red spots on  hand) and RASH (Rash). On 23-Mar-2021, PAPULE (Little red spots on her hand), ERYTHEMA (Little red spots on  hand) and RASH (Rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received: added new event of rash, updated patient demographics, second dose and medical history.
Swelling of the fingers, face, and lips. Flush red and warm to touch on hands and arms.
Severe muscle spasms and leg pain currently  Initially it was in knee and hip joints as well, I was treated with steroids for 5 days, that made the joints feel better.  Still having terrible burning type pain in my right thigh muscles
Patient had been to the gym. She became extremely fatigued and developed a cough. Her husband took her to the Hospital,  and she was admitted for Covid-19 pneumonia, on 6-23-2021. Symptoms reported were fatigue, cough and shortness of breath. She was treated with a 5-day course of Remdesivir. Expected to be discharged from the hospital on 07/01/2021.
pt phoned 2/13/15 stated she believed she had a reaction to vaccine. That night she had a fever reaching 103 degrees F, chills, body aches, headache. She took ADVIL for fever/discomfort. Symptoms subsided by 2/13/15 she began to feel better.
Complaining of rash on arms and legs. No fever. Lack of appetite, light headedness. Doctor today put into a prednisone taper.
The second day I woke up and my arm was on fire. That night I started with a fever. for 10 days I had a fever of 102-103. I had blood in my urine. I had a lung infection where I could not inhale.
TIA after her first shot; Incapacitated for over an hour,lost the whole right side of the body; Fell to the ground, this lasted for 2 or 3 hours; This spontaneous case was reported by a nurse and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) and FALL (Fell to the ground, this lasted for 2 or 3 hours) in an elderly female 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 TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot) (seriousness criteria disability, medically significant and life threatening), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) (seriousness criteria disability, medically significant and life threatening) and FALL (Fell to the ground, this lasted for 2 or 3 hours) (seriousness criteria disability and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA after her first shot), DISABILITY (Incapacitated for over an hour,lost the whole right side of the body) and FALL (Fell to the ground, this lasted for 2 or 3 hours) had resolved.        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.   No concomitant medications were provided.  No treatment information was provided.  Patient was over the age of 60, female who had a TIA after her first shot.TIA was right sided, she was in capitated for over an hour. When she was driving and got to the house, she lost the whole right side of the body. she was tried to get out of the car and fell to the ground, this lasted for 2 or 3 hours. It finally resolved after that.   Company Comment: This case concerns an elderly female subject, who experienced the unexpected events of transient ischaemic attack, Disability and Fall. The event occurred after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns an elderly female subject, who experienced the unexpected events of transient ischaemic attack, Disability and Fall. The event occurred after the first dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Patient presents to the ED secondary to cough, shortness of breath, generalized malaise and fatigue. Patient was recently diagnosed with COVID - 19. Patient reports a one-week history of worsening symptoms, tested positive 2 days prior to admission.  Patient denies any nausea or vomiting. No abdominal pain. No changes in urination or bowel habitus. ID and pulmonology were consulted for COVID pneumonia. Remdesivir and steroids were given. Patient also received antibiotics for bacterial pneumonia. Oxygen supplement via nasal cannula. Symptoms improved and patient felt better, no longer required oxygen supplement. Upon discharge, he had 3 more days of doxycycline for bacterial pneumonia and follow up as outpatient with PCP.