chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Transverse Myelitis; Could not go to bathroom in spite his bladder was full; Could not get out of bed; Could not walk; Chest pain; Pain in middle back; Pain in both of arm; The blood pressure went high; Pain was intense that cannot be describe; Pain across shoulders; A spontaneous report was received from a consumer concerning a 67-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events of chest pain, middle back pain, pain across shoulders/arthralgia, pain in both of arm/pain in extremity, pain was intense that cannot be described, the blood pressure went high/hypertension, could not get out of bed/asthenia, could not walk/gait inability, could not go to bathroom in spite his bladder was full/urinary retension and transverse myelitis.  The patient's medical history as provided by the reporter included, quadruple bypass heart surgery, partial lung removal, back problem and neck problem. No relevant concomitant medications were reported.  On 19 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 002A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient reported that after receiving the vaccine he was taken to the hospital for chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described and the blood pressure went high. On 21 Jan 2021, in the morning, he could not get out of bed, could not walk and could not go to bathroom in spite his bladder was full for which a catheter was installed to go to bathroom and he got hospitalized for three days. The physician diagnosed him having transverse myelitis which is a side effect from vaccine.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the events, could not get out of bed, could not go to bathroom in spite his bladder was full were resolved on 24 Jan 2021. At the time of reporting, (16 Mar 2021), the outcome of the event, could not walk, was recovering/resolving as the patient reported he was able to walk a little and was on physiotherapy.  At the time of this report, the outcome of the events, chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described, the blood pressure went high and transverse myelitis were unknown.; 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.
got the shingles shot and still came down with Shingles/suspected vaccination failure; Shingles; was so very painful/still had pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: got the shingles shot and still came down with Shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: was so very painful/still had pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAY-2023 The case was received from the patient via interactive digital media. The patient said she got the Shingles shot and still came down with Shingles virus. It was so very painful. The reporter thought that the event might have been related to the vaccine. The patient said it lasted almost a month, she still had pain for a couple of weeks after that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Numbness in right hand especially in the two small fingers after the 1st Anthrax shot. irregular heart beat. Tightness in chest, stiffness in joint, itchy skin on right arm around the neck.
Exactly 24hrs after the pt's physical, she had a low grade fever. She had received DPT, MMR, and TB shots. Parent found her on sofa unconscious and non-responsive. 911 was called and went to hospital. The pt had 1 1/4 hrs of seizure activity and went to respiratory complication. Now has an inflammation of the brain on the right hem. top. The inflammation seems to be going down and the pt is on medication for seizure disorder. Has reacted to medication in gaining lot of weight almost 30 lbs since the day. Child is very hyperactive and sometimes non-responding to request (which she could be having small short seizures-unk). Information received on 09/12/02 on a FOLLOW-UP report states  "still have inflammation of brain, We do EEG & MRI every 6 months to see reduction of the site of inflammation." The annual follow up received on 7/17/03 states, "she continues to gain weight even with diet and exercise.
Fast heart rate; General aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate) and MYALGIA (General aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M20A) 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) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HEART RATE INCREASED (Fast heart rate) and MYALGIA (General aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Myalgia, at an unspecified dose and frequency. On 13-Mar-2021, HEART RATE INCREASED (Fast heart rate) had resolved. At the time of the report, MYALGIA (General aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: increased (High) Heart rate increased and lasted for about a couple of hours.         Concomitant medications details were not reported by the reporter. The patient did not experienced any symptoms like this before Moderna COVID-19 vaccine. Patient did not have any medical history of myocarditis/pericarditis.
Patient diagnosed with Covid 19 pneumonia and extreme weakness, debilitation, AKI with CKD likely pre-renal from poor P.O. intake. Patient treated with vitamins, antibiotics. Discharged home with home health.
Whole arm rash itching like crazy; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Whole arm rash itching like crazy), PYREXIA (Fever) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Whole arm rash itching like crazy), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, RASH PRURITIC (Whole arm rash itching like crazy), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant information was not provided.   Treatment information included a cream for the rash.   This case was linked to MOD-2021-368777, MOD-2021-368799 (Patient Link).
Extreme fatigue, chills, stabbing pain in head/eyes, blurry vision, joint pain.
Immediately started seeing blurry and then eyes burned for 24 hours to the point that you couldn?t see.  had to go to the optometrist for eyedrops
PFIZER VACCINE ADMINISTED AFTER DOSE EXPIRATION.  MIXED DOSE EXPIRED 8/30/21 AT 9:30PM BUT WAS WAS ADMINISTERED 8/31/21 AT 10:02 AM
Kinrix administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: A nurse called to asked for information about the administration of Kinrix to a 4 month-old patient. Vaccine was administered on 7th October 2022. The reporter asked for safety information. The reporter consented to follow up. Additional Supportive Information: The patient was administered with kinrix instead of Pediarix, which led to inappropriate age at vaccine administration.
No additional AE; PEDVAX HIB was improperly stored and administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 28-JUL-2020, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number: S031500, expiration date 21-APR-2022 for prophylaxis (exact dose and route of administration were not provided). No adverse event was provided.  The vaccine experienced temperature excursion of 50 degrees of Fahrenheit for 1 hour and 46 minutes. Previous temperature excursion was not detected. The digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000307: US-009507513-2008USA000316:
Myalgia, Arthralgia, Fever, Local adenopathy, fatigue Narrative:
Had headaches; Have dizziness; nauseous; Couldn't eat for a week; Slept all day; she did not feel like that the vaccine is not administered in her muscle but in skin; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had headaches), DIZZINESS (Have dizziness), NAUSEA (nauseous), FEEDING DISORDER (Couldn't eat for a week) and HYPERSOMNIA (Slept all day) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 UNK. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 20-Apr-2021, the patient experienced HEADACHE (Had headaches), DIZZINESS (Have dizziness), NAUSEA (nauseous), FEEDING DISORDER (Couldn't eat for a week), HYPERSOMNIA (Slept all day) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she did not feel like that the vaccine is not administered in her muscle but in skin). At the time of the report, HEADACHE (Had headaches), FEEDING DISORDER (Couldn't eat for a week), HYPERSOMNIA (Slept all day) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she did not feel like that the vaccine is not administered in her muscle but in skin) had resolved and DIZZINESS (Have dizziness) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. The patient used ginger and charcoal supplements as treatment medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-098286 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021. The patient updated that adverse events started on 20-APR-2021 i.e., headaches, dizziness, nausea, slept for all day, and couldn't eat for a week. The patient also believes the pharmacist did not use proper needle and vaccine did not get into the muscle.The patient updated that she used ginger and charcoal supplements to subside the possible adverseevents. The patient also stated that all of the possible adverse events subsided except nausea and dizziness.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098286: Child
I got a brain bleed; I did get a bump on the head around that same time; My memory is worse, since the brain bleed; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (I got a brain bleed) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Dementia since an unknown date.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CEREBRAL HAEMORRHAGE (I got a brain bleed) (seriousness criterion medically significant), LOCALISED OEDEMA (I did get a bump on the head around that same time) and MEMORY IMPAIRMENT (My memory is worse, since the brain bleed). At the time of the report, CEREBRAL HAEMORRHAGE (I got a brain bleed), LOCALISED OEDEMA (I did get a bump on the head around that same time) and MEMORY IMPAIRMENT (My memory is worse, since the brain bleed) outcome was unknown.            No concomitant medication reported. No Treatment Medication reported.  Patient got a brain bleed, about a month after the shots, He also got a bump on his head around that same time. A board dropped on his head around the same time, about a month, or more, before the last shot. His memory was worse, since the brain bleed. he also mentioned a history of dementia in his  family. He thought that the board caused the brain bleed. He received the shots 6-7 months ago.  Company Comment  This case concerns a 79-year-old male patient with a relevant medical history of head injury with a board, who experienced the serious unexpected (AESI) of Cerebral Haemorrhage. The event occurred after an unspecified dose of mRNA-1273 vaccine. (Date of vaccination not provided). The medical history of head injury with a board is a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as / medically significant and retained for consistency with the RA report.; Sender's Comments: This case concerns a 79-year-old male patient with a relevant medical history of head injury with a board, who experienced the serious unexpected (AESI) of Cerebral Haemorrhage. The event occurred after an unspecified dose of mRNA-1273 vaccine. (Date of vaccination not provided). The medical history of head injury with a board is a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as / medically significant and retained for consistency with the RA report.
itching; Pain at injection site; Heat (left); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat (left)), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Pain at injection site) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     The patient's past medical history included Heart valve operation (Heart valve repaired.). Concomitant products included WARFARIN SODIUM (WARFIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat (left)) and VACCINATION SITE PAIN (Pain at injection site). On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. On 23-Feb-2021, VACCINATION SITE WARMTH (Heat (left)) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received  included outcome of the event updated to recovered. Corrections made on the initial, treatment medication  were added.
pt had onset of macular papular rash on medial & ventral surface of rt upper arm w/in hr of vax;rash appears urticarial in mom;pt seen in clinic 3 days p/each onset;
Per patient, reported swelling at the deltoid region the day after vaccine was administered.  Patient reports swelling has increased today (10/22/2012) and accompanied by warmth/induration.
Fever, chills, body aches, fatigue, sharp pain in left arm near injection site that shot down to my fingers and then later across upper back, swelling at injection site
Patient is a 83 y.o.  female with a past medical history significant for atrial fibrillation, CHF, hypertension, and tricuspid valve repair who presents today due to progressive shortness of breath. Patient states that she has been more short of breath over the last several days. The patient was diagnosed with Covid pneumonia on 12/7, but did not require hospitalization. She received monoclonal antibodies.  Patient admitted as inpatient on 12/21 due to acute on chronic right-sided heart failure. Patient was tested for COVID-19 and was positive on 12/7.
Temperature of 103, excruciating body pain, nausea, swollen lympnodes in neck and under armpit on left side,  unbearable headache, burning eyes, blurry vision, mental fog
Headache, Myalgia, SkinRash, Palpitations, Hives Narrative: took benadryl for 2 days and symptoms responded well
Diarrhea; Body aches; Fatigue; Slight fever 100.6; Red spot was about 4 inches at it largest; Red spot was warm; Red spot was painful; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm), PAIN OF SKIN (Red spot was painful), DIARRHOEA (Diarrhea) and PAIN (Body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) 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 historical condition was reported). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 30-Dec-2020 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm) and PAIN OF SKIN (Red spot was painful). On 31-Dec-2020, the patient experienced PYREXIA (Slight fever 100.6). On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body aches) and FATIGUE (Fatigue). On 01-Jan-2021, DIARRHOEA (Diarrhea) and PYREXIA (Slight fever 100.6) had resolved. On 02-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ERYTHEMA (Red spot was about 4 inches at it largest), SKIN WARM (Red spot was warm), PAIN OF SKIN (Red spot was painful) and PAIN (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant product used was birth control. Treatment information was not provided.
16 y.o admitted on 12/14 to the hospital due to chest after receiving 3rd dose of pfizer vaccine on 12/11 - chest pain started on 12/12, vomiting x1 on 12/11, right arm numbness on 12/13, worsening chest pain and palpitation on 12/13. no preceding URI symptoms, no fevers, no shortness of breath.
vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022; booster dose administered to patient after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose administered to patient after use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 VACCINE (primary series). Past adverse reactions to the above products included No adverse event with Janssen COVID-19 VACCINE.  On 11-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose administered to patient after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (booster dose administered to patient after use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-JUN-2022 and vaccine was administered on 11-Jul-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patients had received their 1st booster dose of the Moderna COVID-19 vaccine after the use by date.  The vial was initially stored in the refrigerator on 10-JUN-2022. The vial did not undergo any temperature excursions.  BUD in refrigerator was on 10-Jul-2022 at 10am.  Patients had not reported any adverse reactions post vaccination.  Treatment information was not provided.
Initial and follow-up information has been received from a health professional concerning a 59 year old male with no medical history or allergies who on 23-OCT-2006 at 14:15 was vaccinated subcutaneously with a 0.5 ml first dose of Pneumovax 23 (lot #651401/0619F).  There was no concomitant medication.  On 23-OCT-2006 (previously reported at 24-OCT-2006) the patient's vaccinated arm became painful, red, hot and swollen.  Unspecified medical attention was sought.  No labs were performed.  On approximately 30-OCT-2006 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.