chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness with movement started that day, soreness at injection site at night, arm feels weak.  Soreness continued through 10/21/17, but as of 10/24/17 is "starting to feel better."  Taking OTC motrin which has been effective.  Did not see physician for any follow up.
17 years received  the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years received  the first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years received  the first dose). On 19-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years received  the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The expiration date was 13 Nov 2021. Patient had not exhibited any adverse reactions.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up was received and the  reporter details, patient demographics were updated.
Vaccine was given vaccine intra-muscularly instead if subcutaneously. Patient did not report any symptoms or any adverse reaction.
Swelling and red circular area around injection site.  No treatment but it's been a week now and I see my doctor tomorrow, 4/6 about another issue and plan to mention this as well.
Patient complains of soreness and fading bruise on arm; and a red indentation on injection site.
Patient woke up in middle of night with severe legs pain (lower) and muscle tightness. Persisted for a couple of hours. Also experienced cough. Pt took IBUPJROFEN ate a banana and walked for awhile. Couldn't stand pain. Went to bed. Woke up fine in AM.
About 4 hrs after vaccination, patient felt throat tight, itchy, mucousy eyes, vomiting and fever. Took BENADRYL (Fever 101 degrees). Patient no better/no worse 7PM and 9PM.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as: since August 2014) unspecified number of the patients were vaccinated with VAQTA (dose, route, lot # not provided). On an unknown date in 2014 (reported as: since August 2014) the patients were vaccinated with doses of VAQTA that had been exposed to supported temperature excursion. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Hospitalization - hospitalized for AKI and HTN along with SI. Tested COVID-positive on 3rd day of admission, fully vaccinated.
Patient Progress:   Status: Progress not as expected - plan revision underway     ICU END OF SHIFT SUMMARY   Nursing Primary Problem/Medical Diagnosis 1. Alcoholic Cirrhosis/Hepatitis 2. Coagulopathy     Significant Events and Nursing Interventions   Pt sedated on precedex gtt overnight. Weaned as tolerating this morning. Pt on 15L OFM, lung sounds w/ crackles. Lasix given. Developed SVT/ afib RVR, EKG, Amio bolus and gtt started. Pt converted to SR, developed hypotension. NE gtt started. Weaning as tolerated. Amio stopped. Large BM today, Remains confused and intermittently restless. Mother in law approved to come in and saw pt today.     Delirium Assessment CAM: Positive RASS: -1 Sedation: Low dose Precedex gtt   Mobility Care Plan Baseline level of function: 2 Last recorded mobility level: 1 Current Level of function: 1 Need for Physical Therapy? Not HD stable at this point.   Falls Prevention Care Plan Is the patient at risk for falls? Yes Are the necessary measures in place to promote patient safety? Yes Falls Care Plan documented? Yes   Restraints Care Plan Are restraints being utilized?Yes BUE soft limb restraints.  State reasons/medical necessity for use: to prevent pulling of tubes/lines Orders current and updated? Yes   DVT Prophylaxis: SCDS Isolation Precaution: COVID, enhanced resp and contact Blood sugar levels within acceptable range (less than 180 mg/dl)? Yes If not, is the patient on an insulin regimen?    Infection Prevention Strategies Central line in place: No Necessity/IV Drips:  Dressing change:    Urinary indwelling catheter in place: No Necessity:  Seal patent/ no loops/ off the floor:  Wounds present: Yes Nutrition: NPO   Plans and goals for patient recovery and care: Continue to wean NE as tolerating, safety, continue family updating/ discusions with family.       Note Details  Author (R.N.) File Time 9/12/2023  2:38 PM Author Type REGISTERED NURSE Status Addendum Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct # Admit Date 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023  ED to Hosp-Admission (Current) on 9/4/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  09/04   Admitted from ED 2214 09/06   Code    Transferred to ICT-INTENSIVE CARE NURSE UNIT 1905 09/07   Transferred out of ICT-INTENSIVE CARE NURSE UNIT 1747 09/09   Rapid Response    Transferred to ICT-INTENSIVE CARE NURSE UNIT 0048  pt in house
Post-herpetic neuralgia Severe pains alongside dermatomes, but also intramuscular. Primarily radiating across back, but also more generalized to arms, neck, and head. In line with shingles episode two years ago. Also some fever and joint pains. Onset of neuralgia came a few days after vaccination, got worse over a period of a week, and then started improving. No anti-viral therapy was used. A combination of advil and tylenol was self-administered as needed. After a period of 18 days the pains had subsided.
Swelling and pain of right bicep after vaccination. CL Mid biceps circumference = 22 cm, R = 26 cm. Small bullas surrounding vesicles at site of injection.
Had a reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a reaction to the vaccine) 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 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 VACCINATION COMPLICATION (Had a reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Had a reaction to the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history and concomitant medication use was provided by the reporter.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up received and contact information updated.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick in stomach), DIARRHOEA (severe diarrhea and vomiting), PERIPHERAL SWELLING (arm swelled up real bad with knots on it), VOMITING (severe diarrhea and vomiting) and NAUSEA (nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The patient's past medical history included Surgery. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, HYDROXYCHLOROQUINE for Autoimmune disorder, OMEPRAZOLE for Barrett's oesophagus, ISOSORBIDE, ATENOLOL, LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, BENAZEPRIL, HCTZ, PRAVASTATIN and LORAZEPAM for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (sick in stomach), PERIPHERAL SWELLING (arm swelled up real bad with knots on it) and VOMITING (severe diarrhea and vomiting). 19-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea and vomiting) and NAUSEA (nauseous). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick in stomach), DIARRHOEA (severe diarrhea and vomiting), PERIPHERAL SWELLING (arm swelled up real bad with knots on it), VOMITING (severe diarrhea and vomiting) and NAUSEA (nauseous) outcome was unknown. Patient took lot of medications for heart and blood pressure. Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Nausea and vomiting are consistent with the known safety profile of the vaccine.
Dizziness, Diarrhea & NauseaVomiting Narrative:
From initial information received on 05/29/2003 from a physician regarding an adverse event occurring in the USA, it was reported that a two month old male patient received an ActHIB vaccination, Lot # UA839AA, route and site of administration unknown, an IPOL vaccination, Lot # W0750, route and site of administration unknown, a Tripedia vaccination, Lot # U0856BA, route and site of administration unknown, a Prevnar vaccination, Lot # 492393, manufacturered by Wyeth, route and site of administration unknown, on 05/14/2003 at 14:00.  The patient also received a Hepatitis B vaccination, Lot # ENG5306A9, manufacturered by SKB, route and site of administration unknown, on 03/28/2003.  An unspecified time later, the patient developed inconsolable crying that lasted five to six hours.  No other reactions were reported.  It was reported that the patient recovered from this event.
Soreness and pain in arm and neck , in left arm and left side of neck is constant. Shot was given in right arm.
This spontaneous report as received from a pharmacist refers to approximately 71 year old male patient. Patient's medical history was not provided. Patient's allergies were not known. On 25-OCT-2011, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, frequency unspecified, in the left arm) (lot # and expiration date were unknown). Concomitant medication was not reported. In approximately 2012 also reported as "sometime in 2012 or 2013", the patient developed stage IV low grade B cell lymphoma. On an unknown date, the patient was hospitalized for 5 days. No product quality complaint (PQC) was involved. The outcome of stage IV low grade B cell lymphoma was reported as recovered in October 2013. The relatedness between the event and ZOSTAVAX was not reported. The event required unspecified intervention to prevent serious criteria (medically significant). The reporting pharmacist considered the event to be life threatening. Additional information has been requested.
Lump that developed in the same arm below the injection sites within 24 hours of receiving. The injections were given more than an inch apart. Patient did not want the shots to be given in separate arms.
FLARE UPS; she now had shorter breath; She had allergic reaction so not on Humira; felt more fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease and TICAGRELOR (BRILINTA) for an unknown indication.    The patient's past medical history included Cardiomyopathy on 20-Feb-2020, Heart attack from 20-Feb-2020 to September 2020, Catheterization cardiac in February 2020 and Stent placement (3 stents due to heart attack) in February 2020. Concurrent medical conditions included Passive smoking, Allergic reaction to drug since 2020, Crohn's disease and Rheumatoid arthritis since 2017.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and TICAGRELOR (BRILINTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue). At the time of the report, CONDITION AGGRAVATED (FLARE UPS), DYSPNOEA (she now had shorter breath), HYPERSENSITIVITY (She had allergic reaction so not on Humira) and FATIGUE (felt more fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2020, Chest X-ray: Normal. On 20-Feb-2020, Echocardiogram: Heart attack and heart muscles weakness was observed.. On 20-Feb-2020, Troponin: Elevated.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  HUMIRA 40MG/0.4ML(40 Milligram 1mg in 14 Day) Patient was discharged on 23 Feb 2020. Few days after discharge patient went back hospital due to terrible allergic reaction, had with Brilinta medication wherein patient breakout in hives and shortness of breath.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Soreness - unable to use the arm x 7 days. Improved, but persistent 2-3/10  pain on a numeric pain scale. Also complains of intermittent itchiness. States improves as time goes by. Pain does not radiate anywhere. She denies redness, swelling, fever, or hard lump at the injection site.
7 years ago I received the 1st vaccine in 1996.  I became pregnant then received the 2nd vaccine 2 weeks into my pregnancy.  My pregnancy was fine, but between the years of 1998 and 2000 I miscarried 3 times one after the other.  Before receiving the vaccine I was able to carry 3 healthy pregnancies to term.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe).   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Concomitant medications details were not reported by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporter also reported that HUMIRA was no longer effective. Moderna Vaccine all doses were administered one in once, Humira was citrate free.  The reporters causality for the events of CHILLS and HUMIRA WAS NO LONGER EFFECTIVE was not provided for HUMIRA.  Treatment details were not reported by the reporter.
almost 2 year-old girl has presented for a TD immunization with no adverse event; patient was given expired TD Adsorbed vaccination with no adverse event reported; Initial information received on 25-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 23 months old female patient , almost 2 year-old girl has presented for a TD immunization with no adverse event and patient was given expired td adsorbed vaccination with no adverse event reported while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (expiry date: 22-May-2022; dose, lot number , strength: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number requested.  On an unknown date, an almost 2 year-old girl has presented for a TD immunization with no adverse event (Product administered to patient of inappropriate age) and the patient was given expired td adsorbed vaccination with no adverse event reported (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken : not applicable.  At time of reporting, the outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed Redness, tenderness, and localized swelling of the left upper arm over Deltoid area. Reddened area was warm to touch and measured  7cmx7cm. Evaluated by Dr on 10/30/2019 . instructed to ice the area and take over the counter Ibuprofen if there is discomfort. Seen again by Dr 10/31, decreased size of reddened area, no fever, , decreased swelling. Determined no further need for treatment or surveillance unless S/S worsened.
Chest pain, started the day after the vaccine, continue to be worse and worse. See an urgent care doctor, did ECG and blood tests, did not find abnormality, but still continuous chest pain 2 days after the booster shot.
Have experienced tinnitus since the day after the vaccine.  It manifests as a low level buzzing, like radio static.  It's at a low level (so not able to be heard most of the time when other noise is present) but constant.
Patient was sent from assisted living facility for her 2nd Moderna COVID-19 vaccine.  The facility could not locate her immunization card and provide her first shot was Moderna COVID-19 vaccine on 6-25-2021 list on her document.  The Moderna COVID-19 vaccine was administered at pharmacy on 7/19/21 at 2pm.  The facility contacted the pharmacy after the vaccine was given and provide the information that her immunization card was found and Pfizer COVID-19 was listed as her first dose.  The facility could not explain why the Moderna was recorded on her document as first dose.  Facility contact person:(Restricted)
Huge 2 red oozing spots on body. Had HPV shot again in January now there are numerous spots all over my arm and back and buttocks and waist and breast.
very sore; Itchy rash; Red rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: very sore), itchy rash (Verbatim: Itchy rash) and red rash (Verbatim: Red rash).  The outcome of the pain was recovered/resolved and the outcome of the itchy rash and red rash were not reported.   It was unknown if the reporter considered the pain, itchy rash and red rash to be related to Shingles vaccine.     It was unknown if the company considered the pain, itchy rash and red rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by the patient via interactive digital media.  The patient experienced very sore for almost a week with a red itchy rash. The patient was hoping that the second dose should be less reactive. Follow-up would not possible as no contact details were available.
Anxiety; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Anxiety) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart murmur (Born with heart murmur) on 07-Nov-1994, Pneumonia (Developed  pneumonia at age 1.), Stomach function disorder (Developed stomach problems at age 25-26 (prescribed Dicyclomine)) and Lymph node dissection (Patient had surgery at age 11 for lymph node removal on the right side of the neck.). Concurrent medical conditions included Asthma (Developed asthma at age 1.) and Anxiety (Developed Anxiety at age 26-27 (prescribed Hydroxyzine)). Concomitant products included ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for Stomach function disorder.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced ANXIETY (Anxiety). The patient was treated with HYDROXYZINE ongoing since an unknown date for Anxiety, at a dose of 1 dosage form. In November 2021, ANXIETY (Anxiety) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered ANXIETY (Anxiety) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Followup received on 15-NOV-2021 updated reporter information.
1. Dizziness - Resolved within several hours 2. Injection site reaction - Resolved within 48 hours 3. Neuropsychiatric side effects - Began within about 12 hours from vaccination. Lack of concentration proceeded by vivid dreams overnight. Then began to feel mood disturbance the following morning with profound anxiety and depression as well as continued difficulty concentrating. Depression continued to worsen to the point of crying at the end of the night of 1/25. Vivid dreams continued overnight but today, 1/26, mood disturbance has resolved and back to baseline overall except for mild headache similar to a hangover. No past medical history of anxiety or depression.