chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spit out rotarix during administration; Accidental underdose; This case was reported by a other health professional via call center representative and described the occurrence of regurgitation of medication in a infant patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, immediately after receiving Rotarix, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient spit out rotarix during administration, which led to regurgitation of medication and accidental underdose. The reporter did not consent to follow up.
Chronic Fatigue Syndrome; Night sweats; Brain fog; Pain; Menstrual cramps; Bloating in stomach area; Spotting; Fatigue; Sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), FEELING ABNORMAL (Brain fog), DYSMENORRHOEA (Menstrual cramps), ABDOMINAL DISTENSION (Bloating in stomach area) and INTERMENSTRUAL BLEEDING (Spotting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD from 05-May-2019 to February 2020 and Menopause (Hormonal adjustments due to Menopause.). Concurrent medical conditions included Migraine.   On 15-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Sleeplessness). On 28-May-2021, the patient experienced FATIGUE (Fatigue). On 05-Jun-2021, the patient experienced DYSMENORRHOEA (Menstrual cramps), ABDOMINAL DISTENSION (Bloating in stomach area) and INTERMENSTRUAL BLEEDING (Spotting). On 07-Jun-2021, the patient experienced PAIN (Pain). On 08-Jun-2021, the patient experienced FEELING ABNORMAL (Brain fog). 08-Jun-2021, the patient experienced NIGHT SWEATS (Night sweats). On an unknown date, the patient experienced CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome). The patient was treated with ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) on 21-May-2021 for Night sweats and Sleeplessness, at an unspecified dose and frequency. On 28-May-2021, INSOMNIA (Sleeplessness) had resolved. At the time of the report, PAIN (Pain), FEELING ABNORMAL (Brain fog), DYSMENORRHOEA (Menstrual cramps), ABDOMINAL DISTENSION (Bloating in stomach area), INTERMENSTRUAL BLEEDING (Spotting) and FATIGUE (Fatigue) had not resolved and NIGHT SWEATS (Night sweats) and CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood pressure measurement (115-75): 124/84 (Inconclusive) Unknown. On 28-May-2021, Weight increased: increased (High) Increased. On 07-Jun-2021, Blood pressure measurement (115-75): 134/84 (High) Unknown.         No Concomitant Medications were  provided.  On 20-may-2021, patient experienced elevation in blood pressure which was extremely high on 7-jun-2021 with 134/84. On 05-jun-2021, patient experienced menstrual cramps and extreme fatigue with no sleep of about 8 hours. Patient stated that she is now menstruating due to Medications.   This case was linked to US-MODERNATX, INC.-MOD-2021-116386 (E2B Linked Report). This case was linked to MOD-2021-222815, MOD-2021-222815 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116386:Husband's case
Localized urticarial, erythema; unsure treatment pt seen at her PCP office.
Felt Shaky and flushed about 15 minutes after vaccine. Given pretzels and waters and relaxation techniques were discussed.  Feeling better after 30 minutes.  Still feeling a little shaky. Got an order from a provider to check BG, which was 124 after the pretzels.  Patient felt okay, spoke to PCP and was okay to leave the office.   Note from MD was that patient likely experienced a vasogagal response.  Observed for about 45 minutes total.
A dose was administered to a patient after the punctured vial has been out for more than 12hrs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient after the punctured vial has been out for more than 12hrs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient after the punctured vial has been out for more than 12hrs). On 03-Apr-2021, EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient after the punctured vial has been out for more than 12hrs) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Initial Additional-1
Fever (101.0)/chills, headache, body aches, snuffy/runny nose - signs of improvement on 05/18/2015. Skin sore to touch increased on 05/17/2015 and has not improved yet.
Four days post-vaccination, she had a serious spell with a hiatal hernia which resulted in a possible gastric volvulus. Over the course of the episode, she ended up aspirating while vomiting. Within 24 hours she couldn't hold her O2 sats at an acceptable level and was put on a ventilator in ICU. She recovered enough to extubate and go to a regular room but then ended up back on the vent and in ICU a second time. She was extubated again, but still could not maintain her O2 levels without medical intervention. She passed away on April 3, 2021. She did have covid-19 in late November 2020, with a mild case of pneumonia. She had been under the care of her primary doctor, as well as home health care and physical therapy, as part of her recovery.  Her death may have been unrelated to the vaccine, but I have been told I should report anyway, as a precaution.
Red bumps on the hands and feet; Mild burning and itching on the red bumps; Moderate pain; Patient's feet has mild swelling; Mild burning and itching on the red bumps; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (Red bumps on the hands and feet), BURNING SENSATION (Mild burning and itching on the red bumps), PAIN (Moderate pain), PERIPHERAL SWELLING (Patient's feet has mild swelling) and PRURITUS (Mild burning and itching on the red bumps) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 20-Aug-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 ERYTHEMATOUS (Red bumps on the hands and feet), BURNING SENSATION (Mild burning and itching on the red bumps), PAIN (Moderate pain), PERIPHERAL SWELLING (Patient's feet has mild swelling) and PRURITUS (Mild burning and itching on the red bumps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency and MENTHOL (ICE [MENTHOL]) for Red rash, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red bumps on the hands and feet), BURNING SENSATION (Mild burning and itching on the red bumps), PAIN (Moderate pain), PERIPHERAL SWELLING (Patient's feet has mild swelling) and PRURITUS (Mild burning and itching on the red bumps) 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 did not provide any causality assessments.
I got sick every time I got a flu shot so no more for me; Initial information received on 04-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient).  This case involves an adult patient of unknown age and gender who developed illness (I got sick every time I got a flu shot so no more for me) while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "i got sick every time i got a flu shot so no more for me" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got sick every time I got a flu shot so no more for me).  At time of reporting, the outcome was Unknown for the event i got sick every time i got a flu shot so no more for me.
Syncopy: elevated feet, cold compress, Powerade. Dizziness lasted approx 45 minutes. Refused any more treatment. Left on own.
Patient complained of gait imbalance (drifts to the right) since February 1999. Symptoms getting progressively worse. Received 3 anthrax injections; the 3rd 3 months before gait problems began.
2 days after 2nd Moderna vaccine, patient felt heaviness in chest, went to hospital, diagnosed with myopericarditis
Husband called 12/3/14 and spoke with pharmacist on duty. He stated that patient started having extreme pain in both arms (had Fluzone in left and Pneumovax in right) about 7pm. Husband said she had to take Percocet to help with pain as she equated it to the pain from child birth. Patient also had the shakes quite badly and husband almost took her to the ER.
CLIENT RECEIVED PEDIATRIC PFIZER FORULATION OF 0.2ML AT 12YO. CLIENT SHOULD'VE RECEIVED GRAY-CAP FORMULATION OF 0.3ML.
Pain in shoulders, arms, elbows, and tops of hands. Diagnosed with shoulder adhesive capsulitis on July 18, 2012. Received steroid shot in shoulder that same afternoon. Start Physical Therapy on July 31, 2012.
I received the Pfizer 2nd  covid injection on Wednesday 1/27/2021  Thursday I was very foggy, and tired. In the evening I was very emotional similar to feeling I would have before getting my period. I have been in menopause for over 8 years.  Friday I was still very emotional and very tired. I called out from work.
This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient declared she was hospitalized for a reaction to SHINGRIX vaccine. The patient called for information about what medication was on Xeljanz. This question was originated because the patient felt nausea and sickness with Otezla and her Physician recommended her to change to Xeljanz. The patient had not started on Xeljanz. The call was disconnected before the transfer was completed and after the callback the proper information was provided.
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with Agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Agency, Medical Staff and Others were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Resolution Specialist and Agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4"; got the injection on her left arm, but she thinks it's a little too high; sore and hard to sleep on it; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (sore and hard to sleep on it), ERYTHEMA (it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4") and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the injection on her left arm, but she thinks it's a little too high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A or 042L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (to antibiotics).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (sore and hard to sleep on it) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the injection on her left arm, but she thinks it's a little too high). On an unknown date, the patient experienced ERYTHEMA (it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4"). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Jan-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the injection on her left arm, but she thinks it's a little too high) had resolved. At the time of the report, LIMB DISCOMFORT (sore and hard to sleep on it) outcome was unknown and ERYTHEMA (it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
flu-like symptoms; ear infection; complained of his ear hurting; there was red in his stool; diarrhea,; his 11 year old son received his 5th dose of Daptacel; Initial information received on 09-Aug-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 11 years old male patient who experienced flu-like symptoms, ear infection, red in his stool and diarrhea, while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), and family history were not provided.  The patient developed similar symptoms with every Daptacel immunization, but the symptoms resolved after a few days.   On 15-May-2019, the patient received a 0.5 ml fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient had flu-like symptoms (influenza like illness), ear infection, red in his stool (faeces discoloured), diarrhea (diarrhoea) and complained of his ear hurting (ear pain) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   These events were assessed as medically significant.  It was also a case of medication error due to inappropriate age at vaccine administration.  Lab data was not reported.  Final diagnosis was diarrhea, there was red in his stool, ear infection and flu-like symptoms.   Corrective treatment: antibiotics for ear infection, BRAT ( bland) diet for diarrhea.  At the time of report, the patient had not been recovered from the events.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number was requested.  List of document held by sender: none.; Sender's Comments: This case involved a 11 year old male patient who had flu-like symptoms, ear infection, red in his stool and diarrhea after vaccination with DAPTACEL. Time to onset is unknown. The Patient's past medical history, concomitant medications  and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Itching since the vaccination day and rash appeared 9 days after the vaccine (1/21/2021) and getting bigger.
Day After injection - lots of anxiety and tachycardia.  2 weeks after vaccine - swelling in the back of the left leg. Various heart pain and anxiety when I get the chest pain. 3 weeks after some shortness of breath. Throughout the month neuropathy in the legs. Zapping Random Pains. Having chest pain again tonight.  Awful scary stuff happening to me.
She got her vaccine, she had no problems at first.  Then her BP went ski high, over 200.  She went to the ER on Monday, 9/25/23 it was 190 and then went up to 200/?.  They gave her medicine to bring it down around 6 hours later, gave her a shot.  Her cardiologist wasn't happy about that shot as they do not want to bring it down fast.  She then went home and it has not gone back to her pre-vaccine stage levels.  She was put on Valsartan which she takes at night now.  She did see her cardiologist and that's when he started her on the Valsartan.  She went to ER.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports from the same source.
Office visit on 03/14/2002 with rash all over the body since 03/12/2002 and fever, warm to touch, diarrhea for 2-3 days. Red, raised rash all over the body. On 03/19/2002 rash was fading but still had fever and was diagnosed with ear infection. Amoxil prescribed.
I received my Pfizer booster on 10/13/2021. At around the beginning of 2022, I began noticing hand tremors, which have as of yet progressed to my arms. I went to my PCP who prescribed me propranolol for nonessential tremors and referred me to a neurologist. The doctor ordered a CAT scan and DAT scan. The results came back, and I was informed that it appeared I had Parkinson's disease. The doctor then prescribed rasagiline mesylateand instructed me to return in August 2022.
fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     It was reported that patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor. It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Drug use for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU.    On 23-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (fibromyalgia/ and after the last bivalent booster it really started hitting him pretty bad.) had not resolved. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Company Comment:  This spontaneous case concerns a 54-years-old-male patient, with medical history of previously administered FLU vaccine, treated with duloxetine who experienced the  unexpected event (AESI) fibromyalgia unknown days after 4th. dose of  mRNA-1273 BIVALENT.222 (ORIGINAL AND OMICRON BA.4/BA.5) vaccine. At the time of the report, FIBROMYALGIA had not resolved. The benefit-risk relationship of mRNA-1273 BIVALENT.222 (ORIGINAL AND OMICRON BA.4/BA.5) vaccine is not affected by this report.   This case was linked to MOD-2023-738990 (Patient Link).
Welt-like rash on back, thighs and upper-outer (R) arm. Appeared 3-7 days after flu vaccination. Resolved temporarily with prednisone.