chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Rotavirus, Pneumococcal, Pentacel and Hepatitis B. Past adverse reactions to the above products included No adverse event with Hepatitis B, Pentacel, Pneumococcal and Rotavirus.    On 19-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The multiple-Dose Vial with dark pink cap and Label with yellow box for ages 6 months through 5 years was administer as a 1st dose to 3 patients and as a 2nd dose to 1 patient.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720355:Patient 1 out of 4 Patients
This spontaneous report was received from a Licensed practical Nurse and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. Between 03-NOV-2016 and 07-NOV-2016, the patients were vaccinated improperly stored GARDASIL, lot number L037554, expiration date 25-DEC-2017, (frequency, route and anatomical location were not reported). Temperature of 48.9 Fahrenheit degrees, 45 minutes of time frame and there was a digital data logger involved. No previous temperature excursion was involved. No product quality complain was involved. At the time of reporting, no adverse effects were reported. No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested.
75 years old male with past medical history of Alzheimer's disease, seizure, lung emphysema and diverticulosis presented to ER referred from clinic complaining of worsening COVID-19 symptoms and abnormal lab results.   Started to have COVID-19 symptoms 9 days ago and has been tested positive for COVID-19 6 days ago and he has been having progressive weakness associated with body ache, fever, chills, joint pain and poor appetite associated with altered mental status and loss of taste and smell. His BUN is 38 and creatinine is only 1 and hemoglobin is 17 and patient looked very dehydrated. Patient said that he had chest x-ray done at clinic and he has been told it looks okay.   At the ER patient was given IV fluid lactated Ringer bolus 1 L and Zofran 4 mg IV x1 and Tylenol 1000 mg p.o. x1 COVID-19 infection -Progressive loss of appetite and seemed very dehydrated. He also had chills, muscle ache, fatigue, joint pain and loss of taste and smell. -Patient is not hypoxic and no steroids needed -BUN was 44 and creatinine was 1 with hemoglobin is 17. Looked very dehydrated clinically -Improved with IV fluid hydration  -Full barrier precautions -Procalcitonin was low.  -Chest x-ray was done at the clinic and patient had been told that it looks okay unfortunately I cannot have access for chest x-ray report. -Tylenol and cough medication as needed -Anticoagulation with Lovenox subcu per anticoagulation protocol   2.  Alzheimer disease -Continue PTA Aricept   3.  Seizure -Continue PTA Keppra   4. Thrombocytopenia.  Platelets 109-- >84-- >122-- >132.  Peripheral smear pending. Follow up on results with PCP.    Patient is feeling better and feels comfortable and ready to discharge to home.  He will follow-up closely with his own PCP.
30 days p/vax pt exp aches & pain in muscles of upper arm during activities;BP usually 145/80 rang was 110/76;unable to palpate pulses in either arm;BP 120/80;sed rate 72 (elevated);evidence showed artery stenosis;poss vasculitis;
My right shoulder, on the arm in which I received the vaccine, is in severe pain. I have been two full days with limited mobility and excruciating pain whenever I move my right arm across my body or in other circular motions.
Post 2nd vax in series, pt experienced a miscarriage. Lab work was taken prior to and following the adverse event. This report is part of the pregnancy registry. Correction to this report the pt did not experience a miscarriage as an adverse event.
Twenty minutes after pfizer was administered, pt felt her throat closing and was unable to talk. O2 sat on RA was 81, HR 79. Epinephrine immediately administered and 911 called. Pt place on 15 L non rebreather. Pt O2 sats increased to 100% . HR 120.  Paramendics arrived at 10:32 and took over care, transported by ambulance to ER.
arm is puffy; painful arm; arm is red; arm is very itchy; has like a rash; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (arm is puffy), PAIN IN EXTREMITY (painful arm), ERYTHEMA (arm is red), PRURITUS (arm is very itchy) and RASH (has like a rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN, LISINOPRIL, VITAMIN D3 and SERTRALINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (painful arm), ERYTHEMA (arm is red), PRURITUS (arm is very itchy) and RASH (has like a rash). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm is puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm is puffy), PAIN IN EXTREMITY (painful arm), ERYTHEMA (arm is red), PRURITUS (arm is very itchy) and RASH (has like a rash) outcome was unknown.        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.
Had flu immunization 10/28/05 next day her RUE shakes when she extends her arm. Also complained pain R deltoid and antecubital area, no numbness no area change. No febrile
Patient did not receive 3rd dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 27th January 2022) and Twinrix (2nd dose received on 28th February 2022).   On an unknown date, the patient did not received the 3rd dose of Twinrix and hepatitis A and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Twinrix and hepatitis A and hepatitis B vaccine pre-filled syringe device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 29-AUG-2022 Reporters comment: The patient received first dose on 27th Jan 2022 and second dose received on 28th Feb 2022.Later than 6 months between dose 2 and 3 patient yet did not received 3rd dose of twinrix vaccine. The reporter given consent to follow-up. HCP unable to provide additional AE details at that time, given permission for safety team follow up Additional Supportive information: Till the time of reporting the patient did not received 3rd dose of Twinrix, which led to incomplete course of vaccination.
Stomach pain in upper left abdomen.  Dizziness, blurred vision.  Numbness and tingling in left arm pectoral and jaw.
Immediate allergic reaction; First dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Immediate allergic reaction) and PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Immediate allergic reaction) and PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago). At the time of the report, ALLERGY TO VACCINE (Immediate allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
According to patient's Mom his right arm had a "goose egg" yesterday, but it went away. She reports that today patient's right arm has a square "patch" below the site of the injection that is "a little bigger than a 50 cent piece" and is warm to touch. She reports that today patient's left arm has red streaks near the injection site. Denies any fever or chills. Denies lethargy, nausea, vomiting, or any changes in behavior. Patient has plans to go to swimming lessons later today. Advised Mom to put cool compresses on the sites, give patient ibuprofen and continue monitoring closely. If no improvement today or any worsening at the sites described, advised Mom to take patient to his physician or to ER for further evaluation. Offered for Mom to bring patient in and let me assess the sites. She said she will try the cool compresses and ibuprofen first.
COVID infection - tested positive for COVID-19 on 14Apr2022.; COVID infection - tested positive for COVID-19 on 14Apr2022.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3247), on 02Mar2021 as dose 2, single (Lot number: EL3247) and on 09Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 24 years for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "recovered" and all described as "COVID infection - tested positive for COVID-19 on 14Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Apr2022) Positive, notes: Nasal Swab, OTC test; (15Apr2022) Positive, notes: Nasal Swab, PCR test. Therapeutic measures were taken as a result of vaccination failure, COVID-19 which included OTC medication-NYQUIL. No other vaccine in four weeks, no other medications in two weeks. Adverse event: COVID infection - tested positive for COVID-19 on 14Apr2022. Adverse event start date was on 09Apr2022. Patient had not experienced covid prior vaccination. Covid tested post vaccination. Patient had no known allergies.
Case number PHHY2011US30327, is an initial report from a nurse received on 11 Apr 2011: This report refer to a adult patient. The patient was vaccinated with MENVEO (batch number M10030) intramuscularly on an unspecified date. The patient only received the Men-CYW-135 liquid component and did not received the Men A lyophilized conjugate component of MENVEO. No adverse event had been reported. Non significant follow up received on 12 Apr 2011: No new information was provided.
The shot itself hurt tremendously - like a punch in the arm. The shot was administered very high on the arm - not where I have normally received shots. Ever since the vaccine I have been complaining that my shoulder is sore. It has progressively gotten worse - so much so that I have received a shot of cortisone - with no relief. I have been told that I am developing "frozen shoulder" and that it must be caused by some sort of "trauma." I do not play any sports and have not done anything else that could have caused injury to my shoulder.
Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Havrix. On 07-MAR-2023, an unknown time after receiving Havrix, [the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The patient received Havrix pediatric expired dose, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2023035936, reported by same reporter.; Sender's Comments:  US-GSK-US2023035936:Same reporter
Extreme itching at body-wide sites with rashes on both shoulders/arms. Persistent for two weeks plus. Only now declining (slowly).
Child was taken to eye specialist and was told a change was noticed to the retinal pigmentation of eye.
Patient was reporting numbness of arm , neck and head on left side and ear pain 15 minutes after receiving the vaccine. Patient was observed for another 15 minutes and he reported no numbness but tingling in shoulder and arm on the left side. He still had pain wear his ear was described as a tightness he felt on  his head and neck as well.  A blood pressure was taken and patient's blood pressure was 178/124. 911 was called and EMTs arrived to assess the patient.
Mild leg cramps in right leg. 11/18 cramp in left leg calf becoming severe to inhibit walking and very painful until 11/19 when at 5am severe diarrhea began (all clear fluid at least 12 times) and continuing into today 11/20/15.
Had blood clotting; Had some issues; Scared to take second shot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Had blood clotting), VACCINATION COMPLICATION (Had some issues) and ANXIETY (Scared to take second shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Had blood clotting), VACCINATION COMPLICATION (Had some issues) and ANXIETY (Scared to take second shot). At the time of the report, THROMBOSIS (Had blood clotting), VACCINATION COMPLICATION (Had some issues) and ANXIETY (Scared to take second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. It is stated that patient had some issues and blood clotting, because of that she was scared to take second shot. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information received on 15 Sep 2021, Updated year in date of birth of patient.; Sender's Comments: This case concerns a 61-year-old female patient with no details on previous relevant medical history, who experienced the unexpected event of Thrombosis (reported as Had blood clotting) after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the first dose of Spikevax, temporal relationship is unknown. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Thrombosis was automatically upgraded as serious as per IME list. However, based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.
Information has been received from a healthcare worker referring to a female patient of unknown age. The patient received the first dose of GARDASIL on 02-APR-2015 and second dose on 02-JUN-2015 (both doses were not reported) and finished the series with GARDASIL 9 (lot # K026247, expiration date 28-JAN-2017, dose was not reported) which was determined on 03-AUG-2015 (Interchange of vaccine products and Inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Crying for 2 hours. Woke up at 17:30 and crying on and off until 23:00; fell asleep. Fever of 101 (ax) on the night of 1/8/03. Gave Tylenol on 1/7/03 PM, twice on 1/8/03 AM and PM. Crying on and off until 06:00 this morning with only cat naps. Slight red left ear at 17:30 on 1/9/03.
Patient had mild bronchospasm in throat, father went and got her inhaler, after use of inhaler, recovered and released.
Welt appeared a little over a week post vaccination. Now almost two weeks later the welt has grown to about a 6 inch red circle on the arm where I got the vaccine.
Headaches, fatigue, productive cough, nasal congestion, loss of smell and taste, diminished hearing, excess sweating, dizziness.  Mild symptoms 24 hours post vaccine. Severe symptoms from 48 hours through day 6 post vaccine.
Pt was administered a typhoid VI injection and approx 30 minutes came into the clinic complaining of severe itching and hives.
Menstruation cessation with hormonal symptoms (weight gain, vaginal dryness, amenorrhea, skin changes.
This spontaneous report as received from an administrator refers to an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (which had a lot # of M026315 and an expiration date of 26-JAN-2018; however, dosage number was not reported), for prophylaxis. The administered vaccine experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008006: US-009507513-1701USA014464: US-009507513-1701USA014466:
swelling of lt arm from shoulder to just below elbow; Area painful, firm to the touch & very warm to the touch;
Contracted the flu; Ear ached; Right arm ached; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Contracted the flu), EAR PAIN (Ear ached) and VACCINATION SITE PAIN (Right arm ached) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced EAR PAIN (Ear ached) and VACCINATION SITE PAIN (Right arm ached). On 10-May-2021, the patient experienced INFLUENZA (Contracted the flu). The patient was treated with GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [GUAIFENESIN;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE]) for Flu, at a dose of three pills. On 26-Apr-2021, EAR PAIN (Ear ached) and VACCINATION SITE PAIN (Right arm ached) had resolved. At the time of the report, INFLUENZA (Contracted the flu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Treatment information was updated, new events; right arm ached and ear ached were added.
05/11/22 Vaccination. 05/15/22 03:00AM Sore throat. Rapid test; POS.
This spontaneous report as received from a Licensed Practical Nurse refers to a 1 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 20-OCT-2014 the patient was vaccinated with VARIVAX (Merck), 0.5 ml (lot number unspecified), subcutaneously and PROQUAD (Merck), 0.5 ml (lot number unspecified), subcutaneously. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event overdose was unknown. The causality of the event with VARIVAX (Merck) and PROQUAD (Merck) was not reported. Additional information has been requested.
BLOODY STOOL; DIARRHEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported that the patient received vaccine 9 days ago and had bloody stools and diarrhea. But the patient felt fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bloody stool, and diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210429343-covid-19 vaccine ad26.cov2.s-Bloody stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt c/o tingling of arms p/receiving 1st dose of vax; No further details available; This case is considered to be invalid;