chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Appetite absent/ No appetite; Lumbar vertebra injury/ X-ray shows damage of Lumbar; Flu like symptoms; Numbness of extremities/ Numbness of feet and Arms; Fever/ temperature; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite absent/ No appetite), SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) and PYREXIA (Fever/ temperature) 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) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (Appetite absent/ No appetite), SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar), INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) and PYREXIA (Fever/ temperature). At the time of the report, DECREASED APPETITE (Appetite absent/ No appetite), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever/ temperature) had resolved and SPINAL COLUMN INJURY (Lumbar vertebra injury/ X-ray shows damage of Lumbar) and HYPOAESTHESIA (Numbness of extremities/ Numbness of feet and Arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: abnormal. On an unknown date, X-ray: Damage of lumbar.         No concomitant medications were reported. No treatment medications were reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2022: Live Significant Follow up included Event added. On 05-May-2022: Live Significant Follow up included event was removed and lab test added.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were unknown, lot # M011117 with expiration date 07-DEC-2017, and lot # L026602 with expiration date 19-OCT-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 11/23/21, #939909. pt had a positive COVID test on 8/17/22 from Urgent Care; 9/15/22 pt's passing was witnessed at home by family; brought to ED to be pronounced; pronounced deceased at Medical Center.
Running back and forth to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Running back and forth to the restroom) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced DIARRHOEA (Running back and forth to the restroom). At the time of the report, DIARRHOEA (Running back and forth to the restroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-008233 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
I have five other employees that were given shot same morning all having had adverse side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects). At the time of the report, IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 5th patient out of 5 patients as described by the reporter.  No concomitant medication information was reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748342 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received that contains non-significant information : secondary reporter added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Master case US-MODERNATX, INC.-MOD-2023-748403:same reporter US-MODERNATX, INC.-MOD-2023-748215:same reporter US-MODERNATX, INC.-MOD-2023-748352:same reporter US-MODERNATX, INC.-MOD-2023-748342:same reporter
Date of Admission: 10/19/2022   Date of Discharge: 10/31/2022   Admission Diagnosis: Community acquired pneumonia, unspecified laterality  Community acquired bacterial pneumonia    Hospital Principal Problem (Discharge Diagnoses): Community acquired pneumonia, unspecified laterality
Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. It was reported that RECOMBIVAX HB lot # K010535 (expiration date 27-AUG-2016), lot # K021444 (expiration date 17-SEP-2017) and lot # K020216 (expiration date 17-SEP-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L045117 (expiration date reported as 06-OCT-2017, but auto generated as 06-OCT-2018) and M010212 (expiration date 21-JAN-2019) underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no RECOMBIVAX HB lot number reported in 2017 temperature excursions. It was unknown if unknown number of patients were vaccinated with RECOMBIVAX HB (dose, route, site of administration unknown) for prophylaxis. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001287: US-009507513-1706USA001289: US-009507513-1706USA001290: US-009507513-1706USA001291: US-009507513-1706USA001292:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 1st February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced shingles, erythema, pruritus and eczema. On an unknown date, the outcome of the shingles, erythema, pruritus and eczema were not recovered/not resolved. It was unknown if the reporter considered the shingles, erythema, pruritus and eczema to be related to SHINGRIX. Additional details were reported as follows: After receiving SHINGRIX, few days to a week later the patient had itching, red, eczema looking areas on his face, mostly the left but also on the right. He also had it on both arms and shoulders. The patient states that it looks possibly like shingles but he has never had shingles.  The patient did not receive the previous shingles vaccine on the market, he has had chickenpox but never had shingles. At the time of report, he was getting worse now, but he has not been to a physician about this issue yet. The reporter consented to follow up.
Swollen lip; Rash (on her arm, cross her chest, and legs); This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lip) and RASH (Rash (on her arm, cross her chest, and legs)) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced LIP SWELLING (Swollen lip) and RASH (Rash (on her arm, cross her chest, and legs)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 10-Mar-2021, LIP SWELLING (Swollen lip) had resolved. At the time of the report, RASH (Rash (on her arm, cross her chest, and legs)) had not resolved.            No concomitant medications was reported. Action taken with mRNA-1273 in response to the events was  not applicable.
Pt had a pneumo 23  vaccine yesterday in his right deltoid. He states from his elbow to his shoulder, he has pain, edema, erythema, and it's hot to touch. He states it's severe and it kept him all night. He cannot raise his arm. It is also itchy, but anti-itch cream resolves this. He has also been using ice. No use of any tylenol or benadryl treatment.
Acute myocarditis.  Symptoms of chest pain for about 5 days prior to presenting to the hospital
itching at the injections site; redness at the injections site; injections site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injections site), VACCINATION SITE ERYTHEMA (redness at the injections site) and VACCINATION SITE SWELLING (injections site swelling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-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 VACCINATION SITE PRURITUS (itching at the injections site), VACCINATION SITE ERYTHEMA (redness at the injections site) and VACCINATION SITE SWELLING (injections site swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at the injections site) and VACCINATION SITE SWELLING (injections site swelling) had resolved and VACCINATION SITE ERYTHEMA (redness at the injections site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  7-8 days later after the vaccination, the patient had a delayed reaction, with redness at the injections site, on their left arm, and also swelling and itching that lasted 3 days approximately. Patient wonders if this was normal and whether they should get the second dose.
Constipation. Previously 2-3 bowel movements/day. After regular 4 mo vaccinations 9 days of constipation then 1 bowel movement, then 6 more days constipation then treated with suppository. Continued constipation at this point.
Swelling at injection site; Redness at injection site; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 28-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Diabetes medicines and High blood pressure medicine.  Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI-  Patient doesnot want to continue with the follow up.
This initial spontaneous report was received on 25-OCT-2018 from a physician via a company field representative and refers to a 12 year old patient of unknown gender. The patient had no pertinent medical history or drug reactions/allergies and was taking no concomitant medications. On an unspecified date, the patient received GARDASIL intramuscularly for the indication of human papilloma virus (HPV) vaccination (dose and lot # not provided). It was unspecified how many doses in the series the patient received. An unspecified period of time after receiving GARDASIL, the patient died. Cause of death was not specified. There were no lab diagnostics/studies performed. The physician did not provide causality assessment. The physician told the field representative that Merck was sued.  Upon internal review, death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: Cause of Death: Unknown by reporter.
Hospitalized;  COVID-19 positive (2.17.22);  Fully vaccinated PLUS booster Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/17/2022 Discharge Date: 2/23/2022 HISTORY OF PRESENT ILLNESS: HPI: Patient is a 60 y.o. male who initially presented to Hospital with acute sudden onset cehst pain and shortness of breath. He was worked up and found to have right sided PTX. CT surgery contacted for patient transfer and mgmt of chest tube. Patient arrived to ED in stable condition. Right chest tube placed at bedside by ED physician prior to my arrival in ED. Tube placement confirmed in correct position.  Patient denies prior episodes of ptx. Denies hx of heart of lung procedures. Reports smoking history but quit 10 years ago. Denies vape or inhaled marijuana use. He reports acute onset shortness of breath prior to arrival. After chest tube placement reports some improvement in breathing. Denies home O2 use, denies formal pulmonary diagnosis.  Patient is a 60 y.o. male  who initially presented to Hospital with acute sudden onset cehst pain and shortness of breath. He was worked up and found to have right sided PTX. CT surgery contacted for patient transfer and mgmt of chest tube. Patient arrived to in stable condition.     Progress Note from 2.23.22: ASSESSMENT / PLAN: 60yM former smoker with secondary spontaneous right pneumothorax. CT evidence of severe emphysematous disease, bullae. S/P bedside chest tube placement by ED physician 2/17. Chest tube placement confirmed on CXR. Patient in stable condition. - Chest tube removed uneventfully  - General diet, HLIV - Multimodal pain control - COVID precautions - Pulmonary hygiene, OOB, encourage ambulation, IS use Dispo: discharge home today
Generalized itchy rash. On her chest, arms, legs. Described as small bumps. Patient treated with prednisone.
Eyes red and itchy, face blotchy and swollen.  Scalp itchy and bumpy.  Rash across stomach.  Chills.  Took Benadryl for 3 days.
Since having the series of Hep. B vaccinations, I have developed Chronic Fatigue Immune Dysfunction Syndrome and Fibromyalgia.  I received the first injection in either December of 1998 or January of 1999; the last injection was in June of 1999.  My symptoms include:  Migraines, IBS, weakened immune system (always getting infections), abnormal labs(elevated liver enzymes, white cell count, low human growth hormone, vitamin deficiency, EBV, high fibrinogin levels), memory/concentration problems, fatigue, weak/painful muscles, sleep disturbance, frequent chills/hot flashes, high blood pressure, restless leg syndrome, night sweats  Both Agencies have given me different dates for the vaccinations; I don't remember if I got one or more injections from either source.
The first FLUZONE QIV NP vaccine in her office on 21SEP2021 vaccine in her office on 21SEP2021 with no ae; Initial information received on 14-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 62 years old female patient who was administered an after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (inappropriate schedule of product administration).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE).  On 14-Dec-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination.  On 21-Sep-2021 she also received a dose of the same vaccine  lot number:  UT738NA and expiry date not reported  via intramuscular route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to drug dose administration interval too short (latency: same day).  At the time of reporting, no adverse event was reported.   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 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.
Fever 104.1 ax by 230PM; leg very swollen, seizure activity; hospitalized for 2 days very irritable;
Have a regular pain that's feels like someone punched in the arm like my muscle hurts over it; Neck started itching; Whole entire neck was just itching terrible and all night I was itching; Covered in hives; Still covered in hives like they didn't go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso; Have a regular pain that's feels like someone punched in the arm like my muscle hurts over it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and Expiration date: not reported), via an unspecified route of administration, administered in right arm in Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 in May2021 (a confirm case). The concomitant medications for patient were not reported. It was reported that the patient had COVID back in May a confirm case and then was told by the doctor to get the vaccine (Unspecified vaccine) anyway and she told the patient to get it at Saturday, so the patient went and got first dose. The patient got vaccinated yesterday morning on right arm, it was maybe like 10 O'clock or 11 O'clock something like that. It was Saturday whenever it was 8th or 7th the patient did not know. And it was reported that "I got it in my right arm and probably about 9 O'clock at night my neck started", On an unspecified date in Aug2021, the patient reported to "have a regular pain that's feels like someone punched in the arm like my muscle hurts over it", but according to patient that was not the big deal but about 9 at night "neck started itching; whole entire neck was just itching terrible and all night I was itching". The patient thought maybe the patient was getting bitten by mosquito or something but then the patient went to bed. Then the patient woke up in morning and the patient was "covered in hives; still covered in hives like they didn't go away at all, I have taken a shower, I have done like everything and I am still completely covered on my torso". The patient reported that the patient did not get hives. So, that was not, the only thing the patient did different was to take the vaccine and the patient was covered in hives and it was 8 O'clock at night and the patient was still completely covered on torso. The patient did not want to take Benadryl or something and just wanted to know why the patient having hives. The patient did not want to take the second one if the patient getting the hives. The patient did not want to get any mail. Further probing could not be done as the consumer was unwilling to share any further information at that point of time. Hence limited information available over the call. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.