chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients father passed away; sore arm; Hemorrhagic stroke; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patients father passed away) and HAEMORRHAGIC STROKE (Hemorrhagic stroke) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes and Heart disorder (Heart rhythm was not normal).   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhagic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced DEATH (Patients father passed away) (seriousness criteria death and medically significant) and MYALGIA (sore arm). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGIC STROKE (Hemorrhagic stroke) and MYALGIA (sore arm) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter.  Company comment: Very limited information regarding  these  events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding  these  events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
This non-serious initial spontaneous case, was received on 26-Sep-2017 from other health professional, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, batch number, expiry date, route of administration: not reported, anatomical location: deltoid). It was reported that, the patient developed pain after taking a vaccine in the deltoid muscle. The patient experienced pain after taking the vaccine given either in the deltoid muscle or in the thigh. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Initial misuse report received from a healthcare professional on 23 December 2013. The cases were received at GPV on 21 March 2014. A "15-month-old" patient (no information was provided regarding the patient) had received first dose of second dose series of FLUZONE 0.5 ml, on an unspecified date i.e. overdose. No adverse event was reported. List of documents held  by sender: none
An uncomfortable big circle under his armpit; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (An uncomfortable big circle under his armpit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a, 040a21a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN DISCOLOURATION (An uncomfortable big circle under his armpit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (An uncomfortable big circle under his armpit) had not resolved.            Treatment medication also included A cream.  Concomitant medication was not reported.
Muscle aches, fever, chills, nausea, weakness, fatigue for 5-6 days.
Temporary kaleidoscope vision in right eye along with partial loss of vision. Each episode lasted 3-4 hours. 4 episodes have been experienced so far.
Staff member presented for Covid vaccine and approximately 5 minutes after receiving dose, experienced diaphoresis,  light headedness and palpitations, then stated that she felt her throat swelling. Epinephrine was drawn up but not administered. A Rapid Response was called and they evaluated her and suggested she go to ED for further eval. Staff member refused further treatment and left area ambulatory in stable condition . WB"
her son had trouble breathing; severe allergic reaction; negative titers to mumps; This spontaneous report was received from a consumer, referring to her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions or allergies were not reported.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, anatomical injections site, lot # and expiration date were not disclosed).         Afterwards, on an unknown date, the patient experienced trouble breathing (dyspnea) and had other unspecified but severe allergic reaction (allergy to vaccine). The patient's mother also reported that her son had negative titers to mumps (mumps antibody test negative) after receiving the vaccine.  At the time of this report, the outcome of dyspnoea, mumps antibody test negative and allergy to vaccine was unknown.    The event of allergy to vaccine was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). However, the causality assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the events dyspnea and mumps test negative, was not provided.
"diaper rash".  12/05/2009 AM mother noted rash over majority of trunk/extremities, began clumping together, slight fever.  Later, went to ER with swelling to hands, eye, ears.  Given epinephrine and diphenhydramine, observed and sent home 10/06/2009 at 8:30 AM with prescription for prednisolone.  Patient vomited prednisolone, after naptime swelling worsened and patient returned to hospital.  Remains in hospital at this time on IV meds, father states client is better. 12/08/09 Hospital Admitting Record received for DOS 12/06-12/7/09. Pt. presented with rash all over body x 2-3 days. Had just completed course of Amoxil. Treated with IV fluids, benadryl and solumedrol Impression: allergic reaction to Amoxil, Arthus phenomenon 12/09/09 ER records received for DOS 12/06/09. Pt. seen earlier in day for rash, presents again with with flare up of rash, itching. Admitted to hospital.
Significant headache within 24 hours of taking 2nd injection. Still persisting today .  Within a few weeks of taking the vaccine the patient fell twice and experienced change in mental status.  Incomplete thoughts and became belligerent and combative .  Headache is very bad.
patient had COVID in Feb2022; patient had COVID in Feb2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "recovered" (2022) and all described as "patient had COVID in Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) positive, notes: only lasted about 7 days.  Clinical Course: On 25May2022, it was reported that a patient started treatment on unspecified dates with 3 COVID-19 "shots" (Pfizer) for COVID-19 vaccination. It was reported the she had a very mild case. The patient anticipated getting a 4th booster (unspecified manufacturer) the last week of May2022 or first week of Jun2022. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sometime in December I went to a doctor. The time and date isn't listed in my memory and I hope you can help with finding that. Anyway, I was administered the flu vaccine because the doctor recommended it and from my understanding the doctor is always right because they have a doctorates. But in this case I was wrong; shortly after I was getting the flu vaccine I felt drowsy and faint. The doctor said it will ware off in a matter of days. I had mentioned that I'm currently pregnant and all the prescriptions I was taking which are many. They include, prenatal vitamins, amplify for schizo affective disorder which I question because all I have is a conversation issue, CLARITIN, a nausea medication as needed, TYLENOL for my frequent headaches, turn and possibly there's more but I just can't think of them now. The doctor had nothing for me to help with all I simply came there for was a annual physical; so she was just trying to make think pregnancy was depressing and kept ramparting on pre/post pardon depression. Even gave me a paper for meeting assuming I'm going to be depressed. Weeks past my symptoms got worse, I lost shortness of breath a lot making it hard to breath, my throat very clogged, my nose picking up strange smells and being clogged plus running at times, face became swollen/puffy, I started to feel more nauseous frequently throughout the entire day, my eyes became more swollen shut, concentration worsen, I yawn entirely too much, I feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, ear ache, spine distinction, hands and feet not functional, I cough a lot and sneeze too much, my headaches became worse and more frequent, appetite closed, my shoulders very sore. I also was administered the whooping cough shot as well so I'm not sure where I can go to report that. But I would like this case to court because I really feel sick. It's been over a month and I haven't improved just for worse. Thanks!!
Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.; No adverse event; Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.), PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In March 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.), PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.).    Concomitant medication was not provided.  It was reported that vaccines were administered on 16-Mar-2023 and 17-Mar-2023. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717104 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2023: Non significant follow up received. On 27-Mar-2023: Live Significant FU : Patient details and lot number added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717104:same reporter
It spiked up my sugar; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 20Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included type 2 diabetes mellitus (patient got rid of type 2) from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient experienced spiked up sugar and patient may had eaten too many carbs. Patient read the vaccine has sugar in it. Why is it in there and how much of it is in the vaccine. The patient underwent lab tests and procedures which included blood glucose: spiked up, glycosylated haemoglobin: 5.7 and glycosylated haemoglobin: its been going up to 150. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Shingles; pretty serious rash at the injection site; few spots of rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFECTION (few spots of rash at the injection site), INJECTION SITE RASH (pretty serious rash at the injection site) and HERPES ZOSTER (Shingles) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced INJECTION SITE INFECTION (few spots of rash at the injection site). On 10-Mar-2021, the patient experienced INJECTION SITE RASH (pretty serious rash at the injection site). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, INJECTION SITE INFECTION (few spots of rash at the injection site), INJECTION SITE RASH (pretty serious rash at the injection site) and HERPES ZOSTER (Shingles) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use the product and the start date of the events, a causal relationship cannot be excluded.
Patient was given Pfizer bivalent vaccine as the first dose in her primary series. no complaints/physical symptoms reported from the patient.
Vaccinia infection due to secondary exposure; It was believed that the vaccinia was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions; Information received on 13DEC2019 from a consumer.  A female patient who experienced "vaccinia infection due to secondary exposure" (PT: Vaccinia virus infection) and "it was believed that the vaccinia was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 (smallpox (vaccinia) vaccine, live) and improper precautions (PT: Exposure to vaccinated person). On 26SEP2019, a 40-year-old male (boy friend of patient) received pre-employment vaccination with ACAM2000. On an unknown date in October 2019, his girlfriend was hospitalized. Unspecified testing revealed that she had vaccinia infection due to secondary exposure. Her symptoms included boils on her face. It was believed that the vaccinia was contracted from the male's recent immunization with ACAM2000 and the boyfriend's failure to take certain precautions for the two week period after being vaccinated. She had recovered from the reported event "Vaccinia infection due to secondary exposure" while the outcome of the event "It was believed that the vaccinia was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions" was unknown.  Company Comment: It was believed that the vaccinia infection was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions (Vaccinia virus infection, exposure to vaccinated person). The patient was hospitalized for Vaccinia virus infection and was recovered form the event. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection to household members and close contacts by accidental (contact) inoculation, and the causality of vaccinia virus infection and exposure to vaccinated person is assessed as possible. The case is considered serious due to the medical significance of the Vaccinia virus infection which led to the hospitalization of the patient. Vaccinia virus infection and exposure to vaccinated person is listed as per Agency.; Sender's Comments: It was believed that the vaccinia infection was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions (Vaccinia virus infection, exposure to vaccinated person). The patient was hospitalized for Vaccinia virus infection and was recovered form the event. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection to household members and close contacts by accidental (contact) inoculation, and the causality of vaccinia virus infection and exposure to vaccinated person is assessed as possible. The case is considered serious due to the medical significance of the Vaccinia virus infection which led to the hospitalization of the patient. Vaccinia virus infection and exposure to vaccinated person is listed as per Agency.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided by the reporter.
Plaque psoriasis flare up; Swelling in lymph nodes; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis flare up), LYMPHADENOPATHY (Swelling in lymph nodes), CHILLS (Chills) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second 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 PSORIASIS (Plaque psoriasis flare up), LYMPHADENOPATHY (Swelling in lymph nodes), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PSORIASIS (Plaque psoriasis flare up) outcome was unknown and LYMPHADENOPATHY (Swelling in lymph nodes), CHILLS (Chills) and PYREXIA (Fever) was resolving.            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. No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Humira daily dose was citrate free.   This case was linked to MOD-2021-623542 (Patient Link).
18MAR92 fever reached 104.2; fever had been up & down all noc & mom states unable to keep it down well; pt had sz when temp was around 104; no hx sx; taken to ER; denies further problems in pt;
10/16/14 at 13:25 - Patient received influenza vaccine. 10/16/14 at 16:30 - Dizziness, unable to stand or walk. 10/16/14 at 18:30 - Vomited x 1. 10/16/14 at 20:00 - Symptoms resolved without intervention. 10/21/14 at 14:45 - Adverse reaction reported to provider.
About 3 hours after administration of 3 shots, PT got seizure and fainted. 911 came and checked blood pressure which was in normal range. He was very feeble and couldn't open the eyes. They took him to hospital upon PT's request.
This case was reported by a nurse via call center representative and described the occurrence of eye irritation in a female patient who received HAVRIX pediatric (batch number 002717?, expiry date 2nd JUNE 2017). On an unknown date, the patient received HAVRIX pediatric .5ml. On an unknown date, immediately after receiving HAVRIX pediatric, the patient experienced eye irritation and inadvertent exposure to vaccine. On an unknown date, the outcome of the irritation was recovering/resolving and the outcome of the inadvertent exposure to vaccine was unknown. The reporter considered the eye irritation to be related to HAVRIX pediatric. Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated that while administering HAVRIX pediatric to the infant patient, the patient moved and some of the vaccine squirted into the patient's mother's eye. This led to accidental exposure to vaccine and the patient's mother experienced eye irritation. The reporter would like safety information for the patient's mother. The reporter would also like revaccination information for the infant patient. This case has been linked with the case US2016GSK127686 reported by the same reporter.
Since vaccine, my periods have become worse. Heavy bleeding for days at a time. Using multiple boxes  Prior to the vaccine my period would be 4 days average with the heaviest day being day number 2.  By day 4 the cycle was over. Now my cycle is 8 days  with 5 days using anywhere up to 24 over night pads during a an 8 hour work shiftpads a day. I realize that I?m at an age nearing menopause (for my families female members)   Just know that this iwill affect teenage girls. This is affecting the quality of my work every hour I spend 5-10 minutes in the bathroom.