chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 9:30/10 p.m i started getting a lot of nausea; I started getting a lot of nausea and threw up a lot; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis and aortic aneurysm repair. The patient received unspecified medication within 2 weeks of vaccination (also reported as not enough room) from an unknown date for unknown indication and unknown if ongoing. The patient previously took doxycycline (DOXICYCLINE) and tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 around 21:30/ 22:00, the patient started getting a lot of nausea and threw up a lot and had diarrhea. He only threw up on friday night, but since then he had constant diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, around 9:30/10 pm started getting a lot of nausea was not recovered. The clinical outcome of the event started getting a lot of nausea and threw up a lot was recovered on 05Mar2021.  No follow-up attempts are needed. No further information is expected.
patient received his first pre-exposure prophylactic immunization with Imovax 53 days ago; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patients past medical history, concomitant medication and family history were not provided.   On 26-Feb-2019, the patient received a 0.5ml dose of suspect RABIES (HDC) VACCINE lot N1L132M, expiry date 26-Feb-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to Inappropriate schedule of vaccine administered.  It was reported that patient received his first pre-exposure prophylactic immunization with Imovax 53 days ago.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  List of documents held by sender- none.
Administrative nurse by rural health nurse stated patient returned to clinic 6 days s/p Shingrix: patient requested to speak to me about a rash she developed over her left deltoid, felt related to Zoster vaccine, shown to dr. agrees, will take otc Benadryl. chart flagged
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 5-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# not reported), 0.5 ml, intramuscular. On 05-JUL-2013, the patient had a red spot, swelling and pain at the area. The patient sought medical attention via office visit. No treatment was given for the adverse events. At the time of the report, the outcome of the events were reported as not recovered. Additional information has been requested.
No adverse event; The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     The patient was not diagnosed with or tested positive for COVID-19. The patient not had acute illness at the time of vaccination and up to one month before.     On 25-Aug-2023 at 9:42 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-Aug-2023 at 9:42 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023) 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 EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 13-Jun-2023 and was administered on 25-Aug-2023).    No concomitant medications were reported.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-739012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739012:Same reporter (Patient initial -G-L Gender- Female)
pt had his arm was still sore 28 days after first shot. he said it was sore in the am after getting up but loosened up later. he has a phone call into dr. he is able to use arm
@15 days of age, pt exp sz; ICU;sz difficult to tx; vasospasm of middle cerebral arteries led to bilat parieto-occipital infarctions;encephalomalacia; cortically blind;given phenobarb IV w/cessation of episodes then recurred;
Localized swelling, induration, and pain started two days after the injection and has persistent until appointment today (3/14/19).  t also has fevers but unclear if related to adult still's disease or vaccine reaction.
Left - swollen to twice the size of right upper extremity, red from shoulder to elbow, area of injection is draining serous fluids. Patient started on Cephalexin and Sulfamethoxazole-trimethoprim. This patient was a new patient to us on 4-4-16.
COVID breadthrough first vax 1/12/2021 .  87-year-old female admitted from  rehab seen by MD at the Health Center for hypotension and generalized fatigue and tiredness.  Initially the plan was to have her go to the emergency room and be placed in outpatient observation for IV regeneron infusion however, she started having hypoxia in the emergency room and therefore she was placed in inpatient unit.
Spontaneous splenic hemorrhage and rupture; Spontaneous splenic hemorrhage and rupture; A spontaneous report was received from a consumer who is  a 40-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a spontaneous splenic hemorrhage and rupture.   The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 16 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:013L20A) for prophylaxis of COVID-19 infection.    On 19 Jan 2021, at approximately 8 am, the patient suffered a spontaneous splenic hemorrhage and rupture. He went to the hospital and was admitted.   On 21 Jan 2021, a splenectomy was performed.    On 22 Jan 2021, he was discharged from the hospital after four days. Pathology was performed on the ruptured spleen and nothing pathological was found. All blood tests and virus tests came back negative. Cause of spleen hemorrhage and rupture was unknown.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events spontaneous splenic hemorrhage and rupture was unknown.; Reporter's Comments: This case concerns a 40-year-old male subject, who experienced serious unexpected event of Splenic hemorrhage and splenic rupture. The events occurred 3 days after the first dose of the mRNA-1273 (Lot number:013L20A) administration. Cause of events were unknown. Very limited information regarding these events have been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
It started feeling like a sinus problem under my eye. I started feeling really lousy really quickly with low grade fever. I felt like I was getting a cold or sinus infection. I took a home COVID-19 test and it was positive. I had taken some TYLENOL. During the night I began sneezing, fever 103 degrees, congestion, I wasn't hungry but drank a lot of water. The next morning I took another COVID-19 test and it was still positive. I was still taking some TYLENOL. The NP told me to take some mucous thinner over the counter medicine and she called me in some PAXLOVID which I took for 5 days. It took at least 2 days for me to start having any energy, and sinus congestion was getting better. I started sleeping during the night and kept taking MUCINEX before the congestion started to go away. I didn't have any rebound. This weekend I started feeling better now.
patient was fully vaccinated in terms of DTAP, he only needed a dose of IPOL,with no reported adverse event; Initial informationreceived on 08-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional (HCP) via call center.  This case involves a 9 years old male patient who was fully vaccinated in terms of DTAP (Diphtheria Tetanus AC Pertussis), he only needed a dose of IPOL (Poliovirus Vaccine Inactivated), with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine for Immunisation.  On 01-Mar-2022, the patient received a 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 HYBRID AC Pertussis/ipv (MRC5) Vaccine (formulation and Strength: Unknown) (lot C5862BA, expiry date: unknown) via intramuscular route in the left arm.  On 01-MAR-2022 the patient received a dose of quadracel despite being fully vaccinated in terms of DTAP with no reported adverse event,he only needed a dose of IPOL (wrong product administered) (latency: same day) following the administration of Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event.    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.
Pain at injection site morning after vaccine. Pain progressed to severe pain at injection site and pain radiating down left leg.  Severe flu like symptoms lasting approximately one week.  Lingering pain in arm and leg for 2 weeks. Patient dealt with symptoms at home.
At 18-20 minutes after vaccination, patient developed full body itching, facial flushing, increased throat clearing, injected sclera, and water eyes. Patient given 10 ml of CLARITIN. Symptoms resolved after 90 mins.
Red rash, left arm, itchy morning after shot. Pt took ALLEGRA as usual.
Vaccination site pain; Fever 99.9; Chills; Headache; Muscle aches of the whole body; Tiredness,; Feeling dehydrated; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 12:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. Concomitant medications included ADULT MULTIVITAMIN, calcium (MANUFACTURER UNKNOWN) supplements, glucosamine, chondroitin sulfate (GLUCOSAMINE CHONDROITIN) all from unknown dates, for unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 17Mar2021 at 12:15 as a single dose for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 00:00, the patient experienced soreness at injection site/arm, fever 99.9, chills, headache, muscle aches of the whole body, tiredness, feeling dehydrated despite drinking lots of water. On 08Apr2021, the patient body temperature was measured and the result was 99.9 (Units not reported). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event soreness at injection site/arm, fever 99.9, chills, headache, muscle aches of the whole body, tiredness, feeling dehydrated was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient said she started with a fever and shaking around 7pm on 9/25/17 (the same day she received the vaccines). The fever and shaking lasted 2 days. On 9/28/17 she came to the pharmacy and she had a red welt like soreness on her arm. She said it was itchy, but slowly getting better. I suggested a cool wet washcloth and light application of hydrocortisone cream.
Symptoms: short of breath & heart palpitations after very little exertion, occasional dizziness or light-headedness. Treatments:  (cardiologist) states he will try to get me into the heart rehab facility for monitored exercise. I am thinking I may need to get my lungs checked.
severe rash and hives over entire body; severe rash and hives over entire body; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 09:30 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were reported as eliquis 5mg, venlafaxine 150mg, atorvastatin 10mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that on 22Jan2021 at 11:00 PM patient experienced severe rash and hives over entire body.Patient received the treatment with zyrtec, prednisone, benadryl, hydrocortisone. Outcome of all the events were recovering.
Follow-up information received from the physician on 07-Aug-2003 provided additional patient demographics, birth date, vaccination date, vaccine lot number, vaccines given within four weeks, medical history (negative), and culture results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 10-month-old male patient who developed "strep pneumo meningitis." At 7 moths of age, the patient received the first dose on 11-Mar-2003. Medical History: patient had no relevant medical history. Product Details: Indication for Prevnar was immunization. Product was administered on 11-Mar-2003. Dose regimen was one dose. Concomitant Therapy: The patient was receiving concomitant mediation. Event Details: The patient experienced "strep pneumo meningitis" (meningitis pneumococcal) (drug ineffective) on 13-June-2003, and was subsequently hospitalized in the pediatric intensive care unit for 15 days duration. Treatment medications included unspecified antibiotics. He recovered. The physician indicated that she did not consider this an adverse event because the infant only received one dose of Prevnar.  Test Results: CSF culture (results: positive, S. pneumoniae isolated) and blood culture (results: Postive, S. pneumoniae isolated.) were done on an unspecified date.
Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided.  No concomitant medications were reported. No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the event acausal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received contains  patient demographics, suspect drug start date were  updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event acausal relationship cannot be excluded.
Pt experienced inflammation in the left arm over the injection site, muscle ache and a temperature of 102F.  Days later the pt experienced a knot under her arm the size of a small egg and subsequently tender nodes began to develop in other places with a fever of 103F. One week post vax pt went to the ER and was diagnosed with an allergic reaction to the vaccine and left axillary lymphadenopathy. Pt also experienced headache and occasional fever. On 09/18 the pt was diagnosed with rubella in the ER. Pt continued to experience fatigue, achiness and swelling in the arm.  Pt hurt all over and still had knots in the lymph glands. Pt experienced swelling all over, weakness, fever, neck pain, and chest pain.
Patient returned to phcy 2 days and post administration of Zostavax to ask if reaction at site of injection was OK. The red patch was about the size of a silver dollar, it itches, and is warm to the touch but no blistering was observed, she was concerned increased to about 2 inches across and was worried.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BLOOD POOLING IN HALF OF THE LEFT EYE/LEFT EYE BLOODSHOT; This spontaneous report received from a patient concerned a 55 year old female.  The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series was 1) (suspension for injection, route of admin, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered 1 in total on 03- MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered 1 in total on 26-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced blood was pooling in half of the left eye/left eye bloodshot and cleared after 4 days. The patient visited optometrist on 06-DEC-2021 and stated that there was no residual effects (dose number in series was 2). On 21-DEC-2021, the patient experienced sneezing, on 22-DEC-2021,the patient experienced runny nose, on 23-DEC-2021, the patient experienced nasal congestion, and tested positive for COVID-19 (COVID-19 virus test) ( confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pooling in half of the left eye/left eye bloodshot on 01-DEC-2021, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000208634.; Sender's Comments: V0: 20211254348-COVID-19 VACCINE AD26.COV2.S- Blood pooling in half of the left eye. 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). 20211254348-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS