chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hemoperitoneum; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HAEMOPERITONEUM (Hemoperitoneum) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant Medical history Reported).   On 16-Apr-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) at an unspecified dose. On 17-Apr-2021, the patient experienced HAEMOPERITONEUM (Hemoperitoneum) (seriousness criterion hospitalization). The patient was hospitalized on 17-Apr-2021 due to HAEMOPERITONEUM. At the time of the report, HAEMOPERITONEUM (Hemoperitoneum) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On the night of 16-Apr-2021 into the morning of 17-Apr-2021 patient began to experience severe abdominal pain. CT scan was preformed while the patient was in the emergency room and patient was diagnosed with a hemoperitoneum. The nurse practitioner was unsure of where the bleeding is coming from. Nurse practitioner did not have any information on the patient's first dose of the Moderna vaccine. The patient was admitted to the hospital.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications and treatment details were provided.  Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program. The 17-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 16Apr2021, as 1st dose, single for Covid-19 immunization. Medical history and concomitant medications were not reported. On the 21Apr2021, the patient was tested positive for Covid-19. She had finished her 10 days quarantine and was symptom free. The second dose of the vaccine was scheduled on 08May2021. On an un-known date, in May2021, the outcome was recovered from the event of tested positive for Covid-19.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
After receiving second COVID vaccine, pt reported to provider in waiting area that her heart was racing and she had a metallic taste in her mouth. Initial VS 158/96, HR 58; RR 20; O2-98% on RA; after initial VS check pt reports that her heart racing isn't happening anymore. She does report a history of PVCs, and reports taking Metoprolol. After her 30 minute wait time post vaccination, pt denies any abnormal symptoms, and VS are 130/96; manual HR 54; RR 18; pulse ox 97% on RA. Pt allowed via provider to go home at this time, with post care instructions provided by provider in room at this time
Covid Positve; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid Positve) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Covid Positve). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid Positve) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter. .
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 151 of 190 patients described by the reporter.  No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
extreme joint pain; arthritis; destroys your immune system; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2021US142704.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "extreme joint pain"; ARTHRITIS (non-serious), outcome "unknown", described as "arthritis"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "destroys your immune system". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccine expired on 8/31/2022; vaccine admoinistered on 9/2/2022
When patient was having conversations, patient often was drawing a blank; patient was not as sharp mentally; patient was not as sharp mentally, like patient was in a fog; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (patient was not as sharp mentally) in a 41-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.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MENTAL IMPAIRMENT (patient was not as sharp mentally) (seriousness criterion medically significant) and CONFUSIONAL STATE (patient was not as sharp mentally, like patient was in a fog). On an unknown date, the patient experienced LACK OF SPONTANEOUS SPEECH (When patient was having conversations, patient often was drawing a blank). At the time of the report, MENTAL IMPAIRMENT (patient was not as sharp mentally), CONFUSIONAL STATE (patient was not as sharp mentally, like patient was in a fog) and LACK OF SPONTANEOUS SPEECH (When patient was having conversations, patient often was drawing a blank) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    .
pt recv vax DEC95 & exp a red rash on face & neck accompanied by itching;sx resolved;
eyes were showing bright silver snowflakes; severe abdominal pain; diarrhea; vomited3x in 15 min; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 24Feb2021 14:00 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included high blood pressure, kidney stones (controlled), penicillin allergy, allergy to antibiotics, allergy to trees, allergy to grass and sulfa and cataracts and surg to replace retina 6 years ago (as reported). Concomitant medications included simvastatin, metoprolol, amlodipinum, lisinopril and paracetamol (TYLENOL),all  taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 15:00 the patient experienced severe abdominal pain followed by diarrhea and vomited 3x in 15 min. On 26Feb2021 16:30 the patient had eye problem: she was not able to see because her eyes were showing bright silver snowflakes. Lasted about 15 minutes. Tearing and water made it go away. The patient did not received treatment for the other events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The events were resolved on an unspecified date.   No follow-up attempts are possible. No further information is expected.
red dots on Left hand; Rash on left hand; This is a spontaneous report from a contactable Consumer, patient. A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, fatigue, depression, anxiety, tachycardia. Concomitant medication(s) in two weeks included doxepin; famotidine; metformin; oxcarbazepine; venlafaxine. The patient had allergies with compazine, phenergan, morphine, fentanyl. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 17:00, the patient experienced rash on left hand, red dots. The rash is not raised and there is no pain or sensitivity. The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. No follow-up attempts are possible. No further information is expected.
Extreme itching, burning under skin, pins-and-needles, tingling. Painful. Extreme redness when itched or scratched. Diagnosed by allergist/immunologist with dermatographia.   Treatment: prescribed Claritin (double dose)  Outcomes: Condition still ongoing 7 weeks after shot. Claritin alleviates some itching, but not the burning or pins-and-needles sensation.
Patient starting complaining of tightness in the throat. Call 911 and she eventually went home after 30 minmutes saying she was feeling better.
Low fever of 99.8° F, achy body, particularly sore at injection site. Took some aspirin. Fever resolved after 24 hrs. Injection site soreness gone after 3-4 days.
Blood clot in my Gonadal/Renal vein. Hospitalized 1/2/2022 to 1/4/2022. Received Heparin via IV while in hospital. After being discharged I took another blood thinner (Name starts with a Z) for 21 days. Followed by Pradaxa for three months.
The following two days, I had a migraine. I also had swelling and tenderness at the vaccination site for 6 days afterwards.
Swollen upper lip and swollen nose from Moderna booster shot. My previous two doses were from Pfizer and this did not happen.
p/vax pt found to be 4wk preg on 2/8/99;it was reported if deleterious effects unk, would want to abnorm preg;pt took prenatal vitamins during the preg;pt exp bleeding;ultrasound on 3/1/99 indicated embryonic demise;
Congestion like a head cold, raspy throat,  nausea, headache, low grade fever 100. -Tylenol taken for fever
Child experienced a  febrile seizure on 6/2/2023 and was transported by ambulance to ER  Seizure lasted from 2- 5 minutes  Seemed gray  Shaking  T max 100.8 Parients mother concerned this may be a reaction to the vaccines she received on 5/25/2023
That evening on my right calf was red and burning feeling in my calf, It felt like I had a blood clot. Symptoms remain for a week, My docor though it was a side effect of the vaccine.
Pt read through the list of questions and stated "I am short of breath at baseline, I am chronically anemic and tired, and I get sick for like 2 weeks after my flu shot."  She denies having a flu shot over the last few years.  Discussed at length the risks/benefits of vaccine and potential side effects, expected time frame and duration expected.  Pt stated she had Lupus and consented to her first dose.  Pt also stated she had an anaphylactic history to PCN, Amoxicillin, and Sulfa.  Therefore she was instructed to stay for 30 minutes observation.  Approximately 10 minutes post vaccine, pt stated she was "really hot and tired, like she couldn't keep her eyes open."  She was given an ice pack and water.  She denied any difficulty breathing, throat irritation, dizziness, or vision changes.  She initially stated she did not think she could drive home and requested a work note so she did not have to return back to work.  Requested pt have someone pick her up and she refused and stated "she was fine to drive."  Of note, pt carried on an entire conversation for the one hour she was observed in the lobby here Hospital, laughing and acting appropriately.  She denied the need to be seen at Urgent Care by a Provider for her c/o tiredness.   Upon re-evaluation prior to d/c patient, she was asked by this RN, "do you feel you are able to drive home safely?"  She responded with "I don't know, I still feel very tired and having trouble keeping my eyes open and I have not walked around."  Explained to pt that if she was not able to drive home safely she needed to go to Urgent Care here for further monitoring and pt was lead to registration.
This customer called 7/7/10 at 9am.  He stated that he developed a rash 7/6/10 evening.  This occurred after his visit to his Dr. earlier in the day on 7/7/10.  I recommended he call his physician for further advice.  His physician called us around noon on 7/7/10 stating that he had must seen patient again and believes he has shingles.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 04-JUN-2015, the patient was vaccinated with one dose of improperly  stored (Oka/Merck) VARIVAX (dose, route and site of administration were not reported, lot # K008819, expiration date 19-JUN-2016). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
No immediate signs or symptoms but since it was administered outside of FDA approval the patient went to the ER to be evaluated.
bad taste in his mouth; sore throat; This is a spontaneous report received from a contactable consumer. This consumer (Patient Mom) reported for a 24-year-old male patient (Son) that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) dose 2 via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that on 21Apr2021, her son developed a sore throat that evening and the next day, on 22Apr2021, he started to have a bad taste in his mouth. She wanted to know if this side effect was normal. The reporter stated that she took the Moderna vaccine and felt tired and had chills afterwards. The outcome was unknown for both the events.  No follow-up attempts are needed. No further information is expected. Batch/lot number not obtained.
I was sick on the week; This is a spontaneous report from a Pfizer-sponsored program, contactable consumer (patient). A patient of unspecified age and gender received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization .The patient medical history and concomitant medications were not reported.  On an unspecified date the patient stated that i was sick on the week. Patient reported that "Today I was supposed to have the appointment for my second vaccine but I did get, I was sick on the week". The outcome of event was unknown.  Information about batch/lot number has been requested.
Hives. Patient treated with zyrtec and benadryl; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Ew0185) intramuscular in left arm on 06Jun2021 (at the age of 12-years-old) as second dose, single for COVID-19 immunization. Medical history was reported as none. There were no known allergies reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Ew0185) intramuscular in left arm on 16May2021 (at the age of 12-years-old) for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021, the patient experienced hives. Patient was treated with Zyrtec and Benadryl. The outcome of the event was recovered on an unspecified date in Jun2021.  No follow-up attempts are possible. No further information is expected.
20 MINUTES AFTER RECEIVING VACCINE (YELLOW FEVER) SWEATS, ITCHY, RACING HEART, SWOLLEN LIPS & MOUTH
pt has had t101.9 - 104 R fever since 3MAY94 eve x/for this AM; temp of 98 R then back up to 104 this ever 5MAY; pt also appeared disoriented 3MAY eve; mom states pt taken to ER & MD office for eval; no other s/s;
Sensitive to light; Loss of balance; Stomach pain; Lightheaded; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Sep2021 at 14:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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. The patient did not receive any concomitant medications. On 12Sep2021 at 18:00, the patient had been sensitive to light, lightheaded, experienced stomach pain and felt nauseous and loss of balance. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 sensitive to light, lightheaded, stomach pain, nauseous and loss of balance was not resolved at the time of the report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
pt recv vax & w/in 15min had painful rt shoulder & neck;w/in 1/2 hr couldn't move neck-pain in arm & neck cont
Dose 1 at 11Mar2021 and Dose 2 at 25Mar2021; Chills; Fever; Aching legs; sore arm where shot was given; sweating; This is a spontaneous report from a contactable consumer. A-50-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: er8727) via unspecified route of administration in the left arm on 25Mar2021 at 10:45hrs (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies to medications, food or other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6205) via unspecified route of administration in the left arm on 11Mar2021 at 10:30hrs(at the age of 50-years-old) as a single dose for COVID -19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since having the vaccine. The patient received first dose on 11Mar2021 and second dose on 25Mar2021 (inappropriate schedule of vaccine administered). On 26Mar2021, at 02:00, the patient experienced chills, fever, aching legs, sweating and sore arm where shot was given. The patient underwent lab tests and procedures, which included body temperature and the temperature was 99.2 F. Therapeutic measures were taken and included treatment himself with Tylenols . The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the chills, fever, aching legs, sore arm and sweating was recovered on unknown date and of the inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed. No further information is expected.
11/11/09 Am Seizure at daycare. Was transported by EMS to ER. Was evaluated and released. 11/13/2009 Had second seizure at daycare. Taken to ER and evaluated. Had head CT while there. Was sent home on Keppra and scheduled follow up with Neurology.  11/23/09 Medical records received for DOS 11/8/09 and 11/13/09. Final DX: Primary Seizure Disorder Seizure x2. Second occurred on playground. GTC x30 sec. Post ictal x45 min. Incontinent.  Concurrent ear infection, cough. Afebrile. Repeated startle response w/loss of tone in ED. PE WNL. D/C to home w/Diastat. refer to Neuro. : CT head neg. Bld wrk unremarkable. Diags ordered. ICD9 Codes: 780.39.  11/24/09 Medical records received for date 11/8/09.  Neuro consult. DX: epilepsy. Pt seen for 2 episodes of seizure activity. Assessment: WNL.
Information has been received from a physician concerning an infant with a history of vomiting, who was vaccinated with an oral dose of Rotateq.  Upon administration, the patient vomited immediately and received a partial dose.  Medical attention was sought in the physician's office.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.