chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HAD A BLOOD CLOT; This spontaneous report received from a patient through social media (J&J Corporate) and via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient developed a blood clot, and had stents in legs. It was reported that "Took the j & j now have stents in my legs, had a blood clot, hubby had Sepsis and passed away. I trusted J because they had been around forever and should know what they are doing". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had a blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221222577.; Sender's Comments: V0: 20221222579- had a blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sore throat on 10/19 in the AM - no treatment. Headache and neck pain starting on 10/21. Severe headache, neck pain, and fever on 10/22.  Went to doctor on 10/22.  Doctor sent patient to ER.  CT scan, blood work, and lumbar puncture done in ER.  Given MS 6 mg, Zofran 4 mg X 2, Phenergan 25 mg, 2 gm Rocephin; all IV. Headache and neck pain continued for next 3 days.  CBC done on 10/26.  Patient returned to ER because of severe head ache. Blood patch to lumbar puncture site was done on 10/26 to correct leaking spinal fluid from lumbar puncture.  Patient's headache was still present but pain was much less.  Patient said symptoms subsided completely on 10/29.
Information has been received from a physician concerning a 4 year old female who on 13-JUL-2007 was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process).  Concomitant therapy that same day included diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV), hepatitis A virus vaccine (unspecified and tuberculin purified protein derivative.  On 14-JUL-2007, the patient developed swelling of her left arm at the injection site.  The physician stated "it was normal swelling".  The patient was given "additional medication" on the same day.  Unspecified medical attention was sought.  There was no product quality complaint.
very itchy; hives, in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy) and VACCINATION SITE URTICARIA (hives, in the injection arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (very itchy) and VACCINATION SITE URTICARIA (hives, in the injection arm). On 04-Mar-2021, PRURITUS (very itchy) and VACCINATION SITE URTICARIA (hives, in the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information included, Topical histamine was provided.    This case was linked to MOD-2021-036056 (Patient Link).
Threw up about an hour later 2pm.  Threw up 2 more times in about a 3hr. total time frame.  Achy and sore went to bed and slept till 4:30am.  Felt better but still achy with a headache.  Sun. feeling better.
Pt. states that after receiving the 2nd dose Pfizer 08/20/2021, started experiencing symptoms 09/03/2021 of Shingles diagnosed, auxiliary swelling, and missed periods (x2). Primary visit 09/03/2021, recommendation for anti-viral. Still continuing to experience symptoms.
COVID 19 Treatment; COVID 19 Treatment; Moderna: Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in right arm and on 15May2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 74 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301558A), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jun2022 as dose 4 (booster), single (Lot number: 058A22-2A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "high bp" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Sep2015, stop date: 19Jul2023; D3, start date: Mar2017; LUTEIN ZEAXANTHIN, start date: Sep2021; LOSARTAN POTASSIUM, start date: Mar2023; FISH OIL OMEGA 3, start date: Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Jun2022, outcome "unknown", described as "Moderna: Dose Number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid treatment from 19Jul2023 to 24Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300264982 same patient, different drug/event;
Adverse effect: polyuria, Lower Back Pain (LBP), dysuria treatment: Antibiotic Bactrim (SULFAMETHOXAZOLE 800mg, TRIMETHOPRIM 160mg) BID x 7 days Outcome: Asymptomatic
From initial information received on 2/9/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received her first dose of FLUZONE, lot number U1253AA, administered IM in the right arm on an unspecified day in November of 2003. That evening, the patient experienced soreness in her arm, which she described as a consistent ache that is sharp upon movement. Reportedly, the soreness persists. The patient also claimed to have a limited range of motion, but denied numbness or tingling. At the time of vaccination, the patient also took Premarin. Reportedly, the patient did not recover from this event.
Usual pain and soreness at injection site which by 2-26 was unusually itchy with red raised area 1 1/2" x 2"; Usual pain and soreness at injection site which by 2-26 was unusually itchy with red raised area 1 1/2" x 2"; Unusual that right arm started to ache and has continued 24 hrs so far with the center of pain being swollen lymph nodes in the right arm pit; Unusual that right arm started to ache and has continued 24 hrs so far with the center of pain being swollen lymph nodes in the right arm pit; Usual pain and soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6203), via an unspecified route of administration administered in left arm on 24Feb2021 at 11:45 AM (at 63 years old) as single dose for COVID-19 immunization. The patient received the first dose of BNT162B2 (Lot number: EL9275) via an unspecified route of administration administered in right arm on 29Jan2021 at 09:45 AM (at 63 years old) as single dose for COVID-19 immunization. There were no other vaccines administered within 4 weeks. Medical history included Hashimoto's from unspecified date and unknown if ongoing. The patient previously took tetracycline and experienced known allergies: nausea; ceftriaxone sodium/tazobactam sodium (BACTRUM T) and experienced known allergies: nausea, and esomeprazole sodium (NEXIUM) and experienced known allergies: wheezing with swelling in throat. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole, colecalciferol (D3), tocopherol (VITAMIN E), and multivitamin; all from unspecified date for unspecified indication. The patient experienced on 25Feb2021 at 21:00 unusual that right arm started to ache and has continued 24 hrs so far with the center of pain being swollen lymph nodes in the right arm pit and usual pain and soreness at injection site which by on 26Feb2021 was unusually itchy with red raised area 1 1/2" x 2", which were all considered non-serious. It was unknown whether treatment was given for the events. It was unknown if COVID test was done prior to vaccination. No COVID tests done after vaccination. Outcome of all events was unknown.    No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223429 similar report from same reporter
Muscle aches, headache, fatigue, cough, chest pain, vomiting and congestion beginning August 8, 2021
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient fainted immediately after receiving MCV-4 vaccine. Client was laid down to avoid injury and until she responsed. She left the clinic with her mother after a few minutes. Patient notice in the vehicle her ankle was bruised and beginning to swell. Patient continue to feel light headed, dizzy and had a stomach ache. She ate some food when she got home. Her mother took her to the walk-in clinic for her bruised ankle. Patient continued to feel light headed and had a stomach ache.  The doctor at the clinic assessed her throat, heart and ankle (diagnosised as a sprain). He did not feel any allergic reaction had taken place. Patient ate a light dinner, but continued to feel light headed and dizzy when upright. She stayed home from school the following day. Mother reported no fever, no redness at the injection site or hives. Patient returned to school 08/28/13 and felt normal. Mother called the public health clinic on 08/28/13 to report the event. Mother was called on 08/29/13 to follow up on patient's symptoms, which were resolved.
Pt. reports fever like symptoms, injection site rxn, and chills the night after receiving vaccination. The following morning she reports sx resolved.
Lump at injection site; Tiredness; Weakness; Hot spell; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune deficiency syndrome and raynaud's disease.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced injection site lump, tiredness, weakness and hot flashes. On an unknown date, the outcome of the injection site lump, tiredness, weakness and hot flashes were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, tiredness, weakness and hot flashes to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. About 3 weeks prior to the report, the patient received Shinrix and next morning post vaccination, the patient had tiredness, hot spells, weakness and lump at the injection site. The reporter consented to follow up.
Red, warm,  painful area on right leg where he received shots on 04/03/2002. Also has dry skin and a rash that is erythematous, slightly papular. No respiratory distress.
Extreme muscular soreness; Fever of 102; Nausea; Headache; Fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on an unknown date in Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in Mar2021, the day after the second dose only, the patient experienced extreme muscular soreness, fever of 102 (unspecified units), nausea, headache and fatigue. 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 event's extreme muscular soreness, fever of 102 (unspecified units), nausea, headache and fatigue were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 13 Feb 2003, smallpox vaaince administered in L arm - Robust take.  21 Feb pt presented c/o rash on shoulders, chest, neck - painless, nonpuritic, erythematous papules.  2 days later, rash resolved but pt had Bilat inguinal tenderness without LAD.  2 days later, inguinal pain resolved but multiple joint tenderness, stiffness developed - no erythema, swelling, warmth.  2 days later all sx resolved.  Pt never had fever, malaise.
Patient was at facility for physical therapy and experienced temporary blindness in both eyes, but left eye vision returned. Right eye blurry. Spoke with wife and she advised that he go to the hospital from possible stroke. Went to eye specialist and was told that you had a stroke and has a blood clot in right eye - ruling out that it doesn't travel to the brain. Patient went to the hospital right away and was admitted immediately for testing. No slurred speech, no paralysis.
This is a spontaneous report from a contactable pharmacist. A 64 year-old female patient of an unspecified race and ethnicity received a single dose of PREVNAR 13, lot M88543, expiry date Jul2017, NDC 00005197105) intramuscular in the left arm on 06Dec2016 for  immunization.  The patient medical history and concomitant medications were not reported. On 08Dec2016 the patient's arm was red, warm to touch and there was swelling. Redness was about half a cm below the site of vaccination and it continued three or four inches down the arm. The patient went to her allergy specialist and the doctor said it was an infection and prescribed oral antibiotics, a topical antibiotic, and a steroid cream. The allergy doctor wanted to dispense the next dose of pneumococcal 13-val conj vac (dipht crm197 protein)  at the office to see if the reaction was due to the vaccine itself. At the time of this report the patient was not recovered from the reported events, redness and swelling were worsened.
Erythematous rash to upper back, nape, (R) cheek and upper chest approx. two hours after admin. of above named vaccines. No associated breathing difficulty nor body swelling noted. Diphenhydramine 3.125mg P.O. given & infant closely monitored in clinic. Was referred to ER in case of further reaction but was d/ced home.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-JUN-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
anaphylaxis is reported in a pt who recvd flu vax (possibly Fluogen) in OCT93; reporter stated that anaphylactic episode included resp complications; No further details are known;
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/22/2021, 02/19/2021, and 12/15/2021. They tested positive for COVID-19 on 09/14/2022 when they presented to Emergency Department due to shortness of breath, cough, and rhinorrhea. They were admitted to hospital same day. They were found to have an acute kidney injury for which the family refused dialysis. They were also diagnosed with perforated hollow viscus with a leak and acute encephalopathy. Due to poor prognosis, they were transferred to a hospice facility on 09/23/2022 and died in the hospice facility on 09/29/2022.
12-16hr post vax pt exp fever & 30sec sz;pt does have sibling w/sz disorder;pt seen for t101;
observed post Covid-19 immunization for 15 minutes.  During the observation period, he experienced an adverse reaction with the following symptoms:  weakness, feeling drained as he stated.   Assessment : Time of assessment 0938. Alert and oriented. Face flushed, reported being hot. He sat for an additional 15 minutes for observation. He reported that he felt a feeling of being drained, tiredness, no energy about 12 minutes into his 15 minute initial observation. He reports still feeling drained after the additional 15 minute observation. He ambulated well, no obvious problems noted. Actions taken: Vitals sign taken, 0940: BP 137/81 P 77, 0945: BP 144/86 P 76. Medications administered:No medication administered. Disposition: Patient ambulatory out, still reports feeling drained. Advised to call PCP to discuss symptoms and to call 911 if symptoms worsen.
red a little bit; red spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red a little bit) and INJECTION SITE ERYTHEMA (red spot) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (red a little bit) and INJECTION SITE ERYTHEMA (red spot). At the time of the report, ERYTHEMA (red a little bit) and INJECTION SITE ERYTHEMA (red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Vomiting. Pain. Chills. Lethargy. Arm pain, a lot pf pain. Started on Saturday and has gotten better today Tuesday.
Pt recvd 1st dose of Engerix-B on 3MAY91; On 21MAY91 recvd dose of HBIG & clotting factor IX conc; 21MAY91 tested pos for Epstein-Barr virus; Reporter indicated did not think much of event & felt that EBV was probably false pos result;
Resident received bivalent booster. She was currently unvaccinated and had not received the initial series. Resident is stable. No issues noted.
This spontaneous report as received from a nurse concerning unspecified number of patients age and gender not provided. The nurse reported that since 25-SEP-2014 improperly stored ROTATEQ were administered to unspecified patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202; expiry date: not known), via an unspecified route of administration, administered in arm right on 24Feb2021 11:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020 with reported symptoms of bilateral pneumonia, severe headaches, bronchial cough, low grade fever, and body aches. The patient is not pregnant. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); and codeine phosphate, guaifenesin (CODEINE GUAIFENESIN). The patient previously took gabapentine and experienced allergies. No other vaccine received in four weeks. Clinical course was reported as follows: she tested positive for COVID-19 on 21Dec2020 and recovered. She had bilateral pneumonia, severe headaches with bronchial cough, low grade fever and body aches which lasted five weeks. She was fully recovered but had intermittent mild symptoms lingering. On 25Feb2021 08:00, within 24 hours of getting the first vaccine, she developed all these symptoms again, but they were severe again and had to start prescriptions meds again daily to manage them and she still experiencing them now. She was due to have her second vaccine on Wednesday, 17Mar2021 and she was considering postponing it after her primary care (PC) doctor suggested she did so till her symptoms subsided. These adverse events resulted in doctor/other healthcare professional office/clinic visit. The patient had COVID prior vaccination and had not tested post vaccination. The patient had not recovered from all the events.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a consumer (via a specialty pharmacy, additional information from a physician) that described a 53 year old female patient (race not specified) who commenced LETAIRIS 10 mg once daily on 25 March 2009 for idiopathic pulmonary hypertension. Co-suspect medication included influenza vaccine. Concomitant medications reported were TYVASO and ADCIRCA. Medical history was not reported. The patient was hospitalized on 20 September 2013 for severe palpitations (onset date not reported). The patient reported that she thought the palpitations were a reaction to a flu shot. The patient was discharged on 22 September 2013. Ambrisentan was continued. At the time of this report, the outcome of palpitations was reported as unknown. On 11 October 2013, in response to query, the patient's physician confirmed the event of palpitations. The physician assessed the event as not related to ambrisentan. The initial report was received on 26 September 2013.
Developed onset of chills, shaking unable to stop although no seizure activity, taken to ER body temp felt to be below normal 97 felt reaction to immun had fever to 101 in the morning, no other sx fine 24 hours later.