chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has some little nodules floating around that she can feel; she experienced swollen lymph nodes in her neck. She said they are still swollen, moving a little.; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3248) via an intramuscular route of administration on 25Jan2021 in left arm as single dose for COVID-19 immunization. Previously the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3248) via an intramuscular route of administration on 06Jan2021 at 02:10pm on left arm as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27-Jan-2021 the patient reported that she experienced swollen lymph nodes in her neck. She said they were still swollen, moving a little. Caller wanted to know how long it takes for them to go away. The caller explained that the swelling had improved and was not as bad and not as tender to the touch as it was previously. However, on an unknown date in 2021 she felt nodules all up in there. Her lymph nodes were originally swollen on both sides her neck and now it seems to be swollen on one side, she doesn't really know. Caller made the comment that she wished they would make the Vaccine Record Card fit in a regular wallet. The caller mentions the writing is so tiny and that she needed to get in better light. Callers believed the beginning letter of the Lot number was an E or it could be an F. She thinks it was an E. It was mentioned that the patient did not receive any other products, had no history and no investigation was done, she did not require emergency Room and physician Office visit, no prior vaccinations (within 4 weeks) was done, and no relevant test were done. The outcome of has some little nodules floating around that she can feel was unknown and Swollen lymph nodes was recovering.  Follow-up attempts are completed. No further information is expected.
Patient was given an expired vaccine. MMRV expiration date was 9/1/17 and shot was given 9/8/17. Parents were informed of the expired vaccine. I called parent to have patient get the MMRV in 4weeks for it to be valid. Patient is okay, When talking to parent on Monday 9/11/17 parent stated patient is good.
Systemic: Dizziness / Lightheadness-Severe, Systemic: throat pain but no difficulty breathing-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Additional Details: Patient had me call mother. Patient was responsive, monitored her breathing until her sister arrived 15-20 minutes. Patient stated she has vasovagal syncope & mother advised I not call ambulance. I did not since patient was breathing and was responsive. Gave patient apple juice and held her until sister arrived. She stated she was fine and her sister & I walked her to the car.
Patient states she was experienced some swelling patrolled and feel like she?s gonna pass out. ENS was called, and patient was examined by one of the EMS personnel.
Vomiting, Diarrhea, Chills, Joint pain, Tiredness.
felt cold in the arm that was vaccinated; nervousness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE COLDNESS (felt cold in the arm that was vaccinated) and NERVOUSNESS (nervousness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE COLDNESS (felt cold in the arm that was vaccinated) and NERVOUSNESS (nervousness). At the time of the report, VACCINATION SITE COLDNESS (felt cold in the arm that was vaccinated) and NERVOUSNESS (nervousness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 20Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 13Aug2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 11Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Marginal zone lymphoma" (unspecified if ongoing); "levaquin Allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; NORTRIPTYLINE; LATANOPROST; RHOPRESSA; TIMOLOL. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157708 same reporter/patient, different drug/event;
Had a blood clot in my liver; pinch nerve for 3 months, pinch nerve in my neck and my shoulder; Had a pinch nerve for 3 months, I was in pain every day for 3 months; a pinch nerve in my neck and my shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: THROMBOSIS (hospitalization, medically significant), outcome "recovered", described as "Had a blood clot in my liver"; NERVE COMPRESSION (non-serious), outcome "recovered", described as "pinch nerve for 3 months, pinch nerve in my neck and my shoulder"; NEURALGIA (non-serious), outcome "recovered", described as "Had a pinch nerve for 3 months, I was in pain every day for 3 months; a pinch nerve in my neck and my shoulder". The patient underwent the following laboratory tests and procedures: Blood test: Unknown Result. Therapeutic measures were taken as a result of thrombosis. Clinical course:  Patient was sick. Patient had a pinch nerve for 3 months and was in pain everyday for 3 months for something that has nothing to do with COVID. Patient had a pinch nerve in neck and shoulder so didn't want to deal with it. It was hard time just living life let alone going to work. Patient was normal for past 3 weeks. Patient had encountered blood clots after vaccine shot. Patient stated to check hospital stay and all blood tests that was done. Patient had blood clot in liver and had to take surgery and then cleaning it out and doing some anti blood clot drugs (Treatment) and dissolved it. Patient was not sure of the dates and stated that it was couple months after got the covid shot May and it was in 2019 or 20, Patient was not sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case fully vaccinated with Pfizer vaccine. Tested positive for COVID on 9/15/2021. Admitted to hospital on 8/24/2021. Tested positive for COVID while hospitalized and expired on 9/21/2021.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, 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. On 08-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medications were not reported.  113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as 51 doses from Lot AS7140C and 60 doses from Lot AS7148B.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946:Master case
11 hours after injection got a fever (101 degrees), shivering, muscular aches; I felt like I had the flu; I had to stay in bed all next day.
Left arm upper bruised and painful on 10/21/03. On 10/22/03 developed a hematoma.
A lot of difficulty sleeping with heart palpitations and high levels of anxiety since the vaccine injection. Also having cold sores around my mouth.
She slept all day; pain in all joints,all of the joints hurt; knees hurt like I'm 90; threw up; nausea; debilitating headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept all day), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90) and NAUSEA (nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030BZ1A and 022HPVP;) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (debilitating headache). On an unknown date, the patient experienced HYPERSOMNIA (She slept all day), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90) and VOMITING (threw up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, HYPERSOMNIA (She slept all day), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90), HEADACHE (debilitating headache) and VOMITING (threw up) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-101514 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101514:First dose case
Per parent of patients report: Several days after the vaccine (3-4 days), patient started developing small red bumps on legs, which eventually progressed to palpable bruises. Started having intermittent joint pains and stomach pains. Rash started to improve, then developed cough/cold symptoms, rash and the other above mentioned symptoms recurred again. I saw this patient 3 weeks and 3 days after vaccination, and based on the symptoms and clinical findings of palpable purpura, diagnosed him with Henoch Schonlein Purpura, or IgA vasculitis. He is currently undergoing symptomatic treatment with NSAIDs, fluids, and rest and not yet fully recovered.
Moderna vaccine (HDC 80777-0271-98)  lot #039D21A and GTH 00380777273983  was administered after the beyond date of 10/23/2021.  Contacted manufacturer Moderna = no need to repeat the dose.
admitted for abd pain, upper GI bleed; hypotension; Sent to ICU for COVID PN   -as O2 increased to NRB, then intubation on 2/19. Treat with dexamethasone, given a dose of tocilizumab; pressors.Klebseilla and MSSA PN.  CDIFF and was started and Vanc. (became sepstic due to the Klebsiella, MSSA PN, and CDIFF). Developed DVT, unable to start AC due to severe thrombosytopenia. DEveloped Shock requiring 4 pressors. Eventually developed PEA and arrested.
19DEC91 pt recvd MMR/HIB; 23DEC91 ?febrile seizure w/runny nose; t101.3 R seen @ hosp;
Client reported and I observed her upper left arm with redness and swelling in the same area Varicella vaccine was administered on 4/27/2020.  Client will continue to monitor.  I advised client this needed to be reported.    Client also had a PPD placement on lower left forearm, PPD read on 4/30/2020 before 2:37 pm.
A 41 year old female consumer reported that she received Influenza virus vaccine, Trivalent, Types A and B (2001-2002 formula) (manufacturer unknown) on 23-OCT-2001. Concomitant medication included Zestoctic (manufacturer unknown). On 08-NOV-2001, she developed numbness in her toes and finger, the middle of her back and the tip of her tongue. She also experienced "excruciating" pain. On 23-NOV-2001, she was hospitalized. Laboratory tests included EMG, MRI and spinal taps (results not reported). The reporter noted that Guillian Barre was ruled out. On 27-NOV-2001, she was discharged without a diagnosis. She is scheduled to see a Neurologist. No additional information was available as of the date of this report. Follow up info received 12/31/01. Lab test results were reported. Nuclear magnetic resonance imaging results reported aas "lesion in T-spinal cord." Lumbar puncture results reported increased protein. Electromyogram results were "consistent with peripheral neuropathy."
Headache, chills, fatigue, body ache. Red itchy arm at vaccination site.
Chest felt tight; Eyes were prickly; Cough; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) had a cough, her chest felt tight (chest discomfort) and eyes were prickly (eye pruritus), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient had a cough, her chest felt tight (chest discomfort) and eyes were prickly (eye pruritus) (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
11/06/22 presents to ED for "fall". PMHx of "HTN, DM, A. fib on coumadin, CAD status post stenting, and hyperlipidemia"
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml, single on unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tremendous pain at the injection site, flu like reaction, achiness, fever, feeling sick. The outcome of the events was unknown. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
10/15/2010 @ 1525 Pt reports quarter sized red, raised lump at site. Pain at injection site and nausea.
Parent/Guardian brought minor child to our covid-19 vaccination clinic.   Completed vaccine administration form using birthdate of 09/15/2008.  On 10/07/2021 we were informed that child's actual birthdate is 09/15/2009
2/19/21 - 2/20/21 Chills & achy; 2/21/21 Severe joint pain continuing to present
Headache, Arthralgia, Fever, NauseaVomiting, FATIGUE, CHILLS, PAIN.SWELLING INJ SITE,  Narrative:
she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis; Still having problems with left arm it still burns, itches, and still has a throbbing pain; Still having problems with left arm it still burns, itches, and still has a throbbing pain; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number), via an unspecified route of administration, on 09Apr2021 (at the age of 73 years-old) as a single dose for COVID-19 immunization. Historical vaccine information included bnt162b2 (COMIRNATY), 1st dose on an unspecified date and no adverse reaction. The medical history included: acid reflux. Concomitant medications were not reported. She says that she is a healthy person and does exercise, has no weight problems, nothing but acid reflux. The patient reported that she got the second on Friday at 1 pm and now she have her arm completely swollen to the elbow and it is red with a circle around the injection site. She says that she even developed cellulitis and she is not happy about this. Her left arm was on fire, burned, very swollen from the site all the way down to the elbow. That went away, the swelling finally started to go down Tuesday of last week but she is still having problems with left arm it still burns, itches, and still has a throbbing pain.  She has been in the ER twice already and they told her that if the circle around the injection site gets bigger she would need an IV. She has been to the ER 3 days later twice at two different locations.  Caller states she is still having difficulty after getting her second Pfizer shot. She contacted her doctor to let them know because she wants them to document everything. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 73 year old male patient with diabetes and no known drug reactions/allergies who on approximately 12-JUN-2009 or 13-JUN-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included ZETIA, folic acid and propranolol HCl. After vaccination on 16-JUN-2009 the patient saw his primary care physician because he was experiencing a tingling sensation in his left leg. A couple of days later, the patient developed some blisters. On 20-JUN-2009 the patient went to the emergency room and was diagnosed with shingles. The patient was given VICODIN, acyclovir and prednisone for treatment and was able to leave that day. On 08-JUL-2009 the patient was seen by the doctor because he was experiencing severe muscle weakness in his left leg and he was dragging it. It was reported that at the time of the report, "the patient was recovering but was doing physical therapy for his leg". The patient had unspecified "lab test" performed. The shingles and severe muscle weakness were considered to be disabling by the reporter. Additional information has been requested.
BLURRY VISION; RINGING IN BOTH EARS START IN ONE AND SWITCHES TO OTHER EAR; This spontaneous report received from a patient via a company representative concerned a 59 year old female. 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 not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced blurry vision, and ringing in both ears start in one and switches to other ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurry vision, and ringing in both ears start in one and switches to other ear. This report was non-serious.
1.5 inch and growing raised, hot, red bump on child's arm where shot was administered.
lips burning; red face; increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (lips burning), ERYTHEMA (red face) and BLOOD PRESSURE INCREASED (increased blood pressure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.  On 24-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 ORAL DISCOMFORT (lips burning), ERYTHEMA (red face) and BLOOD PRESSURE INCREASED (increased blood pressure). On 24-Feb-2021, ERYTHEMA (red face) and BLOOD PRESSURE INCREASED (increased blood pressure) had resolved. At the time of the report, ORAL DISCOMFORT (lips burning) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
After injection patient went to waiting room with mother for 15 minutes. Within 5 minutes he began seizing, He stiffened and hit his head on a shelf behind him. Pharmacist called over and did witness second (or continued) seizure. Mom and I held him steady until done. Patient breathing fine and responsive after seizure though not wanting to move. Called 911, stayed with him until paramedics arrived. He was talking to us, though very pale and weak. Refused to lie down. Paramedics transferred the patient to the hospital for further evaluation and treatment.
almost really killed her after taking the shot of the booster shot of the Pfizer (Unspecified Vaccine); nearly died after getting the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: The caller would like to report that his wife who has Lupus. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 Immunization. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost really killed her after taking the shot of the booster shot of the Pfizer (Unspecified Vaccine); nearly died after getting the shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.