chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Aches; This is a spontaneous report from a non-contactable consumer. An 18-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Apr2021, the patient experienced fever, chills and aches. 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 fever, chills and aches were resolved on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
positive for covid; positive for covid; My daughter lives with me so she may have gotten it from me; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a 17-year-old female patient received a first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 21Mar2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that, his daughter was positive for COVID. On 6Apr2021 his daughter tested negative. The reporter travelled outside the country so he may have gotten COVID because of that his daughter lives with him so she may have gotten it from the reporter. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient describes itching and rash on back (in a few spots). Rash is not reported at site of injection. Patient is applying topical cortisone and advised to consider Benadryl..caution drowsiness.
No adverse event; 1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023 at 9:10 AM, 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 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.) 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 (1 dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD/The dose was administered past the 12-hour vial puncture.).    No concomitant medications were reported. It was reported that one dose of Moderna Covid-19 Vaccine, Bivalent was administered BUD. The dose was administered past the 12-hour vial puncture. The vial was first punctured on 13-Feb-2023 at 2pm and the dose was given on 14-Feb-2023 at 9:10am. The vaccine was in the fridge the whole time and was not exposed to room temperature for greater than 24 hours. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2023: Live Significant Follow-up appended: Start date of the suspect product, Event verbatim updated and  Narrative updated.
Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time.  He was lifted back to bed and was reportioned several times because he could not get comfortable.  She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color.  She called "911" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead.  She states sx started at about 4pm and he was pronounced dead at about 5pm.  Medical examiner determined a heart attack cause of death.  The family not sure that the vaccination had anything to do with death but wanted it to be reported.
Client vaccinated with Moderna vaccines x 2 in February 2021.  Not boosted.  Symptoms started on 12/28 - fatigue, nasal congestion.  Exposed on 12/25.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 22-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002944: US-009507513-2104USA002963: US-009507513-2104USA002970: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002981: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002976: US-009507513-2104USA002975: US-009507513-2104USA002974: US-009507513-2104USA002973: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Body sweat; Nausea; Chills; Body ache; Tired; Fever (no temperature given); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Body sweat), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C2621A and C47B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included OXCARBAZEPINE (OXTELLAR XR) for Seizure.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced HYPERHIDROSIS (Body sweat), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (Body ache), FATIGUE (Tired) and PYREXIA (Fever (no temperature given)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Body sweat), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (Tired) had not resolved and PYREXIA (Fever (no temperature given)) had resolved.            This case was linked to MOD-2021-162358 (Patient Link).
Severe nausea,  oral thrush for 6 weeks after 2nd dose.  Went to Emergency Room.  Also went to Gastroenterology they did endoscopy. Was prescribed Promethazine, Zofran and Oral Nystatin. Took Nystatin for over a month and they other 2 medications for almost 2 months.
Patient was given vaccine on friday, one week later she passed away. The family called the pharmacy to inform us on Saturday, Feb 20, 2021. After the phone call was over, we saw in her pharmacy profile that she had received the vaccine one week prior
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient was partially vaccinated and did not complete vaccination schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
I got the vaccine, and a few days later, I developed shingles. This started 4 weeks ago, and I'm still experiencing the symptoms. I informed my doctor who prescribed me famciclovir, a 7-day treatment for my symptoms. Currently, I still have pain from the shingles and that's the only residual thing I have right now.
hx of prostate and pancreatic cancer; 3 days ago had chemotherapy treatment; within 24 hrs after chemo, pt began to experience fever, fatigue, cough and SOB; presented to ED with SOB; chest x-ray showed severe diffuse bilateral asymmetric infiltrates; positive for COVID-19; pt was a DNR/DNI; placed on BIPAP; condition worsened and pt died in the hospital; Acute Respiratory Failure with Hypoxemia; pneumonia due to COVID-19
FEVER OF 103; FEELING COLD; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On 12-MAR-2021 22:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced fever of 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 103, headache and feeling cold was not reported. This report was non-serious.
FEVER, CHILLS, JOINT PAIN, MUSCLE ACHES. COUGHING, SNEEZING AND OTHER RESPIRATORY ISSUES. AS AT 10/23/2017 PATIENT STILL HAD SYMPTOMS.
Urinary tract infection after the 1st vaccine; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, Lot# unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. On an unspecified date patient experienced urinary tract infection after the 1st vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EW0164; expiry date not reported), at the age of 69, via an unspecified route of administration, right arm right, Apr 27, 2021, 13:45, single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease and paroxysmal supraventricular tachycardia (PSVT) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol taken for PSVT, start and stop date not reported. On Apr 27, 2021, patient experienced onset of symptoms. During administration of the shot, patient's heart rate went from 96 and dropped to 70. Patient raised her hand and nurse came over. She said her pulse rate was 70 and saw a bit lower 68. Reportedly, patient had headache, nausea and felt unwell  about 10 min into the vaccine. Exactly 4 hours, patient had a rapid heart rate, which sent her into a tachycardia episode. It was suggested she not take ibuprofen, if possible, to try and endure, otherwise it would stop the effectiveness of the vaccine. So patient did not receive any treatment. Outcome of the events: unknown. No follow-up attempts needed. No further information expected.
A few hours after vaccination c/o nausea and fever. Left work early. Later noted red arm from injection site down to forearm. At 2am 11/30/11 c/o increased heart rate (30bpm), blurry vision and persisting fever & nausea. Called her primary MD at the time but felt better later. No MD visit.
Pt vaccinated with DTP/OPV immediately after vaccine administration, pt had a fever of 100 & was fussy. 17AUG90 pt started having seizures, dx as idiopahtic complex focal seizures. Seizures evolved & dx as having infantile spasms.
I woke up at 3:30am, approximately 12 hours after receiving my second dose, with chills and a fever of 99.1. It kept me up for two hours, then I fell asleep again. When I woke up again at 7:45am I had a fever of 101.0, chills, body aches, swollen painful lymph nodes in my armpits, and a headache. These symptoms have not gone away all day (I am reporting at 4:33pm) and I?ve taken 1000mg of Tylenol twice. It hasn?t touched the fever, body aches, lymph nodes, or headache
PT was administered Pfizer  monovalent as a 2 booster , according to CDC  pt need to get PfizerBivalent , Will follow up in to months to re-vaccination ,
Patient arm felt itchy after vaccination and noticed small area of redness at injection site. This AM redness developed into a 2 1/4 wide x 1.5 L erythematous, tender, raised area at injection site and pain with moving arm. Treated for suspected cellulitis with cephalexin 500 mg BID x 7 days. Ibuprofen for pain.  advised to apply topical hydrocortisone cream for itchiness -prescribed on 6/22/23
pt reported swollen & sore neck, h/a, earache, fatigue & T100-101;
She went to see her doctor who prescribed her prednisone tablets for her knee; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unknown date in 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that She went to see her doctor who prescribed her prednisone tablets for her knee. She has taken 1 dose. she got the Pfizer COVID-19 vaccine first dose two weeks ago and she just went to the doctor who prescribed her Prednisone. Sher says she would like to know, will that mess with the vaccine in her body? She says she only took one dose of it, could it do anything to her? She says that she heard it can take away if take steroids, that it can downplay vaccine. Caller would like to know if prednisone PO would interfere with the Pfizer COVID-19 vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Rash on side of abdomen, consistent with herpes zoster.   Treated with valacyclovir and resolved after 2 weeks.
This spontaneous report was received from an unspecified reporter  concerning a less than 30.000 patients of unknown ages and genders. The patients' concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On unknown dates, the patients were vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates, the patients had complications (adverse event), most of the complications were minor.  At the time of reporting, the outcome of adverse event was not reported. The causal relationship between the event and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) was not reported.  Additional information is not expected as there is no consent to contact the reporter. The correct Initial Receipt Date is 27-MAR-2017 and not 28-MAR-2017 as previously reported. Due to a technical limitation in which the system does not allow to distribute a case with an initial aware date that is earlier to the one previously entered, the safety report is US-009507513-1704USA001016 being deleted from our files and all the information is being captured under this new case US-009507513-1704USA001620. This is an amended report, as corrected. The Initial Receipt Date was changed from 28-MAR-2017 to 27-MAR-2017.; Sender's Comments: US-009507513-1702USA010584: US-009507513-1704USA000707: US-009507513-1704USA000702: US-009507513-1704USA000708: US-009507513-1704USA000709:
Seen 2 months after 2nd HPV for migraines; on second visit for migraines was referred to neurology; seen 3 months later for malar rash, joint pain and swelling and syncope.
SHINGLES OUTBREAK VERIFIED BY NURSE PRACTITIONER ON 5/21/18. NOTED THAT PATIENT HAD AN ELECTROSTIMULATOR PROCEDURE DONE ON SAME DAY AS VACCINATION OCCURRED.
he had a bump that was about size of a golf ball,It went away completely after about 3 days. Now 4 days later, it came back. It's not as hard as before. The bump is at the injection site; He had a left sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a left sore arm.) and VACCINATION SITE MASS (he had a bump that was about size of a golf ball,It went away completely after about 3 days. Now 4 days later, it came back. It's not as hard as before. The bump is at the injection site) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced PAIN IN EXTREMITY (He had a left sore arm.). On 15-Aug-2021, the patient experienced VACCINATION SITE MASS (he had a bump that was about size of a golf ball,It went away completely after about 3 days. Now 4 days later, it came back. It's not as hard as before. The bump is at the injection site). At the time of the report, PAIN IN EXTREMITY (He had a left sore arm.) outcome was unknown and VACCINATION SITE MASS (he had a bump that was about size of a golf ball,It went away completely after about 3 days. Now 4 days later, it came back. It's not as hard as before. The bump is at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.
Admitted with aeseptic meningoencephalitis without any other known cause.  Had some low grade fever for 24 hours s/p 2nd vax. Found by husband aphasic/lethargic/unwell 6 days later, brought to ER.  LP was mildly abnormal; had MRI which showed an incidental anterior cerebral artery aneurysm but nothing else of note.  No high fevers.  She did receive <24 hours of IV acyclovir but really improved rapidly, however still has significant altered mental status; HSV PCR neg, enterovirus PCR neg, cultures neg; Lyme serology neg.   She does in home child care and a couple of children had HFMD/coxsackie virus.
Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el0142), via an unspecified route of administration on left arm on 20Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included solifenacin succinate (VESICARE), dl-alpha tocopheryl acetate (VITAMIN E), omeprazole and Multivitamin. The patient previously received her firs dose of BNT162B2 at 11:00 AM on 02Jan2021 intramuscularly on left arm for Covid-19 immunization. The patient experienced headache, body aches, joint pain, chills and fatigue on 21Jan2021 05:00 AM. The events were reported as non-serious. The patient did not receive any treatment from events. The outcome of events was not recovered.