chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient in office for appointment on 10/25/2022. Patient consented to getting the Moderna Bivalent Booster in office. Due to a failure of vaccine syringe, more than half of the Bivalent dose leaked out of syringe during administration. Patient received less than half the recommended dose of the vaccine.  Following last updated on October 19th, 2022-- > Full dosage of Moderna Bivalent was re-administered. Prior to re-administration, patient was counselled regarding the administration error & the recommendation of re-administering the full dose. Patient given the opportunity to decline re-administration. Patient consented to having the full dose of Moderna Bivalent re-administered.
had pfizer booster . severe side effects (fever, muscle aches) and additionally increased appetite. it would help if these side effects were completely listed for the public
LEFT DELTOID ERYTHEMA/ TENDERNESS/ INDURATION, ONSET WITHIN 24-36 HOURS OF VACCINE, TREATED EMPIRICALLY WITH TMP-SMX FOR SUSPECTED CELLULITIS
pt had febrile illness beginning 11 days p/vax characterized by t103 & erythematous maculapapular rash on trunk & proximal area of limbs;case of measles from MMR vax;
Slight dizziness Tuesday night, but full blown all day Wednesday and was nauseous if moved to fast or bent over. Injection sight had swelling and was red. Extremely tired. Put cool compress on injection sight and took Tylenol. Dizziness mostly gone by Thursday mid morning and completely gone by Friday evening.
He felt like he was getting Covid again; A slight fever; Stomach was bothering him; Appetite wasn't there; mental trauma; after receiving the vaccine it went into his hips; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included hip problems (bone on bone on both hips-scheduled surgery for 11June2021), pulmonary embolism from Feb2021 to an unknown date (hospitalized for three days due to a pulmonary embolism) ,Covid-19 from Feb2021 to an unknown date (in February he tested positive for Covid)  The patient's concomitant medications were not reported.  The patient experienced he felt like he was getting covid again,  a slight fever,  stomach was bothering him,  appetite wasn't there, mental trauma, bone on bone on both hips.  he feels like when he got covid it went into his hips and after receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on Feb2021.  The clinical course was reported as follows Male patient aged 62, received first dose of the Pfizer BioNTech Covid 19 vaccine approximately 3 weeks ago (date unspecified) from his place of employment.  In February he tested positive for Covid and was hospitalized for three days due to a pulmonary embolism.  Two days after receiving his first dose of the vaccine, he started developing symptoms, he felt like he was getting Covid again.  He experienced a slight fever, stomach was bothering him, appetite wasn't there and it took two weeks to recover.  'He has hip problems, bone on bone on both hips.  He feels like when he got Covid it went into his hips and after receiving the vaccine it went into his hips'. He has a scheduled surgery for 11June2021.   He reports mental trauma from having covid and when he got side effects from the vaccine it felt like he was getting Covid all over again.  Callers wife inquired Can you wait six weeks to get second dose? Caller inquired Does he have to get his second dose of the vaccine or does he have enough coverage from having covid and having the first dose? The clinical outcome of the event after receiving the vaccine it went into his hips was unknown while the remaining events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
More than a 2 inch in diameter red, hardened circle/rashing around the injection site
2" red raised patch over deltoid, dizziness, irritability & 2" red raised patch over deltoid are reported in a female pt receiving 1 dose of flu vax; pt recvd flu vax 19OCT93 & exp above sx on 21OCT93; pha has no known allergeis;
Erythematous at site of injection with 3 < 2mm vesicles on (R) arm.
Herpes zoster (shingles) of all 3 branches of right trigeminal nerve Syncopal episode after second dose of Vimpat given for nerve pain Glaucoma from 2 weeks of prednisone for inflammation Horrible incapacitating flare up of fibromyalgia.  2 months later still have pain from shingles and fibromyalgia. Glaucoma being checked 12/07/2021
Information has been received from a pharmacist concerning a pt who was vaccinated with 1 dose of Hep-B vaccine recombinant. Subsequently, the pt experienced injection site soreness which lasted for "2 weeks following vaccination." No further information is available.
Patient  admitted secondary to PE and DVT. Started on heparin drip and was admitted in the ICU. He was bridged with heparin and warfarin for 5 days. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
pt recvd vaax 1130AM & pt broke out w/ generalized urticaria about 1255PM; given DPH;
I had a sore arm after the vaccine for a day. I have had AFIB for four years, but it got worse 11/2022. I went to the emergency room and was admitted for three days and had the cardioversion. Since then, I had two more cardioversion procedures. I am waiting for cardiac ablation in May 2023.
Swelling and redness on site of injection.  Prescribed reflex by mouth 1 teaspoon +10 x 10 days.
On 1/27/2021 I had a mammogram that did not show any calcifications in my right breast. I had to return for a second mammogram on 2/17/2021 which revealed a group calcifications in my right breast. On 3/17/2021 I had a biopsy which indicated Ductal Carcinoma In Situ.
Arm was sore but was very minor; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore but was very minor) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore but was very minor). On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore but was very minor) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-054966 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up received contains No New Information.
Diarrhea, near syncope, extreme fatigue. Started 30 hours post injection & continued x 48 hours.   Site soreness/edema 24 hours after injection that increased to extreme sensitivity at site after 30 hours which lasted 24 hours.  Left deltoid swollen x 1/2 more than usual size started 36 hours after injection and lasted 36 hours.
A few hours after receiving the flu vaccine, the pt began experiencing slurred speech and lightheadedness. These symptoms increased in occurance and severity over several weeks. He was evaluated and the symptoms have lessened but still occur.
patient presented with a light rash which was warm to the touch and extended from the injection sight to approximately the elbow
I got COVID; I got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREVNAR 20 taken for immunisation as dose number unknown, single; AZITHROMYCIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event I got COVID cannot be excluded based on temporal association and available information.
Info has been received from a registered nurse concerning an 8 y.o. male who on 8/5/02 was vax'd w/a first dose of Hep B vax recombinant. On 9/5/02, the PT was seen in the MD's office for a 2nd dose of Hep B vax recombinant, when a 15 mm round, red, raised, scaly area at the inject site was noted. The perimeter of the area had blister-like bumps, and the area was itchy. It was reported to look "more like a wound than a rash". The reaction was reported to have occurred "sometime after administration" and was still present at the office visit. Unspecified medical attention was sought. Add'l info has been requested.
Information has been received from a pharmacist concerning a female who on 17-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not available). On "25-JAN-2008 the patient experienced diagnosed with shingles. "The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Follow-up information from the reporting pharmacist concerning a 72 year old female who on 17-JAN-2008 at 11:18 was vaccinated with her first dose of ZOSTAVAX (Oka/Merck) (lot# 658838/1412U) in the left deltoid. On 19-JAN-2008 the developed a reaction that worsened on 20-JAN-2008. The patient went to the physician and was diagnosed with shingles on 21-JAN-2008. The patient was treated with VALREX. The outcome was unknown. Additional information has been requested.
anterior uveitis in left eye; This is a spontaneous report from a non-contactable consumer (patient).   A 41-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left Arm on 05Apr2021 11:00 (Lot Number: 8734), at the age of 41-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included asthma, mild heart murmur, 1 instance of resolved heart failure from postpartum preeclampsia in 2017, uveitis in both eyes, occurred between Nov2013-May2014. Historical vaccine includes dose 1 of BNT162B2 received on 15Mar2021 10:00am on left arm (Lot number: En6208). The patient is not pregnant at the time of vaccination. Concomitant medications included azelastine; ciclosporin (RESTASIS); cetirizine hydrochloride (ZYRTEC); propranolol, all were taken for unspecified indication, start and stop date were not reported.  The patient previously took Vicodin and experienced itching; Advil and experienced hives.  On 07Apr2021 16:00, patient experienced anterior uveitis in left eye, diagnosed by opthalmologist on 08Apr2021.  The patient underwent lab tests and procedures which included body mass index: 30. The outcome of the event was not recovered. Therapeutic measures were taken as a result for the event which includes Prednisolone AC 1% Eye Drop.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a 32 year old male patient refers to himself with hypertriglyceridemia. The patient had no drug reactions/allergies. On 23-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# unspecified) (route, dose location unspecified). Concomitant therapies included with fenofibrate (dosage and manufacturer unknown), CRESTOR (dose and manufacturer unknown), amlodipine (dosage and  manufacturer unknown). On 23-SEP-2013, the patient reported that he experienced severe pain, soreness, tenderness and limitation of movement in the arm after he received the PNEUMOVAX23 vaccine. The patient did not seek medical attention. No lab diagnostics studies were performed. No treatment was given for the events. At the time of report, the outcome of the events was not recovered. Additional information is not expected.
Slight fever, sinus drainage, lethargy. Symptoms noticed on return travel.  Temperature normal within 2 days. Symptoms largely gone within 2 weeks.
Pneumonia secondary to COVID-19; Congestive heart failure; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 PNEUMONIA (Pneumonia secondary to COVID-19) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M2CA) for COVID-19 prophylaxis.     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-Mar-2021 at 1:40 PM, 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 experienced COVID-19 PNEUMONIA (Pneumonia secondary to COVID-19) (seriousness criteria death and medically significant) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria death and medically significant). The patient died on 13-Aug-2021. The reported cause of death was pneumonia secondary to covid-19 and Congestive heart failure. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Treatment information was not reported.  Company comment:This spontaneous case concerns a 75-years-old female patient, with no medical history reported, who experienced unexpected fatal serious (medically significant) event of Covid-19 pneumonia, cardiac failure congestive, which occurred unspecified days after the second dose of mRNA-1273 vaccination. The patient died on 13-Aug-2021. The reported cause of death was pneumonia secondary to covid-19 and Congestive heart failure. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2023-723375 (Linked Report).; Sender's Comments:  MOD-2023-723375:Father's case; Reported Cause(s) of Death: Pneumonia secondary to COVID-19; Congestive heart failure
Incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother contacted expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Mother informed that subsequent dose may still be administered at the recommended interval. Additionally, a message sent to patient's PCP informing them of error.
Patient was at end of 30 minute monitoring and stated she "felt off, my throat feels dry." Able to sip water. Continuously monitored for additional 10 minutes when she stated her throat felt tight.  BP 150/85, HR 97, RR 20, p. ox 99%. Sent to critical bed in emergency. Epinephrine, Solu-medrol, and normal saline given. Monitored until 11:18 (3.5 hours from onset) and discharged.
Diarrhea; stomach hurt; This is a spontaneous report from a contactable 35-year-old female consumer reported for herself. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0168 and expiration date was not reported), via an unspecified route of administration, administered on left on 29May2021(35-year-old at the age of vaccination) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182) on 08May2021, 01:22 pm (13:22) (at the age of 35-year-old) The patient did not have prior vaccinations within 4 weeks. The reporter stated that, she got second vaccine from Pfizer on Saturday 29May2021. Since that day the patient had diarrhoea, stomach hurts. So, the patient wanted to know if that is the side effect or reaction or what she can do because diarrhoea (Incomplete sentence)." The patient did not receive treatment for the events and wanted to know, if that is alright. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Vaccinated with Pfizer on 1/27/21 and 2/17/21.  Symptom onset 7/18/21 with cough and diarrhea.  Tested positive for covid-19 on 7/20/21.
Swollen, tender, warm to touch on the left thigh. Given MOTRIN at time of onset; Instructed to administer BENADRYL, MOTRIN and TYLENOL as needed and to apply cool compresses to relieve discomfort.
Mom stated 3 days after getting shots she noticed pustular nodule on leg. Now she has been having other boils coming up on legs and draining pus. Had a boil a couple of days prior to getting shots. Fever noted last night.
Had severe headache post second dose, felt weak and nauseous - took vitals with no pertinent issues. Provided Tylenol and water at clinic site and sent patient to ER via ambulance.
Muscle and Joint pain that began in legs and moved to shoulders and arms. Swelling of legs and hands. The worst on left side of body. Has been battling this for over two months now. Received a Corticosteroid shot in left arm on January 8, 2018. The shot helped for a week and a half. The muscle and joint pain and mobility has been debilitating. Difficulty walking, getting out of chair, reaching with arms, and loss of hand strength.
DROPPING LIKE FLIES; GETTING VERY SICK; This spontaneous report received from a patient via a company representative concerned multiple patients. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced dropping like flies, and getting very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dropping like flies and getting very sick was not reported. This report was non-serious.
Information has been received from a 73 year old female with no pertinent medical history or drug allergies who on 19-OCT-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant drug therapy included SYNTHROID and TOPROL XL TABLETS. On 20-OCT-2007 the patient "developed a red rash where the shot was given. The site was hard as a rock, burning, itching and the redness crawled up her arm." The patient did not seek medical attention. The patient was not recovered. There was no product quality complaint. Additional information is not expected. Follow-up information has been received from a 73 year old female indicating that the adverse experiences took several weeks to clear up. Additional information is not expected.
Patient received pfizer dose and went to charting area with mother. Patient began to feel dizzy and mother noticed a skin color change, said he looked "yellow". Patient did appear pale and diaphoretic. Mother held on to son to prevent a fall. Then child was brought to medical bay. Patient laid on cot, legs elevated, vital stable. Blood pressure 110/60, heart rate 103, pulse ox 98%. Patient sat up and left with mother once comfortable. Stable conditions.
Rash three days later, red and itchy, felt bumpy. Tired and arm hurt.  Lasted less than a week.  Gave birth 37 weeks due to preeclampsia, at birth she was whisked away and after fifteen minutes she was fine. She had a brain bleed on the second night around 10 or 11 pm on the 26th. She was placed in hospital NICU for about two weeks. They just got out today. She wants this recorded so no one has to go through that. Baby is fine now.
28DEC96 woke up w/stiff neck & head was cocked to lt, unable to turn head;c/o painful neck;mom gave APAP & advil in AM 28DEC96;per mm & MD pt had no neuro sx, no LOC;unable to move head any further to lt;dec appetite;OM;muscle spasm;
Very next day after 2nd dose developed shingles; Rash on chest, sides, back and breasts; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in the middle of September 2021).   On 15th March 2022, the patient received the 2nd dose of Shingrix. On 16th March 2022, 1 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comments: This case was reported by husband for his wife.  The patient received 2nd dose of Shingrix and very next day she developed shingles, rash on chest, sides, back and breasts.  The patient went to see her physician who prescribed her Valtrex and Gabapentin and that was helping her with the symptoms of shingles. The consent obtained to contact health care professional (HCP) and consumer for follow-up.
On 10/2/2022 I had mild cold symptoms sore throat, achy joints, mild fever and not much energy.  I tested on 10/2/2022 it was negative. I felt slightly bad on 10/3/2022 and I tested positive. I called my doctor on Monday, 10/3/2022 and picked up the prescription, Paxlovid, on 10/4/2022. I just started the Paxlovid this morning and I feel exactly the same at this time.
Patient was having dyspnea, 102 fever, chills, body aches, FLS.
BlurredVision, Myalgia, Fever, NauseaVomiting, ostealgia, blurred vision with reading close up Narrative: continues to c/o blurred vision with attempts to read up close - although states improvements in vision oday
High fever-102; extreme body aches and muscle pain; uncontrollable chills; headache; extreme fatigue; extreme tiredness.
No additional AE reported; Customer reported expired GARDASIL 9 got administered to a patient today 03MAY2023.; This spontaneous report was received from certified medicall assistance and refers to a 12-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1687293, expiration date: 30-APR-2023 (strength, and route of administration were not provided) administered for prophylaxis (expired product administered). No additional adverse event was reported.
approx 4-5min p/vax pt stated having problems breathing & chest is tight;BP 178/98, P108, R20;epi given;
nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 1:00 AM, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.