chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No DCA BOT sheet attached, manual checked performed, no duplicate found- ; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-NOV-2022 Reporters comment: The pharmacist reported that the patient received the expired dose of Havrix vaccine. The reporter did not consent to follow-up. HCP declined giving contact information. Additional Supportive information: The patient received the expired dose of Havrix, which led to expired vaccine used.
61 eruptions of chickenpox; vomited; cough; nose; fever 102 degrees. Sick since 3-16-12. Dx: Varicella, (L) OM.
Developed numbness in left hand then subsequently, sharp burning pain in left upper chest, upper arm radiating to back.  Also felt vertigo type symptoms
pt recv vax NOV97 & felt hot, lightheaded & had a pre-syncope event;BP went down to 110/60;
After first dose of vaccination,I am experincing apnea,nasal congestion,chest pain and neck pain.After second dose feel nasal congestion ,headache. on 5/23 experience severe pounding headache and heart pounding heart and also numbness in left arm, I called 911 and EMS admitted me in the ER.They did ECG and again and after that I experience same tachycardia in 1- 2 days and I went to physician and  on 6/12/2021 I felt chest pressure twicw with in 10 min and palpitation and admitted to ER they did blood tests and chest xray and ECG .I went to cardiologists for the same symptoms .Yesterday I felt severe breathlessness ,heart burn, cough ,tachycardia whole day and then my cardiologists put ECG monitor.Earlier I experience all this in night time ,then start tachycardia in evening too, now I am experiencing in day time.I never slept comfortable after second dose of vaccine.I wake up in middle of night.At night time yesterday when i woke up in middle of night my heart rate was high and feeling lots of sweating,even though fan is on. I am not working right now.these hospital bills and visits after vaccine made my life measurable.
Sudden onset of pounding heart, buzzing sensation throughout body, near blackouts, and shortness of breath.  Buzzing sensation and near blackouts have subsided during past two weeks, but pounding heart and shortness of breath continue on a constant basis.
Information has been received from a pharmacist concerning an 11 year old male who on 05-AUG-2008 was vaccinated with ZOSTAVAX live (Oka/Merck) instead of VARIVAX (oka/merck) (MSD). (Dose, route, site of administration, lot number not reported). It was unknown if the patient sought medical attention. Follow-up information from the pharmacist confirmed that the patient received ZOSTAVAX (Oka/Merck) instead of VARIVAX(Oka/Merck) (MSD). Additional information has been requested.
MS exacerbation; This spontaneous case was reported by an other and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (MS exacerbation) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high, Headache, Malignant hyperthermia, Optic neuritis, Eye disorder, Memory deficit, Pain, Depression and Sleep difficult. Concurrent medical conditions included Relapsing-remitting multiple sclerosis. Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), LORATADINE (LORATAB), METOPROLOL, ZOLPIDEM, MEMANTINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), VENLAFAXINE HCL and MEMANTINE HCL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (MS exacerbation) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (MS exacerbation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a medical assistant (also reported as nurse prescriber) referring to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot # N025929, expiration date 18-MAR-2019, subcutaneously, for prophylaxis (dosage information was not informed), following a temperature excursion. No adverse effects were reported. It was also informed that the temperature was -10.97C, time frame 35 minutes, There was no previous temperature excursion. A "data logger" was involved. This one of two cases from the same reporter.; Sender's Comments:  US-009507513-1805USA001822:
she is experiencing redness, warmth and tenderness; she is experiencing redness, warmth and tenderness; she is experiencing redness  1/4 x 1 inch on her left deltoid; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.   On 20th April 2020, the patient received the 1st dose of Shingrix (intramuscular). In April 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, skin warm and erythema of extremities. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the pain in arm, skin warm and erythema of extremities were unknown.   It was unknown if the reporter considered the pain in arm, skin warm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: Medical assistant reported that a patient notified their office the day before reporting, that she was experiencing redness, warmth and tenderness that measures 1 1 divided by 4 by 1 inch on her left deltoid.   They advised the patient to use topical Benadryl and ice for pain. The reporter consented to follow. This case has been linked with US2020048480, reported by same reporter.
5.5 weeks 3/5/01 my son spontaneously bled from his mouth and nose. Hospitalized for 8 days. Was prescribed Albuterol and Ipratropium bromide with a nebulizer. Mother took patient to another doctor who prescribed vitamin C. Son cleared up respiratory problems.
developing excess mucus dripping down the back of her throat "like motor oil" every time she eats and drinks; This is a spontaneous report from a contactable Consumer (patient).   A female patient of an unspecified age received one dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on 02Jun2015 and on 08Oct2015 for immunization, one at a drugstore and the other at a doctor's office.  The patient medical history and concomitant medications were not reported.  On an unspecified date she started developing excess mucus dripping down the back of her throat "like motor oil" every time she eats and drinks. She received lots of medical advice, regarding the mistake with the administration. Could the excess mucus be a side effect? Her phamacist looked up the side effects, and it is not listed as one. The outcome of event unknown. The patient queried whether there was a difference between Prevnar and Prevnar 13.  No follow up attempts are needed, information about lot/batch number cannot be obtained.
Patient reports approximately 40 min after receiving vaccine became lightheaded, pale, clammy & then became semi unresponsive.  Co-workers called ambulance.  Patient taken to Medical Center.  ER evaluated & released at 5 pm.
Pt diagnosed with intussusception on 4/18/08.  Required surgical reduction.
Clusters of small vesicles with much crusting on posterior (R) thigh in dermatomal distribution. Signs and symptoms 5 days
One week after receiving the vaccine I woke up on 5/21 with a mild rash. As the day went on the rash progressed and swelling of lips and uvula occurred around 5pm. I was taken to an urgent care who transferred me to a hospital via rescue. I spent the night at the hospital receiving multiple epi pen injections, and fluids. I was discharged 5/22 with a dose of prednisone. I was fatigued all day. On 5/23 I woke up to swollen eyes and lips and covered in hives again. I went to the ER where I was given steroids and fluids again. The hives went down but did not go away.  One 5/24 I took multiple doses of Benadryl and dose of prednisone and in the evening time the hives progressed. Today 5/25 I woke up with swollen lips and checks and hives. I went to my doctors office to be evaluated.
This is a spontaneous report from a noncontactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 37, via an unspecified route of administration, left arm, on Apr 8, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 37, via an unspecified route of administration, left arm, on Mar 18, 2021, at 16:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Apr 12, 2021, patient experienced headache on and off, fever on and off, nausea,  body ache and sore throat. No therapeutic measures taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of headache on and off, fever on and off, nausea, body ache and sore throat: not recovered (at the time of this report). No follow-up attempts possible. Information about lot\batch number cannot be obtained.
I have had a fever, chills, and nausea off and on since 4/10/21. The fever can get high at times and it does take a long time to bring it down. Sometimes medication doesn?t work.
Fall; T7-8 fracture; restricts respirations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 at 14:15 as dose 3 (booster), single (Lot number: BA30135) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing), notes: Mild hypertension; "empysematous lung changes due to 2nd hand smoke" (unspecified if ongoing), notes: empysematous lung changes due to 2nd hand smoke; "hypogonadism" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa; "2nd hand smoke" (unspecified if ongoing), notes: empysematous lung changes due to 2nd hand smoke. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, vaccine administration time=03:45 PM, vaccine lot  number=EL0140, vaccine location=Left arm), administration date: 09Feb2021, when the patient was 82-year-old, for Covid-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose:2, vaccine administration time=01:30 PM, vaccine lot  number=EN6205,, vaccine location=Left arm), administration date: 02Mar2021, when the patient was 82-year-old, for Covid-19 Immunization, reaction(s): "COVID-19". The following information was reported: FALL (hospitalization) with onset 12Mar2022, outcome "unknown"; THORACIC VERTEBRAL FRACTURE (hospitalization) with onset 12Mar2022, outcome "unknown", described as "T7-8 fracture"; INSPIRATORY CAPACITY DECREASED (non-serious) with onset 12Mar2022, outcome "unknown", described as "restricts respirations".  Anti-viral details [product=COVID 19 Treatment (Paxlovid), treatment start date=17May2022 and stop date=22May2022, Indication is used for treatment of COVID-19. covid vaccine details [vaccine brand=Pfizer BioNTech, administration on 07Apr2022, at 01:00PM, lot number=FK9894, on dose number unknown reason=UNKNOWN, location=Left arm. other medication details [other medication in 2weeks product=Bystolic, Trazadone, stop date=16May2022, Depo-testosterone, Multiple Vitamin, Calcium, Fish Oil, Vitamin C, Preservision, Eyeleainjections. Reported Event: + on antigen test on 17May, as symptomatic & after wife positive on PCR several days earlier. Took 5 days Paxlovid 17May - 21May.Symptom free & antigen test negative on 25May.27May 07:00 AM at return Covid symptoms of sore throat, cold & lung congestion with cough, low grade fever & fatigue. & tested + on 28May). On 31May remains symptomatic with only minimal improvement in symptoms. The outcome of events was not recovered without any treatment.  No follow-up attempts are needed. No further information is expected.
large urticarial wheel at the site of the injection; Very itchy at injection site; Very red at the injetion site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE URTICARIA (large urticarial wheel at the site of the injection), VACCINATION SITE PRURITUS (Very itchy at injection site) and VACCINATION SITE ERYTHEMA (Very red at the injetion site) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (large urticarial wheel at the site of the injection), VACCINATION SITE PRURITUS (Very itchy at injection site) and VACCINATION SITE ERYTHEMA (Very red at the injetion site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE URTICARIA (large urticarial wheel at the site of the injection), VACCINATION SITE PRURITUS (Very itchy at injection site) and VACCINATION SITE ERYTHEMA (Very red at the injetion site) outcome was unknown.        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.   Concomitant medication was not reported. The large urticarial wheal at the site of injection had extended since 21-Jan-2021. It was about 4 inches in length and 1 inch in width and was very itchy. At the time of report it was somewhat itchy after a dose of Benadryl.
Erythema around injection site.  MMR and Varicella within less than 10 minutes.  No warmth.
I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I suffered from severe allergies, I am suffering from bone pain and my lungs hurt, it is hard to breathe, I have been exhausted, there are times when I can't breathe.; I have been exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 11:45 (at the age of 32-year-old) at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 15Apr2021 12:30 the patient experienced i suffered from severe allergies, i am suffering from bone pain and my lungs hurt, it is hard to breathe, i have been exhausted, there are times when i can't breathe. Adverse events resulted in Emergency room visit. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 03May2021 Nasal Swab (Covid tested post vaccination: Yes). Patient received treatment for the adverse events. Outcome of the events was not resolved.   Follow-up attempts are needed; information about lot/batch number requested.  Follow up (19Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
His left upper arm where he received the flu shot is very swollen.  It is red and itchy and is hot to the touch, even three days later.  It seems to be moving down his arm toward his elbow.  We are treating with ibuprofen and Benadryl.
Covid long haul with MRI brain changes, neurological symptoms, myocarditis, tachycardia, chest pain, fatigue, memory loss, joint pain
Pt reports local burning and pain with administration followed by L upper arm pain and swelling, with deep red macular area at injection site of 4.5x5.5cm. Pt complains of pruritis and fever.
Initially admitted to hospital on 7/15/06 for HA, nausea, malaise. Was held overnight then d/c'd. According to reports was readmitted same day for temp of 106 degrees, however Transfer summary report places day of admission on 7/18/06. According to summary, presented on 7/18/06 with fever, malaise, and pain around lower edge of his ribs. Pain on scale of 1-10 rated at a 9. Temperature was 105.6 degrees. CXR noted perihilar opacities which radiologist felt to be consistent with viral pnuemonia or decreased lung volumes. ST segment elevation and elevated sed rate raised concerns of pericarditis. Echo was done and showed mild pericarditis. Admitted and treated with IV fluids. Treated with IV Toradol for HA, Ibuprofen taken orally prior to d/c for HA and was effective. Discharge diagnoses included Viral Syndrome with mild pericarditis. Follow up visit on 7/19/06 with diagnoses of possible Smallpox reaction based on medical history.
diarrhea, can't eat, 99 fever, dizzy, abdominal pain, muscle pain,fatigue
Lymph nodes in armpit and collarbone are swollen.; dull pain around left arm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s), a pharmacist at a pharmacy  recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-JUN-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 17-DEC-2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
40 minutes after my dose, the left side of my body tingled and went numb. I took shortness of breath for 48 hours. My lips and tongue as well went numb. I took Benadryl and continued the regime until they next day. I saw my doctor and she recommended the max dose of Benadryl. Every four hours. The numbness lasted for four days. On the fourth day I started feeling itchiness and the was a rash in the 1st 24 hours on my left arm. After the 5th day I felt normal my immune response was that I was down for 4 weeks, my glands and my muscle and joints were swollen. My doctor advise that I advised that I do not get the 2nd dose, because the first reaction was a sign that there may be an allergic reaction.
5/15/2023 - 5/17/2023 (2 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia  COVID    HOSPITAL COURSE: Patient is an 87 year old female with past medical history of PE on eliquis, DM2, rheumatoid arthritis on prednisone and Arava, hypertension, 2L nocturnal supplemental dependent post acute sequelae of COVID-19 October 2021, and history of breast cancer who presented from her assisted living facility with dyspnea. Patient requiring 2L NC on admission which typically is only required for her at night. COVID19 positive on admission. Labwork otherwise fairly unremarkable aside from chronic anemia. CXR with patchy basilar airspace disease. She did receive remdesivir and decadron for 2 days. Patient clinically improved, weaned to room air. Patient feeling back to baseline and discharged back to her assisted living facility with home health PT/OT/RN
Patient received the immunocompromised dose of Moderna COVID vaccine at 0.5 mL, instead of the standard 0.25 mL (patient is not severely immunocompromised as currently defined by the CDC). Pt reported that he had a sore arm and felt slightly worn down the next day. After this, patient reports no adverse reactions.
pt woke up next morning feeling ok and took a shower and shortly after she felt light headed, started sweating, got nauseous and passed out. she came to and her husband picked her up and she passed out again.  she went to the emergency room .  the emergency room dr said it could have been due to vaccine or the combination of vaccine, being dehydrated and history of low blood pressure.
Mom called and reported that child had a seizure-like episode on Sun. 7/20/03 after 12 on 7/18/03. Episode lasted 15-20 seconds. Child was conscious and talking throughout but lost balance (couldn't maintain sitting position). Body was stiff, right leg shaking. Did not seek any medical treatment at time but was visiting later in day and a asked nurse on duty about incident, who suggested it be reported as preschool 12 given 2 days to Mom. Checked temp with ear thermometer-98.4. No signs of any illness.
Pt noted three days after Japanese encephalitis shot that he had swelling at injection site at 7am.