chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a four-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-JAN-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.
This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included lymphoma. On 24th September 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, enlargement of lymph nodes and cold sores. The patient was treated with ABREVA. On an unknown date, the outcome of the pain in arm and cold sores were recovered/resolved and the outcome of the enlargement of lymph nodes was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, enlargement of lymph nodes and cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he received the SHINGRIX vaccine on Monday and his arm was extremely sore. In addition, his lymph nodes were greatly inflamed and he had a cold sore break out after the vaccination. The patient stated that his original symptom was a sore arm, which resolved after about 4 days, and 2 to 3 days after he received the vaccine his lymph nodes started swelling up. He had lymphoma and the nodes that have swollen are the ones affected by his lymphoma. They are hard and swollen. About 2 days after the vaccination he developed a cold sore as well. He treated the cold sore with ABREVA and it had resolved. The patient called back to deny permission to contact doctor. He changed his mind and did not want his doctor to be contacted.
Patient developed an injection site reaction to immunization within a day of immunization. Injection site is very red, inflamed, painful to touch and move. Patient was seen by urgent care clinic who recommended ice. Patient is already taking low dose corticosteroids for carpel tunnel syndrome.
Swelling, pain, redness in chest and under arm. Used Aspercreme and Boilease to relieve pain.
12 x 8 cm erythematous area (+) color without tenderness (R) deltoid area.
mom drove home (about 30min) pt t104 gave motrin & cool tub bath;pt vomit & by 2PM temp up to 105;taken MD & put in hosp & pt start seizing;pt vomited numerous times w/elevated temp;pt hosp
Pfizer-BioNTech COVID-19 Vaccine EUA Rash patch on both sides of neck, rash on both sides of upper chest (size of an orange), rash on inside of upper arms. Started 1/9/2021 Rash patch on inside and top of right forearm. Started 1/13/2021. Rash patch on left side of lower back. Started 1/15/2021. Treatment tried without relief - Zyrtec, Benadryl, Hydrocortisone Cream, Atarax, Triamcinolone Cream.
Wrong manufacturer given.    This child should have received the  Moderna Bivalent booster but was given the Pfizer Bivalent 3rd dose.   This child got the Moderna 1st and 2nd dose primary series.
severe high pitched persistent crying over 6 hrs- called pvt MD told to call clinic to report-clinic closed waited until coming for 2nd set shots to report; DT only
I first noticed that I couldn't run as far in the first couple of weeks, but then I developed shortness of breath, chest pain like my heart hurt with each beat, which worsened until I had these symptoms severely at rest. My blood pressure went from normal to 180/110. I also developed severe tinnitus with decreased hearing acuity.  I had aching pain in the bone around my ear. I took steroids which made these symptoms go away, but when I stopped them I was hospitalized the next day with chest pain. 5/7/2021 was the worst day for these symptoms, the day before I was hospitalized. Since then the symptoms go away and come back again like echos, with each episode a little less severe. I currently have mild buzzing in my ears, mild palpitations, and high blood pressure.
Vaccine received 4/28/30. During 4/30/21 resident overall status changed to altered mental status, which included unresponsive and inability to take in food or drink. Breathing became shallow. Skin pale. Lungs congested w/Chest xray ordered. Moved to Covid PUI unit. Hospice notified w/comfort care initiated and preparations made for end of life w/family notification. COVID testing negative. Bedside observations continued w/NP noting possibility of adverse effect to vaccine r/t multiple sclerosis dx. Hx of others w/multiple sclerosis observed by NP included returning to baseline within 24-48 hours. IV gently hydration initiated during time of little to no response. Within 12 hours, resident was observed to exhibit returning to her baseline status which included responsiveness, ability to drink, swallow, eat, interact w/communication. She returned to baseline, was seen by MD and cleared to return to her previous living area. After several weeks of baseline, she did decline gradually overall with end of life under hospice care with exacerbation of multiple sclerosis symptoms and expired at facility.
Flu shot 11/5/08. Arm sore next day, low grade fever, tiredness and cough. 11/8/08, rash to chest, abdomen, groin, hands and lower legs. BENADRYL on 11/10 and 11/11. Getting better with rash on 11/12. Still had cough and residual rash effects - itching and redness.
In July 2021, I developed a severe cough. It lasted for months. I reached out to a doctor on July 20, 2021, to discuss my symptoms. They prescribed a cough suppressant and an albuterol inhaler. I used both for a month. They did not work. My doctor referred me to an ENT specialist. They thought I had GERD. After I revised my diet and took the medication for GERD, my symptoms still did not go away. I contacted my primary doctor again. She performed Barium Swallow Test along with a chest X-ray. Both were normal. Within the next month, I was referred to a Pulmonologist. They gave me several exams to diagnose asthma. They determined I had asthma. They gave me a new inhaler that worked. I'll have to use it for the rest of my life.
Cough; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 04Apr2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not available. The patient had no known allergies to medications, food or other products. Concomitant medication included desogestrel, ethinylestradiol (APRI), from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, the patient experienced cough. No therapeutic measures were taken as a result of the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of cough was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Fever; Redness; Swelling; Hotness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Received call from mother on 9/19/2006 at about 8:30am that child had not voided since night before. Mom also stated child had had a temp of 102 during night and did not want to take breast but was using pacifier. Was also concerned because child was not as alert as usual.Was advised to take to MD. due to child not voiding and change in mental status and to let me know what arose. Was seen by Dr. at noon on 9/19/2006 and was admitted to Hospital with Dx of Dehydration,Oliguria,r/o UTI and r/o adverse reaction r/t vaccinations. Spoke to Mom 9/21/2006 when she called to notify about child's condition and said child had been rehydrated with IV fluids and would be dismissed today. Said child quickly perked up when IV fluids were started. 9/28/06 Received medical records from hospital which reveal patient experienced fever & no urination since vax.  Admitted for 23 hour observation w/dx: dehydration & fever s/p immunization.
Information has been received from an approximately 89 years old female patient referring to herself. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unspecified date in July 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported) subcutaneously in her left arm. On an unspecified date in January 2015, the patient experienced extreme pain in her left arm and saw her physician. It was reported that there was no visual evidence of a rash or blisters. The patient was told by the physician that she had shingles. Treatment was given for the events. At the reporting time, the patient still experienced pain in her left arm. The outcome of the events was reported as not recovered. The causality between the events and ZOSTAVAX was not reported. Additional information is not expected as the physician doesn't want to be contacted.
I20.8 ANGINA EQUIVALENT 5/1/2023 HTN (HYPERTENSION) I20.8 ANGINA EQUIVALENT 5/1/2023 ANGINA EQUIVALENT I20.8 ANGINA EQUIVALENT 5/1/2023 CHEST PAIN
Patient was given Moderna vaccine at age 14.  She should have received Pfizer vaccine.
Sore right arm that resulted in large lump. Felt bruised and patient feels like has had a loss in muscle mass. She now experiences weakness in arm. Still sore to date.
Breakthrough case admission after 4 vaccines Pfizer 2/9/21 Lot# EM9810;  Pfizer 3/2/21 Lot# EM9810;  Pfizer 12/9/21 Lot# FH8028;  Pfizer 7/12/22 Lot# FP7150
PATIENT DEVELOPED A RASH OVER MID-SECTION THAT HAS GOTTEN PROGRESSIVELY WORSE. MY IMPRESSION WAS POSSIBLE SHINGLES OUTBREAK; INSTRUCTED PATIENT TO SEE PCP IF RASH SPREADS OR WORSENS.
body aches; fever (100 to 101 degrees); head ache; This is a spontaneous report from a contactable consumer (parent). An 18-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EP6955), via an unspecified route of administration, administered in left arm on 12Apr2021 11:15 AM (at the age of 18-year-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 dose 1 via an unspecified route of administration, administered in left arm on 22Mar2021 12:15 PM (at the age of 18-year-old) (Batch/Lot Number: EP6955) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other vaccine received within 2 weeks of vaccination. On 13Apr2021 09:00 AM the patient experienced body aches, fever (100 to 101 degrees), headache. The patient underwent lab tests and procedures which included body temperature: 100 to 101 fahrenheit, increased on 13Apr2021. Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
rash, diffuse, including bulbous lesions that cultured strep pneumoniae treated w/cefaclor;mom called 9JUL95 rash reoccurred
Patient complained of sensitivity on head that started 2nd or 3rd day following ZOSTAVAX shot & quit couple of days ago. Also reported red rash on upper chest that only itched if he touched it, which started 2nd or 3rd day following the shot is still present.
Running fever since; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Running fever since) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Running fever since). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PYREXIA (Running fever since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported by reporter    Reporter did not allow further contact
Headache, Myalgia, Fever, NauseaVomiting, SOB<rhinorrhea,fatigue, chills Narrative:
Pt came in to  get the flu vaccine. The vaccine was processed incorrectly and the covid vaccine was given instead. The pt wanted to also get the flu vaccine, this covid dose would've been the 3rd dose ( 1st dose given on  4/6/21 and second dose was on 5/4/21). Pt didn't have any adverse reaction when she left the store
pt recv vax 6FEB98 & reported neck pain rt side took APAP q 4-5hr for pain x 3 day-pain improving on 9FEB98 but still apparent to pt;
arm was sore for 2 days; I never got my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder NOS. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure increased, LEVOTHYROXINE for Thyroid disorder NOS.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose). On 15-Apr-2021, PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) had resolved. On 17-Apr-2021, MYALGIA (arm was sore for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder NOS. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure increased, LEVOTHYROXINE for Thyroid disorder NOS.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose). On 15-Apr-2021, PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) had resolved. On 17-Apr-2021, VACCINATION SITE PAIN (arm was sore for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Severe Migrane from 8/6/2021- 8/20/2021 with nausea, vomiting, lack of appetite.
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
Weakness, tremors, fatigue, muscle pain, joint pain, scratchy throat, headache, neck and back pain, nausea, chills, heart racing/pounding, difficulty catching my breath
Pt was presented to the Emergency Department for 14 days of fatigue, shortness of breath, cough, diarrhea. Has associated chills. No sick contacts. No contacts with covid 19. Was admitted here for cellulitis on 10/3. Upon discharge, patient reports persistent symptoms and felt that she was getting worse, thus came back to the ED for evaluation.  She is vaccinated with pfizer x2.
Systemic: persistant cough-Severe, Systemic: Weakness-Severe, Additional Details: persist cough second day of vaccine and third day of vaccine weakness of legs more in left side
Facility was no longer authorize to administer monovalent as boosters as of 09/03/2022 for ages 12 years and older
This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown. It was unknown if the reporter considered the fatigue and general body pain to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a certified medical assistant. The age at vaccination was not reported. The patient experienced achy feeling all over her body. This was 1 of 3 cases reported by the same reporter.
Woke up covered in hives, was covered on my arms, back, stomach, and legs.
pt says about half hour after taking vax she started having joint pain and headache.  She was in the bed for the next 3 days because she was so fatigued and weak she could barely move.  She went to her PCP and was told the vax had to run its course.  About 7 days later she developed a shingles type rash.  On 3/29/21 she went to ER.  They did blood work and wanted to prescribe steroids but she did not want to take them so she decided to wait it out.  A couple days later the rash was worsening so she went back to her PCP where she was given steroids to treat her symptoms.  Her symptoms were better after taking steroids.
has pain on the right side/was reported as worsened; barely able to move the right arm; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 (Lot number: 30130817) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Breast cancer (unspecified if ongoing); Lymph nodes and the cancer taken out (unspecified if ongoing). There were no concomitant medications. Vaccination history included Bnt162b2 (First Dose Covid-19 shot: 01Mar2021, LOT: EN6205, EXP: Unknown, NDC: Unknown, AE(s) following prior vaccinations: None, Anatomical Location: right shoulder, administration date: 01Mar2021, for COVID-19 immunization, reaction(s): "None"; Bnt162b2 (Second Dose Covid-19 shot: 22Mar2021, LOT: D202HNV, EXP: Unknown, NDC: Unknown, AE(s) following prior vaccinations: None, Anatomical Location: right shoulder), administration date: 22Mar2021, for COVID-19 immunization, reaction(s) None. The following information was reported IMMUNISATION (non-serious) with onset 27Sep2021, outcome unknown, described as Booster; PAIN (non-serious) with onset 28Sep2021, outcome not recovered; MOVEMENT DISORDER (non-serious) with onset 28Sep2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, movement disorder.  Patient stated that she took the shot and she had breast cancer. She was in remission and had been using a garment that was supposed to get the water out of her breast. She didn't know that she could not use the garment for 2 weeks. Right now, she had to go through physical therapy to relive the pain that she had on the right side. She stated that she went to occupational therapy. Patient had pain in the right side. It started the next day after she got the shot. It was in her right arm, up and under the breast and the right side of her back, in that area. It was gotten worse, the pain level. She was barely able to move the right arm. She had to massage it with her left hand some times. Patient was taking pain medication, she was taking Percocet. patient was no longer using the garment because it was making it more painful because of the water build up on that side. She did not have her breast removed, she had lymph nodes and the cancer taken out. Patient did not require emergency room and physician office visit. The patient did not have prior vaccinations within 4 weeks. Patient stated that she had to put it on her shorts and put her arm through and wrap it around.  Follow-up attempts are completed. No further information is expected.
Hospitalized with falls, cough x 5 days, O2 sats 90% new requirement of O2,  Remdesivir and dexamethasone, CPAP with 2 L O2, look for SNF placement
After client received vaccine client stated she had tingling in left arm.  Vital signs obtained by EMS: BP 164/100, repeat 155/87, Pulse 90, O2 sat 98%; Client stated she feels better.  Client discharged home by EMS.
Narrative: 68 yo M with a history of CHF, T2DM with multiple complications, COPD, HTN, tachycardia, diastolic HF, and sleep apnea. Patient received covid vaccinations on 2/14/21 and 3/12/21. Patient death occurred on 3/22/21 but not many details known about death. Patient called the facility telephone to report unbearable left knee pain and was told to use OTC treatments. It is unknown on whether covid vaccinations contributed to patients death.
PT reports the onset of his symptoms, which includes painful muscle cramps, muscle twitches, and painful paresethesias, approximately 2-3 weeks after his receiving his first Moderna COVID-19 vaccination on January 12th 2021. Because of his symptoms, Pt declined the second vaccine.   Based on his clinical exam and EMG, he has a diagnosed of acquired neuromyotonia. Although it is unclear if the COVID-19 vaccine is causal for this condition, acquired neuromyotonia is thought to be autoimmune in orgin and prior associations of this condition with other vaccines have been described.