chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is still massively sore; Hot and cold; Fever; Chills/wakes up about 0100 or 0200 with chills; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is still massively sore), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), PYREXIA (Fever), CHILLS (Chills/wakes up about 0100 or 0200 with chills) and FATIGUE (Very tired) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Arm is still massively sore), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), PYREXIA (Fever), CHILLS (Chills/wakes up about 0100 or 0200 with chills) and FATIGUE (Very tired). At the time of the report, PAIN IN EXTREMITY (Arm is still massively sore), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), PYREXIA (Fever), CHILLS (Chills/wakes up about 0100 or 0200 with chills) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug were reported. The pharmacist asked the patient to take Tylenol as treatment. Patient was sipping water all day.
This is a spontaneous report from a non-contactable consumer (patient). A female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (unspecified trade name) via an unspecified route of administration in Nov2016 (reported as "last November") at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient got one pneumococcal vaccination last November (don't know the name). Afterwards, she could not go back to using her arm. It gave be frozen shoulder. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Fever, fatigue Narrative: Muscle aches, fatigue, low grade fever (101F), headache was the worse side effects. Took Ibuprofen OTC 2 days after for the headache once his fever went  down, wanted to wait to take anything and allow the fever to manifest to elicit a better immune response.
Pt. began having "cold symptoms" on Wed 3/26/03. On Friday, 3/28/03 she developed symptoms of tiredness, chills, (no fever), headache, and shortness of breath. Seen by Dr. at Med clinic for follow-up. Chest X-ray and EKG were normal. On 3/31/03 vaccine site was checked at county vaccine clinic. No vaccine blister seen.
Painful Shingles rash and continuing pain throughout, sleeplessness from 11/26/2021 to present
This spontaneous report was received from a medial assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M047658 with expiry date 29-OCT-2017 (exact dose and route of administration were not reported). The dose was exposed to the temperature between 47 and 77 degrees Fahrenheit for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/20/21 2nd dose01/08/21 Diagnosed covid positive:09/19/21 Symptom onset:09/18/21 Exposure:home Symptoms:muscle aches, runnynose
After 1st shot had reduced appetite and became tired(lasted about 2 weeks) after second shot had dificulty breathing the following day. Has had nose bleeds and a slight skin rash over his body(states it does not itch) also noticed bruising all over legs and arms. Unknown if these symptoms are caused by the vaccine or some other health condition but was advised to report it in the event it was related.
7 days after shingles vaccination patient presented with "1/2 dollar" sized skin rash on her upper right arm.
Tested positive for Covid-19 on 12/3/2021.  Pt not admitted to hospital for Covid-19 or Covid-19 s/s.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 01May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: my Covid test was positive at the same time. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Staff received her vaccine last Saturday 2/27 and reported having fever from Saturday night to Sunday early morning.  3/1/21 Monday - She also said she only noticed red rash on her abdomen and chest area 3/2 Tues - Staff reported to work and informed of reaction.  Medical Director had advised her to see her PMD.  At night,  staff reported rash spread down to her pelvis area 3/3 Wed -  Staff stated her eyes are swollen 3/4 Thur - Seen by doctor; labs drawn (staff unsure what labs),  was prescribed:  Benadryl 25mg 1 tab every 6hrs for 5 days, Claritin 10mg daily for 10 days, Clobetasol prop 0.05% cream
Bad rash all over torso and both arms (not head or legs). Mild fever. Lethargy. Muscle pain -- especially neck and left ear. Rash was red bumps like Chicken Pox/Shingles -- about a hundred of them, not particularly itchy. Patient has had full course of all recommended childhood vaccines, but none recently. Symptoms started to subside on third day. Ibuprofen reduced aches. After fourth day, bumps are still visible but fading and causing no more discomfort.
Chest tightness, rapid heartrate, shortness of breath lasted for 2-3 minutes Warm sensation throughout body for 4-5 min lasting no more than 30 secs at a time.
chest tightness, lightheadedness, nausea.  Patient was very anxious prior to receiving the vaccine.
Had IZ's 6pm 12/6 next afternoon 12/7 started getting swollen arms. No fever red, warm to touch (B) deltoids (R) 3 1/2" x 3"; 3 1/2" x 2" (L) treatment BENADRYL Elixir compresses.
Received 1st dose Pfizer COVID19 vaccine 3/19/2021. Throughout day, patient reported having "unusual symptoms" (unspecified). In the evening, patient noticed rash on chin, face, and chest, itchiness of throat and tightness of breathing.  Treated with epinepherine and benadryl in Emergency Department.
This case was reported by a other health professional via sales rep and described the occurrence of sickness in a patient who received FLULAVAL quadrivalent. On 2nd October 2015, the patient received FLULAVAL quadrivalent. On 5th October 2015, 3 days after receiving FLULAVAL quadrivalent, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This is one of the 7 cases reported by the same reporter. The reporter indicated that FLULAVAL vaccines were administered to a group of individuals at a company or clinic. The sales rep stated that the reporter said six other individuals called out sick (possibly October 5th) after receiving the Flu vaccine but details were unknown and it was not known if related.
Redness, itching, and swelling at injection site of PNEUMOVAX 23.
Soreness; Itchiniess; Redness raised area on left arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
030B21A - the Lot  number could also be this; The acute symptoms: I had severe chest pain and it hurt quite badly (Thursday). I have suffered from heart problems in the past and the pain did not diminish throughout the entire day. I called my endocrinologist at the time. He said it wasn't related to anything he was doing. On the previous Friday, (the 11th)  I moved my dosage of .25. to .5 -  - Ozempic  - Friday previous to the symptoms starting. It seemed related  to lesser pain I had been experiencing after the change of the dosage to the increase on that of the severe chest pain  - Thursday, then it was my second my dose of the increased Ozempic  that I took and I ended up going in to the hospital  ER. They assumed it was a heart attack. They had to put me on two different massive pain killers because I couldn't take morphine. I had a follow up with my primary. I have an appt with a gastroenterologist soon.
I had a high fever of 102F that started around 10:00pm and lasted until 04:00am. I also felt very tired and with body aches. I did not take any treatment.
incorrect product storage; This spontaneous report was received from a vaccine coordinator and refers to an unknown number of unspecified patients. Information regarding the patients' concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patients were vaccinated with the following improperly stored vaccines: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # T009931, expiration date 16-SEP-2021 and lot # T006792 (rHA), expiration date 24-AUG-2021 administered as prophylaxis; and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T000698, expiration date 07-JAN-2022 and lot # S030227, expiration date 26-SEP-2021 administered as prophylaxis. Caller stated all the vaccines were administered after the previous excursion, however, not administered after the current excursion.  The improperly stored doses of the suspect vaccines experienced a temperature excursion of -9 degree Celsius (°C) to 8°C (+3.1°C) for 1 hour and 45 minutes on 25-SEP-2020; a previous temperature excursion was reported, of -9°C to 8°C (1.3°C) for 2 hours and 45 minutes.  The call was made due to a digital data logger.  This case was classified as non-valid due to no patients identifiers
Severe pain in a site of injection Left deltoid, developed redness, swelling, fever. Treated for Cellulitis with KEFLEX.
-  Started with weakness and ?feeling bad? 03/16/2021 at 4pm.  Stated she developed nausea but no vomiting and severe, jerking chills overnight.  C/o leg weakness that caused her to need assistance of cane to ambulate that night and next day.  3/19 patient saw her PCP and the PCP suggested she report her symptoms to the HCHD.  Patient stated the weakness to her legs is slightly better, but not 100% resolved.
Patient is fully vaccinate.  COVID + on 12/8/2021.  ED visit on 12/8/2021. Pt presented with a cough. 90-year-old female with history of atrial fibrillation, cardiac arrhythmia, hip pain, reflux disease, hypertension, osteoporosis, stroke here from an extended care facility with complaints of a cough over the last week. Cough is nonproductive. No shortness of breath. No fever. No chest pain. She denies any calf or thigh pain.BP 125/65  | Pulse 88  | Temp 98.3 °F (36.8 °C) (Oral)  | Resp 16  | Ht 167.6 cm (5' 6")  | Wt 59 kg (130 lb)  | SpO2 97%  | BMI 20.98 kg/m²  CXR:  There is no radiographic evidence of acute cardiopulmonary disease within the limits of this single view obtained. 2.  Hiatal hernia. No distress. Patient's SPO2 is 96%. No evidence for pneumonia. We'll DC and recommend zinc, vitamin D, 14 day isolation.The patient was advised to follow up with their primary care physician in 2-3 days for re-evaluation or return to the Emergency Department if there were any worsening of symptoms of other complications. Discharge instructions were given and the patient was discharged in satisfactory condition.
Narrative: Pt is a 61 YO male with a PMH of cocaine abuse, atherosclerosis, OSA, HLD, HTN, cognitive impairment, and tobacco use. Pt's death was reported to facility by agency.
This is a serious case from a physician involving pulmonary vascular congestion: unlabelled. The reporter causality is not provided. A 15 year old female, who received FluMist on 22Oct04, experienced difficulty breathing, wheezing and coughing on 30Oct04. The pt was seen at the physician's office where she was given Xopenex (levalbuterol) nebulizer treatments and Decadron (dexamethasone) IM injection. Despite the treatments, the pt went into severe respiratory distress and was brought to the ER and was subsequently admitted on 30Oct04 with a principal diagnosis upon admission of asthma. During the four day hospitalization, the pt received nebulizer treatments, steroids and chest physiotherapy. Chest x-ray revealed pulmonary vascular congestion and cardiomegaly. Peak flow rates were monitored and had an average of 360. The pt was discharged home on 02Nov04 in stable condition with discharge medications of albuterol MDI, prednisone, Seroquel (quetiapine). The pt's clinical outcome is unk. The reporter did not assess relationship between events and FluMist vaccination. Information from missing data report states 04/22/05 per reporter at physician's office, they do not have a record of the Flumist lot number.
After administration, pt presented with itchy/ numb tongue .  Patient  took benadryl  first , after 40 minutes, patient complained of trouble swallowing.  At this time, an ambulance was called to evaluate the patient for anaphylaxis.  She was fine after an hour and EMT sent patient home.
For the first week I could not lift my arm enough to even put my hair in a pony tail. I was up every hour of the night. I?m a college athlete who normally works out find, but due to the shot even now (2 1/2 weeks later) I cannot lift any weight with my left arm. I?ve taken Tylenol almost every day since the shot. The first week my arm throbbed all night long. It?s not as bad now as the first week, but I still cannot lift with my left arm and wake up with a very fatigue arm.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately February 2016 (reported as "since 10-FEB-2016"), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # K021881 with expiration date: 30-JUL-2016; lot # L019835 with expiration date: 23-MAR-2017 and lot 3 L014420 with expiration date: 23-FEB-2017 (exact dose, dose number, route of administration and anatomical location were not reported). There were no concomitant medications provided. Administered doses of vaccines experienced temperature excursion of 48.7 degrees Fahrenheit for 30 minutes. There were no previous temperature excursion. There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain at injection site (still have) Fever of 102 following day and fatigue, it subsided later in the day on 11/10/21 Around noon on 11/10/21 started to get itchy and bumps in a few places (chest, arms, and stomach) This morning I woke up and covered in a rash and itchy.
COVID INFECTION, itching, throat swelling Narrative:  COVID infection after completion of COVID vaccine series 02/09 COVID vaccine dose #1 03/02 COVID vaccine dose #2 03/19 reports to PCP "has been having a rash that seem to be more urticarial in nature and been present for last ~ 2 months; also states occasional lip swelling, not present today, no throat irritation or sob. Itchy. responds to antihistamines. No fever or constitutional signs. He is also reporting bil flank area pain that can be improved or worsened with thorax movement. No cough or fever." 04/22 reports cough, fever, headache, myalgia, nasal congestion (stated started 04/21) 04/23-04/27 asymptomatic
fever of 101 degrees F; body aches; headach; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and no side effect was experienced).   On 1st July 2020, the patient received the 2nd dose of Shingrix. On 2nd July 2020, 1 days after receiving Shingrix, the patient experienced fever, general body pain, headache and malaise. On an unknown date, the outcome of the fever, general body pain, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, headache and malaise to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient did not experience any side effects after her 1st dose of Shingrix.  After 2nd dose of Shingrix the patient experienced fever of 101 degrees F, body aches, headache and feeling unwell.  The reporter did not consent to follow up.
Was vaccinated and got Shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Was vaccinated and got Shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by a doctor's patient via interactive digital media. The patient was vaccinated with shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR053044, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR053044:Same reporter
Fever of 102 within 24 hours of immunization, small pink lesions on trunk.
She states that she received her first Moderna COVID-19 vaccination on 2/5/2021 to the right upper arm. She complains of redness to the arm that has been increasing in size since onset. Per the patient, the area was the size of a nickel the morning after, then grew to the size of a half dollar the day after, and is now about 4 inches wide today. She states that she was instructed to take Tylenol for the pain and was not instructed to take Benadryl. She adds that she had some mild body aches and subjective fever right after the injection, but states that these symptoms have since resolved ever since she has been taking the Tylenol. Patient consulted with her PCP earlier today via video chat who instructed her to come to the emergency department for further evaluation and treatment. Diagnosis: cellulitis
sick; Initial information received on 10-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from consumer/non-hcp.  This case involves Adult of an unknown gender patient who experienced sick ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date. the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Flu shot made me so sick and the booster covid shot has made everyone in my family sick and you people do nothing you should be ashamed of themselves! Paid by the state and government to help kill people."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Acute pulmonary embolism with acute cor pulmonale. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.