chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 51 year old female patient. On 02-APR-2013, the patient was vaccinated with ZOSTAVAX lot # 0422AE and expiry date 27-MAR-2013, .65 ml, subcutaneous. On 02-APR-2013, the patient was vaccinated with expired ZOSTAVAX on 02-apr-2013. No adverse effect reported. The outcome of vaccinated with expired ZOSTAVAX on 02-apr-2013 and no adverse effect is unknown. The reporter considered vaccinated with expired ZOSTAVAX on 02-apr-2013 and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
The next day my upper arm swelled up, the site was warm to the touch and it itched.  This lasted for several days.  I saw my doctor, he said what I had was "Moderna Arm" and gave me info to report it to the CDC so they could follow my progress.  It has been to long for me to remember much more. Check with the CDC for more info.  It was fresh back in February, and I reported it all, at that time.
pt recv vax 28MAR96 & mom stated 1-2 wk p/vax pt had congestion & a rash that only lasted 1 day but w/that rash had edema of 1 hand & both feet;saw MD & was told it was not d/t vax but pt had virus;
Paralzed from the waist down upon entering bed at 10 pm Couldn't get in or out of bed at 10:30 Also had trouble during the night to go to the bathroom
Patient (right) arm was sore and began to become red & swollen over a few days. Patient placed on Keflex by her doctor for skin infection.
patient developed severe chest pain, ambulance was called and patient was taken to ER. Patient was transferred to higher level facility and was told he had a heart attack and that it was caused by a "blood clot"
Woke up at 4:30am with a horrible rash all over arms, legs, torso, head.  Jaw started to stiffen with difficulty breathing.  At emergency room face and lips started to swell terribly.  Throat started to tighten. Emergency staff have given me prednisone, Benadryl and a shot of epinephrine.  They are continuing to monitor me.
Local reaction swollen redness injection site left T size right to left  25 X 25 mm up and down sore and hard.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6206), in left arm, as dose 2, single (Lot number: ER8764), in left arm and on 01Nov2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 37 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications, reported as patient received other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: Positive test 7 days in a row; Negative, notes: Recovered and negative for 3 days; Positive, notes: Now returned symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 13Jun2022 and stopped on 18Jun2022. Clinical course was reported as, Covid rebound started on 23Jun2022. patient took paxlovid. Positive test 7 days in a row. Recovered and negative for 3 days. Now returned symptoms and positive test. No treatment received for Covid rebound symptoms treatment and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
angina pectoris; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (hospitalization, medically significant), outcome "unknown", described as "angina". The event "angina" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: never had covid, notes: Antigens taken, never had covid. That was a disaster; false positive, notes: False positive, ended up in the covid unit.  Antigens taken, never had covid. That was a disaster. Therapeutic measures were taken as a result of angina pectoris.The patient received treatment with nitrates for the event angina pectoris.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (16Dec2021): Follow-up activities closed. Batch/lot number not available.; Sender's Comments: As there is limited information in the case provided, the causal association between the angina pectoris and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Extreme dizziness on first night after receiving 2nd vaccine dose. Stumbled and then fainted, hitting head hard on sink and floor. Awoke to then vomit. Extreme dizziness and vertigo has continued throughout each day and night for 5 days. Additionally, each night I awake every hour having sweat in bed and soaked all sheets.
Pt called 9-19-states went to store and RPh told him to call us and report bruising at site of injection. He stated he noticed the next day a 2x3 inch bruised area where band aid from vaccinations. States rectangle black and blue. He does have a picture-states looks like it's getting better.
Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear; lymph nodes swelling; welts on her arm that are the same on forehead; Pain that goes away and comes back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear), LYMPHADENOPATHY (lymph nodes swelling), URTICARIA (welts on her arm that are the same on forehead) and PAIN (Pain that goes away and comes back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised. Concomitant products included AMLODIPINE BESILATE (NORVASC) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear), LYMPHADENOPATHY (lymph nodes swelling) and PAIN (Pain that goes away and comes back). 29-Jan-2021, the patient experienced URTICARIA (welts on her arm that are the same on forehead). At the time of the report, RASH (Breakout on her face going down to her neck/Rash has been present in various areas of the face for approximately 12 days/Rash on ear), LYMPHADENOPATHY (lymph nodes swelling), URTICARIA (welts on her arm that are the same on forehead) and PAIN (Pain that goes away and comes back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was using cellecept.   This case was linked to MOD21-060009 (E2B Linked Report). This case was linked to MOD-2021-071068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-060009:crosslinked
Headache 3 hours post injection. Started feeling body aches within 6 hours. Got home and took off scrubs to find swollen hard injection site, very hot to touch. Had to take off work the next day due to severe muscle aches and lethargy. That night had fever of 102.4 and chills.
flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not was reported. The age group selected as per vaccine specification.  The patient reported flu like symptoms after receiving a dose of shingrix. This case was linked with cases US2019AMR165394 and US2019AMR165390, reported by the same reporter.
After receiving both vaccines, patient complained of the following symptoms later in the evening;Entire mouth and lips were swollen and blistered, Palpitations and hot/cold flashes, light-headed and dizzy, generalized weakness (legs buckled), lost appetite and sharp pains across lower back
at 6 hours post vaccination, pt was seen in ED for racing heart, facial redness and swelling.
Redness around site, pain with movement remaining steady, swelling, with swelling growing in diameter post-injection (on day three it's the size of 1.5 half-dollars).
After getting the vaccine, I had a fever and a headache. I could not work for 2 days. In May, after getting the vaccine, I started having some discomfort and my left side, close to my kidneys, got swollen. I have been feeling very tired since then. On 05/24/2021, I went to the doctor, and he did an x-ray. Everything came back normal. He did not give me any medications. I have a follow up on 11/9/2021 to see if there are any improvements. This week it started to get swollen again. I cannot sit for a long time because I start to feel that discomfort again.
Arm was sore; Red blotch 4 inch long and 6 inch wide at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red blotch 4 inch long and 6 inch wide at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red blotch 4 inch long and 6 inch wide at injection site). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE ERYTHEMA (Red blotch 4 inch long and 6 inch wide at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. Treatment details included ice patch and hot compress.
Stuffy nose; headache; Sore arm on Thursday; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), MYALGIA (Sore arm on Thursday) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included PAROXETINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced MYALGIA (Sore arm on Thursday). On 02-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (Stuffy nose), MYALGIA (Sore arm on Thursday) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.
Patient had flu vaccine on 11/5/18. Went back to school and participated in gym class. The next day, patient participated in gym class again with weight lifting. The evening of 11/06/18 pt started having pain in upper body and abdominals. Pt presented to the ED on 11/9/18 for worsening symptoms. Initial labs show CK Total to be 29,376. Pt admitted to hospital and discharged on 11/11/18. Pt came to clinic for follow up care and labwork. Pt is doing better but still having muscle weakness and some back pain. Pt was diagnosed with Rhabdomyolysis.
Patient is a 84 Y  male with a history of hypertension, hyperlipidemia, CKD stage 4, prostate cancer, peripheral artery disease (s/p bypass), polymyalgia rheumatica, recurrent left pleural effusion s/p left pleurodesis on 5/2022 recent left hip replacement 2/1, presents with shortness of breath for 1 day. Per patient he was with his son over the weekend who tested positive for COVID-19. He states that his weight has been increasing. He previously was 200lbs then lost weight to 170s then now increased back to 185lb due to poor diet? Patient reports since his hip surgery he has not watched his diet. He endorses PND and orthopnea but denies chest pain, fever, shakes, chills, cough, nausea, vomiting, diarrhea, chest pain, abdominal pain. He has productive white phlegm. Patient found to have SpO2 88-89% on room air improved with 1L oxygen. Hypertensive 199/76. COVID+. Chest x-ray with mild pulmonary edema and left sided pleural effusion. BNP elevated 2061. He received IV Lasix 40mg X 1. Consulted for hypoxemia.
Fever, head ache continuously from 2nd day of vaccination. didn't  took any medication for 9 days. on 13th may, took 1 tablet Tylenol
Information was received from a lawyer regarding a case in litigation concerning a female patient, history not provided. In 2016, at approximate age of 68, the patient was administered ZOSTAVAX by a healthcare provider. On an unknown date, the patient was treated by a physician for the following injuries resulting from ZOSTAVAX user: shingles. Outcome of shingles was not provided.  Additional information has been requested.
I exp incontinence, nause, fatigue due to the flare up lost weight the symptoms lasted a month.
pt recv vax & devel a fever to 105 & a very large inj site reaction;pt recovered;
numbness and tingling; numbness and tingling; swelling on the face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness and tingling), PARAESTHESIA (numbness and tingling) and SWELLING FACE (swelling on the face) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, 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 HYPOAESTHESIA (numbness and tingling), PARAESTHESIA (numbness and tingling) and SWELLING FACE (swelling on the face). At the time of the report, HYPOAESTHESIA (numbness and tingling) and PARAESTHESIA (numbness and tingling) outcome was unknown and SWELLING FACE (swelling on the face) had resolved.            No concomitant medications were provided. No treatment drugs were reported.
This spontaneous report was received from two medical assistants referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of VAQTA (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider 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 22-JAN-2014, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 21-NOV-2015, the patient was treated by a healthcare provider 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. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Patient states is feeling "sick" including sore throat and runny nose.  Patient also notes that he is bleeding from the mouth, nose, and rectum which started approximately at 9am this morning. Patient notes bleeding is not heavy. States when he sneezes, he can tell bleeding is coming from his throat which his throat is sore.   Patient questioning if related to the Jynneos Vaccine (2nd dose) which he received yesterday in the clinic around 4:15 pm. Patient encouraged to call PCP regarding bleeding and/or seek medical attention if bleeding is moderate/severe and/or persists.  Patient declines taking any aspirins/blood thinners/ or anticoagulants. Patient states at home COVID test negative; patient encouraged to schedule PCR test.
Administered vaccine after vial being punctured 16 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after vial being punctured 16 hours ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after vial being punctured 16 hours ago). On 02-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after vial being punctured 16 hours ago) had 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.   The reporter stated that the facility administered a vaccine from a punctured vial that was left over night in the counter. They left a punctured vial at 10 pm over the counter and administered it at 1 pm the next day to a patient. The punctured vial was sitting at room temperature for 16 hours.  No concomitant medication information was provided. No treatment medication were provided.
Pt recvd HIB vax & 2 months following vax it was noted that the pt had devel a small nodule @ inject site;
injection site arm was red and hives. patient went to urgent care on Saturday night and was told the arm was infected and started doxycycline treatment. When it did not help, patient went to ER and was told it was anaphylactic reaction. patient was given Benadryl.
Received Moderna Vaccine #1 on March 19. About 8 days later, noticed a large (2" diameter) red welt around the injection site. The welt was hot to the touch, raised, and itchy. On Day 9 the welt had reduced in size, but the redness and itchiness remained. By Day 11 all symptoms were gone.  The only treatment was an ice pack on the affected area with the onset of symptoms for the first day.
Swelling and pain at site of injection about 24 hours afterwards. Heating pad helped with pain now resolved 48 hours post. Edema improving, mild erythema, no fevers no warmth, prescribed ice and Ibuprofen.
vaccine contained large amount of sediment which will not resuspend.  Also, reporter states that he has not seen an increase in the number of reactions; however, he has noted more severity of local rxns, more than nl temp and knot under skn
Queasiness; headache; dizziness; Queasiness, headache, dizziness. Which keeps progressing; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EN6200) via an unspecified route of administration in left arm on 14Feb2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not take any other medications in two weeks. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. On 14Feb2021 at 13:15, the patient experienced queasiness, headache and dizziness which kept progressing. Patient did not receive any treatment. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever 101 F°), chills and myalgia in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included diabetes. On Jan 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced pyrexia  (fever 101 F°), chills and myalgia. At the time of the report, pyrexia (fever 101 F°): resolving; and chills and myalgia outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information provided. This case linked to MOD-2021-018128 (patient link).