chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (RN) concerning a 20 week old male who on 17-MAY-2007 was vaccinated with Rotateq PO first dose. No adverse reactions were reported. Information has been received from a registered nurse concerning a 20-week-old male who on 17-MAY-2007 was vaccinated PO with the first dose of ROTAVIRUS live. It was unknown if medical attention was sought. No adverse reactions were reported. Follow-up information indicated that the patient was never adminstered a dose of ROTAVIRUS  vaccine live. Therefore, WAES0707USA03131 will be deleted from our files for ROTAVIRUS vaccine live. Additional information is not expected.
ill; severe flu-like symptoms; fever; chills; body aches; headache; nasal congestion; chest congestion; sneezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion) and SNEEZING (sneezing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion), SNEEZING (sneezing), COUGH (coughing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, ILLNESS (ill), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), NASAL CONGESTION (nasal congestion), CHEST DISCOMFORT (chest congestion), SNEEZING (sneezing), COUGH (coughing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.
At the time the shot was given, the patient reacted as though the shot was very painful. One week later she came back and advised that her arm was so sore that she was unable to raise it. I examined the shoulder and there was no sign of swelling or discoloration. I advised the patient to see her primary care and as soon as possible. I then called Dr.'s office to advise them of the reaction and spoke to staff.
Moderna vaccine given expired 10/24/2021. Monitoring vitals; stable; no complaints at 14:00.
two children age 8 and 9 were given RECOMBIVAX HB 1.0ml dose inadvertently; two children age 8 and 9 were given RECOMBIVAX HB 1.0ml dose inadvertently; This spontaneous report was received from a consumer referring to a 8 year old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 09-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1.0ml dose inadvertently (lot # T016182 with expiration date  25-JAN-2023; route was not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA009082:
itch around injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (itch around injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itch around injection site). At the time of the report, VACCINATION SITE PRURITUS (itch around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient did not receive any treatment for the event.    Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Since receiving vaccine I have been dealing with unmanaged rash. This has resulted in 2 urgent care visits and several visits with dermatologist. It started with a rash to left arm. It then progressed to both arms and both ankles. Now it is on both arms, both ankles, left side, lower back, and neck. I have done oral prednisone, dexamethasone, doxycycline.  Topical I have tried triamcimilone, clobetasol, betamethasone, non-steroidal cream, and several moisturizers and soaps recommended by dermatologist. Also did 3 months of every 2 week injections of Dupixent.
Swelling of face, eyes and lips that occurred 5 times with the first on 11/2/21; extreme exhaustion
COVID-19 breakthrough. It started with fatigue. I still have a little fatigue but not that much. I also had congestion and coughing. I had a slight fever at the beginning but I don't have that now.
Information has been received from a registered nurse concerning a male (age unknown) with no medical history and no drug allergies, who on 21-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). Concomitant therapy included carvaedilol (COREG), candesartan cilexetil (ATACAND) and clopidogrel bisulfate (PLAVIX). On 22-NOV-2007 the patient developed severe swelling on the whole upper arm, redness, pain, and inability to use the arm. The patient experienced tingling and pain at the arm and ribs. The patient developed reddish vertical streaks that were observed on the arm near or at the injection site. The patient contacted the office. No laboratory diagnostics were performed. The patient recovered after several days on an unspecified date. No product quality complaint was involved. This is one of two reports from the same source.
8:55AM client had immunizations, 9:00AM client was standing beside mother while checking out of clinic.  Became pale and sat down on floor; pale skin, eyes non focusing, able to talk. Had no bkft, recovered in 5 mins.
Pt leg crying and irritability, starting 4 hours, post vax. Crying X 15 hours; glazed eyes; vomiting X 2; diarrhea X 4; febrile to 101.2F; decreased movement of left side. Unable to move left leg or arm at all by 04:00 the next day. Resolved by itself in 2 days. Pt examined by MD. Decreased movement on left side noted. No follow-up done.
Numb around I got the shot, got particularly swelling just like a little wound; Numb around I got the shot, got particularly swelling just like a little wound; Feeling uncomfortable; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 23Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numb around i got the shot, got particularly swelling just like a little wound and feeling uncomfortable on an unknown date in Jul2021. No treatment was given for the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 38-month-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 08-Jan-2012. On 09-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 02-Apr-2012: The patient had no late occurring adverse events.
inconsolable crying and R leg swelling.  Evaluated in ER-improve with Benadryl.
Patient returned to office with redness and swelling near vaccination site. Patient was given 1 gram of Rocephin DM in the office. Patient went home, was given Benadryl, and returned to office on 9/4/08 for a follow up. Patient was seen on 9/4/2008. Redness increased, and three red abscess were noted in vaccination site. Patient was admitted to hospital to culture abscess for MRSA.   9/19/08 Reviewed hospital records of 9/4-9/5/2008. FINAL DX: cellulitis right leg Records reveal patient experienced right leg injection site warmth, pain, swelling, erythema, difficult to walk.  Similar reaction to past vaccinations.  Improved w/antibiotics & d/c to home on continued oral antibiotics.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: ONE MINUTE AFTER GIVEN VACCINE AT 5:15PM PT FAINTED WHILE ON THE CHAIR INTO SPOUSE HANDS, UNCONSCIOUS ,COLD CLAMMY. RPH PLACED PT FLAT ON THE BACK WITH LEGS ELEVATED. ONE LATER CALLED 911, HOWEVER PT RECOVERED ALERT AND ORIENTED X3. PER SPOUSE CONFIRMATION 911 CANCELLED. AT 5:17 BP 113/58, HR 48. MONITORED PT FOR 30MINS. AT 5:36 BP 103/59, HR 48,  SPOUSE SAID HR TYPICALLY LOW.  C/O DIZZINESS BUT CAN STEADILY WALK. PT LEFT PHARMACY WITHOUT FURTHER CONCERN. ADVICE TO REST IN COLD QUIET PLACE.
Measle type rash , worse on this second injection. very bad on the arm where I ejection was given . ( on bottom side of arm ( rash all over body )
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-365178, MOD-2021-363245, MOD-2021-363032, MOD-2021-363226 (Patient Link).
she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.
Extreme fatigue; Headache; Whole body nerve pain; Sweating/fever; Sweating/fever; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 15:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 29Apr2021 at 14:00, the patient experienced extreme fatigue, headache, whole body nerve pain and sweating/fever. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, headache, whole body nerve pain and sweating/fever was not resolved at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 17-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K010016, expiration date 05-AUG-2015 (route was not provided). Concomitant therapy information was not provided. On 17-OCT-2015, there was an expired product administered as the patient received an expired dose of PNEUMOVAX 23. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Left arm numbness that progress to my left neck, left face and left lips - symptoms started less than 10 min the vaccine was given .
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002936: US-009507513-2105USA002932: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002935: US-009507513-2105USA002866:
in March two weeks after the shot, I was getting ready to go to bed and going up the stairs and I was super dizzy and I had to crawl and felt the whole room was spinning and arrived to my room and had to sit on my chair. It didn't last long. I waited for it to stop. Went to bed still a little dizzy. Never had vertigo before. I called the next day to the nurse.
Information has been received from an office manager via a company representative referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified day in April 2018, reported as "sometime last week", the patient was vaccinated with GARDASIL 9, by intramuscular route (1 DF; strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. After receiving GARDASIL 9, the patient experienced a fainting episode (syncope). The outcome of syncope was unknown. The causality assessment between therapy with GARDASIL 9 and the event was not reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was reported. Follow up information has been received from the physician on 02-MAY-2018, referring to a 15 year old male patient. The patient had no concomitant medications, no illness at time of vaccination, no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient had no adverse event following a prior vaccination. No vaccinations within 4 weeks prior to 02-APR-2018 was given to the patient. On 02-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot# reported as N02292, expiration date were not reported) in the left arm. On the same day, the patient experienced fainting spell which was recovered on an unknown date in 2018. No treatment was given to the patient.
Patient received Moderna COVID 19 at COVID Vaccine outreach. Prior to administering vaccine patient was screened for any severe reactions to a vaccine or allergies. After patient was administered vaccine by MA at 1025 am and as waiting out her fifteen minutes post vaccination and began to 'feeling funky' according to patient. States that this is what happens when she has had a reaction in the past and then progressed to coughing and itching without hives.Patient did have flushing and redness of skin. RN attended to patient and her heart was in the 70's. RN gave 50mg IM Benadryl and EMS was called. EMS arrived and patient was checked out and cleared to leave. RN's were there to help pot benadryl administration.
myalgias,  chills, anorexia, vomiting for 2 weeks
p/a bath dad noticed pt eyes rolled back then arms became stiff then legs;same events occurred x 4;
pt recvd vax 21DEC93 & on 25DEC93 lethargic all day w/unusual eye movement & staring spells; 26DEC93 pt hospitalized for 7 days-no fever; CAT Scan & MRI reveal fluid to rt side of brain; pt d/c w/meds w/o good sz control;
shakes; difficulty walking; This is a spontaneous report from a non-contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. It was unknown if the patient received other vaccines in four weeks. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shakes and difficulty walking. The reported events resulted in Doctor or other healthcare professional office/clinic visit and hospitalization on an unspecified date. It was unknown if the patient had COVID-19 prior to vaccination and it was unknown if she was tested for COVID-19 post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness, Myalgia & Fever  Narrative: Felt dizzy and feverish (99.8), left arm tender, felt better after taking OTC Tylenol and Iburofen.
Two pustule filled sacs appeared the next day at the site of injection with tingling/nerve pain also at the site of injection. Patient called doctor and explained to him symptoms and was not prescribed any antivirals or pain medications as it was mild in nature. Patient states it resolved on its own approximately 2 to 3 weeks after appearing.
Arm was sore; Felt like had a bad flu; Headache; Achy body, flu like pain; Nauseous; Felt bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was sore), influenza-like symptoms (Verbatim: Felt like had a bad flu), headache (Verbatim: Headache), general body pain (Verbatim: Achy body, flu like pain), nausea (Verbatim: Nauseous) and feeling bad (Verbatim: Felt bad). The outcome of the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad were not reported.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, influenza-like symptoms, headache, general body pain, nausea and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient went to pharmacy this past monday and got first shingles vaccine. The patient arm was pretty sore the next morning, and he/she felt like he/she had a bad flu. achy body and a headache, nauseous.  Even though patient felt pretty bad. The patient sure from what he/she have read and seen on people. The patient know who have had shingles her/his flu like pain does not compare. The patient will get his/her next vaccine in 6 months.  the patient stated that everyone should get the vaccine like he/she did. even if he/she would get shingles, hopefully it won't be a bad case. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.