chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician's assistant and described the occurrence of shortness of breath in a 19 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history included "mild" asthma since childhood that was "generally triggered by hot weather", and tobacco use (less than one pack of cigarettes per day). Concurrent medications and unspecified oral contraceptive, salbutamol inhaler used as needed, and cetirizine (Zyrtec).  On 07/01/03, the subject received her first dose of Engerix-B.  On 07/002/03, the pt presented to the physician with "upper respiratory symptoms" and shortness of breath, which had begun 10 hours post-immunization.  The symptoms were unresponsive to salbutamol metered-dose inhaler. Other treatment was not specified.  The reporter stated that the pt did not return to the physician's office, so the events had "likely resolved".  The reporter considered the events to be possibly related to Engerix-B or to a "concurrent URI (upper respiratory infection)/mild asthma flare."
This case was reported by a consumer via interactive digital media and described the occurrence of pain in spine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (patient had a very mild case of the shingles many years ago). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in spine, burning sensation, pruritus and pain. On an unknown date, the outcome of the pain in spine, burning sensation, pruritus and pain were not recovered/not resolved. It was unknown if the reporter considered the pain in spine, burning sensation, pruritus and pain to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had a one spot on head and one on tongue. The patient did have the shingles shot way back when. At the time of reporting, patient had pain alongside spine radiating outward. It's a burning, stabbing itching pain.
Information has been received from a pharmacist concerning a 14 year old female who was vaccinated with two doses of GARDASIL. There was no concomitant medication. Subsequently, "one day after the second dose", the patient's leg became aching, not debilitating. It was reported that the patient recovered, but no time to recovery reported. This is one of several reports from the same source. Additional information has been requested.
The evening she received the vaccine, her arm was sore and itchy. Next day it was warm to the touch and very sore when lifting arm up. She then took Extra-Strength TYLENOL. Also said it was red all the way to her elbow area.
pt recv vax 20MAY96 & 15MAY97 pt devel a more mild case of varicella consisting of a rash of 15-20 vesicles primarily in the trunk area;
a lot of swelling; not well enough; soreness/ achiness; huge rash on my arm; headaches; fever finally broke today; fever for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm) and HEADACHE (headaches) 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.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (fever finally broke today). On an unknown date, the patient experienced SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm), HEADACHE (headaches) and PYREXIA (fever for 3 days). At the time of the report, SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm), HEADACHE (headaches) and PYREXIA (fever finally broke today) outcome was unknown and PYREXIA (fever for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
No adverse effect; Patient inadvertently received an expired dose of MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age.    On 17-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N024696 for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT).   On 17-APR-2019, 1 day after onset of therapy the patient experienced expired product administered.  On an unknown date the patient experienced no adverse event.
reports large painful axillary lymphadenopathy in L arm, has been applying heat to site with no relief, advised to f/u with PCP regarding symptoms
Temperature approx. 101F, headache, total body ache and especially joints, fatigue, sore throat, chest congestion and coughing up blood. Sought medical treatment from family MD on or about 11/20/01. Dx'd with bronchitis and put on Z-pack antibiotics. Asthma was triggered and is continuing.
After vaccines pt was fatigued, took at nap. Mom heard pt whining, attempted to give a pacifier which did not help. Mom picked up patient to nurse, he was completely limp, skin pale, seemed unresponsive, eyes rolling back. Called 911. Improved alertness by the time paramedics arrived. Pt was warm to touch. Pt was seen in ER- pt febrile T 100.8 and tachycardia present (198 BPM).
Initial unsolicited report received from a nurse on 06 February 2016. This case involves a 47-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On 02 February 2016, following the vaccination, the patient felt sick. On an unknown date, the patient was tested in health center with positive flu. It was a vaccination failure. It was reported that, the patient had restriction as "not work until 08 January 2016". The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: tested with positive flu and vaccination failure. List of documents held by sender: none. As with any vaccine, Influenza vaccine may not protect 100% of susceptible individuals. Additional information on the vaccination details, time to onset, tests performed to confirm Influenza infection, the strain identified, as well as the patient's immune status at the time of vaccination would be helpful to further assess this case. Based on the available information, a role of the vaccine cannot be assessed.
7 days after shot injection site became red and swollen, hot to the touch.  Painful to touch.
Tinnitus after 2nd dose - started 10 hours after and still continuing after 24 hours when I?m reporting this   Arythmia few minutes after first dose. Lasted a few hours and no issues since
Beginning 4/12/22: Pain and tenderness at injection site, headache,  nausea, arthralgia, inappetence, fatigue, lightheadedness, weakness, fever (39.1°C)   Beginning 4/14/22: Elevated heart rate, elevated blood pressure, palpitations, chest pain, fatigue, weakness, lightheadedness, exercise intolerance, shortness of breath
Patient stated that shortly after vaccination, he became incontinent and began to have difficulty walking. According to patient, the incontinence became better over time but the difficulty walking became worse to he came to the hospital ( a week after vaccination). Patient has MS but stated he has been stable for years and has never had difficulty walking or been incontinent.
Redness to (L) arm. Hardness to injection sight Benadryl given.
Patient is a 72 y.o. male patient of a MD with history of asthma presented on 7/8/2023 with acute respiratory failure with hypoxia 2/2 pneumonia and COVID. HCP consulted by HCF, for continued post ICU medical care.    Acute respiratory failure with hypoxia and hypercapnia Sepsis POA due to Covid 19 multifocal PNA  AF, WBC normal, CTPA without PE, with R>L infiltrates on exam, PCT normal Needed bipap on admission, now on RA ID and Pulm following; completed dexamethasone and remdesivir    Asthma, not in exacerbation   Follows with Dr. last seen 5/2023.  Denies home oxygen use. Patient denies hx of OSA but states pulmonologist has previously recommended sleep s
patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
More than 36 days after the first dose without receiving the second dose.; Had covid; got sick; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.), COVID-19 (Had covid) and ILLNESS (got sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.), COVID-19 (Had covid) and ILLNESS (got sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) had resolved and COVID-19 (Had covid) and ILLNESS (got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included a monoclonal antibodies infusion (Regeneron).
HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and nausea. This report was non-serious.
Fever greater than 100 x 72 hours; vomiting; migraine; generalized erythematous rash to trunk, neck, thighs; myalgias; arthralgias; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Oct2021 11:00 (Lot number: FC3180) at the age of 55 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 08:00, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 55 years old, for Covid-19 immunization; Bnt162b2 (Dose number=1, Dose lot number=EK5730, Location of injection: Left arm, Vaccine Administration Time: 08:30, Route of Administration: Intramuscular), administration date: 29Dec2020, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 22Oct2021 04:00, outcome "recovering", described as "Fever greater than 100 x 72 hours"; VOMITING (non-serious) with onset 22Oct2021 04:00, outcome "recovering", described as "vomiting"; MIGRAINE (non-serious) with onset 22Oct2021 04:00, outcome "recovering", described as "migraine"; RASH ERYTHEMATOUS (non-serious) with onset 22Oct2021 04:00, outcome "recovering", described as "generalized erythematous rash to trunk, neck, thighs"; MYALGIA (non-serious) with onset 22Oct2021 04:00, outcome "recovering", described as "myalgias"; ARTHRALGIA (non-serious) with onset 22Oct2021 04:00, outcome "recovering", described as "arthralgias". The events "fever greater than 100 x 72 hours", "vomiting", "migraine", "generalized erythematous rash to trunk, neck, thighs", "myalgias" and "arthralgias" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, vomiting, migraine, rash erythematous, myalgia, arthralgia.  Additional information: Antiemetics, steroids, analgesics was used for adverse event treatment. No other vaccine was received in four weeks. Patient did not had covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
I21.4 ACUTE NON ST ELEVATION MI 5/2/2023 ELEVATED TROPONIN I
Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: Ek5730), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site rash, vaccination site pain.   Additional information: It was reported that, On 10Sep2022 06:30 AM, Left arm puritic rash with pain 4x6 cm. Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine, with outcome Recovering. The patient received treatment as Tylenol, steroid ointment. The patient did not receive other vaccine in four weeks. Other medication in two weeks included Tylenol, claritin, Flonase. There was no covid prior vaccination. There was no covid tested post vaccination. Other medical history: None
Patient is not yet 18 years of age.  Considered of label use per manufacturer. No symptoms of adverse reaction
Patient did not report any adverse event during administration or the 15 minute wait time.  It was determine at 5:00pm that the patient was administered a Pfizer vaccine past the BUD/time.  Administered at 3:18pm on 9/23 from a vial that remained in the IMZ room from the previous day which was mixed on 9/22 at 12:14pm .  I observed the beyond use time of 6:14pm, however I did not verify the date.  Contacted Pfizer and was informed that there is no protocol for after 24 hours outside of BUD/time.  Consulting the Market Director and Clinical Services team for further guidance.
Prolonged fatigue, nausea, low grade fever, lightheadedness 4 days after 2nd dose and still present 14 days after vaccine dose
Severe pain and swelling joins - felt like they were on fire - recovered in 7 hours  Muscle spasms for multiple hours - seizure like lack of control of muscles randomly across body - still suffering back muscles cramping
9:40 arm itching, redness @ inject site--size of 50-cent piece; 2 welts @ site; 9:45 25mg DPH PO; 10:00 itching all over, to take antihistamine @ home if gets worse; 10:10 R12, face pale, face warm; 10:25 82/40, feels weak; 11:30 chin numb;
About 2 days after DTaP and Prevnar administered, patient developed JRA symptoms--stiff leg, fussy; swollen joints. Patient is still undergoing treatment. Mom is convinced these vaccines gave her JRA even though there is a history in family. Per 60 day follow up: Pt has not recovered. Still stiffness and joint swelling in extremities (continues JRA Sx's) No further comments
developed a rash down face and neck; This spontaneous report was received from a nurse referring to a 40 years old female patient. No illness at the time of vaccination was reported. No known drug allergies was reported. Information about pertinent medical history and concomitant medication was unknown.     On 09-AUG-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# T025369, expiration date 01-DEC-2022; strength and dose were not reported) intramuscularly  in the right deltoid for prophylaxis.    On the same day, 30 minutes after being administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient developed a rash down her face and neck. The patient sought medical attention. The patient was administered acrivastine (BENADRYL) which had addressed the problem. It was unknown if lab diagnostics or studies were performed or not. The patient had recovered from the event on unknown date in August 2021. The reporter consider the event to as attributable to the vaccine. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T025369; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
101.5 fever for two days, extreme sweating, aching of entire body, nausea, headache, exhaustion.
66 year old male presents today with allergic reaction to Pneumovax 23, Lot # S026366.  He was given the vaccine on Monday at appt.  Pneumovax 23 was administered  in left deltoid. Flu Vaccine was received in September at Pharmacy.  He stated, " He noticed the Redness, swelling and warmth to bicep, under arm and up shoulder area this morning after showering. Area on bicep looks like a cellultis. No irritation at injection site and No body rash noted. Dr. notified of reaction.  Instructed patient on  OTC anti-histamines, cool wrap to arm and elevation. Patient and wife verbalized understanding.   Instructed  to call if no signs of improvement.  Called director at  Health Department and reported reaction. Also called, Infection Disease. Emailed at pharmacy.  Completed reaction on Portal and completed Vaccine Adverse Event Reporting System (VAERS) online .
This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (During administration of the vaccine the lady stuck the needle inside and after few minutes that was removed), PAIN IN EXTREMITY (Severe arm pain, right before his elbow up to his neck through his shoulder), RASH MACULAR (Hot spots), PAIN IN EXTREMITY (Intense pain in his arm and about 4 inch into the arm) and FATIGUE (Tiredness) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 26-Feb-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 26-Feb-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (During administration of the vaccine the lady stuck the needle inside and after few minutes that was removed). On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Intense pain in his arm and about 4 inch into the arm), FATIGUE (Tiredness) and CHILLS (Chills). On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain, right before his elbow up to his neck through his shoulder) and RASH MACULAR (Hot spots). The patient was treated with PARACETAMOL (TYLENOL 8 HR ARTHRITIS PAIN) at an unspecified dose and frequency and TRAMADOL at a dose of 50 mg. At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (During administration of the vaccine the lady stuck the needle inside and after few minutes that was removed), PAIN IN EXTREMITY (Severe arm pain, right before his elbow up to his neck through his shoulder), RASH MACULAR (Hot spots), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Intense pain in his arm and about 4 inch into the arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product used included blood pressure medications, diabetic medications and pain pill for treatment of pain.  The patient experienced intense pain which he never had in his life. He was taken to the emergency room and pain was so intense which lasted for 3hrs, then it stopped. Doctors have examined him and found nothing, told him nothing wrong and gave him pain pills. He took 2 of them and pain went away.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up SD added on 09-MAR-2021 updated event information and treatment information.
The patient received the Pfizer Pediatric dose undiluted at 0.2ml. The RPh called Pfizer and it was calculated that the patient received double the dose. The employee also informed the patient that there were studies where patient received double and triple the dose. Side effects reported were fever, headache, soreness. Employee informed pt to monitor for local and systemic effects.  The patient has experienced minor pain and arm soreness. Patient's mom states that her daughter says her arm feels heavy after 48 hours. Within 24 hours, patient had no symptoms and went to school as normal. We told the mother we would follow up again in 7 days to make sure she's ok.