chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an unspecified reporter via company representative referring to 3 patients of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL intramuscular injection (dose, lot # and frequency unspecified). No concomitant medications were reported. On an unknown date, 3 of the patients experienced syncope after receiving GARDASIL 9. Reporter states no other known information concerning this event. No further information reported. The outcome of syncope was unknown. Causality assessment was not reported. Additional information has been requested.
had period of screaming on Mon; probably from being tired; no fever @ that time 22MAR93 on 29MAR93; fever of 101 & rash has become generalized; referred to MD due to screaming on 22MAR93; MD say no ear infect or other problem;
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medications was reported. The patient received half dose of Moderna vaccine. They administered the vaccine to 346 patients after the 30 days by used and total Number of vials was 35. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected. No treatment medications was reported.
Prior to the vaccine patient and parent were given teaching about concerns for fainting.  She was questioned if she had something to eat and drink prior to coming to the clinic and both indicated that she had.  It was volunteered that patient has never had a fainting spell from receiving injections/vaccines.  She was administered 0.3 ml of the Pfizer vaccine at 4:47 p.m. while seated securely in a chair.  At about 4:50 p.m. she lost consciousness and assumed a prone position.  She was held by both the R.N. and her mother and never fell or injured herself.  She was unconscious for approximately 8-10 seconds and regained consciousness.  She was alert and oriented.  She was reassured and given some apple juice and a graham cracker which she consumed.  Charge nurse and nurse manager appeared on the scene.  EMT was summoned who brought a wheel chair and patient was transported to the observation area in the wheel chair.  She was conversing and appeared oriented prior to going to the observation area.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX. Concurrent medical conditions included oral herpes. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. During the call, the patient mentioned 2 occurrences of shingles. The 1st outbreak was managed with valacyclovir which did not work. The patient, sounded as if she had not received SHINGRIX but at end of the call, the patient stated that, she received 1st dose of SHINGRIX. Unable to clarify the timeline of shingles outbreaks in regards to the SHINGRIX administration. No further details were provided.
headache, body ache, nausea,  chills, weakness the second day , took Tylenol, better today but still fatigue
Flu-like symptoms. Woke up with lethargy, chills, body aches, loss of appetite, and moderate pain at injection site. Lasted from 5/7/21 at 5am until 5/8/21 around 6pm. I took Tylenol 500mg every 6 hours, rested, and drank lots of fluids.
he has Covid-19; he has Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he has Covid-19".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported injection site pain initially.  Later pain moved to entire body to include underarm, breast, neck and chest.  She experienced a fever of 104 with chills.  Swollen Lymph nodes
DEEP VEIN THROMBOSIS IN RIGHT LEG (PAIN AND SWELLING); This spontaneous report received from a physician concerned a 69 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial fibrillation, and sedentary lifestyle.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. Concomitant medications included apixaban for chronic atrial fibrillation. It was stated by internist that, on 26-APR-2021, the patient experienced deep vein thrombosis in right leg with symptoms pain and swelling, and was hospitalized on unspecified date. On unspecified date doctor was screening patient for covid-19 infection. On 27-APR-2021, Laboratory data included: Platelet count (NR: not provided) 167000. Laboratory data (dates unspecified) included: Duplex ultrasound (NR: not provided) definite clot in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis in right leg (pain and swelling) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210455157-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Deep vein thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Patient reports hives to face, fever, aches and chills for 3-4 days after receiving the influenza vaccine. Also stated he had a similar reaction to the vaccine the year before.
41 yo female received J&J Covid vaccine on 11AUG2021 at Health Department. Pt states left arm began to feel numb, tingling, within 30 minutes of vaccine. The numbness and tingling described by the patient spread to pt's face, head, neck and right wrist. Pt was evaluated at local urgent care and advised of possible histamine reaction with recommendation for ibuprofen and prednisone. Symptoms have worsened over 8 days reporting heaviness in left arm with continued left arm tingling and numbness. Mild bruising noted at injection site, pt denies pain, redness or rash. No previous immunization reaction reported by pt.
vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Dairy" (unspecified if ongoing); "vaccine dose number=3 Pfizer, vaccine dose number=2, 1 Moderna" (unspecified if ongoing), notes: vaccine dose number=3 Pfizer, vaccine dose number=2, 1 Moderna. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had treatment Paxlovid from 27Apr2022 to 02May2022 as treatment of COVID-19. The patient received other medication in two weeks as birth control pills.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
About 3 hours before bedtime she started having decreased sensation of her left hand.  Involved her entire left hand from the wrist down.  By morning, her numbness had resolved entirely.
Patient developed a throbbing headache (mainly to right temple that will radiate to the forehead) and left sided neck pain. She feels like her neck is stiff. No numbness/tingling to arms/hands. Also complains of a white patch like small rash on right index finger and third digit, starting today. Denies touching anything. Rash is itchy. Presented to ER for evaluation.
Hematuria occurred less than 24 after booster that lasted for 3 days; Protein in urine occurred less than 24 after booster that lasted for 3 days; Dose received=3; Menstrual cycle (off by 7 days); This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 at 14:00 (Lot number: FD0809) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hepatitis B" (unspecified if ongoing), notes: Hep B and "Hematuria" start date: an unknown date in 2017 (unspecified if ongoing), notes: (2 times - 2017 and 2018). Concomitant medication included: TENOFOVIR DISOPROXIL FUMARATE 300 mg. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0171; Anatomical site: Left arm; Administration time: 12:00; Route of Administration: Unspecified), administration date: 26Apr2021, when the patient was 35 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7533; Administration time: 11:00; Route of Administration: Unspecified), administration date: 05Apr2021, when the patient was 35 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 at 14:00, outcome "unknown", described as "Dose received=3"; HAEMATURIA (non-serious) with onset 28Nov2021 at 08:00, outcome "recovered" (01Dec2021), described as "Hematuria occurred less than 24 after booster that lasted for 3 days"; PROTEIN URINE PRESENT (non-serious) with onset 28Nov2021 at 08:00, outcome "recovered" (01Dec2021), described as "Protein in urine occurred less than 24 after booster that lasted for 3 days"; MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), described as "Menstrual cycle (off by 7 days)". The events "Hematuria occurred less than 24 after booster that lasted for 3 days", "Protein in urine occurred less than 24 after booster that lasted for 3 days" and "Menstrual cycle (off by 7 days)" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of haematuria, protein urine present and menstruation irregular.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a physician concerning a 15 year old female with no medical history and drug allergies who, on an unspecified date, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient had experienced hip pain, lower back pain and headache after receiving the first dose of GARDASIL. It was noted that she had experienced pain in both of her hips but the left side had more pain than the right. The pain in her hips had made it difficult for the patient to participate in her soccer games. The patient sought medical attention and was seen by physician. The lot numbers and dates of administration were unknown. At the time of reporting (20-FEB-2009) the patient was recovering. The reporter considered the adverse experiences to be disabling. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 12:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 12:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.74.  Concomitant products were not provided.  On 13-Jan-2021, 30 vials were sent to clinic. On 09-Feb-2021, Vaccine was moved to fridge and On 14-Feb-2021, Temperature excursion reported as 32 degree fahrenheit at 09:00 AM, 10:00 AM, and at 11:00 AM and 35 degree fahrenheit  at 02:00 PM and at 03:00 PM. Vaccine BUD date was reported as 10-Mar-2021  Condition of vaccine prior to administration was not frozen. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt arm swelled up right after needle was pulled out and a bruise formed. We had her wait around for 20-30 minutes recommended her to take BENADRYL and ice arm when she got home. Pt felt fine swelling went down before she left. Told her it takes up to 24 hours for an allergic reaction and to have someone watch her and to go to ER if breathing issues happen.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PEDVAXHIB, with lot number M001814 and expiration date of 15-OCT-2018 (strength, route of administration and dose were not reported), which was stored at 48.6 Fahrenheit degree for 128 hours and 15 minutes. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Patient stated had reaction to PNUEMOVAX site on injection pain, red from inner elbow to top of shoulder as well as neck tenderness for 3 days (right arm).
(R) upper arm 3.5 x 2.5 inch red, warm, swollen area 6/10 pain. Feels tired and has headache.
Patient said he developed a red eye the next day, as if he had a broken blood vessel in his left eye.  He is unsure if this is related to the FLUZONE vaccine, but wanted to report anyway.
Very sore arm at injection site, within two hours, started feeling lightheaded, feverish, and achy. The next day I had moderate body aches, a fever of 101.5, a tender lymph node in my neck, and a rash on the torso.
Fever up to 101.9 rectally. Still having fevers on and off that come down with Tylenol and Motrin.
Information has been received from a RN concerning a 14 month old pt who on 8/7/03 was vaccinated with a dos eof Comvax (643889/0855M). The Comvax was given for the third dose of hep B vaccine recombinant and the fourth dose of Haemophilus B conjugate vaccine. On approximately 9/2/03, a month after vaccination, the pt still had swelling and induration at site of injection on the leg. The pt will be seen in the physician's office on 9/3/03. Unspecified medical attention was sought. There was no product quality complaint. Follow up info indicated that the "mother never brought the child in for evaluation." The reporter noted that the findings of the office concluded that the adverse events were not a result from the Comvax. No further info is expected.
No reported adverse reactions from 1st or 2nd vaccine doses Patient died on 2/6/2021 at Correctional facility- autopsy was performed at medical examiner's office. The COD was artherosclerotic cardiovascular disease
SWELLING AND PAIN IN HAND AND WRIST IN RIGHT ARM (WHICH IS THE ARM THAT WAS VACCINATED).   PAIN AND HEAT AT SITE OF VACCINATION.  INTENSE ITCHING, SORENESS AND REDNESS WHICH BEGAN 2 TO 3 DAYS AFTER VACCINATION OVER INJECTION SITE. THE PINK/RED, ITCHY,  RASHY AREA HAS NOW DESCENDED TO HER ELBOW, IS SLIGHTLY SWOLLEN, 3 INCHES BY 5 INCHES (NO LONGER OVER INJECTION SITE)
Patient received a dose after the vial was punctured more than 20 times.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (Patient received a dose after the vial was punctured more than 20 times.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 026A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT PREPARATION ERROR (Patient received a dose after the vial was punctured more than 20 times.). On 08-Nov-2021, PRODUCT PREPARATION ERROR (Patient received a dose after the vial was punctured more than 20 times.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non-Significant follow up, contact information updated.
Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Systemic: Visual Changes/Disturbances-Severe
Giant red blister burst in right eye; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced giant red blister burst in right eye.  The patient's medical history was not reported. Concomitant medications of blood pressure medications and thyroid medications.  On 03 Feb 2021, approximately two days prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient experienced medically significant event of giant red blister that burst in right eye overnight. Vision was okay and patient does not feel pain. The patient was going to see ophthalmologist. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event giant red blister burst in right eye was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Deep muscle ache and severe pain. Swelling in location of vaccine administration - LVG.
It was reported that an 18 year old male received a Fluzone SV '99-'00 vaccination as well as a PPD-Tubersol skin test on 12/29/99. Approx. 5 hours, post vax, the pt developed dizziness. In the morning of 12/30/99, the pt developed heaviness in chest and a hoarse voice. Pt denies any difficulty breathing. From correspondence received on 1/17/00, additional pt and responsible physician information was provided.