chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reaction/itchiness in her chest until it went to her neck; This is a spontaneous report from Pfizer-sponsored program COVAX US Support from a contactable consumer (patient's Husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient received second dose of bnt162b2 on 06Apr2021 for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient finished the 2 doses of vaccine. After she got the 1st dose 2 weeks after she started had this reaction/itchiness in her chest until it went to her neck, the patient was about to take diphenhydramine hydrochloride (BENADRYL) but they want to talk to someone first before anything else. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Tested positive for COVID - minor symptoms; Tested positive for COVID - minor symptoms; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Mar2021 (at the age of 41 years old) (Batch/Lot number was not reported) as dose 2, single; and via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. On 05Nov2021, the patient tested positive for COVID - minor symptoms. The patient received no treatment for the event COVID-19. The events resulted in physician office visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Nov2021. The patient had been tested for COVID-19 post-vaccination. The outcome of the event vaccination failure was unknown and event COVID-19 was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingles-like rash that spread from injection site up and across shoulder approx. 6 inches. This occurs within 2-4 days post shingles vaccine. Itchiness with rash started about 2 weeks later and continued until prescribed triamcinolone (Kenalog) 0.5% cream on 2/3/20 (about 5 months later). Itchiness and rash subsided with use of triamcinolone cream.   Patient also experienced swelling and redness that subsided after a week.  Soreness subsided after 2 weeks.
Vesiculer rash at various stages of healing on trunk, extremities. No treatments attempted. Brought to urgent care for evaluation.
Patient's arm red & swollen (size of her fist) around injection site. Denies fever. Denies SOB.
Patient had two of the GARDASIL shot the first shot was on 2-19-2014 and the 2 GARDASIL shot on the 7-31-2014. And on Aug 4-2014 I call Dr office and I report it in to them that patient did not get any sleep that night. Patient was saying things over and over and patient had a fever and Dr nurse told me to give patient about 1 or two weeks and patient will get better. And that night patient did went to sleep.
Patient presented to the ED and was subsequently hospitalized with anemia within 6 weeks of receiving COVID vaccination.
rash-chest, abdo & arms; first noticed 4 hrs p/inject; seen by MD next day; mom was told rash probably due to Hep B vax since this was only vax given that not given a/; now devel cold w/runny nose, cough;
30OCT98 c/o diplopia, rt facial numbness;pt is diabetic; tested blood sugar-was WNL; referred to MD;also seen other referred to clinic for consult;c/o muscle aches, n/v;
Event: Upon administration of the dose, more than half of the dose ran back out of the injection site.  Treatment:  Following CDC guidelines: Readminister dose in other arm (left deltoid)  Patient-reported no side effects or adverse outcomes while on clinic grounds.
large erythematous macule scattered over trunk, throat & inj site of MMR occur w/in 5min of inj;began to fade w/in 5min-no other sx;child active;talking;was seen by MD w/in 10min;no tx;
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M046004 with expiration date 18-NOV-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number M044950 with expiration date 30-MAY-2019. No adverse events were reported. The vaccine was exposed to a temperature of 6 to 14 degree Fahrenheit for 180 minutes; the digital data logger was involved. No previous temperature excursion was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA000673: US-009507513-1707USA000674.
An infant had "tremors" approximately lasting 2 seconds in first 2 hours after Prevnar. When seen by the clinic, no abnormal neurological findings.
experienced swelling and loss of strength in the vaccinated arm after he received the vaccine for what he felt was "longer than normal"; "ever since" receiving the vaccine, he has experienced "circulation and joint problems" explaining he "couldn't do push-ups"; "ever since" receiving the vaccine, he has experienced "circulation and joint problems" explaining he "couldn't do push-ups"; experienced swelling and loss of strength in the vaccinated arm after he received the vaccine for what he felt was "longer than normal"; This spontaneous report was received from a physician, who was reporting on himself, via company representative. The patient was a 65-year-old male at the time of vaccination (currently he is 70 years old). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2015 (reported as 5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (route of administration, lot# and expiration date were not reported) for prophylaxis. After receiving the vaccine, the patient experienced swelling and loss of strength in the vaccinated arm for what he felt was "longer than normal". The patient reported that ever since receiving the vaccine, he has experienced "circulation and joint problems" explaining he "couldn't do push-ups". The outcome of the events was reported as not recovered/not resolved. The causality assessment between the events and the suspect therapy was not provided.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX. On 21st September 2015, the patient received FLUARIX. On 21st September 2015, less than a day after receiving FLUARIX, the patient experienced pain in arm, shoulder pain and general body pain. On an unknown date, the outcome of the pain in arm, shoulder pain and general body pain were unknown. The reporter considered the pain in arm, shoulder pain and general body pain to be probably related to FLUARIX. Additional details were received as follows: The patient experienced severe pain in arm, pain in shoulder and body pain. The reporter did not have any further information.
Pt. had multiple erythematous wheals on trunk, neck, face. Stated he was experiencing severe itching, mom present, stated she had applied BENADRYL cream to areas noted, without much relief. Mom instructed to adm. oral BENADRYL to pt., per pkg. instr. and if no relief to take son to ER.
1447 NURSES CALLED TO OBSERVATION ROOM IN REGARDS TO A CLIENT WHO SAYS HER UPPER LIP IS SWELLING AND HER HEAD IS FEELING HEAVY. CLIENTS DAUGHTER PRESENT BESIDE HER. UPON ARRIVAL TO ROOM, CLIENT PRESENTS WITH REDNESS/FLUSHING TO FACE, SWEATING, AND UPPER LIP SWELLING. BP 119/73. O2 ADMINISTERED @ 8L VIA NON-REBEATHER MASK. BENADRYL 1 ML GIVEN TO LEFT DELTOID @ 1453. BP RECHECK 166/115. 1456 EMS CALLED BY AA. 1458 0.3 MG OF EPI ADMINISTERED TO LVL. 1500 BP RECHECK 153/98. 1502 EMS ARRIVED AND TOOK OVER CARE. REPORT GIVEN AT ER. EMS TRANSFERRED CLIENT WITH NO FURTHER INTERVENTIONS AT THAT TIME @ 1521.
4.5" x 5.25" area of redness, induration with central area, 2.75" x 2.25", of bruising - all surrounding shot site. Seen on day 3 after shot, no systemic symptoms. No treatment except BENADRYL.
Case number PHEH2012US023572 is an initial spontaneous report received from a consumer on 28 Nov 2012: This report refers to a patient whose identifiers were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly at a dose of 0.5 ml on an unknown date in Sep 2012. After vaccination the patient experienced pain in the limb which limited the limb movement. The outcome of the event was reported as complete recovery. No further information was provided.
SORE THROAT; HIGH BLOOD PRESSURE; SEVERE DIZZINESS; WHOLE BODY MUSCLE PAIN; LITTLE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breastfeeding, and high blood pressure, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced whole body muscle pain. On 11-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced headache. On 12-APR-2021 06:30, treatment medications included: paracetamol. On 12-APR-2021 21:30, the subject experienced high blood pressure. On 12-APR-2021 21:30, the subject experienced severe dizziness. Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 12-APR-2021 22:30, Laboratory data included: Blood pressure (NR: not provided) 152/102 mmHg. On 13-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 130/100 mmHg. On an unspecified date, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever, and headache on 12-APR-2021, was recovering from severe dizziness, and had not recovered from high blood pressure, whole body muscle pain, and sore throat. This report was non-serious. This parent/child case is linked to 20210432107.; Sender's Comments: V0;MAC is not required for non serious cases as per standard protocol
Complaint of cough, elevated temperature, runny nose/congestion, myalgia, malaise and nausea/vomiting.
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 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:42 AM, 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 56.97.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, temperature was 34 and Excursion time was 10 AM, temperature was 37 and total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: no reported, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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 traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. 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.
Was 30 weeks pregnant at the time of the shot. Had bp issues in early pregnancy. Had dtap and rhogam shot on April first. Only reaction to first shot was numbness and tingling in arm and had that shot was received  about 25 min after shot lasted about 20 min.
Patient became fatigued and noticed excessive bleeding and bruising in September 2021, but didn't understand there was a problem until January 2022. After a few appointments with PCP, he was referred to a Hematologist for Immune Thrombocytopenia. Hematologist did a battery of tests and continues to do so to rule out ITP as a secondary condition.  First treatment: Dexamethasone, 40 mg/day orally for 4 days on 5/9/2022 Outcome: Temporary increase of platelet count from a low of 30 (10^3/uL) to a high of 190 two weeks after treatment. Four weeks after treatment, platelet count returned to ~40.
Migraine; Chills; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 41 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 01Mar2021 10:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination; "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 01Mar2021 11:00, outcome "recovered with sequelae" (2021), described as "Migraine"; CHILLS (non-serious) with onset 01Mar2021 11:00, outcome "recovered with sequelae" (2021), described as "Chills"; FATIGUE (non-serious) with onset 01Mar2021 11:00, outcome "recovered with sequelae" (2021), described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, chills and fatigue.  Additional information: Patient had been diagnosed with COVID-19 prior to vaccination. On 01Mar2021 at 11:00, the patient experienced migraine, chills and fatigue and had to go home from work early. The patient was out of work for two days with symptoms. On 11Mar2021 and 01Apr2021, the patient underwent COVID-19 test, and the results were both negative. The patient had not received any other vaccine within 4 weeks. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Prolonged swollen lymph nodes (all lymph nodes) causing pain and swelling in neck and armpits which persists to present date.
Just about one week after I got my first dose of the Moderna Covid vaccine, my arm developed an itchy rash at the injection site.
Local reaction to (R) upper arm with 3" induration and firmness diameter and 4" diameter of redness and increased temperature. C/O pain and itching at site.
Information has been received from a nurse concerning a 47 month old patient with no pertinent medical history and no allergies who on an unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (lot# 656575/0445U). Concomitant vaccination included MMR and PREVNAR (manufacturer unspecified). On 18-MAY-2010 the patient came into the office with a mild varicella rash. There were no laboratory diagnostics studies performed. At the time of this report, the patient was recovering. Follow up information has been received from the registered nurse concerning the female child who on 19-JUN-2007 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 656575/0445U) into the left deltoid. There was no illness at time of vaccination. On 18-MAY-2010, at 10:00, the patient was see in the office and she was diagnosed with chickenpox. Follow up visit on 25-MAY-2010, the chickenpox was resolving without complication. The patient was also reported to be recovered on 25-MAY-2010. Additional information is not expected.
Headache, Sedation, muscle weakness and chills Narrative: Vaccine administered 1/13/21, Later that day noted a burning sensation at injection site. On 1/14/21 reported extreme muscle weakness, fatigue, headache and chills. Symptoms worsened on 1/15/21 and employee missed work. Chills continued until 1/18/21, other symptoms improved. As of 1/19/21 still had a mild headache, but no other complaints.
Information has been received from a nurse referring to a patient of unknown age and gender. On 24-MAR-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (strength: 19400 PFU; dose and route were not reported, lot # K021624 with expiration 07-FEB-2016) (expired vaccine used). The patient had not reported any adverse effects, Additional information has been requested.
Injection hurt more than normal.  Shoulder pain started immediately after and has never gone away. Hurts shoulder to move arm to left (shutting car door, putting on jacket, etc.) and while sleeping
Initial unsolicited misuse report received from a physician and consumer on 23-Mar-2017. This case involves an 11-year-old male patient who was vaccinated with a first dose of MENACTRA (batch number: U5556BA, expiry date, dose form frequency not reported ) intramuscularly in the left deltoid and inadvertently administered a first dose of TRUMENBA (manufacturer: Pfizer, batch number R45100, expiry date, dose form frequency not reported) intramuscularly in the right deltoid instead of a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (Batch number, expiry date, dose form, frequency, route and site of administration not reported) on 22-Mar-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 23-Mar-2017, at 4 am, one day following the vaccination, the patient experienced 2 episodes of vomiting. It was also a case of wrong vaccine administered and extra dose administered. Relevant laboratory investigations and corrective treatment were not reported. The outcome of the event vomiting was unknown. List of documents held by the sender: None
administration of a dose of Kinrix to an 18 month old patient; third dose in the series was Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pentacel (received 1st dose of the DTPa series in 2019 at 2 months age) and Pediarix (received 2nd dose of the DTPa series on 25th August 2020 at 11 months of age).   On 26th April 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Kinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The (18 month old) patient received Kinrix as 3rd dose of the DTPa series by mistake, which was led to inappropriate age at vaccination and wrong vaccine administered. Reporter consented to follow-up.
Patient experienced some body aches/headaches within the following 3 days after her vaccination. However, 6 days after the vaccination (on 11/19) patient began to experience rash that started on arm and spread to entire body. She also reported the "whites" of her eyes were red. She did seek medical care for this and her doctor prescribed her prednisone which did help with the rash.
little soreness; heart rate started to go up and down, fluctuating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness) and HEART RATE ABNORMAL (heart rate started to go up and down, fluctuating) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MELOXICAM for Arthritis, MONTELUKAST SODIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEART RATE ABNORMAL (heart rate started to go up and down, fluctuating). On an unknown date, the patient experienced PAIN (little soreness). On 09-Mar-2021, HEART RATE ABNORMAL (heart rate started to go up and down, fluctuating) had resolved. At the time of the report, PAIN (little soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 118 /min (High) Heart rate was high., 120 /min (High) Heart rate was high, 85 /min (normal) Heart rate was normal, 125 /min (High) Heart rate was high, 140 /min (High) Heart rate was high, 90 /min (normal) Heart rate was normal. and 177 /min (High) Heart rate was high..     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.
SPOTS APPEARED ON CHILD'S TRUNK, SCALING LOOKING SKIN, DENIES FEVER; RED NON RAISED NON WEEPING SPOTS SPREAD FOR 3 DAYS AND WERE ALSO FOUND ON LEGS AND HEAD REGIONS. CHILD COMPLAINED OF INTENSE ITCHING AND IS ACTING LETHARGIC; COOL BATH FAILED TO ALLEVIATE DISCOMFORT; MOTHER REPORTED THAT SHE WOULD BE TAKING CHILD TO DOCTOR OFFICE.