chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered a pediatric dose of Engerix-B to an adult patient; Administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 55-year-old male patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 20-SEP-2023, the patient received Engerix B pediatric. On 20-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Administered a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: Administered a pediatric dose of Engerix-B to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter was a office manager. The reporter reported that the nurse administered a pediatric dose of Engerix-B to an adult patient, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants was provided. No treatment medications was reported. Vaccine that had been more than 30 days in the refrigerator was given to 16 patients.   This case was linked to MOD-2021-352611 (Patient Link).
1 1/2 cm x 1 1/2 cm area of induration and 3cm x 5cm area of erythema.
patient's booster dose was given too soon after the primary series was completed. this was reported to the patient.
No adverse event; 35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial) 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 assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
Hives / rash from shoulders up onto neck, the night of the vaccination. Went to urgent care, was given scripts for prednisone and famotidine.
Hives like rash; Hives like rash; Small bump; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: not reported), via an unspecified route of administration, administered in arm left on 06May2021 (age at vaccination was 28-year-old) as dose 1, single for COVID-19 immunization at urgent care. Medical history included polycystic ovarian syndrome from an unknown date and unknown if ongoing. Patient had no family history of rash. Concomitant medication included ethinylestradiol, norethisterone (NORTREL [ETHINYLESTRADIOL;NORETHISTERONE], Tablet); taken for polycystic ovarian syndrome from an unspecified start date and was ongoing. The patient reported that she never had a allergic reaction anything in the past but on 11May2021, the patient experienced hives like rash. The patient had been wearing tight pants around her waist so now there was a small bump. No investigation assessment was reported. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient's arm red, swollen and fevered. Mother stated used ice packs, ibuprofen and BENADRYL with no improvement. Advised to go to ER or child doctor to have evaluated.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/29/2021 BACTEREMIA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/29/2021 ANEMIA
Received her first dose on 28Jan and patient was diagnosed with transient global amnesia; This is a spontaneous report from a contactable Nurse (Patient). A 68-year-old female (Non pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wanted to know if a patient can have IV contrast Iohexol 75 ml/350 solution due to a neurological event happened on 16Feb (year not reported), can the patient receive the second dose of the vaccine which will due tomorrow (4 days later of IV contrast) and is it safe to give COVID-19 vaccine 4 days later. Patient wanted to know what arm patient should get their second dose of the bnt162b2 vaccine (opposite arm or same arm). On unspecified date, patient experienced transient global amnesia. Treatment received for the event was unknown. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183970 similar report from same reporter
27JUL95 pt stopped breathing for 6min;paramedics revived pt but severe brain damage sustained;pt lives in long term care facility @ hosp;
Sore Throat; fatigued; pain in his left arm which makes it difficult to move arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his left arm which makes it difficult to move arm), OROPHARYNGEAL PAIN (Sore Throat) and FATIGUE (fatigued) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack since an unknown date, Cancer (cancer in lymph glands) since an unknown date, Diabetes since an unknown date and Spleen operation (spleen removed in 1980's) since an unknown date. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his left arm which makes it difficult to move arm). On 24-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and FATIGUE (fatigued). At the time of the report, PAIN IN EXTREMITY (pain in his left arm which makes it difficult to move arm), OROPHARYNGEAL PAIN (Sore Throat) and FATIGUE (fatigued) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       concomitant medicines: Coumadin (Heart medicine), Insulin pump, Blood pressure medicine,  Treatment medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR follow up received.
2 -1/2 weeks after first Moderna I had extreme vertigo. I was able to resolve it with vestibular therapy. 4 days after second Moderna and the day after resolving the vertigo, I experienced extreme disequilibrium and have been very ill since then?for a month now. Doctors have NOT linked my vertigo and then disequilibrium with the vaccine mor with my previously diagnosed glomus vagale. . I wanted this information known in case it would be helpful.
This spontaneous report was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # L007228, expiration date- 03-SEP-2016, (dose strength and route was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unkonwn. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
THE EVENING OF VACCINATION DAY, THE PATIENT EXPERIENCED PAIN IN JOINTS, GENERALIZED PAIN, ELEVATED TEMPERATURE, AND SWOLLEN LYMPH NODES UNDER LEFT ARM.
Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Patient states arm still hurts from shot, went to doctor and was told there was joint/bone damage resulting from shot administration.
positive covid 19 home test on June 24, 2022. Symptoms included sore throat, fever, headache, head congestion. Loss of sense of smell on June 28, 2022.
severe stomach cramps beginning on  2nd day (shot Thurs - Sat discomfort) after receiving 1st dose of vaccine. Began with stomach cramping and 'lump in throat' continued until severe cramping in stomach going up windpipe into throat.  In bed 2 full days now beginning to recover (3rd day and hoping).  Could not belch or fart wind out of stomach.  Drinking or eating caused pain.
mom reports evening of vax pt devel itchy, swollen feet w/spots;mom gave DPH w/good results over the next few days pt devel hives on chest, back, swollen arm, mom gave DPH w/good results;no other sxs no temp
Modern a COVID-19 vaccine EUA Soreness, swelling, painful to touch at injection site - started a couple of hours after injection, still present 48 hours post Dizziness about 5 hours later - rested for about 15 minutes until it subsided. Drank water.
Patient is a 16 year old male alert and oriented x4 accompanied by his mother who complained of weakness immediately upon administration of vaccine.  The patient and patients mother stated that this same type of event has occurred in the past with previous vaccinations.  Patient was seated on a cot a vital signs stable.  Patient stated the he immediately felt better and no longer had any complaints.  No chest pain, shortness of breath, weakness, dizziness, signs of stroke or allergic reaction.  The offer was made to call paramedics for further evaluation and transport but patient and mother politely refused.  Patient and mother were  advised of all risks and consequences and advised to seek medical treatment if any symptoms return.  Patient left with his mother via private vehicle.
Information has been received from a health professional concerning a 15 month old white male who on 12/15/2005, at 12:00pm, was vaccinated with a subcutaneous dose of MMR and varicella.  Between 1-10 days after vaccination, in approximately December 2005, the patient developed a high fever and blotchy rash all over the body.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow up information from a health professional indicated that on 12/22/2005, in the morning, the patient experienced a high temperature of 100-102 from 12/22/2005 to 12/24/2005.  The patient also experienced a rash on his face.  It was reported that the patient recovered on 12/25/2005.  Additional information is not expected.
dizziness; at times could barely walk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (dizziness) and GAIT DISTURBANCE (at times could barely walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion hospitalization) and GAIT DISTURBANCE (at times could barely walk) (seriousness criterion hospitalization). At the time of the report, DIZZINESS (dizziness) and GAIT DISTURBANCE (at times could barely walk) outcome was unknown.            Treatment and concomitant information was not provided by the reporter.  Action taken with mRNA-1273 in response to the drug was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician, via a company representative, concerning a female patient (age not reported) who on an unknown date was vaccinated with a dose of GARDASIL. Following the vaccination, the patient fainted. She was evaluated by healthcare professionals. Subsequently, the patient recovered (duration not specified).
Itching within 12 hour post shot wheezing that evening - wheeze persists - on albuterol and pulmacort via nebulizer
My upper left arm developed a rash and swollen and hot 9 days after receiving injections.  Also started developing signs of my Lyme disease flaring up.  Muscle weakness on ledt side of my body stared 3 days after receiving vaccine.  Made a Dr appt on Monday 3/22 and complained of weakness in left arm and side of my body since first shot of Moderna Vaccine.  Pending my blood test results to see if my Lyme disease is flaring up (it?s been years and I?ve felt great!! Until taking vaccine). I also felt joint pains 9 days when arm rash happened and overall body feels weak and tired.   It?s two weeks since Vaccine and I have arm weakness and low strength in side where vaccines was administered.   Also note, the rash and swollen arm still continues. It started on 3/25 after my initial visit to my primary dr on Mon 3/22.  I did make the office aware of this additional symptom on Friday 3/26.
1 day after receiving vaccine, covid arm and general feelings of fatigue and of not feeling well.  About 9 days after vaccine, covid arm was more pronounced,  severe nausea and many vomiting episodes, low grade fever and muscle/joint pain. This lasted for about 12-15 hours. Fully recovered the next day & covid arm was fading significantly. I had a similar reaction (and delayed reaction) but much milder after the first shot.
tonic sz, t>103 (temp not measured) p/pt had cool bath & was in ambulance t103;
Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LOSARTAN for Blood pressure, LEVOTHYROXINE for an unknown indication.    On 29-Mar-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 TINNITUS (Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go). At the time of the report, TINNITUS (Tinnitus a little over a week after receiving her 1st dose/little humming in her ears which comes and go) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant FU TCR received : event outcome and patient contact information updated.
Case previously recorded as MA2009-3519. Initial case report received from a physician via agency on 03 NOV 2009. A 19-month-old male patient was vaccinated with 0.5 S-OIV FLUVIRIN (batch no. unknown) i.m. on 03 NOV 2009. No adverse event was reported. Agency reference no.: NA09-007451.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN 3/19/2022 -- RECURRENCE OF SAME SYMPTOMS
05/03/05- Next day became red and size of quarter. Last night, hugely swollen and red, mild pain to touch. Today better but itchy. Vaccine reaction, mild, no cellulitis.
Covid-19 (confirmed by positive COVID-19 test); Covid-19 (confirmed by positive COVID-19 test); This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on 22Dec2020 (at the age of 54-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the first vaccine 22Dec2020. On 10Jan2021, she got COVID-19 and was due to get second shot 2 days later on 12Jan2021. The patient underwent lab tests which included sars-cov-2 test: positive on 10Jan2021. The patient inquired about how long to wait before the second dose after being diagnosed with COVID after receiving the first dose. The clinical outcome of the event COVID-19 was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Begin itching around the groin area, began forming hives all over, skin had a red complexion, face and lips began to swell.  Had couple spells of light headedness and feeling of passing out.  Same day reported to Emergency Center. Received I.V. with steroid medication and benadryl.
Patient became significantly SOB w/ increasing coughing and chest tightness.  Patient also developed lightheadedness.  She was transferred to a litter and had a pulse ox applied.  She noted increased SOB after lying flat and was administered an Epi-pen and then placed in an upright seated position (supported).  Symptoms did improve and she was also administered 4 puffs of her personal inhaler with additional improvement but not complete resolution.  EMS was contacted and patient was evacuated to the ER for further evaluation and treatment. HR remained tachycardic and SPO2 98%.
felling fatigue (for almost three weeks); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felling fatigue (for almost three weeks)) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (felling fatigue (for almost three weeks)). At the time of the report, FATIGUE (felling fatigue (for almost three weeks)) outcome was unknown.            Concomitant medication was reported as "Adviril" for high blood pressure and to treat high cholesterol. Treatment medication was not used.; Sender's Comments: Based on the current available information although temporal association between the use of the product and the start date of the event is unknown, a causal relationship cannot be excluded.
Intense vertigo with vomiting 2 days after second dose. Vertigo with nausea occurred 6 days after first Moderna dose. Incapacitating vertigo with nause occurred a third time after second dose on day 5.
I did not have an adverse reaction to the vaccine. On 03/07/2023, I was diagnosed with diverticulitis, and I was put on an antibiotic. I developed a urinary tract infection and I had tried to flush out the bacteria myself. I found out quickly that it was not getting better. I went to the emergency room 03/26/2023. I was admitted to the hospital on 03/27/2023 and it was determined the infection went to my kidneys. My body does not respond to the standard antibiotics for the bacteria anymore. I was in the hospital for five days. As of today, I am feeling better after taking intravenous antibiotic.
Shoulder joint pain; muscle pain in left and right arms from my shoulder down to my hands; muscle pain in left and right arms from my shoulder down to my hands; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received first dose of bnt162b2 (Solution of injection, Lot Number: EI8982), via an unspecified route of administration, administered in left arm on 11Feb2021 12:30 (at an age of 79-years-old) as single dose for covid-19 immunisation. Medical history included lumpectomy from 17Nov2020, type 2 diabetes mellitus, hypertension, heart attack 20/12, 2 stents. The patient's concomitant medications were not reported. On 11Feb2021 14:30, the patient experienced shoulder joint pain, muscle pain in left and right arms from my shoulder down to my hands. The clinical outcomes of the shoulder joint pain, muscle pain in left and right arms from my shoulder down to my hands were not recovered.  No follow-up attempts are possible.
PT BEGAN TO C/O FEELING FUNNY AND DIZZY IMMEDIATELY FOLLOWING INJECTION. PT ALERT AND ORIENTED X 4, NO LOSS OF CONCIOUSNESS, BREATHING NORMAL, SKIN NATURALLY PALE, W/D WITH NO DIAPHORESIS. PT STATES SHE HAS NOT EATEN TODAY. TAKES BP MED AT 2PM. GAVE A PIECE OF MINT CANDY , OFFERED CRACKERS BUT DECLINED; SHE ALSO TOOK HER BP MED.  OUTCOME: FELT BETTER AFTER 5 MINUTES, SHE STATES SHE THINKS IT WAS HER BLOOD SUGAR. CONTINUED TO MONITOR X 15 MINUTES WITH NO FURTHER INCIDENCE
extreme tiredness the day after the 2d Shingrix shot that lasted 2 days, accompanied by mild body aches;  extreme itchiness at the vaccination site that started on the 4th day after the 2d shot and continues today, the 5th day after the 2d shot I do not know which of the hep A vaccines I received; I just picked one.