chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 09/09/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 2 year old female patient received a dose of ACT-HIB, lot number UE390AA, administered in the left thigh, and a fourth dose of Tripedia, lot number U0848CA, administered in the left thigh on 01/31/2003. The routes of administration were not reported. The following day, on 01/31/03, the patients mother called the doctor's office to report her daughter's leg was swollen and red from the injection site at the upper thigh down to her toes. The patient was not seen for an office visit. It was reported that the patient recovered from these events. On 09/15/04, the reporter was contacted to confirm the lot number provided for ACTHIB. The lot number provided for ACTHIB was recorded as UE390AA, in the patient's chart. This number does not correspond to ACTHIB, but instead is the lot number for PRP-T diluent. A check in the internal database linked this diluent with ACTHIB lot number UA797AA (French lot number W-0795-2). It could not be confirmed whether the patient actually received the ACTHIB or the diluent. From additional information received on 11/22/04 from a health care professional, it was reported that the patient received her fourth dose of Tripedia, lot number U0848CA, administered intramuscularly in the left leg and her fourth dose of ACTHIB, lot number UE390AA, administered intramuscularly in the left leg on 01/30/03, not 01/31/03 as previously reported. The following day, on 01/31/03, the patient's grandmother complained of a possible site reaction, with swelling and redness of the left thigh. The patient was treated with alternating doses of Tylenol and ibuprofen for pain. No laboratory testing was obtained. No further information is anticipated, this case is considered closed.
Pfizer Dose 1 12/22/21 (FE3594) COVID Positive 1/18/22  1/18/22: 60-year-old female with COPD not on home oxygen, obstructive sleep apnea noncompliant with CPAP, hypertension, anxiety/depression, tobacco abuse, cocaine use presented with shortness of breath.  Reportedly called EMS for shortness of breath noted to be wheezing placed on 2 L oxygen for hypoxia.  Patient reports she was having fever , chills and has decreased appetite.  Denies any muscle aches or joint pain, reportedly had exposure to COVID positive contact.  Patient denies any illicit drug use at this time.  Patient is a febrile and hemodynamically stable.  VBG showed pH 7.32 with pCO2 70, influenza A and B negative, COVID-19 PCR is pending unremarkable WBC count. Chest x-ray is unremarkable for acute abnormalities.  Mild elevation of D-dimer, CT chest PE protocol is pending.  1/21/22:  60-year-old woman who presented with complaints of fever, chills, shortness of breath of few days duration.  She was found to be hypoxic on presentation requiring initiation of supplemental oxygen.    CT pulmonary angiogram was negative for pulmonary embolism but demonstrated bilateral airspace disease compatible with pneumonia.  COVID-19 PCR was subsequently positive, she was started on IV steroids and remdesivir as she met criteria for treatment in the presence of hypoxia.  Clinical response was favorable with gradual improvement in cough, shortness of breath and wheezing.  Oxygen walk for home determination was done prior to discharge, she did not meet criteria for home oxygen.  She has been discharged in stable medical condition to continue outpatient follow-up.
Patient explained she felt nausea on Friday (11-3-17) night. She woke on 11-4-17 with a fever of 102.7 degree F. She went to an urgent care where she was diagnosed with cellulitis. Her left arm is swollen and painful. She also had body aches. She was given a prescription for cephalexin, naproxen and ZOFRAN. As of today, 11-6-17 she has taken 2 dosed of cephalexin.
she is about two months pregnant; She reported that she had very mild muscle pain at injection site; She reported that she had very mild muscle pain at injection site; This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A female patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported that she very recently received her first dose of COVID-19 vaccine, and was scheduled for the follow up. She reported that she had very mild muscle pain at injection site. The nurse shared that she was about two months pregnant. She was unaware of any other health issues. The outcome of the events was unknown.
When patient woke up - area was swollen. Left - PNEUMOVAX. Heat and cold compress - 10 minutes per 40 minutes. IBU - 200 mg - BID.
Pt. stated (L) eye vision problems after receiving vaccine. Vaccine adm. approximately 935am. Pt returned to office approximately 11am. Pt was assessed both eyes responsive to light, could read fingers in front and peripheral. Pt has (L) eye drooping and focuses to (L). Mom reports child has glasses to correct his vision and droopy eye, but he will not wear his glasses. Mom reports pt is "slow and not all there". Reports pt ran into door this morning because of poor vision. BP 103/63, HR-74 R-16.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.       Moderna booster vaccines were administered to patient around 490 to 500 people on the date last Oct 20.2021 to Nov 29, 2021, with lot numbers 006C21A (10-10-2021), 026B21A (09-17-2021),031B21A (9-22-2021)
This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (twice) and chemotherapy. Previously administered products included ZOSTAVAX. On 4th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th August 2018, 10 hrs after receiving SHINGRIX, the patient experienced exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever. On an unknown date, the outcome of the exhaustion, shortness of breath, tremor, chills, nausea, pain in extremity, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough, neck pain and fever were recovered/resolved. The reporter considered the exhaustion, shortness of breath, tremor, chills, nausea, gagging, white blood cell count increased, increased blood pressure, heart rate increased, electrocardiogram abnormal, back pain, cough and neck pain to be related to SHINGRIX. It was unknown if the reporter considered the pain in extremity and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th August 2018, at 10:00 hours, the patient received SHINGRIX in the left arm. On 4th August 2018, at 20:00 hours, 10 hours, after receiving SHINGRIX, the patient experienced extreme exhaustion. Five minutes after the experienced the extreme exhaustion, she experienced a strong pain that started in the palms of her hands and the pain went up to her arms. The patient experienced a strong pain that started on the palms of her hands and soles of her feet that shot up to her legs, then her back and neck. Less than a day after receiving SHINGRIX, the patient experienced fever, shaking, chills, nausea, coughing, and gagging. Less than a day after receiving SHINGRIX, the patient experienced soreness in the arm in which she received the injection that lasted 2 days. At this point she went to urgent care and at urgent care they did some testing that revealed an elevated white blood cell count, elevated blood pressure, elevated heart rate and an abnormal electrocardiogram (EKG).  The urgent care sent the patient to the emergency room where she stayed for approximately 7 hours however, she was not admitted to the hospital. The patient released after 7 hours and told her to take Tylenol at home. One day, after receiving SHINGRIX, the patient slept all day on Sunday and when she woke up, the pain was gone and she was back to normal but still very tired. On the day of reporting all symptoms were gone and the patient was back to normal.
6 hrs after shot patient started having watery diarrhea. The following day patient continued with diarrhea, headache, low appetite and was very tired (very unlike patient). The next day, Sunday, patient awoke in morning with fever 100.7, diarrhea, chest congestion, sore throat, nausea and stomach cramps. As the day progressed, fever worsened to 101.9, and large 2-3 inch burgundy marks started to appear on front shoulder of left arm. These marks started appearing moving down the arm, then by late night developed on right shoulder & arm as well. Fever, sore throat, chest congestion continued to occur and vomiting began. Monday the fever, cough, sore throat worsened and patient is very lethargic with no appetite. Rash stayed the same. Tuesday, patient continues to have a headache, sore throat, diarrhea, cough/congestion, and fever.
After two days:  severe nose bleed.  After eight days:  vomited blood; followed by endoscopy to fix stomach bleed.  After 17 days days, lung hemorrhage.
Sore dark red patch will pealing dry skin on top. About the size of a quarter. Red sore patch on the roof of my mouth, also the size of quarter.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 as dose 4 (booster), single (Lot number: FF2587) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 14Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "latex" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ESTRACE; HUMIRA; HYDROXYCHLOROQUINE; METHOTREXATE. Past drug history included: Sodium thiosulfate, reaction(s): "known allergies: sodium thiosulfate". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive; (06Jul2022) Negative; (13Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Adverse event: Rebound COVID infection. tested positive 01Jul, negative by antigen test 06Jul, rebound symptoms 13Jul with positive antigen test that day.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
About 5 minutes after pt got his 1st Moderna shot, he lost consciousness and got a seizure. He turned red and both his arms stiffened up, one of his hands curled and he almost slipped out of his chair; when he regained consciousness about 1 - 2 minutes later he didn't remember what had happened. Gave the patient some water and also called an ambulance for him to check up just in case, kept him seated in the pharmacy waiting area.
passed out; blood pressure was lowered; blood sugar high; weakened; feeling tired and her legs are heavy; feeling tired and her legs are heavy; This is a spontaneous report from a contactable consumer (Patient's Mother). A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 Monday at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced passed out 12 hours post injection (Jan2021). She specified that her daughter was therefore brought to hospital by ambulance. She continued explaining that her blood pressure was lowered, her blood sugar high and that she was weakened (Jan2021).  On 08Jan2021, "day 4", she said that her daughter had been feeling tired and her legs are heavy (Jan2021). The event outcome was unknown. She then asked if those side effects were experienced after the vaccine. It was not reported as serious.  Information on the batch number has been requested.
Information has been received from a health professional concerning a 41 year old Caucasian female patient who on 09/06/00  was vaccinated with a 2nd dose of Hepatitis B vaccine recombinant. Subsequently, the patient experienced a red, hot, swollen deltoid (injection site). The patient experienced injection site itching. There was no generalized symptoms. The patient took Ibuprofen and recovered by 09/09/00. Medical attention was sought. Additional information has been requested.
the patient's age was 5 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 18-MAY-2022, the patient received Kinrix. On 18-MAY-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the patient's age was 5 months). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The reporter was medical assistant. The reporter called to inform that a patient was administered a dose of Kinrix at the age of 5 months.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter called to inform that a patient was administered a dose of Kinrix at the age of 5 months, which led to inappropriate age at vaccine administration.
headache, nausea, low grade fever, muscle pain, chills,  Right are extremely sore and painful to move.
Guillain Barre Sydrome.  Began in late December 2009 with paresthesias of both hands and feet. Decreased reflexes noted during clinic exam.  On 2/9/10 she feels she is getting worse with dropping things from right hand, difficult to walk, some tightness across her abdomen and feels it is more of an effort to breathe.  She has no facial weakness.
Extreme exhaustion, headache, muscle ache, leg,pain, swollen glands left breast End of day two, feeling slowly better, but not great.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 1:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:27 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 34.06 for dose administered on 13-FEB-2021 and 34.16 for dose administered on 20-MAR-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-FEB-2021 with temperature 32 Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-FEB-2021 and beyond use date for the vial was reported as 10-MAR-2021. Product moved to clinic on 13-JAN-2021.  Batch number 031A21A underwent temperature excursion on 20-MAR-2021 with temperature 34 and 37 degrees Fahrenheit from 09:00 AM to 10:00 PM. This vial was moved to fridge on 09-MAR-2021 and beyond use date for the vial was reported as 08-APR-2021. Product moved to clinic on 20-MAR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Headache-Medium, Additional Details: patient also has a history of anxiety
fever; Bad headache; Chills; Nausea; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (Grandmother).  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced bad headache, chills, fever and nausea on an unspecified date after vaccination. It was informed that she was in the hospital receiving treatment. At the time of the reporting the patient had not yet recovered from reported events.
Long lasting chest pain, became quite severe at the one week mark; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: Not reported), via an intramuscular route of administration in right arm on 05Feb2021at 09:30 as single dose for COVID-19 immunization. Patient previously had historical vaccine BNT162B2 as first dose for COVID-19 immunization. Patient medical history included covid-19 positive. The patient previously took Bactrim. There were no other vaccine same date details. Patient did not receive any other vaccines within 2-4 weeks. The patient took concomitant medications (there were other medications in two weeks). On 05Feb2021, patient experienced long lasting chest pain, became quite severe at the one week mark so that he went to the ER to get checked out. All his tests so far have been normal (CT scan of chest, blood work, EKG), but the pain is. On an unspecified date, patient underwent lab tests and procedures which included blood test, CT scan of chest and EKG all were normal. There was no covid prior vaccination and the patient was not tested with covid post vaccination. Patient received treatment for event. Outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.
pt was found approx 4 hrs p/vax in crib moving but not breathing, gray in color; rush to ER-10 mins labored breathing-apnea monitor alarmed twice; fever;
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# K025765, expiry date: 08-JUN-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  Localized redness and swelling with the  pneumococcal 23 vaccine. Patient also developed a headache.
RN called patient to discuss lab results, unrelated to his booster vaccine. While on the phone the patient mentioned that the inside of his right eye was "extremely bloodshot". He said that this occurred after getting his booster of the Pfizer vaccine in left arm. No other symptoms noted.
Sore, achy muscle at the site of injection-going on three weeks now Feels like it is bruised. Hurts upon movement or if touching area, keeps patient awake at night since she can no longer sleep on that side.
This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia (on no prescription). 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 fever, pruritus and fatigue. On an unknown date, the outcome of the fever, pruritus and fatigue were recovering/resolving. It was unknown if the reporter considered the fever, pruritus and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed daily fever of 102 plus degree F after dose of SHINGRIX. The patient had no rash but was pruritic and had fatigue. The patient was improving slowly. This case was linked with US2018GSK113820, reported by the same reporter.