chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use 1 drink per month, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAR-2021 on right deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 20-MAR-2021, the subject experienced injection site pain described as arm pain. On 21-MAR-2021, the subject experienced arm sensitivity. On 21-MAR-2021, the subject experienced pain in right leg. On 21-MAR-2021 10:00, the subject experienced pain in the right hip, groin and ankle. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain described as arm pain, and pain in the right hip ,groin and ankle, and the outcome of arm sensitivity and pain in right leg was not reported. This report was non-serious.
I was in a rush, and the MMR, Varicella and MMRV are stored next to each other, and I took the wrong vaccine out of the freezer. I made the error of giving the wrong vaccine to the child.
shingles on the right side; internal pain still awful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient had 1st Shingles vaccine but got Shingles before getting the 2nd. The reporter reported that, the second week and internal pain was still awful. The patient stated that shingles happened on the right side. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
24 hours later, fever of 103; Sweating; extreme fatigue; muscle aches; muscle tightness; Hard to move; Bad headache; Hot in the face and head; freezing through rest of my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HF9275) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing); "Allergy to cipro" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for influenza immunisation, on 18Sep2023 as dose 1, single, 2023-2024 syr by seqiris. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "24 hours later, fever of 103"; HEADACHE (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Bad headache"; MOVEMENT DISORDER (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Hard to move"; FEELING HOT (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Hot in the face and head"; HYPERHIDROSIS (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "Sweating"; FATIGUE (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "extreme fatigue"; FEELING COLD (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "freezing through rest of my body"; MYALGIA (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered", described as "muscle aches"; MUSCLE TIGHTNESS (non-serious) with onset 28Sep2023 at 15:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient received Advil/tylenol to reduce fever. Only down to 101.
feeling short of breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 20Jan2021 at 11:30 AM at a single dose for COVID-19 immunization administered at the public health department. Relevant medical history included high blood pressure, which was under control with medications (meds). The patient had no allergies to medications, food, or other products. Concomitant medications included hydralazine, carvedilol, rosuvastatin, alendronate sodium (ALENDRONAT), and unspecified meds for high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Jan2021 at 12:00 PM, the patient experienced feeling short of breath for a few minutes soon after leaving the vaccine site. It passed and then happened again a few hours later, but it passed after inhaling some warm mist. The patient assessed the event as non-serious. Therapeutic measures were taken as a result of feeling short of breath, which included inhaling some warm mist. The patient recovered from the event on an unspecified date in Jan2021.
Patient began to have an itchy throat after leaving the pharmacy. The discomfort continued and she went to the ER at 8:00 pm on 8/12/11 where an EPIPEN was administered. Dr. believes pt had unknown egg allergy.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild
Sore arm; Erythema; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. The other health professional mentioned she had received a few complaints on sore arm and redness after receiving a dose of Bexsero. The reporter did not agreed to follow up.
SWOLLEN ARM, SLIGHT FEVER, 4/14 NIGHT THE SWOLLEN AREA MOVED UPWARDS, BUT TEMPERATURE DECREASED BY FRIDAY MORNING. TOOK TYLENOL FOR PAIN AND FEVER. BENADRYL 25MG FOR ALLERGIC REACTION, STARTED ON 4/15. PATIENT WENT TO DR OFFICE ON 4/16 AND RECEIVED CETIRIZINE 10MG RX.
Case PHEH2016US029086 is an initial spontaneous report received from pharmacist on 14 Oct 2016. This report refers to 63 year old female patient (off label use). Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165703) at a dose of 0.5 ml intramuscular on 13 Oct 2016. No adverse event was reported following this medication error.
Status epilepticus starting 2 days after dT vaccine. Patient has a history of seizures but had been seizure free for 6 years and off seizure medications for 4 years. Underlying condition of schizencephaly.
Lungs are not processing oxygen; Shortness of breath; Pulse dropping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG DISORDER (Lungs are not processing oxygen), DYSPNOEA (Shortness of breath) and HEART RATE DECREASED (Pulse dropping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Smoker.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LUNG DISORDER (Lungs are not processing oxygen) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and HEART RATE DECREASED (Pulse dropping) (seriousness criterion hospitalization). At the time of the report, LUNG DISORDER (Lungs are not processing oxygen), DYSPNOEA (Shortness of breath) and HEART RATE DECREASED (Pulse dropping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medications were reported. Treatment of these events included hospitalization with helium therapy, oxygen therapy and steroid therapy.  Action taken with mRNA-1273 was not applicable.   Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
left arm pain at injection site throbbing pain; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for a patient. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EJ1685) intramuscularly on 23Dec2020 at 15:45 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included known allergies to shrimp from an unspecified date and unspecified if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 20:00, the patient experienced left arm pain at injection site throbbing pain. It was reported that the event was non-serious and did not require hospitalization. The patient did not receive any treatment for the event. The clinical outcome of the event left arm pain at injection site throbbing pain was recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
24 hours post vaccinations - patient presented with erythema and swelling to right upper arm - no tenderness or fever noted.
she got a delayed reaction below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she got a delayed reaction below the injection site) 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.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (she got a delayed reaction below the injection site). At the time of the report, VACCINATION SITE RASH (she got a delayed reaction below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.  Concomitant medication was not reported.   Upon in internal review on 21 May 2021, the age was corrected to unknown age.   This case was linked to MOD-2021-016747 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she got a delayed reaction below the injection site) 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.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (she got a delayed reaction below the injection site). At the time of the report, VACCINATION SITE RASH (she got a delayed reaction below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.  Concomitant medication was not reported.   Upon in internal review on 21 May 2021, the age was corrected to unknown age.   This case was linked to MOD-2021-016747 (E2B Linked Report).; Sender's Comments:  MOD-2021-016747:1 reporter with 2 patients
The patient medical history and concomitant medications were not reported. On Feb2021 the patient experienced went for a pet scan and they noted that she has an increased large node under her left arm and swollen lymph. The patient underwent lab tests and procedures which included positron emission tomogram: unknown on they noted that she has an increased large node under her left arm. The outcome of event was unknown.   Information about lot/batch number has been requested.
tired; very achy; feverish; chills; nauseous; heart was racing; cold sore on my right lip; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 20:15 (Lot number: fe13594) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood presure" (ongoing), notes: blood presure being treated with irbesartan 75mg. Concomitant medication(s) included: IRBESARTAN. Past drug history included: Pennicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ewer8134, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 28May2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "Fever", "achey", "Chill", "exhausted"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0170, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 07May2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 20:15, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "tired"; PAIN (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "very achy"; PYREXIA (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "feverish"; CHILLS (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "nauseous"; PALPITATIONS (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "heart was racing"; ORAL HERPES (non-serious) with onset 23Dec2021 08:30, outcome "recovering", described as "cold sore on my right lip". Therapeutic measures were not taken as a result of fatigue, pain, pyrexia, chills, nausea, palpitations, oral herpes.  No follow-up attempts are possible. No further information is expected.
June 23 - Vomiting June 24 - No More Vomiting, Severe Abdominal Pain, ER Visit June 25 - Appendix Removed
3 days fever and very painful arm: onset: 10/11/2016, sore throat with runny nose: onset:  10/12/2016, nausea, no energy, flu like symptoms.
Parents brought child to clinic presenting with a rough, slightly raised, red rash on left thigh at injection site of DTaP vaccine. Had moderate amounts of red dots throughout both legs, and small amount on abdomen and back. Child was alert, playful, warm to touch. Parents denied fever, loss of appetite, N/V. Advised to go pediatrician as soon as possible. Did not have one, so gave them copy of community clinic.
Muscle weakness in both arms and shoulders, this has continued for over 2 months. I had the first shot in left arm on 1/06/2021, and the second shot in right arm on 1/26/2021.
In a local health department on XX/X/11, child, should have received influenza vaccine Lot# UT471AA, by Sanofi Pasteur for children 6mo to 35 months. Instead, child received FLUZONE HIGH-DOSE Lot # UH457AA, manufactured by Sanofi Pasteur for 65 yrs and older. This dose is 8 times more potent than the children's dose. Patient's doctor and head of state immunization program were called, along with patient's mother on day of immunization. Possible side effects were explained and mother was advised to call family physician and health department with any adverse reactions. Called mother back on XX/X/11 (3 days later). Child had slight fever night of immunization (101 F), was given TYLENOL x 1. No other doses needed. Child did not have any other symptoms, including no local redness, swelling or pain observed by mother. Area in refrigerator where flu vaccine was held was rearranged. Color coding of labels on baskets used to hold vaccine and vaccine permission slips were already used. Vaccine lot numbers will be reviewed x 3 before administering any vaccine per protocol. Medication administered to or used by the patient: No. Outcome: Child had slight fever night of immunization (101 F), was given TYLENOL x 1. No other doses needed. Child did not have any other symptoms, including no local redness, swelling or pain observed by mother. Where did the error occur. Local Health Department. Patient counseling provided: Unknown. Reporter's recommendations: Area in refrigerator where flu vaccine was held was rearranged. Color coding of labels on baskets used to hold vaccine and vaccine permission slips were already used. Vaccine lot numbers will be reviewed x 3 before administering any vaccine per protocol. Relevant materials provided: None.
Extreme pain in right shoulder. Treatment: Prescribed to take two (2) ALEVE twice a day. Treatment:  Physical Therapy. Treatment: Cortisone Injection to right shoulder.
Received Pfizer vaccines on 3/16, 4/6, 10/20/21 COVID-19 positive by rapid antigen at Nursing Home on 1/31/22, negative COVID PCR on 2/1/22 at hospital admitted to hospital ICU on 2/1/22 d/t acute hypoxic respiratory failure and septic shock in the setting of COVID-19 pneumonia with concern for superimposed bacterial pneumonia versus UTI
Within 10 minutes post vax pt developed an allergic reaction characterized by hives and paleness. Pt treated with Benadryl.
48 hours after receiving the vaccine, pt developed a shingles rash on left side of neck and back of scalp. Went to doctor's office 11/27/13 to receive treatment for shingles (FAMVIR, prednisone, VICODIN, gabapentin).
Just like the 2nd shot of Moderna on February 16,2021 I have muscle aches in all arms, fingers, neck, back. They were declining slightly until I got the third shot of Moderna on September 21, 2021.  Now muscle aches went right back to where they were after second shot.  Makes it hard to get out of chair or out of bed or out of car. It will be interesting to see if this reaction declines and how fast.
Mother states over telephone that left upper arm was swollen and red from shoulder to 1/2 way towards elbow.  Noted on 04/20/04.  Call received 04/23/04. Benadryl, Motrin, Ice to site ordered.
REDNESS, TENDER, SLIGHT FEVER, WIDTH 30 MM, LENGTH 20 MM AT INJECTION SITE.
arm pain and swelling initially then subsided over the next 7 days/  day 7 arm became swollen / red and itchy arm pain and swelling came back after 7 days
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age. Concurrent condition or medical history was unknown. On an unknown date the patients were vaccinated with doses of incorrect stored (Merck) VARIVAX (dose, route and lot# were unknown). No adverse effects were reported. This is one of several reports received from the same reporter (1505USA005209 and 1505USA004053). Additional information has been requested.
fever accompanied by severe chills for 12 hours; fever accompanied by severe chills for 12 hours; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) reporting for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included the patient was diagnosed with COVID-19 Prior to vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), trazodone, acetylsalicylic acid (BABY ASPIRIN), ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever accompanied by severe chills for 12 hours on 22Dec2020 07:00 PM. Since the vaccination, the patient was not been tested for COVID-19. No treatment received for the events. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.