chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red spot/it's getting bigger; Itched a little bit; Is tender; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot/it's getting bigger), VACCINATION SITE PRURITUS (Itched a little bit) and VACCINATION SITE PAIN (Is tender) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08F21A, 044A20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot/it's getting bigger), VACCINATION SITE PRURITUS (Itched a little bit) and VACCINATION SITE PAIN (Is tender). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot/it's getting bigger) had not resolved and VACCINATION SITE PRURITUS (Itched a little bit) and VACCINATION SITE PAIN (Is tender) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient had booster dose on 17-Nov-2021 and got a red spot and it was getting bigger. Reportedly, it Itched a little bit and was tender but was not sore. The patient reported they had red spot there now.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Reporter Occupation and type has been changed to other Health care professional. The outcome of the event Vaccination site erythema has been changed to Not recovered from previously reported unknown.
Given MMR injection approximately 16:00 on 08/21/2003.  Left arm Lot # 1126M, expiration date 11/14/2004.  Arm became painful--less grip noted, numbness; tingling at approximately 18:00.  ER visit on 08/23/2003.
Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of CROHN'S DISEASE (Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine) outcome was unknown.        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.   No concomitant medication were reported.  The patient had a Crohn's attack after first Monovalent primary Moderna COVID-19 vaccine.  No treatment information was provided by the reporter.  Company Comment: This is a Spontaneous case reported by a nurse, concerning a male patient of unknown age, with underlying Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease aggravated, which occurred on an unknown date after the first dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. Crohn´s disease can present relapses as part of the natural history of disease, confounding this case. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a nurse, concerning a male patient of unknown age, with underlying Crohn´s disease, who experienced the unexpected and serious (due to medically significant) event of Crohn´s disease aggravated, which occurred on an unknown date after the first dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. Crohn´s disease can present relapses as part of the natural history of disease, confounding this case. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (Tiredness). At the time of the report, HEADACHE (headache) and FATIGUE (Tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event were not applicable.  Treatment information was not provided. Concomitant medication were not provided.   This case was linked to MOD-2021-029693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Followup added on 10-june-2021,upated with new events.
Interchange of vaccine products; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 08Mar2021 as dose 2, single (Lot number: EM9810), in right arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FF8641), in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 4 (booster), single (Lot number: 059M21A), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Sulfa Allergy" (unspecified if ongoing). Concomitant medication included: LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 12Dec2022 to 17Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201392435 same patient/drug, different dose/event;
Initial report was received 26 April 2011 from a health care professional. An 11-week-old male patient who had a history of pre-term delivery and reflux, had received a first dose of intramuscular right thigh injection of PENTACEL, lot number C3733AA, and an intramuscular right thigh injection of PREVNAR (lot number E70195), and an oral dose of Rotavirus (Other manufacturer, lot number 1660Z) on 19 April 2011 and three days later in the evening, the patient was listless and unresponsive. He was taken to the emergency room and subsequently admitted. On 26 April 2011, the patient was scheduled for a follow-up visit with their pediatrician. The patient had no concurrent illness at the time of vaccination and he had been taking "PREVICID" concomitantly. The patient's outcome was not reported. Documents held by sender: None.
I received information from the insurance. The patient did not call the pharmacy. The patient went to his doctor next day of the vaccines because of asfixia. The third day went to emergency room.
2 days after the vaccine I noticed a little bit of redness, soreness and itching over the area of administration of the vaccine. A rash developed with bumps. I watched it for a day or 2 and it didn't seem to be getting better but didn't get worse. after 2 more days I found information on CDC website about rash reaction to the vaccine. It probably resolved over a period of 7-10 days altogether. I did not seek clinical care or take any Benadryl or medication.
Dont feel good; Joints ache; Headache; Fever of 100.5F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Dont feel good), PYREXIA (Fever of 100.5F), ARTHRALGIA (Joints ache) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Jan-2021.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever of 100.5F). On an unknown date, the patient experienced MALAISE (Dont feel good), ARTHRALGIA (Joints ache) and HEADACHE (Headache). At the time of the report, MALAISE (Dont feel good), PYREXIA (Fever of 100.5F), ARTHRALGIA (Joints ache) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.5 °F (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
From patient   Two weeks ago today, I had the Covid 19 booster in my right arm in your office.   The pain level in the right side of my head, right ear, and throat is still the same.   The pain in the right side of my head is like a bad headache, but hurts when touched or when the shower water hits my head.   The pain in my right chest and back has increased.
Fever of 101.0F Malaise Fatigue Generalized myalgias and arthralgias Loss of appetite
the patient came in for her second dose and described swelling at the site of injection that lasted for 2 weeks.  it was red and hot to the touch and painful.  she also had flu-like symptom including a low grade fever and fatigue that lasted for 2 days
This spontaneous report as received from a physician who reported that 90-100 patients were inadvertently administered vaccines from December 2013 to March 2014 that had been improperly stored. This report refers to unknown number of these patients who were vaccinated with GARDASIL that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Severe swelling of both armpits  (left > right) and chest with burning / electrical pain through anterior chest wall. Was unable to sleep well for 3 days. Symptoms completely resolved in 3 days.
This case was reported by a physician and described the occurrence of multiple sclerosis in a 30 year old female subject who received with hepatitis B vaccine (manufacture unknown). The subjects medical history was notable for pyelonephritis with reimplantation of the Ureters for reflux at 2 years of age. On an unspecified date on Oct 2001, at 30 years of age, the subject again developed pyelonephritis. Medical history also included chronic back pain, groin pain, dysmenorrhea and ovarian cysts. Concurrent medications included nitrofurantoin (Macrobid) for prophylaxis of pyelonephritis and oral contraceptives to treat ovarian cysts. On Jan 9 2002, the subject received a dose of hepatitis ab vaccine (dose number not provided, lot 1A660 unknown lot number configuration). Approximately 14 days after receipt of hepatitis B vaccine, on 01/23/2002, lab analyses revealed elevated levels of aspartate transaminase (45) and alanine transaminase (89). On an unspecified date in March 2002, the subject experienced weakness of the lower extremities, abdominal pain, back pain, paresthesias and urinary and fecal retention. On an unspecified date in March 2002, magnetic resonance imaging of the brain and spine were negative. The symptoms persisted. On Dec 3 2004 and again on April 15 2004, magnetic resonance imaging of the brain showed two hyperintense lesions in the left hemisphere. On May 19 2004, the subject was diagnosed with multiple sclerosis. The outcome of the events was not provided. Multiple sclerosis, elevated aspartate transaminase, and elevated alanine transaminase were assessed as medically serious by manufacturer (OMIC).
Just had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Just had a fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PYREXIA (Just had a fever). At the time of the report, PYREXIA (Just had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Pulsing, small pulsing pain under below my left breast and it comes in and it comes in at intermittent intervals; It is like for a minute or half, sometimes every five seconds; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown, expiry date: 31Oct2021), via an unknown route of administration on 06Aug2021 (at the age of 75-years-old) as single dose for COVID-19 immunization. The patient's medical history included thyroid from an unknown date to unknown if ongoing. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unknown indication from an unknown date to unknown if ongoing. On an unknown date in Aug2021, the patient experienced pulsing, small pulsing pain under below her left breast and it comes in and it comes in at intermittent intervals; It was like for a minute or half, sometimes every five seconds. Consumer stated, she thought it might be having a reaction, adverse reaction to the shot she got yesterday but she did not know, and wonder if anybody else have had a strange reaction like this. Consumer stated, this was weird, and she have never had anything like this before so that's why she thought that it must be caused by the vaccine, but she meant that was long time to wait, she might, maybe she should call the pharmacist who could see if they had anybody else that have these types of symptoms. The outcome of the event was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
lymph node in the deltoid region and lymphadenopathy in the left axillary region.  Some erythema of the injection site.
Patient presented to clinic 8/10/2022 for Moderna booster dose. Patient was given 0.25 mL of Moderna red cap vial in left deltoid, dose verified. On 8/31/2022 it was identified that patient did not qualify for booster dose as she had already received one and was not in the correct age category for second booster. Nurse manager was notified immediately. Patient was called 8/31/2022 and notified of the incident. Patient states "works in healthcare and was due for booster". Notified of CDC guidelines. Patient verbalized understanding and states "did not have any reaction felt fine and just had a sore arm after injection". QIR also submitted.
This spontaneous report was received from a pharmacist regarding a 67 year old female patient. There was no information about concurrent condition and historical medication. On 17-DEC-2015,t he patient was vaccinated with ZOSTAVAX (Dose/Frequency: 0.65 ml, lot number - L029483, expiration date- 06-NOV-2016, subcutaneous). No concomitant medication was reported. On 06-JAN-2016, the patient a raised rash on her trunk, achy joints and a fever of 99F. No treatment was given to the patient for the adverse event. No laboratory diagnostic tests were done. Patient called pharmacist to seek medical attention. The outcome of raised rash on her trunk was reported as not resolved (continued). The outcome of achy joints and a fever of 99F was reported as resolved. Causality between raised rash on her trunk, achy joints and a fever of 99F and ZOSTAVAX was unknown. Additional information is not expected because does not wants to get contacted.
asthma attack without reason; coughing up phlegm; muscle weakness; nauseous; lethargy; chills; could not sleep; soreness at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep) and MUSCULAR WEAKNESS (muscle weakness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache). On 13-Mar-2021, the patient experienced INSOMNIA (could not sleep) and CHILLS (chills). On 15-Mar-2021, the patient experienced LETHARGY (lethargy). On 16-Mar-2021, the patient experienced ASTHMA (asthma attack without reason), PRODUCTIVE COUGH (coughing up phlegm), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Headache, at a dose of 1 dosage form and SALBUTAMOL (ALBUTEROL HFA) ongoing since an unknown date at a dose of 1 dosage form twice a day. On 13-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) and HEADACHE (headache) had resolved. On 15-Mar-2021, LETHARGY (lethargy) and CHILLS (chills) had resolved. On 16-Mar-2021, ASTHMA (asthma attack without reason) had resolved. At the time of the report, PRODUCTIVE COUGH (coughing up phlegm), INSOMNIA (could not sleep), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: elevated (Inconclusive) temperature was slightly elevated.. In March 2021, Heart rate: increased (Inconclusive) rapid HR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.
Fever PAIN IN INJECTION SITE RADIATING TO L ARM AND L BREAST Narrative:
High fever, dizziness, weakness, tunnel vision, cramping, headache (migraine), tingling in fingers, nausea.  On going.  Have not ceased.
Localized redness Rt upper arm - mom reports "it was the size of a small goldfish".
headache; headache coming from his eyes; his arm started bothering him/ his arm was sore in the muscle/ it was pretty sore; little sore, shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "disability" (unspecified if ongoing), notes: on medication that his psychiatrist and doctor prescribed him; "hurt his ankle" (unspecified if ongoing), notes: prior to first dose of the vaccine , has therapy tomorrow. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for arthralgia. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "his arm started bothering him/ his arm was sore in the muscle/ it was pretty sore"; ARTHRALGIA (non-serious) with onset 24Mar2021, outcome "unknown", described as "little sore, shoulder"; HEADACHE (non-serious), outcome "unknown", described as "headache"; EYE PAIN (non-serious), outcome "unknown", described as "headache coming from his eyes". Therapeutic measures were taken as a result of vaccination site pain, arthralgia. Additional information: Patient's age was reported as 60 (unit was unknown). Clinical course: Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine yesterday in his right arm. He didn't feel the injection, last night his arm started bothering him while he was sleeping; today his arm was sore in the muscle (first he said it was pretty sore and then he said a little sore, shoulder), he has been reading and knew this could happen. He has been using ice on his arm to minor the soreness, he read online that this could be the best treatment. It was reported that the patient got new glasses (last 7 days) and he has been reading a lot. The patient also experienced headache and he knew this has been reported with the vaccine however he believed that his headache was related to the glasses, due to this headache coming from his eyes. It was reported that his teeth and cheek were bothering him. Patient has no fever and he hurt his ankle prior to first dose of the vaccine so he took a small dose of aspirin every morning for his ankle, he also has therapy tomorrow. Patient was also on medication for a disability that his psychiatrist and doctor prescribed him. Patient would like to know if taken Aspirin for his ankle before receiving the first dose could affect the vaccine, how long the pain in his arm will last, if he can continue using ice and how long 30 minutes-1 hour and if he can take Aspirin. Patient was also querying if the second dose of the vaccine needs to be given in the same arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-JUL-2014, the patient was vaccinated with the first dose of GARDASIL 9. On 02-FEB-2015, the patient received the second dose of GARDASIL 9. On 05-NOV-2015, the patient was vaccinated with the third dose of GARDASIL 9. On 05-JUN-2017, the patient inadvertently received the fourth dose of GARDASIL 9 injection, lot # M011117 with expiration date on 07-DEC-2017 (route and site of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Erythemic, non-pruritic area to vaccine administration site measuring 5cm x 4 cm