chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph node; Pain arm (L); Swollen testicle (R test); Tenderness testicle; Lot a pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain arm (L)), TESTICULAR SWELLING (Swollen testicle (R test)), TENDERNESS (Tenderness testicle), TESTICULAR PAIN (Lot a pain) and LYMPHADENOPATHY (Swollen lymph node) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain arm (L)), TESTICULAR SWELLING (Swollen testicle (R test)), TENDERNESS (Tenderness testicle), TESTICULAR PAIN (Lot a pain) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, PAIN IN EXTREMITY (Pain arm (L)), TESTICULAR SWELLING (Swollen testicle (R test)), TENDERNESS (Tenderness testicle), TESTICULAR PAIN (Lot a pain) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Blood Clot in Leg; Tenderness; A spontaneous report was received from a consumer concerning a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg and tenderness.   The patient's medical history was not  provided by the reporter. Concomitant medications reported included diltiazem hydrochloride, atorvastatin calcium and acetyl salicylic acid.  On 13-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:031M2QA) through intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13-Feb-2021, following administration of the vaccine, the patient had tenderness in his leg that continued until he sought out medical treatment. After medical treatment is was concluded that the patient has a blood clot in his leg and has to receive medical treatment to resolve that condition. The treatment information included rivaroxaban.   Action taken with mRNA-1273 in response to the events was not applicable.   The events, blood clot in leg and tenderness were considered recovered.; Reporter's Comments: There is not enough information to assess the causa association between the reported event of blood clot in leg and the administration if the mRNA-1273 vaccine.  Critical details such as the patient's medical history is lacking. Additional information has been requested.  Howe ever, based on temporal association between product administration and the event of tenderness, a causal relationship cannot be excluded.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 44-year-old female patient who experienced "low" fever, head cold, tiredness, weakness, chills and sore throat. The patient received a dose on 19-Nov-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunisation. Product was administered on 19-Nov-2003. Dose regimen was 1 dose 1 time per day (intranasal). Concomitant Therapy: Concomitant medications were not reported. Event Details: On 21-Nov-2003, the patient developed a "low" fever (pyrexia), head cold (nasopharyngitis), tiredness (fatigue), weakness (asthenia), chills (rigors), and sore throat (pharyngolaryngeal pain). During the morning of 25-Nov-2003, the patient stated that she did not feel "feverish" however as the day progressed, she felt "feverish." On 26-Nov-2003, the reporter indicated that she did not feel "feverish" but the tiredness and "a bit of a head cold" persisted. She recovered. No additional information was available at the time of this report.  Additional information received on 05-JAN-2004 and 06-JAN-2004 from the reporter indicated that the patient did not seek medical treatment for the reported adverse events. Information regarding FLUMIST (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a consumer regarding a 44-year-old female patient who experienced "low" fever, head cold, tiredness, weakness, chills and sore throat. The patient received a dose on 19-Nov-2003. On 21-NOV-2003, the patient developed a "low" fever, head cold, tiredness, weakness, chills, and sore throat. During the morning of 25-NOV-2003, the patient stated that she did not feel "feverish" however as the day progressed, she felt "feverish." On 26-NOV-2003, the reporter indicated that she did not feel "feverish" but the tiredness and "a bit of a head cold" persisted. The reporter indicated that she recovered from the fever, chills, and sore throat.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm and pustular skin eruption. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pustular skin eruption was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and pustular skin eruption to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. She reported that her arm hurt for a couple of weeks after shot. Her face broke out with little pustules 2 to 3 weeks after receiving the shots. At first she thought it was acne but it was not resolved and then came back. For tolerance to 2nd dose of SHINGRIX, refer case US2019GSK039410.
At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.
Parsonage-Turner syndrome (R) arm/shoulder pain & weakness tx with prednisone x 2-3 weeks.
After reviewing the record for a client who was interested in a booster of the COVID-19, our team discovered that the client?s 3rd dose of the Janssen vaccine was marked as invalid. After consulting our clinical supervisor, we proceeded with the administration of a booster dose of the Moderna vaccine. Per CDC guidance, boosters do not have to be re-administered regardless of early vaccination. Therefore we are completing a VEARS report due to the administration of 2nd booster. Patient did not experience adverse reaction for the 15 mins monitoring time within our care.
This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a patient who received SHINGRIX for prophylaxis. 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 generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash. On an unknown date, the outcome of the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash were unknown. It was unknown if the reporter considered the generalized muscle aches, discomfort, injection site pain, headache, flushing, pruritus facial, dizziness, tiredness, influenza, pain and rash to be related to SHINGRIX. Additional details were provided as follows: Three months ago, from the reporting date, the patient experienced pain, discomfort, moderate or greater muscle pain in the patient's whole body-especially my lower back, pain at the injection site, headache, flushing, itchiness in various areas-mostly the face, head and back, some dizziness, some tiredness, flu and rash. This case has been linked to the US2018GSK176765, reported by the same reporter.
This spontaneous report was received from a registered nurse and refers to a 22 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (route and site of administration, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001506: US-009507513-1704USA002249:
Day 1 Arm Pain; shivering (8)                              Pain Scale (1-10) " 2 Body aches; fatigue (10) " 3 fatigue, headache (4) " 4 fatigue; Day 5 scalp pain as pressure (5) " 6 fatigue " 7 back pain (8) " 8 back pain (6)
Initial misuse report received from a healthcare professional on 03 May 2013. It was reported that ADACEL was exposed to temperature excursion (20 degree Fahrenheit) for 4-5 days. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
10/30/13 Received influenza (L) deltoid - Developed itchy red bumpy rash on arm - next day then it spread to (R) arm date unknown - He called to report on 11/4 the rash in on his legs too. He was referred to his PCP ASAP without fever or other complaints.
fever; chills; muscle ache; coughing; congestion; gastrointestinal symptoms; top of her foot became itchy; top of her foot is now bruised; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date and had fever, for tolerance refer case US2022011286).   On 17th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder, localized itching and contusion of foot. Rechallenge with Shingrix was positive. In January 2022, the outcome of the fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder and localized itching were recovered/resolved. On an unknown date, the outcome of the contusion of foot was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, cough, nasal congestion, gastrointestinal disorder, localized itching and contusion of foot to be related to Shingrix.     Linked case(s) involving the same patient:  US2022011286  Additional details were provided as follows: The patient received a dose of Shingrix and had experienced fever, chills, muscle ache, coughing, congestion, gastrointestinal symptoms, and the top of her foot became itchy and top of her foot was now bruised. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022011286:Same reporter, same product, same patient, different dose
Patient presented to ED with worsening dyspnea.  The patient had been experiencing chest pain, cough, dyspnea on exertion.  Patient admitted to hospital with Covid pneumonia.
muscle pain in arms, legs, cheeks; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain in arms, legs, cheeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (muscle pain in arms, legs, cheeks). At the time of the report, MYALGIA (muscle pain in arms, legs, cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included the patient's fibromyalgia pain medication.  Concomitant product use was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain in arms, legs, cheeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (muscle pain in arms, legs, cheeks). At the time of the report, MYALGIA (muscle pain in arms, legs, cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included the patient's fibromyalgia pain medication.  Concomitant product use was not provided.
This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 6 months after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patients did not want the 2nd dose of SHINGRIX. Onset date and duration of symptoms were unknown. Expiration date was unknown. The reporter had information for only one patient. This case was linked with the case US2018GSK173030, reported by the same reporter.
Facial pain/fullness on (R) side, chills, body aches, fatigue (10/11), chest pain, SOB, pain at injection site (10/12).
This patient received the Moderna vaccine as an outpatient . Admitted with progrssively worsening leg weakness. Family history of MS.   Diagnosed with transverse myelitis . As per MRI " 2 tiny foci of abnormal intra substance signal  in the spinal cord consistent with demyelinating process .. Patient treated with methlyPrednisone, doing better and discharged . .  Discharged on prednisone . Being followed by Neurology .
Within 10 Minutes of receiving my first dose I began to feel dizzy and my vision was somewhat blurry. I checked my heat rate and it was 160. I motioned for the nurse and the pharmacist who was present monitored me for about an hour. My heart rate did not go below 110 for at least 45 min.  I drank water and was allowed to leave once my HR was 88. I was able to drive home and did not have any other symptoms.
A grandmother reported that her 4 month old grandson received his first dose of Prevnar on 5/21/01. On 6/3/01 he died of sudden infant death syndrome. He was seen earlier in the day by the physician and "everything was normal".
Started choking on spit; Everytime i cough my nose bleeds now; Everytime i cough my nose bleeds now; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Started choking on spit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOKING (Started choking on spit) (seriousness criterion medically significant), COUGH (Everytime i cough my nose bleeds now) and EPISTAXIS (Everytime i cough my nose bleeds now). At the time of the report, CHOKING (Started choking on spit), COUGH (Everytime i cough my nose bleeds now) and EPISTAXIS (Everytime i cough my nose bleeds now) outcome was unknown.            No concomitant product use was reported. No treatment information was provided  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.
I am on day 12 of low-grade fever.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 25Mar2021 at 10:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. Concomitant medications included fluticasone propionate and salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC) and OTC probiotics from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) in the left arm on 25Feb2021 at 10:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 13:00 the patient experienced low-grade fever. The highest hit was 100.8 measured with a forehead/temple touch thermometer. Most of the time it would register between 99.7-100.3. The patient generally had a lower than average temperature, something like 98.2. In 2021, the patient was checked for body temperature and the result was 100.8 The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event low-grade fever was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
felt muscle pain in the arm where they got the Pfizer shot; headache; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced felt muscle pain in the arm where they got the Pfizer shot and headache on an unspecified date. Therapeutic measures were taken as a result of headache included pain killer. Outcome of headache was recovered, other was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.
Fever; body aches; fatigue; redness at injection site; muscle stiffness at injection site; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686, Expiration date: Unknown) via intramuscular route of administration in the left arm on 25Jan2021 10:00 at SINGLE DOSE for COVID-19 Immunization.  The patient had no medical history and had no known allergies. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient was not having COVID-19 prior vaccination. On 25Jan2021 at 21:00 the patient experienced Fever, body aches, fatigue, redness at injection site, muscle stiffness at injection site. On 28Jan2021 post vaccination, the patient had nasal swab for COVID-19 test which was negative. The patient was not given treatment. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
vaccine past its expiration date administered to 11 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  No treatment medication was mentioned.  Patient was administered with booster dose after 30-day Use By Date or after manufacturer date of expiry. Vaccine was expired on 27-OCT-2021.   This case was linked to MOD-2021-370372, MOD-2021-371236 (Patient Link).
Significant dizziness/vertigo from about 8:00pm the day of the vaccination, all of the following day, but better in the morning of the 2nd day after.
Significant swelling of site. On another booster it seemed like I had a breast lump, and ultrasound done.
Pt developed localized swelling in her right upper arm along with redness, warmth and pain.  Pt taking Tylenol for pain along with resting arm. no further treatment needed as pt's arm is better at the time she called the clinic to report this on 3/1/16.
Developed HA evening of vaccination - lasted 1-2 days 2 day post-vaccine developed soreness, feeling of swelling (L) axilla. No lump felt, but area remains sore. Increased discomfort with arm movement. No notable swelling or soreness at injection site (L) arm.
I immediately felt a severe muscle pain at the site of the injection. I went to home and iced the site. The second injection went into the same left arm. The nurse administering the second vaccine suggested same arm so my right arm would not be compromised. I have gone for PT to alleviate the muscle spasm. Now I am experiencing a continued series of muscle pain ranging in moderate to severe pain. The muscles affected are now in both my arms & legs. I have also tried acupuncture for pain relief. This is an ongoing pain to date.
intermittent watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (intermittent watery diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (intermittent watery diarrhea). At the time of the report, DIARRHOEA (intermittent watery diarrhea) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable. Action taken with mRNA-1273 in response to the events was not reported.