chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme, continuous shivering began at 10:00 pm the day I received the shot, and continued off and on throughout the next two days.  It has lessened on the fourth day (today). Nerve sensitivity (tingling) began the day I received the shot and continues through today (beginning to lessen today).  Locations:  both feet and shin areas, right hand, mouth area including tongue and lips. Some random tingling was felt in both legs and both arms on Day 2 & 3, which has now lessened.) Lymph node sensitivity in left underarm area was noticed on Wednesday, but is gone today (Thursday). Injection site was very painful, swollen and hot.  I experienced difficulty in using that arm each day since receiving the injection.  Today it is beginning to lessen. Headache began on Day 2, was worse on Day 3, and is lessening today.  Advil was not helpful to stop the headache. I experience dizziness frequently due to my Vestibular Imbalance condition, but the dizziness became worse after I received this vaccine.  I wasn't able to drive or ride in a car without taking Dramamine since Day 2, which prior to the shot I was mostly able to do. I experienced nausea at an increased level on Day 2 & 3.
muscle and joint pains, headache, chills, swelling on injection site. Finger joints swelling and pain. Dizziness.
Initial soreness at injection site, shivering, chills, fever, sweats, muscle and joint aches managed with Ibuprofen and Acetaminophen. Residual symptoms resolved after ~3 days.
swelling, redness, itching and  warmth to touch which has slowly increased in size. As of 1/8 is about 3 inches X 3 inches.
cold symptoms such as runny nose; cold symptoms such as runny nose; some tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold symptoms such as runny nose), RHINORRHOEA (cold symptoms such as runny nose) and FATIGUE (some tiredness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (NSAIDs allergy) and Sulfonamide allergy.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NASOPHARYNGITIS (cold symptoms such as runny nose), RHINORRHOEA (cold symptoms such as runny nose) and FATIGUE (some tiredness). At the time of the report, NASOPHARYNGITIS (cold symptoms such as runny nose), RHINORRHOEA (cold symptoms such as runny nose) and FATIGUE (some tiredness) 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 relevant concomitant medications reported.  No treatment information was provided.  On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine).
A male, child (age, date of birth not reported) experienced soreness and bruising at the right and left, gluteal injection sites after he received dose 5 of Daptacel (lot number C2626AA, route of administration not reported) in the left gluteus and dose 4 of IPOL (lot number Z0548-2, route of administration not reported) in the right gluteus on 07 May 2007. The patient also received dose 2 of ProQuad (MMR and Varicella, lot number 1484F, route of administration not reported) in the right gluteus. The parent treated the patient with Tylenol. At the time of the report, the patient was resolving. This case has the same reporter as case 2007-1630.
Staring spell and unresponsiveness for about 5 minutes, subsequently, rhythmic twitching of fingers during sleep for a few minutes. (Diagnoses as at least two complex partial seizures by pediatric neurologist.) During the following week, stomach upset, pain, vomiting, fever, diarrhea.
Information has been received from a nurse practitioner concerning a 15 year old female who on 27 Dec 2006 was vaccinated with a first dose of Gardasil concomitantly with a dose of influenza virus vaccine (unspecified) using a different injection site. On 27 Dec 2006, approximately  2 hours after the vaccination, the patient experienced swelling and numbness in her lower lip. On approximately 29 Dec 2006, the patient recovered without treatment. Additional information has been requested.
Left upper arm with approximately 7 cm area of erythema or swelling. Area with itching. Treatment of CLARITIN and ATARAX given. Advised to ice as needed and return if symptoms persist.
After receiving the vaccination I got really sleepy. I got home around 3:30 in the afternoon and went to bed. I woke up around 10:00 p.m. with a bad headache.  The following day I slept all day waking periodically with a headache.
I had strep throat in August and a reoccurrence in September - broad spectrum antibiotic - Amoxicillin the first time and another antibiotics the second time (about a month apart).  I saw an ENT after that - he gave me an all clear - it's strange for an adult to get strep. I had also had Strep in February and then I got both my COVID vaccines and then these occurrences.  I had the booster this last Sunday.
After administration of vaccines I had student and mom come in my office to make follow up appointment.  Student did not complain she was not feeling well.  Student was standing  to my left when suddenly student collapse and hit face with floor. Mom picked student up and sat her on the chair, student was in and out, and started projectile vomiting x4.  Student was noted to be pale.  After a few minutes student became more alert. BP 92/70 P 89 R 20  T 98.3.  EMS was called. By the time EMS came in student was alert and oriented, she verbalized everything suddenly went black, she denies any symptoms prior to fainting.  Mom verbalized student becomes very nervous when she is getting vaccines, and feels dizzy but she has never fainted before.  student sent to the ER via stretcher.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (needs a nuclear stress test after 1st dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (needs a nuclear stress test after 1st dose). At the time of the report, vaccination complication (needs a nuclear stress test after 1st dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
ANAPHYLACTIC NEUROLOGIC SYMPTOMS INCLUDING HALLUCINATIONS DEVELOPING WITHIN 7 DAYS OF VACCINATION, SECOND DOSE NOT ADVISED BY CDC, SECOND DOSE DUE 3/12/2021, SECOND DOSE NOT ADMINISTERED AND DOCUMENTED AS ANAPHYLACTIC REACTION TO FIRST DOSE
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 45-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 4:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:21 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 13-Feb-2021 Age of patient was reported as 45.70 and on 20-Mar-2021 Age of patient was reported as 45.80. No concomitant medications were reported. On 13-Feb-2021 at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 13-Jan-2021. On 20-Mar-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and on at 10:00 A.M., the temperature recorded was 37 degree Fahrenheit and vial was moved to the fridge on 09-Mar-2021 and beyond use date was 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.
He also has the same swelling.; Achiness and the tired feeling.; Achiness and the tired feeling.; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3 (booster), single (Lot number: FM9992, Expiration Date: 22Jun2022) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing), notes: Glaucoma; "Cervicis' and had 'motely' removed/ neck surgery" (unspecified if ongoing), notes: 'cervicis' and had 'motely' removed,. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), FATIGUE (non-serious) all with onset Apr2022, outcome "unknown" and all described as "Achiness and the tired feeling."; SWELLING (non-serious) with onset Apr2022, outcome "unknown", described as "He also has the same swelling."; NAUSEA (non-serious) with onset Apr2022, outcome "unknown". Therapeutic measures were not taken as a result of swelling, pain, fatigue, nausea.  Additional information: A neuro surgeon 'get to' neck surgery on him. The patient was on some pain medication.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200621154 Same product and event, different patient
have administered an expired IPOL to a patient with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old male patient who experienced have administered an expired ipol to a patient with no reported adverse event after receiving vaccine ipv (vero) [ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap); measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3) (mmrvaxpro); and hepatitis b vaccine (hepatitis b [hepatitis b vaccine]).  On 11-Oct-2022, the patient received a  dose of suspect ipv (vero) at dose of 0.5 ml (lot T1E871M, expiry date:10-Oct-2022  via subcutaneous route in the left arm. for Immunization.  On 11-OCT-2022 the patient developed a non-serious have administered an expired ipol to a patient with no reported adverse event (expired product administered)(latency same day) following the administration of ipv (vero).  It was reported "Nurse is calling to get some guidance as they have administered an expired IPOL to a patient. Nurse also wants to know if they need to revaccinate the patient and what to do moving forward".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (have administered an expired IPOL to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event have administered an expired ipol to a patient with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in the Left arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the Left arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in the Left arm). In 2021, PAIN IN EXTREMITY (Pain in the Left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106601:
I woke up around 3:00 a.m. the morning of March 20, 2021, shaking and with pain in my lower right side.  My wife called 911 to be safe because I couldn't stop shaking. I was transported to a nearby hospital where they ran some tests and determined I had a kidney stone. According to the doctor, I passed the stone while I was there. I left the hospital at around 6:00 a.m. following various tests. I expelled the kidney stone at home that morning. I have not had another kidney stone since.
light headed; dizzy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Feb2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included she previously tested positive for COVID-19 on 06Jan2020. Concomitant medication were not provided. On an unknown date, the patient was dizzy and lightheaded. The outcome of the events dizzy and lightheaded was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188074 same reporter, different patient/AE
Vaccination site pain; super tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (super tired) in a patient of an unknown age and gender 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 VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (super tired). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported
Information has been received from a Licensed Practical Nurse concerning a patient (age and gender not specified). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-JUL-2017 the patient was administered a dose of improperly stored VARIVAX, lot # M047660, expiration date  02-DEC-2018, for prophylaxis. Temperature: -9 degrees C to 8 degrees C. Time frame: 3 hours. No previous temperature excursions. Digital data logger was involved. The sterile diluent (manufacturer unknown) that was used to reconstitute the vaccine was properly stored. The outcome of the event was unknown. Additional information has been requested.; Sender's Comments: US-009507513-1708USA001658:
Cellulitis developed about 48 hours after vaccine at site. Patient treated with Omnicef (also had an otitis media).
approx 14mos p/vax pt devel approx 30 lesions which lasted 3-4 days.
Approximately 20 mins. after my first shot, I had a slight allergic reaction. Flushed/hot face, increased heart rate, slightly labored breathing.  Went back into facility and sat for approx. an add'tl 30ish mins. to make sure all was ok. EMT checked me and said all looked good.  Later that night, I began experiencing shoulder pain.  Hurt to lift arm, cross over body, bend arm and hold in front of chest.  Throughout the following day, pain got worse.  The night of 3/18, pain was so severe  that it brought tears to my eyes.  Had to lift arm with my good arm to move it.  Trying to use it was excruciating.  Couldn't sleep. Just rested arm, tried not to move it.  The next day pain was manageable, not nearly as severe.
chronic pain in right side of her body/sharp pain; experiencing a sharp pain or sensation of  burning; This is a spontaneous report from a contactable consumer. This consumer reported for similar events. This is the first of the two reports.  A patient of an unspecified age and gender received the second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Jan2021, she was in the ER for chronic pain in right side of her body and also was experiencing a sharp pain or sensation of burning. The outcome of events was unknown.  The information on the lot number has been requested.
Right upper arm completely swollen, warm but not tender, swelling was beyond elbow on 2/19/09. Recheck if redness starts to extend rather than recede or if fever or tenderness continue warm compresses.
Swelling, redness @ inject site of Td; Fever 102-103; tenderness @ inject, nausea;
patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case); shingles outbreak appeared on neck and chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles outbreak appeared on neck and chest) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced HERPES ZOSTER (shingles outbreak appeared on neck and chest). On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case)). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 3 times daily for seven days. On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case)) had resolved. At the time of the report, HERPES ZOSTER (shingles outbreak appeared on neck and chest) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added second dose of the drug and updated the Action taken from unknown to not applicable in product tab. Added the event Inappropriate schedule of product administration.
Unable to sleep; Headache; Sore shoulder; Sore neck; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm), INSOMNIA (Unable to sleep), ARTHRALGIA (Sore shoulder) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management, OMEPRAZOLE for Heartburn.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced NECK PAIN (Sore neck). 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 24-Feb-2021, the patient experienced INSOMNIA (Unable to sleep) and HEADACHE (Headache). The patient was treated with Physical therapy for Neck pain; Physical therapy for Pain in extremity and Physical therapy for Arthralgia. At the time of the report, NECK PAIN (Sore neck), INSOMNIA (Unable to sleep), ARTHRALGIA (Sore shoulder) and HEADACHE (Headache) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            patient went to emergency room and left after few hours after receiving muscle relaxant.patient was also prescribed with medications for sleep and pain but do not work effectively. patient had lab work MRI and X-ray done. On 26 Feb 2021, patient went to doctor and the doctor gave another muscle relaxer.  .   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Received follow-up updated patient demographics, anatomical location, concomitant medications, new events have been updated
Left deltoid arm pain and weakness at rest and worse with use consistent with SIRVA, lasted for 4 weeks.
High pitched cry greater than 3 hours after shots. This occured approximately 5-6 hours after shots.