chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reported for himself. A 65-year-old male patient received PREVNAR 13 for immunization at single dose on 23Feb2018, via an unspecified route of administration. On 24Feb2018 the patient experienced itching and swelling of the right foot with outcome of recovered on 25Feb2018, on 26Feb2018 the patient experienced swelling of the genitals, swelling of the right side of the face both with outcome of recovered on 28Feb2018, on unknown date swelling of the lower lip, the first episode recovered on 28Feb2018, then the event reoccurred on 02apr2018 and the outcome was recovered. He went to the emergency room on 25Feb2018 and was told it was an allergic reaction to the vaccine. The patient took some antihistamine and put ice. Information on the batch number has been requested.
PAIN SECONDARY TO TOOTHACHE WORSENED; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: toothache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced pain secondary to toothache worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain secondary to toothache worsened. This report was non-serious. This case, from the same reporter is linked to 20161001746 and 20160930945.
Injection was on 3/22/06 at 14:15 in right thigh. That night her thigh was swollen and hurting her. She came back to clinic on 3/24/06. Dr. looked at the thigh. Warm to touch. 9cm induration. No redness noted. She was sent home and was told to put ice on it. Call if it gets worse or if she gets a fever.
severe abdominal pain, chest pain, constipation, fatigue, achey, Myalgias, pharygitis  11/17/09 Medical records received for DOS 11/13/09.  Final Dx: Pleuritic chest pain, nausea.  S/P vaccine records show: 11/13 -C/O mid chest/epigastric pressure. Nausea. CXR neg. Pleuritic chest pain.   Records also note h/o suppurative appendicitis 2/4/09. 12/4/09 Medical records received for date 11/13/09.  DX: chest pain Pt c/o sudden onset of chest pain, difficulty breathing, weakness, HA, chills, dizziness, difficulty walking. Assessment: decreased breath sounds bilat bases. OV 11/11 for c/o daily episodes of nosebleeds x9 days. DX: nosebleeds. OV 10/26 DX: myalgias, abd pain, pharyngitis, H1N1 rx. Pt. c/o severe abd pain, chest pain, constipated, fatigue x4 days, had H1N1 vax 4 days ago. Assessment: WNL except (+)tonsils swelling.
A  male patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161 and expiration date was not reported) via an unspecified route of administration, administered in Arm Left (Left Shoulder Side of the Arm s single dose for covid-19 immunisation. Vaccination facility type was other. Reportedly, patient had no history, no other products and no investigational assessment. Patient did not have any family medical relevant history. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 evening the patient experienced left arm sore, on 17Apr2021 patient experienced fever, head pounding, Lower Half of Body was Very Sore; Muscle Aches (muscle pain). The patient states he was calling about his first dose, he got the first dose on this past Friday, 16Apr2021 and he was fine that day and then the following day, Saturday night, he had a fever and he still has a fever 4 days later. Is it normal to have a fever after 5 days. The report was not related to a study or a program. Patient took treatment Montrin. Patient did not went to emergency room or physician office, he went to urgent care. The outcome of the event pyrexia is not recovered, left arm pain recovered on 18Apr2021, muscle pain (Lower Half of Body was Very Sore; Muscle Aches) recovered on 17Apr2021 and head pounding recovered on 18Apr2021.   No follow-up attempts are needed. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022 at 11:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 02-Mar-2022 at 11:26 AM, the patient experienced 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.   The age of patient was provided as 77.75.  Concomitant products were not provided.  On 02-Mar-2021 the excursion time was 9 AM, 10AM, 11AM, 12PM, 2PM and 3PM temperature was 29, 32, 33, 35 and 36 total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.On 28-Feb-2021 the vial was kept in cooler 1.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Dizziness, Myalgia & NauseaVomiting Narrative:  pt c/o extreme fatigue, body aches all over, and chills. later reported waking up 'good' advised to seek PCP advice/care for worsening of symptoms.  Other Relevant History:
Dense brain fog- slow thought processing, difficulty concentrating, unable to multi-task, word finding difficulties, difficulty remebering what the next task is at work,  difficulty problem solving, problem perfoming routine tasks in proper squence.   Problem started 3.5 hours after injection and continue with minimal improvement 26 days later.
I grew incredibly fatigued after my initial side effects wore off. It felt like I could never get quite enough sleep to feel rested no matter how much I slept. After my second follow up shot, the fatigue became nearly debilitating. I went to the doctor to learn what might be wrong. My bloodwork showed I had a mono reactivation.
onset of right knee pain on 5/24, followed by left knee pain on 5/26.  DVT of left lower extremity diagnosed 5/27
High levels of inflammation in blood tests, levels went up; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (High levels of inflammation in blood tests, levels went up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (High levels of inflammation in blood tests, levels went up). At the time of the report, INFLAMMATION (High levels of inflammation in blood tests, levels went up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-075456 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Email from reporter, sex of patient corrected to female, requests call from Safety in order to relay what happened in detail, then will decide if want to involve doctors/hospital staff.
Caught COVID after being fully vaccinated. I experience a reaction to the vaccine with fever, nausea, lightheadedness, aches and chills at the time of vaccine.
2 - 3 inch circular area around injection site red, raised, warm & painful x 5 days.
Severe headache Insomnia  Cold chills Black spot at injection site Confusion  Difficult to think of words Thoughts jumbled Dizziness  Nausea
Felt tingling in my left breast, armpit, and left arm; I start to get a rash; This case was reported by a consumer via interactive digital media and described the occurrence of tingling of extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 days after receiving Shingrix, the patient experienced tingling of extremity and rash. On an unknown date, the outcome of the tingling of extremity and rash were unknown.   It was unknown if the reporter considered the tingling of extremity and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced tingling in my left breast, armpit and left arm.. The patient got shot on Monday the following Friday patient start to get a rash that by Saturday. The reporter did not consent to follow up.
Red area size of quarter appeared on day 2 and was hot to the touch. Area has grown to size of baseball on day 4 and is hot to the touch.
Pt developed arthritic condition in right hip. He went from normal to barely able to walk in a two week period. Treatments have included Celebrex, hip injections, and physical therapy. The 60 day follow-up states the pain in the right hip remains.
I received my COVID shot on 4/10/2021 without any reactions or side effects. On 11/5/2021 I got my booster shot along with the yearly flu shot. On 11/9/2921 I noticed some back pain and blamed it on the way I slept. It just got worse and drove me the the ER on 11/22/2921. They did tests and diagnosed me with back muscle spasms. It has since migrated us to my shoulders and neck. I currently have zero range of motion in my neck.  I am missing work days and this prohibits me from driving and doing any daily functions like cleaning or even getting dressed.
rash at the injection site; red welts; The are was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site rash, erythema urticarial and pain in arm. On an unknown date, the outcome of the injection site rash and erythema urticarial were recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site rash, erythema urticarial and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash at the injection site presented.   It was described as red welts and arm was sore for a few days also.  The reporter did not consent to follow up. This case linked with US2020219727, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219727:same reporter (reporter´s case)
20 days after my second dose of Moderna vaccine I began to experience itching, redness, and hives widely dispersed on my body.  Every day until I visited an urgent care center the symptoms became worse.  The two days before seeking medical help the symptoms had begun to interfere with my sleep.  The redness and hives were over most of my body.  The least affected areas were my face  and back.  The worst were on over both legs, back and front.
This spontaneous report as received from a Registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of lot # (669692/0615AA, expiration date 02-JUL-2012) of ZOSTAVAX on 03-JUL-2012 (dose and route not reported). No other co-suspects and no concomitant medications were reported. No adverse event was reported. Additional information has been requested.
The pt pesented 10-20 small vesicles on 05/28/2002.
Erythema, edema site of injection noticed around 10 AM 6/11/03. Seemed tender, slightly bruised evening of 6/10/03. On exam on 6/11/03, indurated, erythematous, oval shaped 5 x 6 cm area.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot # L028285 and expiry date: 28-OCT-2016, instead of VARIVAX. No adverse effect was reported. No further information was provided. Additional information has been requested.
immediate (L) shoulder pain & one day of numbness down to index finger seen in clinic 10/16/18 with poss (L) shoulder tendinitis, Rx with cold, ibuprofen  ongoing shoulder pain, pt called 8/13/19 with ongoing sx  -received in clinic 8/15/19 shoulder x-ray with mild narrowing of acromiohumeral distance. -seen by ortho 8/16/19 - mech of injury was flu vaccination Dx with shoulder rotator cuff tendinopathy Rx ice, NSAID, shoulder MRI which showed lateral downsloping acromion with small subacromial/subdeltoid bursa fluid, correlate for rotator cuff impingement -10/15/19 - cortisone injection by ortho for impingement -12/19/19 - some improvement in pain now report burning, tingling down arm -re-eval by me 1/7/2020 - ulnar neuropathy vs cervical radiculopathy of gabapentin  refer for NCS -1/21/2020 seen by ortho given 2nd cortisone injection -2/6/2020 EMG, NCS with (L) axillary mononeuropathy of unclear significance. -2/19/2020 (L) brachial plexus MRI ordered, done 3/7/2020 "Normal MRI (L) brachial plexus" - referred to neurologist -telephone visit with Neurologist dx with (L) axillary nerve injury from vaccination on 9/18. Unclear mechanical or immune mediated
I started waking up after 2-3 hours of sleep and I would be wide awake.  When I would try to go back to sleep I would hear like someone was walking through the house.  I would usually have a pretty good night of sleep the next night and then I would go back to a night of hardly any sleep.  This week I went 3 days with out sleep.  During the day I have troubled staying focused and I am unable to function as well.  I am unsure if it is because I am not getting enough sleep.  I am also having trouble remembering things.  My doctor advised me to take over the counter melatonin .  I feel like that it is not making a difference.
feels shaky; vertigo; slight fever; Dizziness; he feels lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), LETHARGY (he feels lethargic), VERTIGO (vertigo), NERVOUSNESS (feels shaky) and PYREXIA (slight fever) in a 75-year-old male patient who received  .    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.    No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (Dizziness), LETHARGY (he feels lethargic) and PYREXIA (slight fever). On 19-Feb-2021, the patient experienced VERTIGO (vertigo). On an unknown date, the patient experienced NERVOUSNESS (feels shaky). At the time of the report, DIZZINESS (Dizziness), LETHARGY (he feels lethargic), VERTIGO (vertigo), NERVOUSNESS (feels shaky) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included meclizine 25 Mg   This case was linked to MOD21-084284 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Non Significant FU received; Sender's Comments:  MOD21-084284:
I had vaccination on 06/20/2022. I had a dry cough 07/2022 and was diagnosed with Chronic Bronchitis and Pneumonia. I was given an Albuterol Inhaler. On 09/06/2022 I was feeling congested bad sore throat and felt like laryngitis. I would cough but nothing would produce and I felt tired. I went home and slept but felt like I was having a hard time breathing on my right side. I went to patient care on 09/07/2022 and they tested me for COVID-19 and it was positive.
Patient accidentally received third moderna vaccine; Palpitation; Chest heaviness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (Patient accidentally received third moderna vaccine), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Chest heaviness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 042L20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Brain disorder NOS, Benign prostatic hyperplasia and Cocaine abuse.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient accidentally received third moderna vaccine), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Chest heaviness). On 17-Mar-2021, ACCIDENTAL OVERDOSE (Patient accidentally received third moderna vaccine), PALPITATIONS (Palpitation) and CHEST DISCOMFORT (Chest heaviness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information given. As patient has taken 2 scheduled doses of the vaccine (3rd being a mistake) the action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-JUN-2021 contains significant information. ADR form received, updated weight of the patient and new events.
Five days after administration, a 2 inch strip of hot, painful whelps developed on middle of the torso, on the left side. The next dayit spread to the front and back. Patient was seen by the MD ten days after the vaccination date and diagnosed with "typical" shingles. He was prescribed Valtrex, prednisone, and oxycodone.
Pt rec'd DTaP in the R deltoid on 10/23/01. she presented in our office on 10/25/2001 with a cellulitis at the injection site. she is being treated with Keflex 250mg/ 5ml 1 1/2 tsp po QID times 7 days.
left sided numbness//tightness in the face and jaw/ numbness on the other side of her face; left sided numbness//tightness in the face and jaw; Chiari Malformation; This spontaneous report was received from a physician and refers to a 23-year-old female patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapy included drospirenone, ethinyl estradiol (YAZ). On 04-JUN-2019, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, intramuscularly (injection site was not reported), lot # 1602281, expiration date: 21-JUL-2021, for HPV prevention. On 04-JUN-2019, hours after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient experienced left sided numbness or tightness in the face and jaw. On an unspecified date in June 2019, the patient visited an unspecified emergency room, however, was not admitted to the hospital. On an unspecified date in June 2019, while in the emergency room, the patient underwent Magnetic resonance imaging (MRI), which showed Chiari Malformation. It was unknown, if Chiari Malformation was present before or after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date, the patient developed numbness on the other side of her face. The patient did not receive any treatment. The outcome of the events was not reported. The relatedness between the events and the suspect product was not provided.  Upon internal review, the event of Chiari Malformation was considered to be medically significant.
Irritation, red, warm, swelling left upper arm. Rx compressed and APAP
Passed away; A spontaneous report was received from a Pharmacist concerning a 65 years-old, male patient who passed away/MedDRA PT: death, days after receiving the second dose of the Moderna COVID-19 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Lot #012L20A) on 12 Jan 2021. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot # 030M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection.  On an unknown date, days after receiving the second dose of the Moderna COVID-19 vaccine, the patient passed away. The patient did not come to the hospital; therefore the Pharmacist had very little detail of the situation but believed it was due to aspiration based on report received from the patient's boss. The Pharmacist reported there was no report of any issues from the first vaccine. The patient was found at home by spouse and had yellow stuff on face and chest.   Action taken with mRNA-1273 was not applicable as the patient deceased.  The patient died on an unknown date. The cause of death was reported as unknown. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Death days after receiving the second dose of the Moderna Covid-19 Vaccine
-Cold sore (herpes)  appreared in the nostril. (I haven't had it in 6 or 7 years) -Extreme fatigue especially when sitting or laying, feel better when start walking but again feel extremely  tired and sleepy as soon as sit or lay down. No fever.