chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She still has bumps but they are not as raised and itchy; On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy) and PAPULE (She still has bumps but they are not as raised and itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy). On an unknown date, the patient experienced PAPULE (She still has bumps but they are not as raised and itchy). The patient was treated with LORATADINE at a dose of UNK dosage form and ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy) and PAPULE (She still has bumps but they are not as raised and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided. Treatment information was not provided.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild
CEREBRAL VENOUS THROMBOSIS; VISUAL IMPAIRMENT; HYPOAESTHESIA/ NUMBNESS IN ARM; This spontaneous report was received from a health care professional  via a Regulatory Authority Vaccine Adverse event Reporting system (VAERS) (VAER reference number 1207958) and concerned a 64 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported. 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included atorvastatin and lisinopril; both for unknown indication.  On 07-APR-2021, the patient experienced cerebral venous thrombosis, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral venous thrombosis, hypoaesthesia, visual impairment. This report was serious (Disability Or Permanent Damage).  This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added for the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1207958) and concerned a 64-year-old male of unspecified race and ethnicity who experienced cerebral venous sinus thrombosis (CVST) 22 days after vaccine. Concurrent conditions included pollen allergy and concomitant medications included atorvastatin and lisinopril. Twenty-two days after vaccine, the patient experienced CVST, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm. Specific imaging and laboratory results, including platelet count, were not reported. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. The platelet count is not reported and thus this case does not meet the Brighton Collaboration (BC) definition for Thrombocytopenia Thrombosis Syndrome (TTS) with BC Level 5 (not a case of TTS.)
A spontaneous, non-serious event of inadvertently gave H1N1, Intranasal to a 19-month-old patient was received from a registered nurse. There was no adverse event associated with this medication error; therefore, treatment and reporter/company causality assessments are not applicable, and the event is considered resolved.
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Patient had fever, chills, achiness for about 2 days post-vaccination, and about 4 or 5 days post-vaccination began experiencing the following, all of which have been severe and which she was not experiencing prior to vaccination: overly sensitive sense of smell, chest pain, migraines, light sensitive, nausea, insomnia, short term memory loss, mood swings. Patient was advised to contact her physician as soon as possible for further evaluation, diagnosis and treatment of these symptoms.
Patient reported flu like symptoms, body aches, and a fever of 101 degrees F starting the day after the injection and lasting for a few days and numbness in her feet and legs starting 5 days after the injection and also lasting for a few days
had a neuropathic itch on sole of left foot. Not a regular itch.; Like pins; very annoying; Nothing at the injection site except sore; This spontaneous case was reported by a pharmacist and describes the occurrence of NEUROPATHIC PRURITUS (had a neuropathic itch on sole of left foot. Not a regular itch. ), PARAESTHESIA (Like pins), FEELING ABNORMAL (very annoying) and VACCINATION SITE PAIN (Nothing at the injection site except sore) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 017B21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Nothing at the injection site except sore). On 13-Dec-2021, the patient experienced NEUROPATHIC PRURITUS (had a neuropathic itch on sole of left foot. Not a regular itch. ), PARAESTHESIA (Like pins) and FEELING ABNORMAL (very annoying). At the time of the report, NEUROPATHIC PRURITUS (had a neuropathic itch on sole of left foot. Not a regular itch. ), PARAESTHESIA (Like pins), FEELING ABNORMAL (very annoying) and VACCINATION SITE PAIN (Nothing at the injection site except sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient denied to provide concomitant medications.  The patient received the booster of the Moderna COVID-19 vaccine in the left upper arm.   The patient had no rash. The reactions came and went. The patient did not receive any treatments but planning to take Allegra.   This case was linked to MOD-2021-416481, MOD-2021-416488 (Patient Link).
Full body rash/the rash on all over their body; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 4 patients (resident of a long term facility and are above 65 years of age). This is 3rd of 4 reports.   A elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The Pharmacist reported 4 patients who experienced Full body rash/the rash on all over their body after getting pfizer covid vaccine on an unspecified date, It happened 2-3 days after the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112095 Same reporter/ drug/ event for different patients.
constant screamings for 6 hrs p/vax given; unconsolable-no other sx occurred; Td administered next visit w/o sx;
PAIN ON ENTIRE RIGHT-SIDE (FROM RIGHT SHOULDER TO RIGHT ARM, RIGHT HIP AND ALL THE WAY DOWN TO RIGHT FOOT); BONES HURTING; MUSCLES HURTING; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-AUG-2021, the patient experienced pain on entire right-side (from right shoulder to right arm, right hip and all the way down to right foot). On 20-AUG-2021, the patient experienced bones hurting. On 20-AUG-2021, the patient experienced muscles hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on entire right-side (from right shoulder to right arm, right hip and all the way down to right foot), muscles hurting, and bones hurting. This report was non-serious.
pain at injection site; muscle achiness; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th May 2020, 2 hrs after receiving Shingrix, the patient experienced injection site pain, myalgia and tiredness. On an unknown date, the outcome of the injection site pain, myalgia and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, myalgia and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient experienced pain at the injection site, feeling tired, and muscle achiness approximately two hours after the injection. Consented to follow up. The reporter consent to follow up.
Child received immunization on 10/04/2006 in am. During early morning day of 10/05/06. child awakened c/o soreness of arm and mom noticed had fever also. She administered Tylenol. At 8am mom notes swelling of right deltoid and child c/o itchiness. No fever noted at that time. No Tylenol given. Today continues to be swollen, but child acting normal with no complaints.
Narrative: COVID infection following COVID vaccine series 04/07, Moderna, dose #1 05/04, Moderna, dose #2 09/24 COVID swab, result: detected 09/24 pt cc: exposure: unknown
Severe shoulder pain extending into neck. With severe stiffness pain baseline & with movement increasing over days.  With mod headache. No redness. No temp change. Headache improved with NSAID. Pain & stiffness unhelped. .   started within 6 hours of  initial shot, left arm.  Within 2 hours of second shot, right arm, with tingling & numbness accompanying - only numb/tingling continuing mild to date.
Taday 7.3.21 I felt numbness my left hand. More below joint. Previous night was slipness.; Taday 7.3.21 I felt numbness my left hand. More below joint. Previous night was slipness.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 30Jun2021 at 19:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0181) via an unspecified route of administration in the left arm on 09Jun2021 at 19:15 (at the age of 32-years-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 02Jul2021, previous night, the patient experienced slipness. On 03Jul2021, the day of report, the patient felt numbness in his left hand. More below joint. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events previous night, the patient experienced slipness, on the day of report, the patient felt numbness in his left hand; more below joint was not resolved at the time of this report.
didn't sleep all night; knot in arm; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (didn't sleep all night), MUSCLE SPASMS (knot in arm), CHILLS (Chills) and PYREXIA (fever) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INSOMNIA (didn't sleep all night), MUSCLE SPASMS (knot in arm), CHILLS (Chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (didn't sleep all night), MUSCLE SPASMS (knot in arm), CHILLS (Chills) and PYREXIA (fever) had not resolved.            No concomitant information was reported.
Diagnosed as a type 1 diabetic approximately 3 months after vaccine in July.  Started losing eye sight, constant thirst, urination in June.  Not family history of type 1.  I am a over wise health, physically fit person.  5?9? 170 lbs.  I ate a healthy diet.
approximately 5 minutes after receiving vaccine patient experienced blurred vision and dizziness lasted about 15 minutes
Debilitating fatigue, mild-moderate nausea, increased coughing/shortness of breath, general malaise for about 5 1/2 weeks.
The day the vaccine I had body aches all over, chills and cold. I had those symptoms for three days. Over the next week I got a red spot around the site of the shot which got bigger. It was sore itchy and tender. It grew to the size of two inches in a circle around the site of the shot .I also had a headache for a week that was constant for the whole day.  I went to the ER and they just told me to take Tylenol for the pain. My arm was still effected, for two weeks total and it itched toward the last few days. My headache also got better.
Patient was nervous about vaccine. Has history of vasovagal syncope. Patient sat down in the waiting room after vaccines. We noticed he wasn't looking well/ starting to pass out. I went out and started trying to wake him up. Shook shoulder then did sternal rub. Patient came to very quickly. We called 911 just to be safe. Got him some cold water for the back of his neck and an ice pack. He was feeling much better by the time EMS arrived. They checked him out. We had him stick around for awhile and walk around the store before he left.
Extreme acute case of vertigo; Vomit; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and batch/lot number and expiration date were not reported), via an unspecified route of administration in left arm on 19Mar2021 at 12:00 (at the age of 52-year-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history included diverticulitis. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole, birth control pills and ascorbic acid (VITAMIN C); All drugs received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 16:00, the patient experienced extreme acute case of vertigo, she was in bed for 12 days, also had vomit and diarrhea. The patient visited to physician or other healthcare professional office/clinic visit due to adverse events. The patient was treated with a shot of meclizine (ANTIVERT) and 3 pills a day for vertigo. The outcome of the events was resolving.  Information on the lot/batch number has been requested.
Vaccination itself was into left deltoid, was not eventful, did not notice pain or difficulty, described the site of injection as toward the top of the deltoid, to the lateral side.  Later in the day after the vaccination, he experienced a unilateral tingling on the body on the side of the shot, notably in left arm, left neck and rarely into left leg.  It was more pronounced about 24 hours later, then began to improve.  By 9/22/23 when initially reported, he was noticing intermittent numbness/tingling in his lateral left hand, and then positional peripheral neuropathy in lateral hand for the next week.  By 10/1/23 @ 10 pm he states he has not noticed further symptoms.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of no adverse event (in July 2018, the patient received 1st dose). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, fever, malaise, pain and pain in arm. On 10th December 2018, the patient experienced knee pain and buttock pain. On an unknown date, the outcome of the influenza-like symptoms, chills, fever, malaise, pain and pain in arm were recovered/resolved and the outcome of the knee pain and buttock pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, fever, malaise, pain, pain in arm, knee pain and buttock pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in left arm. The patient experienced flu like symptoms consisting of chills, fever, achiness and malaise. The patient also reported arm soreness. Approximately 7 to 10 days later, the patient experienced pain under her right buttock and behind the right knee. The patient had an ultrasound and a blood clot was ruled out. At time of reporting, the symptoms associated with the buttock and knee pain were intermittent and unresolved. The patient did not consent to follow-up.
No additional AE details; Improperly stored vaccine adminsistered; This spontaneous report has been received from an other, referring to a patient of unknown age and gender. The patient's historical condition and current condition were not reported. Concomitant therapy included sterile diluent.   On an unknown date in May 2022 (reported as between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX)(lot#U039949 with expiration date: 16-DEC-2023; dose, strength and route were not reported) that underwent a temperature excursion (TE) (Product storage error).   Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below -14 degree Celsius (C) up to-10C for 2 hours 5 minutes 0 seconds ; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. Previous temperature excursions reported as -14C up to-10C (-12C) for 0 hours 50 minutes 0 seconds. No additional adverse event (AE) details.  This one of the thirteen reports from the same reporter.
application site pain; HEAD PAIN; JOINT PAIN; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (application site pain), HEADACHE (HEAD PAIN) and ARTHRALGIA (JOINT PAIN) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (application site pain), HEADACHE (HEAD PAIN) and ARTHRALGIA (JOINT PAIN). At the time of the report, VACCINATION SITE PAIN (application site pain), HEADACHE (HEAD PAIN) and ARTHRALGIA (JOINT PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
pt recvd vax & 6 hrs later exp a h/a, weakness, sore throat, joint aches, muscle aches, pt was very ill for 30 hrs w/these sx; sx gradually subsided but h/a lingered for 3 more days p/which pt was again feeling nl;
Pt had 3 episodes of 4 minutes seizures consisting of stiffness and lateral nystagmus. All were followed a post ictal period. There was no documented fever. After the 3rd seizures pt was loaded with phenobarbital.  Admitted to hospital. (All 3 seizures occurred within 24 hours of receiving vaccines).  Discharge Summary reviewed stated patient experienced hypoxia and cyanosis.
2nd day started having muscle aches 3rd day mild headaches Severe headaches sore throat
Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown.     Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.   This case was linked to MOD-2021-071149 (Patient Link).