chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 15-minutes of vaccination, the patient had a witnessed syncopal episode. The patient was not in respiratory distress and sustained no injuries. Patient told EMS that she has a history of syncopal episodes and hypotension, also has been very stressed and did not eat breakfast. EMS managed patient's condition on-site. Patient was hypotensive (104/71) with a pulse of 60bpm. Accucheck FSBG noted at 190mg/dL.  Patient passed orthostatic BP test. EMS recommended transport to hospital for evaluation, but the patient refused and left with husband.
Pain in left shoulder. Pain was ongoing until visiting an orthopedist in June 2016 for xray and pain medication. Since then it has turned into a constant dull pain instead of sharp pain.
became cranky w/low grade ttemp 4-6hr p/vax;4AM next morning, temp reached 104.9;saw MD that day;leg swollen & inflamed;last day of elevated temp 1JUN97;rash devel on 3JUN97;MD has advised that pt recv DTAP @ 18mo;
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Influenza vaccine for prophylaxis. Previously administered products included flu shot. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned to do continue to make vaccines that only work 4 percent. Also stated that they all love the wonderful side effects they can get from flu shots like Paralysis. The patient had the flu shot twice and still got the flu with little bit more. This case was considered as suspected vaccination failure as time to onset for the event and laboratory confirmation was unknown.
achy muscles; Off-label use; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 3; manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 4; manufacturer unknown), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (non-serious) with onset 07Sep2022 at 19:00, outcome "unknown", described as "Off-label use"; MYALGIA (non-serious) with onset 08Sep2022 at 07:00, outcome "recovered" (Sep2022), described as "achy muscles". Therapeutic measures were not taken as a result of myalgia.  Additional information: Patient reported day 1 of achy muscles, feeling of needing to have diarrhea most of day but didn't occur. Day 2 patient felt 75% better, a lot less muscle ache. By end of day 2, 48 hours after shot, back to normal. She had no reaction to previous 4 shots but this new bivalent one did, although mild and lasted approximately 48 hours.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a male who in approximately 1996, 11 years ago was vaccinated with a 0.5ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number unspecified). In approximately 1996, 11 years ago the patient developed an unspecified allergic reaction to the vaccine. Unspecified medical attention was sought. The patient was recovered. No product quality complaint was reported. No further information is available.
Increase fussiness, decrease amount of oz with feeds and feeding changed. Having liquid stools with each feed. More stools than wet diaper. Developed severe diaper rash on day 5 which had 14 liquid stool.
My left armpit swelled up to a baseball cut in half size. Very painful to the touch at times.; My left armpit swelled up to a baseball; Second dose on 07Jun2021, first dose received on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old-male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 07Jun2021 14:00 (Inappropriate schedule) (Lot Number: Ew0179) as single dose (at age of 29-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included paracetamol (TYLENOL); celecoxib (CELEBREX). The patient previously took gabapentin and experienced hypersensitivity, pregabalin (LYRICA) and experienced hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 24May2021 at 13:00 (at age of 29-year-old) in Left arm for covid-19 immunisation, lot number: Ew0179. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have COVID prior vaccination and also patient was not tested for COVID since the vaccination.  Patient stated that on 08Jun2021 08:00 his left armpit swelled up to a baseball cut in half size. Very painful to the touch at times. No treatment was received. Events resulted in Emergency room/department or urgent care. Patient had not recovered from the events.
test for the flu shot and was very alergic to it; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case through digital media received from a consumer (Patient).  This case involved adult patient who test for the flu shot and was very allergic to it (Hypersensitivity), while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Allergy to vaccine.   On an unknown date, the patient received a dose  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who test for the flu shot and was very allergic to it (Hypersensitivity), unknown latency following the administration of  INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
No adverse reactions to initial shot other than sore arm, 2nd shot has low fever (99.8), aches, tired, not hungry, Currently experiencing Shingles (7 months later) but was told to report it.
Moderna mistakenly given to child under the age of 18. Moderna is only approved for over the age of 18.
mobility strange/control of my arm weird; lump on my arm/ some kind of muscular tumor; left arm with muscle fiber, right arm is skinner; difficult to sleep; injection site strange; pain on the shoulder and now on my neck; skin feel weird; had a leg injury; now pain up and down of my arm; make my arm spatter; pain on the shoulder and now on my neck; injection site painful for a while; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep) and VACCINATION COMPLICATION (injection site strange) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, 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 experienced VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 81) for Leg injury, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (mobility strange/control of my arm weird), VACCINATION SITE MASS (lump on my arm/ some kind of muscular tumor), LIMB DISCOMFORT (left arm with muscle fiber, right arm is skinner), INSOMNIA (difficult to sleep), VACCINATION COMPLICATION (injection site strange), NECK PAIN (pain on the shoulder and now on my neck), SKIN DISCOMFORT (skin feel weird), LIMB INJURY (had a leg injury), PAIN IN EXTREMITY (now pain up and down of my arm), RASH MACULAR (make my arm spatter), ARTHRALGIA (pain on the shoulder and now on my neck) and VACCINATION SITE PAIN (injection site painful for a while) outcome was unknown.            No concomitant medication information provided by the reporter.  Treatment medication included muscle relaxers.
i felt in a fog or hangover; my hot flashes returned for a couple months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 17Apr2021 09:00 (Lot number: ER8731, Expiration Date: 31Jul2021) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Time: 09:00 AM, Batch Number: ER8733, Expiry Date: 31Jul2021), administration date: 27Mar2021, when the patient was 64 years old, for covid-19 immunization, reaction(s): "I was very tired for 2 days". The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Apr2021, outcome "recovered" (2021), described as "i felt in a fog or hangover"; HOT FLUSH (non-serious) with onset 17Apr2021, outcome "recovered" (2021), described as "my hot flashes returned for a couple months". Therapeutic measures were not taken as a result of feeling abnormal, hot flush.  Additional information: Patient with first dose I was very tired for 2 days. Patient with second dose I felt in a fog or hangover for a week. My hot flashes returned for couple months, they did stop. With booster, had fever 100.4 chills, hot flashes came back and still have then today arm was sore  Follow-up attempts are completed. No further information is expected.
Swollen, approximately 1.5 inch diameter, hot to touch, itchy. Child "super sleepy" in the morning. Swollen area iced and child given Benadryl - per mom both helped relieve symptoms but symptoms returned. Recommended patient go to Urgent Care.
Cried for 2hours steadily following receiving the immunizations, and then became limp, pale  + blue. She was transported via EMS to hospital. She was suspected to have had a shock like reaction to one of the vaccines, or a vasovagal episode. She recovered quickly and was sent home from ER.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-OCT-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pimple behind Rt ear with redness that became larger with discomfort.  No elevated temperature.  Area remains reddened with 5-7 reddened raised areas with edema and soreness to touch.  Dx of herpes zoster by family physician on 12/12/11.  Taking Tylenol for discomfort and Benadryl to sleep as needed.
Patient described extreme pain in upper left arm. She visited Doctor in early February and received a course of corticosteroid treatment.  After treatment there was no significant improvement and she has consulted Doctor who has referred her to an Orthopedic specialist. She reported arm pain to Pharmacy on 3/14/2022.
Severe headaches, fatigue, faint feeling. Autopsy was performed. Diagnosed with pulmonary embolism.
depression; mania; I had to go to bed; Vaccination hurt going in and I could feel it in my arm; light headed/Dizzy; weak; nausea; chills; body aches; low grade fever; extreme fatigue; anxious; This is a spontaneous report received from a contactable other HCP (nurse) (patient). A 70-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration in the left arm on 26Dec2020 (at the age of 70-year-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included fibromyalgia, ADHD (Attention deficit hyperactivity disorder), hypertension, asthma and COVID-19 on an unspecified date in Mar2021 and patient still have no smell or taste. Concomitant medications were not reported. the patient previously took Macrobid and experienced allergy. Prior vaccinations within four weeks were reported as none. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 26Dec2020, the patient experienced vaccination hurt going in and she could feel it in her arm, within 1 hour she started getting lightheaded, weak and dizzy, she had to go to bed. On 26Dec2021, the patient reported that she had nausea, chills, body aches, low grade fever and then extreme fatigue which lasted for 2 days, light fatigue and nausea for 4 days, she was anxious and then one morning fell into a deep, deep depression the next week, after about 4 hrs it turned into mania. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Mar2020, negative; Nasal Swab on Jan2021 and Feb2021. Adverse events did not require Emergency room/Physician office visit. The patient did not receive any treatment for the events. The outcome of the events (extreme fatigue, depression) was not recovered, events (Vaccination hurt going in and I could feel it in my arm, lightheaded/Dizzy, weak, chills, body aches, low grade fever) was recovered on 28Dec2020, event (nausea) was recovered on 30Dec2020, and event (anxiety, mania) was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
ERYTHEMATOUS LESION WITH DEMENSION ON AND A HALF INCHES BY 2 AND A HALF INCHES.
The following day patient developed an effusion in her right shoulder. It was drained on 4/14/2021 and referred to ortho
Possible hearing impairing following vaccination; Fever (104); Tired; Aches and pains; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains), HYPOACUSIS (Possible hearing impairing following vaccination), PYREXIA (Fever (104)) and FATIGUE (Tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE CHONDROITIN CALCIUM) and FISH OIL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Aches and pains), PYREXIA (Fever (104)) and FATIGUE (Tired). On an unknown date, the patient experienced HYPOACUSIS (Possible hearing impairing following vaccination). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches and pains), HYPOACUSIS (Possible hearing impairing following vaccination), PYREXIA (Fever (104)) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 104 (High) fever (104).         Treatment also included Topical steroid.   This case was linked to MOD-2021-061273 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received: Reporter information updated, New event  was added.
Systemic: Lymph Node Swelling-Severe, Additional Details: under left arm pit softball size swollen lymph node, hard and hot to the touch
PLAQUES WAS COMING BACK ON THE BACK OF HEAD; FLUISH REACTION TO THE COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (PLAQUES WAS COMING BACK ON THE BACK OF HEAD) and INFLUENZA (FLUISH REACTION TO THE COVID VACCINE) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SKIN PLAQUE (PLAQUES WAS COMING BACK ON THE BACK OF HEAD) and INFLUENZA (FLUISH REACTION TO THE COVID VACCINE). At the time of the report, SKIN PLAQUE (PLAQUES WAS COMING BACK ON THE BACK OF HEAD) outcome was unknown and INFLUENZA (FLUISH REACTION TO THE COVID VACCINE) had resolved.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of PLAQUES WAS COMING BACK ON THE BACK OF HEAD and FLUISH REACTION TO THE COVID VACCINE with the Humira was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
p/vax pt to ER w/T101, HR 200, R30 p/an episode @ home turning extremely pale;had second episode of becoming very pale w/HR 200 during LP p/admit;impression is rxn to DTP but need to r/o sepsis;
Pt developed significant redness and swelling, was diagnosed with cellulitis and placed on Bactrim. Pt also c/o transient numbness and weakness in arm at time of presentation for cellulitis at an outside er. Pt was seen today in clinic with persisting symptoms of numbness and weakness in the right upper extremity in which vaccine was administered.
arm is very red at injection site; injection site, It really hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comments; The patient had lingering side effects from Shingrex. The patient asked how long they should last. The patient just surprised the side effects were lasting this long. The patient experienced the arm was very red at injection site, it really hurts even 3.5 days later. The patient wanted to know if patient should get the 2nd dose or not. The patient wanted to know what would be considered an allergic reaction. Additional supportive information: Follow-up would not possible, as no contact, details were available.
pt recv vax & states has a total body rash w/eyes sensitive to light;no dyspnea or diff swallowing;advised eval immed but pt declined;rash gone next day eyes still cont 26MAR97, sensitive but condition improving;
Patient was administered a dose of SHINGRIX on 11/14/2018. Patient started experiencing signs/symptoms of shingles on 11/17/2018. Patient was seen by Dr. on 11/20/2018 who diagnosed patient with shingles. Dr. called the pharmacy to inform of diagnosis.