chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My face is swelling a little bit of my mouth but not my throat is not swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. The patient stated "I just had the vaccine the Pfizer vaccine this morning at about 10:15 and I do have an EpiPen and I do have asthma (Intent: History) but I am now just started about 15 minutes ago having a reaction where my face is swelling a little bit of my mouth but not my throat is not swollen. Can I take like maybe a Benadryl for it or should I call 911 or what should I do?" The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT NOTICED A RASH ON THE UPPER LEFT SIDE HER FORHEAD WITHIN 3 DAYS OF RECEIVING THE SHINGRIX VACCINE. SHE HAD A CASE OF SHINGLES 17 MONTHS PRIOR AND THE RASH APPEARED IN THE SAME AREA. SHE WAS NOT EXPERIENCING ANY KIND OF RASH/PAIN/NEURALGIA UPON ADMINISTRATION OF THE VACCINE. SHE CONTACTED HER DOCTOR UPON NOTICING THE RASH AND THE DR ADVISED THAT SHE DID NOT GET THE SECOND DOSE OF THE VACCINE UNTIL THE RASH HAD SUBSIDED FOR AT LEAST ONE MONTH. SHE STILL HAS THE RASH TO THIS DATE (9/27/18). PHARMD ADVISED ANTIVIRALS.
The day after the vaccine I woke up with a red, raised, warm, itchy circular rash on my arm at the injection site. It was about 2 inches by 2 inches. It is currently 3 days after my vaccine and I still have it. I am 7 weeks pregnant with EDD of 12/1/21.
Arm pain, radiating from injection site down to fingers. Constant pain, burning, type. Associated as nerve pain.
Client began wheezing approximately 8-12hrs after receiving a Varicella vaccine. Her condition continued to worsen all night. Her mother took her to the doctor the next morning and he diagnosed her with an asthmatic episode secondary to receiving the Varicella Vaccine. The child did have an axillary temp of 100.6 which was controlled with tylenol. The child was put on Albuterol inhaler 2 puffs QID and her condition is much improved.
Lymphadenopathy under left clavicle 2 days post injection.  Also had minor headache 1 day post vaccination which resolved by day 2. No medical treatment needed at this time.
Worst Fibromyalgia Pain after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of FIBROMYALGIA (Worst Fibromyalgia Pain after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    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 FIBROMYALGIA (Worst Fibromyalgia Pain after vaccination). At the time of the report, FIBROMYALGIA (Worst Fibromyalgia Pain after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  It was reported that a group of patients having fibromyalgia experienced event.  Cross-Linked with Case numbers: MOD21-079869 & MOD21-097145.
Temperature (not measured but most likely), shivering (could not get warm no matter how many covers), then later, felt very hot. Generally very exhausted and also felt my tongue numb.
Patient reported pain, swelling, redness and fever the day following injection. She was seen by ER 4 different times with diagnosis of cellulitis. Dr's office also noted ER noted abscess.
SORE ARM, PAINFUL ELBOW. L4-L5 PAIN IN LEGS (RELATED TO RECURRING BACK PAIN)
Migraine developed the next day. Complete with head pain, sensitivity to light and sounds, nausea and vomiting. Previous symptoms with last Tdap vaccination 6+ years prior.
Bloodwork results showed kidney, liver, and vitamin D values plummeted; Bloodwork results showed kidney, liver, and vitamin D values plummeted; Bloodwork results showed kidney, liver, and vitamin D values plummeted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:45 (Lot number: EN0202) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos Disease" (unspecified if ongoing); "CVID (immune deficiency)" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; SYNTHROID; THIOTHIXENE [TIOTIXENE]. Vaccination history included: Bnt162b2 (Lot number: EN9263, in left arm at 09:00 as dose 1, single), administration date: 18Feb2021, when the patient was 72 years old, for COVID-19 immunisation, reaction(s): "Hair changed dramatically after first vaccine", "became very dry, brittle". The following information was reported: RENAL FUNCTION TEST ABNORMAL (non-serious), LIVER FUNCTION TEST DECREASED (non-serious), VITAMIN D DECREASED (non-serious) all with onset 04Apr2021, outcome "not recovered" and all described as "Bloodwork results showed kidney, liver, and vitamin D values plummeted". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of renal function test abnormal, liver function test decreased, vitamin d decreased.  Additional information: The patient's other medications in two weeks included multivitamins. The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was further reported that her bloodwork values were previously in normal range when drawn on 07Jan2021. She had never had any out of range kidney or liver values in her life before this and had never had to take IV fluids before for bloodwork issues. Events has necessitated/ treated with weekly IV fluids for six months.  No follow-up attempts are possible. No further information is expected.
pt recv vax & 8JUN95 pt seen in clinic for crying;CXR revealed RML infiltrate;BC revealed haemophilus influenza;WBC count was 23,300;pt was tx w/Augmentin;pt was sent home;was seen again in clinic & dx pneumonia,bacteremia;
No adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    Concomitant medication was not provided.  No side effects were reported by the patients. Treatment information was not provided.  This case contains information for the 2nd patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712814, US-MODERNATX, INC.-MOD-2023-712821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712814:Patient 1 case US-MODERNATX, INC.-MOD-2023-712821:Patient 3 case US-MODERNATX, INC.-MOD-2023-712822:Patient 4 case
Around 10:00 AM - Fri morning - Had several blisters @ site of Vaccine on Lt arm - Midday Fri - Lt arm became tight and swollen by 7:30 pm Lips and tongue became swollen and family went to ER - BENADRYL IM was administered by 11:00 pm Pt and family were sent home with oral BENADRYL every 6 hours (child dosage). Today pt has a few hives on Leg, but feeling much better.
ischemic stroke shortly after taking your mRNA jab; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (ischemic stroke shortly after taking your mRNA jab) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 ISCHAEMIC STROKE (ischemic stroke shortly after taking your mRNA jab) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (ischemic stroke shortly after taking your mRNA jab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications was provided by the reporter.  Company comment.  This spontaneous case concerns a patient (unknown age and gender), with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI ischaemic stroke. The event occurred after an unknown time of interval from receiving a dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. it is unknown previous vaccination schedule. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and gender), with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI ischaemic stroke. The event occurred after an unknown time of interval from receiving a dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. it is unknown previous vaccination schedule. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient c/o of hives/itchiness and mild sob the night after vaccination at 9 pm.
The patient was inadvertently administered an undiluted vaccine, receiving 0.3ml of undiluted vaccine. Patient reported no adverse reactions and was observed for 30 minutes. Patient and guardian were informed to inform their primary care physician. Patient and guardian were told to report to an Emergency Room if any adverse reactions were to occur.
Psoriasis; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (Psoriasis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form., third dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis). At the time of the report, PSORIASIS (Psoriasis) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
First mouth ulcer developed after two days, healed in about 6 days, and then developed a different ulcer and the cycle has repeated through the date of this report.
Initial symptoms right after vaccination: sore arm for the first 2-3 days - completely resolved. After 5 days?: Developed small red, slightly elevated dots on left hand.  Also, developed white circular patch on left shoulder.  The red dots on left hand are improving day by day. The white patch on shoulder is still there.  Visited my doctor today (Jan 15). He discussed hypersensitivity on left hand, and vitiligo on left shoulder.  I am concerned about getting 2nd dose of vaccine and possible reaction thereafter.  Why did I get vitiligo? Will vitiligo worsen after 2nd dose? Will the hypersensitivy on hand translate to a stronger reaction/allergic reaction after 2nd dose? Thank you.
The day I received a Moderna Covid vaccine, I had an intense bout of heart palpitations. I had to call the medics, who did an ekg. I did not go to the ER. However these bouts have continued occasionally since, but the hospital couldn't accommodate my schedule to get cardiac tests done. Then this entire week, the palpitations have gotten worse, and are now happening for most of the day, so I went to the ER and was diagnosed with atrial fibrillation. I was given two medicines, a beta blocker and blood thinner and will follow up with a cardiologist. I did not have this issue before that booster.
Itchiness over arms and trunk.  Hives on forearms and a few on neck
Dizzy; weak; body not responding correctly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (weak) and GENERAL PHYSICAL HEALTH DETERIORATION (body not responding correctly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), ASTHENIA (weak) and GENERAL PHYSICAL HEALTH DETERIORATION (body not responding correctly). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (weak) and GENERAL PHYSICAL HEALTH DETERIORATION (body not responding correctly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077920:Case for wife
This case was reported by a consumer via call center representative and described the occurrence of palpitation in a adult female patient who received SHINGRIX. On 3rd May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown. The reporter considered the palpitation to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, 3 to 4 days after receiving SHINGRIX, she experienced palpitations. On 6th May 2018, Sunday, the patient had to bouts and had to go to the emergency room (ER). The patient's doctor thought that, the palpitations are related to the SHINGRIX, but she was not so sure. The patient's doctor thought the patient should still get the 2nd shot, even if the palpitations are related to the SHINGRIX.
Bleeding from the arm; A spontaneous report was received from a female patient, who is physician by profession who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bleeding from the arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, immediately after vaccine administration,the patient experienced bleeding from the arm which was enough to reach the table her arm was resting on. She was not concerned about the bleeding but is concerned that the vaccine may have lost efficacy because of the blood lost. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, bleeding from the arm, was not reported.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history is not provided. The patient experienced an unexpected event of bleeding from the arm. The event occurred on 29 Dec 2020, immediately after  receiving first dose of mRNA-1273.  The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.
pt recv vax 21MAY96 & inadvertently vaccinated  & on 23MAY96 pt awoke @ noc c/o diff breathing;pt sitting up breathing was nl;24MAY96 pt devel vomiting & temp of 100 PO;reporting nurse noted flu was going around area;tx w/APAP
24 minutes post shot developed itchy scratchy throat, clearing throat, dry cough, sweating, sense of impending anaphylaxis ( same feeling I get with shellfish reaction) Bp stable, o2 says dropped 88%RA, tachycardia. Epi x 1 given 50 mg IM Benadryl and O2 placed seats normalized.  Symptoms did not resolve, 6 minutes later second Epi shot given. Within 3 minutes symptoms starting to resolve.  125 Iv solumedrol, and given oral pred 40 mg daily x 3 days   Felt fine next day(1/3)  then  1/4/2020 recurrence of symptoms ( 2nd dose pred a little late 30 hours after last dose)  Gave Epi shot, Benadryl 50 mg po ( pred on board)  Symptoms did not resolve but no desaturation , bp stable, tachy, persistent throat clearing and dry cough 2nd Epi shot given Iv famotidine Iv solumedrol 125 mg, symptoms resolved, albuterol helpful lungs clear Pred 40 mg daily x 3 days add famotidine bid, add cetirizine bid 1/5/2021 felt fine in am, sensation of throat swelling itching and dry cough recurred , albuterol used helped temporarily ( had already taken morning cetirizine, famotidine and pred 40 mg) Saw allergist. Says fine, breathing fine slightly tachy, lungs clear, O2 says wnl, sweaty Albuterol given, helped  Laryngoscopes with ENT negative for swelling, just mild vocal cord swelling from cough  Started on pred taper 40 mg daily x 3, 20 mg qd x3, 10 mg dailyx3 Add Benadryl prn  Add advair bid  Continue cetirizine and famotidine
Approximately 12 hours after I received my second Moderna vaccine dose (around 4:30am EST), I began having chills, fever, body aches, nausea, moderate chest pain/discomfort, vomiting, and shortness of breath. I called 911 and asked for an ambulance because of difficulty breathing. Arrived at Hospital Center ER around 5:00am, given oxygen and several tests (blood, urine, EKG) and also IV fluids in my left arm. Vomited a second time around 8:00am. Continued difficulty breathing until around 11:00am and chest pain improved somewhat. Got chest x rays done and monitored until I could breathe more regularly without oxygen. Discharged around 12:26pm. Heartbeat was abnormally fast for this whole duration and did not return to resting heart rate until about 5:00pm later that evening, 24 hours after vaccine. All symptoms subsided within 48 hours. Diagnosis was nonspecific chest pain and UTI.
This spontaneous report was received from a neurologist and refers to a 67 year old female patient. The patient's concurrent conditions included posterior cortical atrophy and a neurodegenerative condition of brain (reported also as "in the neurodegenerative Alzheimer's family"). The patient's medical history included upper respiratory tract infection. The patient's historical drugs included PREVNAR 13 and influenza virus vaccine (unspecified), which the patient did not experienced any adverse events; ZOCOR which the patient did not tolerate; and amoxicillin and citalopram with which the patient experienced unspecified adverse experiences. The patient was not taking any concomitant medications. On 05-JAN-2017, the patient received an unspecified dose of injectable PNEUMOVAX23 intramuscularly in her left deltoid for routine vaccination (lot# M037669) (strength, dose, and expiration date were not reported). Reportedly, the reporter stated did not know when the patient's symptoms began, but on 11-JAN-2017, the patient could not stand. Subsequently, on 12-JAN-2017, the patient sought medical attention with the neurologist because she was experiencing paralysis of her legs. On the same date, the neurologist performed an electrical testing which resulted "essentially normal, but it usually is early in the development of Guillain-Barre syndrome (GBS)" as stated by the reporter. On 13-JAN-2017, the patient was diagnosed with GBS and she was hospitalized. During the hospitalization, the patient received intravenous immunoglobulin G (IgG) treatments, to which "she responded well". Moreover, on an unknown date in 2017, the patient was performed a magnetic resonance imaging (MRI) (results not provided) and a lumbar puncture that resulted normal. On an unspecified date in 2017, the patient was transferred from the hospital to an affiliated rehabilitation center, and on 06-FEB-2017, she was discharged from the rehabilitation center. At the time of reporting, the patient was recovering from the adverse event as the reporter indicate that the patient was "stable", she was walking without assistance, her reflexes were recovering, and she was currently "about 80% recovered". The relationship between the event and PNEUMOVAX23 was not provided. The event of Guillain-Barre syndrome was considered to be disabling and life threatening by the reporter. Upon internal review, the event of Guillain-Barre syndrome was considered to be medically significant. This is one of two reports received for the same patient. Additional information has been requested. Sender's Comments: US-009507513-1703USA010659.
Day after receiving the shot (10/16/2021) she developed an enlarged area of induration measuring approximately 40 mm with 50 mm of erythema at the site of the injection. The area was itchy and painful, reports headache and temperature of 100. Had smaller areas of redness over upper chest and abdomen. 10/17/2021 the area was larger, approximately 60 mm induration with surrounding erythema measuring approximately 70 mm. Seen in the office 10/20/2021, area of induration measured 30 mm, less erythema, still painful, though not as bad. No headache, no hives or scratch red spots on body.   Received tuberculin mantoux skin test 10/06/2021, 0 mm, negative results.
FEELING ACHY AND FEVER (101.0) 48HRS AFTER ADMINISTRATION ALONG WITH VOMITTING X6 THAT NIGHT AND TWICE THE FOLLOWING MORNING.  MILD RUNNY NOSE, NO COUGHING, NO WHEEZING, NO HIVES,NO DIARRHEA, MILD ABDOMINAL CRAMPING.  NO LETHARGY, NO BEHAVIORAL CHANGES, NO JOINT PAIN OR MUSCLE WEAKNESS.  ADMINISTERED IBUPRIFEN 400 MG PO AT 11AM ON 03-01-07.  ADVISED SYMPTOMATIC CARE AND SEEK EMERGENCY SERVICE IF SYMPTOMS PERSIST OR WORSEN.