chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication were reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
cough, congestion, cold, , headache, body aches starting 1/19/22
1 week after the first dose patient started to have her period. The period consisted of heavy clots and would go through 6-8 pads /day. Period lasted 3 weeks and went to see GYN and they prescribed Provera, which helped stop the bleeding.
mom reported pt c/o redness to rt leg & rt eye & pt fussy;MD instructed to give APAP & rx for Lortab called in;
Red rash about 4 inches long and 2-3 inches wide appeared near the vaccination location 10 days after receiving the moderna shot. It has lasted 5 days so far and is getting darker. It is sometimes itchy and warm to the touch but otherwise not bothersome.
Sudden onset of numbness in the lower extremities with tingling. Hospitalized on January 11, 2022 per ER visit per Dr. instruction. Diagnosed with Guillain barre syndrome due to Covid-19 booster. Treatment in hospital was IVIG and prednisone. Sent home January 13, 2022. Symptoms have not changed.
Sore arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm after 2nd dose). At the time of the report, MYALGIA (Sore arm after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left arm/ right arm/ both legs felt numbness; Left arm/ right arm/ both legs/ hands and feet felt tingling; Left arm/ right arm/ both legs felt muscle weakness; continue to have numbness andtingling in my arms and legs, handsand feet.; continue to have numbness andtingling in my arms and legs, handsand feet.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female 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 11Jun2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to food, medication or other product. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown start date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 21May2021 at 16:00(at the age of 50-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 COVID vaccine. On 11Jun2021 at 16:15, within 10 minutes of receiving the second dose of the vaccine, patient left arm felt numbness and tingling. Within an hour after the vaccine, both of her legs and right arm also felt numbness, tingling, and muscle weakness. It was now 12 days post vaccine and she continued to have numbness and tingling in her arms and legs, hands and feet. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prednisone (MANUFACTURER UNKNOWN). The clinical outcome of the events left arm, both legs, right arm, hands, feet numbness, tingling, muscle weakness were not recovered at the time of this report.
Narrative: 63 year old male admitted on July 31 2022 with cough, clear sputum, low graede fever and nasal congestion. He had received Moderna vaccine x 4 on December 28, 2020, January 25, 2021, October 19, 2021, June 9, 2022. He was treated with remdesivie 200 mg IV x1 then 100 mg daily x2 days and dexamethamethasone 6 mg x5 days. he rapidly improved and was transferred from acute care unit on 8/2/22.
Itchy, swollen, red arm. Started almost one week exactly after I got my first dose.
Syncope/Collapse; Observed posturing; transfer to Port Orange Emergency Room for evaluation seizure activity and rule out vasovagal response to vaccine.  1/18/08 Reviewed hospital medical records which reveal patient experienced syncopal episode while at pcp office after vaccine.  Struck head when fell & had LOC, jerking of arms.  Exam in ER on 12/28/07 revealed HA, nausea & occipital contusion.  Improved w/meds & d/c to home. FINAL ER DX: vasovagal syncopal episode; concussion; fall.  Patient had several episodes of vomiting, HA & lethargy.  Returned & admitted for observation 12/29/2007-1/1/2008.  Neuro consult done. FINAL DX: post-concussive syndrome s/p syncopal episode; CHI w/fontal contusion; possible post traumatic seizure; subgaleal hematoma.
no adverse reactions. Due to the worker who talked to her being a friend and her not putting age just DOB on form we didn't  know she was 17 instead of 18. So she is a bit outside of recommended dose rage
Started feeling dizzy, then massive headache started. I then started feeling nauseated but didn't throw up. Was monitored for another 30 minutes and my wife picked me up. Took tylenol when I got home. Checked blood sugar at home and blood sugar was down to 40. I hadn't eaten before the vaccine. I ate oatmeal and went to bed. After 2 hours, I no longer had symptoms. Returned to work 1/29/2021 without any further issues.
Information has been received from a licensed practical nurse concerning an 87 year old male patient with kidney stone, coronary artery disease, dementia, renal disorder, hypertension, hypercholesterloeaemia, prostate cancer, overactive bladder and impaired fasting glucose who on 15-Jan-2009 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (lot# 662970/1207X) Concomitant therapy included LIPITOR, ECOTRIN, minerals (unspecified) Centrum, NAMENDA, RAZADYNE, K-PHOS ORIGINAL, FOSAMAX, EXELON and NEUROTONIN. The nurse reported that on 16-Jan-2009 the patient diagnosed with shingles. The patient had being treated with VALTREX. VZV analysis refused. The patient sought medical attention. At the time of reporting the patient was not recovered. Additional information has been requested.
About 5 minutes following administration, patient experienced flushing, tingling in the arms, feeling of dizziness and nausea with elevated heart rate and blood pressure with feeling of dyspnea.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
3 days after being vaccinated I woke up with severe abdominal pain that lasted all day.  By the following morning, Thursday 4/29/2021, I went to the ER (Castle Rock Adventist) for severe pain and fever.  The CAT scan revealed I had an inflamed colon, I was diagnosed with colitis for the first time in my life.  I had to be put on two antibiotics and will have to have additional testing.
First dose: Slept 14 hours; This is a spontaneous report from a contactable other hcp (patient herself). A 62-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172, Expiration date were not reported) via an unspecified route of administration on 23Apr2021 16:30 (age at the vaccination 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included hypertension, known allergies to penicillin, sulfa and latex from an unknown date and unknown if ongoing. Patient was not pregnant at time of vaccination. Concomitant medications included atorvastatin calcium, ezetimibe (STATIN EZ) taken for an unspecified indication, start and stop date were not reported. On an unspecified Apr2021, the patient had experienced first dose and slept 14 hours. The reporter (health authority) considered the events as non-serious. The patient had not received any other vaccine within 4 weeks. The patient received other medications in two weeks included blood pressure medicine + statin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since post vaccination. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
AFTER VACCINATING A PATIENT OUR PHARMACY INTERN WAS STRUCK BY THE PATIENTS YOUNG CHILD WHICH CAUSE HIM TO STICK HIMSELF.
TRANSVERSE MYELITIS 10/24/2021 UPPER GI HEMORRHAGE CARDIOGENIC SHOCK 9/17/2021 UPPER GI HEMORRHAGE TRANSVERSE MYELITIS 10/24/2021 ACUTE RENAL FAILURE, UNSPECIFIED CARDIOGENIC SHOCK 9/17/2021 ACUTE RENAL FAILURE, UNSPECIFIED
Swelling at the injection arm; Redness at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection arm) and VACCINATION SITE ERYTHEMA (Redness at the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.
This spontaneous report as received from a physician refers to a 11 year old male patient. On 28-FEB-2013 the patient was vaccinated with the first dose of GARDASIL 0.5 ml (lot # was unknown) intramuscularly, the second dose on 29-APR-2013 and the third dose on 01-JUL-2013. No adverse effects reported. Additional information has been requested.
I noticed a redness below the vaccine site, 8 days after receiving my 1stshot. Also so itching and swelling.  Day 9, my redness was worse, tenderness still present and swelling remains. Day 10, I woke up with a stiff neck and back of head. Redness was not as bad as day before.  Took Motrin for head and neck pain. Somewhat helped.  Today, Day11, I?m still having some neck soreness and  my arm is still tender to the touch, no longer warm to the touch like it was before.
Chills, 101.5 fever, aches, headache, stiffness, unable to walk (joints wobbly)
Pt had J and J vaccine at outside facility on 3/14.   by 3/14 evening, had fever, sweats, bodyaches which he thought was vaccine related since 3/15, some ST w/ dry cough, fatigue, sweats overnight some mild sob when laying down by 3/18: Headaches, fatigue, SOB
Severe muscle ache in upper chest at site of previous muscle stain. Caused severe shortness of breath for 2 days. Fatigue that did not exist before vaccination. Skin outbreaks with small bumpy rash on right side of face, neck, arms. Sore and swollen breast tissue on right side.  Phlegm and coughing (this condition existed prior to vaccine, for many decades).
Arm started hurting; Arm is red; Arm hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Arthritis, ZOLPIDEM TARTRATE (AMBIEN), VITAMINS NOS and CALCIUM for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Painful arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm started hurting), ERYTHEMA (Arm is red) and SKIN WARM (Arm hot to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included an unspecified antidepressant.  Treatment included ibuprofen (ADVIL), which she already takes for arthritis, but it did not help. The patient consulted a doctor, but she cannot remember what he recommended.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event outcomes updated.
Information has been received from a physician concerning a 13 year old female with no pertinent medical history or drug reactions/allergies who on 09-NOV-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. Upon leaving the practice, the patient experienced syncope at the front desk which was identified as a "vaso pagil reaction". The patient was transported to the emergency room, it was not known whether or not the patient was actually admitted to the hospital. It was unknown whether or not the patient will go on to receive the second and third doses. Unspecified medical attention was sought. Additional information has been requested.
felt hot; could not stand; nauseous; sore arm; they became tingly,tingling on the hands,tingling across the stomach; lost feeling in his fingers and toes/ hand, it was like holding a jack hammer for a long time; got pale; started to sweat; stomach felt weird; very cold,freezing cold; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (they became tingly,tingling on the hands,tingling across the stomach), SENSORY LOSS (lost feeling in his fingers and toes/ hand, it was like holding a jack hammer for a long time), PALLOR (got pale), HYPERHIDROSIS (started to sweat) and ABDOMINAL DISCOMFORT (stomach felt weird) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PARAESTHESIA (they became tingly,tingling on the hands,tingling across the stomach), SENSORY LOSS (lost feeling in his fingers and toes/ hand, it was like holding a jack hammer for a long time), PALLOR (got pale), HYPERHIDROSIS (started to sweat), ABDOMINAL DISCOMFORT (stomach felt weird), NASOPHARYNGITIS (very cold,freezing cold), NAUSEA (nauseous) and MYALGIA (sore arm). On an unknown date, the patient experienced FEELING HOT (felt hot) and FALL (could not stand). On 05-Apr-2021, NASOPHARYNGITIS (very cold,freezing cold) had resolved. At the time of the report, PARAESTHESIA (they became tingly,tingling on the hands,tingling across the stomach), SENSORY LOSS (lost feeling in his fingers and toes/ hand, it was like holding a jack hammer for a long time), PALLOR (got pale), HYPERHIDROSIS (started to sweat), ABDOMINAL DISCOMFORT (stomach felt weird), FEELING HOT (felt hot), NAUSEA (nauseous), MYALGIA (sore arm) and FALL (could not stand) 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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non Significant Follow up appended On 30-Apr-2021: Significant FU received
epistaxis, facial paresthesias Narrative: Per nursing report: "States she felt fine after having the vaccine initially [7/27]. She states she then developed tingling on the left side of her face which subsided after a couple of hours. Employee states never lost any movement. She reports having had multiple nose bleeds (6-8), She left this morning [7/30] to see her PCP."
Extreme shoulder pain.  Went to an infectious disease specialist. Thought it was Lymes disease.  Turned out to be Rheumatoid Arthritis.
Patient reported 4 x 3 in whelp at injection site. Still present 48 hours after injection.
severe neck and shoulder pain, several times now; adverse reaction to Moderna covid vaccination; severe neck and shoulder pain, several times now; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe neck and shoulder pain, several times now), VACCINATION COMPLICATION (adverse reaction to Moderna covid vaccination) and ARTHRALGIA (severe neck and shoulder pain, several times now) 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 NECK PAIN (severe neck and shoulder pain, several times now), VACCINATION COMPLICATION (adverse reaction to Moderna covid vaccination) and ARTHRALGIA (severe neck and shoulder pain, several times now). At the time of the report, NECK PAIN (severe neck and shoulder pain, several times now), VACCINATION COMPLICATION (adverse reaction to Moderna covid vaccination) and ARTHRALGIA (severe neck and shoulder pain, several times now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided.
I started to have an itchy rash on my right arm on 4/18/2021. Rash was linear about 2.5 cm in length. Rash was red, painful and itchy. Similar circular rash appered on right arm. Medium and smaller size oval shape rash appeared in upper arm, wrist and hand of right arm. I was diagnosed with  herpes zoster on 4/25/21.  Antibiotics and antiviral medications prescribed.
1st seizure - generalized tonic clonic w/apnea lasting 2 minutes with 45 min postictal period.
Redness around the injection site approximately the size of a half dollar. Also, a knot at the injection site.
had a severe case and even after the shots/Suspected vaccination failure; Shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shot and had severe case of shingles and still got pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Joint soreness in left hand (knuckle joints).  Appeared suddenly yesterday morning and still sore today.   I do not have arthritis.
Heartache, chest pain. I have no underlying health issues, but the pain in my heart was very strong preventing me from being able to sleep on my left side. Right now I feel better (almost 2 days after the first shot of the vaccine). There is still some slight discomfort in the heart area, but it is not significant.
3/24 arm pain, 3/25 rt shoulder and back pain, Tylenol given,   3/25 body aches and tired, Tylenol given 3/25 visit with dr to discuss pain- urinalysis ordered, later Tylenol and biofreeze, temp of 101 noted. 3/26 urinalysis results returned- NNO---- later 3/26This nurse is called to resident's room. Resident noted to have emesis of all bile, pale and lethargic. Complaints of not feeling well. Temp: 102.0, tympanic. Call placed to MA help nurse to update. Await call back .3/30 to dr again, confusion and bp issuesMercy ER,   admit to hospital dx of cholecystitis.
fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient, self-reported) via Pfizer sales representative. A 13-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on unspecified date, as a single dose for COVID-19 immunization. The patient reported that 2 sisters experienced similar symptoms. On an unspecified date, the patient experienced fever chills and fatigue which resolved in 24 hours. The events took place after use of product. The reporter did not wish to be contacted for follow-up. Outcome of the events was resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.