chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has not gotten his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten his 2nd dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 PRODUCT DOSE OMISSION ISSUE (Has not gotten his 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       N concomitant medications was reported. No treatment drug details was reported.
Fatigue/ Weakness; Diarrhea followed by 2-4 days of pellet size stools; Nausea; weight Loss (8 pounds since taking vaccine).
10/20 dizzy, vomiting 4 times till stomach empty. Then yellow, saliva. 10/22 ER, IV, motion sickness pill. Diagnosis: Vertigo.
Redness and hot to the touch at injection site. Cold compress, TYLENOL, if does not resolve see MD.
Had the second vaccine in late May. 12 hours later developed flu-like symptoms of chills, and body aches. Symptoms lasted 24 hours.
arm was red; right fingers was swollen; fingers still/stiff back/left fingers were stiff; arm was red and sore/arm was a little sore; nauseas; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005621A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired). On 23-Aug-2021, the patient experienced ERYTHEMA (arm was red) and PERIPHERAL SWELLING (right fingers was swollen). At the time of the report, ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
EE received Moderna COVID vaccine and  several hours later noted pain in shoulder / arm. Pain increased and ROM decreased. Employee was evaluated by clinician and it was determined that vaccine administration location was incorrect, and vaccine had been injected into bursa of shoulder. Steroid therapy and PT advised by clinician(s)
extreme dizziness - severity of dizziness is very annoying; extreme pain in right arm; headache; swelling of lymph node; chills; a little bit body ache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness - severity of dizziness is very annoying), PAIN IN EXTREMITY (extreme pain in right arm), HEADACHE (headache), LYMPHADENOPATHY (swelling of lymph node) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020 and Colostomy in August 2020.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DIZZINESS (extreme dizziness - severity of dizziness is very annoying), PAIN IN EXTREMITY (extreme pain in right arm), HEADACHE (headache), LYMPHADENOPATHY (swelling of lymph node), CHILLS (chills) and MYALGIA (a little bit body ache). At the time of the report, DIZZINESS (extreme dizziness - severity of dizziness is very annoying), HEADACHE (headache) and MYALGIA (a little bit body ache) had not resolved and PAIN IN EXTREMITY (extreme pain in right arm), LYMPHADENOPATHY (swelling of lymph node) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Ibuprofen, Fexofenadine, Cetirizine and ice. Concomitant medication not provided.
Pain aggravated; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In April 2021, the patient experienced PAIN (Pain aggravated). In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN (Pain aggravated) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  The patient had flare up of all over body pain when she did not her Rinvoq in Apr 2021. She had sore arm from Moderna vaccines. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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.
This spontaneous report as received from a consumer (patient's mother) refers to a 5 month and a few days old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, the patient was vaccinated with ROTATEQ, orally (dose, lot # and expiry date were not reported) for prophylaxis. The patient experienced inappropriate schedule of drug administration. No product quality complaint was reported.
ALLERGIC REACTION, INIT 2/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recvd vax;1 day later,c/o HA,scratchy throat, & feeling warm which persisted til 16oct94;17oct94,exp a heaviness in chest & had a weak voice;
Redness, warmth, edema of bilateral lower extremities with acrocyanosis and delayed capillary refill.  Few small hives on upper extremities, red/puffy eyes and injected left conjunctiva.
pt recvd vax & had sz, grand mal type 1/2 hr after recving vax; taken to hosp; given meds; deferred & at present pt is stable; EEG nl;
fever, chills, headache. day 1. feeling very weak overall.  arm pain at injection and lymph node very sore (3 days)
Aches, fever x 2 nights (101), nausea, diarrhea (never vomited).
Shortly after getting the vaccine I collapsed. I had a Seizure at the Emergency room when I was there. I was diagnosed with a double Stroke. I was hospitalized and about a month later I had another stroke. I was in hospital also had more Seizures.  I have a Defibrillator now which was at the hospital. Currently, it has been 6 months and I have been unable to work and I have a lot of trouble with my short term memory. I am very weak and I have no energy. I had a blood Clot in my neck. I am unsure of details but I was in Rehab two times. I have been seeing a Neurologist and a Cardiologist.
The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023; No adverse event; Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date. Dose administered after 30-day Use By) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Jul- 2023 and administration of vaccine was on 28-Aug-2023).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. The 2.5 ml vial didn't undergo any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-738725 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738725:same reporter ( Patient 2)
Vesicles, fever, erythema multiforme. Treatment with IV fluids, steroids. Hospitalized 7/9/04 to 7/11/04.  Nurse follow up on 08/24/04 states: "Complete."  Nurse follow up on 10/21/04 states: "Review of additional hospital records received on this already completed case confirms final diagnosis of erythema multiforme."
This is a spontaneous report from a contactable consumer. A 19-years-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EW0173, expiration date was not reported) via an unspecified route of administration, administered in arm right on Jun 11, 2021 16:00 (at the age of 19 years) as dose 2, single for COVID-19 immunization (reason: just to get it, everyone in my household got it, just to feel safe) at a medical facility. Medical history included depression (ongoing maybe 6 years ago), anxiety (ongoing maybe 6 years ago). The patient concomitant medications were not reported. No other products. No additional vaccines administered on same date of the Pfizer suspect. Family medical history relevant to adverse event was none. Patient previously received first dose of Pfizer-BioNTech COVID-19 vaccine (Batch/Lot Number: EW0179, expiration date: not reported) via an unspecified route of administration, administered in arm right on May 21, 2021 as dose 1, single for COVID-19 immunization. On Jun 11, 2021 16:00, the patient felt very dizzy and almost feels faint. On Jun 11, 2021 16:30 the patient got very nauseous. No emergency room and physician office visit. Relevant tests were none. The outcome for both events was not recovered. Clinical course was as follow: The patient just got the COVID-19 vaccine exactly 55 minutes before time of call and reported that she was not sure if it was a severe reaction, but she felt very dizzy and almost felt faint. The patient she was in her car and had to pull over. The patient reported that as soon as she got in the car, she felt very nauseous and started to feel dizzy. The patient she waited for 30 minutes after she got the COVID-19 vaccine. The patient began feeling dizzy when she stood up after receiving the COVID-19 vaccine and she had to sit right back down. The patient got some water and when she got the water she felt not as dizzy. The patient walked to her car after and sat there for a little. The patient was still feeling a little nauseous but wanted to get home to get settled. The patient was driving home, she felt herself drifting off, so she had to pull over. She was still feeling dizzy, and she was going to call her friend to pick her up. The patient was not sure what to do and inquired for any advice.
Extensive RLE and DVT, Xarelto initiated on 4/7/21 revealed the clinical finding. Patient in good condition.
Vasovagal, syncope episode.  Client walked to observation area receiving vaccine. Sat for about 5 minutes and started feeling dizzy, had about "80-90" vision, felt like vision was narrowed and leaned back. Found self on side in nurses lap. Nurse in observation area assisted client to ground from chair, controlling the fall. Report per client of history of vasovagal reaction with injections or any needle based procedure.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Jan2021 12:00 (Lot number: EL3246) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; LEVOTHYROXINE; PROGESTERONE. Past drug history included: Doxicycline, reaction(s): "Allergy". The following information was reported: FATIGUE (non-serious) with onset 08Jan2021, outcome "unknown", described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional information: Concomitant medications also included unspecified multivitamin. The patient had not been diagnosed with COVID-19 prior vaccination and not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Violent chills (10 hrs after injection, lasting  7 hrs) severe headache/migraine (10 hrs after injection, lasting 36 hrs) fever (15 hrs after injection, lasting 24 hrs) nausea (12 hrs after injection, lasting a few hours) metallic taste in mouth ( 48 hrs after injection, still have) tenderness in armpits (10 hrs after injection, still have), accelerated heartbeat  (10 hrs after injection, off and on to present)
PATIENT CALLED PHARMACY ON 4/28/21 STATING SHE HAD DEVELOPED A RASH ON FACE (FOREHEAD AND CHEEKS) THAT STARTED SUNDAY 4/25/21 FOLLOWING THE VACCINE ON FRIDAY 4/23/21 AND STILL SEES BUMPS ON FOREHEAD PATIENT WAS NOT SURE IF IT WAS DUE TO VACCINE BUT WANTED TO REPORT. ADVISED PATIENT TO REPORT THROUGH V-SAFE AND CALL MD TO MAKE SURE IT WAS NOT DUE TO ANYTHING ELSE.
This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 70-year-old female patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020) for prophylaxis. On 31st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st April 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms (serious criteria disability), fatigue (serious criteria disability) and fever (serious criteria disability). On an unknown date, the outcome of the flu like symptoms, fatigue and fever were recovered/resolved. The reporter considered the flu like symptoms, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: At 15:35, the patient received SHINGRIX on the right arm. One to two days after receiving SHINGRIX, the patient experienced the flu like symptoms (mostly fatigue and fever) and these resolved three to four days later. The healthcare professional stated that symptoms were disabling in that the patient could not do her job, although the patient went to work, but the patient was not happy. This case is one of 8 cases reported by the same reporter.
Patient reports delayed red rash, not raised, about 6 inches wide around vaccination site that appeared 7 days post- vaccination. She states it was not itchy or painful and lasted for 24-48 hours before going away on it's own.
Patient's mom called this morning, said child was texting her last night c/o severe joint pain, shakes, weakness, and fever was 101.7. I told patient's mom to give TYLENOL or Ibuprofen for the pain, and fever. If patient gets worried to go to the ER, asked if patient was having difficulty breathing, fast heart rate, dizziness, said no just severe weakness, and joint pain.
This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 01-OCT-2013, the patient was vaccinated (route not provided) with M-M-R II (lot number and expiry date not provided). Other suspect therapies included PROQUAD (Merck), PREVNAR 13 and PEDVAXHIB on 01-OCT-2013, 1 day after onset of therapy the child was administered PROQUAD and M-M-R II. The outcome of child was administered PROQUAD and M-M-R II was unknown. The action taken was M-M-R II was not provided. Additional information has been requested.
Fever (99), shoulder pain, soreness ( both arms), fatigue.  Tx:  Tylenol PO 500mg Q 5 hrs
"Pfizer-BioNTech COVID-19 Vaccine EUA" Fainted/lost consciousness for 3-4 seconds after leaving the consultation room and walking through the store.
Patient received undiluted dose of pediatric vaccine. No symptoms had occurred at the time of notification to the parents.
12/7 IN AM WOKE WITH A HEADACHE. BY 5 PM , R ARM IS VERY SORE,RED AND SWELLING AT INJECTION SITE. 12/8 WOKE AT 4 AM AND PO TEMP. OF 103.8 F. WITH ABD PAIN AND VOMITING. CALLED PMD AND ADVISED TO GO TO ED. AT ED TX WITH IV FLUIDS AND ANTEMETICS. SENT HOME AT 6 AM. CONTINUED WITH NAUSEA AND FEVER THROUGH 12/10. FEVER RAN BETWEEN 101-102 F. SORENESS, REDNESS, SWELLING DECREASED IN R ARM. TODAY FEELS BACK TO NORMAL WITH EXCEPTION OF R ARM SLIGHTLY SORE. HE WAS TOLD AT ED ON 12/8 THAT HE HAD A VIRAL ILLNESS BUT TO REPORT TO HEALTH DEPT.
On 5/7 patient (self) had fever of 101.2 and violent chills as side effects. These subsided 5/8. Adverse event on 5/10 was an intermittent cough and deep chest pain that continued to worsen, preventing sleep. Patient took Ibuprofen 800mg.  Event in progress. Will evaluate on 5/11 and decided if doctor visit is needed.
Shot was given on Tuesday October 24,2007. On Wednesday I started have high fevers, chills. Hoarseness and soreness in throat. Called my doctor on Monday10- 29-06 who prescribed me some antibotics still experiencing some  fever hoarness, chills and sore throat.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date in July 2012 the patient was vaccinated with the first dose of GARDASIL, (lot number and expiration date unknown) 0.5 ml, intramuscular, (anatomical location unspecified). The nurse practitioner stated that the patient was in her office on 17-JUN-2014 (reported as "this morning) but did not received the second dose of GARDASIL yet. No adverse effect reported. Additional information has been requested.
Husband stated that pt was vomiting and could not hold anything down. Husband stated that her whole body aches. Husband stated that Pt is lethargic and afraid she might be dehydrated. Husband stated that he called the doctor and doctor stated that if she didn't feel any better in a couple hours then take her to ER. Called and spoke with husband today and husband stated that she is no longer vomiting  but still tired. She's resting.  Asked husband is she getting any better than yesterday and husband stated that she is the same.
Day after receiving immunizations experienced several bouts of vomiting- no advance nausea, no fever, some sweating. Lasted apprx. 12 hours.
had a horrible rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number, and Expiration Date: Not Reported) via unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had a horrible rash on an unspecified date. Patient took diphenhydramine (BENADRYL) as a result of the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No known adverse reaction.  Tdap administered along with MMR, Varicella, Hep A,  PCV7, to soon for vaccines.
Swollen arm, red, warm to touch, hard to touch, rash around injection site approximately 4inches
7/24/12 2200 noticed single vesicular papular on chin 7/25/12 developed sore throat, headache worked 8 hours shift during evening increased symptoms including nausea, fatigue, malaise and vaginal lesion pain on urination. 7/26/12 fever 101.1 nausea, headache increased, 2nd lesion chin, many les. (vaginal) took day off - 7/27/12. Fever res. decreased symp. Ref. to E.R.
Bruising; Soreness and pain in left arm at site; Soreness and pain in left arm at site, under arm pit; Soreness and pain in left arm at site, under arm pit and around breast; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL9261) as single dose for covid-19 immunisation (age at vaccination was 60 years). No other vaccine in four weeks and other medications in two weeks were reported. No Known allergies and no other medical history were reporter. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 05Jan2021 at 07:45 AM, (Batch/Lot Number: EK4176) as single dose for covid-19 immunisation (age at vaccination was 60 years). Following mammogram 26 days after (as reported) second dose the patient experienced bruising and soreness and pain in left arm at site, under arm pit and around breast on 19Feb2021 at 16:00. The patient recovered with lasting effects. No treatment was received for the events. No covid reported prior vaccination. Covid wasn't tested post vaccination. The patient underwent lab tests and procedures which included mammogram: unknown result. Outcome of events was recovered with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.