chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling awful after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling awful after the 2nd dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling awful after the 2nd dose). At the time of the report, FEELING ABNORMAL (Feeling awful after the 2nd dose) outcome was unknown.            Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the event was reported as not applicable.   Reporter did not allow further contact
Arm swelling and ?knot? at injection site. Period began 7 days earlier than usual.
One day after HAVRIX and ADACEL administered child developed a flesh colored papular rash on neck and face, spread intermittently to trunk and legs. Taking CLARITIN due to pruritis, MENVEO also administered.
1 of 3 pts who was vaxed from the same lot (different vial) & exp fever, swelling & excessive redness @ inject site;
pt recv vax 17AUG95 & 26NOV96 pt devel chicken pox w/10 lesion on upper body & presented to MD office;It was noted that pt had been exposed to chickenpox @ day care ctr;
DTAP given on 5-1-07. Patient returned at 1610 to clinic on 5-4-07 at 1445 with right leg swelling. Diagnosis was local reaction versus R leg cellulitis.
I was having issues with my lower back, I went to a doctor and sent me to an MRI and found a tumor. That was last October and now next Wednesday I have another MRI and they will see what the tumor is doing if it has progressed or not. I don't have a lot of information because I am still trying to figure out what going on.
Redness and swelling of R Deltoid, student reported mild fever that resolved and slightly pruritic. Erythema across deltoid that is warm to the touch noted at site when student reported reaction- 3 days post injection
Itchy rash broke out a few days after administration of the shot. Rash was on both arms, across neck, and down torso. Patient was itchy and scratching all over torso, arms, and head. Rash subsided after about 2 weeks.
This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (unknown details). At an unspecified time after vaccination with KINRIX, the subject experienced nonspecific reaction. Per the reporter, a subject was referred to them who had a reaction to KINRIX. No additional details were reported. At the time of reporting the outcome of the event was unspecified.
Child received flu shot on 10/28/13, and next day vomited 2 times. Crying in school from 10/29/13. Gaggs many times, but not vomiting now. vomited once every day on 10/29, 10/30, 10/31, 11/1 also according to mother. Refuses to go to school.
Fever 102.5F Chills Sweats  Severe muscle aches Arm swelling
Mom called-states increased temp for 2-3 days following injections, 101 deg- but continues to have low grade fever now since receiving. As of 7/24/08 100.1 deg.
pt recv vax 25APR97 & 7MAY97 pt devel full blown chickenpox;
Vomiting, Fever, Lethargic for four days, followed by hives upon onset of emotional outbursts. As of 11/22/09, hives continue upon emotional outbursts.
Moderna vaccine booster dose was given in error to a 16 year old male. There are no adverse events to report related to this immunization.
2 hours after vaccine sudden onset burning and cramping abdominal pain with cold sweat, generalized weakness, lightheadedness and flushed sensation required lying flat for 30 minutes before started improving. Day after vaccine arm moderately painful and hot, generalized headache, occasional sweats. Two days after mild generalized headache, arm mildly sore. Sweats less frequent.
Headache and dizziness started at 10:30pm on 2/15/21. I began to feel nauseated around 11:15pm. Body aches, chills and fever started around 11:45. My fever peaked at 101.2 at 2am. Pain relievers and fever reducers did not help. I had cold sweats throughout the night, not able to sleep consistently through the night due to body aches, headache and nausea. Left arm became swollen, hot and hard to the touch, this lasted through 2/17/21. The arm was itchy from 2/18-2/20/21. The fever and body aches lasted through 2/16 until about 10:15pm, around 11:00pm the headache went away. I was feeling mostly recovered with the exception of the arm by the morning of 2/17.
Nausea, vomiting, HA, redness and swelling at injection site. Treated with TORADOL, ZOFRAN.
Patient is fully vaccinated and boosted. COVID positive on 4/25/2022. 86-year-old male that presented to emergency room with shortness of breath. Patient complains of chest congestion over the last few days and a cough. Patient has a history of diabetes and hypertension.Patient denies chest pain.  His CT of chest is compatible with COVID pneumonitis. CT head no acute process.  Labs: PLT 97, D-dimer >10,000. IV Dexamethasone. Other therapies as per ID. Anticoagulation per protocol. Incentive spirometry and flutter valve encouraged. Proning encouraged. Wean oxygen as able. discharged home
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# M027879, expiration date: 24-JAN-2018 (dose and route of administration were not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion.  No adverse effect was reported. Product quality compliant was not involved. This one of several reports received from the same reporter.   Additional information has been requested.; Sender's Comments: US-009507513-1701USA005252: US-009507513-1701USA007888: US-009507513-1701USA007886:
Client vaccinated with Moderna vaccines for Covid in April and May 2021.  Boosted with Moderna on November 6, 2021.  Symptoms started 12/18/2021 - nasal congestion, cough, headache, myalgia.  Evaluated in emergency room but not admitted.  Returned home to isolate.
This case was reported by a nurse and described a 24 year old female subject who was vaccinated with Twinrix during the first trimester of pregnancy. Medical history included rape victim. On 16 August 2005 the subject received 1st dose of Twinrix (lot HAB306A6) during her first trimester of pregnancy. The nurse reported that "the pt was given a Twinrix  injection at her request because she was raped. The pt is 8 weeks pregnant." Follow-up was received on 19 October 2005 from the reporting nurse. The nurse reported that , on an unspecified date after 16 August 2005 and on or before 11 October 2005, "the pt had a requested abortion because she was raped." Comment: Elective termination of pregnancy was assessed as medically serious (OMIC) by the manufacturer.
Allergic reaction; Tingling and numb tongue; blood pressure went up; Heavy arms and legs; unsteady; whole body felt off; Joint pain; Muscle pain; Mild headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs) and UNEVALUABLE EVENT (unsteady) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037V20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs), UNEVALUABLE EVENT (unsteady), FEELING ABNORMAL (whole body felt off), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Mild headache) and INJECTION SITE PAIN (Pain at the injection site). On 16-Jan-2021, HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs), UNEVALUABLE EVENT (unsteady) and FEELING ABNORMAL (whole body felt off) had resolved. On 18-Jan-2021, INJECTION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
- soreness by injection area (started 20 hours after vaccination, lasted about 16 hours gradually dissipating)  - intense stomach pain and diarrhea (started 29 hours after vaccination, lasted about 30 minutes) - headache and dizziness (started 42 hours after vaccination, lasted 3 hours)
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Prostatitis" (unspecified if ongoing), notes: Other medical history: Chronic Prostatitis; "Moderate Asthma" (unspecified if ongoing), notes: Other medical history: Moderate Asthma; "High Blood Pressure" (unspecified if ongoing), notes: Other medical history: High Blood Pressure; "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. Concomitant medication(s) included: TYLENOL, start date: 11Jul2022, stop date: 14Jul2022. Past drug history included: Bactrum, reaction(s): "Drug allergy: Bactrum", notes: Known allergies: Bactrum. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: completed the treatment on Day 5, tested positive through Day 9; Negative, notes: Tested negative on Days 10 and 11; Negative, notes: Tested negative on Days 10 and 11; Positive, notes: and then felt worse (head cold) again on Day 12 and tested positive; Positive, notes: Still testing strongly positive on Day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event Rebound exactly one week (7 days) after completing the treatment. Patient completed the treatment on Day 5, tested positive through Day 9. Tested negative on Days 10 and 11, and then felt worse (head cold) again on Day 12 and tested positive. still positive on Day 17, still with head cold symptoms. Symptoms are less than original (no fever), but consistent and unabating. Still tested strongly positive on Day 17 (Day 5 of rebound). Adverse event start date was reported as 22Jul2022.  No follow-up attempts are needed. No further information is expected.
Patient had a vasovagal event.  Patient was cared for, BP checked and sent home once stable.
This non-serious initial spontaneous case, was received from other non-health professional, concerning a 75-year-old elderly female patient. On 30-Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, after the vaccination, patient complained of muscle aches and coughing, which were ongoing since one month. She also complained of rash on her face and tiredness. She consulted the doctor and took unspecified antibiotics, bout cough had not stopped. The outcome of the events muscle aches, cough was not recovered and rash on her face, tiredness was not reported. The reporter considered the causality of the events as related.
pt started crying as shot was given, mom reports pt cried constantly from then & it lasted for a week;pt had dec feedings & devel a rash @ site of the inj a wk later;temp never over 102;dx allerg to DTP;
Patient received Janssen COVID vaccine on 3/11/21. On 1/12/22, patient tested positive for COVID and was admitted to our inpatient, intubated with acute hypoxemic respiratory failure due to COVID19 and pulmonary embolism. As of today (1/21/22), patient is still in the hospital.
Parents report hives approx 6 hours after injection, that resolved without medication prior to arrival at ED.
Dry face; chest was hurting; throat became tight; hives 4 days after the vaccine (just face) right side and then "lingered" to the left side of my face"; This is a spontaneous report from a contactable consumer, the patient. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0169), via an unspecified route of administration, administered in Arm Left on 18Apr2021, as dose 1, single (age at vaccination: 21 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, on 22Apr2021, 4 days after the vaccine, she started experiencing hives (just face) right side and then "lingered" to the left side of her face, which did not hurt but were just really uncomfortable because of the fact that the hives were all over her face. She stated that she did not notice the hives until she touched her face and she took Benadryl (Strength: 25mg tablet, expiration date is Nov2022, only took 1 tablet) to see if the hives would go away and it did not. She reported that, one day after work on 24Apr2021, one week after she received her vaccination, her chest hurt and then her throat felt tight which scared her and since she was driving she went to urgent care. Reportedly, at urgent care she was given a steroid shot which helped it go away. The symptoms lasted one hour and gradually went away. Reportedly, the hives were also ended around the 25Apr2021 or 26Apr2021 after she received the steroid shot to help with her symptoms. She told that the hives went away and was clearing up and then the dry face started on the 29Apr2021 through until around the 03May2021 or 04May2021. The only after effect was her dry face. Since, her face was dry she used Aquaphor and that helped. Outcome: hives were recovered on an unknown date in Apr2021, chest was hurting and throat became tight were recovered on 24Apr2021 and Dry face was recovered on an unknown date in May2021.  Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning a patient who was vaccinated with the first dose of rotavirus vaccine (human-bovine). The patient subsequently developed 10 days of watery diarrhea. Unspecified medical attention was sought. The patient recovered. Additional information has been requested.
LOW GRADE FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever. This report was non-serious.
Anaphylactic after 15 minutes.  Oral Benadryl-no relief,  two epi pens 5 minutes apart, and one injection for solu-cortef. Pharmacy located inside hospital so patient was taken to ER.  Pulse Ox and BP was monitored the whole time.  Patient was admitted to ICU and on an EPI drip for 36 hours.
Hives developed two weeks after vaccination.  Hives are daily and have not dissipated.
47 year old female with no past medical hx: complaint of shortness of breath s/p Moderna vaccine 2 dose @ 1:30 pm. VS 136/82  HR 66  RR 18  98% RN
Patient laying down when shot was given. Approximately 2 minutes following vaccine administration patient layed back down and exhibited shaking/tremors with eyes rolling back.  Nurse reports patient appeared cyanotic and was not breathing for approximately1 minute.  Physician contacted.  Felt it may have been a vasovagal response.  Father stated "the exact same thing happened last year.  Offered patient provider visit.  Family declined and patient ambulated out independently.
Bilateral facial paralysis    Bilateral facial dystonia with paresthesia Random paresthesia of the upper and lower extremities Episodes last between 30seconds and 6. Hours  No resolution at this time
Get shingles after getting vaccinated with Shingrix/ Suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Get shingles after getting vaccinated with Shingrix/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-MAR-2023 The physician reported that he had seen patients got shingles after getting the Shingrix vaccine. He did not provide additional information and said it was due to a specific Shingles vaccine. He stated this after discussion of Shingrix indication, efficacy and safety, made the above comment and had to return to patients and did not get further clarification. The reporter did not agree to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
The child has a history of an ear infection and was treated with Augmentin, gentamicin and Rocephin on May 5, 2000. On May 17, 2000 the pt developed a large injection site reaction at the site characterized by induration, redness and inflammation. As of May 22, 2000 the patient was recovering.
Reportedly a male infant (DOB 9/5/01) received an ActHIB (lot # UA648AA) and an IPOL (lot # U0426) vaccination administered in his left thigh on 1/14/01. The mother brought the patient back into physician's office a few hours later with the left thigh red, swollen and warm to touch. Hepatitis B injection site, administered on his right thigh, also becoming red and swollen. Physician prescribed Tylenol every 4 hours and cold compresses to the thighs.
pt recvd vax;2-3 hrs later, devel fever, congestion, cough & aches;
47 y.o M with hx of methamphetamine use, HIV on treatment (last  Viral load < 48 on 8/30/21), HCV, pulmonary HTN secondary to HIV and Methamphetamine use (follow at Dr. office), h/o cerebellar infarct, OSA on CPAP, pulm nodules,  history of STDs, history of thyroid nodule, last hospitalization 7/2021 for colitis, who presented on 1/8/22 with 1 day of fever, chills, cough, shortness of breath. Last dose of methamphetamine 6 days PTA.  He was found to have severe sepsis due to covid pneumonia with acute hypoxemic respiratory failure requiring 6L NC, at night required HFNC FiO2 50% on 40-60 LPM. CTA no PE, pulm nodule. He was started on steroids and remdesivir and admitted.  He wanted to leave AMA 1/10/22, at the end convinced to stay. Refusing HFNC. He was been on RA most of the time at rest with O2 sats 96%. On exertion (bedside road test) he desaturates to 87-88% on RA. He feels well and wishes to go home, he is aware of risks of worsening and even death. He still prefers to go home. He has agreed to have home O2, which we will order for exertion.    Severe sepsis with acute hypoxemic respiratory failure due to covid pneumonia:  Symptom onset on 1/8. COVID positive on 1/8. Last fever on 1/8   - Self-proning as tolerated at home.  - Decadron 10 mg BID started on 1/09/22 - 01/18.   - Received Remdesivir 200mg IV x 1 on 1/8 then 100mg IV daily until 01/11/22.  D4/5 - on Baricitinib 4 mg daily x 14 days, D3 nocturnal CPAP for OSA, - pt aware if worsening to return to the hospital, if worsening hypoxemia will most likely not benefit from iNO ( pulm HTN) and given pulm HTN and RV dysfunction, not a good candidate for BiPAP. Case was discussed by Dr. with Dr.  from pulmonology.  - LFTs normal.  - will check CRP as outpt.  - protonix 40 mg daily GI prophylaxis - As inpt he received Lovenox 40mg SQ daily  - continue isolation in hospital per guidance. 1/8-1/28.    History of pulmonary HTN: RVSP 61 mmhg per echo in 4/2021.              - On Tadalafil 40 mg daily & ambristen 10 mg daily.              - Aldactone on hold.    History of HIV: PTA Triumeq 1 tablet daily  History of neuropathy: PTA gabapentin and tylenol  History of methamphetamine use: last use 6 days PTA. Seems in outpatient program. Inpatient rehab per patient bur currently with covid.    Diet: DIET, REGULAR Mobility: ambulatory without assistance, able to get up from bed by himself and ambulate around his bed several times for me today, no assistance.  DVT prophylaxis: As above. Will discharge on ASA.  Code Status: Full Code  EDD/Dispo: discharge today with home O2., HHRN. He is high risk given both covid infection and pulmonary hypertension. He understands the risks of leaving the hospital. Clinically seems stable as his O2 sats are normal on RA at rest and requires minimal O2 on exertion.    Subjective: Feeling well, no SOB, ambulating, eating ok, wishes to go home today.   Reason for Hospital Admission (Admitting Diagnosis):  Acute hypoxemic respiratory failure due to Covid PNA Pt readmitted to Hospital on 1/24 and still in hospital on 1/28