chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain, redness and swelling at the injection site; pain, redness and swelling at the injection site; pain, redness and swelling at the injection site; used for COPD; This spontaneous report was received from an adult male pharmacist in mid of his 50 years referring to himself. Information about medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, lot # and expiration date were not reported), intramuscularly for COPD (chronic obstructive pulmonary disease) (product use in unapproved indication). On unknown dates, the patient experienced pain, redness and swelling at the injection site following the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of pain, redness and swelling at the injection site was reported as recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
A spontaneous report has been received from a health professional, concerning a 16 years 34 weeks 5 days old female patient. Concomitant medications included doxylamine succinate, pyridoxine for nausea and ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos. Patient's medical history was not reported. It was reported that the patient was administered FLUMIST (intranasal) for unknown indication on 18-Nov-2014. At the time patient was not aware of being pregnant but after the administration she found out she was pregnant and it was considered wrongful administration to pregnant female. Patient did not experience any adverse events during or post administration. In subsequent follow up reporter stated that patient had normal delivery with healthy baby. Weight for newly born male baby was 3120 gm. The outcome of the events of vaccine exposure during pregnancy and wrongful administration to pregnant female were unknown. The outcome of the pregnancy was reported to be a healthy baby. The report was considered to be non-serious by reporter. The reporter considered there was no causal relationship between the wrongful administration to pregnant female and FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune on 10-Aug-2015 from health professional: Pregnancy outcome was added with end of pregnancy date. New concomitant medications were added. Patient's demography updated. Narrative was updated. Corrected Report 24-Aug-2015: Product type was updated. Reporter's causality was added. Case category was changed. Periodic report comment was added. Narrative was updated.
2.5cm x 2cm induration, redness R Anterior thigh, 2 days after shots.  Instructions: Benadryl, Motrin, warm compresses
Global Widespread daily Chronic Spontaneous Urticaria began 1 week after vaccination and continues daily still almost 8 months later. Currently taking 3 Fexofenadine (180 mg) and 3 Famotidine (20 mg) daily with no alleviation of symptoms.
Received T-DAP 7/16/12 & developed soreness & redness 24 hr s/p injection. On 7/18/12. Noted left anxiety painful lymphadenopathy. She called 7/18/12 to report & was advised BENADRYL & had no relief. Pt assessed in office by MD 7/19/12 advised MOTRIN 800mg q 8hr & BENADRYL qHS. To call MD if fever/chills or spreading redness.
Tired on day of shot, week later arm was inflamed, warm and puffy. A few days later I now have a big red rash at the injection site
Dry throat, sore throat, headache, body ache, breathing difficulty ( hospitalized twice for breathing) low oxygen levels, back pain, severe fatigue/weakness
dose1 on 12/23/2020, not yet received 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received dose 1 of the shingrix vaccine and at the time of the report, the patient had not received the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
received the booster dose from a vial that expired because it was kept in the refrigerator too long; received the booster dose from a vial that expired because it was kept in the refrigerator too long; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the booster dose from a vial that expired because it was kept in the refrigerator too long) and PRODUCT STORAGE ERROR (received the booster dose from a vial that expired because it was kept in the refrigerator too long) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the booster dose from a vial that expired because it was kept in the refrigerator too long) and PRODUCT STORAGE ERROR (received the booster dose from a vial that expired because it was kept in the refrigerator too long). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received the booster dose from a vial that expired because it was kept in the refrigerator too long) and PRODUCT STORAGE ERROR (received the booster dose from a vial that expired because it was kept in the refrigerator too long) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.  Patient received 3 doses of moderna and was contacted 24 DEC 2021 by the vaccination site where she received her booster dose and was told she received the booster dose from a vial that expired because it was kept in the refrigerator too long. She received the booster dose on 26 OCT 2021. She had not been told if the booster dose was viable or not only that it was expired.
Increasing pain at injection site that spread to shoulder, neck, head. Within 8 hrs, generalized muscle aches. Arm pain lasted 72 hrs. Arm swelling and redness lasting 4 to 5 days. Pain slowly faded to tenderness within 7 days. I thought this was just a bad reaction until provider suggested it may be an allergic reaction as this was just the second time I have recieved a flu shot. Have had the flu only once in my life. Don't believe in the flu shot for myself, felt forced by my employer to have a flu shot.
Hard to swallow; Weird sensation on the throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Hard to swallow) and OROPHARYNGEAL DISCOMFORT (Weird sensation on the throat) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced DYSPHAGIA (Hard to swallow) and OROPHARYNGEAL DISCOMFORT (Weird sensation on the throat). At the time of the report, DYSPHAGIA (Hard to swallow) and OROPHARYNGEAL DISCOMFORT (Weird sensation on the throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Injection site soreness (Day 1 - Day 5), full body aches (Day 2 - Day 4), intermittent chills (Day 2 - Day 4), mild headaches (Day 3), tiredness (Day 1 - Day 6), Dizziness (Day 6), some loss of balance (Day 6), treated with Ibuprofen (aches) and Aspirin (headaches).
bad rash on my arm with blisters in the center; blisters on the back of my tongue; bad rash on my arm with blisters in the center; Arm has a big knot the size of an egg which got bigger; arm  red; Feel very hot to the touch/hotness; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red), FEELING HOT (Feel very hot to the touch/hotness), TONGUE BLISTERING (blisters on the back of my tongue) and RASH VESICULAR (bad rash on my arm with blisters in the center) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red) and FEELING HOT (Feel very hot to the touch/hotness). On 16-Jun-2021, the patient experienced TONGUE BLISTERING (blisters on the back of my tongue) and RASH VESICULAR (bad rash on my arm with blisters in the center). On an unknown date, the patient experienced RASH (bad rash on my arm with blisters in the center). The patient was treated with AZITHROMYCIN (Z-PAK) for Blisters, at an unspecified dose and frequency. At the time of the report, NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red), FEELING HOT (Feel very hot to the touch/hotness) and RASH (bad rash on my arm with blisters in the center) outcome was unknown, TONGUE BLISTERING (blisters on the back of my tongue) had not resolved and RASH VESICULAR (bad rash on my arm with blisters in the center) had resolved.            No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event/s was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Follow up received on 03-Jul-2021. New events were added and Treatment medication were added.
2/5/21 sore arm, 2/6/21 nausea then severe vomiting & severe uncontrollable diarrhea with fever to 100.4 with symptoms lasting 24-36 hrs. L arm at injection site red with rash lasting 1 week
This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 16 year old female patient. There were no concomitant medications, concurrent conditions and medical history reported. On 12-APR-2016, the patient was vaccinated with M-M-R II lot # L012481 exp. 10-APR-2017 (dose, route and site of administration were not reported) and at the same time, the patient was vaccinated with VARIVAX (Merck) L028275 exp. 28-JUL-2017 (dose, route and site of administration were not reported). After receiving the vaccines, on 14-APR-2016, the patient had a "urine pregnancy test" with result: positive. The patient also had a "blood obstetrics panel" performed on 12-APR-2016 (after the vaccines were given), however the results were unspecified. The patient sought medical attention and was treated with unspecified "prenatal vitamins". The patient became pregnant with last menstrual period (LMP) of 14-MAR-2016 and estimated date of delivery (EDD) of 19-DEC-2016. The pregnancy was outcome pending. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Patient was placed 4 vaccines in his Right arm and had a reaction to vaccines. Arm was swollen and red patient was taken to hospital the next day 12/1/2010
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing), notes: Diabetes II; "OSA" (unspecified if ongoing), notes: OSA; "morbid obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: erythromycin, reaction(s): "allergies erythromycin", notes: known allergies erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) positive, notes: Tested positive for COVID 25Jun; (04Jul2022) Negative, notes: tested negative for COVID on 04Jul; (07Jul2022) positive, notes: patient tested positive for COVID 07Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The reporter provided that the patient received treatment for COVID-19 with Paxlovid. And the route of administration by Oral. Treatment start date was 25Jun2022 and stop date was 29Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal role of  reported events cannot be excluded for  suspect  .Case will be reviewed further on receipt of FU information.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Case previously recorded as MA2009-4402.  Initial case report received from a registered nurse via agency on 16 NOV 2009.  A 3 year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 102045P1) i.m. on 14 NOV 2009.  Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures necessary.  Agency reference no.: NA09-008317.
Every inch of her body was hurting; nauseous; Chilled but not sweat; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Every inch of her body was hurting), NAUSEA (nauseous), CHILLS (Chilled but not sweat) and HEADACHE (terrible headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Every inch of her body was hurting), NAUSEA (nauseous), CHILLS (Chilled but not sweat) and HEADACHE (terrible headache). On 19-Feb-2021, PAIN (Every inch of her body was hurting), NAUSEA (nauseous), CHILLS (Chilled but not sweat) and HEADACHE (terrible headache) had resolved.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-017433 (E2B Linked Report).; Sender's Comments:  MOD-2021-017433:same reporter , different patient.
15 hours post 3rd vaccination, the following symptoms appeared: Fever; T: 102.5; intense chills (approximately 15 min) with tachycardia (144 bpm max) without fever; vomiting; joint pain/burning sensation and body aches. Tylenol used to relieve fever. Advil used to relieve body aches and joint pain.
Client & mom called HC; reported vomiting after lunch; unable to stop vomiting. Taken to ER; d/c with diagnosis gastroenteritis.
patient felt fine after receiving vaccine. Next morning her arm was sore. She had a 2 inch red, raised, warm area that was tender to touch. Her arm was quite sore all day. As of today 11-25-2020 9pm she said it looks and feels a little better but is still quite sore.
Tingling in the back of the throat, dry feeling, metallic taste in mouth.  No lightheadedness, pain in chest or difficulty breathing.
Body aches; sweating; Skin pain; Lethargic; Fatigue; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic), FATIGUE (Fatigue), PYREXIA (Low grade fever) and HEADACHE (Headache). The patient was treated with PREDNISONE (oral) at an unspecified dose and frequency; DEXAMETHASONE PHOSPHATE (DECADRON [DEXAMETHASONE PHOSPHATE]) (oral) at an unspecified dose and frequency; METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) (oral) at an unspecified dose and frequency; OFLOXACIN (ZENFLOX [OFLOXACIN]) (oral) at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), HYPERHIDROSIS (sweating), PAIN OF SKIN (Skin pain), LETHARGY (Lethargic), FATIGUE (Fatigue), PYREXIA (Low grade fever) and HEADACHE (Headache) had not resolved. Not Provided          No Concomitant Medications were reported. Treatment Medication includes; Prednisone, Decadron, Medrol, Zenefrax and Cipro. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-082906 (Patient Link).
84 Y/O male fully vaccinated with moderna vaccine in april, states felt very weak and could not move also SOB. seen in PCP office and Dx with COVID 19. CXR showed mild infiltrates . Now on 2 lit nasal oxygen and maintaining SAT> 90 %. PMHX HTN   8/10/2021 tested positive
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Brand was paxlovid, treatment start date at 06Jan2023, treatment stop date at 11Jan2023, indication was treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had sharp pains in my heart that would last five to six seconds. This occurred a couple dozen times between 18:00 Thursday night and midnight Friday.  It has occurred three times since then.
02/18/2015 5:00PM Malaise, Generalized muscle aches. Mild nausea. To bed 8:00 PM. Wakeful night with significant thirst, racing heart. 02/19/2015 Approximately 7:30 AM Arose to tell my husband I didn't feel well and fainted to the floor. 10:00 AM My husband called the doctors office and told them he thought I was having a reaction to Prevnar.  They told him they had not encountered a similar reaction to the vaccine. Throughout that day I continued to be very thirsty, mild nausea, significant fatigue, weakness and generalized muscle aches (muscle aches relieved by Tylenol). Slept most of day. 02/20/2015 Fatigue, weakness remained, no appetite, thirst normal, mild muscle aches. 5:00 PM able to eat some saltines (2). 02/21/2015 9:00 AM Aches gone, able to eat bagel, soda. Fatigue remains. 4:00 Ate cookie. 7:00 PM Ate half of chicken sandwich. 02/22/2015 Up all day. Feel almost normal. No MD visit offered, no medication or treatment.
ED Discharged  8/5/2021 (4 hours) Cough ,Shortness of Breath. Fever
Case number PHHY2012US052006 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 through 30 Jun 2009. This case refers to a fetus (sex not specified) of pregnant female (age not specified) who was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009 (see linked mother file: PHHY2012US052002). The fetus was exposed to this vaccine via transplacental route. On an unknown date at an unspecified gestational period the fetus had arrhythmia. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of INFLUENZA vaccine.
Myalgias, arthralgias, chills, general malaise all beginning around 2015.
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (2nd dose in series 02/06/21). Hospitalized from 08/27/21 - 08/31/21. Below is copied from discharge summary:   Patient with known COVID.  Family states slightly more confused and breathing faster as well as increased fatigue.  Family also contacted PCP and was concerned because of chest pain.  PCP one to rule out PE.  I also discussed with the family the patient's not appear to have a recent cardiac workup for ACS. Patient discharged with no s/s of acute distress noted. Discharge instructions provided. Patient voiced understanding. IV removed. Personal belongings returned to patient. Packet for son given to him at time of pick up
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.