chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 12-APR-2023, the patient received Rotarix lyophilized formulation. On 12-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter
headache; sore arm; This is a spontaneous report from a contactable Consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:00 (at the age of 37 years) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 PM as dose 1, single for covid-19 immunisation. The patient previously took phenothiazine and experienced drug hypersensitivity. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced headache and sore arm on 11Feb2021 08:00. Patient did not receive any treatment for the events. The outcome of events was recovered on unknown date in 2021.  Follow-up attempts completed. No further information expected.
Patient had arthritis in her hands after the Moderna shot; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRITIS (Patient had arthritis in her hands after the Moderna shot) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ARTHRITIS (Patient had arthritis in her hands after the Moderna shot). At the time of the report, ARTHRITIS (Patient had arthritis in her hands after the Moderna shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was provided that the patient is about 50-year-old.  No concomitant medication information was provided.  No treatment medication was provided.  Company comment: This spontaneous case report concerns an adult female patient (about 50-year-old), with no medical history provided, who experienced non-serious unexpected event of special interest - Arthritis. The event occurred after the patient had received the mRNA-1273 vaccine (as booster dose). Temporal relationship between vaccine administration and occurrence of the event cannot be determined since dates were not provided. According to the provided information, the patient had arthritis in hands. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the events were provided. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns an adult female patient (about 50-year-old), with no medical history provided, who experienced non-serious unexpected event of special interest - Arthritis. The event occurred after the patient had received the mRNA-1273 vaccine (as booster dose). Temporal relationship between vaccine administration and occurrence of the event cannot be determined since dates were not provided. According to the provided information, the patient had arthritis in hands. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the events were provided. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
My son has concerns about the side effects relating to heart issues; This spontaneous case was reported by another health care professional and describes the occurrence of CARDIAC DISORDER (My son has concerns about the side effects relating to heart issues) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (My son has concerns about the side effects relating to heart issues). At the time of the report, CARDIAC DISORDER (My son has concerns about the side effects relating to heart issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Initial information received on 11-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a four months old female patient who received third Primary dose of vaccine PENTACEL batch number C5408AB (expiry date 05-Oct-2019) via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that there is a child who obtained the DTap/IPV separately without the ActHiB.) It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Noticed red circle (about 2" in diameter) at injection site. No itchiness or swelling. No pain - just red. I am pregnant with my second child (second pregnancy - no previous miscarriages). I was 18 weeks pregnant at the time of the injection and am due August 9.
Patient given 0.5ml instead of 0.25 ml for his #2 booster and the patient is not complaining of any symptoms at this time.
One arm has lymphedema; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHOEDEMA (One arm has lymphedema) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Breast cancer.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced LYMPHOEDEMA (One arm has lymphedema). At the time of the report, LYMPHOEDEMA (One arm has lymphedema) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: positive (Positive) False positive result.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The reporter stated that other arm gave a false positive result on the mammogram whenever she got the first 2 doses due to the covid vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received included 3rd dose details  of Moderna vaccine..
It was discovered after administering the vaccine to the patient (discovered at approximately 4PM---Unsure of exact time) that the vial had been opened on 8/11/21 and was due to "time out" and be thrown away at 6PM on 8/11/21.  Vaccine was given at 1:25PM on 8/12/21 The patient has suffered no unusual side effects at this point State CDC was consulted and recommended that patient return and be re-vaccinated, as dose thought to be ineffective
2 swollen lymph nodes on my left collar bone.  By 3/5/21, the lymph nodes were reducing.  I took some Advil for 3 days.
Redness, tenderness, mild edema. Site redness approx 10 cm diameter. Developed within 10-12 hours after injection decreased size, redness and tenderness at 48 hours.
2 year old who awoke 22 hours + after receiving Hep A number 1 with painless limp, favoring right leg.  No redness, no swelling, no trauma, no travel.  Occasional complaint of right foot pain 24 hours later.  No constitutional symptoms.  No preceding illness.
First arm to swell up was right arm (flu shot arm)-it bruised as well. She had a fever for 2 days-this started 9/1/22 (day after receiving both shots). Then on 9/5/22 she had SOB and her BP was elevated so she went to ER. Her left arm also became slightly red and both felt hot to the touch on 9/6/22. ER asked why she received 2 shots at one time, and treated her w/ Benadryl for allergic rxn, Ibuprofen for swelling pain, and Omnicef in case of infection.
This case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to ENGERIX B. Additional details were provided as follows: About 4 years ago from the reporting date, the patient was vaccinated with a dose of ENGERIX-B. On an unspecified date, the patient experienced a swollen, red area around the injection site. On an unspecified date, the was patient recovered. No further information was provided.
315PM pt turned red all over-went immed to ER; pt began screaming uncontrollably, feet turned blue & got splotchy all over; ER nurse called for vax given; DPH given & Decadron given in ER; pt discharged 5PM-no sx & happy;(no fever reported)
left hand swelling. entire hand and fingers. not arm or lymph nodes. just hand. painful and difficult to make a fist and bend fingers
very Low energy later in day after shot. Very slight headache. No energy all Next day (unlike Me) "zapped" of course arm very sore. Hurt to lift it outward. Better in couple of days
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years 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: "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment for covid-19 start date was 10Jan2023 and stop date was 15Jan2023, Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Developed fever with measle like rash (red dots, itching) and coughing, runny nose 8 days after vaccination.  Child still has rash and cough.  Fever subsided approximately 2 days later.
suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had both shingles shot still experienced shingles.  The reporter stated that hope vaccine works better for you all. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
fever inc 103; high pitched cry lasting .5h on & off for 2hrs; lethargic, moaning, rolling tongue; seen in ER by MD;
Soreness at injection site within 6 hours, shaking chills, headache, body ache, dizziness, fatigue, temperature increase to 102.6 within 20 hours. All symptoms gone after 36 hours.
The evening after I got shot #5, I noticed shooting sharp pains on the left side of my face that were going from the cheek area to my ear. This happened the next day also, intermittently.  After a few days, I noticed that it felt like my left jaw was painful to chew and open my mouth very wide.  It also hurt my left jaw to move my lower jaw from side to side.  Since that time, I have continued to have jaw/face pain on the left.  I went to the dentist on 10/3 and had x-rays and there was nothing to see on the x-ray.  On 10/17, I went to the oral surgeon, and she did an exam.  She found that I have a muscle spasm on the left side of my face.   I started taking methocarbamol 750 mg tablets.  The Rx is for 1 tablet once/day at bedtime and as tolerated, one every 6 hours as needed for jaw spasm.  I am also using a heating pad, eating soft foods, and stretching my jaw multiple times daily.   I didn't get any NSAIDS prescribed because I have lesions in my stomach from a hiatal hernia.   I have taken 4 pills so far, and I haven't noticed much change in the level of pain.
Monday evening around 6:00 pm, I started feeling like crap. I took my temp. it was 102 degrees. I took TYLENOL. My arm was huge. It was beet red very very hot. And swollen very huge. Couldn't get no clothes to fit my arm. Was in bed from Mon. 30th night until Tues. night 11:20 pm. My fever broke. I couldn't even function, held on to all stuff to walk. Very weak. No appetite at all. I was very very sick. Went to doc on Dec. 3. She was nasty. Not a caring bone in her body. My arm was terrible. All she said you have a reaction from your shots. Oh kids get this, I couldn't stay awake any of those days. I was in La La land. Brain wouldn't work at all. I have not been this sick in years. No more shots for me! I had a nurse look at it Tues. morning too. Bad red rash. High temp. and short of air. Dizzy and aching body real bad (all over). Light headed. Very swollen (left) arm. Wasn't myself until Friday Dec. 4th was feeling better. Still couldn't think.
Pt stated that during injection it felt as if the needle was moved/wiggled while in arm and painful.  A "burning" sensation traveled into her forearm area.  She was provided with ice which provided some relief. She was not light headed or dizzy.  Her arm was still uncomfortable when she left the pharmacy approximately 20 minutes after injection.
Ill; Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill), DIARRHOEA (Diarrhea) and PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Ill), DIARRHOEA (Diarrhea) and PYREXIA (Fever). At the time of the report, MALAISE (Ill), DIARRHOEA (Diarrhea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
some breathing problems; Dizzy; weak; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (some breathing problems), DIZZINESS (Dizzy) and ASTHENIA (weak) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (some breathing problems), DIZZINESS (Dizzy) and ASTHENIA (weak). At the time of the report, DYSPNOEA (some breathing problems), DIZZINESS (Dizzy) and ASTHENIA (weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient stated that the events might be due to her previous positive for COVID-19 in JAN-2021. No treatment information was provided.
Chest pains, unexplained spasms and pains throughout my body, getting dizzy several times throughout the day.
Received vaccine at 8:10 AM at H.D.  Drove to place of employment.  At 9:45 AM started having numbness, tingling in arms, hands, legs, feet.  Called H.D. to report S/S.  Dr recommended pt come to H.D.  Pt in no distress on arrival to H.D.  Cont. to have numbness, tingling in all extremities.  Alert, oriented, normal gait.  Normal hand grips.  BP 100/76 P-100.  Phone call to Dr. OB/GYN.  States for pt to watch s/s today.  If they become worse go to ER.
nerve conduction abnormal; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Onset date: Long term. Concomitant medication(s) included: SINGULAIR oral taken for asthma (ongoing); DULERA nasal taken for asthma (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 07Feb2021, when the patient was 70-year-old, for COVID-19 immunisation; BNT162b2 (Dose:2, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EN6203), administration date: 27Feb2021, when the patient was 70-year-old, for COVID-19 immunisation, reaction(s): "right after second vaccine severe left upper arm pain and also decreased range of motion", "right after second vaccine severe left upper arm pain and also decreased range of motion", "left arm and weakness/ severe weakness of left arm and hand/ weakness on left leg", "frozen shoulder", "trouble walking", "hand atrophy", "suggest ALS". The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 18Nov2021, outcome "unknown", described as "nerve conduction abnormal". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (24Oct2021) normal, notes: brachial plexus; (11Sep2021) Mild C5-C6, moderate degenerative changes,moderat, notes: Mild C5-C6, moderate degenerative changes, moderate canal stenosis, C5-C6, right greaterv than left, mild stenosis/C4, C45 neuroforaminol; (24Oct2021) L3-4, L4-5 dics, L4 and L5 bilaterally; Nerve conduction studies: (18Nov2021) abnormal, notes: Moderate right, mild left median nerve neuropathy, C7 root disease.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event peripheral neuropathy and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
patient reported blurry vision at day 1 post vaccination, and it went away after 24 hours