chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated she obtained a headache after 12 minutes of receiving her second dose of Pfizer. Patient stated she had taken medication for nausea and vomiting prior to receiving vaccine (information was not disclosed prior to receiving vaccine).  Patient was given water and apple juice, refused vital signs at this time.  Patient self-administered  five ibuprofen 200 mg gel caps with water.  Patient was kept longer for observation, after 20 minutes patient left, returned to work.  Patient stated some decrease in headache.  Patient voiced after receiving vaccine, she had reaction to first vaccine and had taken off 2 days, after further speaking to patient, she voiced she had no reaction to first vaccine.
A non-serious spontaneous report of fever and vomiting has been received from a registered nurse concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Sep-2009. On 21-Sep-2009, the patient experienced a fever of 101.4 and vomiting.  No outcome was provided.  The events resolved on 22-Sep-2009.  Additional information was received on 14-Oct-2009 and incorporated into the narrative: outcome and patient's date of birth.
rash is like pimples; ash all over ankles; itchy rash all over body; itchy rash all over body; itching; slight breathing issue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), the first episode of RASH (itchy rash all over body), ACNE (rash is like pimples), RASH (ash all over ankles) and DYSPNOEA (slight breathing issue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (slight breathing issue). On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching). On 07-Apr-2021, the patient experienced the first episode of RASH (itchy rash all over body). 07-Apr-2021, the patient experienced the second episode of RASH (itchy rash all over body). On an unknown date, the patient experienced ACNE (rash is like pimples) and RASH (ash all over ankles). On 07-Mar-2021, DYSPNOEA (slight breathing issue) had resolved. At the time of the report, PRURITUS (itching), ACNE (rash is like pimples), RASH (ash all over ankles) and the last episode of RASH (itchy rash all over body) outcome was unknown.            Treatment medications was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-074848 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074848:MOD-2021-074848 (Case for dose 1)
44 y/o male with onset of cough and runny nose within 24 hours of receiving injectable seasonal flu vaccine.  Patient febrile within 48 hours of vaccination.  3 days post vaccine, patient c/o malaise and fatigue.  On day 4, he reports developing erythematous, macular non-pruritic exanthem, on trunk, extremities and hands/feet to include palms/soles.  Hands and feet show mild edema without pitting.  Patient's overall condition has improved since day 3, but has not completely recovered.
Pt had a syncopal episode by vaccinator table.  Pt brought to triage and move to bed unassisted.  Pt A&Ox3  BP 86/50, HR 68, RR 17 -- > 94/48, 85, 16 -- > 89/50.  Pt able to move around unassisted with no symptoms.  Pt stable and released from the vaccination site.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
This case involves a six months old male patient who was vaccinated with a 0.5 ml expired dose of vaccine PENTACEL (Batch number: C5389AA, expiration date: 17-Jul-2018, route: intramuscular and site of administration was not reported) on 23-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
I started hack having daily headaches one to two months post the vaccine. OTC meds did not help, neuro said if headaches do not stop return to visit him.
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 74-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9265), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 046L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "borderline high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE; FLUTICASONE PROPIONATE; LOSARTAN. The following information was reported: VACCINATION FAILURE (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: (18Aug2022) Negative; (20Aug2022) Positive; (21Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment Paxlovid in Aug2022.  No follow-up attempts are possible. No further information is expected.
Cellulitius, , Red, with swelling, nausea, doesn't feel well, low grade fever.
The pt experienced a mild onset of arthritis, psoriasis. It has been 3 years since the prior vax.
roof of mouth tingling, 2 days late fever, body aches, headache.  One week after vaccination still with bodyaches and head ache, fever resolved but  CP developed.    Dx with  pleracy.
Pt recvd 3 doses of Engerix-B vax titers were checked 6 months p/last dose; titer result was neg;
Why would I have gotten a full dose for the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Why would I have gotten a full dose for the booster) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Why would I have gotten a full dose for the booster). At the time of the report, ACCIDENTAL OVERDOSE (Why would I have gotten a full dose for the booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/8/2021, and 3/1/2021. PMHx of DMII, HTN, CKD s/p kidney transplant on immunosuppression. Covid+ 11/13/21, hospitalizd x3days. D/c'd home on O2. Readmitted 11/18/21 for worsening symptoms, intubated 11/20. Transferred to Medical Center on 11/24/21 for higher level of care due to acute hypoxemic respiratory failure 2/2 Covid-19. Tx'd steroids, nitric oxide, diuresed, merrem, vancomycin and cresemba. Continued to get worse and expired 12/13/21.
Arm black & blue, fever, N/V/D, throat swelling. Pt given Valacyclovir 500 mg QID.
Pt developed fever of 102 with swelling in Left arm 3 by 3 inches. Was on her way to London mother called on 1-2-03 with report and swelling increasing saw Dr in airport and was given Benadryl.Mother called this am and pt arm swollen to elbow now and is seeing a physician in another country.
Noted a lump in the area of the injection. About quarter size. NO PAIN NO REDNESS.
Moderna vaccine booster given at a clinic and at this time we were unaware of the 20 dose limit for punctures of each vial.  The vial was punctured 28 times.  No adverse effects reported
Deceased complained of abdominal pain and was taking aspirin for a headache.  He died within less than a day of initial complaints.
Effects started 2/10/21. Very sore arm (pain level 8/10). Inability to use my left arm for two days. Used ibuprofen 600mg every 6 hours for 2 days. On 2/11/21, felt chills, fatigue, malaise, body aches. On 2/12/21, symptoms subsided except slightly sore arm. Arm became itchy and developed 3 large red lumps on my shoulder/upper arm (only one lump was at the injection site. Other lumps were distal). Benadryl used for itchiness. Lumps subsided by 2/13/21 in the evening with slight skin discoloration.  As of today, 2/25/21, experienced stabbing pain through my upper arm that lasts seconds and subsided. Occurs 2-3 times a day
Reported immediate pain after injection, Injection administered too high, initially had limited range of motion (has improved), continue to have deep pain and limited lifting. Course of treatment has been ant-inflammatory and Medrol pack meds, physical therapy. Most recently MRI ordered 2/5/19 revealed bone contusion and rotator cuff tear.
I am Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was asking how long the side effect would last. The patient received the shingles shot in morning the day before the reporting. The patient was sick till the day of reporting. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
received the 1st dose / about a year and a half ago (2/1/2020) / has not received the 2nd dose; This case was reported by a pharmacist 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 of Shingrix on 1st February 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. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The pharmacist enquired that if the patient could take the second dose. The reporter consented to follow up via postal.
developed cellulitis; it hit my kidney; This spontaneous report was received from an 80-year-old female patient reporting on herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, route and site of administration were not provided).  On an unspecified date, the patient developed cellulitis.   On an unknown date, the patient reported "it hit my kidney" (unspecified renal disorder).  At the time of reporting, the outcome of the event it hit my kidney was not known.   The outcome of the event developed cellulitis was recovering (reported as "did well, only had redness in arm).   The reporter did not provide the causal relationship between suspect therapy and the events.  Upon internal review, the event developed cellulitis was determined to be medically significant.
Pt became very fussy and unconsolable at 45 min intervals for over 24 hrs.
Starting on 6/30 my elbow started to bother me a bit.  I eventually began to experience sharp pain in my elbow that travelled up my arm.  I began to use my left hand more because I felt the strength in my right arm/hand had gotten weaker.  I developed shoulder pain sometime in July.  I went to my doctor around July 20th and was prescribed a rehabilitation medication.
2MAR92 pt recvd 1st dose of Engerix-B & 3MAR92 devel itchy rash on arms & chest; it did not make pt feel bad; rash looked like welts; no tx required; rash lasted for 2 days;
Swollen, warm to touch arm evening of vaccination. Initially could not bend arm. Can now bend, swelling subsiding.
Splotchy, red, and itchy raised rash under both arms and alongg side of torso; Splotchy, red, and itchy raised rash/ rash mainly on right inner thigh near groin, smaller rash on left of inner side groin; Splotchy, red, and itchy raised rash; extremely itchy and dry elbows; extremely itchy and dry elbows/ itchy and red rash on both ankles and up and down both thighs/small itchy rash on back waist; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 17:00 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (medically significant) with onset 20Oct2021, outcome "recovering", described as "Splotchy, red, and itchy raised rash under both arms and alongg side of torso"; RASH (medically significant) with onset 20Oct2021, outcome "recovering", described as "Splotchy, red, and itchy raised rash/ rash mainly on right inner thigh near groin, smaller rash on left of inner side groin"; RASH PRURITIC (medically significant) with onset 20Oct2021, outcome "recovering", described as "Splotchy, red, and itchy raised rash"; DRY SKIN (medically significant) with onset 20Oct2021, outcome "recovering", described as "extremely itchy and dry elbows"; PRURITUS (medically significant) with onset 20Oct2021, outcome "recovering", described as "extremely itchy and dry elbows/ itchy and red rash on both ankles and up and down both thighs/small itchy rash on back waist". Therapeutic measures were taken as a result of erythema, rash, rash pruritic, dry skin, pruritus. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Erythema, Rash, Rash pruritic ,Dry skin, pruritis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Muscle arm/shoulder pain. Can't lift arm. Since the date of vaccination, pain has gotten worse rather than better. Have had flu shot previous years - no ill effects.
Hospitalized with weakness, debility, cough and sore throat. Treated with remdesivir
Ten minutes after vaccine while sitting, I felt a wave of heat through my body, my body flushed, and my heart rate increased to 130s. My mouth felt weird almost numb like and had a strange taste in my mouth. This lasted only a couple of minutes then I was fine, but just wanted to report my experience.
Patient reported that she received the Janssen Covid19 vaccination on 4/2/2021.  She tested for Covid19 on 9/1/2021, and received positive results on 9/3/2021.
Vaccine site erythema and pain. Zone of erythema is 7cm X 5cm. Very tender to light palpation. No reaction to dose 1 and dose 2. Cold compress and acetaminophen ordered.
Immediately light headed and dizzy. Dry mouth, racing heart, tightness in chest, felt like swelling in throat. Checked by doctor and vitals within norma but took an hour before I felt safe to drive. Tiredness the rest of the day. Soreness in arm for multiple days. One week later, redness and soreness at injection site.
Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Tired; Muscle pain in my left thigh; This is a spontaneous report from a contactable consumer (the patient). A 83-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN5318 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 30Jan2021 (age at the vaccination 83-years-old) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications include hydroxychloroquine, methotrexate. The patient received first shot on the 30Jan, and I was okay until 01Feb, and I woke, and I got nauseated and threw up and then later in the day the same thing happened to me. I nauseated and threw up and I had muscle pain in my left thigh. The next day, I was just extremely tired, and I didn't do any more throwing up because I do have Rheumatoid Arthritis and I was already compromised, I wonder should I take the 2nd shot which I due to have on 22Feb. Patient just took Tylenol for the pain in my leg and nothing else, I didn't want to start up again by taking something. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Rebound Covid at day 9 18May, stopped 23May; Rebound Covid at day 9 18May, stopped 23May; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 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. Patient was not pregnant at the time of vaccination. The patient had no relevant medical history. Patient other medical history and known allergies were reported as none. There were no concomitant medications. Patient received the vaccine. Patient did not receive any other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "recovered" (23May2022) and all described as "Rebound Covid at day 9 18May, stopped 23May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid at day 9 on 18May2022, stopped 23May2022. Therapeutic measures were taken as a result of covid-19. Adverse event was reported as rebound COVID-19 at day 9 on 18May2022 and stopped on 23May2022. Patient received the treatment for COVID-19 which included Paxlovid which started from 10May2022 and ended on 14May2022 via oral route of administration with indication as treatment of COVID-19. Adverse events resulted in none of the above.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 to product and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
p/2nd vax pt devel inc of hair loss & dx w/alopecia; remains w/some hair loss but growing back;
rash all over body. physician treated and resolved. Patient discharged for full duty 01/22/2021.