chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a six years old male patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: UI422AB, expiration date: 30-Jun-2016, dose, route and site of administration was not reported) on 26-Sep-2018. The patient's past medical history included Food allergy (egg). The patient's past vaccination(s) included Flu shot and had had an absent Seizure for 3-4 hours (he stared into space). The patient's past medical treatment(s) and family history were not provided. It was an actual medication error due to contraindication to vaccination and product use in unapproved population (received a FLUZONE QUADRIVALENT and he is allergic to eggs). 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 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. List of documents held by sender: none.
Left Arm pain occurred 2 hours after receiving shot headache occurred 15 hours after receiving shot  tiredness occurred 4 hours after receiving shot vomiting  13 hours after receiving shot
Got the 2 shot vx, I have shingles right now; Have shingles right now; Itchy; Legs achy; I'm extra tired; 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus, leg pain and tiredness. On an unknown date, the outcome of the vaccination failure, pruritus, leg pain and tiredness were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, leg pain and tiredness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2021, the patient received two Shingles shots and had shingles at the time of reporting.  The patient stated that the shingles were not bad really, one little spot about the size of a nickel, which was itchy but did not hurt. The patient's legs were achy and was extra tired. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The reporter reported that an expired dose of ZOSTAVAX (Lot# unspecified, expired on 14-SEP-2014) was inadvertently administered to an unspecified patient on 03-OCT-2014 (dose, frequency and route unspecified). This was supported. No adverse effects reported. Outcome of the event was not reported. Additional information has been requested.
Adverse reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication not provided Treatment medication not provided   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received- No new information was provided.
vomiting; diarrhea; stomach cramps; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 16:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 12 years, in left arm for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 02May2022 as dose 2, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Exercise induced Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=FK5618,, prev_dose_lot_unknown=False,, prev_dose_administration_date=01Dec2021, prev_dose_dose_number=2,, prev_dose_vaccine_location=Right, arm},), administration date: 01Dec2021, when the patient was 11-year-old, for Covid-19 Immunization; BNT162b2 ({prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_brand_unknown=False,, prev_dose_lot_number=FK5127,, prev_dose_lot_unknown=False,, prev_dose_administration_date=10N, ov2021, prev_dose_dose_number=1,, prev_dose_vaccine_location=Right, arm}]), administration date: 10Nov2021, when the patient was 11-year-old, for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00), described as "diarrhea"; HEADACHE (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00); ABDOMINAL PAIN UPPER (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00), described as "stomach cramps"; VOMITING (non-serious) with onset 03May2022 at 02:00, outcome "recovered" (03May2022 at 20:00). Therapeutic measures were not taken as a result of vomiting, diarrhoea, abdominal pain upper, headache.  No follow-up attempts are needed. No further information is expected.
Cellulitis right arm. Dicloxacillin 250mg qid x 10 days, started 4/6/06.
Bleeding after administration - a first. Around 2 days later discoloration at injection site the size of silver dollar. Red mark with light green on edges. Using vitamin E. Has taken Flu vax since 1989 with no problems.
The only time I got the flu is when I got the flu shot; Initial information was received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who reported that, the only time I got the flu is when I got the flu shot (influenza), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) (lot number, expiry date and other dosing details were not reported)  for prophylactic vaccination.  On an unknown date in 1979, patient had flu (influenza) (unknown latency), following the administration of INFLUENZA VACCINE. It was reported that  the only time had flu to the patient after flu shot and did not had the shot since and di d not had the flu since.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
Headache, NauseaVomiting, Back ache, fatigue Narrative:
Information has been received from a 68 year old female patient with breast cancer, atrial fibrillation, cardiac valve leak, neuropathy peripheral, sulfonamide allergy, penicillin allergy and allergy to other unspecified medications and a history of shingles who in November 2007, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # not provided). Concomitant medication include unspecified heart medications. After she received vaccine she experienced an area of her skin became inflamed but shingles never broke through the skin. She reported that she had a history of peripheral neuropathy in her fingers and toes but it went away in June 2008 and she felt that vaccine caused it to get better. She also reported that ZOSTAVAX (Oka/Merck) helped her "to get over atrial fibrillation". "Echo test" was performed, but the result was not reported. At the time of the report on 12-JAN-2008 the patient was not recovered. The patient sought medical attention with physician. Additional information has been requested.
1055 S/p vaccination reports "feels anxious"  w/associated palpitations and "feels like sugar is going down" Medical monitoring begins x 30 min, vitals assessed; BP 140/85 P137 RR 19 Po hydration offered/ given; symptoms improve during this time 1115  BP 145/80 P89 RR 18
I got a flu shot (unknown type) and first of two shingles vaccines at same time. By mid afternoon the next day -26 hours later, I had a headache and profound fatigue which lasted about two days. I took over the counter pain meds, and skipped all non-work related activity in favor of sleeping. The injection site was also quite sore from 12 hours after shot to about 2 days out. Feeling much better by now (day5) but now I have a sore throat- most likely unrelated and just the start of a cold.
Flu-like symptoms, fever, nausea, chills, sweats, aches, restlessness, pain.
Fever, body aches, fatigue, headache, red injection site reaction measuring 5.5? x 7.5? that was also swollen, painful and itchy. Sick for 1 1/2 days. In pain 7 days.
p/vax pt exp inflammation of soles of the feet w/burning & redness;pt had great distress walking & could not wear shoes;
hive devel @ MMR site;w/in 5min of inj oral DPH given;
3/28/21 patient states site of injection got red swollen  4/2/21 she started experiencing facial numbness
ABDOMINAL PAIN MENTAL HEALTH ISSUES  PTSD HYPERVIGILANT PANIC ATTACKS SUICIDE IDEATION EXTREME FATIGUE BED BOUND 48 HRS LONG TERM LOST 20 LBS LOSS OF APPETITE  DEHYDRATION BODY VIBRATIONS SITTING TO STANDING CAUSES DIZZYNESS CANNOT STAND FOR LONG PERIODS  FREQUENT URINATION.
Headache, Myalgia, Diarrhea, NauseaVomiting, congestion Narrative:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patient who received SHINGRIX for prophylaxis.  On an unknown date, the patients received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was speaking with his pharmacist about side effects to SHINGRIX and the pharmacist told him that several of his patients had complained about a sore arm after getting SHINGRIX. This case is 1 of the 4 cases reported by the same reporter.
Lightheaded, BP 111/66 (pulse 89). Apple juice given - unwell prior to vaccine (nausea, vomiting, lightheaded).
Immediately after recieving vaccines, developed some redness at injection site and a single urticarial plaque.  Benadryl given.  Observed patient in office for 15 minutes without any additional changes.  No breathing difficulties.  Have called to follow-up but not yet reached the family.
Child was given Tdap instead of Dtap. And was given Proquad and Varicella.
Patient reported swelling of arm 10-20 minutes after administration. While at home, patient became nauseous, fainted & began vomiting. She called EMS who took her to hospital. She reported hospital did not treat her for allergic reaction.
vaccine given that was expired, put in fridge 1/14/23 BUD 2/13/23
inflammatory nodules; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced inflammatory nodules on an unspecified date. Therapeutic measures were taken as a result of inflammatory nodules. Outcome of the event was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Headache, loose bowel, nausea.  Felt good the next day.  But Saturday (10/1)  am woke with sore arm, very red and hot below the injection site
Episode of limpness requiring a call to 911. The patient was seen here on Monday (01/04/2016) for a well check and received his DPT, Prevnar, Hib and Rotateq in the morning. According to mom he went home and had no fever but was more tired than usual. On 01/06/16 during a.m. feeding, he acutely vomited a large amount and had watery diarrhea. At that time he became extremely fussy and inconsolable for about 5 min then he went limp and was unarousable but was breathing shallowly. The parents called 911 and in the meantime tried to arouse the patient he did not arouse until mom says she put some ice on his legs. There estimation of the amount of time between the vomiting and the end of the episode was about 10 min. The EMTs came and did an EKG which they state was normal but they did not take him to the hospital. He had no fever last night and had no new movements during the limp episode. He has been well since the episode without any fever, vomiting, diarrhea. He has been feeding his normal.
She got the first one and then she got Covid.; She got the first one and then she got Covid.; This is a spontaneous report from a contactable consumer (reported for her aunt). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced got the first one and then she got COVID. She said that she had registered her aunt to get that vaccine. She asked, what does she do about her second dose. Caller thinks that, the patient was still having the symptoms. The patient was scheduled for the 16th. Caller asked that, would she contact pharmacy to reschedule. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to a 5 year old female patient. On 18-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010458:
Pediatric Patient Received Dose of Heplisav-B; Initial Report Received on 19-Jan-2022   A nurse practitioner in the reported that a 6-month-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported. Allergies were unknown.   No concomitant medications were reported.   On 19-Jan-2022, the patient received the first dose of HEPLISAV-B (Lot # 934975, expiration date 13 Aug-2022, and NDC # 43528-003-05) in the right thigh by a medical assistant. No adverse reactions were reported. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Ulceration inside mouth,Painful small (oral) ulcers; paintful ulceration; swelling in one area of the mouth; tiny blisters in various stages; Painful peeling lips; Cheilitis; Burning oral mucosa; "moderna arm" (right arm) 12inch long red, indurated area; This spontaneous case was reported by a nurse and describes the occurrence of MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area) and ORAL MUCOSAL BLISTERING (tiny blisters in various stages) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), CALCIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area). On an unknown date, the patient experienced MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), ORAL MUCOSAL BLISTERING (tiny blisters in various stages), LIP EXFOLIATION (Painful peeling lips), CHEILITIS (Cheilitis) and ORAL DISCOMFORT (Burning oral mucosa). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (Ulceration inside mouth,Painful small (oral) ulcers), MUCOSAL PAIN (paintful ulceration), MOUTH SWELLING (swelling in one area of the mouth), VACCINATION SITE REACTION ("moderna arm" (right arm) 12inch long red, indurated area), ORAL MUCOSAL BLISTERING (tiny blisters in various stages), LIP EXFOLIATION (Painful peeling lips), CHEILITIS (Cheilitis) and ORAL DISCOMFORT (Burning oral mucosa) outcome was unknown. Not Provided      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.   Treatment included Cortisone cream on the lips and Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-067676 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067676:Crosslinked with dose 2
A few hours after vaccination, I began to feel like I was getting ill, with fatigue and headache. I also experienced swelling at site of injection, along with hives on my face and neck on the same side as the injection. I had swelling in my neck, throat, tongue, lips, ears and eyes with some tingling. There was a red pallor on both of my cheeks. I also had slightly labored breathing. I took antihistamines and tylenol which helped reduce the symptoms within an hour. If I did not continue to take these round the clock for the next 4 days, the symptoms would get worse. Toward the end of the day, symptoms worsened regardless of antihistamine or tylenol and continue to do so as of yesterday, 1/3/2021. Symptoms have gotten better over the last 4 days. Its hard to say if I am fully recovered as in the evenings when I'm more fatigued, I still have the tingling and mild swelling although the redness and hives have abated.
patient was administered the first dose of GARDASIL 9 when the patient was 13 years old and was administered the second dose of GARDASIL 9 when the patient was 20 years old on unspecified dates; No adverse effects were reported; This spontaneous report was received from a physician concerning a 20-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  The patient had the 1st dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, and frequency were not provided; lot # and expiration date were unknown) was administered intramuscularly for prophylaxis, when the patient was 13-years-old.  The patient's 2nd dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, and frequency were not provided; lot # and expiration date were unknown) was administered intramuscularly, when the patient was 20-years-old (Inappropriate schedule of product administration). No adverse effects were reported and no additional information was provided.
This is a spontaneous report received from a contactable nurse (patient). A 65-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL 3249) via an unspecified route of administration in left arm on 27Jan2021 at 12.30 as 2nd single dose for COVID-19 immunisation. The patient had other medical history. The patient concomitant medications were not reported. The patient had no allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9213 and expiry date was not reported) in left arm on 06Jan2021 at 08:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not have COVID-19 prior to vaccination. On 28Jan2021 at 04:00 (16 hours after second dose), the patient experienced fever 101 (unspecified unit) chills, joint aches and headache. The fever was lasted 12 hours, even though taking Ibuprofen and TYLENOL for the event. No symptoms were appeared after 30 hours post 2nd injection. Low grade temperature 99.5 and chills was showed 48 hour later. The patient was not tested for covid post vaccination. The outcome of the events was recovered on an unspecified date in Jan 2021. Follow-up attempts are completed. No further information is expected.
post vaccine complained of headache, dizziness and itchiness for 5 mins. Patient recovered, Normal V/S.  Zyrtec PO given
This is a 55-year-old male with PMH of HTN, DM, CHF, COPD - dependent O2 at 2L/nc , atrial fibrillation, obstructive sleep apnea on CPAP, lupus, bipolar disorder, chronic pain, osteoarthritis, hypothyroid who presents to ED with complaints of worsening shortness of breath associated with productive cough with white phlegm and headaches x 2 days.  Denies fever or chills.  Reports generalized body aches/malaise.  Denies abdominal pain, nausea or vomiting.  Was hypoxic with O2 sat of 78% on RA upon EMS arrival; oxygen saturation has improved to 94 when place with oxygen inhalation.