chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to clinic for 2 year wcc.  Dr checked his vaccination records on his ECW visit screen, and it appeared that patient recieved only 1 dose of Hepatitis A vaccine.  Dr ordered another dose of the vaccine, which was given. When the Medical Assistant printed the "immunization record" page to give to facility, she noticed that this was the patient's third dose of Hepatitis A.  She informed Dr who was able to explain the situation to the patient's parents before they left the clinic.  This RN informed the manufacturer, who did not have any information regarding 2 doses of Havrix.  Was referred to the Centers for Disease Control and Prevention.  This RN wrote the following email:   To Whom it May Concern,  I was given this email address by a GlaxoSmithKline representative in order to investigate adverse effects related to a third dose of Havrix Hepatitis A vaccine (720EL.U./0.5ml).  I am an RN at a public health clinic, and a 2 year old patient of ours was given 3 doses of Havrix - at ages 1 year, 18 months, and 2 years.  The patient was given the third dose yesterday and did not have any medical issues immediately after the third dose was given.  I spoke with the GSK representative in order to determine if there are any known adverse events associated with a third dose.  I was told that they had no studies regarding 3 doses for children, and that you may have more information.  If you can provide me with any information regarding 3 doses for pediatric patients, it would be helpful.    Please let me know if you need any more information from my end.  Thank you,  and recieved the following response:  We don't have any data on this issue. But hepatitis A vaccine is an extremely safe vaccine and this sort of thing happens all the time without incident. Also keep in mind that we routinely give 3 doses of hepatitis A vaccine as Twinrix (although to an older age group).   Centers for Disease Control and Prevention  Supervisor and Dr were made aware.  In order to attempt to prevent the same issue in the future, we have asked that MAs print out the vaccination records of patients so that the providers are able to see more clearly which vaccines have been given.
Error of administration, a PPV23 vaccine was administered to a 2 months old patient.  No adverse event was observed or reported.
Started out with a temperature, I had a really bad headache, my blood pressure had shot up. I became incoherent my coworkers called an ambulance, and I ended up being admitted overnight for observation. My temp wouldn't go down it was 104.
Large lump at the injection site developed 24-hours after the injection. The large lump was swollen and tender and painful at first, then 48-hours later it started to itch A LOT.   I've also experienced a headache, body ache and chills, and was very tired. Slept a lot.
sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.
Area of redness noted around injection site on Friday, 3/20/20. Raised patches appeared in center redness on 3/23/20. This worsened with expanding redness with 3 distinct circular pustules in center of redness on 3/26/20. Photos were taken and examined by Dr. on 3/26/20. Diagnosis of cellulitis made and cephalexin 25mg/kg X10 days prescribed.
pt devel hives p/flu vax (16 min post vax);tx epi & DPH;
now positive and are sick; now positive and are sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "now positive and are sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive and are sick. caught COVID from her.  Clinical Course: He has a patient on the line and the patient was called regarding Paxlovid and he was prescribed Paxlovid. Report 4. He said what was really strange was his family and sons and daughter all went to withheld for a wedding and he stayed there to take care of the dogs. They got back the first day they all were fine and the next day literally out of a group of 7 people 5 are now positive and are sick. His wife came back in the house and they are together and obliviously caught COVID from her and his symptoms and her mother and aunt and stuff there are vaccinated and sick as a dog and coughing, hacking, fever, tired and his wife is now at her mothers house and sick too trying to help each other. son has it and not as bad. Caller declined report on mother, aunt and others and said it would take all day. He said at the end of the day does he need to contact his doctor and he said he obliviously should not take the pills and asked for call handlers opinion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Individual developed severe body aches,  severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021.
Severe pain left arm and shoulder starting the day after injection pain still active in the same area. Injection was given in my right arm. Went to my PCP has EKG and blood work no issues reported.
pt c/o nausea & dizziness; nurse went to pts home 9PM; pt told had not had anything to eat all day & felt that was the reason was not feeling well;
Information has been received from a nurse practitioner (N.P.) concerning her 5-year-old granddaughter who on an unspecified date "probably at the recommended age" was vaccinated subcutaneously with a 0.5 ml dose of MMR II (manufacturer unknown).  "Within the last day or 2, on approximately 20-MAR-2007, the patient experienced "fifth disease" and strep throat.  Unspecified medical attention was sought.  No outcome was reported.  No product quality complaint was involved.  It was reported that the patient's mother is now 36 weeks pregnant and the N.P. is concerned about the risk of the mother's contact with the patient.  Additional information has been requested. 04/03/2008 Left upper arm erythema and swelling within hours after receiving DTAP. Over next 48 hrs. redness, warmth and swelling increased to a 9x9 cm cellulitic appearing area. 05/30/2008 No additional information is expected.
Syncope.  Pt had syncope while ambulating to OBS area.  Pt denies injuries, A&Ox4.  Prior Hx of Syncope w/ vaccines. BP 97/60 HR 65 RR 20 -- > 101/67, 72, 18.  Patient stablized and released from vaccination site.
Patient was seen initially at the end of April for evaluation of a recurrent rash on the abdomen and legs. Rash first appeared 4/15/22. Within several days, it improved.  Received his scheduled infliximab dose on Wednesday, 4/20/2022 and on the next day, 4/21/2022, developed worsening rash on his lower extremities which spread to his lower anterior abdomen.  Biopsy was consistent with Leukocytoclastic Vasculitis. There were several factors that could have contributed including recent COVID vaccine, possible active IBD, drug reaction from Infliximab, and prior GI infection. His rash improved however he developed worsening proteinuria and elevated creatinine. Renal biopsy showed IgA nephropathy.
Coughing on 8/14 / 10am - gave breathing treatment Albuterol; no difficulty breathing; noticed rash on trunk area Tuesday morning. Came into office; examined and dx with probable contact dermatitis.
Large erythematous allergic reaction to (L) thigh 1-2 days after vaccine given. Instructed to do BENADRYL, cool compresses, call if not responding to med or worsens.
severe sinus like headaches come on in evening with severe neck pain.; hard to sleep; severe sinus like headaches come on in evening with severe neck pain.; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:30 at single dose (Lot # EL8982, EXP-20May2021) for covid-19 immunisation Medical history included Osteoporosis of spine, left thyroid removed, acid reflux. Known allergies: penicillin, latex. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, colecalciferol (VIT D3), omeprazole. The patient experienced after 2nd day severe sinus like headaches come on in evening with severe neck pain. Have had this for 4 nights, hard to sleep. Events start date: 20Jan2021 08:00 PM. Treatment included Advil (cold and sinus) every day to help. It did help, but did not like to take this type of medicine that often. No COVID tested post vaccination. Outcome of events was not recovered.
Injection site was itching; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided. No treatment is given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No information is provided in the attached document of the additional information. On 29-Apr-2021: Additional info-2
This spontaneous report as received from a physician refers to a male patient of unknown age with common variable immune deficiency. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX (Lot # not reported). The physician reported that on an unknown date, the patient developed progressive outer retinal necrosis (PORN), from which he subsequently went blind. The outcome of went blind and progressive outer retinal necrosis was unknown. Upon internal review PORN and blindness were considered to be important medical events. This is one of several reports received from the same source. Additional information has been requested.
Dizziness, fatigue, prolonged fatigue after. Agitation. Headache. Muscle ache. Feeling like blood was running cold, feeling faint. Lasting 4+ days.  Fatigue is still continuing, a week later.
expired dose administered to patient; Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022). On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist stated that, they shipped out 5 vials of the Moderna vaccine to one of their nursing home facilities on 29 Mar 2022 evening and stored them in the refrigerator. On 30-Mar-2022 morning, 3 doses of the Moderna vaccine were administered to 3 staff members at the facility. After administration, it was found out that the doses given had expired on 17 Mar 2022. At this time, no adverse reactions have been reported by the patient.  The vial was initially stored in the refrigerator on 29 Mar 2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Eruption of 2 seborrheic keratoses; hives-like rash with itiching and burning.  New one arising about once every other day; old sites remain visible
After receiving vaccinations patient "felt dizzy" hyperventilated and vomited. She was placed in supine position on exam table, cool compress applied to forehead. BP 84/54. Stated she felt better prior to leaving.
First Vaccine, BRVO in the right eye approx 1 week after injection. (sucks).; This is a spontaneous report from a contactable consumer (patient) reporting different event under the same suspect product. This is one of two reports. A 53-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 06Apr2021 15:45 (Batch/Lot Number: ER8729) at the vaccination age of 53 years old as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, Hypertension, High T3. Patient had allergies penicillin, Tetracycline, "Teramyacin". Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. The patient experienced BRVO in the right eye approx 1 week after injection. Therapeutic measures were taken as a result of the event and patient visited other healthcare professional office/clinic visit. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
He experienced hives next to right eye, was given ZYRTEC and applied hydrocortisone cream. Day 2 from vaccine he woke up with hives on his cheeks. There have been no environmental changes that would cause this. Day 3 from vaccine the rash had spread to his abdomen and thighs as well. The hives abated after given ZYRTEC and applying hydrocortisone cream. The rash is recurring and has spread each day to further areas including his shoulder blades, back, backside, sides of his mouth and his armpit.
loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then; Dose Number:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 08:30 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HYPOTHYROID" (unspecified if ongoing), notes: HYPOTHYROID; "PCOS" (unspecified if ongoing), notes: PCOS; "Allery to Penicillan" (unspecified if ongoing). Concomitant medication(s) included: WILD YAMS; MACA [LEPIDIUM MEYENII]; SOYA LECITHIN. Past drug history included: Amoxicillian, reaction(s): "Amoxicillin: Drug Allergy", notes: AMOXICILLIAN; Doxycycline, reaction(s): "Doxycycline: Drug allergy"; Cephalosphorins, reaction(s): "Cephalosphorins: Drug allergy", notes: Cephalosphorins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 25Feb2021, when the patient was 30 years old, for Covid-19 immunization, reaction(s): "Loss of smell"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 29Jan2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 08:30, outcome "unknown", described as "Dose Number:3"; ANOSMIA (non-serious), outcome "not recovered", described as "loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia.  Additional information : It was reported that patient had loss of smell after 2nd shot and was consistent issues since that second series, never recovered prior enhanced smell since then. No prolonged hospitalization, No Congenital anomaly/birth defect, No Disabling/Incapacitating and was not Life threatening. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Treatment received for the adverse event was nasal spray.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected
experienced a sudden pain to the forehead. Pain increased from 0-100 very rapidly, I became very nauseated to the point of having projectile vomit. Experienced blackout segments. Took 1 dose of 100mg Sumatriptan at about 930pm and tried to sleep w/the immense pain. Took 2nd dose at about 12am. Pain did not dissipate but fell asleep. When i woke up pain was gone but felt very sore, dizzy and disoriented. Fast forward to April 9th while laughing uncontrollably the right side of my face spasmed/cramped  closing my right eye and contracting my right cheek as if having Bell's Palsy. I have never experienced this before. Face did not continue to droop but has left a tick/twitch sensation under my right eye.
Patient experienced fatigue, headache, sore throat, swollen lymph nodes, rash, aches and pains in joints and stiff neck. She said that feeling better. But some symptoms come and go. She said she follow up with md. She said she had the virus a year ago. She said she followed up with the doctor, and they said to get the second dose.
Covid 19 test positive; Covid 19 test positive; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An elderly patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6200), in right deltoid, on 22Mar2021 as dose 2, single (Lot number: EN6208), in left deltoid and on 27Aug2021 as dose 3 (booster), single (Lot number: FD8448), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing); "CKD" (ongoing); "DM2" (ongoing); "CAD" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022, outcome "unknown" and all described as "Covid 19 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive.  Clinical course: Patient age at time of vaccination was 82 years. The Pfizer product had not a casual effect to adverse events. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications. Specific relevant test for thromboembolic events with thrombocytopenia was none. Prior vaccination (within 4 weeks) was none. Patient was given 2 doses of Pfizer Comirnaty booster shots on same day in office setting. One dose of 0.3ml given by Nurse (Name withheld) on 28Apr2022, lot FM9992 on RD. Subsequently ARNP, (Name withheld) was unaware patient already received vaccine booster and gave patient 2nd dose of vaccine, same lot FM9992 on RD as well.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event vaccination failure and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Information has been received from a 66 year old male in October 2006, was vaccinated with Zostavax. On 09-APR-2007 the patient experienced a severe case of shingles. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007, 6/22/2007. Information has been received from a physician concerning a 66 year old male with no known medical history who in October 2006 or November 2006, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot#653965/0622F). There was no illness at the time of vaccination. Subsequently the patient experienced a 'severe case of shingles'. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from the patient indicated that in October 2006 he was vaccinated with ZOSTAVAX (Oka/Merck) (Lot#652965/0622F) on 09-APR-2007 (also reported as 10-APR-2007) he developed a severe case of shingles and was in a great deal of pain. Additional information indicated that the physician saw the patient on 10-APR-2007 in the office. The vaccine was administered on 23-AUG-2006 at 11:00 (previously reported as October or November 2006). The patient ws prescribed VALTREX 1 gm by mouth twice a day. On 11-APR-2007 the patient phones the office saying the valacyclovir was helping, but could he have something for pain. The VALTREX dosage was increased to 1 gm three times a day for 7 days total, VICODIN ES one tablet every 4 to 6 hours was added. The patient was also taking unspecified vitamins and ANDROGEL at that time. Further information from the physician indicated that on 05-MAY-2007 the patient had a blood pressure of 130/83, pulse of 64, and body temperature of 96 degrees F. The patient had a diffuse erythematous maculo-papular rash with lesions on the chest, back, arms, and upper abdomen. Also noted was a keloid abdominal scar. The patient complained of trouble hearing and it wa noted that the patient had bilateral cerumen impaction in the otic canals which was treated with lavage. The patient received a dose of SOLU MEDROL 125 MG im for an unspecifed allergic reaction. Unspecified inflammatory enzyme studies were performed for the arthritis. It was previously reported that on 09-MAY-2007 the patient had recovered though in theses reports it appears to be ongoing. No further information was provided. This is a consolidation of 2 reports concerning the same patient. Additional information is not expected. It has been determined that WAES #0704USA01852 is a duplicate of WAES # 074USA06020. Therefore, WAES # 0704USA01852 is being deleted from our files and the reports consolidated into WAES # 0704USA06020.