chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 64 year old female consumer with no known allergies or pertinent medical history who on 10-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included DIOVAN and LEVOXYL.  Approximately 15 minutes after vaccination on 10-DEC-2007 the patient felt off balance and experienced dizziness coughing, weakness and a drop in her blood pressure.  Medical attention was sought.  There were no lab studies performed.  The patient was treated with diphenhydramine hydrochloride (manufacturer unknown) which did not help her dizziness and weakness.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
This spontaneous report was received from a medical assistant concerning a patient of unknown gender who was currently 1 year old. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA 25/0.5, lot # N020689, expiry date: 22-OCT-2018 intramuscularly for prophylaxis (dosing details, anatomical location was not reported) (product storage error). The vaccine underwent temperature excursion of 10.47 degree Celsius for the time frame of 4 hours. There was no previous temperature excursion reported. Data logger involved. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA008484:
18 days after 2nd vaccination I started feeling intermittent paresthesias in my feet. These slowly progressed to my lower legs. After about a week I noticed numbness/paresthesias in my fingers and forearms. About a week later it progressed to my face and is now also in my oral cavity (teeth, tongue, and posterior oropharynx). The paresthesias have been accompanied with intermittent mild vertigo, headaches, mild shortness of breath, and palpitations.
As of 12pm on February 14th I was sleeping for work and woke to sever pain in my upper abdomen. I believed it was acid reflux and took anti nausea medication (Zofran) and then observed a few hives on the inside of my right arm. Over the next hour the rash spread over my entire body and began burning and itching. I took Benadryl and applied hydrocortisone cream and nothing helped. I then had to be at work and decided to fill this out since I believe it is a reaction from the vaccine.
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
This spontaneous report as received from a healthcare worker refers to a 13 year old patient of unknown gender. On 12-AUG-2014 the patient was vaccinated with the first dose of VAQTA adult dose (route not reported), lot # reported as 9654607 was not a valid lot number for VAQTA. No adverse symptoms reported. Additional information has been requested.
Pt developed hives on face 10 minutes post vax. Pt was treated with Benadryl and the hives resolved within 10 minutes.
From telephone contact received from the reporting nurse stated that a 5 year old old female patient received Tripedia vaccination, lot # UO320AB, on 06/12/01. On 06/14/01, the patient developed a local reaction of redness and swelling. The patient's mother was instructed by Health Department to treat the reaction with ice packs. On 06/17/01, Health Department was Notified that a large knot developed at the site and the redness increased. a physician did not evaluate the patient.
infected by covid on 07Jan; infected by covid on 07Jan; This is a spontaneous report from a contactable Other Health Professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was infected by covid on 07Jan2021 and tested positive for COVID-19 on 07Jan2021. She was given Zanamivir (was not able to verify) on 12Jan2021, started with Bamlanivimab antibodies treatment on 12Jan2021 and has fully recovered from COVID in Jan2021 since then as it was a mild form only. The patient would like to get the second dose as soon as possible, second dose of the vaccine was scheduled for 12Jan2021. She is looking on guidance on pursuing the second dose of the vaccine. Serious: No.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  This case will be reassessed once additional information is available.
On 8/29/01, mother noted redness and hives around the injection site, progressing to hives all over the child's body, over the next 8 days. Seen today in the clinic. No other explanation for urticaria. Rx'd Benadryl.
This spontaneous report was received from an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # K007974, expiry date: 03-JUN-2016) (incorrect product storage). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
initially felt very nauseated, later that day had cold chills, felt like she had a fever, always runs 96.6, temp was 99.5, went to bed, woke up thru the night with 'restless legs' could not get comfortable, joint/body pains, fatigue, as of today 2/1/21 still has joint pains and restless leg syndrome, needs sleep aids, taking several supplements for inflammation, omega 3, turmeric, vit C, apple cider vinegar, Tylenol and Advil (starting to upset stomach), going to MD this week
2 weeks following vaccination first symptoms of obsessive-compulsive disorder appeared in patient. According to psychiatrist following patient, it's very likely vaccine triggered the disease.  12/17/2007 MR received for DOS 01/8-17/2007 with D/C Dx:  Obsessive Compulsive disorder.   In September 2006 pt began having intrusive thoughts about being unclean and needing to wash.  Pt washing hands ~12x/day for 5-10 minutes, and symptoms cause pt great psychic stress. Pt having difficulty concentrating and school performance had declined. (+) depressive sx. Pt to f/u as outpt  Per 60 day follow up: Patient is still on medications and strict care of the psychiatrist. Receives psychotherapy.
Rapid onset vaginal yeast infection; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 13Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient experienced rapid onset vaginal yeast infection on 16Jan2021 12:00. It was treated with Diflucan. The patient reported that she gets this reaction when taking antibiotics but the only thing she received was the vaccine. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
rash suspected shingles; rash suspected shingles; high fever (107F); This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles, rash and fever. On an unknown date, the outcome of the shingles, rash and fever were unknown.   It was unknown if the reporter considered the shingles, rash and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient had the 1st dose vaccine and developed high fever and rash suspected shingles. The reporter asked does patient need to take the 2nd dose of Shingrix.      Lab Comments: On an unknown date body temperature was recorded
pt recv vax in FEB96 & on 16DEC96 pt devel chickenpox on trunk, stomach, back, head & diaper area;
Pt recvd vax on 30JAN92 & 24 hrs later devel sudden onset of back pain, perspiration, nausea, vomiting; pt hospitalized & dx w/stone in the common bile duct; also splenomegaly & sepsis devel to disseminated intravascular coagulation, serum
sore arm when touched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Apr2021 12:30 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergies" (ongoing), notes: Environmental allergies; "Low Vitamin D" (ongoing); "High Blood pressure", start date: 09Jun2007 (ongoing); "Hypothyroidism", start date: 05Sep2008 (ongoing); "High Cholesterol", start date: 09Jun2007 (ongoing); "Anxiety", start date: 03Mar2010 (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ATENOLOL taken for hypertension (ongoing); SERTRALINE taken for anxiety (ongoing); ALLER TEC taken for hypersensitivity (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm when touched".  The lot number for bnt162b2 was not provided and will be requested during follow up.
I noticed a lot of glares at night when I was driving home from work, and it just got worse and worse. I was also seeing double and triple vision. I contacted my doctor and the diagnosed me with Cataract's. I recently had surgery to remove the Cataract's and replace with a lens. I am still healing from surgery, so I don't know if it is better now or not.
Patient fainted after the shot. Her chin hit the carpet and started bleeding. Friend was in the room when it happened. We claimed up her wound and she felt better. Patient then went to  get stitchings.
Information has been received from a physician concerning a male who in June 2007, was vaccinated SC with a dose of Zostavax.  In July 2007, the patient developed shingles.  It was reported that the patient's wife also developed shingles after vaccination with Zostavax (WAES #0710USA03384).  The physician stated that the patient had more severe case of shingles as compared to his wife.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
Patient had 1st dose of Pfizer Covid vaccine and on the same day the pt reported light spotting and cramping. These s/s were limited to only that evening of vaccination and resolved by the following day. Gestation age at time of vaccination =30w4d, EDD 11/05/2021.
during course of administration some of the vaccine leaked out of her arm; during course of administration some of the vaccine leaked out of her arm; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (during course of administration some of the vaccine leaked out of her arm) and VACCINATION SITE DISCHARGE (during course of administration some of the vaccine leaked out of her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (during course of administration some of the vaccine leaked out of her arm) and VACCINATION SITE DISCHARGE (during course of administration some of the vaccine leaked out of her arm). At the time of the report, UNDERDOSE (during course of administration some of the vaccine leaked out of her arm) and VACCINATION SITE DISCHARGE (during course of administration some of the vaccine leaked out of her arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
I woke up at two AM in the morning and I was dizzy when I got up later that morning at four or five am I could not get out of bed as I was so dizzy.  I called the Doctor and so my a NP later that afternoon.
had covid; had COVID; my legs were normal for about 5 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vascular ablation", start date: 2017 (unspecified if ongoing), notes: about 2017 I had vascular ablation in both legs to relieve this.; "extreme swelling in my ankles" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "my legs were normal for about 5 months"; COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "had COVID"; DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: In Jan2022 had Covid.  Clinical course: The patient has extreme swelling in ankles and in about 2017 had vascular ablation in both legs to relieve this. Did not work and legs started swelling as well. Had Covid vaccine in Apr of 2021 and immediately legs were normal for about 5 months (counting second vaccine in May). In Jan2022 had Covid and legs went back to normal for about two months. The patient has not gotten the booster because do not believe it was good but would be willing to be helpful in you developing something that. Event Awareness Date was 02Oct2022. Number. Date Sent toRegulatory Authoritywas 03Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
48 hours after injection patient developed severe and palpable cystic nodule in supraspinateous and trapezious muscles of left shoulder, which did not respond to heat, massage or ultrasound. On 10/18 she was seen  in ER for pain and prescribed prednisone p.o. and released. 4 hours later at about 5:30 PM she became pale and nauseated, resulting in a large (~1 liter) cloudy yellow emesis. 30 minutes later she had massive complete loss of bowel and bladder, and became obtunded. EMT had to be called   resulting in TX to ER where she was hypoxic, hypo- then hypertensive. Cath urine on the 10/19/2021 showed coffee-colored urine, heme negative,  She also had elevated CK, K+, creatinine, and heme positive stool.. She was treated with positive pressure mask O2, IV with insulin, and admitted to the ICU. The painful nodules in her shoulder were seen on US  but not identified.
I had the shots and got it./ Suspected vaccination failure; had the shots and got it; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 20-Jun-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the shots and got it. It was not bad and no blister or rash. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Received vaccine around 4 PM and he woke up around 9 PM and was screaming and when I got him out of his crib, he was twitching (head and arms).  I gave him Tylenol and about 45 minutes later he wasn't twitching.  He didn't have a fever and was lucid, but I have never seen him twich like that before.  No changes in behavior noted, however, it was only 3 days ago.
It was probably mid-morning, just a general ill feeling. Low grade fever. By lunch time that day, I had lunch around 1:10PM and for 30 minutes I slept because I felt bad. I needed to rest. I slept during lunch and got back up and finished working. At 4:20PM, I got off and had a fever of 102. And took Tylenol and went to bed early. By the next day, I was feeling fine.
Pt says she experienced chills, nausea, achiness from the shoulders up, exhaustion and swollen left arm (knot at injection site).
Quick onset of muscle spasms in bilateral temples and around bilateral orbits, sore throat, malaise, excessive fatigue, worsening migraine headache over one week until seen in clinic and received prescription for IMITREX tablet.
Woke up not wanting breakfast, when she did eat she would complain of her stomach hurting.  Complained she didn't feel like eating, not hungry (this is not like her).  Now stating she does not feel good over all.  Under eyes are grey, over all deminished affect.
This spontaneous report as received from a nurse refers to a child patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-JAN-2013 at 2 years of age, the patient was vaccinated with the first dose and on 01-APR-2013 with the second dose of PROQUAD (Merck), 0.5 ml, subcutaneously, lot # reported as H015637, expiration date: 23-FEB-2014. No adverse effects were reported. Additional information has been requested.
Extremely sore injection site(much worse than previous Covid injection vaccine) or flu vaccine. Body aches extremely tired, fever, chills, upset stomach, diarrhea .
On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 18-Aug-2022; No adverse event; expired Moderna Covid-19 vaccine (Monovalent) to 27 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 18-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2022 at 8:47 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022 at 8:47 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 18-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 18-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (Monovalent) to 27 patients) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 18-Aug-2022).    No concomitant medications was reported.  On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2022: Follow-up received contains significant information accepted as patient details updated and dosage regimen updated (vaccination date, dose number and batch number).
Shortness of breath; Body Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and PAIN (Body Pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and PAIN (Body Pain). At the time of the report, DYSPNOEA (Shortness of breath) and PAIN (Body Pain) 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 medications were reported. No treatment medications were reported.
pt recv vax;mom reported events to clinic;mom said found pt having a sz at 9am;mom observed pt's eye rolled back & pt was not breathing;to EMA station;was feverish;to er;inc T;dx as mild ear infect at hosp;PMD said immun spiked a fever;