chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose of Pediarix given; Wrong vaccination schedule; Wrong vaccination schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included PEDIARIX.   On 15-MAY-2023, the patient received the 3rd dose of Pediarix. On 13-FEB-2023, the patient received the 2nd dose of Pediarix. On 13-FEB-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: Wrong vaccination schedule). On 15-MAY-2023, the patient experienced expired vaccine used (Verbatim: Expired dose of Pediarix given) and drug dose administration interval too long (Verbatim: Wrong vaccination schedule). The outcome of the expired vaccine used, drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2023 The information about vaccine, patient and event were provided.  Even though the reporter did not provide information about the incorrect vaccination schedule, adverse event was collected. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.. The patient received 2nd dose of Pediarix earlier than recommended interval and 3rd dose of Pediarix later than the recommended interval after expiration date, which led to shortening of vaccine schedule, lengthening of vaccine schedule and expired vaccine used.
patient stated large red area from shoulder down to below injection site on administration arm and hives that developed 2 weeks after dose 1 of Moderna.
Case number PHEH2014US023110, is an initial spontaneous report from a consumer received on 17 Nov 2014. This report refers to a 22-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 13 Oct 2014. On the same day, after vaccination, she experienced swollen lymph nodes. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported.
During post vaccination observation period, reported feeling flushed & was hypertensive 220/90, no hives, facial swelling or difficulty breathing. Pt did not take her antihypertensive for 2 days. Transferred to ED, 1 dose of antihypertensive med (Toprol XL)  given and discharged to home.
Full DIsclosure: I am a volunteer patient of a specified state program, thus subject to tests required by them x 3 in a 6 month period. I had tests drawn for SARS - CoV-2 (Covid 19 total antibodies) and all three tests were Negative( Jan//April/July 2021). On July 15,2021 Covid -19 Spike Protein antibody test was Positive with quantitative level of 1360 Comment of "OUT of Range in graph.The Reference  Range was <0.8 null. Being a diabetic with CKD, I am being followed periodically n by an endocrinologist and a nephrologist. I had routine labs drawn in June 2021 in preparation for my July appointment with  nephrologist. My June 11,2021, GFR = 23.7. It had plummeted down from a test I had in March 2021,  NOTE ON ITEM 17: Second Shot was also intramuscular( DROP DOWN DOES NOT WORK)  Continuation of Item !8: Adverse Reaction. In June 2021 , My test was reported as Chronic Kidney Disease,Stage IV. In all the 12 years since my diagnosis of CKD,I was always in Stage III- B. A review of prior tests of GFR are as follows :My GFR= 36.7 in March 2021; GFR=36.7 in December 2020; GFR =33.8 in June 2020.. On the follow up visit , the nephrologist recommended: 1. DC Alendronate and RX Prolia 2. Increase po fluids 3. Suggested vegetarian diet 4. Restrict animal protein 5.Repeat test after one month f/U.  Follow labs are as follows: August 02,2021  GFR=29; Sept 21,2021  GFR= 30.8;  December01,2021  GFR =39.2 It took about 6 months and it was a slow rise of my GFR to the levels before I had the primary series of the Covid vaccines 1&2.. Although clinically, I did not feel a significant change, the effects it had on my GFR scared me to risk another Covid  injection especially since there are no significant studies done on this vaccine done on patients with chronic renal disease.Since my baseline levels of GFRs are already in the 30s, I feel I don't have enough leeways to play around with my already damaged kidneys
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017 (dose and route unknown). The vaccine was exposed to 35.3 degree Fahrenheit for 240 hours. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information is not expected as there was no consent to contact physician.
terrible aches all over; headache; there is something wrong with her smell/she can smell but things do not smell right; She has chills really bad; felt really awful; nausea; She had a fever; dry cough; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date:31May2021), via an unspecified route of administration on the left arm, on 22Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation from Nov2019, heart attack 2016, stent placed from 2016, and cardiac ablation from Aug2020. There were no concomitant medications. Patient had her first dose on 22Jan2021 and she felt all the side effects like nausea, fever, chills, headache on 24Jan2021 and wanted to know if that is normal. She also experienced dry cough on Jan2021. Patient reported she was fine and did not even feel it. She was fine that day and the next day. By the third day she started getting every symptom in the world. The one that really bothered her, and she cannot find any information on it was the dry cough. She was asking if dry cough is a reported side effect. She further clarified that the dry cough started either the same day she received the vaccine or the next day and all her other symptoms started on Sunday afternoon (24Jan2021). She had a fever and still has fever at the time of report, and had improved slightly since she takes Tylenol every 6 hours which was keeping the fever at bay. But her temperature was still over 100. She had terrible aches all over which has slightly improved and a headache (she does not think she has one now), and stated it had improved. The nausea was off and on and there was something wrong with her smell. She can smell but things do not smell right. She smelled something like gasoline earlier but she knew it was not gasoline. She thought about food and she wanted to gag, and her taste seems ok. She has chills really bad and clarified all symptoms aside from the dry cough started Sunday around 4 in the afternoon. She felt really awful and took her temperature and it was 101 on Jan2021. The chills are off and on and when her fever goes up, then her chills go up. Outcome of the events of nausea, chills and felt awful was unknown, for events dry cough and something wrong with smell was not recovered, and for the remaining events was recovering. Patient was asking if she somehow contracted covid in between getting her vaccine and now. She had a negative covid test a long time ago when she was going to have procedures done. She confirmed she has not had a covid test recently and stated it was just seems weird since she felt fine right after getting the covid shot.
Two days post vaccination, the patient developed hives on the lower torso. The hives resolved with treatment of Benadryl. The hives returned over the weekend and on 08/27/2001 woke up in the AM with swelling of her hands, feet, and some in the face and body.
At least a 50% increase in my chronic tinnitus. My bilateral tinnitus was for over 2 decades low level and easily masked by TV, music or conversation. After receiving my 1st dose, it became significantly louder and has not ebbed from my initial dose.
Heart palpitations; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event heart palpitations was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
BODY ACHES; WEAKNESS; CHILLS; FATIGUE; FEVER; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: amoxicillin sodium/clavulanate potassium ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin were not reported) dose and frequency were not reported from 18-MAR-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with amoxicillin sodium/clavulanate potassium was not reported. The patient had not recovered from fever, chills, body aches, weakness, fatigue, and headaches. This report was non-serious.  Additional information was received from patient on 26-Mar-2021. The following information was updated and incorporated into the case narrative: Events (fever, chills, body aches, weakness, fatigue, headaches) added, event "side effects" removed. Upon review, the following information was amended: Drug "Amoxicillin-Clavulanate" updated as co-suspect.
PINCHED NERVE; INTERVERTEBRAL DISC BULGING; VACCINATION SITE PAIN; INJECTION SITE PAIN; PAIN IN ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 162.56 centimeters. The patient's past medical history included: neck surgery, bulging disc/disc problems, and tobacco user, and concurrent conditions included: pain, abstains from alcohol, osteoporosis, borderline diabetes, arthritis, penicillin allergy, and unknown antibiotic allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 24-MAY-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) 150 mg, 1 time every 12 weeks, therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) Not provided. On 24-MAY-2021, the patient experienced pain in arm. On an unspecified date, the patient experienced pinched nerve, intervertebral disc bulging, vaccination site pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from pain in arm on 27-MAY-2021, and vaccination site pain, and injection site pain, had not recovered from pinched nerve, and the outcome of intervertebral disc bulging was not reported. This report was non-serious.
I tested positive for COVID; I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 22May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not reported. On 24Jul2021, patient was diagnosed with COVID. Patient had mild symptoms and loss of taste and smell. Patient stated symptoms were mild and was not in the hospital and the vaccine was not 100% effective to begin with, did not consider this an adverse event because it seemed like the vaccine worked like it was supposed to. It was not until patient saw the example in the note sent today (attached) then realized that a positive test (after both doses) was considered an adverse event. The patient underwent lab test and procedures included COVID test was positive on 24Jul2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-MAY-2015, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about MAY-2016, the female patient was treated (by an unspecified health care professional) at a medical center, and was diagnosed with Herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Information has been received from a physician and registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. There were no known symptoms reported. The incident was "due to human error". There was no further information provided. There was no product quality complaint involved. This is one of several reports from the same source. Additional information is not expected.
Right eye twinching; lightheadedness; rash on hands; Nausea; DOB; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BLEPHAROSPASM (Right eye twinching), DIZZINESS (lightheadedness), RASH (rash on hands), NAUSEA (Nausea) and DYSPNOEA (DOB) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy since January 2021.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLEPHAROSPASM (Right eye twinching) (seriousness criterion hospitalization), DIZZINESS (lightheadedness) (seriousness criterion hospitalization), RASH (rash on hands) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and DYSPNOEA (DOB) (seriousness criterion hospitalization). At the time of the report, BLEPHAROSPASM (Right eye twinching), DIZZINESS (lightheadedness), RASH (rash on hands), NAUSEA (Nausea) and DYSPNOEA (DOB) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events include 0.5ml Epinephrine on the left thigh  This case concerns an 18 Y/O F hospitalized with serious unexpected events of blepharospasm, dizziness, rash, nausea, dyspnea. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns an 18 Y/O F hospitalized with serious unexpected events of blepharospasm, dizziness, rash, nausea, dyspnea. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I passed out 12 hours after vaccine received while standing in the bathroom. This followed hours of terrible chills and muscle aches that I couldn?t sleep through. No medications were taken until after the episode and it didn?t happen again. I did not have a working thermometer so unsure how high my temp got. I peed myself when fainted. My husband was present to pick me up off the floor and luckily I didn?t hurt myself in the fall. I didn?t come to until he took me back to bed. I started feeling better a few hours later and much better by 24 hours. Now just lingering body aches and fatigue at 48 hours and still taking ibuprofen/Tylenol.
Onset of urticaria 5 days after the vaccine dose without obvious inciting event; patient has had near-daily urticaria for over one month since the vaccine up to and including the present.
Noticed redness in left breast , felt sore around collar bone, was able to express old blood from nipple. Soreness continues, assuming swollen lymph nodes
Tachycardia (146 on monitor but higher before evaluation), hypertension (BP 160/110), chest tightness, chest pressure, dyspnea, shaking hands (more severe than tremors), dizziness and visual distortions, slight LUQ pain on palpitation. Given IV fluids in ER, which lowered HR and BP, but both still elevated above normal range (HR in 100s and systolic BP 130 and higher). No medications were given. Continue to have periodical tachycardia and chest pressure with pain radiating to back and right shoulder. This pain began on 1/17/21, the day after vaccine was given. I have a sensation of not getting enough air, despite breathing normally. Mild headache night of vaccine and day after.
Information has been received from a pharmacist concerning a 28 year old female patient with diabetes, osteomyelitis and anxiety disorder who on 02-SEP-2008, while hospitalized for vomiting, diarrhea and dehydration was vaccinated with a dose of PNEUMOVAX (lot # not provided) by the intravenous route. After the PNEUMOVAX was given IV the patient had a red face, her oxygen went down to 90% and she developed chest pain. At the time of the report the patient had not recovered. The pharmacist reported that the patient's hospitalization was not prolonged because of her reaction to PNEUMOVAX vaccine. No further information is available. Additional information has been requested.
redness, warm to touch, slight swelling at injection site 48 hrs post injection red rash on neck and upper chest  48 hrs post injection fever 100, body aches, joint pain, and weakness 24-48 hrs post injection
Within 36 hours of receiving this  Pfizer booster shot I did not/could not wake up. My face and eye were droopy and the only way I awoke was my wife started to slap my face and I was not responding or getting up.  Spent four days in the hospital and was diagnosed with a  stroke.
For 4 days after vaccine I had trouble breathing with what felt like muscle spasms in my right side, rib cage, back side. On day 6 I had strange pains again but extended up my chest and neck tightening. Heaviness on my chest. Confusion, couldn?t get comfortable or catch my breath. Overwhelming feeling something was wrong. After 911 responders started monitoring heart I collapsed, heart stopped, they shocked me 3 times, took me to Hosp where cardiologist did angiogram and believes he saw 2 arterial dissections. Other cardiologist said he disagreed and it was Tokotsubo syndrome, broken heart syndrome, did Echo cardio grams and ECG?s. Put me on aspirin, Plavix, metropolol succinate, lisinopril. Gave me heparin shots to abdomen multiple times throughout the day. Stayed for 3 days. ECG?s all showed prolonged Q-T interval, Echo showed 40% heart function. My usual BP is 100-110/60-70. It was continuously very low, 60-80/25-45.  Angiogram  showed zero blockages, no plaque, later CT showed 0 Calcium score, no calcification in all the areas checked. I?ve always had great cholesterol levels (lol LDL, high HDL) low triglycerides, low healthy heart rate (in Hosp approx 45-55.) Two weeks after first Hosp Stay I went back in for another 3 days because of abnormal heart rhythms.
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 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local reaction consisting of increased warmth and lump at injection site; screaming episode for 6 hours, pre convulsive twitching and tremors following DTP/OPV immunizations