chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error 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: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The vaccine administration facility was the same as primary reporter. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKilne). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. Case A0722975A serves as the master case. The other case numbers are A0722979A, A0722980A and A0722981A. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFNARIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who reported limb swelling in a 6-month-old subject. The physician believed there was a problem with this particular lot of INFANRIX.
Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before.     On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 55 years 09 months. No concomitant medications were reported It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. No treatment medication were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.
dizziness, nausea, chills in the morning 28AUG92 diarrhea; PM felt fine;
Received DTaP on 3/14/11. Returned to office on 3/16/11 with (L) arm - red, swollen, hot to touch x 2 days. Had 11cm x 8.5cm red, firm, slightly indurated area to (L) delt area.
4/28/2000 C/O numbness to right lateral lower extremities. Numbness still present
I received my second Moderna booster for COVID-19 at some point in July 2022, though I do not recall the date. On 10/2/2022, I took a domestic flight on a commercial plane and returned home on 10/11/2022. On 10/11/2022, I had a mild cough. The cough continued, and I took some OTC DELSYM a few days later. The cough improved and it was better by 10/14/2022. I took 2 home antigen tests during this period and got a negative result both times. I also began sneezing a lot, and my sneezes were very loud and strong, which is unusual for me. However, I did not experience fever, runny nose, or body aches. A few days later, the cough returned. It wasn't a severe cough, but I started to feel a little tired. I also noticed that when I slept at night, I had a little bit of mild nasal congestion. Whenever I woke up in the morning, though, the congestion would be gone, but I would always be tired afterwards. On 10/21/2022, after the fatigue became more noticeable, I took another home antigen test and got a positive result. I then took a second home antigen test immediately afterwards just to be sure, and it also yielded a positive result. I called my doctor and saw her the same day. She prescribed me a 5-day course of antibiotics instead of antivirals for the COVID-19. She also prescribed cough drops, which I was reluctant to take at first, but I began taking them after my cough worsened. The cough drops did not help, and I continued to cough more every day. I self-isolated at home and tried to drink more water and rest more. On 10/26/2022, I took another home antigen test and got a positive result with a very faint line. On 10/27/2022, I took yet another home test, and it yielded a negative result. At the time of this writing, I no longer have the fatigue from COVID-19, but I still have an occasional lingering cough.
his initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 2014, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as 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. Causality assessment was related. Additional information has been requested.
Patient said symptoms started about 10 pm the night of the first dose, and she "felt fine" around noon the next day. In addition to fever, HA, aches, and chills, she also experienced a dry mouth.
I starting feeling SOB, light-headiness, and dizziness.  I starting having leg cramp that would not stop. It move from my legs to my hips. I could not stand without getting SOB. I went to the ER on Feb. 21st. They did chest x-rays, EKG, CT scan, blood work, lung and heart ultra sound, it show that I had blood clots in both lungs. My heart was okay. I also got pneumonia.
received first dose of Havrix in 2019 / never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in 2019).   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the booster dose of Havrix, which led to incomplete course of vaccination. Patient requesting for 2nd dose is was it advisable to give. No other details of vaccine available. The reporter did not consented to follow up
This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date since 26-NOV-2014, the patients were vaccinated with an incorrect storage doses of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported). No concomitant medication was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reported palpitation had to go to ER, they cleared her stating it isn't from the vaccine. Pt reporting fever 100 degrees and also feel tired and lethargic.
Patient presented with increasing shortness of breath and acute hypoxemic respiratory failure on chronic hypoxemic respiratory failure.  She is placed on IV Solu-Medrol twice daily as well as doxycycline for antibiotics and regularly scheduled nebulizers. Treated and discharged. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patients states she had lip fillers about two years ago. Patient reported lips feeling warm and swelling. Patient had slight itchy in throat and eyes. Benadryl 50mg ordered by Dr. and given to patient. Patient stayed about 40 minutes and was able to leave clinic. Patient advised any worsening to go to ER or call 911. Patient has epi pen and Benadryl at home.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. In approximately 2015, reported as on multiple unspecified dates ranging from 15-OCT-2015 to 06-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL injection (lot # K006191, expiry date 02-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Day 7 - Fever 101 degrees/diffuse myalgias/"flu" feeling.  Day 9 - 51 itchy red spots over chest, abdomen, back and lower neck.  March 3 - Day 10 - "sore muscles" and fatigue.  No fever.  No new skin lesions.  12 of the 51 extra-site lesions became pustules (2-4 mm diameter); the other appear to be fading.  Left arm swelling and area of erythema have decreased.  Two pustules were opened and cultured for vaccinia.
On April 13 2021, my right arm started to bruise close to the shoulder; On April 17 2021 I started with my period, with an extremely heavy flow, by April 22 2021 I got another bruise for no reason on my fore arm and red dots started to appear on my arms, left ear bulb and chest, by April 23 2021 I still had a heavy period, (my period lasts only 3 days and only first two days is extremely heavy)On Friday, April 23 2021, I went to see the doctor to verify what was happening to me, they took blood tests and they told me that on Saturday (April 24 2021) they would tell the result. On Saturday April 24 2021 they call me earlier morning from my doctor's office to let me know that I had to run to the emergency room because I was bleeding to death. In emergencies they tell me that my platelets were very low, the Hematology, Oncology. Asked me a series of questions to verify the reason for the loss of my platelets. He treat me with platelet infusion and iron infusion because I had anemia (Caused by the low platelets). I was hospitalized from April 24 2021 to April 26 2021, they managed to stabilize my platelets. On May 6 2021 I had another appointment with Hematology, Oncology, they did laboratory studies and in the afternoon of that same day he spoke to me to tell me that I had to go back to the emergency room because my platelets had dropped again. At the emergency room They gave me an infusion of immunoglobulin (IVIG, two bags of 1g/kg ) and more iron IV, I had to stay in the hospital from May 6 2021 to May 8 2021, they sent me steroids and they have been treating me as ITP (Immune thrombocytopenic purpura) ever since. Since that day I have to go every Friday to have my blood drawn to check the platelet count, this has all happened after I received the first dose of  pfizer vaccine of covid 19, during the time of the pandemic I have not caught COVID to date, Before this vaccine I was healthy.
I had body aches. A few days later I had a headaches. My arm was sore at injection site.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 18-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd DTP/OPV/HIBtiter on 19DEC90; Pt began exp infantile spasms on 11FEB91; Seen by neurologist; EEG confirmed infantile spasms; No tx initiated; Cat Scan scheduled for 25FEB91; Update on 21MAR91 pt treated w/ACTH inject;
The Patient is a Marine Corps recruit and inadvertently received a second Covid-19 vaccine dose. This facility on administers the Moderna vaccine.   The Patient received his first Moderna vaccine dose here after being screened by our staff, but it was discovered that this was his second dose - the first dose being Pfizer and receiving that dose on 02 Feb 2021. The paperwork  was turned in after receiving the dose and the secondary screening  team then noticed the previous dose documented on the paperwork. Staff were notified and the Patient was monitored for 30 minutes, no adverse reaction was noted by the patient or the staff.
Pt. became pale, and then fainted - after last vaccine was given (approx 5 min - after last given). Had pt. lay down. B.P. 124/71, pulse reg. 70 at 11:25. Gave juice & crkrs. At 11:32 B.P. 131/78 P. 80.
pt exposed to chickenpox & recv vax 3SEP97 & pt became pregnant;pregnancy was confirmed by urine HCG (LMP 2AUG97);estimated date of delivery is 10MAY98;5SEP97 to 6SEP97 devel varicella-like vesicle on legs;
Right ear started ringing suddenly Friday may 14 2021 as I was sitting down at my computer after work. It has been growing in intensity over time since then, and on may 25th 2021 I went to urgent care, advised them I thought I may have a wax or ear infection problem and was prescribed  "ofloxacin 0.3% otic solution commonly known as: FLOXIN" and have been taking the daily drops. The ringing is getting worse and the only thing I can think of that changed in my life recently was the vaccine. I no longer suspect ear infection as I have experienced those before and never taken this long to recover, much less getting worse while taking medication. My day to day life otherwise has been the same. The ringing is so deafening now I cannot sleep and I wanted to make record of this before seeking additional medical help in the morning.
After administering the shot, an immediate wheal reaction developed. It grew to about an inch and a half in diameter, red surrounding area. Administered 50 mg BENADRYL and iced the area for approximately 10 minutes. Area stabilized and no further reaction occurred.
Severe skin reaction/rash/pain at and around injection site, approximately 6?x4?, intensely itchy and warm to the touch. Urgent Care provider suggested high dose antihistamines. Pain continued for 10 days, rash for 9 days.
c/o face swelling, red, itching @ site of inj;no rxn noted on 1st inj;
immed RVL turned bright red w/hives;DPH immed given;several areas of redness noted LVL;small area size of penny noted @ base of scalp;approx 30-60min post DPH redness gone;
Shingles pox along right collar bone. Presenting with oozing tiny blisters on raised and inflamed mound that itches and sent strange sensations.
This spontaneous report was received from a consumer regarding a male patient between 25 and 27 years old. The patient might have a possible skin reaction to amoxicillin. No other pertinent medical history were provided. There were no concomitant medications. On an unspecified date in 2008 (reported as "about 10 years ago"), the patient was vaccinated with GARDASIL intramuscular route, according to the label for prophylaxis, and it was given according to dosing schedule in the prescribing information as he received the completed series (dose, strength, lot# and expiration date were not reported). Other suspect therapies included, an unspecified pertussis vaccine (unspecified) (dose, strength, lot#, expiration date and route of administration were not reported) and an unspecified hepatitis virus vaccine (manufacturer unknown) (dose, strength, lot#, expiration date and route of administration were not reported) both also for prophylaxis. On an unknown date, the patient was diagnosed with gut dysbiosis. Also, the patient on an unknown date, had a hypo response to an unspecified pertussis vaccine and an unspecified hepatitis vaccine (manufacturer unknown) (Vaccination failure). The patient was admitted to an unspecified hospital for inflammatory bowel disease that was related to the gut dysbiosis. It could not be confirmed if the patient was admitted to the hospital more than once. In 2017, about a year ago, the patient had a "growth" forming at an unspecified location, on an unspecified date the patient had a surgery to remove the growth. The growth was a verrucus carcinoma. The verrucus carcinoma was sent to a pathology test due to some abnormal cells on an unspecified date. A Fluorescence in situ hybridization (FISH) test procedure was performed and it was confirmed that the patient was positive "HPV" (human papillomavirus) types 16 and 18. The patient had a second surgery due to the abnormal cells that were not removed during the first surgery. The patient reconstructive surgery from the first surgery was deconstructed, and then a Mohs micrographic surgery was performed. The patient sought medical attention and received treatment for the events. At the reporting time, the patient had not recovered from the events. The causal relationship between the events and GARDASIL was not reported. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) and the events of papilloma viral infection, verrucus carcinoma, dysbacteriosis, and inflammatory bowel disease was unknown. The causality between hepatitis virus vaccine (manufacturer unknown) and pertussis vaccine (unspecified) was reported as related for the event of vaccination failure. The reporter considered the event HPV to be life-threatening. Upon internal review, the events of verrucus carcinoma and inflammatory bowel disease were considered to be medically significant.
On 3/17  Patient reports rash soreness and lump to right arm.  Also reports itchy to left lip and swelling.
Given Fri AM after getting flu shot earlier that morning. No immediately symptoms. 36 hours later noted "red bump" in middle of forehead. ? small blisters in lesion but no oozing/discharge. Over past 5 days, marks slowly resolving. 48 hrs after that, increased dyspnea - need prn inhaler with sxs relief (had not needed inhaler for >6mo). 72 hrs after vaccine had blister on (R) hand only (single); + subjective fever started at 24 hrs.
COVID 19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 at 15:00 as dose 1, single (Lot number: EN6203), in left arm, on 16Mar2021 at 12:00 as dose 2, single (Lot number: EN6207), in left arm and on 19Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 04Mar2018, stop date: 22May2022. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex"; Flagyl, reaction(s): "Known allergies: flagyl"; Bactrim, reaction(s): "Known allergies:bactrim"; Zithromax, reaction(s): "Known allergies: Zithromax". The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "recovered" (2022), described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset May2022, outcome "recovered" (2022), described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of symptoms and positive test at day 10. Tested negative on day 6 with no symptoms; Positive, notes: Rebound of symptoms and positive test at day 10. Tested negative on day 6 with no symptoms. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Anti viral details: product-COVID 19 Treatment, brand Paxlovid, start date11May2022, stop date15May2022. Other medication details in 2weeks product were Synthroid, start date04Mar2018, stop date22May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reports freezing and sweating for 2 days after immunization 12 days ago. Body aches and headaches have persisted since then. Also reports numbness going down left arm to all fingertips since vaccine.
Pt recvd MMR 01AUG90; w/in minutes of vax pt devel half-inch hard, red, inflamed welt @ inject site; tx DPH;