chrisvoncsefalvay/vaers-outcomes huggingface dataset:
go the shot but didn't get them/Suspected vaccination failure; had them; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she had them and even go the shot but did not get them as bad and reported that he/she also got the new shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
She stated that after her second dose she developed a swollen lymph node under her armpit of the arm she got the vaccine in. I explained to her that this is a normal thing and is a known side effect, however she then stated that she now has a raw, red, open skin rash under her armpit on in the same spot the swollen lymph node was. She stated she has been dealing with this for weeks and that it is not responding to any treatment. The patient stated she has not been to her Dr. yet because she hasn't had time, but this has been going on for weeks since her second dose.
rash around the injection site; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 8 years old male patient who experienced rash around the injection site, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patients past vaccination(s) included Fluzone Quadrivalent year 2015- 2016, 0.5 ml prefilled syringe, Lot number- UI493AB, Expiry date: 30-Jun-2016. Had received Fluzone Quadrivalent with no issues for years.  The patient did not receive any concomitant medication.   On 07-Sep-2017, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI839AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid.  On 07-Sep-2017, the patient developed a non-serious rash around the injection site (vaccination site rash) few hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was rash around the injection site.   No corrective treatment was received.  The patient outcome is reported as Recovered / Resolved on its own, on an unknown date for rash around the injection site.  List of documents held by sender: none.
Post PNEUMOVAX 23 shot felt pain down (L) arm that progressively got worse. Progressively got worse where it is now b/l arms and back of neck. Went to multiple neurologist. (-) MRI, (-) brain scan, (-) blood work. Questionable GBS.
Rash - 8 cm localized reaction, red, warm. resolved w/in 3 days. low grade fever, cough
DOSE ADMINISTERED AFTER BRING STORAGE FOR 30 DAYS BETWEEN 2-8 DEGREE C
Received flu shot at 1540 and began itching all over body, mostly in ear canals and eyes.
Rash appeared 8-9 hours post immunization of both the PPD and the seasonal influenza.
She got her vaccine around 4:30, and started getting reactions between 9:30 and 10 having chills, fever, eye hurting really bad.  Her throat was irritated, like burning/numbness like burning your tongue with soup.  She also was very tired and still has the severe headache and gets tired really fast 4 months after vaccine.  She also has a raised lump/lymph node on the right side of her neck, which has not gone down in size nor has it grown.  The only side effect that she still has is the little lump and the numbness irritation on her throat, headache and fatigue.   She took Tylenol and continues to carry it with her all the time as she has the headaches that pop up out of no where.
On April 4/13/2023 at 6:40 pm, patient, came in to see Dr. for a Well Check visit. Patient was seen by dr. at 6:50 pm. Following the visit by dr., I was given instructions to administer vaccines; Dtap vaccine, Hepatitis A vaccine, and Covid Vaccine. My understanding was that we would be administering Covid vaccine 1st and 2nd dose. This was a mistake on my part, we are only giving Covid vaccine booster and not the 1st and 2nd dose. These vaccines were administered at 7:29 pm. The patient received the  Dtap vaccine on her left thigh, Hepatitis A Vaccine on her left thigh, and Covid vaccine booster on her right thigh. The patient was given instructions to wait 15 minutes after to see if he would have any side effect or reaction, but he did not have either and went home.
Mild headache; Low grade fever; Mild chills; Lethargic; Swollen nodes in left armpit for about 4 days; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 17:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had known allergies to cefoxitin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and celecoxib (CELEBREX); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021, 24 hours after second dose, the patient experienced mild headache, low grade fever, mild chills, lethargic which were gone the next day. On 11Feb2021, the patient had swollen nodes in left armpit for about 4 days and they too went away. The patient reported that nothing adverse since. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild headache, low grade fever, mild chills and lethargic was recovered on 12Feb2021; while that of the swollen nodes in left armpit was recovered on 15Feb2021, after the duration of 4 days.   No follow-up attempts are needed. No further information is expected.
PATIENT REPORTS ON DAY OF THE VACCINATION, SHE FELT NAUSEOUS, SORENESS, MUSCLE ACHES IN THE LEGS. PATIENT MENTIONED THAT SHE BLACKED OUT IN THE EVENING AFTER HER FLU SHOT AND WAS UNABLE TO SLEEP THAT NIGHT. THE NEXT DAY PATIENT STATES THAT SHE WAS STILL GETTING NAUSEOUS WHILE STANDING UP.
1st dose 05Jul2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose with (batch number 4F3YY, expiry date 1st January 2023) on 5th July 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device.On an unknown date, unknown after receiving Twinrix and Twinrix 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 Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The reporter reported that the patient did not present back for the second dose of Twinrix until 14th February 2023. At the time of reporting, the second dose had not yet been administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. This was 1 of 3 case, reported by the same reporter.; Sender's Comments:  US-GSK-US2023024465:Same reporter US-GSK-US2023024467:Same reporter
29DEC93 c/o pain @ site of inject; 31DEC93 wouldn't use arm due to  pain, seen by MD;  swelling noted asked to return on 3JAN; 4JAN94 adm to hosp for IV ATB therapy for cellulitis;
Extreme redness > 6 inches in diameter at site of injection, soreness > 7 days & slight fever.
Chills for about 2 hours duration starting at hour 10 after dose. Headache, fatigue, and moderate arm pain at injection that lasted from about hour 12-36 on and off, requiring some acetaminophen and ibuprofen and rest. By 48 hours after vaccine dose, asymptomatic other than arm pain that lingered for 5 days total. I had no symptoms after dose 1.
Expired dose of Menactra was given with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (MI) (Reference number- 00839453) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 41-year-old patient (unknown gender) who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 02-Nov-2021, the patient received a 0.25 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6785AA, expiry date: 31-Oct-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "Medical assistant reporting that an expired dose of MENACTRA was given to a patient, the vaccine was given yesterday, 02Nov2021, but had expired on 31Oct2021."  At time of reporting, no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills/shaking began approximately 8 hours after injection.  Other symptoms of an achy upper body, temperature of 103.1, and nausea came shortly after initial symptoms (within 1 hr.).    In the middle of the night, I began heavily sweating (something I have never experienced).  I was drenched with sweat and needed to change in the middle of the night.   Absolutely no energy and a horrible headache.    24 hrs. after the injection I no longer had a high fever.  However, consistently for a week, every day, I had at least one symptom (headache, nausea, chills, or lack of energy) at some point throughout the day.  When I received the injection, I was on day 2 of my period.  It ended one day later than normal.  However, what was not normal was that on 4/3/21, I began to bleed again.  I passed 2 clots and had spotting for an additional 5 days.  This is in no way normal to my cycle.
Covid vaccine 1: rash, blisters, redness, itchy and painful toes 4 days post vaccine. These lasted 2.5 weeks. Treatment: steroid cream prescription, hydrocortisone cream, NSAIDS. No relief. Went away on its own. Heart palpitations: 1 day post vaccine. No treatment. Went away on their own after a few weeks.  Covid vaccine 2: same symptoms as above. Covid toes last 3.5 weeks, non receptive to medications. Much worse adverse reaction than first vaccine. Heart palpitations persisted for 2-3 months.  Covid booster: same reactions as above. Onsight of covid toes started within 24 hours and are present today 1/9/2022 (booster on 12/10/2021) with no signs of relief an are worse than previous times. Heart palpitations are re-occurring every 2-3 days that take my breathe away. Palpitations are more frequent and tracked manually when occurred due to consistency and pain.
Mother tested positive for covid-19; This is a spontaneous report received from a contactable consumer via Pfizer Sponsored Program. A female patient (mother of reporter) of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 03Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. On 08Mar2021, the patient tested positive for covid-19. The reporter wanted to know if her mother should have her second dose of the vaccine on 24Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
The first thing I noticed was arm pain, which I expected, but I had no idea how bad it was going to hurt. It hurt to the point that when I would move my arm, I thought I was going to throw up which lasted a few days. On the fourth day, I got a severe headache in my crown. I was extremely nauseous with pain in my upper and lower abdomen and I felt very shaky and unsteady. Things began to subside so I went ahead with the second injection.
"For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to; "For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to; "For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to), MOBILITY DECREASED ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) and ARTHRALGIA ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to), MOBILITY DECREASED ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) and ARTHRALGIA ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and CORTISONE at a dose of shot. At the time of the report, PAIN IN EXTREMITY ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) and ARTHRALGIA ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) was resolving and MOBILITY DECREASED ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Added treatment medication[Cortisone]. Updated events outcome:  pain in fingers and shoulder pain from unknown to recovering and mobility decreased from unknown to not recovered.
I have been fully vaccinated and have recently tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I have been fully vaccinated and have recently tested positive for COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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. On an unknown date, the patient experienced COVID-19 (I have been fully vaccinated and have recently tested positive for COVID-19). At the time of the report, COVID-19 (I have been fully vaccinated and have recently tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No Concomitant product details were provided by the reporter. No Treatment information was provided.   Reporter did not allow further contact
pt recv vax 27FEB96 & 17SEP96 pt exp probable herpes zoster on the rt arm & hand;
Information has been received on 26-MAY-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 06-MAY-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed IV opioids, valacyclovir and acetaminophen, oxycodone hydrochloride (PERCOCET) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Immediate welt, approximately 3/8? in diameter and 0.25? tall. Pain followed after roughly 30 seconds. Welt was 90% reduced and pain mostly gone after 5 minutes of rotating arm/rubbing injection site.
4/14/15 5:20 pm medical center for seizure which occurred shortly before then. Witnessed by parents. Generalized sx, postictal st, weakness-generalized. Received Hep A, MMR, VARIVAX 4/14/15 at 9:30 am. (Grand mal seizure)
pt resides in nursing home; pt had a runny nose, cough, and congestion after returning from dialysis on 7/13/22; COVID test came back positive; O2 supplementation via NC; pt passed away 6 days later in the facility
Non-itching, red rash with burning sensation over 70% of body, back, trunk, inside of arms, inner thighs and some whelps formed.
A patient experienced mensuration cycle twice in one month after taking second dose; A patient experienced swollen lymph nodes on left side of her breast after taking second dose; A patient experienced muscle ache after taking second dose; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (A patient experienced mensuration cycle twice in one month after taking second dose), LYMPHADENOPATHY (A patient experienced swollen lymph nodes on left side of her breast after taking second dose) and MYALGIA (A patient experienced muscle ache after taking second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20K) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 02-Feb-2021, the patient experienced POLYMENORRHOEA (A patient experienced mensuration cycle twice in one month after taking second dose), LYMPHADENOPATHY (A patient experienced swollen lymph nodes on left side of her breast after taking second dose) and MYALGIA (A patient experienced muscle ache after taking second dose). At the time of the report, POLYMENORRHOEA (A patient experienced mensuration cycle twice in one month after taking second dose), LYMPHADENOPATHY (A patient experienced swollen lymph nodes on left side of her breast after taking second dose) and MYALGIA (A patient experienced muscle ache after taking second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.     This case was linked to MOD-2021-228449 (Patient Link).
Radiating pain from injection site for at least a week now; significant loss of strength in left arm and overall weakness.
As per patient, developed swelling to (R) upper arm and (R) outer aspect of neck that lasted approximately 4 days. In addition developed a 1/2 inch diameter mass in the area medial to (R) scapula. Pain, discomfort to (L) lower abdominal quadrant.
The consumer was vaccinated with "the measles mumps rubella vaccination as a child and has had plantar's warts for 6 years now; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were unknown. On an unknown date, during her childhood the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date (reported as: 6 years ago), the patient had experienced plantar warts. Furthermore, the patient had sought medical attention. The consumer reported that she tried every treatment. There was no product quality complaint. The outcome of the event was unknown. The relatedness between the event plantar warts and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.
Besides sore arm feeling a little dazed I Noticed a rash on left arm few days after vaccine, they weren?t to itchy, but blotchy and spreading.contact my physician at the time and he saw me same day. I was diagnosed with shingles. Very uncomfortable and painful on my left side. Waited longer before 2nd vaccine . Got that on 5/10/2021
Redness/swelling at injection site - spreading to shoulder area, neck and roof of mouth, itches.
pt recv vax 13NOV96 & 26NOV96 pt exp rash;
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 08-SEP-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L008664, expiration date- 03-NOV-2016 and lot # K008409, expiration date- 04-MAR-2016 and lot # K018528, expiration date- 14-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) 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.