chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected Vaccination failure; My second time to have shingles; This serious 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.   The patient's past medical history included shingles (years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: My second time to have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shot. The patient was just now getting over shingles and still on meds.  The patient second time to have shingles.  The patient had shingles years ago and for sure never hope to have them again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Rash 7 days post vaccine administration, RX with Acyclovir susp. 200 mg/5 ml. 10 ml po q 6 x 7 days.
Approximately 30 min after receiving flu shot pt c/o chest pain, severe headache and chills. Stated she felt like her asthma was acting up. BP slightly elevated at 184/88. She wanted to go home and lay down. Recommended she go to ER. Went to ER w/ employee. During a 4 day stay she failed a stress test, had 2 CAT scans and a heart cath that was neg. Hospital stated she had a systemic rxn to flu shot.   11/30/07 Reviewed hospital medical records which reveal patient experienced substernal chest pain, sweating, SOB & HA approx 30 min s/p flu vax.  Admitted 11/5-11/8/2007. FINAL DX: atypical chest pain w/possible drug reaction vs musculoskeletal pain; bronchial asthma; uncontrolled DM.
Initial report received from healthcare professional on 03 March 2014. (Reference number: 14-0129). A '11-year-old female patient' whose medical history and concomitant medication were not reported, had received a intramuscular dose of ADACEL (Batch number U4655AA, expiration date was not reported) in to the left deltoid on 24 February 2014, a intramuscular dose of MENACTRA (Batch number U4626AA, expiration date was not reported) in to the right deltoid on 24 February 2014, and a dose of HPV (Batch number J011272, expiration date was not reported) in to the right deltoid on 24 February 2014. It was reported that after vaccination the patient experienced right upper arm redness, hot to touch and swollen, local site reactions from 26 February 2014. The detail of lab investigation was not provided. The patient had received corrective treatment of ZYRTEC antihistamine and warm compress. The outcome of the event was unknown at the time of report. List of documents held by sender: none.
Local rxn, redden & swollen, welts on both legs around inject sites then spreading to cover most of body;
On Monday May 3rd I noticed the blisters on my back and they confirmed shingles. It took a week to 10 days for the blisters to disappear.
8/23/21 PMH of CVA, Hypothyroidism, Hypertension, and Bells palsy who presented to the ED with  dizziness and fatigue
12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt,  RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl.  1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied.  1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport.  1323 Pt sitting in chair, calm & no distress, cont. to re-assess.  1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.
I experiences "COVID arm" for several days after the injection and then about 1-2 weeks later became very itchy on my scalp.  That general itch started to spread to random areas of my body following no real pattern to indicate a topical allergy.  I noticed that when I scratched raised welts and lines would appear in the pattern of my scratching.
Patient felt warm and lightheaded after receiving vaccine. Her temperature was 98 and BP 134/95. Patient stayed for 30 minutes and was given water. After drinking water she felt better.
Itching noted @ site with injection given lasting 1-2 mins 10-15 min post injection, Felt left side tongue go numb lasting approx 10 minutes. 24 hours post injection - is soaking in hot bathtub, Noted local reaction-very large , red, raised warm to touch,but no pain. lasted till 11/04/02 -now appears slightly raised and bruised.
Area was red; Area felt warm to touch; Swelling up; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema, feeling of warmth and swelling. On an unknown date, the outcome of the erythema, feeling of warmth and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema, feeling of warmth and swelling to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139422   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had the same reaction (as with 2nd dose) with the first dose of Shingles vaccine minus the bones ache.  The reporter reported that the area was red, felt warm to the touch and swelling. Additional Supportive Information: Follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR139422, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139422:Same reporter
Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 09-OCT-2018, the patient received a dose of expired VARIVAX (lot # M041079; expiration date 06-OCT-2018) intramuscularly for prophylaxis. No adverse effects reported. No temperature excursion reported.
Prior to vaccination patient stated whe had a slight headache and fatigue.   Shortly after receiving Rabies Vaccine patient experience an increase in pain level with headache she had.  One hour later felt hot, flushed, extreme nausea, increased fatigue, headache became severe, shaking, chills, stomach cramping & vomiting.  Three days later she began having diarrhea.  She states she couldn't eat and continued to vomit up to 10 times a day for three days.  After three days her symptoms began to decrease.  She states she stopped vomiting on Sunday, 02/06/2005.  On 02/07/2005 she was still feeling tired and nauseated but had no other symptoms.
Pt. traveled to a foreign country on 2/8/13 for a 2 week vacation. When he returned, received Pneumococcal vaccine in (L) deltoid on 3/1/13. On 3/4/13 began feeling bilateral "hand numbness" and "balance problems". Pt. admitted to hospital on 3/9/13 with "Guillain Barre" diagnosis.
Itchiness with small vesicular lesion; progressive to whole body head to toe; close ruptured and creamy discharge developed; Left arm where injection happened is a most pain; Severity decrease in mobility; Itchiness with small vesicular lesion; progressive to whole body head to toe; close ruptured and creamy discharge developed; Itchiness with small vesicular lesion; progressive to whole body head to toe; close ruptured and creamy discharge developed; This is a spontaneous report from a contactable nurse. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: UNKNOWN) via an unspecified route of administration in left arm on 15Jan2021 (at the age of 55-years-old) as a single dose for covid-19 immunisation. Medical history included hypertension and glucose tolerance impaired/Prediabetes. Concomitant medication included ketorolac tromethamine (TORADOL), hydrochlorothiazide (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The nurse stated, "I just needed to report an adverse reaction to Pfizer Vaccine for the patient of ours. The patient presented to our Clinic from receiving a vaccine on the 15Jan2021. On 19Jan2021, patient began developing itchiness with small vesicular lesion. The itchiness and lesions have progressive to whole body head to toe. Patient reports that close ruptured and creamy discharge developed. Left arm where injection happened is a most pain. Patient denied nausea, fever, vomiting, itchy stroke, shortness of breath or soreness of tongue. Severity decrease in mobility. The patient has been prescribed prednisolone 20 mg with no relief continues with "vesicular" and pain. The patient was taking 3 tablets for the first week. For the second week keep decreasing to the 2 tablets and 1 tablet on the third week and every day. The outcome of the events was not recovered.  Information about Lot/batch number has been requested.
Vaccine use by date 12/12/2021, vaccine given 12/13/2021.
This case meets criteria for vaccine breakthrough review.  SxS includes "feeling ill" Friday PTA, tested positive for COVID.  Dialysis M, W, F, however the dialysis clinic would not accept with + result.
There was a slight tingling in my face and along the jaw area when i received the vaccine. I didn't pay it any attention until someone told me my face looked swollen on my left side. I applied pressure on it with my finger and it left an indention. and then i had a blister on my lip and the next day I had a mouthful of white blisters on the inside of my cheeks and on my gums around my teeth. I could not eat or chew.  I was in a lot of pain. I am taking medication for it prescribed to me by the emergency room. Clovid-something for Zoster Herpes something. Not sure, it is a shingles medication. The medication seems to be working as I am definitely recovering.
Around 2 hours after receiving my 4th dose of Moderna, I started feeling nauseous. I then developed a very bad headache and was throwing up. I also began to feel pain in my limbs. It all got worse over the next few days; my head pain got so bad that I couldn't see clearly. I visited a "doctor on demand" website who said that I should just continue to treat my symptoms with Tylenol and over the counter medication unless things got worse at which point, I should go to the hospital. I am still experiencing a headache, and some pain in my left arm, but it is all getting better at this point. The worst point was the day after I received the vaccination. The 5th and 6th were the worst days.
Local swelling, tenderness, and pain; fever, irritability. Began 10D after vaccines. Local swelling improved as of 2D later, but continued irritability. No vesicles.
Pneumovax give 12/17/07 at approx 10:30 am. Pt called later that afternoon about 4:30pm to report area felt itchy/swollen. Declined to come in-advised to take Benadryl and ice to the area per Dr. 12/18/07 contacted pt-swelling decreased-12/19/07 convinced pt to stop by-mild swelling Rt arm with slight redness toward inside of upper arm-checked by Dr.
marks where she had the injections / had a mark; had a mark that was itching; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (marks where she had the injections / had a mark) and VACCINATION SITE PRURITUS (had a mark that was itching) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (marks where she had the injections / had a mark) and VACCINATION SITE PRURITUS (had a mark that was itching). At the time of the report, VACCINATION SITE REACTION (marks where she had the injections / had a mark) and VACCINATION SITE PRURITUS (had a mark that was itching) 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.   Concomitant medication was not reported. Caller reported that her friend had a mark that was itching. Caller knows her friend had some medical problems. The treatment medication was not reported.
Vaccine was diluted with sodium chloride 0.9% that had expired 1/1/22. Pfizer manufactured the diluent and had no stability data past expiration date, said in the absence of this data to re-dose the vaccine.
Pain on left side of back of head on Wednesday, February 16., 2022.  Sores/blisters began to appear over the next few days with continue pain and extreme tenderness.  Fatigue was also a symptom. February 20, 2022 went to urgent care clinic and was diagnosed with shingles.  Was prescribed Valacyclovir 1 GM tablets, 1 tablet every 12 hours.
Sudden onset of chills, nausea, and weakness and fatigue.  I vomited once.  Chills and nausea lasted about two hours.  Fatigue continued for 18 hours.  By the end of the day after receiving the vaccine (10/10/2020), I was feeling fine.
Patient requested formal report due to following: Developed rash 6/2021. Required high-dose prednisone to control, infectious disease. Allergy consultation; diagnosis of group A strep cellulitis. Patient felt COVID-19 vaccine altered immunity. Patient had COVID+ PCR for symptoms 12/29/2021. He had influenza+ PCR 12/20/2021. Patient now under care of a COVID-19 alliance.
On 9/18/2021 at 10AM I found it hard to breath, had severe shaking and sweats Pulmonary Embolisms. Emergency Room, Several blood tests, chest x-rays, cat scan of chest, followed by three day hospitalization with oral medications including anticoagulant and screenings.  After hospitalization, continued oral anticoagulant, saw general practitioner after one month, continued oral anticoagulant, saw GP after five months, still continuing oral anticoagulant.
a coin-sized redness that is flat and not raised; She wasn't sure if it was subcutaneous or what but the injection was way too lateral and low; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The second dose was low laterally and 48 hours later the caller started seeing a coin-sized redness that was flat and not raised on 14Jan2021. The second vaccine was given way too low and lateral and she has developed a coin shaped redness at the injection site as if the vaccine was given subcutaneously instead of intramuscularly. She mentions were arm is a little fat, too. Patient wanted to know does she need antibody testing or a repeat dose? Does the COVID vaccine even work if they are given subcutaneous? She wasn't sure if it was subcutaneous or what but the injection was way too lateral and low. It was 8 fingerbreadths away from the top of her arm. Event was reported as non-serious. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Numbness and tingling in fourth and fifth fingers almost immediately after vaccine injection.  This resolved in about 30 minutes.  A few days later I have sharp pain on range of motion in my left shoulder that continues to this day, pain in my left shoulder if I sleep on my left side.
3 1/2hr p/vax mom reported pt began vomiting-non projectile, non-forceful, lethargic & not responding to instructions;pt eyes rolled back & looked to have lost consciousness;face turned blue-but never stopped breathing;r/o poss of sz
Confusion, dizziness, tired, headache. I slept for 10 hours straight the first night. Body aches. Diarrhea on day two.  Slept for 10 hours again on 3/26/2021 and slept the majority of the day on 3/27/21.  I had severe shortness of breath at 1pm on 3/27/21. I had to use my nebulizers and 4 puffs of the Combivent inhaler.
This spontaneous report as received from a pharmacist refers to a 52 years old female patient. Concurrent condition included, ADHD, borderline hypertension and hyperlipidemia. The patient was vaccinated with FLUVIRIN on 02-OCT-2013. On 14-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot # J006155, expiry: 30-AUG-2014) 0.65 ml, subcutaneous in the left arm. Concomitant therapies included simvastatin tablets and ADDERALL tablets. Since an unknown date in November 2013 the patient experienced very severe lower back pain, tightness and muscle spasms of the back. The patient could not even walk and was upset regarding the event he experienced. The patient had sought medical attention and contacted a pharmacist. The outcome of very severe lower back pain, muscle spasms of the back, tightness of the back and could not even walk was reported as not recovered. The reporter considered the event of "patient could not even walk" to be disability. Additional information has been requested.
Second Dose - 10 days later - Chest pain - Tingling in neck and shoulder - Increased heart rate at night - dizziness - shortness of breath
Hives begining evening of 11/02/2001, lasting thru 11/04/2001. Took Benadryl syrup to relieve itching. Total body, except head.
Starting  12 hours after injection and lasting until 36 hours post injection: low grade fever (99.9 F degrees), full body muscle aches, fatigue, injection site soreness.
Pt texted mom at work, stating he was having difficulty breathing. Advised mom to arrange to have him examined as soon as possible.
On the morning of April 2 I awoke with pain in every joint in my body.  The worst was my left ankle, which was sprained badly when I was 12 years old.  My right knee which has been diagnosed with mild arthritis was also particularly painful.  The pain was bad enough that I could not walk without a cane.  I took 600 mg of ibuprofen and had a cup of coffee.  About 30 minutes later the pain had largely subsided, but I was somewhat sore for the rest of the day.  I felt much better the morning of April 3.
within 20 minutes: metallic taste in mouth, tingling and numb lips/tongue - resolved with OTC antihistamine use
This case was reported via medical records that were forwarded by lawyers and described the occurrence of polyarthralgia in an adult male subject who was vaccinated with LYMERIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included a family history of rheumatoid arthritis.  Concurrent medical conditions included allergy to steroids and penicillin allergy.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced polyarthralgia.  At the time of reporting the outcome of the event was unspecified.  Initial information was received on 11 May 2009 via medical records.  In 2007, medical records indicated that inguinal adenopathy with an erythematous nodular lesion was noted.  The subject was diagnosed with Lyme disease and received doxycycline treatment.  Review of physical examination notes from 2008 indicated that the subject had polyarthralgia mainly in the hips, knees, shoulders.  Laboratory evaluation in 2008 was notable for negative test results for lupus and rheumatoid arthritis.  According to the statement of injuries, at an unspecified time after vaccination  with LYMERIX the subject experienced "althralgias, vision problems, difficulty walking, cognitive dysfunction and tremors, fatigue, rashes, swollen joints, memory loss and stiffness."  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  The subject also was noted to experience decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 01 June 2009 via medical records.  Records indicated that at least two dose of LYMERIX were administered to the subject.  One on 25 June 1999 and a second on 27 July 1999.  Both injections were given in the right arm.  A note dated 29 December 2002 indicated that the subject had been diagnosed with active/chronic Lyme Borreliosis via a direct antibody test on 07 February 2002.  It was stated that the subject had made minimal progress while being treated for the infection (treatments not specified).  It was noted that the subject was administered the Lyme disease vaccine prior to being examined at this time.  Although attribution of this condition to LYMERIX was not indicated, it was reported that the vaccine had been known to exacerbate the condition.  The examining physician considered the subject to be totally disabled with an unfavorable prognosis.  An incidental finding on review of records was that the subject experienced a fall and loss of vision and was seen in the hospital on 18 February 2002.
Day 1: Swelling of throat, raised bumps in throat and mouth - 2 Benadryl immediately and ER visit. Given 40mg Prednisone at ER. 5 day prescription of Prednisone and Pepcid Day 2: Swelling of throat, raised bumps in throat and mouth, racing heart. ER visit for palpitations and sinus tachycardia. Took daily dose of Prednisone, Pepcid, and 2 Benadryl as needed to help swelling. Day 3 (Today): Swelling of throat, and raised bumps in throat and mouth. Took daily dose of Prednisone and Pepcid. Benadryl as needed to help swelling.