chrisvoncsefalvay/vaers-outcomes huggingface dataset:
never got the second dose on time and wants to have it; first dose of Shingrix on Feb 4th, 2020. On April 16th, 2020 she developed shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 16th April 2020, 72 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix and she developed shingles.  The age at the vacination was not applicable for the 2nd dose. She recovered but never got the second dose on time which led to incomplete course of vaccination. The reporter consented to follow up.
8-12 hrs after injection; became very cold, shivering x 8 hrs. Welt at site of injection commenced at 8-13 hrs. Several other raised, red areas also developed. Welts are sore. Improving now, but arm is still sore.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild
After vaccination, patient was okay until the 8 minute remaining mark. At this point patient became lethargic, clammy and passed out. Patient was revived with smelling salts, for a few seconds and the faded in and out of conciseness. Sternal rub was preformed in order to attempt to keep patient awake and present. Vital signs where taken, BP was elevated at 155/ 115. Patient was still not coherent at this point patient was team lifted to wheel chair and taken to the ER. Patient remains in the hospital at this time admitted for observation.
Since receiving the vaccine, I've noticed a significant change in my menstruation. For all of my life prior to the vaccine, the timing of my cycles was always exact as to the date it would occur. Now I experience unpredictable delays of 1-5 days. The flow has become much heavier, the pain I usually experience from cramps has markedly intensified, and I have been getting migraines in conjunction with the start of my period. I read that these symptoms resolve themselves after several months, but for me, there appears to be no improvement after more than a year since the second dose.
After my first dose vaccine, and four days later I contracted Covid-19. I went to the Urgent Care and tested positive on 01-10-2021.
Rash to elbow from injection site and on stomach. Flu sx bowel changes aching chills. All 2-10 days.
bump on her temple; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (bump on her temple) in a 79-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INDURATION (bump on her temple). At the time of the report, INDURATION (bump on her temple) had resolved.            Concomitant medication were not provided. Treatment information was not provided.   This case was linked to MOD-2021-021449 (Patient Link).   Reporter did not allow further contact
I am a staff pharmacist at a retail pharmacy. Recently when cleaning up consultation room where we administer vaccines, I noticed supplies had been left on counter from a previous ZOSTAVAX appointment. The ZOSTAVAX vaccine had been given by a colleague earlier that day. I noticed the syringe wrapper that was left out was for a 1 inch syringe. We usually use 1 inch for IM vaccines and 5/8 inch for SC vaccines. I checked the patient documentation form, and noted my colleague had documented that she's given that dose in the deltoid. Next day, I asked my colleague and she said yes she'd given the ZOSTAVAX IM, I advised her that SC is the correct route of administration for ZOSTAVAX. She thought it could be given either way, she tried to find information/research to support that belief, but could not. ZOSTAVAX should be administered subcutaneously as a single dose. The vaccine should not be injection intramuscularly. However, it is not necessary to repeat vaccination if the shingles vaccine is administered intramuscularly. My colleague said of the error: "If your ok with it, then I'm ok with it", and no further discussion or documentation of error took place. I felt like the error should've been reported to our supervisor and our authorizing prescriber and documented per our quality assurance program that we use for dispensing near missed and/or errors. Our written protocol should also be reviewed with clear instructions on what to do in case of error. I reviewed all our patient vaccine documentation forms for ZOSTAVAX and was able to find 8 more times previously (over a 2 year period) where the same colleague documented that she gave the shingles vaccine IM/deltoid. Obviously, I think she will give correctly from now on. But these errors highlight, in my opinion, for the need for ongoing training for vaccine administration. As a pharmacist, I am able to take a very detailed educational program once and be certified to administer vaccines. I am required in my state to keep records for healthcare providers (CPR and AED) and Bloodborne Pathogen training up to date. Which required annual or biannual renewal/review. But I am not required to take additional CE credit in vaccine topics. I took approved class/training in 2009 and the colleague took approved training in 2001.
Dizziness & Palpitations Narrative:  Employee stated she felt dizzy and palpitation after 2nd dose of Pfizer Covid vaccine.  Other Relevant History:
Maculopapular erythematous lesions over neck, retro auricular torso, groin and extremities, no adenopathy.
Per phone call with dad, on 10/21/12013 AT 1000. Patient was given the MCV4 vaccine on 10/10/2013 in the p.m. She then came home for supper around 1830 and was feeling tired and not acting like herself so she went to bed early. By 2300 she woke up and came out by her dad with a swollen face, racing heart, and said "something is wrong". She then fainted. Dad, called 911 and then drove her to the emergency room. They gave her muscle relaxants, did a cat scan (which was normal) and then sent her home with some pills. While at home she didn't improve and her breathing seemed to get worse. Dad again took her in to the emergency room on 10/11/2013 and she convulsed in the car. They did another CT scan (which was normal), gave her an injection to stop the convulsions and transferred her to hospital by ambulance. She apparently continued to have convulsions in the ambulance as well as breathing problems. She was admitted to the ICU. During the convulsions, dad reports her eyes roll back in her head, her legs get stiff and then he would run out to the nurse's station and get the nurse to give her VERSED. The convulsions were 2 hours apart and then gradually became more infrequent such that by day 5 she had gone 36 hours without any convulsions. On the 5th or 6th day a different neurologist told patient she needed to get up and start walking. She got up to walk and then had 2 convulsions 20 minutes apart. She again was given VERSED to get them to stop. Her last convulsions were on 10/17/2013 at approximately 1800-1900. She was discharged on 10/20/2013 and has not had any convulsions since discharge. Dad was given a nasal form of VERSED to give immediately if she had another convulsion. There are still tests pending at hospital. She is on BACLOFEN and cyclobenzaprine at home.
pt had a COVID exposure; 10/13/22 pt to hospital with malaise and dyspnea, found to be positive for COVID; pt requiring Vapotherm 40 LPM with FiO2 of 100%; poor oral intake; admitted to ICU; given empirical ABX; pt suffered shock from bradycardia; respiratory and overall status worsened; pt transitioned to DNR, comfort care; he passed away in the hospital
Per patient: injection site was turning red and sore to the touch. Guest proceeded to the hospital 9/18/15 where she was prescribed KEFLEX.
Patient had complaints of dizziness and swollen throat. Patient stated that after she received the flu vaccine she passed out and has passed out before after the administration of previous vaccinations. BP: 110/76, HR: 87, O2: 95%, temp: 97.9 The healthcare team remained with the patient during this time. Patient remained alert and oriented with no breathing or swallowing difficulties. After 10 minutes the patient stated that the swelling feeling of her throat resolved. Vital signs taken again, BP: 110/80, HR: 80, O2: 95%, Temp: 97.9 Patient asked if she could stand up, no dizziness per patient. She remained with us an additional 15 minutes and then was walked to her vehicle in which she performed with no difficultly.
Burn blisters , fever, chills, nausea, vomiting, intense headache
After vaccination, patient started to leave but returned because her arm was feeling hot. MD assessed. The area on the lower right deltoid to just above the elbow was raised approximately1"-1" circle and slightly erythematous and warm to touch. Warmth was also present. Pt placed in exam room and ice applied to site. Pt afebrile. After 10 minutes, pt felt fine other than arm discomfort. Pt monitored for another 10 minutes and then was discharged with ice pack and instructions on seeking medical attention and to take Tylenol for pain prn.
Severe pain in shoulder and difficulty moving arm. Forcing to move the arm with pain, range of motion was still limited. Lasted for 72 hours.
Pt. received pneumococcal 13 vaccination on 7/14/10 w/ in 24 - 48 hours after vacc. pt. began to ambulated w/ intermittent rt. leg limp w/ in 5 days post vacc. pt was ambulating w/ constant rt. leg limp. 6 days post vacc. rash to back of rt. leg noted. 7 days post vacc. pt. c/o pain. 16 days post vacc. sx. persist & pt. developed high fever and admitted to Medical Center.
Fever to 104.7-febrile seizure on 3/6/04.
Exactly 7-8 days after 12 months vaccine appt. fever came then the next morning red small bumps began appearing on stomach and very fast within a half an hour the rash covered the whole face, behind and inside ear, inside of mouth near eyes all the way down to toes lasted for several  days.
lymph node under her tongue on the left side of her jaw that is swollen; sore throat; left jaw is swollen; arm is sore; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that her arm is sore on 10Jan2021, but everything else was fine until on 11Jan2021, she went into the bathroom and it felt a little funny under her tongue. Under her tongue, her left jaw is swollen, like visibly swollen on the left side and her lymph node under her tongue, but just on the left side. She reported that her throat is a little sore too. She was wondering if these are known side effects of the product, because she is trying to decide if she needs to just let it go or wait and see. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
I called the CDC at about 6 weeks after noting that my blood pressure elevated. I am a nurse and I lost 30 something pounds purposely. I was outside trimming hedges and I tilted my head down and my nose started bleeding. After about 15 minutes the bleeding stopped. I went back outside that evening and my nose began bleeding again. When I checked my blood pressure it was 156/96. This was very unusual. A few weeks later when speaking with a friend, I told them that my nose was still bleeding sporadically even when lying in bed. After tracing back to see what I have done differently, the only change was that I received the 2nd dose of the COVID 19 vaccine. I see a cardiologist in relation to heart check ups. I am typically very healthy with blood pressure and I see the cardiologist annually. The CDC contact I spoke with did indicate that they had received reports of this same issue. We kept everything the same. The doctor indicated that he was told that usually takes about 6 to 9 months for this affect to go away. I also saw my family doctor whom I advised about the issue with elevated blood pressure. She noted that in my records as well. I am still currently experiencing elevated blood pressure episodes. My current BP is 145/87 so it is gradually going down.
Bone , kidney and body pains and headaches; Bone , kidney and body pains and headaches; lack of air and dizziness; Lack of air; headache; Bone , kidney and body pains and headaches; 104°F fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air) and HEADACHE (headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 14-Dec-2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air), HEADACHE (headache), MYALGIA (Bone , kidney and body pains and headaches) and PYREXIA (104°F fever). At the time of the report, BONE PAIN (Bone , kidney and body pains and headaches), RENAL PAIN (Bone , kidney and body pains and headaches), DIZZINESS (lack of air and dizziness), DYSPNOEA (Lack of air), HEADACHE (headache), MYALGIA (Bone , kidney and body pains and headaches) and PYREXIA (104°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 104 (High) 104 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant information received on 06-AUG-2021,Contained No New Information.
Symptoms began the morning after receiving the vaccine and included fatigue, nausea, muscle aches, headache, dizziness with change in position. Treatment included rest, fluids, and acetaminophen 1,000mg every four hours x 3 doses. Most symptoms resolved within 24 hours, except headaches and fatigue continued for approximately 48 hours (second and third days after vaccine was administered).
The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; 36 doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included LISINOPRIL, ZOLPIDEM and DICLOFENAC for an unknown indication.    On 06-Apr-2022 at 8:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 8:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that HCP confirmed the patients did not experience any side effects yet.  On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022 and expired. The vial did not undergo any temperature excursions.  Treatment information was not provided.
Shingles rash on belly, back and left side, diagnosed 7/12/21
Received Pfizer vaccines on 5/12/21 and 6/2/21. Admitted to hospital on 7/11/21 d/t non-COVID reasons and tested positive on admission screening for COVID-19 by PCR on 7/11/21. Patient is asymptomatic for COVID.
About 20 hrs after vaccination developed redness, swelling and pain over (R) arm vaccination site which increased in size on ED visit on 4/5/08 AM. About on AM of 7/5/08, (L) arm noted to be red as well but not as painful with concerns for cellulitis (R) arm. Given VANCOMYCIN initially, changed to CLINDAMYCIN. 7/24/08-records received for DOS 7/5/08-DX:Cellulitis of skin. Presented to ED with C/O right arm pain lasting 1 day. Erythema, swelling, tenderness associated with hotness, area of induration, with limitation in range of motion. Received vaccine 2 days prior. Observed and treated with IVAB then discharged on oral antibiotic from ED.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # H010515, exp. 13-FEB-2014) (dose not provided). This is one of several reports received from the same source (linked MARRS#: 1310USA014883, 1310USA014888, 1310USA014891, 1311USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA104853, 1311USA000075, 1310USA014895). Additional information has been requested.
Thirty minutes after vaccine he was running and continuously falling. Experienced leg bruising. Night after vaccine he was painfully crying. Today is day two-quarter size spot and red spot all over legs. Patient may be seen by office today. (Note: History of AE's. As a baby he experienced high fever and and jaundice discoloration. Taken to hospital).
contracted COVID-19; contracted COVID-19; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". Clinical course: Patient contracted covid-19 about two weeks after their Pfizer covid-19 booster shots.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180836 Same reporter/patient, different drug/AE;US-PFIZER INC-202300180963 Same reporter, different patient, different drug/AE;US-PFIZER INC-202300180835 Same reporter/ drug/ event for different patients;US-PFIZER INC-202300180962 Same reporter/patient, drug/AE;
After receiving the vaccine, my arm was sore, but no more than expected - it was like getting the flu vaccine. A week later, I noticed I had a hive around the injection site. It was about 2x3 inches, sore, hot, and bumpy. It stayed that way for about two days, then got super itchy and remained tender and hot. About day five, the hive part became more of a ring and started to expand. I'm now a week in and the hive ring has expanded to about half of my upper arm. The itching has started to subside. It's still warm to the touch, but not hot. The reaction may have been exacerbated by another issue - several years ago I had the shoulder on the same side as the injection replaced and had an allergic reaction to the dermabond used to seal the surgical incision and to the pain meds. I'm also allergic to the metal used in the replacement. The scar reacts by getting red, hot, puffy, and itchy whenever my allergies are bothering me. The injection reaction area included the incision and it's been a major part of the issue. While this may have contributed to the strength of the reaction, the "hive circle" has expanded in all directions - not just over the scar.
Was vaccination and had a very minor case/Suspected vaccination failure; Had a very minor case; 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.   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: Was vaccination and had a very minor case/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had a very minor case). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   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: 17-MAR-2023 The case was received from the patient interactive digital media. The patient was vaccinated and had a very minor case of shingles. The patient requested to get vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot # L024253, expiration date 01-JUL-2017) were inadvertently administered to an unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. This is one of two cases from the same reporter. Additional information has been requested.