chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/had the vaccine and still got shingles.; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
ache on her left arm; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 82-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included breast cancer from 01Dec2020 to an unknown date.  Concomitant medication included simvastatin and lisinopril. It was reported that she got her first dose on 23Jan2021 and she got an ache on her left arm and then she was originally scheduled for second dose on 13Feb2021, however though, she was rescheduled to have the second dose on 9Feb2021, that is 17 days earlier and she is worried about it and matter of fact is she will have an surgery of breast lumpectomy on 11Feb2021. So, her concern is if she can second dose early and or if it's okay to have the surgery prior the vaccination. The patient underwent lab tests and procedures which included weight: about 200 pounds (overweight) on an unspecified date. The outcome of the event was unknown.
Numbness and tingling in the contralateral hand and foot (left side). Numbness now developing in the hand on side of injection. Numbness in hands seems to be mimicking CTS.
He got his vaccine, woke up with buzzing, electrical digital sound to it, can only hear about 10%, constant buzzing.  Occasionally you will hear some electronic noise like getting a hearing exam, but it is nonstop.  It is maddening due to the constant humming noise.  He went to have an ear exam to his PCP on Wednesday, ears are clean, nothing in ear.  Had a steroid shot in his buttock and said that he would see improvement within 24 hours.  He contacted them again and they prescribed an antibiotic which has had no effect yet.  His PCP is in the process of him being referred to a specialist.   He does have a history of tinnitus and is rated at 10% prior to vaccine, but this everything amplified after the vaccine.    He does get infusion treatments of Immune Globulin infusion (Human), Gammunex-C for CIDP on 9/19 and 9/20/22.  He also gets weekly allergy shots but did not get one that week.   He has contacted his PCP regarding the correlation of tinnitus with Moderna and also talked to his pharmacist who told him to report to us.
5 female patients administered expired dose (6 days beyond use date); Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (5 female patients administered expired dose (6 days beyond use date)) and PRODUCT STORAGE ERROR (Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT STORAGE ERROR (Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21). On 23-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (5 female patients administered expired dose (6 days beyond use date)). On 23-Jun-2021, PRODUCT ADMINISTRATION ERROR (5 female patients administered expired dose (6 days beyond use date)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.; Sender's Comments: This report refers to a case of product storage error and product administration error for mRNA-1273, lot # 035C21A with no associated AEs
About 5 hours after, Started feeling shaky, developed a fever of 103 for almost 24 hours, uncontrollable shaking, chills, migraine type headache, uncontrollable vomiting, severe aches and back pain.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm) and headache (light headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 0021C21A) for COVID-19 immunization. No medical history reported. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore arm) and headache (light headaches). At the time of the report, vaccination site pain (sore arm) and headache (light headaches) resolved. This case linked to MOD-2021-217218 (patient link). Most recent follow-up information incorporated: On Jun 29, 2021: Updated reporter information, added patient details, updated product information, dose-1 batch number and route of administration changed from unknown to intramuscular.
Patient reports that arm is red and swollen, warm to the touch. She stated that the redness is nearly all the way around her arm including the inside. She received a PNEUMOVAX shot in the opposite arm at the same time and that arm is fine and showing no symptoms.
Fever, chills, shortness of breath, joint and muscle pain, headache, diarrhea, exhaustion.
My daughter's adverse reaction to the DTaP vaccine happened 24 years ago, but needs to be reported. Within a minute of being given her second round of DTaP vaccine, my 3-month old daughter let out a scream that startled both me and the nurse who administered the shot. I had never heard my baby-or any baby for that matter-make such a sound. Then she went unconscious and went completely limp and stayed that way for several seconds. Our family doctor told us not to give her any more vaccines. She cried a lot as an infant and had sleep issues from then until about age 20.  She has struggled with depression and anxiety for several years. At age 12 she was diagnosed with type 1 auto-immune diabetes. She is my only vaccinated child, and my only child with serious health issues.
Information has been received from a licensed practical nurse concerning an 18 year old female patient with no known medical history and drugs allergies, who on 15-Sep-2008 was vaccinated with a first dose of GARDASIL ,  (lot # 0053X),  intramuscularly. On 17-Nov-2008 the patient received a second dose of GARDASIL (lot#0702X),Intramuscularly. There was no concomitant medication. After both doses the patient developed a "white flat halo " around the injection site. The first halo was not noticed until the patient noticed until the second halo. At the time of this report the patient had not recovered. The patient sought medical attention through an office visit. Additional information has been requested
Vasovagal response (pt fainted). BP: 110/45 HR: 68  All symptoms resolved.
The pt experienced tingling in his arm and right shin. He also experienced unstableness and tingling, he then had right leg and left arm burning. These symptoms occurred about 5 days post vax. He also experienced temperature changes, weakness and numbness. This resolved and no findings were made.
Patient received at 4:45 pm HPV #1. Immediately she stiffened and eyes rolled back. This lasted one minute. Patient could not respond. On exam had face with extreme palor and BP 100/64. Patient laying down. Patient was always on exam table. Then became flushed but skin was cool and clammy. Patient then could talk and said she "felt very faint". Heart rate was normal throughout. Benadryl 12.5/5 10 ml PO given by mouth. Patient aware of surroundings color improved, flushing resolved. Repeat BP was106/70. Current time is 5:12 pm. Event lasted about 22 minutes. Patient is able to drink a soda. Is sitting up and talking. Last BP was 100/60 sitting up. End time is 5:17. Repeat BP - this time standing up at 5:20 BP 100/60. Patient alert - says feels fine. Patient will go home.
left upper arm pain; there was mild swelling with hardness of the muscle at and below the injection site; there was mild swelling with hardness of the muscle at and below the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 (Lot number: 30155BA) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Anatomical site of injection: Left upper arm, Route of administration: Intramuscular, Lot: EN6206), administration date: 05Mar2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "continous Lt upper arm pain", "hard swelling beow injection site", "Continous upper arms muscle pain when raise arms overhead since day after both shots", "Left thyroid gland slightly swollen about 3 days after first vaccination and continues after second shot"; Bnt162b2 (DOSE: 2, Anatomical site of injection: Left upper arm, Route of administration: Intramuscular, Lot: EP6955), administration date: 26Mar2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "continous Lt upper arm pain", "continous upper arms muscle pain when raise arms overhead since day after both shots", "Left thyroid gland slightly swollen about 3 days after first vaccination and continues after second shot". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left upper arm pain"; MUSCLE SWELLING (non-serious), outcome "unknown", MUSCLE RIGIDITY (non-serious), outcome "recovering" and all described as "there was mild swelling with hardness of the muscle at and below the injection site".  Additional information: Vaccination Facility Type was Drug Store. Vaccine administered at was not done at Facility. The patient took no Prior vaccinations (within 4 weeks). The patient stated that there was mild swelling with hardness of the muscle at and below the injection site (lateral deltoid/ triceps area). It was not hard anymore, as of 14Feb2022, but continued to feel hard muscularly after lying on it for 5-10 minutes (used to be immediately hard/painful immediately) until about 01Jan2022. Relevant tests were none.   No follow-up attempts are possible. No further information is expected.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 ) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 24-Dec-2022.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 25-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (COVID-19 ). At the time of the report, COVID-19 (COVID-19 ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2023, SARS-CoV-2 test: Positive.         Concomitant medication was not reported.  It was reported that 9 days following vaccination the symptoms and positive test for COVID-19 had begun. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  Treatment medication was not reported.
Itching on the arm down the injection site; Bullet rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching on the arm down the injection site) and INJECTION SITE RASH (Bullet rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (lymph nodes removed on both her arms and one of the leg). Concomitant products included OLMESARTAN, METOPROLOL and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itching on the arm down the injection site) and INJECTION SITE RASH (Bullet rash). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 15-Mar-2021 at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itching on the arm down the injection site) and INJECTION SITE RASH (Bullet rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Thyroid Medication. The patient mentioned that she got lymph nodes removed on both her arms and one of the leg   Reporter did not allow further contact
Information has been received from a nurse concerning a 13 year old female who on 10-SEP-2008 was vaccinated with her first dose of GARDASIL 0.5ml, intramuscularly. On 11-Sep-2008, the patient's mother reported that the patient developed flu symptoms after vaccination. The outcome of the patient was not reported. The patient sought medical attention by phone. Additional information has been requested.
Initial unsolicited report received from a Physician (pediatrician) on 14 December 2016. This case involves a 3-year-old male patient who was vaccinated with doses of INFLUENZA VACCINE (Flu Vaccine) (batch number, expiry date, dose, dose in series and route were not reported) in the left arm on 12 December 2016. Illness at the time of vaccination and Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also reported as none. On 13 December 2016 in the morning, one day following the vaccination, the patient's arm was noted to have significant swelling from his shoulder to his antecubital area, and the swelling was circumferential and the area was warm to touch, and was non-tender. The physician doses not beleived that, this was a cellulitis. The patient had previous dose of Flu vaccine in the last year. The patient required emergency room (ER) and doctor visit. Laboratory investigations were as none. Corrective treatment was reported as unknown. The outcome of event was reported as unknown. List of documents held by sender: none.
Left deltoid area with raised pink papular rash on non erythematous base, not pruritic otherwise normal exam except runny clear nose, few papules on left cheek, face scant on torso.
Markedly edematous lt deltoid 24-48 hrs post inject; band of erythema 3x11cm, inferior to inject site;
Throat swelling & sore, eyes swelling & gritty feeling, coughing, generalized bad feeling.
Menstrual cycle outside of normal timeframe (birth control has  me go 3 month no period, and the last week of that 3 months a very light cycle) Roughly the day after the first injection on March 24th I began an out of norm cycle that has been extremely heavy and has been ongoing for a month now. There has been no reprieve in this period since it began and after speaking briefly with my doctor she requested I bring these symptoms to the VAERS website.  In summary- Symptoms-Excessive bleeding/length of menstrual cycle ongoing for 3+ weeks.
Noticed severe itching an dpain. Hot feeling L arm indurated 30x34mm, erythema 50x55mm.
Cellulitis at location of vaccine 7cm X 5.5cm, erythema and swelling.
Fever, headache, nausea, congestion, pain, swelling, redness travelling down inside left arm (fevered).  Treated at ER and given BACTRIM DS on 9/24/09.
pt recvd vax;devel erythematous hot area w/ induration at inject site which worsened over the next 2 days;cellulitis was dx;tx w/ Keflex;resolved w/in 2 days;
Sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 10:15 as dose 3 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other Medical History: high blood pressure; "high cholesterol" (unspecified if ongoing); "brain aneurysm" (unspecified if ongoing), notes: Other Medical History: brain aneurysm. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Sensitive to aspirin", notes: known allergies: Sensitive to aspirin; Ibuprofen, reaction(s): "known allergies: Sensitive to ibuprofen", notes: known allergies: Sensitive to ibuprofen. Vaccination history included: BNT162b2 (DOSE 1, lot number: EW0153, location: Left arm), administration date: 14Apr2021, for Covid-19 immunization, reaction(s): "Sore arm", "fatigue"; BNT162b2 (DOSE 2, lot number: EW0167, location: Left arm), administration date: 05May2021, for Covid-19 immunization, reaction(s): "Sore arm", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown". No follow-up attempts are possible. No further information is expected.
C/o itching both hands and spot on right foot. Also c/o tight feeling in airway. Mild erythema on bilat palmar surfaces. Tx no further GARDASIL, return if worsens.
ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE MI
Consumer's  5yo exp swelling & redness @ inject site; MD dx w/cellulitis (3" in diameter); tx w/Duricef suspension;
Information has been received from a health professional concerning a 21 year old white female with no medical history, who on 21-DEC-2006 was vaccinated in the left deltoid with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 653735/0688F). There were no illnesses at the time of vaccination. On 21-DEC-2006, following vaccination, the patient felt faint and queasy and her face appeared flush. The patient's blood pressure was 102/60. The patient was given a cold drink of water and a cold compress and remained seated for 10 minutes and subsequently felt fine. The patient stated that "needles make her scared".  No further information is expected.
weakness in legs; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs) and FATIGUE (fatigue) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 04-Feb-2021, the patient experienced FATIGUE (fatigue). On 05-Feb-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs). On 05-Feb-2021, FATIGUE (fatigue) had resolved. On 06-Feb-2021, MUSCULAR WEAKNESS (weakness in legs) had resolved.            No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Duration of AE, Patient stated that events were  only present for 24 hours and denied email.
Pt immediately felt light headed following Shingrix administration, asked for water, after approx 5 min he "passed out", was unconscious for approx 2 min.  Came awake suddenly and flailed his arms, legs and head for approx 20 sec.  Gradually became more cognizant and complained of dry mouth, numb hands.  We elevated his legs and called 911.  Emergency services arrived approx 5 minutes later.
Information has been received from a registered nurse concerning a patient who at 36 weeks of age, in approximately March of 2008, was vaccinated with a third dose of Rotateq.  No symptoms were reported.  There was no product quality complaint.  Additional information has been requested.
Myalgia, Diarrhea Chills, stomach cramp, facial swelling Narrative:
Pt reports vax site red, sore, swollen itchy. Painful, pt advised to see MD.
This child's shot site was sore at the visit, 12 hours after the shot, he was febrile for 1 day, and his upper shoulder was red in a 3 inch area.
Booster; experiencing tremors to his right hand; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-year-old male patient received bnt162b2 (COMIRNATY Formulation: Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of bnt162b2 on an unknown date (Batch/lot number: Unknown) for covid-19 immunisation. The patient experienced tremors to his right hand on an unspecified date. The reporter would like to know if this was a reported side effect of the Pfizer Covid vaccine. The patient wife wanted to know if they still need to continue to wear masks and social distance, since they were fully vaccinated. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
White, hard, itchy wheel, progressed to red rash. Now appears mottled over RUE.
My first night after being inoculated with the second vaccine,  I developed bone pain from my iliac crest in each hip all the way to my ankles.  I also developed daily migraines as a result.  I have had migraines in the past, but they were wholly controlled.  Now, I have to take medication 3x/day.  The medication makes me nauseous and sleepy, so it is difficult to do my daily chores and drive as I don't feel alert. My PCP dismissed me beyond giving me the pain gel. The PA neurologist referred me to a pain clinic. Overall I feel lethargic and nauseous due to the additional medications. I'm also in more pain, above and beyond my baseline pain. I also don't drive very often because I am in pain and feel so lethargic. Overall my activities of daily living have declined as I am always in pain.
Pt felt sick to stomach, had a bad headache. Went to bed during this time and face at one point felt like it was on fire from the inside out. Felt bad next day.