chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer on 07 October 2014. A 55-year-old female patient, with a history of diabetes and obesity, received an injection of Influenza vaccine and Pneumococcal vaccine (manufacturers and lot numbers not reported) and on an unspecified date. According to the patient she had begun developing "eyesight problems" sometime after 2010. She also admitted that "she didn't deal with her diabetes in a positive way and that due to her denial she developed the diabetic complications including the eyesight problems and high blood sugars." In February 2014, an unspecified amount of time post-vaccination, the patient was hospitalized after experiencing the flu and subsequently developed pneumonia. While in the hospital her blood sugar was "very high, into the 500's", and at that time she developed retinopathy. She reported that she was treated with steroids for her pneumonia, and "her blood sugar went up". She was seen by a nephrologist during her hospitalization, and tested for renal failure (specific tests and results not reported). She also reported that she "almost died three times after hospital stay". The consumer stated that she currently weighed 280 lbs "and her water retention is 2+ and it has been a 4+ in the past". Additionally, the patient reported that in March 2014 she was hospitalized again due to a low blood sugar of 30 in the middle of the night. She reported that the Nephrologist said that "if her condition worsens other measures may need to be taken but at this point it isn't bad." She reported that her doctor increased her LANTUS SOLOSTAR dose up to 100 units daily to manage her blood sugars. Caller reports that she started using the LANTUS SOLOSTAR pens in 2011. Outcome was not reported. Documents held by sender: None.
Swelling of the lips, tongue, throat and feeling of heaviness in the lungs. No loss of ability to breathe. No urgent care or Epipen was used.  No long term effects.
She got light headed; Difficulty breathing; Residual hypersensitive issues; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (She got light headed), DYSPNOEA (Difficulty breathing) and HYPERSENSITIVITY (Residual hypersensitive issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (She got light headed), DYSPNOEA (Difficulty breathing) and HYPERSENSITIVITY (Residual hypersensitive issues). At the time of the report, DIZZINESS (She got light headed), DYSPNOEA (Difficulty breathing) and HYPERSENSITIVITY (Residual hypersensitive issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
About 2 months after i received my second vaccine, I developed parastesia in my Right arm and Right leg that would last about 10 min or so, then resolve, this would happen several times a day, this went on for about a week, which brings me to today, now i seem to have a general mild weakness all over, but as of now its not progresssing, if this keeps up, i will se my PA
pt recv vax & exp abn swelling;pt also exp cont pain in vicinity of upper inside lt arm;@ times the pain shoots down to lt hand, & lymph nod swell under arm;
cry more; This spontaneous report was received from a physician via a company representative and referred to unspecified number of infant patients of unknown age.  The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the babies they had vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (for prophylaxis; anatomical location, strength, dose, route, lot number, and expiration date were not reported)cried more (crying) than the babies that they had vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13)
Narrative:  Patient given COVID booster on 10/29/21. Patient developed low-grade fever with one episode of emesis on 10/30/2021.
Received first dose on 26Apr2021 and second dose on 12May2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021). On 12-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided
Headache, Myalgia, FEELING HOT AND COLD Narrative:  Other Relevant History:
I received the vaccine in my right arm, the placement of the vaccine was more towards the front of my arm, rather then the middle of my deltoid. My right arm was sore the next day (12-30-2020) , which is predicted, but the pain hasn't gone away. I cannot sleep on my right side, if I do, I cannot lift my arm, it takes a few hours for my arm to "warm up" before I can use it again with minimal pain. The pain is right in the middle of my deltoid, I can palpitate the exact location of the pain.
Patient received 1st dose of Shingrix and Flucelvax intramuscularly on each arm on October 22,2019 during a clinic at her work.  It is not known which shot was given on which arm.  Patient's right arm was really sore right after the administration.  The next day October 23, patient had to stay at home because she did not feel well and experienced a very significant seizure that evening.  She was fever free and had no prior history of seizures.  On Thursday October 24, she was admitted to hospital and was an ICU.  Her husband called on Saturday October 26 to inquire which vaccination was given on the right arm since that was the arm that was still swollen.  Pharmacist on duty inquired about patient's health.  Husband indicated that Saturday was the first day patient has become alert.  Pharmacist asked to call husband back in a couple of days to check up on patient.  Pharmacist called husband on 10/29 (Tuesday) to follow up.  Husband stated that she is a little better but right arm is still swollen.  Patient is alert and able to communicated.  She was still in the hospital and all test coming back have been normal.  The facility still do  not know what the root cause of her seizure.  I informed husband I would open up a VAERS and may be contacted for further information.  Pharmacist asked husband to reach out to the pharmacy if there was anything else we could assist with.
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 were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the shot and still got shingles. 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 would not possible as no contact details were available.
The next evening after receiving the injection, I began to feel swelling and tenderness under my left armpit and down to the side of my left breast (same side of body as the injection site). The pain and swelling increased over the weekend, and I could not relax my left arm down to my side in its natural position without discomfort. There was no noticeable discoloration of skin, but visible swelling. I called in to my PCP's on-call doctor who explained that this could be a swelling of the lymph nodes, a side effect of the vaccine. He suggested applying alternating ice and heating pad to relieve discomfort and said the pain and swelling should recede within the next 14 days. He advised if the symptoms continued after 14 days, to make an appointment for a mammogram/ultra sound to investigate further. As he predicted, the pain and swelling receded over the next several days, and I thought all was well.  However, nearly exactly 30 days later on May 30, I began to notice tenderness and swelling in the exact same area. Though the discomfort and swelling was not as pronounced, it was noticeable. And depending on my activity (lifting, cleaning), it became more or less pronounced. At one point, the swelling seemed to be altering the appearance of my left breast, as if it was being weighted down (left breast hanging lower than the right).  I received a referral for a mammogram and ultrasound, which were taken on June 16 (see below results). Since May 30 when swelling/discomfort resumed for the second time post-vaccination, it has receded some, but continues to be more or less noticeable depending on my activity (lifting, cleaning, etc.).
nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.
Received vaccine in AM after night shift, slept. On waking, fell x2 due to dizziness (like room spinning). Subsided, then vomiting next day due to extreme dizziness (had to hold on to things to walk). Less severe as time passes. Taking Antivert and exercises prescribed by neurologist.
she felt blah for half a day; She was tired with the second one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0161) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose,  lot number: ER8734, Anatomical Location: Left arm), administration date: 31Mar2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "pectoralis minor muscle that runs from arm pit to chest was so tense". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "She was tired with the second one"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt blah for half a day".  Additional information:  Patient had a weird thing happen after the first one. patient teaches dance and pole dance requires upper body strength and arm strength. She taught a dance class the night she got her vaccine. It stretched her arms out. At one point, she is strong willed, she was not sure if it was in her head. The pectoralis minor muscle that runs from arm pit to chest was so tense and she couldn't get it to relax. She went to urgent care and they gave her a muscle relaxer. Caller thinks it was more of a life style issue instead of a vaccine issue. She knows she shouldn't have done dance the same day as the vaccine. After the second one she felt blah for half a day, but not bad at all. She was tired with the second one. It was a good reason for a nap. Caller clarified product she received as Pfizer COVID Vaccine. Patient states it is the good one.   No follow-up attempts are possible. No further information is expected.
As per patient 2 days post vaccination he develop blurry vision in his left eye, he went to local ER but they said they could not find anything wrong so they refer him to clinic for further evaluation. Their Doctor diagnose him with Retinal Detachment, left eye (Dx: H33.022). on 04/29/2021 pt had Pars plana vitrectomy, air-fluid exchange with internal drainage retinotomy.
Chills and shivering that lasted about an hour and a half, piled blankets on and eventually warmed up again
Completed series of Twinrix with Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 23-year-old female patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Previously administered products included Twinrix (1st and 2nd dose received on an unknown date).   On 27th January 2022, the patient received Engerix B. On 27th January 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The reporter stated that the patient came in to office stating she needed to get her third dose of Hepatitis B vaccine. The reporter administered dose of Engerix-B, however the first two doses of the series the patient received were Twinrix, which led to wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. HCP gave permission for follow-up.
24 hours post-vaccination, developed localized swelling advancing erythema, tenderness over deltoid just caudal to inject site - suspect secondary cellulitis given si/sx, but cannot r/o localized vaccination reaction.
Swelling; Redness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired). At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact
Site: Redness at Injection Site-Mild, Additional Details: unsure of pt specifics, however lingering complaint
The patient called on 10/04/2018. When she got the first dose of SHINGRIX on 7/3/2018, right after she got the shot, she felt the pain went down from her injection site to her wrist. and "she felt she was run over by a truck". She felt so weak that she stayed in bed for 4 days. After 4 days, all of symptoms and pain were gone. Now she is afraid of her second dose.
Pt fainted after receiving shot. Pt states" I always faint if i see the needle"  Pt laid onto cot and vitals obtained. Pt feels immediately better once laying down.  Observed x 30min.
Generalized urticarial rash, itching.  No respiratory symptoms.  Prescribed prednisolone orally.  Rash resolved by 1/17/08.
Fluzone Quadrivalent was inadvertently administered to patient instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316262, 2019SA316286, 2019SA316289, 2019SA316290, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316261 and 2019SA316288. (Same reporter).  This case involves a 77 years old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms reported at the time of reporting.  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 Directive and Module VI of the 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 18:30 as dose 1, single (Lot number: EN6202), in left arm, on 23Mar2021 at 16:00 as dose 2, single (Lot number: EP6955), in left arm, on 13Dec2021 as dose 3 (booster), single (Lot number: FE3594), in left arm and on 09Jun2022 at 11:00 as dose 4 (booster), single (Lot number: Fch0173) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "narcolepsy type 2" (unspecified if ongoing); "nerve damage on left side of torso from car accident" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE, start date: Oct2021; MODAFINIL, start date: Oct2021; GABAPENTIN, start date: Feb2020; TOPIRAMATE, start date: Apr2005. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 23Aug2022, Treatment stop date: 28Aug2022, Lot number: GD9454, Indication: Treatment of COVID-19. The patient had no known allergies.
slipped and broke her ankle; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (slipped and broke her ankle) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced JOINT INJURY (slipped and broke her ankle). At the time of the report, JOINT INJURY (slipped and broke her ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-202 contains no significant information.
Vomiting, fever 5 days following 4 month immunizations. also had vomiting after 2 month immunizations - decreased PO, screaming.  06/18/2008 MR received for DOS 6/2-6/2008 with D/C DX: Gastroesophageal reflux and vomiting, questionable hypertension.  Infant presented with 4 day hx of vomiting, fever and high pitched screaming.(Similar episode after 2 mon vax without high pitched screaming.) Admitted due to impending dehydration and eval of GERD.  PE (+) for irritability and lethargy. Tx with IVF and Prevacid for GERD with good response. ? HTN with auto cuffs, WNL manually. Will f/u as outpt.
Felt very sick with body aches. Low temperature and had nausea, as well as general weakness.
Next day coming & going fatigue; Soreness at injection sites lasting a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Mar2021 10:00 (Lot number: EN6204) as dose 2, single and intramuscular, administered in arm left, administration date 02Mar2021 10:15 (Lot number: EN6148) as dose 1, single for covid-19 immunisation. Family history included: "Obese" (unspecified if ongoing); "Heart disease" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Peripheral artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Soreness at injection sites lasting a week"; FATIGUE (non-serious), outcome "not recovered", described as "Next day coming & going fatigue".  Additional information: Patient has not received any other vaccines prior to COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.