chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the two dose shot, got shingles /Vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the two dose shot and still got shingles 2 years later it probably would have been worse if I did not have the shot. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Patient passed away 24 hours after receipt of 1st Dose Pfizer vaccine.  Provider does not feel death was due to vaccination. but underlying conditions. No immediate side effects noted from vaccination.
The patient's mother called on 06/27/2001 stating the patient had been screaming non-stop for 1 hour. The patient's thigh was red, swollen and tender. The patient was treated with Tylenol.
Received Tdap on 3/08/07 and on 03/11/07 sudden onset of diplopia followed by months of multiple problems. Headaches, fatigue, generalized muscle weakness in all extremities. Hip pain,lack of ability to climb stairs without pulling self up with railing. Difficulty walking. MRIs done, Neurologist visits, Neuro opthalmalogists, large amount of labwork, retinal specialists.
Increased joint pain, new bilateral shoulder pain, intermittent nausea. Relieved over the course of 2 months.
She had a fever of 100.3F within 12 hours of having the vaccine the first time; blurred vision; nausea; extreme headache; massive migraine; Unwell; muscle pains and chills; muscle pains and chills; fast heartbeat then the nigh, heart rate is 128 bpm-132 bpm; Injection site pain; Joint pain; vomiting; Tiredness; Dizziness; weakness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number, and Expiry date: not reported) age at the time of vaccination was 29 years, administered in Arm Left on 07Apr2021 at 09:30 as dose 1, single for COVID-19 immunization. The patient's medical history included thyroid problem about eight years ago that went away. The patient's concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID-19 vaccine. On 07Apr2021, after the first dose the patient had a fever of 100.3 Fahrenheit within 12 hours of having the vaccine the first time. The patient felt unwell causing blurred vision, nausea from extreme headache comparative to a massive migraine, vomiting. The patient had experienced muscle pains and chills. The patient have a fast heartbeat then the night, heart rate of 128 bpm - 132 bpm, tiredness, injection site pain, joint pain, dizziness, and weakness lasted for five days. The Pfizer was unable to make any treatment recommendations for individual patients who may receive the Pfizer vaccine. Clinical judgement made by your physician/HCP based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken. No investigation assessment. Therapeutic measures included IBUPROFEN for fever. The patient underwent lab tests and procedures, which included Fever 100.3 Fahrenheit, heart rate 128 bpm-132 bpm, Covid19 negative on an unknown date in Jun2020, Jan2021. The outcome of the events was fever, dizziness, weakness resolved, blurred vision, migraine, unwell, fast heartbeat then the nigh, heart rate is 128 bpm-132 bpm, was unknown, nausea, headache, muscle pains, chills, Injection site pain, Joint pain, vomiting, and Tiredness was not resolved.  No follow-up attempts were needed, information about lot/batch number cannot be obtained.
Low Grade Fever 100.4. Flu-like symptoms - body aches, fatigue. Headache, bruise-like pain at injection sight. 9/13-16 Hives & Swelling
Product storage error; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had NKDA(no known drug allergies).  Concomitant medication information was not provided by the reporter.  Moderna vaccine was pulled from  freezer on 16 Dec 2021. Beyond use date of 15 Jan 2022 was printed in red and taped to the top of boxes. On 26 Jan 2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31 Jan 2022, Moderna confirmed that revaccination was not required. Patient notified of error and that a repeat vaccine was not required. Patient denied any adverse effects.  Treatment information was not provided by the reporter.
Lost 50-60% of my sense of taste around 5 pm on 4/1. Drinks taste mild and watery. With food, some flavors are missing and some are amplified. I cannot taste the normal nuance of flavors. Carrots are overwhelmingly sweet, lemon juice and hot sauce feel sour/hot, but don't taste it. Anything lavender flavored tastes like I'm eating straight lavender. This is not a normal vaccine side effect for me, nor is it normal for allergies for me.
Arm warm to the touch; A little bit of itching; Arm very sore; Redness larger, but lighter in color; redness on vaccination site; Soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness larger, but lighter in color), FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching), VACCINATION SITE PAIN (Soreness at vaccination site) and VACCINATION SITE ERYTHEMA (redness on vaccination site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), CARBIDOPA, LEVODOPA, ATORVASTATIN, LOSARTAN POTASSIUM, GABAPENTIN and LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at vaccination site). On 23-Apr-2021, the patient experienced ERYTHEMA (Redness larger, but lighter in color) and VACCINATION SITE ERYTHEMA (redness on vaccination site). On 24-Apr-2021, the patient experienced FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching) and MYALGIA (Arm very sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Redness larger, but lighter in color), FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching), VACCINATION SITE PAIN (Soreness at vaccination site), VACCINATION SITE ERYTHEMA (redness on vaccination site) and MYALGIA (Arm very sore) had resolved.            It was reported that after 10-12 days her rash was completely gone and patient was fine at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and event outcome updated.
Pain at site of injection - starting about a hour after injection and lasting for several days  Fatigue and light headedness requiring bed rest - starting day after injection and lasting about 2 days  Hard swelling of upper arm around injection site and itchiness - starting day 6 after injection   Fatigue requiring bed rest - starting day 6 after injection
generalized inflammation all over her body; can´t feed herself; vision problems; foot pain; her language was odd; foot problems; couldn't feel her feet; couldn't walk, can´t walk; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (foot problems), HYPOAESTHESIA (couldn't feel her feet), GAIT INABILITY (couldn't walk, can´t walk), VISUAL IMPAIRMENT (vision problems) and PAIN IN EXTREMITY (foot pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 032B21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LIMB DISCOMFORT (foot problems), HYPOAESTHESIA (couldn't feel her feet) and GAIT INABILITY (couldn't walk, can´t walk). In December 2021, the patient experienced VISUAL IMPAIRMENT (vision problems), PAIN IN EXTREMITY (foot pain) and LANGUAGE DISORDER (her language was odd). On an unknown date, the patient experienced INFLAMMATION (generalized inflammation all over her body) and FEEDING DISORDER (can´t feed herself). At the time of the report, LIMB DISCOMFORT (foot problems), HYPOAESTHESIA (couldn't feel her feet), GAIT INABILITY (couldn't walk, can´t walk), VISUAL IMPAIRMENT (vision problems), PAIN IN EXTREMITY (foot pain), LANGUAGE DISORDER (her language was odd), INFLAMMATION (generalized inflammation all over her body) and FEEDING DISORDER (can´t feed herself) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: result not reported Result not reported. On an unknown date, Spinal X-ray: result not reported Result not reported.         No concomitant medications were reported Other treatment medications include Steroids, IV Vitamins, narcotics.  Patient reported height as 5.7 Patient was not on any concomitant medications, has no allergies, never had COVID positive test and never had mentioned adverse event and chronic illness at the time of vaccination. Patient did not had any other vaccines within 1 month prior to Moderna COVID-19 vaccine Patient ended up in the hospital and still was in rehab. Patient reported that doctors was still looking for a diagnosis, but its most likely to be Guillain-Barre Syndrome Patient had seek medical care (office visit, Urgent care, ER, hospitalized), Patient did not experienced a similar event in the past.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Live Significant follow up received and updated  Dose information and lot number for the suspect was updated.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-JAN-2015 an expired ZOSTAVAX (lot # J005849, expiration date 17-AUG-2014, dose and frequency not reported) was administered to patient. Potency supported. No adverse effects reported. No additional information provided. The patient did not seek medical attention. Additional information has been requested.
Patient experienced tingling sensation in both hands and potentiation of existing carpel tunnel. Reaction subsided on it's own about 25 minutes after vaccine
patient requested a FLUBLOK vaccine and was accidentally given FLUZONE with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 62 years old male patient who requested a INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and was accidentally given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7681KA and expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for prophylactic immunization instead of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 13-Sep-2022, (latency: same day) the patient requested a flublok vaccine and was accidentally given fluzone with no reported adverse event (wrong product administered).  Action taken was not applicable with both the suspects.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
had both the vaccines / came down with shingles again/suspected vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got both the Shingles vaccine and just came down with shingles again. The patient could not believe it. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
spent the whole time in bed since the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "spent the whole time in bed since the vaccine".  Additional information: It was reported that the patient is very petite less than 100 lbs. Reporter wanted to know why would someone her size vs someone larger get the same dosage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fully vaccinated with J&J, not boosted. COVID infection breakthrough with inpatient hospital stay.
Fatigue; Runny nose; Watery eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03May2021 12:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 09Jun2007 (ongoing), notes: High blood pressure; "Hypothyroidism", start date: 05Sep2008 (ongoing); "High Cholesterol", start date: 09Jun2007 (ongoing); "Anxiety", start date: 03Mar2010 (ongoing); "Low Vitamin D" (ongoing); "Environmental allergies" (ongoing), notes: Environmental allergies. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ATENOLOL taken for hypertension (ongoing); SERTRALINE taken for anxiety (ongoing); ALLER TEC taken for hypersensitivity (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 12:30 PM, Site and route of injection: Left upper arm, Intramuscular, Batch/Lot number: Not available provided at time of report completion, Sore arm when touched), administration date: 12Apr2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Sore arm when touched". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "Watery eyes".  Additional information- Prior vaccinations within 4 weeks reported and  specific relevant test for thromboembolic events with thrombocytopenia reported as none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
elbow is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (elbow is a little swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced JOINT SWELLING (elbow is a little swollen). At the time of the report, JOINT SWELLING (elbow is a little swollen) outcome was unknown.            Patient put ice on it as a corrective treatment.  Patient mentioned it could also be related to hitting her arm and not remembering it.  No concomitant drug information was provided.
Immense difference in my menstrual cycle; Cramps/The cramps are to take the sunlight out of me; The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to; I have been bloated; Swollen; The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to; Immense difference in my menstrual cycle/cycle was light, regular and almost pain-free; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 31 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 01Apr2021 09:00 (Lot number: EW0150) as dose 1, single and intramuscular, administered in arm, administration date 22Apr2021 10:00 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C, start date: Mar2021 (ongoing). The following information was reported: MENSTRUAL DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Immense difference in my menstrual cycle"; DYSMENORRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Cramps/The cramps are to take the sunlight out of me"; PAIN (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Apr2021, outcome "unknown" and all described as "The level of pain has been so unbearable that I cannot live my routine as I cannot live my routine as I used to"; ABDOMINAL DISTENSION (non-serious) with onset Apr2021, outcome "unknown", described as "I have been bloated"; SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Swollen"; MENSTRUAL DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "Immense difference in my menstrual cycle/cycle was light, regular and almost pain-free".  Additional information: Since the patient got the Covid-19 Vaccine from this laboratory patient felt an immense difference in menstrual cycle. The patient has been bloated, swollen, and the cramps were to take the sunlight out of me. The level of pain has been so unbearable that the patient cannot live routine as used to. It started Apr2021, same month took the two dosages of the vaccine. Nothing in diet and routine has changed drastically to justify such change, and the cycle was light, regular, and almost pain-free. Relevant test: None. Anatomical location: Arm Vaccination facility type: Other. Prior vaccination: None. No AE prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 11-year-old healthy female with no allergies who on 24-JUN-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 07-AUG-2005 the patient developed breakthrough varicella, described as less than 50 lesions and a slight fever. The patient was treated with anti-itch medicine. No further information was available. Subsequently, the patient recovered from breakthrough varicella. There were no laboratory studies performed. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Approximately 24 hours after vaccines had episode of eye rolling, shaking and possible apnea lasting 2-3 min. No fevers. Evaluated in ER. Of interest, versions of event differ in ER with primary MD and neurologist who evaluated patient at Mom's request. (all notes included)