chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on forhead, pain hairline; Received 2 doses of Shingrix, got shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis.   In 2021, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received ZOSTAVAX. In July 2022, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced forehead headache. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and forehead headache were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and forehead headache to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comments: The patient self-reported this case. The patient stated that she received Zostavax and 2 doses of Shingrix (2021- did not remember exact dates).  The patient stated that she was diagnosed with shingles 5 months ago from reporting and still had pain on forehead and hairline.  She stated her health care professional prescribed Valtrex for a week and then discontinued it. The reporter was consented to follow up. It was unknown if the reporter considered the Shingles, headache to be related to Zostavax.   Additional supportive information: This case was considered as vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Vaccine administered 7/19/11 - woke up 7/20/11 with left upper arm, red, swollen and warm to the touch at injection site.
Pt. got splotchy red rash on face approx. 10 days after receiving MMR injection. No treatment.
This spontaneous report was received from a registered nurse referring to a currently 3 month year-old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (Lot#N005626, expiry date: 26-NOV-2018) orally, for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA006754: US-009507513-1801USA007189: US-009507513-1801USA007190.
This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified date, the patient received PNEUMOVAX 23 (lot#, expiry date and dosing details were not known) "every year with her influenza virus vaccine (unspecified)". No adverse effect was reported. Additional information has been requested.
I received the second dose 21 days after the first dose; Feeling sad; I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people; lack of focus and concentration; Extremely tired, I was in tears at times; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling sad), AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration), FATIGUE (Extremely tired, I was in tears at times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DEPRESSED MOOD (Feeling sad), AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration) and FATIGUE (Extremely tired, I was in tears at times). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose). At the time of the report, DEPRESSED MOOD (Feeling sad) outcome was unknown, AMNESIA (I had memory loss, lack of focus and concentration, I could not concentrate on /I walk into a room and can't remember why I came there forgetting things forgetting people), DISTURBANCE IN ATTENTION (lack of focus and concentration) and FATIGUE (Extremely tired, I was in tears at times) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received the second dose 21 days after the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Weight: decreased (Low) Lost 12 pounds.         Patient reported that symptoms started after the second dose had difficulty in concentrating, had memory issues and extreme fatigue. The symptoms were gradually resolving. The patient also expressed disappointment at the lack of resources to help in dealing with those side effect.
This spontaneous report as received from a pharmacist refers to an approximately 65 year old female patient. The patient's pertinent medical history was none. The patient had drug reactions/allergies to penicillin with unspecified reactions. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) lot # J006828, expiry date 14-SEP-2013, dose 0.65 ml, subcutaneous. No concomitant medications were reported. Approximately 30-OCT-2013 (reported as 1-2 days after) the patient experienced red area at the injection site. It was reproted that there was no vesicles at reddened injection site and the patient reported that it felt prickly (approximately 30-OCT-2013). The patient reported of experiencing cold symptoms of coughing, sneezing and chills before the injection. The patient sought medical attention and visited her physician and was prescribed with unspecified steroid cream and the rash resolved on 03-NOV-2013. The outcome of felt prickly is unknown. No lab diagnostics studies were performed. Additional information has been requested.
VOMITED THE THIRD DOSE OF VIVOTIF; DID NOT TAKE THE FOURTH DOSE; This spontaneous case report was received from a nurse (PVX2019-414) on 13-Feb-2019 and an additional information was received on 18-Feb-2019. The report describes a 32-year-old adult female consumer who vomited the third dose of Vivotif. The consumer "did not take fourth dose". The consumer was receiving Vivotif for an unknown indication.  The consumer was a healthy adult with no medical history.  The consumer had some vaccines before she took Vivotif but she did not take any vaccines or medications at the same time as Vivotif.  It was reported that the consumer took the first two doses of Vivotif properly but she could not keep down the third dose and vomited it. The reporter confirmed that the consumer did not take the fourth dose.  The action taken with Vivotif with respect to the event vomited the third dose of Vivotif was drug discontinued while with respect to the event "did not take fourth dose" was not applicable.  The clinical outcome of the events vomited the third dose of Vivotif and "did not take fourth dose" was unknown.  Company's Comment: In this case, a 32-year-old adult female consumer vomited the third dose of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also vomiting is labeled as per CCDS. Hence, the causality of the event with Vivotif was assessed as possible. The causality of the event "did not take fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a 32-year-old adult female consumer vomited the third dose of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also vomiting is labeled as per CCDS. Hence, the causality of the event with Vivotif was assessed as possible. The causality of the event "did not take fourth dose" was considered as not applicable.
no adverse event; reported that a dose of PROQUAD was administered to a 15 year old consumer.; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5ml, lot #W006587 (lot number has been verified to be valid),expiration date: 23-AUG-2023 (strength, anatomical location, and route of administration were not provided)as prophylaxis (Inappropriate age at vaccine administration). No adverse event was reported.
Very strong chest pains 28 hours post injection. Felt like the worst heartburn I've ever had, or that I was being stabbed in the chest and back repeatedly.
I ended up basically paralyzed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Other medical history: Hashimoto; "high blood pressure" (unspecified if ongoing), notes: Other medical history:  high blood pressure. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, disability, life threatening) with onset 30Nov2021, outcome "not recovered", described as "I ended up basically paralyzed". The event "i ended up basically paralyzed" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (31Oct2022) Negative; SARS-CoV-2 test: (31Oct2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of paralysis.  Additional information: The patient had no other vaccine in four weeks and had no known allergies.
I passed out unexpectedly, without first being dizzy. When I woke up, my whole body was shaking. My body felt very weak that entire day. I have not passed out in over 10 years.
Low grade "flu" after the first dose; Body aches after the first dose; Sleeping a lot after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 09:00 (Lot number: EN6202) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Reflux", start date: 2019 (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Height had shrunk" (unspecified if ongoing), notes: stated this occurred prior to getting the vaccine. Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing); FAMOTIDINE taken for reflux gastritis, start date: 2019 (ongoing). The following information was reported: INFLUENZA (non-serious) with onset 04Mar2021, outcome "recovered" (11Mar2021), described as "Low grade "flu" after the first dose"; PAIN (non-serious) with onset 04Mar2021, outcome "recovered" (11Mar2021), described as "Body aches after the first dose"; HYPERSOMNIA (non-serious) with onset 04Mar2021, outcome "recovered" (11Mar2021), described as "Sleeping a lot after the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant Lisinopril, Simvastatin taking for over 10 years, famotidine: used to take Zantac which was pulled from the market. It was reported that, he had ongoing symptoms for 3 months. He was calling to give feedback. After receiving the first dose caller experienced a low grade "flu". This lasted for 8 days. He also had body aches. This was not constant. He slept a lot. He bounced back and was able to go out and do yard work. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer Suspect. Adverse event did not require a visit to: Emergency Room or Physician Office. Relevant Tests: None. Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations, Family Medical History Relevant to AE(s) was none.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 10/22/98; on 10/24/98 pt exp raised erythema
Patient states she developed muscle weakness that night and her legs cramped up.  She says she fell out of her chair and went to the emergency room because she hurt her back when she fell.  I called to remind her of her second dose needed in October and that is how I found out.  She says she still feels weak and not like herself before the shot.  She says she still has back pain. Patient reports ER doctor did not feel the muscle weakness was related to the vaccine.  She did not know the name of the ER doctor.
Rash all over body; within 24 hours. No fever. Calamine lotion and Benadryl
This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown gender and age. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were administered improperly stored doses of VARIVAX injection, lot# reported, expiration date 13-JUL-2018 (dose and route of administration were not reported) for prophylaxis. Digital data logger was involved. It was reported that the vaccines were exposed to temperature of 7.5 Fahrenheit degrees for 2 hours 6 minutes before administration to the patients. No prior temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Cough, sore throat, flushed. Wheezing, AP - 120. Ax - temp 98.3.
Period lasting over 14 days (still on going). Multiple pads filled in a 2 hour window. A piece of uterine lining came out of body, approximately 2 inches long and an inch across.
Palpitations of heart, went to PCP. I will be seeing a cardiologist. I wore a Holter monitor, had EKG.
t103 ax to 104 ax, fussy constant crying swollen lt leg; would not sleep longer than 10 mins @ time;
This was my 2nd vaccination:  Severe pain at the site immediately after injection for 10 minutes, then it subsided until 3.5 hours later when the pain became intense, all of a sudden,  at the injection site  and down the front of the left arm to the hand.  Placed ice pack on the injection site, gave some relief, but not enough.  Unable to sleep throughout the night as each time i rolled on my left, the pain woke me. When i woke up this morning, the day after, i was nauseated to the point where i had to sit down.  Now several hours later, painful left upper arm and can only move arm a few degrees to my left.  I can bend the arm, but that's it.  I had the 1st injection several months ago with  unpleasant side effects, intense itching, redness, swelling, burning, but the pain was nothing like this.  I did file a report on those reactions at that time.
One hour post vax, pt felt weak and light headed. Rested with feet elevated. BP and AP wnl. Pt slept from 5:00pm 05/15/2000 until noon on 05/16/2000. Pt felt achy and tired. Was seen by physician on 05/19/2000 and was diagnosed with sinus/ear infection. No unusually high temperature was noted.
12 hours after vax she woke up frezzing cold and shaking, was dizzy, upset stomach, says she has all covid symptoms, muscle pain, weakness
Fever 101.7, nausea, extreme body aches/fatigue impacting mobility, dizziness
horrible headache all night, feel like I have the flu; horrible headache all night, feel like I have the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 21Mar2021, outcome "not recovered" and all described as "horrible headache all night, feel like I have the flu". Therapeutic measures were taken as a result of headache, influenza like illness. Treatment included Tylenol cold and flu medicine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed hives and itchiness all over his body.; If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Developed hives and itchiness all over his body.) and URTICARIA (If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2022, the patient experienced PRURITUS (Developed hives and itchiness all over his body.) and URTICARIA (If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.). At the time of the report, PRURITUS (Developed hives and itchiness all over his body.) and URTICARIA (If he applies any pressure or lightly scratch his arm or any spot on his body he would break out in hives at the spot.  It will raise up in hives in that area.) outcome was unknown.            No concomitant medication were reported. No treatment details were reported.
The whole Rt upper arm swollen & below the elbow red with a blister upper arm 1cm.
ALCOHOL INDUCED POLYNEUROPATHY HYPOXEMIA  7/1/2022 -- RECURRENCE OF SAME SYMPTOMS
Large (3/4"-1") diameter red, raised, hot area around vaccine site temperature up to 104 degrees for 2 days, treatment with Tylenol.
Customer immediately felt arm hurt, it was hot, then got black and blue, one week later...trouble moving backwards, patient as of now cannot put bra on and cannot fix hair with left arm
Patient received two doses of HIB. One from the PENTACEL and one from PEDVAXHIB. PENTACEL was given in right thigh, and PEDVAXHIB was given in left thigh.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age. ON 20-SEP-2013 the unspecified number of patients might be vaccinated with LIQUID PEDVAXHIB (Lot#, dose and route not reported). The healthcare worker reported that LIQUID PEDVAXHIB were out of temperature range and were not supported by their in house stability data and an unspecified number of patients (no patient information know at that time) might have been administered the vaccines. No adverse effects were reported. No PQC (Product Quality Complaints) was involved. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included were not reported.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This case was reported by a consumer and described the occurrence of positive urine test for marijuana in a 39 year old male subject who was vaccinated with Twinrix for prophylaxis. The reporter is the wife of the subject. A physician or other health care professional has not verified this report. Medical history included hepatitis C. The reporter stated that the subject, "is not a drug user." Concurrent medications included Ibuprofen. On an unspecified date in January 2006, the subject receive the 1st dose of Twinrix. On an unspecified date in January 2006, approximately "two weeks before the 2nd dose" of Twinrix, a "drug test was negative." On 12 February
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient felt dizzy, lightheaded and then began seeing spots and proceeded to faint about 5 minutes after receiving vaccine.  He attributes it to getting worked up just before vaccine.