chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 16th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th September 2018, 102 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: he patient was diagnosed with shingles on 26th September 2018 (reporting date). The health care professional stated that the patient was prescribed Valtrex to treat shingles.
Information has been received from a Licensed Visiting Nurse concerning a 23 year old female who on 05-JUL-2007 was vaccinated with Gardasil (Lot #0469U). On 05-JUL-207 the prefilled syringe plunger locked when the patient was administered the injection. The patient's arm bled a small amount when the needle was removed. Additional information has been requested.
administered the adjuvant component of Shingrix only.; administered the adjuvant component of Shingrix only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 27th August 2021, the patient received the 1st dose of Shingrix. On 27th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional detaails were provided as follows: The medical assistant reported that, the patient was administered the adjuvant component of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Pt was given the Moderna original booster shot instead of the bivalent booster shot.
suspected vaccination failure; got it after/ the shot; debilitating pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle shot and got shingles.  The reporter stated that they were painful and over two months of debilitating pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter US-GLAXOSMITHKLINE-US2021AMR179367:same reporter
Patient apparently experienced difficulty breathing for several days at home.  When EMS arrived at home on 9/3/2021, she was in respiratory distress and did not respond to BiPAP reportedly.  She was endotracheally intubated in the field.   Evaluation in the emergency room revealed positive rapid COVID-19 testing.   She was weaned off the ventilator on 9/4/2021.  She received dexamethasone.  She was also treated for fluid overload with fluid restriction, furosemide, and hemodialysis.   She was discharged on 9/7/2021.
The needle hub failed at the end of the injection, such that a couple of drops of the vaccine ran down my arm
Within 2 days after immunization pt had confluent rash medial arms bilaterally and lateral trunk and upper thighs bilaterally also feverish.
63-year-old male with a medical history of hypertension and rheumatoid arthritis reports to the ER today with complaints of shortness of breath. The patient reports that Friday he started not to feel well he was coughing and over the weekend he developed shortness of breath.   This morning he went to see his primary physician who instructed the patient come in urgently to the ER. Here in the ER the patient retested for covid19 it was positive patient noted to have oxygenation of 96% and tachypnea into the 20's as well as tachycardia 116. Chest x-ray completed shows bilateral infiltrates. Labs were significant for elevated D-dimer of 361, INR 1.21, elevated AST. The pt is vaccinated with Moderna.  Patient received IV fluids and Lovenox in the ER, CT of the chest was done not yet resulted will follow-up.  Admit to tele for covid management.
Pregnant patient received the 1st shot of Moderna vaccine; soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st shot of Moderna vaccine) and VACCINATION SITE PAIN (soreness at injection site) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-May-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st shot of Moderna vaccine) and VACCINATION SITE PAIN (soreness at injection site). On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st shot of Moderna vaccine) had resolved. On 19-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.
Received Tdap & Varicella on 8 Nov in (R) arm. On Monday 14 Nov, (R) arm was red and tender and swollen. Wen to doctor. Dx w/ cellulitis Temp 98.4 B/P 100/72 P: 90. Given CLEOCIN 600 mg IM & Tramadol for pain Rx Clindamycin 150 mg x 80 tabs.
Mother stated that approx 3 hours after vaccines were given, child's Right deltoid was swollen by 1 1/2" wide, red, and warm to touch.  Noted that DTaP was given in (R) deltoid.  Mother got concerned over the weekend and on 4/9/2007 took child to Dr.'s office to be checked out, which Dr. gave her some medicine and also diagnosed with start of ear infection.
Pt appears to have the onset of Paranoia, and hearing voices following receipt of the Covid Vaccine.  She did not have any of these symptoms in her prior history.  According to her, and her sister, it seems to have started since receiving the vaccine
The pt experienced swelling and redness, some itching and not much pain to the injection site. Saw MD and was considered a severe reaction. Treated with Benadryl and Prednisone, epinephrine.
On 6/17/11 Pt rec'd DTaP, HIB, PCV13. On 6/18/11 Pt had hyporesponsive-hypotonic reaction = temp 105 degrees, limp, no tonic-clonic movements. To ER via ambulance.
This case was reported in a literature article and described the occurrence of influenza A (H3N2) in a child male subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). This case refers to patient 1 in the literature article. The subject had an underlying medical condition which was not specified. The subject had no exposure to swine prior to illness onset but did have contact with a caretaker 2 days before onset who reported direct contact with healthy-appearing swine over the previous several weeks. No respiratory illness was identified in any closed contacts, including the caretaker and the caretaker's family. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). On 23 July 2011, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced fever, cough, congestion (nos), fatigue. Upper respiratory viral infection was diagnosed and released without receiving influenza antiviral medications. The subject was hospitalised subsequently due to influenza A (H3N2). At the time of reporting, the events were resolved. Summary of the literature article: During August 2011 until April 2012, 13 human infections with Influenza A (H3N2) variant (H3N2v) virus were identified; 8 occurred in the prior 2 years. This virus differs from previous variant influenza viruses in that it contains the MATRIX (M) gene from the Influenza A (H1N1) pdm09 pandemic influenza virus. A case was defined as a person with laboratory-confirmed H3N2v virus infection. Cases and contacts were interviewed to determine exposure to swine and other animals and to assess potential person-to-person transmission. The median age of cases was 4 years, and 12 of 13 (92%) were children. Pig exposure was identified in 7 (54%) cases. Six of 7 cases with swine exposure (86%) touched pigs, and 1 (14%) was closed to pigs without known direct contact. Six cases had no swine exposure, including 2 clusters of suspected person-to-person transmission. All cases had fever; 12 (92%) had respiratory symptoms, and 3 (23%) were hospitalized for influenza. All 13 cases recovered. The author's conclusion stated that H3N2V virus infections were identified at a high rate from August 2011 to April 2012, and cases without swine exposure were identified in influenza-like illness outbreaks, indicating that limited person-to-person transmission likely occurred. Variant influenza viruses rarely result in sustained person-to-person transmission; however, the potential for this H3N2v virus to transmit efficiently is of concern. With minimal preexisting immunity in children and the limited cross-protective effect from seasonal influenza vaccine, the majority of children are susceptible to infection with this novel influenza virus.
PATIENT RECEIVED VZV ON 7-21-09 AND DISCOVERED SHE WAS PREGNANT ON 7-30-09.
Received a dose of MMR that had expired on 1/12/22.  No adverse evert/treatment given
DVT on the left leg was diagnosed and confirmed with an ultrasound.  Medication currently taking is a blood thinner (ELOQUIS 5mg twice a day)
Given: PREVNAR 13 11/5/15, localized allergic reaction (R) upper arm. Complaining of red, swelling and warmth (R) upper arm. Treated with diphenhydramine 25mg tablet. Use as needed.
warm to the touch at injection site; redness; significant itching; vertigo-like, head rush, like going down a roller coaster; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo-like, head rush, like going down a roller coaster), INJECTION SITE WARMTH (warm to the touch at injection site), ERYTHEMA (redness) and PRURITUS (significant itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VERTIGO (vertigo-like, head rush, like going down a roller coaster). On an unknown date, the patient experienced INJECTION SITE WARMTH (warm to the touch at injection site), ERYTHEMA (redness) and PRURITUS (significant itching). On 09-Jan-2021, VERTIGO (vertigo-like, head rush, like going down a roller coaster) had resolved. At the time of the report, INJECTION SITE WARMTH (warm to the touch at injection site), ERYTHEMA (redness) and PRURITUS (significant itching) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Dizziness; Weakness; Chills; Mild headache; Muscle pain at injection site; Nausea; Vomiting; Fever; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Mild headache) and INJECTION SITE PAIN (Muscle pain at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Mild headache), INJECTION SITE PAIN (Muscle pain at injection site), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Mild headache), INJECTION SITE PAIN (Muscle pain at injection site), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The patient was taken to the ER for observation on 10 Mar21 from 10am-6pm.  The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.  No treatment medication was reported.
patient received expired dose of MENACTRA vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via call-center via Global Medical Information (GMI) (Reference number- 00545117) and transmitted to Sanofi on 01-Apr-2021 in the United States.  This case involves a 16 years old male patient who received expired second dose of 0.5 mL MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [strength: standard, frequency: once, batch number: U6565AB and expiry date: 28-Mar-2021 via intramuscular route in deltoid not otherwise specified (NOS)] (expired vaccine used) on 30-Mar-2021 for prophylactic vaccination.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to expired product administered (latency: 1 day).  At the time of reporting, no adverse event was reported.  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 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.
This case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose). Concurrent medical conditions included type I diabetes mellitus. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced blood glucose increased. On an unknown date, the outcome of the blood glucose increased was unknown. It was unknown if the reporter considered the blood glucose increased to be related to SHINGRIX. Additional details were provided as follows: The patient asked whether it was common for a type 1 diabetic to get an elevated blood glucose after receiving the SHINGRIX vaccine. The patient's blood glucose was elevated much like when she had taken prednisone. The patient assumed it was a stress response and the patient did not remember it getting this after her first dose. Lab Comments: On an unknown date, the patient's blood glucose level was elevated.
c/o severe pain night of day received shot in Right deltoid.  c/o pain radiation from shoulder down to antecubital space and around to shoulder blade.  Also had runny nose and sniffles. On a 1-10 scale of pain, that night it was an "8."  He could only lift his arm half way to shoulder level.  No swelling at time he called (10 days later on the 28th of Oct.), but had a light brown circular bruise.  As of Nov 4, 2011, still cannot raise his arm past 90 degrees.  It's feeling slightly better. On Nov. 1 he was seen by a doctor, had an EKG and a shoulder x-ray.  Both were WNL.  He is feeling slightly better today (Nov. 4, 2011).
Vomited twice; Low grade fever on and off; Doesn't have an appetite; Forehead doesn't have temp but cheeks do; Feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Doesn't have an appetite), FEELING HOT (Forehead doesn't have temp but cheeks do), FATIGUE (Feeling tired), VOMITING (Vomited twice) and PYREXIA (Low grade fever on and off) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DECREASED APPETITE (Doesn't have an appetite), FEELING HOT (Forehead doesn't have temp but cheeks do), FATIGUE (Feeling tired) and PYREXIA (Low grade fever on and off). On 06-Mar-2021, the patient experienced VOMITING (Vomited twice). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Doesn't have an appetite), FEELING HOT (Forehead doesn't have temp but cheeks do), FATIGUE (Feeling tired), VOMITING (Vomited twice) and PYREXIA (Low grade fever on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included blood thinners and blood pressure medications.
thought she was going to die; sick just under 4 days after second dose; fever/ high fever; Vomiting; Diarrhea; soaking wet; arm ache; Headache/felt like someone was hitting her in the head with a hammer; Backache; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200417698 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 10:00 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 22Jan2021, when the patient was 70 years old, for COVID-19 Immunization, reaction(s): "had an extremely sore arm". The following information was reported: ANXIETY (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "thought she was going to die"; ILLNESS (non-serious) with onset 13Feb2021 03:00, outcome "recovered" (17Feb2021), described as "sick just under 4 days after second dose"; PYREXIA (non-serious) with onset 13Feb2021 03:00, outcome "recovering", described as "fever/ high fever"; VOMITING (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Headache/felt like someone was hitting her in the head with a hammer"; BACK PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Backache"; PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "body ache"; HYPERHIDROSIS (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "soaking wet"; PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "unknown", described as "arm ache". Relevant laboratory tests and procedures are available in the appropriate section.   Reporter Comment: When she got her first vaccine she had an extremely sore arm, 21 days later she got her second dose. She thought she was going to die, she was sick just under 4 days, 3 days and a quarter and it finally stopped. She got the shot at 10:00 went to bed at 22:30 at 03:00 she had a high fever, was soaking wet, then began vomiting and then she had diarrhea. Then she got back to bed where she continued with fever, headache, felt like someone was hitting her in the head with a hammer, back ache, arm ache and she laid that way for 3 days. 15:30 in the afternoon about three days later, the fever started going down, a couple hours after that symptoms, backache, body aches, and headache went away, just under 4 days later.   The lot number for bnt162b2 was not provided and will be requested during follow up.
have reactions to their recent botox injections; This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague. This consumer reported similar events for 2 patients. This is 1st of two reports.   A patient of unspecified age and gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had reactions to their recent injections on an unspecified date. Reported as "They provide various services. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042317 Same reporter/ drug/ event for different patients
Headache, nausea, chills, fever, weakness, loss of appetite, unusual vivid thoughts (while awake), insomnia, muscle aches, unable to sit or stand upright on days 1-2. diarrhea, fatigue and weakness on day 3
2 hours after 3rd dosage of Hep B vaccine pt reports breaking out in hives, face, UE's, LE's trunk, relieved with Benadryl.
Cellulitis of left arm following administration of influenza vaccine and Tdap vaccine in left arm on 12/2/14.  Treated with Keflex tid for 10 days on 12/5/14.