chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lowest temperature reached 23.7 degrees Fahrenheit and total time out of range unknown with no AE; Initial information regarding an unsolicited Non-valid non-serious case was received from a Other Health Professional via The Company (Reference number-00384919) and transmitted to Sanofi on 08-Dec -2020 via call-center.  This case involves a patient with unknown demographic detail was received vaccine QUADRIVALENT INFLUENZA VACCINE [FLUZONE QUADRIVALENT] (lot and expiry date were unknown), POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot and expiry date were unknown) and INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] (lot and expiry date were unknown) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to product storage error (latency: unknown).  At the time of report, 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.
immed pain from site of puncture in lower lt deltoid up shoulder into neck, also 2x2cm local swelling; also became tight in chest w/ clear exam & pain in lt jaw (coincidental aphthous ulceration;
11/10/2016 @ 0918 I got a call from the patient reporting that she noticed some swelling at her HPV vaccine injection site on right deltoid last night around 6 pm that looked like a mosquito bite. Her arm hurt throughout the night and now her entire arm is red (she denied a splotchy or rash-like appearance), it is swollen from her deltoid nearly halfway down to her elbow, and it itches. She reports that her right pinky is slightly tingly. She denied any known medical conditions and denied any known allergies. She reports that she didn't have any reaction with either of the previous 2 doses of HPV vaccine she has received.  I recommended that she try taking some diphenhydramine and go to an urgent care or her primary care provider today.
Frozen shoulder, couldn't lift arm up past 45 degree angle. Lump on collar bone. Deep aching shoulder pain constantly even at night.
This spontaneous report was received from a licensed practical nurse and refers to a 9 week old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
A report was received from a health care professional on 10/28/2003 concerning a female vaccinee of unspecified age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/27/2003 and injection site swelling and redness and unspecified length of time after vaccination. On 10/27/03 the vaccinee experienced overwhelming pain at the injection site. The vaccinee also experienced injection site redness and swelling on an unspecified date. An ice pack was applied and the pain decreased to soreness. The vaccinee had a prior history of influenza vaccination with no adverse events. the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporters causality assessment. Update 1, 03/01/04: Follow up information received from a health care professional indicated that a 52 year old female vaccinee experienced pain at the injection site running down her arm on 10/23/03 following Flurvirin vaccination. The event lasted approximately 30 minutes and resolved on the same day. No follow up pending. Cross reference with: PJP200300925, PJP200300927, PJP200300928, PJP200300929,PJP200300930.
Arm very sore. Soreness in shoulder and back, 1st night - fever, aches, fever for about 2 days. No energy some sinus problems lasted for about 10 days.
This 41-month-old male received 3 doses of Haemophilus b conjugate vax. Subsequent to the 3rd vax on 02/28/1992, he developed bacteremia related to vax failure. A blood specimen indicated Haemophilus influenzae type B. Upon internal review, the pt's experience was considered to be an "other medical event."  The reporter indicated that the pt "survived" the experience. No further information is available.
65m received J&J vaccine, 10 minutes after admit c/o a gripping pain mid sternum, a 2 on scale of 1-10. Pt brought ot observation area, pain non changing after 15 minutes, eval'd by on site EMS. Transferred to ED for eval. Pt notified his daughter prior to leaving vaccine clinic. He had no complaints of other symptoms.  Per electronic health records, pt drove himself to ED.
Deep aching pain in upper arm, started 9/25/02. Doctor ordered Celebrex, hot compresses and physical therapy.
Pt received Pneumcocal vac in the L deltoid and next 6 hours she had extreme pain an inflamation at injection site. Treated with TYENOL. pt advised to to with cold pack and ibufofen and return if symptoms worsen or notify phyiscian. She notified us on 10/27 and notified that she is fine. Dr notified, pt recovered.
torso was itchy; red dots under the injection site; Off label dosing frequency; swollen lump at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (torso was itchy), RASH PAPULAR (red dots under the injection site), OFF LABEL USE (Off label dosing frequency), INJECTION SITE SWELLING (swollen lump at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, AMIODARONE, BIOTIN, METOPROLOL TARTRATE, SODIUM BICARBONATE, VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN D3 for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (torso was itchy), RASH PAPULAR (red dots under the injection site), OFF LABEL USE (Off label dosing frequency), INJECTION SITE SWELLING (swollen lump at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, PRURITUS (torso was itchy), RASH PAPULAR (red dots under the injection site), OFF LABEL USE (Off label dosing frequency), INJECTION SITE SWELLING (swollen lump at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided Caller also stated that they received the second dose 2 weeks after the first dose (approximately 12March2021).Patient ok for safety follow-up.   This case was linked to MOD-2021-076698, US-MODERNATX, INC.-MOD-2021-076698 (E2B Linked Report).; Sender's Comments:  MOD-2021-076698:2nd dose US-MODERNATX, INC.-MOD-2021-076698:first dose
Pain in upper right arm down to elbow, swelling, redness and tender to palpation from 4cm-5cm under axilla to antecubital fossa. Treated with Keflex for questionable cellulitis.
Severe lethargy for about 12 hours, severe abdominal cramping for about 72 hours Moderate-severe arm pain at injection site and all down arm for about 24 hours
Information has been received from a physician concerning a 7 year old female who on 01/27/1998 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  Concomitant vaccination on the same day included a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 04/30/2004, the patient developed a full case of chickenpox approximately six years after the vaccination.  Subsequently, the patient recovered.
Given VZV vaccine 5/24/17. Pt with varicella 5 days later (fever and lesions).
pt recv vax 18JUL96 & w/in 30 to 60seconds pt exp cough, inspiratory stridor, paresthesias, throat swelling/choking feelings, & pallor;pt tx in office for anaphylaxis & transported to ER;pt tx w/epi & DPH, solu-Cortef & 02;pt recovered
Pt was ro receive 1st dose of Varicella and 1st dose of MMR. Accidentally gave PROQUAD MMRV (which is a new vaccine to our clinic) instead if MMR and Varicella. The PROQUAD MMRV has Varicella in it, so pt received a double dose of Varicella. This was reported to my supervisor, the the pt's PCP and an occurrence report was filed. I informed pt's mother of mistake. She said that the pt is doing fine and was not having any adverse reactions.
Mom reports pt awoke from a nap approx 3 hrs following vax; Had fever 102; seemed "unbalanced & not able to keep head up"; lasted approx 15 mins; Took pt to ER where was given Tempra for t103; was alert & active; irritable but consolable;
Received MMR vaccine and Varivax vaccine on 3/4/06. Seen in the office 3/16/06 with fever and falling to one side. Has lost motor skills. Admitted to Hospital and transferred to another Hospital for tertiary care. Dx: Disseminated encephalomyelitis. 4/5/06 Other Correspondence  Add "very irritable" since hospital d/c. 4/28/06 Review of 16-page medical record (ER record) from intial facility. Final diagnosis was ataxia. Transferred to another hospital. Also reviewed d/c summary and confirmed ADEM by MRI on 3/17/06.
severe headache. severe Body pain. I woke at the middle of night with severe short  of breath. The short of breath lasted proximally 10 minutes. My heart rate was very high. I sweated a lot all night. I had shaking chills for three nights. I Had  Back pain. ( days lates i have flue like symptoms.
Short term memory; brain fog; sleeping a lot; out of breath; This is a spontaneous report from a non-contactable consumer reported for himself. This 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC 59267-1000-01) via unspecified route of administration on 14Aug2021 01:00 AM at the age of 79 years old at single dose for COVID-19 immunization. Medical history included patient was diagnosed with COVID-19 prior to vaccination. No known allergies. Concomitant medications included triamterene, HCTZ. The patient experienced short term memory, brain fog, sleeping a lot, out of breath on 16Aug2021 with outcome of not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Patient was given a pediatric dose of Pfizer instead of an adult dose for her booster.  As per CDC website patient was given a repeat dose of the pediatric Pfizer.
On April 8th, I received my 2nd Phizer vaccination and on Tuesday, April 13th, around 5:00 pm,  I began feeling extremely tightness and chest pain.  It also felt like a heavyweight was on my chest cavity. The symptoms continued the next day. On Thursday, I went into Urgent Care and described my symptoms and questioned whether I could have a blood clot, and the physician's assistant dismissed my symptoms 'stating that it was the J&J vaccine, not the Phizer that contributed to blood clots."  I asked for a chest x-ray and it was denied.  The PA checked my lungs and stated that everything sounded fine and prescribed an inhaler.  I also requested a covid-19 test, suspecting that I may have been exposed to the virus --- the test results were negative.  The symptoms continued for weeks on end and did not dissipate.   On May 29th, I sought medical attention on 5/15, and 5/20 & 5/21.  On  5/20, I was diagnosed with pericarditis.
Symptoms started on 2/4 SOB, nausea, diaphoretic. Pt admitted on 2/5 with STEMI with stent placement and thrombectomy
Nausea, vomiting, light headed, fever, chills, body aches, headache, shaky
"it" has gotten worse since the vaccines/Suspected vaccination failure; "it" has gotten worse since the vaccines; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The patient self-reported this case through a voicemail for Shingrix vaccine. The reporter did not spell her name or address. The patient received both the Shingrix vaccines and stated it (shingles) gotten worse since the vaccines. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Had both shots but still got it/Suspected vaccination failure; Stomach seizures; Still got it / left side / attacking my stomach; Rash; Back pain; Excrusiating pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), gastrointestinal disorder, shingles, rash, back pain and pain. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the vaccination failure, shingles, rash, back pain and pain were unknown and the outcome of the gastrointestinal disorder was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, gastrointestinal disorder, shingles, rash, back pain and pain to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 27-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both shingles shots but still got shingles bad. The patient went to ER (emergency room) with back pain but they never took his/her tee-shirt off so did not see the rash so it was misdiagnosed and they sent him/her home with muscle relaxers.  The patient went to doctor 3 days later because it had gone around his/her left side and across half his/her stomach attacking his/her stomach.  The patient had excruciating pain. The patient stated that, it had been 2 years and still had stomach seizures daily. Additional Supportive Information: This case was considered as suspected vaccination failure as 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. Note: As it was not clear what kind of stomach seizure patient had after the vaccination so it was coded with gastrointestinal disorder conservatively.
Excessive Fatigue, intermittent nausea, intermittent headache, painful enlarged (3-inch in diameter) red and warm to touch lymph node under left arm. Initially was one inch in diameter, grew over two days to 3 inches since today. Painful enough to awaken me during sleep.    Ibuprofen used to control pain and headache. It eased but did not relieve pain. I have never had an allergic reaction to the flu vaccine except a little soreness at the injection site.
Client did not disclose that they had already recieved a dose of Janssen vaccine on 4/30/21 Lot # 201A21A from another provider. Requested  a dose of Pfizer vaccine as his first dose, and it was administered as requested.
Inject site tiredness; Headache; Muscle ache; Arm pain; Nausea; Vaginal pain; Vaginal cyst; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 13:00 (Lot number: Fc3183) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline"; Sulfa, reaction(s): "known allergies: Sulfa", notes: Verbatim: Sulfa; Oxycontin, reaction(s): "known allergies: OxyContin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Sep2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Inject site tiredness"; HEADACHE (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Arm pain"; NAUSEA (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Nausea"; VULVOVAGINAL PAIN (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Vaginal pain"; VAGINAL CYST (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Vaginal cyst"; FATIGUE (non-serious) with onset 05Oct2021 12:00, outcome "unknown", described as "Tiredness". The events "inject site tiredness", "headache", "muscle ache", "arm pain", "nausea", "vaginal pain", "vaginal cyst" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site discomfort, headache, myalgia, pain in extremity, nausea, vulvovaginal pain, vaginal cyst, fatigue. Additional Information: There was no other vaccine in four weeks. There was no covid prior vaccination, neither tested for covid post vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the event was treatment.  Follow-up attempts are completed. No further information is expected.
Significant increase in joint pain, particularly in knees, shoulders, and hips began within a couple weeks of receiving the vaccine. Pain has not decreased since it had begun. I have had multiple blood tests for joint related disorders and autoimmune diseases and all results have come back negative. Due to increasing pain and now frequent dislocations in knees and shoulders I have just recently been diagnosed with Ehlers Danlos Syndrome so I can receive better care through physical therapy.
Same Day: Headache, dizziness, tinnitus, Headache 3-4/10 constant, - worse when looking at computer screen/phone,  ringing in ears constant. Diffuse hyperesthesia, fever, bifrontal headache, nausea, vomiting, arthralgia, fatigue, chest pain, fatigue, local injection site pain, myofascial trigger point pains in neck and back, vertigo and aphasia. As of today - 2/11/2021 - only headache, tinnitus, and balance issues continue..  2/4/2021 - Prescribed Zofran, patient reports taking ibuprofen and acetaminophen sparingly.  (virtual appointment) 2/8/2021 - Seen in clinic - continues to have all symptoms. Given fioricet and referred to neurology for migraine variant, intermittent vertigo.  2/10/2021: virtual - no relief in symptoms, changed to ASAP neurology consult.  2/11/2021: - Ordered - ASAP Brain MRI
Felt nauseated immediately after shot, then: Piercing headache, chills, fever, three days, little better, then hit again with headache, chills.  Just felt really, really sick. . . slept a lot.
usual flu vaccine on 2/12/07, the night of injection got severe pain, swelling in arm, but no fever, SOB, hives or other reaction
diarrhea; Really sick; headache; nausea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ILLNESS (Really sick), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-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. On 23-Nov-2021, the patient experienced DIARRHOEA (diarrhea), ILLNESS (Really sick), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), ILLNESS (Really sick), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            No Concomitant medication details were provided. No Treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received on 24-Nov-2021 contains no new information.
After receiving shot, Infant slept for approx 1 hour and then woke up screaming and cried an unnatural high pitched scream non stop for approximately 5 hours. Could not be soothed with nursing, bath or Tylenol etc.