chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she can't lift her right arm; started to get pain; inflammation; damage to my shoulder; pain to her shoulder; frozen shoulder; can't lift her right arm; getting very bad; she can't work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EW0158) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: she has had this many years. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown, LOT: ER8732, first dose injected in her right arm), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "Caller says after her first dose she had a little pain and fever but that dose was fine. She says her first dose was fine, it hurt but got better in a few days", "Caller says after her first dose she had a little pain and fever but that dose was fine. She says her first dose was fine, it hurt but got better in a few days". The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "damage to my shoulder"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain to her shoulder"; PERIARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "frozen shoulder"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "can't lift her right arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "getting very bad"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "she can't work"; LIMB DISCOMFORT (non-serious) with onset Apr2021, outcome "not recovered", described as "she can't lift her right arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "started to get pain"; INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "inflammation". The events "damage to my shoulder", "pain to her shoulder", "frozen shoulder", "can't lift her right arm" and "getting very bad" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of musculoskeletal discomfort, arthralgia, periarthritis, limb discomfort, condition aggravated, pain, inflammation.  No follow up attempts are possible. No further information is expected.
No Adverse event- patient received Covid 19 bivalent pfizer vaccine that had been at room temperature for 72 hours.
I received my vaccine at 8:40 am on 1/6/20. By that evening I noticed I was having decreased urine output. Starting Thursday morning I had very minimal urine output for18 hours. I also had flank pain. During this time I also had a fever, body aches, etc. I am an ED nurse and knew to hydrate myself. I hydrated all day and evening. Thursday night I had no urine output for 6+ hours. Starting Friday morning I had minimal urine output and it was brown tinged. As the day progressed my output increased slowly and changed from brown to pink/orange. I continued to hydrate drastically. Saturday morning my urine was pale yellow and clear and my pain was gone. I believe I had an acute kidney injury.  Fortunately I knew to drastically hydrate and maintain that.
A report was received from a health care professional on 10/29/03 concerning an unspecified number of vaccinees of unspecified demography who experienced localized hives, swelling, redness and itching an unspecified length of time after receiving Fluvirin on an unknown date. The reporter noted many more local adverse effects than usual with the 2003-2004 Fluvirin. It was not reported if the vaccinee's had recovered at the time of the report. There was insufficient information to determine the reporter's causality. Update 1, 02/16/2004: A follow up report was received from a health care professional indicating that a female vaccinee of unspecified age developed redness and swelling at the injection site which was warm to the touch on 10/28/03, 1 day after receiving Fluvirin on 10/27/2003. The vaccinee also developed a fever of 100F. The outcome of the adverse events was not reported at the time of reporting. Update 2, 04/16/2004: Further information was received from a health care professional which indicated that the vaccinee's symptoms resolved and no further symptoms were reported as of April 2004. No follow up pending, all information received. Cross reference with: PJP200400141, PJP200400142, PJP200400143, PJP200400144, PJP200400145.
Patient received vaccine on 12/4/2018. On 12/5/18 she reported that her arm really hurt and it was a little red at the shot site. On 12/7 she came to the pharmacy again and the redness was larger than on 12/5 but still within the limits of a normal reaction to a vaccine. She was advised to mark with a black marker and if the redness spreads further to follow up with her physician. On 12/8, she went to the doctor and they diagnosed cellulitis. Treament with Cephalexin for 10 days.
Case number PHEH2013US021740 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a 17-year-old female patient. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 01 May 2013 (at 14:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. Her mother declined to revaccinate with MENVEO.
Symptoms similar to when i had covid very bad last march. Fever feeling, headache, achy, tired, sore feet, brain fog.
Dizziness, blurry vision and calf cramps and pain on left leg. Swelling on both knees but mainly on the left one.
Mom states that p/last DTP shot 5JUL90, child had a fever of 104; Given APAP fever down to 101; Mom took child to ER;
Dizziness began at 9:15 p.m.  and lasted throughout the night.  It is better this morning.  Joint pain kept me awake most of the night.  (all joints, especially neck)  Joint pain is better this morning, but it has not completely resolved.  Extreme soreness at the injection site (no redness or swelling, just very sore and trouble lifting arm).
Got COVID-19 again testing positive on 2 tests; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID-19 again testing positive on 2 tests) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Osteoarthritis, Penicillin allergy (Penicillin), Drug allergy (Keflex), Drug allergy (Cipro) and Sulfonamide allergy (Sulfa).   On 15-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 06-May-2022 at 4:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Got COVID-19 again testing positive on 2 tests). On 13-May-2022, COVID-19 (Got COVID-19 again testing positive on 2 tests) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The patient was not taking any other medications/ products within 2 weeks of starting COVID-19 treatment. It was reported that device date was 23-May-2022.  Company comment. This spontaneous case concerns a 75  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 7 months after the third dose of mRNA-1273 vaccine (Drug ineffective was considered since the first two doses were administrated in a correct interval of time). The report stated that the patient received treatment with Paxlovid for COVID  19, and 2 weeks after she finished Paxlovid treatment, she tested positive again on two tests. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 7 months after the third dose of mRNA-1273 vaccine (Drug ineffective was considered since the first two doses were administrated in a correct interval of time). The report stated that the patient received treatment with Paxlovid for COVID  19, and 2 weeks after she finished Paxlovid treatment, she tested positive again on two tests. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Description: I received AVA # 2 12 days ago and had some arm soreness and a low grade fever. What I am concerned about is that within 24 hrs I developed a cough with phlegm and felt like I was catching a cold. this went away and then returned. No fever now but cough and congestion continues. No body pains, but reports sore throat, sinus pressure, post nasal drip, slight stuffy nose and some ear pressure. he is new to the area and has had childhood allergies to dust and certain pollen. Grew in another state. Other than soreness no problem with AVA # 1. Wondering if AVA is causing his problems. Symptom: Cough, productive Start: 01/24/2008; Symptom: fever start: 01/24/2008; Symptom: Nasal Drainage Start: 01/24/2008; Symptom: Ear Pain Start: 01/24/2008; Symptom: Pain Start: 01/24/2008 Comment: throat pain/sore throat.
Pt. states that after receiving the 1st dose of Moderna 07/01/2021, started the experience a spotting period from the 17th continuing with hot flashes, migraines, possible chills. No primary visit noted.
mild sore throats; This is a spontaneous report from a contactable consumer via Medical Information Team. This consumer reported similar events for two patients (himself and partner). This is the second of two reports.   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild sore throats, no fever on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324235 same drug/reporter/event and different patient
pt recvd vax & 12 days later exp a burning sensation on the rt side of neck w/pain radiating down the rt arm;
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (soreness). At the time of the report, ARTHRALGIA (joint pain), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medications were not provided by reporter. Reporter did not allow further contact.
Arm is still sore several weeks after injection. No treatment has been sought. Muscle soreness at the area of injection.
Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The batch number was updated from 57EX3 to 57EX2, as per sales data sheet. The patient received Shingrix and experienced pain at the injection site, it had been almost a month and the patient has not recovered The reporter consented to follow up. The HCP mentioned that patient would not be receiving dose 2 of the Shingrix due to adverse events after dose 1.  This AE was reported previously.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202988:FU1 deleted
This spontaneous report as received from a nurse refers to an unspecified number of patients, also reported as less than 10 patients if any (nurse was unable to say for sure if PNEUMOVAX 23 was administered), of unknown age and gender. No patient information was available. On an unknown date, the patients might have been vaccinated with a dose of PNEUMOVAX 23 (lot # J004747, expiry date 20-JUL-2014, dose, frequency, route and site of administration not specified), which was out of temperature range and not supported by in house stability data, also reported as exposed to unknown temperatures for 17 days in an unmonitored refrigerator that did not have a power failure. No adverse effects were reported. Additional information has been requested.
Fever day 1. Extreme body aches day 1, worse than when actually sick with COVID. Dizziness day 1. Migraine day1.  Day two arm and lymph node next to arm real sore. Migraine. Worse dizziness. Body aches not as bad
Redness, swelling, pain, at site of injection at left upper arm. No fever.  Seen in office 8/17/2012 and treated with prn Benadryl and ibuprofen.
A red, swollen, and tender rash appeared around injection site 8 days after injection.
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was not provided.  On 13-SEP-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1707457, expiration date 23-FEB-2022 (dose number and dose were not reported) for prophylaxis (product storage error).  The vaccine administered to the patient was stored improperly on 10-SEP-2021, in the temperature 48.7 degrees Fahrenheit (F) for a time frame of 10 minutes. There was no previous temperature excursion. The outcome was unknown.
developed bone cancer in the injection arm at the site; Bone metastasis; This is a spontaneous report received from contactable reporter(s) (Physician).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (unspecified if ongoing); "nephrectomy", start date: 2008 (unspecified if ongoing), notes: The patient has had a nephrectomy 15 years ago. The patient's concomitant medications were not reported. The following information was reported: BONE CANCER (medically significant), outcome "unknown", described as "developed bone cancer in the injection arm at the site"; METASTASES TO BONE (medically significant), outcome "unknown", described as "Bone metastasis".  Clinical course details: The reporter is an oncologist and he said that he had a patient that had kidney cancer. The patient has had a nephrectomy 15 years ago and had no problems with any metastasis or cancer until he received the COVID-19 vaccination and the reason he told, it was related to the vaccine with his advancing and his recurrence because he developed bone cancer in the injection arm at the site, Bone metastasis.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported events cannot be excluded. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.
This spontaneous report as received from a nurse refers to a 24 year old female patient. The reporter stated that the patient received her first dose of GARDASIL inj (lot# and expiration date not provided) (dose not reported) on 03-DEC-2007 and her second dose on 18-JUN-2008. No adverse effects were reported. Additional information has been requested.
patient woke up 6 days post injection, with pain in calves, and over past 24 hours, it  has spread into her joints, knees, arms, hands.
On 6-30-03 patient reported right hand tremor. Seen by PCP on7/21/03 with several month history of right arm weakness. MRI Normal. Referred to neurologist for further evaluation. Given a diagnosis of Parkinson's and treated with Artane 2mg BID and CoEnzyme Q-10. Symptoms slightly improved but will be further evaluated at clinic 8/28/2003. Vaccinated on left arm. 60-day follow up on 12/02/2003: "Vaccine recipient has recovered from adverse events that were reported for this vaccination."
No previous trouble or sickness. 6:00 AM the following morning had diarrhea. This continued for four days. That is all.
chest tightness, none, lasted a few minutes, but occurred again a couple of hours later.
Given PREVNAR 13 on 12/9/2014 and had a "grapefruit" sized area of redness that lasted x 3 days. Also had myoclonic jerks x 1 night. (Pt just reported to our office at a recent visit).
Tested positive for Covid-19 7/26/2021 and admitted to hospital 7/31/2021 with SOB and difficulty breathing, with cough and fever. Hypoxemic respiratory failure secondary to Covid-19 PNA. Discharged 8/2/2021 and readmitted 8/5/2021 and placed on CMO.
5/20/09 received telephone call from mother, pt. had received vaccines-Hep A #1;MMR #2 & Varicella #2 on 5/11/09. On 5/18/09 pt. received Td booster, IPV #4 as child was going to be excluded from school for not meeting school law. On 5/19/09 pt. "developed rash on face, arms & chest, appeared as needle points-swollen, red & hard. Child was seen at PCP's office 5/19/09, he prescribed benadryl, tylenol or ibuprofen prn pain.
Resulted in ER visit due to concerns of bowel obstruction; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; GI symptoms  (nausea; vomiting; severe pain/cramps; constipation) after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 27Feb2021 at 10:15 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma, endometriosis, food sensitivity to eggs and wheat, all from an unknown date. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop dates were not reported and an unspecified birth control pill. In Mar2021, the patient experienced gastrointestinal (GI) symptoms (nausea; vomiting; severe pain/cramps; constipation) after the 1st dose. Resulted in emergency room (ER) visit due to concerns of bowel obstruction. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized for all events for 5 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03Mar2021, 11Mar2021, 13Mar2021, Mar2021, 02Apr2021, 05Apr2021, 21Apr2021, 24Apr2021, Jul2021 and Jul2021. Therapeutic measures were taken as a result of all events. The outcome of the events was not recovered.
Excruciating pain in my left hip making it extremely painful to walk. It hurts when I am laying down or sitting. I have been taking Motrin every 6 hours with minimal relief.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Jan2023 to 22Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.