chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 32.46 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Swollen Lymph node (under right armpit); Fever (up to at least 102); Muscle Aches; Fatigue; Headache (mild); This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 11:30 (Lot Number: EP-6955) at SINGLE DOSE in Arm Right for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 in Arm Right on 18Mar2021 11:00 (Lot Number: EP-6955) as SINGLE DOSE for covid-19 immunisation. The patient experienced Fever (up to at least 102), Muscle Aches, Fatigue, Headache (mild), Swollen Lymph node (under right armpit) from 06Apr2021 11:45 PM. The outcome was Recovering. No treatment received. No covid prior vaccination. No covid tested post vaccination. The events were assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
approx 3 hrs p/pt recvd vax had episode of entire body shaking & lasted 20 mins; pt seemed alert during episode; the next day pt had several shorter episodes where lt leg shook uncontrollably;
Systemic: Abdominal Pain-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Unable to Sleep-Medium
Starting at 11:00 am (the day after the vaccine) I started developing cold chills and body aches.  Headache started to persist. As the day proceeded, I continued with those symptoms and a fever spiked up to above 102 degrees Fahrenheit.  I also had no energy.   I just kept hydrated and rested. The fever broke today and body aches and headaches have subsided by 4:00 pm (2 days after vaccine).    These are very similar to the symptoms I experienced when I had Covid 19 back in early December of 2020.
Next day following the injection, patient had severe chills and body aches. Some chest tightness. No fever. Following day, chills improved but still with body aches states bones felt painful. This morning, patient developed a painful and pruritic rash to left side of abdomen. Pain radiates into breast.
Probable infected TD injection site - Responded to Cipro 500mg twice daily.  Had fever, chills, local redness, and lymphangitic spread.
Progressive paralysis, admitted hospital 11/23/2005. Discharge summary states Guillain-Barre syndrome, respiratory failure, bacterial infection, anemia, hypotonia, paresthesia, decreased reflex. msv. 60 Day Follow-up Information 09-MAY-2006: Persistent paralysis and reporter dependent.
flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. Shingrix was discontinued. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The physician reported that she had patients refusing to get the second dose of Shingrix because of the side effects. She mentioned flu like symptoms. Probed for additional information but HCP did not have specific information to provide.  The reporter consented to follow up.
Sever sweating,  feeling like throwing up and bowl movement, regurgitating, light headiness, feeling like passing out.
On 7/30/2017, patient's mother brought patient into the clinic at approximately 1pm to have the vaccine site looked at. The left posterior upper arm had erythema, warmth, and tenderness to palpation extending 9cm down the arm from the injection site; the affected area measured 8cm in width. The child had a temperature of 100.2 orally and mom states that he had a low grade temperature since the evening of the day of the vaccine. Mom stated she had been giving the child TYLENOL but he had not had any so far that day. There was concern for cellulitis due to the warmth and tenderness and treated with cephalexin (250mg/5ml oral suspension) 7ml twice per day for 1 week. Instructed mom to use children's loratadine (otc) daily, according to package directions, until rash cleared. Instructed mom to continue children's TYLENOL according to package directions as needed for pain/fever. Instructed mom to f/u for any worsening or failure to improve.
rash on facew  shortness of breath  body ache and pain sore neck and throat
Vaccine dose was taken from a vial that had been opened for 22 hours/ 12 hours past stability.  Based on CDC and state guidance, patient will return for repeat administration asap (in opposite arm) and then will return 28 days after that for final dose.
At onset c/o muscle aches and fatigue progessing to nausea, tunnel vision, and lightheadness by afternoon of 7/9/10. 7/10/10- c/o of fever of 101.6F chills, night sweats, photophobia, cough and sore throat. Pt spontaneously recovered 7/13/10.
This spontaneous report as received from a registered nurse refers to a 24 year old female patient with no pertinent medical history and no drug reactions or allergies. On 19-SEP-2013 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number 672547/1745AA, expiration date 13-SEP-2014). The nurse reported that within 12 hours of receiving the first dose of GARDASIL, in September 2013, the patient developed a rash on both arms and stomach with night sweats. The patient sought medical attention - contacted office. A treatment was given for adverse event - BENADRYL and unspecified cortisone cream. No lab diagnostics studies were performed. The night sweats were reported for the first night following the vaccination with the GARDASIL (date unspecified), but then resolved. The rash on both arms and stomach was described as getting better, but was still present during an office visit on 23-SEP-2013. Relatedness between vaccination with GARDASIL and rash on both arms and stomach with night sweats was not reported. Additional information has been requested.
Since Pt got the shot in the left arm is been hurting and she's been loosing movement on her arm.
severe local reaction suspected-deltoid tenderness & dec ROM; swelling of lt arm numbness & tingling in finger tips;
SOB after vaccine administration.  lasted 4-5 min,  resolved after taking off mask
Information has been received from a physician concerning a 10 year old female patient with no relevant medical history who on 22-APR-2011, was vaccinated with the third dose of GARDASIL (Lot number not reported). There was no concomitant medication. The patient's relevant past drug history was unknown. On 22-APR-2011, about 4 hours later, the patient's mother contacted the physician and told him that her daughter complained of stomach pain and shortly thereafter had a syncopal episode. On the same date, the patient was took to a local emergency room (ER) and blood count, urinalysis and electrocardiogram were done. The results of every test were normal. On 22-APR-2011, while in the ER, about 4 hours after the first syncopal episode, the patient experienced stomach pain again followed by another syncopal episode. On 22-APR-2011, the patient was admitted to the Intensive Care Unit of the hospital. As of 22-APR-2011, the patient was doing okay per doctor's report. The stomach pain and syncopal episode were considered to be serious due to hospitalization. Additional information has been requested.
Information has been received from a female consumer with lupus erythematous and penicillin allergy who on 20-APR-2007 was vaccinated SC in the right upper arm with a 0.65 ml dose of Zostavax. Concomitant therapy included "KENILOG" injection. Subsequently the patient experienced a bruise at the injection site. Her rheumatologist told her that the "steroid shot" would cancel out the zoster vaccine live vaccination. Unspecified medical attention was sought. As of 01-MAY-2007 the bruise was improving, it was red at center and pink around the edges. There was no product quality complaint involved. Additional information has been requested.
Patient received influenza vaccine on 10/1/08.  15 minutes after the injection, patient reported her lip went numb and her jaw went numb.  Vitals were checked and were WNL.  Symptoms resolved.
Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Caller seeking information when she should retest for anitbodies against the covid 19 infection? Caller also wanted to report "I got three shots and it didn't kill me"; Felt tired; arm was sore; This is a spontaneous report from a contactable consumer (Patient).   A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Caller states that she received two doses of the Moderna covid 19 vaccination series. She then tested negative for antibodies and received a Pfizer BioNtech  covid 19 vaccine. She was seeking information when she should retest for anti bodies against the covid 19 infection and she also wanted to report she got three shots and it didn't kill her she reported she heard a news story that this fall everyone is going to start dying from the shots.  She reported that she received both Moderna Covid 19 vaccines and she tested negative for antibodies, after both Moderna vaccines. Then she went and got one Pfizer Covid 19 vaccine she felt tired, after the vaccine, but otherwise felt alright. She was asking how long should she wait to retest for antibodies she is calling about the Pfizer Covid 19 vaccine and she did receive both Moderna Covid  19 vaccines and did test negative for antibodies she did get one Pfizer Covid 19 vaccine, and re-ports feeling tired, and her arm was sore after the vaccine. She was asking how soon can she be tested for antibodies again. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative tested negative for Covid antibodies after both Moderna Covid 19 vaccines. The outcome for the event felt tired and sore arm was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Information has been received from a woman from a physician's office concerning a 51 year old Caucasian female who on 11/1/99 was vaccinated with the 1st dose of Hep-B. On 11/24/99, the pt experienced a rash. She was seen by a physician. On 11/30/99, the pt was administered a 2nd dose of Hep-B and subsequently, she experienced systemic lupus erythematous. The 3rd dose will not be given. No further information is available.
Five years ago, I was diagnosed with lung cancer. I had a lower lobectomy. In January the found nodules in my right lung. I had a biopsy done on 02/08/2022. On 02/27/2023 I had a right upper lobectomy done. I am feeling fairly well now since surgery.
Very sore arm, fatigue within hours of the vaccine. Then 6th day (morning) throat swelling and face when waking up and rushing to the emergency room where I was given a steroid and Pepcid to open my airways and was discharged by 9:30 AM ET on 03/10/2021 after throat opened back up and swelling decreased. I was given a script for EPI, Medrol Pack and Pepcid. Upon returning home I had began having hiccups at 8 PM that lasted through Saturday 03/12/2021, where I was admitted to the hospital for a lot of antihistamine rash reactions over my body that continued from the morning of 03/10/2021. Then went to the hospital again on 03/13/2021 and was given a muscle relaxer baclofen around 7 PM to rid the constant hiccups that were concurrent from what seemed to be the steroid used to open my airways. Went home and have had fatigue, but feel mostly better with appetite back. My family doctor saw me on 03/16/2021 and saw that I was still having a reaction on my back and arms with antihistamines and said it was the Moderna shot and I needed to consult with a pharmacist on what to do or the FDA/CDC as he didn't know enough on it. Now Pharmacy won't give me my second dose due to the CDC guidelines and they want me in a medical setting to have the second one, if I am allowed - something I am not privy to. I need help and guidance ASAP on what to do.
Recurring nightly fever that occurs around 8:30pm; This is a spontaneous report from a contactable Other Health Care Professional. A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 03Mar2021 at 16:15 (at the age of 56 years old) as single for covid-19 immunisation. Medical history included prostate cancer from an unknown date and unknown if ongoing. The patient did not have any known allergies. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 10Feb2021 at 04:15 PM (at the age of 56 years old) for covid-19 immunisation. The patient didn't receive other medication in two weeks. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 04Mar2021, patient experienced recurring nightly fever that occurs around 8:30pm. Therapeutic measures were taken as a result of recurring nightly fever that occurs around 8:30pm with Tylenol. The outcome of event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & 20mins post vax pt began running a fever;that noc temp reached 104-105;next day was pale & limp & had tremors of the extremities;pt was seen by MD that day;that day pt cried for 4hrs straight & passed out for 1/2 hrs;
Patient developed urticaria days 5-7 post vaccination.  Day 7-10 developed angioedema tongue- not involving lips.
Profuse watery brownish green diarrhea, up to 10 episodes daily, lasted almost 4 weeks.
about a week to two weeks later i had a heaviness in my right eye, It since has resolved itself then i started to get sensitivity on my right side of my gum line in my mouth. and it comes and goes.
pt recv vax 1JUN96 & devel hives 5JUN96;examined pt 6JUN96 antihistamine prescribed;
aortic aneurysms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 2, single (Lot number: EW0172) at the age of 56 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: ER8734, Time: Unknown, in afternoon sometime, Anatomical Site of injection: In arm via intramuscular route), administration date: 06Apr2021, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "Aortic aneurysm". The following information was reported: AORTIC ANEURYSM (medically significant) with onset 18Oct2022, outcome "not recovered", described as "aortic aneurysms". The patient underwent the following laboratory tests and procedures: Weight: About 130 pounds. Therapeutic measures were taken as a result of aortic aneurysm.  Clinical course: Patient reported, she had aortic aneurysms after getting the 3 Pfizer covid-19 vaccine. She was looking for more information if we know anything about this and if there was a correlation between them. Additional Information for Other medicines Levothyroxine: Manufacturer: AbbVie Start date: Years ago. Transfer agent has a patient on the other line calling reporting that caller had an aortic aneurysm after getting 3 of the Pfizer COVID-19 vaccines. Caller asked about the correlation between an aortic aneurysm and the vaccine, transfer agent told caller that Pfizer had no information to provide in regards to that. Going to have to have open heart surgery, confirmed has not had open heart surgery yet. Feels caller was giving a lot of confidential information, wants to make sure this information is kept confidential. Takes medication for caller's thyroid. Clarified, takes Levothyroxine for thyroid. Received 2nd dose in afternoon sometime. No Prior Vaccinations (within 4 weeks). The event require the initiation of new medication/other treatment/ procedure and going to have to have open heart surgery, confirmed has not had open heart surgery yet.
Shooting pain on the arm; Stomach cramping; Night sweats; Headache; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Shooting pain on the arm), ABDOMINAL PAIN UPPER (Stomach cramping) and NIGHT SWEATS (Night sweats) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Hypertension. Concomitant products included CARVEDILOL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), PAIN IN EXTREMITY (Shooting pain on the arm), ABDOMINAL PAIN UPPER (Stomach cramping) and NIGHT SWEATS (Night sweats). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 14-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue), PAIN IN EXTREMITY (Shooting pain on the arm), ABDOMINAL PAIN UPPER (Stomach cramping) and NIGHT SWEATS (Night sweats) 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: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient presented with high fevers, fatigue and lightheadedness approximately 12 hours following his second COVID-19 vaccination. He was bradycardic with borderline hypotension. He was admitted to the hospital overnight for observation and did well, returning to normal.  He was discharged the next day with the diagnosis of "expected response to vaccination".
Woke up the next morning with swollen and chapped lips, swollen eyes, and hives
Information has been received from a physician concerning a 13 year old female who on 20-JUN-2007 was vaccinated with a 0.5 ml dose of the Gardasil. Concomitant therapy included Menactra. On 25-JUN-2007, the patient developed a rash on her forehead. Unspecified medical attention was sought. The rash was diagnosed with shingles which further progressed into the eyes and the patient developed pain in the ear. The patient's shingles and pain in the ear persisted at the time of the report. Additional information has been requested.
Severe pain in upper left arm and shoulder with tenderness at injection site.  I am unable to take off a shirt over my head without assistance; I cannot sleep on my left side; my arm aches from the shoulder about halfway to my elbow; I have difficulty and pain lifting my arm above my head; I am periodically experiencing tingling and numbness in my wrist, hand, and fingers.