chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General not feeling right evening of injection. Morning after, entire body hurt/ached and felt extremely hot. No fever registered. In a mental haze all day and night. All symptoms lasted through the night. When I woke up the next morning, all symptoms were gone. Felt fine, just weak and worn out, like "the day after ".
A report received from a health care professional concerning 70 vaccinees who received Fluvirin on 10/23/2002. On 10/23/2002, 70 vaccinees in a nursing home were administered Fluvirin which was defrosted from frozen. No adverse effects were noted uo to 2 days. The reporter has assessed the relationship of vaccinees to the event unclassifiable.
Starting in Aug, left side facial pain and stiffness, left side pain under ear, tinnitus, feeling of resistance while walking,. As of Nov, right side very sharp and very intense facial pain  (top right teeth) and spreading across right side of face with episodes lasting from 10 minutes to a few hours. Left side facial pain varies in intensity, walking issues have resolved but right side sharp facial pain continues though not daily. MRIs and CT scans have been conducted and were clear so I have no diagnosis or medication solution  that is working.
Patient did not cooperate with vaccine administration. Became very agitated and despite trying to clam him down, he would pull away during multiple attempts to inject. During one attempt, needle was introduced but patient withdrew the arm once he felt the needle. Two vaccine shots were wasted. Mother tried to hold him and fell backwards with the patient on top of some chairs and equipment. Patient also tried to kick the nurse and my person. We decided that there was more risk for everyone involved than the benefit of the vaccine.
Within 2 hours of vaccination child screamed x 12 hours, had fever 101 x 2days, severe redness at sites of vaccination.
Generalized urticaria rash onset 8/1/17 otherwise NL exam. Seen 8/2/17. Rx: Hydroxyzine and to F/U.
Wife called to say his side and face and above the eye was sore, swollen, tender and possibly breaking out.
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 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of cancer" (unspecified if ongoing), notes: Other medical history: History of cancer; "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts; "Known allergies: Peanuts and tree nuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts. Concomitant medication(s) included: LEVOTHYROXINE, start date: 05May2014; LIOTHYRONINE, start date: 15Oct2014. 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: testing positive again on day 9; Negative, notes: negative tests days 5-8. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was hospitalized for an acute COPD exacerbation but was preparing for discharge. When the patient was seen by the nurse on the morning of 7/19/15 she seemed to be moving air well on 2L nasal cannula but on repeat exam a few minutes later, she seemed very tight and to not be moving air with oxygen sats in the 70s. This change occurred 3-5 minutes after receiving the Pneumovax-23 vaccine (Adult 25 mcg/0.5mL; Merck Lot: KO18528; NDC 0006-4943-01), according to the nurse. Breathing treatment was started but patient was still hypoxemic and progressed into tense bronchospasm leading to acute onset hypoxic respiratory failure, followed by cardiac arrest with loss of pulse.  Code blue was called and CPR was started at 1000 with bag mask ventilation, and spontaneous circulation returned within two minutes. Patient had to be intubated and sent to the medical ICU. Patient also experienced hypoxic seizures for which she received lorazepam 2mg twice at 1017 and 1028.Patient remained in the MICU for one day and then was transferred back to the general medicine floor. She was discharged home on 7/24/15.
Patient came in 10/7/16. Had reaction to FLUZONE-HD. Arm got red and itchy at injection site.
Pt devel cervical lymphadenopathy, myalgia, fever & earache following vax w/Recombivax HB; Pt was hospitalized on 29JUL91; five days later pt devel generalized rash w/peeling of the skin & petechial lesions on palms & soles of feet;
Patient became lightheaded, clammy and passed out (typical vagal reaction).  Patient aroused easily, VS monitored.... patient was able to sit up after about 5 minutes.  Monitored for 30 minutes post vaccination. Patient did not need any other intervention or care.
This spontaneous report was received from a registered nurse referring to a 6 month old patient of unknown gender patient. The patient's pertinent medical history, drug reaction/allergies or concomitant medication information was not reported. In approximately July and September 2016 (reported as "at 2 months of age and 4 months of age") the patient was vaccinated with doses of PENTACEL. On 17-NOV-2016, the patient was vaccinated with PEDVAXHIB 0.5 ml, intramuscularly, lot # L042836, expiration date: 24-AUG-2018, with PENTACEL 0.5 ml, intramuscularly (lot # and expiration date were not reported) and with PREVNAR 13 0.5 ml, intramuscularly (lot # and expiration date were not reported), all therapies for prophylaxis. No adverse effects were reported. There was any adverse event reported.  Additional information has been requested.
Left forearm induration, swelling and redness. Swelling approximately >5cm. Pt reported itching. Pt stated he did not receive any vaccinations or new medications since his last visit to the clinic on 11/9/22.
Patient given DTAP, IPV, left deltoid, left arm, next day arm was warm, swollen.  No other problems went away in 3-4 days.  Mom used Motrin and Tylenol, cool wash cloth.
Approx 5 min post vaccine became nauseated.  10 min later, requested to go to restroom.  Stated he felt faint.  Was assisted to floor, eyes closed.  Within 2-3 seconds was alert and talking
Violent migraine treated with Morphine at hospital ER, lumbar puncture did not heal.  Unable to return to work for 4 weeks.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 584 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Made aware of patient passing away on 3/1 per letter from Corporate legal team. Patient passed away on 2/14. Vaccine 1st dose given 1/29/21.-Severe
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent or medical history was reported. The nurse reported that on 05-AUG-2015, the GARDASIL 9 was withdrawn from a vial and was placed into one of the plastic syringes and was put into the refrigerator. On 06-AUG-2015, in morning, a staff member vaccinated the patient with the same GARDASIL 9 (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected as the reporter did not wish further contact.
HPV vaccine given , client wanted Flu vaccine.  Client outside range for HPV vaccine. Client had no adverse reaction to HPV vaccine.
I went to put my seatbelt on the next day and I noticed a lot of tenderness and a lump in my left clavicle area. I went for an ultrasound in March and they found 3 lymph node lumps on the left side and they were reevaluated December 3rd, I have a chest CT coming up on December 24, 2021.
Sore injection site, hot flashes with no fever, styes on both eyes; Sore injection site, hot flashes with no fever, styes on both eyes; Sore injection site, hot flashes with no fever, styes on both eyes; This is a spontaneous report from a contactable nurse (patient).  An adult female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included suspected endometriosis. It was also reported that the patient had allergies to ranitidine (ZANTAC), omeprazole (PRILOSEC), famotidine (PEPCID), kiwi, and adhesive.  Concomitant medications included sertraline hydrochloride (ZOLOFT), fish oil (FISH OIL), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 27Dec2020 07:00, the patient experienced sore injection site, hot flashes with no fever, and styes on both eyes. The patient did not receive any treatment for the events. Outcome of the events were unknown.  Information on the Batch/Lot number has been requested.
1/8/2021 Friday: I started to have bad chills and fever 100, around 10pm that evening after the vaccine.  1/9/2021 Saturday: I was really sick  with fever 101.2, chills, headache, body aches, nausea, weak, no appetite,  sore arm at vaccination site and tired. 1/10/2021 Sunday: 12AM woke up soaking wet  from head to toe BUT felt ok.  Still sore in my arm. As of 10:30AM I feel ok so much better than yesterday.
Tingling and numbness around lips and mouth lasting about 15-20 minutes. It happened about 30 min after the injection.  It felt just like a novocaine shot from the dentist.  I had no other effects at all other than soreness at the injection site.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:38 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 54.30 for dose administered on 13-Feb-2021 and 54.39 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34-, and 37-degrees Fahrenheit from 09:00AM to 10:00 AM. This vial was moved to fridge 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-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).
High fever and fatigue for 2 days. Ear pain, tinnitus and headache for at least a week.
Parsonage Turner Syndrome; Pain down through the upper arm/Arm problem; COVID Arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RADICULITIS BRACHIAL (Parsonage Turner Syndrome), PAIN IN EXTREMITY (Pain down through the upper arm/Arm problem) and VACCINATION SITE REACTION (COVID Arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RADICULITIS BRACHIAL (Parsonage Turner Syndrome), PAIN IN EXTREMITY (Pain down through the upper arm/Arm problem) and VACCINATION SITE REACTION (COVID Arm). At the time of the report, RADICULITIS BRACHIAL (Parsonage Turner Syndrome), PAIN IN EXTREMITY (Pain down through the upper arm/Arm problem) and VACCINATION SITE REACTION (COVID Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.
Syncope episode, nausea and vomiting .Patient needed a minute to catch breath. Patient stated felt better after a minute.
She has trouble with right side and Can't use her right arm; Left injection arm is still very sore; Had a stroke that affected her right side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side) and LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 109B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side) (seriousness criteria disability, medically significant and life threatening). On an unknown date, the patient experienced LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) (seriousness criterion disability) and VACCINATION SITE PAIN (Left injection arm is still very sore). At the time of the report, CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side), LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) and VACCINATION SITE PAIN (Left injection arm is still very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not given. No laboratory was not given. No treatment information was not given.  Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
No adverse event; HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and had other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with influenza vaccine.   On 27-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, but vaccine expired on 24-MAR-2023.).    Concomitant drugs were not reported.  It was reported that patient had no AEs reported.  Treatment medications were not provided.
Fri Oct 07, 2022 29-year-old male with a past medical history of COVID-19 infection on 9-18-20 22, left lower extremity DVT and pulmonary embolus appreciated on 9/28/2022 at emergency department for chief complaint of "leg pain." The patient reports that he has been having intense swelling and pain in his right gluteal region that began this morning.  In addition, the patient is having a shooting radicular-like pain going down the posterior region of his left lower extremity on the right-hand side and causing extreme discomfort.  In addition, the patient has a herniated disc at the level of L5-S1 that is causing pain and stiffness in the patient's back decreasing his passive range of motion. The patient has extreme pain with ambulation secondary to his neuropathic pain, Valium 5 mg tablets and Toradol 50 mg ordered administered to diminish patient's symptoms of muscle tightness and pain.  Vital signs reviewed and are stable at present.  Sat Oct 08, 2022 Patient will be discharged with 5 mg of Valium every 8 hours for the next 3 days.  Patient informed to take prednisone 20 mg twice a day for the next 5 days.  Continue taking your gabapentin as prescribed.  Take Valium 5 mg every 8 hours, as needed, for muscle relaxation.  Take Tylenol 500 mg every 8 hours, as needed, for the next 7 days to decrease inflammation of muscle bodies.  Follow-up for reevaluation of neuropathic pain with your primary care doctor within the next week.
Information has been received from a RN concerning a 28 year old female with no allergies or medical history who on 01/06/05 was vaccinated in the LA with the 1st dose of varicella virus vaccine live. The RN reported that on 01/20/2005 the pt developed  red pimples over her body and  a 50 cent reddened area at the vaccination site. unspecified medical attention was sough and the pt was treated with OTC Benadryl . At the time of the report the outcome was unknown. Additional information has been requested.
Information has been received from a medical assistant a concerning a 15 year old female who on 14-JAN-2008, was vaccinated with the first dose of GARDASIL, on 12-MAR-2008 with the second of GARDASIL and on 14-JUL-2008 with the third dose of GARDASIL. In July 2008, the patient had rash and bumps on her legs and chest and left side of body. The patient's rash then went away but she developed achy joints. These adverse events occurred after the third dose of GARDASIL in July 2008. No adverse reactions were reported after the first or second dose of GARDASIL was given. At time of reporting, the patient was not yet recovered from achy joints. No other information available from medical assistant. Additional information has been requested.
Had sore arm; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MYALGIA (Had sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Apr-2021, the patient experienced MYALGIA (Had sore arm). On 16-Apr-2021, MYALGIA (Had sore arm) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-054491 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054491:pregnancy
Starting the evening after the 2nd dose of the vaccine, participant got chills, nausea and fever 102.9 F and 2 episodes of vomiting.  Symptoms continued throughout  most of the next day and low grade fever, body aches  and nausea. Participant took Tylenol and called a colleague for advice, who advise to take Tylenol, plenty of fluids and rest.  The next several days the symptoms continued to improved and completely resolved within a week.