chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was accidentally given KINRIX instead of PEDIARIX for DTAP-POLIO vaccination.
Patient was 6 months, but was giving vaccinations that where meant for a 1 year old for chickenpox and the MMR. Patient was also given her regular 6 months shots additionally.
Migraine; Frozen shoulder; Shoulder pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PERIARTHRITIS (Frozen shoulder), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Vertigo from June 2021 to July 2021, Cough in December 2021, Illness in December 2021, Head cold in December 2021 and Sore throat in December 2021.   On 03-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced MIGRAINE (Migraine), PERIARTHRITIS (Frozen shoulder) and ARTHRALGIA (Shoulder pain). At the time of the report, MIGRAINE (Migraine), PERIARTHRITIS (Frozen shoulder) and ARTHRALGIA (Shoulder pain) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  In Jan-2022, the patient had Moderna vaccine and had a sore arm and two migraines every month. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Pt provided information via phone:  Vaccinated on 3 Dec 07.  Fluarix -prefilled injectable vaccine.  Pt indicated that he had chest tightness within 10 minutes of the vaccine/light headed (did not notifiy the vaccinator).  Also had sharp pain at the injection site.  Left clinic and 45 minutes later was light headed and pain radiating down left arm.  Presented to ER and cardiac workup completed.  Screening form completed by patient indicates no allergies but pt verbalized allergy to codeine.
I had a (first ever) stroke. I was attempting to take Flecainide for atrial fibrillation to reduce palpitations, the week prior and during the day of the stroke. I tried to take Flecainide twice before in the past few months, but I was unable to tolerate it. When I had the stroke, I didn't realize I was having one since I'm in very good health. I emailed my electro-cardiologist about my symptoms that day and found it difficult to use the appropriate words and reading the email later, I could see a number of mistakes. My ability to comprehend spoken language that day was impaired. I could only keep a few sentences in my head at a time and my attention span was poor as well, like having significant ADHD, which I don't have. I was unable to retain simple amounts of information the day of the stroke. I didn't seek treatment on the day of the stroke since I felt it was more of the side effects I had been experiencing from Flecainide. After going to the hospital I felt good and much improved, cognitively. An ER neurologist said that my stroke was a 2 on a scale of 1 to 42. Over the remainder of March and until this day (April 16, 2021), I have made steady and rapid improvement. I attribute my recovery to the lower level of stroke damage and the fact that I worked out every day with physical exercise and I worked out cognitively by doing a series of activities that I chose myself: reading out loud, reciting poetry and tongue twisters, playing logic and puzzle games on the PC, returning to my writing tasks for work, practicing grammar, and speaking at length with family and friends as a way to practice speaking. I had one appointment with an occupational therapist and two appointments with a speech therapist and have completed assessment. I now feel I am nearly completely recovered with an odd sense of some improvement in certain areas such as heightened mood and quicker connections for noticing practical matters.
Headache, pain at injection site for multiple days, fever, cold chills, fatigue, cold sweats, flu like symptoms, shivers.
body aches; sore arm; fever; chills; A spontaneous report was received from a nurse concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever, body aches, chills and sore arm.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 20 Jan 2021, approximately on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient experienced fever, chills, body aches and sore arm which was resolved.   Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, fever, chills, body aches and sore arm, was considered resolved.
Body aches, chills lasting for 36 hours, joint pain injection site swelling, pain and itching. All lasting for 36 hours
p/vax pt exp hives & went to ER;the reporting MD considered the hives to be potentially life threatening;pt recv tx in ER;
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 28-Jan-2022 at 1:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 1:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 28-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the expiry date of 04-Apr-2022.  No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
4/23 10:32 Adult Td given left deltoid. 4/26 20:15 Seen in ED; left deltoid area red, swollen, and painful. Cellulitis. Given Keflex 500mg times 2 to use and prescription for 30 take QID.
experienced lightheadednes, dizziness, faintness, nausea, tingling in fingers shortly after vaccination then subsided quickly
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had a severe reaction to a flu vaccine around 10 plus years ago before the date of reporting. It was unknown which flu vaccine the patient received, they did not have records for her prior to joining the practice. The reporter gave consent to follow up.
Fluzone 0.5ml IM left deltoid on Sat 11/10/07. Pt called Sunday afternoon to say she had a rash over arms, body, legs (thighs) and stomach. She had taken Benadryl 50mg Q4h but the rash has not subsided.
I got the vaccine and the pharmacist said to take Tylenol for any headache, arm soreness or Fever. I pictured symptoms consistent with other shots I have had. My arm is in so much pain it kept me awake all night even with Tylenol.  More importantly I am running 101 fever, have chills, can't eat, cant go to work. I  am afraid to get the second shot since this one made me this sick. I have never had problems with vaccines in the past. I saw that this is a higher incidence of side effects but I didn't think being this sick would be considered just a side effect. I feel too bad to get up and go to the doctor but I may have to get someone to take me if I don't start to get better.  Evidently this is not that unusual which is scary to me for the elderly who get this shot.
some loss of smell - I can still realize sharp smell (citrus) but the smell of ground coffee is significantly diminished; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 15:45 hours as dose 1, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 06Feb2021, patient had some loss of smell, patient can still realize sharp smell (citrus) but the smell of ground coffee was significantly diminished. Patient received no treatment for the event. The event was reported as non-serious by the patient. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected. Information on the lot/batch number has been requested
Rapid HR; Extreme body ache; Chills; Extreme fatigue; 103F fever for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid HR), PAIN (Extreme body ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (103F fever for 2 days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid HR), PAIN (Extreme body ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (103F fever for 2 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form and IBUPROFEN (MOTRIN IB) at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (Rapid HR), PAIN (Extreme body ache), CHILLS (Chills), FATIGUE (Extreme fatigue) and PYREXIA (103F fever for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
headache; such big headache, not as a regular headache, extreme headache; redness in her shoulder and her neck, down little bit on her back. that's really bad; Fatigue; Some parts are very very red in her neck; Burning sensation all over her neck and shoulders; cold; Night sweat; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat), PYREXIA (Fever) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Shellfish allergy. Concomitant products included VITAMIN D3, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN B6 and ZINC for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat) and PYREXIA (Fever). On 12-Apr-2021, the patient experienced BURNING SENSATION (Burning sensation all over her neck and shoulders), FATIGUE (Fatigue) and ERYTHEMA (Some parts are very very red in her neck). On an unknown date, the patient experienced HEADACHE (headache), HEADACHE (such big headache, not as a regular headache, extreme headache) and ERYTHEMA (redness in her shoulder and her neck, down little bit on her back. that's really bad). At the time of the report, BURNING SENSATION (Burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (Night sweat), PYREXIA (Fever), FATIGUE (Fatigue) and ERYTHEMA (Some parts are very very red in her neck) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-079352 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079352:DOSE 2
2 days after vaccine developed inability to sleep, anxiety that increased over days into being unable to function.  Reality was distorted, unable to eat for 3 days.  On day 10 had sudden projectile vomiting and diarrhea with throat closure.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Fainting / Unresponsive-Severe
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30/4F Two lot numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Per mother, patient has right upper arm swollen, red and hot to the touch on injection site.
Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.; Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.) in a 41-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 003K21-2A) for COVID-19 prophylaxis.     It was unknown if the patient  was allergic to medications, food and other products . It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was  diagnosed acute illness at the time of vaccination and or up to one month before. Chronic or long-standing health conditions was unknown. It was unknown if the patient was on any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.     On 19-May-2022 at 9:15 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 19-May-2022 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 13-May-2022 and was administered to the patient on 19-May-2022.) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine was expired on 13-May-2022 and was placed in the refrigerator on 17-May-2022.and was administered to the patient on 19-May-2022.).    Vials expiration date was reported as 13-May-2022 and were stored in the refrigerator on 17-MAY-2022. It was reported that the events did not cause patient to seek medical care. It was unknown if the patient had experienced a similar event in the past. The vial did not undergo any temperature excursions.  No treatment medications information were reported.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:MCN Number
Tremors, chills, with fever occurred about 2am vaccines need about 12 hours earlier. No unconsciousness. Fatigue, diffuse myalgia but no WKNS and nl neurologic exam,
Patient's husband said her arm, down to her elbow was swollen, red and painful when he called late 10/15/2016. Said was not getting any better.  Recommened benadryl and ice (15 min on and 45 off).  Told if got worse go to urgent care.  Called patient Sunday at 10:00am, she said it was much better, swelling almost gone and red/pink splotchiness gone.  She had taken benadryl and iced last night and this morning.  I told her if it got any worse to seek medical attention.
Rash - Information has been received from a doctor of pharmacy concerning a 45 year old female who on 08 Jan 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 631048/0105k.  On 22 Jan 2001 the patient experienced red rash.  The patient sought medical attention.  The reporter noted that another woman received a vaccine dose from the same lot number and experienced a red rash waes 01030128.
Sore throat; Sweating; Felt really weak; Fever; Head is pounding; Felt like vomiting all night; Arm pain in the arm at the injection; every muscle in the body is aching; Chills; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), ASTHENIA (Felt really weak), PYREXIA (Fever) and HEADACHE (Head is pounding) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), ASTHENIA (Felt really weak), PYREXIA (Fever), HEADACHE (Head is pounding), VOMITING (Felt like vomiting all night), INJECTION SITE PAIN (Arm pain in the arm at the injection), MYALGIA (every muscle in the body is aching), CHILLS (Chills) and ARTHRALGIA (Joint Pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), ASTHENIA (Felt really weak), PYREXIA (Fever), HEADACHE (Head is pounding), VOMITING (Felt like vomiting all night), INJECTION SITE PAIN (Arm pain in the arm at the injection), MYALGIA (every muscle in the body is aching), CHILLS (Chills) and ARTHRALGIA (Joint Pain) outcome was unknown.            No relevant concomitant medication was reported.  Treatment details include, aspirin.  Action taken with mRNA-1273 in response to the event was not applicable.
Awoke next AM w/fever. Diffivult to arouse. On arrival in ER developed seizure activity. Given Valium, observed overnight. Temp 38.2 on arrival in ER.
Called this evening  4/13/21 at 6PM complaining of severe headache with dizziness which started two days ago. She was referred to an Emergency Department which is the closest facility to her. She agreed to go at 6:05PM. We called the ER to advise them that she needs to be worked up for a complication of the vaccine.
First day, could not keep my eyes open, then around 5pm, fever started. 101.  Then the next three day 103.7 temp, Migraine, vomiting, loose stools, and slept all day and night. Then on wed, blisters started, on my lips, inside my nose, and inside my mouth. All these days severe headache, light headed, blurry vision, and could not get out of bed. Missed a week of work, which I can't afford. Was told by my doctor to hold off on the 2nd dose.
immediate bruise/swelling at vaccination; worsened over next several days with moderate pain at injection site for 2-3 days; no other adverse reactions; day 5 = redness/itching extending 1 inch beyond bruise area; day 10 = redness extending 2 inches below bruised area; tiny area of non-bruising at injection site, tiny hard lump
Localized rash at injection site "red but no bumps". 5 days later, 8/11/10, rash spread all over body. At this time rash was "raised and very itchy". Sought care from PMD on 8/12/10 and received oral steroids (methylprednisolone) x 6 days plus Fluocinonide (topical x 6 days) then referred to Dermatology and received Clobetasol 0.05 % cream x 7 days. And has f/u appt with Dermatology 09/08/10. Per Dermatologist probable Granuloma Annulare but not diagnosed.