chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had it 2 years ago and shingles still on/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reproted as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles vaccine 2 years prior to the report and still had shingles that goes off and on. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Fever to 104, irritability, fine red rash lasting 2-3 days on trunk, face, extremities. Also loose stools.
Drive thru flu clinic - 14 y/o child received adult formulation. No phone number provided, mailed letter to notify.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), CHILLS (few chills), FATIGUE (very tired) and HEADACHE (headache) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.  No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), CHILLS (few chills), FATIGUE (very tired) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (pain in arm), CHILLS (few chills), FATIGUE (very tired) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR received on 23-APR-2021 and does not contain any new information
headache; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), glucose tolerance impaired (pre-diabetic), lung cancer, and lymphoma. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a nursing home/senior living facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced headache on 19Jan2021. No treatment was received for the adverse event. Clinical outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Reports bilateral calf pain with numbness concerning  for bilateral DVT. Symptoms began night of 4/21/21. Reports feeling brain fog and fatigue.
Swelling, redness, warmth @ site of VARICELLA - pt denies tenderness - warm compress applied per mom
left arm started hurting and swelling.  It was red and sore to the touch.  It was about 9 times bigger than normal and her wrist where she has had surgery before was like 4 times bigger than usual.  She also had headache and nausea that lasted about 5 days.  She called her orthopedic doctor and was told to take an anti-inflammatory medicine and ride it out.
Itching all over the body two weeks after booster; Hives move around on the body two weeks after booster; Rash all over body two weeks after booster; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062e21a, 031B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported. The doctor ordered blood tests for patient to check if he was allergic to anything.   This case was linked to MOD-2022-450402, MOD-2022-450393 (Patient Link).
Immediately after receiving my first shot, blood pressure shot up to 148/60 (normally 120/60 or less), heart racing, felt dizzy, and legs felt funny, heavy.  This higher heart rate persisted throughout the first day and evening, and on day 2 I woke up with wheezing and was sent to the ER. Blood pressure readings there were the same.  Had a headache for three days also. On day 3, started feeling slightly better, but then awoke with lightheadedness, brain fog, tinnitus, and the feeling of a tight scalp.  This persisted for two more days.  On 6/1 was seen in outpatient care with blood pressure still higher (138/60), and tinnitus, with lower legs feeling like they were in cold water.
After receiving the anthrax vaccine in 1999, the patient started experiencing myalgias, arthralgias, depression, and panic attacks.    Anthrax #1 7/6/99 States that he had a severe local site reaction with this injection. Anthrax #2   7/20/99 Anthrax #3 8/4/99 8/99-9/99 States that he started feeling depressed and was experiencing panic attacks by the end of August. At that time, he was referred to mental health and started therapy for depression and insomnia.  He has been seeing a psychologist on a monthly basis since that time.  States that he feels like he is on an emotional roller coaster. Anthrax #4 1/4/006/00 Diagnosed with chronic depression, anxiety, and panic attacks.  States that he felt tired all the time but could not sleep.  Felt trapped when he was around people and could not fly on airplanes any more due to phobia.     2/01 Transferred. States that he was happy to transfer but continued to feel depressed.  States that after he transferred to another location he would experience periods of deep dark depression that lasted for approximately 6-10 days.  He would sleep to 1600 and go back to bed at 1930.  States that during these times he feels weak and completely worthless.  States that there is no reason to keep going on.  States that it is a real struggle to keep going.  Nothing helps during these periods.       States that he started experiencing right knee pain during this time frame.  Denies any trauma or strain. States that knee pops and clicks most of the time.  States that the pain is intermittent and when it occurs, describes it as a dull ache, which he rates as a 7 on a pain scale from 0-10. States that when it hurts really bad that it causes him to limp and he cannot bear any weight on it.  Is not aware of what causes the intermittent pain.  3/01 Reports that low back pain started around this time.  States that the pain radiates down the back of both legs to the thighs.  States that his pain is also intermittent and when it occurs he cannot sit or stand for long.  States that Percocet is the only thing that helps during this time.  States that the lumbar MRI only showed degenerative joint disease.  5/01 States that right ankle started hurting.  Denies any trauma or strain.  States that the pain feels like an ice pick jabbing through his ankle. Rates the pain as a 10+ on pain scale 0-10.  Cannot recreate the ankle pain.  States that the pain occurs about every other month and lasts for 1-2 days.  States that the MRI of  the ankle is normal.   Attempted suicide.  States that he took an overdose of medication and just wanted to go to sleep and not wake up.  6/03 States that his left elbow started hurting.  States that this pain is constant.  States that the pain radiates from his elbow to his shoulder and from his elbow down his forearm to his middle finger.  States that sometimes his wrist and knuckles hurt and sometimes he may feel a warm sensation down the middle of his forearm.  Cervical MRI reveals some mild bulging.  4/2/04 Placed on profile for Myositis/Myalgias
This spontaneous report was received from a pharmacist concerning to a 4 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 07-Aug-2014, the patient was vaccinated with a dose of GARDASIL (dose number, lot number and expiration date were not reported), 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. The pharmacist reported a 4 year old patient was inadvertently administered GARDASIL on 04-AUG-2014. No adverse effects reported. Additional information has been requested.
Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild
Swelling of throat/gland on left side, only.  Gargled warm salt water, used hot/wet compress, and took naproxen for swelling.
Pt developed a fever of 102 for 2 days which resolved. She developed vesicles in her mouth and on her lips, a couple of which have become pustules. She refuses to drink or eat secondary to the discomfort.
Dizzy around 7 pm; tickle throat; no sneezing; no coughing - no congestion (4 of 10) sore throat, H/A, body aches, stomach pains (nausea) seeing double, photophobia chest pain (L) side. Taking - TYLENOL ADVIL. Not on medications - ?anxiety. Called private MD - Take TYLENOL and ADVIL.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 11-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 57GJ2) for prophylaxis.   On 13-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Mother called to report child's left leg had large red spot around shot site "way bigger than a softball", raised and hot to touch. Complained of itching day after shot but no long bothering her. Advised to use warm compress to area QED, pain control with MOTRIN or TYLENOL and call back if not improving.
herpes simplex keratitis; This is a literature report.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "amblyopia" (unspecified if ongoing), notes: of his left eye. The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES SIMPLEX (medically significant) with onset 22Feb2021, outcome "recovered" (2021), described as "herpes simplex keratitis". The event "herpes simplex keratitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Slit-lamp examination: discreet area of, notes: central edema with keratic precipitates and stromal haze. Therapeutic measures were taken as a result of ophthalmic herpes simplex. Clinical course: Several physicians in our practice noted a cohort of patients presenting with keratitis in temporal proximity to their COVID-19 vaccinations. We hypothesize that the intense immunological reaction following LNP-formulated mRNAbased COVID-19 vaccinations may have triggered or reactivated keratitis. A 60-year-old man with a significant past ocular history of amblyopia of his left eye was referred to the clinic for 2 months of decreased vision in his right eye, which began approximately 2 weeks after his first Pfizer COVID-19 vaccination. Slit-lamp examination of his right cornea revealed a discreet area of central edema with keratic precipitates and stromal haze. Based on the examination, a diagnosis of herpes simplex keratitis and endotheliitis was made. He was prescribed prednisone forte four times a day as well as valacyclovir 1 g twice daily with improvement in vision and examination by 3-month follow-up. Six months later, the patient was seen with no signs of inflammation or infection and no observed infiltrate.; Sender's Comments: Based on the temporal relationship, the association between the event ophthalmic Herpes simplex with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202300145291 Same article/ drug/event and different patient;
long lasting side effects from the Moderna vaccine related to joint inflammation; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (long lasting side effects from the Moderna vaccine related to joint inflammation) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (long lasting side effects from the Moderna vaccine related to joint inflammation). At the time of the report, ARTHRITIS (long lasting side effects from the Moderna vaccine related to joint inflammation) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced unexpected, non-serious AESI arthritis, after receiving a dose of mRNA-1273.  There is very limited information in this case; it was only reported that the patient had long lasting side effects from vaccination related to joint inflammation.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details were not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced unexpected, non-serious AESI arthritis, after receiving a dose of mRNA-1273.  There is very limited information in this case; it was only reported that the patient had long lasting side effects from vaccination related to joint inflammation.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details were not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Patient states immediately after her vaccine she got a metallic taste in her mouth.  She stated it lasted about 15 minutes then went away.  She came back to the pharmacy 30 minutes after her vaccine because she was worried about the side effect.  We asked a series of questions to rule out anaphylaxis or more dangerous side effects.  She denied still tasting it.  She denied swelling or itching of the mouth or tongue.   We did not see it as a reported side effect so we watched the patient a little while longer, told her to keep an eye on it and contacted her at the end of the day to see how she was feeling.  At 5pm she stated she was still feeling fine.
Patient had been admitted to hospice care on 11/3/20. He reportedly declined in health and died 2/12/21.
nose allergy; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of the vaccine last 31jan2021 and is scheduled to get this second dose 19feb2021 experienced nose allergy. Doctor prescribed him with nasal steroid spray for his nose allergy. Patient asked if it was safe for him to take this medication before getting the second dose of the vaccine and if he could take it between or after the dose. Patient received treatment with Flonase (fluticasone propionate) for nose allergy. Therapeutic measures were taken as a result of nose allergy. The clinical outcome of events was unknown. Information on the Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Took fourth dose of Vivotif 12 hours late; Spontaneous report received on 24DEC2019.  A female consumer reported that she took fourth dose of Vivotif 12 hours late (PT: Inappropriate schedule of product administration), while being on Vivotif for immunisation. The consumer reported that she took her first three doses of Vivotif according to the schedule, but took the last dose 12 hours late. She stated that instead of taking the last dose at night of 23DEC2019, she took it the next morning on 24DEC2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took fourth dose of Vivotif 12 hours late (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event. ; Sender's Comments: A consumer took fourth dose of Vivotif 12 hours late (Inappropriate schedule of vaccine administered). The causality of the event is assessed as not related to Vivotif due to the nature of the event.
This spontaneous report as received from a healthcare worker refers to an 11 year old male patient. On 14-MAY-2013 the patient was vaccinated intramuscularly with first 0.5 ml dose of GARDASIL (injection site and lot# not provided). On 15-JUL-2013 and 16-SEP-2013, the patient was vaccinated with second and third dose of GARDASIL respectively (injection site and lot# not provided). Third dose given early and no adverse effects were reported. Additional information has been requested.
Sore Throat, runny nose, coughing  (could also be allergies) came on 2 days after first shot - still having same symptoms (4/1 - present 4/8) Shoulder and Chest pain on Right Arm/Chest - 3 events in 3 hours, last one lasting 45 minutes
Patient complaint of flu symptom on the day of vaccination and the next her right arm was red and had swelling.
arm  was swollen; arm  was sore; arm  was blotchy; arm  was a little bit itchy again; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  was swollen), PAIN IN EXTREMITY (arm  was sore), RASH MACULAR (arm  was blotchy) and PRURITUS (arm  was a little bit itchy again) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm  was swollen), PAIN IN EXTREMITY (arm  was sore), RASH MACULAR (arm  was blotchy) and PRURITUS (arm  was a little bit itchy again). At the time of the report, PERIPHERAL SWELLING (arm  was swollen), PAIN IN EXTREMITY (arm  was sore), RASH MACULAR (arm  was blotchy) and PRURITUS (arm  was a little bit itchy again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Client's symptom onset for COVID-19 was on 8/9/21 and included cough, nausea, fatigue, ABD pain, pneumonia, fever, weakness, and dehydration.  He tested positive for COVID-19 on 8/11/21.  Client was hospitalized on 8/12/21.  Client passed away on 8/25/21.
exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 31-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (4 pregnancies).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's pregnancy positive test, last mensuration period date and conceptions dates were not provided.  No relevant concomitant medications were reported.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.