chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 61-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the adverse reaction and product supply issue were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. After receiving 1st dose of SHINGRIX, the patient experienced very bad reaction. The patient called his provider and said that he thought that he had an allergic reaction but the provider said that it was not an allergic reaction but just a bad reaction. On the day of reporting, the patient went to his physician office to get the second dose but they did not have it and said it was on back order since several months. The patient asked where would he get the vaccine. The call center representative replied that individual medical guidance for patients like yourself should be provided by medical professionals and was not something GlaxoSmithKline provides to the patients. As you may know the FDA approved dosing schedule for SHINGRIX was the first dose at month 0, followed by a second dose 2 to 6 month after the first dose. The Centers for Disease Control and Prevention (CDC) has provided guidance that if it has been more than 6 months since you got the first dose, you should get the second dose a soon as possible; you do not need to restart the vaccine series. Advised to the patient that he should talk to his physician or pharmacist about this guidance and the patient's individual situation.
This spontaneous report as received from a pharmacist refers to a 74 year old male patient with no drug reactions or allergies. On 18-FEB-2008 the patient was vaccinated with ZOSTAVAX (lot#, strength, dosage and route unknown). Concomitant therapies included Bystolic. On 11-JUN-2014, the patient was seen at an unspecified physician's office because "he didn't feel right". The unspecified physician diagnosed him with shingles and prescribed Valtrex. The pharmacist reported that patient also came into the pharmacy on 11-JUN-2014 to fill the Valtrex prescription and to report the adverse event. The pharmacist stated "he had a mild case of shingles". No lab diagnostics studies performed. The outcome of the events was reported as recovered on an unspecified date in 2014. Additional information has been requested.
patient had prolonged muscle soreness in arm following administration of vaccination, lasting months. Doctor diagnosed as frozen shoulder.
Next Day stiff lower neck left side.  Painful to rotate head to left.   Has been sore ever since vaccination.  Otherwise no other reaction to shot.
My infant had a fever the day after her shots. I was never asked or informed that the flu shot was going to be given and it was the second one given in 3 months without talking to me about it. On January 8th, she had a febrile seizure. The ER doctor was stating it was probably caused by the fever due to recent vaccinations. No treatment given.
Felt weird/ Felt bad; Headache; Pain in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt weird/ Felt bad"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in my arm".  Additional information: Patient felt weird because the shots made her have a headache and pain in her arm for over 2 days. All she did was sleep and felt bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax 13MAY93 & 14MAY93 6PM pt exp nausea & devel hives; sx lasted on & off for the next 4 days; On 18MAy93 pt was treated w/DPH;
76 y/o female, BMI 42, PMHx of hyperlipidemia, HTN, DVT, and obstructive sleep apnea, admitted for SOB due to Covid19 on 12/5/21. Chest x-ray taken on 12/6/21 showed diffuse bilateral multifocal pneumonia. Covid was treated with supportive measures. Pt was discharged on with home health on 12/8/21.
High fever, severe head ache covering complete head, dizziness when standing, fatigue, lasting four hours, was given Motrin at 7 AM, fever reduced by 9 AM, headache was mild after this and lasted until 11 AM, today on 5/15 at 3:15 there is still pain at the injection site.
2 covid vaccine shots last year of Apr ang I believed I got my GBS because of the vaccine reaction.and just this year last 18Oct2022 I had a recurrence of the illness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset 18Oct2022, outcome "not recovered", described as "2 covid vaccine shots last year of Apr ang I believed I got my GBS because of the vaccine reaction.and just this year last 18Oct2022 I had a recurrence of the illness.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt vaccinated in L deltoid muscle with seasonal flu vaccine and H1N1 vaccine in R deltoid, 5 - 10 min later patient had tingling and swelling in throat, became lightheaded and short of breath. Nurse gave 2 EPINEPHRINE sq injections and called 911 who took patient to hospital.
I experienced pain in shoulder, tiredness, headaches after my second dose Pfizer vaccine. This lasted for a few days. I did not see a doctor. I can not make the lot# on my vaccine card.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was atrial fibrillation with rapid ventricular response.
On 4/30/10, immunization given was PENTACEL ( L ) leg, HAVRIX ( R ) leg. Mom said (+) redness like before w/immun. Then woke up next day size > grapefruit.
temp elevated as high as 103 x 24 hr did not respond to APAP; vomited 1x morning of 22JUN95; temp nl late afternoon of 22JUN95; seen by MD 23JUN95 early  AM; pt OK
Administered FLUVIRIN at offsite clinic, around 7:00 am on 10-12-15. School nurse called and reported that she was found in responsive and in an apparent seizure at 10L00 at the school. Patient was transported to ER. She was responsive upon transport.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; 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) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 1:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Feb-2022 at 1:11 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received vaccine past its 30 day expiry date on 07-Feb-2022 at 1:11:30 PM. Vaccine went into 2 to 8 degree Celsius thawstate on or about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was reported.
Patient was given the monovalent vaccine vs the bivalent. No known adverse outcome. We were told by local health dept. to record this as a med error.
3 inch area of redness. hot to touch-painful observed by doctor. Advised ice and Tylenol as needed
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Information regarding medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # K007977 and expiry date 03-JUN-2015). No adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
1705: Pt c/o dizziness and blurred vision. Pt transported via stretcher to back room area. VS: BP-136/96, RR-16, SpO2-97% HR- 63 1715:  VS: BP-128/94, RR-16, SpO2-100% HR- 64 1720: Pt reports she is feeling better, states that vision i back to normal
This is a spontaneous report received from 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 26Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 19Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 16Oct2021 as dose 3 (booster), single (Lot number: EW0202) at the age of 30 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Cyclic neutropenia" (unspecified if ongoing); "Peanuts" (unspecified if ongoing); "pollen (seasonal)" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 03Jan2014; VITAMIN D [VITAMIN D NOS]; MUCINEX, start date: 27May2022, stop date: 29May2022; DAYQUIL AND NYQUIL SEVERE+ VICKS VAPOCOOL COLD AND FLU, start date: 25May2022, stop date: 30May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Covid-19 treatment; (03Jun2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical Information: Reporter stated that, Report about Covid treatment. Age Group was reported as, Adult (18-64 Years). Other medication received in 2 weeks. Anti viral details reported as, Product: COVID-19 Treatment, Brand: Paxlovid, Treatment started on 27May2022 and stop date was 01Jun2022, Indication was reported as Treatment of COVID-19. Other medication details reported: Other medication in 2 weeks product reported as, Escitalopram, 20 mg daily, start date: 03Jan2014. Vitamin D, 3000 ug daily. DayQuil/NyQuil, start date: 25May2022 and stop date: 30May2022. Mucinex, start date: 27May2022 and stop date: 29May2022. Adverse event: Rebound Covid. Started Paxlovid 27May, tested negative 03Jun, then began testing positive again 04Jun. Adverse event start date was reported as, 04Jun2022. Patient was Recovering. No treatment ae. Known allergies was reported as, Peanuts, pollen (seasonal). No follow-up attempts are possible. No further information is expected.
4MAY tingling both arms intensified by holding arm away from body tingling in legs also;to MD 7MAY97, t97.6;
lump; itching; swelling; bright red coloring; Incorrect route of product administration; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 12-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Incorrect route of product administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       Patient received the first dose of moderna vaccine on 12Feb201 and had a reaction. 4 days after the shot had itching on the arm of the injection. 6 or 7 days after noticed swelling and discovered the was a lump there, and bright red coloring. This symptoms were better,the swelling was better and itching was gone.
Heavy periods (2) after vaccination. The first period following vaccination was prolonged with some clotting seen in discharge. The second period is shorter but heavier in clotting. Passed a quarter sized clot, thick on  09/10/2022. Severe headache on 09/09/2022.
Blood oxygen level dropped to 80% ! Severe chills/shaking Headaches/body aches/joint aches Resting Heart rate  increased to minimum 95bpm ( basically same symptoms I experienced with covid -except lower Oxy level)
Starting early in the morning 28MAR2023 my Daughter had a vomiting episode early in the morning around four AM that lasted on and off for three hours. I kept her home from school that day it was shortly followed by diarrheas and the she seemed to bounce back fine My husband AND i assumed it was a stomach bug and then it happened again two nights later and we thought she just ate something bad it occurred again over the week around 02APR2023 by the morning of 05APR2023 she had her fourth episode in over a week. That morning we took her to Urgent care and the doctor could not  determine the cause of her symptoms, we told to simply monitor her since we were unsure of the source and we were sent home with a stool sample kit for the diarrhea and  a prescription of Flumodine to help calm the stomach. For about one week she seemed to be doing better until 13APR2023 she threw up two nights in a row after the first night I was able yo collect a stool sample to send to Urgent care and after the third night I made an appoint with our Pediatrician Dr he determined due to the incidents being isolated with no other symptom than vomiting or diarrhea the caudle was food related.
5 minutes after shot my son went pitch white lips and all and felt sick to his stomach.  He started vomiting and they believe he aspirated.  His bronchial area inflamed and severe constant cough for 2 weeks followed.
No additional AE reported.; Patient was administered Improperly Stored, Separate PNEUMOVAX 23; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 23-DEC-2022, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 55.0 Fahrenheit degrees (°F) during 153 hours. On 03-JAN-2023, the patient was vaccinated with an improper stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot # W007035, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent [23-valent] [PNEUMOVAX23], expiration date reported as 23-OCT-2023, but upon internal validation established as 20-OCT-2023) (dose, anatomical location and route of administration were not reported) (Product storage error). The vaccine did not have previous temperature excursion.  No additional adverse event was reported.
Flu like symptoms Saturday/Sunday /Monday  Went to urgent care diagnosed with Covid and pneumonia
This spontaneous report as received from a Registered nurse refers to a unspecified number of patients of unknown gender and unknown age. It was rerpoted that on an unknown date in 2014, the unspecified number of patients received unspecified doses of ROTATEQ, (dose number, lot/batch number, expiration date, route of administration not reproted) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II GARDASIL, PNEUMOVAX and PEDVAX were improperly stored (event captured in MARRS# 1405USA012894, 1406USA000955, 1406USA000956 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Addtioan information has been requested.
I exp muscle spasms(tightening shoulders),tingling in fingers(pointed finger,middle finger) and within last two weeks started to ease in pain. I was taking heat and Icy Hot on my arms.
SARS coronavirus 2 RNA~SARS-CoV-2,  performed on 7/23/21 at 13:35. Test came back detected. Case investigation interview with patient has not been conducted as of the time of this note.
My second vaccination was injected into my left arm. I had no problem for a couple of weeks other than some local pain in a gland at the top of my inner left arm that persisted a week or so. I gradually had reactions going down the same left arm into my elbow joint which caused inflammation  and rash.  I had alot of nerve pain to the touch near the inner side of my elbow which has persisted for months and has just recently subsided over 5 months later. There was a dry rash on both elbows which I've never had.  The most serious side effect I hadn't noticed right away were large lumps under my left arm pit and under my left breast. I see my new Doctor in a couple of days and I'm hoping this is just an auto immune response. an over production of white blood cells. I've read some have had that reaction although it was said to last only a couple of weeks. These enlarged lymph glands have lasted for several months. I've had regular mamograms all coming back clean with negative reports. I've never had this problem before. I exercise and eat nutritious foods. I will request an ultra sound to rule out Cancer. I would like to add my results to this report if I am able to.
Flu like symptoms; Cold; Ear pain; Throat pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), NASOPHARYNGITIS (Cold), EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Throat pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), NASOPHARYNGITIS (Cold), EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Throat pain). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), NASOPHARYNGITIS (Cold), EAR PAIN (Ear pain) and OROPHARYNGEAL PAIN (Throat pain) had resolved.            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.  No concomitant medications were reported.  The reporter causality for the Humira for the events was reported as no reasonable possibility.  The treatment medication was not provided.
pt recv vax 10APR96 & 26APR96 pt devel 6 lesions which itched;
Nodule on clavicle area and large coagulation in the menstrual period.
Information has been received from a medical assistant concerning a 17 year old female with no medical history or drugs allergies, who on 02-JUL-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 660555/0279X), intramuscularly. The patient received a second dose of GARDASIL vaccine (lot 660612/0229X) on 03-SEP-2008 and a third dose of GARDASIL vaccine (lot # 661046/0381X) on 15-SEP-2009. There was no concomitant medication. The patient experienced reactions after her third dose of GARDASIL vaccine. The patient had vomiting, nauseas, and swollen glands. Her throat tightened also. The patient did not have any reactions from the first and the second doses of GARDASIL vaccine. No laboratories studies performed. The patient went to an emergency room but recovered within 10 minutes. A lot check has been initiated. Throat tightened was considered to be immediately life-threatening. Additional information has been requested.
30 seconds after administering the shot, patient said i think i am going to pass out and he had few light jerks and he passed out on the chair that he was sitting. RPh called out to call 911..within 30 seconds patient said I am ok. He was dizzy. Tech went to get lemonade for him. Gave him paper towel to wipeout the sweat. After few minutes he felt better.  He walked to the bench in front of the pharmacy and sat their for about 20 minutes then he said he was feeling good and he wanted to walk . After about 10 minutes he came back said he is feeling good and wanted to leave. I talked to him and checked if he was ok  then he left.
Admitted 4/3 with a cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus.  Pt received covid vaccine 3/18.  Symptoms began 3/26 which started with chills and body aches. Then on 3/27- developed a severe headache in the back of her head with associated nausea. On 3/28 she had the most severe headache  on the right side of her head. She was vomiting from 3/28-3/30.  On 3/30 she went to the ER for evaluation of her severe headache. She was given a "migraine cocktail", no imaging was completed and she was sent home. Appetite improved on 3/31 and she had a small headache relieved with Excedrin.  Then on 4/1-4/2 she had severe bloating , abdominal pain and fever of 100.4. She had been visiting her mom for the holidays and came to the ER. Imaging revealed  cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus.  She was started on a heparin drip and  brought to ICU for monitoring.. She is not on any oral contraceptives and does not have any family history of clotting disorders.
May 7, 2021, approximately 9 hours after receiving the vaccine, I experienced nausea, vomited and diarrhea. After 13 hours after receiving the second dose of the vaccine, my leg muscles began to contract uncontrollably, which caused severe pain. The contractions did not stop for two hours, after taking three Aleve tablets. This was followed by extreme fatigue for an additional 24-hour period alongside bruising down my legs and signs of popped blood vessels. An additional symptom that I continue to experience is massive swelling and pain in my breasts  this has lasted for three days. I was sent to the ER to determine if I had a blood clot in my leg.