chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date unspecified number of patients were vaccinated with improperly stored ROTATEQ (dose, strength and route was unknown). No adverse effects were reported. No concomitant medication was reported. The outcome of improperly stored ROTATEQ administered to unspecified number of patients was unknown. No PQC was involved. This is one of the several reports related via same reporter. Additional information has been requested.
4 month old male, received shots by mistake; Hep A (HAV) and FLUZONE. No adverse reaction occurred.
This spontaneous report as received from a 67 year old female physician who is also the patient. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date in 2006, 9 years ago, the patient was vaccinated with PNEUMOVAX 23 dose 1 (dose, route, anatomical location, lot number and expiration date were unspecified). On 08-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 dose 2, intramuscular (dose, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 08-JAN-2015, 30 minutes after receiving PNEUMOVAX 23 vaccine, the patient experienced neuralgia and movement disorder which were reported as severe pain, clarified as neurological-like pain, and inability to move the arm (also reported as she could not move her arm). The reporter also stated that she had trouble sleeping due to pain at injection site. Treatment given for the adverse events included BENADRYL, lidocaine patch and ALEVE. The outcome of neuralgia and pain at injection site was reported as not recovered. The outcome of movement disorder was reported as recovered on an unknown date in January 2015. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. The patient also experienced malaise while on therapy with AVELOX (case # 1501USA011288). Additional information has been requested.
they all tested positive for COVID-19 after their COVID-19 vaccination; they all tested positive for COVID-19 after their COVID-19 vaccination; sore throat; symptoms; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 (at the age of 39 years old) as Dose 2, single for covid-19 immunization. Medical history included multiple sclerosis Diagnosed either in 2010 or 2011, somewhere in there. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose 1, single for covid-19 immunization. The patient concomitant medications were not reported. The patient experienced they all tested positive for covid-19 after their covid-19 vaccination on 03Aug2021, sore throat and symptoms on an unspecified date in Aug2021. You should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. Please be sure to discuss any questions about receiving the Pfizer-BioNTech COVID-19 vaccine and if you have COVID-19 or develop COVID-19 after receiving the first dose with your vaccination provider, doctor, or other health care professional." Caller's "daughter tested positive for delta variant of COVID-19 last 03AUG2021 and had Multiple Sclerosis". Caller wanted to know if there is a time period for her daughter to wait before she gets the booster dose of the Pfizer BioNTech COVID-19 vaccine. Caller's daughter got off isolation last Monday, 16AUG2021. The dates for tested positive for the delta variant was reported from date 03 Aug2021 to 16 aug2021.No lot number was provided because caller does not have a copy of her daughter's COVID vaccine record card. The caller mentioned about product complaint due to her daughter having delta variant covid infection. The patient underwent lab test and procedure which included covid-19 result included negative on 02Aug2021 and positive on 03Aug2021. The outcome of the event they all tested positive for COVID-19 after their COVID-19 vaccination was recovered on 16Aug2021 and the outcome of other events was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
This spontaneous report was received from a healthcare worker and refers to a 11 year old patient of unknown gender. No information  about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017) (dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information  has been requested.
I received my second Pfizer COVID vaccine shot at 11:00 am.  The first 12 hours after everything was normal and fine.  I ate dinner and got ready for bed.  But then, starting 12 hours after my shot, starting at 11:00 pm, I began to have severe chills and total body shakes.  I was curled up into a ball under blanket, both freezing cold and profusely sweating.  My breathing was very fast and I couldn't slow it down.  My stomach was very upset and I was unable to eat anything.  At 3:30 am, I got a severe Migraine which lasted until 6:00 am.  I continued to feel very ill the whole rest of the day.  Finally, around 9:00 am some 34 hours after syptoms began, they left me.
Outbreak of oral Herpes Simplex on day 3. Lasted till day 10 despite VALTREX 1gm TID.
Suspected Vaccination Failure; I had the shot and still got 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Had to go to patient in car in parking lot to give the vaccination...not long after injecting patient, the area was swollen and bruised looking.
Swelling in L/elbow and forearm distal to injection site with tingling  into l/hand, headache, malaise.
Beginning about 6 hours after the shot, arm pain began.  In the evening of the same day of the shot (approx 8 hours later), onset of fever and chills.  Overnight, (10-12 hours later) chills became very extreme, chattering teeth & inability to feel warmth.  Fever increased to approx 102.  Nausea and migraine at around 12 hours.  Severe exhaustion, headache, body ache, and nausea continued until approximately 24 hours later.  Consistent arm pain.  Approx 36  hours later, itchy rash, redness, and swelling at the injection site was noticed but other symptoms had subsided.  Unclear when the rash and swelling began as the rest of the symptoms were too severe to notice.
On 12/28/21 at approximately 15:30pm,  Employee (Vaccinator) administered a clean syringe containing 'No Vaccine' into the left arm of the patient. The patient had no adverse reaction to the 'needle stick'.  The Patient did receive a Moderna Booster from another Vaccinator with no incident or issues. The empty syringe traveled from the Vaccination Prep Station to the Row Lead/Runner to the Vaccinator without being properly inspected, by all parties involved.   All parties were reminded of Facility's Standard Operating Procedures and remedeation was given to the parties involved.  All Staff were reminded to the '5 Rights of Administering Medications' and to triple check everyones work.
Moderna Covid 19 Vaccine   Rash around both armpits very tender for 48 hours
Patient received the COVID-19 booster dose 6 days earlier than the 6 month time frame.
Over 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over 35 days since first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Over 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment were reported.
On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID; On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose number unknown (booster), single (Lot number: GJ6737) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: 2012 (unspecified if ongoing), notes: Consumer stated, I do not know, 10 years ago; "Heart problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: On 30Nov2022, I accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time I contracted COVID; (07Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  On 30Nov2022, the patient accepted the Bivalent Booster (Pfizer COVID-19 Bivalent Vaccine) and since that time he contracted COVID. Will that virus negate the bivalent booster (Event and Suspect captured conservatively as per verbatim), or the booster just was not, did not have enough time to grab a hold off and benefit him and then Paxlovid, he did not know, was it the symptom or a side effect but while he was taking the 3 in the morning, 3 in the evening for 5 days, he felt my facial cheeks were hot and my eyes were slightly burning and since Monday, which is the last day of the dosage, the dose imaginings or symptom have vanished. Consumer stated, The COVID Booster, the Bivalent. He just wanted to know was 30Nov2022 not enough time for the vaccine (As further clarification were not available over the call hence suspect captured as Unspecified Vaccine) to help him, since he had contracted COVID.
Client called 11/6/14 stating had swollen area under (Lt) armpit. Had not called prior to that but states, has had for awhile - had not see dr yet - recommended to do so. Saw dr next week - blood work done. Either was getting over or getting Mono so combo with vaccines caused lymph node to swell. Resolved shortly - fine when finally connected to pt 11/24/14.
Admission Diagnoses: CAP (community acquired pneumonia) [J18.9] Community acquired pneumonia, unspecified laterality [J18.9]   Discharge Diagnoses:    Deceased Acute Hypoxic Respiratory Failure due to COVID 19 PNA   Hospital Course:  Patient is a 97-year-old female with a history of chronic atrial fibrillation, subdural hematoma, CAD status post CABG, CHF, hypertension, Waldenström's macroglobulinemia who presented for fever and cough.  The patient had a fever of 101 degrees for 2 days along with significant weakness and deconditioning.  She was fully vaccinated for COVID-19.  Upon arrival to the ER she was hemodynamically stable, T-max of 99.1 °F.  She had an admission evaluation which revealed WBC 8.8, elevated lactic acid 2.4.  She underwent a CT of the chest which showed no signs of pneumonia.  CT of the abdomen pelvis showed no evidence of obstruction and no acute abdominal abnormalities.  The patient was admitted under observation status due to generalized weakness.  Prior to transfer to the medical floor her viral PCR results were positive for COVID-19.  She was admitted under isolation status.  During the first few days of her hospitalization she did not have any respiratory symptoms and had significant deconditioning.  She did not meet criteria for remdesivir therapy.  Subsequently the patient had decompensation with hypoxia and respiratory failure requiring transfer to the ICU.  She was treated with steroids and remdesivir.  The patient had quick decompensation requiring BiPAP placement.  She had significant respiratory distress while on BiPAP and her family was consulted in regards to goals of care.  Due to her significant respiratory distress while on BiPAP the decision was made to make the patient comfort care.  The patient had comfort care medications administered along with removal of the BiPAP.  The patient passed away on September 28, 2021 at 7:34 AM.  Family was at the bedside.                 Consults: IP CONSULT  IP CONSULT TO SPIRITUAL CARE   Significant Diagnostic Studies: N/A   Discharge Exam: Blood pressure 96/56, pulse (!) 0, temperature 97.6 °F (36.4 °C), temperature source Temporal, resp. rate (!) 1, height 5' 1" (1.549 m), weight 49.4 kg (108 lb 14.4 oz), SpO2 93 %. Absent Pulses Absent Respirations Pupils fixed and Dilated   Disposition: Deceased   Code status: DNR   Time Spent on Discharge more than 30 minutes     Signed: MD 9/28/2021 10:33 AM
Pt had febrile seizure on the same day as immun given; Pt was hospitalized & found to have bilateral otitis media & viral pneumonia on 23AUG91;
Information has been received from a nurse practitioner concerning a 20 year old black female with no known allergies who on 04/05/2001 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt became pregnant and this was her first pregnancy. The pt's last menstral period was on 03/07/2001. Follow up info received from the consumer indicated that she had no local reaction at the vaccination iste and no varicella symptoms or herpes zoster symptoms post vaccination. An ultrasound was performed on 07/20/2001. It was reported that the pt vomited alot and was hospitalized for dehydration. On 12/07/2001 the pt had a c-section because the navel cord was wrapped around the baby's neck. She gave birth to a normal male 5lb 13oz. It was reported that the baby did not have any feature of congential varicella zoster syndrome. Follow up information from the baby's medical records indicated that the baby was born at 19 weeks gestation. The patient's PKU was collected on 12/10/01 and it was reported that the patient's T4 of 6.4 ug/dl was borderline, and PKU 0.4 mg/dl, GALT 8.1 U/g of Hgb and TSH 5.3 uIU/ml were all normal. The patient's T4 was considered borderline and the TSH was considered normal. On 1/8/02 the patient was seen by a physician for his 1 month old check up the paitne'ts physical examination was normal. It was noted that the patient had thrush on his scalp and was treated with Nystatin. The assessment and plan noted that the patient was a healthy newborn and the free T4 and TSH were to be repeated. on 1/8/02 that patient's T4 free was 1.27 and TSH which were both normal. The patient's trush on his scalp was considered to be an incidental finding. No further info is available.
This spontaneous report was received from the patient's daughter referring to a 69 year old female patient. The patient's concurrent conditions included epilepsy. The patient's medical history was not provided. Additionally, it was reported that the patient was not taken any concomitant medications, and did not have drug reaction or allergies. On an unspecified day in 2011, the patient was vaccinated with ZOSTAVAX 0.65 ml, as single dose, in the right arm (route of administration, lot number and expiration date were not reported) as shingles prevention. On 19-MAR-2017 (past Sunday), the patient started to develop coughing and wheezing episodes and she went to see her primary care physician who prescribed her azithromycin (Z-PAK) antibiotics because the doctor thought the patient had a respiratory infection. On 21-MAR-2017, at the overnight, the patient experienced extreme pain inside her back around to her lower back and when the patient woke up on 22-MAR-2017 (Wednesday), at the morning, she noticed that she had developed a rash all over the right side of her waist; it was covering a large area approximately 9 inches by 9 inches. The reporter mentioned that the patient's rash also consisted of darker red patches and welts. The reporter said that she took the patient to a nearby Emergency Room (ER) on the same date, due to the adverse event (AE). The reporter stated that in the hospital, a nurse and a physician that was working at the ER evaluated the patient's rash and both felt that the patient's rash had the characteristics of a shingles rash. As treatment the patient was placed on prednisone (manufacturer unknown), oxycodone (+) acetaminophen (PERCOCET) and an unknown antiviral. On an unspecified date a blood test was performed but the results were not provided.  The reporter confirmed that the patient was not hospitalized because she was released from the ER on the same day after receiving some treatment. At the time of reporting the patient had not recovered from the respiratory tract infection, the back pain and the shingles.  Upon internal review, the respiratory tract infection was considered to be a medically significant event. The causal relationship between the events and the ZOSTAVAX was not provided.  Additional information has been requested.
headache; This is a spontaneous report contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 20May2021 as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced headache. It was reported that patient wanted to know if she can take Ibuprofen/Advil or pain reliever for headache. Customer and/or medical inquiry was not forwarded or referred to MI. The outcome of the event was unknown.  Information regarding the Lot/Batch number has been requested.
headache and nausea different than usual migraine for 2 wks beginning day after Gardasil vaccine administration
This spontaneous report has been received from a physician refers to a 67 years old female patient with hypertension. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX on an unspecified day in 2009. Concomitant medications included Hypertension medications. On approximately 20-JUL-2012 (reported as this past weekend) the patient experienced shingles. The patient sought medical attention and antiviral was given for the treatment of shingles. There was no lab diagnostic study was performed. The outcome of shingles was reported as not recovered/not resolved. Additional information is not available.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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: "AVR" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Partial complex seizures" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN; ALFUZOSIN; DYAZIDE; LAMOTRIGINE; ROSUVASTATIN; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19".  Clinical course: Partial complex seizure on 15Jul, likely related to low lamotrigine dose. This was not adjusted and not listed on meds to change. All other med interactions were accounted for by adjusting as recommended and sprained shoulder with a fall from the seizure, in sling.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
First dosage: sore arm  Second dosage:  Headaches, body aches, nauseated, sore arm, and dizziness,
Patient complaining of limited range of movement on arm following vaccination, even after 2 & 1/2 weeks.
Itchiness at injection site, left deltoid, beginning 05/05/2021. Affected area is visibly red and sore to touch.  Itchiness on top of left hand and top of left foot beginning 05/06/2021 approximately 18 hours after onset of first symptoms.
Swelling; Numbness; Tingling; received the most recent COVID-19 vaccine subcutaneously; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 subcutaneously administered in left arm on 29Mar2021 12:45 (Lot Number: 1239921-00) as a single dose for covid-19 immunisation. Medical history included type 1 diabetes and allergic to tempeh (it's a food). The patient was not diagnosed with COVID-19 prior vaccination. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine subcutaneously in a pharmacy or drug store. On 29Mar2021 14:00, the experienced swelling, numbness and tingling which was considered serious since the patient was hospitalized (unspecified date in 2021) for 1 day (unspecified date in 2021). The adverse event required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The events required treatment which included Benadryl. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovered on an unspecified date in 2021 with sequel.