chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient family member or friend and describes the occurrence of CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder) and MUSCLE SPASMS (Muscle spasms) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Sep-2022 at 4:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Sep-2022, the patient experienced CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), MUSCLE SPASMS (Muscle spasms), HEADACHE (Severe headaches), MYALGIA (Feels achy all over) and FATIGUE (Tired). On 13-Sep-2022 at 9:00 PM, the patient experienced ARTHRALGIA (Shoulder started getting sore). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder), MUSCLE SPASMS (Muscle spasms), ARTHRALGIA (Shoulder started getting sore), HEADACHE (Severe headaches), MYALGIA (Feels achy all over) and FATIGUE (Tired) outcome was unknown. No concomitant medications were reported. Patient received the Moderna COVID-19 vaccine by intramuscular injection on 25-Feb-2021 (lot number 023M20A, expiration date unknown), 25-Mar-2021 (lot number 013A21A, expiration date unknown), 02-Nov-2021 (lot number 077C21B, expiration date unknown) and 03-Jun-2022 (lot number 056M21A, expiration date unknown). Patient had loss of appetite. They also agreed it hit patient harder. Patient had been taking Advil.
Two weeks after vaccine developed 17 black and blue marks with hematoma all at once for no reason.; Two weeks after vaccine developed 17 black and blue marks with hematoma all at once for no reason; This is a spontaneous report from a contactable consumer, the patient. An 81-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6708) via an unspecified route of administration in the left arm on 21Mar2021 at 16:00 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history included slightly low red blood cells and platelets. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, two weeks after vaccine, the patient developed 17 black and blue marks with hematoma all at once for no reason. A few weeks later, on an unknown date in 2021, the patient underwent blood tests and the result was lowered platelet and red blood cells. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed 17 black and blue marks with hematoma all at once for no reason was resolved with sequalae on an unknown date in 2021.
Post 1st injection 10 mins-he called staff over saying felt lightheaded. Assisted to floor in supine position by responding staff. diaphoretic and pale- syncopal episode- 20 seconds unresponsive , alert and oriented x3 post syncopal episode. Vital signs BP 122/72  HR 61 O2 97% on room air Respirations 20. Patient denies injury, no nausea, just weak. Family called will come get him-encouraged to have driver for 2nd dose and eat prior to coming. Snack's and water provided.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored VARIVAX, lot # R022116, expiration date 02-AUG-2020, subcutaneously, diluted in properly stored sterile diluent for prophylaxis. The vaccine was stored in temperature ranges 15 Fahrenheit degrees to 46 Fahrenheit degrees for 45 minutes. Previous temperature excursion was also reported in ranges 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 8 hours and 5 minutes. The temperature was measured by "data logger". No adverse effects reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1901USA006124; US-009507513-1902USA000279.
This is a spontaneous report from a non-contactable pharmacist received via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date (reported a year and a half ago) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced terrible body aches that lasted a few days. The outcome of the event was unknown.
6days after shot; severe vertigo and vomiting. Sleeping and staying in bed as movement causes dizziness and nausea. Temperature 99.2, goes up if vomiting. Can?t bold anything down, just started on sips of pedialite.
several test done and it has come back that her rare condition is in remission.; Sleeping more; Pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021. The most recent information was received on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping more), PAIN (Pain) and THERAPEUTIC RESPONSE UNEXPECTED (several test done and it has come back that her rare condition is in remission.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Stiff person syndrome (Movement disorder). Concomitant products included DIAZEPAM, CANNABIS and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced SOMNOLENCE (Sleeping more) and PAIN (Pain). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (several test done and it has come back that her rare condition is in remission.). On 24-May-2021, SOMNOLENCE (Sleeping more) and PAIN (Pain) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (several test done and it has come back that her rare condition is in remission.) outcome was unknown.            Treatment medications included pain medicines.  Reportedly, the patient had seen three different doctors for her rare disease Stiff Person Syndrome and had several tests done. The test results showed that her rare condition was in remission.   This case was linked to MOD-2021-208973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up information received, included medical history and additional event.
Her face and throatwere a little puffy; Her face and throatwere a little puffy/throat is swollen; Her throat was swollen and irritated; Inside of the mouth she has a rash that looks like thrush but is very painful; Inside of the mouth she has a rash that looks like thrush but is very painful; Her face and hand were very hot; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother) from a Pfizer Sponsored Program.  A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 17-years-old). The patient medical history and concomitant medications were not reported. The mother of the patient stated that on 16Apr2021 her daughter (the patient) received the first dose of vaccine and afterward her face and hand were very hot and usually she was cold. The next day on 17Apr2021 her face and throat were a little puffy, inside of the mouth she has a rash that looks like thrush but was very painful. Her throat was swollen and irritated. Her doctor prescribed medication prednisone 10mg for one week and she was feeling much better now. Her doctor recommended not taking the second dose, it could be worse than the first. Her doctor suggested calling Pfizer. The patient was recovering from the events at the time of report.   No follow up attempts are needed. Information on lot/batch number cannot be obtained.
This spontaneous report as received from a other health professional refers to a 4 year old patient. On 07-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
DTAP given right arm 08/08/2003.  Complained of fever (100.0 AX).  08/09/2003 AM and 100.7 AX 07/09/2003 evening.  Complained of swelling, redness, warmth right upper arm starting 08/09/2003.  Using arm OK. Denies pain involvement.  Diagnosis: Local reaction.
Received the rabies vaccine all three doses within the 30 days but not on schedule/No AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via call-center via Medical Information (Reference number- 00393542) and transmitted to Sanofi on 15-Dec-2020).  This case involves a female patient of unknown age who received all three doses of RAGE DIPLOIDE   VACCINE [IMOVAX RABIES] ((frequency, strength, lot number and expiry date unknown) via an unknown route within the 30 days but not on schedule (wrong schedule) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to Inappropriate schedule of vaccine administered.  Reporter wanted to know the efficacy of the rabies vaccine when it had not been administered on time and received all three doses of RAGE DIPLOIDE  VACCINE [IMOVAX RABIES].  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JAN-2009, the patient was inoculated with ZOSTAVAX at the pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2012, the patient was treated by the medical group for the onset of a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
13cm x 10cm patch red papular lesions in ring pattern R lateral thigh covering area which was reddish purple for 4-5 days after shot. RX: Westcort cream bid.
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Reports on 1/6/2021 got  Moderna COVID 19 vaccine left upper arm and noticed on 1/16/2021 left upper arm swollen, red, itchy and tender to touch.
administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number ZY9MJ, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The reporter asked if the patient had to be re-vaccinated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Flulaval, which led to expired vaccine used. Suspect was coded as Flulaval tetra 2020-2021 season as both Flualval tetra and Flulaval quadrivalent both are same in terms of active ingredient and also considering the expiration date.
I was in pain for 3 to 4 weeks after I received the seasonal flu shot.  Just one morning I woke up with bad stiff neck with joint pain all over. Then I was okay after taking ibuprofen for a while.  I asked Doctor about it, but she said it is nothing do with flu shot. Then in September of 2011, my left arm was sore and couldn't move up or down. On November of 2011, I went to see the Specialist for Bursitis and Adhesive Capsulitis.  They did the x-ray and confirmed it was Adhesive Capsulitis. On December of 2011, I received treatment for Adhesive Capsulitis but, still not healed.  Presently, I am still doing exercises at home and planning on going back to physical therapy (costly).
had the shingles not nearly as bad as the shot/Suspected Vaccination Failure; Had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shingles not nearly as bad as the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient had the shingles not nearly as bad as the Shingles shot. The patient had every side affect listed. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PT DEVELOPED INFLAMED, WARM, TENDER, TIGHT UPPER RIGHT ARM WITHOUT OBVIOUS LOCAL INFECTION/KNOT/PAIN AT SPECIFIC SITE OF INJECTION. SX PRESENT FROM DELTOID TO NEAR ELBOW AND RESULTED IN HAND PARESTHESIAS.  SX DEVELOPED WITHIN 24 HRS.
PT EXP PAIN AT INJECT SITE. NOT ABLE TO SLEEP SINCE INJECTION D/T PAIN. IBUPROFEN REC, 5-14-90, NOT TAKEN. PT STILL C/O PAIN. REC'D 2nd DOSE 5/12/90 - SAME DAY, ONSET OF SWELLING, HEAT & PAIN @ SITE X 3DAYS. DEV RASH, WEAKNESS
Diarrhea and stomach pain and bloating after first Pfizer shot 7/30 which went away but diarrhea came back 8/21 the day after second Pfizer shot and I still have it.  My oncologist said it couldn't be from the vaccine. I'm not weak or tired but had to stop taking Immodium because it made me dizzy.  I still have loose stools as of today and was told by my nurse practioner yesterday to eat more potassium rich foods which is difficult with diarrhea.
she was tired; This is a spontaneous report from a sponsored program received from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. The patient was tired on an unspecified date. The patient took paracetamol or ibuprofen two after receiving the covid vaccine. The patient later heard that you are not supposed to take pain medication after receiving the vaccine and wanted to know if it will change the effectiveness. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 d after Dtap, (L) deltoid swollen, red, hot and sore also c/o "legs feeling anxious". Tx prednisone 40 mg QD x 3, ICE, Benadryl, Advil
Patient was seated, and received Gardasil 9 vaccine, second dose. No concerns with his first dose. After vaccine was administered, patient stated "he is starting to feel something come on" Nurse quickly started talking with him but patient was already leaned back and passed out. She called for another nurse, while still talking to the patient. The patient had a few jerks of his arms but then opened his eyes and sat up. He was orient to where he was and knew his name. He could talk to the nurses and said he just felt hot. A cool towel was placed on the patient's neck and he sat for another 15 minutes. Patient drank a bottle of water and stated he only had a poptart for breakfast. Patient was able to walk out of the office and was discharged home. He was complaining that he had bit his tongue and had some tightening in the opposite arm than what was vaccinated. Episode lasted less than 1 minute. No treatment was given. Just to be monitored, eat and stay hydrated.
I21.4 ACUTE NON ST ELEVATION MI 4/4/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 4/4/2023 HYPOTENSION DUE TO MEDICATIONS I21.4 ACUTE NON ST ELEVATION MI 4/4/2023 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
Within a few minutes of the shot I had difficulty breathing, swallowing, my throat felt like it was closing up, and I had chest pain. I was incredibly shaky and had to be monitored by the paramedics and receive oxygen for almost 1.5 hours.  In the following days I experienced extreme fatigue, muscle soreness, fever, loss of energy, severe headache. It took me about a month to fully recover and feel well again.
Shivering, low grade fever 100.2 later in the evening 1/20/21. Mild headache, Lasted 12 hours until I took Ibuprofen x 2 doses. All sx resolved now. Narrative:
Covid +ve; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid +ve) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 (Covid +ve). On 22-Mar-2021, COVID-19 (Covid +ve) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient suffered a stroke in January 2015 and has still suffered the residual effects including weakness and dysphagia. Patient's wife requested hospice care due to patient's considerable pain keeping him up all night and her inability to care for him any longer. Palliative care consult placed on 2/18/21 and he passed away on 3/9/21.  Patient had advanced age, carotid artery stenosis, chronic pain, HTN, HLD
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping tome period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 30-JAN-2013, one of the them was vaccinated with a dose of live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
itchy rash w/ small red bumps beginning on the right jaw line noticed upon awakening on 11/6/13, spreading over the next 24 hours first to the right neck and cheek and then to most of the head and neck with the bumps becoming more apparent