chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the injection site; Hardness at the injection site; Itchiness at the injection site; A spontaneous report was received from a 94  year old , female patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site/vaccination site erythema , hardness at the injection site/ vaccination site induration and itchiness at the injection site/vaccination site pruritis.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273(Batch number : unknown) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch number : unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, after receiving mRNA-1273, the patient experienced redness , hardness and itching at the injection site. The reporter wants to know what to do regarding her symptoms. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, redness, hardness and itching at the injection site were not considered to be resolved at the time of report.
A report has been received from consumer. The report concerns a male consumer, who had been receiving FLUMIST (intranasal), 0.2 ml unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient experienced cold, felt sick, runny nose and product quality complaint. The outcome of the event of cold, felt sick, runny nose and product quality complaint was unknown. The report was considered to be non-serious. Corrected report 01-Dec-2015: Key ingredient updated for suspect drug FLUMIST. Narrative was updated.
Patient was admitted to the hospital with COVID symptoms and was treated with typical COVID medications. Patient remains in hospital.
I had Moderma vaccine on 1/22 @ 7:30 am. 15-20 minutes after injection, I had metal taste in my mouth, tongue tingling & felt like I burned it. The metal taste has gone away, but I still have tingling & raw feeling of my tongue & have ulcers in my mouth & nose. I also felt like , I had taken speed. I was very jittery. I took benadryl. My arm was sore for 4 days. On 1/31-2/1 I had horrible headache that lasted 2 days, chills, fever , nausea & more mouth & nose ulcers. I called off work 2 days.   I am a RN ( 33Yrs) I had allergic reaction to flu vaccine 3-4 yrs ago. Huge 3-4 inch hives, abnormal labs, rash that lasted 1 month.
Received first dose of Moderna vaccine on 2/24/21.  Was swabbed for a PCR on 2/25/21 and it was negative.  On 3/1/21 was swabbed for a PCR and was reported on 3/2/21 that the results were positive for Covid-19.  Had been positive from a PCR on 11/13/2020 prior and received Bamlanivimab on 11/19/2020.
swollen lymph node under right arm; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an intramuscular route on 04Feb2021 at 16:00 (at the age of 47-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history included RA, GERD. The patient had no known allergies. The patient concomitant medications included cyanocobalamin (B 12), calcium carbonate, colecalciferol (CALCIUM D3), celecoxib (CELEBREX), duloxetine hydrochloride (CYMBALTA), folic acid, methotrexate, montelukast sodium (SINGULAIR), multivitamin (not coded) from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1285), via an intramuscular route on 14Jan2021 at 16:00 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021 at 18:30, the patient experienced swollen lymph node under right arm. The patient did not received treatment for event. The outcome of the event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
severe joint pain 1 hour after injection,fever,chills, muscle pain, and sweats
Low grade fever; Extreme nausea; Weakness; Fatigue that would not quit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Low grade fever), NAUSEA (Extreme nausea), ASTHENIA (Weakness) and FATIGUE (Fatigue that would not quit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Low grade fever), NAUSEA (Extreme nausea), ASTHENIA (Weakness) and FATIGUE (Fatigue that would not quit). On 04-Feb-2021, PYREXIA (Low grade fever), NAUSEA (Extreme nausea), ASTHENIA (Weakness) and FATIGUE (Fatigue that would not quit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (abnormal) Very low folic acid, Very low vitamin D and K  One liver enzyme was low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported.  Treatment details for events was not provided
DEMAND ISCHEMIA 10/2/2021 COVID-19 PNEUMONIA ACUTE RESPIRATORY FAILURE 10/10/2021 COVID-19 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2021 COVID-19 PNEUMONIA HYPOXIA 9/7/2021 COVID-19 PNEUMONIA DEMAND ISCHEMIA 10/2/2021 ADENOCARCINOMA, LOWER THIRD OF ESOPHAGUS ACUTE RESPIRATORY FAILURE 10/10/2021 ADENOCARCINOMA, LOWER THIRD OF ESOPHAGUS ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2021 ADENOCARCINOMA, LOWER THIRD OF ESOPHAGUS HYPOXIA 9/7/2021 ADENOCARCINOMA, LOWER THIRD OF ESOPHAGUS DEMAND ISCHEMIA 10/2/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION ACUTE RESPIRATORY FAILURE 10/10/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/21/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION HYPOXIA 9/7/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION
This spontaneous report as received from a health care professional refers to unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (K020181, expiry 24-JUN-2015) (K023537, exp 22-JUN-2016) (K024700 exp. 30-JUL-2016) (dose and route unspecified). Other suspect therapies included GARDASIL (K011562 expiry 08-APR-2017) (dose and route unspecified). No adverse effect reported. No further information provided. Additional information has been requested.
Information has been received from a physician concerning an 18 year old female patient with no pertinent medical history reported and no known drug allergies/drug reactions who on 02-SEP-2009 was vaccinated IM with 0.5 ml dose of GARDASIL (lot number not reported) in the patient's arm. There was no concomitant medication. The physician reported that the patient complained of upper leg pain 30 minutes after receiving GARDASIL and her leg was warm and painful to the touch. The patient was directed to take MOTRIN. However the patient went to the emergency room (date not specified) but was not hospitalized. The symptoms resolved and the patient was released on an unspecified date. Additional information has been requested.
Pt received the 2nd dose of the COVID vaccine (Pfizer Lot # EW0161 expiration date 07/05/2021) at 1603. At 1612 the client stood up with his father and both started walking towards the zero gravity chair. Client was being supported by his father. PHN and EMT responded and helped the client into the zero gravity chair at 1612 and raised the client?s feet. Client stated that he felt ?dizzy and lightheaded, and I knew it was happening.? Client was pale but alert and oriented times four. Client was offered a juice, which he accepted and started to drink. Vital signs were taken at 1613 (blood pressure 78/32 oxygen 98% heart rate 48). Client?s father stated, ?he has a history of passing out with needles.? At 1617, color started to return to the client?s face, and client stated, ?I?m feeling fine.? Vital signs were taken at 1617 (blood pressure 98/58, heart rate 74, oxygen 96%). Client finished the juice at 1619, and the color had completely returned to his face. Vital signs taken at 1624 (blood pressure 98/48, heart rate 58, oxygen 96%). Client?s dad stated that the client?s blood pressure is ?normally under 100,? and that his vital signs ?are normal for him.? Client does not have any medical conditions and is not taking any medications. Client is allergic to peanuts and shellfish. Vital signs taken at 1636 (blood pressure 102/50, heart rate 58, oxygen 96%). Vital signs taken at 1642 (blood pressure 104/52, heart rate 59, oxygen 96%). PHN provided client and his father education on when to seek emergency services and to follow up with his primary care provider. At 1642 client stated, ?I feel fine,? and left the facility unassisted with a steady gait.
Iritis right eye; right eye very red; Irititus - right eye very red, swollen; Blurred vision; Irititus - right eye very red, swollen, blurred vision, painful; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 09May2021 at 14:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 16Apr2021 at 10:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 07:30, the patient experienced iritis - right eye very red, swollen, blurred vision, painful. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with medications (Names unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events iritis - right eye very red, swollen, blurred vision, painful was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mild symptoms/ Covid 19; A little sick; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  mild symptoms/Covid 19, a little sick/ illness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced mild symptoms, and a little sick.She did not get tested for Covid but she stated that she knew that was what she had.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  On Feb 2021 the outcome of events mild symptoms, covid-19, a little sick was resolved.
This report from study was reported via Pregnancy Registry (initial receipt 29-Jul-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero, included venlafaxine, prenatal vitamins, Krill oil, diphenhydramine, cinnamon capsules, ondansetron, docusate, TUMS, paracetamol, iron, fibre laxative/supplement and trazodone. The 35-year-old mother had a medical history of high blood pressure (diagnosed in 2010), anemia (diagnosed in 1999), depression (diagnosed in 2001), psoriasis (diagnosed in 2000), Multiple Sclerosis (diagnosed in 2011), indigestion, headache, insomnia and low iron. The mother also consumed coffee (from 03-Mar-2014, oral, 8 oz 3/week), caffeine (soda, from 03-Mar-2014, oral), beer (on 07-Apr-2014), 3 servings a day, oral), and inhaled cigarette smoking (from 03-Mar-2014 to 07-Apr-2014, 2 cigarettes per day, stopped at approximately 5 weeks). The mother had an emergency room visit on 30-Mar-2014 for the cut finger in which she needed stitches and took ibuprofen/diphenhydramine on 30-Mar-2014. (Refer to the mother case: 2015052801). On 01-Oct-2014, the patient received AFLURIA injection (batch number T56905) at 1 shot a day, in utero via the mother. On the same day, the patient also received ADACEL vaccine injection (batch number not provided) at 1 shot a day, in utero via the mother. On 29-Oct-2014, the patient's mother underwent a glucose tolerance test which was normal. On 08-Nov-2014, the patient's mother developed a respiratory infection. The patient was born/stillbirth (gestational age at delivery 37.1, birth weight was 2611 grams), and was diagnosed with right atrial enlargement at birth. Medical record confirmation was pending. The outcome was not reported. Reporter comments: The reporter assessed the event as serious (congenital anomaly).
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Five days after receiving booster I developed shingles; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in Arm Left on 02Sep2021 at 10:00 hours, as DOSE NUMBER UNKNOWN, SINGLE, via an unspecified route of administration, administered in Arm Right on 02Sep2021 (Batch/Lot Number: EL9764) as DOSE NUMBER UNKNOWN, SINGLE, via an unspecified route of administration, administered in Arm Left on 02Sep2021 (Batch/Lot Number: EL3249) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 62-years-old) for COVID-19 immunisation. The patient's medical history included menieres from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced five days after receiving booster I developed shingles on 07Sep2021 at 14:00 hours, injection for vaccine received same date on 02Sep2021. Therapeutic measures were taken as a result of the event and the patient was treated with Valacyclovir HCL 1 gram 3 times day. The event did not cause prolonged hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not received any other medications within 2 weeks of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event five days after receiving booster I developed shingles.
After my booster shot, I have noticed that I have been having frequent shortness of breath, a persistent cough, wheezing as well in general. Fatigue has been a major issue that I have been dealing with. I have also been experiencing both cold flashes and hot flashes with bouts of sweating. I have also had lightheadedness, times where I feel like I am about to pass out and vertigo. Multiple doctors do not know if these symptoms are coming from COVID-19, the vaccine, or something else unfound. I have also been having abdominal pain and migraines are more frequent and prominent since the vaccine and also vision changes.
Information regarding PREVNAR was received from a healthcare professional regarding a 9-month-old patient who experienced facial rash.  The patient received a dose on an unspecified date. The patient experienced facial rash and was treated with BENADRYL.  Patient has since recovered.  No further information was provided.
MENACTRA has been used every 5 years for patient's that are asplenic or are immunodeficient with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered menactra has been used every 5 years  that are asplenic or are immunodeficient with no reported adverse event ,while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported at an unknown dose via unknown route at unknown administration site for immunization.  On an unknown date, the patient developed a non-serious event 0f  menactra has been used every 5 years for patient's that are asplenic or are immunodeficient with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event menactra has been used every 5 years for patient's that are asplenic or are immunodeficient with no reported adverse event.  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 the 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.
Expired drug used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Kinrix and Kinrix 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 details were reported as follows: The registered nurse reported that, the patient might had received Kinrix dose after expiration date, which led to expired vaccine used. The reporter consented to follow up by email. This case was linked with US2022046882 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046882:Same reporter.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of RECOMBIVAX HB (lot # M023718, expiration date 09-AUG-2018; dose and route of administration were not reported) for prophylaxis. No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA005657: US-009507513-1610USA005157: US-009507513-1610USA005656: MERCK 1610USA005658:Mfr number.
Pain; swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were recovered/resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pain and swelling lasting over a week.  The patient asked if this an allergic reaction. The patient did not want again when go for the second shot.
Pt had a positive COVID test on 1/31/22 and was treated with ABX; did not receive monoclonal antibodies; 2/7/22  EMS brought pt to ED with increasing SOB over past 3 hrs; NRB placed with improvement in O2 sats; pt coded in the ED; intubated and placed on ventilator; family requested removing support and pt passed away in the ED
My arm became swollen, tender and red with hours of vaccine.  Stayed red for 5 days. I had a low grade fever for 2 days. I had a horrible headache for 4 days, backache and body aches for 2 days.
patient developed mumps; Information was received from a pharmacy intern referring to a male patient of unkonw age. The patient's concomitant therapy, pertinent medical history and and concurrent conditions were unknown by the reporter.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, dose number, frequency and route, lot number and expiration date were unknown) for prophylaxis.         On an unknown date the patient developed mumps.      No product quality complaint (PQC) was involved. Information about treatment given for the adverse event, lab diagnostics/studies performed, and medical attention was unknown by the reporter. The outcome of mumps was unknown. The causality assessment were not reported.
fatigue, increase SOB from baseline, in setting of testing + for covid Narrative: 92yr male direct transfer from OSH in setting of testing positive for COVID- 19 with increased oxygen supplementation from baseline and worsening of cough/dyspnea. Baseline O2 1-3 L NC secondary to COPD; required in ED 2-3L with continued dyspnea. Was started on COVID therapeutics dexamethasone 6mg IV and remdesivir IV. Oxygen supplementation throughout hospitalization remained around 2-3 L NC; did not escalate. Hospital course 4 days total. Stable at discharge back to baseline oxygen 2L. PMH: COPD, prostate cancer (on bicalutamide), afib, T2DM (no meds), dyslipidemia, osteoporosis, obesity (BMI >25) COVID Vaccination Status: Moderna x 2 (Jan and Feb 2021)