chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician on 16 November 2016. This case is linked with 2016SA210933. This case involves 53-years-old male patient who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, dose, dose number and site of administration was not reported) via intramuscularly on an unspecified date. Patient had no medical history of seizures. Concomitant medications were not reported. On 16 November 2016, few hours following vaccination patient experienced seizure. Lab data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event :seizure. List of documents held by sender: none. Sender's Comments: Seizure is listed with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is compatible with the role of the vaccine. Further information on the patient's previous immunization history, concurrent conditions, detailed medical history and lab data to confirm alternative etiology/diagnosis etc. will be needed to completely assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Mild Nausea, Mild dizziness, Persistent headache, Fatigue
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 180 pounds, and height was 62 inches. The patient's past medical history included aggressive breast cancer in 2015, lumpectomy, chemotherapy, and radiation therapy, and concurrent conditions included non-smoker, abstains from alcohol, and sulfas allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient experienced allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.
developed two health problems/ side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed two health problems/ side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (developed two health problems/ side effects). At the time of the report, VACCINATION COMPLICATION (developed two health problems/ side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
Redness, mild swelling, itching/discomfort or right upper arm. No fevers or other illness. Treatment with Motrin/Tylenol and prn Benadryl
Back trouble due to work she used to do; Cough; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back trouble due to work she used to do) and COUGH (Cough) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced BACK DISORDER (Back trouble due to work she used to do) and COUGH (Cough). At the time of the report, BACK DISORDER (Back trouble due to work she used to do) had not resolved and COUGH (Cough) had resolved.            Concomitant drugs were not reported.  The patient had received the Booster dose of Moderna COVID-19 vaccine.  The reporter's causality for the events of back trouble due to work she used to do and cough with Humira(Adalimumab) was no reasonable possibility.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
DTaP/HIB given- after given- Given Tuesday, no problem- Wed night thumbnail size swelling. Thursday 7cm x 5 cm- redness and swelling.
she has feeling pain in the arm where she received the vaccine./caller's arm is extremely painful, not getting better at all.; Caller is tired today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200506924 (Pfizer).  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 16:00 (Lot number: FH8030) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, Lot number: EN6203 Expiration, date: 30Jun2021 Sees on vaccination card expires 6, hours. Dose and route: 0.3ml, syringe in arm), administration date: 04Mar2021, when the patient was 79 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 2, Lot number: EN6207 Expiration, date: 31Jul2021 Sees on vaccination card, 30mcg / .3ml IM, vial diluted 30Mar at 1400 hours.), administration date: 30Mar2021, when the patient was 80 years old, for Covid-19 immunization, reaction(s): "Headache/After one of the first COVID-19 vaccine shots caller had a headache for 6 weeks or longer. Headache is gone now, took a long time. Caller clarifies this was after the 2nd dose.". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Jan2022, outcome "not recovered", described as "she has feeling pain in the arm where she received the vaccine./caller's arm is extremely painful, not getting better at all."; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Caller is tired today". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Developed pain initially hours after injection, then developed erythema and swelling to medial aspect of left arm below deltoid site to just above the elbow. Patient did have duragesic patch in place, due to be changed today.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAY-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration an anatomical location were not provided, which was stored at 15 Celsius Degrees for 56 hours, 8.33 Celsius Degrees for 392 hours, -1.11 Celsius Degrees for 80 hours and -3.0 Celsius Degrees for 1172 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of malaise in a 71-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date refer case US2018GSK133649.). Concomitant products included Aspirin. On 17th July 2018 09:00, the patient received the 2nd dose of Shingrix (intramuscular). On 17th July 2018, 3 hrs after receiving Shingrix, the patient experienced malaise, shivering and sweating. On 18th July 2018, the patient experienced dizziness, fall, generalized muscle aches and upset stomach. On an unknown date, the outcome of the malaise was unknown and the outcome of the shivering, sweating, dizziness, fall, generalized muscle aches and upset stomach were recovered/resolved. It was unknown if the reporter considered the malaise, shivering, sweating, dizziness, fall, generalized muscle aches and upset stomach to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix on right arm. Three to four hours after getting the vaccine, the patient started feeling malaise. After driving home she started shivering and sweating. The next morning she felt better and while she was walking to teach her class she felt dizzy and fell on the side walkway. The medic and ambulance arrived on site and they checked her blood pressure and temperature came out normal. She refused going to the hospital since she started feeling better. The patient then went on to teaching her class, and she came back home and slept all day. The patient also had muscle ache all over her body along with stomach sickness. On the day of reporting, she was completely fine and everything had resolved. The patient had denied permission to contact their physician. This case has been linked with case US2018GSK133649, reported by the same reporter for 1st dose.
Swollen like a golf ball; Dissipating but little red; Felt a little bit warm for 2 to 3 days; Itchy in the area of the shot; This spontaneous case was reported by a physician and describes the occurrence of   in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), VITAMIN D [VITAMIN D NOS], PROBIOTICS NOS and RAMIPRIL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
pt presents to ED with generalized weakness and cough; A Fib with RVR and worsening hypoxia; sent to ICU; BIPAP with 80 - 199% FIO2; lethargic; started on antibiotics; intubated and sedated; family refused PEG tube placement; pt was extubated and re-intubated due to condition improving then worsening; family decided on comfort care; pt extubated and transferred to hospice; O2 supplementation via NC; pt died later in the hospital
developed DVT with PE; developed DVT with PE; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (developed DVT with PE) and PULMONARY EMBOLISM (developed DVT with PE) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced DEEP VEIN THROMBOSIS (developed DVT with PE) (seriousness criterion medically significant) and PULMONARY EMBOLISM (developed DVT with PE) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (developed DVT with PE) and PULMONARY EMBOLISM (developed DVT with PE) outcome was unknown.            The patient had no history of DVT or clotting issues. No concomitants medicines were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vaccine arm pain comes back on 4/11, 2 weeks after the vaccine. it is occasional sharp pain around the injection area.  still have ongoing pain.
mRNA vaccine reported as an allergy of high severity-- reaction type: hives that bleed no other information provided.
Patient complained of hot, red, swollen area around vaccination (inj.) site.  About 4" X 5" in size.  This occurred approx. 24-36 hours after vaccination.  Patient had difficulty raising arm past chest height about 36 hours after vaccination.
Patient with history of COVID vaccination admitted to hospital with COVID detected PCR. Per provider discharge note, "Patient is a 76 YO male with vascular dementia, chronic systolic CHF, PAF on xarelto, HTN, IDA, BPH presents with worsening confusion and delirium, admitted for Acute hypoxic respiratory failure secondary to covid infection.    Hospital Course: Patient initially required O2 supplementation via nasal cannula. He was placed on Remdesivir and steroids, with significant improvement in respiratory status. His mental status returned to baseline, patient was able to identify his location, why he was in the hospital and his name and DOB.   His admission was complicated by intractable nausea and abdominal pain. Per chart review, this is a chronic issue, and patient has had several studies in the past, which have only revealed a hiatal hernia. Symptoms improved over time, and on day of discharge, patient denies any pain. Stating he is "more than ready to go home""
5/31 Pt given 1.8mg of vaccine instead of 0.3mg.  This was the 2nd booster dose  The next night, pt reported fever (101F), palpitations, flu-like symptoms  6/6 pt reports fever and muscle ache are improving
This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: NVSC2022US033954_NS. A 62-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 62, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary series immunization completed, manufacturer unknown), for immunisation. The patient developed illness (sickness for a couple of weeks), with outcome of recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Information has been received from a physician concerning a 44 yr old female with no allergies or medical conditions who on 10Jan03 was vaccinated SC in the right arm with a dose of varicella virus vaccine live (lot 643120/0505M). There was no illness at the time of vaccination. On 22Sep05, it was reported by the physician that 18 months ago, the pt developed a red area that looked like cellulitis at the site of vaccination. The pt was referred to an adult infectious disease specialist. A product quality complaint was not involved. Follow up information was received from a RN who reported that on 20Jan03, she received a phone call from the pt who reported a silver dollar sized area of redness at the injection site that was hot to the touch. Redness was increased and she was sent to an infectious disease specialist and treated with valacyclovir hydrochloride (Valtrex). There were no signs of systemic toxicity. It was unk if diagnostic lab tests were performed, but some may have been performed by the specialist. Subsequently, the pt recovered. No further information is expected.
sleepy; cold; achy; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female (Non pregnant) patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, formulation: Solution for injection, lot number: EN6201, Expiration date; unknown), in the left arm on 15Feb2021 at 15:00 pm, at a single for COVID-19 immunization at doctor's office/urgent care. Patient medical history included unspecified chronic health conditions. Patient concomitant medication was not reported. Patient took unspecified other medications in two weeks. Patient had known allergies. On 15Feb2021 at 17:00 PM, the Patient became very sleepy had cold and achy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events were not treated. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the post vaccination. The outcome of the events was recovering.
Head congestion and dizziness the following day and for 3 weeks later.  Developed tinnius 24/7 ringing in ears.
Broke Hip at Assisted Living; Fell; Tested positive for COVID-19; A spontaneous report was received from a daughter concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and fell and fractured hip, and tested positive for COVID-19.  The patient's medical history, as provided by the reporter, included Alzheimer's and behavioral problems. The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient fell and fractured her hip at her assisted living facility, and was hospitalized. Treatment for hip fracture was not provided.  On 29 Jan 2021, at the hospital, she subsequently tested positive for COVID-19. Treatment included oxygen through 30 Jan 2021. On 01 Feb 2021, it was reported that the patient was not on a ventilator.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fell and fractured hip and tested positive for COVID-19 were unknown at the time of this report.; Reporter's Comments: This case concerns a 88 year old female with medical history of Alzheimer's and behavioral problems, who experienced a serious unexpected events of fall and hip fracture 12 days after the first dose of mRNA-1273. Information on treatment not provided.  On 29-Dec-2021, she had a serious unexpected event of COVID-19 18 days after mRNA-1273, requiring supplemental oxygen. Based on the current available information and temporal association between the of the product and the start date of the events, a causal relationship cannot be excluded.
flushing, racing heart and light headedness lasting about 2 minutes  25 minutes after the shot and again 2 hours later.
She has never experienced anything like this before and is very scared; Heavier legs; equilibrium is off; She could barely walk; broke out with hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heavier legs), BALANCE DISORDER (equilibrium is off), GAIT DISTURBANCE (She could barely walk), FEELING ABNORMAL (She has never experienced anything like this before and is very scared) and URTICARIA (broke out with hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (broke out with hives) and RASH (Rash). On 14-Mar-2021, the patient experienced LIMB DISCOMFORT (Heavier legs), BALANCE DISORDER (equilibrium is off) and GAIT DISTURBANCE (She could barely walk). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (She has never experienced anything like this before and is very scared). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Heavier legs) and FEELING ABNORMAL (She has never experienced anything like this before and is very scared) outcome was unknown, BALANCE DISORDER (equilibrium is off) had not resolved, GAIT DISTURBANCE (She could barely walk) was resolving and URTICARIA (broke out with hives) and RASH (Rash) had resolved.            Action taken with mRNA-1273 in response to the event was Not Applicable
patient sat down after the vaccine and about 5 minutes later passed out for about 30 seconds.  EMS came out and checked her  out. She refused to  come with ambulance and stayed in the store until a relative came in to pick her up because she was afraid to drive.  She left the store thereafter.
Myalgia, h/a, photophobia; viral menigitis hospitalized x 8 days;
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-OCT-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J0002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (Lot number M040269, Expiry Date 28-APR-2018 and Lot number M035828, Expiry Date 28-MAY-2018), (unknown dose and frequency was not reported) for prophylaxis and no adverse event were reported. It was stated that the timeframe between temperature of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 8 Hours and between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours. Vaccines underwent a previous temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 9 Hours. Call was because of a "data logger". The outcome of incorrect product storage and no adverse event was unknown. Additional information has been requested.