chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 70 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: En6203), in left arm, on 18Mar2021 as dose 2, single (Lot number: Ep7534), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Kidney Disease" (unspecified if ongoing), notes: Other medical history: Kidney Disease; "Known allergies: Shell Fish (enzyme)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 25Aug2023 to 30Aug2023 were taken as a result of vaccination failure, covid-19.
12:51 PATIENT STATES HAS DIZZY AND HEADACHE. 13:09 PATIENT STATES DIZZY AND NAUSEATED 13:12 SPOKE WITH PATIENT STATES STILL DIZZY BUT BETTER WANTS TO GO HOME. PATIENT INSTRUCTED TO GOTO EMERGENCY CLINIC IF SYMPTOMS PERSIST.
A very sore arm; Fever; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and expereinced very sore arm and fever, refer case- US2020AMR220464).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced very sore arm nd fever, after receiving the 2nd dose of Shingrix. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220464:same patient, 1st dose
The patient called stating that she had Pneumococcal -23 on Tuesday and her right arm is swollen and she has red blotches from the injection site to her elbow.  She states the first night after the immunization her arm ached even under her armpit. She denies itching. She denies fever. She denies difficulty swallowing or swelling of her lips or tongue. Per protocol, the patient was asked to go to ER for evaluation. She states that she works at the cancer center and will have the nurse supervisor look at it.  She was again advised to seek medical care. Unsure if she will go.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 26-APR-2016 the patient was vaccinated with an improperly stored (Merck) VARIVAX (lot# was reported as L048466, expiration date was reported as 02-DEC-2017, route and dose were not reported). The vaccine was exposed to 15 F for 30 minutes because of a data logger. There was no previous temperature excursion. Concomitant drug was not reported. No adverse event was reported. Additional information has been requested.
Blockage in vein in left retina. Burst vessel and bleeding on corner of field of vision.
Patient's partner phoned with concern. Mild chest pain 7 days post SPV. Also URI symptoms. Symptoms not suspicious for myopericarditis, but possibility of mild/asymptomatic cannot be ruled out. Explained to patient, engaged his health care providers. Pt. not responding to attempts at contact. No ECG/labs completed. Symptoms: Chest pain, unspecified, fever, unspecified.
8 a.m. woke up with fever of 100 degrees Fahrenheit, administered 250 mg of acetaminophen. 10 a.m. fever had gone up to 102 degrees F, administered 250 mg of acetaminophen. 2 p.m. fever had gone up to 104 degrees F,  called family health facility, they advised 500 mg acetaminophen every 4 to 6 hours, and if fever doesn't reduce take  my son to the ER.
Can hardly walk; Having left ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can hardly walk) and ARTHRALGIA (Having left ankle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced GAIT DISTURBANCE (Can hardly walk) and ARTHRALGIA (Having left ankle pain). At the time of the report, GAIT DISTURBANCE (Can hardly walk) and ARTHRALGIA (Having left ankle pain) outcome was unknown.            No concomitant and medication information provided.  No treatment information provided.
feeling extremely tired for a week and 2 days now.; This is a spontaneous report from a non-contactable consumer. An 81-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was feeling extremely tired for a week and 2 days. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
EXTREME SWELLING OF LYMPH NODES IN LEFT ARM PIT.  Slight itchy rash on both arms but inconsequential.
pt c/o fatigue, loss of appetite p/flu vax on 15NOV92; sx lasted about 8-9 days;
The client received his Covid booster shot on 11/23/2021 at a booster clinic held by the group home where he lived. On 11/26/21 he began to experience urinary incontinence, slurred speech and right sided weakness. He was sent to the ER for evaluation and was diagnosed with CVA. He returned home several days later with ongoing weakness to his right side. On 2/22/22 he began to experience tightness in his chest and tachycardia. He was sent to the ER and admitted with elevated cardiac enzymes and pneumonia. He was then transferred to critical care and placed on a ventilator. On 3/6/22, The patient died. He had no cardiac history, no diagnosis of hypertension, hyperlipidemia, or coronary artery disease prior to his vaccination.
I experienced extreme head pressure, pain in my head, extreme pulsing in my head and sinuses, my heart was pounding and racing, my neck was stiff, I had difficulty walking, my eyes were bloodshot and painful, hard to focus my eyes, I had a burning sensation in my veins, stabbing joint pain, weakness in my legs, and two swollen pockets behind my knees. The two swollen pockets behind my knees have not resolved. I was an avid hiker and active person before the vaccine and it has greatly affected my life. After 2 months the head pressure, sinus pressure, elevated blood pressure, and eye pressure improved. The cardiologist ran tests and that there was no long term damage to my heart, but confirmed pulse rate and blood pressure were elevated. In the last 2 weeks my blood pressure is beginning to settle down a bit, but my pulse has not returned to normal range.
C/O tiredness 45 minutes after receiving vaccine. At 7:30pm 12/12/06 pt noticed bumps on nose. 12/13/06 client noticed bumps on forehead, chin, and side of nose. He also noticed redness of sclera in both eyes. At 12:05 pm 12/13/06 client reported to RN, with a macular, papular rash on forehead, left cheek, and chin, c/o generalized itchiness.
Possibly gave 0.5ml dose of H1N1 vaccine IM instead of 0.25ml.  On 10-20-09 spoke with mom and grandmother - pt was "fine".
Immediate redness to area where vaccine was given subcutaneously (L) arm. Patient was given 5ml BENADRYL liquid pen.
Mom states swelling right arm with redness associated with pain started next day. No treatment necessary. Mom called back Monday 8/27/07 patient doing good. No symptoms patient went to school.
Pt began to have fever 1 day p/immun also broke out in rash all over same day; t102; had 2 seizures same day; Seen in ER; given Phenobarb
Near syncopal episode, diaphoretic and headache a bit sat down and then recovered quickly.
Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on 22Feb2021 at 21:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included daily vitamins (unspecified) and red yeast rice (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the arm left on 29Jan2021 at 16:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 22Feb2021 at 17:00, the patient experienced fatigue. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue was resolved on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax & as soon as last vax given pt cried, then vomited, became diaphoretic & ashen; remained profoundly lethargic for 1 hr; HR 105, RR40, BP 90/50; sleepy x 1 hr then nl;
This spontaneous report was received from a Certified Medical Assistant concerning a patient of unknown age and gender. On 22-NOV-2013 the patient was vaccinated with the third dose of GARDASIL (dose, route, lot number and expiration date not reported). It was reported that the patient received the first two doses of GARDASIL at another facility two or three years ago (approximately in 2010). No adverse event was reported. Patient's outcome was unknown. Additional information is not expected.
Breakthrough case admission after 3 vaccines Moderna 3/16/21 Lot# 001B21A;  Moderna 4/13/21 Lot# 016B21A;  Moderna 12/30/21 Lot# 032H21A
About 18 minutes after receiving the vaccine, I started to feel a little numb on the right side of my collar bone and then a tingling in my right pinky toe and finally under my right eye.  We had already left the vaccine site so I told my daughter who was driving that I felt a little funny and would let her know if she needed to take me to the hospital.  I had not eaten yet that day, only coffee in the morning so we ran a couple of errands and then grabbed lunch.  Around 3:30pm on the same day (3/28/2021) I started to feel better and the only side effect I currently have is tenderness in my arm where I received the shot.  I did not seek medical treatment as it went away within a couple of hours.
Diarrhea; This is a spontaneous report from a contactable consumer or other non Healthcare Professional (the patient, reported for self). A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in Arm right on 15Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. The patient had earlier received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administered in Arm right on 20Feb2021 05:30 PM, (at the time of vaccination 74-years-old), as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications, list of any other medications the patient received within 2 weeks of vaccination included: Atorvastatin, Allopurinol, Metformin, plus others all for unspecified indication from unspecified dates. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. On 20Mar2021 22:00, the patient experienced diarrhea, which has continued through this date - 23Mar2021 at 8:30p.m. Patient visited to Doctor or other healthcare professional office/clinic as a result of adverse event. The patient has not been tested for COVID-19 since the vaccination. Treatment received for the adverse events includes: Ingesting one tablespoon of castor oil 2x daily. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them). At the time of the report, VACCINATION COMPLICATION (Wanting to know the side effectams of the 1st. Dose of moderna, I have about have of them) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was wanting to know the side effects of the first Dose of Moderna. Concomitant and treatment medication was not reported.
Information has been received from a pharmacist concerning his 73 year old father with no known allergies or pertinent medical history who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, 2 days after vaccination the patient developed a severe case of diarrhea. On 14-MAY-2008, medical attention was sought and blood work was performed (results not reported). The patient also contacted his son (the pharmacist). At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Left arm swelling, redness from deltoid to elbow and cough. Primary care provider believes it was the influenza vaccine that caused reaction.
Pt given PNEUMOVAX in left deltoid. Skin got red, hot, erythematous. Pain in arm started within 2 hrs of getting shot. Using ice prn, otc Benadryl 25mg 1 q 6 hours prn + Cephalexin 500mg 1 TID # 15.
Fever, chills, malaise, ha, chest pain, dyspnea, edema and erythema of left deltoid area.
NUMBNESS OF ENTIRE LEFT SIDE OF THE BODY; TINGLING OF ENTIRE LEFT SIDE OF THE BODY; SLIGHT DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced slight dizziness. On 08-APR-2021 14:05, the subject experienced numbness of entire left side of the body. On 08-APR-2021 14:05, the subject experienced tingling of entire left side of the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of entire left side of the body, and tingling of entire left side of the body, and the outcome of slight dizziness was not reported. This report was non-serious.
lot # FL2757 with manufacturer's expiration date of Sept 30, 22. Information has been received from the manufacturer indicating that stability and efficacy data supports the use of this product through Oct.19, 2022. Per guidelines: doses administered between Oct 1 - Oct 19, revaccination is not indicated, patient notification is not required
pt in hospital from 9/10 - 9/28/21 - brought to ED for unresponsiveness; cardiac arrest in ED; intubated; ROSC achieved; pt had a stroke; transitioned to DNR; pt self-extubated and placed on BiPAP; no improvement; 9/14/21 pt had a positive COVID test in the hospital; transitioned to comfort care; GIP hospice; transferred to Hospice center 9/28/21 where she passed away
First day fatigue, second day intense body aches, dizziness, and fever. Third day diarrhea and ringing in the ears. Pulsating tinnitus has continued on for two weeks with progression after other symptoms have subsided.
He has been vomiting for three days now and cannot keep any food down after the DTaP vaccine.
Information has been received from a physician concerning a 76 year old female who on 11/1/01 was vaccinated SC with pneumococcal vaccine 23 polyvalent. Concomitant vaccination included influenza virus vaccine. On 11/5/01, the pt developed a swollen arm and on 11/6/01, the pt became nauseated and vomited. It was also reported that on an unspecified date, the pt became lightheaded and dizzy and felt tired. The pt sought unspecified medical attention. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
As patient was exiting the room he felt suddenly dizzy with a sharp electric pain radiating down his right arm. He felt immediately short of breath and began to get red all over. He was examined and found to have no wheezing and mild tachycardia. Pulse ox was 93% and he was given 2L of oxygen. Tachypnea gradually resolved. He experienced sharp shooting back pain for less than 1 minute. He had received PNEUMOVAX and SHINGRIX just prior to this episode. He was treated with BENADRYL IM 25 mg. He improved. Normal blood pressure 122/72, pulse ox 98% on RA and HR 80 prior to leaving the clinic.
Patient's whole leg swelled up and was limping for 2 days.  Patient was put on an antibiotic and the symptoms went away.  Redness of injection sight also symptoms: also went away after antibiotic.
Scratchy feeling; Feeling an itch in the site of injection\Itchy site of injection; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratchy feeling) and VACCINATION SITE PRURITUS (Feeling an itch in the site of injection\Itchy site of injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 immunisation.     Has patient had COVID + test on Feb2021.  The patient's past medical history included COVID-19 in February 2021.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced SCRATCH (Scratchy feeling) and VACCINATION SITE PRURITUS (Feeling an itch in the site of injection\Itchy site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SCRATCH (Scratchy feeling) and VACCINATION SITE PRURITUS (Feeling an itch in the site of injection\Itchy site of injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not on any concomitant medication and had no allergies. The patient had no history of acute or chronic illness at the time of vaccination.  It was reported that the itchy feeling at the site of injection and scratchy feeling was not fully subsisted since the first dose of the vaccine. The patient also stated that it got worse when she received the second dose.   This case was linked to MOD-2022-478879, MOD-2022-478868 (Patient Link).
Patient was administered incorrect dose of Moderna booster. Instead of receiving 0.25ml she received 0.5ml. No serious reaction or side effects reported.
pt exp gen pruritus especially sever in legs-thigh area med no help; maculopapular rash, (resembled poison ivy rash)spread over all over body next 2 wks; ear had hives. muscle weakness & aching, sever muscle spasms  better aft approx 8 wks
felt sick; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (felt sick) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-408621, MOD-2021-408622 (Patient Link).
Large local Rxn grew to grapefruit-sized painful hot red by 48 hrs then developed headaches -> diarrhea then mid-abdominal pain and chills w/o fever (temp 98) over next 2 days then symptoms abated 3 days later.
Booster; heart attack; This is a spontaneous report from a contactable consumer.  An elderly female patient (not Pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Historical vaccine included the patient received first dose of BNT162B2 on 06Jan2021 for Covid-19 Immunization; second dose of BNT162B2 on 26Jan2021 for Covid-19 Immunization. The patient had heart attack after receiving booster in Oct2021. There was no prior history of heart conditions. She was stable the next day, transferring back to long term care facility. The event resulted in hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for heart attack from Oct2021 to an unknown date.  Therapeutic measures were taken as a result of heart attack included Lasix to remove fluid from heart and nitro paste. The outcome of the events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.