chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT COMPLAINS OF THROAT FEELING TIGHT. STATES SHE IS ABLE TO BREATH AND SWALLOW WELL AT 12:32PM. BENADRYL 50 MG IM, RD ADMINISTERED AT 12:34PM. PATIENT OBSERVED AND VITALS EVERY 5 MINUTES. AT 1:16PM PATIENT BEGINS TUGGING AT HER THROAT, STATES TONGUE AND THROAT FEELS EXTREMELY TIGHT. NURSE NOTES AREAS OF BLOTCHINESS ON POSTERIOR SURFACE OF HANDS. ADMINISTERED 0.5ML OF EPINEPHRINE 1MG/1ML, IM LEFT THIGH AT 1:17PM AND EMS IS CALLED. AFTER MEDICATION ADMINISTRATION PATIENT REPORTS TONGUE AND THROAT FEEL BETTER. EMS ARRIVED ON SITE AT 1:28PM TO EVALUATE PATIENT. PATIENT DECLINES EMS TRANSPORT EMS DEPARTED AT 1:35PM. PATIENT AGREES TO FOLLOW UP WITH HER PRIMARY CARE PROVIDER. PATIENT LEFT CLINIC WITH HUSBAND AND SON.
Pt recvd vax & devel a rash 2wk following vax;pt noted that by the time came to the office, there were only scabs left;No further details were provided;
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 17th September 2018 12:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving SHINGRIX, the patient experienced pain in hip. On 17th September 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and pain in hip were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and pain in hip to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The physician did not have lot or expiration date of SHINGRIX. About 5 hours after vaccination, the patient experienced arm pain and tenderness in his left arm. The patient experienced severe hip pain in his right hip, which felt almost like bursitis.
Headache; Tiredness; This case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache and tiredness. On an unknown date, the outcome of the headache and tiredness were unknown.   It was unknown if the reporter considered the headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had headache and tiredness. The reporter did not consent to follow up. The caller was the patient and health care professional refused to give any additional details about themselves or the vaccine.
Slight headache - 30 min after- continued throughout night; Next morning (2nd) : 11:30 am- chills, body aches, 101 temp, tiredness, sore arm; 3rd - woke up with headache, tiredness, soar arm; 4th day- slight headache
The patient received from vial beyond 30 days use by date; The patient received from vial beyond 30 days use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received from vial beyond 30 days use by date) and PRODUCT STORAGE ERROR (The patient received from vial beyond 30 days use by date) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received from vial beyond 30 days use by date) and PRODUCT STORAGE ERROR (The patient received from vial beyond 30 days use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received from vial beyond 30 days use by date) and PRODUCT STORAGE ERROR (The patient received from vial beyond 30 days use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-363245 (Patient Link).
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated in error with a dose of VARIVAX (Lot # not reported) SQ on 10-JUL-2012. No unknown adverse effects were reported. Additional information has been requested.
warm face; cough; tired; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm face), COUGH (cough), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FEELING HOT (warm face), COUGH (cough), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache). At the time of the report, FEELING HOT (warm face), COUGH (cough), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
sweating a lot; shivering "really bad"; throwing up a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating a lot), VOMITING (throwing up a lot) and CHILLS (shivering "really bad") in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HYPERHIDROSIS (sweating a lot), VOMITING (throwing up a lot) and CHILLS (shivering "really bad"). At the time of the report, HYPERHIDROSIS (sweating a lot), VOMITING (throwing up a lot) and CHILLS (shivering "really bad") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medication information was provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events ,  a causal relationship cannot be excluded.
Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg. Patient/caregiver did not report any adverse event.
Received injection at 0900, at 0910 began feeling sensation of itchy throat. By 0930, increased with raspy voice and urge to cough. Took at approx. 10am. By 1030 itchy throat mildly decreased but with dizziness and chills. O2 sat was 98%. By 1200 most symptoms resolved. At 1400 again with increased itchy throat so took 25mg of Benadryl. No other symptoms, O2 sat 96% and heart rate in the 80's.
12 x 12cm local urticarial rxn dizziness, nausea, diarrhea w/in 24hrs of vax;treated w/Medrol pack & antihistamine
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
he broke out in hives; had muscle fatigue; joint problems; This spontaneous report was received from a 72-year-old male patient, who was referring to himself. The patient's concurrent condition included drug reactions/allergies to generic medications (not further specified). He had no concomitant medications and pertinent medical history.  On an unknown date in 2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 time injection in the left arm (strength, exact dose, route of administration, lot number and expiry date were not reported) for pneumococcal disease prophylaxis.  On an unknown date in 2014, the patient broke out in hives, had muscle fatigue and joint problems over the next few days. The events were treated with diphenhydramine hydrochloride (BENADRYL). No lab diagnostics/studies were performed. The patient recovered from the events on an unspecified date a few months after initial events date.  The relatedness between the events and the suspect vaccine was not provided.
3" x 1" red warm to touch area. Currently blurred vision on 08-16-13 evening, resolved. Tx: ice 20min Q-2-3 hours, ADVIL/ALEVE 1-2 days.
Vaccinator called EMT, client looked pale. Reevaluated by EMT, BP 157/111 @ 3:03 pm with elevated heart rate. Client alert and talking. Client stated was seen at home earlier today for BP concerns. Transported to ER by EMS
This spontaneous report as received from a Nurse refers to unknown amount of patients with unknown demography. The Nurse reported that on 07-APR-2014 (also reported as yesterday morning), unknown amount of patients were vaccinated with ROTATEQ (dose, route and frequency were not reported) which was exposed to 19C for 1.5 hours. No adverse effect reported. No further information was provided. This case is linked to the case 1404USA005550 and 1404USA008613 (same reporter link). Additional information has been requested.
I tested positive for Covid-19. The only symptom that I had was a cough. I developed the cough on 12/22/2021. I received  a Z-Pak antibiotic and cough medicine called brompheniramine-pseudoephedrine-dm.
Had Vaccine Pfizer on 2/22/21 and 3/15/21.  Symptom onset 6/28- cough, muscle ache, nausea, loss of smell, sore throat, headache and fatigue. Tested positive for Covid -19 on 7/9/21
2/23-2/24 4:30 pm - received vaccination 8:30 pm - slight chills 12:30 am - woke up with fever of 101 Fever, chills, aches, sweats continued for 24 hours, alternated Motrin/Tylenol every 4 hours which would bring temp down to 99 but never normal, fever ranged from 100-102  2/25 6:00 am - took temp when I woke up, first time it was normal, has remained normal so far today tired, frequent napping moderate headache
Date of vaccine 11/5 - Pain at injection site, redness, swelling. Unable to lift arm or sleep on arm . Lethargic - overall not feeling well for 3 days post injection (today 11/8)
High fever.  Abdominal type pain.  Liver pain.  Diarrhea.  Nausea.
had first vaccine in March,  have not had second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had first vaccine in March,  have not had second) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had first vaccine in March,  have not had second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had first vaccine in March,  have not had second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
some chest congestion; I have a cold; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACINE), via an unspecified route of administration on an unspecified date (Lot Number: LER8727; Expiration Date: 30Jul2021) as single dose, and the second dose via an unspecified route of administration on 20Apr2021 (Lot Number: LEW0161; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has been having some chest congestion on an unspecified date, and was seen by a healthcare professional HCP and prescribed steroids for chest congestion. The patient also had cold on an unspecified date and was on an antibiotics (unspecified). The patient would like to know if there will be a problem with interaction between the vaccine and the steroids. The outcome of the events was unknown.
Redness, swelling and itchiness at the location of injection; intervals one hour after vaccine injection. Symptoms are improving with motrin.
A big patch of red rash appeared at the site of injection after 3 days of  covid-19 injection and then resolved after 10 days of appearance.
Approx 5 days after vaccination red skin appeared at vaccination site, initially 1.25 inches in diameter and circular growing to an oblong  shape approximately 2 inch by 5 inch spreading across the bicep around the circumference of the arm.  A white or lighter than skin line approximately .25 to .5 inches borders the red area.  Zone closer to injection site is deeper red to brown.   Skin in the red area is warm to touch.  Pressure on arm in the red area yields a moderate but tolerable itching sensation.  A quarter to 50 cent piece sized lump is present under the surface that is firm  and has a defined perimeter shape focused around the injection site.  Pressure on the lump does not yield pain or tenderness.  Adverse event is being reported prior to it running its full course or healing.
Pt c/o elevated heart rate, chest heaviness, and SOB that did not resolve. She states that it started around 7pm the evening that she received the vaccine (this was her 2nd dose and did not have any reaction to the first).
he feels flu like after receiving the covid 19 vaccine; I feel sick; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient stated he feels flu like after receiving the vaccine. The patient also stated that he feel sick. The outcome of the event was unknown. The patient wanted to know how a person can differentiate between the side effects and the flu.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Initial solicited report received on 22 September 2015 from an investigator participating in a study. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This case involves a 19-year-old female subject who developed other and unspecified angina pectoris during the study participation. The subject had a medical history of chest pain and cardiomyopathy. The subject had no other significant medical history. The subject received concomitant therapies with Anthrax on 05 June 2015, Japanese Encephalitis intramuscularly on 05 June 2015 and Typhoid, ViCPs on 05 June 2015 and Varicella on 05 June 2015. On 29 June 2015, 24 days after receiving a first dose of ACAM2000 on 05 June 2015 (route and site of administration and batch number were not reported), the subject developed other and unspecified angina pectoris. The event appeared after visit was not reported. Lab data included Troponin I lab test done on 30 June 2015 and result was normal, electrocardiogram (ECG) done on 29 June 2015 was abnormal, Echocardiogram, MRI (brain, spinal cord, heart) and Lumbar puncture were not performed. The subject's corrective treatment were not reported. The event other and unspecified angina pectoris was considered as important medical event. The outcome of the event other and unspecified angina pectoris was not reported. According to the investigator, the event relation to the concomitant medications given was not reported. Relationship to investigational product according to Company: associated. The information whether the serious adverse event led to the termination of the subject from the study or not, was not reported. List of documents held by sender: none. "Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study."
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient has been treated with Paxlovid from 16Jul2022 to 20Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased erythema, warmth and induration of right thigh, no fever, slight pain in thigh to touch. Treated 2 days after immunization given as erythema was spreading. Treated with Keflex 500mg QID for 10 days.
Right after getting it my arm was just sore for a couple days, like the same as getting a flu shot or other vaccine. Nine days later, a baseball sized red rash appeared at the injection site, it is hot to the touch but not painful. This just happened so I can't say how long it will last.
Pt stated that her arm was swollen after getting the FLUZONE HD vaccine. Pt came back the next day & the arm does not seem to be swollen anymore but pt had pain/soreness in arm 2-3 days after vaccine.
I have been experiencing severe pain at the injection site of my vaccine that has affected the range of motion in my arm. I have completed several checkins with vsafe stating this but no one has called me. It has been 7 months and it still feels like I got the shot yesterday. I need answers
5 hives after immunization. Complained of pain, swelling, welts (increased 1-2 inches).  Applied ice, took Benadryl and Tylenol.  Referred to primary MD.  Prescribed Benadryl.
vaccination failure/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the GSK shingles vaccine. The patient developed shingles despite of shingles shot. The shingles was not as bad as it would be. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
pt recv vax 9DEC97 & 4hr later devel raised whelps w/fever 103, rash covered face, neck, trunk & upper thighs;
Localized redness and warmth - slight firmness. Started 2/10/15 -> no better 2/12/15 after TYLENOL/BENADRYL x2 days then oral prednisone started 2/12/15.
Patient has tried to contact administering facility but no answer Developed pain initially as anticipated day #7- pruritis locally progressed to heat, pain and erythema day#13- today- presents to primary care with >15cm erythema, heat edema, tenderness, extension to the axilla with streaking of erythema; induration; pain photographs taken
serious chest pain; neck pain; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis rheumatoid. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received penicillin (MANUFACTURER UNKNOWN) from unknown date for unspecified indication and unknown if ongoing. Since the vaccination, the patient  was tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, 2 days after 2nd vaccine, the patient experienced serious chest pain neck pain and sore throat. It had been 7 days and the patient still had these symptoms. On an unknown date, the patient underwent nasal swab and the result was negative. The clinical outcome of the event serious chest pain, neck pain and sore throat was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Itchiness at the injection site; redness at the injection site; swelling at the injection site; A Spondaneous report from was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  redness at the injection site, swelling at the injection site, itchiness at the injection site.  The patient's medical history was not given. No information about the concomitant medication was given. On 18-01-2021, 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 18-01-2021, The patient experienced  redness at the injection site, swelling at the injection site. On 27-01-2021, the patient experienced itchiness at the injection site. . The laboratory information is not given. Treatment information is not given. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are unknown.