chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning her daughter with sulfonamide allergy and penicillin allergy who in approximately August 2007, was vaccinated with the first dose of GARDASIL and in November 2007 was vaccinated with the second dose of GARDASIL and in mid January 2008 was vaccinated with GARDASIL.  In December 2007, the patient developed hives.  The hives are located around sweaty spots or around the bra.  On 26-Feb-2008 they were on the arm and on the back.  The patient had the hives since December 2007 and is being treated with levocetirizine dihydrochloride (XYZAL).  The antihistamine suppressed the hives but the hives regressed when the medication is discontinued.  The patient did not have resolution from the hives to date and noted that it developed close to the 24 hour period from the last dose of levocetirizine dihydrochloride (XYZAL).  At the time of reporting, unspecified laboratory diagnostic studies were pending.  Medical attention was sought from an allergist.  At the time of reporting the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submittted on 3/14/2008. Information has been received from a nurse concerning her daughter with an allergy to sulfonamide and penicillin who in approximately August 2007, was vaccinated with the first dose of GARDASIL vaccine and in November 2007 was vaccinated with the second dose of GARDASIL vaccine and in mid January 2008 was vaccinated with the third dose of GARDASIL vaccine. In December 2007, the patient developed hives. The hives are located around sweaty spots or around the bra. On 26-Feb-2008 they were on the arm and on the back. The patient had the hives since December 2007 and was being treated with XYZAL. The antihistamine suppressed the hives but the hives regressed when the medication was discontinued. The patient did not have resolution from the hives to date and noted that it developed close to the 24 hours period from the last dose of XYZAL. At the tme of reporting, unspecified laboratory studies were pending. Medical attention was sought from an allergist. At the time of reporting the patient had not recovered. No product quality compliant was involved. Follow up information was received from a nurse indicating that her daughter had hives after the second and third doses, but not after the first. The hives lasted for months after the administration of GARDASIL vacccine. Her daughter has breathing problems and an allergic response to diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Additional information has been requested. Thisis in follow-up report (s) previously submittedon 3/14/2008, 7/8/2008. Follow-up information was received which reported that the patient is using XYZAL to treat her urticaria. She has had work up by and is under care with allergist. No additonal inforamtion is expected.
This case was reported by a other health professional via sales rep and described the occurrence of low blood pressure in a 17-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis and MENACTRA for prophylaxis. On 14th August 2018, the patient received BEXSERO, Hepatitis A vaccine and MENACTRA. On 14th August 2018, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced low blood pressure, disorientation, fainting and rigidity. On 14th August 2018, the outcome of the low blood pressure, disorientation, fainting and rigidity were recovered/resolved. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: This case was reported by a medical assistant. The patient received BEXSERO, MENACTRA and Hepatitis A vaccine on the same day. The patient almost fainted and had to lie down but recovered completely within 15 minutes. No call back or follow up had been initiated by the patient since then. It was unknown if the reporter considered the low blood pressure, disorientation, fainting and rigidity to be related to MENACTRA as well. This case was linked with case US2018155236, reported by the same reporter.
Immunization was expired.  No additional treatment was given. Patient tolerated well. No injury to patient.
Beside left arm pain, body fatigue for 3 days, noted left neck lymph nodes on 01//02/2021 up to now.
Ever since the shot, that night - severe chills, fever. A week later, I went to ER - I was still having short term memory loss, chest pain and body aches and joint pains I have been scheduled for a Rheumatologist; Neurologist.  I'm still taking prednisone until I can get to the Rheumatologist. As long as I'm on the prednisone, I'm all right but as soon as I come off it I get symptoms back of pressure in my head, all my joints start hurting and have short term memory loss.
UrticariaPruritus TINGLING HANDS AND LIPS, SHORT OF BREATH, CHEST PAIN; ITCHING Narrative:  EMPLOYEE STATES- ITCHING IS INTENSE AND SOMETHING SHE DID NOT EXPERIENCE FROM THE FIRST INJECTION
The next day Jan 6, I had a low-grade fever and chills with fatigue, requiring a mid-day nap.  This resolved on its own after taking ibuprofen.  The next week on Jan 12, I woke to an outbreak of pox like vesicles on my right side.  It took about a couple of weeks to resolve and they did so on there own.  They were sore but not painful.  Periodically, since  I continue to have pox like vesicles appear on my arms, breast, legs, and torso.    Additionally, my axillary lymph nodes swell and are painful with red spots that are visible to see but no vesicles periodically.  Today on March 20, I have a vesicle on my lower abdomen and back of my leg.  My lymph nodes in other parts of my body do not swell nor are they painful.  I am a clinician with over 30 years in healthcare and now a professor, I have pulled as much data as I can, from my health science library and have not seen any documentation on this type of reaction from the shingrix vaccine.
Began having flu symptoms the next morning, right arm became very red by Sunday, went to doctor on Tuesday, October 22, had an ultrasound at Hospital which showed an infection
Fatigue; lightheadedness; sleepiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "lightheadedness"; SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "sleepiness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; Fever; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd September 2022, 1 days after receiving Shingrix, the patient experienced fatigue and fever. On an unknown date, the outcome of the fatigue and fever were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The patient stated that she got the first Shingrix vaccine and on the day of reporting she was experienced fatigue and fever. The patient did not have time to supply anymore information regarding demographics or information about the vaccine. The reporter did not consent to follow-up.
My arm was sore within an hour. By the evening I was achy and started to get a migraine (which is normal). The next day I was fine with the exception of a really sore arm. It was extremely painful. 24 hours later I started to feel achy again, but I didn't want to take any meds. By the 3rd day, my arm was better. On day 8, I noticed this red, puffy, itchy, raised area that was about 3 inches by the end of the day. I messaged by friend who is an allergist, I put some topical cream on it and it was cleared up in about 3 days.
Menstrual cycle is more than a week late; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 21May2021 at 13:00 (at the age of 14-years-old) (Batch/Lot number was not reported) as dose1, single for COVID-19 immunisation. Medical history included MDD (major depressive disorder), SAD (seasonal affective disorder), and GERD (gastrooesophageal reflux disease). The patient was not pregnant at the time of the event. The patient has known allergies to amoxicillin, lamyctil, and adhesives. Concomitant medications included sertraline hydrochloride (ZOLOFT), dexmethylphenidate hydrochloride (FOCALIN), cyproheptadine, and trazodone. The patient did not receive other vaccine in four weeks. Zoloft, focalin, cyproheptadine, and trazodone were received in two weeks.  The patient did not have COVID-19 prior to vaccination and had not been tested for COVID-19 post-vaccination. On 02Jun2021, the patient experienced menstrual cycle is more than a week late. No treatment was received for the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 15:00 as dose 1, single (Lot number: EK9231), on 19Feb2021 at 10:00 as dose 2, single (Lot number: EN9581) and on 11Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve with liver congestion" (unspecified if ongoing); "Mitral valve with liver congestion" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHIAZIDE, start date: 10Feb2021; ROBITUSSIN DM, start date: 09May2022; TYLENOL, start date: 09May2022; IBUPROFEN, start date: 09May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 1, Dose Number: 2, Dose Number: 3; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient had no known allergies. On 12May2022, the patient received Paxlovid for treatment of Covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
No additional AE; Temperature excursion for VARlVAX; This spontaneous report has been received from a physician referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 11-DEC-2020, the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) experienced a temperature excursion (product storage error). It was reported that on the same date, following the temperature excursion, the dose of the vaccine (also reported as: "the doses") was administered to the patient at a dose of 0.5 milliliter (mL) (formulation, route of administration, anatomical location and vaccination scheme were not provided; lot number T010315 has been verified to be a valid lot number, expiration date was reported and validated as 24-MAR-2022), as prophylaxis.  The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was a maximum temperature of 16.2 Fahrenheit degrees (F), for a time frame of 1 hour and 14 minutes, there was no previous temperature excursion. Additionally, a digital data logger was involved. No additional adverse events (AE) were reported.
feeling like I have the flu and its been two days; lost my taste; Headache; Chills; Exhausted; 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 INFLUENZA LIKE ILLNESS (feeling like I have the flu and its been two days), AGEUSIA ( lost my taste), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Exhausted) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling like I have the flu and its been two days), AGEUSIA ( lost my taste), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Exhausted). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like I have the flu and its been two days), AGEUSIA ( lost my taste), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not reported.
No additional AE.; Nurse reporting VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from a nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies, and concomitant medications were not provided.  On 28-APR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) (valid lot number U022320 [expiration date 15-JUL-2023]) for prophylaxis, after a temperature excursion of -12 degrees Celsius (C) for 24 hours (h) (product storage error) (dose number, vaccination scheme, frequency, route and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Unable to raise arm above shoulder- suspect given intra-articular/intra-bursal.
Annual PPD (PMC C1262AA) done, read @ hospital at a 10mm and positive to some of questions on screening. Radiologist noted a questionable node on Lung. MD started pt. on INH 300mg for 90 days. Pt. is compliant with taking medication. RN checked bottle and questioned pt. No s/sx's of problems today.Just received report and approached by pt. today.
(mild) fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ((mild) fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 0011321A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE ((mild) fatigue). At the time of the report, FATIGUE ((mild) fatigue) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395714, MOD-2021-395749 (Patient Link).
Cellulitis, pain at injection site. Methylprednisolone, diphenhydramine, clindamycin.
Smallpox vaccine administered with Anthrax #2 on 12/26/2007.  Onset of symptoms on 01/06/2008.  Symptoms include fever, mayalgia, chest pain, head ache, and local redness & swelling.
I had my vaccination on 10/05/2022. I started to experience a dry and sore throat on 03/02/2023. I tested COVID-19 Positive on 03/04/2023. I was prescribed Paxlovid.
Fatigue; short of breath; body ache; headache pressure; red watering eyes; sharp ear pain; Runny nose; red watering eyes/poor circulation; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), DYSPNOEA (short of breath) and LACRIMATION INCREASED (red watering eyes) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049Cz1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), LACRIMATION INCREASED (red watering eyes) and HEADACHE (headache pressure). On 23-Jun-2021, the patient experienced MYALGIA (body ache). On 24-Jun-2021, the patient experienced DYSPNOEA (short of breath). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) from 22-Jun-2021 to 23-Jun-2021 at a dose of UNK, bid. On 22-Jun-2021, HEADACHE (headache pressure) had resolved. At the time of the report, EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), DYSPNOEA (short of breath), LACRIMATION INCREASED (red watering eyes), MYALGIA (body ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  was reported.
24 hrs post inject - slight warming & redness at inject site progressed to shoulder & neck over a 48 hr period of time. Denies problems 2nd & 3rd day. On 5th day thrombosis of rt carotid Artery resulting in stroke.
Redness; Rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of ERYTHEMA (Redness) and RASH (Rashes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ERYTHEMA (Redness) and RASH (Rashes).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever; Chills; This is a spontaneous report from a contactable Other Healthcare Professional. A 92-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 92-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on an unspecified date. The patient experienced fever and chills on 18Mar2021 for 24 hours. It was reported that the MD was aware. Outcome of events were recovered on 19Mar2021.   No follow-up attempts are needed. No further information expected.
PT RECEIVED INCORRECT DOSE OF COVID -19 VACCINE  BOOSTER (PFIZER). NO ACUTE SIGNS OR SYMPTOMS  OBSERVED DURING 15  MINUTE PATIENT OBSERVATION.   WE PLAN TO DECREASE THE RISK OF INCIDENCE THROUGH ADDITIONAL INSERVICE OF CLINICAL STAFF ON THE APPROPRIATE PREPARATION OF ALL COVID 19 VACCINES. THE PLAN WILL INCLUDE REEDUCATION ON OUR COLOR CODING SYSTEM AND  IMPLEMENTATION OF  A VACCINE PREPARATION VERIFICATION SYSTEM.
elevated liver enzymes; This case was reported by a consumer and described the occurrence of elevated liver enzymes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that her physician informed her that the patient had also experienced elevated liver enzymes after receiving the Shingrix vaccine. This is 2 of 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter US-GLAXOSMITHKLINE-US2020AMR153870:sae reporter US-GLAXOSMITHKLINE-US2020153365:same reporter
9/24/2022 - woke up around 7am and noticed a few round red dots on left  arm, shoulder  & elbow.   9/25/2022 -  work up around 8:28am and my left eye and lower lip was swollen  and noticed more red dots that looked like  mosquito bites in the same area on left arm, shoulder, elbow,  stomach area, back of neck, a few on my stomach.  I immediately took Benadryl  25mg and Zyrtec. I started to monitor myself for any difficulty in breathing, swallowing and more serious swelling.  Took Benadryl 25 mg & Zyrtec again at bedtime (10pm).  Tossing and turning all night due to itching  on my body.   9/26/2022 - Woke up around 6:00am and the swelling of my lip and eye decreased significantly, however, my whole body was covered in hives and was extremely itchy.  Made an appointment right away to see a doctor (appointment scheduled for 11:20am, same day).  At my appointment, hives continued to spread all over my body. Doctor prescribed me Atarax to help with the itching and hives and continue alternating with Zyrtec.  We both agreed to hold off of getting prednisone for the chances of improvement of the atarax & zyrtec.
Redness, swelling, irritability, pain in leg. Administered Tylenol.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age 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 13-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.    Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Reaction to smpx vac site beginning with red streaking extending down arm and across chest-dx w/cellulitis. Also had swollen lymph nodes in armpit and by clavical on left side. Day 5 I had chest pain and high blood pressure. Numerous test given to check my heart with doctor.