chrisvoncsefalvay/vaers-outcomes huggingface dataset:
scratchy throat and irritated; irritated; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281762, 2019SA281531 and 2019SA281764 (same reporter).  This case involves a patient who experienced scratchy throat and irritated (throat irritation) and irritated (irritability), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, the patient had scratchy throat and irritated (throat irritation) and irritated (irritability) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was throat irritation and irritability.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for throat irritation and irritability.  List of document held by sender: none.
Severe Headache, Itching and scratchiness inside throat, hoarseness, because of throat breathing became shallow, fever
pt had dizziness and facial numbness, thought to be due to panic attack or vasovagal syncope
Woke up delirious.  Then went back to sleep, it happened three times.  Then Saturday morning was totally unresponsive and brought to hospital.
This spontaneous report was received from a registered nurse refers to a 4 year old patient (gender unspecified). No medical history was reported. On 21-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# an expiry not reported), 0.65 ml, subcutaneously. The nurse stated that this was related to a staff error and not due to product confusion. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
caller was concerned because with previous Moderna doses his mother and other old people felt really sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (caller was concerned because with previous Moderna doses his mother and other old people felt really sick) in a 97-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (caller was concerned because with previous Moderna doses his mother and other old people felt really sick). At the time of the report, MALAISE (caller was concerned because with previous Moderna doses his mother and other old people felt really sick) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was provided.  Reporter stated that his brother was forcing his mother to get the Moderna COVID-19 Vaccine, but reporter was concerned because with previous Moderna doses his mother felt really sick.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-746711 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746711:other old people
thumb starts twitching; little tingling down her arm to her hand; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (States with her first shot, she had chills and muscle pain), for COVID-19 immunisation, reaction: "chills", "muscle pain". The following information was reported: MUSCLE TWITCHING (non-serious), outcome "unknown", described as "thumb starts twitching"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tingling down her arm to her hand". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136742 same reporter and vaccine, different dose number and event
Tested positive for Covid months after getting the second dose; Tested positive for Covid months after getting the second dose; This is a spontaneous report from Contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated that on an unspecified date her husband and she both tested positive for Covid months after getting the second dose of the Pfizer vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
A report has been received from registered nurse, concerning 22 month old, female patient. No concomitant medication and medical history. Caller states that FLUMIST was inadvertently administered to a 22 month old. No adverse reaction has occurred. The outcome was unknown. The report was considered to be non-serious by the reporting health professional. Follow-up of insignificant information received AstraZeneca/MedImmune on 08-Oct-2012 from health professional: patient's date of birth updated.
On the third day after the Covid 19 vaccine, I developed left sided chest that radiated into the left axillary area. This continued to be present intermittently. I was self medicating with Aspirin. I contacted my PCP who recommended that I come to the office to be evaluated. This pain continued for approximately 3 weeks and then went away. I did not see my PCP until 12/2021. I had chest pain that took me to the ED on 2 occasions. The 12 lead EKG reported previous anteroseptal MI and T wave changes. I was evaluated by cardiology and then underwent heart cath which revealed clear coronaries. I was placed on Amlodipine to treat the chest pain which was likely due to coronary artery spasms. I continue to have intermitted left sided chest pain related to exertion and excessive heat.
In July,  I started to breakout in bumps and welts and they itched severely. At that time I started having more severe and extended  increase flare ups  of my rheumatoid arthritis and FSH muscular dystrophy. Rheumatologist  put me on a 12 day course of steroids, Prednisone. He did it in July, August and September because I kept having these very severe breakout in bumps flare ups. I have never had these breakouts before. The third time in September the Prednisone was less effective. I went to the allergist and immunology doctor, and had allergy test done to see if there was any connections, but there was nothing there. Dr. did a biopsy, it was done on Tuesday,10/05/2021. I will get the results in 12 days. I am still breaking out, and I am now breaking out while I am on the Prednisone.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 15-OCT-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # H019092, expiry date: 09-FEB-2014), dose, frequency and route unspecified, which was expired. No adverse effects reported. No PQC involved. Additional information is not expected as we could not contact the reporter.
The Patient Requested the Bivalent FoRm of the vaccine and received the Booster Instead
Day of second dose : achiness in arm, chest and leg of side of body where vaccine administered. Several days later: developed several aphthous ulcers. Treated with ibuprofen. Pain x 2 days.
Lethargic, vomiting for 9 days 5 to six times a day for the first 7 days and only 1 to 2 times days 8 and 9. Could not keep eye contact or interact well. Slept a lot more than normal.
PATIENT'S WIFE REPORTED THAT PATIENT IS EXPERIENCING FEVER AND CHILLS.
PATIENT'S PARENTS WAS CONTACTED AND WE HAD EXPLAINED THAT WE HAD REACH OUT TO PFIZER TO SEE IF THE VACCINE IS STILL EFFECTIVE 1 DAY PASS EXPIRATION DATE. PFIZER WILL REACH OUT TO US WITH THE DATA WITHIN THE NEXT 2-3 DAYS TO SEE IF PT WOULD STILL NEED TO GET THE VACCINE AGAIN OR IT WILL STILL BE EFFECTIVE FOR THEM. PARENTS DID NOT C/O ANY S/E FROM THIS MISTAKE AND WAITING ON OUR CALL AFTER PFIZER GET BACK WITH US.
Fever marked localized swelling induration, heat. Pt required antibiotics as symptoms started. 48 degrees after infection and have worsened.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 3:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 3:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.44   Concomitant products were not provided.  On 12-Feb-2021, Excursion time was 09 AM,10 AM and 11 AM, temp was 29, 35, 35, total doses given for the day was 55, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021.  Vial was stored on cooler 1, on 12-Feb-2021, Excursion duration At 9 AM: 29, 10 AM: 35, 11 AM: 35, 12 AM: 39, 1PM : 42, 2 PM : 43, 3 PM: 40, 4 PM: 39.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
ACHE (ACHIE); DECREASED APPETITE; HEADACHE; NAUSEA; FEVER; RASH ON INJECTION SITE; WARM INJECTION SITE; DIARRHEA; STOMACH PAIN; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient didn't had any pre-existing medical conditions and no known allergies. The patient was previously treated with paracetamol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced rash on injection site. On 21-MAR-2021, the subject experienced warm injection site. On 21-MAR-2021, the subject experienced diarrhea. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced stomach pain. On 21-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced ache.  On 22-MAR-2021, the subject experienced decreased appetite. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from rash on injection site, and warm injection site on 22-MAR-2021, was recovering from headache, and had not recovered from diarrhea, fever, stomach pain, nausea, ache, and decreased appetite. This report was non-serious.
Pt stated 3 days after receiving the vaccine he had muscle pain in his shoulders, trapezius, upper arms and hamstrings. ALEVE did not relieve the pain. The pain continued and he was seen by the physician on 10/24/17 and started on a MEDROL dose pack.
11/21/22 presents to ED for "shortness of breath". PMHx of "RLD , HFpEF, HTN, HLD,mild OSA not on CPAP, and depression/GAD"
No additional AE experiences reported by the patient; A patient had first injection 10/2016; second injection 02/2017 and is asking if she can get the third now, or doses she have to start all over with injection #1.; the reporter was unsure of which "Gardasil product" the patient received; the reporter was unsure of which "Gardasil product" the patient received; This spontaneous report was received from a physician and refers to a 26-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On an unspecified date in October 2016, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (reported as the reporter was unsure of which "Gardasil product" the patient received) (for both lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. On an unspecified date in February 2017, she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (for both lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. The patient was asking if she can get the third dose now with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), or it has to be start all over with the first injection. No additional adverse event was reported.
Patient developed rash starting about 7 days after the vaccine that appeared very consistent with measles type rash.  She also had low grade fevers initially with the rash.  Not bothered by the rash at all.  No one else in the home or daycare developed similar rash.
Patient got a 0.2ml  second dose of pfizer (age 5-11)  Covid vaccine that was not diluted.
Per the pt.'s mom: the pt's nose was  red, swollen, and had nasal discharge on 8/25/16. On 8/30/16 mom noticed that there was dry pussy discharge from nose and a rash around the pts mouth.
Also, sore throat symptoms started 5 days after injection; Also coughing symptoms started 5 days after injection; Also, cold symptoms started 5 days after injection; Within 5 minutes after injection, sharp pain in right hand; Within 5 minutes after injection, itchy skin at 3 locations; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 05Apr2021 at 15:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to food, medication or other product. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIPINE) both are started on unknown dates, for unspecified indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 15:15, 5 minutes after injection the patient experienced sharp pain in right hand and itchy skin at 3 locations. On 10Apr2021, 5 days after vaccination the patient experienced sore throat, coughing and cold symptoms. On 12Apr2021, the patient underwent lab test which included nasal swab (COVID -19 virus test) and the result was Negative.  Therapeutic measures were not taken as a result of the event(s). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pain in right hand, and itchy skin, sore throat, coughing and cold symptoms were not recovered, at the time of reporting.    No follow-up attempts are needed. No further information is expected.
1 hour after receiving the Td and flu vaccine, I started itching around my neck. I looked in the mirror and notice I had hives on my neck, face, arms and legs. I took two Benadryl pills and went to bed. I woke about 4 hours later and notice the hives were gone.
Patient returned to pharmacy because there was/is swelling redness day after 9/12 after vaccine administration: (around 2 inches) swelling, tenderness.
Pt experienced redness, tenderness at area over right arm 24 hours post vax. Treatment is cool compresses and Tylenol.
3 days later, he broke out it an rash that was diagnosed as pityriasis rosacea. The rash worsened significantly and the patient was sent to dermatology.
Headache & Nausea Vomiting  Narrative: . I had pain in the same evening at the site and had indigestion,  followed by shivering and chills that evening. Did not sleep properly. I reported to  work next morning, however with extreme nausea , fatigue , and chills I had to take  6 hrs leave. I had headache later on for about 2 hours.
had 2 shingles shots and had shingles/Suspected vaccination failure; shingles neck and thigh; itchy; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 shingles shots and had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles neck and thigh), pruritus (Verbatim: itchy) and pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The case was received from the patient interactive digital media. The patient had the 2 Shingles shots and twice within 6 months he/she had shingles in back on my neck and other time was on his/her tight.  The patient stated that it was itchy and some pain but he/she did not had it as bad as other people had it. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Complaining of rash that shows pruritic eruption macula, wrist and perivaginal areas. These areas were round or irregular shaped, brown/black in color. Complaining of itching . On 12/10/1999, pt said she had allergic reaction to Hep-B. Referred to PMD for assessment. Dr will not say IZ caused rash.
Within 48 hours after the vaccine, I started having joint pains in my hips and shoulders, the pain went down to my elbows, and in after a few weeks the pain moved down to my hands. The pain in my elbows and shoulders has let up but my fingers are getting worse, with some swelling. It is getting difficult to do things like open jars with out alot of pain. I have never had pain like this before. There is nothing listed in the vaccine handout that gives any warnings about arthritis being a side effect of the vaccine.
This spontaneous prospective pregnancy report was received from an office manager and refers to a female patient of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2021, the patient became pregnant. The last menstrual period (LMP) was on an unknown date in 2021, the estimated delivery date (EDD) was not known. The pregnancy outcome was pending. On 14-DEC-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, (exposure during pregnancy). No additional adverse events were reported.
Pt. reported that he had swelling in both arms and rashes.  hH had hives around the injection site and hives in his inner arm on the left side as well
all i had was a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced sore arm. Additional Supportive Information: The follow-up would not possible as no contact details were available.