chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH ACHE; REALLY SICK; LOWER BACK PAIN IN THE KIDNEY AREA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stomach ache, really sick, and lower back pain in the kidney area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach ache, really sick and lower back pain in the kidney area was not reported. This report was non-serious.
Rash and hives (itchy) on neck, abdomen, torso, arms, waist and upper legs.
Dizziness, Headache, Myalgia, Arthralgia, L arm soreness Narrative:
Started on a Monday with a sore throat and I took a COVID-19 test because I was going to be around the grandchildren.  The test was positive, so I reached out to my doctor.  I did a video call and was given Paxlovid on 11/23/22 and a Guaiatussin AC liquid. After the second dose the cough went away and within three days my fever was gone. The only thing that stayed was the fatigue.
3 pts recvd 2 doses of Engerix-B & 3 wks following dose 2 exp extreme fatigue;
This spontaneous report was received from a nurse practitioner via a field representative regarding a 12 year old non-pregnant female patient. The patient's pertinent medical history, drug reactions/allergies, and concomitant medications were unknown. On 14-DEC-2013 and 10-JAN-2015, the patient was vaccinated with GARDASIL (route, dose, lot#, and expiration date unknown) for prophylaxis (inappropriate schedule of drug administration). On 09-DEC-2015, the patient experienced weakness and was not able to run (unable to clarify further). Patient was told it was postural related and to see neurologist. On 25-FEB-2016, the patient was vaccinated with GARDASIL 9 (dose, route, lot#, and expiration date not reported) as routine vaccination (interchange of vaccine products). The patient sought medical attention from physician visit and went to emergency room on an unknown date in 2016. She was diagnosed with muscular dystrophy. The event caused a significant disability or incapacity to the patient and patient became wheel chair bound. On an unknown date, the patient was hospitalized for the event. The patient was not treated for the adverse event. It was unknown if lab diagnostics/studies were performed. The outcome of the event muscular dystrophy was unknown. The reporter did not assess the causality of the event with suspect therapies. Product quality complaint was not involved.
Ran fever of unknown level. Ran in the middle of the night and broke at approximately 8:00 am January 12, 2021.  No other adverse effects have been noted thus far.  Treated with acetametaphine.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated intramuscularly with GARDASIL (lot # not reported). Subsequently, the patient fainted. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
First booster dose given after expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First booster dose given after expiration date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A, 0471321A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (First booster dose given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First booster dose given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-607744 (Patient Link).
Mini stroke; Tingling sensation; Numbness at the right side of the body from face down to foot; A spontaneous report was received from a HCP concerning a male patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient's medical history was reported as diabetic and was taking medications for diabetes but did not provide exact name of the medication. No relevant concomitant medications were reported.     24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.   On 29 Dec 2020, 5 days after the dose of injection, the patient experienced and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient was taken to ER and patient was diagnosed with mini stroke at the ER. No Laboratory details provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events experienced tingling sensation and numbness at the right side of the body from face down to the foot was Unknown.; Reporter's Comments: The events developed on five day after first dose of mRNA-1372. Paresthesia, and hypoesthesia were consistent with increased risk of cerebrovascular accidents associated with history of diabetes. 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.
currently sits at 63 days since receiving first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (currently sits at 63 days since receiving first dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (currently sits at 63 days since receiving first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (currently sits at 63 days since receiving first dose) outcome was unknown. Not Provided      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.   No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up
when I stand up or walk, I become dizzy; This is a spontaneous report from a contactable health care professional, the patient. A 39-years-old male patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ek9231), intramuscular in the left arm on 06-JAN-2021 12:45 as a single dose, for COVID-19 vaccination.  The vaccine was administered at a hospital. Medical history includes drug hypersensitivity to sulfa drugs.  There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 07-JAN-2021 03:00, the patient experienced when I stand up or walk, I become dizzy. No treatment was given for the event. The clinical outcome of when I stand up or walk, I become dizzy was not recovered.
Myalgia, Rash, injection site swelling, fatigue, lock jaw (right side)  Narrative:
No additional adverse events; Caller is a nurse who is reporting an expired dose of M-M-R II has been administered to a child today/expired vaccine was given in error; This spontaneous report was received from a Licensed Practical Nurse (L.P.N.) and refers to a 1-year-old female patient. It was reported that the patient had none illness at the time of vaccination and none preexisting physician diagnosed allergies, birth defects or medical conditions (both reported as "none vaccine"). Information regarding concomitant medications was not provided.  On 21-MAR-2022, the patient was vaccinated with her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) at a dose of 0.5 milliliter (ml) administered intramuscularly (IM) on her right (R) thigh (vaccination scheme frequency was not reported; lot number T007231 with an expiration date reported and established as 27-FEB-2022) (expired product administered) for prophylaxis. It was stated that the expired vaccine was given in error and that family and manufacturer were contacted. Additionally, that it was found supported by memo that there was no temperature excursion. Also, it was reported that the vaccine was used according to the instruction leaflet by a trained operator and that this was previously reported to the doctor.   Did the experienced abated after stopping the drug and did the experienced reappeared after reintroduction, both were reported as no; however, assessed as not applicable since the suspect medication was a vaccine.  No adverse reaction was reported (no adverse event).
Patient received Prevnar vaccination on 7/18/2007.  Patient experienced high fever and rash followed by ITP (Immune Thrombocytopenic Purpura), and was hospitalized for IV Imunoglobin treatment. 8/13/08-records received for DOS 7/23-7/24/08-DC DX: Immune thrombocytopenic purpura. Presented with bumpy red rash two days prior to admission followed by fever and diarrhea of 1 day duration, fever of 101. Appetite decreased.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and muscle pain. On an unknown date, the outcome of the influenza-like symptoms and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX 3 months after 1st dose of SHINGRIX and experienced muscle ache and flu like symptoms. The reporter wanted to know how long should side effects last.
MUSCLE SPASM, NERVE PAIN, HEAVY FEELING IN ARM AND IN SEVERE PAIN
Vaccine given at 8 am. That afternoon with onset soreness of swelling. Some limping and difficulty at baseball game but mom told not get to see until home in evening. Sign of induration, edema, tenderness from 2 inch above injection to knee.  Nl CBC, ESR-2, Prednisone started Fri evening with improvement next am at F/U and no symp Monday.
father states pt cried inconsolably & had sl temp afternoon p/vax given; cried approx 1 hr; called PMD who advised was probably  react to pertussis & advised no more;
Soreness; This non-serious case was reported by a physician via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Soreness).  The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-SEP-2023 The reporter reported that the patient received Shingrix vaccine and had adverse reaction of severe soreness for multiple weeks and was now apprehensive to receive the second dose.  The reporter was curious how to approach with patient for second dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023128911:Same reporter
Tinnitus/Ear ringing increased but was intermittent  after first vaccine on Feb, 11, 2021 and became constant and much louder approximately a week after second vaccine 3/16/21 - it is now constant, never goes away and is primarily in my right ear.
"hundreds" of erythematous papular lesions of various sizes (reportedly, ~1/8th to 1/4th inches in diameter) on neck, arms, dorsal surface of hands, and fingers (including areas between fingers). No new lesions since then, but size of lesions and degree of erythema may have increased. Also has "a bit of a" sore throat (viral illness? seasonal allergies?). Recommend daily follow-up and dermatologic evaluation, esp. if rash persists or evolves to become vesicular/pustular.
Chills, joint pain and slight pain in bones. went to bed at 10 PM with chills, at midnight severe sweating. 5 AM woke with pains in joints and bones. Took three Tylenol extra strength. Woke at 8 AM, took two more Tylenol. Currently at 10:30 AM feel OK, a little tired from lack of sleep.  most symptoms gone.
Warmth and pain in both arms where the shots were given. Left worse than right. Child had fever up to 103F. Alternating the Motrin and Tylenol every 4 hours and to keep ice on the are - on for 20 minutes and off for 20 minute. Went to ED then admitted for 24 hrs for observation. Gave antibiotic and Zyrtec.
After 30 minutes of the vaccine my heart started to hurt, i?ve never had heart pain in my life and I was a bit afraid but I figure the symptoms will go away quickly.I got this burning sensation like if my heart had a splinter, The pain was about three out of 10 after the fourth day that the symptoms did not go away I visit my local clinic doctor. He told me I had heart inflammation and he prescribed me some Advil now is day 9/28 and the symptoms have not gone.
Migraine headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Migraine headache) 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 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine headache). At the time of the report, MIGRAINE (Migraine headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was told to take Tylenol and wants to know whether ibuprofen  can be taken for migraine headache .  Concomitant medication use was unknown.  Treatment information was unknown.   Reporter did not allow further contact
He got his vaccine, he did not have any problems initially, was busy and trying to stay active with the holiday coming on, but he slept a lot.  Somewhere around January 3, he noticed some increasing freckles on his hands and all of his pores.  Very small, very light.  He also has some black moles on his chest, neck and shoulders that popped up.  He went to his doctor for his freckles/brown marks which are all over his body.  She said it was due to his age and light skinned and that they see it a lot.  They have not taken any tests or anything.   He also has joint pains.  His son also has similar problems.    On the 2nd vaccine he developed a lumps on his breast that just showed up.  He was at the dentist who sent him to the UC and scheduled for him to get a mammogram on 8/31/21 and was informed that he had gynecomastia and informed to stop drinking which he drank Martini's and also drank a lot of beer, which he has since limited and just drinks a couple of martini's a week now.  The lumps are still present and he measures his chest from time to time and looses weight in the summer, but is a little larger now.  They said that he had a thickening of the tissue inside, and has not have that checked out.  Was told to see his PCP immediately after that who spent some time with him, and said he had hormone changes and things were changing in his body and that is why he had the side effects, and that if it was treated would cause his prostate cancer to be worse and that he would have to live with it, loose weight.    He never thought he would live this long, and just wants to know why he has these spots.
After receiving the MMR my daughter had brain swelling, which left her with lifetime deficits and has epilepsy as a result.
Husband & wife had same vax & illness hx; aching muscles, joints, anorexia; little if any elevated temp; onset 12DEC91 progressed to resp sx & bronchitis dx; 15DEC w/productive cough;
Peripheral Neuropathy. Numbness, burning, pins and needles in arms, hands and one leg.
Right side of face is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Right side of face is swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SUCRALFATE, OMEPRAZOLE, ALPRAZOLAM (ZANAX), METOPROLOL, APIXABAN (ELIQUIS), BACLOFEN, CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (Right side of face is swollen). At the time of the report, SWELLING FACE (Right side of face is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not mentioned
I was having a really bad headache with body aches, fever chills, stuffy head, and diarrhea. I was also very nauseated but did not vomit. I took a COVID-19 home test and it was positive. I went to my doctor the next day and they did a test as well it showed it was positive. They gave me paxlovid, within 24 hours I was feeling much better. After I was done taking the medication I was back at work on the 17th, and I had a bad headache that night and I could not breath so the next morning I took another COVID-19 test and it was positive. I have had a headache, chills, muscle aches, cough, fever, hoarse throat/voice, and I am so tired.
Swelling, fever, rash (both arms, legs and torso). Rash still present 5 days after the vaccination.
A report has been received from consumer, concerning a 15 year old, female patient (one of two sisters). The patient's medical history and concomitant medications were not reported. On 16-Oct-2012, the patient received FLUMIST. On 06-Jan-2013, the patient and her sister, were both diagnosed with Influenza B. On 10-Jan-2013, the patient returned to school and was recovered. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune from consumer on 07-Mar-2013: event stop date entered, outcome changed from unknown to recovered. Corrected report 18-Mar-2013: third reporter, type other, entered.
Body cold, violent chills, ache joints, sharp pains in head, dizzy, nauseated, weak, pain in arm.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 08-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      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.
"Janssen COVID-19 Vaccine EUA" Onset 8hrs after vaccine, lasted 48hrs. 24hr fever 101- 102 degrees. Severe muscle pain for 48hrs. Severe headache lasting 12hrs from onset of symptoms. Loss of appetite for 48hrs.
Altered sensorium (+) irritability, (+) decreased speech , (+) ataxia.
10:15am on 10/11/2018 patient called to report broke out with rash over arms legs back and shoulders this morning. She started itching last evening before went to bed. Flu vaccine was give 10/09/2018 12:15 pm. She went on to say that she received her 2nd dose of HPV vaccine on 10/10/18 at the clinic. When asked how her 1st dose of HPV went she stated that she had Hives around that same time. Instructed her she needed to talk to the clinic about weather or not to get her 3rd dose of HPV. I am thinking it is probably from the HPV but still reporting that she did receive the FLUCELVAX. Clinic was called this am to report s/sx of events.