chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning an approximately 71 year old female with no pertinent medical history, drug reactions or allergies who on 31-JAN-2008 was vaccinated subcutaneously into the anterior deltoid with 0.65 ml of Zostavax (Oka/Merck) (Lot # 659403/1825U).  There was no concomitant medication.  One to two days post vaccination on approximately 01-FEB-2008 the patient experienced swelling, itching and redness at the injection site.  At the time of reporting the patient had not yet contacted her physician and had not yet recovered.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Diarrhea; Headache; Muscle pain; Joint pain; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.
RASH ON CHEST/BACK/SHOULDER/UPPER ARM/NECK/BEHIND EAR/SCALP; HOARSENESS IN VOICE; CLEARING THROAT MORE THAN USUAL; TROUBLE MOVING LEGS; FELT OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included blood sugar, neurological issues, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced felt off. On 25-MAR-2021, the subject experienced hoarseness in voice. On 25-MAR-2021, the subject experienced clearing throat more than usual. On 25-MAR-2021, the subject experienced trouble moving legs. On APR-2021, the subject experienced rash on chest/back/shoulder/upper arm/neck/behind ear/scalp. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hoarseness in voice, and clearing throat more than usual on 25-MAR-2021, had not recovered from trouble moving legs, and rash on chest/back/shoulder/upper arm/neck/behind ear/scalp, and the outcome of felt off was not reported. This report was non-serious.
Rash on upper chest, back and right shoulder. Itch from rash, in nose and throat. Not treated. Took own antihistamine for relief.
Information has been received from a physician concerning a patient who was vaccinated with GARDASIL. After getting the vaccination the patient experienced nausea. This is one of several reports from the same source. Additional information has been requested.
After 1 month since receiving vaccine, patient still sore and hurts to raise arm above her head.
No adverse event; Patient given expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    It was unknown if the patient had experienced any additional symptoms/events.  Concomitant medications were not reported.  No treatment information was provided by the reporter.
Patient's entire right upper arm and shoulder became red, painful, and swollen which lasted for about 2 weeks He also developed hives on his hands and feet which lasted for 1-2 months
Swelling (approximately 3 inches x 2 niches), redness, heat at injection site lasting for 3 days, followed by bruising, which is still occurring at 4 days past swelling and redness
Fever of 102.5 for 2 days, runny nose, cough.
Patient awoke next day Left Arm red & painful, applied ice and took regular anti-inflammatory. Went to doctors on 10/9/15 arm red, sore, swollen, unable to use, swollen from armpit to elbow. Nurse called said patient had allergic reaction to either Fluarix quad or Pneumovax-23 which were both given in left arm. Given prescription for Benadryl and reaction was resolved by 10/12/15.
got the shot first then the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine).   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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot first then the shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received pf-06928316 (ABRYSVO), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "unknown", described as "came down with Covid". Therapeutic measures were taken as a result of covid-19.  Additional information: Caller stated she and her husband received the Pfizer RSV vaccine last Friday on 01Sep2023. Caller stated, immediately after getting the vaccine, they both came down with Covid and are now both on Paxlovid. Caller stated she does not think getting Covid has anything to do with getting the vaccine, as they were out.   The reporter considered "came down with covid" not related to pf-06928316.  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.; Sender's Comments: COVID-19 is considered unrelated to ABRYSVO but represents an intercurrent viral infection.,Linked Report(s) : US-PFIZER INC-202300296340 same reporter/product/AE, different patient;
Severe pain & swelling at injection site. Headache, limited use & movement and extreme weakness of right arm & shoulder. Upper arm & shoulder pain - decreased motor skills right arm & hand. Frozen shoulder.
Swelling and itching on face, eyes, around eyes, across nose, cheeks after I got out of the shower. Took Benadryl tablet, and 1 prednisone pill I had left over from a sting reaction, Elestat for the itching eyes. Swelling went down but skin still hurts and feels weird. Will go to the doctor after work (or sooner).
rash / it was / swollen; rash / it was raised /rash / measured / 5"x9" appeared below the injection site; rash / it was / hot to the touch; feeling achy; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced general body pain. On 28th October 2020, the patient experienced extensive swelling of vaccinated limb, red rash and localized feeling of warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, general body pain, red rash and localized feeling of warmth were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain, red rash and localized feeling of warmth to be related to Shingrix.   Additional details were provided as follows: The reporting nurse was the concerned patient. The patient received the 1st dose of Shingrix in right deltoid and experienced feeling achy, swelling, hot to touch and red rash which was resloved. On day seven following the vaccine, a rash that measured approximately 5inchx9inch appeared below the injection site, It was raised, swollen, red and hot to the touch. The reporter did not conented to follow up. No further information was available.  Note As per the case description the patient experienced ony aching but theadverse event reported muscle pain with no supporting information,so the event was coded as pain as per narrative.
Information has been received from a physician assistant and a licensed practical nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma and no known drug allergies or reactions who on 02-DEC-2008 (after a negative pregnancy test) was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #0152X). Concomitant therapy included albuterol. It was noted that the patient got pregnant around the end of December 2008. About 6-7 weeks ago, the patient was assumed to undergo a miscarriage. She experienced abdominal pain. On 04-JAN-2009 the patient was seen at a hospital. On 06-JAN-2009 the patient was seen at the emergency room, experiencing a threatening spontaneous abortion, with no evidence of gestation sack and no evidence of embryonic pole. She was given birth control after the miscarriage. It was reported that unspecified blood was drawn and testing was done. On 26-JAN-2009 the patient had a HCG quant level of 16, and on 03-FEB-2009 a quant level of 5. But the patient never got her period. On 16-FEB-2009 physician assistant spoke with the patient's physician's office to confirm her lack of pregnancy and gave her a pregnancy test with negative result. On 16-FEB-2009 the patient received the second 0.5 ml IM dose of GARDASIL (lot #01423X). The patient also had an adverse event after this second dose (WAES # 0903USA00527). Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
SORE ARM FROM iNJECTION SiTE TO SWOLLEN WRIST + THUMB ( HAND), SWOLLEN ARM
Started with some nausea around noon on 1/18 that resolved, then experienced nausea without emesis and palpitations while driving to work at 1800. She describes it as feeling like her heart was racing, but also feeling like she was having large pauses in her heart rate in between the palpitation sensations. She drank a bottle of water and the feeling went away temporarily but it returned.  I am an employee, on arriving to work I noted increased shortness of breath which is unusual for me because I am an avid runner and very active. I noted the palpitations from around 1800-2000, including becoming dizzy and lightheaded during my shift which could endanger patient care, so I presented to the ED and was placed in the CCA. I had received both covid vaccines, second one on 1/11/21 and had about 20H malaise/fatigue and some expiratory wheezing which was abnormal for her but all has since resolved. I had intermittent heart palpitations and chest until 1/26
lightheaded and nauseous lasting 2 days, fatigue, chills. Staying hydrated
Rash on injection site, chest face. Face swelling. No resp difficulty. (Still has face swelling).
Cognitive brain functions worsening; harder to focus and do simple tasks for work; daily memory loss and confusion. Events began after second dose of the Pfizer vaccine on 4/7/2021. Visited primary care doctor and no advice was given or treatment plan (4/16/2021). After doctor visit, symptoms have continued to increase.
75-year-old female past medical history of AFib on Eliquis, hypertension, coronary artery disease, CKD 3, hyperlipidemia and insulin-dependent diabetes who presented to the Emergency Department on 08/25 for generalized weakness accompanied by nausea.  Apparently, she was in the emergency department the preceding day for nausea and abdominal pain as well as cough, myalgias and chills, was tested for COVID and found to be positive but given no respiratory symptoms or hypoxia was discharged.  On the subsequent visit she described her general weakness they exited the point she was unable to arise from her floor requiring transportation by EMS. Of note the patient was reportedly hypotensive for EMS at 80/30.   In the emergency department, patient was placed on routine monitoring and basic laboratory studies were obtained.  Her vital signs were stable and laboratory work was significant for unremarkable complete blood count menstruated demonstrated a creatinine of 2.16 up from only 1.09 the preceding day.  Potassium was also elevated at 5. Given her acute kidney injury in the setting of recent COVID infection she also had a chest x-ray that was without acute process.  The patient was ultimately admitted to the hospital for her AKI, felt strongly to be pre renal in this causes as the patient disclosed that she had had poor oral intake with her recent symptomatology from COVID.  She was fluid resuscitated, and received frequent laboratory draws to monitor the for kidney and her serum potassium.  With fluids, she continued to convalesce and is medically stable for discharge 08/28/2022.
sore left injection site arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history for patient was reported.  Concomitant products included ACYCLOVIR [ACICLOVIR] and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after first dose). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment : This case concerns a 64-year-old female patient with no relevant medical history, who experienced the expected event of Vaccination Site Pain. The event occurred the same after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-391834 (Patient Link).; Sender's Comments: This case concerns a 64-year-old female patient with no relevant medical history, who experienced the expected event of Vaccination Site Pain. The event occurred the same after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt had redness & swelling with a bump at the site of inj that is clearing up.
Edema, rubor, calor. Diphenhydramine 25 mg prn.
was given flublok for 18 years of age and older, instead of fluzone for under 18 years of age
Swelling in her forehead/her 'eyebrows' were swollen; some tingling in her forehead; her 'eyebrows' were swollen; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 21Jan2021 at 4pm for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had the vaccine administered at hospital on 21Jan2021 and she had some swelling in her forehead and some tingling in her forehead and her 'eyebrows' were swollen and they send her home. The consumer reported she still has swelling and this is going bad. The consumer inquired about treating the fact that she was swollen after the injection, she asked if she could take Benadryl. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.
Headache, Myalgia, Fever, NauseaVomiting, sweats, abdominal cramps, chills Narrative: Headache -took Ibuprofen, this morning at 3:00am experiencing sweats and a lot of abdominal pain/discomfort which lead to "explosive diarrhea". Very low grade fever 99.2F. Muscle aches, chills, nausea-no vomiting, States symptoms are resolving.
This case was reported in a literature article and described the occurrence of uveitis in a 16-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced uveitis, keratitis, conjunctivitis, scleritis and skin nodule. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Blood pressure increased unexpectedly a few days after shot.  Went to Dr and was told blood pressure unacceptably high and medication was started immediately.  I have been on 4 different medications since this happened, my blood pressure is not well controlled yet.  In addition to BP issues, my heart rate is inexplicably elevated, moving from one room to another can cause a 50 point increase.  I am unable to exercise because of this issue.
This is a spontaneous report from a contactable consumer who reported for his daughter. The reporter was reporting for his two daughters. A 16-year-old female patient started to receive TRUMENBA, via an unspecified route of administration at single dose on 24Apr2015. The patient medical history and concomitant medications were not reported. In Apr 2015, the patient experienced chills with outcome of not recovered, fever with outcome of not recovered, numbness of leg with outcome of unknown. Therapeutic measures were taken as a result of chills and fever.
Shortness of breath/inability to take adequate breath.  Pain in neck and spread to shoulder and upper back.  Potential miocarditis.
Patient received Fluzone HD around 2:45 PM. Around 10-11 PM, she said she started vomiting and it continued for several days.  She was really nauseous and had a slight fever.  She reported the incidence to her physician and her physician advised her to tell the pharmacy so that we could report it.  Her physician did not give her any treatment.  She said she started feeling a little better on the 27th.
Menveo was given to 6 month old, no reaction to injection at time of injection
Information has been received from a consumer concerning her daughter a 17 year old female who on an unspecified dates was vaccinated with the first and second doses of GARDASIL. In December 2008, the patient was vaccinated with a third dose of GARDASIL. Around January 2008, the patient developed headaches and muscle aches. She has a pending diagnosis of lupus. The patient has been in and out school due to sickness and autoimmune systems issues. Upon internal review, lupus was determined to be an other important medical event. Additional information has been requested.
incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1688504 expiration date 19-NOV-2021 for prophylaxis (strength, dose and route were not provided).    No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
14 y/o female with a history of HgSS and asthma who presents 1 day post 2nd Covid vaccination with chest pain and general body aches.  Some of the patients pain and aches may be associated with post-vaccination symptoms, but does have elevated retic count and right leg pain consistent with previous sickle cell pain crisis.  Low concern for acute chest syndrome.