chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; Expired vaccine used; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu (Lot number:3NA4M ,  Route of administration is Intramuscular and first dose.) on 12-Oct-2021. Past adverse reactions to the above products included Adverse event with Flu. Concurrent medical conditions included Asthma since 2001, ADHD since 2011 and GERD since 2010. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for GERD, PHENTERMINE for Weight loss.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and HEADACHE (headache). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. On 27-Oct-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Upon administering the vaccination to the patient, some of the dose was lost. We believe it was due to a faulty connection between the syringe and needle. I contacted the manufacture and the CDC. The CDC recommended to revaccinate the patient. The patient has been contacted and will come in to receive the dose.
had swelling at the injection site and arm pain for 3 or 4 days.; had swelling at the injection site and arm pain for 3 or 4 days.; feeling kind of dizzy that night; This is a spontaneous report from a Pfizer sponsored program. A contactable 61-year-old female consumer (patient) reported for herself. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered anatomical location not reported on unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose and is due to receive second dose next week and is looking for specific statistics of side effects. The patient asked about the percentages of diarrhea for her age group. The Regulatory Authority support gave patient some information but that didn't give percentages for after both the first and second dose. In response information was shared through email and read from attached PI under Table 4: Study 2 - Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population under Diarrhea for both first and second dose. The patient asked about once you get the second dose, do they include that day for the 14 days or after this to be considered fully vaccinated. In response information was shared through email and read from attached doc when does the vaccine start protecting me against covid-19 (v4.0). The patient reported after receiving first dose she experienced some events and asked if this is a reported side effect. In response information was shared through email and read from attached PI under What are the risks of the Pfizer-BioNTech COVID-19 Vaccine and read from attached VR-Consumer Inquiry Management (Off-Label or No Info) (v15.0) under adverse reactions or side effects for dizziness. On unspecified date, after receiving first dose patient experienced started feeling kind of dizzy that night, had swelling at the injection site and arm pain. The outcome of event after receiving first dose started feeling kind of dizzy that night was recovered next day. The outcome of events swelling at the injection site and arm pain was recovered after 3 or 4 days.  Information about lot/batch number cannot be obtained. No further information expected.
Reddened, mildly edematous area noted left upper arm. Pt scheduled for f/u 11/2/02-did not show.
My cholesterol and blood pressure went higher.  The symptoms were not as intense as the first dose. I had intense pain around the front and back of the rib cage in June 2022. I couldn't breathe very well. It felt all contracted and painful.  I was diagnosed with Idiopathic pericarditis. We went to the hospital because it wasn?t going away. I went to the ER and they sent me to the hospital for 5 days. Testing did not find any heart or lung issues. Troponin was elevated it was an indicator of a heart attack.  After 5 days , I was feeling better and they released me  Endometrial Cancer symptoms in Feb2022. I had virginial bleeding and did an ultrasound and  doctor took a tissue sample just before this diagnosis. They took it out in Jul2022 and it was the size of a grapefruit.
shortness of breath for 1 week starting on 4/26/21 that presented at 5 minutes at a time, intermittently,  no medications used, resolved spontaneously. No history of asthma or lung conditions previously
C/O achy body, tissue felt bloated, occasional sharp pains, in muscles/chest area, fever, fatigue October 25-30, swelling left eye lid October 26. Felt "better" October 31.
Third dose given; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number L5A35, expiry date 4th September 2023) and (batch number 2N7NP4, expiry date 4th September 2023) for prophylaxis.   Previously administered products included Shingrix (2nd dose received on 23rd August 2018).   On 14th December 2021, the patient received the 3rd dose of Shingrix. On 14th December 2021, the dose was an unknown dose. On 14th December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The health care professional reported that, recently the patient was administered with 3rd dose of Shingrix, which led to extra dose administered. The reporter could not clarify which lot number was for powder and liquid (vial 1- L5A35 and vital 2- 2N7NP4). The reporter consented to follow-up.
heart rate jumped to 100 bmp and remained throughout night while resting. Sleep was nearly impossible.
Dizziness, Low grade fever, chills, headache, neck pain, fatigue, body aches
Left arm pain, Fatigue, and nausea. Pain goes up into her neck. And dizziness.
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine at a physician office, as recommended for routine adult health maintenance and for the prevention of shingles on 27-APR-2009. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-FEB-2012, the patient was treated at a hospital for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir, prednisone and acetaminophen and oxycodone (PERCOCET) for management of painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
DIFFUSE RED RASH FROM UPPER ARM TO ELBOW. WARM TO THE TOUCH, NO PAIN OR FEVER.
Pt complained of shooting arm pain down to fingers.  Pt stated that she had this with her last moderna vaccination.   Site is clear without redness or demarcation.  Ice pack applied to injection site.  Pt then started to get short of breath and a feeling of discomfort in her chest.  Rapid response called and pt taken to emergency room for monitoring. Wheezing noted.
This 96  year old female received the Covid shot on  4/10/21    and went to the ED on 4/16/21     and was admitted  on 4/17/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)
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 VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "they have the flu i had one when i was five "(influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "this is a public post on the Sanofi flu shot campaign Flu Shot Fridays, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/ Reporter Comment: I am not a doctor and unless you're really vulnerable way older and have issues with your health I've known people who get the flu shot every year and every year they have the flu I had one when I was five in my mid-60s go in strong keep it moving and exercising no flu so I go with what works I think over inoculation doesn't give you any time to build up your own immunity". Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (they have the flu I had one when I was five). At time of reporting, the outcome was Unknown for the event they have the flu i had one when i was five.
I thought parents said patient was 18 years old, and thought he could have either Moderna or Pfizer.  I did not check the vaccine information sheet.
Ended up having a year and half with a mini stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed; unknown Manufacturer, Batch/ Lot number not reported), for COVID-19 IMMUNIZATION. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 2022, 2 days after the suspect product(s) administration, outcome "unknown", described as "Ended up having a year and half with a mini stroke". Therapeutic measures were taken as a result of transient ischaemic attack.  Clinical Course: Reporter was calling to report a potential adverse event. The patient mentioned about a year ago, may be even a little longer, that about two days after they have their Pfizer booster, they ended up having a year and half with a mini stroke.  When probed to clarify is the patient also the reporter, reporter stated, "So, the reporter is the person with the issue, correct. Okay yes, it needs to be a patient." The reporter was unsure about the facility type in which patient was vaccinated - it could have been a pharmacy or a clinic. Name of the facility was unknown. Regarding the indication, it was stated that it was just the booster shot. Reporter not sure of other medications taken, lab test, route of administration, anatomical location of the vaccine administration, date of administration, other vaccines taken within 4 weeks of Pfizer Covid-19 Booster vaccine. When enquired about the date of event, it was stated, "I am not sure. It was sometime last year in 2022. When enquired about the treatment, it was stated that patient was in the hospital and dates or details were unknown for hospitalization.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patients were vaccinated with an improperly stored dose of GARDASIL (strength, route of administration, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain at injuction site, some chills, some body aches, severe headache for 3 days.
The pt experienced a red rash on her arms, legs, back, and chest. Benadryl was given.
Information has been received from an RN concerning a 42 year old white male with no past medical hx who on 23OCT2003 at 10:00 AM was vaccinated with a second dose of pneumococcal vaccine 23v polysaccharide vaccine, IM in the right deltoid. There was no concomitant medication or illness at the time of vaccination. On 24OCT2003 at 7:00 AM , the pt developed a "red, warm, painful reaction to right shoulder to elbow."  The pt reportedly recovered.  It was noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine in 1998. It was also noted that the pt did not have any adverse events following previous vaccinations. There were no relevant diagnostic tests or lab data. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that four other pt had a similar rxn. Additional info is not expected.
pt recv vax; approx 2 hr later, turned blue & shook all over, lasted approx 15 mins; T inc to 104.7;
muscle spasm in my calf in her right bottom leg on the outside/ it was in the right side of her bottom leg; very sleepy and she slept a lot; very sleepy and she slept a lot; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 25Feb2021 (Lot number: EN6200) at the age of 77 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 04Feb2021, when the patient was 77 years old, for COVID-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 26Feb2021, outcome "recovered" (22Mar2021), described as "muscle spasm in my calf in her right bottom leg on the outside/ it was in the right side of her bottom leg"; SOMNOLENCE (non-serious), HYPERSOMNIA (non-serious) all with onset 26Feb2021, outcome "unknown" and all described as "very sleepy and she slept a lot". The events "muscle spasm in my calf in her right bottom leg on the outside/ it was in the right side of her bottom leg", "very sleepy and she slept a lot" and "very sleepy and she slept a lot" were evaluated at the physician office visit. Therapeutic measures were taken as a result of muscle spasms.  Additional information: The patient experienced muscle spasm in her calf in her right bottom leg on the outside. It started the day after she had the (second) shot (also reported that the event started on 27Feb2021). She went to the doctor and he prescribed a muscle relaxer (unspecified medication) which helped but it did not go away. It was quite severe on different days. On 22Mar2021 (reported as "today"), she was clear and that was almost three weeks since she had the shot; she has experienced no pain at all. She further stated that she got some relief from it (unspecified muscle relaxer) but it made her very sleepy and she slept a lot. So, maybe just relaxing helped it to loosen the spasm but it was always there and it was not necessarily in her calf, it was in the right side of her bottom leg.  No follow-up attempts are possible. No further information is expected.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Severe ongoing vertigo. Treated with meclizine 12.5 mg as needed, augmentin 500 mg every 12 hours for ten days, and prednisone 20 mg once daily for five days.
I had a patient who I gave flu shot on last Saturday 1/11/2014. Patient came on Thursday 1/16/2014 claiming the position I gave the flu shot was really hurting. Patient said has gone to dr for check up, took pain medication and apply different kind of topical pain relief application but no relief. Patient claim cannot raise the arm up at all. She claimed the position I gave the shot was too high up on her arm. I remember given patient the shot in the position (deltoid muscle) like I have given to many other Patient that had flu shot with us in the past. I asked Patient if there was any relief at all since she had the shot. Patient said yes but was not satisfied with the progress. I told Patient one of the side effect of the flu shot is soreness in the site of action it may take some days to get relief since there is sign of relief that is good but if still not satisfied with the progress should come back and see us in two day time. She called the pharmacy today 1/20/2014 claiming the condition in her arm is gone worse and was recommended to see a specialist.
Got the two shots still got shingles/suspected vaccination failure; Shingles; 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: Got the two shots still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received two doses of Shingles vaccine and still experienced fortunately lighter case of Shingles. The patient stated that be sure to not leave too much time in between your two doses. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
pt here for routine f/u; Pt received pneumovax 23 IM in lt deltoid. After administration had erythema noted to lt shoulder with itching reported. Pt denies SOB, throat swelling sensation or diffuse body itching. No edema or hives noted to body. Lungs sound clear equal B/L anteriorly and posteriorly. Pt given prophylitically IM of Solu-medrol 125mg, and Benadryl 25 mg PO TID. Benadryl to be taken at home due to sedative effects
shivering; cold; soreness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received Shingrix (intramuscular). On 1st May 2019, 1 days after receiving Shingrix, the patient experienced shivering, cold, pain in arm and upset stomach. On an unknown date, the outcome of the shivering, cold, pain in arm and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the shivering, cold, pain in arm and upset stomach to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm the day before reporting in the evening.  At the reporting date, she felt very cold and was shivering.  The patient also had minor soreness in her arm and a bit of an upset stomach. The reporter did not give consent to follow up.