chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL1283, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 05Jan2021 (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and relevant tests. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EK5730, Expiration date: Mar2021), intramuscularly (administered on the right arm) on 17Dec2020 at 16:30 (at the age of 36-years-old) for COVID-19 immunisation and experienced events which included swollen lymph in my neck and my arm pits, elevated pulse, sweating, severe sore throat, weakness, body ache, couldn't even function and get out of bed, kind of feeling off, fatigue, couldn't swallow, chills, and joint pain. On an unspecified date, the patient experienced chills and joint pain. The events did not require a visit to Physician office. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.
heavy arm; legs were itchy; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 09Feb2021 at 16:00 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the caller was a consumer, asking whether she should take the second vaccine dose after experiencing an adverse reaction to the first. The caller reported that, she had the first dose of the COVID vaccine yesterday on 09Feb2021 at 16:00 and then around 17:00 her legs were itchy and she experienced a heavy arm. The caller reported that, she took some Benadryl and was now fine but not sure what to do about her second dose. Treatment was received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.  Information requested on Lot/ Batch number. Follow-up attempts are completed. No further information is expected.
pt recvd 2 doses of vax;same noc as 1st dose,exp leg/arm cramps for 2-3 noc;subsided;same noc as 2nd dose exp cramps severe enough to be awakened by them; subsided
Boostrix subcutaneously instead of intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.  On 26-APR-2023, the patient received Boostrix (subcutaneous). On 26-APR-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Boostrix subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was unknown.  Additional Information: GSK receipt date: 26-APR-2023 A pharmacist called to inform that earlier that day, a patient had received a dose of Boostrix subcutaneously instead of intramuscularly. The reporter had consented to follow-up. The vaccine administration facility was the same as primary reporter. The patient was vaccinated via the subcutaneous route instead of the Intramuscular route, which had led to Intramuscular formulation administered by other route.
She started feeling horrible like a bad flu; Just feeling unwell/lousy; Body pain/aches/pains; Terrible headache; Joint pain; Injection site pain; Sweating; My heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80; My heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left, at age 77 years, on 12Oct2021 13:00 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization/got the booster to build her immunity. Relevant medical history includes ongoing broken femur from 27Sep2021 and usual heartbeat of 50 or 52. There were no concomitant medications. The patient historically received the first dose of BNT162B2 (Lot number: EL or BL 8982) on the left arm at age 76 years, on 22Jan2021; and then second dose of BNT162B2 (lot number: EL9262) on the left arm at age 77 years, on 12Feb2021, for COVID-19 immunisation and experienced flu like symptoms and felt lousy that are small reactions, fell and broke femur after second vaccine. She fell and is recovering. Patient stated that she had heard the Pfizer vaccine did not have long term efficacy so she got the booster to build her immunity. She received the booster dose around 1:00 pm on 12Oct2021 and she was fine, heartbeat is usually 50 or 52, but when she took it while she was waiting it was 80 on 12Oct2021; then around 11:00 pm after booster, she stated she started feeling horrible like a bad flu symptoms, lousy, aches/pains, terrible headache, joint pain, injection site pain, body pain, sweating, just feeling unwell. She was real sweaty, and her hair was soaking wet. She was concerned how long she will feel like this.  With the second dose she only had symptoms for 6 hours or so and was gone. These symptoms have lasted about 13 hours from the time of report and this is lasting much longer. Patient had body aches, and she took two paracetamol (TYLENOL 8 hour arthritis pain relief 650mg) (Lot: 81830106M, expiration: Oct2023), and it really didn't help much. Patient has not talked to her doctor. The outcome of the event "heartbeat is usually 50 or 52, but when I took it while I was waiting it was 80" was unknown; while for the other events, it was recovering as patient was slightly better.   No follow-up attempts are possible. No further information is expected.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Lymph Node Swelling-Mild
Swelling (Lump) and discomfort to left neck area. Noticed it when I woke up Monday 12/28/2020
Sore neck / musculoskeletal discomfort; Feels like it's a lump / Mass; Swollen lymph node under her jaw; This case was reported by a physician via other manufacturer and described the occurrence of neck pain in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and abaloparatide (Tymlos) for senile osteoporosis.   Concurrent medical conditions included senile osteoporosis.   In May 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th May 2021, the patient started Tymlos (subcutaneous) 80 mcg/mg once daily (80 mcg/mg daily). On 23rd May 2021, less than 2 weeks after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced neck pain, mass and lymphadenopathy. The action taken with Tymlos was unknown. On an unknown date, the outcome of the neck pain, mass and lymphadenopathy were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, mass and lymphadenopathy to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the Twinrix vaccine 2 weeks ago from reporting. On 23rd May 2021, 5 days after receiving Tymlos, the patient experienced neck pain, mass and lymphadenopathy. The patient experienced sore neck and feels like it was a lump, swollen lymph node under her jaw. The patient medical history was significant for age related osteoporosis without current pathological fracture. The relevant surgical, social, or substance-usage history was not provided and relevant concomitant medications were reported as none. No treatment information was provided. No relevant lab or diagnostic test were provided. No action was taken with Tymlos treatment. It was unknown if the reporter considered the neck pain, mass and lymphadenopathy to be related to Tymlos. No further information was reported.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 2:09 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment drugs reported.
Hives- 400-500 red raised painfull, swollen itchy hives from head to feet for 7+ weeks.  Swollen testicles, ears, hands and feet.  Started 12-6-2021 and lasted at leat 7 weeeks.   Treated with Prednisone,  many creams and ointments, infusions and telehealth Urgent care.  ATRIAL FIBULATION n-Afib treated thusfar with 2 Cardioversions, 3 day hospital stay, blood thinners, Beta Blockers, Echo Tests, MRI test, dozens of EKG tests.  Rx:Sotolol, Eliquis, Metoprolo, Flecinde, Prednisone.  Cardioversion - performed 2-3 times inhospital and E.R. to get afib into Sinus rhythm.  Still Afib and need Ablastion surgery June 1st 2022.  Ablation surgery June 1st 2022 needed - Cardioversions only keep heart in Sinus Rythm for 2-3 weeks...  I've had 16+  off Dr office visits, 3 Emergency Room stays, 1 Urgnet care visit with EKG's and Xrays, and Blood Tests.    3 day hospital stay, Allergist appts for Hives,  Cardiologist visits (at least 10), Sleep apnea tests and apnea machine to try to treat AFIB caused by Moderna Virus, EP (Electro Physiological) Specialist for EKG and upcoming ABLATION Surgery June 1st.  3 Appointments with sleep doctors for Apnea, a dozen trips to Pharmacy for BETA BLOCKERS and Blood Thinner Medications i.e. Sotalol, Metorolol, Eliquis, Prednisone.     The Cardioversion and Beta blockers necessitated hospital stay and months of recovery with setback after setback.   I contantly live in state of being AFIB, higher risk of heart issues and complications that could be lethal, and being cardioverted by shocking the heart with electricity and shortly being in rythm, and AFib again...now needing ABLATION surgery on heart.    All stemming from teh Booster shot and Hives and Heart fibulation.   Thousands of dollars spent o for afib.. medical bills and NOT BEING ABLE TO ENJOY A NORMAL LIFELSTYLE ANYMORe. Unable to excercise, travel on planes comfortably, work my regular job anymore and just living in fear of my Heart condition, finacnes and career and anyting normal.
arm is bruised; arm is / swollen; arm is / hot; arm is / itching like mad / hard time resisting scratching it, noping it stops itching soon; This case was reported by a consumer via interactive digital media and and described the occurrence of bruising of arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th April 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, less than a week after receiving Shingles vaccine, the patient experienced bruising of arm, swelling arm, extremities hot feeling of and itchy upper limbs. On an unknown date, the outcome of the bruising of arm, swelling arm, extremities hot feeling of and itchy upper limbs were unknown.   It was unknown if the reporter considered the bruising of arm, swelling arm, extremities hot feeling of and itchy upper limbs to be related to Shingles vaccine.  Additional details were provided as follow: This case was reported by the patient himself/herself. The patient just had received 2nd dose of Shingles vaccine and experienced his/her arm was bruised, swollen, hot and itching like mad. The patient stated he/she had a hard time resisting scratching it and hoping it stops itching soon. The follow-up would not possible as no contact details were available.
Information has been received from a physician, via a company representative, concerning a female patient (age unspecified), who on an unknown date was vaccinated with a dose, 0.5ml, of Gardasil (Lot # not provided). Subsequently "fainted and hit her head on the wall." The physician confirmed the patient had recovered (date unspecified).
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The pharmacist was the patient. The age at vaccination was not reported. The patient stated that the first vaccination was more painful than the second. For the tolerance of 2nd dose of SHINGRIX refer case US2018118644, reported by same reporter for same patient.
5 hours after getting vaccine my left ankle developed a rash. I felt achy and slight headache. The next day the rash had spread up and began to swell. I also had a low fever,99.9 degrees. On Monday my leg and foot were swollen and very pain and warm. I got in to see my Dr. He wasn't sure what it's cause was. He put me on antibiotics. That night when my boyfriend got home he couldn't wake me up. I had a fever of 103, so he called an ambulance and I went to the hospital. They found no blood clots. I was admitted for IV antibiotics and pain meds. I was released Wednesday afternoon. I have severe swelling of my leg and foot. I got blisters and oozing spots on the back of my leg. I am still in a lot of pain and have shingles that I believe was brought on by covid shot. I couldn't work. I have nerve pain that shoots up my leg. I have no energy to do anything. One Dr. said it could be from shot others said it was cellulitis.I still am having major problems with pain and nerve pain. I just don't feel good. I can't sleep at night because of pain. I was on antibiotics for 3 weeks. The swelling is down but my ankle where the rash was is still hard and very, very painful.
Caller states that she tested positive in between doses and she is scheduled for her second dose on 25Apr2021; Caller states that she tested positive in between doses and she is scheduled for her second dose on 25Apr2021; This is a spontaneous report from a contactable consumer(patient). A 55-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on 28Mar2021. The patient's medical history and concomitant medications were not reported. The patient states that she tested positive in between doses and she is scheduled for her second dose on 25apr2021. The patient states that she finished her isolation and asked if she is able to receive the second dose on 25Apr2021. The patient underwent lab tests and procedures which included Covid-19 test: positive- Caller states that she tested positive in between doses.The outcome for the events was Unknown.  Information about the Lot/batch number has been requested.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; First dose received 0.25ml instead of 0.5ml; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and UNDERDOSE (First dose received 0.25ml instead of 0.5ml) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before.     On 10-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and UNDERDOSE (First dose received 0.25ml instead of 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and UNDERDOSE (First dose received 0.25ml instead of 0.5ml) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. It was reported that no adverse events had occurred after administration of vaccine to the patient. No treatment medications were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.
About 9 1/2 hours after receiving the vaccine I began to experience flu-like symptoms : Full body aches, chills and a headache.  Also my armpits felt swollen and hurt a great deal. The symptoms lasted about 30 hours. By 7 am on the second day after the shot I felt fine however, both of my armpits are still hurting. I am assuming it is from swollen lymph nodes.   (After the first shot I went for my annual mammogram and one lymph node in my left arm was still swollen.)
Breakthrough COVID. Patient fully vaccinated plus boostered on 9/23/21. Patient is a 50 yo F who stated she was first diagnosed with COVID on 1/5/22. Her outpt. treatment of albuterol and muinex did not help and pt reports she progressively worsened until arriving to ED on 1/21/22. Pt admits to dry cough and fever but denied all other symptoms. Pt treated in ED with IV steroids, IV mag sulfate and cough syrup. Admitted for acute bronchospasm.
MMR on 12/30/03: Fever 100-102 axillary Friday (01/02/2004-01/04/2004) through Sunday. Rash started on forehead on 01/05/2004.  On 01/06/2004 rash generalized on trunk upper legs, around injection site (right thigh) and neck and face. Very irritable and head itches.
Information was received via telephone call from the mother of a 19 year old male with an unspecified psychiatric condition, who on 24-JUL-2012, was vaccinated with a dose of GARDASIL. Concomitant medication included RISPERDAL and lithium. On 26-JUL-2012, the patient experienced fatigue that had him sleeping almost 24 hours per day. At the time of the telephone call the patient had not recovered. Additional information has been requested.
I have knots on both of my legs under my skin from my knee cap down to my feet. My bone in my right arm hurts really bad.  Last night (6/7/21) my upper right lip swelled just out of the blue.
Tiredness; Shivering; Sweating/profuse sweating; Unable to move legs/she could not walk; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nerve damage (Nerve Damage back lower extremities), arthritis, low back pain (Chronic pelvic low back pain), osteoporosis (Osteoporosis of hip and spine), intervertebral disc protrusion and vertigo. Concurrent medical conditions included mobility decreased.   On 7th June 2022, the patient received the 2nd dose of Shingrix. On 8th June 2022, 1 days after receiving Shingrix, the patient experienced tiredness, shivering and sweating. In June 2022, the patient experienced walking difficulty. In June 2022, the outcome of the tiredness, shivering and sweating were recovered/resolved. On an unknown date, the outcome of the walking difficulty was recovering/resolving.   It was unknown if the reporter considered the tiredness, shivering, sweating and walking difficulty to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comments: This case was reported by the patient herself. The reporter stated that after a couple of days of receiving her second Shingrix dose, she could not walk, she could not move her legs. Gradually, she was improving over the next couple of weeks. The reporter stated that she had an appointment with her neurologist yesterday (day before reporting), but when she got up she could not move her legs again and had to cancel her appointment. The reporter stated that she was better today (on day of reporting) than she was a day before. The reporter stated that she also had experienced profuse sweating, shivering, and tiredness the day after her Shingrix shot, all of which have resolved. The reporter stated that she was highly sensitive to medications. The reporter consented to follow up and gave consent to follow up with healthcare professional.
Patient broke out with full-body rash nine days out from vaccine administration.  Member treated with antihistamines and methylprednisone.  As of today, member still has rash.  Diagnoses made with consults to dermatology.  Member currently deployed.
10JAN92 pt had t102 last night & it was 99 today; pt has no rash but has bilateral swollen glands, sore throat when swallows & mom said had trouble breathing; MD felt pt had sinus infect & the flu & not due to vax;
Pt cried constantly /p 4 hrs. Mother took baby to MD. Tylenol was given q4hrs, then mom states pt slept /p being seen by MD, Dx: Pertussis to be cause
Injection site began to itch. It became at least a three inch red hive around the injection site. It was hot , itchy, and there was some pain off and on. This reaction lasted about 4 days. There was also a headache and achy neck during this time. The headache was worse in the mornings and became better when sitting up throughout the day. All symptoms finally subsided about five days after the reaction began.
This spontaneous report was received from a pharmacist referring to a 74 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient filled out screening questionnaire for covid vaccination and answered "no" on receiving any other vaccines within  the last 14 days. Patient later called the clinic after receiving her covid vaccination that she forgot she did receive the Tdap vaccine on 3/3/21 at another facility for work (12 days between vaccinations). The Tdap vaccine was given on the L arm as well at . Patient was aware she was supposed to wait at least 14 days between vaccinations but forgot. Patient has not reported any symptoms after receiving the covid vaccine. No treatment was administered. Patient advised to call the clinic should any symptoms occur and given ER precautions.