chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was injected in the Bursa sac of her arm causing pain in her left side with tenderness, having pain near the where her arms rotate as well; consumer thinks it was given in the "bursa sac"; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involved a 59 years old female patient for whom vaccine was injected in the Bursa sac of her arm causing pain in her left side with tenderness, having pain near the where her arms rotate as well (pain) was reported, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QUADRIVALENT).  Medical history and concomitant medication were not reported.  On 30-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Lot number- QFAA1937) in left arm.  On an unknown date, unknown latency following vaccination with INFLUENZA QUADRIVAL A-B VACCINE, patient experienced vaccine was injected in the Bursa sac of her arm causing pain in her left side with tenderness, having pain near the where her arms rotate as well (pain).  It was a case of actual medication error due to vaccine administered at inappropriate site. According to the patient injection was given in the "bursa sac" and is complaining of pain.  (Other relevant tests included lab data was not reported.)  Corrective treatment not reported.  Outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
On 03/09/2023 I began having tachycardia with a heart rate of 126-132. Had mild chest pressure and went into ER. ER performed EKG, Lab work, and chest x-ray. Was discharged with instructions for a full cardiology workup. Workup has been scheduled for April and also an echocardiogram has been scheduled.
Given shots 1030am-APAP given.@ 1230pm pt started crying inconsolably-high pitched cry.Slept 20 min-started w/ high pitched cry.@245pm mom PC-pt would move legs but not stand/walk-upper body immobile. Unsteady gait,diff swallow, fever-to ER
During the night after the vaccine, I had muscle aches and pains, headache and tiredness which lasted for 24 hours. I took ADVIL for the pain and two doses made me more comfortable. The aches and headache went away the following day. I then had a bright pink flat rash on my abdomen that did not itch. It slowly faded out over 4 days.
INSOMNIA; SORE ARM; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy and also was an active runner and taking vitamins.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 25-MAY-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from insomnia, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422183.
Tiredness.. flue symptoms..body aches,headaches.. Dizziness..fever chills
dizziness; sweating/sweating profusely; bad cough; diarrhea; losing his voice; he never experienced being this sick before./has been feeling very sick since he received it last Thursday, 22Jul2021; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: PA9484), via an unspecified route of administration on 22Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), on an unspecified date as single dose for covid-19 immunization. On an unspecified date in Jul2021, the patient experienced dizziness, sweating/ sweating profusely, bad cough, diarrhea, losing his voice, he never experienced being this sick before. /has been feeling very sick since he received it last thursday, 22jul2021. Caller wanted to know what to do regarding his adverse events after getting the Pfizer BioNTech Covid-19 Vaccine shot because he was never sick like this before. The outcomes of all reported events were unknown.
coming down with the flu; felt terrible; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (coming down with the flu) and FEELING ABNORMAL (felt terrible) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (first COVID shot with Pfizer in 2020) in 2020. Past adverse reactions to the above products included No adverse reaction with Pfizer.    On 27-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (coming down with the flu) and FEELING ABNORMAL (felt terrible). At the time of the report, INFLUENZA (coming down with the flu) and FEELING ABNORMAL (felt terrible) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He had his first COVID shot with Pfizer in 2020 and he had five since then.  He had a reaction like he couldn't believe. It wasn't anything serious. He felt terrible, like he was coming down with the flu. He was reminded that he has to have a booster.  No treatment medication was reported.   Reporter did not allow further contact
Had cramps but no period; Had cramps but no period; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 19Aug2021 at 12:00 (at the age of 31-years old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient did not receive any concomitant medications. It was reported that the patient was about to start a new cycle the week of the first vaccination shot. On 20Aug2021, the patient experienced cramps but no period. The patient had reported this to multiple doctors and to obstetrician-gynaecologist (OB-GYN). This was not normal and the patient had never missed a period. The patient's last period was on 19Jul2021 and the normal cycle was usually between 28-30 days. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cramps but no period was not resolved at the time of this report.
Information has been received from a physician, referring to a female patient of unknown age. The patient had no pertinent medical history or concomitant medications. The patient had no drug reactions or allergies. On an unknown date, the patient was vaccinated with VARIVAX (dose, strength, route, frequency, lot# and expiration date were unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(TDaP) (dose, strength, route, frequency, lot# and expiration date were unknown) and M-M-R II (dose, strength, route, frequency, lot# and expiration date were unknown) for prophylaxis. Other suspect therapies included sterile diluent (reported as DILUENT). It was later discovered the patient was 3 weeks pregnant during the administration of the vaccines (maternal exposure during pregnancy, first trimester). The patient was planning to continue with the pregnancy and was scheduled for her first obstetric appointment later this week. There was no treatment given to the patient. No lab diagnostics/studies were performed. The last menstrual period (LMP), estimated date of delivery (EDD) and date of conception were unknown. The pregnancy outcome was pending.
Patient received both FLUAD and PNEUMOVAX 23 in the left arm on 10/6/18. The patient has redness, swelling and pain afterwards. Swelling was reduced by 10/8/18 but redness and pain still present. Patient has had flu shots before with no issue.
Patient sat down to receive his flu shot. He has had flu shot without any issue before. Gave him the flu shot. He got up to wait in our wait room.  Mom sat down to get her flu shot and I heard mom yelled out his name. He stood to send a text message and fell right outside our room. I grabbed my smelling salt and EpiPen but he was awake immediately. He muttered "what happened". He laid down for a few min, then slowly sat up. By the time paramedic came, he was able to slowly walk (with mom's help) to the chair. His EKG was normal, BP and HR was normal. They did not take him to the ER due to fear of COVID. He told paramedic he felt fine (no nausea, no dizziness, no pain)  He sat for 15 more min after paramedic left the left the store with mom.
left arm real numb, right and left hand numbness; left arm feels heavy; shaky hand; tingling in legs; weakness in left hand; This spontaneous case was reported by a physician and describes the occurrence of   in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Concomitant medication was not reported  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.   This case was linked to MOD-2020-001375 (Patient Link).; Sender's Comments: 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.
07/14/2021 - 1640 shot given. Rested until 1700. 1720 sweating. 1730 chest heaviness. 1735 headache. 1735 nausea. 1740 upper arm pain. 1856 right hand itching. 1910 pelvic pain. 1940 left wrist pain. 1950 so tired. 1950 left arm pain.  2020 chills. 2030 warm/fever. 2045 left arm numb. 2105 scratchy throat. 2105 hair itching.  2125 hot flash. On-going headache and pelvic (reproductive system sensitivity) pain for 10 full days.
Within 2 to 3 hrs of 4th DTP vax mom called w/jerking of trunk for about 3min, no eye rolling etc., child had repeated unconsolable non high pitched crying for about 12 hrs, more tired & sleepy for about 36 hrs.
Day after vaccination (9/25/16) soreness, redness and swelling about size of 50 cent piece. Started w/flu-like symptoms: hot/cold, coughing on 1st or 2nd day. Pt states wheezing. 9/28/16 less red. Pt reported 9/29/16.
I received my first dose of the Moderna vaccine on Friday around 2:45pm. Felt zero symptoms beside soreness at the injection site, until about 10pm, when I became extremely overheated quite suddenly. I was trying to exit the building to get into cold air when I fainted twice. I was unconscious for 5 seconds or fewer each time. I did not hit my head or sustain any injury from the falls.  Paramedics arrived about 10 minutes later, by which time I had regained consciousness and felt fine aside from weakness, dehydration, and some temperature fluctuation. They said my vitals were perfect and I went home from there. I was feeling completely fine and back to normal by 6pm the next day.
Patient states arm hurt next day. Also that her elbow still persists to hurt to this day 5/24/13. Patient would like a follow up call.
08/29/23: PATIENT CALLED REPORTING SHE STILL HAS REDNESS, INFLAMMATION, ITCHINESS (AT TIMES) AND SORENESS ON THE INJECTION SITE. PATIENT RECEIVED RSV VACCINE ON 08/10/23, NO OTHER SIDE EFFECTS EXPERIENCED ASIDE FROM LOCAL SITE REACTION. DENIED ANY SYSTEMIC SYMPTOMS.   -local site reaction has lasted for 19 days already.
Woke up at 2am with severe migraine. Went back to sleep, woke at 8:30am with severe migraine and HR near 150bpm. Checked fitbit and had been tachy since 2am. Went to ER. Migraine reached 7/10 intensity, was brought down to a 5/10 with 30mL liquid tylenol and two zofran (unknown strength). Was given 1L saline at 400mL/hour. Tachycardia lasted 14hrs before we got it back under 100bpm. During ER visit felt feverish but temp was not rechecked after triage. Checked at home and was 99.1°F (high for me as I don't get fevers). This broke overnight and did not have a recurrence of tachycardia episode. Continued tylenol for 3 more days, migraine was slowly lessening. As of today I still have a headache but it does not warrant tylenol.  I was treated at the ER by a Dr., who diagnosed me with a post-vaccination reaction and stated my POTS likely was why I had such a strong tachycardic response.
Administration of an expired Boostrix dose to a patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On 25-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired Boostrix dose to a patient.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter reported that the patient received Boostrix vaccine which was already expired, which led to expired vaccine used. The reporter asked if the patient had to be re vaccinated. The reporter consented to follow up.
MMR and IPV placed to left thigh. About 30 seconds after administration pt's eyes rolled back and his body began to convulse. His airway was intact throughout however he became cyanotic on both feet and mouth for <10 seconds. Epi administered 3-5 minutes of initial reaction. Convulsions lasted approx 3-5 minutes. Pt was placed in recovery position and monitored closely. Pt was carried by MD to ER where he recovered from post-ictal state.
Pt recvd Hep B vax approx NOV90 & following vax pt exp serum sickness w/diffuse rash over entire body, joint pain & fever; In approx MAR91 pt was vaxed w/Pneumococcal vax & exp the same rxn;
Localized urticaria on day 7 post vaccine with generalized swelling, itching, and tenderness. No prior reaction until day 7.
Anemia diagnosed by routine lab test Symptoms: none except cracked lips at corner of mouth Added iron supplement daily Awaiting results of colonoscopy/endoscopy
3/18 vaccination *In Jan 2021, I never had varicose veins, I was standing up more and ended up with legs hurting me. After having the vaccinations, the veins were more painful on the R side, intense. I am supposed to see a vein specialist. When standing still, it makes them worse. When I don't walk, they hurt more.  *My NP gave me a referral. I haven't made appt yet, it has been a week. I had a couple days where I didn't have pain but then we had bad weather, I wasn't walking and the pain started again. She listed 2-3 places.
Received Hep A vaccine on 1/24/03. On 1/26/03 at night client developed raised, red itchy rash which progressed in intensity for several days and then subsided. Rash only appeared at night. No site reaction.
fever; chills; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever), chills (Verbatim: chills) and headache (Verbatim: headache). The outcome of the fever, chills and headache were resolved (duration 1 day).   It was unknown if the reporter considered the fever, chills and headache to be related to Shingles vaccine.     It was unknown if the company considered the fever, chills and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the vaccine last week. Side effects were fever, chills and headache. It was a rough night. The reporter reported that's it as everyone she believed reacted different to it. Follow-up would not possible, as no contact details were available. This case is linked to the case US2023AMR067499 (husband's case), reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR067499:same reporter
six large red spots size, one w/pus;red marks are still visible on 20NOV
LIGHT/REDDISH/ITCHY RASH OVER MOST OF BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced light/reddish/itchy rash over most of body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light/reddish/itchy rash over most of body was not reported. This report was non-serious.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Additional Details: pt complained of redness, tenderness, mild swelling below the injection site on the left arm which has lasted for 3 days and pt was referred to her primary care physician. we also contacted her primary care physician and made them aware of this adverse reactions
Pt c/o ST and difficulty breathing about 6 hrs after immunizations administered - was given Albuterol neb and steroids at after hours clinic.
Passed away from Covid; Passed away from Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Aug2021 (Lot number: FA7484) at the age of 68 years as dose 3 (booster), single, administered in arm right, administration date 23Feb2021 (Lot number: EN6203, Expiration Date: Jun2021) as dose 2, single and administered in arm right, administration date 02Feb2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney Transplant Recipient", start date: Jul2007 (unspecified if ongoing), notes: Verbatim: Kidney Transplant Recipient; "Occasional AFib", start date: 2021 (unspecified if ongoing), notes: Verbatim: Occasional AFib, Began in the Spring time of 2021. Concomitant medication(s) included: BABY ASPIRIN (ongoing).No additional vaccines administered on same date of the Pfizer suspect.no prior vaccination within 4 weeks The following information was reported: SUSPECTED COVID-19 (death, hospitalization, medically significant), DRUG INEFFECTIVE (death, hospitalization, medically significant) all with onset 17Nov2021, outcome "fatal" and all described as "Passed away from Covid". The patient was hospitalized for suspected covid-19, drug ineffective (start date: 17Nov2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test (0-250): (17Nov2021) 16, notes: More information available: No. The patient date of death was 21Nov2021. The reported cause of death was covid-19. No autopsy was performed. The patient had no predisposing factors, She was restricted for two years and not going out of the house. The patient passed away from Covid. The patient was fully vaccinated including the booster dose of the Adult Pfizer Covid Vaccine. The patient was a kidney transplant recipient and had a suppressed immune system. When the patient was admitted to the hospital an antibody level test was done, the range was 0-250 with higher number being better off. After three doses of the Adult Pfizer Covid Vaccine, the patient's antibody level was 16. The patient was hospitalized on 17Nov2021 and was never discharged prior to passing away. The patient passed away while hospitalized on 21Nov2021.; Reported Cause(s) of Death: Passed away from Covid
Patient representative called and said she had sharp neck pain last night after receiving the vaccine. Also, she had redness, swelling and warmth at the injection site. The symptoms are ongoing.
Complex Partial Seizure lasting 15 minutes treated with Ativan and Dilantin.
Patient reported redness and swelling at injection site the radiated down the arm to the elbow.  She called her doctor and he recommended taking zyrtec and claritin till it resolve along with icing the area.
Severe arm and shoulder pain beginning about 20-40 minutes following the injection. The pain was so severe I was unable to lift my arm for 36 hours. It lessened 48 hours later, but persists  seven days after the vaccine, particularly after sleeping on the shoulder. It was so severe and surprising if a reaction that  I mentioned it to my doctor at a routine appointment, and she said I should report it.
SOB, CP, hot flashes that started later in the day she had received the vaccine.  Pt admitted on 4/6 with symptoms still present and discharged the following, day with noted improvement in SOB.
soreness; tenderness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: soreness) and tenderness (Verbatim: tenderness).  The outcome of the pain and tenderness were unknown.   It was unknown if the reporter considered the pain and tenderness to be related to Shingrix.     It was unknown if the company considered the pain and tenderness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023119283   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was the patient.   The patient received the 1st dose of Shingrix and experienced soreness and tenderness.   The patient received the second dose around August 18, 2023.  Both doses of the vaccine were administered in the upper left arm. The reporter consented to follow up. For tolerance of 2nd dose refer case US2023119283, reported by same reporter.; Sender's Comments:  US-GSK-US2023119283:2nd dose