chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 41-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date unknown) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 22nd December 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 22nd December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental under dose and adult use of a child product. On an unknown date, the outcome of the accidental under dose and adult use of a child product were unknown. 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 reporter reported that 2 adult refugee patients and 41 years inadvertantenly received the dose of pediatric Engerix B (10 mcg), which led to accidental underdose and adult use of a child product. The reporter consented to follow up. The case has been linked to US2022001258, US2022001262,reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022001258:Same reporter; US-GLAXOSMITHKLINE-US2022001262:Same reporter; US-GLAXOSMITHKLINE-US2022001260:Same reporter -Deleted.
Patient received Hep A, Flushot and Pneumovax 9/15/2011, has completed Prevnar series prior to that. Patient developed invasive pneumococcal infection with Strep Pneumo bacteremia as well as Pneumococcal and moraxella positive Pneumonia (pos. brush cx) Pt. required vent support, ECMO support and aggressive, intensive therapy to survive, hospitalized 4/3 -4/20/2012.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient has pain, severe sensitivity, and tenderness at the injection site. Arm becomes numb during physical activity, like exercise, then becomes sore afterwards. There's a dip/pit in her arm at the injection area which has gotten bigger over time. Her PCP described it as it seems to be "eating away at the muscle & the tissue is disappearing." Her blood work & x-ray came back normal so PCP recommended she see an orthopedic specializing in bone & tissue.
A person was having clumps of her hair were coming out after having the COVID-19 vaccine; This is a spontaneous report from a contactable nurse via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that she had heard other people who are having this adverse event. Her friend saw on TV that a person was having clumps of her hair were coming out on an unspecified date after having the COVID-19 vaccine but she isn't sure which vaccine the news is pertaining to. The outcome of the evet was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dose 1 given 4/10/2021 I experienced left face and left arm numbness lasting 4 hours. Was told by site staff to go home and take an anti-inflammatory.    Dose 2 given 5/01/2021 @1:00 pm i experienced immediate full body numbness to include face and neck. Stayed in staging area for 1 hour was told again to go home and take anti inflammatory.  That evening around 11:30pm I began violently shivering, sweating, vomiting, jaw pain (almost lovk jaw) and diarrhea extreme bone pain that last 48 hours. Pressure headache and dizziness lasted 2 weeks. I started my period the same evening (about 5 days sooner than expected) . In the months since receiving the second dose I've experienced pressure in my head, extreme dizziness and nausea,  sudden and sharp leg pains, every period has been wildly different than the previous to include light flow, heavy flow, cramps and extreme bloating.
1/6 severe fatigue/lethargy, severe full body aches/pain, injection site arm on fire in pain, sore throat. 1/7 other symptoms resolved, still sore throat. Narrative: 1/6 noon severe fatigue/lethargic, severe full body aching/pain, injection site entire arm felt like on fire, sore throat. 1/7 had to call out because could not come in due to symptoms, slept for 20 hours, other symptoms resolved, but still sore throat. completed urgent care virtual apt. 1/8 Went to urgent care in person apt @ 9:15 am, rapid covid test negative @1020,and strep test negative. instructed to follow-up with PCP for sore throat.
Local reaction to the R forearm. redness, itching swelling - numbness in the R arm. Reacted only to vaccine given intra dermal. Vaccine was given IM on 17 Feb 09 - No reaction.
Felt like patient was going crazy/Feeling abnormal; Terrible Insomnia; Anxiety going through the roof; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like patient was going crazy/Feeling abnormal), INSOMNIA (Terrible Insomnia) and ANXIETY (Anxiety going through the roof) in a 26-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ELAGOLIX SODIUM (ORILISSA) for an unknown indication.    No Medical History information was reported.   On 13-Apr-2022, the patient started ELAGOLIX SODIUM (ORILISSA) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like patient was going crazy/Feeling abnormal), INSOMNIA (Terrible Insomnia) and ANXIETY (Anxiety going through the roof). At the time of the report, FEELING ABNORMAL (Felt like patient was going crazy/Feeling abnormal), INSOMNIA (Terrible Insomnia) and ANXIETY (Anxiety going through the roof) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter  In 2022 the patient had experienced the events Feeling abnormal, Insomnia & Anxiety  No treatment medications were provided by the reporter
No immediate adverse event but onset of diffuse bilateral hive like confluent erythematous rash both axillae chest breast about 21 days after the 3rd Moderna vaccine (Sept 11-12)  She did not have a rash after the  earlier Moderna vaccines..  First dose 1/13/2021, 2nd dose 2/11/2021.  Patient is not immunocompromised and is not guideline- eligible candidate for  the "early booster" 3rd shot.
redness, tenderness, swelling @ inject site; some muscle aches in shoulders for 1 1/2 days;
I went to a walk-in clinic with pain in my upper left chest at 10:00 AM on 9/2/21. They did a chest x-ray, bloodwork, and a CAT scan. They found a pulmonary embolism and abnormal D-Dimer markers. I was instructed to go straight to the emergency room. In the emergency room, I was admitted and kept overnight. During the course of my overnight stay (I was released from the hospital the next day, 9/3/21) many tests were administered, including a sonogram of my legs. No blood clots were found in my legs. The only blood clot is the pulmonary embolism. I have no history of blood clots or circulatory issues and my family has no history of blood clots or circulatory issues. My attending doctor told me this was most likely from the Pfizer vaccine and instructed me to fill out the VAERS form to report what happened.
Stored in the refrigerator for more than 30 days; Administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-265450 (Patient Link).
On Oct 25, 2018, my husband and I went to store. We were administered the flu vaccine. Within a week I had severe tingling that began in my left thumb. It creeped all the way up my left arm and down my left side and into my left leg, and my left torso. Even the left side of my face. I would even drool a little bit out of the left corner of my mouth. I became extremely fatigued and could not get out of bed without my husband?s help. The following week I saw my chiropractor, and told her my symptoms.  Thinking it was a pinched nerve, she adjusted me.  I went back again the following week.  The tingling was still there but now I was experiencing numbness on my left side. The chiropractor recommended that I call my primary care physician. My PCP was booked, so the office booked me with Dr. I saw her on Nov 15, 2018. She asked me what happened, and I told her, I got a flu shot and these symptoms showed up right away and they haven?t left. She did the neuro checks that they do, checked my reflexes. She recommended that if the symptoms didn?t dissipate with 2 weeks, to call the office and come back. Two weeks came and went with no changes in my symptoms. I called the doctor?s office and got in with Dr, my regular PCP, on Nov 28, 2018. She did the same examination and neuro checks. There was a difference in sensation from the left side to the right side, so she ordered an MRI of the brain. The MRI was completed on Dec 4, 2018. The MRI report came back suggesting a diagnosis of Multiple Sclerosis. I was referred to, a Neurologist. My first appt with her was January 10, 2019. She ordered lots of blood work and further MRI studies of the cervical and thoracic spine. Blood work was done to rule out any other possibilities, and the follow up with her was in February. And she said that she officially diagnosed me with Multiple Sclerosis. The drug therapy she recommended is Tecfidera.  She said there was nothing she could prescribe that would help with any of my symptoms.  Tecfidera would have a 50% chance of preventing a future ?event? but has a long list of nasty and scary side effects not to mention, a hefty price tag.
When I got my third shot it was having trouble injecting from the syringe into my arm, because it was still sort of icy. I don't think that they let the vaccine defrost enough. It was discomfort and pain. She stuck the needle in my arm, and it was in there a long time. She had to force the vaccine into my arm, and it was really painful. It was sore afterwards, but I cannot remember for how long. On 02/20/2023I went into the doctor and was tested positive. The previous day I was having headache, scratchy throat and fatigue. I did have a low-grade fever. I was not prescribed anything, I treated my symptoms with salt water, nasal rinse and Mucinex. Ibuprofen for the headaches. My symptoms lasted four days. It took about another week before I felt one hundred percent again.
sweating; couldn't stand; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced activities of daily living impaired, fever and headache. After the second shot, the patient was sweating and couldn't stand for 4 days. The wife wanted to take the patient to the hospital because he looked like he was dying. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Fever. Tenderness at site (R) arm. Nausea day of vaccine. TYLENOL and Promethazine prescribed.
Breakthrough COVID-19 infection; Breakthrough COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "recovered" and all described as "Breakthrough COVID-19 infection". It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was unknown if COVID prior vaccination or tested post vaccination. Other vaccine in four weeks was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pinched nerve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE COMPRESSION (non-serious), outcome "unknown", described as "pinched nerve". The event "pinched nerve" was evaluated at the physician office visit. Therapeutic measures were taken as a result of nerve compression.  Additional information: The patient went to the doctor and was put on prednisone for his pinched nerve and was wondering if the patient can start the medication.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had a small breakout of shingles rash/blisters 4-18-18. I had major shingles breakout last June. Went to emergency room 7-3-17. Had blisters from my front right side around to spine, above and below my waist. Was prescribed - Lido/Prilocn 2.5 - 2.5% creact, Ondansetron ODT 4mg, Naproxen - 500mg, Oxycod/Acetamin 5 - 325 mg. Took 4 1/2 months to clear up. My skin still is not healthy.
Headache (same day), sore arm for a few days, bruised 2 days after vaccine dose, swollen lymph node on left clavicle 5 days after vaccine dose.
Bruising at injection site the day after the shot (and is still present). Then 8 days after the injection--itchy red rash, which is still present.
Pt was supposed to receive a Menquadfi vaccine per the provider's order on 6/2/23 at 2pm. But the pt received an Adacel vaccine. There are no reported adverse signs or symptoms at this time.
Swelling spreading into elbow, pain that is growing down my arm into my hand, hives developed overnight after vaccine.
Mom states she noted on 6/18/11 quarter size redness of (R) upper posterior arm. On 6/19/11 noted increased redness with increased warmth to approx. 1/2 of upper right posterior arm with few fine raised red bumps. Enc. TYLENOL prn, elevation of arm on pillow & ice packs. Adv. call if worsens or no improvement noted.
Patient has been admitted to the hospital on 9/13/21 with increased dyspnea and 75 oxygen saturation at home. Patient was vaccinated on 8/5/21 and tested positive on 9/8/21.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 at 14:00 as dose 3 (booster), single (Lot number: D3527) at the age of 48 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
Dizziness - within ~5 minutes, peaking in intensity at about 1hr. Lasted about a week, slowly decreasing in intensity over that period. Tinnitus, slowly building in intensity starting at about 30mins(?), peaking within ~6 hrs and remaining severe for about 3 days. Since then, it has slowly abated, but is still only about half gone. Its intensity seems to  parallel my state of hydration.
This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization; and FLUZONE and SHINGRIX, both via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red spot about the size of a hand at the injection site on an unknown date. It was reported that 2 injections in same site (unspecified which drug). The outcome of the event was unknown.
DIFFICULTY BREATHING; LOSS OF APPETITE; DIFFICULTY SLEEPING; UNABLE TO TAKE KIDNEY MEDICATIONS; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 180 pounds, and height was 75 inches.  The patient's concurrent conditions included kidney failure, dialysis, non smoker, and marijuana drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 882A286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced difficulty sleeping. On MAY-2021, the subject experienced unable to take kidney medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, difficulty breathing, difficulty sleeping and unable to take kidney medications was not reported. This report was non-serious.
Unable to sleep within the next 10 days: 1-2 hrs. per night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 13:30 (Lot number: EN6202) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: JANUVIA; METFORMIN; GLIMEPIRIDE; ATORVASTATIN. The following information was reported: INSOMNIA (non-serious) with onset 03Mar2021, outcome "recovered", described as "Unable to sleep within the next 10 days: 1-2 hrs. per night". Therapeutic measures were not taken as a result of insomnia.  Additional information: Patient was not sleeping at all for 10 days, sleeping only maybe an hour at night. Sleepless symptoms were suddenly dropped after that. Caller received the vaccination- clarified Covid vaccine on 02Mar2021 and he was supposed to have his second one on 30Mar2021. Caller reports he developed an adverse effect- he was not sleeping at all for 10 days, sleeping only maybe an hour at night. Caller reports this adverse event has suddenly disappeared and he is okay now. Caller states that he needs to know any suggestions on what to do; if he should get the second vaccination; he was also concerned about how he would feel after the second vaccination. He was concerned that this adverse event would come back and if there was any way for him to sleep at least a little bit. other medications in two weeks: ram  No follow-up attempts are possible. No further information is expected.
On Monday 7/21/14 Mother notice babe right eye would not move out ward. She made an appointment with Dr. today. She also notes she had vomited x1 and had diarrhea on Monday and Tuesday. Monday also notes last night 7/22/14 babe is more irritable and didn't want to sleep.
1 minute after admin. of vaccine pt. was sitting and passed out with jerking x 1 minute. Awoke - BP 116/72. Sat up after 3 minutes - passed out again x 30 sec with jerking, O2 86% - O2 started on x 10 minutes. Sat up and felt llightheaded. Down with O2 x 10 minutes then Ok. BP 110/66, HR48-64.
Patient immediately experienced light headedness and then afterwards ringing in the ears for 3-4 minutes
Breathlessness got worse; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathlessness got worse) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     Concurrent medical conditions included Heart attack (recently diagnosed with Heart Attack and started new medication of blood thinners) and Breathlessness (was little breathless before receiving the Moderna vaccine 1st dose.). Concomitant products included ALPRAZOLAM (XANAX) for COVID-19 vaccination, METOPROLOL SUCCINATE (TOPROL), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) and PARACETAMOL (TYLENOL).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Breathlessness got worse) (seriousness criterion hospitalization). The patient was hospitalized from 18-Mar-2021 to 22-Mar-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Breathlessness got worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included unspecified blood thinners and unspecified oral regular medications. No treatment information was provided.  Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
immed wheal & flare react @ site of MMR inject 5cm x 5cm 10 mins p/shot & 5 mins p/shot devel significant wheeze w/retractions; given DPh when local rxn noted; Albuterol given for wheeze; all clear by 30 mins p/shot;