chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt stating pt had sz on 14MAY93 & was hospitalized for 4 days; pt was vaxed 6MAY93; 14MAY93 pt was lethargic w/t102;
received Infanrix instead of a TDaP; 12-year-old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comments: The nurse reported that the 12-year-old patient received Infanrix instead of a TDaP. The reporter consent to follow up. Additional Supportive Information: The patient received Infanrix vaccine instead of TDaP, which led to wrong vaccine administered. 12 years old patient received Infanrix vaccine, which led to inappropriate age at vaccine administration.
She first developed body aches and the early morning on her first day Post vaccination,she complained of pain on her L gum area, ( like a toothache),  in a few hours she had a severe swelling on all her gum area, more swelling on the lower jaw., its accompanied with pain. No fever. the swelling lasted for 3 days and just subsided on the fourth day. She took Ibuprofen 400 mg, alternating with Tylenol  500 mg at 6 hours interval.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to BOOSTRIX. Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist said a patient told her that, her healthcare professional said she needed to get the vaccine again because there was a lump at the injection site. The reporter consented to follow up.
12/17/2020 Recieved 1st Pfizer covid injection on 12/25/2020 messaged her PCP for a swollen lymph node, not painful, (stated she has noticed for two weeks) was seen in her office on 12/28/2020  Blood work, CBC, US neck recommended CT with contrast 12/30  ct was performed recommended FNA biopsy, states it could be reactive  US guided biopsy is scheduled  states she feels fine and no other concerns  she is planning for 2nd vaccination today.
fever; tiredness; muscle pain; achy; chills; joint pain; one movement of diarrhea/one bowel movement of diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (Lot number: FF8841) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy to aspirin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, single, Lot:EL8982, When I had the other 2 doses I was ok, just a bit tired), administration date: 16Jan2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Tired"; Bnt162b2 (Dose: 2, single, Lot: FL9262, When I had the other 2 doses I was ok, just a bit tired), administration date: 06Feb2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Tired". The following information was reported: PAIN (non-serious) with onset 14Oct2021, outcome "not recovered", described as "achy"; CHILLS (non-serious) with onset 14Oct2021, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 15Oct2021, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 14Oct2021, outcome "not recovered", described as "tiredness"; MYALGIA (non-serious) with onset 14Oct2021, outcome "not recovered", described as "muscle pain"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "joint pain"; DIARRHOEA (non-serious) with onset Oct2021, outcome "unknown", described as "one movement of diarrhea/one bowel movement of diarrhea". Therapeutic measures were taken as a result of pain, chills, pyrexia, fatigue, myalgia.  Additional information: Patient got his booster on Monday 11Oct2021 and yesterday he started to feel achy, and he also had chills, fever, tiredness and muscle pain. Caller stated he had one bowel movement of diarrhea, wanted to know if he should get tested for Covid, agent referred to his HCP. Caller states he does have his taste, states he read the symptoms. Caller states he was a little worried, but that he had the first two, but then with the booster he felt achy at first. Caller states that the symptoms are still there but they come and go, states he woke up and his muscle pain was a little improved, but fever was back, third time today he has had to take Tylenol, states he was surprised he has these symptoms, the pharmacist did not tell him about these symptoms. States he has no throat pain, no coughing, and diarrhea was just a little bit one time. Caller states he is going to sleep away from his wife tonight just in case. States he was worried because his granddaughter is coming to visit, states she is 11 and has not been vaccinated yet. States he is glad to know these could just be symptoms of the vaccine but wishes they would have told him about them when he got the shot.   No follow-up attempts are possible. No further information is expected.
Got shot 9/20 at 0730 at work. Felt fine whole day. Next am at 04:45 am turned alarm off went to stand up out of bed and fell to floor both legs were completely weak and numb. tried to stand and couldnt. Waited 5 mins stood up very weak walked around got strength back and was a little wobbly that am. Was fine that afternoon. No other issues after that.
headache; Extreme soreness at injection site; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Codeine" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; SPIRONOLACTON; B12 [CYANOCOBALAMIN]; D3. Vaccination history included: Covid-19 vaccine (Primary immunization series completed.), for COVID-19 immunization; Covid-19 vaccine (DOSE 3,(BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Sep2023, outcome "recovering", described as "Extreme soreness at injection site"; PAIN (non-serious) with onset 29Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 29Sep2023, outcome "recovering". Therapeutic measures were not taken as a result of headache, vaccination site pain, pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Bell's Palsy with left  sided facial droop,  left sided eyelid lag,  left sided facial numbness Treatment: Prednisone 40mg x 7 days; no improvement of symptoms Currently having persistent Bell's Palsy
This literature report concerns a prospective study on safety and efficacy of H1N1 vaccination in children with chronic inflammatory rheumatic diseases. Patients who had received at least one dose of the H1N1, were included. Fifty six (54%) of the subjects received the vaccine in the clinic and were assessed prospectively; the remainder received their vaccinations elsewhere are were administered questionnaires during their clinic visit. Information gathered included vaccination side effects and the incidence of flu in study subjects. A male patient (further identification not available) developed a flare of his arthritis following the immunization. Time to onset is not clear but reporter stated the event occurred within 6 months. The patient did not have persistent sequelae or complications requiring hospitalization. The event outcome was not reported. Reporter's comment: H1N1 was well tolerated and apparently effective in children with chronic inflammatory rheumatic diseases. The findings support the recommendation that children with rheumatologic conditions should receive the H1N1 vaccine.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.  No Medical History information was reported.  On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  The vial was initially stored in the refrigerator on 04-Nov-2021 and the reporter reported that they thaw the vial on the same day. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-497431 (Patient Link).
Pt developed redness (about 3cm diameter) at injection site (left deltoid) 2-3 days after immunization, as well as about half way down the upper arm (about 3 x 6cm area). A week later she woke at 4am with left arm and left posterior shoulder pain and tenderness, prompting an office visit. On examination, the areas involved were faintly erythematous and with increased warmth, and with some superficial capillary prominence, no appreciable fullness to skin to suggest cellulitis. No arm edema, no arterial cords to suggest UE DVT. Suspect delayed intradermal allergic reaction. No facial, oral, or pharyngeal edema, no breathing problems at any point.
Patient was seen in office for her 12 month Well Child Check.  She was given above vaccines around 10am.  Within 5 minutes of admin, all injection sites were bright red and child's entire body had a hive like appearance including face, belly and legs.  Patient was give dose of Benadryl, remaining in office for another 10-15 minutes.  Patient's symptoms subsided dramatically prior to dismissal.
A 17 YEAR OLD FEMALE WAS ADMINISTERED MODERNA. THERE WERE NO S/S OF ADVERSE REACTION, NO ADVERSE REACTION WAS REPORTED. PATIENT LATER HAD A SECOND DOSE IN THE SERIES.
Patient's arm was inflamed. She went to an Urgent Care and was diagnosed with cellulitis.
Initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 11-OCT-2013, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided).  In November 2013, the patient was treated by a healthcare provider at a primary care office for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
"After receiving the flu vaccine I began to feel very dizzy. My blood pressure was slightly elevated (134/78). After sitting for half an hour or so, the dizziness lifted. I worked my shift and went home, showered and went to bed. This morning (10/4) I woke up with a bad headache, sinus congestion, and a feeling of heaviness to my head. When I mentioned it to someone on the elevator, she said I should report it to employee health. Once I got to my units I found out that other co-workers had also had headaches as a vaccine reaction and that it would probably fade in a day or two. No one else had been told to report it to employee health."  "became dizzy after about 20 minutes, blood pressure went up to 134/78 (slightly higher than normal).  I was vaccinated yesterday (10/3) just before 3 PM and felt very tired for the duration of my shift (3-11:30 pm).  This morning (10/4) I woke up congested and with a sinus headache.  In spite of sleeping 10 hours last night, I still have little energy and my head feels heavy, though the pain is controlled."
Patient's daughter reported at 2/20/21 (next day after her shot) that her mother was experiencing chills, fatigue, sore arm and fever (peak 101F). The patient's daughter gave her a Tylenol when she found out she had a fever and this resolved the fever and the patient was feeling back to normal around midnight that same night.
Hives on entire body from 12/2/21 to 12/12/21 Treatment: 20mg Zyrtec, 40 mg Famotidine, Benedryl, and topical anti-itch cream  Red arm near injection site starting 11/20/21 and moved down the arm, was warm to the touch, and tender for 4 days.  No treatment and did not visit the doctor for this reaction.
Dizziness, nausea, syncope, tachycardia (heart rate was 177)
0945 Patient reported feeling nausea, lightheaded, dizzy, weakness in legs, and tingling in the left side of her face that radiated down to the left lateral side of her neck. Upon assessment, patient noted to be visibly anxious. Patient reported that she has history of anxiety and has been anxious about shot for the past week. States "This is common when I become anxious, however, I have never felt tingling in my mouth and neck before." Also noted some drooling out the side of her left mouth. Patient vitals were BP: 136/90, O2: 100%, HR: 96. No visible signs of stroke with further assessment. After talking with patient and easing anxiety with relaxation techniques for 10 mins, all symptoms resolved. Patient feels she is going to be ok and doesn't want further treatment or intervention. Patient walked out clinic at 1010 with no further issues.
ELEVATED D DIMER; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced elevated d dimer. Laboratory data (dates unspecified) included: Fibrin D dimer elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated d dimer was not reported. This report was non-serious.
Extreme indegestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 13:15 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DYSPEPSIA (non-serious) with onset 16Feb2021, outcome "unknown", described as "Extreme indegestion".  Additional information: No known allergies. Other medical history reported as none. No other vaccine in four weeks. No other medications in two weeks. Extreme indigestion the day after both shots. No covid prior vaccination. Not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
During the evening, patient began to experience labored breathing, nausea, diarrhea and she felt cold at times. No emergency services were rendered.
difficulty breathing at rest and particularly with activity.; noticed increased wheezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 16:00 (Lot number: FF8839) at the age of 14 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL].  The following information was reported: DYSPNOEA (non-serious) with onset 03Oct2021, outcome "not recovered", described as "difficulty breathing at rest and particularly with activity."; WHEEZING (non-serious) with onset 03Oct2021, outcome "not recovered", described as "noticed increased wheezing". The events "difficulty breathing at rest and particularly with activity." and "noticed increased wheezing" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, wheezing.  Additional information: No other vaccine in four weeks. The other medications in two weeks was Albuterol inhaler. No prior covid vaccination and not tested covid post vaccination. It was reported that Asthmatic patient well controlled with medications and symptoms improved however worsened after the second vaccine and have continued to be worse than prior to first vaccination. Currently went on prednisone and was taking increased medication due to worsening symptoms. Penicillin was reported as known allergies.  Follow-up attempts are completed. No further information is expected.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who complained of feeling tired after she received vaccine FLUZONE HIGH DOSE twice by mistake. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation on an unknown date. On 26-Sep-2018, the patient received 0.5 ml dose and on 09-Sep-2018 again received 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA (expiry date: 05-May-2019, via intramuscular route in the left deltoid for both injections. On an unknown date, the patient complaints of feeling tired following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No other symptoms were noted. It was also a case of actual medication error due to Extra dose administered. Final diagnosis was fatigue. Details of lab date was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fatigue. 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.
Initial report received on 04 April 2007, from a health care professional.  A 29 year old female patient received on 16 December 2002, 0.5 ml Fluzone (lot #U0931AA) (site, side and route of administration not reported), to protect against flu.  The patient was pregnant at that time.  No adverse event was reported for the patient.  The patient delivered a baby (unknown gender) on 25 May 2003, vacuum assisted.  The child had developmental disabilities.  The patient's medical history included: hypothyroid and sclerosis.  The patient's concomitant medication included: Synthroid.  No other information was reported.  Follow-up information received on 02 July 2007 from a health care professional.  Fluzone SV 2002-2003 had been administered as a first dose, intramuscular, deltoid injection on 10 December 2002 (previously reported a 15 December 2002).  The patient had experienced pregnancy induced hypertension while in the hospital and was administered MgSO4.  The reporter had also indicated that the patient did not experience any adverse event.  Child case number is 2007-01043.
Acute syncope with two syncopal episodes, found to have bilateral subsegmental pulmonary emboli and oxygen requirement
Almost 15 min after pt received her first dose of Pfizer vaccine, she felt light-headed. Mom who was at side held pt up and called for provider. Provider came over and pt said she had blurred vision and muffled hearing, pupils were dilated. A few seconds later, pt felt better and was able to drink water. Had pt and mother stay a few extra minutes past 15 min for observation time and patient able to slowly stand up and walk out clinic with mom. She did report not drinking water since this morning.