chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Poor response to pneumococcal vaccine; Literature Report:    This literature marketed report has been received from authors of a published article, regarding a 28-year-old male patient. On an unknown dated, the patient was referred to the Allergy, Asthma, and Immunology clinic with 1.5 years of abdominal pain and severe chronic diarrhea causing malnutrition, dehydration, and hospitalization. Of note, the patient did not have a history of recurrent or frequent infections. An extensive gastrointestinal (GI) workup with endoscopic evaluation showed severe villous blunting and increased intraepithelial lymphocytes suggestive of celiac disease, however, serology testing was negative and he did not respond to gluten avoidance. Stool testing did not reveal an infectious etiology. Notably, he also had tryptase of 12.8, but no evidence of mast cell disease. Labs confirmed Common variable immunodeficiency (CVID) with IgG 566, IgM 34, IgA 46, poor response to pneumococcal vaccine, polyvalent (23-valent)/pneumococcal 15v conj vaccine (crm197) (indication default to prophylaxis; strength, dose, frequency, route, lot # and expiration date were not reported) (suspect product reported as pneumococcal vaccine) (vaccination failure). The outcome of vaccination failure was unknown. The causality of vaccination failure was related to pneumococcal vaccine, polyvalent (23-valent)/pneumococcal 15v conj vaccine (crm197).  A copy of the published article is attached as further documentation of the patient's experience.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 11:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 11:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 46.16 for dose administered on 14-Feb-2021.  No concomitant medications were reported. ~ Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 35 degrees Fahrenheit from 10:00 AM to 11:00 AM, on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM and 14-Feb-2021 temperature 32 degrees Fahrenheit from 09:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021 and 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot # L034724, expiry date 09-DEC-2016) (dose and route unspecified), which was improperly stored under 8 degree Centigrade for 4 weeks. Other suspect and concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Her mom is having issues and it's very frustrating; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is patient daughter.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Her mom is having issues and it's very frustrating".  Additional information: The reporter stated that the patient was having issues and it was very frustrating.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (25Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021572104 Different patient, same drug/event.
Pain at the time of injection, no symptoms until 5 hours later, beginning with sore arm and then developing malaise, nausea, chills, body aches and headache. Continuing into and throughout day after injection, minimal relief with acetaminophen.
Patient had Gardasil 9 in the right arm as well as Bexsero and Menactra in the left arm at the same time.  Menactra lot number U6521AA Bexero lot number ABXA32AA
After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day; After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Triglycerides" (unspecified if ongoing). Concomitant medication(s) included: LIVALO. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "After my first Pfizer vaccine, I had a high fever of 103.3 for 5-6 hours the day following vaccination"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours and felt general muscle aching", "After the 2nd dose of Pfizer vaccine, I had a fever of 102. for a few hours and felt general muscle aching". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), FATIGUE (non-serious), outcome "recovered" and all described as "After the 1st Pfizer booster, I had a temp of 99 and just felt tired for a few hours the following day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, fatigue.  Additional information: No known allergies. No other vaccines were received within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was Livalo. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. After the 1st Pfizer booster, patient had a temperature of 99 and just felt tired for a few hours the following day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Five to ten minutes after the administration of the vaccines patient complaint of pain on the back of the head and chest pain she she breaths.
developed Erythem Multiform after receiving the 1st dose of Shingrix, a Gsk flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of erythema multiform-like eruption in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included multiple myeloma.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema multiform-like eruption (serious criteria GSK medically significant). On an unknown date, the outcome of the erythema multiform-like eruption was unknown.   It was unknown if the reporter considered the erythema multiform-like eruption to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix and Influenza vaccine, the patient experienced erythema multiform-like eruption. The patient had tested due to her medical history of Multiple myeloma not related to a vaccine. The reporter consented to follow up. This case was linked with case US2020AMR174273, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR174273:same patient
Site: right arm red and swollen on vaccine site x1 day. No tenderness felt on area. Per Dr. it was a localized vaccine reaction. No treatment necessary at the moment. On 3/11 called mother and she stated theres no redness at site anymore and site is a little purple now.
This case was reported by a nurse and described the occurrence of flu-like symptoms in a 62 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The vaccine provider submitted this report directly to the CDC.  The pt's medical history included allergies to sulfa-containing medications and quinidine. There were no concurrent medications. On 06/13/03, the pt received the 1st dose of Engerix-B and had no adverse event.  On 07/14/03 the pt received the 2nd dose of Engerix-B (Lot # ENG5376A2).  On 07/15/03, 24 hours post-immunization, the pt felt weak and experienced achy joints.  On 07/16/03, she developed eye redness and a headache.  On 07/19/03, the pt developed nausea, vomiting, and diarrhea. The reporter made a diagnosis of flu-like symptoms.  On 07/20/03, the pt was "able to keep crackers down".  The events resolved on 07/21/03; however, the pt was unable to work that day. The reporter considered the events were possibly related to vaccination with Engerix-B.
cough got worse; strong cough with phlegm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough got worse) and PRODUCTIVE COUGH (strong cough with phlegm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough got worse) and PRODUCTIVE COUGH (strong cough with phlegm). At the time of the report, COUGH (cough got worse) and PRODUCTIVE COUGH (strong cough with phlegm) outcome was unknown. Not Provided          No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079302, US-MODERNATX, INC.-MOD-2021-079392, US-MODERNATX, INC.-MOD-2021-079441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079302: US-MODERNATX, INC.-MOD-2021-079392: US-MODERNATX, INC.-MOD-2021-079441:
First day-Stiff frozen neck, gland swollen under left arm .  second day-could not move neck and all glands in body swollen and tender. head ache and body aches entire body.  all joints swollen and tender, difficulty swallowing and breathing.  severe head ache.  3rd day-same symptoms plus fever 102+ body aches and chills.  4th day-All same no improvements.  5th day-Same symptoms and visit to the emergency room.
Headache, fever, chills, nausea, arm pain and arm rash beginning 11 hrs after injection and lasting 40 hrs.  Arm pain and rash still persisting three days after injection.
Patient received a series of immunizations for deployment. He reported after receiving Typhoid vaccination that he felt a lump under left armpit, he broke it open, pus/blood came out. Patient was sent to urgent care for evaluation.
Doses administered after more thandose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more thandose administered to patient after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 10:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more thandose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more thandose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.07 No concomitant medications were reported. On 27-Oct-2021 at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and vial was initially moved to the fridge on 29-Sep-2021 and beyond use date was 29-Oct-2021. Product moved to clinic on 27-Oct-2021, and at 10:00 Am the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 05-Oct-2021 and beyond use date was 04-Nov-2021. Product moved to clinic on 27-Oct-2021 and the vial Condition of vaccine prior to administration was not Frozen. Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
There isn't a Lot number for Dose 3 on my vaccine card.  On 12/6/2021 I started wheezing in the morning. On 12/10/2021 I had heart palpations was 120/147 at around 11:30am throughout the whole day, and shortness of breath, and chest congestion and trouble breathing. Also had headache and dizziness. Also I was unable to work from 12/10/2021.
neck stiffness began at 10pm Feb 18; chills and uncontrollable shaking, muscle aches and pains began at 11:45pm Feb 18; noticed a rapid heartbeat after getting back into bed at 6am on Feb 19; took my temperature orally at 7:20am and got three different, very similar results:  100.9F, 101F, and 100.8F;  plan to take acetominaphen
Pt. phoned in on 8-18-16 with 2" red spot around injection site. Appt on 8-22-16 with Nurse Practic. for shingles rash on lower leg and spot.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-NOV-2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 29-JUN-2015, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
My first symptom after 2nd shot was a baseball size swelling in the arm where I received the shot. In the past few months, I've noticed a ringing in my ears. I only really notice it when things are quiet but it's there all the time, a sort of humming like the sound of cicadas at night but not as loud. On a scale of 1-10, it's a 2. It sometimes makes it hard to sleep but when I'm busy, I don't pay attention to it.
Two weeks prior to seasonal flu vaccine pt stung by swarm of sweat bees. Stings covered upper body to breast line. When received seasonal flu vaccine, patient felt stinging sensation all over her upper body where bee stings had been. Denies sores, hives. No MD visit made.
Within 10 minutes I was very dizzy. The firemen took my blood pressure sitting was 172. They had me stand and it went to 122. Sitting again it went to 199. I was taken to the hospital.  At the hospital  I was made aware my heart rate was under 50.  I was admitted.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207), in right arm and on 13Apr2021 as dose 2, single (Lot number: EW0153), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 068H21A), in left arm 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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative; Positive, notes: Positive COVID test one week after finishing medication. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Reinfection. Positive COVID test one week after finishing medication and testing negative. Subsequent development of headache, fatigue, low grade fever, etc. No known allergies reported.
Symptoms: 1. Rash 2. local swelling.  Suspect Drug #1 Dosing:  one time vaccine dose.
loose bowels, cough (mostly dry, occasionally clear mucous), congestion (clear mucous), fatigue, low back ache, (*no* fever), (*no* nausea)
Child had swelling erythema next day right thigh where DTaP given. Fever 103+ over next 2 days.
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient), program ID: (005570). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jan 2022, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Dec 2021, for immunization. The patient developed alopecia (hair loss), with outcome of not recovered. Additional information: Patient experienced great hair loss after vaccination and wanted to know what can be done to stop this. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Approx. 1-2 min. after vaccination, pt. had syncopal event. Hit her head against the wall with the fall. Appeared somewhat rigid with eyes rolled. RN felt it was a seizure. Lasted < 1 min.
Death report received indicating patient died on 11/23/2022, Immediate Cause:  BILATERAL PNEUMONIA (PNEUMOCOCCAL AND COVID-19) COMPLICATING LEFT PERIPROSTHETIC HIP FRACTURE Submitter does not have access to further medical records. If more information is needed, please contact the admitting hospital.
I should have gotten by second shringrix shot in March of 2023. Unfortunately I forgot.; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I should have gotten by second shringrix shot in March of 2023. Unfortunately I forgot.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2023 The patient self-reported this case. The patient asked should he/she start the series over. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.