chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; started having asthma at that time; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer sponsored program. A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Batch/Lot Number: EP6955; Expiration Date: Jun2021), via an unspecified route of administration, administered in Arm Left on 22Mar2021 11:45 (at age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and ongoing chronic obstructive pulmonary disease. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Adverse events following prior vaccinations was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available)was reported as none. No additional administered vaccines if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported. Concomitant medication(s) included salbutamol (Ventoline [Salbutamol] taken for an unspecified indication from an unspecified start date and ongoing and Brio inhaler (Formulation, Batch/Lot Number and Expiration Date: not reported) only as needed. Clarified spelling of Brio inhaler, documented as provided. The patient experienced sick on an unspecified date and on 26Apr2021 03:00 patient experienced asthma. The patient was scheduled for second dose on 26Apr2021 and has missed her second dose as she was sick. The patient reported that she was in the hospital. She has a history of asthma and chronic obstructive pulmonary disease and she had to go to the hospital for a treatment. Clarified caller went to the emergency room and the caller confirmed she was not admitted to the hospital. The caller needs to know where she can go for her second dose Covid 19 vaccine. She's not sure if the facility where she received her first dose are still doing vaccines at that site. She reports she called the paramedics to take her to the hospital around 3:00AM on 26Apr2021. She started having asthma at that time and she received a treatment in the emergency room and within 45 minutes she was feeling better. She was discharged from the emergency department around 7:00AM-8:00AM on 26Apr2021. The patient underwent lab tests and procedures on 26Apr2021 which included blood test and chest x-ray, the results were unknown. Therapeutic measures were taken as a result of started having asthma at that time (asthma). The outcome of the event sick was unknown and the outcome of the event asthma was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASH ON right hand fingers.  It started with splotches on 3 fingers but has remaned on the right pinky finger
Information has been received from a registered nurse concerning an adult dialysis patient between the age of 60-80 years who was vaccinated with a three dose series of Recombivax HB.  It was reported that the patient had antibody titer that was less than 10 mIU/ml.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
Patient had flu-like symptoms for 3-5 days; was administered 1st Shingrix on 20 SEP 2022 and 2nd dose of 26 OCT 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 05-OCT-2023) and (batch number 4B3RH, expiry date 25-SEP-2023) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 26-OCT-2022, the patient received Shingrix. On 26-OCT-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: was administered 1st Shingrix on 20 SEP 2022 and 2nd dose of 26 OCT 2022). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: Patient had flu-like symptoms for 3-5 days).The outcome of the influenza-like symptoms and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.   It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter reported that administration of Shingrix to an immunocompetent patient more than 50 years old. The patient had flu-like symptoms for 3-5 days after 2nd dose of Shingrix. The reporter consented to follow up.
Swollen lymph node above collarbone,same side as injection.; is_pregnant:Yes/last_menstrual_date:16Oct2020; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in the right arm on 19May2021 at 08:45 at the age of 29-years-old as dose 2, single for COVID-19 immunisation. The patient's gestation period was 32 weeks. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient had last menstrual cycle on 16Oct2020 and expected delivery date was 16Jul2021. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 28Apr2021 at 08:45 at the age of 29-years-old as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021, the patient experienced is_pregnant:yes/last_menstrual_date:16oct2020 (maternal exposure during pregnancy) on 19May2021 and on 20May2021, the patient experienced swollen lymph node above collarbone, same side as injection only after the second shot. The patient did not receive any treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 32 Weeks pregnant at the onset of the event. The mother was due to deliver on 23Jul2021. The clinical outcome of the event, Maternal exposure during pregnancy, third trimester was unknown while swollen lymph node above collarbone, same side as injection was not recovered at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101057903 Mother/fetus
some aches/aching all over; aching all over and in her back; Sciatica pain; This is a spontaneous report from a contactable consumer (patient herself). A 74-years-old female patient received both first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date in Mar2021 single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. In 2021, caller reports she received two doses of Pfizer covid vaccine in March and had some aches. Then three weeks later she is experiencing aching all over and in her back. She stated that she has always had Sciatica pain. She was taking Tylenol. She recently saw her HCP but was feeling good then, she will make an appointment to see HCP about current aching. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
A report was received on 1/2/02 concerning a 51 year old male patient who was hospitalized on 12/19/98 after a visit to the emergency room with Guillain Barre Syndrome which was considered life threatening after receiving Fluvirin vaccine on 10/27/98. (OMIC)
headache (15 hours), fever (5 hours), body aches (18 hours)
After receiving the vaccine my scalp and skin started itching. I noticed that I had dry skin and scabs on my scalp and body. Visited my physician and was Dx with Psoriasis and prescribed Clobetasol prop 30GM (Topical Cream).
Woke with the eyes shut/ face swollen; Whole body covered in a rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Woke with the eyes shut/ face swollen) and RASH (Whole body covered in a rash) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type I diabetes mellitus.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-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 SWELLING FACE (Woke with the eyes shut/ face swollen) and RASH (Whole body covered in a rash). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 40 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Woke with the eyes shut/ face swollen) and RASH (Whole body covered in a rash) outcome was unknown.            Concomitant medication included Medication for Type I diabetes. Treatment medication also included IV and Steroids in a pill form.
Pt recv vax on 11/17/98; on 11/19/98 pt exp red, warm vax site; tx=Tylenol, cold compress
Pt recvd MMR vax on 05NOV90; 10 min following inject, pt exp sz that was unassociated w/fever; Sz was of less than 30 seconds duration;  Tx included unspecified prescription meds & pt recovered;
58yr old patient with history of T2DM, hypothyroidism and HTN received booster Pfizer COVID-19 vaccine (unknown LOT# or location of vaccine administration) on 9/27. Patient previously received Pfizer COVID-19 vaccine on 12/22/2020 (dose 1: LOT # EH9899) and 1/14/2021(dose 2: LOT # EK9231, endorsed feeling "achy and chills" post dose 2). Patient also received Pneumococcal Polysaccharide 23 Valent vaccine on 8/10/2021 (LOT # T016160, site: LD). On 9/28, patient developed muscle pains and sweats, having to leave work. On 9/29, symptoms continued and also endorsed chills. On 9/30, patient noted rash on right flank that had pain around the back and waist area. Patient presented to Urgent care on 9/30. Patient endorse Additional information for Item 18: Patient endorsed being mildly sore and very fatigued. Other symptoms denied. Upon assessment, NP concerned for herpes zoster affecting the back and flank. NP noted no contusion or rash around booster injection site. NP prescribed Rx :  valACYclovir (VALTREX) 1000 MG tablet : 1000mg PO TID x 7 days,  traMADoL (ULTRAM) 50 mg tablet : 1-2 tablets PO Q6H PRN pain, acetaminophen 1000mg alternating Q4H with ibuprofen 600mg.  Patient discharged home in stable condition with instructions to follow up with PCP within 3 days.  Patient works a health care setting and thus qualifies for booster per Authorization guidelines.
a patient with dementia received his second dose of  vaccine before the recommended 28 days (24 day at earliest) interval. Patient came alone and endorsed he was getting his first dose of vaccine. The patient was alert, mentation was grossly intact, in-additional the patient was able to make his needs know.  There was no concerns by vaccinator at the time for dementia. Patient remained clinically stable after receiving dose of vaccine. Caregiver arrived to alert staff that patient has dementia manifested by forgetfulness, and she sent him in alone to get dose of vaccine. A report was submitted. Appropriate parties notified. Education to caregiver provided. I anticipate we will meet to review this and review necessary practice recommendations or changes.  I am available if any additional information is needed.
Pt reports feeling heat on her chest and neck seconds after injection of vaccine. Red pinpoint spots noted to neck and chest and skin is warm to touch. A few minutes later she reported "deep itching" at the injection site. No redeness, swelling, or warmth at the site. Applied ice pack to neck and chest and watched her for an hour. After about 45 minutes pt stated that she felt "normal again." Redness and warmth had resolved at about 40 min. Pt was discharged in stable condition with instructions to contact her PCP to inquire about getting her second vaccine.
she got deathly sick with the first COVID vaccine; fever; cold; cold chills; This is a spontaneous report from Pfizer Program from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; pregabalin (LYRICA) via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated that she got deathly sick with the first COVID vaccine. She had a fever cold chill. She said she was going to get her second shot today (on 09Apr2021). Events outcome was unknown.  Information on the lot/batch number has been requested.
Chills; joints and shoulders hurt; felt a little nauseated; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), ARTHRALGIA (joints and shoulders hurt) and NAUSEA (felt a little nauseated) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M219) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills), ARTHRALGIA (joints and shoulders hurt) and NAUSEA (felt a little nauseated). On 06-Feb-2021, CHILLS (Chills), ARTHRALGIA (joints and shoulders hurt) and NAUSEA (felt a little nauseated) had resolved.            No concomitant medications were provided.   Patient took Tylenol for the treatment of the events.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
She already received the 2 doses and 3 boosters of the Pfizer Covid-19 vaccine. She tested positive for Covid; She already received the 2 doses and 3 boosters of the Pfizer Covid-19 vaccine. She tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) 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 Aug2022, outcome "unknown" and all described as "She already received the 2 doses and 3 boosters of the Pfizer Covid-19 vaccine. She tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173405 same patient/vaccine, different dose/event;
Patient's eyelids started itching 3-4 hours after the vaccination. Sx got worse the next day. Pt. reported waking up with swollen eyes and redness in the upper facial areas. Her face was itchy and tender to touch. There was no adverse effect at the injection site. Pt has had regular strength influenza vaccine before w/o any adverse events.
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 17-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Suspetcted vaccination failure; neuropathy; shingles on the lower left dermatome, wrapping around the patient's back; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix .5 ml. On 29th July 2019, less than a year after receiving Shingrix and 183 days after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, neuropathy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, neuropathy and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by the patient's neighbor, who was nurse practitioner. The age at vaccination was not reported. The patient developed shingles 6 months after getting the 2nd dose of Shingrix.  The shingles was on the lower left dermatome and wrapping around the patient's back.  The patient had developed neuropathy due to the shingles. The field representative was only able to provide the reporter's home address, but did not know her office address. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
The physician diagnosed shingles on 08/14/2001. The patient had multiple erythematous papules following dermatome of the right arm. The patient complained of pain in the right axilla and hand. The patient was treated with Bovirax.
My COVID-19 infection symptoms started on 09/23/2022 at 2:00PM. I had mild symptoms. I had a tickle in my throat and cough, chest congestions. My symptoms got worse throughout the day. On 09/22/2022 I did 2 COVID-19 home tests which were positive. I called my doctor and told my doctor that my husband already had PAXLOVID which was prescribed to him by his doctor and he didn't take it. I asked if I can take it instead since it was there. My doctor advised me to take the PAXLOVID since my symptoms got worse. I took PAXLOVID on 09/24/2022. I felt better on 09/27/2022 no more symptoms. On 10/03/2022 I was feeling tired. As the day went by I had a cough and my symptoms got worse. I went to the urgent care on 10/08//2022. At the urgent care they prescribed me with albuterol, steroids' (prednisone) for 5 days, benzonatate, and guaifenesin for cough (3-4 days).
Reported by mother 11-29-07 - raised swollen reddened, warm area left arm around injection site (viper V2 of arm)
Her arm felt sore and was swollen when she woke on 6/7/18 (the day after the shot) but that went away the following day. She had myalgia on 6/7/18 and felt achy all over which was also better on 6/8/18. She had swollen, tight upper lip on 6/7/18 which later in the day spread to her bottom lip. Today (6/10/18) the swelling has gone down in both lips but she still has an odd sensation in them and they are very dry now.
Red raised bump at injection site appeared approximately 8 days after initial vaccine was received. Was hot to the touch & severely itchy. After a few days it went away. Then came back and had spread to 2 separate red bumps that were hot to the touch and severely itchy. The next day they began to spread wider across my left arm. Went to see the doctor and was advised to take benadryl and ibuprofen to help with the reaction and the swelling.
bad headache; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program COVAX US Support.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified), via unknown route of administration on 09Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she received her 1st shot of COVID-19 vaccine on 09Apr2021, and really had a bad headache. She was asking if she could take Tylenol or Advil or any pain killer. The patient was not sure if her 2nd dose was scheduled on 07May or 09May or when. The events were assessed as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
On 5/7/13, pt received immunization in (L) anti thigh Dtap site is red, swollen, warm to touch, size of baseball states parent. Recommended BENADRYL, cold compress. OV tomorrow. 5/9/13 OV-pt is slightly improved. Afebrile.