chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have  been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have  been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have  been experiencing for 4-5 days; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (Patient) reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL 9264 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EL 9264) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included, chronic kidney disease, coronary artery disease, hypothyroidism, hypertension from an unknown date and unknown if ongoing. No known allergies were reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), dose number; 1 on 18Jan2021 at 09:30 am at left arm for covid-19 immunization. Facility type vaccine was reported as other. The patient did not receive any other vaccines within 4 weeks. Concomitant medications (Other medications in two weeks) included allopurinol taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID), eicosatetraenoic acid ethyl ester (VASCEPA), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 the patient experienced unsteady on feet, almost "tipsy", as if returning to land after being on boat, have been experiencing for 4-5 days. 2 others, not related, with same approx schedules, experiencing same feelings. No treatment was given for the AE. If covid prior vaccination: No, If covid tested post vaccination: No. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
heart palpitaions, sharp chest pain, numbness and coldness in left side of body. goosebumps  on only left side of body.
. No additional AE reported. No PQC report; Pharmacist reports administration of an expired dose of PNEUMOVAX 23 to a patient on 22FEB2023. Caller confirmed product was stored according to the recommended storage range until administered to the patient.; This spontaneous report has been received from pharmacist referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 22-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, lot number U026796 that had been verified to be a valid number with expiration date 28-JAN-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (expired product administered). Product was stored according to the recommended storage range until administered to the patient. No additional adverse event reported.
Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot# not reported). Subsequently, on an unspecified date the patient developed urticaria and erythema at the vaccination site. The physician stated that the patient went to her office. The patient was treated with 2 to 3 days of oral steroids and the patient recovered. The patient was not hospitalized. The patient's mother elected not to have any more of GARDASIL series. This is one of several reports received from the same source. No further information is available.
Pain in upper left arm where shot was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 10:45 (Lot number: EP6955) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were none. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021 12:30, outcome "recovered" (Mar2021), described as "Pain in upper left arm where shot was administered". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
She had colon cancer and they took out half her colon; Chest pain; She had a large heart; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot/NDC number and Expiry date was not reported) via an unspecified route and date in Jan2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, she had colon cancer and they took out half her colon (medically significant), chest pain and she had a large heart. On an unspecified date in 2021, the patient underwent lab tests and procedures which included a scan and found that she had a large heart. Other information included, patient received the vaccine in Jan2021 and 3 weeks later she was having chest pains. She went to her doctor who did a scan which showed she had a large heart. She had to get a stent placed and while they were in there they found out she had colon cancer and they took out half her colon. Now she has stage 4 colon cancer and she isn't going to make it. Reporter does not know the date of her procedure, but thinks it was probably sometime in Feb2021. Healthcare Professional postal address was reported. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Sore, dry throat, hard to swallow, temp 100, body weakness lasting 1 1/2 days, TYLENOL every 4-5 hrs. Reported to pharmacy & PCP.
Swelling and very painful arm. The size of a grapefruit.  Fever,  headache,  weakness and body aches
After shot pt immediatly became pale, apneic, then dusky. Pt's eyes rolled up, pt unresponsive. Stimulation given, pt started breathing in 90 seconds. Pt sao2 4 min after episode 99% pt recovered with no additional treatment.
DVT; PE; This is a spontaneous report from a contactable consumer (patient). This adult male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Mar2021, lot EP6955, in right arm, for COVID-19 immunization. No other vaccine was received in 4 weeks. Medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced DVT and PE. The events resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Events treatment included dabigatran (PRADAXA). The events were resolving at the time of report. COVID was not tested post vaccination.
intractable vomiting; feeling of pins and needles; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; This is a spontaneous report from a contactable Pharmacist. A 20-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 20 years, on 27Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history was none. No COVID prior vaccination. No known allergies. There were no concomitant medications. Patient was admitted to hospital for intractable vomiting and feeling of pins and needles starting after vaccine was given on 27Aug2021. Patient had elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission on 27Aug2021. The patient was hospitalized for 3 days in until 30Aug2021. No other vaccine in four weeks. No other medications in two weeks. AE treatment was fluids. COVID tested post vaccination: Abbott ID Now SARS Cov 2 nasal swab was negative on 29Aug2021. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the events intractable vomiting, feeling of pins and needles, and elevated LFTs with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Received 2 flu vaccinations (standard, H1N1) on Jan 12, 2010, 30 min later, intense nausea, light-headedness and vomiting. 24 hours later, sudden onset of nausea and vomiting. Since then, daily (intermittent thru the day) light-headedness, nausea (only vomited 1 additional time), and feeling of malaise-some relief with meclizine. Some weakness-no vertigo. Standard labs WNL except very slight increase TSH.
Started having a sore throat and fever, took home COVID-19 test and was positive. Contacted doctor and was prescribed PAXLOVID.
Dizziness, Headache, Myalgia, Fever, CHILLS SORE ARM EAR ACHE Narrative:
This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose1, single and second dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had both doses of the PFIZER-BIONTECH COVID-19 VACCINE and tested positive for Covid on 11Aug2021. Patient would like to know more about her antibodies given that she tested positive Covid and has been vaccinated. She would like to know if the booster dose becomes available. Also mentioned that at this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized yet. Events considered as non-serious. Lab tests included that patient tested positive for Covid on 11Aug2021. Outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received a flu shot at our facility 1 week after receiving a flu shot at a different facility. Patient received 2 flu shots this season. Patient did not inform us of any adverse effects. Counseled her on possible adverse effects and that staff re-training would take place.
During a break from basketball she looked in mirror and noted swelling around her eyes.  At the same time she developed some cough and a "full" feeling in her throat. These symptoms subsided within 30-40 minutes but eyes still swollen in am 10/31/08. (Also had contact with a dog before basketball)
Dusky red induration, red ring measuring about 10 cm diameter. Treating for possible cellulitis now w/TMP/SMX for 7 day.
This spontaneous report as received from a project coordinator (not further specified) from another company refers to a 27 years old female patient. On an unknown date, the 27 old patient was vaccinated with GARDASIL. Lot number, expiry date, route of administration and anatomical location of the vaccination were not reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Rash appeared on stomach/groin on 4/15/2018 and continued to spread from initial appearance to back arms and legs. Rash was vesicular with lesions in various stages of healing, some with crusting. Low grade fever started on 4/15/2018 and progressed to a fever up to 102 F.
Immunization BOOSTRIX ordered, when entering information in computer it was noted expired 10-1-15 vaccine given on 10/5/15.
VACCINE DRAWN UP DAY BEFORE AND GIVEN AT THE 15 HOUR MARK, PER MODERNA REP CLIENT TO BE CALLED TO SEE IF ANY ADVERSE REACTIONS.  CLIENT COMPLAINTS OF SORENESS AT INJECTION SITE THAT LASTED FOR 1-2 DAYS.
Child given MMR #2, varicella #2, hep A #2 Tdap, MENACTRA vaccine after checking immunizatoin record provided and this after vaccine given. Mother of child provided other vaccine rciivd showing child had vaccines previously .
4 days after vaccine pt developed rash on face Tx with Hydrocortisone without change. Following day pt with facial swelling : Redness. Redness spread to hands, back, and chest. Pt with peeling of face Pt Tx with BENADRYL follow day redness and swelling spread to all of upper body with swelling and itching. Pt Tx with Prednisone. In 2 days rash and swelling started to slowly.
in Oct2021 was diagnosed with Stage 3 hypertension/have elevated blood pressure readings after the 2nd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2021 as dose 2, single (Lot number: EW0178) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 01May2021, when the patient was 16-year-old, for COVID-19 Immunisation. The following information was reported: HYPERTENSION (medically significant) with onset 01Jun2021, outcome "recovered with sequelae", described as "in Oct2021 was diagnosed with Stage 3 hypertension/have elevated blood pressure readings after the 2nd shot". The event "in oct2021 was diagnosed with stage 3 hypertension/have elevated blood pressure readings after the 2nd shot" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Elevated, notes: began to have elevated blood pressure readings after the 2nd shot; SARS-CoV-2 test: Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of hypertension. Clinical course: No other vaccine in 4 weeks. The patient began to have elevated blood pressure readings after the 2nd shot and in Oct2021 was diagnosed with stage 3 hypertension. She recovered with lasting effects. Treatment included Lisinopril. Covid prior vaccination: No. Device timestamp: 12Nov2022.
Staff had 2nd vaccine yesterday 01/13/2021 at 11:20.  At night 3 am woke up with bodyache, lower back pain, fever 103, could not sleep.  Took Tylenol.  Today at 12 noon staff feels chill, fever 102.  Now ok.  W
It was my live alone and my daughter had told me about the smart Watch and with fall notification and decided to buy a new phone and watch, so I set up my phone and watch, and it alerted me that night while sleeping that I was in a alert and it notified me I was in Atrial fibrillation and to notify my physician and for the next 2 or 3 nights it did it every night.  Then I went a week with no alert and then it started alerting again so I called the Dr, and he wanted me to come in with my watch and he prescribed me Xarelto blood thinner to prevent having a stroke with Atrial fibrillation.
Discomfort at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: The patient was speaking with the healthcare professional regarding needle sizes for vaccines, she stated that she had discomfort with the flu shot. It was related to patient. It appeared that the healthcare professional was referring to discomfort at the injection site.  The reporter did not attempt to gather additional information as the healthcare professional wanted to opt out on providing additional information, therefore unable to verify what flu vaccine she was referring to. The reporter did not consent to follow-up. Additional Supportive Information: This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023031934:Same reporter US-GSK-US2023AMR032489:Same reporter US-GSK-US2023AMR032491:Same reporter US-GSK-US2023AMR032493:Same reporter US-GSK-US2023AMR032492:Same reporter
red bumps in little clusters, cluster of red dots, can feel them and they are raised up and I do not know if something bite me or if this a side effect,  Petechiae or something like that; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6025), via an unspecified route of administration, administered in Arm Left on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced red bumps in little clusters, cluster of red dots, can feel them and they are raised up and she do not know if something bite me or if this a side effect, petechiae or something like that on an unspecified date. It has been several weeks now. It is on my shoulder in two different places and it is kind of like three or four of them at one location. The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This is a 78-year-old female with past medical history of hypertension, hyperlipidemia, type 2 diabetes mellitus insulin dependent, diabetic nephropathy, chronic kidney disease stage 3, myocardial infarction status post 3 stents,  permanent atrial fibrillation on chronic anticoagulation with Eliquis, history of multiple episodes of epistaxis, COPD/emphysema, history of CVA with residual deficit in the vision,  hypothyroidism, peripheral neuropathy, history of skin cancer status post excision, chronic sinusitis.    She came to the hospital with a chief complaint of an episode of syncope this morning.  Patient was here in the emergency room last night for epistaxis.  Patient underwent nasal  8/7/2021 tested positive  This is a 78-year-old female with past medical history of hypertension, hyperlipidemia, type 2 diabetes mellitus insulin dependent, diabetic nephropathy, chronic kidney disease stage 3, myocardial infarction status post 3 stents,  permanent atrial fibrillation on chronic anticoagulation with Eliquis, history of multiple episodes of epistaxis, COPD/emphysema, history of CVA with residual deficit in the vision,  hypothyroidism, peripheral neuropathy, history of skin cancer status post excision, chronic sinusitis.     She came to the hospital with a chief complaint of an episode of syncope this morning.  Patient was here in the emergency room last night for epistaxis.  Patient underwent nasal packing in the emergency room.  She has previous similar episodes of epistaxis.  Eliquis was advised to be held.   Patient was supposed to see her cardiologist Dr. for decision regarding resuming Eliquis.  This morning the patient woke up but she could not really sleep all night due to discomfort in the nasal cavity from the packing.  She felt that the packing was too tight.  She had some difficulty breathing due to tight packing in the nasal cavity.  The patient denied any fevers but did have some chills.  Denies any cough.  Currently the epistaxis is resolved.  Nasal packing is removed.  The patient denies any chest pain, shortness of breath, palpitations, abdominal pain, burning or painful urination, diarrhea.   She did have some nausea but denies any episodes of vomiting.    After the patient got up from the bed this morning she went to the bathroom but she collapsed on the floor, she hit her head, then she suddenly found herself in the bathroom but does not remember how she went there, the episode was unwitnessed.  She came to the hospital and had low blood pressure.   Nasal packing was removed.
This spontaneous report was received from a licensed practical nurse and refers to a 16 month old patient of unknown gender. No information about patient's pertinent medical history, concomitant medications and the drug reactions or allergies were reported. On 28-JAN-2016, the patient was vaccinated with VARIVAX (Merck) injection (lot# L019127, expiration date 27-MAY-2017, dose and route of administration were not reported) in the right thigh. On the same day, the patient was also vaccinated with unspecified "Hib" vaccine (lot#, expiration date. dose, anatomical location and route of administration were not reported) and DTAP vaccine (lot#. expiration date, dose, anatomical location and route of administration were not reported) in another body area. On an unknown date in 2016 (reported as a couple of days later), the patient began to develop dots on the legs. On 09-FEB-2016, the patient was examined and had a macupapular rash, size 2 to 8 mm, over face, torso, arms, legs and peri-area. The patient's injection site for the VARIVAX (Merck) appeared to be developing a secondary infection. The treatment was given and included amoxicillin for a treatment of the VARIVAX (Merck) injection site injection site infection. During the visit, the patient was playful, happy, afebrile, with a good appetite  and energetic. No lab diagnostic studies were performed. The outcome of the events was unknown. The patient sought medical attention and was examined by a nurse practitioner. The reporter considered the event of a maculopapular rash, size 2 to 8 mm, over face, torso, arms, legs and peri-area to be related to VARIVAX (Merck), however the relatedness between this event and other suspect vaccines hib (manufacturer unknown) and DTAP. The relatedness between the events of dots on the legs, a secondary infection, injection site infection and the vaccination with VARIVAX (Merck), hib (manufacturer unknown) and DTAPT was not reported. Additional information has been requested.
Vial was expired, past 10 weeks in the fridge.  Called patient to advise re-vaccination.  Patient was not interested in that.
ErythemaMultiform, UrticariaPruritus, redden area at site of injection with heat and itching occurred  one wekk after injection and has lasted one week. resolving now Narrative: