chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a touch of Pneumonia; still trying to get the second shot, and it's been 8 weeks and 3 days; still trying to get the second shot, and it's been 8 weeks and 3 days; This is a spontaneous report from a non-contactable consumer (patient's daughter) via Medical Information team. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Mar2021 at the age of 87 years old (Batch/Lot number was not reported) as the 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a touch of pneumonia, used inhalers, and cleared up. The patient was hospitalized for the event "a touch of pneumonia" on an unspecified date. The reporter stated that they were still trying to get the second shot, and it's been 8 weeks and 3 days. The reporter was asking if there would be worse side effects after getting 3 doses, if they did get the second dose as a first dose. The reporter was referred to their doctor or health care provider for further guidance, since they were the most familiar with their medical condition. The patient recovered from the event "a touch of pneumonia" on an unspecified date in 2021. The reporter stated that the pneumonia did not have anything to do with the shot she got, but it was after the first dose of the Pfizer vaccine.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of pneumonia.  The reported event likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
THE PATIENT IS STATING THAT HE HAS A LOT OF SORENESS AT THE INJECTION SITE. FROM DATE OF ADMINSTRATION TO 09-25-2015. THE PATIENT IS SAYING THAT HE CAN NOT LIFT HIS ARM.
Patient has had soreness in the arm that shot was administered since that day. Soreness radiates through upper & lower arm; sometimes numbness.
BLOOD CLOT; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had blood clot and died.The cause of death is blood clot. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210627090.; Sender's Comments: V0: 20210627096-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
developed a rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient developed a rash after the 1st dose of Shingrix. The reporter did not consent to follow up. The Pharmacist stated she was not providing PHI and gave no additional information. Collected via chat. PFC declined.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Swollen legs within 2 hours after recovering vaccine that have persisted for past 3 days. I am 31 weeks pregnant. No prior history of swollen legs. While pregnancy can lead to swollen legs/feet, the timing and abrupt onset of leg swelling leads me to believe the vaccine somehow triggered it.
This spontaneous report was received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On unspecified dates the multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (lot # K015994 and expiry date 23-SEP-2016) (lot # L000455 and expiry date 06-JAN-2017) (lot # L004654 and expiry date 11-FEB-2017) (lot # M000760 and expiry date 06-JAN-2018) (lot # M000762 and expiry date 06-JAN-2018) (lot # M006731 and expiry date 09-FEB-2018) (lot # M010482 and expiry date 01-MAR-2018) (lot # M014908 and expiry date 25-MAR-2018) (lot # M017290 and expiry date 07-APR-2018) (lot # M019643 and expiry date 20-APR-2018) (dosing regimen and frequency were not reported for all the lots). No concomitant medications were reported. The vaccine was exposed to temperature of 32 Fahrenheit for 165 hours. Previous temperature excursions reported as on 04-AUG-2016, the vaccine was exposed to temperature of 7.8 Fahrenheit for 1 day and on 08-AUG-2016, the vaccine was exposed to 6.6 Fahrenheit for 1 hour and 48 hours. No adverse effects were reported. No product quality complaint (PQC) was reported. No additional information was provided. Additional information has been requested.
I had my PPPSV23 vaccine injection on July 13,2021 at apprx. 18:05 hrs. in my right arm. Vaccine was administered at Pharmacy The injection itself was uneventful and almost pain free. At around 20:00 hrs I began to have acute pain in my shoulder down along the area of the bicep, down medial aspect of upper arm to the elbow. Also, pain spreading toward scapula.  I started to ice and take Tylenol 2 every 4 hrs. Pain continued with limited ROM, unable to abduct, flex or extend arm without great pain. Unable to get much sleep due to discomfort of arm. Missed 2 days of work. I work in the Operating room.  Made appointment to see my PCP. Upon seeing them they felt that the injection site was to high in my arm. Believing that my shoulder bursa may have gotten the injection. Recommendation continue ice, 2 Tylenol every 4 hrs., and 2 Aleve every 12 hrs until pain subsides and ROM improves. Steroids could be taken in the future if needed.  Have not  returned to work due to my scheduled vacation. Continue to have limited ROM, discomfort, continue with Aleve and ice. Unsure of return to work date after vacation job requires ability to lift 25 lb trays of instruments and other upper body strengh.
Fever, chills, body aches, tiredness, loss of taste, headache, redness and tenderness at site of injection approximately 3x1.5 inches oval shaped, some slight numbness in whole arm  Redness, tenderness, numbness began within a few hours of injection.  Flu-like symptoms began at about 30 hours post injection and continued for at least 10 hours at which point I slept.  All gone like magic the next morning, except for the redness and tenderness at the injection site, which continues as of this report, but is much less.  No treatment except rest and fluids.  I submit this report to help with your statistical analysis.
Sleepy; Pain started in both hips and bottom of tail bone.; Pain started in both hips and bottom of tail bone.; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program COVAX US support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 02Mar2021 as dose 2, single for covid-19 immunisation. Medical history included arthritis, intervertebral disc degeneration from an unknown date and unknown if ongoing. The patient's concomitant medication include NAPROXEN from unknown date to unknown if onoing for an unspecified indication. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unknown date the patient had experienced after vaccine she felt sleepy and pain in both hips and bottom of tail bone. The patient reported Clarified has had them way before 1st dose of vaccine. HCP prescribed Naproxen. The patient was wondering if vaccine made her condition worse and what can she do to minimize effects she had. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arthritis pain, Join pain, Bone pain; Arthritis pain, Join pain, Bone pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BONE PAIN (Arthritis pain, Join pain, Bone pain) and ARTHRALGIA (Arthritis pain, Join pain, Bone pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (doxazosin doxacosin, lisinopril, statin, and ace inhibitors.), Egg allergy and Dairy intolerance. Concomitant products included ACEBUTOLOL HYDROCHLORIDE (SECTRAL), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), LOSARTAN, CELECOXIB (CELEXA [CELECOXIB]) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced BONE PAIN (Arthritis pain, Join pain, Bone pain) and ARTHRALGIA (Arthritis pain, Join pain, Bone pain). The patient was treated with SULINDAC ongoing from 26-Feb-2021 for Arthritis, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SULINDAC on 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, BONE PAIN (Arthritis pain, Join pain, Bone pain) and ARTHRALGIA (Arthritis pain, Join pain, Bone pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
4/4/21 at 11:30 pm the patient started to make snoring-like sounds in her sleep and could not be woken up.  911 was called and in the hospital a CT scan identified extensive large right-sided intraparenchymal hemorrhage within the frontal, parietal and temporal regions, extending into the ventricular system.  The patient was put on the ventilator and administered blood pressure medication. A-line was inserted to read blood pressure. 4/11/21 at 8:11 pm the patient passed away due to cardiac arrest
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received ENGERIX B adult. Previously administered products included ENGERIX B (Dose 1 (more than 3 months ago)). On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: The pharmacist reports that the patient received her  ENGERIX B dose more than 3 months ago. She is late to receive her second dose. She has not received the second dose yet. The caller did not have any other information about this adverse events.
- 2 emergency room visits 21 and 24 June 21.  Shortness of breath and dizziness. -Auto immune disease -Shortness of breath -Hypo Thyroidism disease -Arthritis
Information has been received from a physician and medical assistant concerning a 22 year old patient who on 29-MAY-2008 was vaccinated IM with a 0.5ml of ZOSTAVAX (Merck) instead of with VARIVAX (Merck). It was reported that the patient was snot experiencing any known symptoms at the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Pt came in next day to show us her (L) deltoid was red and warm to touch and swollen.
Information has been received from a physician concerning a 5 year old female who on 06/13/2000 was vaccianted with a dose of varicella virus vaccine live. The physisican reported that on 01/15/05 the pt developed  a mild case of breakthrough characterized by less than 25 lesions. The pt also noted to have a mild fever that lasted for about 1 and 1/2 days. Unspecified medical attention was sought. But no treatment was required. Subsequently the pt fully recovered from the mild case of breakthrough. Additonal information has been requested.
Due to illegible year of birth and miscommunication from mother/guardian at time of vaccination documentation it was thought that the patient was only three years old. Thought the year of birth was 2011 when it actually was 2017. Vaccine was given correctly.
Initially started as itching at the injection site. A couple of days later swelling, redness appeared.
Patient developed a large knot about the size of a softball she says and developed a fever lasting 2 days, she notified me about this today.
No adverse effect; was administered a dose of Improperly stored PROQUAD; This spontaneous report was received from medical assistant regarding a a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were unknown.  The patient's concomitant medication included sterile diluent. On 10-OCT-2019, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: digital data logger) (dose, anatomical location were unknown) (lot # S006835 and expiration date: 02-SEP-2020) via route intramuscular for prophylaxis (product storage error). It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion of 15 degree Fahrenheit (°F) to 46°F (20.7°F) for 2 hours 8 minutes, as recorded by digital data logger. The vaccine had a previous temperature excursion of 6°F to 14°F (13.8°F) for 32 minutes.
Pt reported extremely cold feet app 10 minutes after vaccine administration. Vital signs were taken, initial BP 186/87, P 65, PO2 100%. Pt said BP was extremely high for her. F/U BP = 194/84. Pt was subsequently assessed by MD, who knew pt as a PCP. Reported elevated BPs for pt in past, but not that high. Next BP 202/97. Pt then went to the bathroom, took a walk outside. Came back, manual BP 160/89, coldness in feet resolved. Pt was started on amlodipine 2.5 mg PO daily, to f/u with PCP in 2 weeks.
2-3 days after vaccine nausea, sweats, lethargic, no appetite. Got worse over the next 7 days. Unable to complete climb planned. Back to normal after 2 wks.
tested positive for COVID; tested positive for COVID; fever of 102.3 F; body aches; congestion; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FH8020) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 039B21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Apr2021, when the patient was 43 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022 01:30, outcome "recovering" and all described as "tested positive for COVID"; PYREXIA (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "fever of 102.3 F"; PAIN (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 21Jan2022 01:30, outcome "recovering", described as "congestion"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 21Jan2022 01:30, outcome "recovering" and all described as "Dose 1: Moderna, Dose 2: Moderna". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, pyrexia, pain, nasal congestion, off label use, interchange of vaccine products.  Clinical information: The patient did not take other vaccine in four weeks and did not take other medications in two weeks. The patient did not have COVID prior vaccination and tested COVID positive post vaccination. On Thursday, 20Jan2022 (at approximately 5:24 PM), he tested positive for COVID. In the early morning of Friday, 21Jan2002 (at approximately 1:30 AM), he developed a fever of 102.3 F, body aches, and congestion. At the time that event was being submitted, he no longer have fever and the body aches had improved significantly.
Redness, swelling, warmth, itching, pain, and area hard to the touch at injection site.
w/in minutes p/vax pt devel gen itching followed rapidly by hypotension & bradycardia;responded to DPH plus epi;then was wheezing given albuterol & steroids;
lip swelling/lip swelling is bad on the left side of his lip; tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.; neck swelling; scattered red papules that itch severely on his back and arms; Patient has difficulty swallowing due to his tongue swelling.; facial swelling; cough due to the swelling of his tongue.; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms) and DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson vaccine (primary series). Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On 17-May-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms), DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.), SWELLING FACE (facial swelling) and COUGH (cough due to the swelling of his tongue.). At the time of the report, LIP SWELLING (lip swelling/lip swelling is bad on the left side of his lip), SWOLLEN TONGUE (tongue swelling/. Patient has difficulty swallowing due to his tongue swelling/swelling is constant but varies in severity which is intermitent.), SWELLING (neck swelling), PAPULE (scattered red papules that itch severely on his back and arms), DYSPHAGIA (Patient has difficulty swallowing due to his tongue swelling.), SWELLING FACE (facial swelling) and COUGH (cough due to the swelling of his tongue.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received the Moderna Covid-19 vaccine on 17-May-2022 for his booster dose of Covid-19 vaccine. Patient had experienced several side effects shortly after receiving his Moderna Covid-19 vaccine booster dose. It was reported that patient swelling was constant but varies in severity which was intermittent. No treatment medication was reported.
This initial serious spontaneous case, was received on 25-Sep-2017, from a Pharmacist, concerning a 52-year-old female patient. On 22-Sep-2017, the patient received ALFURIA (batch number: XT32208 (as reported), expiry date: Jun-2018, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid). On 23-Sep-2017, the patient woke up with numbness in the left side of her face, had pain at the site of injection and it was hard. It was reported that, the patient had consulted the doctor and the doctor stated that, the patient had Bell's palsy and the events would recover on its own without any treatment. At the time of this report, the outcome of the event was not recovered. Follow-up received from the reporter on 03-Oct-2017: The patient's current condition, route of administration of suspect product and anatomical location were updated. Narrative amended accordingly. Significant case correction received on 03-Oct-2017: The case was upgraded from non-serious to serious. The Bell's palsy which was current condition was taken as an event. The Narrative was amended accordingly.
L deltoid swollen red and warm to touch site 4" x 2"  moderate pain - T/O. 10/08/09 returned for evaluation. L upper arm swollen hot to touch involving entire upper arm referred her to contact her physicians d/t increased s/s. Instructed to elevate and apply ice.