chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old.  Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported.  The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering.  Information on the lot number has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-NOV-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K007797 and expiry date: 29-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
MOTHER REPORTS NOTING 1 LARGE RAISED WELT ON CHILD'S LEG AFTER HER BATH, AROUND 7:30 PM.  THE FOLLOWING MORNING, SHE NOTED 4 WELTS, AND BY AROUND 3:30 PM, AFTER HER NAP ON 10/17/12, THE CHILD WAS REPORTEDLY "COVERED WITH HIVES. THERE WERE 17 ON HER LEGS, AND SEVERAL MORE ON HER ARMS AND TORSO."  CHILD WAS GIVEN 3/4 TSP DIPHENHYDRAMINE AT THAT TIME, WHICH WAS SUCCESSFUL IN ELIMINATING THE WELTS.  NO FURTHER MEDICATION WAS NEEDED.
SINUS INFECTION; AFFECTED BY BAROMETRIC PRESSURE AND EXPERIENCED JOINT PAIN/THROBBING WHEN A STORM COMES THROUGH; TIRED; FELT FATIGUED; This spontaneous report received from a patient and concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number: 1140349 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis; and methotrexate ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included leflunomide. On an unspecified date, the patient experienced sinus infection, affected by barometric pressure and experienced joint pain/throbbing when a storm comes through, tired, and felt fatigued. The action taken with covid-19 vaccine was not applicable. The patient recovered from sinus infection, and tired, and had not recovered from affected by barometric pressure and experienced joint pain/throbbing when a storm comes through, and felt fatigued. This report was non-serious.
I started experiencing mild symptoms on 12/17/2022 I had some coughing and chest congestion for about 2 days I tested positive on 12/19/2022 on 12/20/2022 I tested positive for COVID-19 and contacted the nurse from urgent care. I was not prescribed PAXLOVID since my symptoms were relatively mild. I started feeling better on 12/23/2022.
On 12/30/99, the pt received his first IM-left deltoid dose of Lymerix. A few hours later on 12/30/99, the pt experienced injection site soreness and a tingling prickly sensation on his whole body. An MD visit was required and anti-inflammatories were prescribed. The symptoms lasted a few days and then subsided. However they reoccurred and persist.  The most information received on 1/5/00 report the condition of the pt is ongoing.
product was administered to patient post excursion, with no reported adverse event; product storage error temperature too low, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an adult patient (gender: unknown) to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (strength: unknown, lot number: UT7683NA; UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient stated she was having itching on her ankles and face that started about 15mins after the injection. She was given a dose of oral Benadryl 25mg and monitored for another 20 minutes. Patient stated the itching had not gotten any worse and denied any other symptoms.
got the first Moderna COVID-19 shot in in Mar2021/did not get the second shot; whole body sore; She got the first Moderna COVID-19 shot and got so terribly sick; felt like I had COVID again; chills; fever; headache; Arm super super achy; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first Moderna COVID-19 shot in in Mar2021/did not get the second shot), PAIN (whole body sore), ILLNESS (She got the first Moderna COVID-19 shot and got so terribly sick), FEELING ABNORMAL (felt like I had COVID again) and CHILLS (chills) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included ENALAPRIL for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (whole body sore), ILLNESS (She got the first Moderna COVID-19 shot and got so terribly sick), FEELING ABNORMAL (felt like I had COVID again), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE PAIN (Arm super super achy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first Moderna COVID-19 shot in in Mar2021/did not get the second shot). In March 2021, PAIN (whole body sore), ILLNESS (She got the first Moderna COVID-19 shot and got so terribly sick), FEELING ABNORMAL (felt like I had COVID again), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE PAIN (Arm super super achy) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first Moderna COVID-19 shot in in Mar2021/did not get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that for the adverse events patient took Tylenol or Advil, she does not remember which as treatment. The symptoms resolved after 24 hours.
plaintiff alleges that recv vax 25FEB88 & subsequently was caused to suffer severe, permanent injuries to body;
The inflammation reactivate the PMR virus that I had cured a couple years ago.  PMR is poly myalgia rheumatica
Left anterior thigh with slight swelling, significant erythema, & slightly warmer to touch.
Patient presented back to office after going to get ice cream with hives around her eyes.  Benadryl given and hives started to resolve within 15 minutes.  Patient continued to eat ice cream comfortably in exam room.  Hives resolved within 30 minutes and patient left the office.  Mom thinks brother had reaction to combination DTAP when he was little.
SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA HYPOXIA 2/25/2022 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Merck) PROQUAD (route, dose and lot # not reported). The temperature excursion for the (Merck) PROQUAD was unsupported with in house stability data. No adverse symptoms were reported. Additional information has been requested.
Chest very uncomfortable and can't sleep at night. Blood pressure 55-120, normally over 60. Head felt heavy and uncomfortable. According to the patient, she suspected the pressure was too low for the lower-side.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On an unknown date in approximately 2012 (reported as about 4 to 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot number and expiration date were not provided). On 24-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
My 16 month old son experienced a "nephrotic episode" after receiving his first rabies and JE shots in a series.  Extremely high ESR (140+), extremely low IGG (159), proteinimia, and low alburemn. Follow up 11/11/2003: "Adverse Event onset date/time missing, Nothing checked in box 8: Unknown the family was going to provide the information."
Mom  is one of SO FAR 10 FULLY VAXX people with COVID at her senior facility over the past few weeks. (Last report was 5 days ago..probably many more now...) She and one other..SO FAR have been hospitalized. She is on day 8 of hospitalization.   Prior to VAXX ZERO cases of COVID...Since...these 10 the last few weeks.....but right after vaccine....5 got Covid...2 died. I sure hope they were reported. I thought I better report all of this. I am not sure which vaccine they all got. kI asked the nurse on the Covid floor of the hospital..she said ONLY one has the variant.
however her wife got Covid; however her wife got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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), outcome "unknown" and all described as "however her wife got Covid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed a red, circular rash (diameter of ~2.5 inches) at site of injection. The is slightly raised, warm, and itches occasionally. Patient denies any systemic adverse events and denies any pain at the site.
Patient's spit up contained blood.  This occurred once, on the day following the vaccinations.  No treatment was pursued.
Arm was numb and soreness. Hives around the injection and also on her left arm, thighs, side and chest.
PATIENT BEGAN HAVING ABDOMINAL PAIN THEN  NAUSEA AND VOMITING ON 10.11.2022. ON 10.12.2022 IT PROGRESSED TO HER RIGHT LOWER QUADRANT. PATIENT DEVELOPED APPENDICITIS. APPENDECTOMY SCHEDULED FOR 10.13.2022.
One week after receiving my first dose, my arm became red, swollen and itchy a few inches below where I had received the injection.  The redness spread over most of my bicep within 24 hours.  It cleared within about 5 days or so.
This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine Pfizer, lot ER8737), via an unspecified route of administration in the left arm on 02Apr2021 14:15 as SINGLE DOSE for Covid-19 immunization. Medical history included sinus infection and ongoing sulfa allergy. He found out about this allergy probably 25 years ago. He was taking a big white tablet for a sinus infection. Says that he was hospitalized for his reaction; doctor told him he almost died. He was also out of work for 2 months after hospitalization. Caller stated he ended up in the hospital with a spiked fever, vomiting, got sweaty and large purple spots  and lost weight and was in the hospital for two weeks due to the sulfa reaction. There were no concomitant medications. On 03Apr2021, he felt extremely tired, like he had been drugged and washed out. He just felt awful on 04Apr2021. He got so sick and was not doing very well on 05Apr2021. On 08Apr2021, he had diarrhea and stated it was like dysentery, just water. He drank 2 bottles of Electrolyte replacements he got from a pharmacy and he was weak as a kitten. He had chills, vomiting, shaking, he could not stand or lift his head on 10Apr2021. The patient underwent procedure which included biopsy liver: unknown result on unspecified date. Therapeutic measures were taken as a result of got so sick/ not doing very well, chills ,vomiting, he could not stand or lift his head, he could not stand or lift his head. The outcome of events fatigue was recovered on 03Apr2021; for malaise was recovered on 05Apr2021; for chills, vomiting, tremor, dysstasia, head discomfort was recovered on 11Apr2021; for diarrhea was recovering; for asthenia was recovered on unspecified date; for other events was unknown.  Information on the batch number was already obtained.
Information has been received from a health professional concerning a female over the age of 65 who in 2004 (date not reported) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  Subsequently the patient developed an injection site reaction, including hot, swollen, painful area at injection site. the patient sought unspecified medical attention and was treated with acetaminophen (Tylenol) and fexofenadine hydrochloride (Allegra). It was also reported that 2 other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P) (WAES0411USA02570, WAES0411USA03858). There was no product quality complaint involved. Additional information has been requested.
Temp 102 on Saturday, reduced with ice packs and 650mg tab Tylenol to 101.3 on Sunday. Fever broke through night Sunday using ice packs  w slight 99 on Monday. Severe headache and joint pain Saturday morning- took 600 mg advil no affect, took 400mg advil Saturday afternoon, 2 rounds of 400mg advil Sunday. By late afternoon Sunday joint pain subsided. Monday feel sore and very stiff with mild  headache. Also experienced skin sensitivity Saturday morning. Hurt to touch my skin. Had difficulty with moving clothes across my legs. Monday general fatigue.  Throughout weekend took in water and B complex drink supplement to maintain hydration. Staggered advil and tylenol by 4 hours.
Around 12 hrs after injection, on set of mild fever, chills, fatigue, and body aches similar to second dose.  However, also developed increased resting heart rate up to 110bpm.  Heart rate consistently remained over 90bpm for several hours throughout the first night.
Rt leg circular erythema 4x7cm in diameter. Tx given Atarax.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff) via phone. This case involves 18 months old male patient who was vaccinated with a 0.5 ml dose of ACT-HIB (Expiration date: 19-Nov-2018, lot UI821AAA via intramuscular route in the right thigh) on 26-Nov-2018. The patient's medical history and concomitant medications were not reported. Concomitant medications included DTAP VACCINE for Immunisation; and INFANRIX for Immunisation. It was an actual medication error due to expired vaccine used. Caller reports an expired dose of ACT-HIB was given to a patient. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 30-Nov-2018 from a consumer (Office Staff) via phone. Patient details, concomitant medication and vaccination details updated. List of documents held by sender: none.
Metallic taste in mouth that lasted approximately 3 hours; increased salivation after metallic taste began that went away after the metallic taste also went away.
Client arrived at vaccination site. Client received hers first COVID vaccine (Pfizer on 01/05/22 lot: FL3209 exp: unknown). Per Client, "2 days after my first dose I started noticing that I developed some rashes on my neck, both arms and my inner thighs down to my knees. I still have a little bit on my inner thighs, but the rest are gone." Client reported that she did not use any new products on her skin before or after her first dose and that she did not report this rash to her Primary Care Physician. Client requested to receive her second Pfizer COVID vaccine. Client reported that she has no chronic medical conditions, she is currently not taking any medications and has no known allergies. RN, submitted a medical consult via text to Vaccine Operations and approval via text from Dr. was obtained for client to receive second the Pfizer COVID vaccine. RN educated client on ER precautions and when to follow up with her Primary Care Physician and recommended for client to see her Physician about her rash. Client verbalized understanding. Client received her second Pfizer COVID vaccine lot: FK9896 exp: 06/30/22. Client completed 30 minutes observation with no adverse reactions and left facility at 11:15 AM.
This case was reported by a other health professional via sales rep and described the occurrence of general body pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, chills and nausea. On an unknown date, the outcome of the general body pain, chills and nausea were unknown. It was unknown if the reporter considered the general body pain, chills and nausea to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The medical assistant reported that, after receiving a dose of SHINGRIX the patient experienced nausea, chills and body aches. The caller did not have any additional information.
no adverse effects reported; patient was indavertently adminsitered a dose of Pneumovax 23 which had expired on 7/31/2020; This spontaneous report was received from a pharmacy technician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  On 25-NOV-2020, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength and route of administration were not provided, frequency and lot number were unknown; expiration date was reported as 31-JUL-2020) (expired product administered). No adverse effects were reported. The outcome of expired product administered was unknown.
Patient presented to the ED and was subsequently hospitalized for right sided weakness and dysarthria within 6 weeks of receiving COVID vaccination.