chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy student refers to a currently 33 years old female patient. The patient was vaccinated with a dose of MMR-II (lot #, dose an route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient broke out in hives following vaccination with a dose of MMR-II in early childhood. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for broke out in hives was unknown for MMR-II. Additional information is not expected.
temperature excursion with no adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA290846.  This case involves a patient (unknown age and gender) who reported temperature excursion with no adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and HIB (PRP/T) VACCINE [ActHIB].    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 HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE llot C5873AA; Expiration: 30-Jun-2023 ), ODIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7249AB; Expiration: 11-Mar-2024 ), DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ613AA; Expiration: 25Feb2023 ), DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE , DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT l(strength, dose, formulation, route, lot number: not reported) all for immunization.  On an unknown date the patient reported temperature excursion with no adverse event (product storage error) (unknown latency) following the administration of HIB (PRP/T) VACCINE, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE,  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event temperature excursion with no adverse event.   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 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.
PT VACCINATED USING JANSSEN 4/8/21 (LOT 201A21A). S/O BEGAN 9/1/21, TESTED + 9/6/21
Fell down; Hurt knee; Hurt knee and hand; Any injury on body due to falling down etc takes more time to heal compared to how it used to be earlier / fell down and hurt knee and hand and it took almost 2-3 months to recover; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date unknown (Batch/Lot number: UNKNOWN) at the age of 41 years as dose 1, single for COVID-19 immunisation and also received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date unknown (Batch/Lot number: UNKNOWN) at the age of 41 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Brufen, reaction: "Drug allergy", notes: Known allergies: Brufen. The following information was reported: FALL (non-serious), JOINT INJURY (non-serious), LIMB INJURY (non-serious), IMPAIRED HEALING (non-serious), all with onset 07Aug2021, outcome "recovered with sequelae" (an unknown date in 2021), described as "any injury on body due to falling down etc., takes more time to heal compared to how it used to be earlier / fell down and hurt knee and hand and it took almost 2-3 months to recover". Therapeutic measures were not taken as a result of fall, joint injury, limb injury and impaired healing.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient reported that the same injury would have taken a week to recover before the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
all tested positive for Covid last week.  No hospitalizations resulted.; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: COVID-19 (medically significant) with onset 30May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 30May2022, outcome "unknown", described as "all tested positive for Covid last week.  No hospitalizations resulted.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: The first positive case was on 30May2022 for the oldest son.  Clinical course: Reporter reported that, his wife and all three of the children who were all fully vaccinated with Pfizer Covid vaccine all tested positive for Covid last week. No hospitalizations resulted. His wife was 46 years old and has had other medical issues. She was prescribed Paxlovid and reports a foul taste in her mouth after starting the initial does on 02Jun2022. The children are 11, 8 and 7 years old and had only received the initial two doses. The first positive case was on 30May2022 for the oldest son. The 8 year old tested positive on 01Jun2022. His wife tested positive on 01Jun. The seven year old tested positive on 04Jun  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SWEATS; SWOLLEN EYES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 44 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and hospitalisation, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sweats. On 06-APR-2021, the subject experienced swollen eyes. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats on 08-APR-2021, swollen eyes, and fatigue on 07-APR-2021, and headache on 10-APR-2021. This report was non-serious.; Sender's Comments: V0-Medical assessment comment is not required, as per standard operating procedures, as case was assessed as non-serious.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling and warm at the injection site on an unspecified date. Pharmacist applied ice pack at the injection site. The outcome of both events was recovered. No follow-up attempts are possible. No further information is expected.
No adverse RXN.  Syringe defect.Upon injection it was noted that all vaccine came out of the syringe at a fracture site and was not injected in the patient. It was visible on the patient's skin.  On syringe inspection by the medical lead and the lead pharmacist at the site, the syringe was noted to have a small fracture in the base resulting in fluid being expelled but not via the needle.  The patient was injected with a new syringe after inspection. Bare Hypodermic Syringe DPS 1ml Lot 20201206 2020-12-23, Expiration  2025-12-22, Version Bare Syringe
w/in approx 1 min of getting inject, pt said "that hurt" then "mom" & fainted away; came to w/in seconds & was pale & diaphoretic w/yellowish coloring; was crying; saying "I can't breathe";
Varicella site 5/29 immediately after injection site got swollen, hard & red.  Gave BENADRYL.  Then got white around site (per mom).  5/24 redness spreading.  5/25 redness.  5/26 a red raised & "fired red" had knot.  10x8 cm swollen area.  Seen in ER.  Given KEFLEX.  5/27 seen in clinic swelling decreased.  MMR & VAR site after injection swollen & red.  Seen in ER for varicella site reaction.
Employee reports that she got itchy eyes, green drainage and it felt like something was in her throat several hours after receiving injection. She stated that she thought her throat was closing up on her. Lasted 2-3 hours. Pt still has hoarse voice today, but not the throat closing feeling. She did not seek medical attention.
pt recvd vax & noticed numbness in rt arm & hand; Saturday  noticed numbness in the rt leg & foot; seen by MD & ordered anti-inflammatory & checked the pt out neurologically & did not find any changes;
Blurred vision; Swollen lymph node in armpit; Headache; Rash on arm; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ew0185) via an unspecified route of administration on 30Jun2021 as a single dose for COVID-19 immunisation. Medical history,  concomitant medications and past drug history were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in 2021, the patient experienced swollen lymph node in armpit, headache, blurred vision and rash on arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node in armpit, headache, blurred vision and rash on arm was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
On the day following the immunization, patient developed a non-itching rash wrapped around her upper trunk.  Patient stated it was slightly tender on her back if she laid on it, but otherwise very mild, and disappeared completely after two days.  She did not treat it with any oral or topical medications.
This is a serious literature case, initially received on 01-Oct-2018 and concerns an 82-year-old, elderly, male patient. On an unspecified date (reported as 2 weeks prior), the patient was administered Influenza Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture name: not reported). On an unspecified date (reported as one week prior), after the vaccination (reported as following influenza vaccination), the patient developed pruritic and burning rash. Dermatological examination revealed an erythematous maculopapular rash involving the neck, chest and bilateral upper extremities. Histological examination of punch biopsies from the medial and lateral left shoulder revealed a neutrophilic infiltrate involving the vessels of the superficial vascular plexus, extravasation of erythrocytes into the surrounding dermis, and extensive nuclear debris. The endothelial cells within the affected vessels appeared enlarged and damaged. Subsequently, the patient was diagnosed with leucocytoclastic vasculitis. At the time of this report, the outcome of the events was not reported. The development of various types of vasculitides occurring in timely association with influenza vaccination had been rarely reported.
I had very mild pain in arm at injection site. On the 8th day after the shot, however, I hard a hard, red swollen area at the injection site, a small but hard swollen lump at the base of my neck and left arm, pains and aches throughout my body (especially lower abdomen, sides, and lower back,  a fever of 100  degrees that night which went away the next day, fatigue, and light nausea. It has been a little over 24 hrs now and all but the fever continue. This was unexpected as these side effects were all delayed rather than occurring immediately after the shot. There is a small likelihood this is all something else but it's doubtful.
arm was itching below the injection site - left arm; rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across; red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site), VACCINATION SITE PRURITUS (arm was itching below the injection site - left arm) and VACCINATION SITE RASH (rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across) in a 79-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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site) and VACCINATION SITE RASH (rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm was itching below the injection site - left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash - area has grown to 6 inches across the bottom of the arm past the top of the injection site), VACCINATION SITE PRURITUS (arm was itching below the injection site - left arm) and VACCINATION SITE RASH (rash where the shot was administered - left arm - It's about 6 inches long, 5 inched across) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.
DOSE WAS GIVE AFTER THE BEYOND USE DATE OF 02/02/2023. PATIENT HAS NOT REPORTED ANY ADVERSE EVENTS OR REACTIONS.
Pt experienced redness and swelling in area of administration. on 5/2/00, the pt went to the ER with a fever, more redness and swelling on arm. Pt prescribed Benadryl. On 5/3/00 after rising, pt experienced sweats, chills, fainting, sick to stomach, arm red, swollen for a week. Arm still has some discoloring.
First two days just had a lot of joint pain and generally achey. Also had some tingling in my hands and feet that later went away. 4 days later, very tired, foggy brain, and having a lot of palpitations and skipped beats on and off durring the day and into the evening. Higher blood pressure and heart rate along with these episodes.
01/22/21; Moderna Dose 1: Injection Left Arm: Approximately 7 days later first sign of reaction, left arm swollen from injection site to elbow and spreading, temperature in arm 102 degrees (patient temp normal); on 01/30/21 contacted medical source and provided pictures; began Benadryl for several days till subsided and temp receded in arm. 6 months later there remains a discoloration at the injection site, which is more visible after a hot shower. Documented complaint.  Patient had Covid @ 04/15/21  08/08/21: Moderna Dose 2: Injection Right Arm: on 08/09/21 lasting through 08/11/21 severe dizziness, nausea, headache, brain fog and vertigo to the point where left work and was bed ridden for two days. Drank fluids, aspirin and rested.
Patient have very tender, painful, swelling and redness to the area. It was spreading down her arm. It started small, was the size of a donut after 24 hours. After 48 hours it had spread down to her elbow. Provider diagnosed it as a staph infection. She was give a 7 day course of Augmentin 875 mg + cetirizine + diphenhydramine. The area of redness and pain seems to be going down with the antibiotic.
diagnosis of polymyalgia rheumatica; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (diagnosis of polymyalgia rheumatica) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event. Previously administered products included for an unreported indication: NABUMETONE since an unknown date. Concomitant products included NABUMETONE for Fibromyalgia.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (unknown route) 2 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (diagnosis of polymyalgia rheumatica) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (diagnosis of polymyalgia rheumatica) outcome was unknown. Not Provided          It was reported that concomitant drugs were not provided because they have been taking it for many years and it does not have to do with what Moderna vaccine did to them..  Treatment medication included Nabunetone for fibromyalgia and to treat also this diagnose. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-072076 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of polymyalgia rheumatica, a causal relationship cannot be excluded. Underlying condition may have been contributory.
Information has been received from a physician concerning a 14 year old female pt who on 9/7/00 was vaccinated with a 3rd dose of Hep-B vaccine recombinant (yeast). On 9/10/00, the pt presented with "right lower extremity paralysis and loss of bladder control (acute disseminated encephalomyelitis versus transverse myelitis)" and was hospitalized. Additional information has been requested. A 15-day follow up report received 12/28/2000 adds: (In the hospital, on 09/30/2000) an MRI was performed and results were not reported. Follow up info from a physician stated that the pt was seen on 11/03/2000 with significant improvement in her leg symptoms. Follow up info from a nurse indicated that the pt was having "problems" with her leg (did not recall which leg) prior to vaccination with hepatitis B vaccine recombinant (yeast) on 09/07/2000. She reported that prior to the vaccination, the pt complained of recurring "bumps" or lesions on the leg, which would scab over. The nurse also thought this was associated with some discomfort in the leg. The nurse also stated that she did not believe that pt's current adverse experiences were in any related to her vaccination with the hepatitis B vaccine recombinant (yeast). Additional info has been requested. Information has been received from a physician concerning a 14 year old female patient with an allergy to bee stings who on Sept 07, 2000 was vaccinated with a third dose of hepatitis B vaccine recombinant in the right arm (lot #636030/0429K). The patient had no known illness at the time of vaccination. On Sept 30, 2000, the patient presented with "right lower extremity parlysis and loss of bladder control (acute disseminated encephalomyelitis vs transverse myelitis)" and was hospitalized. An MRI was performed and results were not reported. Follow up information from a physician stated that the patient was seen on Nov 3, 2000 with significant improvement in her leg symptoms. Follow up information from a nurse indicated that the patient was having problems with her leg (did not recall which leg) prioir to vaccination with hepatitis B vaccine recombinant (yeast) on Sept 7, 2000, she reported that prioir to the vaccination, the patient complained of reurring bumps or lesions on the leg, which would scab over, the nurse also thought this was associated with some discomfort in the leg. The nurse also stated that she did not believe that patient's current adverse experiences were in any way related to her vaccination with the hepatitis B vaccine recombinant. Follow up information from a physician indicated that the patient had temporary, bilateral leg paralysis that was felt to be secondary to inflammatory myelitis. No additional information was provided.
On 06/22 after the 2nd dose I had panic attacks symptoms. I would wake up with panic attacks and sleep with panic attacks. My heart was racing. I couldn't focus at all. I was lack of memory. At work I get distracted easily. I had 5 panic attacks each of them lasted for weeks. 2 months later while I was driving the panic attack happened again. I called my doctor he said to track it. After 30 days later I went to a cardiologist after speaking to my doctor. The Cardiologist diagnosed me with Hyper Tachycardia. They did MRI and everything came back as normal. I am a healthy person. I ran marathons, now I can't even run or do the things I used to do regularly. I get tired easily. My hand shakes when I get panic attacks. The second Cardiologist I went to did EKG, and had me on a heart monitor for 24 hours. The result came out good. My doctor said they are keeping an eye on me to see why I kept getting panic attacks out of nowhere.
Severe pain followed by loss of function in left shoulder.  Treated with anti-inflammatory meds then physical therapy and ten steroid injection.
Child developed hives on right arm immediately after leaving office.  She returned the next day with hives all over.  No wheezing or mucous membrane swelling.