chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. was given Tdap, IM, in (L) deltoid, presented 12/15/08 with redness, firmness, warm to touch area on (L) deltoid, 4" x 6"in size. C/O pain and burning about 24 hours after immunization - ice  20 minutes on 20 minutes off x 4, recommended.
Approximately one hour after vaccination a hematoma formed just above the elbow. It appears black and blue about 2 inches across. It was originally very puffy but it has decreased in size, but is still inflamed. Color has gone unchanged.
15 month old boy given MEURAVAX II on 11/6/08. About 3 hours after the injection, developed spots, slight welt-like rash on cheeks and evolved coalesced appearing. Over next 4 days rash progressed from face down to trunk extremity. Examined on 11/10/08. Positive generalized erythematous macular  papular rash. No lymphadenopathy, no fever.
This spontaneous report as received from a registered nurse refers to patients of unknown demographics. It was reported that (Oka/Merck) PROQUAD was placed in the refrigerator when it was received at her facility, and she believes that someone placed it in the refrigerator because it was mistaken as M-M-R II. She stated that the cartons of both products look similar, in that the cartons both have blue on them and the name MMRV is on the (Oka/Merck) PROQUAD carton. No patients received any doses of (Oka/Merck) PROQUAD in error, and no patients were involved in this product confusion. Additional information has been requested.
When vaccine injected, patient stated it was "super painful", does not recall ever having this pain with flu shot before.  Pt stated the nurse giving the vaccine commented, "you have really said strong deltoids and hard to get it in". Pt states that pain went away within 20 minutes. That night pt woke up in middle of night could not move left arm initially, after a little while able to lift small amount about 15 degrees only.  By next day, better, but not 100%, so kept watching.  For about a week no real issues.  Starting around 10/22 again having limited ROM and pain at rest. Unable to lift her left arm over her head without increased pain. Stated feels "stuck". Sore all the time, at times has to use right hand to move
Covid symptoms were slight and tested pos; Covid symptoms were slight and tested pos; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, notes: Known allergies: No. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid symptoms were slight and tested pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid symptoms were slight and tested pos; Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 03Jun2022 to 08Jun2022 for Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticarial vasculitis; This is a literature report.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIAL VASCULITIS (medically significant), outcome "recovered", described as "Urticarial vasculitis". The patient underwent the following laboratory tests and procedures: biopsy skin: revealing superficial perivascular inflammation, notes: with rare eosinophils and leukocytoclastic debris, raising suspicion for prior vascular injury; c1 esterase inhibitor test: within normal limits; full blood count: acceptable limits; hepatitis b virus test: negative; hepatitis c virus test: negative; immune complex assay: within normal limits; investigation: within normal limits; within normal limits; within normal limits; within normal limits; laboratory test: showed results; metabolic function test: acceptable limits. Therapeutic measures were taken as a result of urticarial vasculitis.  Clinical course: The patient was treated with oral prednisone 40 mg daily for 5 days,topical triamcinolone ointment, oral fexofenadine, and oral diphenhydramine as needed for itch. She reported progressive improvement with resolution within 2 weeks of treatment initiation.; Sender's Comments: Based on information provided and temporal association, causal relationship between the reported event urticarial vasculitis and the suspect BNT162B2 cannot be 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.,Linked Report(s) : US-PFIZER INC-202200312449 Same article/drug and different patient/event
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Headache-Severe
About 9 hours after receiving the injection, I experienced an abrupt and very intense burning in my left big toe under the toenail. The burning was so intense I jumped off my couch and ran to my bathroom. When I examined my toe, it was red and slightly puffy, and blazing hot to the touch. There was also a noticeable pattern (raised skin) around the cuticle area. My right big toe, by comparison, looked totally normal and was ice cold to the touch. My left big toenail started turning a purple color at first in the lower right hand corner, and now the purple color is about 1/3 of the way up my nail. The lower right corner of the nail is now turning white, and I believe the nail will most likely fall off.
Developed arthralgia leading to sustained joint pain and inflammation which has persisted for 2 years.  Annual follow up on 01/29/04: "Pt has not recovered from adverse events.  Pt continues to have polyarthritis symptoms.  However, rheumatologists are unwilling to say the symptoms are due to the TD injection.
ACTHIB that was given after expiration with no reported adverse event; Initial information received on 02-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old male patient who was given HIB (PRP/T) vaccine [ACT-HIB] after expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13); AND ROTAVIRUS VACCINE LIVE reassort oral 5V (Rotateq).  On 01-Dec-2022, the patient received 0.5 ml total dose of suspect HIB (PRP/T) vaccine with standard strength (lot UJ611AAB and expiry date 30-Nov-2022) (form: unknown)  via intramuscular route in the left thigh for Immunization.  On 01-DEC-2022 the patient was given HIB (PRP/T) vaccine after expiration with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 reported to pharmacy the day after receiving vaccine, (FLUARIX QUAD) 18-19. Stated that she felt lethargic a few hours following admin, then a rash traveling down right arm from admin. site.
Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage; Ear would hurt/strong ear pain for a couple of minutes; Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body; Nauseous/nausea; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), BACK PAIN (Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage), EAR PAIN (Ear would hurt/strong ear pain for a couple of minutes), PAIN (Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body) and NAUSEA (Nauseous/nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced DIZZINESS (Felt dizzy), EAR PAIN (Ear would hurt/strong ear pain for a couple of minutes), PAIN (Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body) and NAUSEA (Nauseous/nausea). On 30-Oct-2021, the patient experienced BACK PAIN (Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage). In October 2021, DIZZINESS (Felt dizzy), EAR PAIN (Ear would hurt/strong ear pain for a couple of minutes), PAIN (Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body) and NAUSEA (Nauseous/nausea) had resolved. At the time of the report, BACK PAIN (Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.   It was reported that patient experienced strong ear pain in both sides for a couple of minutes.  Treatment information was not provided.
Allergic reaction: pt states that since getting the pneumococcal vaccine in July, she has experienced a number of problems. She lost all her fingernails. She has burning in her fingertips, Left arm pain, watery eyes, headaches, throat feels swollen and raw. She also cannot tolerate her partial as well and had some sores in her mouth. Skin eruptions.
BRUISING, NUMBNESS ON THE LEFT ARM AFTER INJECTION SYMPTOMS DOES NOT RESOLVE AFTER 1 WEEK. PATIENT SAID SHE CANNOT LIFT/MOVE HER LEFT ARM AS NORMAL. EXCRUCIATING PAIN ON LEFT SHOULDER
In February I had a known exposure for COVID-19 on Wednesday February 8, 2023.  On Friday the 10th I had a scratchy throat.  I got tested with a PCR test that was positive.  That night I had a low-grade fever.  I called my doctor and was prescribed Paxlovid.  I started taking it on Saturday.  My fever shot up to 103.6.  My fever was gone in a couple of days.  I was hoarse.  By the following Thursday I was negative but tested positive again on February 19th.  I had cold symptoms with head cold.  My taste was altered.  I did not test negative until February 28th.  I also had postnasal drip cough and fatigue.
Patient received MENACTRA & TDAP.  Became faint after.  Diaphoretic & pale.  Had client sit with head down till color returned.  About 15 min.  Left with mother.
Pharmacy incorrectly administered a second dose Pfizer vaccine when patient was due to receive a second dose Moderna vaccine. Patient reported no adverse effects.
Pt recvd DTP/HIB on 28JAN92 PM & @ 1AM started crying, generalized shaking, fever 101 x 1/2 hr resolved @ 8AM t103 whole body jerks x 6; APAP given;
LEFT DELTOID AREA WHERE PT HAD COVID VACCINATION HAS SMALL RED RASH 5 INCHES BY 5 INCHES NOT RAISED NO WHELPS.  DENIES ANY FEVER, SHORTNESS OF BREATH, ITCHING.
extreme anxiety; neuro inflammation; headaches; vertigo; central nervous system was so irritated/central nervous system irritation/neuro inflammation; This is a spontaneous report from a contactable nurse. This nurse reported same events for herself and 2 patients (twin sister and daughter). This is a third of three reports.   A female patient (reporter's twin sister) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced neuro inflammation, central nervous system was so irritated/central nervous system irritation, headaches, vertigo, and extreme anxiety ever since. Events resulted in disability or permanent damage. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anxiety, inflammation, vertigo, headache and CNS disorder and the suspect drug.  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. ,Linked Report(s) : US-PFIZER INC-202100911195 Same reporter/ drug/ AE, different patient.;US-PFIZER INC-202100911256 Same reporter/ drug/ AE, different patient.
This spontaneous report as received from a registered nurse refers to a 13 year old patient (gender unknown). On 30-SEP-2013, the patient was vaccinated subcutaneously with a 0.5 ml dose of PROQUAD. No adverse effects were reported. Additional information has been requested.
Allergy to Prevnar 13; Arm redness; Body aches; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways. A contactable nurse reported that a 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose, for immunisation. The patient's medical history included angiotensin-converting enzyme inhibitors (ACEI) allergy with a reaction of induced cough. Concomitant medications were not reported. On an unspecified date, the patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) with reaction of arm redness and body aches. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Student vaccinator accidentally gave the flu shot instead of the COVID vaccination. The patient previously received the flu vaccination a week ago. The patient has now received 2 flu vaccinations one week apart.
fever of 102; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102) and FATIGUE (tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PREDNISONE for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (fever of 102) and FATIGUE (tired). On 24-Apr-2021, PYREXIA (fever of 102) had resolved. On 25-Apr-2021, FATIGUE (tired) had resolved. Not Provided          No treatment medications were reported.   This case was linked to MOD-2021-114264 (Patient Link).
Headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On May2021, the patient experienced headache, fatigue, muscle aches. Patient reported could someone get side effects after single dose of Pfizer vaccine 2 weeks later. Meaning delayed side effects, having headache, fatigue and muscle aches and got first dose on 05May2021 second dose scheduled for 26May2021. The event reported as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.
During the post vaccine observation period, patient had a sync opal episode and fell off a charge face down on the floor.  He was turned over he came to immediately and was oriented to place, person, time ,and ,situation . He was noted to be diaphoretic. He reported to staff that he usually passes out after a vaccination  and had not had eaten. He was observed for an additional 45 mins  before leaving the site of the vaccination.
Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th.  I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading.  I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed
Septic Arthritis.Pt. received an inj. of expired Flu Sheild on 10/14/99, revaccinated w/ Flu Sheild(99/2000 Form.) on 10/21/99.On 11/19/99 she was unable to walk.  Admitted to hosp. w/ fever of 102.Dx of inflamm/septic arthritis was made
Tiny bot from redness lil lower from the site of injection; little bit warm on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Tiny bot from redness lil lower from the site of injection) and VACCINATION SITE WARMTH (little bit warm on her left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Tiny bot from redness lil lower from the site of injection) and VACCINATION SITE WARMTH (little bit warm on her left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Tiny bot from redness lil lower from the site of injection) and VACCINATION SITE WARMTH (little bit warm on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
A 6 month old was given Tdap in error, should have been given DTaP.
Patient reported feeling very confused within a few minutes of vaccine, drove home and sat in his car for 15 minutes before his wife came out of the house to check on him. Doesn't remember taking off shoes and going to bed. Confusion  continued the next 2 days, tongue began swelling and was concerned about his ability to go to work. Instructed to go to the physician. We have had no further conversations with him.
Starting the day after the vaccine he noticed tingling on the roof of his mouth and a lump.
Nose bleeds after each shot. After second shot nose bleeds would not stop and kept happening every 5 days or so where I had to go to ER and then I was hospitalized for 5 days.; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9264), via an unspecified route of administration, at the age of 83 years, administered on the left arm, on 29Jan2021 12:00 at a SINGLE DOSE, (Lot Number: EN6201) the second dose was received via an unspecified route of administration, administered on the left arm on 25Feb2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included heart issues and liver disease from an unknown date and unknown if ongoing. On 30Jan2021 02:30, the patient experienced nose bleeds after each shot. After second shot nose bleeds would not stop and kept happening every 5 days or so where the patient had to go to ER and then was hospitalized for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Mar2021. Therapeutic measures (Packing and observation while off blood thinners) were taken as a result of the event. The outcome of the events was recovering.
This is a spontaneous report from a contactable physician from a non-clinical-study program Customer Service received via a Pfizer vaccine sales representative. An adult male patient was vaccinated with 0.5mL single dose in a pre-filled syringe of PREVENAR 13, at 0.5 mL via an unspecified route of administration on 12Feb2014. Vaccines given on the same day and vaccines given within the last four weeks were unknown. Illness at the time of vaccination was none. Concomitant medications were not reported. Relevant sibling information was unknown. On 12Feb2014 while being vaccinated, the patient experienced heart flutter and heart palpitation. Relevant lab data was unknown. The clinical outcome for the events of heart flutter and heart palpitation was recovered on 13Feb2014.