chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diabetic; Toes did not bend; Infected toe/ infected right big toe/infection under callus on toe; Patient received third dose COVID-19 Vaccine; Pain; Patient received third dose COVID-19 Vaccine; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3772691-00).   A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation; and adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, (citrate free) for psoriatic arthritis moderate to severe chronic plaque psoriasis. The patient's medical history and concomitant medications were not reported. Historical vaccines included BNT162b2 received by the patient on 01Feb2021 as dose 1, single and on 01Mar2021 as dose 2, single; both intramuscular at the age of 63 years old for COVID-19 immunisation. On an unspecified date, the patient experienced "toes did not bend" (also reported as joint range of motion decreased), diabetes (diabetic) and infected right big toe/infection under callus on toe. In 2021, the patient experienced pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The patient has not recovered from diabetes and infected toe; recovered from pain in 2021; while outcome of the remaining event (joint range of motion decreased) was unknown. Causality for BNT162b2: The reporter's causality for the events of TOES DID NOT BEND, DIABETIC, INFECTED RIGHT BIG TOE/INFECTION UNDER CALLUS ON TOE was not provided. The reporter's causality for the event of PAIN with BNT162b2 was reported as possible and not reported. Causality for adalimumab (HUMIRA): The reporter's causality for the events of TOES DID NOT BEND, DIABETIC, PAIN was not provided. The reporter's causality for the event of INFECTED RIGHT BIG TOE/INFECTION UNDER CALLUS ON TOE with adalimumab (HUMIRA) was a reasonable possibility.   The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.
Patient received the FLUZONE HIGH DOSE flu shot on 10/28/17. She said that around 2 AM on 10/29/17, she woke up in the middle of the night with a fever of 102 degrees, aches, sweating, and a headache. This lasted for about 12 hours and then all symptoms went away. The patient did mention that she had some nausea on Friday 10/27/17 (before flu shot) without any other symptoms.
pt recv vax & exp inj sit pain which has persisted since the date of the inj;no redness was noted @ inj site;
COVID-19 positive 03/11/2020 prior year at begin of COVID-19. May 4, 2021 felt like I had milder version of COVID-19 again, have running fever every month since the vaccination. Hospital for four day 10/3/2021 9PM by ambulance with fever of 104.7 with fatigue, and body aches, head pounding. COVID-19 09/9/2021 tic, disease, stars, blood oxygen to 71; was put on oxygen.
Symptoms began almost immediately as constant dizziness, body aches, overall weakness. Two months later I woke up with severe chest pain and difficulty breathing. As a military pilot, my flight doctor took an EKG (abnormal results) and instructed me to visit the ER. I was diagnosed with inflammation of the heart cavity and pulmonary arteries. Upon being admitted to a local Medical Center, I was later diagnosed with vasculitis, specifically aortitis. During this timeframe I was also diagnosed with gastroesophageal reflux disease. I was completely healthy prior to the vaccination and there is not a single member of my family with any of the listed conditions. Presently, I am on a high dosage of prednisone and methotrexate to deal with the inflammation. I am also awaiting a medical evaluation board with the military group to determine if I'm allowed to remain on flying status and in the military.
2 days redness 5 inches across left arm warm to the touch 1 day after: soreness at site of ZOSTAVAX shot. Red at site of injection 2 days later at Right arm.
Information has been received from a physician concerning her 17 year old female daughter, with no pertinent medical history and no drug reaction/allergies, who on unspecified dates was vaccinated with the first, second and third dose of GARDASIL vaccine INJ. There was no concomitant medication. After receiving the third dose of GARDASIL vaccine, in June 2008, the patient was experiencing continuous bleeding of the vagina. At the time of reporting the patient had not recovered. The patient sought medical attention unspecified. Additional information has been requested.
I was standing at the toilet when I became dizzy and nearly collapsed.  I called for help and my son assisted me to my bed where I collapsed and could hardly move while I broke out in cold sweats and my wife monitored my heart rate and placed an oxygen monitor on my finger.  she said my pulse held steady and slow.  The event lasted about 10 minutes and I felt I must return to the toilet for a bowl movement.  I began having diarrhea and then began to throw up. After that i took a cool shower and laid in bed. I stayed in bed for about 48 hours.
I got out of bed at 5:10 am, and tried to make it to the bathroom to void, falling to the right 3 times en route. I was stable while sitting and voiding but again experienced instability trying to walk back to bed in the dark.   I did take 3 aspirin.   I developed severe diaphoresis, dry heaves on 3 separate occasions usually after trying to walk. I had no problems with finger to nose, arm drift, leg instability and according to my wife, no nystagmus.  I was able to balance on each foot individually, but still had a perception of a tendency to veer to the right while walking. My wife drove me to the ER and I was stable if still.  Nausea improved with Zofran. Instability resolved with Meclizine. Labs and CT angiography was essentially normal. Glu was 204 with known diabetes, although slightly higher than expected, perhaps related to vomiting etc.
Approximately 5" red, raised welt on left thigh from the varicella vaccine given. Itchiness at site level. No fever, no cough, no vomiting, no runny nose, no diarrhea, no recent change sin appetite, no headache, no abdominal pain and no known history of sick contacts. No other concerns at time of report.
I developed  a large swollen mass  on my left collarbone.  It is painful and about the size of a grape or olive with a similar consistency.
Information has been received from a registered nurse concerning a 30 year old female with allergies to penicillin, sulfa, and "myocin" who on 07/15/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  On 07/31/2002 the patient developed "a rash on her head, chest, face, arms and legs.  She reported having a sore throat, swollen glands, and fever".  On 08/01/2002 labs revealed that the patient had measles.  Unspecified medical attention was sought.  Additional information has been requested.
1st dose to arm feeling numb and Heavy . 2nd dose to Arm Felt immediately numb and heavy, Fainted  1HR 50minutes ago. Pale Clammy "shock like" 5 seconds of shaking (seziure) other arm and feet felt a little numb pain in fist.
Developed Idiopathic thrombocytopenic (ITP), admitted to the hospital with platelet count of 6, hospitalized for 8 days. Receiveds teriods,  Ivig treatment and rituxan infusion.
Woke with a headache and that got progressively worse. When standing experienced severe vertigo and nausea. On February 28 went to ER and tested positive for COVID-19. Sent home and by that Tuesday, 3/2/2021, had issues breathing. Was prescribed nausea medication but did not take it much because it did not help. It took about 3 weeks to recover.
Pruritic rash on down rt arm shortly after administration of vaccine, this resolved after 2hrs.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.            No concomitant medications reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-029852 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up document not received . No new information provided
Pt recvd 1st dose of vax 21MAY90 & exp weakness, blurred peripheral vision, postural hypotension, dizziness & aching joints. Pt recvd 2nd vax 21JUN90 & exp. same events, & pt. recvd. 3rd vax 27NOV90 & later exp. same events.
Death:  5/7/2021 Causes of death listed on death certificate: 1) COVID-19  2) Sepsis  3) Sarcoidosis  4) End stage renal disease  Other: Hypertension, Congestive heart failure
Patient reported having severe chills and uncontrollable shaking for 2-3 hours about 24 hours after receiving her first dose. Symptoms resolved on their own and patient is no longer experiencing this issue.
Information has been received from a licensed practical nurse concerning a 20 year old female with no medical history or allergies who on 04-AUG-2009 was vaccinated IM with 0.5 ml of GARDASIL (lot # 659182/1757U). Concomitant therapy included sertraline HCl (birth control pill). On 06-AUG-2009 the patient called the office stating she experienced nausea and dizziness. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Follow-up information has been received from the registered nurse concerning the 20 year old female who on 04-AUG-2009 at 13:30 was vaccinated with the first dose of GARDASIL in her left arm. Concomitant therapy also included TCA applied to vulva "same day as GARDASIL given" on 04-AUG-2009. The nurse reported the patient complained of nausea, dizziness and being unsure of temperature. The patient stated that she ran "hot and cold". The patient had recovered. Additional information is not expected.
lump that was tender consistent with a supraclavicular node; Case reference number US-BN-2021-000035 is a spontaneous case report initially received from a consumer via GSK on 20-JAN-2021, and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) in left arm at unknown dose and route of administration for unknown indication.   On an unspecified date, on next day, it was reported as last night and this day the patient noticed a lump that was tender consistent with a supraclavicular node.  At the time of this report the outcome of the event was not provided.  The reporter did not provide the seriousness and causality assessment.  Additional information received from Agency on 25-Jan-2021 included the confirmation that the case should be process as a case; Reporter's Comments: Lymphadenopathy is listed for RabaVert as per prescriber information  and as per Agency. The patient received RabaVert and on the next day experienced a lump that was tender consistent with a supraclavicular node. No information was provided regarding the patient's medical history and concomitant medications. However, due to plausible temporal relationship and as the contributory role of RabaVert cannot be excluded, the causality is assessed as possibly related.; Sender's Comments: Lymphadenopathy is listed for RabaVert as per  prescriber information  and as per Agency. The patient received RabaVert and on the next day experienced a lump that was tender consistent with a supraclavicular node. No information was provided regarding the patient's medical history and concomitant medications. However, due to plausible temporal relationship and as the contributory role of RabaVert cannot be excluded, the causality is assessed as possibly related.
LOC, tongue and throat swelling. Evaluated by EMS, transported to nearest ER.
After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD since July 1968. Concomitant products included TIMOLOL for Glaucoma.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site). At the time of the report, VACCINATION SITE PAIN (After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-339287 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up information received on 05-OCT-2021 included patient's medical history, concomitant medication and updated patient details.
sweating like you couldn't believe; Had a 104 fever; on bed all day and night; After first dose patient was 5 days sick; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like you couldn't believe), ILLNESS (After first dose patient was 5 days sick), PYREXIA (Had a 104 fever) and FATIGUE (on bed all day and night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (before getting the vaccine and naturally recovered.).    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating like you couldn't believe), ILLNESS (After first dose patient was 5 days sick), PYREXIA (Had a 104 fever) and FATIGUE (on bed all day and night). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating like you couldn't believe), PYREXIA (Had a 104 fever) and FATIGUE (on bed all day and night) outcome was unknown and ILLNESS (After first dose patient was 5 days sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 fever.     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.   No concomitant medication was reported. Treatment medication included Gabapentin which did not help much.   This case was linked to MOD-2021-407247 (Patient Link).
fever 100-102, lethargy, irritability starting on day of immun, persisted for 8 days; fretful, inconsolable crying for long periods of time; fever difficult to control w/antipyretics;
This spontaneous report was received from a nurse practitioner regarding to multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of ROTATEQ lot # L029618, expiry date 20-MAY-2017 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Other suspect therapies included PEDVAX HIB Lot/batch# L038502, expiry date 16-AUG-2018, lot L035878, expiry date 11-AUG-2018 started on unknown dates. Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, skin sensitivity, abdominal pain, chest pain  Narrative:
pt recv vax 24JUN97 & 30JUN97 pt devel brown blotches on rt arm below inj site from forearm up of inj site;
administered vaccine to minor. Mother  consented on 2nd dose. No symptoms reported from 1st dose.
pain in arm; feel like i cant breath; little a nauseous a couple hours after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, DYSPNOEA, and NAUSEA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY, DYSPNOEA, and NAUSEA. At the time of the report, PAIN IN EXTREMITY, DYSPNOEA, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT WAS GIVEN WRONG INJECTION. SHE SHOULD HAVE BEEN GIVEN THE PFIZER FOR THE APPROPRIATE AGE
tremors; chills; body aches; fatigue; This case was reported by a nurse via sales rep and described the occurrence of tremor in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number j9b25, expiry date unknown) for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced tremor, chills, general body pain and fatigue. On an unknown date, the outcome of the tremor, chills, general body pain and fatigue were unknown.   It was unknown if the reporter considered the tremor, chills, general body pain and fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 30-NOV-2022 Reporters comment: The nurse reported that the patient was given first dose of shingrix and within a few days reported tremors chills, body aches fatigue. The reporter consent to follow-up from GlaxoSmithKline.
dose 1 of Shingrix on August 30, 2018 / received dose 2 of Shingrix on April 11, 2019; decreased short term memory; difficulty sleeping; fatigue; headache; brain fog; This case was reported by a consumer via call center representative and described the occurrence of short-term memory impairment in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LP5Y, expiry date 27th February 2021) and (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On 30th August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 11th April 2019, the patient received the 2nd dose of Shingrix. On 30th August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced short-term memory impairment, difficulty sleeping, fatigue, headache and foggy feeling in head. On 11th April 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the short-term memory impairment, difficulty sleeping, fatigue, headache and foggy feeling in head were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the short-term memory impairment, difficulty sleeping, fatigue, headache and foggy feeling in head to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and experienced headache, fatigue, difficulty sleeping, brain fog and decreased short term memory. The patient was seen by the headache specialist and underwent testing and the cause of the headache had not been determined. The event were unresolved. The patient received the 2nd of Shingrix later than recommended schedule time, which led to lengthening of the vaccination schedule. The patient had no events after 2nd dose. The reporter consented to follow up.
Rash on upper arm that has spread to both arms, legs, back of the neck and cheeks. Itchiness, redness, swelling. Joints swollen - particularly left elbow. No other symptoms (no difficulty breathing or other issues).
Administration of Bexsero second dose less than 1 month apart form the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Administration of Bexsero second dose less than 1 month apart form the first dose).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Aug-2023 Pharmacist administered Bexsero second dose less than 1 month apart. The reporter were on the car with no access to information regarding this adverse event.  The reporter accepted follow up email to her personal email. The patient received second dose earlier than the recommended interval, which led to shortening of vaccine schedule.
9/23/2014: Bilateral hip pain, the day after receiving flu vaccine, which still persists, until this day. Bilateral hip pain relieved with ADVIL.