chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via company representative regarding a 77 year old male patient. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapy were not provided. On 14-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # L003227 with an expiry date 13-OCT-2016 (dosing details and anatomical location not known). On an unspecified date in September 2016 reported as after administration of PNEUMOVAX 23, the patient experienced "pain in the left arm and a rash at the injection site, on the left leg and on his trunk". On 26-SEP-2016, the patient called pharmacy, reported the adverse effects and sought medical attention. At the time of reporting, the pain in the left arm, as well as the rash at the injection site and on his trunk had resolved (unknown date in September 2016) but he still had the rash on his left leg. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient had severe immobility, soreness in vaccinated arm.  Had blood pressure 172-178/114, quite hypertensive, several readings.  Patient felt tired, diaphoretic for 48 hours - 96 hours after injection.
This spontaneous report as received from a consumer refers to a 19 year old female patient with drug reaction to sulfa drugs. No concomitant medications and pertinent medical history were reported. On 31-JUL-2013, the patient was vaccinated with VARIVAX (Merck) dose 1, .5 ml, subcutaneous (lot number and expiry date not provided). On 14-AUG-2013, 15 days after onset of therapy the patient developed a rash at the injection site of her arm since receiving her first VARIVAX injection. The reporter stated that the rash did not develop until about two weeks after receiving the injection. The patient did not receive any treatment. The outcome of developed a rash at the injection site of her arm since receiving her first VARIVAX was reported as not recovered/not resolved. The reporter did not assess the relationship between the event and VARIVAX (Merck). The patient did not seek medical attention. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 as dose 2, single (Lot number: EW0185, Expiration Date: 31Aug2021) at the age of 29 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROPRANOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible and no further information is expected.  Follow-up (17May2022): This is a follow-up spontaneous report from product quality group providing investigation results. This report included that:  Updated Information Included Batch and lot tested and found within specifications was checked. (All release testing performed prior to the release of the reported batch was within specifications). Clinical course: Investigation results reported: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process. Product Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 with Lot-# (CR): EW0185 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, fill lot EP8735, and the formulated drug product lot EP8616. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   No follow-up attempts are possible. No further information is expected.
Severe vomiting: Onset 13-14 hours post injection. Duration: 6 hours. Severe diarrhea: Onset 13 - 14 hours post injection. Duration: 48 hours. Nausea: Onset: 13 - 14 hours post injection. Duration: 96 hours.
Patient received higher than recommended dose do to vaccine given undiluted, patient is experiencing mild arm pain no more severe than the previous two doses.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication received in 2 weeks. No known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash at injection site on R leg/hip, persisted for 15 days post-injection but is now improving. initial blistering, swelling and redness.
Patient stopped by pharmacy on 11/6 to let us know that she had developed an injection site reaction. The site was red and inflamed. Patient noted that it was significantly larger yesterday. In addition, she noted that she had developed blisters on the roof of her mouth, a headache and achy joints. She noted that this all occurred on 11/5 (she was vaccinated on 11/2 without incident). She was advised to notify her PCP of the reaction as well. She is better today. Injection site still reddened.
Sweating; fever 101.8F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and PYREXIA (fever 101.8F) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0320L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating) and PYREXIA (fever 101.8F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating) and PYREXIA (fever 101.8F) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt received flu shot on 10/5/09; noted pain at injection site on 10/7/09. Also on 10/7/09 pt noted numbness/paresthesia in thumb, index and middle finger of RT hand, progressed to involve forearm, elbow, upper arm and shoulder. Required treatment with gabapentin. Symptoms: 1. numbness/paresthesia in thumb, fingers, elbow and shoulder Treatment drugs used: 1. gabapentin dose: 100 units: MG freq: TID Route; PO
Pt has redness, swelling and itching at the injection site. Approximately 3 inches in diameter.
It felt warm to touch; indurated; Small local redness reaction; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE WARMTH (It felt warm to touch), INJECTION SITE ERYTHEMA (Small local redness reaction) and INJECTION SITE INDURATION (indurated) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced INJECTION SITE ERYTHEMA (Small local redness reaction). On 30-Dec-2020, the patient experienced INJECTION SITE WARMTH (It felt warm to touch) and INJECTION SITE INDURATION (indurated). At the time of the report, INJECTION SITE WARMTH (It felt warm to touch), INJECTION SITE ERYTHEMA (Small local redness reaction) and INJECTION SITE INDURATION (indurated) 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.   The patient's medical history was not provided.  Treatment included unspecified antibiotics.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Rheumatoid arthritis flare up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) outcome was unknown. Not Provided          It was reported that the patient had started to have Rheumatoid Arthritis flare ups after beening in remission for 8 years. The patient reported RA flare ups after  each COVID-19 vaccine. I t was reported that the patient went to see Rheumatologist who stated 4 other of his RA patients reported RA flare ups after COVID-19 vaccine. Concomitant and treatment information was not reported.   This case was linked to MOD-2021-231450, MOD-2021-114609, MOD-2021-114592 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested. Causality is confounded with patient's medical history of rheumatoid arthritis as it is a complex disease with variable course, characterized by remissions and flares which can be triggered by various environmental factors in genetically susceptible individuals.
1 to 1-1/5 hours post vax pt experienced allergy symptoms, nausea, myalgia, pain in the neck and shoulder as well as other symptoms. Reportedly not treated Recovery status was unreported.
pain upper left chest area, chest is sore; hard to take deep breath; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st January 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 1st February 2023, the patient experienced chest pain and difficulty breathing. On an unknown date, the outcome of the injection site pain, chest pain and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, chest pain and difficulty breathing to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter was the patient/RN (Registered nurse ). The reporter reported adverse reactions after receiving her Shingrix in the left arm.  The reporter reported pain at the injection site and pain in the upper left chest area (at the bra line).  The reporter reported it was hard to take a deep breath because the chest was sore. The reporter did not give permission to contact healthcare professional because she did not have the healthcare professional name and phone number with her. The reporter did not consent to follow-up.
Moderate pain at injection site and in arm pit, fever, chills, headache, muscle/joint aches, tiredness.
29JUN95 PM pt reports exp joint pain in both knees & lt hand on 28JUN95; @ this time reports discomfort to these areas; denies any other sx;
Patient received first dose of Moderna 040A21A on 3/5/21 and received second dose  026B21A on 4/6/21. When filing consents found out this patient received another round of vaccinations of Moderna. third dose 044B21A on 4/23/21 and fourth dose 023C21A on 5/27/21
Mother was at health department today (7/18/2014) and was told by her pediatrician to report this adverse event next time she was here (which was for appt today). Mother states that child had severe swelling to right thigh ("2-3 times the regular size of his thigh") which began approximately 2 days after vaccine administration. Right thigh became extremely "tight" (swollen) and was painful to the touch. Her pediatrician initially thought it was a cellulitis, and then later told her it was an allergic reaction. The area did not subside until the child received steroids. The pediatrician told mother that patient should not receive this vaccine again for fear of respiratory difficulties or anaphylaxis.
my arm my left side of my body this is not normal,this is so very painful; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my arm my left side of my body this is not normal,this is so very painful), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (my arm my left side of my body this is not normal,this is so very painful), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (my arm my left side of my body this is not normal,this is so very painful), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. Patient had vaccine  shot over 2 weeks ago. No treatment information provided.
Covid19 breakthrough.  1st vaccine received on 08/04/2021.   51y/o PMH Asthma, HTN, ETOH abuse presented to ED with c/o Stabbing epigastric pain, N/V.  Pt admits to being a heavy drinker for many years.   Pt denies any c/o fever, SOB, cough, CP.  Pt started on IV Abx.
1st dose on 25Apr2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th April 2019 with batch number 2YN4S and expiry date 9th July 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Sept-2022 Reporter's comment: The pharmacist reported that the patient was not  immunocompromised received only one dose of Shingrix and never got the 2nd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
tested positive after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 (tested positive after first dose). At the time of the report, COVID-19 (tested positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment information was provided.   This case was linked to MOD-2021-044179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 and contains no new information.
Mental fog, joint pain in elbows and knees, pain the injection site, fatigue. Mind you these are persistent symptoms through out the day.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN
Large eyrthematous rash covering the entire deltoid area of the right arm. Upper area clearing up with the lower area still beefy red.
Patient recieved his vaccine at vaccine clinic. During his 15 min post vaccine wait, he lost conciousness and rolled off of the chair onto the floor. Pt was unconcious for approx 5-10 seconds. He woke up and was able to stand and walk with assistance to the treatment area. He was markedly diaphoretic and grey in color. He was oriented to name and location at this time. Reports he did not eat today and drank a beer this morning only. He worked all day, then came for his vaccine. Initial vials as follows: 95/44, Pulse 75, Pulse ox 95% on RA. Dexi 104. temp 97.7 oral. Pt is not a diabetic and denies any heart disease or other medical conditions. He does not have a primary care provider and has not had any check up in years. Given a protein bar, a juice and a bottle of water. Also 1 glucose tablet. He reports he is feeling better. Second set of vitals as follows: 97/59, pulse 80, Pulse 97% on RA. LCTA bil, RRR with no murmurs. Palpated skull, spine and pt denied any pain. No chest pain, difficulty breathing, dizziness or confusion. Second water given. Vitals as follows: 100/60, Pulse 85, Pulse ox 96% on RA. Pt is refusing ambulance. Risks and benefits of EMS evaluation and transport to ER given and pt still refusing x 2.  Spoke to supervising nurse who contacted Dr. Dr states pt ok to be monitored if he is refusing the ambulance. Pt will be discharged home under the care of his wife and his daughter. Daughter will drive him home. Dexi repeated: 125. Repeat vitals: 109/67, pulse 77, Pulse ox is 95% on RA. Discussed with patient need to eat a high protein meal, drink plenty of water and get rest. No work tomorrow and no alcohol. Pt has appt with PCP tomorrow at 11 am for an evaluation. Pt taken outside with RN in wheelchair with a 3rd water. Wife at his side. APN
I received my vaccination on December 29, 2020.   January 7, 2021,  at around 4:00am I woke up and my injection site had become  itchy,  hard  and hot to the touch.
Information has been received from a physician, concerning a 12 year old female patient who on 10-APR-2007, was vaccinated with the first dose,  0.5ml, IM, of Gardasil (Lot #656051/0244U). There was no concomitant medication. The physician reported that the patient developed pruritus at the injection site within minutes of the vaccine administration. Treatment included Benadryl. At the time of this report, the physician confirmed that the patient had recovered (date not specified). Additional information has been requested.
Red circular spot developed on my upper left arm at the vaccination site.  It was a bit sore and hard in nature.  It commenced on 3/9 and went away by 3/14.  It continued to grow in size to approx. a 6 x 61/2 inch circle.
Patient was indicated to receive and father consented to provision of HiB vaccine. HPV was accidentally administered in its place by the Medical Assistant. Upon realization of the error, Dr (myself) called the family to report the error, explain what to expect, and to answer any questions or concerns. I called again the next day, about 18 hours after the error occurred. At that time, patient's mother reported no change in behavior or symptoms.