chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Weight decreased
Clinical narrative: Intense diarrhea; Soreness in the area of administration; Rash in the area of administration; Redness in the area of administration; Nauseas; Lost 10 pounds; This spontaneous case was received on 25-Oct-2022 from pharmacist via Communications (reference number: SEQW22-05019) and concerned a 54-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 13-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 350379 and expiry date: 30-Jun-23.   On 14-Oct-2022, one day after receiving Flucelvax Quadrivalent the patient experienced soreness, rash and redness in the area of administration, and also experienced intense diarrhea and nausea.   On an unspecified day in Oct-2022, the patient stated that had lost 10 pounds.  On an unspecified day in Oct-2022, the patient visited physician's office, however, further details were not reported.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 54-year-old female patient experienced pain, rash, and erythema at vaccination site, intense diarrhea and nausea one day after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. As reported, the patient also had lost 10 pounds. Information regarding the underlying medical history and concomitant medications has not been provided. Based on  information provided causality for the event of weight decreased is not related. Causality for the remaining events is assessed as possibly related. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.; Sender's Comments: A 54-year-old female patient experienced pain, rash, and erythema at vaccination site, intense diarrhea and nausea one day after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. As reported, the patient also had lost 10 pounds. Information regarding the underlying medical history and concomitant medications has not been provided. Based on  information provided causality for the event of weight decreased is not related. Causality for the remaining events is assessed as possibly related. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 08-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was asking how many days required for redness to disappear after the shingles injection. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm is still hurting; Hurts to lift my arm up; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm and pain upon movement. On an unknown date, the outcome of the pain in arm and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain upon movement to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's comment:  The patient reported that arm was still hurting after getting the shot almost two and half weeks ago. Still hurts to lift arm up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on Sep 2021, 2nd dose on 1 Oct 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 53L2Z, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th Sep 2021.).   On 1st October 2021, the patient received the 2nd dose of Shingrix. On 1st October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 08-NOV--2022 Reporters comment:  The patient received the first dose of shingrix on september 17th 2021 and the second dose of shingrix on October 1st 2021. The vaccine administration facility is the same as primary reporter The reporter consent to follow-up. Additional Supportive information: The patient received the first dose of shingrix on september 17th 2021 and the second dose of shingrix on October 1st 2021 which led to shortening of vaccinations schedule.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: Got COVID after 1st dose; Never received dose 2; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2018).   In 2020 the patient received the 1st dose of Shingrix (intramuscular) .5 ml and did not received  2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment: The reporter was patient,she received the first dose of shingrix about 2 years ago . The patient stated that she got covid and never received dose 2 .  She also mentioned she had shingles in 2018. The reporter consent 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
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 10-NOV-2022 Reporter's Comment: The patient was in accelerated schedule for Twinrix and missed the second dose at 7 days and wanted to know how to proceed. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix ,which led to incomplete course of vaccination.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Pyrexia, Vaccination site pain
Clinical narrative: had a sore arm; fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (had a sore arm) and PYREXIA (fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Malignant neoplasm of abdomen (removed in 2019), Appendicitis, Nephrectomy in 2017 and Tumorectomy in 2019. Concurrent medical conditions included Drug allergy, Bladder cancer since 2010 and Sleep disorder NOS. Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder NOS.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a sore arm) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (had a sore arm) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F. On an unknown date, Computerised tomogram: found that previous cancer was spread again..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2021-290627, MODERNATX, INC.-MOD-2021-290368 (E2B Linked Report). This case was linked to MOD-2021-674162, MOD-2021-291235, MOD-2022-673536, MOD-2022-673532 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Live follow-up included historical condition, current condition, lab data and concomitant medication added.; Sender's Comments:  MODERNATX, INC.-MOD-2021-290627:Wife case MODERNATX, INC.-MOD-2021-290368:Wife case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired dose of a vial for 6 to 11 years "booster doses"; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of a vial for 6 to 11 years "booster doses") and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR4504B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of a vial for 6 to 11 years "booster doses"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of a vial for 6 to 11 years "booster doses") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of a vial for 6 to 11 years "booster doses").    No concomitant medications were reported.  No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022 at 2:23 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Nov-2022 at 2:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture).    Concomitant medications details were not reported by the reporter.  On 06-Jan-2021, the patient received first dose of Moderna COVID-19 vaccine (Intramuscular), lot number 027L20A. On 04-Feb-2021 , the patient received second dose of Moderna COVID-19 vaccine (Intramuscular), lot number 028L20A. On 21-Sep-2021 , the patient received third dose of Moderna COVID-19 vaccine (Intramuscular), lot number 023C21A. On 28-Apr-2022 , the patient received fourth dose of Moderna COVID-19 vaccine (Intramuscular), lot number 005M21A.  The 30 day BUD for the vial was 17-NOV-2022. The vial stored post puncture was reported as predawn into syringe and stored in refrigerator. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range is less than 5 mins.  Treatment details was not reported by the reporter.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling
Clinical narrative: after receiving the flu shot, both this year and last year, the left side of patient neck, injected side, has become enflamed causing a pocket of swelling to the left side of neck that is easily seen and palpable, it was also itchy. The only difference from last year, was that 2021 the effect was more immediate, as in the next day. This year it was 4-5 days later.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Malaise, Paraesthesia
Clinical narrative: On 17NOV22, patient came to the local Clinic. She was screened by a Nurse at this time the patient did not indicate that she had a history of vaccine reactions. She then proceeded to the vaccine administration area and received a Moderna Bivalent Booster Vaccine, lot # 016H22A, around 10:15.   After receiving the vaccine, she started to feel ill and sat down on the floor. Her husband, then approached the staff and said his wife was not doing well after receiving the vaccine. At this point, staff volunteers and the triaged patient. Vital signs were BP: 150/90, HR: 120, RR: 30, SAT: 99%. She stated that she takes a GI stimulate medication everyday but no other medications. PT stated she was allergic to Sulfa medications. Patient stated that she didn?t feel right, and this had never happened before. She stated, that the last Moderna vaccine she had received had made her arm tingle all the way up to her shoulder.   Local ambulance and HCP were called. Staff volunteers and HCP continued to assess patient until EMS arrived on scene. The EMS arrived on scene and reassessed vitals: BP: 148/94, HR: 86, RR: 22, SAT: 99% and determined patient should be transported by ambulance to another Clinic locally.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 021B21A, 27C21A and 002M21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Seizures and Epileptic seizure. Concomitant products included PRAVASTATIN, SERTRALINE and LEVETIRACETAM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was). At the time of the report, IMMUNISATION REACTION (his wife experienced a minor one day reaction after a Moderna COVID-19 vaccine but he did not remember which one it was) had resolved.            On 14Nov2022 a HCP from their vaccination site called and told him he and his wife needed to be revaccinated with half of a dose since they only received half of a dose on 12Sep2022. No Allergies were reported by reporter. Patient had never done COVID positive test or diagnosis. No Treatment information was provided by reporter.   This case was linked to MOD-2022-672845 (Patient Link).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to two patients; This case was reported by a physician and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 8th November 2022, the patient received Havrix. On 8th November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The reporter wanted to get the information on the stability of Havrix. The reporter stated that, they had a medical error at the time of reporting wherein a dose of expired vaccine was given to the patient at the time of reporting. The reporter wanted to ask, the data on the stability of this Havrix vaccine after the official expiration date. It had been properly stored since it was arrival at their clinic in a refrigerator whose temperature was monitored daily. Additional Supportive Information: The patient received the expired dose of Havrix, which led to expired vaccine used. This was 1 of 4 cases, reporter by the same reporter.; Sender's Comments:  US-GSK-US2022AMR163515:Same reporter. Patient 1. US-GSK-US2022AMR164695:same reporter US-GSK-US2022163626:same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness 2 inches below the injection site; This case was reported by a nurse via call center representative and described the occurrence of erythema in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18th September 2023) for prophylaxis.   On 3rd November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th November 2022, 5 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's comments: Nurse reported that the patient received her first Shingrix dose in the right deltoid and experienced redness 2 inches below the injection site.  Nurse stated that the redness area was about 10 centimeter by 7 centimeter in size. Nurse stated she was unsure whether this redness was caused by Shingrix vaccine administration or something else.  The reporter consented to follow up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 18-May-22 and second dose on 07-Jun-22; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Drug allergy and Drug allergy.   On 18-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-May-22 and second dose on 07-Jun-22).    No concomitant medication information was provided. No treatment medications were provided   This case was linked to MOD-2022-673503 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Tremor
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site injury, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: patient pushed needle from injection site resulting in abrasion-Mild, Additional Details: Patient pushed needle with hand and had superficial abrasion at injection site. Needle was intact. Covered in bandage. Full dose administered.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt has pain/swelling/redness at injection site that has lasted greater than 10 days; advised how to self treat at home and to call md if no improvement
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Adiposis dolorosa, Back pain, Cardiovascular autonomic function test, Condition aggravated, Disability
Clinical narrative: On January 7th, 2021 few minutes after the first injection, I became dizzy and had heart palpitations and hyperhidrosis. I was about to start my shift for work and notified a coworker. I sat down for a few moments until the symptoms resolved. For the remainder of the month, I noticed that my back pain especially in the area of my lipomas had worsened. On January 28, 2021 I received my second vaccine and  by the 3rd of February my back pain was so severe that it was hard to climb stairs. I remember this now because looking back through my calendar that is the time that my husband and I took a mini vacation to go South to  see if a warmer climate may help. Shortly after that I noticed the ill-feeling that I had experienced for a week or two for a few years was now a daily experience and that I had more lipomas, mainly in my back. I had surgery to remove 4 lipomas in my back in May 2021. After that, beginning around August or September of 2021, the malaise and pain were an every day experience and then I noticed lipomas everywhere from neck to feet. It was so bad that I had to end my career. I stopped working in January 2022 and was awarded Disability in July 2022. I often asked if it could be from the vaccine but because it was so new, nobody knew. After reading about others with an Immune Response to the vaccine, I am convinced that mine is also from that. Dercum's Disease is my new diagnosis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electromyogram, Gait disturbance, Hyperhidrosis, Impaired work ability
Clinical narrative: On January 7th, 2021 few minutes after the first injection, I became dizzy and had heart palpitations and hyperhidrosis. I was about to start my shift for work and notified a coworker. I sat down for a few moments until the symptoms resolved. For the remainder of the month, I noticed that my back pain especially in the area of my lipomas had worsened. On January 28, 2021 I received my second vaccine and  by the 3rd of February my back pain was so severe that it was hard to climb stairs. I remember this now because looking back through my calendar that is the time that my husband and I took a mini vacation to go South to  see if a warmer climate may help. Shortly after that I noticed the ill-feeling that I had experienced for a week or two for a few years was now a daily experience and that I had more lipomas, mainly in my back. I had surgery to remove 4 lipomas in my back in May 2021. After that, beginning around August or September of 2021, the malaise and pain were an every day experience and then I noticed lipomas everywhere from neck to feet. It was so bad that I had to end my career. I stopped working in January 2022 and was awarded Disability in July 2022. I often asked if it could be from the vaccine but because it was so new, nobody knew. After reading about others with an Immune Response to the vaccine, I am convinced that mine is also from that. Dercum's Disease is my new diagnosis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lipoma, Malaise, Pain, Palpitations
Clinical narrative: On January 7th, 2021 few minutes after the first injection, I became dizzy and had heart palpitations and hyperhidrosis. I was about to start my shift for work and notified a coworker. I sat down for a few moments until the symptoms resolved. For the remainder of the month, I noticed that my back pain especially in the area of my lipomas had worsened. On January 28, 2021 I received my second vaccine and  by the 3rd of February my back pain was so severe that it was hard to climb stairs. I remember this now because looking back through my calendar that is the time that my husband and I took a mini vacation to go South to  see if a warmer climate may help. Shortly after that I noticed the ill-feeling that I had experienced for a week or two for a few years was now a daily experience and that I had more lipomas, mainly in my back. I had surgery to remove 4 lipomas in my back in May 2021. After that, beginning around August or September of 2021, the malaise and pain were an every day experience and then I noticed lipomas everywhere from neck to feet. It was so bad that I had to end my career. I stopped working in January 2022 and was awarded Disability in July 2022. I often asked if it could be from the vaccine but because it was so new, nobody knew. After reading about others with an Immune Response to the vaccine, I am convinced that mine is also from that. Dercum's Disease is my new diagnosis.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: On January 7th, 2021 few minutes after the first injection, I became dizzy and had heart palpitations and hyperhidrosis. I was about to start my shift for work and notified a coworker. I sat down for a few moments until the symptoms resolved. For the remainder of the month, I noticed that my back pain especially in the area of my lipomas had worsened. On January 28, 2021 I received my second vaccine and  by the 3rd of February my back pain was so severe that it was hard to climb stairs. I remember this now because looking back through my calendar that is the time that my husband and I took a mini vacation to go South to  see if a warmer climate may help. Shortly after that I noticed the ill-feeling that I had experienced for a week or two for a few years was now a daily experience and that I had more lipomas, mainly in my back. I had surgery to remove 4 lipomas in my back in May 2021. After that, beginning around August or September of 2021, the malaise and pain were an every day experience and then I noticed lipomas everywhere from neck to feet. It was so bad that I had to end my career. I stopped working in January 2022 and was awarded Disability in July 2022. I often asked if it could be from the vaccine but because it was so new, nobody knew. After reading about others with an Immune Response to the vaccine, I am convinced that mine is also from that. Dercum's Disease is my new diagnosis.
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Medium
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: generalized urticaria, medical attention needed, treatment with oral antihistamine, ongoing as of today.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: got covid-19 from family member
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Narrative:  Timing error, 2nd COVID-19 vaccine dose given too soon 15 days after first dose.
Age: 65.0
Sex: M
Vaccine: COVID19-2, PNC20, TDAP, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient came in to receive 4 vaccines and instead of getting the Fluad 65+ shot received the Shingrix instead. Patient was immediately contacted and no side effects had occured. Patient will be coming in next week for the flu shot.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: I started with fatigue, fever, body aches and nausea. Pain also occurred at the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Mass, Pain, Pruritus, Sensitive skin
Clinical narrative: PER PT:  IT STARTED ABOUT 2 DAYS AFTER INJECTION AS WELT, HARD KNOT, SENSITIVE TO TOUCH, HURT TO MOVE ARM.  NOW THOSE SYMPTOMS HAVE SUBSIDED BUT IT ITCHES RANDOMLY AND LOOKS LIKE THE SKIN IS PEELING (LIKE AFTER A SUNBURN).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Urticaria
Clinical narrative: PER PT:  IT STARTED ABOUT 2 DAYS AFTER INJECTION AS WELT, HARD KNOT, SENSITIVE TO TOUCH, HURT TO MOVE ARM.  NOW THOSE SYMPTOMS HAVE SUBSIDED BUT IT ITCHES RANDOMLY AND LOOKS LIKE THE SKIN IS PEELING (LIKE AFTER A SUNBURN).
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, headache, body aches, fatigue
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Pharyngeal paraesthesia, Throat irritation
Clinical narrative: The patient reported filling a tingling and itching sensation in her throat. The doctor on site administered 20cc's of Benadryl and monitored the patient for 30 minutes at which time the patient reported feeling better prior to being cleared to return home.
Age: 48.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Colonoscopy, Injection site reaction, Peripheral swelling, Skin weeping
Clinical narrative: He got his vaccine, his arm was swollen and that was it.  This morning when he woke up at 7:00 AM went to the restroom and listed up the sleeve of his shirt and noticed that the injection site skin was kind of worn away like scraping it as a fall and it was wet.  There is a mark on the T-shirt where it was oozing.  It was  not itching, and he did not have to put cream on it like the first vaccine, had no reaction.  He is arm is normal swollen, but wet.  There is no clear color of the discharge other than the staining on the shirt.  He did put Neosporin on it and a band-aide.  You did call the department of health where he had it done, and they gave him our phone #.   He has no numbness, problem with moving the arm or anything.  This is the same arm that he had the 1st vaccine on.   He does feel fine, no fever, just this oozing/wet area on the injection site itself.   This injection is in the upper arm underneath the shoulder muscle in the front.    He did have a colonoscopy on Tuesday of this week with sedation, and everything was fine.    With Moderna COVID vaccines had some reactions, fever, extreme fatigue.  He got a flu vaccine and had extreme depression for months which his doctor said was normal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy on 10/27/2022 to get her 2nd shingles vaccine (shingrix). Rph followed the correct procedure by using hand sanitizer and wearing gloves. Then, used alcohol swab to clean the skin then used the proper needle to mix shingrix vaccine and used proper needle into the muscle at 90 degree with a quick thrust. Patient suddenly moved her arm after finishing administering the vaccine while the needle was still in her arm. RPh took the needle out and make sure no bleeding or swelling as result of the sudden movement. Patient came next day to the store and mentioned she has pain in her arm and she doesn't know if it's because of the vaccine or it's a local site reaction
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, Asthenia, Atrial fibrillation, Blood lactic acid normal
Clinical narrative: Patient is a 74-year-old male past medical history significant for type 2 diabetes and hypertension presenting today for generalized weakness.  Patient reports feeling generally weak.  Patient says he fell forward and smashed his face earlier today due to weakness.  No palpitations.  No loss of consciousness.  Patient has slight nosebleed.  This is since resolved.  Patient is concerned about his general weakness.  Feels short of breath.  Wife passed message to EMS that patient may have COVID. 6:34 PM: Patient evaluated the emergency department for weakness.  Concern for hypoxia initial presentation.  Patient was placed on oxygen.  Patient has evidence of increased respiratory rate present as well.  Concern for infectious process/COVID/urinary tract infection.  We will get chest x-ray for pneumonia, COVID swab, we will get CBC, CMP, urinalysis.  Fluid bolus will be given.  Cultures and lactic obtained.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Coronary artery disease, Culture, Dyspnoea
Clinical narrative: Patient is a 74-year-old male past medical history significant for type 2 diabetes and hypertension presenting today for generalized weakness.  Patient reports feeling generally weak.  Patient says he fell forward and smashed his face earlier today due to weakness.  No palpitations.  No loss of consciousness.  Patient has slight nosebleed.  This is since resolved.  Patient is concerned about his general weakness.  Feels short of breath.  Wife passed message to EMS that patient may have COVID. 6:34 PM: Patient evaluated the emergency department for weakness.  Concern for hypoxia initial presentation.  Patient was placed on oxygen.  Patient has evidence of increased respiratory rate present as well.  Concern for infectious process/COVID/urinary tract infection.  We will get chest x-ray for pneumonia, COVID swab, we will get CBC, CMP, urinalysis.  Fluid bolus will be given.  Cultures and lactic obtained.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epistaxis, Face injury, Fall, Hypertension, Hypoxia
Clinical narrative: Patient is a 74-year-old male past medical history significant for type 2 diabetes and hypertension presenting today for generalized weakness.  Patient reports feeling generally weak.  Patient says he fell forward and smashed his face earlier today due to weakness.  No palpitations.  No loss of consciousness.  Patient has slight nosebleed.  This is since resolved.  Patient is concerned about his general weakness.  Feels short of breath.  Wife passed message to EMS that patient may have COVID. 6:34 PM: Patient evaluated the emergency department for weakness.  Concern for hypoxia initial presentation.  Patient was placed on oxygen.  Patient has evidence of increased respiratory rate present as well.  Concern for infectious process/COVID/urinary tract infection.  We will get chest x-ray for pneumonia, COVID swab, we will get CBC, CMP, urinalysis.  Fluid bolus will be given.  Cultures and lactic obtained.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insulin therapy, Leukocytosis, Pneumonia, Pyrexia, Respiratory rate increased
Clinical narrative: Patient is a 74-year-old male past medical history significant for type 2 diabetes and hypertension presenting today for generalized weakness.  Patient reports feeling generally weak.  Patient says he fell forward and smashed his face earlier today due to weakness.  No palpitations.  No loss of consciousness.  Patient has slight nosebleed.  This is since resolved.  Patient is concerned about his general weakness.  Feels short of breath.  Wife passed message to EMS that patient may have COVID. 6:34 PM: Patient evaluated the emergency department for weakness.  Concern for hypoxia initial presentation.  Patient was placed on oxygen.  Patient has evidence of increased respiratory rate present as well.  Concern for infectious process/COVID/urinary tract infection.  We will get chest x-ray for pneumonia, COVID swab, we will get CBC, CMP, urinalysis.  Fluid bolus will be given.  Cultures and lactic obtained.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sepsis, Tachycardia, Type 2 diabetes mellitus, Urinary tract infection
Clinical narrative: Patient is a 74-year-old male past medical history significant for type 2 diabetes and hypertension presenting today for generalized weakness.  Patient reports feeling generally weak.  Patient says he fell forward and smashed his face earlier today due to weakness.  No palpitations.  No loss of consciousness.  Patient has slight nosebleed.  This is since resolved.  Patient is concerned about his general weakness.  Feels short of breath.  Wife passed message to EMS that patient may have COVID. 6:34 PM: Patient evaluated the emergency department for weakness.  Concern for hypoxia initial presentation.  Patient was placed on oxygen.  Patient has evidence of increased respiratory rate present as well.  Concern for infectious process/COVID/urinary tract infection.  We will get chest x-ray for pneumonia, COVID swab, we will get CBC, CMP, urinalysis.  Fluid bolus will be given.  Cultures and lactic obtained.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Breast pain, Rash erythematous
Clinical narrative: red rash has appeared from the left shoulder down to the elbow and deep soreness into the left breast area
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: bivalent booster given instead of dose 1 pediatric dose
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product storage error
Clinical narrative: After vaccine was administered it was discovered that the punctured vial was the day before vial. Contacted vaccine committee who directed me to reach out to Pfizer. Pfizer provided me with data to support inadvertent excursions to the labeled storage for vaccine in Punctured vials and or syringes. Within the supported 24 hours post puncture at 2 degrees Celsius and 30 degrees Celsius
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Oropharyngeal pain
Clinical narrative: I tested positive for COVID-19 on 8/30/22. I had a sore throat, and congestion at first. Then, I developed a cough, nasal drip, diarrhea, body aches, and a fever. I never had trouble breathing though. That is when I decided to test for COVID-19 and tested positive. I called the doctor, and they told me I could take Paxlovid, but I declined. I took Alka-Seltzer Plus and Mucinex. My sense of smell is still altered, and I have lingering fatigue, but other than that I feel good.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Parosmia, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 8/30/22. I had a sore throat, and congestion at first. Then, I developed a cough, nasal drip, diarrhea, body aches, and a fever. I never had trouble breathing though. That is when I decided to test for COVID-19 and tested positive. I called the doctor, and they told me I could take Paxlovid, but I declined. I took Alka-Seltzer Plus and Mucinex. My sense of smell is still altered, and I have lingering fatigue, but other than that I feel good.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: I tested positive for COVID-19 on 8/30/22. I had a sore throat, and congestion at first. Then, I developed a cough, nasal drip, diarrhea, body aches, and a fever. I never had trouble breathing though. That is when I decided to test for COVID-19 and tested positive. I called the doctor, and they told me I could take Paxlovid, but I declined. I took Alka-Seltzer Plus and Mucinex. My sense of smell is still altered, and I have lingering fatigue, but other than that I feel good.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram head normal, Fatigue, Headache
Clinical narrative: For the first two three the patient experienced the worst headaches that she had ever had. Also extreme tiredness. The headaches lasted lasted most days for two weeks,  though only occasionally were they as extreme as during the first three days. A visit to the emergency on 11/05/22 did not reveal any cause for the headaches or tiredness. Treatment was Tylenol and Ibuprofin.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood urine present, Cough, Diarrhoea, Dizziness
Clinical narrative: 8,5 hours after getting the vaccine, I had been on the floor wrapping gifts all afternoon.  I stood up and suddenly realized all my muscles and joints hurt like a sudden flu and my left arm hurt to move it.  Symptoms until next Sunday night:  Sore throat, copious rhinorrhea, headache, myalgias, arthralgias, severe fatigue, fever, and cough.  Sunday night, I blew out a massive amount of yellow drainage from L nostril and felt like I was getting better (very typical reaction to Covid vaccine for me).  Monday morning the next morning, I got up at 6:30 AM and suddenly started having uncontrollable bilious vomiting, watery diarrhea, dizziness, severe fatigue and muscle weakness, and subsequently developed severe muscle cramping.  Emergency Phenergan suppositories at 2:30 PM and Gatorade hydration kept from an ER visit/hospitalization.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Influenza A virus test negative, Influenza B virus test, Muscle spasms
Clinical narrative: 8,5 hours after getting the vaccine, I had been on the floor wrapping gifts all afternoon.  I stood up and suddenly realized all my muscles and joints hurt like a sudden flu and my left arm hurt to move it.  Symptoms until next Sunday night:  Sore throat, copious rhinorrhea, headache, myalgias, arthralgias, severe fatigue, fever, and cough.  Sunday night, I blew out a massive amount of yellow drainage from L nostril and felt like I was getting better (very typical reaction to Covid vaccine for me).  Monday morning the next morning, I got up at 6:30 AM and suddenly started having uncontrollable bilious vomiting, watery diarrhea, dizziness, severe fatigue and muscle weakness, and subsequently developed severe muscle cramping.  Emergency Phenergan suppositories at 2:30 PM and Gatorade hydration kept from an ER visit/hospitalization.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness, Myalgia, Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: 8,5 hours after getting the vaccine, I had been on the floor wrapping gifts all afternoon.  I stood up and suddenly realized all my muscles and joints hurt like a sudden flu and my left arm hurt to move it.  Symptoms until next Sunday night:  Sore throat, copious rhinorrhea, headache, myalgias, arthralgias, severe fatigue, fever, and cough.  Sunday night, I blew out a massive amount of yellow drainage from L nostril and felt like I was getting better (very typical reaction to Covid vaccine for me).  Monday morning the next morning, I got up at 6:30 AM and suddenly started having uncontrollable bilious vomiting, watery diarrhea, dizziness, severe fatigue and muscle weakness, and subsequently developed severe muscle cramping.  Emergency Phenergan suppositories at 2:30 PM and Gatorade hydration kept from an ER visit/hospitalization.