chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of Fluad for the 2024-2025 season. Patient received first vaccination on 07/29/2024 and second vaccination on  08/22/2024. Corporate office notified pharmacy of the duplication. Have contacted patient to inform them but have not heard back from patient yet. Corporate asked pharmacist to report to VAERS.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Confusional state, Headache, Lethargy, Nausea, Pain
Clinical narrative: Increasing lethargy, arm soreness, confusion, nausea, right side pain near the liver, severe headache. Started within 3 hours and worsened within 6 hours. Arnica and Asa taken for pain, rest, and electrolytes added to water for hydration.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Increasing lethargy, arm soreness, confusion, nausea, right side pain near the liver, severe headache. Started within 3 hours and worsened within 6 hours. Arnica and Asa taken for pain, rest, and electrolytes added to water for hydration.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No side effects reported
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu shots.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTION
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTION
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTION
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Soreness in arm from shoulder to elbow, redness, swelling, underarm soreness, fatigue, itching, hard knot at injection site. Symptoms began the afternoon I received the injection and lasted for 6 days. Worst day was the 21st.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: Soreness in arm from shoulder to elbow, redness, swelling, underarm soreness, fatigue, itching, hard knot at injection site. Symptoms began the afternoon I received the injection and lasted for 6 days. Worst day was the 21st.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTION
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED, MAY HAVE RECEIVED DUPLICATE VACCINATION
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: patient presented prescription to pharmacy for Abrysvo vaccine.  Arexvy was administered. Spoke with patient on 8/27/24  no adverse events reported at this time
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTIONS
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTIONS
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTIONS
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTIONS
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTIONS
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO REPORTED ADVERSE REACTIONS
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose; adult patient were accidentally administered with pediatric doses of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On 15-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B/wrong dose) and adult use of a child product (Verbatim: adult patient were accidentally administered with pediatric doses of Engerix-B). The outcome of the accidental underdose was unknown and the outcome of the adult use of a child product was not reported.   Additional Information: GSK Receipt date: 15-AUG-2024 An HCP reported that a patient are accidentally administered with pediatric doses of Engerix-B which led to accidental underdose and Adult use of child product. The case is linked with US2024AMR105807, US2024101902, by same reporter.; Sender's Comments:  US-GSK-US2024AMR105807: US-GSK-US2024101902:Original Case : US2024101902
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 18Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FW1331, Expiration Date: 31Dec2022) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset 18Jul2022 at 16:00, outcome "recovered" (04Aug2022), described as "Tested positive for COVID-19". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient not received other medication in 2 weeks. Patient tested positive for COVID 19 via an antigen rapid test on 18Jul2022 at 4 pm. Within 3 hours patient began a 5 -day period of taking Paxlovid. No known allergies were reported. Product Quality Group provided investigational results on 27Sep2022 for BNT162b2: The complaint did not reasonably suggest device malfunction. Severity of harm was reported as N/A. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FW1331 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FW1331, fill lot FT6957, and the bulk formulated drug product lot FT6936. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.   Follow-up attempts completed. No further information expected.  Follow-up (27Sep2022): This is a spontaneous follow-up report from a Product Quality Group. Updated information: suspect product detail (expiration date) and investigation results.  Follow-up attempts are completed. No further information is expected.  Follow-Up (07Oct2022): Follow-up attempts are completed. No further information is expected.  Follow- up (26Aug2024): This is a follow-up report to notify that the case 202200925353 and 202400243624 are duplicates. The current and all subsequent follow-up information will be reported under manufacturer report number 202400243624.
Sex: U
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Paraesthesia
Clinical narrative: Gillian barre syndrome; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Gillian barre syndrome". The patient got rsv shot and then got Gillian barre syndrome. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Gillian barre syndrome; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Gillian barre syndrome". The patient got rsv shot and then got Gillian barre syndrome. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Inbound Contact from Medical Assistant to report that an additional dose was administered to a patient after a TE. See related AEs 02637629, 02637628, 02637625, 02637624, 02637623, 02637596. No PQC.   Name of vaccine(s)GARDASIL 9 Temperature  51F  Ti; This spontaneous report was received from Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUN-2024, the patient started therapy with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #X019625, expiration date: 23-APR-2025, administered for prophylaxis (strength, , dose, dose number, frequency, scheme, route of administration, and anatomical location were not provided) (Product storage error). The vaccine underwent a temperature excursion of 51 Fahrenheit Degrees during a timeframe of 446 h.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2407USA015881: US-009507513-2407USA015892: US-009507513-2407USA010431:02645760
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Product storage error
Clinical narrative: Inbound Contact from Medical Assistant to report that an additional dose was administered to a patient after a TE. See related AEs 02637629, 02637628, 02637625, 02637624, 02637623, 02637596. No PQC.   Name of vaccine(s)GARDASIL 9 Temperature  51F  Ti; This spontaneous report was received from Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUN-2024, the patient started therapy with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #X019625, expiration date: 23-APR-2025, administered for prophylaxis (strength, , dose, dose number, frequency, scheme, route of administration, and anatomical location were not provided) (Product storage error). The vaccine underwent a temperature excursion of 51 Fahrenheit Degrees during a timeframe of 446 h.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2407USA015881: US-009507513-2407USA015892: US-009507513-2407USA010431:02645760
Sex: U
Vaccine: PNC15, RV5
Symptoms: Product storage error
Clinical narrative: HCP reported patient administered VAXNEUVANCE and ROTATEQ after products experienced a T/E.  T/E filed.  This case also related to AE cases. No symptoms reported.  Consent to correspond was granted; No additional AE; This spontaneous report was received from a Medical Assistant (M.A) concerning a patient of unknown gender who is currently 3 months old. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.     On an unknown date, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # X022475, expiration date: 23-JAN-2026, 0.5 milliliter for prophylaxis.   Other suspect therapies included rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, 2.0 ml, Lot# 2003161, expiration date: 01-SEP-2025 for prophylaxis. The pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) were administered after vaccines experienced a temperature excursion (product storage error). No additional Adverse Event (AE)/No PQC.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient calling to report that since receiving the PNEUMOVAX 23 injection, she has experienced pain at the site, redness, and severe swelling.; Patient calling to report that since receiving the PNEUMOVAX 23 injection, she has experienced pain at the site, redness, and severe swelling.; Patient calling to report that since receiving the PNEUMOVAX 23 injection, she has experienced pain at the site, redness, and severe swelling.; This spontaneous report was received from a consumer and refers to a 72-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included drug hypersensitivity. Historical drugs included penicillin and atorvastatin calcium (LIPITOR). Concomitant medications included lysine, omeprazole, lisinopril, amlodipine, trazodone and hopantenate calcium (VIVANT).   On 21-AUG-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, administered for prophylaxis (indication also reported as vaccine) (strength, lot #, expiry date, and route of administration were not provided).  On the same date (also reported as since receiving the vaccine), she experienced pain at the site, redness, and severe swelling. It was starting to go down after treating with diphenhydramine (BENADRYL), acetaminophen (TYLENOL PM), and hydroxyzine (ATARAX). At the time of reporting, the patient had not recovered from the events.   The causal relationship between the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEP
Symptoms: Feeling cold, Incorrect route of product administration, Injection site pain, Sensory disturbance
Clinical narrative: Accidentally Injected Into the Blood Stream Instead of the Muscle; Entire Arm Felt Cold and Strange; Entire Arm Felt Cold and Strange; Bleeding at Injection Site; Raised Bump at Injection Site; Initial report received on 31-Jul-2024.  A consumer reported that a 24-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was accidentally injected into the blood stream instead of into the muscle.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Jul-2024, the patient received a dose of HEPLISAV-B (lot # 944918, expiration date 19-Nov-2026, and NDC # 43528-002-01) intravenously in the left deltoid from a pharmacist.   Concomitant vaccines administered included an influenza vaccine (lot # and expiration date not provided) in the left arm.    On 30-Jul-2024, the same day as having received HEPLISAV-B accidentally injected into the blood stream instead of the muscle, the patient stated her entire arm felt cold and strange. This has gone away. The patient reported a raised bump at the injection site but states she had the influenza vaccine right next to this spot. The patient reported bleeding at the injection site for approximately 8 minutes and then stopped. The reporter noted that this dose of HEPLISAV-B was received as a booster for preparation for nursing school. She received unspecified hepatitis vaccines as a baby in Mar-2000, Apr-2000, and Jul-2001.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: I always feel uncomfortable when I get the shot; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (I always feel uncomfortable when I get the shot) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Amoxicillin, Prednisone, Amoxicillin and Amoxicillin (every inch of my body had purple spots and urticaria on top of it itchy). Past adverse reactions to the above products included Itchy with Amoxicillin; Paraesthesia with Amoxicillin; Tachycardia with Prednisone; and Urticaria with Amoxicillin.   In 2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2022, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (I always feel uncomfortable when I get the shot). At the time of the report, DISCOMFORT (I always feel uncomfortable when I get the shot) outcome was unknown.            Patient had a really bad allergic reaction to amoxicillin several decades ago. It was a disaster, head to toe. And then they gave her prednisone to calm It. she was with her husband on his business trip and because she took some vacation time from work to go down and when they were driving home, head to toe, she woke up one morning, every inch of her body had purple spots and urticaria on top of it itchy. Her feet were tingling.  Concomitant product use was not provided by the reporter.  Patient had itchy and it had almost like little kind of like bumps, just a couple on it. It was on her arm only with no other symptomatology. it's not systemic. In December it was not systemic means it goes over whole body but what's to say that her next exposure won't result in a more severe reaction. He said it won't because this is an injection site reaction.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-772934 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772934:Same patient, different product
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Abdominal distension, Abdominal pain upper, Impaired work ability, Myalgia, Pain
Clinical narrative: body and muscle aches, 101F fever, bloated sore stomach (but not nausea), too uncomfortable to do any work. Normally I have experienced similar with FLU vaccination for 24 hours. However I am still experiencing these side effects 4 days later. It does not seem to be getting worse (or much better).  I will wait another day or 2, and report to doctor if not improvement.
Age: 65.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: body and muscle aches, 101F fever, bloated sore stomach (but not nausea), too uncomfortable to do any work. Normally I have experienced similar with FLU vaccination for 24 hours. However I am still experiencing these side effects 4 days later. It does not seem to be getting worse (or much better).  I will wait another day or 2, and report to doctor if not improvement.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 20-AUG-2024 The nurse practitioner reported that the patient received a subsequent dose of Shingrix vaccine and had two episodes of shingles within a month.  The patient received second dose of Shingrix two prior to first episode of shingles. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva956a, expiry date 31-JUL-2024) for prophylaxis.   On 16-AUG-2024, the patient received Menveo. On 16-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-AUG-2024 The other health professional reported that Menveo was administered on 16th August 2024 to a female patient. The reporter reported that after administration the health care professional noted the vial containing the MenA lyophilized conjugate component (orange cap) was expired, which led to expired vaccine used. The other health professional reported that the vial containing the MenCYW-135 liquid conjugate component (gray cap) was not expired (different expiry date listed as 2025.)   The health care professional did not had the lot number from liquid conjugate. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEPAB, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS SENT TO HEALTH DEPT BY NEPHROLOGY FOR RECOMMENDED VACCINES DUE TO BEING ON TRANSPLANT LIST FOR KIDNEY.  SHE WAS TOLD TO GET A TWINRIX, RSV, AND FLU VACCINE(CURRENTLY WE DO NOT HAVE).  TWINRIX AND ABRYSVO WAS GIVEN TO PATIENT AND SHE IS ONLY 58 YRS OLD.   RSV GIVEN BEFORE 60 YRS OLD (OUTSIDE OF RECOMMENDATIONS) BY NURSE IN ERROR.  PATIENT DID NOT EXPERIENCE ANY PROBLEMS FROM GETTING VACCINE.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac ventricular thrombosis, Cardiovascular disorder, Cerebrovascular accident, Cognitive disorder, Coronary artery bypass
Clinical narrative: Developed a cough and could not lay flat had to sleep sitting up.  Then had swelling of the legs so went to ER October 2021 and had to be transported to another hospital for a triple bypass due to a large blood clot in the heart.  At the time of surgery the blood clot got loose and went to my leg had to have emergency surgery to remove that blood clot.  Have never regained feeling in the bottom of that leg and foot.  With the lack of blood flow I lost a toe and had a stroke they believe.  I then found out that I had developed MS.  Thru all of this I have lost a lot of physical and cognitive abilities.  There has been a lot that has happened in the past almost three years.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Disability, General physical health deterioration, Hypoaesthesia, Impaired work ability
Clinical narrative: Developed a cough and could not lay flat had to sleep sitting up.  Then had swelling of the legs so went to ER October 2021 and had to be transported to another hospital for a triple bypass due to a large blood clot in the heart.  At the time of surgery the blood clot got loose and went to my leg had to have emergency surgery to remove that blood clot.  Have never regained feeling in the bottom of that leg and foot.  With the lack of blood flow I lost a toe and had a stroke they believe.  I then found out that I had developed MS.  Thru all of this I have lost a lot of physical and cognitive abilities.  There has been a lot that has happened in the past almost three years.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Multiple sclerosis, Peripheral swelling, Sleep disorder, Thrombectomy
Clinical narrative: Developed a cough and could not lay flat had to sleep sitting up.  Then had swelling of the legs so went to ER October 2021 and had to be transported to another hospital for a triple bypass due to a large blood clot in the heart.  At the time of surgery the blood clot got loose and went to my leg had to have emergency surgery to remove that blood clot.  Have never regained feeling in the bottom of that leg and foot.  With the lack of blood flow I lost a toe and had a stroke they believe.  I then found out that I had developed MS.  Thru all of this I have lost a lot of physical and cognitive abilities.  There has been a lot that has happened in the past almost three years.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Toe amputation
Clinical narrative: Developed a cough and could not lay flat had to sleep sitting up.  Then had swelling of the legs so went to ER October 2021 and had to be transported to another hospital for a triple bypass due to a large blood clot in the heart.  At the time of surgery the blood clot got loose and went to my leg had to have emergency surgery to remove that blood clot.  Have never regained feeling in the bottom of that leg and foot.  With the lack of blood flow I lost a toe and had a stroke they believe.  I then found out that I had developed MS.  Thru all of this I have lost a lot of physical and cognitive abilities.  There has been a lot that has happened in the past almost three years.
Age: 68.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: patient relayed that he is seeking further medical attention due to continued arm pain after the vaccine
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal
Clinical narrative: Received Pneumococcal Conjugate 20-Valent at 9:41am Thursday, July 18,  2024. Bloodwork done 8:00 am, Friday, July 19, 2024.  Test results showed liver ALT shot up to 512  and AST was  201. Previous bloodwork completed June 4, 2024 , my  AlLT was 19  and my AST was 20.  The vaccine caused an extremely negative immune response/ reaction.
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver injury
Clinical narrative: Received Pneumococcal Conjugate 20-Valent at 9:41am Thursday, July 18,  2024. Bloodwork done 8:00 am, Friday, July 19, 2024.  Test results showed liver ALT shot up to 512  and AST was  201. Previous bloodwork completed June 4, 2024 , my  AlLT was 19  and my AST was 20.  The vaccine caused an extremely negative immune response/ reaction.
Age: 14.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: New patient to office was administered PCV 20 immunizations at age 14 years in error. He moved from another country and did not receive immunization as child however aged out of requirement. He was not due for this immunization. He is not high risk.  Patient had no adverse reaction to this immunization. I am reporting my error of administration.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site induration, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: After receiving the vaccine, I started to experience slight pain and swelling at the injection site. I know this is to be expected, however, I started seeing red spots on my arm. By the middle of the night, I started to have some fever, chills, and increased swelling. This got worse over the next several days. The swelling was so bad I had to have my sleeve cut because it was too tight on my arm. I applied a hydrocortisone topical cream on my arm and took Benadryl over the next week or so. Even though I have had this vaccine in the past, I have never had a serious reaction before. The swelling has decreased and the rash is almost gone, but the red spots now appear to be dark spots on my arm. I still have a hard knot where I had the injection.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash macular
Clinical narrative: After receiving the vaccine, I started to experience slight pain and swelling at the injection site. I know this is to be expected, however, I started seeing red spots on my arm. By the middle of the night, I started to have some fever, chills, and increased swelling. This got worse over the next several days. The swelling was so bad I had to have my sleeve cut because it was too tight on my arm. I applied a hydrocortisone topical cream on my arm and took Benadryl over the next week or so. Even though I have had this vaccine in the past, I have never had a serious reaction before. The swelling has decreased and the rash is almost gone, but the red spots now appear to be dark spots on my arm. I still have a hard knot where I had the injection.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Injection site bruising, Injection site pain, International normalised ratio
Clinical narrative: Bruising "dark blotch" at injection site that has lasted 2 weeks.  She also states that another bruise appeared along the wrist of same arm.  She still feels sore at injection site when she presses on it.  She denies any joint pain, decreased range of motion, chest pain, sob, or warmth at site of injection.
Age: 8.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered, Wrong product administered
Clinical narrative: Gave Pentacel IM in right deltoid instead of just DTap.  The vial was not reconstituted with the powder, so the HIB was not activated.  Patient was due for his second IPV and Dtap.  Spoke to manufacture stating since HIB was not activated and patient due for second IPV this was not considered an adverse event.     Spoke to mom and school nurses informing them of which vaccine patient received.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: SECOND SHOT FOR PATIENT, 1ST GIVEN IN OCTOBER 2023 AND SHE WAS NOT 75.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered to early
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Crying, Injection site erythema, Injection site rash
Clinical narrative: Patient had a well visit today in our office and the 2 month vaccines were ordered and administered. After administration of the Pediarix, Prenvar, and Hibrix patient experienced a light reticular skin rash on bilateral legs and erythema on left knee and anterior right thigh and anterior right shin. Rash and erythema occurred for 5 minutes and then cleared up. Patient had 98% oxygen saturation, 154 heart rate, 36 respiratory rate, and was not in any respiratory distress. Patient was crying for about 10 minutes after vaccine administration. Patient tolerated a bottle of formula after vaccination as he usually does per mom. Patient remained in office for 20 minutes for observation prior to discharge. Provider, ARNP made aware.
Age: 11.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event
Clinical narrative: patient did not have any adverse effects and handled that vaccination well
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received the shingles and Flu vaccine in her left arm on Sunday.  She called to report that her left arm was still swollen, red, and tender.  She says that it is the size of a 3x6 index card and is red and warm to the touch.  I advised the patient to contact her doctor's office. She is going to follow up with us to let us know how she is doing.
Age: 27.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: She got her vaccine, did not notice any severe symptoms.  As the time went on and on Saturday she started noticing that the area around the injection site is still raised and red and hot, and sore.  It feels like a bruise.  Then on Sunday she noticed that she was itchign quite a bit and then developed a rash acrossher chest and up her neck.  She does not see a rash on her face and scalp but those areas are itchy as well.  She did not take anything for her symptoms or call her doctor.  The areas are lessing, the itching has mostly gone and definitely less severe than it was.  The rash itself kind of resemble zits, some have white heads and some do not, but are subsiding.  The soreness, red raised area and hotness is still present.
Age: 27.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Rash pruritic
Clinical narrative: She got her vaccine, did not notice any severe symptoms.  As the time went on and on Saturday she started noticing that the area around the injection site is still raised and red and hot, and sore.  It feels like a bruise.  Then on Sunday she noticed that she was itchign quite a bit and then developed a rash acrossher chest and up her neck.  She does not see a rash on her face and scalp but those areas are itchy as well.  She did not take anything for her symptoms or call her doctor.  The areas are lessing, the itching has mostly gone and definitely less severe than it was.  The rash itself kind of resemble zits, some have white heads and some do not, but are subsiding.  The soreness, red raised area and hotness is still present.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: patient called pharmacy stating her leg is blowing up like a balloon. Vaccine was given under 1 hour ago.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Supraventricular extrasystoles
Clinical narrative: In the following 6 months to a year after receiving the 3rd booster for covid, I would be working out and having heart rates recorded in the 180's.  I have never recorded a heart rate above 160 while working out prior to receiving this injection. And for the years following I started having PAC's on my ekg. The PAC's continue to happen a 4-5 times per week.
Age: 1.17
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was given an additional dose of Rotateq vaccine. This was pass the interval on the manufacturers package insert.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: The patient was administered a pediatric dose of Hep B Energix vaccine instead of the age appropriate Adult Hep B vaccination.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received first dose of Shingrix vaccine on 7/25/24. On 8/28/24, patient returned to pharmacy complaining that arm has been sore since vaccine and is unable to lift the arm. Patient states she contacted her prescriber who did not examine the patient but instructed her to contact pharmacy.  Patient states she has been applying heat, cold, and Bengay for 3 days with no relief. Patient states the pain is muscle related, not joint related.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Headache, Myalgia, Nausea, Neck pain
Clinical narrative: Headache the night of the vaccine; the morning after, she had headache, significant neck pain/myalgias, throat pain, stomach discomfort including nausea and pain, and shin/calf pain as well as subjective numbness of the lateral lower legs. Of note, she did not complain of arm pain and there was no redness nor swelling at the injection site. No fever.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Headache the night of the vaccine; the morning after, she had headache, significant neck pain/myalgias, throat pain, stomach discomfort including nausea and pain, and shin/calf pain as well as subjective numbness of the lateral lower legs. Of note, she did not complain of arm pain and there was no redness nor swelling at the injection site. No fever.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient cannot raise her arm up. This started two days after the vaccine was given. Patient can more her arm out front and back but just can't raise it up more than 3 inches. Symptoms started all the sudden.  Patient is still experiencing symptoms. Her arm doesn't hurt until she tries to raise it up.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: EXTREME MUSCLE SORENESS - POTENTIAL RHABDOMYOPATHY
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Pt had a hep A vaccine ordered, Hep B vaccine was given. Provider just discovered when reviewing vaccine history. When preforming same order under test patient, System will allow this mistake to happen and does not flag that its wrong medication. NDC number for the Hep B vaccine will populate under Hep A order. NDC 58160-820-43 Lot F3y25 exp. 2/15/25.  System correction ticket placed, appears System team is still researching how to correct this (was found on 7/11/2024). Project in place currently to add barcode scanning to ambulatory sites where this error occurred.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Product administered at inappropriate site, Skin irritation
Clinical narrative: Patient received a flu vaccine on 8/24/24 and developed cellulitis related to the vaccination and location on the left arm.  The location of the where the shot was given was more to the left of the deltoid than preferred and that could have inflammed the surrounding tissue. The Cellulitis spread onto the inside of her arm and she had been tracking the spread each day after she notices the irritation after the day of the immunization. Patient was seen by 2 different doctors and prescribed a Zpack and also Augmentin which she was starting last night on 8/27/24.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Throat tightness
Clinical narrative: Pt reported a reaction to the Moderna vaccine with a reaction of dyspnea, throat tightness/numbness. She reported this during a visit with a pulmonologist (for an unrelated visit). Additional vaccination information and ADE information is not available in the EMR.
Age: 2.0
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Injection site discharge, Injection site erythema
Clinical narrative: Patient came in for a physical @9AM and received immunizations patient went home and the next day and her right arm was red with some clear puss coming out looks irratated at site of immunizations no fever.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site mass
Clinical narrative: Parents called to report a lump on the proximal upper and outer right thigh.  Lump is firm.  No erythema.  No rash. No pain. Parents sent a picture of a small lump protruding from the thigh.  Provider explained that this is probably due to delayed absorption, continue to monitor for changing symptoms/concerns.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dehydration, Shock, Vomiting
Clinical narrative: PATIENT ENDED UP GOING TO HOSPITAL 1 HOUR AFTER VACCINE ADMINISTRATION.  PATIENT STATED SHE WAS IN SHOCK, HAD EXCESS VOMITTING, DEHYDRATION. WAS TAKEN BY AMBULANCE TO HOSPITAL. SHE WAS RELEASED FROM HOSPITAL LATER THAT NIGHT.
Age: 85.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient developed redness and itchiness on the inferior of the right arm. Patient came to pharmacy to show us so visually verified. Patient came to pharmacy on 08/27 and she stated that she is getting better already.
Age: 85.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient developed redness and itchiness on the inferior side of the right arm. Patient came to pharmacy to show up the reaction. Patient stated that she is getting better already.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Skin lesion, Tenderness
Clinical narrative: Patient had vaccination 48 hours back and is presenting today 8/28/24 with right deltoid area swelling and erythema  with a clear demarcation around  the area.   The lesion is measuring about 10 cm in diameter and is tender to touch.  He has a low-grade temperature as well.  He is asked to take antibiotics and do Cold compression.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE
Age: 17.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Cold sweat, Eye movement disorder, Hypotonia, Loss of consciousness, Pallor
Clinical narrative: After administering  the 3rd vaccine (Varicella) , the patient passed out. He became pale, his eyes rolled back in his head, skin got cold  aand moist, and he was not responding to verbal commands,.  He then slumped over in chair.  After less than a minute, patient was more responsive however then vomited large amount of white fluid.  Over the next 5 minutes, the patient slowly became more responsive and alert and  staff were able to assist him from the chair to exam table.  After approximately 15 minutes of lying down, the patient stated he felt better and was able to sit up independently, drank water, and his normal facial coloring returned.  The patient assessment returned to normal and he stated he felt "fine".  Patient was able then to ambulate unassisted and waited in the waiting room for documentation to be completed.  At that point (approximately 30 minutes after the incident) the patient left the clinic with is uncle.
Age: 17.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: After administering  the 3rd vaccine (Varicella) , the patient passed out. He became pale, his eyes rolled back in his head, skin got cold  aand moist, and he was not responding to verbal commands,.  He then slumped over in chair.  After less than a minute, patient was more responsive however then vomited large amount of white fluid.  Over the next 5 minutes, the patient slowly became more responsive and alert and  staff were able to assist him from the chair to exam table.  After approximately 15 minutes of lying down, the patient stated he felt better and was able to sit up independently, drank water, and his normal facial coloring returned.  The patient assessment returned to normal and he stated he felt "fine".  Patient was able then to ambulate unassisted and waited in the waiting room for documentation to be completed.  At that point (approximately 30 minutes after the incident) the patient left the clinic with is uncle.
Age: 1.0
Sex: F
Vaccine: FLUC4, HEPA, MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient was in for the 1 year wcc appt. Vaccines ordered were Hepatitis A, Flu, MMR and Varicella. Patient was given Hepatitis A, Flu, MMR and MMRV.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received report from system of age inappropriate vaccines given, verified of vaccine given checked with chart, no AR reported to this clinic from parent or patient since receiving vaccine on May 29, 2024
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Papule
Clinical narrative: scattered pink papules on extremities and few on trunk
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to 5 yo child.
Age: 38.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Electrocardiogram normal
Clinical narrative: pt had blood draw thwen she got dizzy after blood draw, pt recvied tetanus vaccine before blood draw, pt was sent to the ER via EMS after calling 911
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Left shoulder pain x 5 months with limited ROM and radiation of pain. Pain worst in L deltoid. Started within 24 hours of injection
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Left shoulder pain x 5 months with limited ROM and radiation of pain. Pain worst in L deltoid. Started within 24 hours of injection
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Dyspnoea, Pain, Tremor
Clinical narrative: Patient stated to nursing staff at this office, that she had symptoms of back pain radiating down both legs, shakiness and shortness of breath when the injection was being given.  It was given at a pharmacy, not this office.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: Awoke middle of night with severe pain in right wrist. By morning I could not move my wrist in any direction and the pain was throbbing and severe. It is now the second day and the pain is constant and I'm essentially unable to use my right hand because of the pain in my wrist. I am treating it with alternating warm and cold compresses.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: Patient arm started to swell/bruise (discolor) that afternoon along with tiching. Two weeks later the patient still reports constant itching and discoloration still present.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Customer received another Arexvy  shot. Received 2 injections in 7 months
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Gait disturbance, Incoherent, Laboratory test
Clinical narrative: Patient reported after receiving flu and covid vaccines at pharmacy earlier in the day, patient became incoherent and was unable to walk straight.  Patient was hospitalized, remained inpatient for 3 days.