chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vestibular disorder
Clinical narrative: Vestibular disorder - imbalance, visual vertigo, brain fog, head pressure, memory issues
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody increased, Fatigue, Headache, Neuralgia
Clinical narrative: nerve pain; headache; I have high ANA; Fatigue extreme; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of neuralgia (Received 3 Covid vaccines, had a nerve pain, headache and extreme fatigue.).   On 29-JAN-2024, the patient received Shingrix. On 30-JAN-2024, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue extreme). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain), headache (Verbatim: headache) and antinuclear antibody increased (Verbatim: I have high ANA). On 17-APR-2024, the outcome of the fatigue was resolved (duration 2 months 18 days). The outcome of the nerve pain and headache were resolving and the outcome of the antinuclear antibody increased was not reported.   It was unknown if the reporter considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.     It was unknown if the company considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient self reported this case for herself. The reporter reported that, she had a nerve pain, headache and extreme fatigue as a result of 3 covid vaccines. After 2 plus weeks, it was considerably improved.  After 3 plus weeks the patient was back to normal.  The reporter reported, this happened with Shingrix and she only improved slightly.  The reporter's physician ran tests and the reporter had high antinuclear antibody, multiple nuclear dots pattern. The reporter was getting further tests.  The reporter asked was it possible that she had an extreme reaction to Shingrix and it threw off her tests temporarily.   The gastroenterologist said the reporter's liver could had reacted to Shingrix as a toxin and done this.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Fatigue
Clinical narrative: nerve pain; headache; I have high ANA; Fatigue extreme; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of neuralgia (Received 3 Covid vaccines, had a nerve pain, headache and extreme fatigue.).   On 29-JAN-2024, the patient received Shingrix. On 30-JAN-2024, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue extreme). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain), headache (Verbatim: headache) and antinuclear antibody increased (Verbatim: I have high ANA). On 17-APR-2024, the outcome of the fatigue was resolved (duration 2 months 18 days). The outcome of the nerve pain and headache were resolving and the outcome of the antinuclear antibody increased was not reported.   It was unknown if the reporter considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.     It was unknown if the company considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient self reported this case for herself. The reporter reported that, she had a nerve pain, headache and extreme fatigue as a result of 3 covid vaccines. After 2 plus weeks, it was considerably improved.  After 3 plus weeks the patient was back to normal.  The reporter reported, this happened with Shingrix and she only improved slightly.  The reporter's physician ran tests and the reporter had high antinuclear antibody, multiple nuclear dots pattern. The reporter was getting further tests.  The reporter asked was it possible that she had an extreme reaction to Shingrix and it threw off her tests temporarily.   The gastroenterologist said the reporter's liver could had reacted to Shingrix as a toxin and done this.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypersomnia, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: nerve pain; headache; I have high ANA; Fatigue extreme; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of neuralgia (Received 3 Covid vaccines, had a nerve pain, headache and extreme fatigue.).   On 29-JAN-2024, the patient received Shingrix. On 30-JAN-2024, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue extreme). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain), headache (Verbatim: headache) and antinuclear antibody increased (Verbatim: I have high ANA). On 17-APR-2024, the outcome of the fatigue was resolved (duration 2 months 18 days). The outcome of the nerve pain and headache were resolving and the outcome of the antinuclear antibody increased was not reported.   It was unknown if the reporter considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.     It was unknown if the company considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient self reported this case for herself. The reporter reported that, she had a nerve pain, headache and extreme fatigue as a result of 3 covid vaccines. After 2 plus weeks, it was considerably improved.  After 3 plus weeks the patient was back to normal.  The reporter reported, this happened with Shingrix and she only improved slightly.  The reporter's physician ran tests and the reporter had high antinuclear antibody, multiple nuclear dots pattern. The reporter was getting further tests.  The reporter asked was it possible that she had an extreme reaction to Shingrix and it threw off her tests temporarily.   The gastroenterologist said the reporter's liver could had reacted to Shingrix as a toxin and done this.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Selective IgM immunodeficiency
Clinical narrative: nerve pain; headache; I have high ANA; Fatigue extreme; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of neuralgia (Received 3 Covid vaccines, had a nerve pain, headache and extreme fatigue.).   On 29-JAN-2024, the patient received Shingrix. On 30-JAN-2024, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue extreme). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain), headache (Verbatim: headache) and antinuclear antibody increased (Verbatim: I have high ANA). On 17-APR-2024, the outcome of the fatigue was resolved (duration 2 months 18 days). The outcome of the nerve pain and headache were resolving and the outcome of the antinuclear antibody increased was not reported.   It was unknown if the reporter considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.     It was unknown if the company considered the fatigue, nerve pain, headache and antinuclear antibody increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient self reported this case for herself. The reporter reported that, she had a nerve pain, headache and extreme fatigue as a result of 3 covid vaccines. After 2 plus weeks, it was considerably improved.  After 3 plus weeks the patient was back to normal.  The reporter reported, this happened with Shingrix and she only improved slightly.  The reporter's physician ran tests and the reporter had high antinuclear antibody, multiple nuclear dots pattern. The reporter was getting further tests.  The reporter asked was it possible that she had an extreme reaction to Shingrix and it threw off her tests temporarily.   The gastroenterologist said the reporter's liver could had reacted to Shingrix as a toxin and done this.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: The vaccine expired on March 31st 2024 and the vaccine was administered on April 11th 2024; 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 24-year-old female patient who received Men B NVS (Bexsero) (expiry date 31-MAR-2024) for prophylaxis.   On 11-APR-2024, the patient received Bexsero. On 11-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: The vaccine expired on March 31st 2024 and the vaccine was administered on April 11th 2024). The outcome of the expired vaccine used 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: 16-APR-2024 The health care professional called and reported regarding the administration of an expired Bexsero dose to a patient, which led to expired vaccine used. The reporter asked if the patient had to be revaccinated. The reporter did not provided lot number.
Sex: U
Vaccine: HEPAB
Symptoms: Product dispensing error, Product storage error, Recalled product administered
Clinical narrative: Twinrix that was stored outside of temperature range at manufacturer; and is part of a recall; drug dispensing error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAB (Twinrix adult) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   On an unknown date, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incorrect storage of drug (Verbatim: Twinrix that was stored outside of temperature range at manufacturer), recalled drug administered (Verbatim: and is part of a recall) and drug dispensing error (Verbatim: drug dispensing error). The outcome of the incorrect storage of drug, recalled drug administered and drug dispensing error were 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: 18-APR-2024 The pharmacist requested stability data on Twinrix that was stored outside of temperature range at manufacturer and was part of a recall, however 1 vaccine was administered to a patient which led to incorrect storage of drug. The pharmacist reported, Twinrix was stored at 25 Fahrenheit for 60 minutes during manufacturing process.  The pharmacist reported, Twinrix had returned to manufacturer.  The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received his second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The pharmacist reported that a patient only received his first dose of Shingrix and he had not yet received his second dose. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received his first dose of Shingrix, States that he never received his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd August 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received his first dose of Shingrix, States that he never received his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The patient self-reported this case. The patient stated that he never received his second dose.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a patient that is 30 months old and she is behind on her vaccine, she came in for her third dtap/ipv but she was given a Kinrix; She came in for her third doses of DTAP and IPV and then she was given a Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient that is 30 months old and she is behind on her vaccine, she came in for her third dtap/ipv but she was given a Kinrix) and inappropriate schedule of vaccine administered (Verbatim: She came in for her third doses of DTAP and IPV and then she was given a Kinrix). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 18-APR-2024 Medical Doctor called to report the following They had a patient that was 30 months old and she was behind on her vaccine, she came in for her third dtap/ipv but she was given a Kinrix, and there was appropriate space in between second and the third dose. The patient came in for her third doses of DTAP and IPV and then she was given a Kinrix. Lot number, 34MF9 provided by HCP was an Infanrix vaccine. 30 months old patient received Kinrix as 3rd dose of dtap and ipv, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administration. Did not consent to follow-up. Lot number provided by HCP was an INFANRIX vaccine.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site oedema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: immediately felt pain; noticed edema at the injection site; a warm sensation when touching the skin at injection sit; felt nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2024 12:10, the patient received the 2nd dose of Shingrix (injection, left deltoid). On 20-APR-2024, 2 hrs after receiving Shingrix, the patient experienced nausea (Verbatim: felt nausea). On 20-APR-2024 12:10, the patient experienced injection site pain (Verbatim: immediately felt pain), injection site edema (Verbatim: noticed edema at the injection site) and injection site warmth (Verbatim: a warm sensation when touching the skin at injection sit). The patient was treated with acetylsalicylic acid (Asprin). The outcome of the injection site pain and nausea were resolved and the outcome of the injection site edema and injection site warmth were not resolved.   It was unknown if the reporter considered the injection site pain, injection site edema, injection site warmth and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site edema, injection site warmth and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-APR-2024 The reporter was the patient.  The reporter stated that she received Shingrix suspect vaccine last Saturday at 12:10 pm in her left deltoid. The reporter reported that she immediately felt pain, a warm sensation when touching the skin at injection sit and noticed edema at the injection site.  The reporter stated that these symptoms were very mild and did not interfere with her activities of daily living.  The reporter stated that the pain was resolved but the warmth and edema at injection site remained. The reporter reported that she treated her symptoms with Aspirin. The reporter reported that 2 hours after receiving suspect product she felt nausea that continued for 2 day and then resolved. The lot number was not available at the time of report. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YC75, expiry date 17-MAY-2026) for prophylaxis.   On 09-APR-2024, the patient received Shingrix. On 09-APR-2024, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter stated that she went to one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 Celsius.  The reporter stated that that facility had not documented a temperature recording since 5th April 2024, so she was unsure how long the temperature was out of range.  There was a dose of Shingrix administered on 9th April 2024 to a patient which led to incorrect storage of drug. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024050074:same reporter US-GSK-US2024050077:same reporter US-GSK-US2024050075:same reporter US-GSK-US2024050072:same reporter US-GSK-US2024050076:same reporter
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: HPV Vaccine was extremely painful during injection, soreness the next day after injection. Soreness has not gone away. I feel it deep into my muscle. Scheduled to have second HPV vaccine 3/29/2024
Age: 75.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Chills, Feeling cold, Gait disturbance, Headache, Tremor
Clinical narrative: To whom it may concern: Over the years I have received a multitude of vaccine shoots with no side effects. Yesterday changed all that. I received my second Shingles shot and the RSV shots. Exactly 8 hours later I developed a headache. I don't get headaches. Worse yet, 15 minutes later I got the chiils which morphed into my entire body shaking and I could barely walk. I got into bed with heavy blanket and still could not get warm. That lasted for hours before I finally warmed up. Today, the headache persists. I don't know if this is a common reaction from getting both shots at once, but if it is, people should be warned about it OR the shots should be given separately. I tried to report this but don't have the form
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Axillary pain
Clinical narrative: I received the RSV AREXVY INJECTION IN MY RIGHT ARM. THE PAIN IS UNBEARABLE IN MY ARM PIT..THIS ISN'T LIST AS A SIDE EFFECT. I RECEIVED THE VACCINE AT PHARMACY
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Chills, Dyspnoea, Fatigue, Off label use
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Received two doses, 11-Feb-2023 and 04-May-2023; Chills; Very heavy fatigue; Difficulty breathing; Lot of congestion; Fever; This serious, initial spontaneous safety report was received by Novavax on 05-APR-2024 from a consumer via the contact center.  A 53 year old female of an unspecified race was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 11-FEB-2023 and dose 2 on 04-MAY-2023 at a community clinic.  Medical history included Diabetes mellitus, a food allergy and hypersensitivity to penicillin.  No concomitant medications were reported.  On 04-MAY-2023, the individual was vaccinated with their second dose of Novavax (PT: Off label use). On an unspecified day in NOV-2023, after vaccination, the individual tested positive for covid-19 (PT: Breakthrough COVID-19) (PT: Vaccination failure). On an unspecified date in 2023, after vaccination, the individual experienced chills (PT: Chills), fever (PT: Pyrexia), very heavy fatigue (PT: Fatigue), difficulty breathing (PT: Dyspnoea), with a lot of congestion (PT: Unevaluable event). At no point did the individual suspect that her life was in danger.  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; NOV-2023).  At the time of reporting, the event outcomes of Breakthrough COVID-19, Chills, Fatigue, Dyspnoea, Unevaluable event, Pyrexia and Vaccination failure were recovered/resolved.  On 08-Apr-2024, non-significant additional information was received and there was no new information reported.  On 09-APR-2024 significant additional information was received from a consumer via the contact center. Updated reporter's country of incidence from one country to another country once the patient received Novavax Covid-19 Vaccine, Adjuvanted formula. Updated the event onset date and stop date of Vaccination failure event to 04-May-2023. Dose 1 of Novavax administered on 11-Feb-2023 was captured in the patient past therapy as there were no events associated with this dose.; Sender's Comments: This 53 year-old female experienced: Vaccination failure, Off Label Use, Chills, Dyspnoea, Fatigue, Pyrexia, Unevaluable event and Breakthrough COVID-19 after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events Off Label Use, Chills, Dyspnoea, Fatigue, Pyrexia, Unevaluable event and Breakthrough COVID-19 were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event of Vaccination failure is considered Related, Novavax Covid-19 Vaccine, Adjuvanted and the other reported events is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Unevaluable event, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Received two doses, 11-Feb-2023 and 04-May-2023; Chills; Very heavy fatigue; Difficulty breathing; Lot of congestion; Fever; This serious, initial spontaneous safety report was received by Novavax on 05-APR-2024 from a consumer via the contact center.  A 53 year old female of an unspecified race was vaccinated with intramuscular use Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 11-FEB-2023 and dose 2 on 04-MAY-2023 at a community clinic.  Medical history included Diabetes mellitus, a food allergy and hypersensitivity to penicillin.  No concomitant medications were reported.  On 04-MAY-2023, the individual was vaccinated with their second dose of Novavax (PT: Off label use). On an unspecified day in NOV-2023, after vaccination, the individual tested positive for covid-19 (PT: Breakthrough COVID-19) (PT: Vaccination failure). On an unspecified date in 2023, after vaccination, the individual experienced chills (PT: Chills), fever (PT: Pyrexia), very heavy fatigue (PT: Fatigue), difficulty breathing (PT: Dyspnoea), with a lot of congestion (PT: Unevaluable event). At no point did the individual suspect that her life was in danger.  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; NOV-2023).  At the time of reporting, the event outcomes of Breakthrough COVID-19, Chills, Fatigue, Dyspnoea, Unevaluable event, Pyrexia and Vaccination failure were recovered/resolved.  On 08-Apr-2024, non-significant additional information was received and there was no new information reported.  On 09-APR-2024 significant additional information was received from a consumer via the contact center. Updated reporter's country of incidence from one country to another country once the patient received Novavax Covid-19 Vaccine, Adjuvanted formula. Updated the event onset date and stop date of Vaccination failure event to 04-May-2023. Dose 1 of Novavax administered on 11-Feb-2023 was captured in the patient past therapy as there were no events associated with this dose.; Sender's Comments: This 53 year-old female experienced: Vaccination failure, Off Label Use, Chills, Dyspnoea, Fatigue, Pyrexia, Unevaluable event and Breakthrough COVID-19 after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events Off Label Use, Chills, Dyspnoea, Fatigue, Pyrexia, Unevaluable event and Breakthrough COVID-19 were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event of Vaccination failure is considered Related, Novavax Covid-19 Vaccine, Adjuvanted and the other reported events is considered Possible.
Age: 41.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: On 04/24/2024 patient stated she developed pain with redness and swelling at injection site on left arm. Denies any itching . Patient has had some fevers. Denies any nausea or vomiting. Treament plan to give Keflex QID and Tylnelol.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Alanine aminotransferase normal, Bilirubin conjugated, Blood lactic acid
Clinical narrative: Redness, swelling, pain,  fever,  shallow breathing,  chills, hives, itching, urticaria continuing to spread 5 days post vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Differential white blood cell count normal, Full blood count normal, Hypopnoea, International normalised ratio normal
Clinical narrative: Redness, swelling, pain,  fever,  shallow breathing,  chills, hives, itching, urticaria continuing to spread 5 days post vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, Prothrombin time normal, Pruritus, Pyrexia
Clinical narrative: Redness, swelling, pain,  fever,  shallow breathing,  chills, hives, itching, urticaria continuing to spread 5 days post vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urine analysis normal, Urobilinogen urine, Urticaria
Clinical narrative: Redness, swelling, pain,  fever,  shallow breathing,  chills, hives, itching, urticaria continuing to spread 5 days post vaccine
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Patient's daughter and patient said when patient received the 2nd Pfizer vaccine she lost vision in her right eye for 3 hours and the doctor discontinued all further Covid-19 vaccines. No additional information available regarding if the patient sought treatment following vision loss. Conflicting information regarding whether vision loss persisted for 5 minutes vs 3 hours.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given expired no symptoms
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Anger, Blood test, Circumstance or information capable of leading to medication error, Exposure during pregnancy, Headache
Clinical narrative: She got her vaccine, she went to the lab to have blood work done as she is 12 weeks pregnant to have work done for that, not a vaccine.  There apparently was a mix up and they gave her the HPV vaccine instead.  After she got the vaccine, and they came to talk to her and let her know what was going on and told her that there was a mix up and that they had gotten her confused with somebody else.  Her name was verified, her DOB was not verified or anything else.  They went a got the head of the department, and the nurse came in and did the blood work.  The head of the department came in and told her what the HPV was for, and she is angry that she was given this.  They told her to call if she had any problems, she has a headache that will not go away and she has taken Tylenol but it will not go away.  She has called her OB and left a message that she got this vaccine by accident.  She is not having any other symptoms besides the headacahe.   She has not had any headaches without any morning sickness or anything, said she has been perfectly fine.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Wrong patient received product
Clinical narrative: She got her vaccine, she went to the lab to have blood work done as she is 12 weeks pregnant to have work done for that, not a vaccine.  There apparently was a mix up and they gave her the HPV vaccine instead.  After she got the vaccine, and they came to talk to her and let her know what was going on and told her that there was a mix up and that they had gotten her confused with somebody else.  Her name was verified, her DOB was not verified or anything else.  They went a got the head of the department, and the nurse came in and did the blood work.  The head of the department came in and told her what the HPV was for, and she is angry that she was given this.  They told her to call if she had any problems, she has a headache that will not go away and she has taken Tylenol but it will not go away.  She has called her OB and left a message that she got this vaccine by accident.  She is not having any other symptoms besides the headacahe.   She has not had any headaches without any morning sickness or anything, said she has been perfectly fine.
Age: 74.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient mistakenly administered 2 doses of Heplisav-B vaccine instead of Heplisav and Havrix vaccines
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product preparation error
Clinical narrative: the patient needed Polio, DTAP, and HIB. The provider opted to use the combination vaccination Pentacel. During the preparation of the Pentacel vaccine the DTAP and Polio component was drawn up but not combined with the HIB component. The patient was then administered the DTAP and Polio only. The patient's guardian was notified that the patient is missing the HIB component of vaccination. The patient has been scheduled for O5/01/2024 to receive the missing HIB vaccination.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE ADVENTS.
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Hep B was ordered by Dr.. Hep A was administered in error. Notified Dr and Nursing Manager. Couched parents and reassured patient will be okay. Answered any questions they had. Parents agreed to bring pt back in one month to give Hep B.
Age: 10.0
Sex: M
Vaccine: FLU4, HEPA, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions noted. Pfizer vaccine given was stored in -25 C.  Per manufacturer vaccine is non viable..
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired COVID Spikevax vaccine to patient. Patient did not experience an adverse reaction post administration.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions noted. Pfizer vaccine given was stored in -25 C.  Per manufacturer vaccine is non viable..
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered expired Moderna Spikevax vaccine. No current side effects.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large area on deltoid area of redness, hot to touch and tender.  Small raised bump right at injection site(felt like a mosquito bite)
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have any adverse reactions. Vaccine was given outside of recommended age range.  Dr. telephoned mother and explained the situation to her.  Mother reported that child was doing fine at the time of the call
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was accidently administered an expired vaccination on 4/30/2024  that was inactive on 4/6/2024. Provider realized immediately after completing documentation and notified leadership and Merck representative of incident. No recommendations per Merck but revaccinations is upon providers discretion.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: miscarriage at 8 weeks gestation
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pyrexia
Clinical narrative: PROVIDER NOTIFIED 4/25/24 - BENADRYL & TYLENOL GIVEN RESPONDED WELL BUT STILL HAD MINOR ISSUES THROUGHOUT THE NIGHT OF THE 25TH AND THE MORNING OF THE 26TH - POSSIBLE VASOVAGAL RESPONSE OR DEHYDRATION - ELEVATED FEVER OFF AND ON FOR 24 HOURS. PATIENT RECEIVED HPV VACCINE #2 ON 2/6/24 WITHOUT INCIDENT.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given 2nd dose before 6 month interval had passed
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Macule, Papule, Rash
Clinical narrative: Rash noted on extremities, the morning after the vaccine- Rash described has red papules/macules.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MCV (MenQuadfi) was administered instead of PCV. No side effects reported per parent.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose was given  4/26/24, expiration date was 4/25/24. No adverse reaction noted.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient presented for Well Child check- on reviewing the printed Immpact record and noting that patient was due for a Polio vaccine and Dtap as well as Hep A- MA opted to give patient a Kinrix and Hepatitis A vaccine as patient is very difficult to give vaccines to, the thought process was that less needlesticks would be most beneficial. After giving vaccine and entering into system, it was noted that Kinrix is authorized for only fourth and fifth doses. I have contacted system administrator and spoke w/ employee who informed me that this dose can be counted as "valid" but should be reported to VAERS as it was given outside of the authorized range.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient accepted flu vaccine and stated he had not had a flu vaccine this season. After administering the flu vaccine, it was determined that the patient had received a flu vaccine in January 2024. No problems related to the injection are noted at this time.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Patient was given the 0.3 COVID vaccine without being diluted as prescribed. Called Pfizer safety reporting system. They informed me that minimal to no adverse reactions should be seen.  NO adverse reaction was observed or voice by mother of patient. MD spoke with mother and was instructed to watch for any adverse reactions with irritation at the site or fever.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Type 2 diabetes mellitus
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 3/31/2024. Patient has no report adverse effects from vaccination. GSK contacted and states they do not have studies to support stability of vaccine past expiration, advised the CDCs guideline recommends the patient be vaccinated again.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 3/31/2024. Patient has no reported adverse effects from vaccination. GSK contacted and states they do not have studies to support stability of vaccine past expiration, advised the CDCs guideline recommends the patient be vaccinated again.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired on 3/31/2024. Patient has no reported adverse effects from vaccination. GSK contacted and states they do not have studies to support stability of vaccine past expiration, advised the CDCs guideline recommends the patient be vaccinated again.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no adverse effects noted
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose was expired. No adverse effects noted.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired. No adverse effects noted.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose was expired. No adverse effects.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired. No adverse effects noted.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered was expired. No adverse effects noted.
Age: 75.0
Sex: M
Vaccine: COVID19, PNC20, TDAP, VARZOS
Symptoms: Cervical vertebral fracture, Computerised tomogram spine abnormal, Dizziness, Fall, Nausea
Clinical narrative: Patient found lying on his right side on the floor and sustained laceration on the left occipital area.  Complained of pain, dizziness and nausea post unwitnessed fall. Patient transferred to emergency care for further evaluation.
Age: 75.0
Sex: M
Vaccine: COVID19, PNC20, TDAP, VARZOS
Symptoms: Pain, Presyncope, Skin laceration
Clinical narrative: Patient found lying on his right side on the floor and sustained laceration on the left occipital area.  Complained of pain, dizziness and nausea post unwitnessed fall. Patient transferred to emergency care for further evaluation.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient experienced a fever the day after receiving the vaccine. This reaction lasted only 1 day. Patient also experiencing redness and swelling around the injection site.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired. No adverse effects noted.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis at HPV vaccine administration site. Per state ID, he may receive second dose of HPV vaccine per recommended schedule.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Ear pain, Full blood count, Gait inability, Headache
Clinical narrative: extreme lethary, prolonged pain in head/ear/neck, 24 hours, inability to walk, drive a car, think initially.  sweating,
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypothyroidism, Impaired driving ability, Inflammatory marker increased, Mental impairment
Clinical narrative: extreme lethary, prolonged pain in head/ear/neck, 24 hours, inability to walk, drive a car, think initially.  sweating,
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: extreme lethary, prolonged pain in head/ear/neck, 24 hours, inability to walk, drive a car, think initially.  sweating,
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired. No adverse effects noted.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was suppose to receive Meningococcal ACYW vaccine but was instead given Meningococcal B. Patient had no adverse symptoms or signs after vaccine administration. Patient was given the Meningococcal B vaccine the same day with provider's  consent and acknowledgment.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired but no adverse effects noted
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Presyncope, Vision blurred
Clinical narrative: Patient was fine after getting up and going out to sit down. Went to check on patient about 7 minutes after vaccine given. Patient stated feeling dizzy and had blurred vision. Stated was unable to see me clearly-began to have what appeared to be a vagel response, was sweating profusely and clammy. Patient almost lost consciousness. Reported to management and was sent to ER for evaluation. Patient called today and was doing fine. It was ruled a reaction to the vaccine.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Neuropathy peripheral, Vitamin D deficiency
Clinical narrative: Neuropathy of feet started within 2 weeks and then spread to legs and torso by January 2024
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling
Clinical narrative: swollen thigh
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects were noted.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no adverse effects
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Pollakiuria
Clinical narrative: FREQUENT URINATION
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired no adverse effects
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired no adverse effects noted
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, not adverse effects
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient received Varicella 02/20/2024 and I gave again a dose today 04/30/24
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 39.0
Sex: M
Vaccine: TYP, YF
Symptoms: Expired product administered
Clinical narrative: Patient arrived at clinic to receive vaccines for travel. Yellow fever vaccine and Typhoid vaccine were ordered by Dr. after doctor's visit. CMA administered Yellow fever vaccine and Typhoid vaccine on patient's left arm at 08:25AM. Patient waited 15 minutes in clinic for any adverse reactions. At 8:40AM, CMA had input the vaccines into patient's medical record and found vaccine for Yellow fever vaccine was expired.  Yellow Fever vaccine: LOT: UJ818AA, EXP: 18APR24, Typhoid vaccine: LOT: V2A501M, 08NOV24. CMA notified clinic administrator and Dr.. CMA contacted pharmacist at facility for further instructions on whether patient will need to be readministered Yellow fever vaccine. Pt was notified by CMA at 10:30AM to visit clinic. Pt was personally notified of incident regarding administered expired vaccine at 12:30PM with HS1, and HS2 present. Once the facility pharmacist notifies CMA on further instructions, CMA will notify patient. Patient will be traveling starting this Sunday, May 05, 2024.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Inflammation, Mobility decreased, Skin warm
Clinical narrative: Red,inflammed and hot unable to lift arm 4/25/24
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bursitis, Injected limb mobility decreased, Magnetic resonance imaging joint, Shoulder injury related to vaccine administration
Clinical narrative: Sirva - Shoulder pain & loss of mobility.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: itching for 1 week