chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Illness, Influenza, Insomnia, Pain
Clinical narrative: second shot made me sick; I had the flu plus my arm for it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, burning sensation, pain, pruritus and sleeplessness. Previously administered products included Shingrix with an associated reaction of illness (1st dose received on an unknown date, refer case US2023AMR101740).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: second shot made me sick) and influenza (Verbatim: I had the flu plus my arm for it). Rechallenge with Shingles vaccine was positive. The outcome of the sickness and influenza were not reported.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she had shingles and it was no joke, the burning and the pain and itching were all at the same time which made it hard to sleep.  The patient stated that as soon as the shingles went away he/she got vaccinated.  The second shot made the patient sick like he/she had the flu plus his/her arm for it. The patient stated that but it was worth it because if you do not get vaccinated, even if you had Shingles, you can get it again. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR101740:same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: second shot made me sick; I had the flu plus my arm for it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, burning sensation, pain, pruritus and sleeplessness. Previously administered products included Shingrix with an associated reaction of illness (1st dose received on an unknown date, refer case US2023AMR101740).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: second shot made me sick) and influenza (Verbatim: I had the flu plus my arm for it). Rechallenge with Shingles vaccine was positive. The outcome of the sickness and influenza were not reported.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     It was unknown if the company considered the sickness and influenza to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she had shingles and it was no joke, the burning and the pain and itching were all at the same time which made it hard to sleep.  The patient stated that as soon as the shingles went away he/she got vaccinated.  The second shot made the patient sick like he/she had the flu plus his/her arm for it. The patient stated that but it was worth it because if you do not get vaccinated, even if you had Shingles, you can get it again. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR101740:same patient, 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Suspected COVID-19
Clinical narrative: experienced covid like symptoms; This non-serious case was reported by a other health professional via call center representative and described the occurrence of suspected covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced suspected covid-19 (Verbatim: experienced covid like symptoms). The outcome of the suspected covid-19 was not reported.   It was unknown if the reporter considered the suspected covid-19 to be related to Shingrix.     It was unknown if the company considered the suspected covid-19 to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The reporter reported personal adverse reaction to Shingrix injection, experienced Covid like symptoms and declined 2nd dose. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: It knocks your arm down for a few days; Hurts the first 72 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Hurts the first 72 hours) and arm discomfort (Verbatim: It knocks your arm down for a few days). The outcome of the pain in arm was resolved (duration 72 hrs) and the outcome of the arm discomfort was resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUL-2023 This case was reported by a patient via interactive digital media. By coincidence the patient went to the pharmacy and received free Shingles vaccine. The patient reported that the vaccine knocked out arm for a few days and it hurt for the first 72 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Vaccine positive rechallenge
Clinical narrative: redness; swelling; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (For tolerance of 1st dose, refer case US2023AMR103380).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: redness) and swelling (Verbatim: swelling). Rechallenge with Shingrix was positive. The outcome of the erythema and swelling were not reported.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     It was unknown if the company considered the erythema and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 It was reported that patient upon receiving both of her doses of Shingrix, had redness and swelling afterwards. No other information reported. The reporter did not consent to follow up. For tolerance of 1st dose, refer case US2023AMR103380.; Sender's Comments:  US-GSK-US2023AMR103380:Same patient/shingrix second dose
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Epilepsy, Myocarditis
Clinical narrative: EPILEPSY, LOCALIZATION RELATED MYOCARDITIS
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Live vaccine administered to soon after prior live vaccine administration.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dressler's syndrome
Clinical narrative: PERICARDITIS POST ACUTE MI
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: Mild fever, rash, & cough 1-2 days after 12 month vaccinations.  Received all 4 vaccines at same time on 4/20/23.  Mild fever started 4/21/23 and persisted through 4/22/23.  TMax 101.4F.  No trouble breathing, no nausea, vomiting, or diarrhea.  Patient presented to ED w/ guardian on 4/24/23 with no fever, but mild rash.   Symptomatic treatment w/ Benadryl and Tylenol as needed for fever.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Myocardial ischaemia
Clinical narrative: ACUTE NON ST ELEVATION MI DEMAND ISCHEMIA
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: WE HAVE CONTACTED PFIZER ABOUT THIS EVENT. THERE HAS NOT BEEN ANY SIDE EFFECTS NOTE BY THE PATIENT.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: WE HAVE CONTACTED PFIZER. THERE WAS NO ADDITIONAL SIGNS AND SYMPTOMS BROUGHT TO OUR ATENTION BY THE PATIENT.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Nurse administered undiluted vaccine.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Nurse administered undiluted vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 6/17/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angina unstable
Clinical narrative: UNSTABLE ANGINA
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Nocturnal hypoventilation
Clinical narrative: SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: WE CONTACTED PFIZER. THERE WERE NO SIGN AND SYMPTOMS BROUGHT TO OUR ATTENTION BY PATIENT.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriovenous fistula, Hypotension
Clinical narrative: I95.89 CHRONIC HYPOTENSION 11/25/2022 ACQUIRED ARTERIOVENOUS FISTULA I95.9 HYPOTENSION 11/16/2022 ACQUIRED ARTERIOVENOUS FISTULA
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, COVID-19 pneumonia, Death, Dyspnoea, Fall
Clinical narrative: My mother became ill not even a week after her second covid vaccine.  She was constantly sleeping and had sudden onset breathing issues.  She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs.  She was inpatient at Hospital.  Multiple COVID tests were given while she was hospitalized all of which returned back negative.  Death certificate indicated she died from pneumonia as a result of COVID.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Haematological infection, Hypersomnia, Malaise, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: My mother became ill not even a week after her second covid vaccine.  She was constantly sleeping and had sudden onset breathing issues.  She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs.  She was inpatient at Hospital.  Multiple COVID tests were given while she was hospitalized all of which returned back negative.  Death certificate indicated she died from pneumonia as a result of COVID.
Age: 66.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Injection site rash, Rash pruritic
Clinical narrative: Patient came in on 08/01/2023 at 10:47 am to report a reaction to a vaccination she received on 07/08/2023. She stated that on the 2nd day, she had a few bumps appear, which increased in size. They were itchy and burning. It was localized to the area underneath the injection size. After around 3 days, blisters started appearing. She stated that she tried over the counter Benadryl, Calamine, and Neosporin cream. She had a consultation with her primary care physician (Dr.) on 8/1/23, who prescribed Valtrex and Gabapentin. The patient stated that it appeared as if the patient was having a shingles outbreak.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: SADDLE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dermatitis acneiform, Pain, Pruritus, Rash
Clinical narrative: Patient states that he started having body aches and soreness with weakness a day after the vaccination. later this progressed to red rash all over his body, rash looks like clusters of pimples with itching all over his body. He spoke with a nurse at his insurance who advised him to use benadryl oral and cortisone cream. So far it is getting worse so I advised him to go see a doctor.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient states that he started having body aches and soreness with weakness a day after the vaccination. later this progressed to red rash all over his body, rash looks like clusters of pimples with itching all over his body. He spoke with a nurse at his insurance who advised him to use benadryl oral and cortisone cream. So far it is getting worse so I advised him to go see a doctor.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given too early, was due to be administered on or after 12/14/2023 but administered in error today 8/01/2023
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bladder pain, Dysuria, Monoplegia, Myalgia
Clinical narrative: not able to urinate naturally and to empty bladder completely resulting in pain; Bladder incontinence; not able to urinate naturally and to empty bladder completely resulting in pain; was not able to urinate naturally and to empty bladder completely resulting in pain; pain in the muscle of both legs that progressed to paralyzed both legs; pain in the muscle of both legs that progressed to paralyzed both legs; back pain; This serious case was reported by a consumer via call center representative and described the occurrence of leg paralysis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-FEB-2023, the patient received the 1st dose of Shingrix. In MAY-2023, between 2 and 3 months after receiving Shingrix, the patient experienced leg paralysis (Verbatim: pain in the muscle of both legs that progressed to paralyzed both legs) (serious criteria GSK medically significant), myalgia of lower extremities (Verbatim: pain in the muscle of both legs that progressed to paralyzed both legs) and back pain (Verbatim: back pain). On an unknown date, the patient experienced unable to urinate (Verbatim: not able to urinate naturally and to empty bladder completely resulting in pain) (serious criteria GSK medically significant), bladder incontinence (Verbatim: Bladder incontinence), bladder pain (Verbatim: not able to urinate naturally and to empty bladder completely resulting in pain) and painful urination (Verbatim: was not able to urinate naturally and to empty bladder completely resulting in pain). The outcome of the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities and back pain were unknown and the outcome of the painful urination was not reported.   It was unknown if the reporter considered the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities, back pain and painful urination to be related to Shingrix.     It was unknown if the company considered the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities, back pain and painful urination to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 On behalf of patient, reporter stated that his girlfriend received the first dose of Shingrix, after couple of weeks later experienced bladder incontinence. She was not able to urinate naturally and to empty her bladder which resulted in pain. She visited the doctor to check kidneys, which were fine. In May 2023 she had developed with back pain and pain in the muscle of both legs that progressed to paralyzed both her legs. Since the patient was in rehab. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence, Urinary retention
Clinical narrative: not able to urinate naturally and to empty bladder completely resulting in pain; Bladder incontinence; not able to urinate naturally and to empty bladder completely resulting in pain; was not able to urinate naturally and to empty bladder completely resulting in pain; pain in the muscle of both legs that progressed to paralyzed both legs; pain in the muscle of both legs that progressed to paralyzed both legs; back pain; This serious case was reported by a consumer via call center representative and described the occurrence of leg paralysis in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-FEB-2023, the patient received the 1st dose of Shingrix. In MAY-2023, between 2 and 3 months after receiving Shingrix, the patient experienced leg paralysis (Verbatim: pain in the muscle of both legs that progressed to paralyzed both legs) (serious criteria GSK medically significant), myalgia of lower extremities (Verbatim: pain in the muscle of both legs that progressed to paralyzed both legs) and back pain (Verbatim: back pain). On an unknown date, the patient experienced unable to urinate (Verbatim: not able to urinate naturally and to empty bladder completely resulting in pain) (serious criteria GSK medically significant), bladder incontinence (Verbatim: Bladder incontinence), bladder pain (Verbatim: not able to urinate naturally and to empty bladder completely resulting in pain) and painful urination (Verbatim: was not able to urinate naturally and to empty bladder completely resulting in pain). The outcome of the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities and back pain were unknown and the outcome of the painful urination was not reported.   It was unknown if the reporter considered the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities, back pain and painful urination to be related to Shingrix.     It was unknown if the company considered the leg paralysis, unable to urinate, bladder incontinence, bladder pain, myalgia of lower extremities, back pain and painful urination to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 On behalf of patient, reporter stated that his girlfriend received the first dose of Shingrix, after couple of weeks later experienced bladder incontinence. She was not able to urinate naturally and to empty her bladder which resulted in pain. She visited the doctor to check kidneys, which were fine. In May 2023 she had developed with back pain and pain in the muscle of both legs that progressed to paralyzed both her legs. Since the patient was in rehab. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Angina unstable, Symptom recurrence
Clinical narrative: UNSTABLE ANGINA ANGINA, UNSPECIFIED 1/29/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Infection Breakthrough
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site cellulitis, Vaccination site erythema, Vaccination site oedema, Vaccination site warmth
Clinical narrative: Assessment Left leg cellulitis (L03.116). Impression well appearing afebrile 4 yo F with cellulitis of L leg at vaccination site  skin with erythema, edema, and warmth that is ttp on anterior and medial L thigh.   we will treat with Cephalexin TID for 7 days Other care and return precautions discussed. Patient Plan Cellulitis treatment: Keflex 3 times per day for 7 days Improvement should begin within 24-72 hours on antibiotics. Take ibuprofen 7-8 ml up to 3 times per day as needed for pain or irritation. Follow up if redness spreading after 24 hours on antibiotics, if an area of pus develops or grows, there is increasing pain in the area or in involved lymph nodes, or if you develop new fevers.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma-chronic obstructive pulmonary disease overlap syndrome, Hypoxia
Clinical narrative: R09.02 HYPOXIA 4/19/2023 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
Age: 0.25
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction . He was over 14 wks. old
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough indection
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, Blood oestrogen decreased, Blood oestrogen increased, COVID-19, Heart rate decreased
Clinical narrative: June 21, 2021 FIRST PFIZER VACCINE LOT NUMBER: EW0181  That first night I couldn't walk. Chills and high ever. My body was hurting. Took Motrin. It lasted 2 days.  Every 3 months I would get the reaction.  Lab work came out abnormal Quantitative level were high 1454 a whole year later. In between the episodes of the 3 months I was getting sick.  nov. 11 2021 estrogen was low and now high, Over 800.  december thyroids went high again Antibodies were very high glands and neck were swallon Feb 2022 - my heart rate started going low in the 50's.  April 3rd Sever Sinus infection -steroids and medications. May 2022 - glands were swallon July 2022 -pneumonia fractured ribs , tested positive for covid  Sep 2022- NOW  I kept getting sick and sick.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Inflammation, Laboratory test abnormal, Lymphadenopathy, Malaise
Clinical narrative: June 21, 2021 FIRST PFIZER VACCINE LOT NUMBER: EW0181  That first night I couldn't walk. Chills and high ever. My body was hurting. Took Motrin. It lasted 2 days.  Every 3 months I would get the reaction.  Lab work came out abnormal Quantitative level were high 1454 a whole year later. In between the episodes of the 3 months I was getting sick.  nov. 11 2021 estrogen was low and now high, Over 800.  december thyroids went high again Antibodies were very high glands and neck were swallon Feb 2022 - my heart rate started going low in the 50's.  April 3rd Sever Sinus infection -steroids and medications. May 2022 - glands were swallon July 2022 -pneumonia fractured ribs , tested positive for covid  Sep 2022- NOW  I kept getting sick and sick.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Rib fracture, SARS-CoV-2 test positive, Sinusitis, Swelling
Clinical narrative: June 21, 2021 FIRST PFIZER VACCINE LOT NUMBER: EW0181  That first night I couldn't walk. Chills and high ever. My body was hurting. Took Motrin. It lasted 2 days.  Every 3 months I would get the reaction.  Lab work came out abnormal Quantitative level were high 1454 a whole year later. In between the episodes of the 3 months I was getting sick.  nov. 11 2021 estrogen was low and now high, Over 800.  december thyroids went high again Antibodies were very high glands and neck were swallon Feb 2022 - my heart rate started going low in the 50's.  April 3rd Sever Sinus infection -steroids and medications. May 2022 - glands were swallon July 2022 -pneumonia fractured ribs , tested positive for covid  Sep 2022- NOW  I kept getting sick and sick.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RV1
Symptoms: Incorrect dose administered, Vomiting
Clinical narrative: While administering RV1 orally, patient vomited large amount of white (formula looking ) liquid.  Patient received about half of the RV1 dose. Mother of patient requested to not administer the rest of the RV1. Patient's temporal temperature was 99.1 F. No other systems noted. Mother requested that the Vaxelis and PCV be given in the right thigh.  Patient tolerated the intramuscular injections with issues and breastfed after shots with any further issues.
Age: 66.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: She got her vaccine, it started like a little bump around where the vaccine was done.  The 2nd day it started a little more.  The third day she was getting 3 or 4 sores with blisters that burned and itched, and continued getting more blisters all around her arm in the front where the vaccine was given.  It burned and itching, never had this before.  She went to her doctor today and she prescribed her two prescriptions and sent her to a dermatologist.  She gave her Gabapentin 300 mg, and also was given a Valacyclovir 1 tablet as well for 7 days, and told to FU with the dermatologist.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia, Pulmonary embolism
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM HYPOXEMIA
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid Breakthrough Infection
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Plasma cell myeloma
Clinical narrative: Multiple Myeloma; This serious case was reported by a consumer via call center representative and described the occurrence of multiple myeloma in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2021, the patient received the 1st dose of Shingrix. In DEC-2021, between 4 and 6 months after receiving Shingrix, the patient experienced multiple myeloma (Verbatim: Multiple Myeloma) (serious criteria GSK medically significant). The outcome of the multiple myeloma was unknown.   It was unknown if the reporter considered the multiple myeloma to be related to Shingrix.     It was unknown if the company considered the multiple myeloma to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 In December 2021 she was diagnosed with multiple myeloma and the doctor recommended her not to administer the second dose of Shingrix. She received her second dose in August 2022 and completed her Shingrix series. The reporter did not consent to follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: An expired dose of COVID was given. The vaccine was expired by 1 day.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Altered state of consciousness, Condition aggravated, Eye pruritus, Eye swelling, Irritable bowel syndrome
Clinical narrative: She got her vaccine, no reaction for the first time ever, no reaction, felt fine all day on the 20th, even her arm was fine.  She woke up on 6/21/23 was fine, but by midday her lips were swollen, her eyes were swollen and itchy.  She had not taken any NSAIDS and had not had any mangos.  She had the classic symptoms she gets.  She took a Claritin that night and by the next morning the symptoms were gone.  She did not feel well on 6/22/23 and had an odd neurological reaction, had an altered state of consciousness, not a stroke or a TIA, did not loose consciousness, but it was odd.  She felt like she was in two realities at the same time that lasted about 7 minutes.  She was continuing to talk and acted normally.  She did mention it to her neurologist, and it was like an aura.  She did not feel well for the entire month, incredibly drowsy where she just wanted to sleep all the time.  Her IBS symptoms were worse, which was normal give the circumstances.  This makes her nervous about getting another one, but probably will.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lip swelling, Malaise, Nervousness, Neurological symptom, Somnolence
Clinical narrative: She got her vaccine, no reaction for the first time ever, no reaction, felt fine all day on the 20th, even her arm was fine.  She woke up on 6/21/23 was fine, but by midday her lips were swollen, her eyes were swollen and itchy.  She had not taken any NSAIDS and had not had any mangos.  She had the classic symptoms she gets.  She took a Claritin that night and by the next morning the symptoms were gone.  She did not feel well on 6/22/23 and had an odd neurological reaction, had an altered state of consciousness, not a stroke or a TIA, did not loose consciousness, but it was odd.  She felt like she was in two realities at the same time that lasted about 7 minutes.  She was continuing to talk and acted normally.  She did mention it to her neurologist, and it was like an aura.  She did not feel well for the entire month, incredibly drowsy where she just wanted to sleep all the time.  Her IBS symptoms were worse, which was normal give the circumstances.  This makes her nervous about getting another one, but probably will.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Allergy to vaccine, Anion gap, Blood calcium normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Per ED note:  Patient here for possible allergic reaction.  Brought in by EMS.  Patient reports a history of asthma, last major symptoms were around age 10 or 11.  States that about an hour prior to calling EMS he had preemployment vaccinations.  Computer records indicate that these included anthrax, Japanese encephalitis, typhoid and yellow fever.  He was feeling normal before the vaccination but about an hour later he started to feel short of breath and had some vague right-sided chest discomfort.  EMS was called and noted that his oxygen sat was around 90% and that he was wheezing apparently.  They administered Solu-Medrol 125 mg, Benadryl 25 mg and a DuoNeb.  The shortness of breath and wheezing completely resolved.  Patient still describes some vague right-sided discomfort of the chest.  He has no other symptoms.  Denies any swelling of the lips, tongue, throat, difficulty breathing or swallowing.  No vomiting.  No nausea.  No history of similar reaction.  11:16 -patient evaluated after EMS arrival.  Sent here is 98-99% on room air.  Lung exam and rest of physical exam completely normal at this time.  We will continue to monitor.  Do not feel any new or other medication required at this time.  1323: Patient has been largely asymptomatic throughout ED course.  Sleeping most of the time.  He woke up now states he feels back to normal except he noticed that his upper back is a little bit itchy.  On exam the upper portion of his back has a few small urticarial lesions.  Nothing extensive and no others patches on his body.  Will give extra Benadryl and continue to observe.  1453: Patient rechecked and doing well.  No symptoms.  No itching.  No significant rash.  Patient has been observed here for several hours without significant changes or signs of anaphylaxis.  Will give prescriptions for prednisone, Benadryl, EpiPen, albuterol inhaler.  Patient instructed on use of the medications.  Patient to follow-up with PCM.  Also, I spoke with Dr. from allergy clinic.  We will follow-up as a routine consult for specific testing for allergy to vaccine components.  Nurse to list vaccines under his allergy list in the meantime.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Blood glucose normal, Blood osmolarity decreased, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Per ED note:  Patient here for possible allergic reaction.  Brought in by EMS.  Patient reports a history of asthma, last major symptoms were around age 10 or 11.  States that about an hour prior to calling EMS he had preemployment vaccinations.  Computer records indicate that these included anthrax, Japanese encephalitis, typhoid and yellow fever.  He was feeling normal before the vaccination but about an hour later he started to feel short of breath and had some vague right-sided chest discomfort.  EMS was called and noted that his oxygen sat was around 90% and that he was wheezing apparently.  They administered Solu-Medrol 125 mg, Benadryl 25 mg and a DuoNeb.  The shortness of breath and wheezing completely resolved.  Patient still describes some vague right-sided discomfort of the chest.  He has no other symptoms.  Denies any swelling of the lips, tongue, throat, difficulty breathing or swallowing.  No vomiting.  No nausea.  No history of similar reaction.  11:16 -patient evaluated after EMS arrival.  Sent here is 98-99% on room air.  Lung exam and rest of physical exam completely normal at this time.  We will continue to monitor.  Do not feel any new or other medication required at this time.  1323: Patient has been largely asymptomatic throughout ED course.  Sleeping most of the time.  He woke up now states he feels back to normal except he noticed that his upper back is a little bit itchy.  On exam the upper portion of his back has a few small urticarial lesions.  Nothing extensive and no others patches on his body.  Will give extra Benadryl and continue to observe.  1453: Patient rechecked and doing well.  No symptoms.  No itching.  No significant rash.  Patient has been observed here for several hours without significant changes or signs of anaphylaxis.  Will give prescriptions for prednisone, Benadryl, EpiPen, albuterol inhaler.  Patient instructed on use of the medications.  Patient to follow-up with PCM.  Also, I spoke with Dr. from allergy clinic.  We will follow-up as a routine consult for specific testing for allergy to vaccine components.  Nurse to list vaccines under his allergy list in the meantime.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Carbon dioxide normal, Chest discomfort, Dyspnoea, Eosinophil count, Glomerular filtration rate
Clinical narrative: Per ED note:  Patient here for possible allergic reaction.  Brought in by EMS.  Patient reports a history of asthma, last major symptoms were around age 10 or 11.  States that about an hour prior to calling EMS he had preemployment vaccinations.  Computer records indicate that these included anthrax, Japanese encephalitis, typhoid and yellow fever.  He was feeling normal before the vaccination but about an hour later he started to feel short of breath and had some vague right-sided chest discomfort.  EMS was called and noted that his oxygen sat was around 90% and that he was wheezing apparently.  They administered Solu-Medrol 125 mg, Benadryl 25 mg and a DuoNeb.  The shortness of breath and wheezing completely resolved.  Patient still describes some vague right-sided discomfort of the chest.  He has no other symptoms.  Denies any swelling of the lips, tongue, throat, difficulty breathing or swallowing.  No vomiting.  No nausea.  No history of similar reaction.  11:16 -patient evaluated after EMS arrival.  Sent here is 98-99% on room air.  Lung exam and rest of physical exam completely normal at this time.  We will continue to monitor.  Do not feel any new or other medication required at this time.  1323: Patient has been largely asymptomatic throughout ED course.  Sleeping most of the time.  He woke up now states he feels back to normal except he noticed that his upper back is a little bit itchy.  On exam the upper portion of his back has a few small urticarial lesions.  Nothing extensive and no others patches on his body.  Will give extra Benadryl and continue to observe.  1453: Patient rechecked and doing well.  No symptoms.  No itching.  No significant rash.  Patient has been observed here for several hours without significant changes or signs of anaphylaxis.  Will give prescriptions for prednisone, Benadryl, EpiPen, albuterol inhaler.  Patient instructed on use of the medications.  Patient to follow-up with PCM.  Also, I spoke with Dr. from allergy clinic.  We will follow-up as a routine consult for specific testing for allergy to vaccine components.  Nurse to list vaccines under his allergy list in the meantime.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Haematocrit decreased, Haemoglobin decreased, Lymphocyte count, Neutrophil count abnormal, Platelet count normal
Clinical narrative: Per ED note:  Patient here for possible allergic reaction.  Brought in by EMS.  Patient reports a history of asthma, last major symptoms were around age 10 or 11.  States that about an hour prior to calling EMS he had preemployment vaccinations.  Computer records indicate that these included anthrax, Japanese encephalitis, typhoid and yellow fever.  He was feeling normal before the vaccination but about an hour later he started to feel short of breath and had some vague right-sided chest discomfort.  EMS was called and noted that his oxygen sat was around 90% and that he was wheezing apparently.  They administered Solu-Medrol 125 mg, Benadryl 25 mg and a DuoNeb.  The shortness of breath and wheezing completely resolved.  Patient still describes some vague right-sided discomfort of the chest.  He has no other symptoms.  Denies any swelling of the lips, tongue, throat, difficulty breathing or swallowing.  No vomiting.  No nausea.  No history of similar reaction.  11:16 -patient evaluated after EMS arrival.  Sent here is 98-99% on room air.  Lung exam and rest of physical exam completely normal at this time.  We will continue to monitor.  Do not feel any new or other medication required at this time.  1323: Patient has been largely asymptomatic throughout ED course.  Sleeping most of the time.  He woke up now states he feels back to normal except he noticed that his upper back is a little bit itchy.  On exam the upper portion of his back has a few small urticarial lesions.  Nothing extensive and no others patches on his body.  Will give extra Benadryl and continue to observe.  1453: Patient rechecked and doing well.  No symptoms.  No itching.  No significant rash.  Patient has been observed here for several hours without significant changes or signs of anaphylaxis.  Will give prescriptions for prednisone, Benadryl, EpiPen, albuterol inhaler.  Patient instructed on use of the medications.  Patient to follow-up with PCM.  Also, I spoke with Dr. from allergy clinic.  We will follow-up as a routine consult for specific testing for allergy to vaccine components.  Nurse to list vaccines under his allergy list in the meantime.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Pruritus, Skin lesion, Urticaria, Wheezing, White blood cell count decreased
Clinical narrative: Per ED note:  Patient here for possible allergic reaction.  Brought in by EMS.  Patient reports a history of asthma, last major symptoms were around age 10 or 11.  States that about an hour prior to calling EMS he had preemployment vaccinations.  Computer records indicate that these included anthrax, Japanese encephalitis, typhoid and yellow fever.  He was feeling normal before the vaccination but about an hour later he started to feel short of breath and had some vague right-sided chest discomfort.  EMS was called and noted that his oxygen sat was around 90% and that he was wheezing apparently.  They administered Solu-Medrol 125 mg, Benadryl 25 mg and a DuoNeb.  The shortness of breath and wheezing completely resolved.  Patient still describes some vague right-sided discomfort of the chest.  He has no other symptoms.  Denies any swelling of the lips, tongue, throat, difficulty breathing or swallowing.  No vomiting.  No nausea.  No history of similar reaction.  11:16 -patient evaluated after EMS arrival.  Sent here is 98-99% on room air.  Lung exam and rest of physical exam completely normal at this time.  We will continue to monitor.  Do not feel any new or other medication required at this time.  1323: Patient has been largely asymptomatic throughout ED course.  Sleeping most of the time.  He woke up now states he feels back to normal except he noticed that his upper back is a little bit itchy.  On exam the upper portion of his back has a few small urticarial lesions.  Nothing extensive and no others patches on his body.  Will give extra Benadryl and continue to observe.  1453: Patient rechecked and doing well.  No symptoms.  No itching.  No significant rash.  Patient has been observed here for several hours without significant changes or signs of anaphylaxis.  Will give prescriptions for prednisone, Benadryl, EpiPen, albuterol inhaler.  Patient instructed on use of the medications.  Patient to follow-up with PCM.  Also, I spoke with Dr. from allergy clinic.  We will follow-up as a routine consult for specific testing for allergy to vaccine components.  Nurse to list vaccines under his allergy list in the meantime.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Patient uncooperative
Clinical narrative: Pt did not get the full vaccine dose due to pt. moving.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Polyneuropathy, Pulmonary embolism
Clinical narrative: DRUG INDUCED POLYNEUROPATHY HYPOTENSION ACUTE PULMONARY EMBOLISM
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Intense redness, swelling, and warmth approx 4-6 hours after injection site. Fatigue, swelling, and redness lasting >72-96 hours
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: WE CALLED PFIZER. THERE WERE NO SIDE EFFECTS BROUGHT TO ATTENTION BY PATIENT.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient vaccinated against and then contracted COVID-19
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: CALLED PFIZER. THERE WERE NO SIDE EFFECTS NOTED BY PATIENT.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: CALLED PFIZER. NO ADDITIONALLY SYMPTOMS NOTED BY PATIENT
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Moderna COVID19 vaccine for Age 6m-5y was ordered and given to a 12yo. No reported adverse events.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Hypoxia, Lacunar stroke, Symptom recurrence
Clinical narrative: EPILEPSY, UNSPECIFIED ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY HYPOXIA 2/24/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 84.0
Sex: M
Vaccine: PNC20
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: He experienced arm and neck pain limiting movement, which made him unable to play golf on Thursday. I talked to him on 7-31-23 and he was better. Today on the phone it was not completely gone but much better. He texted his doctor and he said he believed it was a local reaction and to take Tylenol or Motrin and apply a warm compress.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Left arm (site of injection) experiences pain especially at night. Recommended patient to take Tylenol for pain and apply warm compress to arm
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Pfizer 4/6/21 lot# Ew0151;  Pfizer 4/27/21 Lot# ER8735
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Pulmonary embolism, Pulmonary infarction
Clinical narrative: SADDLE PULMONARY EMBOLISM HYPOTENSION PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Moderna 1/12/21  lot# 025J20A;  MOderna 2/9/21 lot# 004M20A; Moderna 11/24/21 lot# 012h21B
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC13, DTPPVHBHPB, HEPA, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC13, DTPPVHBHPB, HEPA, PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC15
Symptoms: Syringe issue
Clinical narrative: After administering the Vaxneuvance vaccine, I went to engage the safety on the needle and the syringe broke and the needle came off. I was able to completely engage the safety, so nobody was injured.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/9/21 no lot#;  Pfizer 4/30/21 no lot#
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 1/28/21 lot# 028L20A;  Moderna 2/25/21 lot# 004M20A
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema multiforme
Clinical narrative: Developed Erythema Multiform on day 4 after vaccine
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines ; Moderna 1/19/21 lot# 037K20A;  Modern a2/16/21 lot# 037K20A;  Moderna 10/27/21 no lot#
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Moderna 1/19/21 lot# 011L20A;  Moderna 2/16/21 lot# 016M20A
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one dose Janssen
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE