chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    Concomitant Medication use information was not provided by reporter.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 25th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: No adverse event; Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 41 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant Medication use information was not provided by reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 73rd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Poor quality vaccine administered; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 42 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    This case contains information for the 45 of 104 patients described by the reporter.  No concomitant medication was reported.  It was reported that there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 74th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 76th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: Had a blood clot and suffered heart attack
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID test
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles Rash
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Administered bivalent dose as part of primary series, dose #2
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I was infected with Covid seven weeks after my 5th vaccine.  CDC called me and instructed me to fill out this form.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Anaemia, Aortic arteriosclerosis, Arterial rupture, Back pain
Clinical narrative: Experienced chest that radiated into my arm and jaw. I was taken to the hospital and told I had an NSTEMI. I was taken to the cath lab and had 1 stent placed in my RCA. A plaque had ruptured and caused a 90% occlusion. I was sent home the next day.  My pregnancy was normal except that I am high risk and developed hypertension prior to becoming pregnant. I was induced at 37 weeks due to my blood pressure becoming getting higher. During my induction, I received magnesium infusion and an epidural. I gave birth. I was then hospitalized fora  post partum hemorrhage on 11/21/2021 and discharged the next day. While I was home, I found that I felt poorly and was exhausted. On 12/02/21 I went to the hospital with chest pain that radiated to my back and jaw and was admitted for anemia that required a blood transfusion. I was admitted until 12/7/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood lactate dehydrogenase increased, Blood thyroid stimulating hormone decreased, Catheterisation cardiac abnormal, Chest pain, Coronary arterial stent insertion
Clinical narrative: Experienced chest that radiated into my arm and jaw. I was taken to the hospital and told I had an NSTEMI. I was taken to the cath lab and had 1 stent placed in my RCA. A plaque had ruptured and caused a 90% occlusion. I was sent home the next day.  My pregnancy was normal except that I am high risk and developed hypertension prior to becoming pregnant. I was induced at 37 weeks due to my blood pressure becoming getting higher. During my induction, I received magnesium infusion and an epidural. I gave birth. I was then hospitalized fora  post partum hemorrhage on 11/21/2021 and discharged the next day. While I was home, I found that I felt poorly and was exhausted. On 12/02/21 I went to the hospital with chest pain that radiated to my back and jaw and was admitted for anemia that required a blood transfusion. I was admitted until 12/7/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Echocardiogram, Electrocardiogram, Epidural injection, Fatigue
Clinical narrative: Experienced chest that radiated into my arm and jaw. I was taken to the hospital and told I had an NSTEMI. I was taken to the cath lab and had 1 stent placed in my RCA. A plaque had ruptured and caused a 90% occlusion. I was sent home the next day.  My pregnancy was normal except that I am high risk and developed hypertension prior to becoming pregnant. I was induced at 37 weeks due to my blood pressure becoming getting higher. During my induction, I received magnesium infusion and an epidural. I gave birth. I was then hospitalized fora  post partum hemorrhage on 11/21/2021 and discharged the next day. While I was home, I found that I felt poorly and was exhausted. On 12/02/21 I went to the hospital with chest pain that radiated to my back and jaw and was admitted for anemia that required a blood transfusion. I was admitted until 12/7/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gestational hypertension, Glycosylated haemoglobin normal, High risk pregnancy, Labour induction
Clinical narrative: Experienced chest that radiated into my arm and jaw. I was taken to the hospital and told I had an NSTEMI. I was taken to the cath lab and had 1 stent placed in my RCA. A plaque had ruptured and caused a 90% occlusion. I was sent home the next day.  My pregnancy was normal except that I am high risk and developed hypertension prior to becoming pregnant. I was induced at 37 weeks due to my blood pressure becoming getting higher. During my induction, I received magnesium infusion and an epidural. I gave birth. I was then hospitalized fora  post partum hemorrhage on 11/21/2021 and discharged the next day. While I was home, I found that I felt poorly and was exhausted. On 12/02/21 I went to the hospital with chest pain that radiated to my back and jaw and was admitted for anemia that required a blood transfusion. I was admitted until 12/7/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Live birth, Maternal exposure before pregnancy, Mineral supplementation, Pain, Pain in extremity
Clinical narrative: Experienced chest that radiated into my arm and jaw. I was taken to the hospital and told I had an NSTEMI. I was taken to the cath lab and had 1 stent placed in my RCA. A plaque had ruptured and caused a 90% occlusion. I was sent home the next day.  My pregnancy was normal except that I am high risk and developed hypertension prior to becoming pregnant. I was induced at 37 weeks due to my blood pressure becoming getting higher. During my induction, I received magnesium infusion and an epidural. I gave birth. I was then hospitalized fora  post partum hemorrhage on 11/21/2021 and discharged the next day. While I was home, I found that I felt poorly and was exhausted. On 12/02/21 I went to the hospital with chest pain that radiated to my back and jaw and was admitted for anemia that required a blood transfusion. I was admitted until 12/7/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Postpartum haemorrhage, Prohormone brain natriuretic peptide increased, Transfusion, Troponin
Clinical narrative: Experienced chest that radiated into my arm and jaw. I was taken to the hospital and told I had an NSTEMI. I was taken to the cath lab and had 1 stent placed in my RCA. A plaque had ruptured and caused a 90% occlusion. I was sent home the next day.  My pregnancy was normal except that I am high risk and developed hypertension prior to becoming pregnant. I was induced at 37 weeks due to my blood pressure becoming getting higher. During my induction, I received magnesium infusion and an epidural. I gave birth. I was then hospitalized fora  post partum hemorrhage on 11/21/2021 and discharged the next day. While I was home, I found that I felt poorly and was exhausted. On 12/02/21 I went to the hospital with chest pain that radiated to my back and jaw and was admitted for anemia that required a blood transfusion. I was admitted until 12/7/21.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Tingling in arms and hands around 10:30pm on the day of receiving the flu vaccine around 3:45pm. I felt numb in that area while having intercourse with my husband that night it was very odd completely unusual. I woke up this morning 12/23/22 while body sore and developed a headache by 11am. Food does not taste right. By this evening my body feels weird right tupper arm hurts very much I feel weak and light headed and nauseous.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Nausea, Pain, Paraesthesia, Taste disorder
Clinical narrative: Tingling in arms and hands around 10:30pm on the day of receiving the flu vaccine around 3:45pm. I felt numb in that area while having intercourse with my husband that night it was very odd completely unusual. I woke up this morning 12/23/22 while body sore and developed a headache by 11am. Food does not taste right. By this evening my body feels weird right tupper arm hurts very much I feel weak and light headed and nauseous.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: None stated.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: none
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I received my 4th dose of Pfizer Bivalent Booster on 09/22/2022. My COVID-19 symptoms started on 10/11/2022 at around 8:00PM. I had a sore throat, fatigue, and lymph nodes in my neck were swollen. I did a COVID-19 home test which was positive. I didn't see my doctor. I took over the counter medications such as MUCINEX, throat lozenges, and DAYQUIL. I took it for at least 1 week. I still have the lingering fatigue as of today 12/23/2022 but all the other symptoms have resolved.
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 77.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 74.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 40.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 45.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Patient states that she received a steroid shot 1 week before receiving Pfizer vaccine.  At the time that she received the Pfizer vaccination she could fill a sensation down the entire left side where the steroid shot was given
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 58.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Retinal detachment, Retinopexy
Clinical narrative: Two weeks after the 1st injection of Shingrix, I had a detached retina in my right eye.  Two weeks after the 2nd injection of Shingrix on 05/30/2019, I had a detached retina in my left eye.  Both resulted in surgical repair.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 62.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 67.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Respiratory symptom, Upper respiratory tract infection
Clinical narrative: Upper respiratory symptoms and ear infections.  For weeks.  Had just finished a zpac and gotten over a URI so went and had my vaccine.  The next morning it was back with a vengeance.  It hung in for weeks in spite of going to the dr and getting antibiotic / steroid ear drops.  And I still have the tail end of it.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: THE PFIZER BI-VALENT FOR AGES 5 YEARS OLD TO LESS THAN 12 YEARS OLD WAS ADMINISTERED TO THIS PATIENT INSTEAD OF THE ADULT DOSE.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Eye movement disorder, Loss of consciousness
Clinical narrative: PATIENT COMPLAINTED OF FEELING DIZZINESS AFTER THE VACCINE. PATIENT HAD FACIAL REDNESS, EYES ROLLING, FEW SECONDS OF UNCONCIOUSNESS THEN RETURNED BACK TO NORMAL STATUS (VITAL SIGNS)
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Blood test abnormal, Chills, Computerised tomogram, Epstein-Barr virus infection reactivation
Clinical narrative: Became extremely ill within 2 days of 2nd vaccine. First vaccine was given 11/26/2021.  Unable to eat, had fever and chills and spleen enlarged to 17 cm.  and had reactivation of EBV virus.  Had to medically withdrawal from school in Jan 2022 and lost his athletic baseball scholarship. He was told he either took the vaccine or would not be able to travel with his school baseball team, Splenomegaly continued for 8 months.  Diagnosed with Hashimoto that he never had prior to vaccine as well. No medication needed at this time as thyroid hormones were in normal range, but ultrasound showed vascularity of thyroid gland. Testicles and Lymph nodes swollen. He moved home from school and continued treatment at the Clinic until August, where he continues to follow up and also found specialists to continue care at home with Endocrinology and Gastroenterology.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Illness, Lymphadenopathy, Pyrexia, Splenomegaly
Clinical narrative: Became extremely ill within 2 days of 2nd vaccine. First vaccine was given 11/26/2021.  Unable to eat, had fever and chills and spleen enlarged to 17 cm.  and had reactivation of EBV virus.  Had to medically withdrawal from school in Jan 2022 and lost his athletic baseball scholarship. He was told he either took the vaccine or would not be able to travel with his school baseball team, Splenomegaly continued for 8 months.  Diagnosed with Hashimoto that he never had prior to vaccine as well. No medication needed at this time as thyroid hormones were in normal range, but ultrasound showed vascularity of thyroid gland. Testicles and Lymph nodes swollen. He moved home from school and continued treatment at the Clinic until August, where he continues to follow up and also found specialists to continue care at home with Endocrinology and Gastroenterology.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis, Testicular swelling, Thyroid disorder, Ultrasound abdomen, Ultrasound pelvis
Clinical narrative: Became extremely ill within 2 days of 2nd vaccine. First vaccine was given 11/26/2021.  Unable to eat, had fever and chills and spleen enlarged to 17 cm.  and had reactivation of EBV virus.  Had to medically withdrawal from school in Jan 2022 and lost his athletic baseball scholarship. He was told he either took the vaccine or would not be able to travel with his school baseball team, Splenomegaly continued for 8 months.  Diagnosed with Hashimoto that he never had prior to vaccine as well. No medication needed at this time as thyroid hormones were in normal range, but ultrasound showed vascularity of thyroid gland. Testicles and Lymph nodes swollen. He moved home from school and continued treatment at the Clinic until August, where he continues to follow up and also found specialists to continue care at home with Endocrinology and Gastroenterology.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound testes abnormal, Ultrasound thyroid abnormal
Clinical narrative: Became extremely ill within 2 days of 2nd vaccine. First vaccine was given 11/26/2021.  Unable to eat, had fever and chills and spleen enlarged to 17 cm.  and had reactivation of EBV virus.  Had to medically withdrawal from school in Jan 2022 and lost his athletic baseball scholarship. He was told he either took the vaccine or would not be able to travel with his school baseball team, Splenomegaly continued for 8 months.  Diagnosed with Hashimoto that he never had prior to vaccine as well. No medication needed at this time as thyroid hormones were in normal range, but ultrasound showed vascularity of thyroid gland. Testicles and Lymph nodes swollen. He moved home from school and continued treatment at the Clinic until August, where he continues to follow up and also found specialists to continue care at home with Endocrinology and Gastroenterology.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Electrocardiogram, Full blood count, Urine analysis
Clinical narrative: Confusion; observed in ER for 2-3 hours;  no treatment
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: Reaction to 2nd booster with covid arm syndrome, red dots and rash on arm and leading down to wrist and arm
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphasia, Computerised tomogram head, Electrocardiogram
Clinical narrative: Expressie aphasia
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Fall, Gait disturbance, Visual impairment
Clinical narrative: Having had a stroke around 2019 and after the initial vaccine I suffer a bad reaction to my eyesight which was already affecting my vision, the eyes were progressively more unstable and crossing giving me double vision with the legs needing some walking lessons as my legs were not quite affected severely but my efforts to learn to correct my walking and the double crossing of my eyes are becoming an issue with my falling down.
Age: 72.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent pfizer vaccine was given isntead of bivalent pfizer, no immediate risk at the moment will notify patient and offer a bivalent in two months. PCP has reviewed her chart
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Patient fainted 9 hours after shots. Will be referred to Cardiology
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent pfizer was given instead of bivalent. Will contact patient offer bivalent in three months. PCP has been notified and agreed with the plan.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: the injection penetrated my one of my nerves; the injection penetrated my one of my nerves; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; This is a spontaneous report received from a contactable reporter(s) (Consumer),. The reporter is the patient. A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 02Dec2022, outcome "unknown" and all described as "I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck."; INJECTION SITE NERVE DAMAGE (non-serious) with onset 02Dec2022, outcome "unknown", PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "the injection penetrated my one of my nerves".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Mobility decreased, Neck pain, Paraesthesia
Clinical narrative: the injection penetrated my one of my nerves; the injection penetrated my one of my nerves; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; This is a spontaneous report received from a contactable reporter(s) (Consumer),. The reporter is the patient. A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 02Dec2022, outcome "unknown" and all described as "I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck."; INJECTION SITE NERVE DAMAGE (non-serious) with onset 02Dec2022, outcome "unknown", PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "the injection penetrated my one of my nerves".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Arthralgia, Injection site nerve damage, Neck pain, Pain in extremity, Product administration error
Clinical narrative: the injection penetrated my one of my nerves; the injection penetrated my one of my nerves; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck.; This is a spontaneous report received from a contactable reporter(s) (Consumer),. The reporter is the patient. A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 02Dec2022, outcome "unknown" and all described as "I have been in pain in my (1) full left arm, (2) left shoulder; and, (3) bottom of my neck."; INJECTION SITE NERVE DAMAGE (non-serious) with onset 02Dec2022, outcome "unknown", PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "the injection penetrated my one of my nerves".  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.