chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Headache, Secretion discharge, Sinus disorder
Clinical narrative: headache, sinus issues, mucus, ccoughing
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: EXPIRED HAV VACCINE GIVEN TO PT EXP 1/30/23
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Heavy menstrual bleeding, Swelling
Clinical narrative: Excessive bruising with slightest bump, longer and heavier menstruation starting about 3 weeks after vaccine and lasting 4 months with some improvement now
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Brain natriuretic peptide increased, COVID-19, COVID-19 pneumonia, Cardiac failure
Clinical narrative: Presented to ED on 11/29/2022 with presented with acute onset altered mental status and acute hypoxemic respiratory failure requiring BiPAP in the emergency department.  Imaging studies did not have any signs of consolidation concerning for additional consolidative pneumonia. Significantly elevated BNP with a history of known diastolic dysfunction concerning for possible volume overload.  Point-of-care ultrasound the emergency department was showing minimal B-lines, however chest x-ray did not show any significant volume overload.  The patient was also noted to have a lactic acidosis in the setting of hypotension and presumed hypovolemia with improvement in blood pressure with fluids, pointing against significant pulmonary edema.  Tachypnea and hypokalemia were noted Patient died on 12/3/2022 Immediate Cause: Acute Hypoxic Respiratory Failure Due to or as a consequence of: Covid Pneumonia, Possible Bacterial Pneumonia, HFPEF Other Significant Conditions contributing to death: pulmonary HTN, altered mental status, HX CVA Submitter does not have access to further medical records. If additional information is needed, please contact Hospital
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray normal, Condition aggravated, Death, Hypokalaemia, Hypotension
Clinical narrative: Presented to ED on 11/29/2022 with presented with acute onset altered mental status and acute hypoxemic respiratory failure requiring BiPAP in the emergency department.  Imaging studies did not have any signs of consolidation concerning for additional consolidative pneumonia. Significantly elevated BNP with a history of known diastolic dysfunction concerning for possible volume overload.  Point-of-care ultrasound the emergency department was showing minimal B-lines, however chest x-ray did not show any significant volume overload.  The patient was also noted to have a lactic acidosis in the setting of hypotension and presumed hypovolemia with improvement in blood pressure with fluids, pointing against significant pulmonary edema.  Tachypnea and hypokalemia were noted Patient died on 12/3/2022 Immediate Cause: Acute Hypoxic Respiratory Failure Due to or as a consequence of: Covid Pneumonia, Possible Bacterial Pneumonia, HFPEF Other Significant Conditions contributing to death: pulmonary HTN, altered mental status, HX CVA Submitter does not have access to further medical records. If additional information is needed, please contact Hospital
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypovolaemia, Imaging procedure, Lactic acidosis, Mental status changes, Positive airway pressure therapy
Clinical narrative: Presented to ED on 11/29/2022 with presented with acute onset altered mental status and acute hypoxemic respiratory failure requiring BiPAP in the emergency department.  Imaging studies did not have any signs of consolidation concerning for additional consolidative pneumonia. Significantly elevated BNP with a history of known diastolic dysfunction concerning for possible volume overload.  Point-of-care ultrasound the emergency department was showing minimal B-lines, however chest x-ray did not show any significant volume overload.  The patient was also noted to have a lactic acidosis in the setting of hypotension and presumed hypovolemia with improvement in blood pressure with fluids, pointing against significant pulmonary edema.  Tachypnea and hypokalemia were noted Patient died on 12/3/2022 Immediate Cause: Acute Hypoxic Respiratory Failure Due to or as a consequence of: Covid Pneumonia, Possible Bacterial Pneumonia, HFPEF Other Significant Conditions contributing to death: pulmonary HTN, altered mental status, HX CVA Submitter does not have access to further medical records. If additional information is needed, please contact Hospital
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary hypertension, SARS-CoV-2 test positive, Tachypnoea, Ultrasound chest
Clinical narrative: Presented to ED on 11/29/2022 with presented with acute onset altered mental status and acute hypoxemic respiratory failure requiring BiPAP in the emergency department.  Imaging studies did not have any signs of consolidation concerning for additional consolidative pneumonia. Significantly elevated BNP with a history of known diastolic dysfunction concerning for possible volume overload.  Point-of-care ultrasound the emergency department was showing minimal B-lines, however chest x-ray did not show any significant volume overload.  The patient was also noted to have a lactic acidosis in the setting of hypotension and presumed hypovolemia with improvement in blood pressure with fluids, pointing against significant pulmonary edema.  Tachypnea and hypokalemia were noted Patient died on 12/3/2022 Immediate Cause: Acute Hypoxic Respiratory Failure Due to or as a consequence of: Covid Pneumonia, Possible Bacterial Pneumonia, HFPEF Other Significant Conditions contributing to death: pulmonary HTN, altered mental status, HX CVA Submitter does not have access to further medical records. If additional information is needed, please contact Hospital
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient came in and requested shingrix shot, went to put in state registration and found that patient received first dose 15 days prior to administration instead of recommended 2-6 month interval
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: vaccine administration error,   pt had stem cell transplant she was getting covid series re-vaccinated had pfizer  monovalent 12/5/22,  she couldn't find monovalent so her Dr told her to get the bivalent.  CDC told us to count this as 1 of her primary series and to continue with series
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Covid Bivalent vaccine given as first dose in the series. Patient has not had primary dosing series.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2nd Pfizer Bivalent dose at pharmacy 02/08/2023. Pharmacist later found out patient had first Pfizer COVID bivalent at pharmacy on 10/6/22. Patient thought he needed to get a booster every 4 month. Vaccine card was not presented at the time of administration. Patient was advised to report to the pharmacy if adverse effect occurs after vaccination.  No adverse events observed at the time and 15 minutes after injection.
Age: 7.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received a Pfizer Monovalent booster instead of a bivalent booster.  Patient's dad informed of the immunization error. Dad states patient did not have an adverse reaction to the vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Flu like ... Slight fever, aches, muscle pain, fatigue, headache. Normal soreness at vaccination site. 3rd day now.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like ... Slight fever, aches, muscle pain, fatigue, headache. Normal soreness at vaccination site. 3rd day now.
Age: 28.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED INFLUENZA VACCINE DESPITE HAVING RECEIVED AN INFLUENZA VACCINE EARLIER THE SAME DAY FROM ANOTHER FACILITY.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Flow cytometry, General physical condition abnormal, Laboratory test abnormal
Clinical narrative: She had a poor response to a full course of PCV7 with PPSV23 booster (9 of 23 > 1.3).; Literature Article.  Information has been received from the authors in a published literature article entitled as stated above concerning a 15-year-old female patient with history of developmental delay, multiple congenital defects, and lymphedema who was referred to the immunology clinic for evaluation of recurrent ear infections that began at 3 months of age requiring tympanostomy tube placement at 18 months. Her physical exam was notable for abnormal facies, scoliosis, strabismus, abnormal thumbs, and unilateral lymphedema. Her laboratory evaluation revealed macrothrombocytopenia, mild leukopenia with low T-cells and markedly low B-cells by flowcytometry, and notably low IgA (11.7, RR 69 - 309) and IgG (423, RR 613 - 1295) (units not reported). Whole exome sequencing identified a heterozygous mutation in Cell Division Cycle 42 consistent with Takenouchi-Kosaki Syndrome (TKS).  On an unspecified date, the patient was vaccinated with the full course of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (lot#, expiration date, strength, dose, route of administration and anatomical location were unknown) as booster.   Subsequently it was noted that she had a poor response pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (9 of 23 > 1.3) (Vaccine response impaired).   At reporting time, the outcome of the event was unknown. The causality assessment between the Vaccine response impaired and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was related.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Leukopenia, Lymphocyte count decreased, Lymphoedema, Scoliosis, Strabismus
Clinical narrative: She had a poor response to a full course of PCV7 with PPSV23 booster (9 of 23 > 1.3).; Literature Article.  Information has been received from the authors in a published literature article entitled as stated above concerning a 15-year-old female patient with history of developmental delay, multiple congenital defects, and lymphedema who was referred to the immunology clinic for evaluation of recurrent ear infections that began at 3 months of age requiring tympanostomy tube placement at 18 months. Her physical exam was notable for abnormal facies, scoliosis, strabismus, abnormal thumbs, and unilateral lymphedema. Her laboratory evaluation revealed macrothrombocytopenia, mild leukopenia with low T-cells and markedly low B-cells by flowcytometry, and notably low IgA (11.7, RR 69 - 309) and IgG (423, RR 613 - 1295) (units not reported). Whole exome sequencing identified a heterozygous mutation in Cell Division Cycle 42 consistent with Takenouchi-Kosaki Syndrome (TKS).  On an unspecified date, the patient was vaccinated with the full course of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (lot#, expiration date, strength, dose, route of administration and anatomical location were unknown) as booster.   Subsequently it was noted that she had a poor response pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (9 of 23 > 1.3) (Vaccine response impaired).   At reporting time, the outcome of the event was unknown. The causality assessment between the Vaccine response impaired and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was related.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Thrombocytopenia, Zhu-Tokita-Takenouchi-Kim syndrome
Clinical narrative: She had a poor response to a full course of PCV7 with PPSV23 booster (9 of 23 > 1.3).; Literature Article.  Information has been received from the authors in a published literature article entitled as stated above concerning a 15-year-old female patient with history of developmental delay, multiple congenital defects, and lymphedema who was referred to the immunology clinic for evaluation of recurrent ear infections that began at 3 months of age requiring tympanostomy tube placement at 18 months. Her physical exam was notable for abnormal facies, scoliosis, strabismus, abnormal thumbs, and unilateral lymphedema. Her laboratory evaluation revealed macrothrombocytopenia, mild leukopenia with low T-cells and markedly low B-cells by flowcytometry, and notably low IgA (11.7, RR 69 - 309) and IgG (423, RR 613 - 1295) (units not reported). Whole exome sequencing identified a heterozygous mutation in Cell Division Cycle 42 consistent with Takenouchi-Kosaki Syndrome (TKS).  On an unspecified date, the patient was vaccinated with the full course of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (lot#, expiration date, strength, dose, route of administration and anatomical location were unknown) as booster.   Subsequently it was noted that she had a poor response pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (9 of 23 > 1.3) (Vaccine response impaired).   At reporting time, the outcome of the event was unknown. The causality assessment between the Vaccine response impaired and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was related.
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Information has been received from a lawyer, regarding a case in litigation and concerning a patient (pt) of unknown age and gender, who at the time of suspect vaccine's administration was approximately 59 or 60 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 27-JUL-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: polymyalgia rheumatica. The outcome of the event of polymyalgia rheumatica was not reported. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of polymyalgia rheumatica was determined to be medically significant.
Age: 0.17
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a medical assistant and referred to a 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On 14-DEC-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #W006596 has been verified to be a valid lot number, expiration date was reported as 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided), and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot #1892784 has been verified to be a valid lot number, expiration date was reported as 03-DEC-2023, administered orally for prophylaxis (strength was not provided).   The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported (no adverse event).  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:009507513
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE/PQC was reported at time of call.; Pharmacist reporting that a dose of MMRII was inadvertently administered via intramuscular route rather than the intended subcutaneous route. No additional information provided. No additional AE/PQC was reported at time of call.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 ml dose, lot #W021189, expiration date: 29-MAR-2024, inadvertently administered via intramuscular route rather than the intended subcutaneous route (incorrect route of product administration) for prophylaxis (strength and dose number were not provided). No additional adverse event (AE)/product quality complaint (PQC) was reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temp excursion 47.9 degrees; This spontaneous report was received from a certified medical assistant and refers to a 6-month-old male patient.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-DEC-2022, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and exact dose were not provided).  The vaccine underwent temperature excursion of 47.9 degrees Fahrenheit for 47 min (incorrect product storage) in clinical Practice on 01-DEC-2022. Data Logger was involved. No additional adverse event (AE) was reported. There was no product quality complaint (PQC).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: an expired dose of ROTATEQ was accidentally administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 02-FEB-2023, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1742431, expiration date: 31-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).  It was reported that the vaccine had not undergone temperature excursion. No product quality complaint. No additional information.
Age: 14.0
Sex: F
Vaccine: PNC20, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They intended to vaccinate this patient with PNEUMOVAX 23, however she was mistakenly given PREVNAR 20; No additional AE details available / No additional AE reported; This spontaneous report was received from a nurse and refers to a 14-year-old female patient.  The patient's medical history and concomitant therapies were not reported.  The patient qualified to receive pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as she was at high risk for pneumococcal disease due to pulmonary disease. On an unspecified date, it was intended to vaccinate this patient with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), however, she was mistakenly vaccinated with pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) instead (strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong product administered). No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Healthcare provider reports administration of an expired dose of PNEUMOVAX 23 (prefilled syringe)  to a patient on 2/8/2023.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 08-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, lot number U026796 with expiration date 28-JAN-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (expired product administered).  The reporter confirmed product was not involved in a temperature excursion and has been stored within recommended storage range until date of administration. No additional adverse event or product quality complaints reported.
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2nd dose 2019, Shingles in 2021; 1st Shingles after COVID booster, single dermatome; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   Previously administered products included Covid-19 vaccine (received 5 times Covid vaccines in total since 2020).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 BOOSTER. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.       Additional Information: receipt date: 3-Feb-2023 Reporter's comment: The patient received the 2nd dose of Shingrix vaccine in 2019 just before COVID began. The patient had one occurrence of Shingles in 2021, one month after receiving a COVID booster. The reporter clarified to be sure that it was Shingrix (not Zostavax) that the patient received and whether he had previously reported it. It was definitely Shingrix, he said, and commented that it was never reported.  The reporter was happy for it to be reported and willing to provide any additional information, should any be needed.  The reporter commented that 3 independent seasoned clinicians confirmed the diagnosis to be shingles as he was very much an advocate of Shingrix (and still was) for his patients.  The reporter was surprised at the reoccurrences but believe them both to be true, fairly mild cases of shingles. Lots numbers were not available but the information was complete, per the form. The case was linked with case US2023AMR018087, reported by same reporter for second occurrence. The reporter consented to follow-up. Additional supportive information: It was unknown if the reporter considered the shingles to be related to Covid-19 booster.; Sender's Comments:  US-GSK-US2023AMR018087:Same reporter.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Mouth haemorrhage, Pain in extremity, Pyrexia, Toothache
Clinical narrative: Oral bleeding; Toothache; Chest pain; Leg pain; Fever 101F; This case was reported by a physician via call center representative and described the occurrence of mouth hemorrhage in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 5th October 2023) for prophylaxis.   Concurrent medical conditions included obstructive sleep apnea syndrome and irritable bowel syndrome. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 17th October 2022, less than a day after receiving Shingrix, the patient experienced mouth hemorrhage, toothache, chest pain, leg pain and fever. On 20th October 2022, the outcome of the mouth hemorrhage, toothache, chest pain, leg pain and fever were recovered/resolved.   The reporter considered the mouth hemorrhage, toothache, chest pain, leg pain and fever to be possibly related to Shingrix.     Additional Information: GSK receipt date: 02-FEB-2023 Reporter's comment : The patient had received the second dose of vaccine via intramuscular route.  The patient height was 69 inch and weight was reported as181 pounds. The patient had experienced mouth hemorrhage, toothache, chest pain, leg pain and fever  Additional supportive information: Adverse event (AE) outcome captured conservatively as recovered/resolved based on the event outcome date provided and AI was raised to confirm the same.  The reporter had consented to follow-up.
Age: 63.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site swelling, Pain, Pain in extremity
Clinical narrative: BURNING IN ARM IMMEDIATELY AT TIME OF  SHINGRIX INJECTION.  SWOLLEN AT INJECTION SITE. PAIN RADIATING FROM SHOULDER TO HAND. PATIENT WENT TO DOCTOR AND DOCTOR PRESCRIBED AN ANTIBIOTIC AND A STEROID.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given booster in error. Indicated primary series with no previous hx of vaccine.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt presented to the clinic for his second dose of the Pfizer monovalent 6m-4yr series. Unfortunately, the medical assistant did not dilute the vial prior to administration. A dose of 0.2 ml was drawn up from the vial without being diluted with sodium chloride first. The patient's family has been notified and advised to monitor for any signs/symptoms of an adverse reaction.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: Patient was given a Fluzone on 2/3/2023, but she had already received a flu shot for the 2022-2023 season on 10/7/2022. No adverse reaction or symptoms. Patient was made aware of error immediately after Fluzone was given on 2/3/2023.  Provider notified her and provider did not have any recommendations or concerns
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED COVID VACCINE
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Not an adverse event however, wrong drug was administered to the patient. Patient was supposed to receive Pfizer monovalant 12+ second dose to complete their series vaccine. Patient was instead given pfizer biavalant 12+. Supervisor contacted on call MD and he recommends that this patient would receive another bivalant dose as long as the 2 months have passed.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: Inadvertently administered Pfizer bivalent vaccine (6mo-4y) as second dose in series instead of monovalent dose.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Heart rate increased, Insomnia, Myalgia
Clinical narrative: feel my head pounding; rapid heartbeats; Muscle aches on neck & shoulders (has eased up); can't sleep, side effects, unable to sleep; This case was reported by a consumer and described the occurrence of pounding in head in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2023 17:00, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced muscle pain and sleeplessness. On 30th January 2023 21:00, the patient experienced pounding in head and heartbeats increased. On an unknown date, the outcome of the pounding in head, heartbeats increased and sleeplessness were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving.   It was unknown if the reporter considered the pounding in head, heartbeats increased, muscle pain and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment:  On 30th January 2023 4 hours after receiving Shingrix, the patient experienced pounding in head and heartbeats increased. The patient reported that received Shingrix vaccine on 30th January 2023 at 5 pm. Patient felt fine for couple of hours however around 9 pm patient began to feel pounding head, radid heartbeats and muscles aches neck and shoulder. Patient also reported could not sleep. The patient still experienced pounding head, rapid heartbeats and unable to sleep. The muscle aches around neck and shoulder has eased up little. Reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: Didn't feel well; 1st shot 2 years ago, didn't feel well so didn't go back for 2nd; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date,  unknown after receiving Shingrix, the patient experienced feeling unwell and incomplete course of vaccination. On an unknown date, the outcome of the feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     Additional Information: GSK receipt date: 1-Feb-2023 Reporter's comment: The patient received 1st shot 2 years ago and did not felt well for several weeks afterward  the patient did not go back for the second shot. (Also, the COVID shots were coming out and was focused on getting those). The patient asked that he/she should get 2nd shot this long after the 1st one. Additional supportive information: Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: The second one gave me eczema; This case was reported by a consumer via interactive digital media and described the occurrence of eczema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix vaccine with an associated reaction of illness (1st dose was received on unknown date. Kindly refer this case - US2023AMR018247).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   The reporter considered the eczema to be possibly related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR018247   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media. She had stated that she got the shingles vaccine.  The first one made her sick. The second one gave him/her eczema.  The reporter had asked others to skip the shot.  Additional supportive information: Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR018247:Same reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Decreased appetite, Fatigue, Headache
Clinical narrative: Fatigue & Muscle Aches all over body developed later in day on 2/12/22. Bad headache, lots of body aches and pains (especially legs, neck, head, shoulders, and abdomen), nausea, loss of appetite throughout 2/13/22 Fatigue and body aches on 2/14/22 Continued fatigue, body aches, some chest pain on 2/15/22 In the six months following, I experienced increased chest pain that was undiagnosed. I had experienced chest discomfort prior as a Long Covid issue but it had simnifically lessened before this booster vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Fatigue & Muscle Aches all over body developed later in day on 2/12/22. Bad headache, lots of body aches and pains (especially legs, neck, head, shoulders, and abdomen), nausea, loss of appetite throughout 2/13/22 Fatigue and body aches on 2/14/22 Continued fatigue, body aches, some chest pain on 2/15/22 In the six months following, I experienced increased chest pain that was undiagnosed. I had experienced chest discomfort prior as a Long Covid issue but it had simnifically lessened before this booster vaccination.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, Joint swelling, Skin warm, Type III immune complex mediated reaction
Clinical narrative: patient received Tdap vaccine at her primary care (not this location). Started having apparent arthus reaction at side within the day of recieving vaccine. Came to clinic day 8 after vaccine. Swelling on arm still present but lessened, still warm to touch. Also now having swelling and inflammation of many of her joints. Worst in clinic 2/10 were wrist (L) and bilat elbows.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Myalgia, Pyrexia, Swelling
Clinical narrative: Fever, sore muscles, redness, swelling.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Spoke with patient 2/10/23 around 0800, patient relates no adverse reactions since time of administration.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Affect lability, Chest discomfort, Chest pain, Dizziness, Dysgeusia
Clinical narrative: Dizzyness upon injection, continuing to build for several hours. 35 minutes after injection, severe light headedness, chest pain. Pulse skyrocketed and both arms and upper lip began severely tingling. Difficulty breathing. Nausea and headache. Tingling radiated into feet. Emotional liability. Called 911 but did not require ambulance, a nurse friend picked me up and monitored me for 4 hours. 1 hour after injection, metallic taste in mouth, difficulty breathing, fatigue, intermittent tingling in hands and feet. Muscular pain. High blood pressure. 9.5 hours after injection, tight chest, intermittent metallic taste, ongoing headache, periodic tingles, extreme fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate increased, Myalgia
Clinical narrative: Dizzyness upon injection, continuing to build for several hours. 35 minutes after injection, severe light headedness, chest pain. Pulse skyrocketed and both arms and upper lip began severely tingling. Difficulty breathing. Nausea and headache. Tingling radiated into feet. Emotional liability. Called 911 but did not require ambulance, a nurse friend picked me up and monitored me for 4 hours. 1 hour after injection, metallic taste in mouth, difficulty breathing, fatigue, intermittent tingling in hands and feet. Muscular pain. High blood pressure. 9.5 hours after injection, tight chest, intermittent metallic taste, ongoing headache, periodic tingles, extreme fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Dizzyness upon injection, continuing to build for several hours. 35 minutes after injection, severe light headedness, chest pain. Pulse skyrocketed and both arms and upper lip began severely tingling. Difficulty breathing. Nausea and headache. Tingling radiated into feet. Emotional liability. Called 911 but did not require ambulance, a nurse friend picked me up and monitored me for 4 hours. 1 hour after injection, metallic taste in mouth, difficulty breathing, fatigue, intermittent tingling in hands and feet. Muscular pain. High blood pressure. 9.5 hours after injection, tight chest, intermittent metallic taste, ongoing headache, periodic tingles, extreme fatigue.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Onset of tinnitis about an hour after vaccine administration.  No treatment.  Still persists now, 16 weeks later.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling
Clinical narrative: Swelling (Tennis ball size circumference) started evening of 2/7/23.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, Product administration error
Clinical narrative: Administration Error-Repeat dose of COVID-19 Moderna BiValent given on 2/6/2023; Moderns Bivalent given on 10/27/2022.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Persistent Right arm pain after vaccination. Evaluated on 01-31-23. Referred for xray and given mobic 15mg daily x 14 days.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2nd covid Bivalent vaccine. No adverse reaction was noticed. Contacted HD to report.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 1, single (Lot number: FE3592) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to most fruits and some nuts" (unspecified if ongoing), notes: allergic to most fruits and some nuts; "allergic to most fruits and some nuts" (unspecified if ongoing); "allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive"; DRUG INEFFECTIVE (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300060692 same patient/drug and different event;
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune thyroiditis, Balance disorder, Burning sensation, Fatigue, Gait disturbance
Clinical narrative: Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 1, single (Lot number: FE3592) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to most fruits and some nuts" (unspecified if ongoing), notes: allergic to most fruits and some nuts; "allergic to most fruits and some nuts" (unspecified if ongoing); "allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive"; DRUG INEFFECTIVE (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300060692 same patient/drug and different event;
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 1, single (Lot number: FE3592) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to most fruits and some nuts" (unspecified if ongoing), notes: allergic to most fruits and some nuts; "allergic to most fruits and some nuts" (unspecified if ongoing); "allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive"; DRUG INEFFECTIVE (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300060692 same patient/drug and different event;
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Spinal pain, Vertigo
Clinical narrative: Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 1, single (Lot number: FE3592) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to most fruits and some nuts" (unspecified if ongoing), notes: allergic to most fruits and some nuts; "allergic to most fruits and some nuts" (unspecified if ongoing); "allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive"; DRUG INEFFECTIVE (medically significant) with onset 16Nov2022, outcome "unknown", described as "Test: Nasal Swab Result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300060692 same patient/drug and different event;
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: muscle pain; low grade fever; flu like symptoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 7 decade for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Crohns Disease" (unspecified if ongoing), notes: Drug Name: Mesalamine (Lialda), Reason for use: Crohns Disease. Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6201), administration date: 11Feb2021, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness", "Covid-19"; BNT162b2 (Dose: 2nd, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6206), administration date: 04Mar2021, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness", "Covid-19"; BNT162b2 (Dose: 3rd, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FF2587), administration date: 24Sep2021, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness", "Covid-19"; BNT162b2 (Dose: 4th, Anatomical Site of injection: Arm, Batch/Lot number: FJ6369), administration date: 22Apr2022, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Covid-19", "Tiredness". The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: Patient Age at Time of Vaccination: 67 - 68 Years. Prior vaccinations (within 4 weeks): None, Patient medical history: None. Relevant tests: None, Specific relevant test: For Thromboembolic events with Thrombocytopenia: None. Mild reaction to all covid vaccines including muscle pain, low grade fever, flu like symptoms, tiredness.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: muscle pain; low grade fever; flu like symptoms; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient in their 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 7 decade for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Crohns Disease" (unspecified if ongoing), notes: Drug Name: Mesalamine (Lialda), Reason for use: Crohns Disease. Concomitant medication(s) included: LIALDA oral taken for crohn's disease (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); LIOTHYRONINE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6201), administration date: 11Feb2021, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness", "Covid-19"; BNT162b2 (Dose: 2nd, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: Lot: EN6206), administration date: 04Mar2021, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness", "Covid-19"; BNT162b2 (Dose: 3rd, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: FF2587), administration date: 24Sep2021, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Tiredness", "Covid-19"; BNT162b2 (Dose: 4th, Anatomical Site of injection: Arm, Batch/Lot number: FJ6369), administration date: 22Apr2022, for COVID-19 immunization, reaction(s): "Muscle pain", "Low grade fever", "Flu like symptoms", "Covid-19", "Tiredness". The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional information: Patient Age at Time of Vaccination: 67 - 68 Years. Prior vaccinations (within 4 weeks): None, Patient medical history: None. Relevant tests: None, Specific relevant test: For Thromboembolic events with Thrombocytopenia: None. Mild reaction to all covid vaccines including muscle pain, low grade fever, flu like symptoms, tiredness.