chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: No adverse event; patient received second Bivalent dose before authorized; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT USE ISSUE (patient received second Bivalent dose before authorized) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In February 2023, the patient experienced PRODUCT USE ISSUE (patient received second Bivalent dose before authorized). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT USE ISSUE (patient received second Bivalent dose before authorized) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT USE ISSUE (patient received second Bivalent dose before authorized).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. It was reported that patient got one in Sep2022 when it came out and a second Feb2023. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 20-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date).    It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient received 4 doses of Moderna vaccine previous on an unspecified date.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vials were set to expire June 01, 2023 / Vaccines have been administered to 1 patient as well. Lot number 022H22A) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that vaccine was administered this morning, no side effects. Expiry date of the vaccine was 01-Jun-2023 reported as vials were set to expire on 01-Jun-2023.  Treatment information was not provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023; Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023), WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PCV 20. Past adverse reactions to the above products included No adverse event with PCV 20.    On 15-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023) and WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023), WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-JUN-2023 and was utilized to administer with patient on 15-JUN-2023) and WRONG PRODUCT ADMINISTERED (Adult patient was administred with Moderna covid-19 vaccine,bivalent as primary series dose instead of Spikevax).    Patient have received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown patient have any relevant medical history/conditions, allergy, concomitant diseases and risk factor.  No concomitant medication was reported.  No additional AE details reported No treatment information was reported.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: Fall, Pallor, Presyncope
Clinical narrative: turned pale approximately 5 minutes after vaccines were administered and fell from the chair,slumped on the ground.per MD was a vasovagal response
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Customer said arm very sore and redness at injection site.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Blood thyroid stimulating hormone decreased, Graves' disease, Thyroid stimulating immunoglobulin, Thyroxine free, Tri-iodothyronine normal
Clinical narrative: Grave's disease
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was not diluted before being drawn and given to patient.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase normal, Blood sodium decreased, Carbon dioxide decreased, Computerised tomogram thorax, Electrocardiogram abnormal
Clinical narrative: He felt odd on 6/22/23. Patient had a seizure on 06/22/2023.  Seen and evaluated in ER. No prior seizure history, nor family history or any other new or inciting events.  Saw me today.  Will refer to neurology.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Metabolic function test abnormal, Neutrophil percentage increased, Seizure, Sinus tachycardia, Troponin normal
Clinical narrative: He felt odd on 6/22/23. Patient had a seizure on 06/22/2023.  Seen and evaluated in ER. No prior seizure history, nor family history or any other new or inciting events.  Saw me today.  Will refer to neurology.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood thyroid stimulating hormone decreased, Graves' disease, Thyroid stimulating immunoglobulin, Thyroxine free increased, Tri-iodothyronine
Clinical narrative: Grave's disease
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was drawn without being diluted and given to patient.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Ear pain, Headache, Injected limb mobility decreased, Injection site reaction, Injection site warmth
Clinical narrative: Injection site warm and stiff. Painful to lift arm past 45 degrees from side. Lymph node on neck (right side) tender, pain radiates to ear causing dull headache.
Age: 41.0
Sex: F
Vaccine: PNC20
Symptoms: Lymph node pain, Musculoskeletal stiffness, Pain
Clinical narrative: Injection site warm and stiff. Painful to lift arm past 45 degrees from side. Lymph node on neck (right side) tender, pain radiates to ear causing dull headache.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gastrointestinal disorder, Urinary tract infection
Clinical narrative: dizziness, bowe issues, uti, lesions,
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: extreme arm pain, decreased ability to move arm. Pain continued through the week, though less, but worsened 7 days later when hit on arm during sporting event
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Agency recommends being revaccinated at their earliest convenience.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Blood test abnormal, Computerised tomogram normal, Headache, Hypertension
Clinical narrative: In May 2023 I went to bed and woke up in the middle of the night and woke up with a terrible headache.  The next day it happened again.  I took ibuprofen to help.  The following night, it happened a third time.  That afternoon I went to the emergency department because I still had a headache.  My blood pressure was elevated.  I had a CT and an MRI.  I had an elevated troponin number.  Because of that I was admitted to the hospital.  My headache got worse.  I asked for ibuprofen, and they would not give it to me.  They gave me ice packs to help.  The cardiologist visited.  A hospitalist visited and thought it was a migraine caused by hypertension.  The cardiologist said my heart was fine.  I had another headache on June 14th and the ibuprofen helped this time.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging normal, Middle insomnia, Migraine, Troponin increased
Clinical narrative: In May 2023 I went to bed and woke up in the middle of the night and woke up with a terrible headache.  The next day it happened again.  I took ibuprofen to help.  The following night, it happened a third time.  That afternoon I went to the emergency department because I still had a headache.  My blood pressure was elevated.  I had a CT and an MRI.  I had an elevated troponin number.  Because of that I was admitted to the hospital.  My headache got worse.  I asked for ibuprofen, and they would not give it to me.  They gave me ice packs to help.  The cardiologist visited.  A hospitalist visited and thought it was a migraine caused by hypertension.  The cardiologist said my heart was fine.  I had another headache on June 14th and the ibuprofen helped this time.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Ear pain, Fatigue, Headache, Tinnitus
Clinical narrative: Patient reported that within 5 minutes of getting the injection, she got a sudden headache that lasted 10 minutes. About 10-20 minutes after the headache, she developed bilateral ringing in her ears and ear pain. This also lasted about 10 minutes and then resolved. She continues to have a mild/trace headache 2 hours after injection and feels tired.  Via phone call, Advised patient to hydrate, rest, and monitor symptoms. Advised to take Tylenol PRN for continued headache. Advised to call back if symptoms persist after 24 hours
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue
Clinical narrative: Was attempting to take the needle cap off the needle and  the syringe broke just under the base of the top of the vaccine syringe. Snapped completely off.  NDC:49281-400-89 LOT: U7665BA EX: 04MAR25
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac function test, Computerised tomogram, Heart rate decreased, Idiopathic intracranial hypertension
Clinical narrative: Idiopathic intracranial hypertension (IIH)  Tingling in arm, face, legs Low heart rate Pain in joints, hands toes, knees
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Idiopathic intracranial hypertension (IIH)  Tingling in arm, face, legs Low heart rate Pain in joints, hands toes, knees
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Pain
Clinical narrative: chest pain,body aches,chills for 3 days than subsided
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Nausea, Pain, Pyrexia
Clinical narrative: I am not sure what tdap I took , 12 hours after takin vaccines i have been experiencing severe aches, fevers with rigors, nausea, poor appetite
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Fatigue, excessive chills/shivering, headache, all over muscle/body aches and fever of 101.8
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue, excessive chills/shivering, headache, all over muscle/body aches and fever of 101.8
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: 102 degree fever for 2 days beginning 13 days after receiving immunization. Then head to toe measle like bumps all over the body for 36 hours before peaking and beginning to subside.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Pentacel expired on 4/22/23. No symptoms at all. Pt. was recalled to come in
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Swolleb upper am, erythematous tender to touch
Age: 74.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Death
Clinical narrative: Patient was found expired in bed in the morning of next day ( after the vaccination); This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 at 11:00 as dose 5 (booster), single (Lot number: GJ6796) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A.fib," (unspecified if ongoing); "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing); "OA" (unspecified if ongoing); "lymphedema" (unspecified if ongoing); "recurrent cellulitis of LEs" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; FUROSEMIDE; LEVOTHYROXINE; METOPROLOL; ACETAMINOPHEN; VITAMIN D [ERGOCALCIFEROL]; TRAMADOL; NYSTATIN; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 21Jun2023 at 07:00, outcome "fatal", described as "Patient was found expired in bed in the morning of next day ( after the vaccination)". Therapeutic measures were not taken as a result of death. The patient date of death was 21Jun2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: The patient did not take any other vaccines in four weeks and was not tested for COVID-19 prior to vaccination and post vaccination. Patient was found expired in bed in the morning of next day (after the vaccination).; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event death and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.  ; Reported Cause(s) of Death: found expired
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), 5 days after the suspect product(s) administration, outcome "unknown".  Additional information: The patient reported that after 5 days after taking the latest covid booster shot, started having some dizziness which was not enough to hinder activity. There was no effects to all other booster shots  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported. No fuerther AE details; Expired dose administered; Temperature 70F / Time frame 0 Hours 9 minutes 0 Seconds; This spontaneous report was received from pharmacist and refers to a 7-year-old. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 14-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered for prophylaxis (formulation, dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; therapy type rHa, valid lot number W024548 with an expiration date: 31-JAN-2024 (conflicting information, also reported as it was mentioned that an expired vaccine was administered with an expiry date of 06-JUN-2023)). The administered dose of the vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Product storage error
Clinical narrative: No symptoms reported. No further AE details; HCP called to report an expired dose of PROQUAD was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Temperature: 70F Date of excursion: 3/2/2023; This spontaneous report was received from a pharmacist, referring to a 4-year-old patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 14-JUN-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W028565, expiration date was reported as 02-JUN-2023, but upon internal validation was established as 06-MAR-2024 (conflicting information, reported as expired dose)) as prophylaxis, which also experienced a temperature excursion (expired product administered and product storage error).  The vaccine experienced a temperature excursion of 70 degrees Fahrenheit (F) for 9 minutes on 02-MAR-2023.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: patient has not had any symptoms.; an expired dose of PROQUAD was inadvertently given to a patient on 6/19/2023.; This spontaneous report was received from a healthcare worker regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-JUN-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, expiration date: 14-JUN-2023, administered as prophylaxis (strength, dosage regimen, lot #, and route of administration were not provided) (Expired product administered). The patient did not have any symptom.
Sex: F
Vaccine: HPV9
Symptoms: Imaging procedure, Local reaction, Swelling
Clinical narrative: Gardasil 9 rec'd dose 6 weeks prior local reaction; now clavicle swelling with no lymph node swelling; This spontaneous report has been received from a physician via company representative concerning a 14-year-old female patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 09-MAY-2023 (also reported as "6 weeks prior local reaction"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (IM) for prophylaxis (dose, anatomical location, lot#, and expiration date were not reported).  On 20-JUN-2023, the patient's clavicle was swelling with no lymph node swelling and approximately on the same date, she had a local reaction. It was informed that an imaging test was performed; however, the results were not provided. Moreover, treatment was given for the adverse event (unspecified). At the reporting time, the outcome of the events was unknown.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date 09Jun2023, Treatment stop date 13Jun2023). The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300227625 same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Wrong product administered
Clinical narrative: Diarrhea started next day and continues; DOSE 1: bivalent: False; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2023 at 16:00 as dose 1, single (Lot number: EW0191), in left arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Colorectal cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Jun2023 at 16:00, outcome "unknown", described as "DOSE 1: bivalent: False"; DIARRHOEA (non-serious) with onset 16Jun2023 at 14:00, outcome "not recovered", described as "Diarrhea started next day and continues". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient did not experience COVID prior to vaccination. Patient does not have any allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300227899 same patient different drug/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (ongoing). Concomitant medication(s) included: ACTEMRA taken for immunodeficiency (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from Jun2023 to Jun2023. Clinical course: Unknown for Other medication in 2weeks. Unknown Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300227961 same patient, different drug/event;