chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Head discomfort, Hypertension, Sinus disorder
Clinical narrative: I had gone to the doctor for a double ear infection and sinus issues. My Blood pressure was really high. I thought it may be because of the meds I took for the head and sinus issues but they said it was too high and that I needed to see a specialist. I got put on Lipitor but that was making me sick and I had to switch to a new medication which has allowed my blood pressure to level out and so far we have not had to move me off the lowest dose. So far with the medication working I have not had to do many tests and things and if it does not get better or remain low on the medication then I will have to following up cardiologist.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood test normal, COVID-19, Cardiac flutter, Chest discomfort
Clinical narrative: I was having a heart attack (Later clarified as panic attack); This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Anatomical site of vaccination was reported as left forearm or upper arm. Patient stated after taking Ativan, she was knocked out for 5 hours and then when left they wrote a prescription for an anti-inflammatory and an inhaler. No concomitant medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia, Insomnia, Panic attack
Clinical narrative: I was having a heart attack (Later clarified as panic attack); This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Anatomical site of vaccination was reported as left forearm or upper arm. Patient stated after taking Ativan, she was knocked out for 5 hours and then when left they wrote a prescription for an anti-inflammatory and an inhaler. No concomitant medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I was having a heart attack (Later clarified as panic attack); This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Anatomical site of vaccination was reported as left forearm or upper arm. Patient stated after taking Ativan, she was knocked out for 5 hours and then when left they wrote a prescription for an anti-inflammatory and an inhaler. No concomitant medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Panic attack
Clinical narrative: I was having a heart attack (Later clarified as panic attack); This spontaneous case was reported by a patient and describes the occurrence of PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency. At the time of the report, PANIC ATTACK (I was having a heart attack (Later clarified as panic attack)) outcome was unknown.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal.  Anatomical site of vaccination was reported as left forearm or upper arm. Patient stated after taking Ativan, she was knocked out for 5 hours and then when left they wrote a prescription for an anti-inflammatory and an inhaler. No concomitant medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with Covid; fully vaccinated.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4, FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Pain immediately following injection to high in uppper right arm and range of motion has continued
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Product administered at inappropriate site
Clinical narrative: Pain immediately following injection to high in uppper right arm and range of motion has continued
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen, Rash, Urticaria
Clinical narrative: Felt under the weather for 24 hours; Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather for 24 hours) and RASH (Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Prostate cancer (Started to come back in 2000.) since 1998. Concomitant products included RELUGOLIX (ORGOVYX), BICALUTAMIDE (CASODEX), DUTASTERIDE (AVODART) and BISOPROLOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MALAISE (Felt under the weather for 24 hours) and RASH (Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.). At the time of the report, MALAISE (Felt under the weather for 24 hours) and RASH (Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported that had a rash for each 10-12 days after the shot. Patient had flu vaccine in September 2022 No treatment information was provided.   This case was linked to MOD-2021-339509, MOD-2022-648659 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow up received contains I narrative was updated.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Rash
Clinical narrative: Felt under the weather for 24 hours; Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather for 24 hours) and RASH (Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Prostate cancer (Started to come back in 2000.) since 1998. Concomitant products included RELUGOLIX (ORGOVYX), BICALUTAMIDE (CASODEX), DUTASTERIDE (AVODART) and BISOPROLOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MALAISE (Felt under the weather for 24 hours) and RASH (Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.). At the time of the report, MALAISE (Felt under the weather for 24 hours) and RASH (Rash around different parts of patient body - arm and legs, patient thought it was minor poison ivy.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported that had a rash for each 10-12 days after the shot. Patient had flu vaccine in September 2022 No treatment information was provided.   This case was linked to MOD-2021-339509, MOD-2022-648659 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow up received contains I narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: STOMACH ACHE; Generalized body pain; Dizziness; FEVER; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (STOMACH ACHE), PAIN (Generalized body pain), DIZZINESS (Dizziness), PYREXIA (FEVER) and HEADACHE (HEADACHE) in an adult female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Kidney stones in 1991, Hives (Iodine allergy manifested by generalized body hives), Asphyxia (Cefazolin allergy manifested by asphyxia), Lithotripsy renal (Lithotripsy in left kidney) in 2017 and Lithotripsy renal (Right kidney lithotripsy) in September 2019. Previously administered products included for Drug use for unknown indication: Iodine and Ancef. Past adverse reactions to the above products included Hives with Iodine; and No adverse event with Ancef. Concurrent medical conditions included Headache, Fibromyalgia since 2020, Fatty liver since 2019, Rheumatoid arthritis, Iodine allergy (Iodine allergy manifested by generalized body hives) and Allergic reaction to antibiotics (Cefazolin allergy manifested by asphyxia). Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Fibromyalgia and Muscle relaxant, ERENUMAB (AIMOVIG [ERENUMAB]) for Headache.   In October 2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 06-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 06-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (STOMACH ACHE), PAIN (Generalized body pain), DIZZINESS (Dizziness), PYREXIA (FEVER) and HEADACHE (HEADACHE). At the time of the report, ABDOMINAL PAIN UPPER (STOMACH ACHE), DIZZINESS (Dizziness), PYREXIA (FEVER) and HEADACHE (HEADACHE) was resolving and PAIN (Generalized body pain) had not resolved.            No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of DIZZINESS, FEVER, HEADACHE, GENERALIZED BODY PAIN and STOMACH ACHE with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623959 (Patient Link).
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: no adverse event; improperly stored dose of PEDVAXHIB and ROTATEQ; This spontaneous report was received from a registered nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 29-AUG-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, (strength not provided, lot # W002453 has been verified to be a valid lot number, expiration date reported as 24-JUN-2024) for prophylaxis; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (strength was not provided; lot# 1742465 has been verified to be a valid lot number, expiration date reported as 21-SEP-2022) administered orally for prophylaxis after temperature excursion at 35.7 Fahrenheit (F) for 4 hours 26 minutes (product storage error).There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; an improperly stored dose of PEDVAXHIB was administered to the patient on 30AUG2022; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 30-AUG-2022, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose 0.5 milliliter, lot #U029145, expiration date: 30-MAR-2024, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, and anatomical location were not reported) after a temperature excursion (temperature: 35.7 Fahrenheit (F); time frame: 4 hours and 26 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received only 2 doses of GARDASIL 9 when she was 45 years of age. Patient is now 46 years of age; No additional AE reported.; This spontaneous report was received from a pharmacist referring to a 46 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On unknown dates the patient was vaccinated with only 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product quantity: 1; dose, route, lot# and expiration date were not reported) for prophylaxis when she was 45 years old. The patient was now 46 years of age (inappropriate schedule of product administration). No additional adverse event (AE) reported.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse reactions; receiving the injection intramuscularly as opposed to subcutaneously; This spontaneous report was received from a pharmacist and referring to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (recombinant human albumin), subcutaneous injection, lot #U029620, expiration date: 22-SEP-2023, administered intramuscularly for prophylaxis in her right arm(dose and strength were not provided) (incorrect route of product administration). The patient had no adverse reactions after receiving the injection intramuscularly as opposed to subcutaneously. No additional information provided. No additional adverse event.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine.; This spontaneous report was received from the healthcare worker and referred to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2022, the patient received improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #W003118, expiration date: 13-JUL-2023; lot #W015191, expiration date: 27-OCT-2023; dose, strength and route were unknown) for prophylaxis (Product storage error). The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine. The temperature was 11.3C and time frame was 34 minutes. No previous temperature excursion. No additional AEs were reported, no further information provided (No adverse event).
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: measles type rash; This spontaneous report was received from an office manager via company representative referring to a non-pregnant female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) at a local health department for prophylaxis.         On an unknown date in August 2022, the patient experienced a measles type rash. No treatment was given for the event. The outcome of the event was unknown.       The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse event; Medical Assistant reported that an expired dose of MMR-II was administered to a patient; This spontaneous report was received from a medical assistant referring to a 13-month-old male patient. The patient's medical history, concurrent conditions and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 15-AUG-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5ml subcutaneously, 1 dose, lot #T029549, expiration date: 10-SEP-2022 (expiration date reported as 30-JUL-2022) for prophylaxis (expired product administered). It was unable to provide sterile diluent information stating they do not have a way to document the lot and expiration for the diluent. There were no side effects reported (no adverse event). The vaccine has not had any temperature excursions.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2209USA002318: US-009507513-2209USA002251:
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: MMR II that had undergone temperature excursion was administered to 2 patient's; no adverse event; This spontaneous report was received from a office manager referring to a currently 5-year-old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), quantity 1, lot #T034388, expiration date: 08-OCT-2022, administered for prophylaxis (strength, dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) after a temperature excursion (temperature: 54.7 Fahrenheit (F), time frame: 58 minutes) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; improperly stored dose of MMR-II was administered to a patient; This spontaneous report was received from a medical assistant referring to unknown age and gender patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-AUG-2022, the patient was vaccinated with 1 dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, (0.5 ml, lot number U022985 which was determined to be valid with expiration date: 22-JUL-2023) subcutaneously for prophylaxis (product storage error). The vaccine was exposed to a temperature of -12.3 Celsius degree for a time frame of 1 hour. No previous temperature excursion was provided. No additional adverse event (AE) information was provided.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No other adverse events were reported.; This pharmacist states that they administered Pneumovax 23 to an elderly male patient on 09Sep2022 then realized it had expired 4 months ago; This spontaneous report was received from a pharmacist referring to an elderly male patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 09-SEP-2022, the patient was administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, dose detail, expiration date, route of administration, vaccination site were not specified) for prophylaxis, which had expired 4 months ago (expired product administered).  The patient did not experience any adverse event.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient received two doses of GARDASIL 9, first on 15MAR2011 and second on 31MAY2011/the patient never got the third dose of GARDASIL 9; Information was received from the patient's mother referring to a 35 year old female patient. Information about concurrent condition, concomitant medication and medical history of the patient was unknown.  On 15-MAR-2021 and 31-MAY-2021, the patient was vaccinated with first dose and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot# and expiration date were not reported) for prophylaxis.  The patient never got the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and was inquiring dosing/revaccination recommendations (inappropriate schedule of product administration).
Sex: F
Vaccine: HPVX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received two of the three dose regiment in "2017."; no additional AE was reported; This spontaneous report was received from a 37-year-female patient referring to herself. Concomitant medication and drug reactions/allergies were none. In 2016, she was diagnosed with an unidentified type of human papillomavirus (HPV) infection, it was recommended by her healthcare provider at the time that she got the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine to "prevent future infections."   On unknown dates in 2017, the patient was vaccinated with two of the three dose regiment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for future infections (strength, lot #, expiry date, and route of administration were not provided) in another unidentified country (inappropriate schedule of product administration). She was just made aware of the benefits regarding the prevention of cancer in receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and wanted to know if getting a third dose was recommended. No further information or additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/no PQCs.; HCP called in and reported that the improperly stored vaccine was administered on 09/12/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011625, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was exposed to temperature from -10 Celsius to 8 Celsius (-4 C) for 2 Hours 30 Minutes. No previous temperature excursion was reported. No additional AEs/no PQCs.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported.; improperly stored vaccine administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) underwent a temperature excursion at 9.3 Fahrenheit (F) for 5 minutes. The previous temperature excursion occurred at 14F up to 46F (25.9 F) for 1 hour 20 minutes.  On 07-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, one dose, lot #U039955, expiration date: 14-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional AE information reported (No adverse event).; Sender's Comments:  US-009507513-2209USA004559:
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, Product storage error
Clinical narrative: No additional AE reported; Healthcare provider reports the administration of ROTATEQ involved in a temperature excursion to a 4 month female patient on 12SEP2022. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): ROTATEQ:  Lot: 174242; expiration date: 11-SEP-2022; This spontaneous report was received from a nurse referring to a 4-month-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1742429, expiration date not reported, but upon internal validation established as 11-SEP-2022, for prophylaxis (dose, strength, and route of administration were not provided) (product storage error; expired product administered). Temperature and time frame was 2 Celsius degree (C) to 8 C (8.8 C) for 11 hours 57 minutes and 0 seconds. The previous temperature excursion was reported as not applicable. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; HCP reporting a patient was administered expired VAQTA. The VAQTA expired on 4JUN2021, but the patient received the VAQTA on 17AUG2021.; This spontaneous report was received from a nurse and refers to a patient with unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 17-AUG-2021 (onset date also reported as 21-AUG-2021), the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T008697 (route of administration was not provided) for prophylaxis, which expired on 04-JUN-2021 (expired product administered). It was unknown if the hepatitis a vaccine, inactivated (VAQTA) had any previous temperature excursions. No additional adverse event information provided.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a dose of PROQUAD was administered to a 13 year old patient on 14Sep2022; This spontaneous report has been received from a registered nurse regarding a 13-year-old adolescent of unknown gender. The patient's concomitant medications, pertinent medical history, and drugs reactions/allergies were not reported.  On 14-SEP-2022, a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, therapy type, route, lot#, and expiration date were not provided) was administered to the 13-year-old patient for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient did not have any other adverse events.; The caller said VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion at temperature -10.4C with time frame 30 hours. There was no previous temperature excursion.  On 16-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #w011626, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). The patient did not have any other adverse events (No adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA007224:
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Accidental underdose, Incorrect dose administered, No adverse event, Product preparation error, Underdose
Clinical narrative: No additional AE information provided.; HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline administering it to patients/accidentally; the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering it to patients; This spontaneous report was received from a registered nurse and referred to a 15-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-SEP-2022, the patient was going to receive the 15-month booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #W002453, expiration date: 24-JUN-2024, strength, dose, frequency and route were unknown) for prophylaxis. During the preparation, the vaccine was diluted with sodium chloride (NORMAL SALINE) 0.5 milliliter (ml) (strength, lot #, expiry date, route of administration, and indication were not provided) and then drawn up 0.5 ml of the mixed solution and administered it to this patient (vaccine preparation error, accidental underdose). No additional adverse events were reported.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Accidental underdose, Product preparation error
Clinical narrative: No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; This spontaneous report was received from a registered nurse and referred to a 15-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-SEP-2022, the patient was going to receive the 15-month booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #W002453, expiration date: 24-JUN-2024, strength, dose, frequency and route were unknown) for prophylaxis. During the preparation, the vaccine was diluted with sodium chloride (NORMAL SALINE) 0.5 milliliter (ml) (strength, lot #, expiry date, route of administration, and indication were not provided) and then drawn up 0.5 ml of the mixed solution and administered it to this patient (vaccine preparation error, accidental underdose). No additional adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Throat tightness, Tryptase
Clinical narrative: Anaphylactic reaction; Lightheadedness; Sensation of throat closure; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Latex allergy (Had a reaction to latex in the past). Concurrent medical conditions included Environmental allergy (dust mites).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). an unknown date, the patient experienced DIZZINESS (Lightheadedness) and THROAT TIGHTNESS (Sensation of throat closure). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), DIZZINESS (Lightheadedness) and THROAT TIGHTNESS (Sensation of throat closure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Tryptase: elevated (High) Elevated.         Concomitant medications reported include ibuprofen and loratadine.  Treatment for the event included epinephrine injection and intravenous diphenhydramine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20 Apr 2021 included non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This spontaneous case was reported by a nurse and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. Patient was taking Benadryl because she had a slight reaction to first and second dose, it was an anaphylactic reaction that required observation not hospitalization.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-019001 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 19 Apr 2021 included no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Ear pain, Headache, Lymphadenopathy, Pharyngeal swelling
Clinical narrative: allergist confirmed it was an anaphylaxis reaction; both sides of her throat started swelling; lingering residual swelling in lymph nodes, upper chest, and throat 67 days after vaccination; ears were really affected in the beginning with throbbing ear pain; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (allergist confirmed it was an anaphylaxis reaction) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reaction to food coloring.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (allergist confirmed it was an anaphylaxis reaction) (seriousness criterion medically significant), PHARYNGEAL SWELLING (both sides of her throat started swelling), LYMPHADENOPATHY (lingering residual swelling in lymph nodes, upper chest, and throat 67 days after vaccination), EAR PAIN (ears were really affected in the beginning with throbbing ear pain) and HEADACHE (headaches). At the time of the report, ANAPHYLACTIC REACTION (allergist confirmed it was an anaphylaxis reaction), PHARYNGEAL SWELLING (both sides of her throat started swelling), LYMPHADENOPATHY (lingering residual swelling in lymph nodes, upper chest, and throat 67 days after vaccination), EAR PAIN (ears were really affected in the beginning with throbbing ear pain) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 29 Jan 2021, 45 minutes after administration of the second dose, both sides of her throat started swelling and she was taken to the Emergency Room (ER) Treatment medications in the ER included Epipen (epinephrine), unspecified steroids, and Benadryl (diphenhydramine). At home, she took loratidine, famotidine and two rounds of a 5-day tapering regimen of prednisone. The allergist confirmed it was an anaphylaxis reaction, and thought she was allergic to the base, polyethylene glycol, which has not been tested. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-073672, MOD21-14991, MOD-2021-002300, MOD21-00576 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Vaccination site pain
Clinical narrative: Headache upon waking; General joint pain; Burning in the armpits; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning in the armpits), HEADACHE (Headache upon waking) and ARTHRALGIA (General joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient has large complexion.  Concurrent medical conditions included Gluten sensitivity and Dairy intolerance.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Burning in the armpits), HEADACHE (Headache upon waking) and ARTHRALGIA (General joint pain). At the time of the report, VACCINATION SITE PAIN (Burning in the armpits), HEADACHE (Headache upon waking) and ARTHRALGIA (General joint pain) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Reporter would like to be guided on what to do to eliminate intense pain in the elbow and how or what to do to eliminate the general pain.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-619929:Husband case
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (Itching), FATIGUE (Fatigue) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273   (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itching), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PRURITUS (Itching) had not resolved and FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site itching; Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (Injection site swelling) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter did not have the lot number information, because the packaging was discarded.  No concomitant medication reported. No treatment medication reported.