chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Infected cyst
Clinical narrative: diagnose of with hyperthyroidism after the second dose; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTHYROIDISM (diagnose of with hyperthyroidism after the second dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051c21a and 036c21a) for COVID-19 vaccination.     Patient  medical history includes Acute and chronic illnesses at the time of vaccination.  Concurrent medical conditions included Anemic. Concomitant products included VITAMIN D NOS and IRON for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-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 experienced HYPERTHYROIDISM (diagnose of with hyperthyroidism after the second dose) (seriousness criterion medically significant). At the time of the report, HYPERTHYROIDISM (diagnose of with hyperthyroidism after the second dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicine included Thyroids medicine. Patient sought medical care due to AE occurred. Patient was treated Antibiotics.  Company Comment: This spontaneous case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Hyperthyroidism. The event occurred on an unknown date after vaccination of the second dose of mRNA-1273 vaccine. Presenting symptoms and medical investigations conducted were not reported in the case. The patient is currently being treated with unspecified thyroid medications. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-500706 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Hyperthyroidism. The event occurred on an unknown date after vaccination of the second dose of mRNA-1273 vaccine. Presenting symptoms and medical investigations conducted were not reported in the case. The patient is currently being treated with unspecified thyroid medications. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperthyroidism
Clinical narrative: diagnose of with hyperthyroidism after the second dose; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTHYROIDISM (diagnose of with hyperthyroidism after the second dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051c21a and 036c21a) for COVID-19 vaccination.     Patient  medical history includes Acute and chronic illnesses at the time of vaccination.  Concurrent medical conditions included Anemic. Concomitant products included VITAMIN D NOS and IRON for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-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 experienced HYPERTHYROIDISM (diagnose of with hyperthyroidism after the second dose) (seriousness criterion medically significant). At the time of the report, HYPERTHYROIDISM (diagnose of with hyperthyroidism after the second dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicine included Thyroids medicine. Patient sought medical care due to AE occurred. Patient was treated Antibiotics.  Company Comment: This spontaneous case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Hyperthyroidism. The event occurred on an unknown date after vaccination of the second dose of mRNA-1273 vaccine. Presenting symptoms and medical investigations conducted were not reported in the case. The patient is currently being treated with unspecified thyroid medications. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-500706 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Hyperthyroidism. The event occurred on an unknown date after vaccination of the second dose of mRNA-1273 vaccine. Presenting symptoms and medical investigations conducted were not reported in the case. The patient is currently being treated with unspecified thyroid medications. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Rash, SARS-CoV-2 test
Clinical narrative: All the vaccines gave her a rash since day 1; Received a Fourth dose for immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Dry mouth, Burning mouth syndrome, Migraine, Anxiety, Hyperlipidemia, Digestion impaired (to help with digestion), Gastrointestinal disorder (for gut problem), Immunocompromised, Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome and Hypothyroidism (Hypothyroidism Syndrome). Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, METFORMIN for Digestion impaired, PILOCARPINE for Dry mouth, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised). The patient was treated with MUPIROCIN at a dose of 3 times a day; PIMECROLIMUS (topical) at a dose of 1% topical cream twice a day and TRIAMCINOLONE (topical) at a dose of 0.1% topical cream twice a day. At the time of the report, RASH (All the vaccines gave her a rash since day 1) had not resolved and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was could not detect what it was.         She did not tested positive for COVID-19 and she did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. She said she was a swimmer and that she was embarrassed to go the pool to swim. She was also treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503094 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Biopsy, Headache, Influenza like illness, Mobility decreased
Clinical narrative: All the vaccines gave her a rash since day 1; Received a Fourth dose for immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Dry mouth, Burning mouth syndrome, Migraine, Anxiety, Hyperlipidemia, Digestion impaired (to help with digestion), Gastrointestinal disorder (for gut problem), Immunocompromised, Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome and Hypothyroidism (Hypothyroidism Syndrome). Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, METFORMIN for Digestion impaired, PILOCARPINE for Dry mouth, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised). The patient was treated with MUPIROCIN at a dose of 3 times a day; PIMECROLIMUS (topical) at a dose of 1% topical cream twice a day and TRIAMCINOLONE (topical) at a dose of 0.1% topical cream twice a day. At the time of the report, RASH (All the vaccines gave her a rash since day 1) had not resolved and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was could not detect what it was.         She did not tested positive for COVID-19 and she did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. She said she was a swimmer and that she was embarrassed to go the pool to swim. She was also treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503094 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Peripheral swelling, Rash
Clinical narrative: All the vaccines gave her a rash since day 1; Received a Fourth dose for immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Dry mouth, Burning mouth syndrome, Migraine, Anxiety, Hyperlipidemia, Digestion impaired (to help with digestion), Gastrointestinal disorder (for gut problem), Immunocompromised, Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome and Hypothyroidism (Hypothyroidism Syndrome). Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, METFORMIN for Digestion impaired, PILOCARPINE for Dry mouth, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised). The patient was treated with MUPIROCIN at a dose of 3 times a day; PIMECROLIMUS (topical) at a dose of 1% topical cream twice a day and TRIAMCINOLONE (topical) at a dose of 0.1% topical cream twice a day. At the time of the report, RASH (All the vaccines gave her a rash since day 1) had not resolved and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was could not detect what it was.         She did not tested positive for COVID-19 and she did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. She said she was a swimmer and that she was embarrassed to go the pool to swim. She was also treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503094 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Biopsy, Extra dose administered, Rash
Clinical narrative: All the vaccines gave her a rash since day 1; Received a Fourth dose for immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Dry mouth, Burning mouth syndrome, Migraine, Anxiety, Hyperlipidemia, Digestion impaired (to help with digestion), Gastrointestinal disorder (for gut problem), Immunocompromised, Drug allergy (Promethazine), Drug allergy (Betadine), Drug allergy (Lovenox), Psoriatic arthritis, May-Thurner syndrome and Hypothyroidism (Hypothyroidism Syndrome). Concomitant products included BUPROPION for Anxiety, CLONAZEPAM for Burning mouth syndrome, METFORMIN for Digestion impaired, PILOCARPINE for Dry mouth, OMEPRAZOLE for Gastrointestinal disorder, ATORVASTATIN for Hyperlipidemia, TOPIRAMATE for Migraine, LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced RASH (All the vaccines gave her a rash since day 1) and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised). The patient was treated with MUPIROCIN at a dose of 3 times a day; PIMECROLIMUS (topical) at a dose of 1% topical cream twice a day and TRIAMCINOLONE (topical) at a dose of 0.1% topical cream twice a day. At the time of the report, RASH (All the vaccines gave her a rash since day 1) had not resolved and EXTRA DOSE ADMINISTERED (Received a Fourth dose for immunocompromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: could not detect what it was could not detect what it was.         She did not tested positive for COVID-19 and she did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. She said she was a swimmer and that she was embarrassed to go the pool to swim. She was also treated with Phototherapy. None of the treatments worked.   This case was linked to MOD-2022-503106, MOD-2022-503107, MOD-2022-503094 (Patient Link).
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Migraine, Vision blurred, Vomiting
Clinical narrative: Migraine, vomiting, hot sweats, blurry vision
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: New onset Plaque Psoriasis in index finger and middle finger of right hand, controlled through BID application of compound Dithranol ointment (a compound product consisting of Dithranol IP 1.15% w/w, Salicylic Acid IP 1.15% w/w, Solution of Coal Tar 5.3% w/w, white soft paraffin IP q.s.). I have mentioned recovered from adverse event cause the exacerbation has been treated with the ointment.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Skin discolouration, Vaginal discharge, Vulvovaginal pruritus, Vulvovaginal swelling
Clinical narrative: I experienced vaginal itchiness within hours of receiving the vaccination.  At around 830pm/9pm at night, I observed my vagina and it was swollen about 3 times the regular size.  It was also deep purple in color.  For a few days after the vaccination, I had a clear discharge emitting from my vagina.  I also got my period a week earlier than expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation reaction, Limb mass, Peripheral swelling, Pruritus
Clinical narrative: Covid arm. Days after getting the shot, my arm got a large red and hot bump that developed. It was also itchy. It lasted for over a week.   Same thing happened with the second shot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Covid arm. Days after getting the shot, my arm got a large red and hot bump that developed. It was also itchy. It lasted for over a week.   Same thing happened with the second shot.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Chest discomfort, Chromaturia, Fatigue, Feeling abnormal
Clinical narrative: I got Longhaul COVID symptoms after the vaccine. Prior to the vaccine, I did NOT have these symptoms. My initial infection was in October of 2020. This was almost a year later. I currently have left sided chest pressure daily, PEM, chronic fatigue, insomnia, brain fog, neuralgia, frequent palpitations, flat ribbon stools, and dark, foamy urine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Malnutrition, Neuralgia, Palpitations
Clinical narrative: I got Longhaul COVID symptoms after the vaccine. Prior to the vaccine, I did NOT have these symptoms. My initial infection was in October of 2020. This was almost a year later. I currently have left sided chest pressure daily, PEM, chronic fatigue, insomnia, brain fog, neuralgia, frequent palpitations, flat ribbon stools, and dark, foamy urine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, Urine abnormality
Clinical narrative: I got Longhaul COVID symptoms after the vaccine. Prior to the vaccine, I did NOT have these symptoms. My initial infection was in October of 2020. This was almost a year later. I currently have left sided chest pressure daily, PEM, chronic fatigue, insomnia, brain fog, neuralgia, frequent palpitations, flat ribbon stools, and dark, foamy urine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient was in for annual visit and advised she was needing a meningococcal vaccine that would be required for college. Pt. stated she will receive today. Patient returned the following day for COVID vaccine and made staff aware patient received dose 2 in Feb 2021 but it was not documented and that she received three doses of the vaccine due to error.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Haemoglobin increased, Headache, Myalgia, Pain
Clinical narrative: Hemoglobin levels went up; Ache after Booster Dose; Body ache after Booster Dose; Head ache after Booster Dose; After receiving the Booster, hemoglobin recount went up to 10; Immunocompromised patient given booster dose after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN INCREASED (Hemoglobin levels went up), PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose), HEADACHE (Head ache after Booster Dose) and THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myelodysplastic syndrome and Allergy. Concomitant products included EPOETIN ALFA (PROCRIT) for an unknown indication.    On 24-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMOGLOBIN INCREASED (Hemoglobin levels went up), PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose), HEADACHE (Head ache after Booster Dose), THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) and ACCIDENTAL UNDERDOSE (Immunocompromised patient given booster dose after 2nd dose). At the time of the report, HAEMOGLOBIN INCREASED (Hemoglobin levels went up), THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) and ACCIDENTAL UNDERDOSE (Immunocompromised patient given booster dose after 2nd dose) outcome was unknown and PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose) and HEADACHE (Head ache after Booster Dose) had resolved.            No treatment medication were reported Patient did not experienced a similar event on the past. All the vaccines were given in her deltoid muscle. She never tested positive for Covid-19. She did not received any other vaccine within 1 month prior to Moderna's.   This case was linked to MOD-2022-504281 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Hemoglobin levels went up; Ache after Booster Dose; Body ache after Booster Dose; Head ache after Booster Dose; After receiving the Booster, hemoglobin recount went up to 10; Immunocompromised patient given booster dose after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN INCREASED (Hemoglobin levels went up), PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose), HEADACHE (Head ache after Booster Dose) and THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myelodysplastic syndrome and Allergy. Concomitant products included EPOETIN ALFA (PROCRIT) for an unknown indication.    On 24-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMOGLOBIN INCREASED (Hemoglobin levels went up), PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose), HEADACHE (Head ache after Booster Dose), THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) and ACCIDENTAL UNDERDOSE (Immunocompromised patient given booster dose after 2nd dose). At the time of the report, HAEMOGLOBIN INCREASED (Hemoglobin levels went up), THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) and ACCIDENTAL UNDERDOSE (Immunocompromised patient given booster dose after 2nd dose) outcome was unknown and PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose) and HEADACHE (Head ache after Booster Dose) had resolved.            No treatment medication were reported Patient did not experienced a similar event on the past. All the vaccines were given in her deltoid muscle. She never tested positive for Covid-19. She did not received any other vaccine within 1 month prior to Moderna's.   This case was linked to MOD-2022-504281 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A little ringing in the ear after booster Shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (A little ringing in the ear after booster Shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced TINNITUS (A little ringing in the ear after booster Shot). At the time of the report, TINNITUS (A little ringing in the ear after booster Shot) outcome was unknown.            No Concomitant medication reported. No Treatment medication reported.   This case was linked to MOD-2022-504241 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Heavy nosebleeds on more than 4 occasions; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious) with onset 14Nov2021 10:00, outcome "not recovered", described as "Heavy nosebleeds on more than 4 occasions". Therapeutic measures were not taken as a result of epistaxis.  Additional information: No other vaccine was taken in four weeks. The patient did not have covid prior to the vaccination. The patient was not covid tested post vaccination. The patient did not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: congestive heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "congestive heart failure".  Customer Verbatim: Did you give the warning that your Covid-19 it giving me congestive heart failure  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 38 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccines were discarded after excursion developed (reported as discarded vaccines that were no longer usable). On 18-JAN-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) (route/site: intramuscular/deltoid) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (route/site: subcutaneous/"triage") at public health clinic hospital. The vaccines purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccines were not available for return/evaluation. The vaccines used according to the instruction leaflet.  This is one of four reports from  the same reporter.; Sender's Comments:  US-009507513-2202USA008508: US-009507513-2202USA008507: US-009507513-2202USA008509:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired MMR II; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 04-FEB-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot #: T001213, expiration date: 12-JAN-2022, status albumin: recombinant human albumin (rHA) (exact dose, strength, site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; Vaccine administered after temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 07-JAN-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliters (ml) intramuscularly (IM) (anatomical site of vaccination and vaccine scheme were not reported; lot number U010534 has been verified to be valid, expiration date reported and established as 31-OCT-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 49.1 degrees Fahrenheit (F) for 5 hours and 9 minutes, 56.3F for 14 hours and 7 minutes, 49.6F for 35 hour and 9 minutes. There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
Age: 0.75
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs reported; She stated that a 9 month old patient was administered PROQUAD; This spontaneous report as received from a nurse refers to a 9-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 08-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin, (PROQUAD) 0.5 ml dose, lot # U022722, expiration date 16-JAN-2023 (route of administration and anatomical location were not reported) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP reports no further AE's; inadvertent administration of PROQUAD to a 29 year old female instead of MMR II; This spontaneous report was received from a medical assistant referring to a 29-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 24-FEB-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, one time, lot number T032150, expiration date 20-MAR-2022 for prophylaxis (route of administration not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) was diluted with 0.5 milliliters of sterile diluent(STERILE DILUENT) lot number S024969, expiration date 17-MAR-2022. No adverse event was reported.
Age: 42.0
Sex: F
Vaccine: HEP, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 42 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccines were discarded after excursion developed (reported as discarded vaccines that were no longer usable). On 13-JAN-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (route/site: intramuscular/deltoid, single use vaccine) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (route/site: subcutaneous/"triage", single use vaccine) at public health clinic hospital. The vaccines purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccines were not available for return/evaluation. The vaccines used according to the instruction leaflet.  This is one of four reports from the same reporter.; Sender's Comments:  US-009507513-2202USA008508: US-009507513-2202USA008509: US-009507513-2201USA004692:
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 19 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccine was discarded after excursion developed (reported as discarded vaccine that were no longer usable). On 14-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (lot# U011995 with expiration date: 15-APR-2023, route/site: subcutaneous/"triage", single use vaccine) at public health clinic hospital. The vaccine purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccine was not available for return/evaluation. The vaccine used according to the instruction leaflet.  This is one of four reports from the same reporter.; Sender's Comments:  US-009507513-2202USA008507: US-009507513-2201USA004692: US-009507513-2202USA008509:
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 23 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccines were discarded after excursion developed (reported as discarded vaccines that were no longer usable). On 14-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (lot# U011995 with expiration date: 15-APR-2023, route/site: subcutaneous/"triage", single use vaccine) at public health clinic hospital. The vaccines purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccines were not available for return/evaluation. The vaccines used according to the instruction leaflet.  This is one of four reports from the same reporter.
Age: 71.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumonia vaccine administered on 10-OCT-2007 and Pneumovax administered on 15-OCT-2009; This spontaneous report has been received from an other healthcare professional via an immunization records from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2111USA004903), concerning a 71-year-old patient of unknown gender. The patient was not allergic to egg, neomycin, latex and gelatin. The patient's concomitant vaccine included unspecified quadrivalent influenza vaccine. The patient's concurrent conditions and medical history were not reported. On 10-OCT-2007, the patient was vaccinated with the first dose of unspecified pneumococcal polysaccharide vaccine (PPV) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiry date were not reported) for prophylaxis. On 15-OCT-2009, the patient received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX) as a second dose (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis (Inappropriate schedule of product administration).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2111USA004903:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information; a dose of VARIVAX was administered after being improperly stored; This spontaneous report was received from an other refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 07-FEB-2022 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot numbers T031388, U007471 and T041685, expiration dates 15-SEP-2022, 08-MAR-2023 and 10-DEC-2022 respectively for prophylaxis (dose and route of administration not reported) (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of -14 degrees Celsius for 672 hours. No previous temperature excursion were reported.
Age: 5.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE reported; a 5 year old patient was administered GARDASIL 9; Spontaneous information has been received from a nurse referring to 5-year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On 01-MAR-2022, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route, indication, were not provided; which had a lot # 1687293, expiration date: 30-APR-2023) (formulation,route of administration, vaccination scheme frequency and anatomical location were not reported) for prophylaxis. It was reported that the patient had not had any side effects associated with the administration. No additional adverse event reported.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: adverse reaction/side effect experienced: none; Pnumococcal vaccines administered less than five years apart; This spontaneous report has been received from lawyer, via a Fact sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1810USA005844), concerning an 86-year-old male patient. The patient's medical history included an unspecified pneumococcal vaccine; her concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2011 and 01-OCT-2015, he was vaccinated with separate doses of pneumococcal vaccine, polyvalent (23-valent) (reported as "pneumonia") (manufacturer unknown) (Inappropriate schedule of product administration) as prophylaxis (strengths, doses, routes of administration, anatomical location, lot numbers, and expiration dates were not reported), no adverse events were reported. The outcome of the events was unknown.   This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1810USA005844:
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: male patient over the age of 45, received two doses of Gardasil 9/his old doctor recommended for him; the patient is trying to received the third dose of GARDASIL 9; no additional AE reported; Spontaneous information has been received from a nurse referring a 53-year-old male patient. Information regarding the patient's medical history, concomitant therapies and drug allergies or reactions were not provided. The patient's pre-existing condition included condyloma.  On an unknown date, the patient received the first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route, lot # and expiration date were not provided) (Product administered to patient of inappropriate). The patient was currently living in another area and was trying to get the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but it was stated that in the area the patient was living was much stricter (product availability issue). No additional adverse event reported.