chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Severe flu like symptoms; Massive headache; Constant chills; Bouts of intense sweating; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unspecified date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 02:00, the patient experienced severe flu like symptoms like massive headache, constant chills, bouts of intense sweating and diarrhea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe flu like symptoms, massive headache, constant chills, bouts of intense sweating and diarrhea was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nasopharyngitis, Pain in extremity
Clinical narrative: really tired: Ibrance, Pfizer COVID vaccine; Does not have much energy; cold; sore arm: Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:15 (Age at vaccination 69 years old) (Batch/Lot Number: EW0169) as DOSE 1, SINGLE for covid-19 immunisation, IBRANCE, via an unspecified route of administration from Jul2018 (Batch/Lot number was not reported) and ongoing, at 100 mg, [21 days, off for 7 days] for an unspecified indication. Medical history included neoplasm malignant Cancer, diabetes mellitus, hypertension, hypothyroidism, neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medication(s) included BABY ASPIRIN taken for hypertension, METFORMIN taken for diabetes mellitus, LISINOPRIL taken for hypertension, LEVOTHYROXINE taken for hypothyroidism, ATORVASTATIN CALCIUM taken for blood cholesterol increased, LETROZOLE taken for neoplasm malignant from Jul2018 and ongoing; VITAMIN B12, insulin NOVOLIN 70/30 taken for diabetes mellitus from an unspecified start date and ongoing. On 22Apr2021 the patient experienced sore arm, pfizer covid vaccine, really tired IBRANCE, pfizer covid vaccine does not have much energy, cold. The action taken in response to the events for palbociclib was dose not changed. Therapeutic measures were taken as a result of sore arm: pfizer covid vaccine (pain in extremity). Outcome of the event was Pain in extremity recovered on unspecified date of 2021, fatigue was not recovered, asthenia, nasopharyngitis was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 41-years-old) as a 0.3 mL single dose for COVID-19 immunisation. Medical history was not reported. On 15Jan2021, the patient underwent nasal swab test and the result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on an unknown date at 17:00, as a 0.3 mL single dose for COVID-19 immunisation. The patient previously received morphine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 22:00, after second dose, the patient experienced tinnitus in both ears- constant and increasing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after second dose began getting tinnitus in both ears - constant and increasing was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Swollen lymph nodes; Fever; Body aches; Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, rheumatoid arthritis, postural orthostatic tachycardia syndrome (POTS) and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced swollen lymph nodes, fever, body aches, nausea and vomiting, headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes, fever, body aches, nausea and vomiting, headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Swollen lymph nodes; Fever; Body aches; Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, rheumatoid arthritis, postural orthostatic tachycardia syndrome (POTS) and allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced swollen lymph nodes, fever, body aches, nausea and vomiting, headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes, fever, body aches, nausea and vomiting, headache were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Periorbital swelling, Pyrexia
Clinical narrative: Under eye swelling/puffiness; Diarrhea; Nausea; Headache; Low grade temperature; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, spondylosis of neck (cervical spondylosis), sciatica, low back pain and anxiety depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and paroxetine (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received naproxen (MANUFACTURER UNKNOWN) and experienced nauseous. On 03May2021 at 04:30, the patient experienced under eye swelling/puffiness, diarrhea, nausea, headache and low-grade temperature. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of nausea which included treatment with nausea medication called in by her primary care doctor.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events under eye swelling/puffiness, diarrhea, nausea, headache and low-grade temperature was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Extreme nausea; Vomiting 2x per day for 5 days following vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shellfish and peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 13:00, the patient experienced extreme nausea and vomiting 2 times per day for 5 days following the vaccine. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme nausea and vomiting was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: Fever in excess of 103; Full body rash; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 05May2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis, alopecia areata and known allergies to penicillin and iodine/iodine contrast fluid. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and diazepam (MANUFACTURER UNKNOWN); for unknown indication from unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 11:00 the patient experienced fever in excess of 103 degrees (unspecified units), full body rash and fatigue. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. On 05May2021, the patient had body temperature test and the result was 103 degrees (unspecified units). The clinical outcome of the event fever in excess of 103, full body rash and fatigue was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; PNEUMOVAX23 underwent temperature excursions was administered; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided.  On 20-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T020639, for prophylaxis (strength, dose and route were not provided). The administered vaccine underwent temperature excursions (Product storage error). The storage temperature of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was reported as below 36 degree Fahrenheit (34.0 degree Fahrenheit) for a time frame of 12 hours 57 minutes. There was no previous temperature excursion. No additional adverse effect reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA007275:
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number pp9l5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows; On 22nd October 2021, the patient received Kinrix, which was already expired on 16th October 2021. No further events were reported. The reporter agreed to be contacted for follow-up. The reporter consented to follow-up.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test abnormal, Bone pain, Inflammation, Mobility decreased
Clinical narrative: pain in all bones jaw, neck, shoulders, hips and feet; arm inflammation; sluggish/ could not get out of bed; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2021, 8 hrs after receiving Shingrix, the patient experienced fever and sluggishness. On 24th September 2021, the patient experienced inflammation localized. On 27th September 2021, the patient experienced bone pain. The patient was treated with paracetamol (Tylenol). On 25th September 2021, the outcome of the fever, inflammation localized and sluggishness were recovered/resolved. On an unknown date, the outcome of the bone pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, sluggishness and bone pain to be related to Shingrix. The reporter considered the inflammation localized to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient. The patient received her 2nd dose of Shingrix vaccine on her left arm, that night she had a high fever that resolved on 25th September 2021, in the morning.  The patient felt sluggish from 23rd September 2021 and was resolved on 25th September 2021.  On 24th September 2021, 1 day after vaccination, the patient's left arm was inflamed and resolved on 25th September 2021.  On 27th September 2021, 4 days after vaccination, upon rising, she had pain in all her bones including her jaw, neck, shoulders, hips and feet.  On a pain scale she was at an 8 or 9.  The patient could not get out of bed.  The patient went to her health care professional (HCP) on 19th October 2021 because her bones were still painful.  The took bloodwork and urinalysis and it showed inflammation.  HCP felt the inflammation was from the Shingrix vaccine and that the caller should report it to the company.  HCP advised her to take Tylenol for pain.  The pain was getting better, pain scale at a 5 or 6 now, but not resolved. The reporter did not consent to follow-up also did not give permission to contact HCP.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain assessment, Pain in extremity, Pain in jaw
Clinical narrative: pain in all bones jaw, neck, shoulders, hips and feet; arm inflammation; sluggish/ could not get out of bed; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2021, 8 hrs after receiving Shingrix, the patient experienced fever and sluggishness. On 24th September 2021, the patient experienced inflammation localized. On 27th September 2021, the patient experienced bone pain. The patient was treated with paracetamol (Tylenol). On 25th September 2021, the outcome of the fever, inflammation localized and sluggishness were recovered/resolved. On an unknown date, the outcome of the bone pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, sluggishness and bone pain to be related to Shingrix. The reporter considered the inflammation localized to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient. The patient received her 2nd dose of Shingrix vaccine on her left arm, that night she had a high fever that resolved on 25th September 2021, in the morning.  The patient felt sluggish from 23rd September 2021 and was resolved on 25th September 2021.  On 24th September 2021, 1 day after vaccination, the patient's left arm was inflamed and resolved on 25th September 2021.  On 27th September 2021, 4 days after vaccination, upon rising, she had pain in all her bones including her jaw, neck, shoulders, hips and feet.  On a pain scale she was at an 8 or 9.  The patient could not get out of bed.  The patient went to her health care professional (HCP) on 19th October 2021 because her bones were still painful.  The took bloodwork and urinalysis and it showed inflammation.  HCP felt the inflammation was from the Shingrix vaccine and that the caller should report it to the company.  HCP advised her to take Tylenol for pain.  The pain was getting better, pain scale at a 5 or 6 now, but not resolved. The reporter did not consent to follow-up also did not give permission to contact HCP.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sluggishness, Urine analysis abnormal
Clinical narrative: pain in all bones jaw, neck, shoulders, hips and feet; arm inflammation; sluggish/ could not get out of bed; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd September 2021, 8 hrs after receiving Shingrix, the patient experienced fever and sluggishness. On 24th September 2021, the patient experienced inflammation localized. On 27th September 2021, the patient experienced bone pain. The patient was treated with paracetamol (Tylenol). On 25th September 2021, the outcome of the fever, inflammation localized and sluggishness were recovered/resolved. On an unknown date, the outcome of the bone pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, sluggishness and bone pain to be related to Shingrix. The reporter considered the inflammation localized to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient. The patient received her 2nd dose of Shingrix vaccine on her left arm, that night she had a high fever that resolved on 25th September 2021, in the morning.  The patient felt sluggish from 23rd September 2021 and was resolved on 25th September 2021.  On 24th September 2021, 1 day after vaccination, the patient's left arm was inflamed and resolved on 25th September 2021.  On 27th September 2021, 4 days after vaccination, upon rising, she had pain in all her bones including her jaw, neck, shoulders, hips and feet.  On a pain scale she was at an 8 or 9.  The patient could not get out of bed.  The patient went to her health care professional (HCP) on 19th October 2021 because her bones were still painful.  The took bloodwork and urinalysis and it showed inflammation.  HCP felt the inflammation was from the Shingrix vaccine and that the caller should report it to the company.  HCP advised her to take Tylenol for pain.  The pain was getting better, pain scale at a 5 or 6 now, but not resolved. The reporter did not consent to follow-up also did not give permission to contact HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose:2018, second not received yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th October 2018, (batch number 419A1AB, expiry date 16th March 2019)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, SARS-CoV-2 test, Skin lesion
Clinical narrative: Psoriasis, 2 weeks after second dose; Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis, 2 weeks after second dose) and SKIN LESION (Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PSORIASIS (Psoriasis, 2 weeks after second dose) and SKIN LESION (Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body). At the time of the report, PSORIASIS (Psoriasis, 2 weeks after second dose) and SKIN LESION (Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Two weeks after the second dose, the patient was diagnosed with Psoriasis and is ongoing. As treatment ointments were added. the lesion in one place better, the other seem to be emerging.  Patient tested for COVID-19 four times with negative results .  No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received on 22Oct2021 contains significant information like lab data.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Really sick for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick for 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Overweight.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ILLNESS (Really sick for 3 days). In October 2021, ILLNESS (Really sick for 3 days) had resolved.            Patient had Medical history Lupus Concomitant information was not provided It was reported that the patient experienced sickness right after getting the booster shot. Treatment information was not provided.   This case was linked to MOD-2021-358530 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hair texture abnormal
Clinical narrative: Hair loss, hair feels thinner/Hair loss; Hair texture feels different, hair feel dryer; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, hair feels thinner/Hair loss) and HAIR TEXTURE ABNORMAL (Hair texture feels different, hair feel dryer) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ALOPECIA (Hair loss, hair feels thinner/Hair loss) and HAIR TEXTURE ABNORMAL (Hair texture feels different, hair feel dryer). The patient was treated with BETAMETHASONE SODIUM PHOSPHATE (BETAMETHASONE [BETAMETHASONE SODIUM PHOSPHATE]) for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (Hair loss, hair feels thinner/Hair loss) and HAIR TEXTURE ABNORMAL (Hair texture feels different, hair feel dryer) had not resolved.            Concomitant medication was not provided. The patient went to her doctor and her doctor ran batteries of tests associated with why her hair loss might be occurring. Everything came back normal, no thyroid issues or nothing.The only thing she can attribute it to was it started two to three months after her second shot. It has not resolved, she has never had this in her life. She attributes it to the vaccine.She was later prescribed Minoxidil, but she did not used it due to the expected side effects.   This case was linked to MOD-2021-358794 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Added reporter's details, patient DOB, age, suspect drug start date and updated events outcome from recovering to not recovered.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Body temperature, Fatigue, Myalgia
Clinical narrative: Lack of taste; Had no energy; Completely wiped out; Fever of 100.2 F; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AZ1A and 038AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches). At the time of the report, AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.5 (High) Patient experienced fever 100.5.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient was fine in a few days and was pending for his third dose.  This case concerns a 86-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the first dose of Spikevax and resolved after a few days. The rechallenge is negative, since the event did not recurr after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report; Sender's Comments: This case concerns a 86-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the first dose of Spikevax and resolved after a few days. The rechallenge is negative, since the event did not recurr after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lack of taste; Had no energy; Completely wiped out; Fever of 100.2 F; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AZ1A and 038AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches). At the time of the report, AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.5 (High) Patient experienced fever 100.5.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient was fine in a few days and was pending for his third dose.  This case concerns a 86-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the first dose of Spikevax and resolved after a few days. The rechallenge is negative, since the event did not recurr after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report; Sender's Comments: This case concerns a 86-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the first dose of Spikevax and resolved after a few days. The rechallenge is negative, since the event did not recurr after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Hypersensitivity, Pruritus
Clinical narrative: Suffered allergies; Started to feel an itching in the face/time was passing by the body was itching more and more; Afraid; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Suffered allergies), PRURITUS (Started to feel an itching in the face/time was passing by the body was itching more and more) and FEAR (Afraid) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, HCTZ, LOSARTAN and ALLOPURINOL for an unknown indication.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced HYPERSENSITIVITY (Suffered allergies) and PRURITUS (Started to feel an itching in the face/time was passing by the body was itching more and more). 22-Aug-2021, the patient experienced FEAR (Afraid). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in August 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Suffered allergies), PRURITUS (Started to feel an itching in the face/time was passing by the body was itching more and more) and FEAR (Afraid) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-358758 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Dyspnoea, Fatigue, Injection site erythema, Myalgia
Clinical narrative: Dyspnoea; myalgia; fatigue; Large erythema (3x2') at the site of injection; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Dyspnoea), INJECTION SITE ERYTHEMA (Large erythema (3x2') at the site of injection), MYALGIA (myalgia) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (gluten), Milk allergy (diary), Allergy to aluminium (alum dyes), Food allergy (eggs) and Autoimmune hypothyroidism since 1995. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyreosis.    On 24-Mar-2021 at 11:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE ERYTHEMA (Large erythema (3x2') at the site of injection). On 12-Apr-2021, the patient experienced DYSPNOEA (Dyspnoea), MYALGIA (myalgia) and FATIGUE (fatigue). On 05-Apr-2021, INJECTION SITE ERYTHEMA (Large erythema (3x2') at the site of injection) had resolved with sequelae. On 21-May-2021, DYSPNOEA (Dyspnoea), MYALGIA (myalgia) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: very high (High) Very high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height was 5' 2". Patient had experienced fatigue in the past at the time of hypothyreosis diagnosis in 1995. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant follow up received ,and reporter information, patient information, past medical history, suspect drug information,concomitant information and event information was updated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 patient received a dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (1 patient received a dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had reported that on 15Oct2021, the vaccine vial was moved to refrigeration.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Significant FU appended. Include updated patient demographics, dose details, Batch number. On 21-Oct-2021: Include no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received third dose from vial refrigerated for more than 30 days; received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-358921, MOD-2021-359183, MOD-2021-358773, MOD-2021-358799, MOD-2021-358800, MOD-2021-358841, MOD-2021-358865, MOD-2021-359032, MOD-2021-359764, MOD-2021-358773 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient receiving a vaccine that is expired/vaccine was given to a patient and it's expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose administered after manufacturer date of expiry[11October2021Number of doses/vials:1 vial, 4 doses for 4 patients Date the vial was initially stored in the refrigerator: 17October2021 Date(s) of administration of vaccine: 17October2021  No concomitant medications were reported   No treatment information was provided
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days/received third dose and it is unknown if patient is immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-358773 (Patient Link).