chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This case was reported by a consumer interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's child. The age at vaccination was not reported. The patient got Shingles vaccine and 2 weeks later got shingles. The patient had been in pain for 6 months. The reporter advised to skip the vaccine. The follow-up would not possible as no contact details were available. This case was linked with the case US2021AMR249100, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249100:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT AND ALMOST DIED; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, (Dose Number in Series: 1), start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Consumer reported that "I personally know one person who got blood clots, and almost died". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot and almost died was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20211205693- covid-19 vaccine ad26.cov2.s blood clot and almost died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: RED FACE AND CHEEKS; FACE HOT TO TOUCH; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 01-DEC-2021, the patient experienced red face and cheeks. On 01-DEC-2021, the patient experienced face hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face hot to touch on 02-DEC-2021, and was recovering from red face and cheeks. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain, soreness in shoulder
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: 4-year-old received pediatric Pfizer formulation of COVID-19 vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Chest discomfort, Dyspnoea exertional, Echocardiogram
Clinical narrative: palpitations, dyspnea on exertion, chest tightness, oxygen desaturation
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Metabolic function test, Oxygen saturation decreased, Palpitations
Clinical narrative: palpitations, dyspnea on exertion, chest tightness, oxygen desaturation
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: palpitations, dyspnea on exertion, chest tightness, oxygen desaturation
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chest pain, Extra dose administered, Impaired work ability
Clinical narrative: Severe joint paint and nausea starting 12 hours after booster received. Severe muscle pain from left arm, across chest, armpit area, down to left side starting 36 hours after booster received lasting greater than 24 hours. Severe muscle pain has not gotten better at this time, causing me to call in into work as I cannot move my left arm due to swelling.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Nausea, Pain in extremity
Clinical narrative: Severe joint paint and nausea starting 12 hours after booster received. Severe muscle pain from left arm, across chest, armpit area, down to left side starting 36 hours after booster received lasting greater than 24 hours. Severe muscle pain has not gotten better at this time, causing me to call in into work as I cannot move my left arm due to swelling.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: 1. After I got the first shot, I began having itchy symptoms on my body.  2. After I got the second shot, for the first day, my symptom was nausea. The second day, my symptom was fever.  The third day, hives appeared. It has not gone. I have been taking medications listed below.  a. RA CETIRIZINE HCL 10 MG b. HYDROXYZINE HCL 25 MG c. FAMOTIDINE 20 MG Before I started taking medications mentioned above, my doctor prescribed me TRIAMCINOLONE 0.5% OINTMENT and LORATADINE 10 MG. Unfortunately, these two medications did not improve my symptoms.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hot flush, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Night of vaccine pain in injection site and body aches followed by a long stretch (nearly 24 hrs) of intense body aches, nausea, cold and hot flashes, shivering etc. Treatment was increased hydration and Tylenol. Symptoms gradually faded but did not completely improve until 3 days after injection. Hot/cold flashes and body aches (especially neck stiffness) lasted, although much less extreme.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Night of vaccine pain in injection site and body aches followed by a long stretch (nearly 24 hrs) of intense body aches, nausea, cold and hot flashes, shivering etc. Treatment was increased hydration and Tylenol. Symptoms gradually faded but did not completely improve until 3 days after injection. Hot/cold flashes and body aches (especially neck stiffness) lasted, although much less extreme.
Age: 18.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: Swollen lymph nodes under arm and neck. Extensive, itchy hives on legs, scalp and neck.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Memory impairment, Pain in extremity
Clinical narrative: Headache, fever, soreness in arm, extreme fatigue, foggy brain, forgetfulness, pain in right calf,
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, fever, soreness in arm, extreme fatigue, foggy brain, forgetfulness, pain in right calf,
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash all over body. Moved from one area to another. Still ongoing 4 days into side effects.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: did not feel good; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel good) and FATIGUE (tired) in a 69-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (did not feel good) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL A) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel good) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes Thyroid Medication.   This case was linked to MOD-2021-404024, MOD-2021-404070 (Patient Link).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from medical assistant referring to unspecified patients of unknown age and gender. The information about patients' concurrent conditions, medical history, concomitant medications was unknown. On 22-OCT-2021, doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to 54.9 Fahrenheit for 2 hours 1 minute. It was reported that there was no previous temperature excursion. On an unknown date in 2021, three improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number T012807 has been verified to be a valid lot number, expiration date was 14-APR-2022) and two improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U015847 has been verified to be a valid lot number, expiration date was 19-MAY-2023) were administered to unspecified amount of patients for prophylaxis (strengths, doses, vaccinate schemes, route of administration, and anatomical location were not reported) (product storage error). No further information, adverse event or product quality complaints were reported. This is a non- valid report due to lac of patients.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a shot of Shingles vaccine and had shingles which were terrible. The patient was ready to take 2nd one. The follow-up could not be possible as no contact details were available. Note: Case was conservatively kept valid case it was not clear if the patient experienced shingles before or after administration of 1st dose.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: received a pediatric dose instead of an adult; received a pediatric dose instead of an adult; 1 dose: 11/8/2021, 2 dose: 11/29/2021; received a pediatric dose instead of an adult; patient receiving as a 2 dose of Engerix-B a pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 8th November 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 8th November 2021, not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On 29th November 2021, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product, drug dose administration interval too short, underdose and adult use of a child product were 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 provided as follows: The reporter stated that, a 20 year old patient received 2 doses of Engerix-B a pediatric dose instead of an adult one, which led to underdose and adult use of a child product. The patient received the 2nd dose of Engerix B, earlier than the recommended schedule, which led to shortening of vaccination schedule. The Healthcare professional didn't have more demographic data of the patient.  The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: 12 DOSES ADMINISTERED TO 12 PATIENTS THAT DID NOT ADHERE TO STORAGE CONDITIONS OUTLINED IN THE PRODUCT FACT SHEET; DOSES EXPOSED 18 TIMES TO A MIN TEMPERATURE OF 32.2F FOR A CUMULATIVE PERIOD OF 28 HOURS AND 49 MINUTES; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced doses exposed 18 times to a min temperature of 32.2f for a cumulative period of 28 hours and 49 minutes. On 25-OCT-2021, the patient experienced 12 doses administered to 12 subjects that did not adhere to storage conditions outlined in the product fact sheet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the doses exposed 18 times to a min temperature of 32.2f for a cumulative period of 28 hours and 49 minutes and 12 doses administered to 12 patients that did not adhere to storage conditions outlined in the product fact sheet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little tired. This report was non-serious. This case, from the same reporter is linked to 20211210246.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria, Urticaria chronic
Clinical narrative: chronic urticaria week after shot; hives are a small itch in one spot/The hives popped up; hives are a small itch in one spot/The hives popped up; develops angry red rash, with hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA CHRONIC (chronic urticaria week after shot), URTICARIA (hives are a small itch in one spot/The hives popped up), PRURITUS (hives are a small itch in one spot/The hives popped up) and RASH ERYTHEMATOUS (develops angry red rash, with hives) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Concurrent medical conditions included Cold sores. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Cold sores, SERTRALINE and ATORVASTATIN for an unknown indication.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced URTICARIA CHRONIC (chronic urticaria week after shot), URTICARIA (hives are a small itch in one spot/The hives popped up), PRURITUS (hives are a small itch in one spot/The hives popped up) and RASH ERYTHEMATOUS (develops angry red rash, with hives). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of 2 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 50 mg. At the time of the report, URTICARIA CHRONIC (chronic urticaria week after shot), URTICARIA (hives are a small itch in one spot/The hives popped up) and PRURITUS (hives are a small itch in one spot/The hives popped up) had not resolved and RASH ERYTHEMATOUS (develops angry red rash, with hives) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter called on behalf of her husband who developed chronic urticaria a week after receiving his Moderna COVID-19 booster dose.  The hives popped up, he went to a local urgent care, they gave him a steroid pack for 5 days. The patient took Zyrtec in the morning and Benadryl at night.  The angry red rash, with hives were transient and then goes away. patient had a follow up appointment.   This case was linked to MOD-2021-403273, MOD-2021-403274, MOD-2021-402691 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: intense vomiting/she said she had grade 4 vomiting; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING (intense vomiting/she said she had grade 4 vomiting) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VOMITING (intense vomiting/she said she had grade 4 vomiting) and NAUSEA (nausea). At the time of the report, VOMITING (intense vomiting/she said she had grade 4 vomiting) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided Patient taken Ginger, natural things   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Somnolence
Clinical narrative: she started coughing that occurred once in a while. It is a deep cough; sleeping a lot; Usual chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (she started coughing that occurred once in a while. It is a deep cough), SOMNOLENCE (sleeping a lot) and CHILLS (Usual chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     The patient's past medical history included Smoker (Used to smoke 3 cigarettes a day. Quit smoking 17 months ago.), Walking difficulty (Before the vaccine, she went on vacation, came back and was not able to walk.), Muscle strain and Knee replacement. Concomitant products included CITALOPRAM for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COUGH (she started coughing that occurred once in a while. It is a deep cough), SOMNOLENCE (sleeping a lot) and CHILLS (Usual chills). At the time of the report, COUGH (she started coughing that occurred once in a while. It is a deep cough), SOMNOLENCE (sleeping a lot) and CHILLS (Usual chills) was resolving.            No treatment information was provided.  Earlier  patient used to smoke and never used to cough then. The coughing scared her.She was still not 100 percent.   Before the vaccination, patient went on vacation,came back and was not able to walk. patient  had a knee replacement, did blood work for it, took an X ray,  had pulled a muscle. She had to go to the hospital for this and did lung work there.This was not a reaction to the vaccine, patient mentioned as  this in passing from happening before.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up information received contain Non significant information. On 02-Dec-2021: Non Significant Follow up
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Magnetic resonance imaging
Clinical narrative: severe chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (severe chest pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (severe chest pain) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to CHEST PAIN. At the time of the report, CHEST PAIN (severe chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) clear and normal.         Concomitant medication was not provided.  Treatment information was not provided.  The patient had Laboratory test and X-ray. whose result were unknown  This is a spontaneous case concerning a 33-year-old male patient with no medical history reported, who experienced the unexpected event of chest pain. The event occurred approximately 2 days after the second dose of mRNA  1273 vaccine. Patient was hospitalized for 2 days because of chest pain and at the time of report outcome of the event was unknown. MRI results was clear and normal. The rechallenge is not applicable since no information about the first dose was provided. The reporter assessment was not provided. The benefit-risk relationship of mRNA  1273 vaccine  is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 33-year-old male patient with no medical history reported, who experienced the unexpected event of chest pain. The event occurred approximately 2 days after the second dose of mRNA  1273 vaccine. Patient was hospitalized for 2 days because of chest pain and at the time of report outcome of the event was unknown. MRI results was clear and normal. The rechallenge is not applicable since no information about the first dose was provided. The reporter assessment was not provided. The benefit-risk relationship of mRNA  1273 vaccine  is not affected by this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Vaccination site reaction
Clinical narrative: Covid arm; dizziness; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21a and 007C21a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). In May 2021, VACCINATION SITE REACTION (Covid arm), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.            No concomitant medication was given.  No treatment medication was given.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very sick). At the time of the report, ILLNESS (got very sick) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up received , contains No New Information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021 at 11:21 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.  Total amount of time the vial was exposed to room temperature range  8 degree to 25 degree C, 46degree to 77degree F) 14 hours, Date the vial was initially stored in the refrigerator-29NOV2021
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: did not feel good; she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel good) and FATIGUE (she was tired) in a 69-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (did not feel good) and FATIGUE (she was tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel good) and FATIGUE (she was tired) outcome was unknown.            Concomitant medication included thyroid medication.   This case was linked to MOD-2021-404069, MOD-2021-404024 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Chills lasting <1-hour, Fever 103.8 lasting about 6-hours, soreness at injection site last >24-hour.  Took OTC Tylenol and 325mg aspirin.  Fever broke after approximately 6-hours and temperature was normal 8-hours after onset of chills/fever.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Laboratory test normal, Liver function test normal, Pruritus, Rash
Clinical narrative: My skin is very itchy. There is no rash, but when I itch my skin becomes red and swollen. Hives will appear after my skin is itched. I have seen the ER and an urgent care. They have given me prednisone which doesn?t really help. Zyrtec and Benadryl make me less itchy but the skin rash still appears if I itch. Eucerin / ice packs helps relieve itching once itched
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Renal function test normal, Skin swelling, Urticaria
Clinical narrative: My skin is very itchy. There is no rash, but when I itch my skin becomes red and swollen. Hives will appear after my skin is itched. I have seen the ER and an urgent care. They have given me prednisone which doesn?t really help. Zyrtec and Benadryl make me less itchy but the skin rash still appears if I itch. Eucerin / ice packs helps relieve itching once itched
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Additional Details: Immediately after vaccine, the patient started to feel faint. He became very lethargic, light headed, and was sweating profusely. Patient also experienced nausea but no vomiting. I had him sit in head down position and gave him an ice pack and some water. Patient's wife also attended to him during this time. After about 20 minutes, he was able to get up and walk out of the store on his own.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Additional Details: Immediately after vaccine, the patient started to feel faint. He became very lethargic, light headed, and was sweating profusely. Patient also experienced nausea but no vomiting. I had him sit in head down position and gave him an ice pack and some water. Patient's wife also attended to him during this time. After about 20 minutes, he was able to get up and walk out of the store on his own.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Culture urine, Echocardiogram
Clinical narrative: Diagnosed  with PMR/GCA 6 days after injection, 4 hospitalizations and prostate surgery 2 months after injection. Now taking Glipizide,Tamsulsine,Prednisone, Gabapentin  D3, Magnesium. In addition to Metformin and Lisinopril which were the only meds taken before injection.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Giant cell arteritis, Magnetic resonance imaging, Polymyalgia rheumatica, Prostatic operation, Scan
Clinical narrative: Diagnosed  with PMR/GCA 6 days after injection, 4 hospitalizations and prostate surgery 2 months after injection. Now taking Glipizide,Tamsulsine,Prednisone, Gabapentin  D3, Magnesium. In addition to Metformin and Lisinopril which were the only meds taken before injection.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Urine analysis, X-ray
Clinical narrative: Diagnosed  with PMR/GCA 6 days after injection, 4 hospitalizations and prostate surgery 2 months after injection. Now taking Glipizide,Tamsulsine,Prednisone, Gabapentin  D3, Magnesium. In addition to Metformin and Lisinopril which were the only meds taken before injection.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Extra dose administered, Interchange of vaccine products
Clinical narrative: 6 days after receiving my covid19 booster (moderna) my low-mid back started hurting badly.  I got pfizer for my first 2 shots.  I experienced this back pain after my last 2 flu shots as well.  I haven?t done any serious physical exertion since my booster so i know it is unrelated to physical activity.  The type of back pain is exactly like the flu shot reaction.  Like someone went to down punching my kidneys and ribs in my back.  I had to sit on my couch to put my socks on because I can pick and hold my feet high enough to do it.  I have to use my hands to support my thighs to get up and bend over.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Headache, Injection site discolouration
Clinical narrative: Severe headache Insomnia  Cold chills Black spot at injection site Confusion  Difficult to think of words Thoughts jumbled Dizziness  Nausea
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea
Clinical narrative: Severe headache Insomnia  Cold chills Black spot at injection site Confusion  Difficult to think of words Thoughts jumbled Dizziness  Nausea
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient reports a history of fainting with various vaccinations. This was the patient's second dose, she was okay with the first. Patient reports that this happens from time to time when given vaccines. Monitored for 30 minutes before patient left for home stating she was okay. She recovered consciousness within a minute of fainting. She drank plenty of water after the event occurred and reported feeling fine by the time she left.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT with large saddle PE and other PEs
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Immediate metallic taste upon receiving vaccination; lasted several hours.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Hypoaesthesia, Mouth swelling
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site pruritus, Interchange of vaccine products, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called 12/5/2021 to report generalized rash and itching the day after Moderna booster. Patient reported history of anaphylaxis to tree nuts. He has an EpiPen on hand. He reported no other symptoms. Advised patient to take antihistamine & monitor. Patient received Pfizer as first 2 doses without issue. Patient will follow-up with primary care physician.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: Had very unusually heavy menstrual period after the 1st dose. Bleeding through 1 Ultra Tampon every hour.  Passing clots half the size of my palm. Soaking through pads and through clothing overnight. Then this month I had very heavy Bleeding for 1 day on 12/6  between my period. I had blood clots as well. Just one lone day.... never had this happen to me ever in my life.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pruritus, Rash, Skin discolouration
Clinical narrative: MAY 2021 I BECAME COVERED IN WATER BLISTERS ON MY ARMS AND CHEST    NOVEMBER 2021 MY CALVES BECAME COVERED IN RED WELPS AND TURNED BLUEISH-LIKE A BRUISE COLERING- MY HANDS DEVELOPED A RED RASH AND HIVES-   ALL ITCHING HORRIBLEY  FIRST SHOT APRIL 7,2021    SECOND SHOT MAY 5, 2021 I HAVE PHOTOS OF MY LEGS CONCERNING THE SECOND EVENT- I DO NOT HAVE THE FIRST INCIDENT.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: MAY 2021 I BECAME COVERED IN WATER BLISTERS ON MY ARMS AND CHEST    NOVEMBER 2021 MY CALVES BECAME COVERED IN RED WELPS AND TURNED BLUEISH-LIKE A BRUISE COLERING- MY HANDS DEVELOPED A RED RASH AND HIVES-   ALL ITCHING HORRIBLEY  FIRST SHOT APRIL 7,2021    SECOND SHOT MAY 5, 2021 I HAVE PHOTOS OF MY LEGS CONCERNING THE SECOND EVENT- I DO NOT HAVE THE FIRST INCIDENT.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's spouse forwarned RPH that patient passes out after each and every injection; patient did faint but was responsive; he did recover after about 5 mins. RPH contacted to inform them of the inicident as well.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Mild
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: THE PATIENT DESCRIBED FEELING LIGHTHEADED AFTER HIS VACCINATION. HE BECAME ALMOST UNRESPONSIVE WHILE SITTING IN THE VACCINE ADMINISTRATION AREA WHEREBY I WENT TO GET a staff member FOR ASSISTANCE. WE WERE ABLE TO GET THE PATIENT INTO A SUPINE POSITION AND staff member MEASURED HIS BLOOD PRESSURE, WHICH WAS APPROXIMATELY 70/50. Staff member WAS UNABLE TO GET A O2 READING ON THE PULSOXIMETER AT WHICH POINT WE CALLED 911. THE PATIENT LEFT ON HIS OWN AFTER EVALUATION BY THE EMTS.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood oestrogen normal, Blood testosterone normal, Extra dose administered
Clinical narrative: Started losing my hair in patches after the second shot and after the booster. Am currently working with a dermatologist who started having me use a steroid foam, dandruff shampoo, and gave me a steroid shot in one of the bald spots. The first bald spot is starting to grow back slowly. The second bald spot has just started and there is no new growth yet.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Injection site pain, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Eye swelling, Mouth swelling, Pruritus
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Dizziness / Lightheadness-Severe
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Dizziness / Lightheadness-Severe
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Last known alive on the date of vaccination (September 4). Found dead and decomposing in his residence on September 7.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Mouth swelling, Pharyngeal swelling, Rash
Clinical narrative: Anaphylactic reaction - throat/mouth swelling; rash; trouble swallowing
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills and aches about 2 hours after injection. Fever of 100.8 until about 9 pm. Took Tylenol and ibuprofen. Woke up next morning feeling fine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. Constant ringing in ears.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site mass, Injection site pain, Mobility decreased, Muscular weakness
Clinical narrative: Chills for first 48 hours.  Arm muscle at injection site sore since injection, experiencing muscle weakness in that arm. There is a lump where the shot was administered. I cannot raise my arm and it aches and throbs. The aching is getting worse every day and radiates down my arm. It has been almost a week and I cannot lift things with my left arm. Muscle feels weak all the way up to shoulder. Cannot raise arm. Entire upper arm muscle sore and throbbing, worse every day. Constant ache and muscle weakness plus lump at shot injection site.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Chills for first 48 hours.  Arm muscle at injection site sore since injection, experiencing muscle weakness in that arm. There is a lump where the shot was administered. I cannot raise my arm and it aches and throbs. The aching is getting worse every day and radiates down my arm. It has been almost a week and I cannot lift things with my left arm. Muscle feels weak all the way up to shoulder. Cannot raise arm. Entire upper arm muscle sore and throbbing, worse every day. Constant ache and muscle weakness plus lump at shot injection site.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cough, Immune system disorder, Rash, Scan normal
Clinical narrative: 2/3/21 Urgent Care-Had acid burn on complete groin area. Dr. never seen anything like it. Sent TO ER-No diagnosis-Prescribed Nystatin ointment. That finally took burn away and rash came in groin area, all over back and neck, then moved to arms and legs. 2/23/21 Got into Dr. office. He said Moderna caused an implosion to my Immune System. Lasted 5 weeks. Still have cough it caused. He advised Not to get 2nd vaccine due to severity of the problem.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Thermal burn
Clinical narrative: 2/3/21 Urgent Care-Had acid burn on complete groin area. Dr. never seen anything like it. Sent TO ER-No diagnosis-Prescribed Nystatin ointment. That finally took burn away and rash came in groin area, all over back and neck, then moved to arms and legs. 2/23/21 Got into Dr. office. He said Moderna caused an implosion to my Immune System. Lasted 5 weeks. Still have cough it caused. He advised Not to get 2nd vaccine due to severity of the problem.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site swelling
Clinical narrative: Minor itchiness and a small raised (approximately 0.5 inch diameter) bump at the vaccination site on my left arm.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Nasal congestion, Pain
Clinical narrative: FEVER, COUGH, CHEST CONGESTION, NASAL CONGESTION, BODY ACHES
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: FEVER, COUGH, CHEST CONGESTION, NASAL CONGESTION, BODY ACHES
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Burning sensation, Lymphadenopathy, Pruritus, Sleep disorder
Clinical narrative: Wednesday morning about 2:30 AM I woke up with a burning sensation in my left under arm and into my breast. I went to the bathroom, and I could see a lump in my left arm pit, and I could feel it.  It kept me up all night. It was itching and painful. The next morning, I called my OBGYN, Dr. She saw me on that Friday, she did a breast exam, and she felt a lump in my left armpit. She did not feel anything in the left breast. She did advise she has seen these before after the vaccine. She advised to get a ultrasound on my left armpit. On Monday, I went to the Medical Center, and they did an ultrasound. They did not find anything under my arm and did not find anything worrisome. I have a mammogram scheduled. It is not something that keeps me up at night, but it is still sore and hurts.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Wednesday morning about 2:30 AM I woke up with a burning sensation in my left under arm and into my breast. I went to the bathroom, and I could see a lump in my left arm pit, and I could feel it.  It kept me up all night. It was itching and painful. The next morning, I called my OBGYN, Dr. She saw me on that Friday, she did a breast exam, and she felt a lump in my left armpit. She did not feel anything in the left breast. She did advise she has seen these before after the vaccine. She advised to get a ultrasound on my left armpit. On Monday, I went to the Medical Center, and they did an ultrasound. They did not find anything under my arm and did not find anything worrisome. I have a mammogram scheduled. It is not something that keeps me up at night, but it is still sore and hurts.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: I received my Moderna booster and approximately 2-3 weeks later started getting urticaria and dermatographia occurring daily over my neck, torso, back and legs, lasting for a few hours each time with mild itchiness, improved by cetirizine. I'm also a physician so I was able to self-diagnose. I've never had this before and the only change in my routine was the booster. I've not been exposed to new foods/products so I think it's related to the booster.  This did not occur after the 1st or 2nd moderna shots.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Rash, Urticaria
Clinical narrative: Developed a rash with raised hives all over my body. It started on my neck/chest area and then quickly spread to my trunk area, and all down my arms and legs. Every joint in my body was sore and felt swollen and hard to move.  I did take photos if needed.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Soreness and swelling in armpit in shot arm
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: severe headaches pain in arm
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Eye disorder, Headache, Tinnitus
Clinical narrative: Constant headache since the day after 1st dose. Ear pain, pressure, periodically ringing. Vertigo. Eyes feel like the are crossing, blurred vision.