chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: sore joints; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore joints), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Vestibular migraine. Concomitant products included IBUPROFEN for Vestibular migraine.    On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ARTHRALGIA (sore joints), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ARTHRALGIA (sore joints), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that she took 2 Ibuprofens 3 hours before receiving the vaccine because she had vestibular migraine. She forgot about not taking medications before receiving the vaccine. She took the medications to keep her migraines from getting worse.  Reporter clarified that her migraines had nothing to do with the vaccines and she had been experiencing migraines before receiving any Moderna vaccine.  She had sore joints, headache, and fever after receiving the vaccine.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: UNK
Symptoms: Discomfort, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: generalized body aches; localized arm pain; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (generalized body aches), PAIN IN EXTREMITY (localized arm pain), NAUSEA (nausea) and FATIGUE (tiredness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PAIN (generalized body aches), PAIN IN EXTREMITY (localized arm pain), NAUSEA (nausea) and FATIGUE (tiredness). At the time of the report, PAIN (generalized body aches), PAIN IN EXTREMITY (localized arm pain), NAUSEA (nausea) and FATIGUE (tiredness) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had side effects as localized arm pain, nausea, tiredness, generalized body aches (heaviness feeling). The injection was on 28-Sep-2023 and today was 10-Oct-2023.Patient concerned that this was lasting too long.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Live follow-up received: Reference number added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product APIXABAN (ELIQUIS) for an unknown indication.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller has high blood pressure and it's under control on medication. Caller also has Afib and is taking Eliquis.  The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Blood pressure high.   On 10-Jun-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started APIXABAN (ELIQUIS) (unknown route) at an unspecified dose. On 10-Jul-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication or treatment medication not provided.
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: adverse reaction to the moderna Spikevax; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (adverse reaction to the moderna Spikevax) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (adverse reaction to the moderna Spikevax). At the time of the report, IMMUNISATION REACTION (adverse reaction to the moderna Spikevax) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Illness
Clinical narrative: Sickness; Difficulty breathing; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness) and DYSPNOEA (Difficulty breathing) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness) and DYSPNOEA (Difficulty breathing). At the time of the report, ILLNESS (Sickness) had not resolved and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had all her shots for COVID was of Moderna. Patient was sick and can hardly breathe.  Treatment information was not reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Hurt for a day or two; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Hurt for a day or two) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient had a mild case of COVID-19. She was given Molnupiravir.) on 15-Sep-2022. Previously administered products included for Product used for unknown indication: Pfizer (1st dose Pfizer lot number EL3249) on 15-Jan-2021, Pfizer (2nd dose Pfizer lot number EL9264) on 15-Feb-2021, Pfizer (3rd dose Pfizer booster lot number FE3590) on 13-Oct-2021, Pfizer (4th dose Pfizer lot number FK9994) on 05-May-2022 and PFIZER BIONTECH COVID-19 VACCINE (5th dose Pfizer unknown.) in December 2022; for Osteoporosis: Flu shot and Prolia for osteoporosis and Flu shot and Prolia for osteoporosis; for COVID-19: Molnupiravir. Past adverse reactions to the above products included No adverse event with Flu shot and Prolia for osteoporosis, Flu shot and Prolia for osteoporosis, Molnupiravir, PFIZER BIONTECH COVID-19 VACCINE, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Osteoporosis (Caller had osteoporosis.), DVT and Pulmonary embolism. Concomitant products included RIVAROXABAN (XARELTO) from 16-Jun-2014 to an unknown date for Pulmonary embolism and DVT.    On 06-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Hurt for a day or two). At the time of the report, VACCINATION SITE PAIN (Hurt for a day or two) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had already received 5 Pfizer shots and 1 Spikevax vaccine. Last dose was Spikevax, but she did not remember very well the date, it was probably 6OCT2023, and the only side effect was that it hurt for a day or two.  Caller mentioned that patient was concerned because after the Spikevax shot was given the vaccination provider gave her a sheet with information about the vaccine and it mentioned that previous to get the vaccine she should inform the HCP if she was in a blood thinner, and she was indeed taking Xarelto.  Treatment Medication use information was not provided by reporter.
Age: 84.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Nasopharyngitis, Tremor
Clinical narrative: Shakes; Cold; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shakes) and NASOPHARYNGITIS (Cold) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030338) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had no known allergies. No health conditions were reported.  The patient's past medical history included Stent placement (Caller had a couple of stents put in around 2014.) in 2014 and Surgery (Caller had an operation on spine 5 weeks ago.) in 2023.   On 11-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 12-Oct-2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced TREMOR (Shakes) and NASOPHARYNGITIS (Cold). At the time of the report, TREMOR (Shakes) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Heart rate: Pulse rate went to 110 and it was hours before it got down to a 70. Probably about 6 or 7 o'clock this morning..     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  On 12 March 2021, patient took 1st dose of Moderna vaccine having batch lot number 027A21A and on 10 March 2022, patient took 2nd dose of Moderna vaccine that having batch lot number 001M21A.  The patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had the Moderna shot yesterday around noon and did not experience symptoms around 4:30PM and had severe shakes and really really cold.  Patient definitely had the most severe symptoms that they ever had for being cold. Patient was surprised because he had no symptoms of the previous ones.   Treatment Medication use information was not provided by reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms, fever, and weakness for a few days after the vaccines; flu-like symptoms, fever, and weakness for a few days after the vaccines; flu-like symptoms, fever, and weakness for a few days after the vaccines; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms, fever, and weakness for a few days after the vaccines), ASTHENIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) and PYREXIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 030G22B and AS7664B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Aug-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms, fever, and weakness for a few days after the vaccines), ASTHENIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) and PYREXIA (flu-like symptoms, fever, and weakness for a few days after the vaccines). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms, fever, and weakness for a few days after the vaccines), ASTHENIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) and PYREXIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) had resolved.            No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient had scheduled his Spikevax Vaccine for 21-Oct-2023 which will be exactly 2 months a good enough span or will it cause other symptoms besides what people normally get with vaccines. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745569 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745569:Same patient (Monovalent case)
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Pain, Peripheral swelling
Clinical narrative: Red in the spot where it was injected; my arm is swollen; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (my arm is swollen) and INJECTION SITE ERYTHEMA (Red in the spot where it was injected) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Pain in arm. Previously administered products included for Product used for unknown indication: pfizer (dose 1), pfizer (dose 2), pfizer (dose 5), pfizer (dose 4) and pfizer (dose 3). Past adverse reactions to the above products included No adverse event with pfizer, pfizer, pfizer, pfizer and pfizer.    On 13-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 13-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PERIPHERAL SWELLING (my arm is swollen). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red in the spot where it was injected). At the time of the report, PERIPHERAL SWELLING (my arm is swollen) and INJECTION SITE ERYTHEMA (Red in the spot where it was injected) outcome was unknown.            No concomitant medication was reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The dosage text was reported as unknown. The patient received the sixth vaccine for COVID in the evening and got the Moderna, previously, the patient got all Pfizer and the arm was swollen and red in the spot where it was injected. The patient didn't had anything like this before. Actually, the patient had just like, obviously small area that was sore, but this was swollen quite big and with a big red mark on it. No treatment medication was reported.
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Side effect; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (Side effect) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effect). At the time of the report, IMMUNISATION REACTION (Side effect) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Oct-2023: Live follow-up received and added secondary reporter.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site discomfort, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: itchy; redness; swelling; The reaction is localized just in the injection site; lump in the injection site; chills; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site) and INJECTION SITE MASS (lump in the injection site) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 370268) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (batch no-011A21A  and 1st dose) on 02-Mar-2021; for Product used for unknown indication: COVID-19 VACCINE on 28-Oct-2022, RSV vaccines - 2 weeks before in October 2023 and Flu vaccines - 2 weeks before in October 2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Flu vaccines - 2 weeks before, Moderna and RSV vaccines - 2 weeks before. Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs).    On 10-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site), INJECTION SITE MASS (lump in the injection site) and CHILLS (chills). At the time of the report, PRURITUS (itchy) had not resolved, ERYTHEMA (redness) and INJECTION SITE MASS (lump in the injection site) was resolving and SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site) and CHILLS (chills) had resolved.            No concomitant medication was reported. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient started the call by saying that the patient was feeling much better. The patient received Spikevax and experienced a reaction. The patient had a lump in the injection site. It was quite uncomfortable. It was the first day that the arm was not swollen and red. It was still mildy red and awfully itchy. The itch started about half way from receiving the vaccine until now. The reaction was localized just in the injection site. The patient also had chills for one day. The patient thought that the patient was never getting warm again. The patient stayed in bed for 2-3 days. This was the first time the patient had any reaction.  No treatment medication was reported.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: itchy; redness; swelling; The reaction is localized just in the injection site; lump in the injection site; chills; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site) and INJECTION SITE MASS (lump in the injection site) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 370268) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (batch no-011A21A  and 1st dose) on 02-Mar-2021; for Product used for unknown indication: COVID-19 VACCINE on 28-Oct-2022, RSV vaccines - 2 weeks before in October 2023 and Flu vaccines - 2 weeks before in October 2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Flu vaccines - 2 weeks before, Moderna and RSV vaccines - 2 weeks before. Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfa drugs).    On 10-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), ERYTHEMA (redness), SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site), INJECTION SITE MASS (lump in the injection site) and CHILLS (chills). At the time of the report, PRURITUS (itchy) had not resolved, ERYTHEMA (redness) and INJECTION SITE MASS (lump in the injection site) was resolving and SWELLING (swelling), INJECTION SITE REACTION (The reaction is localized just in the injection site) and CHILLS (chills) had resolved.            No concomitant medication was reported. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient started the call by saying that the patient was feeling much better. The patient received Spikevax and experienced a reaction. The patient had a lump in the injection site. It was quite uncomfortable. It was the first day that the arm was not swollen and red. It was still mildy red and awfully itchy. The itch started about half way from receiving the vaccine until now. The reaction was localized just in the injection site. The patient also had chills for one day. The patient thought that the patient was never getting warm again. The patient stayed in bed for 2-3 days. This was the first time the patient had any reaction.  No treatment medication was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Combination vaccine Dtap/Polio that is labeled use for children less than 7 years old, patient was 7 years old at time of vaccination. No adverse reactions.
Age: 8.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient was administered both vaccines and then stood up then passed out and fell to the floor. EMS was called and all the child's vitals came out normal. The parents choose to take their child home instead of taking him to the hospital.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Product administered to patient of inappropriate age, Vaccination error, Wrong product administered
Clinical narrative: Patient given Fluzone High Dose instead of regular Fluzone as patient is only 63 years of age, patient notified at 7:07pm of vaccine error and instructed to follow up if they experience any adverse reactions, patient in agreement with plan of care.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 51.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Back pain, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: Severe onset of flu like symptoms in an hours time Friday 3-4 pm.  Fever, chills, stuffy nose, muscle aches, head ache, difficutly taking deep breaths.  Symptoms became much worse by Saturday and on Sunday needed to start using rescue inhaler every 2-3 hours, due to inability to breath properly.  Tremendous pain in the chest and back (left side more then right).  Took Zyzal, Tylenol, Advil, Nyquil at various times on Sunday and Monday.  Unable to go to work on Monday.   Today, Tuesday Oct 17, 2023, still have muscle weekness and severe coughing due to congestion and productive yellow mucus.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Headache, Impaired work ability, Influenza like illness, Muscular weakness, Myalgia
Clinical narrative: Severe onset of flu like symptoms in an hours time Friday 3-4 pm.  Fever, chills, stuffy nose, muscle aches, head ache, difficutly taking deep breaths.  Symptoms became much worse by Saturday and on Sunday needed to start using rescue inhaler every 2-3 hours, due to inability to breath properly.  Tremendous pain in the chest and back (left side more then right).  Took Zyzal, Tylenol, Advil, Nyquil at various times on Sunday and Monday.  Unable to go to work on Monday.   Today, Tuesday Oct 17, 2023, still have muscle weekness and severe coughing due to congestion and productive yellow mucus.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Nasal congestion, Productive cough, Pyrexia, Respiratory tract congestion, Secretion discharge
Clinical narrative: Severe onset of flu like symptoms in an hours time Friday 3-4 pm.  Fever, chills, stuffy nose, muscle aches, head ache, difficutly taking deep breaths.  Symptoms became much worse by Saturday and on Sunday needed to start using rescue inhaler every 2-3 hours, due to inability to breath properly.  Tremendous pain in the chest and back (left side more then right).  Took Zyzal, Tylenol, Advil, Nyquil at various times on Sunday and Monday.  Unable to go to work on Monday.   Today, Tuesday Oct 17, 2023, still have muscle weekness and severe coughing due to congestion and productive yellow mucus.
Age: 51.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Sputum discoloured
Clinical narrative: Severe onset of flu like symptoms in an hours time Friday 3-4 pm.  Fever, chills, stuffy nose, muscle aches, head ache, difficutly taking deep breaths.  Symptoms became much worse by Saturday and on Sunday needed to start using rescue inhaler every 2-3 hours, due to inability to breath properly.  Tremendous pain in the chest and back (left side more then right).  Took Zyzal, Tylenol, Advil, Nyquil at various times on Sunday and Monday.  Unable to go to work on Monday.   Today, Tuesday Oct 17, 2023, still have muscle weekness and severe coughing due to congestion and productive yellow mucus.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus developed around 1 am, I did not have ringing in my ears before. Too early to say whether this will be permanent.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Urinary incontinence
Clinical narrative: PT REPORTS SHE HAD CHILLS BEGINNING THE DAY AFTER RECEIVEING THE FLU VACCINE. PT ALSO REPORTS WHEN ATTEMPTING TO USE THE RESTROOM  HER BLADDER EMPTYING PRIOR TO MAKING IT TO THE TOILET. PT SAYS IT SEEMS AS IF SOMEONE CUT OPEN HER BLADDER AND EMPTIED EVERYWHERE. PT REPORTS  SHE HAS ALWAYS RECEIVED THE FLU VACCINE BUT HAS NEVER EXPERICED ANY SIDE EFFECTS. PT WAS COUNSELED THAT SHE MAY EXPERIENCE FEVER OR CHILLS AFTER RECEIVING THE VACCINE.
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Fatigue, Sleep disorder, Urinary incontinence
Clinical narrative: PT REPORTS SHE HAD CHILLS BEGINNING THE DAY AFTER RECEIVEING THE FLU VACCINE. PT ALSO REPORTS WHEN ATTEMPTING TO USE THE RESTROOM  HER BLADDER EMPTYING PRIOR TO MAKING IT TO THE TOILET. PT SAYS IT SEEMS AS IF SOMEONE CUT OPEN HER BLADDER AND EMPTIED EVERYWHERE. PT REPORTS  SHE HAS ALWAYS RECEIVED THE FLU VACCINE BUT HAS NEVER EXPERICED ANY SIDE EFFECTS. PT WAS COUNSELED THAT SHE MAY EXPERIENCE FEVER OR CHILLS AFTER RECEIVING THE VACCINE.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eye irritation, Headache, Malaise
Clinical narrative: Severe chills, extreme back pain, headache, burning eyes Fever of 102 degrees for two days Fever of 100 on 3rd day Fever of 99.5 on 4th day Malaise on day 5
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe chills, extreme back pain, headache, burning eyes Fever of 102 degrees for two days Fever of 100 on 3rd day Fever of 99.5 on 4th day Malaise on day 5
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Within first 10 minutes after injection, patient was rubbing her arm and noted increasing pain. She also  noted swelling. She had on long sleeves, so she pulled her arm out and there was a large area of swelling noted in the right upper arm, measuring 10 cm x 10 cm. No erythema or heat noted.  Ice applied for 10 minutes, no further swelling noted. Denied difficulty swallowing, breathing. No rash noted. This all occured while she was still in the clinic.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine was diluted with sterile water instead of 0.9% sodium chloride
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Paraesthesia oral
Clinical narrative: Elevated blood pressure and parathesia of the tongue and lip.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Axillary mass, Bedridden, Colonoscopy abnormal
Clinical narrative: The day after the first vaccine I briefly passed out in my shower. When I came to, I heaved and almost vomited. I then began having bouts of diarrhea. Later in the day I had a fever.  I continued to have bouts of dizziness for months. The bouts of diarrhea continued to this day. I received the second vaccine. I had a fever the next day and as before, continued to have daily diarrhea that I had never experienced prior to the first vaccine.  After the third vaccine, I had a fever the next day and I had a lump under my left armpit the size of an orange for approximately 7 days. I continuted this whole time to have worsening diarrhea and right sided deep burning abdominal pain. I went from having migraines a few times a year to 2-3 per week.  The diarrhea and pain have persisted and are daily since the vaccine. I have to work from home and can rarely leave my home due to how sick I now get. I am sometimes bedridden from how sick I get now. I cannot go to holidays, family events or my son's school events due to how much my health has affected me.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Condition aggravated, Diarrhoea, Dizziness
Clinical narrative: The day after the first vaccine I briefly passed out in my shower. When I came to, I heaved and almost vomited. I then began having bouts of diarrhea. Later in the day I had a fever.  I continued to have bouts of dizziness for months. The bouts of diarrhea continued to this day. I received the second vaccine. I had a fever the next day and as before, continued to have daily diarrhea that I had never experienced prior to the first vaccine.  After the third vaccine, I had a fever the next day and I had a lump under my left armpit the size of an orange for approximately 7 days. I continuted this whole time to have worsening diarrhea and right sided deep burning abdominal pain. I went from having migraines a few times a year to 2-3 per week.  The diarrhea and pain have persisted and are daily since the vaccine. I have to work from home and can rarely leave my home due to how sick I now get. I am sometimes bedridden from how sick I get now. I cannot go to holidays, family events or my son's school events due to how much my health has affected me.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endoscopy abnormal, Full blood count normal, Impaired work ability, Loss of consciousness, Magnetic resonance imaging abdominal normal
Clinical narrative: The day after the first vaccine I briefly passed out in my shower. When I came to, I heaved and almost vomited. I then began having bouts of diarrhea. Later in the day I had a fever.  I continued to have bouts of dizziness for months. The bouts of diarrhea continued to this day. I received the second vaccine. I had a fever the next day and as before, continued to have daily diarrhea that I had never experienced prior to the first vaccine.  After the third vaccine, I had a fever the next day and I had a lump under my left armpit the size of an orange for approximately 7 days. I continuted this whole time to have worsening diarrhea and right sided deep burning abdominal pain. I went from having migraines a few times a year to 2-3 per week.  The diarrhea and pain have persisted and are daily since the vaccine. I have to work from home and can rarely leave my home due to how sick I now get. I am sometimes bedridden from how sick I get now. I cannot go to holidays, family events or my son's school events due to how much my health has affected me.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Mastocytic enterocolitis, Migraine, Pyrexia, Retching
Clinical narrative: The day after the first vaccine I briefly passed out in my shower. When I came to, I heaved and almost vomited. I then began having bouts of diarrhea. Later in the day I had a fever.  I continued to have bouts of dizziness for months. The bouts of diarrhea continued to this day. I received the second vaccine. I had a fever the next day and as before, continued to have daily diarrhea that I had never experienced prior to the first vaccine.  After the third vaccine, I had a fever the next day and I had a lump under my left armpit the size of an orange for approximately 7 days. I continuted this whole time to have worsening diarrhea and right sided deep burning abdominal pain. I went from having migraines a few times a year to 2-3 per week.  The diarrhea and pain have persisted and are daily since the vaccine. I have to work from home and can rarely leave my home due to how sick I now get. I am sometimes bedridden from how sick I get now. I cannot go to holidays, family events or my son's school events due to how much my health has affected me.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Stool analysis normal
Clinical narrative: The day after the first vaccine I briefly passed out in my shower. When I came to, I heaved and almost vomited. I then began having bouts of diarrhea. Later in the day I had a fever.  I continued to have bouts of dizziness for months. The bouts of diarrhea continued to this day. I received the second vaccine. I had a fever the next day and as before, continued to have daily diarrhea that I had never experienced prior to the first vaccine.  After the third vaccine, I had a fever the next day and I had a lump under my left armpit the size of an orange for approximately 7 days. I continuted this whole time to have worsening diarrhea and right sided deep burning abdominal pain. I went from having migraines a few times a year to 2-3 per week.  The diarrhea and pain have persisted and are daily since the vaccine. I have to work from home and can rarely leave my home due to how sick I now get. I am sometimes bedridden from how sick I get now. I cannot go to holidays, family events or my son's school events due to how much my health has affected me.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Erroneous vaccine given for age. Vaccine later approved by pharmacist
Age: 20.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Diarrhoea, Dizziness, Nausea, Syncope
Clinical narrative: Fainting, diarrhea, nausea, light headedness, dizziness
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin exfoliation
Clinical narrative: Her arm got swollen and the skin got scaly
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: The nurse that gave the vaccine diluted the vial with 0.25ml of sterile dilutant and then drew up 0.25ml and administered the vaccine. Patient did not have any adverse reactions, notified mom of the mistake.  Per the recommendations of Moderna when called, we are going to repeat the vaccine at his next office visit.
Age: 74.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Chest discomfort, Dyspnoea, Pulmonary embolism
Clinical narrative: Patient reported having chest tightness/ trouble breathing 9 days after vaccination, went to ED and was diagnosed with Pulmonary Embolism.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Mother called the pharmacy on 10/17/23 at about 500 pm inquiring who gave her son his vaccine. The vaccinators name was provided, and she said the shot was given too high, and that her son now required physical therapy. No further information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash
Clinical narrative: Bumpy rash on arms and chest
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypotension, Photopsia
Clinical narrative: I received a regular flu shot in my left arm on Monday at 4 pm on Tuesday at 2pm I felt extremely dizzy and saw white lights feeling like I was going to faint. Took my blood pressure it was extremely low lol 97/63, this feeling lasted about 45 minutes. After 45 minutes I felt better and my B/P returned to normal. This has never happened to me before after taking a flu shot.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Agitation, Asthenia, Fatigue, Injection site pain
Clinical narrative: About 2 hrs after the vaccine became very tired, Sore injection site, no energy,  agitated state of mind, more pronounced TD symptoms throughout the rest of the day.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient felt dizzy and vomited after she got the flu vaccines. Parent declined to get emergency help from urgent care or hospital or report to pediatrician.
Age: 34.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Dizziness, Fatigue, Loss of consciousness, Skin warm
Clinical narrative: AFTER GIVING 1ST SHOT OF MODERNA ON LEFT DELTOID AND 2ND SHOT OF FLUBLOK ON RIGHT DELTOID, PATIENT FEELS FAINTED, LIGHTHEADEADED, DIZZY, AND LOSES CONSCIOUSNESS IN 1 MINUTE. PATIENT FEELS BETTER WHEN DRINKING GATORADE AND EAT CANDIES. BUT AROUND 3-5 MINUTES LATER, PATIENT FEELS TIRED AND DIZZY AGAIN AND ASK THE PHARMACY TO CALL 911. THE PATIENT PULSE FEELS STEADY AND STRONG; BREATHING NORMAL; BODY TEMPERATURE FEELS WARM.  PATIENT FEELS NORMAL WHEN THE EMS TEAM COMES AND HE LET THE EMS TEAM LEAVE THEN HE LEAVE THE PHARMACY. HE STATES THAT HE OFTEN FAINTED AFTER VACCINATION MANY TIMES ALREADY, EVEN THOUGH HE DIDNOT WRITE IT DOWN ON CONSENT FORM, AND JUST ANSWERED NO ON QUESTION OF FAINTING AFTER VACCINATION.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Peripheral swelling
Clinical narrative: burning and swelling of hands that worsens at night
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Diarrhoea, Headache, Nausea
Clinical narrative: elevated blood pressure (150-172/80)/headache/queezy/diarrhea (within one hour after vaccination patient reports)
Age: 96.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Dizziness, Malaise
Clinical narrative: Patient was dizzy 10 minutes after. Needed to lay her down. Called parademics because she was not feeling well.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Brain fog, Echocardiogram, Fatigue, Impaired work ability
Clinical narrative: The Covid19 vaccines have left me with chronic fatigue and brain fog. This continues today,  2 1/2 years later. I have been unable to work due to the severity of the symptoms. I have been to many doctors and none has found any other cause for my sysmtoms. These include: internist, rhuematologist, gastroenterologist, oncologist, cardiologist, and allergist. The onset of my symptoms coincide with the time of the vaccines. There has been absolutely no other possible diagnosis for these symptoms and no one has been able to offer any help in getting over them and living a life again and returning to my career. This continues to devastate my life.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inflammatory marker test, Quality of life decreased
Clinical narrative: The Covid19 vaccines have left me with chronic fatigue and brain fog. This continues today,  2 1/2 years later. I have been unable to work due to the severity of the symptoms. I have been to many doctors and none has found any other cause for my sysmtoms. These include: internist, rhuematologist, gastroenterologist, oncologist, cardiologist, and allergist. The onset of my symptoms coincide with the time of the vaccines. There has been absolutely no other possible diagnosis for these symptoms and no one has been able to offer any help in getting over them and living a life again and returning to my career. This continues to devastate my life.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: patient experienced severe dizziness and nausea and vomiting, reported going to the emergency room
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Rash
Clinical narrative: fever for one night that went away in a few hours; little fatigue; little headache; small rash in one spot; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever for one night that went away in a few hours), FATIGUE (little fatigue), HEADACHE (little headache) and RASH (small rash in one spot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 039K20A, 226D21A and 005M21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: CALCIUM (Vitamins like Calcium) and Vitamins like Calcium (Vitamins like Calcium). Past adverse reactions to the above products included No adverse event with CALCIUM and Vitamins like Calcium.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever for one night that went away in a few hours), FATIGUE (little fatigue), HEADACHE (little headache) and RASH (small rash in one spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever for one night that went away in a few hours) had resolved and FATIGUE (little fatigue), HEADACHE (little headache) and RASH (small rash in one spot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient did not have nausea or vomiting. Patient had been taking Tylenol and might be keep taking it.   This case was linked to US-MODERNATX, INC.-MOD-2023-744995 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744995:same patient, different dose
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pyrexia
Clinical narrative: Feeling sick; probably had a fever; Redness in the torso; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of erythema (received last year in 2022, refer case  US2023AMR141634) and COVID-19 VACCINE with an associated reaction of erythema (received last year in 2022, refer case  US2023AMR141634).   On 28-JUL-2023, the patient received the 1st dose of Shingrix (left arm). On 29-JUL-2023, 1 days after receiving Shingrix, the patient experienced erythema (Verbatim: Redness in the torso). On an unknown date, the patient experienced sickness (Verbatim: Feeling sick) and fever (Verbatim: probably had a fever). The outcome of the erythema, sickness and fever were resolved.   It was unknown if the reporter considered the erythema, sickness and fever to be related to Shingrix.     It was unknown if the company considered the erythema, sickness and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR141634   Additional Information: GSK receipt date: 09-Oct-2023 The reporter was a pharmacist who received first dose of Shingrix and next day she developed a redness in the torso only, up to her neck, not affecting legs, arms or back.  The redness went gradually away until it disappeared 4 to 5 days later.  The reporter stated she felt a little bit sick, and she probably had fever but she was not sure. The reporter had the same symptoms a year before in 2022 when she got both covid-19 and Influenza vaccine. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORD IN AN UNAPPROVED STORAGE UNIT