chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Her reaction to previous Moderna vaccine was very little; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Her reaction to previous Moderna vaccine was very little) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 025B21A and 048A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-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 IMMUNISATION REACTION (Her reaction to previous Moderna vaccine was very little). At the time of the report, IMMUNISATION REACTION (Her reaction to previous Moderna vaccine was very little) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2023-748142 (Patient Link).
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; 100 degree temperature; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE INCREASED (100 degree temperature) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE INCREASED (100 degree temperature). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and BODY TEMPERATURE INCREASED (100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2023, Body temperature: 100 degree Celsius.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient took all the Moderna shots and no problems at all. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: At most she experienced a headache or sore arm, but that's it.; At most she experienced a headache or sore arm, but that's it.; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (At most she experienced a headache or sore arm, but that's it.) and VACCINATION SITE PAIN (At most she experienced a headache or sore arm, but that's it.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 027A21A, 031H21B and 037A22B) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor. The patient had no allergy and no COVID-19 diagnosis.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-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 HEADACHE (At most she experienced a headache or sore arm, but that's it.) and VACCINATION SITE PAIN (At most she experienced a headache or sore arm, but that's it.). At the time of the report, HEADACHE (At most she experienced a headache or sore arm, but that's it.) and VACCINATION SITE PAIN (At most she experienced a headache or sore arm, but that's it.) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2023-748230, MOD-2023-748243 (Patient Link).
Sex: M
Vaccine: UNK
Symptoms: Headache
Clinical narrative: severe headache; ran a 99 F low grade temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (severe headache) and PYREXIA (ran a 99 F low grade temperature) in a male 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 HEADACHE (severe headache) and PYREXIA (ran a 99 F low grade temperature). At the time of the report, HEADACHE (severe headache) and PYREXIA (ran a 99 F low grade temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 F.     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 has no immune system. No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: UNK
Symptoms: Autoimmune disorder, Fatigue, Malaise
Clinical narrative: Thinks this is related to autoimmune stuff; Usually in bed the first day with all kinds of feeling sick; Had fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Thinks this is related to autoimmune stuff) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 AUTOIMMUNE DISORDER (Thinks this is related to autoimmune stuff) (seriousness criterion medically significant), MALAISE (Usually in bed the first day with all kinds of feeling sick) and FATIGUE (Had fatigue). At the time of the report, AUTOIMMUNE DISORDER (Thinks this is related to autoimmune stuff), MALAISE (Usually in bed the first day with all kinds of feeling sick) and FATIGUE (Had fatigue) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. The dosage text was reported as unknown. The patient had all kinds of different symptoms. This was related to autoimmune stuff. The patient had fatigue. The patient usually in bed the first day with all kinds of feeling sick. The patient was having symptoms and extreme fatigue with the first couple doses. It did feel like it was dragging on for a couple of weeks. No treatment medication was reported. Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event autoimmune disorder. A dose of SPIKEVAX 2023-2024 vaccine was administered. Onset date of the event and vaccination date was not provided; hence, latency cannot be assessed. It was reported patient had all kind of different symptoms. She thinks this is related to autoimmune stuff. She had fatigue. Usually in bed the first day with all kinds of feeling sick. She was having symptoms and extreme fatigue with the first couple doses. It did feel like it was dragging on for a couple of weeks. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report   Reporter did not allow further contact
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Malaise, Pain in extremity
Clinical narrative: not feeling well; Spikevax is the patient 6th dose. She had sore arm like she always has, and her stomach is hurting.; stomach is hurting; Patient had a lot of diarrheas all night.; Patient is tired; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), PAIN IN EXTREMITY (Spikevax is the patient 6th dose. She had sore arm like she always has, and her stomach is hurting.), ABDOMINAL PAIN UPPER (stomach is hurting), DIARRHOEA (Patient had a lot of diarrheas all night.) and FATIGUE (Patient is tired) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis.     Patient did not had any medical history or condition.  Previously administered products included for Product used for unknown indication: Flu vaccine in October 2023. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 31-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 31-Oct-2023, the patient experienced MALAISE (not feeling well), PAIN IN EXTREMITY (Spikevax is the patient 6th dose. She had sore arm like she always has, and her stomach is hurting.), ABDOMINAL PAIN UPPER (stomach is hurting), DIARRHOEA (Patient had a lot of diarrheas all night.) and FATIGUE (Patient is tired). At the time of the report, MALAISE (not feeling well), PAIN IN EXTREMITY (Spikevax is the patient 6th dose. She had sore arm like she always has, and her stomach is hurting.), ABDOMINAL PAIN UPPER (stomach is hurting) and FATIGUE (Patient is tired) was resolving and DIARRHOEA (Patient had a lot of diarrheas all night.) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. The dosage text was reported as unknown. No concomitant medication was reported. The patient never had any side effects like this with the other vaccine. Except sore arm. The patient had sore arm like she always has, and the stomach was hurting. Patient had a lot of diarrheas all night. Now it had stop. Patient was not feeling well. Patient was tired. Patient was feeling better but still not feeling great. No treatment medication was reported.   This case was linked to MOD-2023-748086 (Patient Link).
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Body temperature increased, Muscle spasms, Pain in extremity
Clinical narrative: stomach pain; extreme cramping; arm very sored since this morning; temperature at about 24 hours after 103°F; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), MUSCLE SPASMS (extreme cramping), PAIN IN EXTREMITY (arm very sored since this morning) and PYREXIA (temperature at about 24 hours after 103°F) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (first dose, ER8727) on 24-Mar-2021, Pfizer (second dose ,EW0182) on 26-Aug-2021, Pfizer (third dose  and FK9895) on 01-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concomitant products included LOSARTAN, TRAMADOL HYDROCHLORIDE (PAXILFAR), VITAMIN B COMPLEX, FISH OIL, VITAMIN B COMPLEX (VITAMIN B CO), CLONAZEPAM and ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) for an unknown indication.    On 31-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), MUSCLE SPASMS (extreme cramping), PAIN IN EXTREMITY (arm very sored since this morning) and PYREXIA (temperature at about 24 hours after 103°F). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) was resolving, MUSCLE SPASMS (extreme cramping) and PAIN IN EXTREMITY (arm very sored since this morning) had not resolved and PYREXIA (temperature at about 24 hours after 103°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2023, Body temperature: 103 A F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that following vaccination after18 hours patient arm very sored since that morning, about 24 hours or 23 hours he started with severe stomach pain, temperature at about 24 hours after 103°F, extreme cramping without any medicine. At the time of the call pain started to ease and be more relief, 3 hours since it started caller stated that the Tylenol must have helped about 30 minutes ago.
Age: 57.0
Sex: F
Vaccine: FLUC3, UNK, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Flushing, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Flushed; Upset stomach; Achyness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), FLUSHING (Flushed), ABDOMINAL DISCOMFORT (Upset stomach), PAIN (Achyness) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 80777-0102-96) for COVID-19 prophylaxis.    Co-suspect products included non-company products VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication and INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for an unknown indication.    The patient's past medical history included COVID-19 on 27-Jul-2023.   On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FLUSHING (Flushed), ABDOMINAL DISCOMFORT (Upset stomach), PAIN (Achyness) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral use) at a dose of 600 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), FLUSHING (Flushed) and FATIGUE (Fatigue) was resolving and ABDOMINAL DISCOMFORT (Upset stomach) and PAIN (Achyness) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no medical history, concomitant disease or risk factor.   The events partially resolved two days after dose but upset stomach and achyness persisted. The patient did not experience any additional symptoms/events. There were no lab data/results available.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Musculoskeletal chest pain, Pain, Pain in jaw, Retching
Clinical narrative: Jaw pain; Ribs hurt; Gagged; Body aches; Headache; Nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN JAW (Jaw pain), MUSCULOSKELETAL CHEST PAIN (Ribs hurt), RETCHING (Gagged), MYALGIA (Body aches) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Tylenol. Past adverse reactions to the above products included No adverse event with Tylenol. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 01-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced PAIN IN JAW (Jaw pain), MUSCULOSKELETAL CHEST PAIN (Ribs hurt), RETCHING (Gagged), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). On 02-Nov-2023, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN JAW (Jaw pain), MUSCULOSKELETAL CHEST PAIN (Ribs hurt), RETCHING (Gagged), MYALGIA (Body aches) and HEADACHE (Headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 19-Mar-2021, patient had 1st primary monovalent dose (Lot: 048A21A and Exp. Date: unknown).  On 17-Apr-2021, patient had 2nd primary monovalent dose (Lot: 025B21A and Exp. Date: unknown).  On 25-Oct-2021, patient had 3rd (1st monovalent booster) dose (Lot and Exp. Date: unknown).  On 30-Apr-2022, patient had 4th (2nd monovalent booster) dose (Lot: 056M21A and Exp. Date unknown).  On 05-Oct-2022, patient had 5th bivalent booster (Lot and Exp. Date: unknown).   On 01-Nov-2023 around noon, she received Spikevax vaccine and by midnight she got every side effect listed except for a rash. Side effects began at midnight: headache, body aches, nausea, gagged, ribs hurt and jaw pain.  On 02-Nov-2023, nausea went away in the morning.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748138, US-MODERNATX, INC.-MOD-2023-748219, US-MODERNATX, INC.-MOD-2023-748144 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received: Reference number was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748138:Different patient (Sister-in-law) US-MODERNATX, INC.-MOD-2023-748219:Monovalent dose US-MODERNATX, INC.-MOD-2023-748144:Husband's case
Sex: M
Vaccine: UNK
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) 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 taken vaccine around noon time and by midnight he had side effects. Card and lot number was not provided by facility. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748138 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748138:Different patient (Same vaccine)
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: due to a reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (due to a reaction) 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 IMMUNISATION REACTION (due to a reaction). At the time of the report, IMMUNISATION REACTION (due to a reaction) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient was asking that she can take ibuprofen for several days due to knee pain. Will ibuprofen reduce the effectiveness of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received contains significant information: Patient details, event details, references and narrative were updated.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT is complaining of swollen, red arm at the site of injection.  As well as severe soreness.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Covid Vaccine approved for 12+ SDV instead of  the recommended Covid Vaccine  6month-11 yr. No side effects reported to clinic after the vaccine was administered. no further treatment required per Health care provider
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: The pediatric dose was administered to the patient instead of the 12+ dose, no other reactions at this time
Age: 1.92
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event
Clinical narrative: Patients mother states no adverse reaction and has been given flu shots previously with no reactions. Patients Pediatrician was notified through Voicemail.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Angiogram cerebral abnormal, Cerebellar stroke, Dizziness, Magnetic resonance imaging head abnormal, Nausea
Clinical narrative: Experienced a cerebellar stroke, currently in hospital  recovering Pt felt, dizziness, nausea, vomiting.  Ambulance was called to get pt.  get MRI and CT Angiogram confirmed a stroke occurred.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Experienced a cerebellar stroke, currently in hospital  recovering Pt felt, dizziness, nausea, vomiting.  Ambulance was called to get pt.  get MRI and CT Angiogram confirmed a stroke occurred.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Axillary pain, Burning sensation, Joint swelling, Mobility decreased
Clinical narrative: About 3 days after vaccination, underarm was swollen and sore, then spread to shoulder, and forearm with burning forearm, tingling hand and now I cannot raise my arm due to pain and I have lost most grip strength on the left side.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Oedema peripheral, Pain, Pain in extremity, Paraesthesia
Clinical narrative: About 3 days after vaccination, underarm was swollen and sore, then spread to shoulder, and forearm with burning forearm, tingling hand and now I cannot raise my arm due to pain and I have lost most grip strength on the left side.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: About 3 days after vaccination, underarm was swollen and sore, then spread to shoulder, and forearm with burning forearm, tingling hand and now I cannot raise my arm due to pain and I have lost most grip strength on the left side.
Age: 75.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Extra dose administered
Clinical narrative: The RSV vaccine lot HF5017 was administered on 10/3/2023. The patient returned for additional vaccinations and was administered a second RSV vaccine by mistake. It was a duplication of therapy for this single dose vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Lichen planus
Clinical narrative: Patient stated that she developed lychen planus about 2 weeks after vaccine administration.
Age: 4.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Moderna vaccine was for 12+ not the 6m-11 yr old but only 0.25mL was given
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: developed systemic varicella infection
Age: 88.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event, Product administration error
Clinical narrative: Patient did not have an adverse event or reaction; however, she accidentally received a dose of Arexvy (which was a duplication as she previously had received a dose of an RSV vaccine 2 weeks prior to today's date) when she intended to have received Spikevax.  This was an error made by the vaccinator which has been reported accordingly.  Apologized to patient and after having spoke with her proceeded to give correct vaccine that she wanted to receive and administered Spikevax to her.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Cough, Fatigue, Somnolence, Throat irritation
Clinical narrative: Within 24 hours of getting vaccine severe fatigue and drowsiness developed which lasted for 10 days.  At the same time tickle in the throat without sore throat and lingering cough developed.   Cough is still lingering but severity has gone down somewhat after Prednisone pack
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Dizziness, Dysarthria, Eye movement disorder, Feeling hot
Clinical narrative: Light headed, body felt light it was burning up, sweating continuously, speech started sluring, eyes rolled back, vomiting, and lost control of my bowls.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: Light headed, body felt light it was burning up, sweating continuously, speech started sluring, eyes rolled back, vomiting, and lost control of my bowls.
Age: 72.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Syncope, Weight bearing difficulty
Clinical narrative: Patient describes going straight home after vaccination about 10 minutes away.  She felt like all the weight of her body went straight to her feet and she crumpled to the floor inside the entrance of her house.  She was not light-headed.  Feet felt very heavy and legs didn't want to support her weight.  She claimed to have laid on the floor for the rest of the day, but later in the conversation mentioned moving about the house.  She made sure she kept her phone with her at all times when getting food or going to the bathroom.  She was completely better the next day. She has been getting the flu vaccine for more than 50 years without any adverse reaction other than sore arm.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle spasms, Muscle swelling
Clinical narrative: Swollen muscle with spams,
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Facial paralysis, Hypoglossal nerve paralysis, Laboratory test normal
Clinical narrative: Pt experienced facial palsy, was seen in ER and worked up for stroke. Stroke was ruled out and dr diagnosed him with hyoglosal nerve palsy and indicated that his recent vaccine was most likely cause and that it would resolve on its own and it did after about a week or so.
Age: 89.0
Sex: M
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: Patient returned to pharmacy 10/11/23 with complaint that he has felt ill for the past month and stated he has never felt like this before in his life.
Age: 12.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Disorientation, Hypotonia, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: Patient loss conscientiousness after administration of second vaccine.  Patient went limp in chair and was non response for 2 minutes.  Then patient woke up and was pale and disoriented.  After several minutes patient could respond to questions and was breathing normally.  Color returned to patients face.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse drug reaction, Adverse food reaction, Autonomic nervous system imbalance, Brain fog, Gastrointestinal motility disorder
Clinical narrative: Severe brain fog within the hour of taking vaccine, GI motility stopped, hormones began fluctuating wildly - periods twice per month for months, reactions to foods and meds began, temperature dysregulation started, sleeping issues, nausea and headaches, meds that helped my conditions no longer work, dysautonomia affecting my nervous system where things that are usually regulated without thinking are no longer functioning correctly.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hormone level abnormal, Menstruation irregular, Nausea, Nervous system disorder
Clinical narrative: Severe brain fog within the hour of taking vaccine, GI motility stopped, hormones began fluctuating wildly - periods twice per month for months, reactions to foods and meds began, temperature dysregulation started, sleeping issues, nausea and headaches, meds that helped my conditions no longer work, dysautonomia affecting my nervous system where things that are usually regulated without thinking are no longer functioning correctly.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Temperature regulation disorder, Therapeutic product effect decreased
Clinical narrative: Severe brain fog within the hour of taking vaccine, GI motility stopped, hormones began fluctuating wildly - periods twice per month for months, reactions to foods and meds began, temperature dysregulation started, sleeping issues, nausea and headaches, meds that helped my conditions no longer work, dysautonomia affecting my nervous system where things that are usually regulated without thinking are no longer functioning correctly.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, FLU4, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Resident received Influenza Fluzone High-Dose and Covid 19 vaccinations at approximately 9:00am and then received both vaccines again at approximately 12:30pm. Resident had no immediate adverse reactions, vital signs were taken and within normal range. He was monitored for 30 minutes and after no signs or symptoms of an adverse reaction, Pt was okay to leave the clinic.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Rash macular
Clinical narrative: Gave the Prevnar 20 into Right thigh, about 5-10 minutes later right leg started having blotching of skin. Doctor came into and checked on pt. Had pt. stay another 10-15 min. Pt. was breathing and acting normal after vaccine and during the watching in office. Gave pt. Benadryl dosage if needed for later. Called pt. family to check on her 1 hr. Later and she was back to normal, no visible blotching.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5 days after injection patient got a warm red raised area at site of injection, warmth and redness improved after 24 hrs but still present at visit
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Patient became "light-headed" and "pale" shortly after vaccines. Sx lasted "a few minutes"
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Nausea, Urine analysis, Vomiting
Clinical narrative: Day after vaccine was given when I would drink or eat anything I would throw up within 1-or 2 minutes. This went on for 9 days. Was able to eat drink on 10-26-23 without vomiting.  dehydration - I.V. to get Liquid in body 2 injections to help with nausea on two ocasions
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Throat tightness
Clinical narrative: Tightness of throat (oral pharynx) and cough within 3-4 mins and subsided within 5 mins.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10/18/23 (1 day post vaccine)  Significant swelling, warmth, tenderness to anterior Right thigh associated with limp/difficulty ambulation onset <24hrs after vaccine administration thigh circumference R 1 inch < Left  Patient returned for f/u  10/23/23  6 days post vaccine with complete resolution of symptoms
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Cardiac failure acute, Cardiac imaging procedure abnormal, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: Pt began with cough about 1 wk after receiving vaccine with SOB, chest pressure worsening, LE edema. Sent to hospital found to have acute heart failure. neg cath (10/30/23); CTA chest neg 10/27/23; cardiac MRI (10/31/23) - global hypokinesis Echo 11/2/23 - mild-mod mitral regurg
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Echocardiogram abnormal, Mitral valve incompetence, Oedema peripheral
Clinical narrative: Pt began with cough about 1 wk after receiving vaccine with SOB, chest pressure worsening, LE edema. Sent to hospital found to have acute heart failure. neg cath (10/30/23); CTA chest neg 10/27/23; cardiac MRI (10/31/23) - global hypokinesis Echo 11/2/23 - mild-mod mitral regurg
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular hypokinesia
Clinical narrative: Pt began with cough about 1 wk after receiving vaccine with SOB, chest pressure worsening, LE edema. Sent to hospital found to have acute heart failure. neg cath (10/30/23); CTA chest neg 10/27/23; cardiac MRI (10/31/23) - global hypokinesis Echo 11/2/23 - mild-mod mitral regurg
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hit her like a ton of bricks; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose in July 2018 and had hit her like a ton of bricks. reference case US2023149435.) and Proton pump inhibitors (was on Proton Pump Inhibitors for years, but no longer takes these medications). Concurrent medical conditions included renal disease (had 3rd Stage Kidney Disease in 2016), intestinal resection (a bowel resection in 2015) and diverticulitis (a diverticulitis abscess on her colon). Concomitant products included famotidine (Pepcid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced pain (Verbatim: hit her like a ton of bricks). Rechallenge with Shingrix was positive. The outcome of the pain was resolved (duration 1 day).   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023149435   Additional Information: GSK receipt date: 27-OCT-2023 The reporter was a patient who, received the 1st dose of Shingrix and the 2nd dose of Shingrix (date not provided), and that both shots hit her like a ton of bricks. This started about 18 hours after receiving both the 1st and 2nd dose of Shingrix, and lasted for about a day.  No further information was provided about these events. The patient had 3rd Stage Kidney Disease in 2016, a bowel resection (2015), a diverticulitis abscess on her colon all pre existing Shingrix and Arexvy, and she was being monitored for all of this. The patient was on Proton Pump Inhibitors for years, but no longer took these medications (no drug information provided).   The patient currently took Pepcid the smallest dose (no product information provided). The reporter consented to follow up. The case is linked with US2023149435, by same reporter.; Sender's Comments:  US-GSK-US2023149435:Shingrix Dose 1 US-GSK-US2023AMR153165:same patient
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Pain
Clinical narrative: Injection area was swelling; injection area was red/red streak going down from the injection site about 4 inches; iItching; sometimes hot; joint pain; achy/soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included diverticulitis, renal disease (had 3rd stage kidney disease in 2016), intestinal resection and peridiverticular abscess. Previously administered products included Proton Pump Inhibitors (for years), Shingrix with an associated reaction of pain (received 1st dose in July 2018 had hit her like a ton of bricks, refer case US2023AMR153165) and Shingrix with an associated reaction of pain (received 2nd dose (date not provided) had hit her like a ton of bricks, refer case US2023AMR149797). Concurrent medical conditions included hypothyroidism. Concomitant products included famotidine (Pepcid).   On 20-OCT-2023, the patient received Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: joint pain) and pain (Verbatim: achy/soreness). On 23-OCT-2023, the patient experienced injection site swelling (Verbatim: Injection area was swelling), erythema (Verbatim: injection area was red/red streak going down from the injection site about 4 inches), pruritus (Verbatim: iItching) and feeling hot (Verbatim: sometimes hot). The outcome of the injection site swelling was unknown and the outcome of the erythema, pruritus, joint pain and pain were not resolved and the outcome of the feeling hot was resolved.   It was unknown if the reporter considered the injection site swelling, erythema, pruritus, feeling hot, joint pain and pain to be related to Arexvy.     It was unknown if the company considered the injection site swelling, erythema, pruritus, feeling hot, joint pain and pain to be related to Arexvy.   Linked case(s) involving the same patient:  US2023AMR149797, US2023AMR153165   Additional Information: GSK receipt date: 27-Oct-2023 The patient received the Arexvy vaccine and reported starting on Monday (23rd October 2023), she was itching really bad at the injection site and the injection area was red, swelling, sore, and sometimes hot (more when itching). The patient also reported that starting Wednesday 25th October 2023, she noticed a red streak going down from the injection site about 4 inches, that is hot. The red area started about the size of a dime or quarter and is now the size of a 50 cent piece on the day of reporting.  The patient reported that her arm was still sore, itchy and red. The patient also reported that she had joint pain and achy, but that was common for her and she cannot say it was worse since receiving Arexvy. The patient did not had any lot/expiry information with her. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023AMR149797:Shingrix Dose 2 US-GSK-US2023AMR153165:Shingrix Dose 1
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 0.5
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product packaging quantity issue
Clinical narrative: Patient is a 6 month old infant and was given Moderna 0.5ml dose and the 0.25ml dose is indicated for a 6 month old patient.   Patient monitored and did not have a reaction.  No treatment needed.
Age: 0.5
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient is a 6 month old infant and was given Moderna 0.5ml dose and the 0.25ml dose is indicated for a 6 month old patient.   Patient monitored and did not have a reaction.  No treatment needed.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reporting temperature excursion. Vaccine has been administered.; This spontaneous report has been received from other regarding a patient of unknown age and gender. Patient's pertinent medical history, concomitant medications, drug reactions and allergies were not provided.  On 12-OCT-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliters (lot# X006982 is a valid lot for varicella virus vaccine live (oka/merck) (VARIVAX) , expiration date was reported and stablished upon internal validation to be 07-MAR-2025), administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (product storage error).
Age: 0.17
Sex: M
Vaccine: HIBV, RV1
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; HCP called to report mixing liquid PEDVAX HIB with the powdered component of ROTARIX/the products were reconstituted incorrectly; This spontaneous report was received from a licensed practical nurse referring to a 10-week-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 25-SEP-2023, the patient was inadvertently vaccinated with mixing the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # X003656, expiration date 06-NOV-2025, intramuscular in the left vastus lateralis; dose was not reported) with the powdered component of rotavirus vaccine live oral 1v(ROTARIX) (lot # 959LS, expiration date 17-FEB-2025, intramuscular in the left vastus lateralis; dose was not reported) for prophylaxis, the products were reconstituted in error (product preparation error). No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose of Shingrix 30 days after receiving the 1st one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 7KG39, expiry date 17-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received the 2nd dose of Shingrix 30 days after receiving the 1st one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date- 31-OCT-2023 The pharmacist reported that the patient received the 2nd dose of Shingrix 30 days after receiving the 1st one which led to drug dose administration interval too short. The reporter consented to follow up
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Malaise, Squamous cell carcinoma
Clinical narrative: she felt sick approximately during 1 week; squamous cell carcinoma; This spontaneous case was reported by a patient and describes the occurrence of SQUAMOUS CELL CARCINOMA (squamous cell carcinoma) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (when she was little but got all their shots later.) and Infusion. Concurrent medical conditions included Allergy NOS.   On an unknown date, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2023, the patient experienced SQUAMOUS CELL CARCINOMA (squamous cell carcinoma) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (she felt sick approximately during 1 week). At the time of the report, SQUAMOUS CELL CARCINOMA (squamous cell carcinoma) had not resolved and ILLNESS (she felt sick approximately during 1 week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2023, Biopsy: squamous cell carcinoma in the wrist.         No concomitant medication was reported.  Patient will undergo a surgery next week. No treatment information was reported.  Company comment: This spontaneous case concerns an 83-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of squamous cell carcinoma and non serious event of illness (occurring for 1 week after 2nd dose). The event of squamous cell carcinoma occurred after the third dose of SPIKEVAX 2023-2024. Temporal relation is unclear. As reported patient received three doses of Moderna vaccine and was diagnosed by biopsy with squamous cell carcinoma in the wrist. The patient had a scheduled surgery and was wandering whether it is recommended to receive Spikevax if surgery is scheduled. No further information about the event was provided. Considering the nature of event, lack of biological plausibility for causality and patient's advanced age as risk factor, causality for the event of squamous cell carcinoma is assessed as not related. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.