chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradycardia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Reported Symptoms:  10006093:BRADYCARDIA;  10038678:RESPIRATORY DEPRESSION;  10043088:TACHYPNEA;  10084401:COVID-19 RESPIRATORY INFECTION; Narrative:  PFIZER 12/13/2021, 03/04/2021, 02/09/2021    Admitted 9/8/2022, DX:  covid pna with hypoxemia,  systematic bradycardia. August 19th 2022.  Admitted on 9/8/2022 with COVID PNA with hypoxemia and bradycardia Other:  covid-19 infection
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Feeling cold, Hypoxia, Pyrexia
Clinical narrative: Reported Symptoms:  10006093:BRADYCARDIA;  10038678:RESPIRATORY DEPRESSION;  10043088:TACHYPNEA;  10084401:COVID-19 RESPIRATORY INFECTION; Narrative:  PFIZER 12/13/2021, 03/04/2021, 02/09/2021    Admitted 9/8/2022, DX:  covid pna with hypoxemia,  systematic bradycardia. August 19th 2022.  Admitted on 9/8/2022 with COVID PNA with hypoxemia and bradycardia Other:  covid-19 infection
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory depression, SARS-CoV-2 test positive, Staphylococcus test negative, Tachypnoea
Clinical narrative: Reported Symptoms:  10006093:BRADYCARDIA;  10038678:RESPIRATORY DEPRESSION;  10043088:TACHYPNEA;  10084401:COVID-19 RESPIRATORY INFECTION; Narrative:  PFIZER 12/13/2021, 03/04/2021, 02/09/2021    Admitted 9/8/2022, DX:  covid pna with hypoxemia,  systematic bradycardia. August 19th 2022.  Admitted on 9/8/2022 with COVID PNA with hypoxemia and bradycardia Other:  covid-19 infection
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Musculoskeletal stiffness
Clinical narrative: Reported Symptoms: 10003988:BACK PAIN; 10040617:SHOULDER PAIN; 10042043:STIFF NECK;  Narrative: Pt. stated that he received the Spikevax last 10/18/23. Pt. stated that after 6-7 days after the shot, he started having a stiff neck, severe upper back pain, and severe headache. Pt.  stated that he did not go to the ER at that time. Pt. stated that he called his PCP and was given Methocarbamol 750mg last Friday 10/27/23. Pt. stated that his symptoms started to subside yesterday. Pt. stated that he still has a headache, rates pain a 3 out of ten. Pt. stated that the pain on his back is all gone. Pt. stated that he has no more stiffness in his neck. Pt. was advised to go to the nearest ER with a driver today for evaluation. Pt. refused to go to the ER.  Other Relevant HX: other: tiff neck, upper back and shoulder pain
Age: 79.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Laboratory test normal, Sedation, Staring, Unresponsive to stimuli
Clinical narrative: Reported Symptoms:  10010300:CONFUSION; 10039897:SEDATION;   Narrative: Per caregiver (daughter), patient was admitted 11/02/23 due to "possible stroke".   She states that "he was out of it, just starring off unresponsive for 8-10 min" Ambulance was called and patient stayed at hospital until discharged on 11/04/23. States that the work up was negative for stroke, seizures, UTI. He is back home resting comfortably, at baseline cognition and function.  She had concerns that symptoms may have been due to flu and covid vaccines having been given 48 hrs prior.  No updated records to review from other facility therefore unable to confirm complete course of tx.  Other Relevant Hx: Per caregiver (daughter), patient was admitted 11/02/23 due to "possible stroke".   She states that "he was out of it, just starring off unresponsive for 8-10 min" Ambulance was called and patient stayed at hospital until discharged on 11/04/23. Stated that the work up was negative for stroke, seizures, UTI. He is back home resting comfortably, at baseline cognition and function.  She had concerns that symptoms may have been due to flu and covid vaccines having been given 48 hrs prior.   No updated records to review from other facility therefore unable to confirm complete course of tx. Other:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pyrexia, Vomiting
Clinical narrative: Reported Symptoms:     Narrative: 79 year old patient with PMH with complete quadriplegia, past hx of UTI and bacteremia, overactive bladder, CVA, AV stenosis, HTN, HLD presented to ED after developing fever, nausea, vomiting, and weakness the day after receiving COVID-19 booster.  fever at home reported to be 103F. In the ED he was treated with IV acetaminophen and fluids (sodium chloride 0.9%). Patient was admitted to hospital from 10/31/23 to 11/2/23.  Patient was treated with IV antibiotics during stay due to concern for UTI given previous history of UTI. Patient previously developed fever > 100F after last two COVID-19 vaccine administrations. One of those previous two fevers resulted in hospital admission. Other Relevant HX:   Other:
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Feeling abnormal, Gait inability, Malaise, Monoplegia
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10024131:LEG PARALYSIS; 10039100:RHINORRHEA;  Narrative: Caregiver stated that patient started to feel bad on the evening of friday 10/13/23, following an influenza immunization on Wed 10/11/23. Patient had also gone out into the community with his son prior to being ill.  Patient was coughing and blowing his nose and was unable to walk telling the caregiver that his legs were paralyzed. Issues self resolved. ADE reported by Clinical Pharmacist, Other Relevant HX:  Other: runny nose, leg paralyzed
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Nasal disorder, Rhinorrhoea
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10024131:LEG PARALYSIS; 10039100:RHINORRHEA;  Narrative: Caregiver stated that patient started to feel bad on the evening of friday 10/13/23, following an influenza immunization on Wed 10/11/23. Patient had also gone out into the community with his son prior to being ill.  Patient was coughing and blowing his nose and was unable to walk telling the caregiver that his legs were paralyzed. Issues self resolved. ADE reported by Clinical Pharmacist, Other Relevant HX:  Other: runny nose, leg paralyzed
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Chills, Pruritus
Clinical narrative: Reported Symptoms: 10005216:BLISTERS; 10008531:CHILLS; 10037067:PRURITUS; Narrative:  Other Relevant HX:  Other:  CHILLS; ITCHING; BLISTERS
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms:  10002218:Anaphylaxis;        Narrative:    Other Relevant HX:   Other: Anaphylaxis
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Reporter Symptoms:  10002218:ANAPHYLAXIS;       Narrative:   Other Relevant HX: Other:  ANAPHYLAXIS
Age: 75.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: Reported Symptoms:  10011232:COUGHING;  10016558:FEVER; 10028411:MYLAGIA;           Narrative:   Other Relevant HX:   Other:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Malaise, Syncope, Urinary incontinence, Vomiting
Clinical narrative: Reported Symptoms:  10021643:INCONTINENCE URINARY;  10042772:SYNCOPE;  10047700:VOMITNG;     Narrative:  Syncopal episode. Patient was receiving her first COVID vaccine today when she had a syncopal event.  She received the vaccine at 11:41 AM on 3/24/2021.  She had immediate onset of general malaise and was noted to have syncope at 11:45 AM. She was reportedly diaphoretic at the time.  She had hypotension with blood pressure 83/57 but otherwise normal vital signs.  She is brought to the emergency department for further evaluation.  On arrival to the emergency department she is awake and alert. No chest pain.  She reports that she has experienced syncope in the past with blood draws. She also has a history of allergic reaction to CT  contrast dye but denies other known allergies.  She was given 1 L of lactated Ringer's and 4 mg Zofran in the emergency department.  Her overall clinical presentation is most concerning for vasovagal syncope related to receiving her vaccination today.      Other Relevant HX:    Other: Syncope, incontinent of urine, vomiting
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Reported Symptoms:  10025197:LYMPHADENOPATHY;     Narrative:    Other Relevant HX:   Other:  Lymphadenopathy
Age: 96.0
Sex: M
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Reported Symptoms:  10033987:PARESTHESIA;    Narrative:    Other Relevant HX: Other:  paresthesia
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Reported Symptom: 10008531:CHILLS; 10016558:FEVER;   Narrative: Pt developed fever and chills for 3 days after receiving Tdap. Other Relevant HX: Other: chills
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Hallucination, Mental status changes
Clinical narrative: Reported Symptoms:  10019077:HALLINATIONS;   10048294:MENTAL STATUS CHANGES; Narrative:    Other Relevant HX:  Other:  MENTAL STATUS CHANGES
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat tightness
Clinical narrative: Reported Symptoms:  10043528:THROAT TIGHTNESS;      Narrative: Other Relevant HX:  Other: SWELLING OF THROAT
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash pruritic
Clinical narrative: Reported Symptoms:  10037007:PRURITUS;  10037844:RASH;      Narrative:    53 yo f, c/o rash to face and neck that started within a few days of getting the pneumovax injection. Pt denies any previous reactions to vaccinations. Pt denied shortness of breath, throat closing, or change in voice.  Pt states rash was mildly itchy. Other Relevant HX:  Other:
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Anaphylactic reaction, Cough, Dizziness, Dysphonia, Pruritus
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS: Narrative: Patient received pneumococcal vaccine and 45 minutes after she was transferred to the ED for scratchy throat, dry cough, voice change and itchy skin. Her voice became worse and throat was closing and began feeling lightheaded. She was treated with epinephrine stat 0.3 mg IM followed by Solu-Medrol 125, Benadryl 25 subsequently changed to 50 mg, famotidine 20 normal saline and Oxygen 2 L nasal cannula. Other Relevant HX: Other:
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS: Narrative: Patient received pneumococcal vaccine and 45 minutes after she was transferred to the ED for scratchy throat, dry cough, voice change and itchy skin. Her voice became worse and throat was closing and began feeling lightheaded. She was treated with epinephrine stat 0.3 mg IM followed by Solu-Medrol 125, Benadryl 25 subsequently changed to 50 mg, famotidine 20 normal saline and Oxygen 2 L nasal cannula. Other Relevant HX: Other:
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Reported Symptoms:  10039897:SEDATION;  10047700:VOMITING;  10052104:DRY HEAVES;        Narrative:  Patient's wife reported that after the vaccine, he was experiencing excessive fatigue and sleeping for most of the day, along with nausea and dry heaving.  Patient also had injection site reaction (red and warm to the touch).  Other Relevant HX:   Other:  dry heaves
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Retching, Sedation, Vomiting
Clinical narrative: Reported Symptoms:  10039897:SEDATION;  10047700:VOMITING;  10052104:DRY HEAVES;        Narrative:  Patient's wife reported that after the vaccine, he was experiencing excessive fatigue and sleeping for most of the day, along with nausea and dry heaving.  Patient also had injection site reaction (red and warm to the touch).  Other Relevant HX:   Other:  dry heaves
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: Reported Symptoms:  10016558:FEVER;  10019211:HEADACHE;  10028411:MYALGIA; Narrative:  Patient experienced cold symptoms, headache, fever, and myalgia after his second COVID vaccine  Other Relevant HX:  Other:
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Anaphylactic reaction, Back pain, Chest discomfort, Dysarthria, Dyspnoea
Clinical narrative: Reported Symptom: 10002218: ANAPHYLAXIS; Narrative: pt was noted to be having difficulty walking and complaining of chest tightness, back pain, dyspnea, difficulty talking and there were hives noted to pt face and arms after administration
Age: 63.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Gait disturbance, Urticaria
Clinical narrative: Reported Symptom: 10002218: ANAPHYLAXIS; Narrative: pt was noted to be having difficulty walking and complaining of chest tightness, back pain, dyspnea, difficulty talking and there were hives noted to pt face and arms after administration
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Narrative: Other Relevant HX: Patient was given High Dose
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching to scalp and face within 6 hours of injection. 10/20/23 began treatment with oral steroid & oral antihistamine. Treatment continued through 10/30/23
Age: 11.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given Meningococcal B vs Meningococcal. No advers reaction. Patient will need to return for the correct vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, COVID-19 pneumonia, Computerised tomogram head normal, Cough, Dehydration
Clinical narrative: Patient became sleepy later in the day on 11/6. She slept until 11/8. Since 11/8, patient has had garbled sppech, difficulty forming words/sentences. Tremors to upper extremities, leaning to either the right or left side, involuntary movements of lower extremities. one or both legs will violently twitch and kick straight out in front of her. Patient keeps her eyes closed a lot since 11/8. She is unable to feed herself, and if she is given a cup she tries to drink and dumps it down her shirt.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dyskinesia, Dyspnoea, Exposure to SARS-CoV-2, Feeding disorder
Clinical narrative: Patient became sleepy later in the day on 11/6. She slept until 11/8. Since 11/8, patient has had garbled sppech, difficulty forming words/sentences. Tremors to upper extremities, leaning to either the right or left side, involuntary movements of lower extremities. one or both legs will violently twitch and kick straight out in front of her. Patient keeps her eyes closed a lot since 11/8. She is unable to feed herself, and if she is given a cup she tries to drink and dumps it down her shirt.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Intensive care, Laboratory test normal, Muscle twitching, Positive airway pressure therapy
Clinical narrative: Patient became sleepy later in the day on 11/6. She slept until 11/8. Since 11/8, patient has had garbled sppech, difficulty forming words/sentences. Tremors to upper extremities, leaning to either the right or left side, involuntary movements of lower extremities. one or both legs will violently twitch and kick straight out in front of her. Patient keeps her eyes closed a lot since 11/8. She is unable to feed herself, and if she is given a cup she tries to drink and dumps it down her shirt.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Posture abnormal, Pyrexia, Somnolence, Tremor, Urine analysis normal
Clinical narrative: Patient became sleepy later in the day on 11/6. She slept until 11/8. Since 11/8, patient has had garbled sppech, difficulty forming words/sentences. Tremors to upper extremities, leaning to either the right or left side, involuntary movements of lower extremities. one or both legs will violently twitch and kick straight out in front of her. Patient keeps her eyes closed a lot since 11/8. She is unable to feed herself, and if she is given a cup she tries to drink and dumps it down her shirt.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU4, MMRV
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation error
Clinical narrative: *Forgot to use Diluelent for vaccine covid 19 6mo-4yrs* -patient just complained of sore arm for 12 hours. no other symptoms.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Headache, Oral appliance application
Clinical narrative: Moderna & Pfizer Tachycardia 7-8 HRS after vaccine High Fever, Chills teeth chattering w/4 tooth fractures despite mouthguard. Tops of feet/hands & spine could not get warm. Fainting vomiting, severe headache joint pain
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia, Syncope, Tooth fracture, Vomiting
Clinical narrative: Moderna & Pfizer Tachycardia 7-8 HRS after vaccine High Fever, Chills teeth chattering w/4 tooth fractures despite mouthguard. Tops of feet/hands & spine could not get warm. Fainting vomiting, severe headache joint pain
Age: 2.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was 2.5 years old at the time of the incident. The COVID 6mo-4yo vaccine dose was ordered but the nurse mistakenly administered the COVID 5-11yo vaccine dose. There were no adverse events after the vaccine.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Computerised tomogram thorax, Electrocardiogram, Pneumonia
Clinical narrative: Atrial fibrillation Pneumonia - covid neg
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Atrial fibrillation Pneumonia - covid neg
Age: 61.0
Sex: F
Vaccine: COVID19, FLUC3, COVID19, FLUC3
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches; Chills; Headache; This spontaneous case was retrieved on 16-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2703516-1), reported by pharmacist (consumer) and concerned a 61-year-old, female patient.  The patient's concurrent conditions included mixed connective tissue disease (MCTD) and hypercholesterolemia. The patient's concomitant medications included atorvastatin, prednisone, pantoprazole, and cetirizine, all used for unreported indications. The patient's historical drug included Bactrim (trimethoprim/sulfamethoxazole) after which the patient had reaction reported as drug allergy.The patient's historical vaccines included five doses of COVID-19 vaccines (brand not specified; dose, date, route of administration and anatomical location: not reported for all doses) all for Covid-19 immunization. The patient was not pregnant.  It was reported that on 21-Oct-2023, the patient was vaccinated with Flucelvax TIV (influenza vaccine inact sag 3v; dose: reported as 'one'; anatomical location: left arm, route of administration, and indication: not reported). The batch number reported was 375291. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Flucelvax TIV. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.   On the same date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine reported as bnt162b2 omi xbb.1.5 (Comirnaty (2023-2024 formula)) (unspecified active ingredients; dose: reported as 'one', anatomical location: right arm, and route of administration: not reported) for Covid-19 immunisation. The batch number reported was HG4664.  On 22-Oct-2023, one day after receiving Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine, reported as at 06:30, the patient experienced body aches, chills, and headache.   At the time of initial reporting, the patient was recovering from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. One day after vaccination, the patient experienced body aches, chills, and headache. Causality is confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pain, chills and headache, due to biological and chronological plausibility.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. One day after vaccination, the patient experienced body aches, chills, and headache. Causality is confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pain, chills and headache, due to biological and chronological plausibility.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Feeling abnormal, Illness, Muscle tightness, Palpitations
Clinical narrative: feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back; pain in my sternum; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (medically significant) with onset 2021, outcome "unknown", described as "feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; BONE PAIN (medically significant) with onset 2021, outcome "unknown", described as "pain in my sternum". Therapeutic measures were taken as a result of muscle tightness, bone pain. Clinical course: Vaccines caused her body to lock up from neck, down arms, and thoracic area of back. Her husband could feel her muscles tightening and she could feel heart palpitations and had pain in her sternum. She endured one month of Medrol treatments, plus a trigger point injections in thoracic and epidural for Lumbar. People with autoimmune conditions shouldn't get this. She had been sick since her first vaccine and every one after.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300189774 same reporter/product/same event, different dose number;US-PFIZER INC-202300385262 same patient/drug/events, different dose (Dose 2);US-PFIZER INC-202300385263 same reporter/patient, different product/ event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Muscle tightness, Palpitations
Clinical narrative: feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back; pain in my sternum; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (medically significant) with onset 2021, outcome "unknown", described as "feel my muscles tightening/my body to lock up from neck, down arms, and thoracic area of back"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; BONE PAIN (medically significant) with onset 2021, outcome "unknown", described as "pain in my sternum". Therapeutic measures were taken as a result of muscle tightness, bone pain. Clinical course: Vaccines caused her body to lock up from neck, down arms, and thoracic area of back. Her husband could feel her muscles tightening and she could feel heart palpitations and had pain in her sternum. She endured one month of Medrol treatments, plus a trigger point injections in thoracic and epidural for Lumbar. People with autoimmune conditions shouldn't get this. She had been sick since her first vaccine and every one after.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300189774 same reporter/product/same event, different dose number;US-PFIZER INC-202300385262 same patient/drug/events, different dose (Dose 2);US-PFIZER INC-202300385263 same reporter/patient, different product/ event;
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergic respiratory symptom, Chills, Cough, Dizziness, Gastrointestinal disorder
Clinical narrative: His IBS is worst than usual.; sneezing; runny nose; cough; chills; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058581) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient reported having IBS. Patient stated they never stated positive for COVID-19.  Concurrent medical conditions included Irritable bowel syndrome.    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills). At the time of the report, IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient reported he took the latest vaccine on 18Oct2023. It was the 6th Moderna dose he received. He stated he did not have any real side effect with the 5th dose. He had IBS his entire life. After the 5th dose his IBS was aggravated for about two weeks. However, after the 6th dose he had real problem. It seems to be allergy related. He was sneezing, has runny nose, chills, and cough. His IBS was worst than usual. He read specifically in spikevax.com if you had serious reaction to COVID-19 before do not take the vaccine.  1st dose received 10Feb2021 and the lot number is 041L20A. 2nd dose received 10Mar2021 and the lot number is 001A21A. 3rd dose received 23Nov2021 and the lot number is Unknown. Same CVS as the 6th dose 4th dose received 10Jun2022 and the lot number is 058A22.2A. 5th dose received 05Nov2022 and the lot number is 049022A.   This case was linked to US-MODERNATX, INC.-MOD-2023-750743 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750743:Same Patient different dose
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pruritus, Sneezing
Clinical narrative: His IBS is worst than usual.; sneezing; runny nose; cough; chills; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058581) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient reported having IBS. Patient stated they never stated positive for COVID-19.  Concurrent medical conditions included Irritable bowel syndrome.    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills). At the time of the report, IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient reported he took the latest vaccine on 18Oct2023. It was the 6th Moderna dose he received. He stated he did not have any real side effect with the 5th dose. He had IBS his entire life. After the 5th dose his IBS was aggravated for about two weeks. However, after the 6th dose he had real problem. It seems to be allergy related. He was sneezing, has runny nose, chills, and cough. His IBS was worst than usual. He read specifically in spikevax.com if you had serious reaction to COVID-19 before do not take the vaccine.  1st dose received 10Feb2021 and the lot number is 041L20A. 2nd dose received 10Mar2021 and the lot number is 001A21A. 3rd dose received 23Nov2021 and the lot number is Unknown. Same CVS as the 6th dose 4th dose received 10Jun2022 and the lot number is 058A22.2A. 5th dose received 05Nov2022 and the lot number is 049022A.   This case was linked to US-MODERNATX, INC.-MOD-2023-750743 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750743:Same Patient different dose
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Irritable bowel syndrome, Rhinorrhoea, Sneezing
Clinical narrative: His IBS is worst than usual.; sneezing; runny nose; cough; chills; This spontaneous case was reported by a patient and describes the occurrence of IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058581) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient reported having IBS. Patient stated they never stated positive for COVID-19.  Concurrent medical conditions included Irritable bowel syndrome.    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills). At the time of the report, IRRITABLE BOWEL SYNDROME (His IBS is worst than usual.), SNEEZING (sneezing), RHINORRHOEA (runny nose), COUGH (cough) and CHILLS (chills) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Patient reported he took the latest vaccine on 18Oct2023. It was the 6th Moderna dose he received. He stated he did not have any real side effect with the 5th dose. He had IBS his entire life. After the 5th dose his IBS was aggravated for about two weeks. However, after the 6th dose he had real problem. It seems to be allergy related. He was sneezing, has runny nose, chills, and cough. His IBS was worst than usual. He read specifically in spikevax.com if you had serious reaction to COVID-19 before do not take the vaccine.  1st dose received 10Feb2021 and the lot number is 041L20A. 2nd dose received 10Mar2021 and the lot number is 001A21A. 3rd dose received 23Nov2021 and the lot number is Unknown. Same CVS as the 6th dose 4th dose received 10Jun2022 and the lot number is 058A22.2A. 5th dose received 05Nov2022 and the lot number is 049022A.   This case was linked to US-MODERNATX, INC.-MOD-2023-750743 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750743:Same Patient different dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Bladder dysfunction, Blood test, Computerised tomogram, Electroencephalogram
Clinical narrative: Admitted to the hospital on 11/6/21 with acute loss of sensation and paralysis from the waist down.  Had a 22 day admission and still have altered sensation and some weakness of lower extremities, partial intestinal paralysis, and bladder dysfunction to this day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Ileus paralytic, Lumbar puncture, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Admitted to the hospital on 11/6/21 with acute loss of sensation and paralysis from the waist down.  Had a 22 day admission and still have altered sensation and some weakness of lower extremities, partial intestinal paralysis, and bladder dysfunction to this day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Sensory loss
Clinical narrative: Admitted to the hospital on 11/6/21 with acute loss of sensation and paralysis from the waist down.  Had a 22 day admission and still have altered sensation and some weakness of lower extremities, partial intestinal paralysis, and bladder dysfunction to this day.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: E-mail received in the Contact Center mailbox on 26OCT2023 at 2:58 PM with the following request:  I hope you are doing well. We had a mobile clinic event and inadvertently the team froze 100 vials of the MMR II diluent. They wasted the diluent; No adverse event; This spontaneous report was received from Pharmacist and refers to a child of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unknown, lot #Unknown, administered for prophylaxis (strength, expiry date, and route of administration were not provided). Reconstituted with improperly stored Sterile diluent (Merck Sterile Diluent) which was frozen.  No additional adverse events were reported.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, MMR, MMR, MMR, VARCEL, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; was accidentally given extra doses of MMR II, GARDASIL 9, and VARIVAX; Caller aware that second and third doses of GARDASIL 9 were administered outside of PI guidelines.; This spontaneous report was received from a medical assistant referring to a 16-year-old male patient. The patient's pertinent medical history and drug reactions/ allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).   On 19-MAR-2023, the patient was vaccinated with the first doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (lot#: W034593, expiration date not reported, upon internal validation established as 10-MAY-2024), varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot #: X010535, expiration date not reported, upon internal validation established as 11-APR-2025) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot #: W028355, expiration date not reported, upon internal validation established as 07-JUN-2025). All products (strength, dose, and route of administration were not provided) were used for prophylaxis at a clinic.  On 20-SEP-2023, the patient was seen in another clinic and received the second doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, varicella virus vaccine live (Oka/Merck) (VARIVAX) injection and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, all used for prophylaxis (strength, dose, lot, expiration date and route of administration were not provided).   On 01-NOV-2023, the patient was seen in the reporter's clinic (reported as accidentally given extra doses) and received the third doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) subcutaneous injection 0.5 mL, subcutaneous in the left arm (lot #: W029541, expiration date 15-SEP-2024), varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5mL subcutaneous in the left arm (lot #: X011424, expiration date 19-APR-2025) (Extra dose administered) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection 0.5 mL, via injection in the left deltoid (route of administration was not provided) (lot#: 1965044, expiration date 07-JAN-2026) (Inappropriate schedule of product administration). All products were used for prophylaxis (strength was not reported). The reporter stated that no adverse reactions had been reported by the patient (No adverse event).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate schedule of vaccine administered (first dose of Varicella vaccine administered on 06-DEC-2000, second dose on 27-MAR-2009), at the age of 9 years old; This spontaneous report has been received from an unspecified healthcare provider, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (2309USA001668), concerning a 9-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Historical vaccines included unspcified diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DPT) vaccine or unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTaP) vaccine or unspecified diphtheria vaccine toxoid (+) tetanus vaccine toxoid (DT) vaccine (reported as DTP/DTAP/DT), unspecified polio vaccine (POLIO), unspecified haemophilus influenzae type B (HIB) vaccine, unspecified hepatitis b vaccine (HEP B), unspecified pneumococcal conjugate vaccine (PCV). Concomitant vaccines included unspecified polio vaccine (POLIO), unspecified pneumococcal vaccine conj (PCV) vaccine and unspecified measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (MMR).  On 06-DEC-2000, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection, administered for prophylaxis (exact dose, lot #, expiry date, and route of administration were not provided). On 27-MAR-2009, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (exact dose, anatomical location, lot #, expiry date and route of administration were not provided) at the age of 9 years old (product administered to patient of inappropriate age).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2309USA001668:original case
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, No adverse event
Clinical narrative: first dose was administered in 2006, second dose in 2007, and she never received the third dose; No additional AE information was able to be provided; This spontaneous report was received from pharmacist and refers to a 42-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2006, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date in 2007, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. And she never received the third dose (inappropriate schedule of product administration). The patient inquired whether she should get the third dose. No additional adverse event (AE) able to be provided (no adverse event).; Sender Comments: Keywords : LIT
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of GARDASIL 9 that was administered to a patient.  Medical Assistant stated that the GARDASIL 9 dose had a labeled expiration date of 11/9/2023 and was administered on 11/10/2023; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml / two or three dose series, lot #1780876, expiration date: 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The reported called to report this expired dose of vaccine that was administered to the patient. It was confirmed no report of medical concerns or symptoms from the patient related to the expired administration of the vaccine. No additional information provided. No additional adverse event was reported (No adverse event).
Age: 27.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reports patient received 1st dose of GARDASIL 9 in 2014 and did not return to complete series until 2023.; No additional AEs; This spontaneous report was received from a pharmacist referring to a 36-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2014, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). It was reported that patient did not return to complete series until 2023 (Inappropriate schedule of product administration). The patient had not received any additional doses at the time of the call however the patient was scheduled to receive the vaccine later in the day on 10-NOV-2023. No additional adverse event reported (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP called to report T/E for GARDASIL 9. HCP stated 2 patients inadvertently received GARDASIL 9 during the T/E.; This spontaneous report as received from a nurse, and refers to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.     On 31-OCT-2023 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1957405 and expiration date 11-NOV-2025 (route and anatomical location were not reported) for prophylaxis.    It was reported that the dose of dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) applied to the patient had  previous temperature excursions 26-OCT-2023 and 27-OCT-2023 as follows:  -2.04C 2 hours 0 minutes -1.61C 1 hour 30 minutes  -1.56 0 hours 45 minutes  -1.04C 0 hours 30 minutes  -0.82C 1 hour 15 minutes  -1.21C 1 hour 15 minutes  No additional AE reported.  This is one of several reports from the same source. ; Sender's Comments:  US-009507513-2311USA005526:MSD
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No signs/symptoms of adverse reactions have been reported; ROTATEQ was administered to a patient after the expiration date. (11/19/2023); This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 20-NOV-2023, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, beyond its expiration date (expiration date reported as 19-NOV-2023) (expired product administered), administered orally for prophylaxis (strength, and lot number were not provided). No additional adverse events were reported for this patient.
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects were reported; HCP calling to report RECOMBIVAX HB was inadvertently administered today, 21-NOV-2023, after its labeled expiry date of 18-NOV-2023. No side effects were reported; This spontaneous report was received from a registered nurse referring to a 7-year-old male patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-NOV-2023, the patient was inadvertently vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 0.5 ml, lot # W008704, expiration date on 18-NOV-2023 for prophylaxis (frequency and route were not reported) after its labeled expiry date. There was no side effects reported. No additional information was provided and no temperature excursions were reported.
Age: 19.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, Underdose
Clinical narrative: the patient did not report any medical concerns or symptoms related to the administration of the pediatric dose of VAQTA; a 19 year old patient was administered a pediatric dose of VAQTA/1 mL / Two dose series; This spontaneous report was received from a office manger referring to a 19-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-SEP-2023, the patient was vaccinated with 2 series of pediatric dose of hepatitis a vaccine, inactivated(VAQTA) lot # X015720, expiration date was reported as 05-FEB-2024, but internally established as 05-DEC-2024; 0.5 milliliter each dose (1ml in total) for prophylaxis (route was not reported). The patient did not report any medical concerns or symptoms related to the administration of the pediatric dose of hepatitis a vaccine, inactivated(VAQTA). No additional information was provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE; HCP called to report that the patient inadvertently received a dose of PROQUAD and VARIVAX today. No symptomatic events occured. No further information provided. No additional AE/ no PQC.   Operator of device = HCP; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 22-NOV-2023 the patient inadvertently was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot #x012609 and expiration date 29-OCT-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) and  varicella virus vaccine live (oka/merck)(VARIVAX) lot # x011424 and expiration date 19-APR-2025, 0.5 milliliter for prohylaxis (dose number, route and site of administration were not provided) on that same (accidental overdose and no adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the infant has no symptoms post vaccination; she administerd both PROQUAD and VARIVAX to a 12-month-old patient; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 21-NOV-2023 at 17:30, the patient was vaccinated with both varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, lot # W024335, expiration date on 01-AUG-2024,  for prophylaxis (route was not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 ml, once, lot#X007087, expiration date on 04-SEP-2024 for prophylaxis (route not reported). The infant had no symptoms post vaccination. No further information was obtained. No Product quality complaint reported.