chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender 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.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that the patient experienced the events anytime during the 2 days after the COVID-19 vaccination, which occurred Saturday, Dec 23, 2023 and Sunday, Dec 24, 2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Injection site pain, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Mild fever (100.4 to 101.2 °F); Mild injection site pain and no interference with activity/Mild injection site tenderness; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)) and INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)) and INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)) and INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 °F, Mild fever..         Concomitant medication was not provided.  Treatment information was not reported. The events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Wednesday 20-Dec- 2023 and Thursday 21-Dec-2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Mild fever (100.4 to 101.2 °F); Mild injection site pain and no interference with activity/Mild injection site tenderness; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)) and INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)) and INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), PYREXIA (Mild fever (100.4 to 101.2 °F)) and INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 °F, Mild fever..         Concomitant medication was not provided.  Treatment information was not reported. The events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Wednesday 20-Dec- 2023 and Thursday 21-Dec-2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild injection site pain and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of INJECTION SITE PAIN (Mild injection site pain and no interference with activity) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced INJECTION SITE PAIN (Mild injection site pain and no interference with activity). At the time of the report, INJECTION SITE PAIN (Mild injection site pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Master case
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and FATIGUE (Mild fatigue and no interference with activity). At the time of the report, INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on Monday, 01-Jan -2024 and Tuesday, 02-Jan-2024.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest); Mild injection site redness; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), INJECTION SITE PAIN (Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest)), INJECTION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a  patient of an unknown age and gender 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 MALAISE (Mild malaise/feeling sick and no interference with activity), INJECTION SITE PAIN (Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest)), INJECTION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), INJECTION SITE PAIN (Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest)), INJECTION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient had experienced events during the 2 days after COVID-19 vaccination, which occurred on Wednesday, 03-Jan-2024 and Thursday, 04-Jan-2024.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Master case
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fatigue and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred Thursday, 04-Jan-2024 and Friday, 05-Jan-2024.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Mild muscle pain and no interference with activity; Mild fatigue and no interference with activity; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and INJECTION SITE ERYTHEMA (Mild injection site redness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and INJECTION SITE ERYTHEMA (Mild injection site redness). At the time of the report, MYALGIA (Mild muscle pain and no interference with activity), FATIGUE (Mild fatigue and no interference with activity), INJECTION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and INJECTION SITE ERYTHEMA (Mild injection site redness) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not provided. During the 2 days after COVID-19 vaccination 24-Dec-2023 and 25-Dec-2023, patient experienced mild injection site pain and no interference with activity, mild injection site tenderness (tender to touch), mild injection site redness, mild fatigue and no interference with activity and mild muscle pain and no interference with activity. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-755971 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755971:Master case
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of INJECTION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) and INJECTION SITE ERYTHEMA (Mild injection site redness) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced INJECTION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) and INJECTION SITE ERYTHEMA (Mild injection site redness). At the time of the report, INJECTION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)) and INJECTION SITE ERYTHEMA (Mild injection site redness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred Saturday, 23-Dec- 2023 and Sunday, 24-Dec-2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Headache, Malaise, Mobility decreased
Clinical narrative: After approximately six hours I developed an extremely bad headache and began to feel extremely nauseous but was not physically sick.  Although I took paracetamol every four hours my temperature was 39 degrees throughout the night and when I tried to get out of bed I was very dizzy.  The following day also suffered from diarrhoea. All there symptoms lingered for about twenty four hours then began to abate but I remained a little unwell for the next day or two.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: After approximately six hours I developed an extremely bad headache and began to feel extremely nauseous but was not physically sick.  Although I took paracetamol every four hours my temperature was 39 degrees throughout the night and when I tried to get out of bed I was very dizzy.  The following day also suffered from diarrhoea. All there symptoms lingered for about twenty four hours then began to abate but I remained a little unwell for the next day or two.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Audiogram abnormal, Bacterial test, Blood electrolytes, C-reactive protein
Clinical narrative: ?Patient started 24 hours after vaccination (12/15/2023) with sensation of fullness pressure in her left ear and tinnitus. Examined on (12/18/2023), began treatment on 12/20/2023 with decongestants and inhaled steroids first. Following this as she didn?t improve (12/26/2023), patient requests an appointment with a ENT specialist. ENT review (12/27/2023) due to tinnitus and associated pain to left ear after 10days of having received a COVID vaccine. Also noted fullness sensation, tinnitus and hearing loss. Ear, oral cavity and oropharynx exams normal. Audiometry performed finding a left side perceptive hearing loss for high sounds with drop to 75dB in 4KHz, maintaining conversational frequencies. Diagnosis of sudden left ear hearing loss and  started on oral steroids (9 days course). 24 hours later (12/28/2023) patient experimented hypoesthesia on the left side of her face and pain in maxillary, mandibular and ophthalmic branches of the trigeminal nerve for which patient went to ER and was admitted under neurology specialty with a diagnosis of Multiple Mononeuritis of possible immunologic etiology.?
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Coagulation test, Computerised tomogram head, Computerised tomogram spine, Deafness unilateral
Clinical narrative: ?Patient started 24 hours after vaccination (12/15/2023) with sensation of fullness pressure in her left ear and tinnitus. Examined on (12/18/2023), began treatment on 12/20/2023 with decongestants and inhaled steroids first. Following this as she didn?t improve (12/26/2023), patient requests an appointment with a ENT specialist. ENT review (12/27/2023) due to tinnitus and associated pain to left ear after 10days of having received a COVID vaccine. Also noted fullness sensation, tinnitus and hearing loss. Ear, oral cavity and oropharynx exams normal. Audiometry performed finding a left side perceptive hearing loss for high sounds with drop to 75dB in 4KHz, maintaining conversational frequencies. Diagnosis of sudden left ear hearing loss and  started on oral steroids (9 days course). 24 hours later (12/28/2023) patient experimented hypoesthesia on the left side of her face and pain in maxillary, mandibular and ophthalmic branches of the trigeminal nerve for which patient went to ER and was admitted under neurology specialty with a diagnosis of Multiple Mononeuritis of possible immunologic etiology.?
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Enzyme level test, Full blood count, Hypoaesthesia
Clinical narrative: ?Patient started 24 hours after vaccination (12/15/2023) with sensation of fullness pressure in her left ear and tinnitus. Examined on (12/18/2023), began treatment on 12/20/2023 with decongestants and inhaled steroids first. Following this as she didn?t improve (12/26/2023), patient requests an appointment with a ENT specialist. ENT review (12/27/2023) due to tinnitus and associated pain to left ear after 10days of having received a COVID vaccine. Also noted fullness sensation, tinnitus and hearing loss. Ear, oral cavity and oropharynx exams normal. Audiometry performed finding a left side perceptive hearing loss for high sounds with drop to 75dB in 4KHz, maintaining conversational frequencies. Diagnosis of sudden left ear hearing loss and  started on oral steroids (9 days course). 24 hours later (12/28/2023) patient experimented hypoesthesia on the left side of her face and pain in maxillary, mandibular and ophthalmic branches of the trigeminal nerve for which patient went to ER and was admitted under neurology specialty with a diagnosis of Multiple Mononeuritis of possible immunologic etiology.?
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging head, Mononeuropathy multiplex, Red blood cell sedimentation rate, Sudden hearing loss
Clinical narrative: ?Patient started 24 hours after vaccination (12/15/2023) with sensation of fullness pressure in her left ear and tinnitus. Examined on (12/18/2023), began treatment on 12/20/2023 with decongestants and inhaled steroids first. Following this as she didn?t improve (12/26/2023), patient requests an appointment with a ENT specialist. ENT review (12/27/2023) due to tinnitus and associated pain to left ear after 10days of having received a COVID vaccine. Also noted fullness sensation, tinnitus and hearing loss. Ear, oral cavity and oropharynx exams normal. Audiometry performed finding a left side perceptive hearing loss for high sounds with drop to 75dB in 4KHz, maintaining conversational frequencies. Diagnosis of sudden left ear hearing loss and  started on oral steroids (9 days course). 24 hours later (12/28/2023) patient experimented hypoesthesia on the left side of her face and pain in maxillary, mandibular and ophthalmic branches of the trigeminal nerve for which patient went to ER and was admitted under neurology specialty with a diagnosis of Multiple Mononeuritis of possible immunologic etiology.?
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Trigeminal neuralgia, Urine analysis, Viral test
Clinical narrative: ?Patient started 24 hours after vaccination (12/15/2023) with sensation of fullness pressure in her left ear and tinnitus. Examined on (12/18/2023), began treatment on 12/20/2023 with decongestants and inhaled steroids first. Following this as she didn?t improve (12/26/2023), patient requests an appointment with a ENT specialist. ENT review (12/27/2023) due to tinnitus and associated pain to left ear after 10days of having received a COVID vaccine. Also noted fullness sensation, tinnitus and hearing loss. Ear, oral cavity and oropharynx exams normal. Audiometry performed finding a left side perceptive hearing loss for high sounds with drop to 75dB in 4KHz, maintaining conversational frequencies. Diagnosis of sudden left ear hearing loss and  started on oral steroids (9 days course). 24 hours later (12/28/2023) patient experimented hypoesthesia on the left side of her face and pain in maxillary, mandibular and ophthalmic branches of the trigeminal nerve for which patient went to ER and was admitted under neurology specialty with a diagnosis of Multiple Mononeuritis of possible immunologic etiology.?
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects vaccine given at 1 month not 2 month
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Muscle tightness, Pain, Product administered at inappropriate site, Swelling
Clinical narrative: Pt received covid vaccine on Left shoulder/left deltoid, pain since administration, with talking with patient sounds like vaccine was given in an incorrect location. She could feel it in her Pec muscle. She needs to stagger vaccines due to Methotrexate. she has had muscle tightness to the left neck . left trapezius and left shoulder with decreased ROM due to swelling since the vaccination she has no warmth, no fever and no overlying skin changes to the area of the vaccine. There is no SOB, wheezing or coughing.  This was administered at a store location.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU4, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was in office for routine well child check. Pt received three vaccines: HPV, COVID and Flu. Pt was given COVID 12+, 0.5 ml, instead of COVID 6 mo - 11yr 0.25 dosage.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4, MNQ, TDAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt was in office for routine well child check. Pt received four vaccines: COVID, flu, MenQuadfi and Tdap. Pt ws given COVID 12+ 0.5 ml, instead of COVID 6 mo 11 yr 0.25 ml dosage. (see back)
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Epistaxis, Lymphadenopathy, Measles antibody positive, Pyrexia
Clinical narrative: 12/9/23 - epistaxis 12/10/23 - conjunctivitis, rash on the face 12/13/23 - Rash spread 12/14/23 - worsens epistaxis 12/15/23 - Fever 101/5 F and worsening rash on to the body 12/16/23 - Lymphadenopathy 12/17/23 - Rash now wide body
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 12/9/23 - epistaxis 12/10/23 - conjunctivitis, rash on the face 12/13/23 - Rash spread 12/14/23 - worsens epistaxis 12/15/23 - Fever 101/5 F and worsening rash on to the body 12/16/23 - Lymphadenopathy 12/17/23 - Rash now wide body
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Dysgeusia, Eye movement disorder, Hyposmia, Parosmia, Tachycardia
Clinical narrative: I received both the flu and TDAP vaccines at my annual physical. That evening, I noticed that my sense of smell was greatly diminished (everything tasted/smelled burnt). I had tachycardia for the next 48 hours. My eyes had trouble tracking for up to a week later. My smell//test still have no come back to 100% and I am seeking help with an ENT. My ENT has confirmed that my smell is diminished via a smell test where I scored 25/40 correctly, indicating a severe smell issue.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Gastrointestinal disorder, Inappropriate schedule of product administration, Liver disorder, Malaise
Clinical narrative: Started getting Orencia infusions for R/A on April 27, 2022, thru September 21, 2022. After getting my Covid Booster and Flu Shot on September 26, 2022, per the Dr's orders. I started getting very sick. After reading up on this - the shots were not supposed to be given to me for 3 months after getting the Orencia infusion. This is the start of all the side effects and then causing my liver problems. I have been very sick for over 1 year. Now I am on the liver transplant list and weekly dr. appointments and stomach draining and albumin infusions. After stopping Orencia infusions on 9/21/22, I received the Covid booster and flu shot on 9/26/22. After that I started getting very sick. now as of Oct 2023, I've finally feeling a little better but now this has developed liver problems. I've been on liver meds and Dr's starting Feb. 2, 2023 (my 1st start of stomach draining). I still have my stomach drained as of now. Weekly Dr. appointments! This all was caused by the Orencia infusions!
Age: 71.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Back pain, Blood test, Inflammation, Injection site pruritus, Musculoskeletal chest pain
Clinical narrative: I've had the Covid-19 vaccine and every booster. I've also gotten the annual Flu shot each year without a problem until this most recent shot. On October 11, 2023 I got the most recent Covid booster along with the new flu shot at my pharmacy. One day later, I started having a strong pain behind my right shoulder blade. I thought I must have strained a muscle unknowingly. But I also started to have a strong itch all around and on my right shoulder. The next day, the intense pain had moved from behind my right should blade to the middle of my back. The day after that, the pain moved to behind my left shoulder blade, and the day after that to my left rib cage. I also have a strong annoying constant itch bothering me a lot on and around the left shoulder and my upper arm. I realized that this was not normal, and I figured I must be having a reaction to whatever shot I received in my right arm. The pain in my back which had moved across my back to my ribcage had disappeared, but the strong itch was still there. So I called pharmacy to ask which shot I had gotten in my right arm. They told me it was the "regular flu shot", so asked the details of the shot. They said it was the flu shot made by Seqirus Inc, .05 ML. Administered using Fluad Quad 2023-2024 syringe. I think they mentioned Physer too, but I'm not sure. Now, about 3 months after the shot, the itch has not gotten any better. On Jan. 3rd, 2024, I saw my family physician, Dr. She said the pain I experienced, and the itch that's annoying me badly, could be a reaction to the shot. She gave me 2 prescriptions or the itch. One is Triamcinolone Acetonide Ointment USP,0.1%, which I have taken for 3 days and seen no improvement yet. The 2nd medication is Ammonium Lactate 12% Lotion, which I intend to start using tomorrow because the itch hasn't changed and is still there. I feel that it is important that I report all of this to the FDA, and probably to the CDC as well. Also, please let me know if you have had any similar reports about the latest Flu or Covid shots? I did have a blood and urine test late last week which I saw the results that showed something that indicates "inflammation". Dr hasn't reviewed the results yet because the test was done just before the weekend.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Musculoskeletal pain, Urine analysis
Clinical narrative: I've had the Covid-19 vaccine and every booster. I've also gotten the annual Flu shot each year without a problem until this most recent shot. On October 11, 2023 I got the most recent Covid booster along with the new flu shot at my pharmacy. One day later, I started having a strong pain behind my right shoulder blade. I thought I must have strained a muscle unknowingly. But I also started to have a strong itch all around and on my right shoulder. The next day, the intense pain had moved from behind my right should blade to the middle of my back. The day after that, the pain moved to behind my left shoulder blade, and the day after that to my left rib cage. I also have a strong annoying constant itch bothering me a lot on and around the left shoulder and my upper arm. I realized that this was not normal, and I figured I must be having a reaction to whatever shot I received in my right arm. The pain in my back which had moved across my back to my ribcage had disappeared, but the strong itch was still there. So I called pharmacy to ask which shot I had gotten in my right arm. They told me it was the "regular flu shot", so asked the details of the shot. They said it was the flu shot made by Seqirus Inc, .05 ML. Administered using Fluad Quad 2023-2024 syringe. I think they mentioned Physer too, but I'm not sure. Now, about 3 months after the shot, the itch has not gotten any better. On Jan. 3rd, 2024, I saw my family physician, Dr. She said the pain I experienced, and the itch that's annoying me badly, could be a reaction to the shot. She gave me 2 prescriptions or the itch. One is Triamcinolone Acetonide Ointment USP,0.1%, which I have taken for 3 days and seen no improvement yet. The 2nd medication is Ammonium Lactate 12% Lotion, which I intend to start using tomorrow because the itch hasn't changed and is still there. I feel that it is important that I report all of this to the FDA, and probably to the CDC as well. Also, please let me know if you have had any similar reports about the latest Flu or Covid shots? I did have a blood and urine test late last week which I saw the results that showed something that indicates "inflammation". Dr hasn't reviewed the results yet because the test was done just before the weekend.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19-2, PNC13, RSV
Symptoms: CSF test abnormal, Cognitive disorder, Dysphagia, Dyspnoea, Fall
Clinical narrative: Shortly after booster with Pfizer Covid vaccine, patient developed sensory neuropathy, presented to ED 1/1/24 with repeated falls due to leg weakness, and altered mental status with slowed responses. From couple days after vaccine - initially couldn't feel feet touching ground. Worsened over time with weakness in leg. Next hit hands which have numbness, not as sure about weakness in hands/arms. Has shortness of breath. More recently some trouble feeling like choking on food/drink. Returned to ED 1/6/24 and admitted with rapidly progressive four extremity sensorimotor deficits, onset after recent vaccination, also with some shortness of breath and intermittent dysphagia. History, exams, reassuring CNS imaging, and marked cytoalbuminologic dissociation on CSF testing all fit with AIDP (acute inflammatory demyelinating polyradiculoneuropathy, aka Guillain-Barre syndrome). Recommend intensifying monitoring including respiratory parameters, and starting IVIG now. Per Tele-neurology at University. -IVIG, 0.4g/kg (ideal body weight) daily x 5days
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19-2, PNC13, RSV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Imaging procedure, Immunoglobulin therapy, Mental status changes
Clinical narrative: Shortly after booster with Pfizer Covid vaccine, patient developed sensory neuropathy, presented to ED 1/1/24 with repeated falls due to leg weakness, and altered mental status with slowed responses. From couple days after vaccine - initially couldn't feel feet touching ground. Worsened over time with weakness in leg. Next hit hands which have numbness, not as sure about weakness in hands/arms. Has shortness of breath. More recently some trouble feeling like choking on food/drink. Returned to ED 1/6/24 and admitted with rapidly progressive four extremity sensorimotor deficits, onset after recent vaccination, also with some shortness of breath and intermittent dysphagia. History, exams, reassuring CNS imaging, and marked cytoalbuminologic dissociation on CSF testing all fit with AIDP (acute inflammatory demyelinating polyradiculoneuropathy, aka Guillain-Barre syndrome). Recommend intensifying monitoring including respiratory parameters, and starting IVIG now. Per Tele-neurology at University. -IVIG, 0.4g/kg (ideal body weight) daily x 5days
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19-2, PNC13, RSV
Symptoms: Muscular weakness, Peripheral sensory neuropathy, Sensory loss
Clinical narrative: Shortly after booster with Pfizer Covid vaccine, patient developed sensory neuropathy, presented to ED 1/1/24 with repeated falls due to leg weakness, and altered mental status with slowed responses. From couple days after vaccine - initially couldn't feel feet touching ground. Worsened over time with weakness in leg. Next hit hands which have numbness, not as sure about weakness in hands/arms. Has shortness of breath. More recently some trouble feeling like choking on food/drink. Returned to ED 1/6/24 and admitted with rapidly progressive four extremity sensorimotor deficits, onset after recent vaccination, also with some shortness of breath and intermittent dysphagia. History, exams, reassuring CNS imaging, and marked cytoalbuminologic dissociation on CSF testing all fit with AIDP (acute inflammatory demyelinating polyradiculoneuropathy, aka Guillain-Barre syndrome). Recommend intensifying monitoring including respiratory parameters, and starting IVIG now. Per Tele-neurology at University. -IVIG, 0.4g/kg (ideal body weight) daily x 5days
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19-2, PNC13, RSV
Symptoms: Ageusia, Anosmia, Asthenia, Confusional state, Dysarthria
Clinical narrative: Shortly after booster with Pfizer Covid vaccine, patient developed sensory neuropathy, presented to ED 1/1/24 with repeated falls due to leg weakness, and altered mental status with slowed responses. From couple days after vaccine - initially couldn't feel feet touching ground. Worsened over time with weakness in leg. Next hit hands which have numbness, not as sure about weakness in hands/arms. Has shortness of breath. More recently some trouble feeling like choking on food/drink. Returned to ED 1/6/24 and admitted with rapidly progressive four extremity sensorimotor deficits, onset after recent vaccination, also with some shortness of breath and intermittent dysphagia. History, exams, reassuring CNS imaging, and marked cytoalbuminologic dissociation on CSF testing all fit with AIDP (acute inflammatory demyelinating polyradiculoneuropathy, aka Guillain-Barre syndrome). Recommend intensifying monitoring including respiratory parameters, and starting IVIG now. Per Tele-neurology at University. -IVIG, 0.4g/kg (ideal body weight) daily x 5days
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19-2, PNC13, RSV
Symptoms: Fall, Guillain-Barre syndrome, Hallucination, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Shortly after booster with Pfizer Covid vaccine, patient developed sensory neuropathy, presented to ED 1/1/24 with repeated falls due to leg weakness, and altered mental status with slowed responses. From couple days after vaccine - initially couldn't feel feet touching ground. Worsened over time with weakness in leg. Next hit hands which have numbness, not as sure about weakness in hands/arms. Has shortness of breath. More recently some trouble feeling like choking on food/drink. Returned to ED 1/6/24 and admitted with rapidly progressive four extremity sensorimotor deficits, onset after recent vaccination, also with some shortness of breath and intermittent dysphagia. History, exams, reassuring CNS imaging, and marked cytoalbuminologic dissociation on CSF testing all fit with AIDP (acute inflammatory demyelinating polyradiculoneuropathy, aka Guillain-Barre syndrome). Recommend intensifying monitoring including respiratory parameters, and starting IVIG now. Per Tele-neurology at University. -IVIG, 0.4g/kg (ideal body weight) daily x 5days
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19-2, PNC13, RSV
Symptoms: Incontinence, Lumbar puncture, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Shortly after booster with Pfizer Covid vaccine, patient developed sensory neuropathy, presented to ED 1/1/24 with repeated falls due to leg weakness, and altered mental status with slowed responses. From couple days after vaccine - initially couldn't feel feet touching ground. Worsened over time with weakness in leg. Next hit hands which have numbness, not as sure about weakness in hands/arms. Has shortness of breath. More recently some trouble feeling like choking on food/drink. Returned to ED 1/6/24 and admitted with rapidly progressive four extremity sensorimotor deficits, onset after recent vaccination, also with some shortness of breath and intermittent dysphagia. History, exams, reassuring CNS imaging, and marked cytoalbuminologic dissociation on CSF testing all fit with AIDP (acute inflammatory demyelinating polyradiculoneuropathy, aka Guillain-Barre syndrome). Recommend intensifying monitoring including respiratory parameters, and starting IVIG now. Per Tele-neurology at University. -IVIG, 0.4g/kg (ideal body weight) daily x 5days
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Gait inability, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: At a yearly physical and determined I was in great health, I got a pneumococcal pneumonia vaccine from the facility in my muscle in the upper left arm within two weeks I couldn't walk or use my hands. On 09/08/2023 my wife took me to the emergency room. My levels were up and determined I must see Dr and be treated for Rheumatoid Arthritis. For several months I could not dress myself. Slowly I began to walk again but still don't have much strength in my arms. In July 2023 I moved. Now I got a personal doctor and seeing a facility doctor both doctors say I don't have RA. But still weak and tired.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Musculoskeletal disorder, Red blood cell sedimentation rate, Rheumatoid arthritis
Clinical narrative: At a yearly physical and determined I was in great health, I got a pneumococcal pneumonia vaccine from the facility in my muscle in the upper left arm within two weeks I couldn't walk or use my hands. On 09/08/2023 my wife took me to the emergency room. My levels were up and determined I must see Dr and be treated for Rheumatoid Arthritis. For several months I could not dress myself. Slowly I began to walk again but still don't have much strength in my arms. In July 2023 I moved. Now I got a personal doctor and seeing a facility doctor both doctors say I don't have RA. But still weak and tired.
Sex: U
Vaccine: RSV
Symptoms: Genital herpes simplex, Genital pain
Clinical narrative: a very large and painful outbreak of genital herpes, simplex 1; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENITAL HERPES SIMPLEX (non-serious), outcome "recovered", described as "a very large and painful outbreak of genital herpes, simplex 1". Additional information: the very large and painful outbreak of genital herpes, simplex 1, disappeared within 24 hours after receiving the vaccine.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Thrombosis
Clinical narrative: blood clots; cancer; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". The reporter (spouse) stated they think the events are from the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; adult dose of VAQTA was administered to a pediatric patient.; This spontaneous report was received from a nurse referred to a currently a 17-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-DEC-2023, the adult dose of hepatitis a vaccine, inactivated (VAQTA) was administered to the child patient (also reported as pediatric patient), 1 dose, lot #W028824, expiration date: 07-JAN-2024, as prophylaxis (dose, strength, and route of administration were not provided) (Incorrect dose administered). The operator of the device was a healthcare professional. There was no additional adverse event (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The physician is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a physician and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions and allergies, and concomitant therapies were not reported.  On 28-DEC-2023, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered as prophylaxis (lot number x004368 has been verified to be a valid lot number, expiration date reported and validated as 02-JUN-2024) recombinant human albumin (rHA) (strength, dose, vaccination scheme and route of administration were not provided) after a temperature excursion of 8.6 Fahrenheit degrees (F) for a time frame of 2 hours (Product storage error). There were no previous temperature excursion and there was no additional adverse event reported.