chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray, Cough, SARS-CoV-2 test
Clinical narrative: Her doctor told her not to get the vaccine until her cough is better; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Her doctor told her not to get the vaccine until her cough is better) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Her doctor told her not to get the vaccine until her cough is better). At the time of the report, COUGH (Her doctor told her not to get the vaccine until her cough is better) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Chest X-ray: diagnosed her with IOD (she thought). In 2023, SARS-CoV-2 test: Negative.         No relevant concomitant medications were reported.  The patient had previously received Moderna COVID-19 vaccines with dose 1 on 02FEB2021 lot 007M20A, dose 2 on 02MAR2021 lot 00A21A, dose 3 on 29APR2022 lot 005M21A.  She had not had any trouble. When she went to the doctor in September he told her it was early to get SPIKEVAX, flu shot or RSV vaccines. She recently went to urgent care and got tested for COVID-19 and was negative. They did a chest X-ray and diagnosed her with IOD (she thought). She wont be able to get with a lung doctor for a while. Her doctor told her not to get the vaccine until her cough was better. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747782 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747782:Monovalent dose
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: stomach aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) in a 74-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Loss of balance (loss of balance due to a concussion, asthma.), Concussion and Asthma.   On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches). At the time of the report, ABDOMINAL PAIN UPPER (stomach aches) and HEADACHE (headaches) had resolved. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747591 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747591:Same patient (Different vaccine)
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Face injury
Clinical narrative: Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.; This spontaneous case was reported by a patient and describes the occurrence of FACE INJURY (Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Lot 013L20A) on 19-Jan-2021, MODERNA COVID-19 VACCINE (Lot 012M20A) on 16-Feb-2021, MODERNA COVID-19 VACCINE on 10-Sep-2021 and MODERNA COVID-19 VACCINE (lot 048L21A) on 19-Mar-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Asthma since 2017, Hypogammaglobulinemia, Brain tumor since 2016 and Meningioma.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FACE INJURY (Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.). At the time of the report, FACE INJURY (Had a facial injury August 11, 2023. I had dermal fillers in both eye troughs and nasolabial and chin area.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: bloodwork, fine.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment medication were not reported.   Patient had a facial injury August 11, 2023. She had dermal fillers in both eye troughs and nasolabial and chin area.   This case was linked to US-MODERNATX, INC.-MOD-2023-747593 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747593:Case for SPIKEVAX 2023-2024 PFS
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: Loss of appetite; High fever; chills; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus, Mitral valve disease, Irritable bowel syndrome, Blood pressure high, Drug allergy, Drug allergy and Drug allergy.    On 20-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had received all Moderna COVID-19 vaccines so far and her reactions have been high fever, chills, loss of appetite. She would only have to stay at home for a couple of days after which she was able to return to work. With one of the doses, her fever went to 104F.   This case was linked to MOD-2023-747892, MOD-2023-747880 (Patient Link).
Sex: F
Vaccine: UNK
Symptoms: Anaemia, Weight decreased
Clinical narrative: she developed anemia; loss of weight; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (she developed anemia  ) and WEIGHT DECREASED (loss of weight) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD and Rheumatoid arthritis.    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 ANAEMIA (she developed anemia  ) and WEIGHT DECREASED (loss of weight). At the time of the report, ANAEMIA (she developed anemia  ) and WEIGHT DECREASED (loss of weight) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that already received all of their Moderna doses and boosters, but after receiving the shots she developed anemia and loss of weight, and every time she gets another booster she gets worse.   This case was linked to US-MODERNATX, INC.-MOD-2023-747881 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747881:Same reporter (SPIKVAX NOS)
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration, Injection site induration, Injection site swelling, Tenderness
Clinical narrative: Hard swelling at injection site; tenderness; bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above); bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Hard swelling at injection site), TENDERNESS (tenderness), CONTUSION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) and SKIN DISCOLOURATION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 19-Oct-2023, the patient experienced INJECTION SITE SWELLING (Hard swelling at injection site), TENDERNESS (tenderness), CONTUSION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) and SKIN DISCOLOURATION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)). At the time of the report, INJECTION SITE SWELLING (Hard swelling at injection site), TENDERNESS (tenderness), CONTUSION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) and SKIN DISCOLOURATION (bruising under the skin which started slightly below the injection site and seemed to migrate down the arm each day (fresh bruising at the leading edge of the migration and yellowing of the older bruise area above)) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: UNK
Symptoms: Cardiac disorder, Head injury, Heart rate irregular, Loss of consciousness, Migraine
Clinical narrative: my heart wasn't working as well it caused me to pass out; migraines; affected my heart rate and made my heart weaker; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (my heart wasn't working as well it caused me to pass out) in an adult patient of an unknown 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 SYNCOPE (my heart wasn't working as well it caused me to pass out) (seriousness criterion medically significant), MIGRAINE (migraines) and CARDIAC DISORDER (affected my heart rate and made my heart weaker). At the time of the report, SYNCOPE (my heart wasn't working as well it caused me to pass out) and CARDIAC DISORDER (affected my heart rate and made my heart weaker) outcome was unknown and MIGRAINE (migraines) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: irregular.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   The patient got vaccine it affected heart rate and made heart weaker. Patient was doing an activity one day and because heart wasn't working it as well caused patient to pass out and hit head really hard and patient getting constant migraines.  Treatment medication not reported.   Company Comment This spontaneous case concerns adult patient of an unknown gender with no medical history reported who experienced the seriousness criterion medically significant unexpected event of syncope; the unexpected events of migraine and cardiac disorder unknown days after a dose of mRNA-1273.815 vaccine.  Concomitant medication details nor Treatment details were reported. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: she only had a bit issue moving her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (she only had a bit issue moving her arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A, 008B21-2A, 017F21A and 056M21A) for COVID-19 prophylaxis.     The patient's past medical history included Lip swelling and Swelling of tongue. Concurrent medical conditions included Allergy to animal dander, Latex allergy, Grass allergy, Ragweed allergy, Allergy to animal dander, Allergic to dogs, Environmental allergy, Lactose intolerance, Fruit allergy, Rubber sensitivity, Fruit allergy, Fruit allergy and Spice allergy.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (she only had a bit issue moving her arm). At the time of the report, LIMB DISCOMFORT (she only had a bit issue moving her arm) had resolved.            It was reported that patient did not receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that Since she was very allergic to a lot of things physican took precautions and listed the ingredients of the first dose, asking her if she had a previous reaction to any of the ingredients, she said no and then she got the vaccine without any adverse events. After second dose it was less traumatic to get the vaccine since she knew that with the first one was ok, she was prepared and hydrated to avoid inconveniences, and she only had a bit issue moving her arm but then she felt fine. With the rest of the vaccines she also felt a bit of an issue in her arm but next day she was fine.  Treatment information was not provided.   This case was linked to MOD-2023-747721 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: UNK
Symptoms: Cardiac disorder, Coordination abnormal, Fatigue, Head injury, Headache
Clinical narrative: his heart is now very weak and not as strong as it used to be; he does not have a vision and he does not know what he is looking at; I can't function regularly due to the head injury that I got from the vaccine; problems with vision and coordination and speech; he has been having severe headache; he gets too exhausted right away unlike before; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be), VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech) and HEADACHE (he has been having severe headache) in an adult male patient 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 first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be), VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech), HEADACHE (he has been having severe headache) and FATIGUE (he gets too exhausted right away unlike before). At the time of the report, CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be) had not resolved and VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech), HEADACHE (he has been having severe headache) and FATIGUE (he gets too exhausted right away unlike before) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Speech disorder, Visual impairment
Clinical narrative: his heart is now very weak and not as strong as it used to be; he does not have a vision and he does not know what he is looking at; I can't function regularly due to the head injury that I got from the vaccine; problems with vision and coordination and speech; he has been having severe headache; he gets too exhausted right away unlike before; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be), VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech) and HEADACHE (he has been having severe headache) in an adult male patient 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 first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be), VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech), HEADACHE (he has been having severe headache) and FATIGUE (he gets too exhausted right away unlike before). At the time of the report, CARDIAC DISORDER (his heart is now very weak and not as strong as it used to be) had not resolved and VISUAL IMPAIRMENT (he does not have a vision and he does not know what he is looking at), HEAD INJURY (I can't function regularly due to the head injury that I got from the vaccine), SPEECH DISORDER (problems with vision and coordination and speech), HEADACHE (he has been having severe headache) and FATIGUE (he gets too exhausted right away unlike before) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Herpes zoster, Neuralgia, Paraesthesia, Pyrexia
Clinical narrative: shingles; nerve pains; She felt that there were pins sticking out of her whole body for 24 hours; fever; chilling; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles), NEURALGIA (nerve pains), PARAESTHESIA (She felt that there were pins sticking out of her whole body for 24 hours), PYREXIA (fever) and CHILLS (chilling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 041L20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced HERPES ZOSTER (shingles), NEURALGIA (nerve pains), PARAESTHESIA (She felt that there were pins sticking out of her whole body for 24 hours), PYREXIA (fever) and CHILLS (chilling). At the time of the report, HERPES ZOSTER (shingles), NEURALGIA (nerve pains), PARAESTHESIA (She felt that there were pins sticking out of her whole body for 24 hours), PYREXIA (fever) and CHILLS (chilling) had resolved.             No treatment information was reported.
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Death
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 COVID-19 (COVID-19) (seriousness criterion death). The reported cause of death was covid-19. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  It was reported that the patient passed away from COVID-19. It was unknown if they previously received COVID-19 vaccines. They closed his primary healthcare clinic because of this. No treatment medication reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious, fatal, unexpected, event of COVID-19, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine (unknown COVID-19 vaccination schedule). The reported cause of death was Covid-19. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-396655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-396655:Reporter's case; Reported Cause(s) of Death: COVID-19
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: blood pressure was significantly higher; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (blood pressure was significantly higher) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure high.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced HYPERTENSION (blood pressure was significantly higher). At the time of the report, HYPERTENSION (blood pressure was significantly higher) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERTENSION (blood pressure was significantly higher) to be related.    Concomitant medications were not reported.  It was reported that patient blood pressure had been well controlled for many years on a low dose ARB. After he received the covid vaccine, his blood pressure was significantly higher. This required 2 subsequent increases in his ARB medication dose in order to bring his blood pressure back into normal range. Patient convinced that adverse event was vaccine related.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Weight decreased
Clinical narrative: she developed anemia; loss of weight; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (she developed anemia) and WEIGHT DECREASED (loss of weight) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, COPD and Rheumatoid arthritis.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (she developed anemia) and WEIGHT DECREASED (loss of weight). At the time of the report, ANAEMIA (she developed anemia) and WEIGHT DECREASED (loss of weight) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that the patient already received all of their Moderna doses and boosters, but after receiving the shots she developed anemia and loss of weight. Every time the events got worse upon taking booster.   Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747917 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747917:Same reporter (SPIKVAX 2023-2024)
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bell's palsy
Clinical narrative: the patient had Bell's Palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (the patient had Bell's Palsy) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: moderna (Dose 1), moderna (Dose 3) and moderna (Dose 2). Past adverse reactions to the above products included No adverse event with moderna, moderna and moderna.    On 17-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (the patient had Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (the patient had Bell's Palsy) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported. About 3 weeks ago, the patient had Bell's Palsy.  Company comment- This is a spontaneous case concerning an 80-year-old female patient with no medical history reported, who experienced the expected and serious (medically significant) AESI Bell´s Palsy. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered.  Exact onset date of the event was not provided; hence, latency cannot be assessed. No further information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Blood pressure abnormal
Clinical narrative: On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE ABNORMAL (On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83) in a 63-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 21-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced BLOOD PRESSURE ABNORMAL (On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83). At the time of the report, BLOOD PRESSURE ABNORMAL (On 21 Oct 2023, vaccination, his blood pressure went up to 125/83 again on 1Nov2023 it is 132/83) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2023, Blood pressure measurement: 125/83. On 01-Nov-2023, Blood pressure measurement: 132/83.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication and treatment medication were not provided.  Patient states that he received Spikevax on 20OCT2023. His blood pressure is normally at 112-114 over 70. One day after vaccination, his blood pressure went up to 125/83. He checked it again today, 01NOV2023, and it is 132/83. He states that he did not have Myocarditis / Pericarditis symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Device breakage, Device issue
Clinical narrative: the stopper flew off side ways and cracked the screws/syringe where the needle would connect; the stopper flew off side ways and cracked the screws/syringe where the needle would connect; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Lot number: HG9498, Expiration Date: 31Jan2024) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "the stopper flew off side ways and cracked the screws/syringe where the needle would connect".  Additional information: when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force in 2 cases, the stopper flew off side ways and cracked the screws/syringe where the needle would connect for Pfizer-Biontech Covid-19 Vaccine Injectable (Combo)  The reporter considered "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" not related to bnt162b2 omi xbb.1.5. Causality for "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300177003 Same reporter/drug/AE, different patient;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jul2023 at 13:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (23Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 16Oct2023 to 21Oct2023. Clinical course: It was unknown if patient got other medication in 2 weeks.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300349457 Same reporter/patient, different drug/event;
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Underdose
Clinical narrative: The needle literally was still in the patient's arm but broke away from the syringe; Needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe; Became unlock from the lower lock portion of the diluent syringe; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 75-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 26Oct2023 at 12:50 as dose number unknown ,single (Lot number: HF5522, Expiration Date: Mar2025) at the age of 75 years intramuscular, in right arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), described as "The needle literally was still in the patient's arm but broke away from the syringe"; NEEDLE ISSUE (non-serious), described as "Needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe"; SYRINGE ISSUE (non-serious), described as "Became unlock from the lower lock portion of the diluent syringe". Additional information:Needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe     Causality for "the needle literally was still in the patient's arm but broke away from the syringe", "needle broke off and diluent spurt from the side simultaneously; needle literally was still in the patient's arm but broke away from the syringe" and "became unlock from the lower lock portion of the diluent syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Aug2023 as dose number unknown, single (Lot number: GK1337), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: neosporin, reaction(s): "drug allergy"; Known allergies: lisinopril, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350442 same reporter/patient, different product/events;
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Lot number: GK0924) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included 15Oct2023 to 19Oct2023. Clinical Course: Patient started taking Paxlovid two days after symptom onset (sore throat). It worked fine, he had very little symptoms after started to take it. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350557 Same reporter/patient, different drug/events;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 51 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EP6955), on 18Oct2021 as dose 3 (booster), single (Lot number: 320308D) and on 14Apr2022 as dose 4 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid for treatment of COVID-19 from 20Oct2023 to 24Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350598 Same reporter/patient, different drug/events;
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Pemphigoid, Skin infection, Stress
Clinical narrative: Pemphigoid/it was Bullous, it was Pemphigoid; Has horrible blisters on her skin which are infected, swollen and leaking; Affecting immune system; Stressed out; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 50-year-old female patient received bnt162b2 (BNT162B2), in 2021 as dose number unknown, 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: PEMPHIGOID (medically significant), outcome "unknown", described as "Pemphigoid/it was Bullous, it was Pemphigoid"; SKIN INFECTION (medically significant), outcome "unknown", described as "Has horrible blisters on her skin which are infected, swollen and leaking"; IMMUNE SYSTEM DISORDER (medically significant), outcome "unknown", described as "Affecting immune system"; STRESS (medically significant), outcome "unknown", described as "Stressed out". The events "pemphigoid/it was bullous, it was pemphigoid", "has horrible blisters on her skin which are infected, swollen and leaking", "affecting immune system" and "stressed out" required physician office visit. Therapeutic measures were taken as a result of pemphigoid, skin infection. Clinical course: Patient stated that she had the Pfizer covid vaccine two years ago and it was affecting her immune system. She had been diagnosed with pemphigoid. She had horrible blisters on her skin which were infected, swollen and leaking. She had seen her primary doctor and two dermatologists and had been given creams and antibiotics. They all thought it was related to the vaccine. She read on the internet that pemphigoid and autoimmune arthritis had been reported with the vaccine. She had an appointment to see a specialist in 3 weeks but she was calling Pfizer to find out what to do about it. She was so stressed out. She wanted to talk to a medical doctor at facility because she had Pemphigoid from some immune system disease, rash whatever on her skin that was infected that she could not get help from any doctor. When paraphrased the above concern, she stated that it was not a rash it was Bullous, it was Pemphigoid, one of the side effects from Pfizer Vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 08Feb2021 as dose number unknown, 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: URTICARIA (hospitalization) with onset 08Feb2021, outcome "not recovered", described as "hives". The event "hives" required physician office visit. Therapeutic measures were taken as a result of urticaria. Clinical course:  She took the Pfizer vaccine 08Feb2021 she had been broken out in hives every single day since. In the past 2 years she had been to several doctors, allergist, and even the hospital. She had been on Xolair for 8 months now and it was no longer helping.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Influenza, Pericarditis
Clinical narrative: got the flu; pericarditis symptoms began on week of 09Oct2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 47-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (hospitalization) with onset 09Oct2023, outcome "recovering", described as "pericarditis symptoms began on week of 09Oct2023"; INFLUENZA (hospitalization) with onset 17Oct2023, outcome "recovering", described as "got the flu". The patient was hospitalized for pericarditis, influenza (start date: 25Oct2023, discharge date: Oct2023, hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of pericarditis, influenza. Clinical Course: Patient had treatment with pills exact type unknown.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Bell's palsy
Clinical narrative: I came down with Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for influenza immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORETHINDRONE ACETATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: BELL'S PALSY (medically significant) with onset 06Oct2023 at 22:00, outcome "not recovered", described as "I came down with Bell's Palsy". The event "i came down with bell's palsy" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy. Clinical course: A week after receiving the covid vaccine, patient came down with Bell's Palsy. The right side of her face started freezing up late on 06Oct2023, and by the next morning it was completely immobile. Her eye will not blink, and her speaking and eating are affected. Three weeks later, it still had not improved. Patient took Prednisone, valacyclovir treatment. She has COVID prior to vaccination, did not test for COVID post vaccination.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.