chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Ear discomfort, Eye pain, Fatigue
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff) and JOINT SWELLING (Swollen ankles, knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022). January 2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: increased Excessive weight gain despite barely eating.         Concomitant medications were not reported. Patient had reported not been the same since third dose of Moderna vaccination.Patient had to leave her job for months and she was due to go back. The booster dose made patient incredibly ill within a day of receiving it. The symptoms that occurred had lasted for days, weeks , months. She was  a single mother with two children and had to work The events has started back in Jan-2022 and patient was still experiencing those changes/ events. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis, Hypoaesthesia, Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff) and JOINT SWELLING (Swollen ankles, knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022). January 2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: increased Excessive weight gain despite barely eating.         Concomitant medications were not reported. Patient had reported not been the same since third dose of Moderna vaccination.Patient had to leave her job for months and she was due to go back. The booster dose made patient incredibly ill within a day of receiving it. The symptoms that occurred had lasted for days, weeks , months. She was  a single mother with two children and had to work The events has started back in Jan-2022 and patient was still experiencing those changes/ events. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Muscular weakness, Pain, Productive cough, Sleep disorder
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff) and JOINT SWELLING (Swollen ankles, knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022). January 2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: increased Excessive weight gain despite barely eating.         Concomitant medications were not reported. Patient had reported not been the same since third dose of Moderna vaccination.Patient had to leave her job for months and she was due to go back. The booster dose made patient incredibly ill within a day of receiving it. The symptoms that occurred had lasted for days, weeks , months. She was  a single mother with two children and had to work The events has started back in Jan-2022 and patient was still experiencing those changes/ events. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Weight
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff) and JOINT SWELLING (Swollen ankles, knees) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022). January 2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue). At the time of the report, ILLNESS (The booster made me incredibly ill within a day of receiving, Been sick since Jan 2022), FEELING OF BODY TEMPERATURE CHANGE (Severe temp changes/Temp off), DISTURBANCE IN ATTENTION (Concentration), PRODUCTIVE COUGH (Coughing up chunks of white stuff), JOINT SWELLING (Swollen ankles, knees), EYE PAIN (Sore eyes), SLEEP DISORDER (Disrupted sleep), EAR DISCOMFORT (Ear issues), HYPERHIDROSIS (Sweats), MUSCULAR WEAKNESS (Weakness in arms and legs), PAIN (Pain), HYPOAESTHESIA (Loss of feeling in hands and feet), DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in arm at sight), HEADACHE (Headaches) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Weight: increased Excessive weight gain despite barely eating.         Concomitant medications were not reported. Patient had reported not been the same since third dose of Moderna vaccination.Patient had to leave her job for months and she was due to go back. The booster dose made patient incredibly ill within a day of receiving it. The symptoms that occurred had lasted for days, weeks , months. She was  a single mother with two children and had to work The events has started back in Jan-2022 and patient was still experiencing those changes/ events. Treatment information was not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: she is still getting rash patches on her body intermittently; 48 hours later she developed hives on her chest, arms, and legs; This spontaneous case was reported by a nurse and describes the occurrence of RASH (she is still getting rash patches on her body intermittently) and URTICARIA (48 hours later she developed hives on her chest, arms, and legs) in a 37-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 13-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced URTICARIA (48 hours later she developed hives on her chest, arms, and legs). On an unknown date, the patient experienced RASH (she is still getting rash patches on her body intermittently). At the time of the report, RASH (she is still getting rash patches on her body intermittently) and URTICARIA (48 hours later she developed hives on her chest, arms, and legs) was resolving.        mRNA-1273 (Spikevax) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not experience similar event in the past. Patient reported that symptoms improved. Patient did not received the second dose because she developed hives (rash) after receiving first Moderna COVID-19 dose. She reported that she was at the risk of losing her job if she doesn't get the second Moderna primary series dose. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRALGIA (shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder pain). At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.            Concomitant medication was not reported. It was reported that after booster, within 2-3 days patient had shoulder pain and had to go to the orthopedic doctor to get a shot. Treatment medication was not reporter.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Skin test
Clinical narrative: itching of skin; rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching of skin) and RASH (rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRURITUS (itching of skin) and RASH (rash). The patient was treated with TRIAMCINOLONE ACETONIDE in June 2021 at an unspecified dose and frequency and CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) in June 2021 at a dose of Foam. At the time of the report, PRURITUS (itching of skin) and RASH (rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: result not provided Result not provided.         No concomitant medication was reported. One month after completing the primary series of the vaccine, patient had experienced a rash and itching on the skin. Patient went to see a dermatologist in JUN2021 who ran tests and gave the patient 2 medications (triamcinolone Acetonide, clobetasol propionate foam) which did not help.   This case was linked to MOD-2022-588109 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Follow-up  received: Images received
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Insomnia, Positron emission tomogram, Pruritus
Clinical narrative: itching of skin; rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching of skin) and RASH (rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRURITUS (itching of skin) and RASH (rash). The patient was treated with TRIAMCINOLONE ACETONIDE in June 2021 at an unspecified dose and frequency and CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) in June 2021 at a dose of Foam. At the time of the report, PRURITUS (itching of skin) and RASH (rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: result not provided Result not provided.         No concomitant medication was reported. One month after completing the primary series of the vaccine, patient had experienced a rash and itching on the skin. Patient went to see a dermatologist in JUN2021 who ran tests and gave the patient 2 medications (triamcinolone Acetonide, clobetasol propionate foam) which did not help.   This case was linked to MOD-2022-588109 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Follow-up  received: Images received
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Skin test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (skin turned bright red, and itching like the patient wanted to take the skin off), INSOMNIA (patient had only been getting 2-3 hours of sleep each night because of the itching) and ERYTHEMA (skin turned bright red) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (skin turned bright red, and itching like the patient wanted to take the skin off), INSOMNIA (patient had only been getting 2-3 hours of sleep each night because of the itching) and ERYTHEMA (skin turned bright red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency; HYDROXYZINE at an unspecified dose and frequency and CLOZAPINE at an unspecified dose and frequency. At the time of the report, PRURITUS (skin turned bright red, and itching like the patient wanted to take the skin off), INSOMNIA (patient had only been getting 2-3 hours of sleep each night because of the itching) and ERYTHEMA (skin turned bright red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: results not reported Results not reported.         No concomitant medication information was provided.  In Dec-2021, the patient received the booster dose of Moderna vaccine.   The patient had seen multiple (at least eight) healthcare professionals including a hematologist, immunologist for the symptoms. They have performed multiple tests for the patient including a PET (Positron emission tomography) scan to evaluate for cancer. The patient had also been given multiple other medications including Sanotidine and three rounds of steroids. The steroids helped the patient for a period of three to four days but the patient then had rebound of the symptoms when the symptoms would come back worsened. The patient described it as side effect of the COVID vaccine.   This case was linked to MOD-2022-587912 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Live significant follow up contains information about images of occurred events.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Insomnia, Positron emission tomogram, Pruritus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (skin turned bright red, and itching like the patient wanted to take the skin off), INSOMNIA (patient had only been getting 2-3 hours of sleep each night because of the itching) and ERYTHEMA (skin turned bright red) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (skin turned bright red, and itching like the patient wanted to take the skin off), INSOMNIA (patient had only been getting 2-3 hours of sleep each night because of the itching) and ERYTHEMA (skin turned bright red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency; HYDROXYZINE at an unspecified dose and frequency and CLOZAPINE at an unspecified dose and frequency. At the time of the report, PRURITUS (skin turned bright red, and itching like the patient wanted to take the skin off), INSOMNIA (patient had only been getting 2-3 hours of sleep each night because of the itching) and ERYTHEMA (skin turned bright red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: results not reported Results not reported.         No concomitant medication information was provided.  In Dec-2021, the patient received the booster dose of Moderna vaccine.   The patient had seen multiple (at least eight) healthcare professionals including a hematologist, immunologist for the symptoms. They have performed multiple tests for the patient including a PET (Positron emission tomography) scan to evaluate for cancer. The patient had also been given multiple other medications including Sanotidine and three rounds of steroids. The steroids helped the patient for a period of three to four days but the patient then had rebound of the symptoms when the symptoms would come back worsened. The patient described it as side effect of the COVID vaccine.   This case was linked to MOD-2022-587912 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2022: Live significant follow up contains information about images of occurred events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm after her Covid vaccines for a day or so at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm after her Covid vaccines for a day or so at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, Lot number ER8727, 0.3ml in the Right arm) on 27-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, Lot number EW0161, 0.3ml in the left arm) on 17-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (3rd dose, Lot number 32030DB and 0.3ml in the Right arm) on 25-Oct-2021. Past adverse reactions to the above products included Vaccination site pain with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm after her Covid vaccines for a day or so at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm after her Covid vaccines for a day or so at the injection site) had resolved.            No concomitant product reported by reporter.  Patient was administered with Prevnar 20 on 27-May-2022 with lot number FJ2601 0.5ml ml injection in left arm and experienced muscle sore on 27-May-2022 and outcome was recovering. It was the most painful shot she had ever gotten. Patient was not sure if the symptoms she was feeling were from the product or from the way the pharmacist administered it. Patient arm was sore as usual. Patient muscle was so sore that she had to use her other arm to lift her left arm up so she would not engage the muscle.she had a sore arm after her COVID vaccines for a day or so at the injection site. No significant side effects from the COVID vaccines.  No treatment medication reported by reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Prostatic specific antigen
Clinical narrative: Flu-like symptoms including fever and headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms including fever and headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms including fever and headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms including fever and headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Prostatic specific antigen: 3.73 Result: 3.73. On 11-May-2022, Prostatic specific antigen: 4.43 (High) Elevated to 4.43. On 10-Jun-2022, Prostatic specific antigen: 4.64 (High) measured at 4.64.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, the symptoms occurred the same day as the injection, but much later in the day around 8-9 PM. It was stated that these symptoms that had experienced were typical to what he had reading on all the websites.   Additionally, Patient had been going to receive PSA tests for his prostate for the past 10 years and over the past 2-3 years he had been going to receive these tests more often and was scheduled to had this test at the beginning of MAY. Patient had discussed these findings with his urologist who recommended to received an MRI of his prostate and also had been following the research of another urologist online who had been seeing similar trends in patients after vaccination.   Patient had not taken any medications or treatments for any of his symptoms.   This case was linked to MOD-2022-588201, MOD-2022-588203, MOD-2022-588204, MOD-2022-588207 (Patient Link).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: sore left arm; 12 year old child recived a Moderna Covid-19 booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child recived a Moderna Covid-19 booster dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child recived a Moderna Covid-19 booster dose). On 07-May-2022, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old child recived a Moderna Covid-19 booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nodule
Clinical narrative: Small nodule to each side of her face at the marionette lines; This spontaneous case was reported by an other health care professional and describes the occurrence of NODULE (Small nodule to each side of her face at the marionette lines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product HYALURONIC ACID, LIDOCAINE (RESTYLANE L) for an unknown indication.    No Medical History information was reported.   On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient started HYALURONIC ACID, LIDOCAINE (RESTYLANE L) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NODULE (Small nodule to each side of her face at the marionette lines). At the time of the report, NODULE (Small nodule to each side of her face at the marionette lines) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received Restylane Lyft on 13-APR-2021. She received 0.4 mL to each cheek (0.8mL total); 0.4mL to each marionette line (0.8mL total) and 0.4mL to her chin. Total of two syringes of Lyft were given her. Fast forward to this year. Patient would like to get more filler. She mentioned that she experienced a small nodule to each side of her face at the marionette lines, almost immediately from that initial visit, but she did not report it to anyone. Today (10-JUN-2022) one nodule has resolved on its own, and the remaining nodule has shrunk-- it's now the size of a BB.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: All covid vaccinations caused pain with Humira; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All covid vaccinations caused pain with Humira) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (All covid vaccinations caused pain with Humira). At the time of the report, PAIN (All covid vaccinations caused pain with Humira) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication was not reported.   This case was linked to MOD-2022-588180, MOD-2022-588246 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Inappropriate schedule of product administration, Pain
Clinical narrative: All covid vaccinations caused pain with Humira; Low energy; Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All covid vaccinations caused pain with Humira), ASTHENIA (Low energy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid Arthritis).   On 14-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Mar-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period)). On 17-Mar-2022, the patient experienced ASTHENIA (Low energy). On an unknown date, the patient experienced PAIN (All covid vaccinations caused pain with Humira). At the time of the report, PAIN (All covid vaccinations caused pain with Humira) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period)) outcome was unknown and ASTHENIA (Low energy) was resolving. No concomitant medication were reported. No treatment drug were reported. This case was linked to MOD-2022-588245, MOD-2022-588180 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3248), in right arm, on 24Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 12Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ADVAIR (also reported as ADVAIR 250/50) resp inhalation, start date: Jan2020; KETOTIFEN oral, start date: Aug2021; ESTRADIOL oral, start date: Jan2018; MONTELUKAST oral, start date: Jan2018; METFORMIN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 treatment included PAXLOVID treatment (Lot number: GA1188) start date on 02Jun2022 via oral. Group provided investigational results on 06Jun2022 and 07Jun2022 for bnt162b2: The complaint for lack of effect of the Pfizer biotech COVID-19 vaccine INJECTABLE lot FL3197, lot EN6200 and lot EL3248 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FL3197, fill lot FJ8803, and the formulated drug product lot FL3180; lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321; lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned and photographs were not received. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause  were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Palpitations
Clinical narrative: had heart palpitations with a fast heart beat; had heart palpitations with a fast heart beat; she doesn't feel good constantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 13-year-old female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 1, single (Lot number: FG4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), HEART RATE INCREASED (non-serious), outcome "unknown" and all described as "had heart palpitations with a fast heart beat"; MALAISE (non-serious), outcome "unknown", described as "she doesn't feel good constantly".  Additional information: Caller is a grandmother, calling on behalf of her granddaughter. Caller reports her granddaughter received her first dose of the Pfizer covid 19 vaccine on 02Jun2022. Caller says her granddaughter has had heart palpitations with a fast heart beat that comes and goes since yesterday evening. The caller provided LOT FG4991. Caller declined transfer as she wants to prioritize medical care for patient at this time. Encouraged caller to contact granddaughter's primary doctor and if she were highly concerned could take the patient to the nearest emergency medical treatment center. Reporter stated, I am calling regarding my grand daughter. She got the COVID shot yesterday, the Pfizer and since she has got it, she feels like really fast palpitations and then it goes down and then she feels it again and she doesn't feel good constantly since yesterday.   Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: vaccination failure; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4420185-00.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), on 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 03May2022, outcome "recovered" (2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "unknown", described as "vaccination failure". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "vaccination failure" and "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 virus test positive; Vaccination failure; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4419968-00.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis, psoriasis, crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 02Jun2022, outcome "unknown", described as "COVID-19 virus test positive"; VACCINATION FAILURE (medically significant) with onset 02Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in COVID-19 Vaccine trial.  The reporter's assessment of the causal relationship of "covid-19 virus test positive" and "vaccination failure" with the suspect product(s) BNT162b2 was possibly related.  Causality for Humira (Adalimumab). The reporter's causality for the event(s) of tested positive for Covid with Humira (Adalimumab) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aching all over; Running a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injecion), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1 and 2), for covid 19 immunization; Covid-19 vaccine (Dose 3 (booster), MANUFACTURER UNKNOWN), for covid 19 immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Aching all over"; PYREXIA (non-serious), outcome "unknown", described as "Running a fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient and his wife had their second booster shot and the patient was aching all over and running a fever. The reporter asked on how long she should worry about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID infection; positive test with NO symptoms; Breakthrough COVID infection; positive test with NO symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "recovered" and all described as "Breakthrough COVID infection; positive test with NO symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid test, positive test with NO Symptoms; Negative, notes: The PCR test was negative.  Clinical course: Breakthrough COVID infection in fully vaccinated patient; positive test with NO symptoms. Patient's mother thinks the rapid test may have produced a false positive and was taking him to get a PCR test this morning (07Jun2022). The PCR test was negative, so patient's mother suspects the original rapid was a false positive. Event took place after use of the product.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 12May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history was not reported. Concomitant medication(s) included: amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) 15 mg, start date: 16May2022, stop date: 21May2022; FLUOXETINE 20 mg, start date: 16May2022, stop date: 21May2022. Patient had no known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The patient underwent the following laboratory tests and procedures: COVID-19 test: (unspecified date) negative, notes: I was diagnosed with covid and prescribed Paxlovid and took the entire course. On the last day of the course, I tested negative; (03Jun2022) positive, notes: Eighteen days later, on 03Jun, I tested positive. On the last day of the course, I tested negative. Eighteen days later, on June 3, I tested positive. I developed symptoms on June 5 and continue to test positive; (05Jun2022) Positive, notes: days later, on June 3, I tested positive. I developed symptoms on 05Jun and continue to test positive. Therapeutic measures were taken as a result of covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.