chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Chills; Body aches; achiness; Fatigue; my back is hurting me so bad; I cannot stand straight, I cannot bend. I am only laying in the bed; Joint pain; Soreness in arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "surgery in my back", start date: Dec2020, stop date: Dec2020, notes: I had surgery in my back about in Dec2020. Concomitant medication(s) included: AZO. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches; achiness"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "my back is hurting me so bad"; DYSSTASIA (non-serious), outcome "unknown", described as "I cannot stand straight, I cannot bend. I am only laying in the bed"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm where the injection was".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Injection site mass, Musculoskeletal pain, Pain in extremity
Clinical narrative: Chills; Body aches; achiness; Fatigue; my back is hurting me so bad; I cannot stand straight, I cannot bend. I am only laying in the bed; Joint pain; Soreness in arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "surgery in my back", start date: Dec2020, stop date: Dec2020, notes: I had surgery in my back about in Dec2020. Concomitant medication(s) included: AZO. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches; achiness"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "my back is hurting me so bad"; DYSSTASIA (non-serious), outcome "unknown", described as "I cannot stand straight, I cannot bend. I am only laying in the bed"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm where the injection was".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Sitting disability
Clinical narrative: Chills; Body aches; achiness; Fatigue; my back is hurting me so bad; I cannot stand straight, I cannot bend. I am only laying in the bed; Joint pain; Soreness in arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "surgery in my back", start date: Dec2020, stop date: Dec2020, notes: I had surgery in my back about in Dec2020. Concomitant medication(s) included: AZO. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches; achiness"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "my back is hurting me so bad"; DYSSTASIA (non-serious), outcome "unknown", described as "I cannot stand straight, I cannot bend. I am only laying in the bed"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm where the injection was".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Dysstasia, Fatigue
Clinical narrative: Chills; Body aches; achiness; Fatigue; my back is hurting me so bad; I cannot stand straight, I cannot bend. I am only laying in the bed; Joint pain; Soreness in arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "surgery in my back", start date: Dec2020, stop date: Dec2020, notes: I had surgery in my back about in Dec2020. Concomitant medication(s) included: AZO. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches; achiness"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "my back is hurting me so bad"; DYSSTASIA (non-serious), outcome "unknown", described as "I cannot stand straight, I cannot bend. I am only laying in the bed"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm where the injection was".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Chills; Body aches; achiness; Fatigue; my back is hurting me so bad; I cannot stand straight, I cannot bend. I am only laying in the bed; Joint pain; Soreness in arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "surgery in my back", start date: Dec2020, stop date: Dec2020, notes: I had surgery in my back about in Dec2020. Concomitant medication(s) included: AZO. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches; achiness"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "my back is hurting me so bad"; DYSSTASIA (non-serious), outcome "unknown", described as "I cannot stand straight, I cannot bend. I am only laying in the bed"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in arm where the injection was".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer, Inc) concerned a 51 year old female. Initial information was processed along with the additional information received on 17-MAY-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (unspecified), and other pre-existing medical conditions included: The patient had not taking any other medications/products within 2 weeks of starting of COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 50 years old.  The patient additionally received non-company suspect vaccine Moderna (elasomeran), (Dose number in series 2), (batch number: 065F21A, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 18-NOV-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-MAY-2022, the patient tested positive for covid-19 and experienced confirmed covid-19 infection (Dose number in series 2) and had confirmed clinical vaccination failure (Dose number in series 1). Patient took Paxlovid the day after she tested positive for covid-19, and took 4 doses over 2 days. She felt better immediately and discontinued because her mouth tasted like dirty metal. She then tested negative over the following five days on 12-MAY-2022 and felt fine. Suddenly on day 6 on 13-MAY-2022, after stopping Paxlovid, she felt ill with congestion and was feeling very tired, and tested positive within seconds of taking two home tests. The action taken with covid-19 vaccine ad26.cov2.s, and Moderna (elasomeran) was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000231591.; Sender's Comments: V0: 20220532773 -Covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer, Inc) concerned a 51 year old female. Initial information was processed along with the additional information received on 17-MAY-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (unspecified), and other pre-existing medical conditions included: The patient had not taking any other medications/products within 2 weeks of starting of COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 50 years old.  The patient additionally received non-company suspect vaccine Moderna (elasomeran), (Dose number in series 2), (batch number: 065F21A, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 18-NOV-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-MAY-2022, the patient tested positive for covid-19 and experienced confirmed covid-19 infection (Dose number in series 2) and had confirmed clinical vaccination failure (Dose number in series 1). Patient took Paxlovid the day after she tested positive for covid-19, and took 4 doses over 2 days. She felt better immediately and discontinued because her mouth tasted like dirty metal. She then tested negative over the following five days on 12-MAY-2022 and felt fine. Suddenly on day 6 on 13-MAY-2022, after stopping Paxlovid, she felt ill with congestion and was feeling very tired, and tested positive within seconds of taking two home tests. The action taken with covid-19 vaccine ad26.cov2.s, and Moderna (elasomeran) was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000231591.; Sender's Comments: V0: 20220532773 -Covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain in site of injection; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004S21A, 023MCOA and 041LCOA) for COVID-19 vaccination.     Patient had no COVID positive test or diagnosis.  The patient's past medical history included Palpitations (Patient had heart palpitations before due to her thyroid problems). Concurrent medical conditions included Penicillin allergy, Food allergy (Allergy to spicy food) and Thyroid disorder (Patient had heart palpitations before due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYUREA and VITAMIN D [VITAMIN D NOS] 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 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache). At the time of the report, VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) outcome was unknown.  Patient was also given calcium supplement. Treatment information was not provided. This case was linked to MOD-2022-569007, MOD-2022-569005, MOD-2022-569004 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Pain in site of injection; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004S21A, 023MCOA and 041LCOA) for COVID-19 vaccination.     Patient had no COVID positive test or diagnosis.  The patient's past medical history included Palpitations (Patient had heart palpitations before due to her thyroid problems). Concurrent medical conditions included Penicillin allergy, Food allergy (Allergy to spicy food) and Thyroid disorder (Patient had heart palpitations before due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYUREA and VITAMIN D [VITAMIN D NOS] 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 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache). At the time of the report, VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) outcome was unknown.  Patient was also given calcium supplement. Treatment information was not provided. This case was linked to MOD-2022-569007, MOD-2022-569005, MOD-2022-569004 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cardiac stress test, Decreased appetite, Electrocardiogram, Extrasystoles
Clinical narrative: Pain in site of injection; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004S21A, 023MCOA and 041LCOA) for COVID-19 vaccination.     Patient had no COVID positive test or diagnosis.  The patient's past medical history included Palpitations (Patient had heart palpitations before due to her thyroid problems). Concurrent medical conditions included Penicillin allergy, Food allergy (Allergy to spicy food) and Thyroid disorder (Patient had heart palpitations before due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYUREA and VITAMIN D [VITAMIN D NOS] 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 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache). At the time of the report, VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) outcome was unknown.  Patient was also given calcium supplement. Treatment information was not provided. This case was linked to MOD-2022-569007, MOD-2022-569005, MOD-2022-569004 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling of body temperature change, Influenza like illness, Myocardial necrosis marker
Clinical narrative: Pain in site of injection; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004S21A, 023MCOA and 041LCOA) for COVID-19 vaccination.     Patient had no COVID positive test or diagnosis.  The patient's past medical history included Palpitations (Patient had heart palpitations before due to her thyroid problems). Concurrent medical conditions included Penicillin allergy, Food allergy (Allergy to spicy food) and Thyroid disorder (Patient had heart palpitations before due to her thyroid problems). Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYUREA and VITAMIN D [VITAMIN D NOS] 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 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache). At the time of the report, VACCINATION SITE PAIN (Pain in site of injection) and MYALGIA (body ache) outcome was unknown.  Patient was also given calcium supplement. Treatment information was not provided. This case was linked to MOD-2022-569007, MOD-2022-569005, MOD-2022-569004 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and contains no new information.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: she had a delayed reaction; slight sore throat; Slightly congested nose; she was tired; Had a slight Fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she had a delayed reaction), OROPHARYNGEAL PAIN (slight sore throat), NASAL CONGESTION (Slightly congested nose), FATIGUE (she was tired) and PYREXIA (Had a slight Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 071F21A, 008B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), NASAL CONGESTION (Slightly congested nose), FATIGUE (she was tired) and PYREXIA (Had a slight Fever). On an unknown date, the patient experienced IMMUNISATION REACTION (she had a delayed reaction). On 02-May-2022, OROPHARYNGEAL PAIN (slight sore throat), NASAL CONGESTION (Slightly congested nose), FATIGUE (she was tired) and PYREXIA (Had a slight Fever) had resolved. At the time of the report, IMMUNISATION REACTION (she had a delayed reaction) outcome was unknown.            No concomitant medication was reported. After the 2nd booster, the patient had a delayed reaction.  Four days after the 2nd booster, the patient was tired, had a slight Fever, slight sore throat and Slightly congested nose for 1 day. No treatment medication was reported.   This case was linked to MOD-2022-569365, MOD-2021-225686, MOD-2022-569417 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: she had a delayed reaction; slight sore throat; Slightly congested nose; she was tired; Had a slight Fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she had a delayed reaction), OROPHARYNGEAL PAIN (slight sore throat), NASAL CONGESTION (Slightly congested nose), FATIGUE (she was tired) and PYREXIA (Had a slight Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 071F21A, 008B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), NASAL CONGESTION (Slightly congested nose), FATIGUE (she was tired) and PYREXIA (Had a slight Fever). On an unknown date, the patient experienced IMMUNISATION REACTION (she had a delayed reaction). On 02-May-2022, OROPHARYNGEAL PAIN (slight sore throat), NASAL CONGESTION (Slightly congested nose), FATIGUE (she was tired) and PYREXIA (Had a slight Fever) had resolved. At the time of the report, IMMUNISATION REACTION (she had a delayed reaction) outcome was unknown.            No concomitant medication was reported. After the 2nd booster, the patient had a delayed reaction.  Four days after the 2nd booster, the patient was tired, had a slight Fever, slight sore throat and Slightly congested nose for 1 day. No treatment medication was reported.   This case was linked to MOD-2022-569365, MOD-2021-225686, MOD-2022-569417 (Patient Link).   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Menstrual disorder, SARS-CoV-2 test positive
Clinical narrative: Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FF2593) and on 17Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "recovering" and all described as "Test: Nasal Swab Result: Positive". The event "test: nasal swab result: positive" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19 included corticosteroid injections and oral medications. Patient had eczema around her eyes and a period that lasted two weeks and then no evident menstrual cycles 2 months after.  Additional information: The patient did not receive any other vaccine in four weeks. Patient did not receive any other medication in two weeks of vaccination. No Covid was diagnosed prior to Covid vaccination. At Pharmacy or Drug Store patient administered the most recent COVID-19 vaccine. Covid tested positive post vaccination via Nasal Swab test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.The case will be reevaluated should additional information become available.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test: Nasal Swab Result: Positive; Test: Nasal Swab Result: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FF2593) and on 17Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Nov2021, outcome "recovering" and all described as "Test: Nasal Swab Result: Positive". The event "test: nasal swab result: positive" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19 included corticosteroid injections and oral medications. Patient had eczema around her eyes and a period that lasted two weeks and then no evident menstrual cycles 2 months after.  Additional information: The patient did not receive any other vaccine in four weeks. Patient did not receive any other medication in two weeks of vaccination. No Covid was diagnosed prior to Covid vaccination. At Pharmacy or Drug Store patient administered the most recent COVID-19 vaccine. Covid tested positive post vaccination via Nasal Swab test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.The case will be reevaluated should additional information become available.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: No adverse event. Patient was given 1 dose of undiluted pediatric Pfizer instead of adult. Checked with  Pfizer manufacturer to ensure patient safety
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: No adverse event. Patient was given 1 dose of undiluted pediatric Pfizer instead of adult. Checked with  Pfizer manufacturer to ensure patient safety
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Rash, Urticaria
Clinical narrative: severe generalized itching, urticaria, rash, dermographism on bilat lower extremities, scalp, palms,neck bilat, forearms  Rx - prednisone , benadryl, famotidine
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient states noticed a bump developed at injection site which was red . He believed I gave this injection Subcutaneously rather than IM.  I am very sure I gave IM  with right technique. other than that he did not mention any other adverse event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears, more like hissing
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Incorrect administration of an immunization authorized as a booster for patients over 18. Patient is 16 yrs old. The day after he is experiencing low grade fever.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Incorrect dose administered, No adverse event
Clinical narrative: Patient received 0.5ml of Moderna Booster instead of 0.25ml. Patient did  not have any adverse reaction to vaccination.  Patient is G1 P0 and is 16wks. EDD 07NOV2022
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error. The patient is 12 yrs old and received moderna mRNA vaccine as a booster. He is experiencing fatigue and some chills.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: booster volume indicated 0.25 ml, volume administered 0.5 ml
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received 0.5ml of Moderna for booster instead of 0.25ml. Patient w/o any adverse symptoms on date of vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dosing for Moderna mRNA booster. 0.5 ml was given instead of 0.25 ml. She has no adverse effect to report as of the day after.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: this patient received an incorrect booster dose.  0.5 mL were administered when the booster dose for Moderna is 0.25 mL.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received 0.5ml of Moderna for booster instead of 0.25ml. No adverse reactions noted on date of administration
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received 0.5ml of Moderna for booster instead of 0.25ml. No adverse reaction on date of administration
Age: 40.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: No adverse side effects reported; The PROQUAD expired on 4/11/2022 and was administered today, 4/19/2022; It was also reported that ther PROQUAD was administered intramuscularly instead of subcutaneosuly; This spontaneous report was received from a licensed practical nurse and refers to a 40-year-old female patient. The patient's concurrent conditions and medical history were not provided.   On 19-APR-2022, the patient was vaccinated with 1 dose of an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD), lot # T034828, expiration date 11-APR-2022, 0.5 ml administered intramuscularly instead of subcutaneously (exact dose number and anatomical location were not provided) for prophylaxis (expired product administered, incorrect route of product administration). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) was reconstituted with an sterile diluent (MERCK STERILE DILUENT), lot # U005104, expiration date 01-JUL-2023. It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) and sterile diluent (MERCK STERILE DILUENT) have had no temperature excursions. No adverse side effects were reported (no adverse event).
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a 13-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live recombinant human albumin (rha) (M-M-R II).   On 18-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliters (ml), administered subcutaneously (SQ) (lot number U024220 has been verified to be valid, expiration date reported and established as 04-AUG-2023; formulation, strength, and anatomical location were not provided) for prophylaxis.  The administered dose of the suspect vaccine experienced a temperature excursion of 41 degrees Fahrenheit (°F) for 8 hours, 20 minutes, and 0 seconds (product storage error). There was no previous temperature excursion. No additional adverse events (AE) were reported (no adverse event).
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: she recently gave a 3rd dose of ROTATEQ to a 9 month old; This spontaneous report was received from a nurse practitioner (discrepant information, also reported as physician) and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as recently), the patient was vaccinated with a third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral (dose, frequency, strength, lot #, and expiry date were not provided) administered for prophylaxis (product administered to patient of inappropriate age). The reporter stated she did not realize that the vaccine should not to be given after 32 weeks of age per prescribing Information (PI).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007064:
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse event reported; Caller reports administering pediatric dose of RECOMBIVAX HB to an adult; This spontaneous report has been received from a licensed practitioner nurse, regarding a patient of unknow age and gender (reported as adult). The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 20-APR-2022, the patient received a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 milliliters intramuscularly as prophylaxis (lot number T032918, which was determined to be a valid lot number for a vial formulation, expiration date: 12-NOV-2022) (anatomical location not reported) (Incorrect dose administered). No additional adverse event was reported.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; expired doses of PROQUAD were administered to 3 different patients; This spontaneous report was received from a registered nurse and refers to 3 patients of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that expired doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered to 3 different patients on 16-APR-2022, 18-APR-2022, and 20-APR-2022, with expiration date of 14-APR-2022 (strength, dose, route of administration, frequency, indication and lot/batch # were not reported).  Product had never experienced temperature excursion and had supported outcome.  No adverse event reported.   Follow-up information has been received from a registered nurse on 02-MAY-2022.  The nurse reported that the patient was a 4 years old female patient.  On 20-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously on left arm, for prophylaxis (strength, lot number and expiration date were not provided) and with diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) in the left deltoid, lot number E2L54, expiration date 03-MAR-2023 (strength, route of administration and indication were not provided).; Sender's Comments:  US-009507513-2205USA000842:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Customer reported that an expired ROTATEQ was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 59-day-old male patient. Information regarding his concurrent conditions, concomitant therapies and medical history was not provided.  On 14-APR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, lot # 1707502, expiration date 31-MAR-2022 for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; patient received an expired VAQTA; This spontaneous report was received from a licensed practical nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 05-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter once, lot #T037788, expiration date: 30-APR-2022 (strength, anatomical location and route of administration were not provided) for prophylaxis (Expired product administered). No additional adverse events were reported (No adverse event).
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of GARDASIL 9 past the 12 month recommendation in the PI.; No additional AE information available.; This spontaneous report was received from nurse prescriber and refers to an adolescent patient (exact age not reported) of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2021, at the age of 11-year-old, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #T007024, expiration date: 23-APR-2022 (dose, route of administration and exact location were not provided) for prophylaxis.  The patient missed his 6 month follow-up. Next visit to receive a second dose was scheduled on 10-MAY-2022.This would be 1 year and 6 days from his first dose (Inappropriate schedule of product administration). No additional adverse event information (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD being administered after an excursion that occurred on 4/25/2022; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 27-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #U029319, expiration date: 19-MAR-2023 (anatomical location and route of administration were not provided) for prophylaxis, after the vaccine undergone temperature excursion in -2 Celsius degrees (C) for 1 hour and 12 minutes on 25-APR-2022 (Product storage error). Previous temperature excursions were as follows: -10 C up to 8 C (7.3C) for 2 hours 37 minutes 0 seconds, and -10 C up to 8 C (0.7C) for 2 hours 56 minutes 0 seconds.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: She developed a rash on the evening of 5/11/2022; This spontaneous report as received from a nurse practicioner (also reported as nurse prescriber) and refers to a 24-year-old female patient. Concomitant medications included oral contraceptive pills. No information regarding the patient's concurrent conditions and medical history was provided.  On 11-MAY-2022, the patient was vaccinated intramuscularly with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # U008316, expiration date repored as 14-AUG-2023, but upon internal validation established as 15-AUG-2023 (dose and anatomical location were not reported), for prevention of human papilloma virus infection.   On the evening of the same day, the patient developed a rash, requiring the patient to go to the emergency department where she received intravenous diphenhydramine. The rash improved and the patient was discharged from the emergency department on the same day. The outcome of the event was reported as recovered. Suspect therapy was not discontinued.  The relatedness between the rash and HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Customer calling to report that an adult patient was administered a pediatric dose of VAQTA.; This spontaneous report has been received from a nurse concerning an adult patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 16-MAY-2022, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (lot number U031911 and expiration date 11-NOV-2022, was verified to be a valid lot number) (strength, dose, frequency, anatomical injection site, were not provided) for prophylaxis (incorrect dose administered). No other issues or concerns were noted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular, Visual impairment
Clinical narrative: postherpetic neuralgia; vision issues; multiple outbreaks of herpes zoster; This spontaneous report was received on 16-MAY-2022 from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, blistering rash, pain and vision issues. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not resolved. The lawyer determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling by a reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered a expired dose of MMRII; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-APR-2022, the patient was vaccinate with an expired dose of measles (+) mumps and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot #T012807 with an expiration date on 14-APR-2022) administered for prophylaxis (strength,  dose, and route of administration were not provided) (expired product administered).  No other issues or concerns were noted.   .