chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Back pain, Blood pressure increased, Blood pressure measurement, Cardiac disorder
Clinical narrative: felt a sharp stabbing pain in my heart that lasted seconds; shooting pains through my jaw and left arm and a few more stabbing pains in my heart; had slightly elevated blood pressure of 146/81; pulse of 94; fatigue; felt a slight pressure on my heart/chest tightness; heart was being squeezed; chest pain; slight throat tightness; upper back pain/It hurt more when lying down or bending forward; upper back tightness; shooting pains through my jaw and left arm and a few more stabbing pains in my heart; This is a spontaneous report from a contactable consumer. A 39-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right at the age of 39 years old on 22Sep2021 15:15 (Batch/Lot Number: FF2588) as dose 1, single for covid-19 immunisation. The patient had no medical history. Concomitant medications included buspirone (BUSPIRONE); bupropion (BUPROPION); finasteride (FINASTERIDE). On 23Sep2021, 24 hours after the vaccine, the patient felt a sharp stabbing pain in his heart that lasted seconds. Over the next 24 hours, the patient felt 7 to 8 more stabbing pains in his heart. Over the next few days in Sep2021, he felt a slight pressure on his heart, but it was not painful. On the sixth day the pressure built to be very painful. It felt like his heart was being squeezed. He had chest pain, chest tightness, slight throat tightness, heart pain, upper back pain, upper back tightness and shooting pains through my jaw and left arm and a few more stabbing pains in his heart. It hurt more when lying down or bending forward. He went to the Urgent Care on day 7 to have his vitals checked. The patient had slightly elevated blood pressure of 146/81 and pulse of 94. He has scheduled an appointment with a cardiologist. No treatment was received. The patient had a slight pain in his upper left chest still and fatigue. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Heart rate, Muscle tightness
Clinical narrative: felt a sharp stabbing pain in my heart that lasted seconds; shooting pains through my jaw and left arm and a few more stabbing pains in my heart; had slightly elevated blood pressure of 146/81; pulse of 94; fatigue; felt a slight pressure on my heart/chest tightness; heart was being squeezed; chest pain; slight throat tightness; upper back pain/It hurt more when lying down or bending forward; upper back tightness; shooting pains through my jaw and left arm and a few more stabbing pains in my heart; This is a spontaneous report from a contactable consumer. A 39-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right at the age of 39 years old on 22Sep2021 15:15 (Batch/Lot Number: FF2588) as dose 1, single for covid-19 immunisation. The patient had no medical history. Concomitant medications included buspirone (BUSPIRONE); bupropion (BUPROPION); finasteride (FINASTERIDE). On 23Sep2021, 24 hours after the vaccine, the patient felt a sharp stabbing pain in his heart that lasted seconds. Over the next 24 hours, the patient felt 7 to 8 more stabbing pains in his heart. Over the next few days in Sep2021, he felt a slight pressure on his heart, but it was not painful. On the sixth day the pressure built to be very painful. It felt like his heart was being squeezed. He had chest pain, chest tightness, slight throat tightness, heart pain, upper back pain, upper back tightness and shooting pains through my jaw and left arm and a few more stabbing pains in his heart. It hurt more when lying down or bending forward. He went to the Urgent Care on day 7 to have his vitals checked. The patient had slightly elevated blood pressure of 146/81 and pulse of 94. He has scheduled an appointment with a cardiologist. No treatment was received. The patient had a slight pain in his upper left chest still and fatigue. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw, Pulse abnormal, Throat tightness
Clinical narrative: felt a sharp stabbing pain in my heart that lasted seconds; shooting pains through my jaw and left arm and a few more stabbing pains in my heart; had slightly elevated blood pressure of 146/81; pulse of 94; fatigue; felt a slight pressure on my heart/chest tightness; heart was being squeezed; chest pain; slight throat tightness; upper back pain/It hurt more when lying down or bending forward; upper back tightness; shooting pains through my jaw and left arm and a few more stabbing pains in my heart; This is a spontaneous report from a contactable consumer. A 39-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right at the age of 39 years old on 22Sep2021 15:15 (Batch/Lot Number: FF2588) as dose 1, single for covid-19 immunisation. The patient had no medical history. Concomitant medications included buspirone (BUSPIRONE); bupropion (BUPROPION); finasteride (FINASTERIDE). On 23Sep2021, 24 hours after the vaccine, the patient felt a sharp stabbing pain in his heart that lasted seconds. Over the next 24 hours, the patient felt 7 to 8 more stabbing pains in his heart. Over the next few days in Sep2021, he felt a slight pressure on his heart, but it was not painful. On the sixth day the pressure built to be very painful. It felt like his heart was being squeezed. He had chest pain, chest tightness, slight throat tightness, heart pain, upper back pain, upper back tightness and shooting pains through my jaw and left arm and a few more stabbing pains in his heart. It hurt more when lying down or bending forward. He went to the Urgent Care on day 7 to have his vitals checked. The patient had slightly elevated blood pressure of 146/81 and pulse of 94. He has scheduled an appointment with a cardiologist. No treatment was received. The patient had a slight pain in his upper left chest still and fatigue. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Swelling face, X-ray
Clinical narrative: sore arm; swollen cheeks and swollen neck/puffy face; swollen cheeks and swollen neck; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 05Mar2021 09:15 (age at vaccination 72 years and non-pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant or within 2 weeks of vaccination the patient received medication was diltiazim 360mg. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EM9801) via an unspecified route of administration, administered in arm left on 12Feb2021 11:30 AM (age at vaccination 72 years) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. Since the vaccination, patient has not been tested for COVID-19. Prior to vaccination, patient was not diagnosed with COVID-19. On 10Mar2021 13:00 The patient had event reported as swollen cheeks and swollen neck/puffy face and sore arm. Patient stated a few day after the second shot, her face was swollen and she looks like she has chipmunk cheeks and normally she had a thin face. She stated that she didn't think anything about it, until they went to her daughter's and the daughter said to her father what was wrong with mom's face and under her neck was all swollen. States she thinks it had to do with the covid vaccine. Patient stated that she went to her dentist about the swelling and he did x-rays and said there was no abscess and he can't see anything. She states that she doesn't look like herself, she looks like different person. Adverse event results in doctor or other healthcare professional office/clinic visit. Patient asking for recommendations and wants to know how long it will last. Patient did not receive treatment for the adverse events. The outcome of events swollen cheeks and swollen neck, puffy face was reported as not recovered. The outcome of event sore arm was reported as unknown.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330223 Pfizer
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Swelling, Swelling face, X-ray
Clinical narrative: sore arm; swollen cheeks and swollen neck/puffy face; swollen cheeks and swollen neck; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 05Mar2021 09:15 (age at vaccination 72 years and non-pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant or within 2 weeks of vaccination the patient received medication was diltiazim 360mg. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EM9801) via an unspecified route of administration, administered in arm left on 12Feb2021 11:30 AM (age at vaccination 72 years) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. Since the vaccination, patient has not been tested for COVID-19. Prior to vaccination, patient was not diagnosed with COVID-19. On 10Mar2021 13:00 The patient had event reported as swollen cheeks and swollen neck/puffy face and sore arm. Patient stated a few day after the second shot, her face was swollen and she looks like she has chipmunk cheeks and normally she had a thin face. She stated that she didn't think anything about it, until they went to her daughter's and the daughter said to her father what was wrong with mom's face and under her neck was all swollen. States she thinks it had to do with the covid vaccine. Patient stated that she went to her dentist about the swelling and he did x-rays and said there was no abscess and he can't see anything. She states that she doesn't look like herself, she looks like different person. Adverse event results in doctor or other healthcare professional office/clinic visit. Patient asking for recommendations and wants to know how long it will last. Patient did not receive treatment for the adverse events. The outcome of events swollen cheeks and swollen neck, puffy face was reported as not recovered. The outcome of event sore arm was reported as unknown.  No follow-up attempts are needed. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330223 Pfizer
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: developed hives on her palm and at the bottom of her feet; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Mar2021, the patient developed hives on her palm and at the bottom of her feet. The patient was asking if she should get the second dose given her reaction to the first. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: developed hives on her palm and at the bottom of her feet; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Mar2021, the patient developed hives on her palm and at the bottom of her feet. The patient was asking if she should get the second dose given her reaction to the first. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: developed hives on her palm and at the bottom of her feet; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Mar2021, the patient developed hives on her palm and at the bottom of her feet. The patient was asking if she should get the second dose given her reaction to the first. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Musculoskeletal stiffness, Myalgia
Clinical narrative: muscle and joint pain that has been ongoing ever since; muscle and joint pain that has been ongoing ever since; This is a spontaneous report from a contactable consumer (patient).   A 66-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date a week later, the patient experienced muscle and joint pain that has been ongoing ever since, stating that "it has been a month of pain" (as reported). The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, X-ray
Clinical narrative: muscle and joint pain that has been ongoing ever since; muscle and joint pain that has been ongoing ever since; This is a spontaneous report from a contactable consumer (patient).   A 66-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date a week later, the patient experienced muscle and joint pain that has been ongoing ever since, stating that "it has been a month of pain" (as reported). The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle and joint pain that has been ongoing ever since; muscle and joint pain that has been ongoing ever since; This is a spontaneous report from a contactable consumer (patient).   A 66-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date a week later, the patient experienced muscle and joint pain that has been ongoing ever since, stating that "it has been a month of pain" (as reported). The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lip swelling, Palpitations
Clinical narrative: swollen lips; fatigued; heart racing; This is a spontaneous report from a contactable consumer (patient), received from Pfizer Sponsored Patient Support Program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date, the patient had a reaction to the vaccine. It had been 10 days since patient had received vaccine and experienced still had swollen lips, fatigued, heart racing and more. The outcome of the events was not recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 21-SEP-2021) .5 ml, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006371, 20211006668, 20211006798, 20211009632, 20211009653, 20211018630, 20211018742, 20211018746, 20211018754, 20211018761, 20211018789, 20211019260, 20211019478 and 20211022904.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 21-SEP-2021) .5 ml, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006371, 20211006668, 20211006798, 20211009632, 20211009653, 20211018630, 20211018742, 20211018746, 20211018754, 20211018761, 20211018789, 20211019260, 20211019478 and 20211022904.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Discomfort
Clinical narrative: injection site pain; tiredness; chills; fever; nausea; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2021, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, chills, fever, nausea, diarrhea and headache. On 10th October 2021, the outcome of the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine in the left arm and on the same day, approximately 6 hours later experienced pain at the injection site, tiredness, chills, fever, nausea, diarrhea, and headache. All the above listed symptoms were resolved completely in 4 days. No other details of symptoms had given. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: injection site pain; tiredness; chills; fever; nausea; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2021, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, chills, fever, nausea, diarrhea and headache. On 10th October 2021, the outcome of the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine in the left arm and on the same day, approximately 6 hours later experienced pain at the injection site, tiredness, chills, fever, nausea, diarrhea, and headache. All the above listed symptoms were resolved completely in 4 days. No other details of symptoms had given. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Irritability, Nausea, Pyrexia, Sleep disorder
Clinical narrative: injection site pain; tiredness; chills; fever; nausea; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2021, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, chills, fever, nausea, diarrhea and headache. On 10th October 2021, the outcome of the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine in the left arm and on the same day, approximately 6 hours later experienced pain at the injection site, tiredness, chills, fever, nausea, diarrhea, and headache. All the above listed symptoms were resolved completely in 4 days. No other details of symptoms had given. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling cold, Headache, Injection site pain
Clinical narrative: injection site pain; tiredness; chills; fever; nausea; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2021, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, chills, fever, nausea, diarrhea and headache. On 10th October 2021, the outcome of the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine in the left arm and on the same day, approximately 6 hours later experienced pain at the injection site, tiredness, chills, fever, nausea, diarrhea, and headache. All the above listed symptoms were resolved completely in 4 days. No other details of symptoms had given. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: injection site pain; tiredness; chills; fever; nausea; diarrhea; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2021, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, chills, fever, nausea, diarrhea and headache. On 10th October 2021, the outcome of the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, chills, fever, nausea, diarrhea and headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine in the left arm and on the same day, approximately 6 hours later experienced pain at the injection site, tiredness, chills, fever, nausea, diarrhea, and headache. All the above listed symptoms were resolved completely in 4 days. No other details of symptoms had given. The reporter did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES EVERYWHERE ON ARMS, LEGS AND TORSO; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, alcohol consumer, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage, no medical history, experienced hives allergy when received penicillin and experienced hallucination as allergy when received codeine. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-OCT-2021, the patient experienced hives everywhere on arms, legs and torso. On 11-OCT-2021, treatment medications included: acrivastine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives everywhere on arms, legs and torso was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: HIVES EVERYWHERE ON ARMS, LEGS AND TORSO; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, alcohol consumer, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage, no medical history, experienced hives allergy when received penicillin and experienced hallucination as allergy when received codeine. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-OCT-2021, the patient experienced hives everywhere on arms, legs and torso. On 11-OCT-2021, treatment medications included: acrivastine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives everywhere on arms, legs and torso was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 17 YEAR OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-OCT-2021, the patient experienced vaccine administered to a 17 year old. On 13-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 17 year old and off label use was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 17 YEAR OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-OCT-2021, the patient experienced vaccine administered to a 17 year old. On 13-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 17 year old and off label use was not reported. This report was non-serious.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Fatigue, Headache, Muscle spasms, Pain in extremity
Clinical narrative: Covid19 Moderna given to a 13 year old. No known adverse event, but she should not have received this vaccine due to her age
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Covid19 Moderna given to a 13 year old. No known adverse event, but she should not have received this vaccine due to her age
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest discomfort, Chills, Dyspnoea, Fatigue
Clinical narrative: NAUSEA; VOMITING; BODY ACHE; REALLY BAD FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. The patient had no drug abuse or illicit drug usage. Patient had no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced really bad fever. On 09-OCT-2021, the patient experienced nausea. On 09-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad fever on 10-OCT-2021, and nausea, and vomiting on OCT-2021, and was recovering from body ache. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Nausea, Night sweats, Pyrexia, Vomiting
Clinical narrative: NAUSEA; VOMITING; BODY ACHE; REALLY BAD FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. The patient had no drug abuse or illicit drug usage. Patient had no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced really bad fever. On 09-OCT-2021, the patient experienced nausea. On 09-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad fever on 10-OCT-2021, and nausea, and vomiting on OCT-2021, and was recovering from body ache. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: NAUSEA; VOMITING; BODY ACHE; REALLY BAD FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. The patient had no drug abuse or illicit drug usage. Patient had no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced body ache. On 08-OCT-2021, the patient experienced really bad fever. On 09-OCT-2021, the patient experienced nausea. On 09-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad fever on 10-OCT-2021, and nausea, and vomiting on OCT-2021, and was recovering from body ache. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypersensitivity, Oligomenorrhoea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red; swollen; itchy; warm bump; resulted in longer bleeding; Induced my period and resulted in longer bleeding; delayed hypersensitivity reaction in left arm a week after vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 31-Years-old) (Batch/Lot Number: EN6062) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism, PCOS and allergies to Shellfish. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and multivitamin. On 14Mar2021, the patient experienced induced my period and resulted in longer bleeding, red, swollen, itchy, warm bump, resulted in longer bleeding. On an unknown date in Mar2021, patient experienced delayed hypersensitivity reaction in left arm a week after vaccination. Event resulted in physician office visit. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not receive other vaccine in four weeks. Patient received Prednisone, Benadryl, and Dilation and Curation was the treatment received for the events. Therapeutic measures were taken as a result of events. At the time of this report, the outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red; swollen; itchy; warm bump; resulted in longer bleeding; Induced my period and resulted in longer bleeding; delayed hypersensitivity reaction in left arm a week after vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 31-Years-old) (Batch/Lot Number: EN6062) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism, PCOS and allergies to Shellfish. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and multivitamin. On 14Mar2021, the patient experienced induced my period and resulted in longer bleeding, red, swollen, itchy, warm bump, resulted in longer bleeding. On an unknown date in Mar2021, patient experienced delayed hypersensitivity reaction in left arm a week after vaccination. Event resulted in physician office visit. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not receive other vaccine in four weeks. Patient received Prednisone, Benadryl, and Dilation and Curation was the treatment received for the events. Therapeutic measures were taken as a result of events. At the time of this report, the outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: diarrhea; vomiting; has become sick from her two month old baby, who received ROTATEQ; This spontaneous report was received from a pharmacist who refers to her dautgher, a 31-year-old non-pregnant female patient. There was no information about the patient' concurrent conditions, concomitant medications and medical history provided.  On 08-SEP-2021, the patient's child was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, orally (exact dose, lot number and expiration date were not provided).  On 15-SEP-2021 (reported as one week after the child being vaccinated ), the patient became sick from her two month old baby, who received rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by shedding and transmission of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to non-vaccinated person through the babies stool on an unknown date in September 2021. The patient experienced diarrhea and vomiting for two constant days. The two month old infant was not experiencing any adverse events after vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ).   The outcome of the event was unknown. The causality assessment was not provided.
Sex: F
Vaccine: MMR
Symptoms: Disorientation, Fatigue, Generalised oedema, Laboratory test, Migraine
Clinical narrative: severe fatigue; migraines; double pneumonia; seizures; disorientation; severe swelling over her whole body; her quality of life has diminished; This spontaneous report was received from an approximately 25-year-old female patient concerning herself. The patient was allergic to latex. No concomitant therapy was reported. The patient reported not having any health issues and was not on any medication before the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  In 2003, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.        The patient experienced severe reactions to the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  In 2003, one hour after the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), she experienced disorientation and then quickly experienced severe swelling over her whole body. On unknown dates, the patient experienced severe fatigue, seizures, migraines and double pneumonia. She had to be hospitalized on different occasions due to her suffering from symptoms on unknown dates. Her quality of life had diminished since the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient sought medical attention. Due to the symptoms, she received seizure medications, treatments for migraines, and antibiotic therapy from when she was suffering from the double pneumonia. Multiple labs and diagnostics were completed when she was hospitalized, but she was unable to provide information at this time. The patient was not recovered from all events. The reporter considered all events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  Upon internal review, pneumonia and seizure were determined to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Pneumonia, Quality of life decreased, Seizure
Clinical narrative: severe fatigue; migraines; double pneumonia; seizures; disorientation; severe swelling over her whole body; her quality of life has diminished; This spontaneous report was received from an approximately 25-year-old female patient concerning herself. The patient was allergic to latex. No concomitant therapy was reported. The patient reported not having any health issues and was not on any medication before the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  In 2003, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.        The patient experienced severe reactions to the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  In 2003, one hour after the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), she experienced disorientation and then quickly experienced severe swelling over her whole body. On unknown dates, the patient experienced severe fatigue, seizures, migraines and double pneumonia. She had to be hospitalized on different occasions due to her suffering from symptoms on unknown dates. Her quality of life had diminished since the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient sought medical attention. Due to the symptoms, she received seizure medications, treatments for migraines, and antibiotic therapy from when she was suffering from the double pneumonia. Multiple labs and diagnostics were completed when she was hospitalized, but she was unable to provide information at this time. The patient was not recovered from all events. The reporter considered all events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  Upon internal review, pneumonia and seizure were determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of PNEUMOVAX 23 was administered to the patient; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 06-OCT-2021, an expired dose (0.5 milliliters) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot # T007383 was administered to the patient for prophylaxis (route of administration and anatomical location were not provided). The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) expired on 23-AUG-2021 and did not has prior temperature excursions. No additional information was provided. No adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Pharmacist inadvertently administered a PNEUMOVAX 23 to a patient several months after its expiration date; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.     On 12-OCT-2021, the patient was inadvertently vaccinated with an expire dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiration date 10-JUN-2021 (dose and route were not reported) for prophylaxis (expired product administered).  No additional adverse event details or product quality complaint were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; the vaccine was administered after expiration; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 12-OCT-2021 the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml; lot # R036912 was confirmed to be valid, expiration date 23-SEP-2021 (route of administration, anatomical location were not reported) for prophylaxis. No additional adverse effect was reported. The vaccine did not experience a temperature excursion.