chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Pruritus, Rash, Urticaria
Clinical narrative: She developed a rash; She developed a rash and hives; The rash was so itchy,; Patient cry; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 06Mar2021 (age at vaccination 40 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Mar2021 the patient experienced she developed a rash, she developed a rash and hives, the rash was so itchy, patient cry. Reporter stated, Patient had a really bad reaction to the first dose. Patient has not received her second dose of the covid vaccine yet. Patient is supposed to get her second dose of the covid vaccine tomorrow. Patient is not sure if she should get the second dose of the covid vaccine because her rash and hives were so bad. Reporter is calling for patient to help give her some guidance on whether or not she should get the second dose. It was not until the last couple of days that patients rash and hives have cleared up. Patient is reporter's co worker. She developed a rash and hives: Patient described the rash and hives together. Reporter does not know if these occurred separately. Reporter is going off of how patient described it to reporter. The rash was so itchy, that it made the patient cry. The rash and hives started to appear Saturday night or Sunday morning. Rash and hives resolved a couple of day ago. Patient told reporter that now the rash and hives are pretty much completely gone. Patient had a rash and hives for a full month. Patient visited physician office for event developed rash. The doctor told her to take Benadryl. Patient received treatment for developed a rash Even with Benadryl, the rash did not get better. The Benadryl did not work. Unknown NDC, lot number or expiration date for Benadryl. The outcome of event rash, hives was recovered rest of event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Coagulation time, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: fatigue; trouble breathing with a mask on/shortness of breath while wearing a mask/ difficulty breathing; she has not been feeling well since her second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date: 30Jun2021), via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 61 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266; expiration date: 31May2021), via an unspecified route of administration, on 18Feb2021 (at the age of 61 years) as dose 1, single for COVID-19 immunization. Patient stated she has not been feeling well since her second dose. On 11Mar2021 (the day of the vaccine) the patient mentioned having some issues such as fatigue and trouble breathing/ difficulty breathing/ shortness of breath while wearing a mask. Patient was now wondering if these things were common to the vaccine. Patient stated she went on a walk with her friends and could not catch her breath, she was wearing a mask at the time. Patient also mentioned she had been religiously wearing a mask this whole year and did not have a problem until now. Patient stated she was two and a half weeks past her second vaccine and still feeling fatigued and if she wears a mask she had troubled breathing. patient wanted to know whether we have advice regarding treatment of the side effects from the COVID vaccine. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood tests: tests for blood clots, EKG, chest X-ray all negative. Also had a COVID test on Friday which was negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: fatigue; trouble breathing with a mask on/shortness of breath while wearing a mask/ difficulty breathing; she has not been feeling well since her second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date: 30Jun2021), via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 61 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266; expiration date: 31May2021), via an unspecified route of administration, on 18Feb2021 (at the age of 61 years) as dose 1, single for COVID-19 immunization. Patient stated she has not been feeling well since her second dose. On 11Mar2021 (the day of the vaccine) the patient mentioned having some issues such as fatigue and trouble breathing/ difficulty breathing/ shortness of breath while wearing a mask. Patient was now wondering if these things were common to the vaccine. Patient stated she went on a walk with her friends and could not catch her breath, she was wearing a mask at the time. Patient also mentioned she had been religiously wearing a mask this whole year and did not have a problem until now. Patient stated she was two and a half weeks past her second vaccine and still feeling fatigued and if she wears a mask she had troubled breathing. patient wanted to know whether we have advice regarding treatment of the side effects from the COVID vaccine. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood tests: tests for blood clots, EKG, chest X-ray all negative. Also had a COVID test on Friday which was negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: fatigue; trouble breathing with a mask on/shortness of breath while wearing a mask/ difficulty breathing; she has not been feeling well since her second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date: 30Jun2021), via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 61 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266; expiration date: 31May2021), via an unspecified route of administration, on 18Feb2021 (at the age of 61 years) as dose 1, single for COVID-19 immunization. Patient stated she has not been feeling well since her second dose. On 11Mar2021 (the day of the vaccine) the patient mentioned having some issues such as fatigue and trouble breathing/ difficulty breathing/ shortness of breath while wearing a mask. Patient was now wondering if these things were common to the vaccine. Patient stated she went on a walk with her friends and could not catch her breath, she was wearing a mask at the time. Patient also mentioned she had been religiously wearing a mask this whole year and did not have a problem until now. Patient stated she was two and a half weeks past her second vaccine and still feeling fatigued and if she wears a mask she had troubled breathing. patient wanted to know whether we have advice regarding treatment of the side effects from the COVID vaccine. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood tests: tests for blood clots, EKG, chest X-ray all negative. Also had a COVID test on Friday which was negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: fatigue; trouble breathing with a mask on/shortness of breath while wearing a mask/ difficulty breathing; she has not been feeling well since her second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206; expiration date: 30Jun2021), via an unspecified route of administration, administered in left arm on 11Mar2021 (at the age of 61 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266; expiration date: 31May2021), via an unspecified route of administration, on 18Feb2021 (at the age of 61 years) as dose 1, single for COVID-19 immunization. Patient stated she has not been feeling well since her second dose. On 11Mar2021 (the day of the vaccine) the patient mentioned having some issues such as fatigue and trouble breathing/ difficulty breathing/ shortness of breath while wearing a mask. Patient was now wondering if these things were common to the vaccine. Patient stated she went on a walk with her friends and could not catch her breath, she was wearing a mask at the time. Patient also mentioned she had been religiously wearing a mask this whole year and did not have a problem until now. Patient stated she was two and a half weeks past her second vaccine and still feeling fatigued and if she wears a mask she had troubled breathing. patient wanted to know whether we have advice regarding treatment of the side effects from the COVID vaccine. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood tests: tests for blood clots, EKG, chest X-ray all negative. Also had a COVID test on Friday which was negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Pain
Clinical narrative: felt like arm was going to explode after first dose of vaccine; shortness of breath; Tired; body aches but they have been worse; cannot get out of bed/hard to raise her head she is so weak; This is a spontaneous report received from a contactable Female consumer reported for herself. A 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via an unspecified route of administration on 10Mar2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included rods in back. The patient's concomitant medications were not reported. She had her shots last month, clarified the Pfizer Covid vaccines, stated 31Mar2021 was her second dose, first dose was 10Mar2021. She felt fine until this past weekend. She stated she has slight shortness of breath, was very tired and weak, cannot stay out of bed, has a hard time getting up. Her appetite was great, no nausea or vomiting or anything. She stated her symptoms started this week no exact dates provided. She stated she has rods in her back so maybe that was why she cannot get out of bed, she needs help stated it was hard to raise her head she was so weak has to use her hands, she stated she typically deals with body aches but they have been worse this week. She stated that all of her symptoms have just been persisting since they started this week. She stated after the first dose, she felt her arm was going to explode, she has a rotator cuff in her right arm that needs to be repaired which was an issue prior to the vaccine, and that was probably why it hurt so badly. She stated that has gotten better, exact details not provided. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in right arm on 31Mar2021 for covid-19 immunisation. The outcome of events was unknown.  No Follow-up attempts are needed. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Limb discomfort, Pain
Clinical narrative: felt like arm was going to explode after first dose of vaccine; shortness of breath; Tired; body aches but they have been worse; cannot get out of bed/hard to raise her head she is so weak; This is a spontaneous report received from a contactable Female consumer reported for herself. A 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via an unspecified route of administration on 10Mar2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included rods in back. The patient's concomitant medications were not reported. She had her shots last month, clarified the Pfizer Covid vaccines, stated 31Mar2021 was her second dose, first dose was 10Mar2021. She felt fine until this past weekend. She stated she has slight shortness of breath, was very tired and weak, cannot stay out of bed, has a hard time getting up. Her appetite was great, no nausea or vomiting or anything. She stated her symptoms started this week no exact dates provided. She stated she has rods in her back so maybe that was why she cannot get out of bed, she needs help stated it was hard to raise her head she was so weak has to use her hands, she stated she typically deals with body aches but they have been worse this week. She stated that all of her symptoms have just been persisting since they started this week. She stated after the first dose, she felt her arm was going to explode, she has a rotator cuff in her right arm that needs to be repaired which was an issue prior to the vaccine, and that was probably why it hurt so badly. She stated that has gotten better, exact details not provided. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in right arm on 31Mar2021 for covid-19 immunisation. The outcome of events was unknown.  No Follow-up attempts are needed. No further information expected.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: rash spots are raised; Bright Red Rash; Pimples/bigger than a pimple, like a blister but with no liquid inside; itchy rash/ it itches/itching; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Occurred when child). Concomitant products included Herpes zoster (Shingrix).   On 24th September 2021 17:00, the patient received the 2nd dose of Shingrix. On 25th September 2021, 1 days after receiving Shingrix, the patient experienced fever. On 26th September 2021, the patient experienced raised rash, red rash, pimples and itchy rash. The patient was treated with diphenhydramine hydrochloride (Benadryl Gel). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the raised rash, red rash, pimples and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, raised rash, red rash, pimples and itchy rash to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. On 8th July 2021, the patient received her 1st dose of Shingrix vaccine and no reaction was reported for this dose. The patient got the 2nd dose of Shingrix in her left arm and she had fever of 101 degree F.  On 26th September 2021, in the morning, 2 days after receiving Shingrix, she noticed a bright red rash. 2 days after receiving Shingrix, the rash spots were raised, and they were about 7x4 inches in size. The spots were 1 to 2 inches apart and they were itchy.  The rash were red bright spots and 2 days after receiving Shingrix, like pimples or mosquito bites. They were raised and were bigger than a pimple, like a blister but with no liquid inside.  2 days after receiving Shingrix, the patient reported that it itches and was recommended Benadryl gel by health care professional (HCP).  The patient was concern because it had been 10 days and she still had the itchiness and the rash.  The patient reported it was not devastating but it was annoying. The reporter did not find the lot and expiration date of the 2nd dose of Shingrix.  No information was provided about the 1st dose of Shingrix, only the date of vaccination Patient did consent to follow up with health care professional. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Pyrexia, Rash erythematous, Rash macular, Rash papular
Clinical narrative: rash spots are raised; Bright Red Rash; Pimples/bigger than a pimple, like a blister but with no liquid inside; itchy rash/ it itches/itching; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Occurred when child). Concomitant products included Herpes zoster (Shingrix).   On 24th September 2021 17:00, the patient received the 2nd dose of Shingrix. On 25th September 2021, 1 days after receiving Shingrix, the patient experienced fever. On 26th September 2021, the patient experienced raised rash, red rash, pimples and itchy rash. The patient was treated with diphenhydramine hydrochloride (Benadryl Gel). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the raised rash, red rash, pimples and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, raised rash, red rash, pimples and itchy rash to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. On 8th July 2021, the patient received her 1st dose of Shingrix vaccine and no reaction was reported for this dose. The patient got the 2nd dose of Shingrix in her left arm and she had fever of 101 degree F.  On 26th September 2021, in the morning, 2 days after receiving Shingrix, she noticed a bright red rash. 2 days after receiving Shingrix, the rash spots were raised, and they were about 7x4 inches in size. The spots were 1 to 2 inches apart and they were itchy.  The rash were red bright spots and 2 days after receiving Shingrix, like pimples or mosquito bites. They were raised and were bigger than a pimple, like a blister but with no liquid inside.  2 days after receiving Shingrix, the patient reported that it itches and was recommended Benadryl gel by health care professional (HCP).  The patient was concern because it had been 10 days and she still had the itchiness and the rash.  The patient reported it was not devastating but it was annoying. The reporter did not find the lot and expiration date of the 2nd dose of Shingrix.  No information was provided about the 1st dose of Shingrix, only the date of vaccination Patient did consent to follow up with health care professional. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: rash spots are raised; Bright Red Rash; Pimples/bigger than a pimple, like a blister but with no liquid inside; itchy rash/ it itches/itching; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Occurred when child). Concomitant products included Herpes zoster (Shingrix).   On 24th September 2021 17:00, the patient received the 2nd dose of Shingrix. On 25th September 2021, 1 days after receiving Shingrix, the patient experienced fever. On 26th September 2021, the patient experienced raised rash, red rash, pimples and itchy rash. The patient was treated with diphenhydramine hydrochloride (Benadryl Gel). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the raised rash, red rash, pimples and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the fever, raised rash, red rash, pimples and itchy rash to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. On 8th July 2021, the patient received her 1st dose of Shingrix vaccine and no reaction was reported for this dose. The patient got the 2nd dose of Shingrix in her left arm and she had fever of 101 degree F.  On 26th September 2021, in the morning, 2 days after receiving Shingrix, she noticed a bright red rash. 2 days after receiving Shingrix, the rash spots were raised, and they were about 7x4 inches in size. The spots were 1 to 2 inches apart and they were itchy.  The rash were red bright spots and 2 days after receiving Shingrix, like pimples or mosquito bites. They were raised and were bigger than a pimple, like a blister but with no liquid inside.  2 days after receiving Shingrix, the patient reported that it itches and was recommended Benadryl gel by health care professional (HCP).  The patient was concern because it had been 10 days and she still had the itchiness and the rash.  The patient reported it was not devastating but it was annoying. The reporter did not find the lot and expiration date of the 2nd dose of Shingrix.  No information was provided about the 1st dose of Shingrix, only the date of vaccination Patient did consent to follow up with health care professional. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Chest pain, Cytokine increased, Dyspnoea
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Interleukin level increased, Macrophage inflammatory protein-1 alpha increased, Muscular weakness
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuralgia, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 test positive
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Blood pressure measurement, Blood test, Chest pain, Cytokine test
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Interleukin level, Neuralgia, Platelet disorder, SARS-CoV-2 antibody test
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vasculitis
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Blood pressure measurement, Blood test, Chemokine test
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cytokine increased, Cytokine test, Dyspnoea, Fatigue
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Interleukin level, Interleukin level increased, Macrophage inflammatory protein-1 alpha, Macrophage inflammatory protein-1 alpha increased
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Neuralgia, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vascular endothelial growth factor assay
Clinical narrative: ELEVATED BLOOD PRESSURE; PLATELET ACTIVATION; CHEST PAIN/PAIN INSIDE OF HEART ON LEFT SIDE OF CHEST WHICH FELT ON CHEST AND BACK; VASCULAR INFLAMMATION; NERVE PAIN LIKE SHOOTING PAIN ON LEGS; This spontaneous report received from a consumer concerned a 72 year old female. 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced vascular inflammation. On MAR-2021, the patient experienced nerve pain like shooting pain on legs. On APR-2021, the patient experienced chest pain/pain inside of heart on left side of chest which felt on chest and back. On 07-SEP-2021, the patient experienced platelet activation. Laboratory data included: Cytokine test (NR: not provided) Elevated, and Interleukin-6 (NR: not provided) Elevated. On an unspecified date, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) positive, Blood pressure (NR: not provided) Trend of elevated blood pressure, 160 over something, Blood test (NR: not provided) no underlying conditions, and COVID-19 antibody test (NR: not provided) confirmed antibody from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pain inside of heart on left side of chest which felt on chest and back, had not recovered from nerve pain like shooting pain on legs, vascular inflammation, and elevated blood pressure, and the outcome of platelet activation was not reported. This report was non-serious. This case, from the same reporter is linked to 20210340967.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Seizure like phenomena, Syncope
Clinical narrative: 6-8 minutes after injection my son passed out and fell on floor. He was extremely pale and having convulsions for 3-5 minutes until he came to and was very confused and weak. The paramedics arrived about 10 minutes after and his blood pressure was 70/30 and very slow pulse. They tried to sit him in a chair and he passed out again. They transported him to the hospital in an ambulance to the ER. The ER doctors did blood work and a CT which came back good. He was orthostatic positive for hours until he finally started having good results on the monitors and was released around 9pm.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Confusional state, Heart rate decreased
Clinical narrative: 6-8 minutes after injection my son passed out and fell on floor. He was extremely pale and having convulsions for 3-5 minutes until he came to and was very confused and weak. The paramedics arrived about 10 minutes after and his blood pressure was 70/30 and very slow pulse. They tried to sit him in a chair and he passed out again. They transported him to the hospital in an ambulance to the ER. The ER doctors did blood work and a CT which came back good. He was orthostatic positive for hours until he finally started having good results on the monitors and was released around 9pm.