chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Bone pain, Fatigue, Myalgia
Clinical narrative: muscle pain; fatigue; collarbone area pain; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included mass. Patient had a biopsy done due to a prior mass and result came back ok. The patient's concomitant medications were not reported. From 12Feb2021, patient experienced muscle pain and fatigue. On 13Feb2021, everything went away except the collarbone area pain. She stated its kept going worse. She was following up with the ENT doctor and he wanted to prescribe her steroids. Patient wanted to know information about it and what she could do about it. Outcome of events muscle pain and fatigue was resolved, and of event collarbone area pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; headache; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8730), via an unspecified route of administration in the left arm on 30Mar2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included "maybe" was exposed to COVID-19 in Apr2021. Concomitant medications were none. There were no other vaccines administered on the same date or within 4 weeks of BNT162B2. Within a couple of days of the first vaccination dose (Apr2021), the patient went for a trip and "maybe" was exposed to COVID-19. On Apr2021, the patient felt some kind of tiredness and headache. The patient took ibuprofen (ADVIL) and paracetamol (TYLENOL) for the tiredness and headache. The patient reported that he drove a lot of distance and did a lot of things during the trip, so these were not COVID-19 symptoms. On 05Apr2021, the patient tested positive for COVID-19 via a nasal COVID-19 test and experienced COVID-19 symptoms. On an unspecified date, the patient had some cough, so he went to the emergency room and was given azithromycin and a cough tablet and cough syrup. The patient queried when he can receive his second dose as he had already completed his 2-week isolation period and had no more symptoms. The clinical outcome of "positive COVID-19 test with symptoms", headache and tiredness was resolved on Apr2021.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; headache; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8730), via an unspecified route of administration in the left arm on 30Mar2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included "maybe" was exposed to COVID-19 in Apr2021. Concomitant medications were none. There were no other vaccines administered on the same date or within 4 weeks of BNT162B2. Within a couple of days of the first vaccination dose (Apr2021), the patient went for a trip and "maybe" was exposed to COVID-19. On Apr2021, the patient felt some kind of tiredness and headache. The patient took ibuprofen (ADVIL) and paracetamol (TYLENOL) for the tiredness and headache. The patient reported that he drove a lot of distance and did a lot of things during the trip, so these were not COVID-19 symptoms. On 05Apr2021, the patient tested positive for COVID-19 via a nasal COVID-19 test and experienced COVID-19 symptoms. On an unspecified date, the patient had some cough, so he went to the emergency room and was given azithromycin and a cough tablet and cough syrup. The patient queried when he can receive his second dose as he had already completed his 2-week isolation period and had no more symptoms. The clinical outcome of "positive COVID-19 test with symptoms", headache and tiredness was resolved on Apr2021.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: hospitilization  with multitude of symptoms: fever, chills, rigors, myalgia, rhinorrhea, cough, SOB, chest pain, fatigue, ABD, congestion
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: hospitilization  with multitude of symptoms: fever, chills, rigors, myalgia, rhinorrhea, cough, SOB, chest pain, fatigue, ABD, congestion
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Polymerase chain reaction positive, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: hospitilization  with multitude of symptoms: fever, chills, rigors, myalgia, rhinorrhea, cough, SOB, chest pain, fatigue, ABD, congestion
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site indentation, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: RASH ACROSS ARM; INJECTION SITE INDENTATION; PAINFUL ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, alcoholic, environmental allergy, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced injection site indentation. On 18-MAR-2021, the subject experienced painful arm. On an unspecified date, the subject experienced rash across arm. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 3 at resting and 7-9 when exercising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site indentation, and painful arm, and the outcome of rash across arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site indentation, Pain assessment, Pain in extremity, Rash
Clinical narrative: RASH ACROSS ARM; INJECTION SITE INDENTATION; PAINFUL ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, alcoholic, environmental allergy, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced injection site indentation. On 18-MAR-2021, the subject experienced painful arm. On an unspecified date, the subject experienced rash across arm. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 3 at resting and 7-9 when exercising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site indentation, and painful arm, and the outcome of rash across arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around the collar bone.  Upon self examination the area the lymph node in that area was significantly swollen, painful to the touch and squishy which is to say I did not hard. The skin in the area was red.  I had several other symptoms that are being commonly reported.  The symptoms listed below started to occur at approximately 4 hours after the second shot.   These  symptoms lasted for approximately 18 hours after the shot was administered.   Headache, stomach ache, muscle cramps, fatigue, chills, overall body aches and dizziness.  I contacted my doctor four days after regarding the lymph node concerns as the swelling was still a concern.  I was seen the same day and advised to report back if the swelling did not go down.  I am reporting this two days after my doctor's visit.  The swelling is  continuing to go down.  The area is still somewhat painful when gently rubbed.  The skin in the area is no longer red.  I checked the box as not having recovered because the swelling has not completely gone away as of the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around the collar bone.  Upon self examination the area the lymph node in that area was significantly swollen, painful to the touch and squishy which is to say I did not hard. The skin in the area was red.  I had several other symptoms that are being commonly reported.  The symptoms listed below started to occur at approximately 4 hours after the second shot.   These  symptoms lasted for approximately 18 hours after the shot was administered.   Headache, stomach ache, muscle cramps, fatigue, chills, overall body aches and dizziness.  I contacted my doctor four days after regarding the lymph node concerns as the swelling was still a concern.  I was seen the same day and advised to report back if the swelling did not go down.  I am reporting this two days after my doctor's visit.  The swelling is  continuing to go down.  The area is still somewhat painful when gently rubbed.  The skin in the area is no longer red.  I checked the box as not having recovered because the swelling has not completely gone away as of the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Muscle spasms, Neck pain
Clinical narrative: Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around the collar bone.  Upon self examination the area the lymph node in that area was significantly swollen, painful to the touch and squishy which is to say I did not hard. The skin in the area was red.  I had several other symptoms that are being commonly reported.  The symptoms listed below started to occur at approximately 4 hours after the second shot.   These  symptoms lasted for approximately 18 hours after the shot was administered.   Headache, stomach ache, muscle cramps, fatigue, chills, overall body aches and dizziness.  I contacted my doctor four days after regarding the lymph node concerns as the swelling was still a concern.  I was seen the same day and advised to report back if the swelling did not go down.  I am reporting this two days after my doctor's visit.  The swelling is  continuing to go down.  The area is still somewhat painful when gently rubbed.  The skin in the area is no longer red.  I checked the box as not having recovered because the swelling has not completely gone away as of the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Approximately 24 hours after the second shot I noticed moderate neck pain on the left side around the collar bone.  Upon self examination the area the lymph node in that area was significantly swollen, painful to the touch and squishy which is to say I did not hard. The skin in the area was red.  I had several other symptoms that are being commonly reported.  The symptoms listed below started to occur at approximately 4 hours after the second shot.   These  symptoms lasted for approximately 18 hours after the shot was administered.   Headache, stomach ache, muscle cramps, fatigue, chills, overall body aches and dizziness.  I contacted my doctor four days after regarding the lymph node concerns as the swelling was still a concern.  I was seen the same day and advised to report back if the swelling did not go down.  I am reporting this two days after my doctor's visit.  The swelling is  continuing to go down.  The area is still somewhat painful when gently rubbed.  The skin in the area is no longer red.  I checked the box as not having recovered because the swelling has not completely gone away as of the time of this report.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Aphasia, Cognitive disorder, Depression, Mental impairment
Clinical narrative: she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking.   Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking.   Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Aphasia, Cognitive disorder, Condition aggravated, Depression
Clinical narrative: she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking.   Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Mental impairment, Nausea
Clinical narrative: she was spent; She had terrible depression. She said she had a history of depression and took medication for the depression; 2 days after her second Pfizer COVID-19 Vaccine shot, she had terrible nausea. She said the nausea was like morning sickness or being punched in the stomach; Stomach ache; she was having trouble processing information since her second Pfizer COVID-19 Vaccine shot. She said things get jumbled easily; She was having trouble expressing herself and speaking. She found it very difficult to find words during a conversation.; her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose; Event: her cognitive issues had gotten worse after the second Pfizer COVID-19 Vaccine dose was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE (at the age of 57 years-old) for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing for at least 30 years, breast implant placed about 31 years ago and started having cognitive issues, struggling with words, and following instructions since Dec2020. She said when she takes her medicine, fluoxetine, she couldn't even tell she had depression. She said she had been on fluoxetine for a decade fluoxetine. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) and experienced slight fatigue in 2021 and recovered. She said she was OK on 10Mar2021. In Mar2021, the patient was having trouble processing information since her second Pfizer covid-19 vaccine shot. She said things get jumbled easily on Mar2021, 2 days after her second pfizer covid-19 vaccine shot, she had terrible nausea like morning sickness or being punched in the stomach on 11Mar2021, stomach ache on 11Mar2021, terrible depression, having trouble expressing herself and speaking, found it very difficult to find words during a conversation on Mar2021, her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose on Mar2021, event: her cognitive issues had gotten worse after the second pfizer covid-19 vaccine dose was reported as worsened on Mar2021. She said she had seen many doctors with her nausea. She said her nausea had nothing to do with her bowels. She said it had been about a month since the nausea and depression started, and she felt she had just turned the corner on both of them. On an unknown date, she was spent. Treatment for depression worsened included depression medication. The clinical outcome of trouble processing information and cognitive issues had gotten worse was not recovered, recovering for nausea, stomach ache and depression and unknown for trouble expressing herself, spent and speaking.   Information on the Lot/Batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Deafness neurosensory
Clinical narrative: Sudden sensironeural hearing loss of left ear and Bell's palsy left side of face
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Bell's palsy, Deafness, Magnetic resonance imaging
Clinical narrative: Sudden sensironeural hearing loss of left ear and Bell's palsy left side of face
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Pharyngeal swelling, Throat irritation, Throat tightness
Clinical narrative: Swelling and itchiness of back of mouth and throat that did not interfere with breathing, but was treated effectively with 2 benadryl and 90 mins observation at facility.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Oral pruritus, Pharyngeal swelling, Throat irritation
Clinical narrative: Swelling and itchiness of back of mouth and throat that did not interfere with breathing, but was treated effectively with 2 benadryl and 90 mins observation at facility.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Swollen tongue, Throat irritation
Clinical narrative: pt is a 19 yr old female who presented to the ER by EMS for allergic reaction following her second moderna covid 19 vaccine. She received her shot and then began to feel her tongue swelling and she developed body wide itching. She was given an injection of her Epi-pen at the facility and transferred to the emergency room. She was observed on a cardiac monitor in the er for several hours then discharged home. Covid vaccination will now be listed as an allergy.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Hypersensitivity, Pruritus, Swollen tongue
Clinical narrative: pt is a 19 yr old female who presented to the ER by EMS for allergic reaction following her second moderna covid 19 vaccine. She received her shot and then began to feel her tongue swelling and she developed body wide itching. She was given an injection of her Epi-pen at the facility and transferred to the emergency room. She was observed on a cardiac monitor in the er for several hours then discharged home. Covid vaccination will now be listed as an allergy.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: The patient  was crying at time of shot administration,  came out to waiting area, after about 10-15 minutes, we were asked to come help by his mom.  He had passed out, we checked his pulse it was present., patient was very tense with head laid back.  after about 30 seconds patient woke up and was agitated and was jerking his arms about .  mom tried to calm him down.  He was very pale , was sweating, and said he felt he had to throw up.  We called 911 and has management staff come to area.  He stated his arm was numb that he received shot in and was very emotional.  We moved him to a more private area and got him a cold cloth and waited for ambulance to arrive.  He refused to go in ambulance and mom was gonna take him to er in her vehicle.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Agitation, Crying, Emotional distress, Hyperhidrosis, Hypoaesthesia
Clinical narrative: The patient  was crying at time of shot administration,  came out to waiting area, after about 10-15 minutes, we were asked to come help by his mom.  He had passed out, we checked his pulse it was present., patient was very tense with head laid back.  after about 30 seconds patient woke up and was agitated and was jerking his arms about .  mom tried to calm him down.  He was very pale , was sweating, and said he felt he had to throw up.  We called 911 and has management staff come to area.  He stated his arm was numb that he received shot in and was very emotional.  We moved him to a more private area and got him a cold cloth and waited for ambulance to arrive.  He refused to go in ambulance and mom was gonna take him to er in her vehicle.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Pallor
Clinical narrative: The patient  was crying at time of shot administration,  came out to waiting area, after about 10-15 minutes, we were asked to come help by his mom.  He had passed out, we checked his pulse it was present., patient was very tense with head laid back.  after about 30 seconds patient woke up and was agitated and was jerking his arms about .  mom tried to calm him down.  He was very pale , was sweating, and said he felt he had to throw up.  We called 911 and has management staff come to area.  He stated his arm was numb that he received shot in and was very emotional.  We moved him to a more private area and got him a cold cloth and waited for ambulance to arrive.  He refused to go in ambulance and mom was gonna take him to er in her vehicle.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Deep vein thrombosis, Erythema, Fibrin D dimer, Pain in extremity
Clinical narrative: The pharmacy was contacted by the local health department and this is what was relayed: Patient started having leg pain and swelling on 5/1 and was concerned that it may be a blood clot. Patient then reported to the urgent care and saw.  I spoke with this provider and she said that a DVT in that leg was confirmed via ultrasound and the patient was discharged with xarelto.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral embolism, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: The pharmacy was contacted by the local health department and this is what was relayed: Patient started having leg pain and swelling on 5/1 and was concerned that it may be a blood clot. Patient then reported to the urgent care and saw.  I spoke with this provider and she said that a DVT in that leg was confirmed via ultrasound and the patient was discharged with xarelto.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: The pharmacy was contacted by the local health department and this is what was relayed: Patient started having leg pain and swelling on 5/1 and was concerned that it may be a blood clot. Patient then reported to the urgent care and saw.  I spoke with this provider and she said that a DVT in that leg was confirmed via ultrasound and the patient was discharged with xarelto.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient experienced an epidose of syncope after adminstration of GARDASIL 9; This spontaneous report has been received from a Nurse Practitioner via a Company representative, referring to a 14 year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.    On an unknown date, the patinet was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at 0.5 milliliter, intramusculary as vaccine series (strength, frequency, lot number and expiration date were not reported).         On an unknown date, after administration was complete the patient experienced an episode of syncope. The outcome of syncope was unknown. No product quality complaint (PQC) reported.      The causality assessment between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and syncope was not provided.   Upon internal review, syncope was determined to be medically significant.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Muscle spasms
Clinical narrative: SPORADIC NOSE BLEEDS; LEG CRAMPS IN CALVES LIKE CHARLIE HORSE; CONSTANT HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced sporadic nose bleeds. On APR-2021, the subject experienced leg cramps in calves like charlie horse. On APR-2021, the subject experienced constant headache. On APR-2021, the subject experienced extreme fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headache, and the outcome of sporadic nose bleeds, leg cramps in calves like charlie horse and extreme fatigue was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Vaginal haemorrhage
Clinical narrative: WEIRD BLOOD SYMPTOMS (BLOOD SYMPTOMS); EARLY PERIOD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced weird blood symptoms (blood symptoms). On APR-2021, the subject experienced early period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient thought symptoms would have passed by now was still experiencing them. The patient had not recovered from weird blood symptoms (blood symptoms), and the outcome of early period was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY  EMBOLISM; This spontaneous report was received from a female patient of unspecified age, race and ethnicity not reported. The patient's weight, height, concurrent condition, or medical history were not reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown) dose, start therapy date were not reported for prophylactic vaccination. The patient was taking XARELTO (rivaroxaban) (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient reported that she was taking XARELTO and developed a pulmonary embolism after taking J&J vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210457869-COVID-19 VACCINE Ad26.COV2.S-Pulmonary embolism. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS/ FEVER/CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms/ fever/chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms/ fever/chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER 105F; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever 105f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever 105f was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Depression, Emotional distress, Head injury, Hypertension
Clinical narrative: COLLAPSE(DIZZINESS/FAINTNESS); DEPRESSION; EMOTIONAL DISTRESS; HIGH BLOOD PRESSURE; HIT HEAD(HEADACHE); This spontaneous report received from a patient via legal source (legal reference number: JJL2021007215) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no pre-existing conditions at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date in APR-2021 after vaccination, the patient experienced dizziness-faintness and was collapsed and hit head. The patient also had depression, emotional distress, high blood pressure, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapse(dizziness/faintness), emotional distress, depression, high blood pressure and hit head(headache) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Medical Assessment comment not required as per standard operating procedure for legal case.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: COLLAPSE(DIZZINESS/FAINTNESS); DEPRESSION; EMOTIONAL DISTRESS; HIGH BLOOD PRESSURE; HIT HEAD(HEADACHE); This spontaneous report received from a patient via legal source (legal reference number: JJL2021007215) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no pre-existing conditions at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date in APR-2021 after vaccination, the patient experienced dizziness-faintness and was collapsed and hit head. The patient also had depression, emotional distress, high blood pressure, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapse(dizziness/faintness), emotional distress, depression, high blood pressure and hit head(headache) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Medical Assessment comment not required as per standard operating procedure for legal case.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: THROAT PAIN; MUSCLE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a and expiry: 01-MAY-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced muscle pain. On 01-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced throat pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and muscle pain, and had not recovered from throat pain. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: UNSPECIFIED REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 55.9 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received iloprost (inhalation vapour, solution, route of admin not reported, batch number: MA03S04 expiry: 31-AUG-2024) 5 ug, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included bosentan for primary pulmonary hypertension, and tadalafil. On an unspecified date, the subject experienced unspecified reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with iloprost was withdrawn. The outcome of unspecified reaction was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: PUNCTURED VACCINE WAS ADMINISTERED TO PATIENT PAST THE 6 HOURS STABILITY WINDOW; This spontaneous report received from a pharmacist concerned a 77 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021 13:00, the subject experienced punctured vaccine was administered to subject past the 6 hours stability window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured vaccine was administered to patient past the 6 hours stability window was not reported. This report was non-serious. This case, from the same reporter is linked to.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, fever, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FELT TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm, and felt tired. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore arm, and felt tired. This report was non-serious. This case, from the same reporter is linked to.