chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: I received the Moderna #1 vaccine on 4/30/21 (lot 048B21A) at the same store as the #2 vaccine on 5/28/21 (lot 014C21A).  I keep track of my monthly menstrual cycles and they were normal and regular prior to the vaccines.  My last regular cycle before the vaccines began 5/7.    After the 2nd vaccine on 5/28, I began having menstrual cramps on 5/31 which was about a week early and menses started on 6/3.  This was a long cycle as I was still spotting daily through 6/16.  Beginning on 6/27 and for about 2.5 weeks I had severe hot flashes on a daily basis and many times each day.  In July I only had one day of light spotting on 7/12 and two days of mild cramping 7/13-14.  I had no menses in July.  On 8/4- 8/6 I had some light spotting and menses began 8/9 through-8/13 (short).  There was a gap of about 8 weeks between menses.  I also had no menstrual cycle at all in September.  I had some random days of cramping on 10/8, 10/12 and 10/16.  Menses started again on 10/22 through 10/30.  There was an 11 week gap between menses this time.  My cycles started occurring regularly monthly again after this point and had start dates of 11/14, 12/10, 1/7 and 2/3.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Heat therapy, Injected limb mobility decreased, Injection site pain, Massage, Pain
Clinical narrative: - L shoulder pain - point tenderness to posterior deltoid - soreness and pain with abduction greater than 100 degrees     also extension greater than 30 degrees - Treating w/ Ibuprofen, heat, rest, massage
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypersensitivity, Illness, Inappropriate schedule of product administration, Seizure
Clinical narrative: Almost immediately after the 2nd shot she had to go to the ER and she went into convulsions and had to be given EpiPen b/c  her throat was closing up and was taken to the ER. Was sick for 2 months after the 2nd dose. Chest pains and had allergic reactions. Second dose on 5/25/2021 1st dose 024c21a on 4/15/21
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Almost immediately after the 2nd shot she had to go to the ER and she went into convulsions and had to be given EpiPen b/c  her throat was closing up and was taken to the ER. Was sick for 2 months after the 2nd dose. Chest pains and had allergic reactions. Second dose on 5/25/2021 1st dose 024c21a on 4/15/21
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: General symptom, Laboratory test abnormal
Clinical narrative: Tested positive 5 days PTA and arrived for worsening symptoms. Did not require O2 during stay. Was discharged home in good condition with outpatient orders for monoclonal antibody infusion.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2d vaccine; breakthrough case admission
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Death related to COVID 19 infection
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Muscular weakness, Nerve conduction studies
Clinical narrative: leg weakness 2 days after vaccine booster
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Depressed level of consciousness, Hyporesponsive to stimuli, Loss of consciousness
Clinical narrative: Event occurred after 2nd admission; breakthrough case admission
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lung opacity, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: Event occurred after 2nd admission; breakthrough case admission
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd admission; breakthrough case admission
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Fibrin D dimer
Clinical narrative: FEELING LIKE GOING TO PASS OUT; DIZZINESS; TINGLING; SKIN STARTED COMING OFF; HANDS AND FEET BLUISH; PULMONARY EMBOLISM; BLOOD CLOTS IN LEFT KNEE AND LEFT LEG; This spontaneous report received from a patient concerned a 50 year old male of unspecified ethnicity. 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: 211D21A, expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced chest pain. On 06-JAN-2022, patient experienced his hands and feet become bluish and skin started coming off. On 17-JAN-2022, patient visited his primary doctor and found out he has high D-dimer and later found out patient has blood clots in lower left lung (pulmonary embolism). CT scans, sonogram and ultrasound in legs and arms showed blood clots in knee and left leg. On an unspecified date, patient experienced dizziness and when patient has dizziness his oxygen level falls below 90-92 and pulse goes up as the patient monitors and measures them himself. patient also experience of tingling and feeling like he will pass out. Treatment medications included: acetylsalicylic acid for chest pain. On JAN-2022, treatment medications included: apixaban for pulmonary embolism and blood clots in knee and left leg.  On 17-JAN-2022, Laboratory data included: CT scan (NR: not provided) blood clots, Diagnostic ultrasound (NR: not provided) blood clots, Fibrin D dimer (NR: not provided) high, and Sonogram (NR: not provided) blood clots. On FEB-2022, treatment medications included: apixaban. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) below 90-92. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and blood clots in left knee and left leg, and the outcome of tingling, skin started coming off, feeling like going to pass out, hands and feet bluish and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220221100- covid-19 vaccine ad26.cov2.s-Pulmonary embolism, Blood clots in left knee and left leg. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: FEELING LIKE GOING TO PASS OUT; DIZZINESS; TINGLING; SKIN STARTED COMING OFF; HANDS AND FEET BLUISH; PULMONARY EMBOLISM; BLOOD CLOTS IN LEFT KNEE AND LEFT LEG; This spontaneous report received from a patient concerned a 50 year old male of unspecified ethnicity. 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: 211D21A, expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced chest pain. On 06-JAN-2022, patient experienced his hands and feet become bluish and skin started coming off. On 17-JAN-2022, patient visited his primary doctor and found out he has high D-dimer and later found out patient has blood clots in lower left lung (pulmonary embolism). CT scans, sonogram and ultrasound in legs and arms showed blood clots in knee and left leg. On an unspecified date, patient experienced dizziness and when patient has dizziness his oxygen level falls below 90-92 and pulse goes up as the patient monitors and measures them himself. patient also experience of tingling and feeling like he will pass out. Treatment medications included: acetylsalicylic acid for chest pain. On JAN-2022, treatment medications included: apixaban for pulmonary embolism and blood clots in knee and left leg.  On 17-JAN-2022, Laboratory data included: CT scan (NR: not provided) blood clots, Diagnostic ultrasound (NR: not provided) blood clots, Fibrin D dimer (NR: not provided) high, and Sonogram (NR: not provided) blood clots. On FEB-2022, treatment medications included: apixaban. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) below 90-92. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and blood clots in left knee and left leg, and the outcome of tingling, skin started coming off, feeling like going to pass out, hands and feet bluish and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220221100- covid-19 vaccine ad26.cov2.s-Pulmonary embolism, Blood clots in left knee and left leg. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cyanosis, Dizziness, Fibrin D dimer, Oxygen saturation
Clinical narrative: FEELING LIKE GOING TO PASS OUT; DIZZINESS; TINGLING; SKIN STARTED COMING OFF; HANDS AND FEET BLUISH; PULMONARY EMBOLISM; BLOOD CLOTS IN LEFT KNEE AND LEFT LEG; This spontaneous report received from a patient concerned a 50 year old male of unspecified ethnicity. 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: 211D21A, expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced chest pain. On 06-JAN-2022, patient experienced his hands and feet become bluish and skin started coming off. On 17-JAN-2022, patient visited his primary doctor and found out he has high D-dimer and later found out patient has blood clots in lower left lung (pulmonary embolism). CT scans, sonogram and ultrasound in legs and arms showed blood clots in knee and left leg. On an unspecified date, patient experienced dizziness and when patient has dizziness his oxygen level falls below 90-92 and pulse goes up as the patient monitors and measures them himself. patient also experience of tingling and feeling like he will pass out. Treatment medications included: acetylsalicylic acid for chest pain. On JAN-2022, treatment medications included: apixaban for pulmonary embolism and blood clots in knee and left leg.  On 17-JAN-2022, Laboratory data included: CT scan (NR: not provided) blood clots, Diagnostic ultrasound (NR: not provided) blood clots, Fibrin D dimer (NR: not provided) high, and Sonogram (NR: not provided) blood clots. On FEB-2022, treatment medications included: apixaban. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) below 90-92. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and blood clots in left knee and left leg, and the outcome of tingling, skin started coming off, feeling like going to pass out, hands and feet bluish and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220221100- covid-19 vaccine ad26.cov2.s-Pulmonary embolism, Blood clots in left knee and left leg. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pulmonary embolism, Skin exfoliation, Thrombosis, Ultrasound scan
Clinical narrative: FEELING LIKE GOING TO PASS OUT; DIZZINESS; TINGLING; SKIN STARTED COMING OFF; HANDS AND FEET BLUISH; PULMONARY EMBOLISM; BLOOD CLOTS IN LEFT KNEE AND LEFT LEG; This spontaneous report received from a patient concerned a 50 year old male of unspecified ethnicity. 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: 211D21A, expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-DEC-2021, the patient experienced chest pain. On 06-JAN-2022, patient experienced his hands and feet become bluish and skin started coming off. On 17-JAN-2022, patient visited his primary doctor and found out he has high D-dimer and later found out patient has blood clots in lower left lung (pulmonary embolism). CT scans, sonogram and ultrasound in legs and arms showed blood clots in knee and left leg. On an unspecified date, patient experienced dizziness and when patient has dizziness his oxygen level falls below 90-92 and pulse goes up as the patient monitors and measures them himself. patient also experience of tingling and feeling like he will pass out. Treatment medications included: acetylsalicylic acid for chest pain. On JAN-2022, treatment medications included: apixaban for pulmonary embolism and blood clots in knee and left leg.  On 17-JAN-2022, Laboratory data included: CT scan (NR: not provided) blood clots, Diagnostic ultrasound (NR: not provided) blood clots, Fibrin D dimer (NR: not provided) high, and Sonogram (NR: not provided) blood clots. On FEB-2022, treatment medications included: apixaban. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) below 90-92. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and blood clots in left knee and left leg, and the outcome of tingling, skin started coming off, feeling like going to pass out, hands and feet bluish and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220221100- covid-19 vaccine ad26.cov2.s-Pulmonary embolism, Blood clots in left knee and left leg. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Anaphylactic shock  EpiPen Auto-injection  emergency  room care
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock  EpiPen Auto-injection  emergency  room care
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: This is a 77y.o. female with a PMH significant for HFrEF, CAD s/p stent placement and CABG, hx MI, Hx high grabe AV block, COPD, HLD, HTN, mitral valve stenosis s/p replacement, raynauds, sjogrens disease. Patient was recently admitted to geropsych and medicine was following. Patient was transferred out of geropsych and admitted to medicine. Patient tested positive for COVID on random testing in geropsych. Patient remains asymptomatic with regards to new COVID diagnosis. Psych to follow. Per chart review, patient originally here for aggressive behavior along with suicidal ideation.    Per discussion with nursing staff, patient remains risk of leaving room. Patient does not comprehend why she is in the hospital. Acknowledges that she recently tested positive for COVID. Patient is concerned wether or not her sons can visit, instructed they will likely not be able to with recent diagnosis.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aggression, Asymptomatic COVID-19, COVID-19, Confusional state, Nucleic acid test
Clinical narrative: This is a 77y.o. female with a PMH significant for HFrEF, CAD s/p stent placement and CABG, hx MI, Hx high grabe AV block, COPD, HLD, HTN, mitral valve stenosis s/p replacement, raynauds, sjogrens disease. Patient was recently admitted to geropsych and medicine was following. Patient was transferred out of geropsych and admitted to medicine. Patient tested positive for COVID on random testing in geropsych. Patient remains asymptomatic with regards to new COVID diagnosis. Psych to follow. Per chart review, patient originally here for aggressive behavior along with suicidal ideation.    Per discussion with nursing staff, patient remains risk of leaving room. Patient does not comprehend why she is in the hospital. Acknowledges that she recently tested positive for COVID. Patient is concerned wether or not her sons can visit, instructed they will likely not be able to with recent diagnosis.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Suicidal ideation
Clinical narrative: This is a 77y.o. female with a PMH significant for HFrEF, CAD s/p stent placement and CABG, hx MI, Hx high grabe AV block, COPD, HLD, HTN, mitral valve stenosis s/p replacement, raynauds, sjogrens disease. Patient was recently admitted to geropsych and medicine was following. Patient was transferred out of geropsych and admitted to medicine. Patient tested positive for COVID on random testing in geropsych. Patient remains asymptomatic with regards to new COVID diagnosis. Psych to follow. Per chart review, patient originally here for aggressive behavior along with suicidal ideation.    Per discussion with nursing staff, patient remains risk of leaving room. Patient does not comprehend why she is in the hospital. Acknowledges that she recently tested positive for COVID. Patient is concerned wether or not her sons can visit, instructed they will likely not be able to with recent diagnosis.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Discomfort, Insomnia, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: Pinched nerve, cervical area; neck hurt and throb / intense pain; Heaviness on shoulder; soreness/ shoulder muscle soreness; could not move neck; This case was reported by a consumer via call center representative and described the occurrence of pinched nerve in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid 19 vaccine (received 1st dose on an unknown date), Moderna covid 19 vaccine (received 2nd dose on an unknown date) and Moderna covid 19 vaccine (the 3rd dose being end of September 2021).   On 12th January 2022, the patient received the 1st dose of Shingrix. On 12th January 2022, less than a day after receiving Shingrix, the patient experienced neck pain (serious criteria clinically significant/intervention required), sensation of heaviness (serious criteria clinically significant/intervention required), localized muscle pain and stiff neck. On 24th January 2022, the patient experienced pinched nerve (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol), ibuprofen and tramadol. On an unknown date, the outcome of the pinched nerve, neck pain, sensation of heaviness, localized muscle pain and stiff neck were not recovered/not resolved.   The reporter considered the pinched nerve to be possibly related to Shingrix. It was unknown if the reporter considered the neck pain, sensation of heaviness, localized muscle pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced heaviness on top of her shoulder in the muscle on the day she received the vaccine and was still experiencing the soreness. The patient reported that, during the night her neck started to hurt and throb and could not move her neck, and the pain got intense.  The patient took Tylenol extra for the pain, but it did not help so the patient took Ibuprofen at 3 am on 13th January 2022. On 18th January 2022, the patient made an appointment with a physician (specialist in infection diseases) and prescribed her a Soft cervical collar told her to contact her primary care physician. The patient had an X-Ray of her neck and 12 days after vaccination with Shingrix, the physician suggested it could be a pinched nerve in the cervical area and the vaccine might had triggered it. The physician prescribed Ibuprofen 800 mg. The patient reported that, was told to see a cervical and spine specialist, who she saw and who prescribed her tramadol 50 mg 1 a day as needed (as she could not take Percocet and Gabapentin), that masked the pain but did not get rid of it. On the day of reporting in the morning, the patient had a cervical magnetic resonance imaging. The patient was very upset and asked the legal team to contact her. The patient declined to provide healthcare professional information The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain, Sleep disorder, Spinal X-ray abnormal, Swelling
Clinical narrative: Pinched nerve, cervical area; neck hurt and throb / intense pain; Heaviness on shoulder; soreness/ shoulder muscle soreness; could not move neck; This case was reported by a consumer via call center representative and described the occurrence of pinched nerve in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid 19 vaccine (received 1st dose on an unknown date), Moderna covid 19 vaccine (received 2nd dose on an unknown date) and Moderna covid 19 vaccine (the 3rd dose being end of September 2021).   On 12th January 2022, the patient received the 1st dose of Shingrix. On 12th January 2022, less than a day after receiving Shingrix, the patient experienced neck pain (serious criteria clinically significant/intervention required), sensation of heaviness (serious criteria clinically significant/intervention required), localized muscle pain and stiff neck. On 24th January 2022, the patient experienced pinched nerve (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol), ibuprofen and tramadol. On an unknown date, the outcome of the pinched nerve, neck pain, sensation of heaviness, localized muscle pain and stiff neck were not recovered/not resolved.   The reporter considered the pinched nerve to be possibly related to Shingrix. It was unknown if the reporter considered the neck pain, sensation of heaviness, localized muscle pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced heaviness on top of her shoulder in the muscle on the day she received the vaccine and was still experiencing the soreness. The patient reported that, during the night her neck started to hurt and throb and could not move her neck, and the pain got intense.  The patient took Tylenol extra for the pain, but it did not help so the patient took Ibuprofen at 3 am on 13th January 2022. On 18th January 2022, the patient made an appointment with a physician (specialist in infection diseases) and prescribed her a Soft cervical collar told her to contact her primary care physician. The patient had an X-Ray of her neck and 12 days after vaccination with Shingrix, the physician suggested it could be a pinched nerve in the cervical area and the vaccine might had triggered it. The physician prescribed Ibuprofen 800 mg. The patient reported that, was told to see a cervical and spine specialist, who she saw and who prescribed her tramadol 50 mg 1 a day as needed (as she could not take Percocet and Gabapentin), that masked the pain but did not get rid of it. On the day of reporting in the morning, the patient had a cervical magnetic resonance imaging. The patient was very upset and asked the legal team to contact her. The patient declined to provide healthcare professional information The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: Pinched nerve, cervical area; neck hurt and throb / intense pain; Heaviness on shoulder; soreness/ shoulder muscle soreness; could not move neck; This case was reported by a consumer via call center representative and described the occurrence of pinched nerve in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid 19 vaccine (received 1st dose on an unknown date), Moderna covid 19 vaccine (received 2nd dose on an unknown date) and Moderna covid 19 vaccine (the 3rd dose being end of September 2021).   On 12th January 2022, the patient received the 1st dose of Shingrix. On 12th January 2022, less than a day after receiving Shingrix, the patient experienced neck pain (serious criteria clinically significant/intervention required), sensation of heaviness (serious criteria clinically significant/intervention required), localized muscle pain and stiff neck. On 24th January 2022, the patient experienced pinched nerve (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol), ibuprofen and tramadol. On an unknown date, the outcome of the pinched nerve, neck pain, sensation of heaviness, localized muscle pain and stiff neck were not recovered/not resolved.   The reporter considered the pinched nerve to be possibly related to Shingrix. It was unknown if the reporter considered the neck pain, sensation of heaviness, localized muscle pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced heaviness on top of her shoulder in the muscle on the day she received the vaccine and was still experiencing the soreness. The patient reported that, during the night her neck started to hurt and throb and could not move her neck, and the pain got intense.  The patient took Tylenol extra for the pain, but it did not help so the patient took Ibuprofen at 3 am on 13th January 2022. On 18th January 2022, the patient made an appointment with a physician (specialist in infection diseases) and prescribed her a Soft cervical collar told her to contact her primary care physician. The patient had an X-Ray of her neck and 12 days after vaccination with Shingrix, the physician suggested it could be a pinched nerve in the cervical area and the vaccine might had triggered it. The physician prescribed Ibuprofen 800 mg. The patient reported that, was told to see a cervical and spine specialist, who she saw and who prescribed her tramadol 50 mg 1 a day as needed (as she could not take Percocet and Gabapentin), that masked the pain but did not get rid of it. On the day of reporting in the morning, the patient had a cervical magnetic resonance imaging. The patient was very upset and asked the legal team to contact her. The patient declined to provide healthcare professional information The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Magnetic resonance imaging neck, Movement disorder, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pinched nerve, cervical area; neck hurt and throb / intense pain; Heaviness on shoulder; soreness/ shoulder muscle soreness; could not move neck; This case was reported by a consumer via call center representative and described the occurrence of pinched nerve in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid 19 vaccine (received 1st dose on an unknown date), Moderna covid 19 vaccine (received 2nd dose on an unknown date) and Moderna covid 19 vaccine (the 3rd dose being end of September 2021).   On 12th January 2022, the patient received the 1st dose of Shingrix. On 12th January 2022, less than a day after receiving Shingrix, the patient experienced neck pain (serious criteria clinically significant/intervention required), sensation of heaviness (serious criteria clinically significant/intervention required), localized muscle pain and stiff neck. On 24th January 2022, the patient experienced pinched nerve (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol), ibuprofen and tramadol. On an unknown date, the outcome of the pinched nerve, neck pain, sensation of heaviness, localized muscle pain and stiff neck were not recovered/not resolved.   The reporter considered the pinched nerve to be possibly related to Shingrix. It was unknown if the reporter considered the neck pain, sensation of heaviness, localized muscle pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced heaviness on top of her shoulder in the muscle on the day she received the vaccine and was still experiencing the soreness. The patient reported that, during the night her neck started to hurt and throb and could not move her neck, and the pain got intense.  The patient took Tylenol extra for the pain, but it did not help so the patient took Ibuprofen at 3 am on 13th January 2022. On 18th January 2022, the patient made an appointment with a physician (specialist in infection diseases) and prescribed her a Soft cervical collar told her to contact her primary care physician. The patient had an X-Ray of her neck and 12 days after vaccination with Shingrix, the physician suggested it could be a pinched nerve in the cervical area and the vaccine might had triggered it. The physician prescribed Ibuprofen 800 mg. The patient reported that, was told to see a cervical and spine specialist, who she saw and who prescribed her tramadol 50 mg 1 a day as needed (as she could not take Percocet and Gabapentin), that masked the pain but did not get rid of it. On the day of reporting in the morning, the patient had a cervical magnetic resonance imaging. The patient was very upset and asked the legal team to contact her. The patient declined to provide healthcare professional information The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Nerve compression, X-ray abnormal
Clinical narrative: Pinched nerve, cervical area; neck hurt and throb / intense pain; Heaviness on shoulder; soreness/ shoulder muscle soreness; could not move neck; This case was reported by a consumer via call center representative and described the occurrence of pinched nerve in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna covid 19 vaccine (received 1st dose on an unknown date), Moderna covid 19 vaccine (received 2nd dose on an unknown date) and Moderna covid 19 vaccine (the 3rd dose being end of September 2021).   On 12th January 2022, the patient received the 1st dose of Shingrix. On 12th January 2022, less than a day after receiving Shingrix, the patient experienced neck pain (serious criteria clinically significant/intervention required), sensation of heaviness (serious criteria clinically significant/intervention required), localized muscle pain and stiff neck. On 24th January 2022, the patient experienced pinched nerve (serious criteria clinically significant/intervention required). The patient was treated with paracetamol (Tylenol), ibuprofen and tramadol. On an unknown date, the outcome of the pinched nerve, neck pain, sensation of heaviness, localized muscle pain and stiff neck were not recovered/not resolved.   The reporter considered the pinched nerve to be possibly related to Shingrix. It was unknown if the reporter considered the neck pain, sensation of heaviness, localized muscle pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced heaviness on top of her shoulder in the muscle on the day she received the vaccine and was still experiencing the soreness. The patient reported that, during the night her neck started to hurt and throb and could not move her neck, and the pain got intense.  The patient took Tylenol extra for the pain, but it did not help so the patient took Ibuprofen at 3 am on 13th January 2022. On 18th January 2022, the patient made an appointment with a physician (specialist in infection diseases) and prescribed her a Soft cervical collar told her to contact her primary care physician. The patient had an X-Ray of her neck and 12 days after vaccination with Shingrix, the physician suggested it could be a pinched nerve in the cervical area and the vaccine might had triggered it. The physician prescribed Ibuprofen 800 mg. The patient reported that, was told to see a cervical and spine specialist, who she saw and who prescribed her tramadol 50 mg 1 a day as needed (as she could not take Percocet and Gabapentin), that masked the pain but did not get rid of it. On the day of reporting in the morning, the patient had a cervical magnetic resonance imaging. The patient was very upset and asked the legal team to contact her. The patient declined to provide healthcare professional information The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Aspiration, COVID-19 pneumonia, Cerebrovascular accident, Computerised tomogram head normal
Clinical narrative: Client passed away on 2/13/2022 while positive with covid.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hemiparesis, Hypoxia
Clinical narrative: Client passed away on 2/13/2022 while positive with covid.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Client passed away on 2/13/2022 while positive with covid.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: Expired dose of M-M-R II were administered; No additional Adverse event reported; This spontaneous report was received from medical assistant referring patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 02-FEB-2022, the patient vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, Live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter, (lot #T001212, expiration date reported as 12-JAN-2022), administered subcutaneously for prophylaxis (Expired product administered).
Age: 65.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Injection site inflammation, Rash erythematous, Vomiting
Clinical narrative: Patient Received one dose of Prevnar-20 pneumonia vaccine on 2/5/2022. She returned to the pharmacy today on 2/14/2022 and informed me that she had a significant reaction  to the vaccine the day after administration.  She was bed ridden for 2 days. significant vomiting for 2 days. Not feeling well. Her entire arm from shoulder to wrist was red and swollen.  She showed me a pic of her arm.  She is doing better now but wanted to let me know that she had such a severe reaction.
Age: 65.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Erythema, Malaise, Peripheral swelling, Vomiting
Clinical narrative: Patient Received one dose of Prevnar-20 pneumonia vaccine on 2/5/2022. She returned to the pharmacy today on 2/14/2022 and informed me that she had a significant reaction  to the vaccine the day after administration.  She was bed ridden for 2 days. significant vomiting for 2 days. Not feeling well. Her entire arm from shoulder to wrist was red and swollen.  She showed me a pic of her arm.  She is doing better now but wanted to let me know that she had such a severe reaction.
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Cough, Headache, Nausea, Pain
Clinical narrative: Fever for 48 hours ranging from 100.1 to 100.8 Headache  Fatigue Burning and tingling on entire body  Weakness in joints  Nausea
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain of skin, Pyrexia, Skin burning sensation, Tachycardia
Clinical narrative: Fever for 48 hours ranging from 100.1 to 100.8 Headache  Fatigue Burning and tingling on entire body  Weakness in joints  Nausea
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Burning sensation, Fatigue, Headache, Nausea
Clinical narrative: Fever for 48 hours ranging from 100.1 to 100.8 Headache  Fatigue Burning and tingling on entire body  Weakness in joints  Nausea
Age: 69.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fever for 48 hours ranging from 100.1 to 100.8 Headache  Fatigue Burning and tingling on entire body  Weakness in joints  Nausea
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Inadvertently administered improperly stored vaccine; This spontaneous report was received from medical student referring to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 28-OCT-2021, the patient vaccinated with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, (lot number T034380, expiration date established as 08-JAN-2022, dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. the patient inadvertently administered improplerly stored vaccine (Product storage error). the vaccine was stored for the time frame of 2 hours in the temperature of 50.29 Fahrenheit (F). There was no previous temperature excursion.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and concurrent conditions included: G6PD (glucose-6-phosphate-dehydrogenase deficiency), and other pre-existing medical conditions included: Patient was not on any medication before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 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 an unspecified date in AUG-2021, the patient experienced heart attack. Patient reported that it was second heart attack and it was almost an occluded artery. Patient was taking blood thinner and other medications (total 3).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220219093-JANSSEN COVID-19 VACCINE Ad26.COV2.S- HEART ATTACK. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral coldness, Pruritus
Clinical narrative: My legs and arms were itching.  I was get needle like pains in my legs and feet.  It felt like cold water in my feet some times.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Soreness and pain at the site of injection and on my shoulder blades since the injection day until today
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatologic examination, Muscle spasms, Pruritus, Rash, Urticaria
Clinical narrative: Itchiness and hives 10 days later.  Went to urgent care and was prescribed Benadryl, Claritin, and Famotidine. After breaking out in full-body hives on day 13 after moderna booster, I went to out of state dermatologist  and was prescribed a prednisone taper. I am still experiencing rashes and some breathing/chest spasms, so my local dermatologist has me taking Zyrtec twice a day. I have an appointment with an allergy specialist in 3 days. I have been messaging with my primary care provider.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan normal
Clinical narrative: Swollen lymph node left side of neck
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Oral pruritus, Pain in extremity, Skin warm
Clinical narrative: Welts Hot to touch Itchy mouth/tongue  Red Severe arm pain Nausea  Fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration, Urticaria
Clinical narrative: Welts Hot to touch Itchy mouth/tongue  Red Severe arm pain Nausea  Fatigue
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Gait disturbance, Hypersomnia, Muscular weakness, Nausea
Clinical narrative: Extreme muscle weakness, nausea, heart palpitations, sleeping 20-22 hours a day for 2 weeks, sleeping 18-20 hours a day for another week. Inability to walk between rooms, shortness of breath
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: Extreme muscle weakness, nausea, heart palpitations, sleeping 20-22 hours a day for 2 weeks, sleeping 18-20 hours a day for another week. Inability to walk between rooms, shortness of breath
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Migraine
Clinical narrative: Had headaches; Had migraines; This case was reported by a consumer via call center representative and described the occurrence of headache in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Shingrix. On 3rd February 2022, 2 days after receiving Shingrix, the patient experienced headache and migraine. On an unknown date, the outcome of the headache and migraine were not recovered/not resolved.   It was unknown if the reporter considered the headache and migraine to be related to Shingrix.  Additional details were provided as follows: On 1st February 2022 Tuesday, the patient had first shot of the vaccine. The patient had headaches and migraines since Thursday (3rd February 2022). The patient enquired if it could be a reaction to Shingrix. The reporter consented to follow-up
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: vaccine expired, used for a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 4th February 2022, patient received a dose of Bexsero by mistake thinking it was not expired, but it was expired on 31st January 2022 The reporter wondered if needed to give another dose or the vaccine had a beyond use date and was still viable. It had been stored in the fridge the whole time. The reporter consented to follow up. No further details provided on web form.  The reporter was unable to reach health care professional and a voicemail was left. . The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019, not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter declined to provide patient demographics. The reporter consented to follow-up via postal.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Syncope
Clinical narrative: COLLAPSED TWICE; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a patient via a company representative via media concerned a 12 year old of unspecified sex, race and ethnicity. 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 and batch number was not reported) dose, 1 total, 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 patient experienced collapsed twice, off label use, and product administered to patient of inappropriate age. "Reporters cousin 12 year old had collapsed twice after the vaccine. Reporters husband had changed sense getting vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapsed twice, off label use and product administered to patient of inappropriate age was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220224963.; Sender's Comments: V0:20220224739-covid-19 vaccine ad26.cov2.s-collapsed twice. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Feeling hot, Pruritus, Pyrexia, Rash
Clinical narrative: Pain Joints, fever and rash all over the body. The skin looks as if it is sunburned. Covers 90% of the body. It feels hot to the touch and very itchy. The ER doctor supplied Benadryl 50 mg methylprednisolone.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: Pain Joints, fever and rash all over the body. The skin looks as if it is sunburned. Covers 90% of the body. It feels hot to the touch and very itchy. The ER doctor supplied Benadryl 50 mg methylprednisolone.