chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperaesthesia, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: On Sunday 08Aug2021 my right arm, shoulder & forearm was very sensitive to touch.; On Sunday 08Aug2021 my right arm, shoulder & forearm was very sensitive to touch.; My right arm, shoulder & forearm was stiff/Still sore & stiff; On Sunday Aug. 8, 2021 my right arm, shoulder & forearm was very sore,/Still sore; My arm aches at night before & during bedtime.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 12:00 (Lot number: EW0173) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NAPROXEN; ACETAMINOPHEN taken for pain, start date: 07Aug2021, stop date: 22Aug2021. Past drug history included: Acetaminophen, start date: 17Jul2021, stop date: 20Jul2021, notes: Reason for Use: pain, Route: oral. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0173,, dose number=1,, vaccine location=Left arm, Route of administration:Intramuscular, No events reported), administration date: 17Jul2021, when the patient was 51 years old. The following information was reported: HYPERAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Aug2021 09:00, outcome "not recovered" and all described as "On Sunday 08Aug2021 my right arm, shoulder & forearm was very sensitive to touch."; ARTHRALGIA (non-serious) with onset 08Aug2021, outcome "not recovered", described as "On Sunday Aug. 8, 2021 my right arm, shoulder & forearm was very sore,/Still sore"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 08Aug2021 09:00, outcome "not recovered", described as "My right arm, shoulder & forearm was stiff/Still sore & stiff"; PAIN (non-serious) with onset Aug2021, outcome "not recovered", described as "My arm aches at night before & during bedtime.". Therapeutic measures were not taken as a result of hyperaesthesia, pain in extremity, arthralgia, musculoskeletal stiffness. Therapeutic measures were taken as a result of pain.   Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.List of any other medications the patient received within 2 weeks of vaccination as Naproxen 500mg.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination,the patient has not been tested for COVID-19.Known allergies was None.Other medical history as None.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (24Sep2021):This is a spontaneous follow-up report from a contactable female consumer reported that,Concomitant drugs,past drug history and product route of administration was added.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inflammation, Myalgia, Nausea, Neck pain
Clinical narrative: Vertigo; sore neck starting that day and continues currently; site inflammation; chills; nausea; muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 18:00 (Lot number: FD8448) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic bronchidis" (unspecified if ongoing); "Allergy: Penicllin" (unspecified if ongoing), notes: Allergy: Penicllin. Concomitant medication(s) included: IBUPROFEN. Past drug history included: Zyban, reaction(s): "known allergies: zyban", notes: known allergies: zyban. The following information was reported: VERTIGO (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "Vertigo"; NECK PAIN (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "sore neck starting that day and continues currently"; INFLAMMATION (non-serious) with onset 12Aug2021 12:30, outcome "recovered" (13Aug2021), described as "site inflammation"; CHILLS (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 12Aug2021 12:30, outcome "recovered" (13Aug2021), described as "nausea"; MYALGIA (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "muscle aches". Therapeutic measures were not taken as a result of vertigo, neck pain, inflammation, chills, nausea, myalgia.  Additional information: Patient has not been vaccinated prior to 4 weeks of vaccination.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; sore neck starting that day and continues currently; site inflammation; chills; nausea; muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 18:00 (Lot number: FD8448) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic bronchidis" (unspecified if ongoing); "Allergy: Penicllin" (unspecified if ongoing), notes: Allergy: Penicllin. Concomitant medication(s) included: IBUPROFEN. Past drug history included: Zyban, reaction(s): "known allergies: zyban", notes: known allergies: zyban. The following information was reported: VERTIGO (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "Vertigo"; NECK PAIN (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "sore neck starting that day and continues currently"; INFLAMMATION (non-serious) with onset 12Aug2021 12:30, outcome "recovered" (13Aug2021), described as "site inflammation"; CHILLS (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 12Aug2021 12:30, outcome "recovered" (13Aug2021), described as "nausea"; MYALGIA (non-serious) with onset 12Aug2021 12:30, outcome "not recovered", described as "muscle aches". Therapeutic measures were not taken as a result of vertigo, neck pain, inflammation, chills, nausea, myalgia.  Additional information: Patient has not been vaccinated prior to 4 weeks of vaccination.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Overdose, Rash, Rash pruritic
Clinical narrative: Had 2nd dose and 3 weeks after had a terrible itching rash behind my legs and groin; Still have rash on whole body; Dose 1 and dose 2 both was administered on same day; Dose 1 and dose 2 both was administered on same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: ER8732) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bone degeneration" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; FISH OIL; POTASSIUM; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE  EN6198  Vaccine Location: Left arm), administration date: 08Mar2021, for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 21Apr2021 08:00, outcome "recovered" (2021), described as "Had 2nd dose and 3 weeks after had a terrible itching rash behind my legs and groin"; RASH (non-serious) with onset 21Apr2021 08:00, outcome "not recovered", described as "Still have rash on whole body"; OVERDOSE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 08Mar2021, outcome "unknown" and all described as "Dose 1 and dose 2 both was administered on same day". The events "had 2nd dose and 3 weeks after had a terrible itching rash behind my legs and groin" and "still have rash on whole body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash pruritic, rash.  Additional information:Race Information was available. Ethnicity information was available. Facility information was available. Other vaccine in four weeks was unknown. Other medications in two weeks were Adderall, fish oil, potassium, vitamin D. Patient Had 2nd dose and 3 weeks after had a terrible itching rash behind legs and groin. Went to pcp 2x given Prednisone, Zyrtec,  caladryl Then dermatologist was given hydroxyzine, triamcinolone acetonide for the treatment of adverse event. Legs and groin had cleared. Still have rash on whole body. This was going on 5months. AE was resulted in reported as [Doctor or other healthcare professional office/clinic visit].Patient was not recovered. No Known allergies. No covid prior vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. the Pfizer product had a causal effect to the adverse event was reported as No.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present; Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present; Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 17:00 (Lot number: ER8731) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRETOR; LEXAPRO; WELLBUTRIN.  The following information was reported: PAIN (non-serious), ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 14Apr2021 20:00, outcome "recovered with sequelae" (Apr2021) and all described as "Severe joint and muscle pain in upper body. 8 days after 1st shot, 3 days after 2nd, and persistent joint pain in shoulders and elbows through present". Therapeutic measures were not taken as a result of pain, arthralgia, myalgia.  Additional Information: Patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 17:00 (Lot number: ER0158) as dose 2, single for covid-19 immunisation. The outcome of event was recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: after 2nd, and persistent joint pain in shoulders and elbows through present; after 2nd, and persistent joint pain in shoulders and elbows through present; after 2nd, and persistent joint pain in shoulders and elbows through present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 17:00 (Lot number: EW0158) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR; LEXAPRO; WELLBUTRIN. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: ER8731, Lot unknown: False, Administration date: 14Apr2021, Administration time: 05:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 14Apr2021, when the patient was 38 years old, for COVID-19 immunisation, reaction(s): "Pain", "Joint pain", "Muscle pain". The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 08May2021, outcome "recovered" (2021) and all described as "after 2nd, and persistent joint pain in shoulders and elbows through present". Therapeutic measures were not taken as a result of arthralgia, arthralgia, arthralgia.  Additional Information: Patient had not taken other vaccine in four weeks. Clinical course: It was reported that adverse event were severe joint and muscle pain in upper body. 8 days after first shot, 3 days after second, and persistent joint pain in shoulders and elbows through present and Recovered with lasting effects. After the first dose, Adverse event start date was 14Apr2021 and Adverse event start time was 08:00 PM. Patient had no Covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got them, got the shot/suspected vaccination failure; got them; hurt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got a shot and got shingles about five days ago. The patient stated it hurt. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact detail were available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chest discomfort, Headache, Night sweats, Pain in extremity
Clinical narrative: Night sweats, woke up 4 times; Sore arm; Tightness in chest; Fever; Headache; Pain under armpit; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2022, the patient received the 2nd dose of Shingrix. On 24th January 2022, less than a day after receiving Shingrix, the patient experienced pain in arm, chest tightness, fever, headache and axillary pain. On 26th January 2022, the patient experienced night sweat. On an unknown date, the outcome of the pain in arm, chest tightness, fever and headache were recovered/resolved and the outcome of the axillary pain and night sweat were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chest tightness, fever, headache, axillary pain and night sweat to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter stated that she experienced a sore arm, tightness in the chest, fever, headache, and pain under the armpit which started on that day.  All symptoms had resolved except for the pain under the armpit which was still present. The reporter also stated that she started to experience night sweats last night on 26th January 2022 and woke up 4 times during the night.  The night sweats had not resolved. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Night sweats, woke up 4 times; Sore arm; Tightness in chest; Fever; Headache; Pain under armpit; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2022, the patient received the 2nd dose of Shingrix. On 24th January 2022, less than a day after receiving Shingrix, the patient experienced pain in arm, chest tightness, fever, headache and axillary pain. On 26th January 2022, the patient experienced night sweat. On an unknown date, the outcome of the pain in arm, chest tightness, fever and headache were recovered/resolved and the outcome of the axillary pain and night sweat were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chest tightness, fever, headache, axillary pain and night sweat to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter stated that she experienced a sore arm, tightness in the chest, fever, headache, and pain under the armpit which started on that day.  All symptoms had resolved except for the pain under the armpit which was still present. The reporter also stated that she started to experience night sweats last night on 26th January 2022 and woke up 4 times during the night.  The night sweats had not resolved. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS FOR COUPLE OF DAYS; This spontaneous report received from a patient via a company representative concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had covid-19 before. 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. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills for couple of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills for couple of days. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myopericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myopericarditis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myopericarditis) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to MYOCARDITIS. At the time of the report, MYOCARDITIS (myopericarditis) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (myopericarditis) to be related.    No concomitant and treatment medications were reported.  Patient's age was reported to be between 18-24 years  Company comment: This is a literature-non-study case concerning a adult female patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-469162 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a adult female patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myopericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myopericarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myopericarditis) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to MYOCARDITIS. At the time of the report, MYOCARDITIS (myopericarditis) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (myopericarditis) to be related.    No concomitant and treatment medications were reported.  Patient age was reported to be between 18-24 years  Company comment: This is a literature-non-study case concerning a adult male patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-467841 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a adult male patient of unknown age with no reported medical history, who experienced the expected, serious, AESI event of myocarditis. The event myocarditis exact occurrence unknown but stated that the event occurred after the second dose of mRNA-1273 vaccine administration and resulted to hospitalization. No reported treatment information. The outcome of the event myocarditis was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Respiratory failure
Clinical narrative: Respiratory failure; COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: (Privacy)    The patient's past medical history included Liver transplant.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death and medically significant) and COVID-19 (COVID-19). The patient died on an unknown date. The reported cause of death was Respiratory failure. It is unknown if an autopsy was performed. At the time of death, COVID-19 (COVID-19) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RESPIRATORY FAILURE (Respiratory failure) and COVID-19 (COVID-19) to be related.    Concomitant medications were not reported.  Treatment details were not provided.  Patient developed COVID-19, 18 days after the second dose of mRNA-1273 vaccine and died from respiratory failure.  Company Comment: This is a literature case concerning an 80-year-old male patient with medical history of liver transplant, who experienced the non-serious unexpected AESI of COVID-19 and serious unexpected fatal event of respiratory failure. The events occurred 18 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 was not applicable to the product administration and conservatively assessed as related for respiratory failure event. Very limited information available on the disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   This case was linked to MOD-2022-469634 (Patient Link).; Sender's Comments: This is a literature case concerning an 80-year-old male patient with medical history of liver transplant, who experienced the non-serious unexpected AESI of COVID-19 and serious unexpected fatal event of respiratory failure. The events occurred 18 days after the second dose of the mRNA-1273 vaccine. Causality for the event of COVID-19 was not applicable to the product administration and conservatively assessed as related for respiratory failure event. Very limited information available on the disease course and treatment at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.; Reported Cause(s) of Death: Respiratory failure
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fear of death, Tremor
Clinical narrative: During night shaking uncontrollably/thought I might have had a stroke when I was shaking. scared me to death; My hip hurt me so bad. Lasted 3 hours and then immediately went away.; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (During night shaking uncontrollably/thought I might have had a stroke when I was shaking.), FEAR OF DEATH (scared me to death) and ARTHRALGIA (My hip hurt me so bad. Lasted 3 hours and then immediately went away.) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (During night shaking uncontrollably/thought I might have had a stroke when I was shaking.), FEAR OF DEATH (scared me to death) and ARTHRALGIA (My hip hurt me so bad. Lasted 3 hours and then immediately went away.). At the time of the report, TREMOR (During night shaking uncontrollably/thought I might have had a stroke when I was shaking.) and FEAR OF DEATH (scared me to death) outcome was unknown and ARTHRALGIA (My hip hurt me so bad. Lasted 3 hours and then immediately went away.) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Aches; headache; chills; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 14:30 (Lot number: FC3181) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PRILOSEC [OMEPRAZOLE].  The following information was reported: PAIN (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "Aches"; HEADACHE (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "headache"; CHILLS (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "chills"; PYREXIA (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "fever". Therapeutic measures were not taken as a result of pain, headache, chills, pyrexia.  Additional information: Most recent COVID-19 vaccine was administered at the hospital facility. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient received Lisinopril, and Prilosec within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Serum sickness
Clinical narrative: serum sickness; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SERUM SICKNESS (non-serious), outcome "unknown," described as "serum sickness."  Additional information: The reporter was asking for any information on serum sickness with Prevnar 13. The reporter had a patient, who experienced this, but did not have any patient information right now. The reporter was just gathering information and had the website to report online.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.; Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.; Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Aug2021 15:00 (Lot number: FC3183) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "known allergies: Yes, azithromycin". Vaccination history included: Bnt162b2 (lot number FA6780, administration time 15:00, vaccine location Right arm, dose 1, single), administration date: 28Jul2021, when the patient was 24 years old, for COVID-19 Immunisation. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), URTICARIA (non-serious) all with onset 18Aug2021 20:00, outcome "not recovered" and all described as "Large, red, itchy welts covering both legs. Around 20 welts spread out over the front and back legs.". Therapeutic measures were not taken as a result of erythema, pruritus, urticaria.  Additional information: patient has not taken any other vaccine in four weeks. Patient has not tested covid-19 prior to vaccine and not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Pruritus
Clinical narrative: First dose resulted in intense itching in legs and arms; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 (Lot number: EW0167) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe environmental allergies" (unspecified if ongoing); "OAS" (unspecified if ongoing); "acute asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA. Past drug history included: Azithromycin, reaction(s): "allergies"; Pediazole, reaction(s): "allergies"; Rynatan, reaction(s): "allergies". The following information was reported: PRURITUS (non-serious) with onset 14May2021, outcome "recovered with sequelae" (2021), described as "First dose resulted in intense itching in legs and arms"; PANIC ATTACK (non-serious) with onset 14May2021, outcome "recovered with sequelae" (2021), described as "panic attack". Therapeutic measures were taken as a result of pruritus, panic attack.  Additional information: If other vaccine in four weeks: No. other medications in two weeks: Allegra 180 mg Adverse event: First dose resulted in intense itching in legs and arms which brought about a panic attack. If patient recovered: Recovered with lasting effects. if Covid prior vaccination: Yes. if Covid tested post vaccination: No.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Paraesthesia
Clinical narrative: felt a tight pinching feeling in the left side " elbow pit"; purple looking bruise; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 14:30 (Lot number: FC3181) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot number: FA6780, Administration time: 10:30 AM, Dose number: 1, Vaccine location: Left arm), administration date: 22Jul2021, when the patient was 50 years old, for Covid-19 immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 21Aug2021 12:30, outcome "not recovered", described as "felt a tight pinching feeling in the left side " elbow pit""; CONTUSION (non-serious) with onset 21Aug2021, outcome "not recovered", described as "purple looking bruise". Therapeutic measures were not taken as a result of paraesthesia, contusion.  Additional information: Patient did not have any vaccine in four weeks. Prior and post vaccination patient was not tested for Covid. Patient did not had any allergies and medical history.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Cough, Dyspnoea, SARS-CoV-2 test
Clinical narrative: shoulder pain; shortness of breath; cough; tickle sensation in my chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: Er2613) as dose 1, single and administered in arm right, administration date 12Apr2021 (Lot number: Er8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE].  The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; COUGH (non-serious), outcome "unknown", described as "cough"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tickle sensation in my chest". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Other medications in two weeks: Flonase. If other vaccine in four weeks: No. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. Adverse event: She had shoulder pain for over three months also she had a shortness of breath and cough tickle sensation in her chest that comes and goes every day every hour.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter
Clinical narrative: shoulder pain; shortness of breath; cough; tickle sensation in my chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: Er2613) as dose 1, single and administered in arm right, administration date 12Apr2021 (Lot number: Er8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE].  The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; COUGH (non-serious), outcome "unknown", described as "cough"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tickle sensation in my chest". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Other medications in two weeks: Flonase. If other vaccine in four weeks: No. If COVID prior vaccination: No. If COVID tested post vaccination: Yes. Adverse event: She had shoulder pain for over three months also she had a shortness of breath and cough tickle sensation in her chest that comes and goes every day every hour.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Chills; arm pain; Fever; Nausea; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 09:00 (Lot number: FC3181) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CENTRUM MULTIGUMMIES; GRAPE SEED EXTRACT [CITRUS AURANTIUM FRUIT;VITIS VINIFERA SEED]; TART CHERRY. Vaccination history included: Bnt162b2 (Covid vaccine details:, Product: COVID 19, Brand: Pfizer, Lot number: Fa7484, Lot unknown: False, Administration time: 12:00 PM, Vaccine location: Left arm, Dose number: 1), administration date: 30Jul2021, when the patient was 60 years old, for COVID-19 Immunisation.  The following information was reported: CHILLS (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "arm pain"; PYREXIA (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Fever"; NAUSEA (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Nausea"; MALAISE (non-serious) with onset 20Aug2021 19:00, outcome "recovering", described as "Feeling unwell". Therapeutic measures were not taken as a result of chills, pain in extremity, pyrexia, nausea, malaise.  Additional information: No other vaccine received with in four weeks. No Covid prior vaccination and has not been tested after vaccination. Patient did not receive any treatment.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Magnetic resonance imaging
Clinical narrative: When I walk I kind of have a little short of breathe; Short breathing when I walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FC3181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neuralgia" (unspecified if ongoing), notes: Verbatim: Nerve pain. Concomitant medication(s) included: GABAPENTIN taken for neuralgia. The following information was reported: DYSPNOEA (non-serious) with onset 19Aug2021, outcome "not recovered", described as "When I walk I kind of have a little short of breathe; Short breathing when I walk". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had not received any vaccination 4 weeks prior to COVID 19 Vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: Nausea; Chills; elevated temperature; temperature is 100.4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 18Aug2021 (Lot number: FC3180) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EW0176, Deltoid left), administration date: 27Jul2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 19Aug2021, outcome "unknown", described as "Nausea"; CHILLS (non-serious) with onset 19Aug2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset 19Aug2021, outcome "unknown", described as "elevated temperature; temperature is 100.4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, chills, pyrexia.  Additional Information: Treatment for AE: Reporter stated, "No, we have I looked to the information sheet to see if he took Tylenol or something for it but I can't see anything on the information sheet advising us what to take if he did had symptoms other than the call." Anatomical site: Reporter stated, "Both of them left, left deltoid." When asked for any other help: Reporter stated, "What should we do for him he is having chills and his temperature is 100.4."  Follow-up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Experiencing on and off chest pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN.), for COVID-19 immunisation. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Experiencing on and off chest pain".  Additional Information: This consumer (patient's daughter) reported for a 74-year-old female patient that: Daughter of the patient reported an event for Comirnaty. The daughter mentioned that following 2nd dose of Comirnaty, the patient has been experiencing on and off chest pain. No further details provided, no consent for follow-up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Lip swelling, Oral discomfort, Paraesthesia
Clinical narrative: red, hot, swollen lips; red, hot, swollen lips; red, hot, swollen lips; tingling sensation on back of neck (left side); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jun2021 (Lot number: EW0180) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Severe environmental allergies" (unspecified if ongoing); "OAS" (unspecified if ongoing); "acute asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: ALLEGRA. Past drug history included: Azithromycin, reaction(s): "Allergy"; Pediazole, reaction(s): "Allergy"; Rynatan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number: EW0167, vaccine location: Left arm), administration date: 14May2021, when the patient was 34 years old, for Covid-19 Immunisation, reaction(s): "panic attack", "intense itching in legs and arms". The following information was reported: LIP SWELLING (non-serious), LIP ERYTHEMA (non-serious), ORAL DISCOMFORT (non-serious), outcome "recovered with sequelae" and all described as "red, hot, swollen lips"; PARAESTHESIA (non-serious), outcome "recovered with sequelae", described as "tingling sensation on back of neck (left side)".  Additional Information: The patient was an adult (18-64 Years). The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. other medications in two weeks: Allegra 180 mg. The patient had been diagnosed with COVID-19 prior to vaccination and had not been tested post the vaccination.  Follow-up attempts are completed. No further information is expected.