chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Pruritus
Clinical narrative: felt a little tired; scalp and left side of my face still numb; scalp still itches in the evenings; This case was reported by a consumer via  interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced tiredness, numbness and itchy scalp. On an unknown date, the outcome of the tiredness was unknown and the outcome of the numbness and itchy scalp were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, numbness and itchy scalp to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient just received 2nd shot of Shingles vaccine. On next day, the patient felt a little tired but beats getting it again. The patient's scalp and left side of face still numb and scalp still itches in the evenings. Note: The event itchy scalp and numbness were conservatively captured as events, as it was not clear if their events occurred before or after vaccination.
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Tenderness for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of tenderness in a adult female patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tenderness. On an unknown date, the outcome of the tenderness was recovered/resolved.   It was unknown if the reporter considered the tenderness to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by patient's parent. The age at vaccination was not reported The patient had received Bexsero vaccine and had tenderness for a couple of days and got recovered on 10th March 2022. The reporter attempted to call consumer back to gather additional details for adverse event reporting, left message for consumer.  The adverse event was left on the afterhours VM in Medical Information and reported in its entirety based on the VM message.  No additional details regarding adverse event. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Dry mouth, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: her heart was racing due to "adrenaline rush"; heart was racing; dry mouth increased; felt lightheaded; numbness in her hands and feet worsened; tingling in her hands and feet worsened; tingling in her hands and feet worsened; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of dizziness (received COVID-19 vaccine on an unknown date). Concurrent medical conditions included cerebral palsy, paresthesia, dry mouth and numbness. Concomitant products included botulinum toxin type a (Botox).   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 10th March 2022, less than a day after receiving Shingrix, the patient experienced tachycardia, heart racing, mouth dry aggravated, light headedness, numbness of extremities, tingling feet/hands and condition aggravated. The patient was treated with glucose oxidase + lactoferrin + lactoperoxidase + lysozyme (Biotene) and muscle relaxants. On an unknown date, the outcome of the tachycardia, heart racing, mouth dry aggravated and light headedness were recovered/resolved and the outcome of the numbness of extremities, tingling feet/hands and condition aggravated were unknown.   It was unknown if the reporter considered the tachycardia, heart racing, mouth dry aggravated, light headedness, numbness of extremities, tingling feet/hands and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient also had lightheadedness, tachycardia, dry mouth and paresthesia after receiving a COVID vaccine at an unknown time in the past. The patient received dose of Shingrix vaccine at a pharmacy about 2 hours ago and immediately felt lightheaded. The patient felt her heart was racing. She was not sure if the racing heart was due to the vaccine or walking up a flight of stairs. The patient had a history of chronic dry mouth. The dry mouth increased immediately after the injection. The patient also had a history of numbness and tingling in her hands and feet and it worsened. The patient took Biotene to treat the dry mouth and was recovered. The patient also took Botox and muscle relaxants as a treatment medication. The patient consulted the pharmacist who administered the vaccine and he felt the effects were due to adrenaline rush after getting a vaccine. The reporter consented to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Paraesthesia, Tachycardia
Clinical narrative: her heart was racing due to "adrenaline rush"; heart was racing; dry mouth increased; felt lightheaded; numbness in her hands and feet worsened; tingling in her hands and feet worsened; tingling in her hands and feet worsened; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of dizziness (received COVID-19 vaccine on an unknown date). Concurrent medical conditions included cerebral palsy, paresthesia, dry mouth and numbness. Concomitant products included botulinum toxin type a (Botox).   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 10th March 2022, less than a day after receiving Shingrix, the patient experienced tachycardia, heart racing, mouth dry aggravated, light headedness, numbness of extremities, tingling feet/hands and condition aggravated. The patient was treated with glucose oxidase + lactoferrin + lactoperoxidase + lysozyme (Biotene) and muscle relaxants. On an unknown date, the outcome of the tachycardia, heart racing, mouth dry aggravated and light headedness were recovered/resolved and the outcome of the numbness of extremities, tingling feet/hands and condition aggravated were unknown.   It was unknown if the reporter considered the tachycardia, heart racing, mouth dry aggravated, light headedness, numbness of extremities, tingling feet/hands and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient also had lightheadedness, tachycardia, dry mouth and paresthesia after receiving a COVID vaccine at an unknown time in the past. The patient received dose of Shingrix vaccine at a pharmacy about 2 hours ago and immediately felt lightheaded. The patient felt her heart was racing. She was not sure if the racing heart was due to the vaccine or walking up a flight of stairs. The patient had a history of chronic dry mouth. The dry mouth increased immediately after the injection. The patient also had a history of numbness and tingling in her hands and feet and it worsened. The patient took Biotene to treat the dry mouth and was recovered. The patient also took Botox and muscle relaxants as a treatment medication. The patient consulted the pharmacist who administered the vaccine and he felt the effects were due to adrenaline rush after getting a vaccine. The reporter consented to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dermatitis, Post herpetic neuralgia
Clinical narrative: Postherpetic neuralgia on stomach; Flared up of chronic dermatitis; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia (had postherpetic neuralgia off and on). Previously administered products included zostavax with an associated reaction of herpes zoster (received Zostavax in 2015). Concurrent medical conditions included dermatitis (chronic dermatitis).   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several weeks after receiving Shingrix, the patient experienced post herpetic neuralgia and dermatitis flare-up. On an unknown date, the outcome of the post herpetic neuralgia was not recovered/not resolved and the outcome of the dermatitis flare-up was recovering/resolving.   It was unknown if the reporter considered the post herpetic neuralgia and dermatitis flare-up to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received a dose of Shingrix vaccine into the left arm and a few weeks later she experienced post-herpetic neuralgia on the right side of her stomach that was still present. The patient also had chronic dermatitis that flared up less than 6 months after having her first Shingrix vaccine (currently in remission). The patient was calling to ask if it was okay to go ahead with her second vaccine. The patient was referred to health care professional. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient got an accidental third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st and 2nd dose in 2018).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was anonymous Healthcare professional. The reporter stated that, they had the patient who told them she never had a shingrix vaccine and got one in December. She came back for the second one and found out she had the 2 shot series in 2018 already and dose received in December (year not specified), was a 3rd dose of Shingrix, which led to Extra dose administered. The reporter queried about any risk or literature of getting an accidental third dose. The reporter disconnected the chat before credentials could be gathered. No additional information available. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: was given one, did have the 2 shot series; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 shot series of shingrix back in December (year unknown)).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient stated that she never had a shingrix shot before and was given one in December (year unknown). The patient now came back for her second dose and told that she found out she did have the 2 shot series back in December but forgot.  The reporter did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D4CZ3, expiry date 10th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose of shingrix in 2018).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that a patient received full dose schedule of Shingrix in 2018 but last year in December patient received 3rd dose of Shingrix, which led to extra dose administered.  The reporter wanted to know if there was any further information regarding safety of patient. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site, size of baseball; Injection site was hard; redness at the injection site; pain at injection site; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site erythema (1st dose received on 11th January 2022 and had injection site redness, pain, headache and malaise, for tolerance refer case US2022AMR046709).   On 11th March 2022, the patient received the 2nd dose of Shingrix. On 12th March 2022, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site induration, injection site erythema, injection site pain, headache and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site induration, injection site erythema, injection site pain, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site induration, injection site erythema, injection site pain, headache and malaise to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR046709  Additional details were provided as follows: The patient self-reported this case. The patient received 2nd dose of Shingrix vaccine and second day after vaccination she experienced swelling at the injection site which grew to be the size of a baseball and was hard, redness at the injection site, pain at injection site, headache and malaise. The patient stated that the above side effects had not gone away.  Referred patient to HCP (health care professional) and provided medical advise disclaimer. Offered PI (package insert). The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046709:Same patient, different dose
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: swelling at the injection site, size of baseball; Injection site was hard; redness at the injection site; pain at injection site; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site erythema (1st dose received on 11th January 2022 and had injection site redness, pain, headache and malaise, for tolerance refer case US2022AMR046709).   On 11th March 2022, the patient received the 2nd dose of Shingrix. On 12th March 2022, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site induration, injection site erythema, injection site pain, headache and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site induration, injection site erythema, injection site pain, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site induration, injection site erythema, injection site pain, headache and malaise to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR046709  Additional details were provided as follows: The patient self-reported this case. The patient received 2nd dose of Shingrix vaccine and second day after vaccination she experienced swelling at the injection site which grew to be the size of a baseball and was hard, redness at the injection site, pain at injection site, headache and malaise. The patient stated that the above side effects had not gone away.  Referred patient to HCP (health care professional) and provided medical advise disclaimer. Offered PI (package insert). The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046709:Same patient, different dose
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, never received a second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 case was reported by patient herself. The age at vaccination was not applicable for this report. The patient received her first dose but she never received a second dose, which led to incomplete course of vaccination. The reporter wanted to know what the recommendation. The provided information per content and PI. Referred to HCP and offered medical advise disclaimer. The reporter consented to follow up to contact health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose in july 2021, didn´t received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in July 2021).   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 for this report. The patient received only one dose of shingrix and still did not received 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, now wants to get 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2019, batch number:AP257, expiry date: 26th November 2021).   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 for this report. The pharmacist reported that patient received 1st dose of Shingrix and now wanted to complete schedule. The reporter asked how to proceed. Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.  The case has been linked with the case US2022046171 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046171:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2019, now wants to get 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019, batch number AP257, expiry date 26th November 2021).   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 for this report. The pharmacist reported that patient received 1st dose of Shingrix and now wanted to complete schedule. The reporter asked how to proceed. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.  The case has been linked with the case US2022046170 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046170:Same Reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: HCP diagnosed shingles; rash was itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2022, the patient received the 1st dose of Shingrix. On 12th March 2022, 7 days after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient noticed a rash which was itchy begin to form.  The patient went to the doctor on 14th Mar 2022 and her health care professional diagnosed shingles. The patient was started on treatment for it but it was not resolved. Provided patient with requested data per content and package insert. Provided medical advise disclaimer and referred to health care professional. The reporter consented to follow up and permission to contact health care professional.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4-month-old was administered a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that a 4 month old was administered a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Developed urticaria that is still ongoing. Body is itchy and becomes red and swells into welts when scratched. Started on January 19, 2022.
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Asthenia, C-reactive protein, Electrocardiogram, Magnetic resonance imaging heart
Clinical narrative: MYOPERICARDITIS; MYALGIA; WEAKNESS; This spontaneous report was received from literature: Myopericarditis after COVID-19 vaccination. The objective of the study was to observe myopericarditis among individuals who received the BNT162b2-mRNA and mRNA-1273 COVID-19 vaccines. In this case series, they describe the initial experience with myopericarditis following COVID-19 vaccination across the largest healthcare system. Of 11 total cases, 9 presented with chest pain and troponin elevation following their second BNT162b2-mRNA vaccine dose, 1 after their second mRNA-1273 dose, and 1 after their Ad26.COV2.S vaccine. This report concerned a 53 year old male of unspecified 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 not reported, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total administered 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, after 8 days of vaccination the patient experienced myopericarditis, chest pain, weakness and myalgia, and patient was hospitalized, and discharged after 8 days (date unspecified).  Laboratory data (dates unspecified) included: Coronarography with result as no significant flow limiting epicardial coronary artery disease, ECG with results as Sinus tachycardia, widespread PR-segment depression, borderline inferior ST-segment elevation, High-sensitivity C-reactive protein: more than 300 mg/l, Magnetic resonance imaging heart: LVEF 70%. RVEF 51%. Possible small area of subepicardial enhancement affecting the myocardium. Diffuse, circumferential pericardial enhancement. Small pericardial effusion with mild thickening, and Troponin T: 0.27 ng/mL.  Treatment medications (dates unspecified) included: colchicine, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myopericarditis,myalgia and weakness was not reported. The authors emphasized that, There were no severe acute complications in patients, though long-term data was needed. The presentation of patients appears distinct from COVID-19 associated myocarditis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220314163-Covid-19 vaccine ad26.cov2.s- myopericarditis (myocarditis)- 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.  20220314163-Covid-19 vaccine ad26.cov2.s- myalgia, weakness This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Myopericarditis, Troponin T
Clinical narrative: MYOPERICARDITIS; MYALGIA; WEAKNESS; This spontaneous report was received from literature: Myopericarditis after COVID-19 vaccination. The objective of the study was to observe myopericarditis among individuals who received the BNT162b2-mRNA and mRNA-1273 COVID-19 vaccines. In this case series, they describe the initial experience with myopericarditis following COVID-19 vaccination across the largest healthcare system. Of 11 total cases, 9 presented with chest pain and troponin elevation following their second BNT162b2-mRNA vaccine dose, 1 after their second mRNA-1273 dose, and 1 after their Ad26.COV2.S vaccine. This report concerned a 53 year old male of unspecified 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 not reported, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total administered 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, after 8 days of vaccination the patient experienced myopericarditis, chest pain, weakness and myalgia, and patient was hospitalized, and discharged after 8 days (date unspecified).  Laboratory data (dates unspecified) included: Coronarography with result as no significant flow limiting epicardial coronary artery disease, ECG with results as Sinus tachycardia, widespread PR-segment depression, borderline inferior ST-segment elevation, High-sensitivity C-reactive protein: more than 300 mg/l, Magnetic resonance imaging heart: LVEF 70%. RVEF 51%. Possible small area of subepicardial enhancement affecting the myocardium. Diffuse, circumferential pericardial enhancement. Small pericardial effusion with mild thickening, and Troponin T: 0.27 ng/mL.  Treatment medications (dates unspecified) included: colchicine, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myopericarditis,myalgia and weakness was not reported. The authors emphasized that, There were no severe acute complications in patients, though long-term data was needed. The presentation of patients appears distinct from COVID-19 associated myocarditis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220314163-Covid-19 vaccine ad26.cov2.s- myopericarditis (myocarditis)- 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.  20220314163-Covid-19 vaccine ad26.cov2.s- myalgia, weakness This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MULTIPLE SERIOUS ADVERSE REACTIONS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. 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 were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple serious adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple serious adverse reactions was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard  procedure as the case is assessed as non serious
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Initial insomnia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; DIFFICULTY FALLING ASLEEP; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 in left arm for prophylactic vaccination.  On 01-MAR-2022, patient had confirmed clinical vaccination failure (dose number in series 1). The patient received additional non-company suspect vaccine included: mrna 1273 (Moderna, ELASOMERAN) (form of admin, and route of admin were not reported, batch number: 084J21A expiry: Unknown) dose was not reported, administered on 16-FEB-2022 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-MAR-2022, the patient experienced stuffy nose and sneezing (confirmed covid-19 infection) and had difficulty falling asleep (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable. The patient recovered from confirmed covid-19 infection, and difficulty falling asleep on 03-MAR-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220324974-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure . 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a parent concerned a female of unspecified age, 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 were not reported) dose, start therapy date were not reported, 1 total administered 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, after receiving the vaccine the patient died from an unknown cause of death and it was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0.20220326240-covid-19 vaccine ad26.cov2.s -Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media (J and J corporate concerned two patients of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered on an unspecified date 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 patients died from unknown cause of death. As per report, " I lost two good friends who were fully vaccinated." It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with a product quality complaint: 90000221662. This case, from the same reporter is linked to 20220327300 and 20220327336.; Sender's Comments: V0: 20220327382-covid-19 vaccine ad26.cov2.s -Death. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 20-DEC-2021) dose was not reported, 1 total, administered at left arm on 08-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 08-JUL-2022) dose was not reported, 1 total, administered at left arm on 04-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient took Binax Now at home test laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) and tested positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20220329517.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 129 pounds, and height was 62 inches. The patient's past medical history included: Covid-19, and Covid-19 (omicron), and other pre-existing medical conditions included: The patient denied taking any medications regularly (except for vitamins and supplements like biotin for her hair for the past few years) or suffering from any other illness. She was generally super healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, administered on 07-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced not able to eat anything, very slight exertion like walking resulted in heavy breathing, body felt like intoxicated by vaccine/ felt like alcoholic drink, felt like exercising heavily which resulted staying in bed, dehydration, and she felt tired and entire time sick. On 07-MAR-2022, the patient experienced body aches, and chills. On 11-MAR-2022, the patient experienced very severe diarrhea. On 12-MAR-2022, the patient experienced super sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, super sick, not able to eat anything, very slight exertion like walking resulted in heavy breathing, body felt like intoxicated by vaccine/ felt like alcoholic drink, chills, and very severe diarrhea on 14-MAR-2022, was recovering from she felt tired and entire time sick, and felt like exercising heavily which resulted staying in bed, and had not recovered from dehydration. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Feeling drunk, Illness, Pain
Clinical narrative: This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 129 pounds, and height was 62 inches. The patient's past medical history included: Covid-19, and Covid-19 (omicron), and other pre-existing medical conditions included: The patient denied taking any medications regularly (except for vitamins and supplements like biotin for her hair for the past few years) or suffering from any other illness. She was generally super healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, administered on 07-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced not able to eat anything, very slight exertion like walking resulted in heavy breathing, body felt like intoxicated by vaccine/ felt like alcoholic drink, felt like exercising heavily which resulted staying in bed, dehydration, and she felt tired and entire time sick. On 07-MAR-2022, the patient experienced body aches, and chills. On 11-MAR-2022, the patient experienced very severe diarrhea. On 12-MAR-2022, the patient experienced super sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, super sick, not able to eat anything, very slight exertion like walking resulted in heavy breathing, body felt like intoxicated by vaccine/ felt like alcoholic drink, chills, and very severe diarrhea on 14-MAR-2022, was recovering from she felt tired and entire time sick, and felt like exercising heavily which resulted staying in bed, and had not recovered from dehydration. This report was non-serious.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 16 Dec 2021 and administered on 18 Feb 2022) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 16 Dec 2021 and administered on 18 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 16 Dec 2021 and administered on 18 Feb 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported- received 1/2 booster dose. The vial didn't undergo any temperature excursions. No concomitant drug reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BELL'S PALSY (Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.). At the time of the report, BELL'S PALSY (Developed Bell's Palsy after receiving the Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment.  This spontaneous case concerns a patient with no medical history reported, who experienced the expected, non  serious AESI of Bell´s palsy. Temporal association cannot be assessed due to lack of information on onset date of the event and the administration date of mRNA-1273 vaccine. The report stated that the patient developed Bell's Palsy after receiving the Moderna COVID-19 vaccine. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with no medical history reported, who experienced the expected, non  serious AESI of Bell´s palsy. Temporal association cannot be assessed due to lack of information on onset date of the event and the administration date of mRNA-1273 vaccine. The report stated that the patient developed Bell's Palsy after receiving the Moderna COVID-19 vaccine. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). The patient was treated with Radiotherapy (Radiation therapy) for Breast cancer. At the time of the report, BREAST CANCER (breast cancer) had not resolved.            Patient reported that was diagnosed with breast cancer recently, after received 2 doses of the Moderna COVID-19 vaccine.  Concomitant product use was not provided by reporter.  On 14-Mar-2022, patient wis going to start radiation for cancer. The cancer diagnosis was early, so patient was just doing radiation.   Patient was scheduled to get a booster dose this Thursday. Patient heard that the booster can inflame lymph nodes and cause problems with diagnosis and asking when radiation started patient can get booster dose or not.  Company comment: This is a spontaneous case concerning a 61 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, event of breast cancer, approximately 9 months after the second dose of mRNA-1273 vaccine. She reported she is starting radiation therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, event of breast cancer, approximately 9 months after the second dose of mRNA-1273 vaccine. She reported she is starting radiation therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.