chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of product storage error in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.   It was unknown if the reporter considered the product storage error to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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 information was provided as follows: On 27th September 2021 the retail pharmacy called medical information to obtain temperature excursion data because theirwholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product.  The product had already been administered to 3 individuals.  On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 4th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion.  The product was shipped from GSK to the wholesaler ia but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks.  The wholesaler then put the FLUARIX product back in the refrigerator and subsequently shipped it to the pharmacy. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose each to 3 individual patients. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208518:same reporter US-GLAXOSMITHKLINE-US2021AMR208519:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 12/31/2018, not had 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 31st December 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 reported as follows: The age at vaccination was not applicable for this report. Pharmacist stated that a patient had not received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter unable to provide vaccine details because they did not administer the 1st dose. The reporter did not consent to follow-up.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 month old received BOOSTRIX; received BOOSTRIX instead of INFANRIX; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   On 5th October 2021, the patient received Boostrix. On 5th October 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration and underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and underdose were unknown.  Additional details were reported as follows: The patient received Boostrix instead of Infanrix vaccine, which led to inappropriate age at vaccine administration and underdose. No further details were provided at the time of the call and no adverse reactions were reported. The reporter consented to follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 9/14/2020, would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1sr dose on 14th September 2020, batch number 73T27, expiry date 9th September 2022).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist asked should patient restart the series or can she still get the second dose. The reporter did not consent to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Vaccination that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 74FN7, expiry date 1st March 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. On 6th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported via chat with Practice manager. On 6th October 2021, the patient received a dose of a Pediarix which was already expired on 1st March 2021. The reporter asked that what was the procedure to fix this error. The reporter consented to follow up via email.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: given expired doses; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 6th October 2021, the patient received Havrix. On 6th October 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: On 6th October 2021, the patient received a dose of a Havrix which was already expired on 16th September 2021. The reporter consented to follow up via email. This case was linked with the case US2021208270 (Twin's case with same initials), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208270:same reporter
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Libido decreased
Clinical narrative: Low sex drive; No stamina; This spontaneous case was reported by a pharmacist and describes the occurrence of LIBIDO DECREASED (Low sex drive) and ASTHENIA (No stamina) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIBIDO DECREASED (Low sex drive) and ASTHENIA (No stamina). At the time of the report, LIBIDO DECREASED (Low sex drive) and ASTHENIA (No stamina) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Ocular discomfort, Vertigo
Clinical narrative: Experiencing severe vertigo; Eyes feel like they are flying back and forth; She feels off balanced/ When she's up and moving around is when she feels the worst; feels the worst,head feels weird; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Experiencing severe vertigo) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D48F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced VERTIGO (Experiencing severe vertigo) (seriousness criterion disability), OCULAR DISCOMFORT (Eyes feel like they are flying back and forth), BALANCE DISORDER (She feels off balanced/ When she's up and moving around is when she feels the worst) and FEELING ABNORMAL (feels the worst,head feels weird). At the time of the report, VERTIGO (Experiencing severe vertigo), OCULAR DISCOMFORT (Eyes feel like they are flying back and forth), BALANCE DISORDER (She feels off balanced/ When she's up and moving around is when she feels the worst) and FEELING ABNORMAL (feels the worst,head feels weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were provided.  No treatment information were provided.  Company comment: This case concerns a  42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vertigo, Ocular discomfort, Balance disorder, and feeling abnormal. The events occurred approximately 6 days after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown as the events occurred after the first dose and no information about second dose is available.The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The event Vertigo was considered Serious as the source document described the event resulted in a Disabling/Incapacitating outcome.; Sender's Comments: This case concerns a  42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vertigo, Ocular discomfort, Balance disorder, and feeling abnormal. The events occurred approximately 6 days after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown as the events occurred after the first dose and no information about second dose is available.The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The event Vertigo was considered Serious as the source document described the event resulted in a Disabling/Incapacitating outcome.
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia, Thrombosis
Clinical narrative: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA; This spontaneous report was received from literature, following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. This report concerned multiple (24) patients with unspecified demographics. The objective of this literature was to describe vaccine-induced immune thrombotic thrombocytopenia following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. No past medical history or concurrent conditions were reported. The patients 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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The article explains 28 cases of rare syndrome of vaccine-induced immune thrombotic thrombocytopenia following COVID-19 vaccination with a recombinant adenoviral vector encoding the SARS-CoV-2 spike protein, Ad26.COV2.S out of of over 8.7 million vaccinated (dates were not specified) [(RRT: Vaccine-induced immune thrombotic thrombocytopenia, PT: Thrombosis) and (RRT: Thrombocytopenia, PT: Thrombocytopenia)]. According to the literature, as of 07-MAY-2021, 3 (11%) of the 28 reported and published cases of VITT (vaccine-induced immune thrombotic thrombocytopenia) following Ad26.COV2.S vaccination had died from this syndrome VITT (captured in AER 20211011609), and 1 male patient improved from VITT following Ad26.COV2.S (captured in AER 20211004121). The author commented that this literature highlighted the critical importance of knowing COVID-19 vaccine history. The author emphasized as on timely recognition that would be essential to prevent catastrophic complications and will require knowing the patient's vaccine history. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombocytopenia and vaccine induced immune thrombotic thrombocytopenia was not reported. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20211004121 and 20211011609.; Sender's Comments: V0: 20211006771-COVID-19 VACCINE AD26.COV2.S- Vaccine induced immune thrombotic thrombocytopenia, thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, SARS-CoV-2 antibody test, Therapeutic response unexpected, Therapy non-responder
Clinical narrative: GI SYMPTOMS WERE BACK; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE (LACK OF ANTIBODIES); ULCERATIVE COLITIS RELATED TO LUPUS SYMPTOMS RESOLVED; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis related to lupus, benign mass on breast, huge mass on other breast, unknown nature, lost all teeth from colitis and broke neck twice, no feeling on arm due to this. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, with frequency as 1 total administered on left arm on 19-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  It was reported that the patient called to ask for help regarding her situation and mentioned that the day after she got the vaccine, her ulcerative colitis symptoms went away (ulcerative colitis related to lupus symptoms resolved). The patient stated she felt little bit sick on 20-MAR-2021 (referring to symptoms from ulcerative colitis) after that she experienced regular bowel movements (BM), no diarrhea, no extreme pain, she was not wearing diapers, etc. And she stated having no side effects from vaccine. This lasted about 3 months. Before the pandemic, she had a mastectomy and biopsy scheduled but because it was deemed not an emergency surgery, it got postponed until this year.  On 16-AUG-2021, the patient experienced confirmed immunological vaccine failure (lack of antibodies). It was reported, during preoperative preparation laboratory data included: COVID-19 antibody test (NR: not provided) Negative. And on an unknown date, her gastrointestinal (GI) symptoms were back which made patient not want to get the surgery. The patient wants to get revaccinated so that she can get surgery.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure (lack of antibodies), ulcerative colitis related to lupus symptoms resolved and GI symptoms were back was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000196486.; Sender's Comments: V0:20211008750-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned two female patients of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical histories or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two patients developed clots. As per the reporter "uncle and two sisters have clots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the two patients of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211009150.; Sender's Comments: V0: 20211009238-covid-19 vaccine ad26.cov2.s-Clots. This event(s) is considered unassessable. 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).
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a physician via a company representative concerned a patient of unspecified age and sex. 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, 1 total, 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 died from blood clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211009193 and 20211010279.; Sender's Comments: V0:20211010045- covid-19 vaccine ad26.cov2.s -blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia, Back pain, Conjunctivitis
Clinical narrative: CONJUNCTIVITIS; BACK PAIN; SEVERE REACTION; JOINT PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced conjunctivitis. On MAY-2021, the patient experienced back pain. On MAY-2021, the patient experienced severe reaction. On MAY-2021, the patient experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, back pain, and conjunctivitis, and the outcome of severe reaction was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dehydration, Pain, Rash
Clinical narrative: ACHES; RASH; CHILLS; DEHYDRATION; This spontaneous report received from a consumer concerned a 62 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: 2-2A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021 (about 4 days later), patient experienced chills (was cold and could not warm up), aches (head to toe) and a rash (sides, stomach, arms and fingers). Patient used unscented lotion to help manage, but it continued to spread. It looked like the rash had spread into an infection. The rash looked similar to the rash which was listed as a side effects with all vaccines. Patient had been admitted in the hospital on 03-OCT-2021, for the past three days and was discharged on 06-OCT-2021. The hospital could not find anything wrong with patient. They gave patient IV (intravenous) saline. On an unspecified date in 2021, the patient also experienced dehydration. All symptoms were still present. Reporter stated that had only spoken with the doctors in the hospital about the patient's symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, rash, and dehydration. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211011470-covid-19 vaccine ad26.cov2.s  Aches and dehydration. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211011470--covid-19 vaccine ad26.cov2. s chills and rash .This evens are labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Facial pain, Fatigue, Feeling cold
Clinical narrative: ACHES; RASH; CHILLS; DEHYDRATION; This spontaneous report received from a consumer concerned a 62 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: 2-2A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021 (about 4 days later), patient experienced chills (was cold and could not warm up), aches (head to toe) and a rash (sides, stomach, arms and fingers). Patient used unscented lotion to help manage, but it continued to spread. It looked like the rash had spread into an infection. The rash looked similar to the rash which was listed as a side effects with all vaccines. Patient had been admitted in the hospital on 03-OCT-2021, for the past three days and was discharged on 06-OCT-2021. The hospital could not find anything wrong with patient. They gave patient IV (intravenous) saline. On an unspecified date in 2021, the patient also experienced dehydration. All symptoms were still present. Reporter stated that had only spoken with the doctors in the hospital about the patient's symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, rash, and dehydration. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211011470-covid-19 vaccine ad26.cov2.s  Aches and dehydration. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211011470--covid-19 vaccine ad26.cov2. s chills and rash .This evens are labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: ACHES; RASH; CHILLS; DEHYDRATION; This spontaneous report received from a consumer concerned a 62 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: 2-2A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021 (about 4 days later), patient experienced chills (was cold and could not warm up), aches (head to toe) and a rash (sides, stomach, arms and fingers). Patient used unscented lotion to help manage, but it continued to spread. It looked like the rash had spread into an infection. The rash looked similar to the rash which was listed as a side effects with all vaccines. Patient had been admitted in the hospital on 03-OCT-2021, for the past three days and was discharged on 06-OCT-2021. The hospital could not find anything wrong with patient. They gave patient IV (intravenous) saline. On an unspecified date in 2021, the patient also experienced dehydration. All symptoms were still present. Reporter stated that had only spoken with the doctors in the hospital about the patient's symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, rash, and dehydration. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211011470-covid-19 vaccine ad26.cov2.s  Aches and dehydration. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211011470--covid-19 vaccine ad26.cov2. s chills and rash .This evens are labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Intracardiac thrombus, Laboratory test, Pneumonia
Clinical narrative: ACHES; RASH; CHILLS; DEHYDRATION; This spontaneous report received from a consumer concerned a 62 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: 2-2A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021 (about 4 days later), patient experienced chills (was cold and could not warm up), aches (head to toe) and a rash (sides, stomach, arms and fingers). Patient used unscented lotion to help manage, but it continued to spread. It looked like the rash had spread into an infection. The rash looked similar to the rash which was listed as a side effects with all vaccines. Patient had been admitted in the hospital on 03-OCT-2021, for the past three days and was discharged on 06-OCT-2021. The hospital could not find anything wrong with patient. They gave patient IV (intravenous) saline. On an unspecified date in 2021, the patient also experienced dehydration. All symptoms were still present. Reporter stated that had only spoken with the doctors in the hospital about the patient's symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, rash, and dehydration. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211011470-covid-19 vaccine ad26.cov2.s  Aches and dehydration. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211011470--covid-19 vaccine ad26.cov2. s chills and rash .This evens are labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Renal failure, Septic shock
Clinical narrative: ACHES; RASH; CHILLS; DEHYDRATION; This spontaneous report received from a consumer concerned a 62 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: 2-2A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021 (about 4 days later), patient experienced chills (was cold and could not warm up), aches (head to toe) and a rash (sides, stomach, arms and fingers). Patient used unscented lotion to help manage, but it continued to spread. It looked like the rash had spread into an infection. The rash looked similar to the rash which was listed as a side effects with all vaccines. Patient had been admitted in the hospital on 03-OCT-2021, for the past three days and was discharged on 06-OCT-2021. The hospital could not find anything wrong with patient. They gave patient IV (intravenous) saline. On an unspecified date in 2021, the patient also experienced dehydration. All symptoms were still present. Reporter stated that had only spoken with the doctors in the hospital about the patient's symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, rash, and dehydration. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211011470-covid-19 vaccine ad26.cov2.s  Aches and dehydration. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211011470--covid-19 vaccine ad26.cov2. s chills and rash .This evens are labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dehydration, Pain, Rash
Clinical narrative: SEVERE PAIN ALL OVER WITH WEAKNESS IN MUSCLES.    COLD CHILLS, EXETREMELY COLD, PAIN IN SIDE OF FACE.    FATIGUE AND WEAK, VERY WEAK.     ALL THE SYMPTONS ARE ASSOCIATED WITH GUILLAIN-BARRE SYNDROME.    SYMPTOMS ARE EXACTLY  THE SAME.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Facial pain, Fatigue, Feeling cold
Clinical narrative: SEVERE PAIN ALL OVER WITH WEAKNESS IN MUSCLES.    COLD CHILLS, EXETREMELY COLD, PAIN IN SIDE OF FACE.    FATIGUE AND WEAK, VERY WEAK.     ALL THE SYMPTONS ARE ASSOCIATED WITH GUILLAIN-BARRE SYNDROME.    SYMPTOMS ARE EXACTLY  THE SAME.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: SEVERE PAIN ALL OVER WITH WEAKNESS IN MUSCLES.    COLD CHILLS, EXETREMELY COLD, PAIN IN SIDE OF FACE.    FATIGUE AND WEAK, VERY WEAK.     ALL THE SYMPTONS ARE ASSOCIATED WITH GUILLAIN-BARRE SYNDROME.    SYMPTOMS ARE EXACTLY  THE SAME.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Intracardiac thrombus, Laboratory test, Pneumonia
Clinical narrative: SEVERE PAIN ALL OVER WITH WEAKNESS IN MUSCLES.    COLD CHILLS, EXETREMELY COLD, PAIN IN SIDE OF FACE.    FATIGUE AND WEAK, VERY WEAK.     ALL THE SYMPTONS ARE ASSOCIATED WITH GUILLAIN-BARRE SYNDROME.    SYMPTOMS ARE EXACTLY  THE SAME.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Renal failure, Septic shock
Clinical narrative: SEVERE PAIN ALL OVER WITH WEAKNESS IN MUSCLES.    COLD CHILLS, EXETREMELY COLD, PAIN IN SIDE OF FACE.    FATIGUE AND WEAK, VERY WEAK.     ALL THE SYMPTONS ARE ASSOCIATED WITH GUILLAIN-BARRE SYNDROME.    SYMPTOMS ARE EXACTLY  THE SAME.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, abstain alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included rituximab.  On 23-SEP-2021, the patient experienced confirmed immunological vaccine. Patient doctor had recommended to get the Pfizer vaccine and patient mom doctor also had recommended to get a booster shot of the Johnson and Johnson COVID 19 vaccine. Patient was inquired about how would to know if the Johnson & Johnson COVID 19 vaccine worked, if patient had a negative antibody test before patient gets the booster of J&J vaccine. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196337; Sender's Comments: V0:20211011523-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure .These events are considered not related. The events 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 than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: NOT FEELING WELL (JUST NOT QUITE RIGHT); VERY VERY HIGH BLOOD PRESSURE; RAPID HEARTBEATS; NAUSEA; DIZZINESS (LIGHTHEADEDNESS); HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no prior medical history or chronic conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-SEP-2021 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 29-SEP-2021, the patient experienced dizziness (lightheadedness). On 29-SEP-2021, the patient experienced headaches. On 30-SEP-2021, the patient experienced very very high blood pressure. On 30-SEP-2021, the patient experienced rapid heartbeats. On 30-SEP-2021, the patient experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Very very high, and Heart rate (NR: not provided) Rapid. On 05-OCT-2021, the patient experienced not feeling well (just not quite right). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very very high blood pressure, and rapid heartbeats on 05-OCT-2021, and nausea on 30-SEP-2021, and was recovering from dizziness (lightheadedness), headaches, and not feeling well (just not quite right). This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Nausea
Clinical narrative: NOT FEELING WELL (JUST NOT QUITE RIGHT); VERY VERY HIGH BLOOD PRESSURE; RAPID HEARTBEATS; NAUSEA; DIZZINESS (LIGHTHEADEDNESS); HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no prior medical history or chronic conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-SEP-2021 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 29-SEP-2021, the patient experienced dizziness (lightheadedness). On 29-SEP-2021, the patient experienced headaches. On 30-SEP-2021, the patient experienced very very high blood pressure. On 30-SEP-2021, the patient experienced rapid heartbeats. On 30-SEP-2021, the patient experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Very very high, and Heart rate (NR: not provided) Rapid. On 05-OCT-2021, the patient experienced not feeling well (just not quite right). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very very high blood pressure, and rapid heartbeats on 05-OCT-2021, and nausea on 30-SEP-2021, and was recovering from dizziness (lightheadedness), headaches, and not feeling well (just not quite right). This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Echocardiogram, Hypertension, Insomnia, Pruritus
Clinical narrative: HIGH BLOOD PRESSURE; COULD NOT SLEEP AT NIGHT; RASH; ITCHINESS ON ONE SPOT AROUND THE HEART; This spontaneous report received from a patient concerned a 69 year old female The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, diabetes, no alcohol use, and non-smoker, and patient had no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced rash and itchiness on one spot around the heart which resolved in 3 weeks. Three to four weeks after vaccination on 01-APR-2021, the patient experienced high blood pressure and could not sleep at night. Patient's daughter who was a nurse took her to the hospital. They tested her for brain bleed and stroke all negative. Patient also underwent Laboratory data included: Blood pressure (NR: not provided) high (250/150), Echocardiogram of the heart (NR: not provided) negative, and Eosinophils (NR: not provided) really elevated. They said that was because of the vaccine. They raised the dose of her blood pressure medication and added a second one and it took 2 weeks before her blood pressure came back to her normal. They released her the same day and sent her to a cardiologist which mentioned the same thing that it was because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 15-APR-2021, itchiness in one spot around the heart, and rash on 01-APR-2021, and could not sleep at night. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211011824.; Sender's Comments: V0 20211012327-COVID-19 VACCINE AD26.COV2.S-high blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: HIGH BLOOD PRESSURE; COULD NOT SLEEP AT NIGHT; RASH; ITCHINESS ON ONE SPOT AROUND THE HEART; This spontaneous report received from a patient concerned a 69 year old female The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, diabetes, no alcohol use, and non-smoker, and patient had no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced rash and itchiness on one spot around the heart which resolved in 3 weeks. Three to four weeks after vaccination on 01-APR-2021, the patient experienced high blood pressure and could not sleep at night. Patient's daughter who was a nurse took her to the hospital. They tested her for brain bleed and stroke all negative. Patient also underwent Laboratory data included: Blood pressure (NR: not provided) high (250/150), Echocardiogram of the heart (NR: not provided) negative, and Eosinophils (NR: not provided) really elevated. They said that was because of the vaccine. They raised the dose of her blood pressure medication and added a second one and it took 2 weeks before her blood pressure came back to her normal. They released her the same day and sent her to a cardiologist which mentioned the same thing that it was because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 15-APR-2021, itchiness in one spot around the heart, and rash on 01-APR-2021, and could not sleep at night. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211011824.; Sender's Comments: V0 20211012327-COVID-19 VACCINE AD26.COV2.S-high blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 91 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 06-OCT-2021 and 07-OCT-2021. 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:1805029 expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient did not have antibodies (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000196498 and 90000196262.; Sender's Comments: V0: 20211012353-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. This event(s) is considered not related. 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
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING SENSATION BEHIND THE LEFT KNEE (LIKE PINS AND NEEDLES WHEN FOOT FALLS ASLEEP, BUT NOT PAINFUL); This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: 07-MAR-2022) dose was not reported, administered on 06-OCT-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced tingling sensation behind the left knee (like pins and needles when foot falls asleep, but not painful). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation behind the left knee (like pins and needles when foot falls asleep, but not painful). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ISSUES PARTLY BECAUSE OF THE VACCINE; This spontaneous report received from a parent via a company representative concerned a female 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. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced issues partly because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of issues partly because of the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211009810.