chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received 3rd dose of Shingrix; received 1st dose 03/06/2018 2nd dose 05/04/2018; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 7S3NF, expiry date 18th December 2022) and (batch number 3B55B, expiry date 18th December 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 06th March 2018).   On 21st October 2021, the patient received the 3rd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 4th May 2018, the patient received the 2nd dose of Shingrix. On 4th May 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 21st October 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short were unknown.  Additional details were provided as follows: The reporter called to report that a patient received shingrix 2nd dose 04th May 2018 and also received a 3rd dose of Shingrix, which led to drug dose administration interval too short and extra dose administered. The reporter stated that they want to have data on this. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose over a year ago, has not received 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19. Previously administered products included Shingrix (1st dose received over a year before reporting (between February - April 2020) and route of administration was injection).   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 the patient. The patient age was 65 years old (66 years old in March 2022). The age at vaccination was not applicable for this report. The patient reported he had Covid-19 in December 2019 and had a ANA (Antinuclear antibodies) test that showed low antibodies. The reporter called to report that the patient had not received the 2nd dose, which led to incomplete course of vaccination. The reporter would like to know if he could receive the 2nd dose and if taking a second dose would increase his antibodies. The reporter offered medical Information contact information was declined. The reporter gave medical disclaimer and referred to healthcare professional.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Given a third dose of Shingrix; second dose 20210715; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 2393s, expiry date 20th April 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 393C7, expiry date 25th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5ml on 17th November 2020 at left deltoid intramuscularly, batch no:9kt7t, expiry date:13th March 2021).   On 28th December 2021, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 15th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th July 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 28th December 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were provided as follows: The nurse from a medical office stated that a patient was accidently given a third dose of the Shingrix vaccine on the day of reporting, which led to extra dose administered. The patient was not exhibiting any side effects as of the time she called.  The patient also received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule Documenting per content and encouraged her to call back if had any further details. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Death, Pulmonary thrombosis, Thrombosis, Vaccination failure
Clinical narrative: DIED IN THREE WEEKS TIME AFTER SUFFERING TERRIBLY; COVID PNEUMONIA; THREE BLOOD CLOT IN LEGS; SIX BLOOD CLOTS IN LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media from a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date in /FEB/2020, the patient was previously treated with covid-19 vaccine from an unspecified manufacturer (form of admin, route of admin, and batch number were not reported), dose was not reported for prophylactic vaccination.(Dose number in series 1). No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.(Dose number in series 2). 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, following covid-19 vaccine ad26.cov2.s vaccination, the patient experienced covid, which was followed by covid pneumonia (Suspected clinical vaccination failure), six blood clots in lungs and three blood clots in legs. It was reported that the patient died in three weeks time after suffering terribly. The cause and date of death was unspecified. It was unknown whether an autopsy was performed.(Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died in three weeks time after suffering terribly on an unspecified date, and the outcome of covid pneumonia, Suspected clinical vaccination failure, six blood clots in lungs and three blood clot in legs was not reported. This report was serious (Death, and Other Medically Important Condition). This case is associated with Product Quality Complaint number 90000208090.; Sender's Comments: V0: 20211249023-covid-19 vaccine ad26.cov2.s-died in three weeks time after suffering terribly, covid pneumonia, six blood clots in lungs and three blood clot in legs. 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). 20211249023-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; OFF LABEL USE; RECEIVED 2 DOSES BEFORE THE BOOSTER WAS AUTHORIZED; This spontaneous report received from a patient concerned a 6 decade old male. Initial information was processed along with additional information received on 23-DEC-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: cannabis consumer. The patient received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on JUN-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. It was reported that patient received 2 doses before the booster was authorized (off label use and Inappropriate schedule of vaccine administered), and that it was like patient was part of a study without being in a study.  On an unspecified date, the patient experienced three to five days of flu like symptoms with yellow phlegm which indicates suspected covid-19 infection and suspected clinical vaccination failure (dose number in series 2). The patient stated that it was unsure if this was a break through case as he has not been tested for Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of off label use, suspected clinical vaccination failure and received 2 doses before the booster was authorized was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208210. The suspected product quality complaint has been confirmed to be voided (did not meet regulatory authority criteria as reported complaints were adverse events) based on the regulatory authority evaluation/investigation performed.; Sender's Comments: V0: 20211250896-covid-19 vaccine ad26.cov2.s- Suspected clinical Vaccination 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: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION (SNIFFLES, A SORE THROAT AND CONGESTION); OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a consumer via a company representative concerned an adolescent male. 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 is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection (sniffles, a sore throat and congestion), off label use, and product administered to patient of inappropriate age. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the covid-19 infection (sniffles, a sore throat and congestion), off label use and product administered to patient of inappropriate age was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208213. This case, from the same reporter is linked to 20211251102 and 20211251230.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Testicular swelling
Clinical narrative: TESICLES BLEW TO SIZE OF A BASEBALL; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 1, administered 1 in total for prophylactic vaccination. It was unknown whether patient had any adverse events (Dose number in series was 1).  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 (dose number in series was 2) 1 in total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s the patient experienced testicles blew to size of a baseball (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of testicles blew to size of a baseball was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Testicular swelling
Clinical narrative: BALLS BLEW UP TO ABOUT THE SIZE OF A BASEBALL; This spontaneous report received from a patient via a social media  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 previously received covid-19 vaccine ad26. cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) dose not reported, 1 total, start therapy date was not reported 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 covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported) dose not reported, 1 total, start therapy date was 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, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient had testicles blew up to about the size of a baseball. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of testicles blew up to about the size of a baseball was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021 after primary shot, the patient experienced fatigue (dose number in series 1).  On 15-DEC-2021, the patient received booster dose. No adverse events were reported (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: WHOLE ARM HURT FOR DAYS; This spontaneous report received from a consumer via a social media 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported,1 total, start therapy date were not reported for prophylactic vaccination. The patient was ok after primary vaccination and no adverse events reported (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose not reported,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 experienced whole arm hurt for days (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole arm hurt for days was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: LOSS OF SENSE OF TASTE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On unspecified date, the patient previously received covid-19 vaccine from an unspecified manufacturer (dose number in series: 1) (form of admin, route of admin, and batch number were not reported), dose was not reported, 1 total administered, for prophylactic vaccination. It was unknown whether patient had adverse events following vaccination with covid-19 vaccine from an unspecified manufacturer (dose number in series: 1). On unspecified date, the patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced loss of sense of taste (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of sense of taste was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Anaphylactic reaction, Arthralgia, Chills, Diarrhoea
Clinical narrative: THROMBOCYTOPENIA; ANAPHYLAXIS; INJECTION SITE REACTION; OTHER ADVERSE EFFECTS; OTHER PAIN; SORE/SCRATCHY THROAT; DIZZINESS; BRAIN FOG; CHILLS; RASH; JOINT PAIN; FATIGUE; MUSCLE ACHE; HEADACHE; INJECTION SITE PAIN/SORENESS; FEVER; INJECTION SITE REDNESS; INJECTION SITE SWELLING; NAUSEA; VOMITING; DIARRHEA; SWOLLEN LYMPH NODES; ALLERGIC REACTION; This spontaneous report was received from literature: This report concerned multiple patients aged 18 years and older. The objective of this study was to evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The patients' heights and weights were not reported. No past medical histories or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, anaphylaxis, injection site reaction, other adverse effects, other pain, sore/scratchy throat, dizziness, brain fog, chills, rash, joint pain, fatigue, muscle ache, headache, injection site pain/soreness, fever, injection site redness, injection site swelling, nausea, vomiting, diarrhea, swollen lymph nodes, and allergic reaction (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, thrombocytopenia, fatigue, muscle ache, headache, chills, injection site pain/soreness, joint pain, fever, injection site redness, injection site swelling, sore/scratchy throat, nausea, vomiting, diarrhea, dizziness, brain fog, swollen lymph nodes, injection site reaction, rash, other pain, other adverse effects and allergic reaction was not reported. The authors concluded that in this real-world cohort, serious COVID-19 vaccine adverse effects were rare, and overall adverse effects were similar to industry and government reports. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211255877-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia. 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) .20211255877-COVID-19 VACCINE AD26.COV2.S- Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: THROMBOCYTOPENIA; ANAPHYLAXIS; INJECTION SITE REACTION; OTHER ADVERSE EFFECTS; OTHER PAIN; SORE/SCRATCHY THROAT; DIZZINESS; BRAIN FOG; CHILLS; RASH; JOINT PAIN; FATIGUE; MUSCLE ACHE; HEADACHE; INJECTION SITE PAIN/SORENESS; FEVER; INJECTION SITE REDNESS; INJECTION SITE SWELLING; NAUSEA; VOMITING; DIARRHEA; SWOLLEN LYMPH NODES; ALLERGIC REACTION; This spontaneous report was received from literature: This report concerned multiple patients aged 18 years and older. The objective of this study was to evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The patients' heights and weights were not reported. No past medical histories or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, anaphylaxis, injection site reaction, other adverse effects, other pain, sore/scratchy throat, dizziness, brain fog, chills, rash, joint pain, fatigue, muscle ache, headache, injection site pain/soreness, fever, injection site redness, injection site swelling, nausea, vomiting, diarrhea, swollen lymph nodes, and allergic reaction (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, thrombocytopenia, fatigue, muscle ache, headache, chills, injection site pain/soreness, joint pain, fever, injection site redness, injection site swelling, sore/scratchy throat, nausea, vomiting, diarrhea, dizziness, brain fog, swollen lymph nodes, injection site reaction, rash, other pain, other adverse effects and allergic reaction was not reported. The authors concluded that in this real-world cohort, serious COVID-19 vaccine adverse effects were rare, and overall adverse effects were similar to industry and government reports. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211255877-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia. 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) .20211255877-COVID-19 VACCINE AD26.COV2.S- Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Lymphadenopathy
Clinical narrative: THROMBOCYTOPENIA; ANAPHYLAXIS; INJECTION SITE REACTION; OTHER ADVERSE EFFECTS; OTHER PAIN; SORE/SCRATCHY THROAT; DIZZINESS; BRAIN FOG; CHILLS; RASH; JOINT PAIN; FATIGUE; MUSCLE ACHE; HEADACHE; INJECTION SITE PAIN/SORENESS; FEVER; INJECTION SITE REDNESS; INJECTION SITE SWELLING; NAUSEA; VOMITING; DIARRHEA; SWOLLEN LYMPH NODES; ALLERGIC REACTION; This spontaneous report was received from literature: This report concerned multiple patients aged 18 years and older. The objective of this study was to evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The patients' heights and weights were not reported. No past medical histories or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, anaphylaxis, injection site reaction, other adverse effects, other pain, sore/scratchy throat, dizziness, brain fog, chills, rash, joint pain, fatigue, muscle ache, headache, injection site pain/soreness, fever, injection site redness, injection site swelling, nausea, vomiting, diarrhea, swollen lymph nodes, and allergic reaction (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, thrombocytopenia, fatigue, muscle ache, headache, chills, injection site pain/soreness, joint pain, fever, injection site redness, injection site swelling, sore/scratchy throat, nausea, vomiting, diarrhea, dizziness, brain fog, swollen lymph nodes, injection site reaction, rash, other pain, other adverse effects and allergic reaction was not reported. The authors concluded that in this real-world cohort, serious COVID-19 vaccine adverse effects were rare, and overall adverse effects were similar to industry and government reports. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211255877-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia. 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) .20211255877-COVID-19 VACCINE AD26.COV2.S- Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: THROMBOCYTOPENIA; ANAPHYLAXIS; INJECTION SITE REACTION; OTHER ADVERSE EFFECTS; OTHER PAIN; SORE/SCRATCHY THROAT; DIZZINESS; BRAIN FOG; CHILLS; RASH; JOINT PAIN; FATIGUE; MUSCLE ACHE; HEADACHE; INJECTION SITE PAIN/SORENESS; FEVER; INJECTION SITE REDNESS; INJECTION SITE SWELLING; NAUSEA; VOMITING; DIARRHEA; SWOLLEN LYMPH NODES; ALLERGIC REACTION; This spontaneous report was received from literature: This report concerned multiple patients aged 18 years and older. The objective of this study was to evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The patients' heights and weights were not reported. No past medical histories or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, anaphylaxis, injection site reaction, other adverse effects, other pain, sore/scratchy throat, dizziness, brain fog, chills, rash, joint pain, fatigue, muscle ache, headache, injection site pain/soreness, fever, injection site redness, injection site swelling, nausea, vomiting, diarrhea, swollen lymph nodes, and allergic reaction (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, thrombocytopenia, fatigue, muscle ache, headache, chills, injection site pain/soreness, joint pain, fever, injection site redness, injection site swelling, sore/scratchy throat, nausea, vomiting, diarrhea, dizziness, brain fog, swollen lymph nodes, injection site reaction, rash, other pain, other adverse effects and allergic reaction was not reported. The authors concluded that in this real-world cohort, serious COVID-19 vaccine adverse effects were rare, and overall adverse effects were similar to industry and government reports. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211255877-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia. 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) .20211255877-COVID-19 VACCINE AD26.COV2.S- Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Thrombocytopenia, Vomiting
Clinical narrative: THROMBOCYTOPENIA; ANAPHYLAXIS; INJECTION SITE REACTION; OTHER ADVERSE EFFECTS; OTHER PAIN; SORE/SCRATCHY THROAT; DIZZINESS; BRAIN FOG; CHILLS; RASH; JOINT PAIN; FATIGUE; MUSCLE ACHE; HEADACHE; INJECTION SITE PAIN/SORENESS; FEVER; INJECTION SITE REDNESS; INJECTION SITE SWELLING; NAUSEA; VOMITING; DIARRHEA; SWOLLEN LYMPH NODES; ALLERGIC REACTION; This spontaneous report was received from literature: This report concerned multiple patients aged 18 years and older. The objective of this study was to evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. The patients' heights and weights were not reported. No past medical histories or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, anaphylaxis, injection site reaction, other adverse effects, other pain, sore/scratchy throat, dizziness, brain fog, chills, rash, joint pain, fatigue, muscle ache, headache, injection site pain/soreness, fever, injection site redness, injection site swelling, nausea, vomiting, diarrhea, swollen lymph nodes, and allergic reaction (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, thrombocytopenia, fatigue, muscle ache, headache, chills, injection site pain/soreness, joint pain, fever, injection site redness, injection site swelling, sore/scratchy throat, nausea, vomiting, diarrhea, dizziness, brain fog, swollen lymph nodes, injection site reaction, rash, other pain, other adverse effects and allergic reaction was not reported. The authors concluded that in this real-world cohort, serious COVID-19 vaccine adverse effects were rare, and overall adverse effects were similar to industry and government reports. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211255877-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia. 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) .20211255877-COVID-19 VACCINE AD26.COV2.S- Anaphylaxis. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: IT TOOK AWAY THE PAIN IN SHOULDERS AND ARMS BECAUSE OF DIABETES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included: diabetes. The patient was previously vaccinated with Covid-19 vaccine ad26. cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 1) 01 in total, administered dose was not reported for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, (dose number in series 2) 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) 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. The patient took Johnson & Johnson vaccine and it took away the pain in shoulders and arms because of diabetes (Unexpected therapeutic benefit) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of it took away the pain in shoulders and arms because of diabetes (Unexpected therapeutic benefit) was unknown (dose number in series 2). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAIN; This spontaneous report received from a consumer 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 previously received 2 doses of BNT 162 (Dose number in series 1)(suspension for injection, route of admin and batch number were not reported) dose was not reported, start therapy date were not reported for prophylactic vaccination. After Pfizer doses, the patient had Chest pain and difficulty in breathing for about one week. The patient parent's were both physicians and they suspected that he had myocarditis from Pfizer vaccine but diagnosis was not confirmed. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 2)(suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 24-DEC-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 24-DEC-2021, within 5 hours of booster dose, the patient experienced chest pain again. They did not seek medical attention this was based off their own clinical judgment, they were monitoring him at home. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, and batch number: unknown, expiry: unknown) 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, following vaccination with covid-19 vaccine ad26. cov2. s, the patient experienced covid and that "still had symptoms 20 days after" (coded as suspected clinical vaccination failure and suspected covid-19 infection) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product Quality Complaint number: 90000208871.; Sender's Comments: V0 - 20211258498- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination 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
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: VACCINE INDUCED INJURY; This spontaneous report received from a consumer 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, 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/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine induced injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced injury was not reported. This report was non-serious. This case, from the same reporter is linked to 20211259197.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergy. 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 and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced flu-like symptoms (Dose number in series: 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20211258986 (Dose number in series: 2, Booster dose) This case, from the same reporter is linked to 20211258107 and 20211258204.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered, (Dose number in series 1), 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 (reporter's friend) had stroke (dose number in series 1).  The action taken with covid-19 vaccine was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211248907, 20211258812.; Sender's Comments: V0: 20211258956- JANSSEN COVID-19 VACCINE Stroke. 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).
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: COMPLICATIONS AFTER THE VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced complications after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of complications after the vaccine was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Fatigue, Influenza, Musculoskeletal chest pain
Clinical narrative: LEFT ARM FELT LIKE IT WAS JUST VACCINATED FOR ONE DAY ONLY; BOTH ARMS HURT; FLU/CHILLS SYMPTOMS; BACK ACHE/ BACK DISCOMFORT/PAINS ARE BETWEEN SHOULDER BLADES; RIBCAGE ACHE/ RIB DISCOMFORT; FEELING TIRED; NO FEVER BUT FELT LIKE IT WAS BURNING UP INSIDE; LITTLE ACHINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 120 pounds, and height was 63 inches. The patient's concurrent conditions included: bronchitis, allergenic asthma, environmental allergies, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 11-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced little achiness. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 11-DEC-2021, the patient experienced no fever but felt like it was burning up inside, and feeling tired. On 12-DEC-2021, the patient experienced flu/chills symptoms, back ache/ back discomfort/pains are between shoulder blades, ribcage ache/ rib discomfort, and both arms hurt. On 22-DEC-2021, the patient experienced left arm felt like it was just vaccinated for one day only. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no fever but felt like it was burning up inside, flu/chills symptoms, and both arms hurt, and left arm felt like it was just vaccinated for one day only on 23-DEC-2021, had not recovered from back ache/ back discomfort/pains are between shoulder blades, ribcage ache/ rib discomfort, and little achiness, and the outcome of feeling tired was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test, Sensory disturbance
Clinical narrative: LEFT ARM FELT LIKE IT WAS JUST VACCINATED FOR ONE DAY ONLY; BOTH ARMS HURT; FLU/CHILLS SYMPTOMS; BACK ACHE/ BACK DISCOMFORT/PAINS ARE BETWEEN SHOULDER BLADES; RIBCAGE ACHE/ RIB DISCOMFORT; FEELING TIRED; NO FEVER BUT FELT LIKE IT WAS BURNING UP INSIDE; LITTLE ACHINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 120 pounds, and height was 63 inches. The patient's concurrent conditions included: bronchitis, allergenic asthma, environmental allergies, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 11-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced little achiness. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 11-DEC-2021, the patient experienced no fever but felt like it was burning up inside, and feeling tired. On 12-DEC-2021, the patient experienced flu/chills symptoms, back ache/ back discomfort/pains are between shoulder blades, ribcage ache/ rib discomfort, and both arms hurt. On 22-DEC-2021, the patient experienced left arm felt like it was just vaccinated for one day only. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no fever but felt like it was burning up inside, flu/chills symptoms, and both arms hurt, and left arm felt like it was just vaccinated for one day only on 23-DEC-2021, had not recovered from back ache/ back discomfort/pains are between shoulder blades, ribcage ache/ rib discomfort, and little achiness, and the outcome of feeling tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a health care professional 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: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 06-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. 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.