chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose but not 2nd; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient received the 1st dose of Shingrix but did not return within 2-6 months for the 2nd dose, which led to incomplete course of vaccination. The reporter wanted to know if the patient had to retake the 1st dose of Shingrix. The reporter did not have the patient identifiers or the exact date of the first dose at the time of reporting. The reporter consented to follow up via post.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old received Kinrix; 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 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient 7 years old received Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 7th December 2023) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th January 2022, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter stated that the patient received a pediatric dose of Engerix B, 2nd dose in series, which led to underdose and adult use of a child product. No reactions were reported. The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 61-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (received 1st dose 3 years before reporting). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not gotten his second dose till the time of reporting due to limited availability, which led to Product Supply issue. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Feeling abnormal, Gait disturbance, Limb discomfort
Clinical narrative: problems with my feet / kinda up to my knee; Most of the time it is my right foot but sometimes it is in my left / she can no longer walk 10 miles a day; has been "miserable" for her; how bad her walking is now; pain is affecting her hip and knee from her "foot giving into it; This case was reported by a consumer via call center representative and described the occurrence of limb discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia. On an unknown date, the outcome of the limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia were not recovered/not resolved.   The reporter considered the limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia to be probably related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that after she got the Shingrix shot she started having problems with her feet mostly the one on her right side and kinda up to her knee. The patient had bloodwork done, went to a foot specialist, also went to a vascular doctor but nothing was showing up and wanted to know had anyone else reported this. The patient reported most of the time it was her right foot but sometimes it was her left. The patient stated she never had this problem until she got Shingrix shot. The patient was seeking treatment recommendations. The patient stated that the doctors that she was going through were not coming up with any answers for her. The patient reported this to the pharmacy where she got the shot but they said that there was no way her problem could be due to Shingrix. The patient believed that the event was related to Shingrix because she stated the problem did not start until after the shot. The patient stated that it had been miserable for her. The patient gave an example: she said prior to the shot last summer, when she was on vacation, she was walking 10 miles a day but after the Shingrix shot she could no longer do that. The patient would have use a scooter, if they go back to the same place this summer, because of how bad her walking was. The patient stated the pain was affecting her hip and knee from her foot giving into it. The patient said they had her on gabapentin which she said helps some but even after they increased the dosage she was still dealing with pains. The patient stated it was devastating and the foot doctor might give her a shot. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: problems with my feet / kinda up to my knee; Most of the time it is my right foot but sometimes it is in my left / she can no longer walk 10 miles a day; has been "miserable" for her; how bad her walking is now; pain is affecting her hip and knee from her "foot giving into it; This case was reported by a consumer via call center representative and described the occurrence of limb discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia. On an unknown date, the outcome of the limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia were not recovered/not resolved.   The reporter considered the limb discomfort, mobility decreased, feeling miserable, walking difficulty and arthralgia to be probably related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that after she got the Shingrix shot she started having problems with her feet mostly the one on her right side and kinda up to her knee. The patient had bloodwork done, went to a foot specialist, also went to a vascular doctor but nothing was showing up and wanted to know had anyone else reported this. The patient reported most of the time it was her right foot but sometimes it was her left. The patient stated she never had this problem until she got Shingrix shot. The patient was seeking treatment recommendations. The patient stated that the doctors that she was going through were not coming up with any answers for her. The patient reported this to the pharmacy where she got the shot but they said that there was no way her problem could be due to Shingrix. The patient believed that the event was related to Shingrix because she stated the problem did not start until after the shot. The patient stated that it had been miserable for her. The patient gave an example: she said prior to the shot last summer, when she was on vacation, she was walking 10 miles a day but after the Shingrix shot she could no longer do that. The patient would have use a scooter, if they go back to the same place this summer, because of how bad her walking was. The patient stated the pain was affecting her hip and knee from her foot giving into it. The patient said they had her on gabapentin which she said helps some but even after they increased the dosage she was still dealing with pains. The patient stated it was devastating and the foot doctor might give her a shot. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal, Flank pain, Pain
Clinical narrative: Pulmonary embolism; pain on his side; pain in his chest area; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 16th September 2021, 1 days after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced pulmonary embolism (serious criteria GSK medically significant), pain and chest pain. On an unknown date, the outcome of the pulmonary embolism was recovered/resolved and the outcome of the pain and chest pain were unknown.   It was unknown if the reporter considered the pulmonary embolism, pain and chest pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the patient himself. The patient received his second dose of the Engerix-B vaccine in his right arm.  On 16th September 2021 he woke up with pain on his side and in his chest area.  He went to the emergency room on the following Tuesday. They performed a chest x-ray and a CT (computerized tomogram) scan to find he had multiple pulmonary embolisms (AE).  The patient was requesting information regarding GlaxoSmithKline to do additional testing on him to determine causation of the pulmonary embolisms. The reporter provided permission to contact healthcare professional. The reporter consent to follow up. No additional details were provided by the reporter.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Pulmonary embolism, Sleep disorder
Clinical narrative: Pulmonary embolism; pain on his side; pain in his chest area; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 16th September 2021, 1 days after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced pulmonary embolism (serious criteria GSK medically significant), pain and chest pain. On an unknown date, the outcome of the pulmonary embolism was recovered/resolved and the outcome of the pain and chest pain were unknown.   It was unknown if the reporter considered the pulmonary embolism, pain and chest pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the patient himself. The patient received his second dose of the Engerix-B vaccine in his right arm.  On 16th September 2021 he woke up with pain on his side and in his chest area.  He went to the emergency room on the following Tuesday. They performed a chest x-ray and a CT (computerized tomogram) scan to find he had multiple pulmonary embolisms (AE).  The patient was requesting information regarding GlaxoSmithKline to do additional testing on him to determine causation of the pulmonary embolisms. The reporter provided permission to contact healthcare professional. The reporter consent to follow up. No additional details were provided by the reporter.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 20 year old patient received a pediatric dose; 20 year old patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Engerix B pediatric 10 mcg and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 20 years old patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th January 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Havrix and Havrix 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 provided as follows: The age at vaccination was not reported. The patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up. This case was linked with case US2022005766, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2022005766:same reporter.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Adult patient got a dose of Engerix B 10 mcg; Adult patient got a dose of Engerix B 10 mcg; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number 97kt7, expiry date 15th March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Engerix B pediatric 10 mcg and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional etails were provided as follows: The 36 years old patient inadevertedly administrated Engerix-B pediatric dose instead of the 20 mcg adult one, which led to underdose and adult use of a child product. No further events were reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (received 1st dose on 16th January 2021). On an unknown date, the patient received the 2nd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt received 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 31st July 2019) and Shingrix (received 1st dose on 30th March 2019).   On 12th January 2022, the patient received the 3rd dose of Shingrix. On 12th January 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (received 1st dose in September 2020). 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 reporter did not consent to follow up. The VAERS details were reported for 1st dose.
Age: 0.08
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of 4 weeks old received Flulaval; 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 4-week-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 5N7J, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 12th January 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The office manager reported that, patient received Flulaval at the age of 4 weeks old, which led to inappropriate age at vaccine administration. The reporter wanted to know if there was any further information regarding the safety of the patient or any side effects due to this matter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; SORENESS AROUND SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A , and expiry: UNKNOWN) dose was not reported,1 total, administered on 18-JUN-2021 for prophylactic vaccination. On an unspecified date in late AUG-2021 and early SEP-2021, the patient had 5 or 6 Covid-19 test, all result showed negative. No adverse events reported post vaccination (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 not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported,1 total, administered on 24-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced soreness around shot. On 03-JAN-2022, the patient was tested positive for Covid-19 through rapid nasal swab, hence covid-19 test positive (dose number in series 2). The patient was enquiring that is it possible to get a positive/false positive result receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness around shot on 26-DEC-2021, and the outcome of covid-19 test positive was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: IMMUNE THROMBOCYTOPENIC PURPURA; This solicited report received from a physician: concerned a 78 year old 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 not reported, batch number: Unknown) dose was not reported,1 total, administered on an unspecified date in 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 an unspecified date, 4 days after vaccination the patient was diagnosed with immune thrombocytopenic purpura (ITP). His platelet count were significantly lowered. He was treated with immunoglobulin human normal (IVIG), 2 units of platelets, and decadron (dexamethasone). He visited physician's office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune thrombocytopenic purpura was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura as related. Company causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220110559 -covid-19 vaccine ad26.cov2.s-immune thrombocytopenic purpura. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Pyrexia, SARS-CoV-2 test
Clinical narrative: FEELING HOT; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 130 pounds and height was 64 centimeters. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) (dose number in series 1), 01 in total was administered on APR-2021, dose was not reported for prophylactic vaccination. No adverse events were reported following administration of 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: 211A21A and expiry: Unknown) dose was not reported, (dose number in series 2), 01 in total was administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JAN-2022, following administration of covid-19 vaccine ad26.cov2.s, he said that felt hot and thought that his fever could be probably due to sudden weather change. On the same day, the patient self-medicated with two Motrin and 1 Motrin the next day.  On 06-JAN-2022, he tested his body temperature which was 100.1 degree celsius (C), and has tested twice for (COVID-19) corona virus disease via self test and the result was negative for both tests.  On 07-JAN-2022, he again tested his body temperature which was in range of 98-99 degree celsius (C). He used oral thermometer and had been measuring his temperature regularly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and fever on 06-JAN-2022 (Dose number in series 2). This report was non-serious. This case was a duplicate of 20220112244.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This solicited report received from a physician concerned a 56 year old 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 was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced deep vein thrombosis and pulmonary embolism, diagnosed approximately 17 days post Johnson and Johnson vaccine. Treatment medications (dates unspecified) included: heparin, and methylprednisolone sodium succinate. Patient was survived. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the deep vein thrombosis and pulmonary embolism was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and deep vein thrombosis, and pulmonary embolism as related. Company causality between covid-19 vaccine ad26.cov2.s, and deep vein thrombosis, and pulmonary embolism was related. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220114526.; Sender's Comments: V0: 20220114454-covid-19 vaccine ad26.cov2.s- deep vein thrombosis, pulmonary embolism. This event(s) is considered related. 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: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: IMMUNE THROMBOCYTOPENIC PURPURA (ITP); This solicited report received from a physician concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). 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, approximately 16 days post vaccine, the patient was diagnosed with immune thrombocytopenic purpura (ITP) and was treated with immunoglobulin human normal (Octagam), platelets, and dexamethasone (Decadron). The patient was hospitalized (date unspecified) and number of days hospitalization was not reported (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from immune thrombocytopenic purpura (ITP). The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura (ITP) as related. The company causality between covid-19 vaccine ad26.cov2.s, and immune thrombocytopenic purpura (ITP) was related. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220114526.; Sender's Comments: V0 : 20220114483-COVID-19 VACCINE AD26.COV2.S-immune thrombocytopenic purpura. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Laboratory test, Thrombocytopenia
Clinical narrative: ACUTE MYOCARDIAL INFARCTION; THROMBOCYTOPENIA; This solicited report received from a physician concerned a 47 year old 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 (dose series number:1) (suspension for injection, batch number was not reported, expiry date: 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, the patient experienced acute myocardial infarction (AMI) 11 days post JNJ vaccine and was diagnosed with thrombocytopenia at same time by labs (not specified). The patient was treated with aspirin, heparin drip and statins. It was reported that the patient survived. The physician suspected the events to be linked to JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute myocardial infarction and thrombocytopenia was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and acute myocardial infarction, and thrombocytopenia as related. Company causality between covid-19 vaccine ad26.cov2.s, and acute myocardial infarction, and thrombocytopenia was related. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220114454 and 20220114483.; Sender's Comments: V0: 20220114526 -covid-19 vaccine ad26.cov2.s- acute myocardial infarction, thrombocytopenia. This event(s) is considered related. 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: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENTS NOS; 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, 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 adverse events nos (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events nos was not reported. This report was non-serious. This case, involving the same patient is linked to 20220112515.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test
Clinical narrative: MIGRAINE; This spontaneous report received from a patient concerned a 45 year old  female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker and drug allergy to hydrocodone/acetaminophen and metronidazole.  On 02-JAN-2022, the patient experienced symptoms like bad headache, cough, congestion, feeling cold and hot, pain, fatigue and loss of apatite which is a suspected clinical vaccine failure and suspected covid-19 infection (dose number in series was 1) when previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 02-OCT-2021) dose was not reported, (dose number in series was 1), administered 1 in total on 28-May-2021 to the right arm for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 and expiry: UNKNOWN) dose was not reported, (dose number in series was 2) administered 1 in total on 21-DEC-2021 to the left arm  for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022, the patient experienced migraine (dose number in series was 2). Patient visited urgent care and took a rapid test. Patient was told to quarantine for 10 days. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220107394 (booster series 1 case).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood cholesterol, Blood cholesterol increased, Fatigue
Clinical narrative: INFLAMMATION LOCALISED; TIREDNESS; FEVER; CHOLESTEROL HIGH; PAINFUL FEET; SWELLING OF FEET; BACK PAIN; PAIN IN HIP; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 22-JUL-2021, the patient experienced back pain, and pain in hip. On AUG-2021, the patient experienced swelling of feet, and painful feet. On an unspecified date, the patient experienced inflammation localised, tiredness, fever, and cholesterol high (Dose number in series 1). Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) Bit high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from fever, had not recovered from swelling of feet, back pain, pain in hip, painful feet, and tiredness, and the outcome of inflammation localised and cholesterol high was not reported. This report was non-serious. This case, involving the same patient is linked to 20220119776 (Dose number in series 2, booster case).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: INFLAMMATION LOCALISED; TIREDNESS; FEVER; CHOLESTEROL HIGH; PAINFUL FEET; SWELLING OF FEET; BACK PAIN; PAIN IN HIP; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 22-JUL-2021, the patient experienced back pain, and pain in hip. On AUG-2021, the patient experienced swelling of feet, and painful feet. On an unspecified date, the patient experienced inflammation localised, tiredness, fever, and cholesterol high (Dose number in series 1). Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) Bit high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from fever, had not recovered from swelling of feet, back pain, pain in hip, painful feet, and tiredness, and the outcome of inflammation localised and cholesterol high was not reported. This report was non-serious. This case, involving the same patient is linked to 20220119776 (Dose number in series 2, booster case).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test, SARS-CoV-2 test positive, Thrombosis, Vaccination failure
Clinical narrative: BLOOD CLOTS; SOME PROBLEMS; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 51 year old female. 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 was not reported, batch number: unknown, expiry: unknown) 1 total, dose not reported, between March- 2021 and April- 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that patient had some problems after receiving the Covid 19 vaccine (1st shot), but did not knew what were those problems. On 09-JAN-2022, the patient went to the hospital. Laboratory data included: COVID-19 test (NR: not provided) Positive. The patient was currently in the hospital with 4 blood clots. The patient also experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some problems, had not recovered from covid-19 test positive, and blood clots, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000211275.; Sender's Comments: V0.20220118491-covid-19 vaccine ad26.cov2.s -Thrombosis. 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). 20220118491-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: F
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: STIFFNESS OF JOINTS; STIFFNESS OF NECK DOWN; WORST HEADACHE; This spontaneous report received from a patient 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) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No adverse events reported post primary vaccination (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 and expiry date were not reported) dose was not reported 1 in 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 some bad reaction from the booster shot. Patient got the worst headache, stiffness of joints and stiffness of neck down (reported as single term: stiffness of joints and neck down, captured as two separate events) (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, stiffness of joints and stiffness of neck down was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac ablation
Clinical narrative: CARDIAC ABLATION; 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. The patient's pre-existing medical conditions included: Patient had unspecified pre-existing health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was not reported, expiry: unknown) 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, due to unknown reason the patient was to undergo cardiac ablation later that month. Patient had taken the vaccine due to pre-existing health condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac ablation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220119117-COVID-19 VACCINE AD26.COV2.S-cardiac ablation . 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: F
Vaccine: COVID19
Symptoms: Blood test, Inappropriate schedule of product administration, Off label use, Pyrexia
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; MILD FEVER; This spontaneous report received from a patient concerned a 38-year-old female, unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency one total administered on 30-MAR-2021 for prophylactic vaccination. After administration of the initial dose to the patient reported that her back and hip had been hurting for the last month on 22-JUL-2021. Her feet was hurting and it was very swollen after being on her feet all day on 29-AUG-2021 at the fair with her kids. She had mild fever on her first booster covid vaccine. Her cholesterol was a bit high in her last blood work. Physician told her to not concerned but keep an eye on it. Her L-5 on her spine had inflammation which was why she had numbing and pain going down her right leg and foot (all events occurred in dose number series 1). It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The patient was previously received upadacitinib (Rinvoq) for moderate to severe rheumatoid arthritis. The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (manufactured by Johnson and Johnson) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, frequency one total administered on an unspecified date for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s (dose number series 2). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 3) (manufactured by Johnson and Johnson) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination which was an off label use and inappropriate schedule of vaccine administered (both event with dose number in series 3). 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 mild fever (event with dose number in series 3). Laboratory data (dates unspecified) included: Blood test (NR: not provided) cholesterol bit high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220117248. (Dose number in series 1).