chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Nodule, Pain, Pyrexia, Somnolence
Clinical narrative: injection site started itching; pain at the injection site; swelling at the injection site; fever; sleepiness; pain in the right arm / used my arm for 4 hours and after it was hurting / arm is still sore; joint pain in my right shoulder; knot on her armpit, like a swollen gland; knot on her armpit very painful; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus. Concomitant products included drug used in diabetes (Diabetes Medication (Nos)).   On 21st August 2021 16:30, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, fever, sleepiness, pain in arm, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain. On 21st August 2021, the patient experienced injection site pain. On 25th August 2021, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, fever, sleepiness, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain were unknown and the outcome of the injection site itching and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site itching, fever, sleepiness, pain in arm, pain in joint involving shoulder region, axillary lymph nodes enlarged and pain to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. Patient reported that she had diabetes mellitus type 2 and was on medications (unspecified) for this condition.  The patient received first dose of Shingrix vaccine in right arm at a local pharmacy and immediately experienced pain at the injection site. The patient experienced swelling at the injection site, fever, sleepiness, pain in the right arm and joint pain in right shoulder. The patient reported that she had a knot on her armpit, like a swollen gland and it was very painful. The patient reported that she ate right and exercises daily.  On the day of reporting, 4 days after receiving vaccination, the injection site started itching and arm was still sore.  The patient reported that at her part time job she used her arm for 4 hours and after it was hurting.  The patient provided consent to follow up with healthcare professional. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: was not administered with dose and first dose was given more than one (1) month ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 58-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.   Concomitant products included HBV (Engerix B) and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and an unknown time after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable. The health care provider reported that a patient 1st dose was given more than one month ago with batch number N4GA4 and expiry date 28th February 2023. Till the time of reporting, the patient was not administered with 2nd dose of Engerix-B dose which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to US2021179663, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179663:same reporter
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: 1st dose in Sept 2020, and didn't get the 2nd dose until 8/23/2021 (due to COVID).; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020).   On 23rd August 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not receive 2nd dose of Shingrix due to COVID pandemic situation, which led to social problem. The reporter stated that, the patient did not receive 2nd dose of Shingrix until 23rd August August 2021, batch number 9ZJ25, expiry date 23rd January 2023. The patient asked did need a 3rd dose. The reporter consented to follow up via email
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient only received liquid portion; patient only received liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMBA5808, expiry date 31st August 2022) for prophylaxis.   On 25th August 2021, the patient received Menveo. On 25th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient only received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Administered third dose; First dose given 02/03/2020 and second dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 3rd February 2020).   On 25th August 2021, the patient received the 3rd dose of Shingrix. On 5th April 2021, the patient received the 2nd dose of Shingrix. On 5th April 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 25th August 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 reported as follows: The patient received 2nd dose of Shingrix later then the recommended schedule, which led to lengthening of vaccination schedule. The patient also received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 years old male patient was administrated with 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 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237c4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Kinrix Pre-Filled Syringe Device was unknown. 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 medical assistant reported that a 9 years old patient was administrated with Kinrix, which led to inappropriate age at vaccine administration. No adverse event was reported . The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received second dose due to COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not receive 2nd dose of Shingrix due to COVID 19 pandemic, which led to social problem. The reporter did not provide batch number neither expiration date. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the adjuvant was given; Only the adjuvant was given; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C4B3, expiry date 14th November 2022) for prophylaxis.   On 17th August 2021, the patient received Shingrix. On 17th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only the adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021182200, US2021182201 reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182200:Same reporter US-GLAXOSMITHKLINE-US2021182201:Same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the adjuvant was given; Only the adjuvant was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 7C4B3, expiry date 14th November 2022) for prophylaxis.   On 20th August 2021, the patient received Shingrix. On 20th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021182200, US2021182199, reported by same reporter for differnt patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182199:Same reporter US-GLAXOSMITHKLINE-US2021182200:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a patient of unspecified age and sex, race and ethnic origin. Initial information was processed along with the additional information received on 25-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose, one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient diagnosed with guillain barre syndrome and was paralyzed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210845247.; Sender's Comments: V0: 20210844560 -COVID-19 VACCINE AD26.COV2.S- Guillain barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; DIZZINESS; KIDNEY PAIN; LOWER BACK PAIN; CHEST PAIN; ALMOST LETHARGIC; PAIN AT INJECTION SITE; VERY TIRED; NAUSEA; SLEPT THE MOMENT HE GOT VACCINE; This spontaneous report received from a consumer concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included: adenoids removed, spleen removed, gallbladder removed, and tonsils removed, and concurrent conditions included: cigarettes smoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced slept the moment he got vaccine. On 24-AUG-2021, the patient experienced shortness of breath. On 24-AUG-2021, the patient experienced dizziness. On 24-AUG-2021, the patient experienced kidney pain. On 24-AUG-2021, the patient experienced lower back pain. On 24-AUG-2021, the patient experienced chest pain. On 24-AUG-2021, the patient experienced almost lethargic. On 24-AUG-2021, the patient experienced pain at injection site. On 24-AUG-2021, the patient experienced very tired. On 24-AUG-2021, the patient experienced nausea. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, kidney pain, lower back pain, very tired, pain at injection site, chest pain, shortness of breath, almost lethargic, nausea and slept the moment he got vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Nausea, Renal pain, Somnolence
Clinical narrative: SHORTNESS OF BREATH; DIZZINESS; KIDNEY PAIN; LOWER BACK PAIN; CHEST PAIN; ALMOST LETHARGIC; PAIN AT INJECTION SITE; VERY TIRED; NAUSEA; SLEPT THE MOMENT HE GOT VACCINE; This spontaneous report received from a consumer concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included: adenoids removed, spleen removed, gallbladder removed, and tonsils removed, and concurrent conditions included: cigarettes smoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced slept the moment he got vaccine. On 24-AUG-2021, the patient experienced shortness of breath. On 24-AUG-2021, the patient experienced dizziness. On 24-AUG-2021, the patient experienced kidney pain. On 24-AUG-2021, the patient experienced lower back pain. On 24-AUG-2021, the patient experienced chest pain. On 24-AUG-2021, the patient experienced almost lethargic. On 24-AUG-2021, the patient experienced pain at injection site. On 24-AUG-2021, the patient experienced very tired. On 24-AUG-2021, the patient experienced nausea. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, kidney pain, lower back pain, very tired, pain at injection site, chest pain, shortness of breath, almost lethargic, nausea and slept the moment he got vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Hypertension, Oedema peripheral
Clinical narrative: HIGH BLOOD PRESSURE; EDEMATOUS ANKLES BILATERALLY; SHORTNESS OF BREATH; HEART WAS RACING; SHAKING AND TREMORS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 135 pounds, and height was 66 inches. 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced shaking and tremors. On an unspecified date, the patient experienced high blood pressure, edematous ankles bilaterally, shortness of breath, and heart was racing. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Heart rate (NR: not provided) Rapid (increased). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking and tremors on MAR-2021, and the outcome of high blood pressure, edematous ankles bilaterally, shortness of breath and heart was racing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: HIGH BLOOD PRESSURE; EDEMATOUS ANKLES BILATERALLY; SHORTNESS OF BREATH; HEART WAS RACING; SHAKING AND TREMORS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 135 pounds, and height was 66 inches. 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced shaking and tremors. On an unspecified date, the patient experienced high blood pressure, edematous ankles bilaterally, shortness of breath, and heart was racing. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Heart rate (NR: not provided) Rapid (increased). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking and tremors on MAR-2021, and the outcome of high blood pressure, edematous ankles bilaterally, shortness of breath and heart was racing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: This spontaneous report received from a consumer concerned a male of unspecified age, 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency time 1 total was administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-AUG-2021, the patient had confirmed immunological vaccination failure. Laboratory data included: COVID-19 antibody test (NR: not provided) negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210843278. This report was associated with product quality complaint 90000190438.; Sender's Comments: V0: 20210853492-COVID-19 VACCINE AD26.COV2.S-confirmed immunological 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
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 year old  female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was allergic to NSAIDS and had no previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient received a negative IgG antibody test and then again on 24-AUG-2021 (confirmed immunological vaccine failure). The patient was calling to inquire if there is any information regarding that situation. She had no other symptoms to report. Patient received vaccination aged 58 years, had birthday week after vaccination and experienced adverse event aged 59 years.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210854725-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via (social media) 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Since MAY-2021, the patient was paralyzed from Guillain-barre syndrome from the waist down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-barre syndrome. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210854750-covid-19 vaccine ad26.cov2.s-Guillain-Barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 62 year old,  male. The patient's height, and weight were not reported. The patient's past medical history included diagnosed with prostate. Other pre-existing medical conditions included No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, frequency one total, administered on 05-MAY-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. Patient got the JNJ Covid 19 vaccine on 05-MAY-2021. He had a blood work done with an antibody test on 15-AUG-2021 result was negative (coded to confirmed immunological vaccine failure). He did not mentioned the name of the antibody test. He also stated that he did not had the confidence in the JNJ booster shot since the first shot did not worked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000191134.; Sender's Comments: V0:20210854788-Covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hypothyroidism, and concurrent conditions included: hypertension, non-alcohol user, non-smoker (quit smoking in 1991), unspecified auto immune disease, celiac disease, immunocompromised, penicillin allergy (cardiac arrest), sulfa allergy (rash), and rheumatoid arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported and batch number: 1808980 expiry: 18-SEP-2021) dose was not reported, one total, administered on 07-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced confirmed immunological vaccine failure. The patient had done antibody test and stated that did not known specific of the test that was done and whether the antibody was against the spike protein. Laboratory data included: Blood test (NR: not provided) zero antibodies. The patient further stated that had done COVID-19 virus test (NR: not provided) couple of months after vaccination result was Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210854815-COVID-19 VACCINE AD26.COV2.S-confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Magnetic resonance imaging
Clinical narrative: DIZZINESS; TEMPORAL HEADACHE; This spontaneous report received from a health care professional concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Raynaud's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 dizziness, and temporal headache. Laboratory data (dates unspecified) included: MRI (NR: not provided) No blood clot was found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporal headache and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210856312.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown ) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. As per the reporter "he heard rumors in his neighborhood that someone down the street was vaccinated with the Janssen Covid-19 vaccine and had blood clots. He said that there are rumors always being spread and did not believe it to be true nor did he want to provide any further detail regarding the incident." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210854934-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer 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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient was vaccinated in April and got sick with covid-19 infection in AUG-2021, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000191148 This case, from the same reporter is linked to 20210855235 and 20210855254.; Sender's Comments: V0 - 20210854979- 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: Pneumonia, Suspected COVID-19, Vaccination failure
Clinical narrative: LUNG INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race, 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency one total, administered on an unspecified date in Apr-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 in Jul-2021, the patient caught the variant (suspected Covid-19 infection, suspected clinical vaccination failure), was pretty sick and the lungs got infected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lung infection, suspected Covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191186.; Sender's Comments: V0: 20210854989- Covid-19 vaccine ad26.cov2.s- Lung infection. 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). 20210854989- 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
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED ON 23-AUG-2021 FROM A VIAL THAT WAS PUNCTURED ON 19-AUG-2021 (VACCINE GIVEN AFTER 6 HOURS OF PUNCTURE); This spontaneous report received from a pharmacist concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced vaccine administered on 23-aug-2021 from a vial that was punctured on 19-aug-2021 (vaccine given after 6 hours of puncture). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered on 23-aug-2021 from a vial that was punctured on 19-aug-2021 (vaccine given after 6 hours of puncture) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855201 and 20210854749.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 210 pounds, and height was 69 inches. The patient's concurrent conditions included hypertension controlled by medication, social alcohol user, and non-smoker. The patient had known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient underwent COVID-19 SARS-CoV-2 Antibody (IgG), Spike, Semi-quantitative test, and it came back negative (confirmed immunological vaccine failure). The patient reported that according to the package, this particular test provides insight to antibody response to infection and exposure to the vaccine. The patient not discussed this results with her health care provider (HCP). The patient performed this test because of the recent discussion of boosters, and she wanted to know if she was still covered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191192.; Sender's Comments: V0. 20210855625-covid-19 vaccine ad26.cov2.s-Confirmed immunological 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
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: SORE THROAT; DIARRHEA; VOMITING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 165 pounds, and height was 68 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced sore throat. On 23-AUG-2021, the patient experienced diarrhea. On 23-AUG-2021, the patient experienced vomiting. On 23-AUG-2021, the patient experienced headache. On 23-AUG-2021, the patient experienced nausea. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, sore throat, headache, vomiting and nausea was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SORE THROAT; DIARRHEA; VOMITING; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 165 pounds, and height was 68 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced sore throat. On 23-AUG-2021, the patient experienced diarrhea. On 23-AUG-2021, the patient experienced vomiting. On 23-AUG-2021, the patient experienced headache. On 23-AUG-2021, the patient experienced nausea. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, sore throat, headache, vomiting and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Insomnia, Malaise, Pyrexia
Clinical narrative: SHAKING ALL OVER; COULD NOT SLEEP/INSOMNIA ALL NIGHT LONG; SICK; HAD A FEVER OF 102; FEELING TIRED; 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, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced shaking all over, could not sleep/insomnia all night long, sick, had a fever of 102, and feeling tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking all over, could not sleep/insomnia all night long, sick, had a fever of 102, and feeling tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING ALL OVER; COULD NOT SLEEP/INSOMNIA ALL NIGHT LONG; SICK; HAD A FEVER OF 102; FEELING TIRED; 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, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced shaking all over, could not sleep/insomnia all night long, sick, had a fever of 102, and feeling tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking all over, could not sleep/insomnia all night long, sick, had a fever of 102, and feeling tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LOST APPETITE; This spontaneous report received from a consumer concerned a 57-year-old male, race and ethnicity unknown. 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, frequency 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 in Mar-2021, the patient experienced aching muscles, dry cough, trouble breathing, and fever (suspected covid-19 infection and suspected clinical vaccination failure), and lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, lost appetite and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210856012- covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Influenza like illness, Insomnia, Nausea
Clinical narrative: EXTREME FLU LIKE SYMPTOMS (FEVER); SHAKINESS; NAUSEA; INSOMNIA; FEELING BAD; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, treatment medications included: paracetamol. On 26-AUG-2021, the patient experienced insomnia. On 26-AUG-2021, the patient experienced feeling bad. On 27-AUG-2021, the patient experienced extreme flu like symptoms (fever). On 27-AUG-2021, the patient experienced shakiness. On 27-AUG-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 F, up to 102 F, and Respiratory rate (NR: not provided) between 14-18. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme flu like symptoms (fever), and shakiness, and the outcome of nausea, insomnia and feeling bad was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Tremor
Clinical narrative: EXTREME FLU LIKE SYMPTOMS (FEVER); SHAKINESS; NAUSEA; INSOMNIA; FEELING BAD; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, treatment medications included: paracetamol. On 26-AUG-2021, the patient experienced insomnia. On 26-AUG-2021, the patient experienced feeling bad. On 27-AUG-2021, the patient experienced extreme flu like symptoms (fever). On 27-AUG-2021, the patient experienced shakiness. On 27-AUG-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 F, up to 102 F, and Respiratory rate (NR: not provided) between 14-18. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme flu like symptoms (fever), and shakiness, and the outcome of nausea, insomnia and feeling bad was not reported. This report was non-serious.