chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 year old received received SHINGRIX; received Shingrix instead of Meningitis vaccination; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 17-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The other health professional reported that 17 year old patient had received Shingrix instead of Meningitis vaccination, which led to inappropriate age at vaccine administration and wrong vaccine administered. No further details were provided at the time of the call.  The reporter consented to follow up. This case was linked with US2021214420, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021214420:same reporter
Age: 15.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received SHINGRIX; received SHINGRIX instead of Meningitis vaccination.; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 15-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were reported as follows: The Glaxosmithkline account manager called to report that  patient received SHINGRIX instead of Meningitis vaccination, which led to inappropriate age at vaccine administration and wrong vaccine administered. No further details were provided at the time of the call. The reporter consented follow-up. This case was linked with USUS2021214417, Reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021214417:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 02Dec2019 and not received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02nd 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the pharmacy student. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No vaccine data was available. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on the 11th March, 2021 went back today to get her second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 44-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 11th March 2021, batch number GG3S5 and expiration date 28th February 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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 provided as follows: The age  at vaccination was not applicable for this report. The patient received 1st dose of Twinrix at primary reporter's facility. Till the time of reporting, the patient did not receive the second dose of Twinrix which led to incomplete course of vaccination. The patient went back on the day of reporting, to get her second dose. The patient was not vaccinated with the second dose at the time of the call. No further details were provided at the time of the call. The reporter consented to followup by phone.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on buttocks; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) and (batch number J5255, expiry date 13th November 2022) for prophylaxis.   On 9th August 2021, the patient received the 1st dose of Shingrix.On an unknown date, the dose was an unknown dose. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported that patient received shingrix vaccine and developed a rash on her left buttocks.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy intern reported that, a patient received the two dose series of Shingrix in the appropriate timeframe, then patient went to pharmacy and stated they were at the pharmacy to receive a 2nd dose. A dose was administered and then it was discovered to be the third dose.  After investigating, the patient received this third dose approximately one year after the second Shingrix dose, which led to extra dose administered. The reporter did not have patient details, exact dates administered, or vaccine lot number/expiration dates. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not receive the  2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2019).   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 consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on October 31st 2019 / 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st October 2019, batch number 3HTSJ, expiry date 26th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019, inquiring for second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   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 reporter was the patient. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Fluish-like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: This age at the vaccination was not reported. The physician reported that patient had flu-like symptoms after 12 hours of Shingrix vaccine and lasted for about 36 hours. The reporter consented to follow-up.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose of Engerix-B was administered to an adult; pediatric dose of Engerix-B was administered to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 69-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.   Previously administered products included Engerix B (1st dose received on an unknown date).   On 18th October 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 18th October 2021, 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: Nurse Practitioner reported that the pediatric dose of Engerix-B was inadvertently administered to an adult female patient, which led to underdose and adult use of a child product. The HCP gave permission for follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination complication
Clinical narrative: Vaccination adverse reaction; Pain; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided No concomitant medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Adverse Event Added
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; Protocol: 21-0012: A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that a subject of unspecified age and gender (subject number: 827645449, site number not reported) reported they fainted (grade 1). The event occurred an unspecified amount of days after the subject was administered the open label COVID-19 vaccine AD26.COV2.S as prophylactic vaccination. At the time of this report, the event outcome was recovered/ resolved. The action taken with the open label COVID-19 vaccine AD26.COV2.S was not applicable.  The subject's weight, height, and medical history were not reported. No concomitant medications were reported.   On an unspecified date, the subject was administered the open label COVID-19 vaccine AD26.COV2.S (suspension for injection, dose, route of admin, and batch number were not reported) as prophylactic vaccination.  On 23-JUL-2021, the subject fainted, and subsequently recovered.  Investigator's causality assessment: The event of syncope was not related to the vaccine.  Company causality assessment: The event of syncope was not related to the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Polyarthritis, Rheumatoid factor, Rheumatoid factor positive
Clinical narrative: This spontaneous report received from a physician concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No prior history of either ITP, symmetric polyarthritis, RH positive. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the healthy patient developed Immune thrombocytopenic purpura after vaccination. On an unspecified date, the patient developed a symmetric polyarthritis with positive rheumatoid factor. The outcome of the immune thrombocytopenic purpura and symmetric polyarthritis with rheumatoid factor positive was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211028796- covid-19 vaccine ad26.cov2.s - immune thrombocytopenic purpura and symmetric polyarthritis. 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: 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 via a company representative through social media concerned a 48 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included he was healthy. 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, with frequency time 01 total, administered in MAR-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.  The reporter stated that, he had read a story about a healthy man who got vaccine in MAR-2021. On an unspecified date, patient died from Covid-19 (suspected covid-19 infection) and suspected clinical vaccination failure. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000197778; Sender's Comments: V0: 20211031836-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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 V0: 20211031836-Covid-19 vaccine ad26.cov2.s-Suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID-19
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 pneumonia, Dysphonia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; COVID-19 PNEUMONIA; VOICE NOT FULLY BACK; This spontaneous report received from a consumer concerned a 39 year old male. The patient's weight was 220 pounds, and height was 70 inches. The patient's pre-existing medical conditions included: the patient had no known allergies and the patient was pretty healthy up until COVID. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported,1 total administered to left arm on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced covid-19 pneumonia (confirmed clinical vaccine failure).  On an unspecified date, the patient voice affected and voice was not fully back. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F and COVID-19 virus test (NR: not provided) positive. Treatment medications (dates unspecified) included: remdesivir. On 27-SEP-2021, the patient was hospitalized for 4 days. the patient reported to still had low energy, lingering cough and the patient was no longer on supplemental oxygen when he was discharged from hospital. patient required nasal cannula and was not intubated. The consumer reports patient was recovering well, almost back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 pneumonia, and affected voice, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211031970-COVID-19 VACCINE AD26.COV2.S- COVID-19 Pneumonia. 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). 20211031970-COVID-19 VACCINE AD26.COV2.S-Confirmed 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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CLINICALLY CONFIRMED POSITIVE COVID INFECTION; This spontaneous report received from a consumer concerned a 5 decade 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: Unk) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced clinically confirmed positive covid infection. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clinically confirmed positive covid infection. This report was non-serious. This report was associated with product quality complaint: 90000197951.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: SARS-COV-2 POSITIVE; This spontaneous report received from a consumer 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, batch number: Unknown) dose was not reported, administered on 16-AUG-2021 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 sars-cov-2 positive. Laboratory data (dates unspecified) included: SARS-CoV-2 test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 positive was not reported. This report was non-serious. This report was associated with product quality complaint number:90000197913 This case, from the same reporter is linked to 20211032892.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HYPERTENSION (HIGH BLOOD PRESSURE); This spontaneous report received from a pharmacist concerned a 74 year old female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,1 total administered on 14-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-OCT-2021, the patient experienced hypertension (high blood pressure) with blood pressure over 200/100 mmHg and was brought to the emergency room for treatment and was hospitalized for unspecified duration.    The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypertension (high blood pressure). This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000197924.; Sender's Comments: V0: 20211033134-covid-19 vaccine ad26.cov2.s-Hypertension (high blood pressure). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: MILD ANAPHYLACTIC REACTION IN THROAT; This spontaneous report received from a patient via social media concerned of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: systemic sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose was not reported, administered on 01-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 01-APR-2021, one hour post vaccination the patient experienced mild anaphylactic reaction in throat which lasted for an hour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild anaphylactic reaction in throat on 01-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211034108-covid-19 vaccine ad26.cov2.s-mild anaphylactic reaction in throat. This event(s) is labeled per agency and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia, Thrombosis
Clinical narrative: COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On an unspecified date, the patients experienced covid-19 vaccine-induced thrombotic thrombocytopenia,  On an unspecified date, the patient died from covid-19 vaccine-induced thrombotic thrombocytopenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211034157.; Sender's Comments: V0: 20211034195-COVID-19 VACCINE AD26.COV2.S-COVID-19 vaccine-induced thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; COVID-19 VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: ABNORMAL BLEEDING; This spontaneous report received from a consumer concerned two patients of unspecified age, sex. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter was told that two other patients experienced abnormal bleeding by her physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abnormal bleeding was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211032981.; Sender's Comments: V0:20211034387-Covid-19 vaccine ad26.cov2.s  Abnormal bleeding. 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).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 21 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, intramuscular, batch number: 201A21A, expiry: 21/SEP/2021) 0.5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Hot flush, Impaired work ability
Clinical narrative: SKIN BECOME BLUEISH WHEN TOUCH TO SKIN; TIGHTNESS IN LEFT LEG; SHAKING LEG; HEART PALPITATIONS; NOT SLEEP AND WAKES UP AT NIGHT; CANNOT GO TO WORK; LEFT LEG PAIN; BOTHERING HEADACHES; PAIN IN LEFT EAR; DIZZINESS; VERY BAD FEVER; PAIN AT SITE OF INJECTION; HOT FLUSHES; BLURRED VISION/LOOSING VISION; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 29-DEC-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced pain in left ear. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced hot flushes. On 30-SEP-2021, the patient experienced blurred vision/loosing vision. On 30-SEP-2021, the patient experienced very bad fever. On 30-SEP-2021, the patient experienced pain at site of injection. On an unspecified date, the patient experienced skin become blueish when touch to skin, tightness in left leg, shaking leg, heart palpitations, not sleep and wakes up at night, cannot go to work, left leg pain, and bothering headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bothering headaches, and pain in left ear, and the outcome of very bad fever, pain at site of injection, dizziness, skin become blueish when touch to skin, tightness in left leg, shaking leg, hot flushes, blurred vision/loosing vision, heart palpitations, left leg pain, not sleep and wakes up at night and cannot go to work was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Muscle tightness, Pain in extremity, Palpitations
Clinical narrative: SKIN BECOME BLUEISH WHEN TOUCH TO SKIN; TIGHTNESS IN LEFT LEG; SHAKING LEG; HEART PALPITATIONS; NOT SLEEP AND WAKES UP AT NIGHT; CANNOT GO TO WORK; LEFT LEG PAIN; BOTHERING HEADACHES; PAIN IN LEFT EAR; DIZZINESS; VERY BAD FEVER; PAIN AT SITE OF INJECTION; HOT FLUSHES; BLURRED VISION/LOOSING VISION; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 29-DEC-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced pain in left ear. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced hot flushes. On 30-SEP-2021, the patient experienced blurred vision/loosing vision. On 30-SEP-2021, the patient experienced very bad fever. On 30-SEP-2021, the patient experienced pain at site of injection. On an unspecified date, the patient experienced skin become blueish when touch to skin, tightness in left leg, shaking leg, heart palpitations, not sleep and wakes up at night, cannot go to work, left leg pain, and bothering headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bothering headaches, and pain in left ear, and the outcome of very bad fever, pain at site of injection, dizziness, skin become blueish when touch to skin, tightness in left leg, shaking leg, hot flushes, blurred vision/loosing vision, heart palpitations, left leg pain, not sleep and wakes up at night and cannot go to work was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Tremor, Vision blurred
Clinical narrative: SKIN BECOME BLUEISH WHEN TOUCH TO SKIN; TIGHTNESS IN LEFT LEG; SHAKING LEG; HEART PALPITATIONS; NOT SLEEP AND WAKES UP AT NIGHT; CANNOT GO TO WORK; LEFT LEG PAIN; BOTHERING HEADACHES; PAIN IN LEFT EAR; DIZZINESS; VERY BAD FEVER; PAIN AT SITE OF INJECTION; HOT FLUSHES; BLURRED VISION/LOOSING VISION; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 29-DEC-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced pain in left ear. On 30-SEP-2021, the patient experienced dizziness. On 30-SEP-2021, the patient experienced hot flushes. On 30-SEP-2021, the patient experienced blurred vision/loosing vision. On 30-SEP-2021, the patient experienced very bad fever. On 30-SEP-2021, the patient experienced pain at site of injection. On an unspecified date, the patient experienced skin become blueish when touch to skin, tightness in left leg, shaking leg, heart palpitations, not sleep and wakes up at night, cannot go to work, left leg pain, and bothering headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bothering headaches, and pain in left ear, and the outcome of very bad fever, pain at site of injection, dizziness, skin become blueish when touch to skin, tightness in left leg, shaking leg, hot flushes, blurred vision/loosing vision, heart palpitations, left leg pain, not sleep and wakes up at night and cannot go to work was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Malaise, Pain, Pyrexia
Clinical narrative: COUGH; ACHES; FELT SICK; RUN DOWN; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 MAY-2021, the patient experienced cough. On MAY-2021, the patient experienced aches. On MAY-2021, the patient experienced felt sick. On MAY-2021, the patient experienced run down. On MAY-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt sick, and the outcome of fever, run down, cough and aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Illness, Insomnia
Clinical narrative: BODY ACHE/ EVERYTHING HURTS; CANT SLEEP; SICK; FELT SO BAD; FEELING COLD; SHAKING CHILLS; VOMITED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-OCT-2021 14:00 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 18-OCT-2021, the patient experienced body ache/ everything hurts. On 18-OCT-2021, the patient experienced cant sleep. On 18-OCT-2021, the patient experienced sick. On 18-OCT-2021, the patient experienced felt so bad. On 18-OCT-2021, the patient experienced feeling cold. On 18-OCT-2021, the patient experienced shaking chills. On 18-OCT-2021, the patient experienced vomited. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cant sleep, sick, felt so bad, feeling cold, vomited, body ache/ everything hurts, and shaking chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: BODY ACHE/ EVERYTHING HURTS; CANT SLEEP; SICK; FELT SO BAD; FEELING COLD; SHAKING CHILLS; VOMITED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-OCT-2021 14:00 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 18-OCT-2021, the patient experienced body ache/ everything hurts. On 18-OCT-2021, the patient experienced cant sleep. On 18-OCT-2021, the patient experienced sick. On 18-OCT-2021, the patient experienced felt so bad. On 18-OCT-2021, the patient experienced feeling cold. On 18-OCT-2021, the patient experienced shaking chills. On 18-OCT-2021, the patient experienced vomited. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cant sleep, sick, felt so bad, feeling cold, vomited, body ache/ everything hurts, and shaking chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SEVERE REACTION TO JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction to Johnson and Johnson vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction to Johnson and Johnson vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dyskinesia, Eye pain, Headache, Hyperhidrosis
Clinical narrative: EYEBALL HURTING; CHILLS; HEADACHES; FEVER; BODY MOVEMENT ALL THE TIME; SWEATING; PAIN; 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 was fine for 2 hours after taking the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-OCT-2021 16:00 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 OCT-2021, the patient experienced body movement all the time. On OCT-2021, the patient experienced sweating. On OCT-2021, the patient experienced pain. On 18-OCT-2021, the patient experienced eyeball hurting. On 18-OCT-2021, the patient experienced chills. On 18-OCT-2021, the patient experienced headaches. On 18-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of fever, chills, headaches, eyeball hurting, body movement all the time and sweating was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: EYEBALL HURTING; CHILLS; HEADACHES; FEVER; BODY MOVEMENT ALL THE TIME; SWEATING; PAIN; 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 was fine for 2 hours after taking the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-OCT-2021 16:00 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 OCT-2021, the patient experienced body movement all the time. On OCT-2021, the patient experienced sweating. On OCT-2021, the patient experienced pain. On 18-OCT-2021, the patient experienced eyeball hurting. On 18-OCT-2021, the patient experienced chills. On 18-OCT-2021, the patient experienced headaches. On 18-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of fever, chills, headaches, eyeball hurting, body movement all the time and sweating was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Skin irritation
Clinical narrative: BUTTOCK CHEEKS AND ANAL AREA FEELS LIKE BURNING SENSATION; BUTTOCK CHEEKS AND ANAL FEELS IRRITATED; BUTTOCK RASH; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: Patient had no other symptoms/complaints after receiving vaccine. Patient's family doctor did not see any rash or any blood in stool and redness. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, the patient experienced buttock rash. On 15-SEP-2021, the patient experienced buttock cheeks and anal area feels like burning sensation. On 15-SEP-2021, the patient experienced buttock cheeks and anal feels irritated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from buttock rash, and the outcome of buttock cheeks and anal area feels like burning sensation and buttock cheeks and anal feels irritated was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: This spontaneous report received from a patient concerned an 8 decade 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 not reported, batch number: 1805029, expiry: 23-AUG-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling dizzy, headache, and numbness on both sides of face from cheeks down to jaw line. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling dizzy, and had not recovered from headache, and numbness on both sides of face from cheeks down to jaw line. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; 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, 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Impaired quality of life
Clinical narrative: TORPEDOED QUALITY OF LIFE AFTER VACCINATION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient 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 torpedoed quality of life after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from torpedoed quality of life after vaccination. This report was non-serious.