chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 9/10/ 2019, 2nd dose last week; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2019).   On 5th January 2022, the patient received the 2nd dose of Shingrix. On 5th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter was in a rush so she did not have patient and vaccine´s details at the moment of the call. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Mixed Shingrix with NS instead of Shingrix adjuvant; Mixed Shingrix with NS instead of Shingrix adjuvant; This case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 9PR2P, expiry date 17th April 2023) for prophylaxis.   On 12th January 2022, the patient received Shingrix. On 12th January 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received shingrix mixed with normal saline instead of shingrix adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No additional details available at time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2020, not received second; 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 March or April 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The 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: Incomplete course of vaccination
Clinical narrative: 1st dose 12Oct2020, late for 2nd; This case was reported by a pharmacist 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 on 12th October 2020, batch number YZ325, expiry date 9th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose was administrated; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received HBV (Engerix B) (batch number 73h93, expiry date 10th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 12th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertedly administrated expired dose of Engerix B, which led to expired vaccine used. No further events were reported. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA587A, expiry date 20th August 2022) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient was administered the powder portion of Menveo (MenA component) reconstituted with sterile solution instead of using the correspondent liquid portion of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have information about patient's identifiers and was not sure if the administration might had occurred on 31th December 2021. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Had a fever; So tired, couldn't get off of the couch; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (8 years before reporting). Concurrent medical conditions included immune system disorder nos, asthma and atopic dermatitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR007153  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after her first Shingrix dose she had a fever and was so tired she couldn't get off of the couch for three days. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2022AMR007153.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR007153:Same reporter
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number kn3j4, expiry date 29th June 2023) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 28th December 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 28th December 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter stated that the patient received only the diluent component of Rotarix vaccine, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter denied consent to follow-up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix with an associated reaction of pain (received first dose of shingrix on 18th November 2019, for tolerance refer case US2022AMR007322). On 24th September 2021, the patient received the 2nd dose of shingrix (intramuscular) .5 ml. In September 2021, 12 hrs after receiving shingrix, the patient experienced injection site pain and general body pain. On 24th September 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, general body pain and drug dose administration interval too long were recovered/resolved. The reporter considered the injection site pain and general body pain to be related to shingrix. Linked case(s) involving the same patient: US2022AMR007322; Additional details were reported as follows: The patient self-reported this case. The patient received a dose of shingrix and about 12 hours later experienced injection site pain and body aches which resolved 3 days later. The patient's two doses were greater than 6 months apart, which led to lengthening of vaccination schedule. The patient asked if he should restart the series. The patient did not provide consent to follow up. This case has been linked to US2022006705, reported by same patient for his wife.; Sender's Comments: US-GLAXOSMITHKLINE-US2022006705:Same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Body aches; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, an unknown time after receiving Shingrix, the patient experienced general body pain and injection site pain. On an unknown date, the outcome of the general body pain and injection site pain were recovered/resolved.   It was unknown if the reporter considered the general body pain and injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR007267  Additional details were reported as follows: The reporter was patient's husband.  The patient received a dose of Shingrix and 12 hours later experienced injection site pain and body aches which resolved 2 days later. The patient received first dose on 18th November 2019 and second dose on 24th September 2021. The reporter wanted to know if his wife should restart the series. Consent to follow up was denied. For tolerance of 2nd dose of Shingrix, refer case US2022AMR007267; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006699:Same reporter. US-GLAXOSMITHKLINE-US2022AMR007267:Same reporter.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: The patient inadvertently received pediatric dose (10mcg); The patient inadvertently received pediatric dose (10mcg); This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number N234J, expiry date 21st January 2022) for prophylaxis.   On 11th January 2022, the patient received the 3rd dose of Engerix B pediatric (intramuscular) 10 ug. On 11th January 2022, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: The reporter reported that, the patient inadvertently received pediatric dose (10mcg) of Engerix-B in the right arm, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest pain, Dyspnoea, Mycobacterium tuberculosis complex test
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received seasonal influenza vaccine on APR-2020, and streptococcus pneumonia (pneumococcal) vaccine on 17-NOV-2020 for prophylactic vaccination. The patient had not received BCG (Bacille Calmette Guerin) vaccination. On 18-NOV-2020, the patient was screened for tuberculosis and was negative.  On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported. On an unspecified date, the patient received booster dose of non company vaccine mrna 1273 (dose number in series: 2) (form of admin unknown, intramuscular, batch number was not reported), dose, start therapy date were not reported for prophylactic vaccination.  On an unspecified date, three to four weeks after the booster dose, the patient experienced chest pain, and shortness of breath (dose number in series: 2). The patient stated that he went to hospital when he could not breathe and was having bad chest pain. The patient was hospitalized (dates and duration unspecified). The patient continued with shortness of breath since the cardiac event and was seeing a cardiologist to determine possible heart attack verses blood clot. The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable; and action taken with adalimumab was not reported. The patient was recovering from chest pain, and had not recovered from shortness of breath. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220117359-covid-19 vaccine ad26.cov2.s-Chest pain and shortness of breath. 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: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: unspecified allergy (had allergies, Itchy eyes runs and runny nose from allergies, did not know what she was allergic to and took a medication in evenings for it). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination.  Non-company suspect vaccine included: mrNA-1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination as a booster dose. No concomitant medications were reported.  On 12-JAN-2022, the patient had cold like symptoms and stuffy nose and the patient had positive Covid 19 test (rapid test) on same day (suspected clinical vaccination failure and suspected covid-19 infection) (dose number in series 1).  Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority; Sender's Comments: V0:20220121036-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: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, SARS-CoV-2 test, Suspected COVID-19, Swelling of eyelid, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; RIGHT EYE LID SWOLLEN; RIGHT EYELID REDNESS; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry: unknown) 1 total, administered on JUL-2021 (end of JUL-2021) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, two weeks after the patient received vaccine, the patient experienced swollen right eye lid and had redness. It happened daily and had varying degrees of redness and swollen. It (redness and swollen) presented again two days before he took a rapid test and got COVID again. He never had right eye lid issue before receiving vaccine. Its intensity was on and off. On 02-JAN-2022, the patient was diagnosed with COVID (suspected clinical vaccination failure and suspected covid-19 infection). Laboratory data included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right eye lid swollen, suspected covid-19 infection, suspected clinical vaccination failure and right eyelid redness was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211631.; Sender's Comments: V0:20220121837 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: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 204B21A and expiry: Unknown) dose was not reported, dose number in series was 1, 01 total administered in left arm on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022, the patient had headaches, fever, head congestion and runny nose (suspected covid-19 infection) till 09-JAN-2022. Antigen rapid test was positive on 02-JAN-2022 confirming infection for Covid-19 (suspected clinical vaccination failure) and was advised to remain at home for 10 days (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 09-JAN-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.; Sender's Comments: V0. 20220122115-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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a 64 year old male. 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 test positive. This report was non-serious. This report was associated with product quality complaint: 90000211582 and 90000211583.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Magnetic resonance imaging, Movement disorder, Neck pain
Clinical narrative: NUMBNESS; PINS AND NEEDLES IN ARMS; HANDS FEEL PARALYSIS; NECK PAIN; HANDS NOT WORKING WELL/HARD TO GRIP STUFF/HARD TO MAKE A FIST; CAN NOT MOVE FOREARM AND BICEPS WELL/ARM SEIZED UP; ARM PAIN/HANDS ARM HURTING/SORE FOREARM; This spontaneous report received from a patient concerned a 34 year old male with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy individual. The patient used to work 12 hours a day, would never experience this arm pain before and never had this experience before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  After eight days of the vaccine (21-DEC-2021) hands and arm of the patient was hurting a lot, patient could not move forearm well and biceps also. Forearm of the patient was super sore right now. It was pretty bad. The patient felt hands paralysis, experienced neck pain, hands not working well, hard to grip stuff, hard to make a fist. On 03-JAN-2022 patient went to primary care physician get a magnetic resonance imaging (result was not reported). On an unspecified date patient experienced numbness, pins and needles in arms and got a professional massage to get pain reduced but that did not help either. On an unspecified date patient visited to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, hands feel paralysis, arm pain/hands arm hurting/sore forearm, hands not working well/hard to grip stuff/hard to make a fist., can not move forearm and biceps well/arm seized up, numbness and pins and needles in arms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220123924-COVID-19 VACCINE AD26.COV2.S-hands feel paralysis. 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: Pain in extremity, Paraesthesia, Paralysis
Clinical narrative: NUMBNESS; PINS AND NEEDLES IN ARMS; HANDS FEEL PARALYSIS; NECK PAIN; HANDS NOT WORKING WELL/HARD TO GRIP STUFF/HARD TO MAKE A FIST; CAN NOT MOVE FOREARM AND BICEPS WELL/ARM SEIZED UP; ARM PAIN/HANDS ARM HURTING/SORE FOREARM; This spontaneous report received from a patient concerned a 34 year old male with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy individual. The patient used to work 12 hours a day, would never experience this arm pain before and never had this experience before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  After eight days of the vaccine (21-DEC-2021) hands and arm of the patient was hurting a lot, patient could not move forearm well and biceps also. Forearm of the patient was super sore right now. It was pretty bad. The patient felt hands paralysis, experienced neck pain, hands not working well, hard to grip stuff, hard to make a fist. On 03-JAN-2022 patient went to primary care physician get a magnetic resonance imaging (result was not reported). On an unspecified date patient experienced numbness, pins and needles in arms and got a professional massage to get pain reduced but that did not help either. On an unspecified date patient visited to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, hands feel paralysis, arm pain/hands arm hurting/sore forearm, hands not working well/hard to grip stuff/hard to make a fist., can not move forearm and biceps well/arm seized up, numbness and pins and needles in arms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220123924-COVID-19 VACCINE AD26.COV2.S-hands feel paralysis. 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Depressed mood, Dizziness, Headache
Clinical narrative: BODY ACHE; FELT DOWN; CHEST PRESSURE; DIZZINESS; FEVER; HEADACHE; NAUSEA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FLU A AND B; This spontaneous report received from a patient concerned a 44-year-old female. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included iron deficiency, iron infusion, Covid 19 infection, and circulation problems. Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, 1 total administered on 13-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unknown date, the patient had side effects from the vaccine which were fever, headache, nausea, body ache, felt down. On 24-DEC-2021, Patient had tested negative with PCR (polymerase chain reaction) and antigen test. On 28-DEC-2021, she tested positive for COVID-19 with rapid test and had suspected clinical vaccination failure. On 28-DEC-2021, She also tested positive for flu A and B. 01-JAN-2022, She tested negative again on with rapid test. She also stated someone touched her phone at the airport. She felt chest pressure, little cough, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 01-JAN-2022, and flu a and b, body ache, felt down, dizziness, fever, headache, and nausea, and the outcome of suspected clinical vaccination failure and chest pressure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211586.; Sender's Comments: V0:  20220124040 -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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Influenza virus test, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; FELT DOWN; CHEST PRESSURE; DIZZINESS; FEVER; HEADACHE; NAUSEA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FLU A AND B; This spontaneous report received from a patient concerned a 44-year-old female. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included iron deficiency, iron infusion, Covid 19 infection, and circulation problems. Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, 1 total administered on 13-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unknown date, the patient had side effects from the vaccine which were fever, headache, nausea, body ache, felt down. On 24-DEC-2021, Patient had tested negative with PCR (polymerase chain reaction) and antigen test. On 28-DEC-2021, she tested positive for COVID-19 with rapid test and had suspected clinical vaccination failure. On 28-DEC-2021, She also tested positive for flu A and B. 01-JAN-2022, She tested negative again on with rapid test. She also stated someone touched her phone at the airport. She felt chest pressure, little cough, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 01-JAN-2022, and flu a and b, body ache, felt down, dizziness, fever, headache, and nausea, and the outcome of suspected clinical vaccination failure and chest pressure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211586.; Sender's Comments: V0:  20220124040 -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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: BODY ACHE; FELT DOWN; CHEST PRESSURE; DIZZINESS; FEVER; HEADACHE; NAUSEA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FLU A AND B; This spontaneous report received from a patient concerned a 44-year-old female. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included iron deficiency, iron infusion, Covid 19 infection, and circulation problems. Patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, 1 total administered on 13-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unknown date, the patient had side effects from the vaccine which were fever, headache, nausea, body ache, felt down. On 24-DEC-2021, Patient had tested negative with PCR (polymerase chain reaction) and antigen test. On 28-DEC-2021, she tested positive for COVID-19 with rapid test and had suspected clinical vaccination failure. On 28-DEC-2021, She also tested positive for flu A and B. 01-JAN-2022, She tested negative again on with rapid test. She also stated someone touched her phone at the airport. She felt chest pressure, little cough, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 01-JAN-2022, and flu a and b, body ache, felt down, dizziness, fever, headache, and nausea, and the outcome of suspected clinical vaccination failure and chest pressure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211586.; Sender's Comments: V0:  20220124040 -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: M
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Headache, Muscle spasms, Myalgia
Clinical narrative: RUNNY NOSE; COUGH; CUTS ON NECK AND DIFFERENT PARTS OF THE BODY STARTED AFTER THE SHOT AND DID NOT GO AWAY; CUTS HAVE BURNING SENSATION; LITTLE SPASMS; CUTS HAVE PAIN; MUSCLE PAINS; HEADACHES; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced runny nose, cough, cuts on neck and different parts of the body started after the shot and did not go away, cuts have burning sensation, little spasms, cuts have pain, muscle pains, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, had not recovered from cuts on neck and different parts of the body started after the shot and did not go away, and the outcome of muscle pains, runny nose, headaches, cuts have burning sensation, little spasms and cuts have pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Skin laceration
Clinical narrative: RUNNY NOSE; COUGH; CUTS ON NECK AND DIFFERENT PARTS OF THE BODY STARTED AFTER THE SHOT AND DID NOT GO AWAY; CUTS HAVE BURNING SENSATION; LITTLE SPASMS; CUTS HAVE PAIN; MUSCLE PAINS; HEADACHES; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced runny nose, cough, cuts on neck and different parts of the body started after the shot and did not go away, cuts have burning sensation, little spasms, cuts have pain, muscle pains, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, had not recovered from cuts on neck and different parts of the body started after the shot and did not go away, and the outcome of muscle pains, runny nose, headaches, cuts have burning sensation, little spasms and cuts have pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Body temperature, Fatigue, Pyrexia
Clinical narrative: FELT LIKE SOMETHING HAD HAPPENED; HIT A WALL OF TIREDNESS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt like something had happened, hit a wall of tiredness, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Bit of temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like something had happened, hit a wall of tiredness, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Gait disturbance, Headache, Impaired quality of life, Pain
Clinical narrative: CIRCULATION PROBLEMS; CANNOT WALK LIKE BEFORE BECAUSE OF PAIN; PAIN; PROBLEMS IN LEGS; HEADACHE; QUALITY OF LIFE HAS GONE DOWN DRASTICALLY; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-OCT-2021, the patient experienced quality of life has gone down drastically. On an unspecified date, the patient experienced circulation problems, cannot walk like before because of pain, pain, problems in legs, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot walk like before because of pain, pain, and quality of life has gone down drastically, and the outcome of headache, circulation problems and problems in legs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CIRCULATION PROBLEMS; CANNOT WALK LIKE BEFORE BECAUSE OF PAIN; PAIN; PROBLEMS IN LEGS; HEADACHE; QUALITY OF LIFE HAS GONE DOWN DRASTICALLY; This spontaneous report received from a patient concerned a 55 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-OCT-2021, the patient experienced quality of life has gone down drastically. On an unspecified date, the patient experienced circulation problems, cannot walk like before because of pain, pain, problems in legs, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot walk like before because of pain, pain, and quality of life has gone down drastically, and the outcome of headache, circulation problems and problems in legs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: ARM SORENESS; VOMITING; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced arm soreness, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and arm soreness was not reported. This report was non-serious. .This case, from the same reporter is linked to 20220126579 and 20220126642.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal infection, Illness
Clinical narrative: VERY SICK FOR A MONTH; INTESTINAL INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick for a month, and intestinal infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for a month, and the outcome of intestinal infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: VERY MILD HEADACHE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced very mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very mild headache. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided  No treatment medication information provided  The patient was healthy before getting the vaccines.  Company comment:  This case concerns a 43-year-old male patient with no reported medical history who experienced serious unexpected event of death, that occurred after the dose of the mRNA-1273 . No further details were provided. The rechallenge was not applicable due to fatal outcome, as well as unspecified number of doses administered.  The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-445808, MOD-2022-445819.; Sender's Comments: This case concerns a 43-year-old male patient with no reported medical history who experienced serious unexpected event of death, that occurred after the dose of the mRNA-1273 . No further details were provided. The rechallenge was not applicable due to fatal outcome, as well as unspecified number of doses administered.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death