chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Pain in extremity
Clinical narrative: having pain under my arm; lymph node on the left side is painful, and it started moving up to my shoulder on the left side of my lymph node; lymph node on the left side is painful, and it started moving up to my shoulder on the left side of my lymph node; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in arm left on 26May2021 (at the age of 26-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation. On 26May2021, after patient got the injection in left arm and almost immediately, no, not immediately; about 5 hours later she started having pain under her arm and lymph node on the left side was painful, and it started moving up to her shoulder on the left side of lymph node. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: felt like she would come down with a urinary tract infection; This is a spontaneous report received from a contactable consumer (Patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported), as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received her second dose of the Pfizer COVID Vaccine a couple of hours ago before calling. She felt like she would come down with a urinary tract infection on an unspecified date and would want to know if it would affect the shot. She emphasized that she did not considered this as a side effect. Seriousness of the event was reported as non-serious. The outcome of the events was reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: It got worse/ his hips have gotten worse; developed pain and stiffness in both hips and shoulders simultaneously; developed pain and stiffness in both hips and shoulders simultaneously; developed pain and stiffness in both hips and shoulders simultaneously; developed pain and stiffness in both hips and shoulders simultaneously; This is a spontaneous report from a contactable consumer(patient).A 73-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. In Mar2021, week after vaccination the patient developed pain and stiffness in both hips and shoulders simultaneously. The patient stated he never had pain before other than pain usually associated with yard work. On 22Mar2021, he went for his semiannual physical with his doctor, he was told it might be some kind of reaction to the vaccine. It got worse, so on his following visit on 05May2021, he got a lot of bloodwork done (checked for lupus, inflammation, rheumatoid arthritis, etc), 4 days later, his results were normal. The patient was referred to a rheumatologist, whom he will see on 09Jun2021. However, his hips have gotten worse, his right shoulder is extremely sore, and on some days, he can't lift the right arm above the right shoulder. The outcome events were unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: TTOX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00601597) and transmitted to Sanofi on 14-May-2021.  This case involves a patient (demographics unknown) who was tested with a whole vial of TUBERCULIN TEST [TUBERSOL] (lot number and expiry date not reported) via unknown route at an unknown administration site but was supposed to receive a TETANUS TOXOID (Wrong product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Wrong product administered (latency same day)  At the time of report, no adverse event was reported.  The pharmacist called for guidance because a nurse injected a whole vial of Tubersol to a consumer. The consumer was supposed to receive a Tetanus vaccine but the vials got mixed up. The pharmacist was not sure of their phone number so she provided 2 options. It was attempted to get more information regarding the event and the consumer but the pharmacist said that this happened in a site, and they just called it in so she does not have any other information. Lot number and expiration were also unknown to pharmacist at the time of the call.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the patient only received the DTaP-IPV liquid portion of Pentacel; the patient did not receive the HIB powder portion, no AE; Initial information received on 14-May-2021 regarding an unsolicited valid  non-serious case from a other health professional and physician via Media Information (reference number 00601852).  This case involves a 15 months old male patient who received only dtap-ipv liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and did not receive the hib powder portion (lot UJ402AAA,UJ413AA and expiration date :09-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination on 06-May-2021 (product preparation issue).  The patient's past vaccinations included first, second and third dose of Pentacel (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on 12-Mar-2020, May-2020 and Jul-2020 respectively.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included a dose of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination .  It was an actual medication error due to inappropriate reconstitution technique (same day latency).  Caller stated that a patient was supposed to receive PENTACEL but the patient only received the DTaP-IPV liquid portion of PENTACEL; the patient did not receive the HIB powder portion and wants to confirm that counts as a full dose of DTaP-IPV and was looking for guidance on documentation. Also Caller states a patient was supposed to receive PENTACEL but the patient only received the DTaP-IPV liquid portion of PENTACEL; the patient did not receive the HIB powder portion; there was some confusion about giving both vials, so only the liquid portion was given to the patient. Referred caller to the Pentacel Reconstitution Video. Caller reported that they checked in with the patient's mom and the child was doing great; they recommended to patient's mom to get the HIB component.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Almost immediately after receiving the first Pfizer vaccine my throat began to constrict, my heart started pumping and I was having a hard time breathing.  I walked over the the EMT nearby who took my blood pressure which was 188/120.  He asked me if I had forgotten to take my BP meds and I responded, I take no meds.  He told me to take a seat while he took notes.  A few minutes later he took my BP again and it was the same.  He gave me a benedryl and a glass of water.  The swelling in my throat receded somewhat.  He watched me for the next 30 minutes then took my BP again which was 177/120.  Feeling somewhat better, I  waited another 30 minutes and asked the EMT if I could go home.  He took my BP again which was the same and asked me if I wanted to go to the hospital.  I said NO.  I told him I have a BP cuff at home and would monitor my BP which was normal after 3 days.  Needless to say, I have been frightened to get my second shot.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Full blood count, Laboratory test, Nausea
Clinical narrative: body aches, nausea,, subjective fever/chills, near syncope.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: body aches, nausea,, subjective fever/chills, near syncope.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/no additional information provided; VARlVAX and MMR II that underwent multiple temperature; This spontaneous report has been received from a medical assistant referring to a 4-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 06-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# T020652, expiration date was reported and validated as 16-JUN-2022; strength, dose, and route were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) (lot# S035352, expiration date was reported and validated as 05-NOV-2021; strength, dose, and route were not reported) for prophylaxis. Both vaccines were improperly stored under multiple temperature excursions (product storage error), which were at -14.03 degree Celsius for 1 hour 15 min, at -14.9 degree Celsius for 9 min, at -10.3 degree Celsius for 1 hour, at -6.3 degree Celsius for 2 hours. The temperature excursion was detected by a data logger. There were previous temperature excursions at -14.03 degree Celsius for 1 hour 15 min and at -14.9 degree Celsius for 9 min. No additional adverse event or additional information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA003554: US-009507513-2105USA003472:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Hallucination, Head discomfort
Clinical narrative: Hallucination; Decreased appetite; Head discomfort; Hyperhidrosis; Insomnia; Toothache; Tremor; Chills; Fatigue; Nausea; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to sulfa drug). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and TOPIRAMATE (TOPAMAX) for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), DECREASED APPETITE (Decreased appetite), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), INSOMNIA (Insomnia), TOOTHACHE (Toothache), TREMOR (Tremor), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HALLUCINATION (Hallucination), DECREASED APPETITE (Decreased appetite), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), INSOMNIA (Insomnia), TOOTHACHE (Toothache), TREMOR (Tremor), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product information was provided  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Nausea, Toothache, Tremor
Clinical narrative: Hallucination; Decreased appetite; Head discomfort; Hyperhidrosis; Insomnia; Toothache; Tremor; Chills; Fatigue; Nausea; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to sulfa drug). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and TOPIRAMATE (TOPAMAX) for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), DECREASED APPETITE (Decreased appetite), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), INSOMNIA (Insomnia), TOOTHACHE (Toothache), TREMOR (Tremor), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HALLUCINATION (Hallucination), DECREASED APPETITE (Decreased appetite), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), INSOMNIA (Insomnia), TOOTHACHE (Toothache), TREMOR (Tremor), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product information was provided  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shot but had shingles just the same; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that the patient had the shot but had shingles just the same. This case was considered as suspected vaccination failure since the details regarding time to onset, completion of primary vaccination schedule and laboratory confirmation of shingles was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Incorrect route of product administration, Injection site haematoma, Injection site haemorrhage, Injection site pain
Clinical narrative: PAIN IN LEFT SHOULDER RADIATING ALL THE WAY DOWN FOREARM INTO DIGITS AND EXTENDS INTO THE SHOULDER; SUSPECTED INAPPROPRIATE ROUTE OF VACCINATION; DIZZY; SWELLING AT INJECTION SITE; INTENSE PAIN AT THE INJECTION SITE THAT SEEMS TO HAVE GOTTEN WORSE; UNABLE TO SLEEP AT NIGHT DUE TO PAIN; LARGE HEMATOMA AT INJECTION SITE; UNUSUAL AMOUNT OF BLOOD IN ARM AFTER INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient was treated with covid-19 vaccine (intramuscular, and 205AZ1A, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced large hematoma at injection site, unusual amount of blood in arm after injection, unable to sleep at night due to pain, swelling at injection site, and intense pain at the injection site that seems to have gotten worse. Laboratory data included: Pain scale (NR: not provided) 7/10. On 08-MAY-2021, the patient experienced pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder, suspected inappropriate route of vaccination, and dizzy. Treatment medications (dates unspecified) included: hydrocodone, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder on MAY-2021, and dizzy on 08-MAY-2021, had not recovered from intense pain at the injection site that seems to have gotten worse, large hematoma at injection site, and swelling at injection site, and the outcome of unusual amount of blood in arm after injection, unable to sleep at night due to pain and suspected inappropriate route of vaccination was not reported. This report was non-serious. This case is a duplicate of 20210544916.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Pain, Pain assessment
Clinical narrative: PAIN IN LEFT SHOULDER RADIATING ALL THE WAY DOWN FOREARM INTO DIGITS AND EXTENDS INTO THE SHOULDER; SUSPECTED INAPPROPRIATE ROUTE OF VACCINATION; DIZZY; SWELLING AT INJECTION SITE; INTENSE PAIN AT THE INJECTION SITE THAT SEEMS TO HAVE GOTTEN WORSE; UNABLE TO SLEEP AT NIGHT DUE TO PAIN; LARGE HEMATOMA AT INJECTION SITE; UNUSUAL AMOUNT OF BLOOD IN ARM AFTER INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient was treated with covid-19 vaccine (intramuscular, and 205AZ1A, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced large hematoma at injection site, unusual amount of blood in arm after injection, unable to sleep at night due to pain, swelling at injection site, and intense pain at the injection site that seems to have gotten worse. Laboratory data included: Pain scale (NR: not provided) 7/10. On 08-MAY-2021, the patient experienced pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder, suspected inappropriate route of vaccination, and dizzy. Treatment medications (dates unspecified) included: hydrocodone, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder on MAY-2021, and dizzy on 08-MAY-2021, had not recovered from intense pain at the injection site that seems to have gotten worse, large hematoma at injection site, and swelling at injection site, and the outcome of unusual amount of blood in arm after injection, unable to sleep at night due to pain and suspected inappropriate route of vaccination was not reported. This report was non-serious. This case is a duplicate of 20210544916.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: SEIZURE LIKE ACTIVITY; SYNCOPE; CHEST PAIN; HYPOTENSION; DIZZINESS/LIGHTHEADEDNESS; VOMITING; PALLOR; DIAPHORESIS; TACHYCARDIA; ANXIETY-RELATED EVENTS; NAUSEA; This spontaneous report was received from multiple patients. No past medical history or concurrent conditions were reported. The patients 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,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced seizure like activity, syncope, chest pain, hypotension, dizziness/lightheadedness, vomiting, pallor, diaphoresis, tachycardia, anxiety-related events, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety-related events, syncope, chest pain, hypotension, dizziness/lightheadedness, nausea, vomiting, pallor, diaphoresis and tachycardia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210553168-covid-19 vaccine ad26.cov2.s-syncope and seizure like activity. 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: Nausea, Pallor, Seizure like phenomena, Syncope, Tachycardia
Clinical narrative: SEIZURE LIKE ACTIVITY; SYNCOPE; CHEST PAIN; HYPOTENSION; DIZZINESS/LIGHTHEADEDNESS; VOMITING; PALLOR; DIAPHORESIS; TACHYCARDIA; ANXIETY-RELATED EVENTS; NAUSEA; This spontaneous report was received from multiple patients. No past medical history or concurrent conditions were reported. The patients 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,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced seizure like activity, syncope, chest pain, hypotension, dizziness/lightheadedness, vomiting, pallor, diaphoresis, tachycardia, anxiety-related events, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety-related events, syncope, chest pain, hypotension, dizziness/lightheadedness, nausea, vomiting, pallor, diaphoresis and tachycardia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210553168-covid-19 vaccine ad26.cov2.s-syncope and seizure like activity. 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: Vomiting
Clinical narrative: SEIZURE LIKE ACTIVITY; SYNCOPE; CHEST PAIN; HYPOTENSION; DIZZINESS/LIGHTHEADEDNESS; VOMITING; PALLOR; DIAPHORESIS; TACHYCARDIA; ANXIETY-RELATED EVENTS; NAUSEA; This spontaneous report was received from multiple patients. No past medical history or concurrent conditions were reported. The patients 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,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced seizure like activity, syncope, chest pain, hypotension, dizziness/lightheadedness, vomiting, pallor, diaphoresis, tachycardia, anxiety-related events, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety-related events, syncope, chest pain, hypotension, dizziness/lightheadedness, nausea, vomiting, pallor, diaphoresis and tachycardia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210553168-covid-19 vaccine ad26.cov2.s-syncope and seizure like activity. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the patient experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210553711-COVID-19 VACCINE AD26.COV2.S-Blood clots. 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: Antibody test, COVID-19, SARS-CoV-2 test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned an elderly male of unspecified Ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total dose administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient had antigen test and he was tested positive for covid. On 22-May-2021 he had antibody test and result was negative (confirmed immunological vaccine failure). He was afraid of getting infected once again as he was old and the vaccine did not produce antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for covid and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000181111.; Sender's Comments: V0. 20210556637-COVID-19 VACCINE AD26.COV2.S. Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Intracardiac thrombus, Pain in extremity, Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN HEART; BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LEGS; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by patient that on 06-APR-2021 patient experienced sore arm and on 07-APR-2021 patient had experienced chill. The patient stated that on 27-MAY-2021, the patient experienced chest pain which led to him hospitalization on an unspecified date. While hospitalized they discovered that he had blood clots in the heart and lungs (also reported as blood clots in the legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills, and the outcome of blood clots in heart, blood clots in lungs and blood clots in legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210557848-covid-19 vaccine ad26.cov2.s-Blood clots in heart, Blood clots in lungs, Blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Anticoagulant therapy, Catheterisation cardiac, Chest pain, Coronary arterial stent insertion
Clinical narrative: BLOOD CLOTS IN HEART; BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LEGS; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by patient that on 06-APR-2021 patient experienced sore arm and on 07-APR-2021 patient had experienced chill. The patient stated that on 27-MAY-2021, the patient experienced chest pain which led to him hospitalization on an unspecified date. While hospitalized they discovered that he had blood clots in the heart and lungs (also reported as blood clots in the legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills, and the outcome of blood clots in heart, blood clots in lungs and blood clots in legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210557848-covid-19 vaccine ad26.cov2.s-Blood clots in heart, Blood clots in lungs, Blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery occlusion, Coronary artery thrombosis, Deep vein thrombosis, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: BLOOD CLOTS IN HEART; BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LEGS; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by patient that on 06-APR-2021 patient experienced sore arm and on 07-APR-2021 patient had experienced chill. The patient stated that on 27-MAY-2021, the patient experienced chest pain which led to him hospitalization on an unspecified date. While hospitalized they discovered that he had blood clots in the heart and lungs (also reported as blood clots in the legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills, and the outcome of blood clots in heart, blood clots in lungs and blood clots in legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210557848-covid-19 vaccine ad26.cov2.s-Blood clots in heart, Blood clots in lungs, Blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Percutaneous coronary intervention, Thrombectomy, Troponin increased, Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOTS IN HEART; BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LEGS; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808982 expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by patient that on 06-APR-2021 patient experienced sore arm and on 07-APR-2021 patient had experienced chill. The patient stated that on 27-MAY-2021, the patient experienced chest pain which led to him hospitalization on an unspecified date. While hospitalized they discovered that he had blood clots in the heart and lungs (also reported as blood clots in the legs). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and chills, and the outcome of blood clots in heart, blood clots in lungs and blood clots in legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210557848-covid-19 vaccine ad26.cov2.s-Blood clots in heart, Blood clots in lungs, Blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Muscle spasms, Nausea
Clinical narrative: SEVERE CHILLS; FEELING WEAK; NAUSEA; VOMITING; EXCRUCIATING TIGHTNESS BETWEEN HER UPPER CHEST RADIATING AROUND TO BILATERAL SHOULDER BLADES AND BACK; MUSCLE SPASM; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic - diet controlled, arthritis, high cholesterol, penicillin antibiotics allergy, and sulfa antibiotics allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vomiting. On 28-MAY-2021, the subject experienced excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back. On 28-MAY-2021, the subject experienced muscle spasm. On 28-MAY-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 10/10. On 29-MAY-2021, the subject experienced severe chills. On 29-MAY-2021, the subject experienced feeling weak. Treatment medications (dates unspecified) included: acetylsalicylic acid, and loperamide hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back, muscle spasm, severe chills, and feeling weak on 29-MAY-2021, and nausea on 28-MAY-2021, and the outcome of vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Vomiting
Clinical narrative: SEVERE CHILLS; FEELING WEAK; NAUSEA; VOMITING; EXCRUCIATING TIGHTNESS BETWEEN HER UPPER CHEST RADIATING AROUND TO BILATERAL SHOULDER BLADES AND BACK; MUSCLE SPASM; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic - diet controlled, arthritis, high cholesterol, penicillin antibiotics allergy, and sulfa antibiotics allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vomiting. On 28-MAY-2021, the subject experienced excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back. On 28-MAY-2021, the subject experienced muscle spasm. On 28-MAY-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 10/10. On 29-MAY-2021, the subject experienced severe chills. On 29-MAY-2021, the subject experienced feeling weak. Treatment medications (dates unspecified) included: acetylsalicylic acid, and loperamide hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back, muscle spasm, severe chills, and feeling weak on 29-MAY-2021, and nausea on 28-MAY-2021, and the outcome of vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not started, 1 total, 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 28-MAY-2021, the patient developed deep vein thrombosis and had pulmonary embolism throughout the body. The patient was prescribed with xarelto ((but had not started) to treat deep vein thrombosis and pulmonary embolism. The patient stated that she had no health conditions or concerns before the vaccine. The patient took no medications nor she did any pharmacy coverage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210558443-covid-19 vaccine ad26.cov2.s -pulmonary embolism ,deep vein thrombosis . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: HAD THE SIDE EFFECTS OF THE VACCINATION SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported,  batch number: unknown) dose was not reported, administered on 10-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. On 2021, the subject had the side effects of the vaccination shot. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from had the side effects of the vaccination shot. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Underdose
Clinical narrative: VACCINE WAS PUT IN SYRINGES AT 0.3ML INSTEAD OF THE AUTHORIZED 0.5ML; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAY-2021, the subject experienced vaccine was put in syringes at 0.3ml instead of the authorized 0.5ml. On 31-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was put in syringes at 0.3ml instead of the authorized 0.5ml and medication error was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Confusional state, Fatigue, Headache, Muscle spasms
Clinical narrative: TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; CONFUSED; GROGGY; TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; TIRED; UPSET STOMACH; HEADACHE; MUSCLE ACHES; SHARP PAIN IN LEFT ARM; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 205 pounds, and height was 73 inches. The patient's concurrent conditions included irritable bowel syndrome, alcohol user, cigarette smoker, and depression, and other pre-existing medical conditions included patient had no know allergy and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced sharp pain in left arm. On 27-MAY-2021, the subject experienced sore arm. On 30-MAY-2021, the subject experienced upset stomach. On 30-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced muscle aches. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced confused. On 31-MAY-2021, the subject experienced groggy. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate, and ondansetron. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain in left arm on 27-MAY-2021, had not recovered from sore arm, upset stomach, headache, muscle aches, tightness and cramping in left leg and right arm, tired, confused, groggy, and tightness and cramping in left leg and right arm, and the outcome of nausea was not reported. This report was non-serious.