chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Adverse event, Product storage error
Clinical narrative: Medical Assistant calling to report a limited adverse event on a dose of PROQUAD; PROQUAD that was administered improperly stored during a temperature excursion; This spontaneous report was received from a medical assitant referring to a  patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided      On 13-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T034614, expiration date 10-APR-2022 (route of administration not provided) for prophylaxis (product storage error).  On that same date, the patient experienced a limited adverse event.      The outcome of adverse event as well as its causal relationship with measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) were not reported.  The vaccine underwent a temperature excursion between 6 degrees Farhrenheit (°F) and 14°F, with an average of 8.5°F for 18 minutes, and between 6 degrees Farhrenheit (°F) and 14°F, with an average of 11.9°F for 1 hour. No previous temperature excursions reported.
Sex: F
Vaccine: PPV
Symptoms: Therapy non-responder
Clinical narrative: she had no response to the polysaccharide pneumococcal vaccine; Literature report:    This literature marketed report has been received from authors of the literature article entitled as stated above, referring to 78-year-old female patient with a history of common variable immune deficiency (CVID), anti-IgA antibodies, pemphigus vulgaris, allergic rhinitis, asthma, and obstructive sleep apnea presented after vaccination with the Pfizer COVID-19 mRNA vaccine. Her medical history includes an initial diagnosis of Selective IgA deficiency in her 30 s with positive anti-IgA antibodies. In 2004, when she was 61 years old, she started to have an increase in upper respiratory tract and gastrointestinal infections. A repeat immune work up found a global decrease in immunoglobulins with IgG of 444, IgM of 5, and IgA lower than 16.   A vaccine challenge with a pneumococcal polysaccharide vaccine and subsequent challenge with a conjugated pneumococcal vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration were not reported; as prophylaxis) showed nonresponse with 0 out of 14 titers protective before vaccination, and 0 out of 14 titers protective after vaccination (therapy non-responder).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was given MMRII IM instead of SQ; This spontaneous report was received from a medical student referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 28-OCT-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), for prophylaxis (dose, vaccination scheme frequency, anatomical site of vaccination, lot # and expiration date were not reported). The vaccine was administered intramuscularly instead of subcutaneously (incorrect route of product administration).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; The nurse was documenting the information before administration and noticed the vial was expired; This spontaneous report was received from a physician referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   The physician reported a near miss for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On an unknown date in October 2021, the product was drawn into the syringe but not administered. The nurse was documenting the information before administration and noticed the vial was expired (expiration date was 07-OCT-2021) (intercepted product administration error).  No additional adverse event reported.
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Myalgia, Pyrexia, Syncope
Clinical narrative: Weakness; Fainted; Fever; Muscle Aches; Initial Report Received on 16-Sep-2021  A nurse in employee health in reported that a 21-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 12-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot # 934967, Expiration Date 01-Apr-2022, NDC # 4352800301) in the right deltoid.   On 12-Aug-2021, in the evening after having been vaccinated the HEPLISAV-B, the patient had a fever, weakness, muscle aches and "fainted." The patient regained consciousness and then went to sleep.  On 13-Aug-2021, the patient woke up in the morning still with a fever, but "felt better."  At 1000-1100, the patient's fever ended.    No additional information was provided.   Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 91.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered a Dose of Heplisav-B that Underwent a Temperature Excursion; Initial Report Received 24-Sep-2021  A nurse reported that a 91-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 30-Aug-2021, a dose of HEPLISAV-B (Lot # 935840, Expiration Date 11-Sep-2022, NDC # 43528-003-01) was administered in the left deltoid.   It was reported that the HEPLISAV-B administered had undergone a temperature excursion.  No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Heplisav-B that Expired was Administered; Initial Report Received on 13-Oct-2021  A registered nurse reported that a 24 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   The patient has an allergy to Cipro (ciprofloxacin). No other relevant medical history was reported.    No relevant concomitant medications were reported.  On 13-Oct-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021, NDC # 43528-003-05, and serial # not reported) in the left deltoid. The patient had not reported any adverse reactions.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: 5 Weeks Post-Vaccination Titer Did Not Reflect Adequate Immunity; Initial Report Received on 18-Oct-2021  A pharmacist reported that a female patient of unspecified age (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and her titer did not reflect adequate immunity.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient was reported to have completed the HEPLISAV-B series (Lot #, expiration date and NDC # not reported), route and site not specified.  Approximately 5 weeks after vaccination with HEPLISAV-B, the patient received a titer. Her titer did not reflect adequate immunity.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 3rd Dose of Heplisav-B was Accidentally Given; Initial Report Received on 12-Oct-2021  A pharmacist in the US (OK) reported that a 58 year-old female (race and ethnicity not provided) received 3 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 13-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022 and NDC # 43528-003-05) in the left deltoid.  On 29-Aug-2021, the patient received the second dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022 and NDC # 43528-003-05) intramuscularly in an unknown site.  On 02-Oct-2021, the patient received the third dose of HEPLISAV-B (Lot # 934974, expiration date 29-Apr-2022 and NDC # 43528-003-05) intramuscularly in the right deltoid from a pharmacist. The second dose that was given did not show entered in the system, therefore another dose was given (third dose).  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave an Expired Dose of Heplisav-B; Initial Report Received on 20-Oct-2021  A certified medical assistant in the US (IA) reported that a 33 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as anxiety mood disorder, obesity and "Toprimax" allergy.  No relevant concomitant medications were reported.    On 20-Oct-2021, the patient received an expired dose of HEPLISAV-B (Lot # 934259, expiration date 25-Sep-2021 and NDC # 43528-003-05) in the right deltoid from a certified medical assistant.   The patient had not reported any adverse reactions at the time of the report. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Received the 1st Dose of Heplisav-B at 23 Weeks; Initial Report Received on 22-Oct-2021  A pregnant 30 year-old female (race and ethnicity not provided) reported that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at 23 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 24-Sep-2021, at 23 weeks of pregnancy, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a pharmacist.   On 22-Oct-2021, at 27 weeks gestation, the patient went back to receive her second dose of HEPLISAV-B but was informed by her pharmacist that it was not recommended for pregnant women.  The patient had the pharmacy send her documentation to her physician and had not spoken with her physician about this yet.  The patient's due date is 16-Jan-2022. She did not report any adverse reactions.   On 22-Oct-2021, the patient contacted the pregnancy registry but was not interested in enrolling since she was enrolling into another trial. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant; Initial Report Received on 22-Oct-2021  A pregnant female, over the age of 18 years, in the US (state, race and ethnicity not provided) reported to the pregnancy registry that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 16-Sep-2021, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) through an unknown route and site. The patient provided her last menstrual period as 11-Sep-2021.   At the time of the report, the patient was currently pregnant. The patient had gone to see her primary care physician (PCP) for a third vaccination and was advised during that visit that she would not be receiving another vaccination and requested she call the pregnancy registry. She had not yet seen an OB/GYN.  She declined participation in the registry and no additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Second Dose Vaccine Manufactured by Glaxo Smith Kline; Initial Report Received on 26-Oct-2021  A registered nurse reported that a 41 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and an adult hepatitis B vaccine manufactured by Glaxo Smith Kline for the second dose.   Medical history was reported as fatty liver, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), migraine, anxiety, depression, herniated disc (cervical), chronic midline backpain, hepatic ulceration, and Biaxin (clarithromycin) allergy.  No relevant concomitant medications were reported.    On 07-Sep-2021, the patient received the first dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022 and NDC # 4352800305) through an unknown route and site.   On 26-Oct-2021, the patient received the second dose of the hepatitis B vaccine series with an adult hepatitis B vaccine manufactured by Glaxo Smith Kline (Lot# P4DJ5 expiration date 15-Feb-2022) through an unknown route and site.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Possible administration of expired Vaccine; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced possible administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible administration of expired vaccine was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Liver disorder, Vaccination complication
Clinical narrative: LOW PLATELET COUNT; STOMACH ACHE; STARTED FEELING BAD; POSSIBLE COVID-19 VACCINE REACTION; THIS REACTION ATTACKED HER LIVER; FELT WEIRD; This spontaneous report received from a patient concerned a 47 year old female race and unknown ethnicity.. The patient's height, and weight were not reported. The patient's past condition included: hepatitis c. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: Unknown) dose was not reported, 1 total, administered in right arm on 14-OCT-2021 for prophylactic vaccination. Concomitant medications included lactulose, lorazepam, omeprazole, sucralfate and folic acid.  On 14-OCT-2021, the same day of vaccination patient felt weird. The next day on 15-OCT-2021 patient started feeling bad and experienced stomach pain. On 15-OCT-2021, patient was admitted to hospital and was hospitalized for 6 days. Laboratory data included: Platelet count (NR: not provided) 75. Patient was discharged on 20-OCT-2021 with a diagnosis of low platelet count and this reaction attacked her liver. Patient's discharge summary states that this could be a possible Covid-19 vaccine reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and the outcome of stomach ache, felt weird, started feeling bad, possible covid-19 vaccine reaction and this reaction attacked her liver was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211107885-JANSSEN COVID-19 VACCINE Ad26.COV2.S.- low platelet count, stomach ache, started feeling bad, possible covid-19 vaccine reaction ,this reaction attacked her liver -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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Guillain-Barre syndrome, Migraine, Nasopharyngitis, Pyrexia
Clinical narrative: DECREASED QUALITY OF LIFE; POSSIBLE GUILLAINBARRE SYNDROME; CHILLS; LOW GRADE FEVER; COLD SYMPTOMS; STABBING MIGRAINE; This spontaneous report received from a pharmacist concerned a 50 year old old female. Initial information was processed along with the additional information received from Central Complaint on 03-NOV-2021. The patient's height, and weight were not reported. The patient's past medical history included shoulder injury and concurrent conditions included hypothyroidism and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN)1 total, dose was not reported, administered to left arm on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient had stabbing migraine and had pain from her head to her big toe Immediately after vaccination. On 21-SEP-2021, the patient had a low grade fever with cold symptoms and chills. On 27-SEP-2021 (a week after the vaccine) the patient was not being able to sleep due to tingling pain in her feet. Later on in mid-october, these symptoms started getting worse, patient was unable to do daily activities such as carrying an infant, cooking, driving, etc. Around (oct 18th/19th) patient was prescribed lyrica, which helped her few hours or moments and then the symptoms returned. Patient described lethargy, pain and tingling. Patient had decreased quality of life and had been out of work, does not drive, clean, cook, swim, walk or do activities because of these symptoms. Daughter (HCP) states patient was fine before the vaccination. Physician/neurologist reported that it was a uncharted territory to state the reason behind these symptoms but possible guillain barre syndrome. On an unspecified date patient went to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stabbing migraine, cold symptoms, low grade fever, chills, decreased quality of life and possible guillain barre syndrome. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000200300. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211107992-COVID-19 VACCINE AD26.COV2.S-Possible Guillain barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Quality of life decreased
Clinical narrative: DECREASED QUALITY OF LIFE; POSSIBLE GUILLAINBARRE SYNDROME; CHILLS; LOW GRADE FEVER; COLD SYMPTOMS; STABBING MIGRAINE; This spontaneous report received from a pharmacist concerned a 50 year old old female. Initial information was processed along with the additional information received from Central Complaint on 03-NOV-2021. The patient's height, and weight were not reported. The patient's past medical history included shoulder injury and concurrent conditions included hypothyroidism and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN)1 total, dose was not reported, administered to left arm on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient had stabbing migraine and had pain from her head to her big toe Immediately after vaccination. On 21-SEP-2021, the patient had a low grade fever with cold symptoms and chills. On 27-SEP-2021 (a week after the vaccine) the patient was not being able to sleep due to tingling pain in her feet. Later on in mid-october, these symptoms started getting worse, patient was unable to do daily activities such as carrying an infant, cooking, driving, etc. Around (oct 18th/19th) patient was prescribed lyrica, which helped her few hours or moments and then the symptoms returned. Patient described lethargy, pain and tingling. Patient had decreased quality of life and had been out of work, does not drive, clean, cook, swim, walk or do activities because of these symptoms. Daughter (HCP) states patient was fine before the vaccination. Physician/neurologist reported that it was a uncharted territory to state the reason behind these symptoms but possible guillain barre syndrome. On an unspecified date patient went to physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stabbing migraine, cold symptoms, low grade fever, chills, decreased quality of life and possible guillain barre syndrome. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000200300. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211107992-COVID-19 VACCINE AD26.COV2.S-Possible Guillain barre syndrome. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; PAIN; DONT FEEL WELL; This spontaneous report received from a patient concerned a 67 year old female of unspecified 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) dose, 1 total administered, 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 suspected clinical vaccination failure, pain. The patient stated covid-19 (chest cold, ha (headache)), 21 days and she was never been so sick and it is the delta variant. The patient had IVs (Intravenous solutions) in the hospital and was given monoclonal antibodies. The patient said she would never be the same and still did not feeling feel well.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, pain and don't feel well was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint (PQC).; Sender's Comments: V0: 20211108755-Covid-19 vaccine ad26.cov2.s- suspected covid-19 infection, Pain. 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). 20211108755-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: Ageusia
Clinical narrative: LOSS OF TASTE; 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 admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN BOTH FOREARM; 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 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 pain in both forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both forearm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM; SEVERE FATIGUE/FATIGUE; HEADACHES; This spontaneous report received from a consumer concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 sore arm, severe fatigue/fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe fatigue/fatigue, and headaches, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211110917.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: FEEL COLD; HANDS AND HEAD ARE SWEATING; LIKE SOMEONE SITTING ON CHEST; FEELS LIKE GOT HIT BY A DAMN TRUCK; ARM HURTS LIKE HELL; HEADACHE ON AND OFF; FEVER; TIRED; BODY ACHES; BONES HURT; MOUTH HURTS; DIZZINESS / WOOZY; PRETTY EXTREME LIKE A BAD FLU/FEEL SICK; FEELS LIKE CLOGGED NOSE; HARD TO TAKE DEEP BREATH; WOKE UP IN MIDDLE OF NIGHT SWEATING; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: No known medical history. The patient's grandfather died of aneurysm. Headaches come and go and really bad last night. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced bones hurt. On 02-NOV-2021, the patient experienced mouth hurts. On 02-NOV-2021, the patient experienced dizziness / woozy. On 02-NOV-2021, the patient experienced pretty extreme like a bad flu/feel sick. On 02-NOV-2021, the patient experienced feels like clogged nose. On 02-NOV-2021, the patient experienced hard to take deep breath. On 02-NOV-2021, the patient experienced woke up in middle of night sweating. On 02-NOV-2021, the patient experienced feels like got hit by a damn truck. On 02-NOV-2021, the patient experienced arm hurts like hell. On 02-NOV-2021, the patient experienced headache on and off. On 02-NOV-2021, the patient experienced fever. On 02-NOV-2021, the patient experienced tired. On 03-NOV-2021, the patient experienced hands and head are sweating. On 03-NOV-2021, the patient experienced like someone sitting on chest. On 03-NOV-2021, the patient experienced feel cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, tired, fever, bones hurt, mouth hurts, dizziness / woozy, arm hurts like hell, pretty extreme like a bad flu/feel sick, feels like clogged nose, hard to take deep breath, headache on and off, feel cold, hands and head are sweating, and like someone sitting on chest, and the outcome of woke up in middle of night sweating and feels like got hit by a damn truck was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: FEEL COLD; HANDS AND HEAD ARE SWEATING; LIKE SOMEONE SITTING ON CHEST; FEELS LIKE GOT HIT BY A DAMN TRUCK; ARM HURTS LIKE HELL; HEADACHE ON AND OFF; FEVER; TIRED; BODY ACHES; BONES HURT; MOUTH HURTS; DIZZINESS / WOOZY; PRETTY EXTREME LIKE A BAD FLU/FEEL SICK; FEELS LIKE CLOGGED NOSE; HARD TO TAKE DEEP BREATH; WOKE UP IN MIDDLE OF NIGHT SWEATING; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: No known medical history. The patient's grandfather died of aneurysm. Headaches come and go and really bad last night. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced bones hurt. On 02-NOV-2021, the patient experienced mouth hurts. On 02-NOV-2021, the patient experienced dizziness / woozy. On 02-NOV-2021, the patient experienced pretty extreme like a bad flu/feel sick. On 02-NOV-2021, the patient experienced feels like clogged nose. On 02-NOV-2021, the patient experienced hard to take deep breath. On 02-NOV-2021, the patient experienced woke up in middle of night sweating. On 02-NOV-2021, the patient experienced feels like got hit by a damn truck. On 02-NOV-2021, the patient experienced arm hurts like hell. On 02-NOV-2021, the patient experienced headache on and off. On 02-NOV-2021, the patient experienced fever. On 02-NOV-2021, the patient experienced tired. On 03-NOV-2021, the patient experienced hands and head are sweating. On 03-NOV-2021, the patient experienced like someone sitting on chest. On 03-NOV-2021, the patient experienced feel cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, tired, fever, bones hurt, mouth hurts, dizziness / woozy, arm hurts like hell, pretty extreme like a bad flu/feel sick, feels like clogged nose, hard to take deep breath, headache on and off, feel cold, hands and head are sweating, and like someone sitting on chest, and the outcome of woke up in middle of night sweating and feels like got hit by a damn truck was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Night sweats, Oral pain, Pain, Pain in extremity
Clinical narrative: FEEL COLD; HANDS AND HEAD ARE SWEATING; LIKE SOMEONE SITTING ON CHEST; FEELS LIKE GOT HIT BY A DAMN TRUCK; ARM HURTS LIKE HELL; HEADACHE ON AND OFF; FEVER; TIRED; BODY ACHES; BONES HURT; MOUTH HURTS; DIZZINESS / WOOZY; PRETTY EXTREME LIKE A BAD FLU/FEEL SICK; FEELS LIKE CLOGGED NOSE; HARD TO TAKE DEEP BREATH; WOKE UP IN MIDDLE OF NIGHT SWEATING; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: No known medical history. The patient's grandfather died of aneurysm. Headaches come and go and really bad last night. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced bones hurt. On 02-NOV-2021, the patient experienced mouth hurts. On 02-NOV-2021, the patient experienced dizziness / woozy. On 02-NOV-2021, the patient experienced pretty extreme like a bad flu/feel sick. On 02-NOV-2021, the patient experienced feels like clogged nose. On 02-NOV-2021, the patient experienced hard to take deep breath. On 02-NOV-2021, the patient experienced woke up in middle of night sweating. On 02-NOV-2021, the patient experienced feels like got hit by a damn truck. On 02-NOV-2021, the patient experienced arm hurts like hell. On 02-NOV-2021, the patient experienced headache on and off. On 02-NOV-2021, the patient experienced fever. On 02-NOV-2021, the patient experienced tired. On 03-NOV-2021, the patient experienced hands and head are sweating. On 03-NOV-2021, the patient experienced like someone sitting on chest. On 03-NOV-2021, the patient experienced feel cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, tired, fever, bones hurt, mouth hurts, dizziness / woozy, arm hurts like hell, pretty extreme like a bad flu/feel sick, feels like clogged nose, hard to take deep breath, headache on and off, feel cold, hands and head are sweating, and like someone sitting on chest, and the outcome of woke up in middle of night sweating and feels like got hit by a damn truck was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEEL COLD; HANDS AND HEAD ARE SWEATING; LIKE SOMEONE SITTING ON CHEST; FEELS LIKE GOT HIT BY A DAMN TRUCK; ARM HURTS LIKE HELL; HEADACHE ON AND OFF; FEVER; TIRED; BODY ACHES; BONES HURT; MOUTH HURTS; DIZZINESS / WOOZY; PRETTY EXTREME LIKE A BAD FLU/FEEL SICK; FEELS LIKE CLOGGED NOSE; HARD TO TAKE DEEP BREATH; WOKE UP IN MIDDLE OF NIGHT SWEATING; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: No known medical history. The patient's grandfather died of aneurysm. Headaches come and go and really bad last night. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced bones hurt. On 02-NOV-2021, the patient experienced mouth hurts. On 02-NOV-2021, the patient experienced dizziness / woozy. On 02-NOV-2021, the patient experienced pretty extreme like a bad flu/feel sick. On 02-NOV-2021, the patient experienced feels like clogged nose. On 02-NOV-2021, the patient experienced hard to take deep breath. On 02-NOV-2021, the patient experienced woke up in middle of night sweating. On 02-NOV-2021, the patient experienced feels like got hit by a damn truck. On 02-NOV-2021, the patient experienced arm hurts like hell. On 02-NOV-2021, the patient experienced headache on and off. On 02-NOV-2021, the patient experienced fever. On 02-NOV-2021, the patient experienced tired. On 03-NOV-2021, the patient experienced hands and head are sweating. On 03-NOV-2021, the patient experienced like someone sitting on chest. On 03-NOV-2021, the patient experienced feel cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, tired, fever, bones hurt, mouth hurts, dizziness / woozy, arm hurts like hell, pretty extreme like a bad flu/feel sick, feels like clogged nose, hard to take deep breath, headache on and off, feel cold, hands and head are sweating, and like someone sitting on chest, and the outcome of woke up in middle of night sweating and feels like got hit by a damn truck was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chest pain, Groin pain
Clinical narrative: HORRIBLE CHEST PAIN; BODY ACHES; CONSTANT NEED TO STRETCH OVERNIGHT; PAIN IN GROIN AREA; PAIN IN NIBBLES; PAIN ON BOTH SHOULDERS; NO ENERGY; TEMPERATURE; HEADACHE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced horrible chest pain, body aches, constant need to stretch overnight, pain in groin area, pain in nibbles, pain on both shoulders, no energy, temperature, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, horrible chest pain, temperature, pain on both shoulders, body aches, constant need to stretch overnight, no energy, pain in groin area and pain in nibbles was not reported. This report was non-serious. This case, from the same reporter is linked to 20210858507.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Nipple pain, Pain
Clinical narrative: HORRIBLE CHEST PAIN; BODY ACHES; CONSTANT NEED TO STRETCH OVERNIGHT; PAIN IN GROIN AREA; PAIN IN NIBBLES; PAIN ON BOTH SHOULDERS; NO ENERGY; TEMPERATURE; HEADACHE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced horrible chest pain, body aches, constant need to stretch overnight, pain in groin area, pain in nibbles, pain on both shoulders, no energy, temperature, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, horrible chest pain, temperature, pain on both shoulders, body aches, constant need to stretch overnight, no energy, pain in groin area and pain in nibbles was not reported. This report was non-serious. This case, from the same reporter is linked to 20210858507.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ciprofloxacin allergy).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 31-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy. The vaginal delivery occurred on 30-Sep-2021, which was reported as Full-term. For neonate 1, the birth weight was 3000 grams (6lbs 10oz) with an APGAR score of 9 at 5 minutes. The outcome was reported as Delivered NOS. Fetus/infant details, week of gestation 40, weight 3 Kg, length 48 cm, head circumference unknown, APGAR score at 1 min unknown and APGAR score at 5 min was 9. The patient was treated with MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency. On 31-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  CC: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected event of Maternal exposure during pregnancy. The patient received the first dose of vaccine at 6 weeks of gestation. The patient did not have any issues during pregnancy, had vaginal delivery full term and neonate had good APGAR scores. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant Follow-up received on 12-Oct-2021 includes reporter details, patient details and pregnancy information.; Sender's Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected event of Maternal exposure during pregnancy. The patient received the first dose of vaccine at 6 weeks of gestation. The patient did not have any issues during pregnancy, had vaginal delivery full term and neonate had good APGAR scores. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypersensitivity, Product dose omission issue
Clinical narrative: Cannot get the 2nd dose; Brusing; Allergic reaction,Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Brusing), PRODUCT DOSE OMISSION ISSUE (Cannot get the 2nd dose) and HYPERSENSITIVITY (Allergic reaction,Hypersensitivity reaction) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction,Hypersensitivity reaction). On 21-Apr-2021, the patient experienced CONTUSION (Brusing). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cannot get the 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. On 20-Apr-2021, HYPERSENSITIVITY (Allergic reaction,Hypersensitivity reaction) had resolved. At the time of the report, CONTUSION (Brusing) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Cannot get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Patient visited ER on 19-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Reporter details, Patient demographics, suspect details, treatment medication and events were updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Loss of personal independence in daily activities, Pyrexia, Vaccination site pain
Clinical narrative: "could not function Saturday"; sore left arm/lingering sore left arm especially if she lifts her arm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("could not function Saturday"), VACCINATION SITE PAIN (sore left arm/lingering sore left arm especially if she lifts her arm), CHILLS (chills) and PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, "0,2 or Z"1B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("could not function Saturday"), VACCINATION SITE PAIN (sore left arm/lingering sore left arm especially if she lifts her arm), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("could not function Saturday"), VACCINATION SITE PAIN (sore left arm/lingering sore left arm especially if she lifts her arm), CHILLS (chills) and PYREXIA (fever) was resolving.            No concomitant medications were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient got a second dose from a vial past the Use by Date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a second dose from a vial past the Use by Date.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 0939902) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a second dose from a vial past the Use by Date.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a second dose from a vial past the Use by Date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow up appended and updated race, ethnicity, Route, Body site.