chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Dizziness, Dizziness exertional
Clinical narrative: * First 48 hours: Fever to 101 degrees, headache, excruciating muscular pain, joint pain, nerve pain (sensitive to touch), extreme fatigue, stomach discomfort, inflammation of injection site and left underarm * Every day after the first 48 hours: All Mild but lingering symptoms of fatigue, lack of energy (not feeling like my normal self), headache, joint pain, brain fog (memory, concentration, sleep problems), few occasions of fast pounding heartbeat lasting for few minutes, dizziness when I stand up or move quickly. Fatigue, brain fog and dizziness get worse even after mild activities (physical, mental such as studying). All symptoms got better now than the first 7 days but still lingering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate increased, Injection site inflammation
Clinical narrative: * First 48 hours: Fever to 101 degrees, headache, excruciating muscular pain, joint pain, nerve pain (sensitive to touch), extreme fatigue, stomach discomfort, inflammation of injection site and left underarm * Every day after the first 48 hours: All Mild but lingering symptoms of fatigue, lack of energy (not feeling like my normal self), headache, joint pain, brain fog (memory, concentration, sleep problems), few occasions of fast pounding heartbeat lasting for few minutes, dizziness when I stand up or move quickly. Fatigue, brain fog and dizziness get worse even after mild activities (physical, mental such as studying). All symptoms got better now than the first 7 days but still lingering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Pyrexia
Clinical narrative: * First 48 hours: Fever to 101 degrees, headache, excruciating muscular pain, joint pain, nerve pain (sensitive to touch), extreme fatigue, stomach discomfort, inflammation of injection site and left underarm * Every day after the first 48 hours: All Mild but lingering symptoms of fatigue, lack of energy (not feeling like my normal self), headache, joint pain, brain fog (memory, concentration, sleep problems), few occasions of fast pounding heartbeat lasting for few minutes, dizziness when I stand up or move quickly. Fatigue, brain fog and dizziness get worse even after mild activities (physical, mental such as studying). All symptoms got better now than the first 7 days but still lingering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Herpes zoster, Neck pain, Pruritus
Clinical narrative: Had prior pain from shoulder blade up to neck and ear.  Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck.  Went to dr rash not there.   Treated for shingles. Rash reappeared later that evening.  Husband received vaccine same date/time. Being Treated for shingles.  He reported his event
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had prior pain from shoulder blade up to neck and ear.  Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck.  Went to dr rash not there.   Treated for shingles. Rash reappeared later that evening.  Husband received vaccine same date/time. Being Treated for shingles.  He reported his event
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Well around injection site that is hard , red, and itchy. Warm to touch.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia, Rash
Clinical narrative: Immediate rash on hands, spread to arms and metallic taste in tongue and tingling.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Myosclerosis, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: COVID Arm - swelling, redness, rash, hot to the touch, hardening of muscle, pain.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: COVID Arm - swelling, redness, rash, hot to the touch, hardening of muscle, pain.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Heart rate increased, Peripheral swelling, Skin tightness
Clinical narrative: The patient reported that they were experiencing tightness in their arm and believed it swelled initially. They left the pharmacy area and went to get Tylenol that was recommended by the pharmacist. They then began to get lightheaded and had syncope, attempted to get back up and the cashier asked to if they wanted to sit, but fell again. It was not clear initially to the employee who was helping them they had received the vaccine. 911 was called and the employee helping them let the pharmacist know they had just gotten their vaccine. The immunizing pharmacist went to check on the patient. EMTs were already helping the patient and had taken his blood pressure which was normal the lightheadedness had stopped and both sitting and standing blood pressure was the same. He had an elevated heart rate per the patient but didn't know any of the numbers the EMTs had taken. His father was driving him. He was not experiencing any symptoms and the injection site had no swelling and was otherwise unremarkable.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The patient reported that they were experiencing tightness in their arm and believed it swelled initially. They left the pharmacy area and went to get Tylenol that was recommended by the pharmacist. They then began to get lightheaded and had syncope, attempted to get back up and the cashier asked to if they wanted to sit, but fell again. It was not clear initially to the employee who was helping them they had received the vaccine. 911 was called and the employee helping them let the pharmacist know they had just gotten their vaccine. The immunizing pharmacist went to check on the patient. EMTs were already helping the patient and had taken his blood pressure which was normal the lightheadedness had stopped and both sitting and standing blood pressure was the same. He had an elevated heart rate per the patient but didn't know any of the numbers the EMTs had taken. His father was driving him. He was not experiencing any symptoms and the injection site had no swelling and was otherwise unremarkable.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia
Clinical narrative: Soreness in arm that rapidly came on roughly 10 hours later, but subsided significantly following 24 hours after the shot was given. All soreness subsided within 3 days.   Sudden sensitivity to light developed about 26 hours after the shot was given. This side effect remained for about 8 days afterwards and still has some very slight residual effect (now 12 days after).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Extreme chills, shivering, 102 fever that lasted 6 hours, severe fatigue, moderate headache, severe body aches, severe nausea  .
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme chills, shivering, 102 fever that lasted 6 hours, severe fatigue, moderate headache, severe body aches, severe nausea  .
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Product administration error, Wrong product administered
Clinical narrative: no adverse event; PROQUAD and MMR II both vaccines were inadvertenly administered at the same time to a 12 month old patient; This spontaneous report was received from a medical assistant (conflicting information also reported a nurse) referring to a 12-month-old patient of unknown gender. The patient concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not reported.  On 30-MAR-2021, the patient was vaccinated with the first doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter injection (strength, route of administration were not ; lot# was T029099 and expiration date was 23-FEB-2022); and on the same date, with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter injection, (strength, route of administration were not provided; lot# was S037498 and expiration date was 20-NOV-2021) for prophylaxis. On the same date, the patient was inadvertently administered with both suspect vaccines at the same time. No additional adverse events occurred (AEs). No further information was reported.  The causal relationship between the event and the suspect vaccines was not reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was administered improperly stored RECOMBIVAX HB; No additional; This spontaneous report was received from a Pharmacist, referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided.    On an unknown date, the patient was vaccinated with and incorrect stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (pediatric formulation) lot # T004378 with expiration date on 01-NOV-2022 (strength and route were not reported) for prophylaxis, however no adverse effects reported.    It was reported that the vaccine was exposed to temperature of 34.5 Farenheit grades range for a time frame of 30 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions,pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  and patient was asymptomatic (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported  and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously(lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported  and patient was asymptomatic.  This is one of several reports from the same reporter; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated  that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported  and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: with post-vaccine diarrhea/rotavirus infection;   Information has been received from the authors in a published literature article titled as stated above concerning to a child patient of unknown age and gender who was enrolled in a study to analyze the group A Rotavirus (RVA) genotype prevalence during consecutive RVA seasons (2014-2016). The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.       On an unknown date the patient was vaccinated with an unspecified dose (1-3) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (dose, frequency, Lot # and expiration date not provided) oral for prophylaxis.         On an unspecified date in 2015 (season reported as 01-DEC-2014 through 30-NOV-2015), the patient experienced post-vaccine diarrhea (Rotavirus infection) and was hospitalized. A Rotaclone enzyme immunoassay was performed in 2015 by using stool sample or eluted fecal material from diaper which tested positive for Rotavirus of group A (RVA) and unspecified genotype.  The authors reported the importance of continuous RVA surveillance post-vaccine licensure to identify emergent RVA genotypes and other gastrointestinal pathogens causing Acute Gastroenteritis (AGE) and to guide treatment and intervention strategies.   At the time of the report, the outcome of rotavirus infection was unknown.    The reporting authors considered rotavirus infection to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).     A copy of the published article is attached as further documentation of the patient's experience.  This is one of several cases from the same article (US-009507513-2104USA007698, US-009507513-2104USA007699).; Sender's Comments:  US-009507513-2104USA007698: US-009507513-2104USA007699:
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis, Rotavirus infection, Rotavirus test positive
Clinical narrative: with post-vaccine diarrhea/rotavirus infection;  Information has been received from the authors in a published literature article titled as stated above concerning to a child patient of unknown age and gender who was enrolled in a study to analyze the group A Rotavirus (RVA) genotype prevalence during consecutive RVA seasons (2014-2016). The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.       On an unknown date the patient was vaccinated with an unspecified dose (1-3) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (dose, frequency, Lot # and expiration date not provided) oral for prophylaxis.         On an unspecified date in 2016 (season reported as 01-DEC-2015 through 30-JUN-2016), the patient experienced post-vaccine diarrhea (Rotavirus infection) and was hospitalized. A Rotaclone enzyme immunoassay was performed in 2016 by using stool sample or eluted fecal material from diaper which tested positive for Rotavirus of group A (RVA) and unspecified genotype.  The authors reported the importance of continuous RVA surveillance post-vaccine licensure to identify emergent RVA genotypes and other gastrointestinal pathogens causing Acute Gastroenteritis (AGE) and to guide treatment and intervention strategies.   At the time of the report, the outcome of rotavirus infection was unknown.    The reporting authors considered rotavirus infection to be related to Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).     A copy of the published article is attached as further documentation of the patient's experience.  This is one of several cases from the same article (US-009507513-2104USA006886, US-009507513-2104USA007699).; Sender's Comments:  US-009507513-2104USA006886: US-009507513-2104USA007699:
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via a company representative concerned two patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 (a month prior to this report) for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, two patients' suffered a heart attack and died. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked. Sender's Comments: V0: COVID-19 VACCINE AD26.COV2.S - Heart Attack. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: HEART ATTACK
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging, Scan, Thrombosis, Ultrasound Doppler
Clinical narrative: STROKE; BLOOD CLOT IN LEG; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy with no health issues. 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, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on an unspecified date in 2021, the patient started with symptoms after 13 days of vaccination. The patient woke with leg pain That morning, he got in the vehicle to go to work and pulled over due to heaviness in his left arm and slurred speech. An ambulance was called and they took him to the emergency room. From there he was life flighted to another hospital and was continued with laboratory tests. Laboratory data included: doppler ultrasound (NR: not provided) not reported, MRI (magnetic resonance imaging) (NR: not provided) not reported, scan (NR: not provided) not reported and other tests. It was due to the blood clot in his leg that caused him to suffer a stroke. He spent days in the hospital and had to wear a heart monitor for two weeks. He was  on blood thinners until further notice to prevent this from happening again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in leg and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a 51 year-old male with no prior medical issues who was hospitalized for a stroke and blood clot in his leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications, family history, and social history were not reported. Thirteen days post-vaccination, the patient awoke with leg pain. While driving to work, he experienced heaviness in his left arm and slurred speech and pulled his car over. An ambulance took him to a local hospital and from there, he was air-lifted to another hospital where doppler ultrasound, MRI, and other unspecified tests were performed.  He spent an unspecified number of days in the hospital and wore a heart monitor for 2 weeks. He was treated with blood thinners. Per the reporter (patient's daughter), the blood clot caused the stroke. Outcome was not reported. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule, Vein discolouration
Clinical narrative: HARD KNOT SIZE OF A PEA/NODULE IN HER LEFT ELBOW CREASE AND ON HER LEFT SHOULDER (AREA WAS SWOLLEN, WARM AND VERY SENSITIVE/PAINFUL; TIRED; DARK PURPLE VEINS IN ELBOW REGION; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dark purple veins in elbow region. On 09-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced hard knot size of a pea/nodule in her left elbow crease and on her left shoulder (area was swollen, warm and very sensitive/painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 10-APR-2021, and was recovering from dark purple veins in elbow region, and the outcome of hard knot size of a pea/nodule in her left elbow crease and on her left shoulder (area was swollen, warm and very sensitive/painful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: SHINGLES (MUSCLE ACHE,PAINFUL RASH,FEVER,HEADACHE,CHILLS); FATIGUE; REDNESS AT INJECTION SITE; SWELLING AT INJECTION SITE (2 INCHES BY 3 INCHES); This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included chicken pox, and concurrent conditions included gave birth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced shingles (muscle ache, painful rash, fever, headache, chills). On APR-2021, the subject experienced redness at injection site. On APR-2021, the subject experienced swelling at injection site (2 inches by 3 inches). On an unspecified date, the subject experienced fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: aciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness at injection site, and swelling at injection site (2 inches by 3 inches) on APR-2021, and the outcome of shingles (muscle ache,painful rash,fever,headache,chills) and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not 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, per procedure no follow up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 2021, and the outcome of fever was not reported. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Herpes zoster, Ill-defined disorder
Clinical narrative: has trouble getting up; phlegm/infection in the chest; phlegm/infection in the chest; first one leaked; Two doses of vaccine on same day; Feeling achy; tired; throat irritation; back pain; neck pain; headache; shingles; Pain from second shot; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Feb-2021, the patient experienced SYRINGE ISSUE (first one leaked), INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles) and VACCINATION SITE PAIN (Pain from second shot). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) (seriousness criterion medically significant), ILL-DEFINED DISORDER (has trouble getting up) and PRODUCTIVE COUGH (phlegm/infection in the chest). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles), ILL-DEFINED DISORDER (has trouble getting up), PRODUCTIVE COUGH (phlegm/infection in the chest) and VACCINATION SITE PAIN (Pain from second shot) outcome was unknown and SYRINGE ISSUE (first one leaked) and INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day) had resolved.            The patient provided a lot number 025A21A but did not specify as to which dose it is for. Treatments of this events include taking Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of syringe issue and inappropriate dose administered for mRNA-1273, lot # unknown with associated AEs vaccination site pain, fatigue and ache/pain..
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Lower respiratory tract infection, Neck pain, Pain, Productive cough
Clinical narrative: has trouble getting up; phlegm/infection in the chest; phlegm/infection in the chest; first one leaked; Two doses of vaccine on same day; Feeling achy; tired; throat irritation; back pain; neck pain; headache; shingles; Pain from second shot; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Feb-2021, the patient experienced SYRINGE ISSUE (first one leaked), INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles) and VACCINATION SITE PAIN (Pain from second shot). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) (seriousness criterion medically significant), ILL-DEFINED DISORDER (has trouble getting up) and PRODUCTIVE COUGH (phlegm/infection in the chest). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles), ILL-DEFINED DISORDER (has trouble getting up), PRODUCTIVE COUGH (phlegm/infection in the chest) and VACCINATION SITE PAIN (Pain from second shot) outcome was unknown and SYRINGE ISSUE (first one leaked) and INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day) had resolved.            The patient provided a lot number 025A21A but did not specify as to which dose it is for. Treatments of this events include taking Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of syringe issue and inappropriate dose administered for mRNA-1273, lot # unknown with associated AEs vaccination site pain, fatigue and ache/pain..
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Throat irritation, Vaccination site pain
Clinical narrative: has trouble getting up; phlegm/infection in the chest; phlegm/infection in the chest; first one leaked; Two doses of vaccine on same day; Feeling achy; tired; throat irritation; back pain; neck pain; headache; shingles; Pain from second shot; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Feb-2021, the patient experienced SYRINGE ISSUE (first one leaked), INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles) and VACCINATION SITE PAIN (Pain from second shot). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) (seriousness criterion medically significant), ILL-DEFINED DISORDER (has trouble getting up) and PRODUCTIVE COUGH (phlegm/infection in the chest). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles), ILL-DEFINED DISORDER (has trouble getting up), PRODUCTIVE COUGH (phlegm/infection in the chest) and VACCINATION SITE PAIN (Pain from second shot) outcome was unknown and SYRINGE ISSUE (first one leaked) and INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day) had resolved.            The patient provided a lot number 025A21A but did not specify as to which dose it is for. Treatments of this events include taking Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of syringe issue and inappropriate dose administered for mRNA-1273, lot # unknown with associated AEs vaccination site pain, fatigue and ache/pain..
Sex: U
Vaccine: COVID19
Symptoms: Kidney infection
Clinical narrative: kidney infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of KIDNEY INFECTION (kidney infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion medically significant). At the time of the report, KIDNEY INFECTION (kidney infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatments to the events are not reported.  Based on the current case data, this case has been classified as invalid. It can be considered for assessment if only the follow up information provides some valid data.; Sender's Comments: Based on the current case data, this case has been classified as invalid. It can be considered for assessment if only the follow up information provides some valid data.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Choking, Dizziness, Dyspnoea
Clinical narrative: chocking in her throat; Shortness of breath; dizzy; Arms hurt; body aches; could barely speak; no energy; body aches; Severe headache; No energy - gets tired easily; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHOKING (chocking in her throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included RITUXIMAB for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHOKING (chocking in her throat) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), PAIN IN EXTREMITY (Arms hurt), PAIN (body aches), APHASIA (could barely speak), MYALGIA (body aches), HEADACHE (Severe headache) and FATIGUE (No energy - gets tired easily). On an unknown date, the patient experienced ASTHENIA (no energy). At the time of the report, CHOKING (chocking in her throat), DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), PAIN IN EXTREMITY (Arms hurt), PAIN (body aches), APHASIA (could barely speak), ASTHENIA (no energy), MYALGIA (body aches), HEADACHE (Severe headache) and FATIGUE (No energy - gets tired easily) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medication and pain management medication for fractured hip.  Treatment included steroids (step-down) - solu-medrol then prednisone, benadryl, pepcid, and zyrtec, as advised by their HCP to try to alleviate the symptoms.  This case concerns a 59-year-old female with a serious unexpected event of choking, and nonserious unexpected dyspnea, aphasia, dizziness, pain in extremity, pain, and expected headache, myalgia, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of choking, and nonserious unexpected dyspnea, aphasia, dizziness, pain in extremity, pain, and expected headache, myalgia, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: chocking in her throat; Shortness of breath; dizzy; Arms hurt; body aches; could barely speak; no energy; body aches; Severe headache; No energy - gets tired easily; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHOKING (chocking in her throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included RITUXIMAB for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHOKING (chocking in her throat) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), PAIN IN EXTREMITY (Arms hurt), PAIN (body aches), APHASIA (could barely speak), MYALGIA (body aches), HEADACHE (Severe headache) and FATIGUE (No energy - gets tired easily). On an unknown date, the patient experienced ASTHENIA (no energy). At the time of the report, CHOKING (chocking in her throat), DYSPNOEA (Shortness of breath), DIZZINESS (dizzy), PAIN IN EXTREMITY (Arms hurt), PAIN (body aches), APHASIA (could barely speak), ASTHENIA (no energy), MYALGIA (body aches), HEADACHE (Severe headache) and FATIGUE (No energy - gets tired easily) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medication and pain management medication for fractured hip.  Treatment included steroids (step-down) - solu-medrol then prednisone, benadryl, pepcid, and zyrtec, as advised by their HCP to try to alleviate the symptoms.  This case concerns a 59-year-old female with a serious unexpected event of choking, and nonserious unexpected dyspnea, aphasia, dizziness, pain in extremity, pain, and expected headache, myalgia, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of choking, and nonserious unexpected dyspnea, aphasia, dizziness, pain in extremity, pain, and expected headache, myalgia, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Feeling abnormal
Clinical narrative: Cellulitis; head feels mentally in the fog; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    The patient's past medical history included Cellulitis and Foggy feeling in head.  On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and FEELING ABNORMAL (head feels mentally in the fog). At the time of the report, CELLULITIS (Cellulitis) and FEELING ABNORMAL (head feels mentally in the fog) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. 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. Patient had a huge rash and doctor diagnosed it as cellulitis which itched, burned and felt kind of achy. The same thing happened with flu shot. This case was linked to MOD-2021-086069 (Patient Link).; 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.