chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product administration error
Clinical narrative: A patient received accidently rabies in the same area, about 3 inches from where the immune globulin dose went , no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Regulatory authority  (Reference number- 00638528) and transmitted to Sanofi on 12-Jun-2021.  This case involves a patient (unknown demographics) who received accidently a dose of suspect  RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) via an unknown route in an unknown administration site for unknown indication in the same area, about 3 inches from where the immune globulin dose went on an unknown date (product administration error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for prophylactic vaccination.  The caller was reporting potential adverse event (AE) information and she said they were wondering if they need to redose the vaccine, but they were not sure what to do.   The pharmacist also wanted to know if there was any information on giving a second Imovax vaccine. Upon call back the initial caller was on another call, so this information was given to another pharmacist and the e-mail address was not asked for since there was no information to provide. The reporter gave the vaccine around the bite and then gave the rest of the shot and the vaccine in the same spot in the arm. She stated that there did not seem to be a place for what to do in that situation and all they can do is find out that it shouldn't be given in the same area.   This was a case of actual medication error due to Product administration error (latency same day).  At the time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: No adverse event, Product preparation issue
Clinical narrative: MA accidentally injected a 15 month old patient, with only the Daptacel/Ipol portion of the Pentacel vaccine and the patient did not receive the ActHIB powdered portion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Regulatory authority (Reference number- 00642362) and transmitted to Sanofi on 15-Jun-2021.  This case involves a 15-month-old male patient who only received the Daptacel/Ipol portion and did not received the Act-HIB powdered portion, while patient was receiving a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [Diluent Vial: Lot number: U6986AA, expiry date: 22-Jul-2022, National Drug Code (NDC): 4928156005, Powder: Lot number: UJ529AA, expiry date: 22-Jul-2022, NDC: 4928154858, Box: Lot number: UJ529AAA, expiry date: 22-Jul-2022, NDC: 4928151005, Vaccine presentation: vial] on 15-Jun-2021 for prophylactic vaccination (product preparation issue).   Medical history, medical treatment, vaccination and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day)  It was reported that, the medical assistant (MA) accidentally injected the only the Daptacel/Ipol portion of the suspect and patient did not received the Act-HIB powder portion.   At the time of report, the MA wanted to know how she can give the ActHIB portion to patient and stated that, the error was occurred because she did not pay attention when she was getting the Pentacel out of the box and did not mix them together. The MA noticed the error after the patient was gone and when she was documenting.   At the time, it was reported that, the patient did not had any adverse event as result and discussed the way to give Act-HIB portion to patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 1 year old patient was administered with expired DAPTACEL/ no AE; Initial information was received on 17-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Regulatory authority (Reference number- 00646038) and transmitted to Sanofi on 17-Jun-2021.  This case involves a 20-year-old patient (unknown gender) who was vaccinated with 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].(5 dose series, 4th dose) (lot number C5621AA, expiry date 23-May-2021) via intramuscular route in left thigh on 17-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination; and HIB VACCINE (HIB) for Prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an vaccine that expired a month ago/ no AE; Initial information was received on 17-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via regulatory authority (Reference number- 00646123) and transmitted to Sanofi on 17-Jun-2021.  This case involves a 20-year-old patient (unknown gender) who was vaccinated with 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (total) (lot number U6575AA, expiry date 08-May-2021) via intramuscular route in left deltoid on 17-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Lethargy
Clinical narrative: Day after vaccine: low fever and lethargy that lasted for a day, swelling and pain at injection site that lasted a few days Week after:  reaction dubbed "COVID-arm", small patch of hardness and itching at injection site that is still ongoing at this time
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Day after vaccine: low fever and lethargy that lasted for a day, swelling and pain at injection site that lasted a few days Week after:  reaction dubbed "COVID-arm", small patch of hardness and itching at injection site that is still ongoing at this time
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Moderna COVID-19 Vaccine EUA Fatigue and then rash appearing like pityriasis rosea on chest and legs, continuing to spread over weeks.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: I had common side effects such as nausea, sore arm, swelling from the injection site, fatigue, and headaches. All has gone away since then except for the headaches. I?ll get a handful of headaches a day from bending over, laughing or sometimes breathing deeply. Before my vaccine headaches were not this common for me.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Initially I had arm pain, as expected later in the evening on day of shot.  I iced and took Tylenol as advised by staff at health department.  Saturday morning I woke to nausea, lightheadedness and increased arm pain.  I pushed fluid intake, rested off and on all day, took Tylenol as needed.  Sunday morning felt tired, but other symptoms were better so went about the day.  Sunday afternoon I noticed my joints started hurting, and chills set in.  By Monday morning every joint in my body hurt, and not just an ache - because all of my muscles were aching as well - but my toes, ankles, knees, elbows, hips felt like they had been hammered and were throbbing.  I've been taking Tylenol, resting, fluids as tolerated and three days from onset it's still hanging on.  I've never experienced joint pain like this in my life ...
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Initially I had arm pain, as expected later in the evening on day of shot.  I iced and took Tylenol as advised by staff at health department.  Saturday morning I woke to nausea, lightheadedness and increased arm pain.  I pushed fluid intake, rested off and on all day, took Tylenol as needed.  Sunday morning felt tired, but other symptoms were better so went about the day.  Sunday afternoon I noticed my joints started hurting, and chills set in.  By Monday morning every joint in my body hurt, and not just an ache - because all of my muscles were aching as well - but my toes, ankles, knees, elbows, hips felt like they had been hammered and were throbbing.  I've been taking Tylenol, resting, fluids as tolerated and three days from onset it's still hanging on.  I've never experienced joint pain like this in my life ...
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: Diarrhea x 3 weeks  Headache 2 weeks Fever chills x 3 days
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain in extremity, Rhinorrhoea
Clinical narrative: 3-36 hours after shot: sore arm; 20-36 hours after shot: slight headache; 30-48 hours after shot: swollen lymph nodes & nasal drainage
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Computerised tomogram, Echocardiogram, Tachycardia
Clinical narrative: Tachycardia, chest pain for several hours. Outcomes: resolved on its own. Cardiac stress test, X-ray, echo and CT with contrast revealed no abnormalities.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Tachycardia, chest pain for several hours. Outcomes: resolved on its own. Cardiac stress test, X-ray, echo and CT with contrast revealed no abnormalities.
Age: 60.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chest discomfort, Fatigue, Limb discomfort
Clinical narrative: About a week and a half after receiving my second dose, I noticed a tightness in my chest. I have been feeling very fatigue and heaviness in my legs when I walk.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash with itching started on both inside of arms. Hydrocortisone  cream used until rash went away. Then rash moved to neck same treatment used but didn?t go away. Caladryl used to stop itch rash still visible. Rash with intense itching started under navel waist area hydrocortisone used first but still exist. Caladryl controlling the itching. Area under breast stopped with hydrocortisone but when it continued with intensivity caladryl used to stop itching. Started around June 13 until present date June 23, 2021 rash in areas still exist itching can be stopped or control with use of Caladryl .
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Meningitis viral, Vaccination failure
Clinical narrative: Got the vaccine/ ( shingles of the spinal cord)./suspected vaccination failure; viral meningitis; shingles of the spinal cord; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), viral meningitis (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, viral meningitis and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, viral meningitis and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Two months after receiving Shingles vaccine, the patient experienced viral meningitis (shingles of spinal cord). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Am living proof that the injection does NOT work for everyone/suspected vaccination failure; Am living proof that the injection does NOT work for everyone; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient stated that he or she was the living proof that the injection does not work for everyone. The patient further suggested that everyone should talk to doctor first, make sure know all of the side effects and consequences of this medication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site pain, Pain in extremity, Rash
Clinical narrative: on his back / active case of shingles; history of a rash / on his lower back / after / first / dose / rash on his back; left arm soreness and tenderness at the injection site; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bacterial infection, itchy rash, red rash, skin irritation and shingles (outbreaks since age nineteen).   On 16th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th June 2021, 4 hrs after receiving Shingrix, the patient experienced shingles, rash, injection site pain and pain in arm. On an unknown date, the outcome of the shingles, rash, injection site pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The reporter reported that a long history of intermittent shingles outbreaks since age nineteen. He states that they have became less frequent and less intense as the years have gone by. He also reported a history of a rash, diagnosed as a bacterial infection on his lower back. It was itching, sore, red and irritated.  The patient was treated by a dermatologist. The patient experienced left arm soreness and tenderness at the injection site and shingles.   About four hours after receiving the Shingrix dose, his wife noticed the rash on his back was an active case of shingles. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Headache, Insomnia, Irritable bowel syndrome
Clinical narrative: IRRITABLE BOWEL SYNDROME; DIFFICULTY SLEEPING; HEADACHES; This spontaneous report received from a patient concerned a 60-year-old white and not Hispanic or Latino male. The patient's weight was 280 pounds, and height was 71 inches. The patient's past medical history included upper/lower GI (gastrointestinal) done take some bowels removed, and concurrent conditions included lactose intolerance, alcohol user (2 Drinks per week), and smoker (1 pack per 2 week). Patient had no known allergies. He had no any drug abuse or illicit drug usage. On an unspecified date colonoscopy was done and result was unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported,1 total administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient experienced IBS (irritable bowel syndrome)/stomach pain/constipation/nausea. On same day patient experienced difficulty sleeping and headaches. On an unspecified date, he was admitted to hospital emergency room for several days. His physician was aware of his situation and patient was advised to take Miralax and fiber and was also prescribed morphine during hospital visit.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, IBS (irritable bowel syndrome), headaches. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210629530.; Sender's Comments: V0: 20210629309-covid-19 vaccine ad26.cov2.s-irritable bowel syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities
Clinical narrative: CAN'T CONTINUE TO FUNCTION; SEVERE HEADACHE EVERYDAY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 can't continue to function, and severe headache everyday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache everyday, and can't continue to function. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: MIGRAINES; MUSCLE ACHES; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced migraines, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraines and muscle aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a parent via a company representative via social media concerned a 30 year old male, unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported, expiry: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. 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 patient was died. The patient died from unknown cause of death. It was unknown if the autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210644799-COVID-19 VACCINE AD26.COV2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: DULL ACHES; MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 dull aches, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dull aches and mild headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: RECURRENT LEG PAIN; SWELLING IN AREA OF INJECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included leg pain, and concurrent conditions included leg injury, and other pre-existing medical conditions included received pain medication for leg injury prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUN-2021, the subject experienced recurrent leg pain. On JUN-2021, the subject experienced swelling in area of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recurrent leg pain and swelling in area of injection was not reported. This report was non-serious.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: passed away; received second vaccine 44 days after receiving the first dose; Pain the injection site from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 91-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.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain the injection site from the first dose). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose). On 05-Apr-2021, VACCINATION SITE PAIN (Pain the injection site from the first dose) had resolved. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose) had resolved. The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 medication were reported. No treatment information was reported.  Company comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273,  with  associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject  who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-132760 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Case upgraded to Serious due to death.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273,  with  associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject  who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time.  Further information has been requested. US-MODERNATX, INC.-MOD-2021-132760:Son; Reported Cause(s) of Death: Unknown cause of death
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Chest pain, Chills, Feeling abnormal
Clinical narrative: really bad tummy ache; shaking; chest pain; body is not my body; severe chills; Abdominal Pain; unbearable pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad tummy ache), TREMOR (shaking), CHEST PAIN (chest pain), FEELING ABNORMAL (body is not my body), ABDOMINAL PAIN (Abdominal Pain) and CHILLS (severe chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021 at 5:30 PM, the patient experienced ABDOMINAL PAIN (Abdominal Pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (really bad tummy ache) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), FEELING ABNORMAL (body is not my body) (seriousness criterion hospitalization), CHILLS (severe chills) (seriousness criterion hospitalization) and MYALGIA (unbearable pain). The patient was hospitalized on 25-May-2021 due to CHILLS and FEELING ABNORMAL, and then on 29-May-2021 due to ABDOMINAL PAIN. On 29-May-2021, ABDOMINAL PAIN (Abdominal Pain) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (really bad tummy ache), TREMOR (shaking), CHEST PAIN (chest pain), FEELING ABNORMAL (body is not my body), CHILLS (severe chills) and MYALGIA (unbearable pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided.  Company Comment: Based on the 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received on 12 Jun 2021, added patient demographics (height, weight) and event (abdominal pain).; Sender's Comments: Based on the 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tremor
Clinical narrative: really bad tummy ache; shaking; chest pain; body is not my body; severe chills; Abdominal Pain; unbearable pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad tummy ache), TREMOR (shaking), CHEST PAIN (chest pain), FEELING ABNORMAL (body is not my body), ABDOMINAL PAIN (Abdominal Pain) and CHILLS (severe chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021 at 5:30 PM, the patient experienced ABDOMINAL PAIN (Abdominal Pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (really bad tummy ache) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), FEELING ABNORMAL (body is not my body) (seriousness criterion hospitalization), CHILLS (severe chills) (seriousness criterion hospitalization) and MYALGIA (unbearable pain). The patient was hospitalized on 25-May-2021 due to CHILLS and FEELING ABNORMAL, and then on 29-May-2021 due to ABDOMINAL PAIN. On 29-May-2021, ABDOMINAL PAIN (Abdominal Pain) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (really bad tummy ache), TREMOR (shaking), CHEST PAIN (chest pain), FEELING ABNORMAL (body is not my body), CHILLS (severe chills) and MYALGIA (unbearable pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided.  Company Comment: Based on the 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received on 12 Jun 2021, added patient demographics (height, weight) and event (abdominal pain).; Sender's Comments: Based on the 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.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: hearing loss; This spontaneous case was reported by a pharmacist and describes the occurrence of DEAFNESS (hearing loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss) had not resolved.        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 medication was reported. Treatment drug information was not given.  The consumer received the first dose of the Moderna Covid-19 vaccine on 06Jun2021 and experienced hearing loss that was still ongoing.  Based on the 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: Based on the 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Deafness, Ear discomfort, Feeling abnormal
Clinical narrative: Some hearing loss on right side after 2nd dose; Felt so bad she thought she was going to need an ambulance after 2nd dose; Got up and lost her balance after 2nd dose; Vertigo after 2nd dose; Pressure in ears after 2nd dose; Ringing in right ear after 2nd dose; Blood pressure went up after the vaccine; Headaches after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Some hearing loss on right side after 2nd dose) in a 69-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.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DEAFNESS (Some hearing loss on right side after 2nd dose) (seriousness criterion medically significant), FEELING ABNORMAL (Felt so bad she thought she was going to need an ambulance after 2nd dose), BALANCE DISORDER (Got up and lost her balance after 2nd dose), VERTIGO (Vertigo after 2nd dose), EAR DISCOMFORT (Pressure in ears after 2nd dose), TINNITUS (Ringing in right ear after 2nd dose), HYPERTENSION (Blood pressure went up after the vaccine) and HEADACHE (Headaches after 2nd dose). At the time of the report, DEAFNESS (Some hearing loss on right side after 2nd dose), FEELING ABNORMAL (Felt so bad she thought she was going to need an ambulance after 2nd dose), BALANCE DISORDER (Got up and lost her balance after 2nd dose), VERTIGO (Vertigo after 2nd dose), EAR DISCOMFORT (Pressure in ears after 2nd dose), TINNITUS (Ringing in right ear after 2nd dose), HYPERTENSION (Blood pressure went up after the vaccine) and HEADACHE (Headaches after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: elevated (High) BP was123-127 and it got elevated after vaccination..         Concomitant medication were not provided.Treatment information was not provided.  The patient reported that it took eight weeks to recover and became normal from the events.  Action taken with mRNA-1273 in response to the event were not applicable.  Based on the 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: Based on the 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Tinnitus, Vertigo
Clinical narrative: Some hearing loss on right side after 2nd dose; Felt so bad she thought she was going to need an ambulance after 2nd dose; Got up and lost her balance after 2nd dose; Vertigo after 2nd dose; Pressure in ears after 2nd dose; Ringing in right ear after 2nd dose; Blood pressure went up after the vaccine; Headaches after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Some hearing loss on right side after 2nd dose) in a 69-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.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DEAFNESS (Some hearing loss on right side after 2nd dose) (seriousness criterion medically significant), FEELING ABNORMAL (Felt so bad she thought she was going to need an ambulance after 2nd dose), BALANCE DISORDER (Got up and lost her balance after 2nd dose), VERTIGO (Vertigo after 2nd dose), EAR DISCOMFORT (Pressure in ears after 2nd dose), TINNITUS (Ringing in right ear after 2nd dose), HYPERTENSION (Blood pressure went up after the vaccine) and HEADACHE (Headaches after 2nd dose). At the time of the report, DEAFNESS (Some hearing loss on right side after 2nd dose), FEELING ABNORMAL (Felt so bad she thought she was going to need an ambulance after 2nd dose), BALANCE DISORDER (Got up and lost her balance after 2nd dose), VERTIGO (Vertigo after 2nd dose), EAR DISCOMFORT (Pressure in ears after 2nd dose), TINNITUS (Ringing in right ear after 2nd dose), HYPERTENSION (Blood pressure went up after the vaccine) and HEADACHE (Headaches after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: elevated (High) BP was123-127 and it got elevated after vaccination..         Concomitant medication were not provided.Treatment information was not provided.  The patient reported that it took eight weeks to recover and became normal from the events.  Action taken with mRNA-1273 in response to the event were not applicable.  Based on the 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: Based on the 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Injection site pain, Lymphadenopathy
Clinical narrative: Lightheadedness, nausea, sore throat, headache, sharp intermittent stomach pain, swollen lymph nodes in throat, pain with swallowing, chills, low grade fever, sore arm at injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Lightheadedness, nausea, sore throat, headache, sharp intermittent stomach pain, swollen lymph nodes in throat, pain with swallowing, chills, low grade fever, sore arm at injection site.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - severe, constant
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My next period was very light?normally quite heavy. I haven?t had a light one in years. It did seem to return to normal the next cycle, but I was concerned about the effect on younger, developing systems of girls and wanted to report it.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Nausea
Clinical narrative: Fever, cold chills, cold sweats, nausea and fatigue. Aches as in like my bones feel like they hurt especially around my joints.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, cold chills, cold sweats, nausea and fatigue. Aches as in like my bones feel like they hurt especially around my joints.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Presyncope
Clinical narrative: About 10 min after receiving first dose of Pfizer COVID vaccine, pt had vasovagal response and fell to floor. Hit cheek on floor, and was very scared of event, but returned to baseline in a minute or two. Cold towel applied to left cheek and educated mother to take pt to be evaluated if cheek continues to hurt after applying ice at home. After waiting an additional 10 min, pt able to walk out of clinic waiting area with mother.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: When exercising at a moderate pace, I experienced chest pain and intense shortness of breath. The chest pain lasted several hours after the event. This occured 3 days after my second dose and again, when I tried to exercise again, 7 days later. On day 8, I went to the Emergency Department at my local hospital.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Ultrasound scan normal
Clinical narrative: When exercising at a moderate pace, I experienced chest pain and intense shortness of breath. The chest pain lasted several hours after the event. This occured 3 days after my second dose and again, when I tried to exercise again, 7 days later. On day 8, I went to the Emergency Department at my local hospital.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: 97/47, HR 70, c/o lightheadedness.  Pt. received vaccine via RD started getting pale and stated felt faint.  Pt. lowered in passenger front seat.  Fire Rescue called, checked vitals.  Pt. stated feeling better.  Sat back up in seat, sipped water.  Pt. stable.  No acute distress noted.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrointestinal disorder, Headache, Muscle spasms, Myalgia
Clinical narrative: Extreme chills, fever, headache, muscle spasms/aches, and gastrointestinal issues.  Started approximately 16 hrs after injection. Lasted for 18 hrs.  Still have pain in arm, but that was nothing compared to the other stuff.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme chills, fever, headache, muscle spasms/aches, and gastrointestinal issues.  Started approximately 16 hrs after injection. Lasted for 18 hrs.  Still have pain in arm, but that was nothing compared to the other stuff.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Angiogram, Anti-thyroid antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial catheterisation, Atrial fibrillation, Bacterial test, Bilirubin conjugated, Blood calcium
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood magnesium
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood phosphorus, Blood test, Body fluid analysis, C-reactive protein, Calcium ionised
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac electrophysiologic study, Cardiac stress test, Cardioversion, Catheterisation cardiac, Chest X-ray
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulation time, Complement factor C3, Complement factor C4, Computerised tomogram thorax, Culture
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cytology, Differential white blood cell count, Double stranded DNA antibody, Echocardiogram, Electrocardiogram
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Fungal test, Haemoglobin, Influenza A virus test, Influenza B virus test
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio, Laboratory test, Lipids, Liver function test, Metabolic function test
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericardial drainage, Pericardial excision, Pericarditis, Positron emission tomogram
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time, Red blood cell count, Red blood cell sedimentation rate, Respiratory syncytial virus test, Rheumatoid factor
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Scleroderma, Sjogren's syndrome, Troponin, Ultrasound scan
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: myocarditis and pericarditis Afib  pericardial window  cardioversion
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: I had chills and a low grade fever 99.8 the night I got vaccinated.