chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: she did cut her thumb on the broken part of the plunger; 2 syringes of GARD ASIL 9 where the round portion of the plunger broke which occurred once when a nurse was giving the injection and once when the nurse was about to give an injection; This spontaneous report as received from a registered nurse refers to a nurse female patient of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On 15-FEB-2021, the patient had 2 syringes of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringes where the round portion of the plunger broke, which occurred once when she was giving the injection and once when the she was about to give an injection  for prophylaxis (lot # T008152, dose:0.5 milliliter, intramuscularly, expiration date reported as 01-JUN-2022, but upon internal validation established as 21-JUN-2022).    The nurse, who was giving the injections did cut her thumb on the broken part of the plunger. The registered nurse described the portion of the plunger breaking as a snap, with once small piece breaking off. No additional adverse events. No further information provided. It was reported that she was unable to obtain broken syringes/plunger as they had been placed in the sharps disposal. It was reported that the patientt did not received treatment for the events. It was mentioned that the patient did no seek medical attention. It was stated that the plunger rod (only) did not fell out of syringe barrel during use or loose and the circular part of plunger broke during use. the broken area was of one piece broken off.  The nurse mentioned that the one syringe broke after removal from tray and rather easily per costumer.  It was reported that when nurse went to give vaccine bottom of where plunger is (circular area) broke off. This occurred with 2 syringes, with one resulting in nurses thumb getting cut. The broken area was of one piece broken off.  The outcome of skin laceration was reported as recovered, on an unspecified date in 2021. The causal relationship between the skin laceration  and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-FEB-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T027115, expiration date: 07-FEB-2022 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the dose of the product administered to the patient was stored improperly for the time frame of 22 hours in the temperature between -10 degrees Celsius (C) and 8 degrees C (-3.7 C). There was no previous temperature excursion. Digital Data Logger was involved.  There was no additional adverse effect reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The twin boys are now 18 years old and did not complete the series.; No additional AE reported; This spontaneous report was received from a registered nurse, referring to a 18-year-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   In September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis (formulation, strength, route of vaccination, anatomical site of vaccination, lot number and expiration date were not reported).   At the reporting time, the patient was 18-year-old, and he did not received yet the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse event were reported.   This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported.; Nurse calling to report an adverse event on improperly stored administered PROQUAD; This spontaneous report was received from a registered nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.   On 24-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T023919, which has been verified to be valid, expiration date reported and validated as 09-JAN-2022). The vaccine administered, experienced a temperature excursion of -5.2 degrees Celsius (C), for a time frame of 15 minutes as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Fatigue
Clinical narrative: Fatigue; a patient was given GARDASIL 9 vaccine, two injections of GARDASIL 9 were administered on the same day by accident; This spontaneous report was received from a physician, referring to a 18 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 26-FEB-2021, the patient was vaccinated with two injections of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly, for prevention for human papillomavirus (strength, frequency, lot# and expiration date were not reported) by mistake. On the same date, the patient experienced fatigue symptoms. The patient did not receive any treatment. It was unknown if diagnostic laboratories were performed.  At the time of reporting, the outcome of fatigue was reported as unknown. The causality assessment between fatigue with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse events reported; Pneumovax23 was given to a 4 month old in error; Caller reports that PREVNAR 13 was intended to be given; This spontaneous report has been received from other health professional referring to a 4 month old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 03-MAR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T032761, 0.5 milliliter for prophylaxis. pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) was intended to be given (product administered to patient of inappropriate age and wrong product administered). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T032761; expirationdate: 30-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient recived a premature second dose of Peneumovax; This spontaneous report has been received from a pharmacist referring to a 55 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. 3 years and 8 months later, the patient received an additional dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (inappropriate schedule of product administration). The causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm Pain; Headache; Fever; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, headache and fever. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, headache and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported, but it could be 50 or 51 years. After receiving Shingrix, that night or the next night, the patient experienced fever, headache, and arm pain for four to five hours. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2021007474. This case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007475:Husband's 1st dose US-GLAXOSMITHKLINE-US2021AMR008140:Husband's 2nd dose US-GLAXOSMITHKLINE-US2021007474:same patient, 2nd dose
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site itching; injection site red; vaccination site awrmth; kidney infection; Low grade temperature; Arm sore; A spontaneous report was received from Physician regarding a 39 year old female who received first dose of Moderna Covid-19 vaccine and have experienced delayed skin reaction, sore arm, fever and kidney infection.  The patient's medical history included botulinum toxin injection. Her concomitant medications were not provided. No information on allergies.   On 29-DEC-2020, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly on Left arm for the prophylaxis of Covid-19 infection (Lot number 011L20A). On 07-JAN-2021, 9 days after vaccination, patient had visited health care professional and says that her arm was sore for about 5 to 6 days after vaccination and then she felt fine. Today, she woke up with injection site itching, red (half dollar size), and hot. She has been on antibiotics for her kidney infection for the past three days. She also had low grade temperature for last three days. She was diagnosed with delayed skin reaction and report was sent to regulatory authority. She was given instructions to check temperature, axillary lymph node swelling and apply cool pack to the area and take Ibuprofen/Tylenol as directed and as needed. Patient states that she heard about these reactions in people who use Botox in the past and she had used it in the past.  Action taken with the 2nd dose of vaccine in unknown.  The outcome of the event sore arm was resolved on 03 Jan 2021. Other events delayed skin reaction, kidney infection and fever are not recovered at the time of report.; Reporter'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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site itching; injection site red; vaccination site awrmth; kidney infection; Low grade temperature; Arm sore; A spontaneous report was received from Physician regarding a 39 year old female who received first dose of Moderna Covid-19 vaccine and have experienced delayed skin reaction, sore arm, fever and kidney infection.  The patient's medical history included botulinum toxin injection. Her concomitant medications were not provided. No information on allergies.   On 29-DEC-2020, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine intramuscularly on Left arm for the prophylaxis of Covid-19 infection (Lot number 011L20A). On 07-JAN-2021, 9 days after vaccination, patient had visited health care professional and says that her arm was sore for about 5 to 6 days after vaccination and then she felt fine. Today, she woke up with injection site itching, red (half dollar size), and hot. She has been on antibiotics for her kidney infection for the past three days. She also had low grade temperature for last three days. She was diagnosed with delayed skin reaction and report was sent to regulatory authority. She was given instructions to check temperature, axillary lymph node swelling and apply cool pack to the area and take Ibuprofen/Tylenol as directed and as needed. Patient states that she heard about these reactions in people who use Botox in the past and she had used it in the past.  Action taken with the 2nd dose of vaccine in unknown.  The outcome of the event sore arm was resolved on 03 Jan 2021. Other events delayed skin reaction, kidney infection and fever are not recovered at the time of report.; Reporter'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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure acute, Dyspnoea exertional
Clinical narrative: Dyspnea on exertion; Acute on chronic systolic (congestive) heart failure; A spontaneous report was received from a other healthcare professional  concerning a 79-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dyspnea exertional and acute on chronic systolic (congestive) heart failure.  The patient's medical history, as provided by the reporter, included pulmonary fibrosis, elevated troponin, paroxysmal trial fibrillation paroxysmal (PAF), major depressive disorder, and cardiac pacemaker insertion.   Concomitant medications was not provided.  On 21 Jan 2021 at 11:30 am, approximately twenty two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021 the patient was hospitalized. Onset of the dyspnea was noted on the same date and acute cardiac failure started on 13 Feb  2021. He was  discharged on 14 Feb 2021.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, dyspnea on exertion and acute on chronic systolic (congestive) heart failure considered was recovered/resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information is requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Flare up; A spontaneous report  was received from a consumer concerning her daughter, a 41-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history included rheumatoid arthritis and migraine. Products known to have been used by the patient, within two weeks prior to the event, included steroid injections, antibiotics and medications for rheumatoid arthritis and migraine (not specified).  On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the pregnant patient had a flare up of her condition which is a medically significant event.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was not reported.; Reporter'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: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site discharge
Clinical narrative: liquid from the injection site was dripping through the arm; liquid from the injection site was dripping through the arm; A spontaneous report was received from a pharmacist concerning, a female patient (HCP) of unspecified age who received Moderna (mRNA-1273) vaccine and experienced an adverse event of liquid from the injection site was dripping through the arm (Vaccination site discharge and Underdose).   The patient's medical history was not reported.   Concomitant product use was not provided by the reporter.    On 19 Feb 2021 morning, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.   On 19 Feb 2021 morning, after receiving the vaccine, the patient raised the arm and saw that liquid from the injection site was dripping through the arm. The reporter wanted to know how to proceed and if the dose could be repeated. Reporter did not have much information about patient.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event of liquid from the injection site was dripping through the arm was considered as Resolved on 19 Feb 2021.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot # unknown), reporting Vaccination site discharge and Underdose without any associated adverse events. Event considered as resolved.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-Year-Old Vaccinated; A spontaneous report (United States) was received from health care professional(nurse) concerning 16 years-old, male patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake;    The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date in Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 [Batch Number: Unknown] intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, a 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, 16 year old male patient was administered the first dose of Moderna COVID-19 vaccine about 30 days ago by mistake was considered recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Sensation of a throat closure; Swelling of the lips; Swelling of the tongue; A spontaneous report  was received from a consumer concerning a 74-year-old male patient, who experienced a sensation of throat closure, lip swelling and swelling of the tongue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number:016m20a) in the left arm for prophylaxis of Covid-19 infection.  The patient reported that while he was driving home less than an hour after receiving the vaccine, he started to have a sensation of a throat closure, swelling of the lips and swelling of the tongue. As he was noticing increasing reaction while time was passing by, he went to the hospital. In the ER, they gave him Decadron, Diphenhydramine (injections) and Pepcid. The following day, he visited his primary physician by advice of health care workers at the ER. Right now, he has no symptoms. No further information was provided.   Treatment for the events included Decadron, Diphenhydramine(injections), and Pepcid.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events of sensation of a throat closure, lip swelling and swelling of the tongue were considered to be recovered on 16 Feb 2021.; Reporter's Comments: This case concerns a 74-year-old male who experienced Serious unexpected events of pharyngeal swelling, lip swelling, swollen tongue. The events occurred within 1 hour after the first dose of mRNA-1273. Treatment included Decadron, diphenhydramine, and Pepcid. Events resolved. 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.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Lost some of vaccination out of syringe; Lost some of vaccination out of syringe; A spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender who received Moderna's COVID-19 Vaccine and lost some vaccination out of syringe.  The patient's medical history was not provided. No concomitant medications were provided.  On 19 Feb 2021, prior to onset of the event lost some vaccination out of syringe, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient lost some vaccination out of syringe as connection between the syringe and needle was loose.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event lost some vaccination out of syringe was considered recovered.; Reporter's Comments: This reports refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273 (lot number unknown) with no associated AEs. Causality for this medication error is not applic
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received both doses of the Moderna vaccine today 20FEB2021 within 10 minutes; A spontaneous reportwas received from a healthcare professional, concerning a 73-year-old, male patient, who received both doses of Moderna's COVID-19 Vaccine (mRNA-1273) on 20 Feb 2021 within 10 minutes/ Inappropriate schedule of product administration.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) on 20 Feb 2021. On 20 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient received both doses of the Moderna vaccine within 10 minutes gap. The patient was anxious from the event but does not had side effects. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event was resolved/recovered on 20 Feb 2021.; Reporter's Comments: This case concerns a 73-year-old male patient who received their first and second of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate schedule of product administration without any associated adverse events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some of the vaccine leaked into syringe cap; Patient did not receive total dose; A spontaneous report was received from a nurse  concerning a 62 years old, female patient who was administrated Moderna's COVID-19 vaccine at under dose and had a device connection issue during vaccination.   The patient's medical history was not provided. No relevant concomitant medications were not reported.  On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  While administrating the vaccine, on 19 Feb 2021, some of the vaccine leaked into syringe cap and patient did not receive total dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, some of the vaccine leaked into syringe cap and patient did not receive total dose was resolved.; Reporter's Comments: This report refers to a case of device connection issue and underdose,  for Moderna's COVID-19  mRNA-1273, vaccine (lot # unknown) with no associated AEs.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old vaccinated; A spontaneous reportwas received from a Pharmacist regarding 16-year-old individual, unknown race, and ethnicity, who was administered first dose of Moderna Covid-19 vaccine on 19-FEB-2021 (Inappropriate age at vaccine administration).  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 19-FEB-2021, individual received first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot : 029L20A).   It was not known whether the individual experienced any adverse event after vaccination.   Action taken with 2nd dose of vaccine was not reported.  The outcome of the event inappropriate age at vaccination was recovered.; Reporter's Comments: This report refers to a case of 'Inappropriate age at vaccine administration'  for mRNA-1273, Lot : 029L20A with no associated AEs. Causality for the medication error is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous administraion; A spontaneous report was received from a health care professional concerning a patient of unknown gender and unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneously/Incorrect route of product administration.  The patients medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of events, the patient received their second of two planned dose of mRNA-1273 (lot number: unknown) vaccine subcutaneously for prophylaxis of COVID-19 infection.  On an unknown date, the patient was administered mRNA-1273 vaccine subcutaneously in the triceps area, rather than the recommended intramuscular deltoid location.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event inappropriate route of vaccination was recovered.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration without any associated adverse events.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Rash, Renal failure
Clinical narrative: Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report  was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure.  The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported.   On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection.   On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had  received his first dose.   On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood pressure measurement, Hypertension
Clinical narrative: drooping of the left side of her face/Bell's Palsy; very high BP; A spontaneous report was received from a consumer concerning an approximately 44-years-old female patient who received Moderna's  Covid 19 vaccine (mRNA1273) and who developed Bell's Palsy (facial paralysis) and high blood pressure (BP) (hypertension).  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The patient received first of two planned dose of mRNA-1273 intramuscularly on 19-JAN-2021 for prophylaxis of Covid 19 infection.  On 22-FEB-2021 patients had a high BP of 130/80 mmHg. Patient noticed drooping of the left side of face. The patient went to the emergency room, was found to have very high BP, and was diagnosed with Bell's Palsy and was getting a CT scan. Treatment for the event included Prednisone.  Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the event were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Gastrointestinal haemorrhage
Clinical narrative: GI Bleed; Blood count dropped; A spontaneous report was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a GI Bleed and her blood count dropped.   The patient's medical history included high blood pressure, obesity and type 2 diabetes.  Products known to have been used by the patient, within two weeks prior to the event, were Metformin and Lisinopril.   The patient received their first of two planned doses of mRNA-1273 (LOT 041L20A) on 02-Feb-2021, approximately six days prior to the onset of event, intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 08-Feb-2021, patient reported having gone to the ER and was subsequently admitted to the hospital with a GI bleed.  She reported that she received 10 units of blood during her hospitalization. She received 10 units of blood over the days she was in hospital, from 02-08-2021, up until 02-16-2021. Patient asks is it safe for her to get the second vaccine? She never had a GI bleed like that before. Her blood count dropped. She was discharged on 16-Feb-2021. Patient expressed concerns about receiving the second dose of mRNA-1273.   No relevant laboratory details were included.  Action taken with the drug in response to the event, GI bleed, was not reported.  The outcome of the event, GI bleed, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events of GI bleed and blood count dropped, a causal relationship cannot be excluded. Patient's significant medical history included high blood pressure.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: A-fib; Rapid heart beat; A spontaneous report was received from a consumer concerning a 79 year old, female patient who experienced rapid heartbeat and atrial fibrillation (A-fib).  The patient's medical history included hypertension and renal disease. Concomitant product used were losartan potassium ,levothyroxine,  fluorseminde ,levotiroxine, multivitamin, zinc , vitamin for knee joint movement,  vit D3 , alpha lipoic acid, rosuvastatin calcium ,  elequis,  milatonin , probtotic 10.   On 27 JAN 2021, approximately 30 minutes prior to the onset of the symptoms, the patient received her first of two planned doses of mrna-1273, batch number was not provided, intramuscularly in an unknown injection site  for the prophylaxis of COVID-19 infection.  On 27th  JAN 2021,  after receiving the vaccine she experienced rapid heartbeat and she reached out to the pharmacy where she took the vaccine. From there the pharmacist called 911.   On 27th JAN 2021 she was hospitalized, and the hospitalization prolonged for four days and discharged on 31 JAN 2021.  Treatment for the event included Eliquis 5 milligrams (mg) and Metoprolol Succinate ER 25mg.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events rapid heart beat and A-fib were unknown.; Reporter's Comments: This case concerns a 79-year-old female, with medical history of hypertension, who was hospitalized with serious unexpected events of atrial fibrillation and heart rate increased. The events occurred the same day as the first dose of mRNA-1273 and were treated with Eliquis and Metoprolol. Event outcomes unknown. 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.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: approximately 0.1 mL leaked; A spontaneous report was received from a Pharmacist regarding an unidentifiable individual who was administered Moderna covid-19 vaccine and when giving the vaccine to a patient, approximately 0.1 mL  leaked, so the patient received 0.4 mL (Vaccine underdose).  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On an unspecified date, prior to the onset of events, individual received (first or second dose is not specified) Moderna Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot: Unknown). During the administration 0.1ml leaked and only 0.4 ml was given to the patient (Vaccine underdose).  She wants to know if they could administer to the patient the 0.1 mL.  Action taken with 2nd dose of vaccine was not reported.  The outcome was resolved for event.; Reporter's Comments: This report refers to a case of a patient who was administered Moderna covid-19 vaccine and when giving the vaccine to a patient, approximately 0.1 mL leaked, (Vaccine under dose). (Lot # not provided). No associated AEs were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old was administered the vaccine; A spontaneous report was received from a Consumer (patient's mother), concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events inappropriate age at vaccine administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unknown date, the Moderna's COVID-19 vaccine was administered to a 17-year-old female patient, resulting in inappropriate age at vaccine administration.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event- inappropriate age at vaccine administration was considered resolved.; Reporter's Comments: This report refers to a case of a 17-year-old female who experienced Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated adverse events.  Event considered resolved.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Arrhythmia
Clinical narrative: Had Arrhythmias and skipping beats after vaccination; May have been giving 1.5 dose instead of 1 dose; A spontaneous report was received from a consumer concerning a 72 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (arrhythmia, heart rate irregular, Accidental overdose).  The patient's medical history was not provided. Relevant concomitant medication included beta blocker.  On 15Feb2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm  for prophylaxis of COVID-19 infection.  On 15Feb2021 the patient experienced the events  (arrhythmia) with seriousness criteria (medically significant).  Laboratory details not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event unknown.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # 024M20A) with associated AE reported of arrhythmia. 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. Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, C-reactive protein, Ear pain, Fatigue, Headache
Clinical narrative: Trigeminal neuralgia; Bell's Palsy; pain in the ear; Fatigue; Headache; A spontaneous report was received from a consumer concerning 74-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced trigeminal neuralgia, Bell's palsy, fatigue, headache, and pain in the ear.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, 2 days prior to the onsent of the events of fatigue and headache, the patient received their first of two planned doses of mRNA-1273(lot/batch number: 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced fatigue and headache.  On 14 Feb 2021, she had swelling in her left jaw. She described it as if there was "an abscess tooth and my side of the face swelled up as if I had the mumps." She had facial pain and her lips were tingling and numb. Her dentist determined that she had no infection, no tooth abscess, or jaw issue to cause this extreme swelling. On an unknown date in Feb 2021, Her physician ran some tests and diagnosed her with bells palsy and trigeminal neuralgia based on examination.  On an unknown date in Feb 2021, CRP (C-reactive protein) was 135.2 (0-5).  From 19 Feb 2021 to 21 Feb 2021, the patient was treated with prednisone 20 mg. The patient's swelling went down and was able to open her mouth again.  On 22 Feb 2021, her pain was back and she experienced severe pain in the ear to the point where it woke her up at 3:30 am and she couldn't wear her glasses either. She was taking pain medication hydrocodone 10.325 mg to help with the pain. As of 22Feb2021, her pain and swelling was back.  Treatment for the pain included hydrocodone 10.325 mg.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events trigeminal neuralgia, Bell's palsy, fatigue, headache, and pain in the ear were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia; Bell's Palsy; pain in the ear; Fatigue; Headache; A spontaneous report was received from a consumer concerning 74-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced trigeminal neuralgia, Bell's palsy, fatigue, headache, and pain in the ear.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, 2 days prior to the onsent of the events of fatigue and headache, the patient received their first of two planned doses of mRNA-1273(lot/batch number: 007M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced fatigue and headache.  On 14 Feb 2021, she had swelling in her left jaw. She described it as if there was "an abscess tooth and my side of the face swelled up as if I had the mumps." She had facial pain and her lips were tingling and numb. Her dentist determined that she had no infection, no tooth abscess, or jaw issue to cause this extreme swelling. On an unknown date in Feb 2021, Her physician ran some tests and diagnosed her with bells palsy and trigeminal neuralgia based on examination.  On an unknown date in Feb 2021, CRP (C-reactive protein) was 135.2 (0-5).  From 19 Feb 2021 to 21 Feb 2021, the patient was treated with prednisone 20 mg. The patient's swelling went down and was able to open her mouth again.  On 22 Feb 2021, her pain was back and she experienced severe pain in the ear to the point where it woke her up at 3:30 am and she couldn't wear her glasses either. She was taking pain medication hydrocodone 10.325 mg to help with the pain. As of 22Feb2021, her pain and swelling was back.  Treatment for the pain included hydrocodone 10.325 mg.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events trigeminal neuralgia, Bell's palsy, fatigue, headache, and pain in the ear were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: Pulmonary insufficiency; A spontaneous report  received from a Consumer concerning, an unknown age male patient who received a second dose of the Moderna COVID-19 vaccine and experienced pulmonary insufficiency.   The patient's medical history was not included. Patient's concomitant was not included.   On unknown date, the patient received their Second dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Reporter stated her daughter's friend apparently developed a severe reaction a day or two after receiving the second dose of the vaccine resulting in pulmonary insufficiency. He had just traveled  on vacation. He is now in an ICU at a U.  Medical Center  and may be moved into a respirator soon because of clinical deterioration. Reporter stated two days of steroids apparently have not helped. Other treatment information was not provided/unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/ not reported.; Reporter'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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given 19 days after 1st dose; A spontaneous report  was received from a pharmacist concerning a patient (age and gender unspecified) who received second dose of Moderna's COVID-19 vaccine (mRNA-1273), 19 days after 1st dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration and unknown arm, for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the second dose was given 19 days after 1st dose (inappropriate schedule of vaccine administered).  No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the event second dose given 19 days after 1st dose was considered resolved.; Reporter's Comments: This report refers to a case of a consumer who received second dose for mRNA-1273 (lot # not provided) 19 days after the first dose, with no associated AEs.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age had vaccine administered; A spontaneous report  was received from other healthcare professional (Nurse) concerning a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 043L20A), unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the Moderna vaccine was administered to patient under 18 years of age.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Moderna vaccine was administered to patient under 18 years of age was considered recovered.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 043L20A  with no associated AEs.