chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to someone less than 18 years old; A spontaneous report was received from a physician concerning an adolescent patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to someone less than 18 years old.  There were no medical history and concomitant medications provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The physician reports the vaccine was given to someone less than 18 inadvertently. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to someone less than 18 years old, was considered resolved on an unknown date.; Reporter's Comments: This concerns an adolescent patient of unspecified age and gender, less than 18 years old who received their first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 5 ml of vaccine; A spontaneous report was received from a healthcare professional concerning a 35-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient received 5 milliliters (mL) of vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Jan 2021, approximately 0 days prior to the onset of the event, the patient received doses of mRNA-1273 (Lot number 013L20A) intramuscularly in the right and left arms for prophylaxis of COVID-19 infection.  On 18 Jan 2021, the patient received 5 mL of the vaccine. She was given 2.5 mL in the left arm and 2.5 mL in the right arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received 5 ml of vaccine, was considered resolved on 18 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 013L20A), where 5 ml of vaccine was administered. There were no reported AEs associated with this case of Incorrect dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the vaccine even tho she is 16; A spontaneous report was received from a physician concerning a 16-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) even tho she is 16 product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were provided.  On an unspecified date, prior to the onset of the event, the patient received a dose of mRNA-1273 (Lot number: not provided) for COVID-19 infection prophylaxis.    The physician stated that a pediatric patient had received the Moderna vaccine even though she was 16. No additional information was available at the time of this report. No treatment information was provided for the event.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event received Moderna's COVID-19 vaccine (mRNA-1273) even tho she is 16 (product administered to patient of inappropriate age) was considered resolved on an unspecified date.; 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash on left arm where shot was given on day10.  Left arm for a day after shot.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site erythema, Injection site mass, Product administered at inappropriate site
Clinical narrative: Felt the vaccine run down her arm; Was more SQ instead of IM; Hard lump around injection site; Red hard lump around the injection site; A spontaneous report was received from a nurse concerning a 42-year-old female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and felt the vaccine run down her arm, was more subcutaneous (SQ) instead of intramuscular (IM), red hard lump around the injection site.  The patient's medical history and concomitant medications were not provided.  On 07-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 011J20A) via left deltoid subcutaneously for prophylaxis of COVID-19 infection.   The registered nurse (RN) who vaccinated patient reported that some of the dose of vaccine had dribbled out and patient felt the dripped vaccine ran down her arm. When HCP looked at the injection site of patient, RN stated that she went to high and the administration was of more subcutaneous than intramuscular. Patient also had red hard lump at the left deltoid around the injection site. No treatment information was provided for the event.   Action taken with mRNA-1273 in response to the events was not provided.   The events felt the vaccine run down her arm and was more SQ instead of IM were considered to be resolved on 07-Jan-2021. The outcome of event red hard lump around the injection site was unknown.; Reporter's Comments: This report refers to a case of a 42 year-old female patient who experienced non-serious event of felt the vaccine run down her arm, was more subcutaneous (SQ) instead of intramuscular (IM), (Incomplete dose administered; Vaccine given subcutaneously, Vaccine administered at inappropriate site)   and event of red hard lump around the injection site. (lot # 011J20A), Exp date-unknown). The event of red hard lump around the injection site is temporarily associated with the administration of mRNA-1273 vaccine, hence a causal association cannot be excluded. The events of felt the vaccine run down her arm, was more subcutaneous instead of intramuscular are considered not applicable
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine administer in her hip; This spontaneous report was received from a consumer concerning a 67-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccine was administered in her hip.   The patient's medical history was not provided. Concomitant medications were not reported.  On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the hip (Lot number: 025J20-2A) for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient received the vaccine in hip instead of her deltoid.  Action taken with mRNA-1273 in response to the events was not reported.   The event vaccine administer in her hip was resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine was not completely thawed before administration; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and vaccine was not completely thawed.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date not provided) intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that the patient received a dose of the Moderna COVID-19 vaccine 30 minutes after being taken out of the freezer instead of the full hour. The vaccinator was able to draw up a full dose (liquid) and administer the vaccine, however the vaccine was not completely thawed.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, vaccine was not completely thawed, was considered resolved.; Reporter's Comments: This report refers to product preparation error, where the patient was administered mRNA-1273 that was not completely thawed. There were no reported AEs associated with this case of product preparation error.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Rash erythematous
Clinical narrative: Itchy then small bumps then bumps went away and red rash developed on arm
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Pharmacist gave a dose of the Moderna vaccine that had been opened for more than 6 hours; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and gave a dose of the Moderna vaccine that had been opened for more than 6 hours.   The patient's medical history was not provided. No concomitant medications were provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient received the vaccine that was opened for more than 6 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, out of specification product use, was considered recovered/resolved on an unknown date.; Reporter's Comments: This report refers to a case of Out of specification product use (gave a dose of the Moderna vaccine that had been opened for more than 6 hours) for mRNA-1273. There were no reported AEs associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: The syringe loosened; Some of the vacine filtered through; Most of the vaccine was given to the patient; A spontaneous report  was received from a pharmacist concerning a male patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Jan-2021, during vaccine administration, the syringe had loosened and some of the vaccine was filtered through. The patient stated that he felt a liquid on his arm, but however the vaccinator believed that the events occurred after he pushed the plunger and most of the vaccine was already given to the patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient were considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a male patient of unspecified age who received their first dose of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient.  There were no reported adverse events associated with the event of while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Rash/hives to chest, arms and face and headache. Swelling of lips as well as itching. Started 2 hours after vaccine. Rash resolved in 24 hours, itching lasted 3 days, headache ongoing.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Felt some of the vaccine dribble down my arm; A spontaneous report was received from a 65-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt some of the vaccine dribble down her arm.   There were no medical history and concomitant medications reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient reported that she felt some of the vaccine dribble down her arm. She was not sure if she received the full dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, "felt some of the vaccine dribble down her arm" was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 65-year-old female patient who received her first of two planned doses of mRNA-1273 (Lot number 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and after receiving the vaccine, she felt some of the vaccine dribble down her arm. There were no reported adverse events associated with the event after receiving the vaccine, she felt some of the vaccine dribble down her arm.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine I received had been sitting for a period of time in the sunlight; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and was concerned because the vaccine received had been sitting for a period of time in the sunlight.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient received her first dose of vaccine at a drive through facility. The vaccine was in individual vials sitting in a box without a lid. Provider started scheduling people at 8am, but however the patient received shot around noon between 11am and 12pm, when the temperature was in the 40s. The patient was concerned that the vaccine they received had been sitting for a period of time in the sunlight. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine received had been sitting for a period of time in the sunlight, was resolved on an unspecified date.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event of vaccine received had been sitting for a period in the sunlight (Product storage error) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with the event of vaccine received had been sitting for a period in the sunlight.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Needle popped out and vaccine leaked, most of the vaccine was not administered; A spontaneous report was received from a nurse concerning a 68 year old female patient who was participating in the mRNA-1273 vaccine program and the needle popped out and vaccine leaked, most of the vaccine was not administered [Incorrect dose administered].  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20 Jan 2021 the patient received their second of two planned doses of mRNA-1273 (lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection.    At the time of vaccination the needle popped out and vaccine leaked. Nurse states that most of the vaccine was not administered.  No treatment was provided for the event.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, needle popped out and vaccine leaked, most of the vaccine was not administered, was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered (Nurse states that most of the vaccine was not administered) for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Day of (1/19/21) patient experienced pain, aches (at injection site and in same arm and should as injection site), chills, headache, tiredness. Recovered in 24 hours from initial side effects. Pain at injection site subsided in 3 days. Approximately 6 days after injection (1/25), injection site started swelling and entire upper shoulder had a deep red patch on skin surface. Site became very itchy, hot to the touch, with raised skin and a hardened/firm feeling. Itching, swelling, and pain began to subside approximately 48 hours later (1/27). As of 1/28 the site and upper arm are still mildly itchy, although redness and swelling have entirely subsided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Day of (1/19/21) patient experienced pain, aches (at injection site and in same arm and should as injection site), chills, headache, tiredness. Recovered in 24 hours from initial side effects. Pain at injection site subsided in 3 days. Approximately 6 days after injection (1/25), injection site started swelling and entire upper shoulder had a deep red patch on skin surface. Site became very itchy, hot to the touch, with raised skin and a hardened/firm feeling. Itching, swelling, and pain began to subside approximately 48 hours later (1/27). As of 1/28 the site and upper arm are still mildly itchy, although redness and swelling have entirely subsided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Day of (1/19/21) patient experienced pain, aches (at injection site and in same arm and should as injection site), chills, headache, tiredness. Recovered in 24 hours from initial side effects. Pain at injection site subsided in 3 days. Approximately 6 days after injection (1/25), injection site started swelling and entire upper shoulder had a deep red patch on skin surface. Site became very itchy, hot to the touch, with raised skin and a hardened/firm feeling. Itching, swelling, and pain began to subside approximately 48 hours later (1/27). As of 1/28 the site and upper arm are still mildly itchy, although redness and swelling have entirely subsided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the second dose of vaccine 6 days early based on 28 days intervals; A spontaneous report was received from a nurse concerning a 53-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was involved in inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Dec-2020, the patient received his first dose of two planned doses of mRNA-1273 and on 20-Jan-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 041L20A) in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.   On 20-Jan-2021, the patient received his second dose of Moderna COVID-19 vaccine 6 days early based on the 28-day internals. Reporter provided consent to follow up. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The event inappropriate schedule of product administration was reported as resolved on 20 Jan 2021.; Reporter's Comments: This report refers to a case of a 53-year-old patient who experienced non-serious event of received the second dose of vaccine 6 days early based on 28 days intervals (inappropriate schedule of vaccine administered) for mRNA-1273 (lot # 041L20A, Exp date-unknown). There were no reported AEs associated with the event of received the second dose of vaccine 6 days early based on 28 days intervals.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Some of the vaccine came out and spilled on patient arm (maybe a fourth of the vaccine) and ran down from arm to his fingers; Some of the vaccine came out and spilled on patient arm (maybe a fourth of the vaccine) and ran down from arm to his fingers; A spontaneous report was received from a consumer, concerning himself, a 59-year-old male patient, who received Moderna's COVID-19 Vaccine and some of the vaccine came out and spilled on patient arm (maybe a fourth of the vaccine) and ran down from arm to his fingers.  There were no medical history and concomitant medications provided by the reporter.  On 19 Jan 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient reported that, the nurse who administered him the vaccine did not check if the needle of the syringe was attached correctly, the needle part was not secured to the syringe really well (needle wasn't screwed right). Hence during the vaccine shot, when the nurse put the pressure to push the vaccine in patient' arm, some of the vaccine came out and spilled on patient arm (maybe a fourth of the vaccine) and ran down from arm to his fingers. As patient was concerned, he queried nurse if he had got vaccine, nurse confirmed him that he received enough of it. Patient also stated that as he lost a ml or 2 doses of vaccine (didn't get a full dose on the first vaccine), he still doesn't have the full inoculation as his second dose was on post 30 days. No additional information was available at the time of this report. No treatment information was provided for the event.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, some of the vaccine came out and spilled on patient arm (maybe a fourth of the vaccine) and ran down from arm to his fingers was considered to be resolved on 19-Jan-2021.; Reporter's Comments: This report refers to a case of a 59-year-old male patient who experienced non-serious event of some of the vaccine came out and spilled on patient arm (maybe a fourth of the vaccine) and ran down from arm to his fingers (Incomplete dose administered) for mRNA-1273 (lot # 013L20A, Exp date-unknown). There were no reported AEs associated with the event of some of the vaccine came out and spilled on patient arm  and ran down from arm to his fingers.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pain, Sinus headache
Clinical narrative: Severe body aches, sinus headache and fever 101
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some vaccine squirted out the hole; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and some squirted out of the hole [Incomplete dose administered].  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after receiving the vaccine some squirted out of the hole. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, some squirted out of her arm was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of a female patient who experienced non-serious event of some squirted out of the hole (Incomplete dose administered)  for mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of some squirted out of out the hole
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Not sure if she got enough of her first dose; A spontaneous report was received from a 48-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was not sure if she got enough of her first dose.   There were no medical history and concomitant medications provided.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, during her vaccination, the needle went in and she felt poke of the needle. When the technician pulled the syringe out, some of the liquid squirted inside her windshield. The patient described it as "It was not a drop or two. It was more of a squirt that splattered and dripped down. It was more than a sprinkle of raindrop." She was not sure if she got enough of her first dose. She was told by the vaccination provider that "It was some of the extra dose in the vaccine known as the zero dose that had splattered on the windshield. You don't get the full dose as there is always something left in the syringe and the zero dose was what had splattered. The zero dose being the little bit of extra liquid that is left in the syringe after the vaccine." No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, was not sure if she got enough of her first dose was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 48-year-old, female patient who received her first of two planned doses of mRNA-1273 (Lot number: 043L20A) intramuscularly for prophylaxis of COVID-19 infection and was not sure if she got enough of her first dose. There were no reported AEs associated with this case of not sure if she got enough of her first dose.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient did not get a full dose (0.25ml); A spontaneous report  was received from a healthcare professional concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and the patient did not get a full dose.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   On an unknown date, the patient did not get a full dose (0.25mL) during their immunization.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, did not get a full dose 0.25mL, was considered resolved.; Reporter's Comments: This spontaneous report refers to a case of a patient who experienced non-serious event of patient did not get a full dose (0.25ml) (Incomplete dose administered) for mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of a patient did not get a full dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Diarrhoea, Fatigue, Headache
Clinical narrative: Within 2 hours of receiving second dose of vaccine, severe injection site pain with inability to move arm without pain.  Approx 12 hours later, nausea, extreme tiredness and diarrhea.  Approx 20 hours later, severe headache, continued injection site pain, nausea and diarrhea.  First dose caused injection site pain and mild nausea symptoms along with slight chest tightness/pain that lasted for 4-6 days after administration of vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Movement disorder, Nausea
Clinical narrative: Within 2 hours of receiving second dose of vaccine, severe injection site pain with inability to move arm without pain.  Approx 12 hours later, nausea, extreme tiredness and diarrhea.  Approx 20 hours later, severe headache, continued injection site pain, nausea and diarrhea.  First dose caused injection site pain and mild nausea symptoms along with slight chest tightness/pain that lasted for 4-6 days after administration of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administration error
Clinical narrative: Injected 0.5mL of air instead of vaccine; Sore arm and pain; A spontaneous report was received from a nurse concerning an 81-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulted in the following events injected 0.5mL of air instead of vaccine, sore arm and pain.  No relevant medical history and concomitant medications were reported.  On 21-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of MRNA-1273 (lot number 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21-Jan-2021, the patient was injected with 0.5mL of air instead of vaccine and was evaluated, where she complained about sore arm and pain. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, injected 0.5mL of air instead of vaccine was considered to be resolved on 21-Jan-2021. The outcome of the event, sore arm and pain was unknown.; Reporter's Comments: This case concerns a 81-year-old, female patient. This report refers to a case of Product administration error for mRNA-1273 (lot number 029L20A), when 0.5 ml of air was injected instead of vaccine. The adverse event of pain in arm is associated with this case of product administration error.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Illness, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: pain in the arm of the injection; hot flashes; feeling very sick; it hurts; chills; eleven days apart between the two doses of the vaccine; A spontaneous report was received from a consumer concerning a 64-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced pain in the arm of the injection (Pain in extremity), chills, hot flashes (hot flush), it hurts (Injection site pain), feeling very sick (illness) and eleven days apart between the two doses of the vaccine (Inappropriate schedule of product administration).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included supplements.  On 08-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19-Jan-2021 the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  A consumer who is the patient called to report she received her second dose of the Moderna COVID-19 vaccine eleven days apart. From 19-Jan-2021, the patient started feeling pain in the arm of her injection, chills, hot flashes and felt very sick. No treatment had been taken for the events.  Action taken with mRNA-1273 in response to the events was not provided.   The event eleven days apart between the two doses of the vaccine was considered resolved on 19-Jan-2021. The remining events, pain in the arm of the injection, Injection site pain, chills, hot flashes and feeling very sick, were considered resolved on 20-Jan-2021.; Reporter's Comments: This case concerns a 64 years old female patient, who experienced inappropriate schedule of product administration, and a non-serious unexpected event of pain in extremity, hot flush, illness, and non-serious expected events of injection site pain, and chills. There were no reported AEs associated with this case of inappropriate schedule of product administration. The events (pain in extremity, hot flush, illness, injection site pain, and chills) occurred 1 days after second dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm of the injection; hot flashes; feeling very sick; it hurts; chills; eleven days apart between the two doses of the vaccine; A spontaneous report was received from a consumer concerning a 64-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced pain in the arm of the injection (Pain in extremity), chills, hot flashes (hot flush), it hurts (Injection site pain), feeling very sick (illness) and eleven days apart between the two doses of the vaccine (Inappropriate schedule of product administration).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included supplements.  On 08-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19-Jan-2021 the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  A consumer who is the patient called to report she received her second dose of the Moderna COVID-19 vaccine eleven days apart. From 19-Jan-2021, the patient started feeling pain in the arm of her injection, chills, hot flashes and felt very sick. No treatment had been taken for the events.  Action taken with mRNA-1273 in response to the events was not provided.   The event eleven days apart between the two doses of the vaccine was considered resolved on 19-Jan-2021. The remining events, pain in the arm of the injection, Injection site pain, chills, hot flashes and feeling very sick, were considered resolved on 20-Jan-2021.; Reporter's Comments: This case concerns a 64 years old female patient, who experienced inappropriate schedule of product administration, and a non-serious unexpected event of pain in extremity, hot flush, illness, and non-serious expected events of injection site pain, and chills. There were no reported AEs associated with this case of inappropriate schedule of product administration. The events (pain in extremity, hot flush, illness, injection site pain, and chills) occurred 1 days after second dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Contusion, Dysphagia
Clinical narrative: About 9PM after the receiving the vaccine I started had riggers which lasted for about an hour. I couldn't reach for my phone or call for help. I either passed out or fell asleep. Around 1AM I woke up and checked my temperature 102.7.  Some point after I took some Tylenol but don't remember when. I finally had to call for help from my family in the morning because I was not able to pee or drink. Tuesday was my fever was still 102.7 with taking Tylenol and Advil it would just go back up.  Tuesday I had Riggers again about 5:30 it only lasted 3-5 minutes. Wednesday my fever went down to 101.4-101.5. Have had difficulty swallowing when the fever is high, did not feel as if I had a allergic reaction or that my throat was sore it was just hard to swallow.  I have a weird bruise on my arm I have clue where I got it. I didn't urinate for 9 hours. Headache. Pulse OX was at 93-94 for Monday and Tuesday but then it came it up 95-98 yesterday.  As of today I still pretty weak no fever when I woke up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Loss of personal independence in daily activities, Oxygen saturation, Urinary incontinence
Clinical narrative: About 9PM after the receiving the vaccine I started had riggers which lasted for about an hour. I couldn't reach for my phone or call for help. I either passed out or fell asleep. Around 1AM I woke up and checked my temperature 102.7.  Some point after I took some Tylenol but don't remember when. I finally had to call for help from my family in the morning because I was not able to pee or drink. Tuesday was my fever was still 102.7 with taking Tylenol and Advil it would just go back up.  Tuesday I had Riggers again about 5:30 it only lasted 3-5 minutes. Wednesday my fever went down to 101.4-101.5. Have had difficulty swallowing when the fever is high, did not feel as if I had a allergic reaction or that my throat was sore it was just hard to swallow.  I have a weird bruise on my arm I have clue where I got it. I didn't urinate for 9 hours. Headache. Pulse OX was at 93-94 for Monday and Tuesday but then it came it up 95-98 yesterday.  As of today I still pretty weak no fever when I woke up.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Clear fluid leaked out after patient received the vaccine/t's possible that patient received the partial dose; A spontaneous report was received from a pharmacist concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and its clear fluid leaked out after patient received the vaccine/it's possible that patient received the partial dose.  No relevant medical history and concomitant medications were provided.   On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, pharmacist stated that, the vaccinator noted a clear fluid leaking out after patient receiving the vaccine and also stated that it was possible that the patient had received a partial dose. The patient didn't have any other symptoms. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, clear fluid leaked out after patient received the vaccine/it's possible that patient received the partial dose was considered to be resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: got the vaccine subQ instead of IM; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and got the vaccine subQ instead of IM (Incorrect route of product administration).  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) subcutaneously for prophylaxis of COVID-19 infection.   A healthcare provider called to report a patient stated they received the vaccine subcutaneously instead of intramuscularly. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, got the vaccine subQ instead of IM, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect route of product administration (patient received vaccine subcutaneously instead of intramuscularly) for mRNA-1273, lot # not provided.  There were no reported AEs associated with this case of Incorrect route of product administration. The reported event is unlisted and company causality was assessed s not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: incorrectly administered covid vaccine; A spontaneous report was received from a non-health care professional concerning a male patient, of unknown age, who was administered Moderna's COVID-19 and incorrectly administered covid vaccine (Product administration error).  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 number: unknown) for prophylaxis of COVID-19 infection.     The patient was administered mRNA-1273 vaccine incorrectly, on an unknown date. No treatment information was provided.  Action taken with the first dose of mRNA-1273 in response to the event was not reported.    The event, incorrectly administered vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273. There were no reported AEs associated with this case.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Fever of 103.3.  Head aches, body ache, fatigue.  Lasted 24 hours.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: if they received the 1st dose, can the second dose be given; A spontaneous report was received from a health care professional concerning a 17-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and if they received the 1st dose, can the second dose be given (Product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first dose of two planned doses of MRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. No treatment for the event was provided. Pharmacist asked if a 17 year old received the 1st dose, can the second dose be given.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, if they received the 1st dose, can the second dose be given (Product administered to patient of inappropriate age) was considered as resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: a single drop of the vaccine run down the patient arm; A spontaneous report was received from a health care professional concerning a patient of unknown age and unknown gender who received Moderna's COVID-19 vaccine and experienced a single drop of the vaccine run down the patient arm (Incorrect dose administered).    The patient's medical history was not provided. There were no concomitant medications provided.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced a single drop of the vaccine run down the patient arm. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event of a single drop of the vaccine run down the patient arm (Incorrect dose administered) was considered recovered.; Reporter's Comments: This spontaneous report refers to a case of a patient who experienced a non-serious event of a single drop of the vaccine run down the patient arm (Incorrect dose administered) for mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of a single drop of the vaccine run down the patient arm.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse accidentally gave a 16 year old patient a vaccination; A spontaneous report was received from a healthcare professional concerning a 16-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and a nurse accidentally gave a 16-year-old patient a vaccination.   The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date of vaccination not provided) for prophylaxis of COVID-19 infection.   A healthcare provider called to report a nurse accidentally administered the vaccine to a 16-year-old patient. The patient has done well post vaccine without any issues.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, a nurse accidentally gave a 16-year-old patient a vaccination, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Sxs started around 2 H post vaccination: fatigue followed by difficulty sleeping.  The next day, fatigue, slight cough,  stomach upset, and severe headache (before noon).  After noon, nausea, diarrhea, cough, SOB, and fever (max 103); in addition to all previous Sxs.  Sxs lasted through 48 H.   In total, 1.5 days was missed from work.  I have never felt this sick before.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Loss of personal independence in daily activities, Malaise
Clinical narrative: Sxs started around 2 H post vaccination: fatigue followed by difficulty sleeping.  The next day, fatigue, slight cough,  stomach upset, and severe headache (before noon).  After noon, nausea, diarrhea, cough, SOB, and fever (max 103); in addition to all previous Sxs.  Sxs lasted through 48 H.   In total, 1.5 days was missed from work.  I have never felt this sick before.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Sxs started around 2 H post vaccination: fatigue followed by difficulty sleeping.  The next day, fatigue, slight cough,  stomach upset, and severe headache (before noon).  After noon, nausea, diarrhea, cough, SOB, and fever (max 103); in addition to all previous Sxs.  Sxs lasted through 48 H.   In total, 1.5 days was missed from work.  I have never felt this sick before.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old daughter is a first responder on an ambulance and was administered the wrong vaccine by accident at the hospital; A spontaneous report was received from a health care professional concerning a 16-years-old, female patient who received Moderna's COVID-19 Vaccine, and 16-year-old daughter is a first responder on an ambulance and was administered the wrong vaccine by accident at the hospital (Product administered to patient of inappropriate age).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 19-Jan-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 lot#unknown lintramuscularly for prophylaxis of COVID-19 infection.   On 19-Jan-2021,16-year-old daughter is a first responder on an ambulance and was administered the wrong vaccine by accident at the hospital Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, 16-year-old daughter is a first responder on an ambulance and was administered the wrong vaccine by accident at the hospital was considered resolved on 19-Jan-2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16-year-old girl was administered the wrong vaccine by accident at the hospital) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age. The reported event is unlisted and company causality was assessed s not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore arm at injection site for 48 hours
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: fever, headache, congestion, muscle pain, chills, back pain, and nausea.   600mg ibuprofen   have not resolved yet