chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, UNK
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: throwing up; Tiredness; Chills; Nausea; Feeling unwell; Dizzy; Rapid heartbeat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and gabapentin (unknown manufacturer), via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for neuropathy. The patient's medical history and concomitant medications were not reported. On Monday (unknown date), the patient had the Pfizer COVID-19 Vaccine, then the patient was fine on Tuesday. On Wednesday, the patient took for the first time Gabapentin pill because the patient have neuropathy. About 2 hours after the patient took the Gabapentin, the patient started throwing up, and was not feeling well. But that all passed over. Since Wednesday (unknown date), the patient had tiredness, chills, nausea, felling unwell, dizziness, and rapid heartbeat. And the patient looked up and saw that all these could be side effects of the vaccine. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Fatigue, Inflammatory pain
Clinical narrative: Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in wrist; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer's COVID Vaccine; lot number: EL1284; expiration date: 30Apr2021), via an unspecified route of administration left upper arm on Jan2021 at a single dose for covid-19 immunization. Medical history included lupus. There were no concomitant medications. The patient reported that she got her first dose of the COVID Vaccine 2 weeks ago today (Jan2021), and this is her second dose next Saturday. She was a non-medicated, non-kind of remission level of lupus. She mentioned that she was okay the second day, she thinks. She had a little dizziness, fatigue and light headedness that kind of thing. But the top 3 or 4 days ago, so like on her 8th or 9th day, she started to get like inflammatory symptoms like arthritis pain in her hip, in her hand, in her wrist. It was also reported that the patient experienced inflammatory pain on an unspecified date. So, she was just wondering if there are any reports of people with lupus and if the other people have reported that. She mentioned that she wanted to get the second dose but was a little concerned if those arthritis symptoms are going to be worse. No treatment was received. The causality was reported as yes. The patient she hasn't gone visit any emergency room/ physician's office for the adverse events. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: hiccups for last 5 days for sometimes; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included patient was on hearing aid (ongoing). Concomitant medications were not reported. Patient had hiccups for the last 5 days (Jan2021), not for a while but sometimes may be every 5 or a minute. The outcome of the event hiccups was unknown.   Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bowel movement irregularity, Burning sensation, Cough, Fatigue
Clinical narrative: coughing; fatigued / tired; Not felt good/ Not been myself; My body has not been normal like my specimen not good and it was dark; I am very irregular with going to bathroom so I have not felt good; Might have ulcer because it burns when I eat anything; Might have ulcer because it burns when I eat anything; I have aches, body aches; Slept like all the way around the clock; This is a spontaneous report from a contactable consumer (the patient).  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot E13246), via an unspecified route of administration on 05Jan2021 (at the age of 83-years old) as a SINGLE DOSE for Covid-19 immunization.  Medical history included hypertension, reported as pretty regular, from an unknown date and unknown if ongoing. Family medical history included bleeding ulcer from her mother. Concomitant medications included benazepril and felodipine for hypertension. The patient experienced my body has not been normal like my specimen not good and it was dark; i am very irregular with going to bathroom so i have not felt good; might have ulcer because it burns when i eat anything; I have aches, body aches; slept like all the way around the clock all in Jan2021; I was coughing and felt fatigued / tired on 15Jan2021; and not felt good/ not been myself in Jan2021. The patient underwent lab tests and procedures which included body temperature which was checked 3 times with no fever on an unknown date.  Therapeutic measures were taken as a result of slept like all the way around the clock which included ibuprofen (ADVIL). The outcome of the events bowel movement irregularity, burning sensation, ulcer, pain, hypersomnia, cough, fatigue and malaise was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise, Pain, Ulcer
Clinical narrative: coughing; fatigued / tired; Not felt good/ Not been myself; My body has not been normal like my specimen not good and it was dark; I am very irregular with going to bathroom so I have not felt good; Might have ulcer because it burns when I eat anything; Might have ulcer because it burns when I eat anything; I have aches, body aches; Slept like all the way around the clock; This is a spontaneous report from a contactable consumer (the patient).  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot E13246), via an unspecified route of administration on 05Jan2021 (at the age of 83-years old) as a SINGLE DOSE for Covid-19 immunization.  Medical history included hypertension, reported as pretty regular, from an unknown date and unknown if ongoing. Family medical history included bleeding ulcer from her mother. Concomitant medications included benazepril and felodipine for hypertension. The patient experienced my body has not been normal like my specimen not good and it was dark; i am very irregular with going to bathroom so i have not felt good; might have ulcer because it burns when i eat anything; I have aches, body aches; slept like all the way around the clock all in Jan2021; I was coughing and felt fatigued / tired on 15Jan2021; and not felt good/ not been myself in Jan2021. The patient underwent lab tests and procedures which included body temperature which was checked 3 times with no fever on an unknown date.  Therapeutic measures were taken as a result of slept like all the way around the clock which included ibuprofen (ADVIL). The outcome of the events bowel movement irregularity, burning sensation, ulcer, pain, hypersomnia, cough, fatigue and malaise was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash from neck all the way down, all over my body; It's been really severe; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249; expiration date: not known), via an unspecified route of administration in the left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included thyroid (disorder). Concomitant medication included thyroid medication (unspecified). The patient experienced rash from neck all the way down, all over her body; it's been really severe on an unspecified date. The patient gone to the doctor and gave her prednisone. The patient didn't really know whether to take the second shot or not because of this. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Site of vaccination is red and it has a rash; Site of vaccination is red and it has a rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration on 13Jan2021 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID vaccination and had several different reactions to it. The patient stated that the one thing that was bothering the most was that the site of vaccination was red and it had a rash. The patient needed to know if there is anything to put on it to keep it from itching. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: body ache; Chills; Low fever; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown (as reported: "EK5230 or EK5730, it could 52 or 57, I am not sure, that may be 5730"), via an unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient reported some side effects from the COVID vaccine. The patient reported she had 3 days (as reported-pending clarification) of really bad body ache, chills, low fever, and fatigue from 14Jan2021. The patient received "Flu syrup" as treatment for the adverse events. The outcome of events was not recovered (as reported "still experiencing"-pending clarification).  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: Had a lot of body ache; This keeps coming and going; My whole back and shoulders and arms were hurting; My whole back and shoulders and arms were hurting; My whole back and shoulders and arms were hurting; This is a spontaneous report from a contactable consumer (patient). A 80-years-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , on unspecified date at SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. Consumer stated, "I got the Pfizer vaccine last Friday, the 8 (not clarified) and I had the reaction right away that night and the side effects the whole day, I had a lot of body ache. With the week, it got somewhat better but this keeps coming and going. Like this morning, I was, also the same thing, my whole back and shoulders and arms were hurting and when I took a hot shower, it seems to help like for a half an hour or so. Now, I have the same pain again. So, I had called the center, I went back because I am in a community, and we got the vaccine there. So, I went back and I asked them, can I take Advil, because Tylenol did not do nothing for me. So, the Advil did helped me somewhat and by Saturday night, it went away. However, the whole week again comes and goes and this morning, I do not know I took Advil at night like at 01:00 and it just made me sweat but the pain in the morning, I still get the same reaction. So, what can I do for it? I am just calling to know."Outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle pain; Fever; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, headaches, muscle pain, fever. The patient outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 84.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Injection site erythema, Injection site pain
Clinical narrative: I got injection site redness and it kind of hurt, just kind of pain; I got injection site redness and it kind of hurt, just kind of pain; I am kind of hard of hearing; This is a spontaneous report from a contactable consumer. A 84-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1283, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical historyand concomitant medications were not reported. The patient experienced "injection site redness and it kind of hurt, just kind of pain but definitely it is red "on an unspecified date with outcome of unknown, and "I am kind of hard of hearing" on an unspecified date with outcome of unknown. The action taken  was not applicable.
Age: 84.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: I got injection site redness and it kind of hurt, just kind of pain; I got injection site redness and it kind of hurt, just kind of pain; I am kind of hard of hearing; This is a spontaneous report from a contactable consumer. A 84-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1283, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical historyand concomitant medications were not reported. The patient experienced "injection site redness and it kind of hurt, just kind of pain but definitely it is red "on an unspecified date with outcome of unknown, and "I am kind of hard of hearing" on an unspecified date with outcome of unknown. The action taken  was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 42-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), via an unspecified route of administration on 22Dec2020 09:00 at single dose for COVID-19 immunisation. The patient medical history was not reported.  There were no concomitant medications.  The patient previously took nitroglycerin and experienced drug hypersensitivity. The patient had mild headache after the first dose on 22Dec2020 with outcome of unknown.
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: headache; Initial information was received on 06-Jan-2021 regarding an unsolicited valid non-serious case from other health care professional.  This case involves a 74-Year-old elderly male patient who experienced headache, when he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, suspension for injection (batch number and expiration date not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced headache, (latency: unknown) following administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment for headache  Outcome of the events was reported as unknown.  There will be no information available regarding batch number in this case.
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Feeling cold, Pain, Tremor
Clinical narrative: Being miserable; Having total body aches; shaking; Feeling frigid; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case is linked to case 2021SA008600 (death case).  This case involves an 85 years old male patient who became miserable (Feeling abnormal, having total body aches (pain), shaking (tremor) and feeling frigid (feeling cold), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccinations included Flu vaccine after which he got sick for 2 to 3 days and had a pneumonia shot a while back and had a reaction (that the provider told him the reaction was due to the immune system working and that he is sensitive to medications that with a dose of morphine he goes crazy).  Medical history, medical treatments, concomitant medication and family history were not provided.   On 15-Oct-2020 at 08:30 am, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 15-Oct-2020, the patient became miserable (feeling abnormal), had total body aches (pain), shaking (tremor) and feeling frigid (feeling cold) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient had to turn his heat up in the house due to the reaction.  The patient taken 2 Advil, 2 PARACETAMOL (TYLENOL), BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE], SLEEP AID [DIPHENHYDRAMINE HYDROCHLORIDE] and kept on a cot.  The patient recovered from all the events on an unknown date.  There will be no information on the batch number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Ipol and the other vaccine, Pentacel and both have polio in the vaccine with no AE; Initial information received on 07-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old male patient who received a 0.5 ml dose of vaccine QUADRIVALENT INFLUENZA VACCINE [FLUZONE] (lot: UJ146AAA, expiry date: 14-Feb-2021) and  POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) (lot number and expiry date unknown), both via unknown route at unknown administration site, on an unknown date (wrong product administered) as prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations, and family history were not provided.  Concomitant vaccines included HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE 13V.  It was an actual medication error due to ipol and the other vaccine, pentacel and both have polio in the vaccine (Extra dose administered).    At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on one side of face, the side she got the vaccine; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via The Agency (Reference number- 00428151) and transmitted to Sanofi on 13-Jan-2021.   This case involves a 73-year old female patient who experienced hives on one side of face, the side she got the vaccine (urticaria), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Past medical history included allergic reaction (hypersensitivity) (she put sunscreen all over her face for a yard sale and after the yard sale she saw she had an allergic reaction).  Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing drug hypersensitivity (she was allergic to Sulfur and praba)  On 23-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: unknown and expiration date: unknown] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced non serious hives on one side of face, the side she got the vaccine (urticaria), (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for 9 days and EPINEPHRINE (EPIPEN) for Urticaria.  On an unknown date, the patient recovered from urticaria (reported as hives lasted for 9 days).  The patient wanted to know if any of the components of the vaccine contain sulfa or PABA similar to sulfur to cause this reaction and if taking Benadryl before receiving a vaccine would prevent any potential side effects. Patient stated that she was surprised that hives lasted for nine days because she read the hives would only last for three days. The patient also stated that her doctor told her the hives could not be a side effect and that she must have touched her face.   There will be no information regarding batch number in this case.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020 08:00, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix experienced fever and headache. The reporter stated that had fever for 2.5 days and have headache on and off. The reporter inquired How long do side effects like headache and fever typically would last. The information regarding consent to follow was not reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Some soreness of the injected arm; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had received the vaccine around August,2020 on an unknown arm and she had some soreness of the injected arm. The reporter consented to follow-up. For tolerance to the 2nd dose of Bexsero, refer case US2020248584.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215496:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020AMR249184:same reporter US-GLAXOSMITHKLINE-US2020248584:same patient (2nd dose)
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pain in extremity
Clinical narrative: sore arm; redness; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecifid number of patients who received Men B NVS (Bexsero) for prophylaxis  Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated that, after vaccination with Bexsero, the patient had sore arm and redness. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: half of the vaccine pushed out around the needle (the needle was not tight on the syringe); A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and half of the vaccine pushed out around the needle (the needle was not tight on the syringe) (Incorrect dose administered).  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 # unknown) for prophylaxis of COVID-19 infection.   On an unknown date, during a drive through COVID vaccine event, after injecting the arm and pushing the plunger, about half of the vaccine pushed out around the needle (the needle was not tight on the syringe). No treatment information was provided.    Action taken with the mRNA-1273 in response to the event was not reported.     The event, half of the vaccine pushed out around the needle (the needle was not tight on the syringe) was considered recovered on an unknown 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.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and who was 17 years old (experienced inappropriate age at vaccine administration).  The patient's medical history was not provided. Concomitant product use was not provided.  On 09-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 09-Jan-2021 a 17-year-6-month-old female volunteered to receive the Moderna COVID-19 vaccine.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, inappropriate age at vaccine administration, was considered resolved on 09 Jan 2021.; 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: Incorrect dose administered
Clinical narrative: Nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse concerning a 62-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate dose administered.  There were no medical history and concomitant medications reported.  On 06 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06 JAN 2021, the nurse gave the patient a double dose (1 ml) of the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, "inappropriate dose administered" was considered resolved on 06 JAN 2021.; Reporter's Comments: This case concerns a 62-year-old, male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse concerning a 81-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and a nurse did a double dose (1ml) in error.   The patient's medical history was not provided.  No concomitant medications were provided.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, a nurse gave the patient a double dose (1 ml) of the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, a nurse did a double dose (1ml) in error, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of a 81-year-old female patient who experienced non-serious event of nurse did a double dose (1ml) in error (Inappropriate dose of vaccine administered for mRNA-1273 (lot # 025L20A, Exp date-unknown). There were no reported AEs associated with the event of Inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse, concerning a 49-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate dose administration.  There were no medical history and concomitant medications reported.  On 06 Jan 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient received a double dose (1ml) of the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, "inappropriate dose administered" was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 49-year-old, male patient who received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A), reporting Incorrect dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse concerning a 36-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate dose administered.  There were no medical history and concomitant medications provided.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the nurse gave the patient a double dose (1 ml) of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event "inappropriate dose administered" was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 36-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A), reporting Incorrect dose administered.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15yo male received the COVID19 vaccine; A spontaneous report was received from a pharmacist concerning a 15-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  There were no medical history and concomitant medications reported.  On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011520A) intramuscularly for prophylaxis of COVID-19 infection.    On 10 Jan 2021, the patient was administered the mRNA-1273 vaccine at the age of 15. The patient tolerated COVID-19 vaccine. Treatment information 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, 15-year-old patient receiving the mRNA-1273 vaccine, was considered resolved on 10 Jan 2021.; Reporter's Comments: This case concerns a 15 year old male who received their first of two planned doses of mRNA-1273 (Lot number: 011520A) intramuscularly 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: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under eighteen years old received the first dose of Moderna COVID-19 Vaccine; A spontaneous report was received from a health care professional who was also a pharmacist concerning a 15-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in the event, COVID-19 vaccine to 15-year-old.  The patient's medical history, s provided by the reporter, included diabetes mellitus (DM). Concomitant medications reported included treatment for DM (unknown name).   On 09 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was under eighteen years old under special situation.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, COVID-19 vaccine to a 15-year-old, 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.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose given to patient that is 17 years and 11 months old; A spontaneous report was received from a pharmacist concerning a 17-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, dose given to patient that is 17 years and 11 months old.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, during vaccine administration, the patient was 17 years and 11 months old. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, dose given to patient that is 17 years and 11 months old, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: Younger than 18 years old at the time of vaccination; Injection site pain; A spontaneous report was received from a physician concerning a female 16-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient was younger than 18 years old at the time of vaccination and experienced injection site pain.  The patient's medical history was not provided. The patient current conditions included Hashimoto's disease and premature ovarian failure. Concomitant medications included Tylenol for menstrual cycle, Estradiol, Progesterone and Vitamin D all for unknown indications.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient took the vaccine when she was 16 after her doctor told her not to take the Moderna COVID-19 vaccine. The patient also experienced injection site pain. Treatment information was not provided.  Action taken for the events was not reported.  The event younger than 18 years old at the time of vaccination was considered resolved on 12 Jan 2021.  The outcome of the event injection site pain was unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 and concerns a 16 year-old, female patient with medical history of Hashimoto's disease and premature ovarian failure, who experienced the event of injection site pain. The event occurred on an unknown date after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Did not get the full 0.5ml dose; A spontaneous report was received from a physician concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine but did not get the full 0.5ml dose.  The patient's medical history was not provided.  Concomitant medications were not reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273, intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, the patient did not get the full 0.5ml dose, but however received only 0.35 to 0.4 ml of the vaccine due to a syringe malfunction. No treatment information was provided for the event.  Action taken in response to the event was not reported.  The event did not get the full 0.5ml dose was considered to be resolved on an unreported date.; Reporter's Comments: This report refers to a case of Incorrect dose administered for COVID-19 vaccine, mRNA-1273. There were no reported AEs associated with this case of Incorrect dose administered for COVID-19 vaccine, mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the vaccine spilled down the patients arm; A spontaneous report was received from a healthcare professional concerning a female, of unknown age, patient who received Moderna's COVID-19 vaccine and some of the vaccine spilled down her arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in the arm for prophylaxis of COVID-19 infection.    On 14 Jan 2021, during administration of the mRNA-1273 vaccine some of the vaccine spilled down the patient's arm. The patient reported that she thinks things were not screwed on properly. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event some of the vaccine spilled down her arm was considered resolved on 14 Jan 2021.; 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: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site bruising, Injection site erythema, Injection site mass, Pruritus
Clinical narrative: Itchiness; Vaccine injected Subcutaneously; Redness at the injection site; Injection site bruise; Injection site unsual lump; A spontaneous report was received from a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccine received subcutaneously and experienced redness at the injection site, bruise, injection site unusual lump and itchiness.   The patient's medical history was not provided. concomitant medications were metoprolol, clonixin lysinate, pargeverine hydrochloride, levothyroxine sodium, magnesium malate, zinc glycinate and vitamin d [vitamin d nos].   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) "subcutaneously" in her right arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient stated that the vaccine was applied on the lower part of the deltoid muscle. Her health care professional checked that it was done subcutaneously. She experienced redness at the injection site, bruise and an unusual lump.   On 13 Jan 2021, the patient began to experience itchiness, which was treated with diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, Redness at the injection site, bruise and injection site unusual, were considered ongoing.   The outcome of event, vaccine injected subcutaneously, was resolved 06 Jan 2021.   The outcome of the event, Itchiness, was resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 67 year-old, female patient, who experienced the events of redness at the injection site, bruise, injection site unusual lump and itchiness. The events of redness at the injection site, bruise, injection site unusual lump occurred the same day after the first and only dose of mRNA-1273 vaccine administration. The event of itchiness occurred approximately 7 days after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pfizer Covid19 vaccine first and then the Moderna Covid19 vaccine second; A spontaneous report was received from a healthcare professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received the Pfizer Covid19 vaccine first and then the Moderna Covid19 vaccine second (Interchange of vaccine products).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the pharmacist called to report that they had a mix up of the Pfizer Covid-19 vaccine and the Moderna Covid-19 vaccine.  A patient received both brands, receiving first the Pfizer Covid-19 vaccine and then the Moderna Covid-19 vaccine second.  Consent given to Safety for follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, Pfizer Covid19 vaccine first and then the Moderna Covid19 vaccine second, was considered resolved on unknown date.; Reporter's Comments: This report refers to a product administration error where the patient who had received first dose of Pfizer vaccine was then administered mRNA-1273 as the second dose. There were no reported AE's associated with this case of wrong product administered.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: deviation from dosage (less than 0.5mL); A spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced deviation from dosage (less than 0.5mL) (Incorrect dose administered).  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On an unknown 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, 3 or 4 drops of the vaccine fell on the patient's arm during injection. There were 0.5mL in the syringe during the administration, and the patient received almost all of the vaccine except for those three or four drops. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The event deviation from dosage (less than 0.5mL) (Incorrect dose administered) was considered resolved on an unknown 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: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Appeared to be leakage out of the hub of the needle; A spontaneous report was received from a pharmacist, concerning an 83-years old male patient, who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced incorrect dose administration.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 15-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for COVID-19 infection.    During the vaccination, the vaccine appeared to be leaking out of the hub of the needle. However, the reporter stated that most of the dose was believed to be successfully administered to the patient. No additional information was reported at the time of this report. Reporter provided consent to follow-up. No treatment information was provided for the event.   Action taken in response to the events were not reported.  The outcome of the event, incorrect dose administration was considered to be resolved on 15-Jan-2021.; 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: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose is scheduled 19 days after the 1st dose; A spontaneous report was received from a non-health care professional concerning a male patient who received Moderna's COVID-19 Vaccine and 2nd dose is scheduled 19 days after the 1st dose (Inappropriate schedule of product administration).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 15-Jan-2021, patient received their first of two planned doses of mRNA-1273.  Patient was scheduled for his Moderna vaccine 1st dose on 15-Jan-2021. His 2nd dose was scheduled on 02-Feb-2021, which is only 19 days after his first dose. The patient wants to know if this will affect the efficacy and safety of the vaccine.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event 2nd dose is scheduled 19 days after the 1st dose was not reported.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.