chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: injection site infection; injection site swelling measuring 8 inches by 4 inches; injection site hardness; injection site redness; injection site heat; This case was reported by a pharmacist and described the occurrence of injection site infection in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 53X42, expiry date 9th September 2022) for prophylaxis.   On 11th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, 4 days after receiving Shingrix, the patient experienced injection site infection, extensive swelling of vaccinated limb, injection site induration, injection site erythema and injection site warmth. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site infection, extensive swelling of vaccinated limb, injection site induration, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site infection, extensive swelling of vaccinated limb, injection site induration, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in the left deltoid and developed injection site redness, heat, hardness, and swelling measuring 8 inches by 4 inches (extensive swelling of vaccinated limb). The patient was examined by her health care provider and diagnosed the patient with an injection site infection and was prescribed Bactrim as treatment. Till the time of reporting, the events were reported as ongoing. The reporter consented to follow-up. This case had been linked with US2020AMR251357, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR251357:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female; A spontaneous report was received from a pharmacist. This case concerns a 16 year old female patient who experienced inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female with the use of mRNA-1273.    There was no medical history provided. There were no concomitant medications provided.   On 16 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # 026L20A), for prophylaxis of COVID-19 infection.   On 16 Jan 2021, it was inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female. It was noted the patient did not experience any adverse reactions during the 15 minute observation period. There was no treatment information provided.  Action taken with mRNA-1273 to the event of inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female was not provided.  The outcome for the event of inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female was resolved on 16 Jan 2021.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot # 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: some of the product came out and ran down his arm/backflow after administration; some of the product came out and ran down his arm; A spontaneous report was received from a 29-year-old male nurse who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced backflow after the administration, and some of the product came out and ran down his arm.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on an unknown date.   On 21 Jan 20201, the patient received their second of two planned doses of mRNA-1273 (Lot 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that there was backflow after the administration, and some of the product came out and ran down his arm.  No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the event, experienced backflow after the administration, and some of the product came out and ran down his arm, was considered resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 29-year old White, male nurse patient. The patient's medical history and concomitant medications were not provided. The patient experienced a non serious event of some of the product came out and ran down his arm/backflow after administration. The event occurred on the same day as the planned second dose of the mRNA-127 administration, with no reported AEs.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Nurse stated when she administering the second dose of the Moderna vaccine to one of her patients, some of the vaccine leaked out and the patient didn't get full dose.; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and vaccine leaked out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   Nurse stated that while administering the second dose of the Moderna vaccine to one of her patients, some of vaccine leaked out and the patient didn't get full dose.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event vaccine leaked out was not reported.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 011L20A), where the vaccine leaked out during administration. There were no reported AEs associated with this case of incomplete dose administered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: moderna covid 19 vaccine eua fever, chills, terrible headache, body aches, nausea, can barely move my left arm taking acetaminophen and ibuprofen to manage symptoms without much resolution
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: moderna covid 19 vaccine eua fever, chills, terrible headache, body aches, nausea, can barely move my left arm taking acetaminophen and ibuprofen to manage symptoms without much resolution
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine administration to a 17 year old; A spontaneous report was received from a pharmacist concerning a 17-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)  vaccine given to a 17-year-old patient.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The reporter reported the vaccine was given to 17-year-old. 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 a 17-year-old, was considered resolved on 14 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (t 025J20-2A), reporting Product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: partial dose of the vaccine was administered; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced partial dose of the vaccine was administered.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  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 reported a partial dose of the vaccine was administered. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, experienced partial dose of the vaccine was administered, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of an unknown age and gender. The patient's medical history and concomitant medications were not provided. The patient experienced a non serious event of partial dose of the vaccine was administered. The event occurred on the same day the first dose of the mRNA-127 was administered, with no reported AEs.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: age 16 received vaccine; A spontaneous report was received from a consumer relative, concerning a 16 year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for COVID-19 infection prophylaxis.   On 22 Jan 2021, the patient's mother stated that her daughter received the vaccine, which was required by her employer. No adverse reactions were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, age 16 received vaccine, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 16 year-old white female patient, who received the first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for COVID-19 infection prophylaxis. No adverse reactions were reported to this event pf product administered to patient of inappropriate age
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: About a day after getting the vaccine, I felt a strange sensation of moving up and across the left side of my face.  It stopped about half way across my face, with a tingle sensation .  My face was then numb for the rest of the day.  It only affected half of my face, the left side (I got the vaccine in left arm).   The same sensation occurred with the second vaccine dose, but it happened earlier on the day of the vaccine about 5 hours after getting the shot.  The same tingle and numbing sensation filled half of my face.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: Injected 0.5 ml subcutaneous into her right arm; Right arm very painful; A spontaneous report was received from a pharmacist concerning a 40-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was injected 0.5 ml subcutaneous (SQ) into right arm and right arm very painful.  The patient's medical history was not provided. Concomitant medications reported included birth control (not specified).   On 21 Jan 2021, 'the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) subcutaneously in the right arm for COVID-19 infection.   On 21 Jan 2021, the nurse vaccinator injected 0.5 ml subcutaneously (SQ) into the underside, fatty part, of the patient's right arm, in error. That night, the patient's right arm "hurt like hell" and was very painful. No treatment medications were reported at the time of this report.  Action taken with mRNA-1273 in response to the events was not reported.   The event,  injected 0.5 ml subcutaneous (SQ) into right arm, was resolved on 21 Jan 2021. The outcome of the event, right arm very painful, was not reported.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number: 027L20A) , where the first dose of the vaccine was administered subcutaneously. The event of Pain in arm was associated with this case of incorrect route of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Moderna vaccine as minor, age 17; A spontaneous report was received from a consumer concerning a 17-years-old, female patient who received Moderna's COVID-19 Vaccine, and the patient received Moderna vaccine at the age 17.  The patient's medical history included a positive Covid-19 test in Aug 2020, symptoms resolved, and she completed her quarentine. Concomitant product use was not provided by the reporter.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 28 Dec 2020, patient received Moderna vaccine as minor, age 17.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event received Moderna vaccine as minor, age 17 was resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot number 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Potentially injected vaccine into the subcutaneous fat beneath the deltoid; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced potentially injected vaccine into the subcutaneous fat beneath the deltoid.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection, after that the patient experienced fever and chills, which was resolved within 24 hours.  On an unknown date, the patient received their second dose of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection.  On an unknown date, the patient's second dose was administered by a nurse who squeezed the recipient's arm and potentially injected vaccine into the subcutaneous fat beneath the deltoid. The patient did not experience symptoms after their second dose. No treatment information was provided.   There was no change planned to the dosing schedule of mRNA-1273 in response to the events fever and chills. The patient received both scheduled doses of mRNA-1273 prior to the event potentially injected vaccine into the subcutaneous fat beneath the deltoid, therefore action taken with the drug in response to the event is not applicable.  The events, potentially injected vaccine into the subcutaneous fat beneath the deltoid was considered resolved. The outcome of the events fever and chills were unknown.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, where the vaccine was administered into the subcutaneous fat. There were no reported AEs associated with this case of incorrect route of product administration.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose was given to 17 years old; A spontaneous report was received from a pharmacist concerning a 17-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient received the vaccine at the age of 17 years old.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 013L20A) intramuscularly (IM) in the right arm for prophylaxis of COVID-19 infection.   Pharmacist confirmed the age of the patient is 17 years old, not 15 as stated in the voicemail. She reports that the patient received the Moderna COVID19 vaccine on 21 Jan 2021 on right arm as IM injection. Patient reported no symptoms.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event dose was given to 17 years old was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot number 013L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound breast
Clinical narrative: Swollen lymph nodes in bilateral axilla.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the Moderna COVID-19 vaccine to a 17 year old; A spontaneous report was received from a pharmacist concerning a 17-years-old, female patient who received Moderna's COVID-19 Vaccine, and who was administered the Moderna COVID-19 vaccine to a 17-year-old.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19 Jan 2021, Pharmacist administered the Moderna COVID-19 vaccine to a 17-year-old.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event administered the Moderna COVID-19 vaccine to a 17-year-old was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient 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: Wrong product administered
Clinical narrative: received the Moderna COVID-19 vaccine for their first dose on 30Dec2020 and then the Pfizer COVID-19 vaccine for their second dose on 21Jan2021/ vaccine mix-up; A spontaneous report was received from a consumer concerning a 57-years-old, female patient who received Moderna's COVID-19 Vaccine, and received the Moderna COVID-19 vaccine for their first dose on 30Dec2020 and then the Pfizer COVID-19 vaccine for their second dose on 21Jan2021/ vaccine mix-up (wrong product administered).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30-Dec-2020, patient received the Moderna COVID-19 vaccine for their first dose and then the Pfizer COVID-19 vaccine for their second dose on 21-Jan-2021. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event received the Moderna COVID-19 vaccine for their first dose on 30Dec2020 and then the Pfizer COVID-19 vaccine for their second dose on 21Jan2021/ vaccine mix-up (wrong product administered) was not provided.; Reporter's Comments: This report refers to a case of wrong product administered for mRNA-1273. There were no reported AEs associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Wrong product administered
Clinical narrative: Received Pfizer vaccine for first dose and Moderna vaccine for second; Arm pain; Fatigue; Headache; A spontaneous report was received from a nurse concerning a 49-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received Pfizer vaccine for first dose and Moderna vaccine for second, arm pain, fatigue, and headache.  The patient's medical history included intervertebral disc disorder. No relevant concomitant medications were reported.   On 08 Jan 2021, prior to the onset of the events arm pain and fatigue, the patient received a dose of mRNA-1273 (Lot number 25L20A)  intramuscularly for prophylaxis of COVID-19 infection.  On 21 Dec 2020, the patient received their first dose of the Pfizer vaccine.   On 08 Jan 2021, the patient was inadvertently administered a dose of the Moderna vaccine, and experienced some arm pain, fatigue, and headache. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, received Pfizer vaccine for first dose and Moderna vaccine for second was considered resolved on 08 Jan 2021. The events, arm pain and fatigue, were considered resolved on 09 Jan 2021. The outcome of the event, headache, is unknown.; Reporter's Comments: This case concerns a 49-year old female patient with a medical history of intervertebral disc disease. The patient experienced Wrong product administered and non-serious listed events of Pain in extremity, Fatigue and Headache after receiving a dose of mRNA-1273 (Lot number 25L20A).   Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's underlying intervertebral disc disease may have been contributory for the event of headache.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain in  injection srea
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Incorrect dose administered
Clinical narrative: Some of the vaccine spilled down the patients arm; Some of the vaccine spilled down the patients arm; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and some of the vaccine spilled down the patient's 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 intramuscularly 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 believed 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 the patient's arm, was considered resolved on 14 Jan 2021.; Reporter's Comments: This case concerns a male patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered and Accidental exposure to product.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Poor quality product administered
Clinical narrative: soreness; vaccinated after the 6 hour mark; A spontaneous report was received from a hospital office manager concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness and was vaccinated after the 6 hour mark.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, it was reported that the facility was delivered 3 vials of the vaccine, with no documentation, from the Department of Public Health. Some vaccines were left out more than 6 hours punctured but were refrigerated. The vaccines were used to vaccinate staff and patients, approximately 20 people. Of the 20 people vaccinated at least 10 were vaccinated after the 6 hours mark.  On 06 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 and received vaccine that from a vial that had been punctured more than 6 hours previously.    On an undisclosed date, the patient also experienced a soreness after receiving the vaccine. No details were provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, soreness, was not reported. The event, was vaccinated after the 6 hour mark, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA, where the vaccine was administered from a vial punctured more than 6 hours. The event of pain was associated with this case of out of specification product use.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Splash when vaccine was being administered and doesn't think she got 0.5 ml; A spontaneous report was received from a consumer concerning a 39-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and reported splash when vaccine was being administered and she doesn't think she got 0.5mL.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 on unknown date.   On an unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number 041L20) intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, while receiving the second dose of vaccine it splash and the patient did not received full dose (0.5ml). The person who gave the vaccine said the hub was stuck on syringe. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, splash when vaccine was being administered and she doesn't think she got 0.5mL was considered resolved.; Reporter's Comments: This case concerns a 39-years-old, female patient who patient received their second of two planned doses of mRNA-1273 (Lot number 041L20) intramuscularly for prophylaxis of COVID-19 infection and reported a splash when vaccine was being administered and she doesn't think she got 0.5mL. There were no reported adverse events associated with the event of a splash when vaccine was being administered and she doesn't think she got 0.5mL.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: About a week after I received the 1st dose of the vaccination I noticed redness, swelling, and tenderness just below the the site of the injection. The symptoms lasted for about 24 hours before they resolved.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a 16 year old; A spontaneous report was received from a parent concerning a 16-year-old, male, patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient received his first dose of the Moderna vaccine and he is only 16 years old. The patient was fine and has had no side effects. Consent given for Safety to follow up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine was administered to a 16 year-old, was considered resolved on 22 Jan2021.; Reporter's Comments: This case concerns a 16-year-old, male, patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. There were no reported adverse events per reporter for this case of product administered to patient of inappropriate age
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: had a 16 year old who accidentally got the moderna covid vaccine; A spontaneous was received from a health care provider (HCP)  concerning a 16-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273)accidentally.  The patient's medical history was not provided. Products known to have been used by the patient, were not provided.  On an unknown date, the patient accidentally received mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    Treatment information was not provided. Consent has been given to contact the HCP.  HCP was inquiring as to whether or not the second dose of mRNA-1273 should be given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, a 16-year-old accidentally receiving the vaccine, was considered resolved.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever,  body aches
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hypersomnia, Injection site pain
Clinical narrative: 1/25/2021- severe pain at vaccination site, I could not move my arm, was unable to sleep. 1/26/2021- dizzy, achy, chills, fever 101.8 degrees to 102.6 degrees. 1/27/2021- slept most of the entire day, achy, dizzy. 1/28/2021 & 1/29/2021- fatigue.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: 1/25/2021- severe pain at vaccination site, I could not move my arm, was unable to sleep. 1/26/2021- dizzy, achy, chills, fever 101.8 degrees to 102.6 degrees. 1/27/2021- slept most of the entire day, achy, dizzy. 1/28/2021 & 1/29/2021- fatigue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Aches, Chills, Headache, Fever
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Out-of-sequence COVID-19 vaccination was given.  Person involved was a community member (non-affiliated healthcare provider) who showed up to a hospital based clinic that was administering first doses to 1A non-affiliated healthcare providers on 1/27/21.  Unknown to the clinic organizers this person had previously received one dose of the Pfizer vaccine 13 days earlier (1/14/21).  On 1/27/21 a dose of Moderna vaccine was administered and then after administration it was revealed that the person had previously received Pfizer and was not due for re-vaccination on 1/27/21.  Person was held for routine observation and no side effects resulted.  Person was provided with contact information for a hospital hotline to report any side effects that may result in the meantime.  As of 1/29 no effects have been reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: I have freckles or spots on my entire body.  These spots became much darker and much more noticeable about 24 hours later.  At 36 hours after the initial dose, the spots are not noticeable again.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Pain, Pyrexia
Clinical narrative: Body aches, headache, fatigue, fever Soreness and mild headache started within a few hours of the vaccine. The next morning I woke with severe headache, diffuse body aches, and low grade fever (99.3). Mid afternoon body aches resolved but headache progressed to a migraine. I also developed a 101.4 fever. All symptoms resolved overnight.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hypogeusia, SARS-CoV-2 test negative
Clinical narrative: Vaccine taken on 1/20.  1/24 began symptoms of exhaustion, fatigue, headache and brain fog.  1/24 began additional symptoms of decrease /altered taste in mouth.  symptoms last 3-4 days.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Vaccine taken on 1/20.  1/24 began symptoms of exhaustion, fatigue, headache and brain fog.  1/24 began additional symptoms of decrease /altered taste in mouth.  symptoms last 3-4 days.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Pfizer vaccine in LH arm, arm was sore for 2 days, arm continues to feel tender and has pins and needles feeling, worse when elevated or moved
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Feeling hot, Headache, Insomnia, Malaise
Clinical narrative: Whole body hot, then general malaise, cephalgia and insomnia.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Rash, Urticaria
Clinical narrative: Patient developed hives/rash on chest and arms immediately after receiving vaccine, administered 50 mg Benadryl po, took vitals twice fifteen minutes apart and was then driven home by her husband. Vital signs remained stable throughout episode.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash, Rash macular, Skin warm
Clinical narrative: The injection site is itchy and splotchy however this was not a symptom until after a week of getting the shot. My arm is the only area of this rash like symptom. NO fever after injection has occurred. My arm is warmer to the touch than the other arm. I have taken progression pictures if needed to be emailed and dated. I have taken benedryl after I noticed the rash and seemed to have no changes.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash, Rash erythematous
Clinical narrative: Patient developed red pinpoint rash all over arms, feet, trunk within 15 minutes of vaccine which eventually spread from trunk up abdomen to chest and neck. Patient vitals remained stable and had no problem breathing but rash spread and injection site was itchy.  Patient was given benadryl cream at injection site and as rash spread, was given 25 mg oral benadryl.  After 30 min observation, no change in symptoms. Rash did stop spreading, remained constant over arms, hands, chest and abdomen, flank, and feet.  Did not extend to legs.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Erythema, Eye pruritus, Flushing, Hypoaesthesia
Clinical narrative: Numbness and tingling in lips and oropharynx progressing to face; flushing and redness on chest, itching of hands, eyes, neck; nausea and stomach cramping all onset approx 30-40 minutes after vaccine. Treated in the emergency department w/ famotidine 50mg, solumedrol 125 mg, 1L NS. Noted frequent multifocal PVCs and runs of ventricular bigeminy during Emergency Dept evaluation and ongoing intermittent facial tingling and itching. Admitted for overnight observation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Nausea, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: Numbness and tingling in lips and oropharynx progressing to face; flushing and redness on chest, itching of hands, eyes, neck; nausea and stomach cramping all onset approx 30-40 minutes after vaccine. Treated in the emergency department w/ famotidine 50mg, solumedrol 125 mg, 1L NS. Noted frequent multifocal PVCs and runs of ventricular bigeminy during Emergency Dept evaluation and ongoing intermittent facial tingling and itching. Admitted for overnight observation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Numbness and tingling in lips and oropharynx progressing to face; flushing and redness on chest, itching of hands, eyes, neck; nausea and stomach cramping all onset approx 30-40 minutes after vaccine. Treated in the emergency department w/ famotidine 50mg, solumedrol 125 mg, 1L NS. Noted frequent multifocal PVCs and runs of ventricular bigeminy during Emergency Dept evaluation and ongoing intermittent facial tingling and itching. Admitted for overnight observation.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, low grade fever
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: generalized pruritus, onset 5-10 minutes after the vaccine, no other symptoms, vitals stable
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: bump at injection site. turned red and warm. moist heat does not help go down.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Lymphadenopathy
Clinical narrative: Injection was at 4:30/pm on January 26.  January 27, 2021 I woke at 4:15/am with  a major headache which lasted  for approximately 15 hours.    January 29, 2021 woke with swollen and sore lymph node under right armpit.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: FEVER, SORE THROAT, BODY ACHES, HEADACHE
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: Chills, muscle aches, mild headache, swollen lymph node (right side near clavical), right arm pain at site of injection
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Report of body aches, cough, congestion and sore throat.  No home remedies. Outcome: referred for testing.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: Arm where I got shot was very sore.  To be expected. Around 6:30 in the evening I started feeling tired, sick, and sore all over.  Got chills, feeling very cold.  Took temperature at 8:00 pm and had a fever of 99.2. Had  severe headache too. Took 2 acetaminophen tablets and went to bed. Chills got very severe, couldn?t stop shaking for a long while. Also felt very week.  Had trouble sleeping, body very sore. Got up around 2:00 am and checked temperature again. It was 100.6. Took 3 acetaminophen and went back to bed.  Severe headache persisted. Checked temperature at 8:15 am and it was 99.7.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Arm where I got shot was very sore.  To be expected. Around 6:30 in the evening I started feeling tired, sick, and sore all over.  Got chills, feeling very cold.  Took temperature at 8:00 pm and had a fever of 99.2. Had  severe headache too. Took 2 acetaminophen tablets and went to bed. Chills got very severe, couldn?t stop shaking for a long while. Also felt very week.  Had trouble sleeping, body very sore. Got up around 2:00 am and checked temperature again. It was 100.6. Took 3 acetaminophen and went back to bed.  Severe headache persisted. Checked temperature at 8:15 am and it was 99.7.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 102 fever body aches exhaustion splitting headache 36 hours
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence, Limb discomfort, Pain in extremity
Clinical narrative: Arm pain , arm feels heavy and very painful.  Lots of stomach growling, and some stomach discomfort, gases and diarrhea,
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Heart rate increased
Clinical narrative: Light headedness, headache, chills, fever, shivering, rapid heartbeat started at 7pm the same evening.  Chills, fever, shivering continued at bedtime, 9pm through the night until approximately 3am.   Light headedness, headache and weakness were still apparent at 5am.  Took Tylenol 500MG since 9pm every 4 hours.  0900am of Jan 29, 2021, still a slight headache and fever subsided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Light headedness, headache, chills, fever, shivering, rapid heartbeat started at 7pm the same evening.  Chills, fever, shivering continued at bedtime, 9pm through the night until approximately 3am.   Light headedness, headache and weakness were still apparent at 5am.  Took Tylenol 500MG since 9pm every 4 hours.  0900am of Jan 29, 2021, still a slight headache and fever subsided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Hyperhidrosis, Inclusion body myositis, Mobility decreased
Clinical narrative: On day 6 he woke up feeling very weak. Needed help getting out of bed. He has a degenerative muscle disease (Inclusion Body Myositis) so is already very weak, wheelchair bound. House is set up with all lift chairs or elevated (Bed, Toilet) so he can get out of them with very weak legs. By mid morning he was not able to use legs or arms at all to get up and had difficulty holding head up (usually no problem). By afternoon temperature went to 103.6. and he ached all over. After 2 - 3 hours with dose of 2 extra strength Tylenol temperature came down to 100.6 and then another hour later he became very sweaty all over body and temp returned to normal. Continued very weak for a few days. Gradually regained strength and back to normal strength for him over 6 days.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscle atrophy, Muscular weakness, Pain, Wheelchair user
Clinical narrative: On day 6 he woke up feeling very weak. Needed help getting out of bed. He has a degenerative muscle disease (Inclusion Body Myositis) so is already very weak, wheelchair bound. House is set up with all lift chairs or elevated (Bed, Toilet) so he can get out of them with very weak legs. By mid morning he was not able to use legs or arms at all to get up and had difficulty holding head up (usually no problem). By afternoon temperature went to 103.6. and he ached all over. After 2 - 3 hours with dose of 2 extra strength Tylenol temperature came down to 100.6 and then another hour later he became very sweaty all over body and temp returned to normal. Continued very weak for a few days. Gradually regained strength and back to normal strength for him over 6 days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: on the evening of January 28,2021, I experienced mild itching on right arm and when I looked it was a light blotchy pink. It is the same this morning. I reported it to my doctor.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Full blood count, Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: ? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip and upper right lip swelling. Scratchy throat ? Day 10 post vaccine #2 wheezing like an asthma attack ? Day 12 post vaccine #2 Left, lower lip swelling, tingling in my tongue ? itchy for 2 weeks, 14 days post vaccine #2. Developed a sporadic, ever changing rash ? Day 16 post vaccine #2 a different, new rash
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Throat irritation, Wheezing
Clinical narrative: ? Day 10 after vaccine #1 upper lip swelling AKA angioedema ? Day 6 post vaccine #2 lower right lip and upper right lip swelling. Scratchy throat ? Day 10 post vaccine #2 wheezing like an asthma attack ? Day 12 post vaccine #2 Left, lower lip swelling, tingling in my tongue ? itchy for 2 weeks, 14 days post vaccine #2. Developed a sporadic, ever changing rash ? Day 16 post vaccine #2 a different, new rash
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue for 2 days
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site pain, Erythema, Induration, Skin warm
Clinical narrative: Covid Arm- one week after shot got big red spot on same arm as shot was administered. Did not itch, warm to touch, also hard knot. About a 3 x 3 spot. Lasted two days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Oropharyngeal pain, Throat tightness
Clinical narrative: Throat felt very tight, cough and sore throat. difficulty swollening. took Tylenol sinus and steriods 4mg started 8pm on the 1/20/21
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Influenza virus test negative, Migraine, Polymerase chain reaction, SARS-CoV-2 test negative
Clinical narrative: 6 days later - 101-102 degree degree fever for 3 days (1/1/2021-1/4/2021) followed by 3 days of migraine headache (1/5/2021-1/8/2021)
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pain, Restlessness
Clinical narrative: Restless, chills, body ache, neck pain- (possible fever- did not take temp)
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Rash erythematous, Swelling
Clinical narrative: 9 days later, red rash, minor swelling, some soreness and itching at site in left deltoid
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Felt fever flu like symptoms aches chills
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Sweeping in arm- about 1-1/2 inch diameter  has lasted 9 days now
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Fever 102 Chills Headache Extreme Fatigue Nausea Weakness Arm pain at site
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever 102 Chills Headache Extreme Fatigue Nausea Weakness Arm pain at site
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain, Pyrexia
Clinical narrative: Woke up the following morning with a headache, fever, body aches, stomach ache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, X-ray with contrast lower gastrointestinal tract
Clinical narrative: 2 days after the injection, I developed nausea, headache and extreme fatigue.  I slept for most of the following 2 days, and continued to be more fatigued than normal for about a week.  I then had flu-like symptoms  (lower GI, nausea, headache, fatigue) that lasted about 3 days and caused me to miss work.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Antibiotic therapy, Asthenia, Dizziness, Incoherent, Psychomotor skills impaired
Clinical narrative: Weakness and dizziness. Not fully coherent to take evening blood pressure pill at 7:30 pm. Right hand motor skills not good. Could not hold water bottle to take pill.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Weakness and dizziness. Not fully coherent to take evening blood pressure pill at 7:30 pm. Right hand motor skills not good. Could not hold water bottle to take pill.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: rash on rt upper arm..  itchy ,warm,  and pink
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Lethargy, Nausea, Unresponsive to stimuli
Clinical narrative: 1-6-21 Fatigue, nausea 1-7-21 T. 99.6, lethargic, unresponsive   to hospital
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tongue disorder
Clinical narrative: FEVER, "THICK TONGUE", LOWER BODY ACHES
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over starting 1/23/21 and lasting for several days
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Red rash on arm approximately 4x5 inches in diameter at injection site. Warm to touch and  painful. The Dr. thought the injection site was infected . He prescribed Keflex twice daily for 7 days and Mupirocin 2% ointment three times daily. Symptoms disappeared slowly over four days. I took all the antibiotics as prescribed.