chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No additional adverse event reported; Administered a dose of MMRII in the middle of the arm instead of the outer aspect of the upper arm (deltoid region); This spontaneous report was received from a pharmacist, referring to a 37 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 11-FEB-2021, the patient vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA)(M-M-R II) 0.5 ml, lot # T006167, expiration date 19-FEB-2022, subcutaneously, for prophylaxis (strength and frequency were not reported). The pharmacist stated that the administration was subcutaneously as directed but in the middle of the arm instead of the outer aspect of the upper arm (deltoid region).No additional adverse events reported.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Injection site pain, Joint stiffness, Mobility decreased
Clinical narrative: Arthritic pain in the toes, hips, thumb, elbow/ elbow pain/ thumb pain; Soreness in his chest muscle; wrist stiff; Arm began to swell; Limited arm movement; Burning at the injection site; This case was reported by a consumer via and described the occurrence of injection site burning in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral arthritis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2020, 1 days after receiving Shingrix, the patient experienced injection site burning. On 29th September 2020, the patient experienced swelling arm, mobility decreased and stiff joint. On 9th October 2020, the patient experienced arthritic pains and musculoskeletal chest pain. On an unknown date, the outcome of the injection site burning, swelling arm, arthritic pains and stiff joint were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the musculoskeletal chest pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, swelling arm, mobility decreased, arthritic pains, musculoskeletal chest pain and stiff joint to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on left arm. Four days after receiving Shingrix, the patient's right arm began to swell, wrist stiff and had limited arm movement. Two weeks after receiving Shingrix, the patient experienced arthritic pain in the toes, hips, thumb, elbow and soreness in his chest muscle. No other address available at time of report. The reporter consented to follow up. The patient noted that he had emailed this information to GSK, but no report or patient name could be found. He reported getting an email back with case 01469077. It was not known if this was reported prior to day of reporting.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arthritic pain in the toes, hips, thumb, elbow/ elbow pain/ thumb pain; Soreness in his chest muscle; wrist stiff; Arm began to swell; Limited arm movement; Burning at the injection site; This case was reported by a consumer via and described the occurrence of injection site burning in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral arthritis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2020, 1 days after receiving Shingrix, the patient experienced injection site burning. On 29th September 2020, the patient experienced swelling arm, mobility decreased and stiff joint. On 9th October 2020, the patient experienced arthritic pains and musculoskeletal chest pain. On an unknown date, the outcome of the injection site burning, swelling arm, arthritic pains and stiff joint were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the musculoskeletal chest pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, swelling arm, mobility decreased, arthritic pains, musculoskeletal chest pain and stiff joint to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on left arm. Four days after receiving Shingrix, the patient's right arm began to swell, wrist stiff and had limited arm movement. Two weeks after receiving Shingrix, the patient experienced arthritic pain in the toes, hips, thumb, elbow and soreness in his chest muscle. No other address available at time of report. The reporter consented to follow up. The patient noted that he had emailed this information to GSK, but no report or patient name could be found. He reported getting an email back with case 01469077. It was not known if this was reported prior to day of reporting.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: First dose / in February 2020; Injection site redness; Body aches; Fever; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema, general body pain, fever and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, general body pain and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: On an unknown date in February 2020, the patient received 1st dose of Shingrix at a different facility. About 1.5 days after receiving Shingrix, the patient experienced body aches, fever, and injection site redness. Body aches and fever lasted for about 24 hours. The injection site redness, however, lasted for 5 days. Till the date of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Information like lot number was not available. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: Vaccine leaked from injection site; A spontaneous report was received from a nurse concerning a patient who received COVID-19 vaccine and experienced the event, vaccine leaked from the injection site. The patient's medical history was not provided. Concomitant product use was not reported.   On an unknown date, the patient received their first of two planned doses intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, the  vaccine leaked from the injection site. No treatment information was provided.   Action taken with in response to the event was not provided.   The event, vaccine leaked from the injection site, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses intramuscularly for prophylaxis of COVID-19 infection and vaccine leaked from the injection site. There were no reported adverse events after the vaccine was administered in this case of vaccine leaked from the injection site.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Exposure via skin contact
Clinical narrative: A spontaneous report was received from a pharmacist concerning a patient, who received COVID-19 vaccine and experienced more than half the liquid came out onto the patient's skin (accidental under dose, exposure via skin contact).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Feb 2021, the patient received their first of two planned doses intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, during administration of the vaccine, more than half of the liquid came out onto the patient's skin. No treatment information was provided.  Action taken in response to the event was not reported.   The event, more than half the liquid came out onto the patient's skin, was considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Accidental under dose, lot # unknown with no associated AEs.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Death, Dyspnoea, Malaise, Myalgia
Clinical narrative: Two days later passed away; difficulty breathing, shortness of breath; difficulty breathing, gurgling; Not feeling well; Achiness; Severe fever; Chills; A spontaneous report was received from a physician concerning a 56-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, achiness, shortness of breath, gurgling and unresponsive.     The patient's medical history was not provided. Concomitant product use was not provided.  On 19 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine on 19 Jan 2021, the patient experienced fever, chills, shortness of breath, gurgling and achiness. On 21 Jan 2021, the patient was found unresponsive. Emergency medical services were called to perform life saving measures however, they were unsuccessful. No further treatment information was provided.   The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was planned.; Reporter's Comments: This case concerns a 56-year-old, female, who experienced a serious event of death, with many other events after receiving second dose of mRNA-1273 (Lot# 042L20A). Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiration abnormal
Clinical narrative: Two days later passed away; difficulty breathing, shortness of breath; difficulty breathing, gurgling; Not feeling well; Achiness; Severe fever; Chills; A spontaneous report was received from a physician concerning a 56-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, achiness, shortness of breath, gurgling and unresponsive.     The patient's medical history was not provided. Concomitant product use was not provided.  On 19 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine on 19 Jan 2021, the patient experienced fever, chills, shortness of breath, gurgling and achiness. On 21 Jan 2021, the patient was found unresponsive. Emergency medical services were called to perform life saving measures however, they were unsuccessful. No further treatment information was provided.   The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was planned.; Reporter's Comments: This case concerns a 56-year-old, female, who experienced a serious event of death, with many other events after receiving second dose of mRNA-1273 (Lot# 042L20A). Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous report was received from a health care professional (HCP) concerning three to four patients who received COVID-19 vaccine and experienced the inappropriate dose of vaccine administered.  The patients' medical history was not provided. Concomitant products were not provided.  On an unknown date, the patients received their doses (Lot number unknown) for prophylaxis of COVID-19 infection.   The HCP stated that the patients received invalid doses (0.3ml each) and they called back the patients to give them the rest of the dose (0.2ml).   Treatments of these events were not provided.  The event inappropriate dose of vaccine administered was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered (Lot number unknown) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: took pfizer dose earlier as the 1st dose and moderna as the second; A spontaneous report was received from a consumer concerning a 20-years-old-male patient who received took Pfizer dose earlier as the 1st dose and Moderna as the second.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On unknown date, the patient received the Pfizer vaccine for the 1st dose and the Moderna vaccine as the second. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event took Pfizer dose earlier as the 1st dose and Moderna as the second was unknown.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 with no associated AEs, where wrong product was administered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Muscular weakness, Nausea
Clinical narrative: left hand was paralyzed; muscles got real weak, hands real weak then could feel it in legs,but not as bad as arms; nauseous; A spontaneous report was received concerning a 70 year old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced monoplegia, muscle weakness and nausea.  The patient's medical history was not provided. Concomitant product use was not provided.  On 01 Feb 2021, prior to the onset of events, the patient received his first of two planned dose of mRNA-1273, (batch number 013L20A), intramuscularly into his left arm for prophylaxis of Covid-19 infection.  The patient received his first dose of mRNA-1273 at the hospital which is 3 hours away from his home.  While driving home, the patient's "muscles got real weak". His left hand was "like paralyzed". "He couldn't move his fingers". Then if he moved his wrist down, his wrist would "lock up".  He had his hands on the steering wheel, he could tell they were "real weak and wanted to fall".  Then he could "feel it in his legs, and they weren't as bad as his arms". He had his foot on the accelerator and was "worried". He was "real nauseous".  It was "real scary", and he was "praying a lot".   The symptoms lasted about 4 hours in total. Two hours while driving home and two hours after arriving home. He stated he had no other reaction. No medical tests or treatment were reported.    Action taken with mRNA-1273 in response to the event was not provided.  The events, monoplegia, muscle weakness and nausea, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Administered with 0.3 ml of the vaccine; A spontaneous report was received from a pharmacist concerning a 44-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with 0.3 ml of the vaccine.  The patient's medical history was not provided. No concomitant medications were reported.  On an undisclosed date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the patient received less than the 0.5 ml dose of the Moderna Covid-19 vaccine because the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The event, administered with 0.3 ml of the vaccine, was considered resolved.  Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273. There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 83-year-old female patient who received COVID-19 vaccine and was administered with 0.3 ml of the vaccine (vaccine under dose). The patient's medical history was not provided. No concomitant medications were reported. On an undisclosed date, prior to the onset of the events, the patient received their first of two planned doses (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the patient received less than the 0.5 ml dose of the Covid-19 vaccine because the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, administered with 0.3 ml of the vaccine, was considered resolved.; Reporter's Comments: This case concerns a 83-year old female patient who received COVID-19 vaccine and was administered with 0.3 ml of the vaccine (vaccine under dose). Medical history and con meds were not provided. There are no associated AEs or SAEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 42-year-old female patient who received COVID-19 vaccine and was administered with 0.3 ml of the vaccine (vaccine under dose). The patient's medical history was not provided. No concomitant medications were reported. On an undisclosed date, prior to the onset of the events, the patient received their first of two planned doses (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the patient received less than the 0.5 ml dose of the Covid-19 vaccine because the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided. Action taken in response to the events was not provided. The event, administered with 0.3 ml of the vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of 42-year-old female patient administered with 0.3 ml of the vaccine (vaccine under dose) for lot # 030L20A). There were no associated adverse events with the event of vaccine under dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema, Vaccination site joint erythema, Vaccination site pruritus
Clinical narrative: A spontaneous report was received from a consumer concerning a 65-years-old-female patient who experienced her right arm is red, itchy, site of injection was way lower than where it should be given, arm is red, and redness spread down injection site and passed her elbow. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses (Lot # 029L20A) intramuscularly in the right arm on 18 Jan 2021 for prophylaxis of COVID-19 infection. On 18 Jan 2021, the patient received vaccination with no problems on the day of injection. On 19 Jan 2021, patient's right arm was red and itchy. On 25 Jan 2021 (7 days later), patient got redness on arm, severe itching with the redness spreading down injection site and passed the elbow. The patient saw the physician and was given antibiotics. The patient went to the emergency room and was told it was a delayed reaction with vaccine. Patient was given Benadryl and five days later all these reactions cleared - redness was gone, little bit itchy, and everything was essentially resolved. The patient stopped taking Benadryl probably from Sunday. The patient was concerned on whether to receive the second shot scheduled on 15 Feb 2021. The patient was informed by physician that site of injection was way lower than where it should be given. Patient inquired about injection site and delayed reaction. Treatment for the events included antibiotics and Benadryl. Action taken was unknown. The events her right arm is red, itchy, site of injection was way lower than where it should be given, arm is red, and redness spread down injection site and passed her elbow were considered recovered / resolved.; Reporter's Comments: This case concerns a 65-year-old female patient who received their first of two planned doses (Lot 029L20A), reporting Product administered at inappropriate site and associated non-serious adverse events of Vaccination site pruritus, Vaccination site erythema, and Vaccination site joint erythema. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Wrong technique in device usage process
Clinical narrative: Inadvertently used 1/2 inch needle instead of a 1inch needle to administer the vaccine to 20 patients; Concerned if those injections were subcutaneous; A spontaneous report was received from a consumer concerning 20 patients , who received Moderna's COVID-19 vaccine using a ½ inch needle.  The patients identity, medical history were not provided. No relevant concomitant medications were reported.  On an unknown date, 20 patients received their first dose of two planned doses of mRNA-1273 1273 (Batch number not provided) for prophylaxis of COVID-19 infection by the Pharmacist.  On an unknown date, safety received the report that Pharmacist gave the vaccine using ½ inch needle instead of 1-inch needle. He is concerned those given may be subcutaneous as he used wrong technique in device usage and inappropriate of administration. He is provided with medical information needed to administer the vaccine.  Action taken with the second dose of Moderna vaccine in response to the event was not reported. Outcome of the event wrong technique in device usage and inappropriate route of administration were recovered on an unknown date.; Reporter's Comments: This report refers to a case of wrong technique in device usage process and incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: A spontaneous report was received from a consumer concerning a 90-year-old-female patient who while receiving COVID-19 Vaccine injection a lot ran out down arm. The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.  The patient received their first of two planned doses of  Batch number 027L20a on 20-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.  Action taken with   response to the event(s) was not provided. The event when given injection a lot ran out down arm and incomplete dose administered, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of device connection issue and vaccine under dose, lot # 027L20a with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: A spontaneous report was received from a health care professional concerning a non-identifiable patient, who was received COVID-19 Vaccine and there was a drop that was not administered. The patient's medical history was not provided. No relevant concomitant medications were reported. At an unknown date, the patient received his/her 1st dose of two planned doses for prophylaxis of COVID-19 infection. On 02 Feb 2021 15:15 EST, a call came from a health care professional saying that "there was a drop that was not administered at the full vaccine". HCP had a question whether this was considered a full dose or had to re vaccinate. Attempted to contact the reporter for additional info, but no response at this time of report. Action taken with the first dose in response to the event was not reported. The outcome of the event there was a drop that was not administered (accidental under dose) was considered as resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses (Lot unknown), reporting Accidental under dose without any associated adverse events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Most of the vaccine leaked out onto my shirt; contact with skin; A spontaneous report was received from a healthcare professional concerning a 55-year-old female patient, who experienced most of the vaccine leaked out onto my shirt and contact to skin.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received her second of two planned doses of mRNA-1273 ( Lot/Batch number not provided).  On 03 Feb 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of Covid-19 infection.  The patient was administered the mRNA-1273 vaccine and stated that most of the vaccine leaked out onto her shirt, it was wet. The patient spoke with the pharmacist and a doctor at the vaccination site, asking if she is protected. Both told her she has some protection from what she received, but she is not so sure.  No treatment information was 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 events most of the vaccine leaked out onto my shirt and contact skin were considered resolved.; Reporter's Comments: This case concerns 55-year-old female patient who received her second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of Covid-19 infection and experienced most of the vaccine leaked out onto my shirt and contact to skin. There were no reported adverse events after second dose of vaccine administration in this case of incorrect dose administered and exposure via skin contact.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous report was received from a pharmacist concerning a patient, unknown age, who received COVID-19 vaccine and the needle coming off the syringe and some of the dose went down the patient's arm. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Feb 2021, the patient received their first of two planned doses (Batch number not provided) intramuscularly in arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, while vaccination the halfway through administration of the vaccine, the needle came off the syringe and some of the dose went down patient's arm. Action taken with response to the event was not reported. The outcome of the event was considered resolved on 04 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous report was received from a nurse concerning a patient, unknown age, who received COVID-19 Vaccine and some vaccine leaked out of syringe on patient's arm. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Feb 2021, the patient received their first of two planned doses (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, the nurse reported that while administering the COVID vaccine some of the vaccine leaked out of the syringe on the patient's arm. Treatment information was not provided. Action taken with second dose response to the event was not provided. The event was considered resolved on 04 Feb 2021; Reporter's Comments: This report refers to a case of Incorrect dose administered  with no associated AEs.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A spontaneous report was received from a pharmacist concerning a 17 year old, female patient who received COVID-19 vaccine at an inappropriate age.  The pharmacist would like guidance on how to report this. Medical director is in contact with the patient's primary care provider and they think it will be fine. Just want to make sure we are reporting correctly. The patient's medical history was not provided. No concomitant medication was reported. On 03 Feb 21, the patient received their first of two planned doses of (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken in response to the event was not provided. The outcome of the event was considered resolved on 03 Feb 21; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for.  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: A spontaneous report was received from a healthcare professional concerning a group of 6 patients under 18 years of age, of unknown gender, who were given COVID -19 Vaccine product administered to patient of inappropriate age. Each patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, each patient received their first of two planned doses of the prophylaxis of Covid-19 infection. On an unknown date, 6 patients under 18 years of age were given COVID-19 Vaccine. They were all 17 and a half or older. No treatment information was provided. Action taken with the second dose in response to the event was not reported. The event, 6 patients under 18 years of age were given COVID-19 vaccine, was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: small leakage from the needle onto the patients arm; A spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The pharmacist who was giving vaccinations yesterday and upon administration to a patient there was a small leakage from the needle onto the patients arm.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273. Batch number not provided on 04 Feb 2021 for prophylaxis of COVID-19 infection.  On 04 Feb 2021,the pharmacist was giving vaccinations and upon administration to a patient there was a small leakage from the needle onto the patients arm. The pharmacist was informed that in the event of a deviation from the interval between doses or deviation from the recommended dose, the vaccine recipient should be followed closely for safety outcomes, but the dose should not be repeated, as data are not available on the administration of 3 doses of the Moderna COVID-19 Vaccine. Action taken with first dose of mRNA-1273 in response to the events was not provided.  The outcome of the events small leakage from the needle onto patients arm (Vaccine underdose and Exposure via skin contact) were considered as resolved on 04 Feb 2021.  Reporter's Comments: This report concerns a subject of unknown age and gender who experienced non-serious unexpected events of a small leakage from the needle onto the patient's arm (Exposure via skin contact) and Vaccine underdose for mRNA-1273, lot # not provided. At the time of this report, there were no associated adverse events. Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Some of the vaccine leaked on her arm; Some of the vaccine leaked on her arm; Some of the vaccine leaked on her arm; A spontaneous report was received from a consumer concerning a 56-year-old, female patient, who was administered Moderna's COVID-19 vaccine and some of the vaccine leaked on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Batch/Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of Covid-19 infection. The patient received the 1st dose of the vaccine on her left arm at Pharmacy. Some of the vaccine leaked on her arm.   No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The event some of the vaccine leaked on her arm was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Product administration error of Underdose , Exposure via skin contact, Device connection issue for mRNA-1273, lot # 012L20A, with no associated AEs.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A spontaneous report was received from a consumer, concerning a 49 years-old, female patient, unknown race and ethnicity, who was administered COVID-19 vaccine, and the patient experienced reaction to the injection nine days out, red, swelling, hot and painful, and vaccine was injected below the deltoid in error. The patient's medical history was not provided. No concomitant medications were reported. On 13 JAN 2021, prior to the onset of events, the patient received their first dose of (Lot number: unknown), intramuscular in the deltoid area for prophylaxis of COVID-19 infection. It was reported that the patient had a reaction to the injection, nine days out from it on an unknown date. The reaction was red, swollen, hot and painful. The patient took ibuprofen and acetaminophen and was rotating every few hours for eight days, along with icing it. She went to the doctor's office yesterday and was prescribed steroids and loratadine. The patient also stated that the vaccine was injected below the deltoid area in error. The patient discussed with her doctor if she should get the second dose and they advised her not to take due to her adverse reactions and would like to know more information about vaccine. Action taken with second dose in response to the events was not reported. The outcome of the events, reaction to the injection nine days out, red, swelling, hot and painful, were not reported and that of event, vaccine was injected below the deltoid in error, was reported as resolved on an unknown date.; Reporter's Comments: This case concerns a 49 year old female with NS unexpected event of Incorrect route of product administration and NS expected injection site erythema, injection site swelling, injection site pain, injection site warmth. Event onset 9 days after first dose. Treatment: ibuprofen, acetaminophen, steroids, loratadine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got 1st dose of vaccine on 22 Jan 2021 and 2nd dose 08 Feb 2021; A spontaneous report  was received from a nurse concerning a 60-year old male patient who received the first dose Moderna's COVID-19 vaccine (mRNA-1273), and received the second dose on 08 Feb 2021 (17 days after the first dose).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 08 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) for prophylaxis of COVID-19 infection.  On 09 Feb 2021, a nurse reported a patient received the second dose of Moderna vaccine 17 days after the first dose. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, patient got 1st dose of vaccine on 22 Jan 2021 and 2nd dose 08 Feb 2021, was considered resolved on 08 Feb 2021.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: A spontaneous report received from a pharmacist concerning a 45-year-old female patient who received COVID-19 vaccine and experienced receiving COVID-19 vaccine as a second dose after a Pfizer Vaccine. The patient's medical history was not provided. Patient's concomitant was not provided.  On 16 Dec 2020, the patient received a first dose of Pfizer's COVID-19 vaccine for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient received a dose (Batch number: 026120A) intramuscularly for prophylaxis of COVID-19 infection and experienced wrong vaccine administered. No adverse events were experienced, and no treatment was reported. Action taken with 73 in response to the event was not provided. The outcome of the event, receiving a COVID-19 vaccine as a second dose after  Vaccine, was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 45-year-old female patient who received a COVID-19 vaccine as a second dose after P Vaccine, reporting Wrong product administered without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haemorrhage urinary tract, Urine analysis
Clinical narrative: On Saturday little blood clot, no liquid blood, and this morning this same; a little blood in the urine; This is a spontaneous report from a contactable consumer (the patient). A male patient (Age: 77, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included little blood clot, no liquid blood, 7 years ago (unspecified date in 2014). The patient's concomitant medications included fish oil and acetylsalicylic acid (ASPIRIN). The patient stated he received the first dose of the COVID shot on Thursday (unspecified date). The next morning, there was a little blood in the urine. On Saturday, little blood clot, no liquid blood, and this morning the same. The patient had this before 7 years ago. The patient asked if anyone else reported this and for information. The clinical outcome of little blood clot and a little blood in urine was unknown.   Information on Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Tinnitus
Clinical narrative: Ringing in ears (tinnitus), Constant for 4 weeks (and still taking place) plus severe neck pain and pain in back of head.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Post-acute COVID-19 syndrome, Pruritus
Clinical narrative: COVID arm. Redness and itching
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Developed a localized red rash at injection site the size of the palm of my hand. Hard, red, itching. At the time of this report it was still hard, red with less itching. Since beginning I have been taking pepcid 20mg and 12.5mg benadryl daily and applying ice to site 2x daily.  No extreme allergic reactions i.e. SOB, lightheadedness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash papular, Rash pruritic
Clinical narrative: Red bump at injection site. Itchy, raised rash a week after the injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Depression, Fatigue
Clinical narrative: At first, chills and extreme fatigue, within 24 hours, which I expected. What I did not expect, and was surprised at its severity, was 72 hours after the chills subsided, (almost 5 days after my vaccine), was a depressive episode that lasted almost three full days. (Please note I am not a depressed individual nor was I sad before this event- that?s what made this so noticeable for me). On the fourth day after the depression hit, I felt fine. It was truly palpable: to the point I feel compelled to report this so you have data in case others are affected this way, as well.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Sensitive skin, Skin irritation
Clinical narrative: C/o worsening facial irritation along with rash since last Fri. couldn't sleep due to itching and pain. states has very sensitive skin. took Benadryl on Fri and Sat but not helped. COVID vaccinated on 28 Dec 2020. denies sob or difficulty to breath
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: C/o worsening facial irritation along with rash since last Fri. couldn't sleep due to itching and pain. states has very sensitive skin. took Benadryl on Fri and Sat but not helped. COVID vaccinated on 28 Dec 2020. denies sob or difficulty to breath
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site mass, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Soreness was the initial symptom after the flu vaccination.  After the pain did not subside I felt what seemed like a lump in my arm where I was vaccinated, it hurt to touch.  Soon after the pain was accompanied by loss of range of motion through today.   Due to the pandemic I have been taking ibuprofen and Tylenol daily and icing my shoulder and arm.  I can no loner lift my arm completely, change my cloths comfortably.  I am in constant pain.  I do not know if the flu shot was injected into my tendon or what caused this reaction.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under arms
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: 02/13/21  Headache, fatgue, shortness of breath, pain at injection site 02/14/21  Same 02/15/21  Fatigue, shortness of breath increased and dizziness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Lump and pain under arm near right breast
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Covid Arm 8 days after injecting
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Genital lesion
Clinical narrative: developed genital herpes lesions 3-4 days after vaccination with no other prior exposure or occurence of HSV-2
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Chills headache arm soreness achy
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Arm pain/soreness/induration/stiffness - Tylenol; early onset within hours  Chills - onset ~18hrs, lasted 2 hours Muscle aches - onset 18hrs, lasted about a day Joint pain - onset 24hrs, lasted about 1/2 day Fatigue - onset 12 hours, worsened after 48 hours Nausea - onset after 72 hours
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Skin induration
Clinical narrative: Arm pain/soreness/induration/stiffness - Tylenol; early onset within hours  Chills - onset ~18hrs, lasted 2 hours Muscle aches - onset 18hrs, lasted about a day Joint pain - onset 24hrs, lasted about 1/2 day Fatigue - onset 12 hours, worsened after 48 hours Nausea - onset after 72 hours
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Post-acute COVID-19 syndrome
Clinical narrative: Covid arm, rash around injection site and slight pain one week after first vaccine shot
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Tension headache
Clinical narrative: Bad headache, 10/10 pain, squeezing feeling on brain.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Significant Loss of smell and taste
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Significant bruising at injection site approximately 2 inches in diameter lasting approximately 10 days to 2 weeks.  No treatment and bruise eventually dissipated.  Never had this happen with any other vaccine and the injection was uneventful.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Hypoaesthesia, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: Arm pain for over 3 weeks at the injection site by my right arm, it?s so sore it?s hard to lift hand up or to hold things, also breast pain in the right side that I never had before. This has lasted 3 weeks. Within 48 hours after the shot I had tingling and numbing and soreness. Distressed about my arm pain 3 weeks later it feels like someone punched my arm.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Arm pain for over 3 weeks at the injection site by my right arm, it?s so sore it?s hard to lift hand up or to hold things, also breast pain in the right side that I never had before. This has lasted 3 weeks. Within 48 hours after the shot I had tingling and numbing and soreness. Distressed about my arm pain 3 weeks later it feels like someone punched my arm.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: Dizzy, headache, feeling weird/off, stomach off.  Happened once the first week, felt crappy the second week, more sporadic the 3rd week, but happened again today for the first time in 4 days, for a few hours. Starting my 4th week.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash
Clinical narrative: Bruise at lower leg, rash on arms
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Flushing, Injection site erythema, Injection site induration
Clinical narrative: Moderna COVID?19 Vaccine EUA "Covid Arm"  8 days after the first dose, there was a firm bump at the injection site, approx the size of a kiwi. It was red, slightly itchy, and warm to the touch. No pain. It faded away over the course of 4 hours. At the four hour mark, my face/cheeks flushed bright red and were warm for approx 20-30 mins (no fever). I went to urgent care and they sent me away with no treatment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth, Post-acute COVID-19 syndrome
Clinical narrative: Moderna COVID?19 Vaccine EUA "Covid Arm"  8 days after the first dose, there was a firm bump at the injection site, approx the size of a kiwi. It was red, slightly itchy, and warm to the touch. No pain. It faded away over the course of 4 hours. At the four hour mark, my face/cheeks flushed bright red and were warm for approx 20-30 mins (no fever). I went to urgent care and they sent me away with no treatment.