chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Deviated from his course of Vivotif / did not complete the Vivotif course in time; Spontaneous report received on 24FEB2020.  A nurse reported that a male consumer who "deviated from his course of Vivotif / did not complete the Vivotif course in time" (PT: Incomplete course of vaccination). The consumer was receiving Vivotif capsule for immunisation. The consumer did not take the Vivotif doses according to the schedule. The doses were taken on 13FEB2020, 16FEB2020, and 18FEB2020. He has yet to take the fourth dose. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer deviated from his course of Vivotif  and did not complete the Vivotif course in time (Incomplete course of vaccination). Vivotif should be taken every other day. Considering the nature of the event, the causality of Incomplete course of vaccination is assessed as not applicable to Vivotif.; Sender's Comments: A consumer deviated from his course of Vivotif  and did not complete the Vivotif course in time (Incomplete course of vaccination). Vivotif should be taken every other day. Considering the nature of the event, the causality of Incomplete course of vaccination is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took third dose of Vivotif 24 hours late; Spontaneous report received on 24FEB2020.  A physician reported that a female consumer "took third dose of Vivotif 24 hours late" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunisation. The consumer took the first two doses of Vivotif as per schedule but took the third dose 24 hours late. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took her third dose of Vivotif 24 hours late (Inappropriate schedule of product administration). Vivotif should be take every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took her third dose of Vivotif 24 hours late (Inappropriate schedule of product administration). Vivotif should be take every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took two doses of Vivotif on consecutive days; Spontaneous report received on 26FEB2020.  A caregiver reported that his daughter "took two doses of Vivotif on consecutive days" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunisation. The consumer took two doses of Vivotif every day instead of every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took two doses of Vivotif on consecutive days (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took two doses of Vivotif on consecutive days (Inappropriate schedule of product administration) instead of taking every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed third and fourth dose; Spontaneous report received on 27FEB2020.  A nurse reported that a consumer "missed third and fourth dose" (PT: Product dose omission) while being on Vivotif for immunisation. Onan unknown date, the consumer took fisrt and second dose of Vivotif. However, the consumer missed the third and fourth dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first two doses of Vivotif and then missed the third and fourth dose (missed dose). Vivotif should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first two doses of Vivotif and then missed the third and fourth dose (missed dose). Vivotif should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif two days in a row; Spontaneous report received on 27FEB2020.  A female consumer reported that she "took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunisation. She took the first and second dose of Vivotif on 26FEB2020 and 27FEB2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first and second doses of Vivotif two days in a row (Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first and second doses of Vivotif two days in a row (Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif two days in a row; Spontaneous report received on 27FEB2020.  A pharmacist reported that a female consumer "took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunisation. She took the first and second dose of Vivotif on 24FEB2020 and 25FEB2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first and second dose of Vivotif two days in a row (Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first and second dose of Vivotif two days in a row (Inappropriate schedule of product administration) instead of taking it every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site pain, Pruritus, Swelling
Clinical narrative: soreness/tenderness; bruising around injection.; itching; bruising that radiated into her hand and wrist.; redness; soreness / and aching that radiated into her hand and wrist.; swelling; This case was reported by a physician and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received Shingrix. On 15th December 2020, 1 days after receiving Shingrix, the patient experienced erythema, pain and swelling. On an unknown date, the patient experienced injection site pain, injection site bruising, pruritus and contusion. On an unknown date, the outcome of the injection site pain, injection site bruising, pruritus and contusion were recovering/resolving and the outcome of the erythema, pain and swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site bruising, erythema, pain, swelling, pruritus and contusion to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced redness, soreness, swelling that lasted 2-3 days, then she began to experience itching, bruising and aching that radiated into her hand and wrist, also reports tenderness around injection site, soreness and bruising around injection. The patient reported event were mildly improving. The patient said aching was worse at night. The reporter gave consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: soreness/tenderness; bruising around injection.; itching; bruising that radiated into her hand and wrist.; redness; soreness / and aching that radiated into her hand and wrist.; swelling; This case was reported by a physician and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received Shingrix. On 15th December 2020, 1 days after receiving Shingrix, the patient experienced erythema, pain and swelling. On an unknown date, the patient experienced injection site pain, injection site bruising, pruritus and contusion. On an unknown date, the outcome of the injection site pain, injection site bruising, pruritus and contusion were recovering/resolving and the outcome of the erythema, pain and swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site bruising, erythema, pain, swelling, pruritus and contusion to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient experienced redness, soreness, swelling that lasted 2-3 days, then she began to experience itching, bruising and aching that radiated into her hand and wrist, also reports tenderness around injection site, soreness and bruising around injection. The patient reported event were mildly improving. The patient said aching was worse at night. The reporter gave consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Skin discolouration
Clinical narrative: dark, discolored spot; dark, discolored spot that itches; This case was reported by a consumer and described the occurrence of skin discoloration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin discoloration and pruritus. On an unknown date, the outcome of the skin discoloration and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the skin discoloration and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. At the time of reporting, the patient still had a dark, discolored spot that itches.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: pain; developed the shingles rash; Developed the shingles rash; still has lesions; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2020, the patient received the 1st dose of Shingrix. In December 2020, less than 2 months after receiving Shingrix, the patient experienced shingles, rash and skin lesion. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the shingles and rash were unknown and the outcome of the skin lesion and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, skin lesion and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. About a month before the reporting, the patient developed the shingles rash and still had lesions on the day of reporting.  The patient was to receive 2nd dose of Shingrix on the day of reporting. The reporter asked if they can give the vaccine during an active outbreak and how long they should wait after lesions and pain were gone.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: ringing in the ears (tinnitus); This case was reported by a consumer and described the occurrence of tinnitus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus.   On 12th July 2020, the patient received the 1st dose of Shingrix. In July 2020, an unknown time after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient stated that, there were days when his ears ring for 24 hours straight and there was times where could had a day with no ringing.  The patient did see two ENT doctors and there was nothing wrong with his ears or eardrums.  The patient received Shingrix and 12 hours after developed ringing in the ears tinnitus and never had that prior to receiving the vaccine.  He stated, it was just ironic that he lived 61 years of life without ringing in ears until 12 hours after received the vaccine and did had the second vaccine in December hoping it would reverse it, but it did not. The patient felt should let know this happened to see if there are any suggestions GSK might had.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This case was reported by a consumer and described the occurrence of pain in extremity in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for 1stdose refer case US2021027897).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was recovered/resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional details were reported as follows: The patient had shingrix and his arm hurt for about a day before resolving. Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021027897:same patient
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms after the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The age at vaccination was not reported. Patient received the dose of Shingrix and had flu like symptoms. The reporter did not consent to follow up. The case was linked with US2021010484 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010484:same reporter US-GLAXOSMITHKLINE-US2021AMR011092:same patient, 2nd dose
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Treponema test false positive
Clinical narrative: positive syphilis test was revealed; This case was reported by a consumer via call center representative and described the occurrence of syphilis test false positive in a 47-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than 2 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced syphilis test false positive. On an unknown date, the outcome of the syphilis test false positive was unknown.   It was unknown if the reporter considered the syphilis test false positive to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received the vaccine in September 2020 and in November 2020 and December 2020, a false positive syphilis test was revealed when the patient was attempting to donate blood.   The patient was an active blood donor and these false tests are keeping him from providing blood to those who need it.  The patient was contributing the false positive test directly to the Fluarix vaccine. The reporter consented to follow up.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness presenting a couple of inches below the injection site; This case was reported by a pharmacist and described the occurrence of erythema in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H3Z4, expiry date 27th August 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknkown date).   On 26th January 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2021, less than a week after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The patient received her dose in left arm and experienced redness presenting a couple of inches below the injection site. The information regarding consent to follow was not reported. No further information was available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Hypertension
Clinical narrative: hypertension; This case was reported by a consumer via call center representative and described the occurrence of hypertension in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced hypertension (serious criteria death). On an unknown date, the outcome of the hypertension was fatal. The patient died on 14th August 2020. The reported cause of death was hypertension.   It was unknown if the reporter considered the hypertension to be related to Shingrix.  Additional information was provided as follows: The case was reported by a friend of the patient. The patient received a dose of Shingrix in a pharmacy.  Two days later on 14th August 2020, the patient was found dead in his bed at his home. The cause of death was listed as hypertension. It was not known if the patient had a history of hypertension. No other details were known at time of report. The physician might be contacted for further details. The reporter who was a friend of the patient, did not wish to be known. ; Reported Cause(s) of Death: Hypertension
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Incorrect route of product administration, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Injected the Moderna Vaccine into the joint space of proximal head of right humerus/posterior; Pain raditaing from injection site to right hand; local aching pain 5-6(10) at site; Fever; A spontaneous report received from a Consumer concerning, 72-year-old female patient who received 2nd dose of the Moderna COVID-19 vaccine that was not injected into the muscle. /MedDRA PT: [Injection error]  ~ The patient's medical history included Asthma. Patient's concomitant was not included.   On 05-FEB-2021 date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in right arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated the she received her 2nd dose of the Moderna COVID 19 vaccine on 05FEB2021 and the person who gave the vaccine, injected the Moderna COVID-19 vaccine into the joint space of proximal head of right humerus/ posterior. Patient stated that the injection was exquisitely painful for 3 days and she had a fever of 101.2. Patient stated that she had local aching pain 5-6(10) days and radiating pain from injection site to right hand for 4 days. Patient stated that she would like to know is the dose invalid since it was not given intramuscularly. Dose she needs to repeat  2nd dose of the vaccine. What are the concerns injecting into tendon/ ligament?  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of  inappropriate route of administration with reported non-serious events of pain in extremity, fever, and vaccination site pain. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Myalgia, Peripheral swelling, Pneumonia
Clinical narrative: pneumonia; Tired; Achy; Muscle weakness in left arm; Arm  was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia.  The patient's medical history was not provided. Concomitant medications were not reported.   On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia.  On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about".  The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine.  The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Volume difference in syringe from first dose and second dose; A spontaneous report was received from a consumer concerning a 69 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medication error of volume difference in syringe from 1st and 2nd dose/MedDRA PT: inappropriate dose of vaccine administered.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included tamsulosin, clonazepam, apixaban and metoprolol.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) on 13 Jan 2021.  On 10 Feb 2021, approximately 29 days later, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported that he was told by one person at the facility that both doses were the same; however, he reported that the person who administered the second dose told him that the second dose was a lot higher than the first dose because it was a booster dose and that she showed him the volume difference in the syringe from the first dose and what she would be administering.  The patient reported that the amount in the syringe for the second dose was significantly more, but he did not remember the amount from the syringe.  The patient was told by a third person at the facility that both doses were the same.  The patient did not experience any side effects yet but was concerned and confused if he received a potential overdose.  Treatment for the event included none.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was resolved.; Reporter's Comments: This is a case of 69-year-old male patient who was administered volume difference in syringe from 1st and 2nd dose (inappropriate dose of vaccine administered) for mRNA-1273 vaccine Lot # 041L20A. There was no associated adverse event reported for the event of inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: mixing vials for quite a few patients to make up missing parts; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine.  Patients' medical history was not provided. No relevant concomitant medications were reported.  On 27 JAN 2021, patient received their one of two planned doses of mRNA-1273(Lot/ batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 27 JAN 2021, when patient received the vaccine, the reporter stated that her office has been mixing vials of Moderna's COVID-19 vaccine for quite a few patients to make up missing parts. She wanted to know, was it efficient to open a different vial and get parts missing for an already punctured vial to administer. Treatment for the event was not provided.  Action taken with the other dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, mixing vials for quite a few patients to make up parts, was considered recovered/resolved on 27 JAN 2021.; Reporter's Comments: This report refers to a case of "Interchange of vaccine products" for mRNA-1273, lot # unknown,  with no associated Adverse Events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Moderate fever; Fatigue; Chills; Patient received first dose 27Jan2021, and second dose 8Feb2021; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine first dose on 27 JAN 2021, and second dose on 08 FEB 2021 and experienced moderate fever, fatigue, chills after second dose.  The patient's medical history, as reported by pharmacist, include COVID-19 infection. Relevant concomitant medications reported were, include Alendronate  70 milligram, Aspirin- 81 milligram, Atorvastatin- 40 milligram, Basaglar Insulin, Vitamin D2, Lexapro- 10 milligram, Gabapentin 100 milligram. On 27 JAN 2021, patient received their first of two planned doses of mRNA-1273(BATCH/LOT number: unknown), for the prophylaxis of COVID-19 infection. On 08 FEB 2021, patient received second dose of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On unknown date, after receiving second dose of mRNA-1273 vaccine, patient experienced moderate fever, fatigue and chills. Treatment for the events were not provided. Action taken the second dose of mRNA-1273 in response to the events were not reported. The outcome of the events, moderate fever, fatigue, chills after second dose, were unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered associated with events of pyrexia, fatigue and chills. 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.  The causality for inappropriate schedule of vaccine administered remains not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Needle issue, Pyrexia
Clinical narrative: fever; rigors; muscle aches; during administration the barrel broke off from the needle and most of the vaccine leaked out; Needle issue; feeling faint; A spontaneous report was received by a consumer regarding themselves, a patient. Age and sex were not provided. The patient experienced the barrel breaking off the needle and most of the injection leaking out/incomplete dose administration, feeling faint/dizziness, fever/pyrexia, rigors/chills and muscle aches/myalgia.   The patient's medical history was not provided. No concomitant medications provided.   On 09 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: not provided) injected into the arm for prophylaxis of COVID-19 infection.  The patient received the second injection on 09 Feb 2021 and reported that the needle broke off the barrel during administration, and most of the vaccine leaked out. They reported that the health care provider offered to administer another dose. The patient declined due to feeling faint.   On 10 Feb 2021, the patient woke in the middle of the night with a robust immune response that included fever, rigors and muscle aches. Treatment information was not provided.   Patient consented to be contacted.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, the barrel breaking off the needle and most of the vaccine leaked out, feeling faint, immune response fever, rigors and muscle aches was considered resolved/recovered.; Reporter's Comments: This report refers to a case of vaccine underdose and needle issue,  for mRNA-1273, lot number unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: fever; rigors; muscle aches; during administration the barrel broke off from the needle and most of the vaccine leaked out; Needle issue; feeling faint; A spontaneous report was received by a consumer regarding themselves, a patient. Age and sex were not provided. The patient experienced the barrel breaking off the needle and most of the injection leaking out/incomplete dose administration, feeling faint/dizziness, fever/pyrexia, rigors/chills and muscle aches/myalgia.   The patient's medical history was not provided. No concomitant medications provided.   On 09 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: not provided) injected into the arm for prophylaxis of COVID-19 infection.  The patient received the second injection on 09 Feb 2021 and reported that the needle broke off the barrel during administration, and most of the vaccine leaked out. They reported that the health care provider offered to administer another dose. The patient declined due to feeling faint.   On 10 Feb 2021, the patient woke in the middle of the night with a robust immune response that included fever, rigors and muscle aches. Treatment information was not provided.   Patient consented to be contacted.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, the barrel breaking off the needle and most of the vaccine leaked out, feeling faint, immune response fever, rigors and muscle aches was considered resolved/recovered.; Reporter's Comments: This report refers to a case of vaccine underdose and needle issue,  for mRNA-1273, lot number unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some of the vaccine leaked out while administered; Some of the vaccine leaked out while administered; A spontaneous report was received from a nurse concerning a 31-years-old, male patient who experienced some of the vaccine leaked out while administered.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 07 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number 011m20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 07 Feb 2021, the patient experienced some of the vaccine leaking out while being administered. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event some of the vaccine leaked out while administered was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose  and Syringe connection Issue for mRNA-1273 [Lot number 011m20a]  with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Did not receive the full dose; A spontaneous report was received from a health care professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive full dose/accidental underdose.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, during administration of the Moderna COVID-19 vaccine, the nurse pulled the needle out of the patient's arm too quickly and the patient did not receive the full dose of the vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, did not receive full dose/accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273(Lot number: not provided) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received a lower dose (0.4ml) of the Moderna Vaccine; A spontaneous report was received from a nurse, concerning a 57-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) of lower dose (0.4ml).  The patient's medical history was not provided. No concomitant product use was reported.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) intramuscularly for prophylaxis of COVID-19 infection.   On 08 Feb 2021, a health care professional reported that a patient was given 0.4 milliliters of the Moderna COVID-19 vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, received a lower dose (0.4ml) of the Moderna vaccine, was considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the first shot 10 days before; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and the patient had received the first shot ten days before/inappropriate schedule of product administration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 FEB 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection.   On 22 FEB 2021, at approximately 09:00 am, the patient received the second dose of Moderna vaccine (Lot number: O3OM2OA). The patient did not feel the vaccine went in, there was no blood on the band aid. The patient had received the first shot ten days before. 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 was not applicable.  The outcome of event, received the first shot ten days before, was considered as resolved.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273(Lot number: O3OM2OA), with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Circumoral oedema, Myalgia, Orbital oedema, Pyrexia
Clinical narrative: worsening bilateral infraorbital perioral edema; worsening bilateral infraorbital perioral edema; generalized myalgias; fever of 101.6F; A spontaneous report was received from a literature article  regarding, a 36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Circumoral edema, Orbital Edema, myalgia, and fever/pyrexia.  The patient's medical history was not included, other than that she was considered a healthy female. Concomitant medications known to have been used by the patient were not included.  In November 2019, prior to the vaccination, the patient received hyaluronic acid injections in the tear troughs and in both the upper and lower lip.  On 05 Jan 2021, prior to the onset of the events, the patient received the first of two doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 05 Jan 2021, about 12 hours after the vaccine was administered, the patient presented with a fever of 101.6 Fahrenheit and had generalized myalgia. Treatment included acetaminophen.   On 06 Jan 2021, the fever and myalgia were resolved. As the day continued, the patient noticed pain and swelling in the right tear trough and increasing swelling around her mouth.   On 07 Jan 2021, approximately 36 hours after vaccination, the patient was administered 10 mg of cetirizine. At 48 hours the patient reported that the swelling was at it's peak and she was unable to open her right eye. The patient then took 20 milligrams of cetirizine. Throughout the morning, the left tear trough began to increase, and the rest of her face remained persistently swollen. The patient was administered 5mg lisinopril. Within about 5 hours of dose of lisinopril, the patient reported that swelling had stopped and was decreasing. Over the next 24 hours, edema was improved, and patient returned to baseline.  Action taken with mRNA-1273 was not provided.  The outcome of the events, circumoral edema, periorbital edema, myalgia and fever, was considered 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate increased, Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; Chest pain; rapid heartbeat; A spontaneous report was received from a 20-year- old male patient who experienced chest pain, myocarditis, pericarditis, inflammation of pericardium.  The patient's medical history was not provided. Concomitant medications included phenylpropanolamine, diclofenac sodium, and colchicine.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021 intramuscularly for the prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced chest pain, rapid heartbeat and went to emergency room (ER). He was hospitalized and was diagnosed with myocarditis, pericarditis, inflammation of pericardium. The patient was discharged on 31 Jan 2021.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, chest pain, myocarditis, pericarditis, inflammation of pericardium, was considered not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. The use of concomitant medication, Pnenylpropanolamine, which is a sympathomimetic agent, is a risk factor and confounding factor for causality.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Seizure
Clinical narrative: Convulsions due to pain; Severe pain; A spontaneous report was received via voicemail from daughter, concerning her mother, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced convulsions due to pain and severe pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, the reported stated her mother experienced severe pain to the point of convulsing. She mentioned her mother was at the doctor. No treatment information provided.   The outcome for the event, convulsions due to pain and severe pain, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: vaccine leaked out during administration of the injection; needle was not snuggly attached to the syringe; A spontaneous report was received from a nurse practitioner concerning a patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced needle that was not snuggly attached to the syringe/MedDRA PT: device connection issue and vaccine leaked out during administration of the injection/MedDRA PT: underdose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28 Jan 2021, the patient received unknown dose number of mRNA-1273 (Lot # not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, upon administering Moderna vaccine, the needle was not snuggly attached to the syringe; therefore, some of the vaccine leaked out.   Action taken with mRNA-1273 in response to the events was not provided.  The events needle was not snuggly attached to the syringe and vaccine leaked out during administration of the injection were considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Limb discomfort
Clinical narrative: Cellulitis; Arm was sore; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis and arm was sore/limb discomfort.  The patient's medical history was not provided.  Concomitant medication included an unspecified low dose blood pressure medication.  On 18Jann2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan2021, the patient experienced sore arm.  On 24Jan2021, the patient experienced itching, swelling and feeling hot at the injection site.  The patient was diagnosed with cellulitis and was treated with unspecified antibiotics for 10 days.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of cellulitis (itching, swelling, hot at the injection site) and limb discomfort was considered 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Hemiparesis, Pneumonia
Clinical narrative: left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report  received from a Consumer concerning, 79-year-old female patient who received the first dose of Moderna COVID-19 vaccine and woke up the next morning not feeling well. /PT: [Not Feeling Well].   The patient's medical history included COPD, hypertension and hyperlipidemia. Patient allergies included sleep medications. Patient's concomitant included Gabapentin, Simvastatin, Advair, Spiriva and Proventil.    On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in left arm (Batch #: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient daughter called on behalf of her mother. Patient daughter stated that her mother received the Moderna COVID-19 vaccine on 04FEB2021 and on 05Feb2021 her mother woke up and wasn't feeling well. She stated her mother had weakness on her left side. The daughter stated that ambulance took her mother to hospital. The daughter stated that her mother had stroke like symptoms. The daughter stated her mother had difficulty speaking and slurred speech. The daughter stated the doctor Called it "Neglect for sensation". The daughter stated her mother was treated like she had a stroke. The daughter stated that the doctor gave her mother a "Clot buster" treatment and it started to normalize. The daughter stated the MRI was negative. She daughter that her mother was still hospitalized and now has pneumonia. Wanted to know if this has been previously reported.  Treatment that was given in the hospital was a "Clot Buster"  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Hemiparesis, dysarthria, and pneumonia were consistent with increased risk of cerebrovascular accidents related to high blood pressure confounded by elderly age of patient. Very limited information regarding this event/s has been provided at this time. 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.