chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain, redness, and swelling at the injection site; Pain, redness, and swelling at the injection site; Swelling at the injection site; Stayed in bed for 24 hours; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 23rd October 2020, refer linked case US2021AMR002675) and PNEUMONIA VACCINE (patient received on 23rd October 2020, refer linked case US2021AMR002675).   On 4th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, weakness generalized, muscle pain, tiredness, headache, shivering, fever and upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were not recovered/not resolved and the outcome of the weakness generalized was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, weakness generalized, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient had received second dose of Shingrix at the MD office. The batch number and expiry date of Shingrix was unknown. After the second Shingrix shot, the patient had to stay in bed for 24 hours and then felt better.  The patient experienced all the side effects listed on the website such as pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002675:Same suspect, same reporter, same patient, different dose (1st dose)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Chicken Pox-like rash on chest, torso and upper buttocks; Itchiness where rash is located; This case was reported by a consumer and described the occurrence of varicella-like rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included flu vaccine.   On 25th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 23rd December 2020, 28 days after receiving Shingrix and 30 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced varicella-like rash and itchy rash. On 7th January 2021, the outcome of the varicella-like rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash and itchy rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by the patient for herself. The patient had a flu vaccine before and never had any reactions to it.  The patient received the 1st dose of Shingrix vaccine in an unknown arm. She also received a flu vaccine (unknown manufacturer) in the opposite arm on the same day. She broke out in a chicken Pox like rash on her chest, torso (including abdomen) and upper area of her buttocks.  She reported there was itchiness on the areas she has the rash. The symptoms were not improving and it actually be getting worse. The reporter did not have lot or expiration date of the vaccine.  The reporter consent to follow up. Vaccinations dates reported as 25th November 2020 and 23rd  November 2020 for Shingrix and  Flu vaccine respectively however description in source document stated the patient received on same day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Pain in extremity, Rash
Clinical narrative: Rash; Swelling; Redness; Burning down to her hand; severe Pain shooting down her arm / arm continues to be Painful; This case was reported by a consumer and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th January 2021, less than an hour after receiving Shingrix, the patient experienced rash, swelling, erythema, burning sensation and pain in arm. The patient was treated with ibuprofen, steroids nos (Steroid (Not Specified)) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the rash, swelling, erythema and burning sensation were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the rash, swelling, erythema, burning sensation and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix on 6th January 2021 in her right arm. Approximately twenty to thirty minutes later, the patient had severe Pain shooting down her arm and Burning down to her hand. The patient also reported a rash, redness and swelling. The patient went to the emergency room, and received a recommendation for ibuprofen. On 7th January 2020, the patient went to an urgent care and received steroids, and an antibiotic. The patient was also taking ibuprofen. Her arm continued to be Painful. The reporter consented to follow up. Emergency room visit required.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Rash; Swelling; Redness; Burning down to her hand; severe Pain shooting down her arm / arm continues to be Painful; This case was reported by a consumer and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 6th January 2021, less than an hour after receiving Shingrix, the patient experienced rash, swelling, erythema, burning sensation and pain in arm. The patient was treated with ibuprofen, steroids nos (Steroid (Not Specified)) and antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the rash, swelling, erythema and burning sensation were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the rash, swelling, erythema, burning sensation and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix on 6th January 2021 in her right arm. Approximately twenty to thirty minutes later, the patient had severe Pain shooting down her arm and Burning down to her hand. The patient also reported a rash, redness and swelling. The patient went to the emergency room, and received a recommendation for ibuprofen. On 7th January 2020, the patient went to an urgent care and received steroids, and an antibiotic. The patient was also taking ibuprofen. Her arm continued to be Painful. The reporter consented to follow up. Emergency room visit required.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Inappropriate schedule of product administration
Clinical narrative: alternating feeling of hot and cold; two doses of Shingrix were 10 months apart; This case was reported by a consumer via call center representative and described the occurrence of feeling hot and cold in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in 2017, lot number 524S7, expiry date 12th February 2021, VAREs: CVS Pharmacy, Washington DC).   In August 2018, the patient received the 2nd dose of Shingrix. In August 2018, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced feeling hot and cold. On an unknown date, the outcome of the feeling hot and cold were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   The reporter considered the feeling hot and cold to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. The patient initially thought the shingles vaccine she got was Zostavax but she would check again because she received 2 shingles vaccine shots. Later on it was confirmed that the patient's first shingles vaccine was not Zostavax. The patient received 2nd dose 10 months after the 1st dose, which led to lengthening of vaccination schedule. The patient went to the emergency room for alternating feeling of hot and cold after receving 2nd dose of Shingrix. Emergency room provider said it was a reaction to the shingles vaccine.  The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pain in extremity, Pruritus, Sensitive skin
Clinical narrative: welt on her upper arm; Itching; Redness; sensitivity and arm pain; sensitivity in arm; This case was reported by a consumer via call center representative and described the occurrence of welts in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th January 2021, 5 days after receiving Shingrix, the patient experienced welts, pruritus, erythema, pain in arm and sensitive skin. On an unknown date, the outcome of the welts, pruritus, erythema, pain in arm and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the welts, pruritus, erythema, pain in arm and sensitive skin to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of Shingrix and patient began experiencing a welt on her upper arm, itching, redness, sensitivity and arm pain. These symptoms were continuing till the time of reporting and were not resolved.  The reporter gave permission to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: welt on her upper arm; Itching; Redness; sensitivity and arm pain; sensitivity in arm; This case was reported by a consumer via call center representative and described the occurrence of welts in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 13th January 2021, 5 days after receiving Shingrix, the patient experienced welts, pruritus, erythema, pain in arm and sensitive skin. On an unknown date, the outcome of the welts, pruritus, erythema, pain in arm and sensitive skin were not recovered/not resolved.   It was unknown if the reporter considered the welts, pruritus, erythema, pain in arm and sensitive skin to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of Shingrix and patient began experiencing a welt on her upper arm, itching, redness, sensitivity and arm pain. These symptoms were continuing till the time of reporting and were not resolved.  The reporter gave permission to follow up.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Fever / Required ambulance and ER evaluation; Chills / Required ambulance and ER evaluation; Aches / Required ambulance and ER evaluation; Weakness / Required ambulance and ER evaluation; This case was reported by a nurse and described the occurrence of fever in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th May 2019).   On 18th November 2019, the patient received the 2nd dose of Shingrix. On 20th November 2019, 2 days after receiving Shingrix, the patient experienced fever, chills, pain and weakness. On an unknown date, the outcome of the fever, chills, pain and weakness were unknown.   It was unknown if the reporter considered the fever, chills, pain and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced fever, chills, weakness and aches. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: continuous pain for 4 months; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) (batch number H552G, expiry date 20th September 2022) 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 pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, he had continual pain for 4 months after receiving the first shingrix vaccine. The reporter would not provide any demographic information. No further adverse event information was provided. The reporter did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Carpal tunnel syndrome, Constipation, Dehydration, Diarrhoea
Clinical narrative: carpal tunnel syndrome in left wrist; Pain in shoulders / pain is more severe in the left shoulder; pain in the groan; loss of range of motion in arms; trouble walking; constipation; diarrhea; dehydrated; He is sensitive to hot and cold; trouble sleeping due to all the pain; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, carpal tunnel syndrome (on right wrist for tunnel syndrome), cervical disc herniation and back injury.   On 18th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping. The patient was treated with paracetamol (Tylenol), ibuprofen, tramadol and hydrocodone. On an unknown date, the outcome of the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, constipation, diarrhea, dehydration, temperature intolerance and difficulty sleeping were not recovered/not resolved and the outcome of the walking difficulty was unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose and had pain at the injection site that lasted a week.  The rest of the symptoms began to appear approximately a week following the shot. Pain in shoulders and pain in groin area presented. The pain was more severe in the left shoulder which was the injection arm. The pain in the groin was noticed when he had trouble walking because of it. He had loss of range of motion in arms due to the shoulder pain. He had been experiencing constipation, diarrhea and had dehydrated. The patient was sensitive to hot and cold and gets overheated easily with a blanket. He was diagnosed with carpal tunnel syndrome in his left wrist and has trouble sleeping due to all the pain. He was taking Tylenol, Ibuprofen, Tramadol and Hydrocodone to manage the pain. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Groin pain, Injection site pain, Insomnia, Mobility decreased
Clinical narrative: carpal tunnel syndrome in left wrist; Pain in shoulders / pain is more severe in the left shoulder; pain in the groan; loss of range of motion in arms; trouble walking; constipation; diarrhea; dehydrated; He is sensitive to hot and cold; trouble sleeping due to all the pain; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, carpal tunnel syndrome (on right wrist for tunnel syndrome), cervical disc herniation and back injury.   On 18th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping. The patient was treated with paracetamol (Tylenol), ibuprofen, tramadol and hydrocodone. On an unknown date, the outcome of the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, constipation, diarrhea, dehydration, temperature intolerance and difficulty sleeping were not recovered/not resolved and the outcome of the walking difficulty was unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose and had pain at the injection site that lasted a week.  The rest of the symptoms began to appear approximately a week following the shot. Pain in shoulders and pain in groin area presented. The pain was more severe in the left shoulder which was the injection arm. The pain in the groin was noticed when he had trouble walking because of it. He had loss of range of motion in arms due to the shoulder pain. He had been experiencing constipation, diarrhea and had dehydrated. The patient was sensitive to hot and cold and gets overheated easily with a blanket. He was diagnosed with carpal tunnel syndrome in his left wrist and has trouble sleeping due to all the pain. He was taking Tylenol, Ibuprofen, Tramadol and Hydrocodone to manage the pain. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Temperature intolerance
Clinical narrative: carpal tunnel syndrome in left wrist; Pain in shoulders / pain is more severe in the left shoulder; pain in the groan; loss of range of motion in arms; trouble walking; constipation; diarrhea; dehydrated; He is sensitive to hot and cold; trouble sleeping due to all the pain; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, carpal tunnel syndrome (on right wrist for tunnel syndrome), cervical disc herniation and back injury.   On 18th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping. The patient was treated with paracetamol (Tylenol), ibuprofen, tramadol and hydrocodone. On an unknown date, the outcome of the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, constipation, diarrhea, dehydration, temperature intolerance and difficulty sleeping were not recovered/not resolved and the outcome of the walking difficulty was unknown and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, shoulder pain, groin pain, mobility decreased, walking difficulty, constipation, diarrhea, dehydration, injection site pain, temperature intolerance and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose and had pain at the injection site that lasted a week.  The rest of the symptoms began to appear approximately a week following the shot. Pain in shoulders and pain in groin area presented. The pain was more severe in the left shoulder which was the injection arm. The pain in the groin was noticed when he had trouble walking because of it. He had loss of range of motion in arms due to the shoulder pain. He had been experiencing constipation, diarrhea and had dehydrated. The patient was sensitive to hot and cold and gets overheated easily with a blanket. He was diagnosed with carpal tunnel syndrome in his left wrist and has trouble sleeping due to all the pain. He was taking Tylenol, Ibuprofen, Tramadol and Hydrocodone to manage the pain. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Pyrexia, Somnolence
Clinical narrative: Feeling weak; Feeling / sleepy; Temperature this morning of 101 degrees and now / below 100 degrees.; Burning sensation on his back; This case was reported by a consumer and described the occurrence of weakness in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th February 2021, 1 days after receiving Shingrix, the patient experienced weakness, sleepiness, fever and burning sensation. On an unknown date, the outcome of the weakness, sleepiness, fever and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the weakness, sleepiness, fever and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient and reports he was having adverse effects to his second Shingrix vaccine.  The patient received his second Shingrix vaccine and the next day the patient feeling weak and sleepy. The patient temperature this morning of 101 degrees and now, in the afternoon, it was below 100 degrees. The patient reported a burning sensation on his back. The patient was treating symptoms with Tylenol with good results. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: A lot of pain, "intense pain" at the injection site; Headache; Symptoms similar to mild flu like body pain; body pain; This case was reported by a consumer and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2021, the patient received the 1st dose of Shingrix. On 16th February 2021, 11 hrs after receiving Shingrix, the patient experienced injection site pain, headache, flu-like aching and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, flu-like aching and general body pain were unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, flu-like aching and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient had the mild symptoms. The patient had a lot of pain and intense pain at the injection site, it was not swollen or red. The patient had headache and symptoms similar to mild flu like body pain. On the day of report, in the morning the patient still had a mild headache and took Tylenol. The lot and expiration date were unknown at the time of report. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac tamponade
Clinical narrative: Cardiac tamponade; very weak; A spontaneous report was received from a consumer concerning a female patient of unknown age who, experienced cardiac tamponade, and very weak.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   On 21JAN2021, approximately 4days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:039L20A) intramuscularly for prophylaxis of COVID-19 infection.  Caregiver-patient's daughter called to report that her mother potentially experienced an adverse reaction to the vaccine. Patient received the first dose of the vaccine on 21JAN2021, and 4 days later the patient developed cardiac tamponade and was very week. Patient went to the doctor's office where they were directed to wait for the second dose of the vaccine. Caller/caregiver wants to know how long they can wait for the second dose of the vaccine.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the events was unknown/not reported.; 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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Passed Out; Felt really bad and weak; Achy in his shoulders and neck; Chills; Temperature started at 99.6 then 100-101F; Burn really bad when he urinated; Traces of blood in urine; Threw up really bad; Fatigue; Joint Pain; Nausea; A spontaneous report received from a Consumer concerning, 82-year-old male patient who received first dose of the Moderna COVID-19 vaccine and experienced a lot of incidences. /MedDRA PT: [Incidences]   The patient's medical history included Type 2 Diabetic. Patient's concomitant included Metformin 500mg daily.   On 13FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient friend stated he got the Moderna vaccine on 13FEB2021 at 2:30pm in the right arm. He urinated fine at church the next day on 14FEB2021. At 2:30pm, Patient friend stated he started feeling bad and weak and could barely unlace his shoes. Patient friend stated that he had achy in his shoulders and neck, and chills. Patient friend stated he is a type 2 diabetic and he thought his blood sugar was very high and took a 500mg metformin (usually takes it once a day). Patient checked blood sugar which was 99 (low for him). Patient friend stated that she gave him apple juice to bring it back to normal. Patient friend stated his temperature started at 99.6F and an hour later it was 100-101F. Patient was told by HCP to take Tylenol. Patient friend stated that he had burning and traces of blood in his urine. Patient friend stated that the second time he urinated; it was less burning. Patient friend stated that he had severe vomiting and passed out. Patient went to bed at 7PM and then at 8:45PM, without the Tylenol, temperature went back to 99.6F. Patient friend stated that he feels completely fine now. Patient friend stated that she only gave him only two 500mg Tylenols for the whole 24 hours of the reactions. Patient friend stated that he had other symptoms including fatigue, muscle pain, joint pain, chills, nausea, vomiting, and fever but no headache. Patient friend would like to know if the Moderna COVID-19 do something to his kidney or bladder? Patient friend would like to know if he should get the second Moderna COVID-19 vaccine. However, the patient still would like to get the second vaccine to be protected from COVID-19.  Patient was treated with 1 500mg Metformin and 2 500mg Tylenols.    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: This case concerns an 82-year-old male who experienced a serious unexpected event of Loss of consciousness along with NS unexpected feeling abnormal, dysuria, blood in urine, and NS expected fever, chills, myalgia, arthralgia, nausea, vomiting, fatigue.  Event onset 1 day after the first dose of mRNA-1273. Treated with Tylenol. Based on 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Could not hear anything 2 days post-vaccination; A spontaneous report was received from a consumer who was also a female patient, unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not hear anything 2 days post-vaccination.  The patient's medical history included Meniere's disease and hearing aids user. No relevant concomitant medications were reported.  On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) for prophylaxis of COVID-19 infection.  The patient received her first shot on 13 Feb 2021 and could not hear anything two days post-vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, could not hear anything 2 days post-vaccination, was considered resolved on 22 Feb 2020.; 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.  The patient's medical history of Meniere's disease and use of  hearing aids is a confounder to the causality.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, Exposure via skin contact
Clinical narrative: didn't receive the entire dose; felt the medication on her skin/medication leaked out around the needle during injection; felt the medication on her skin/medication leaked out around the needle during injection; A spontaneous report was received from a healthcare facility staff member concerning a 39 years old, female patient who didn't receive the entire dose of vaccine, felt the medication on patient's skin and medication leaked out around the needle during injection while administration of Moderna's COVID-19 vaccine. The patient's medical history included Augmentin as a child. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: not provided) on an unknown date. On 17-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch number004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The reporter reported that, patient didn't receive the entire dose, felt the medication on her skin and medication leaked out around the needle during injection while administration of vaccine. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events: therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: This report refers to a case of accidental underdose and syringe connection issue for mRNA-1273 (Batch number004M20A) associated with the event of exposure via skin.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Instead of a 5cc dose was given a 3 cc dose; A spontaneous report was received from a female nurse who received Moderna COVID-19 vaccine (mRNA-1273) and was administered an incomplete dose.    The patient's medical history includes bronchiolitis, asthma and high blood pressure. Concomitant medications included an unspecified inhaler and three different medications for high blood pressure.   On 15-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly in left arm (Lot# 011M209). On that day, instead of 5cc dose, she was given 3cc as the person administering the vaccine was giving Pfizer drug previously. She didn't experience any adverse event following the vaccine administration.    No treatment information was provided.   Action taken with 2nd dose of vaccine is not reported.  The outcome of the event, incomplete dose administered, was considered resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 011M209 with no associated AEs.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received two 2nd doses on same day; A spontaneous report was received from a physician concerning a 84-year old, female patient who received Moderna's COVID-19 vaccine and was administered two second doses on the same day (MedDRA PT: extra dose administered).    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their first dose of mRNA-1273 on 20-JAN-2021.  On 18-FEB-2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On 18-FEB-2021, the patient received two doses on the same day. One dose was given at the health department. One dose was given at the reporter's clinic. A total of three doses were given.    Treatment information was not provided/unknown.    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, extra dose given was considered recovered/resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Incorrect dose administered
Clinical narrative: exposure to skin; invalid dose; exposure to skin; A spontaneous report was received from a healthcare facility staff member concerning male patient who had invalid dose of administration and exposure to skin of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 18-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection.  The reporter reported that, the syringe cracked, and the Moderna Covid-19 Vaccine ran down patient's arm. Reporter was not sure about the patient received very much of the dose. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the events was not provided.  The outcome of the events, were considered as recovered.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issue and exposure via skin for mRNA-1273 (Batch number unknown) with no associated AEs.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle popped out and vaccine landed in her hand; Not sure if received full dose; A spontaneous report was received from a (Consumer) concerning a 45 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle popped out and vaccine landed in her hand and not sure she received full dose.    The patient's medical history included unspecified surgery. Concomitant product use included duloxetine hydrochloride, zolpidem tartrate, and ketorolac tromethamine.    On an unknown date, the patient received their first of two planned doses of mRNA-1273. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot #not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, during administration of injection, the needle popped out and vaccine landed on the patient's hand. The nurse put the needle back on and administered the remaining dose. The patient was not sure if full dose was received.  Action taken with mRNA-1273 in response to the events was not applicable as the patient received both doses.   The events were resolved on 18 Feb 2021.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 (lot #not provided) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Under Age only 16 years old; arm pain; A spontaneous report was received from a consumer concerning a 16 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was provided as asthmatic. No relevant concomitant medications were reported.    On 18-Jan-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. It was reported that the patient had slight arm pain, which went away in two days on 20-Jan-21. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, "underage only 16 years old" was unknown.  The outcome of event arm pain was resolved on 20 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number unknown) with reported listed nonserious event of injection site pain.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: worried they didn't get enough of the first dose; the dose came out the side of the syringe; Most of the dose ran down patient's arm; A spontaneous report was received from a pharmacist concerning a 61 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the dose came out side of the syringe.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16 Feb 2021, the patient received their first  planned dose of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the deltoid muscle for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the pharmacist was injecting the Moderna vaccine and the dose came out of the syringe. Most of the dose ran down the patient's arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events outcome was recovered.; Reporter's Comments: This report refers to a case of Product administration error  Underdose ,Device connection issue,Exposure via skin contact  for mRNA-1273, lot # 031M20A with no associated AEs.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25 Jan 2021, the first dose of vaccine was administered to 17 year old female  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was recovered.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: syringe was visibly bent after administration and vaccination fluid ran down arm; syringe was visibly bent after administration and vaccination fluid ran down arm; Exposure via skin; A spontaneous report was received from a pharmacist concerning female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and she stated that the syringe was visibly bent after administration and vaccination fluid ran down arm.  No relevant medical history was provided. Concomitant medications were not listed.  On 11 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection.  On 11 Feb 2021,the reporter stated that the syringe was visibly bent after administration and vaccination fluid ran down arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event syringe was visibly bent after administration and vaccination fluid ran down arm was resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe connection issues and exposure via skin for mRNA-1273 (batch: unknown) with no associated AEs.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Mistakenly received the first dose of the vaccine; A spontaneous report was received from a nurse concerning a 17 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Product administered to patient of inappropriate age.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On Date 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) at unknown route and anatomical location for prophylaxis of COVID-19 infection.   The patient experienced the event medication error- 17 years old individual mistakenly received the first dose of the vaccine.   Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event 17 years old individuals mistakenly received the first dose of the vaccine unknown.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (lot/batch: unknown)  with no associated AEs.; Sender's Comments:  MOD-2021-015769:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dermatitis allergic, Fatigue, Incorrect route of product administration, Pain
Clinical narrative: A large lesion - erythematous, with very large bullae; Feels more painful now than when it contained fluid; It's more like a burn; Felt very tired; Stressed; Cutaneous hypersensitivity; A large lesion - erythematous, with very large bullae; The vaccine went SC or ID instead of IM; A spontaneous report (United States) was received from a  concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced  cutaneous hypersensitivity, large lesion - erythematous, with very large bullae, tiredness, stress, burning sensation, pain, blisters.  The patient's medical history was not provided. Concomitant medications were not reported.   On 13-Feb-2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  12 hours post vaccination patient experienced cutaneous hypersensitivity. and large lesion-erythematous, with very large bullae. On 18-Feb-2021, patient experienced  burning sensation, pain, blisters, tiredness, stress.  No treatment was given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected event of Dermatitis allergic along with NS unexpected events of Incorrect route of product administration, skin lesion, blister, pain, skin burning sensation, fatigue and stress.  The events occurred the same day as the first dose of mRNA-1273. Based on 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: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Skin lesion, Stress
Clinical narrative: A large lesion - erythematous, with very large bullae; Feels more painful now than when it contained fluid; It's more like a burn; Felt very tired; Stressed; Cutaneous hypersensitivity; A large lesion - erythematous, with very large bullae; The vaccine went SC or ID instead of IM; A spontaneous report (United States) was received from a  concerning female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced  cutaneous hypersensitivity, large lesion - erythematous, with very large bullae, tiredness, stress, burning sensation, pain, blisters.  The patient's medical history was not provided. Concomitant medications were not reported.   On 13-Feb-2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  12 hours post vaccination patient experienced cutaneous hypersensitivity. and large lesion-erythematous, with very large bullae. On 18-Feb-2021, patient experienced  burning sensation, pain, blisters, tiredness, stress.  No treatment was given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced serious unexpected event of Dermatitis allergic along with NS unexpected events of Incorrect route of product administration, skin lesion, blister, pain, skin burning sensation, fatigue and stress.  The events occurred the same day as the first dose of mRNA-1273. Based on 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Osteonecrosis of jaw
Clinical narrative: Osteonecrosis of the jaw; A spontaneous report was received from a consumer concerning a 48 years-old female patient who received Moderna's Covid 19 vaccine (mRNA1273) and developed osteonecrosis of jaw.  The patient's medical history included active breast cancer with bone metastasis. Products known to have been used by the patient, within two weeks prior to the event, included denosumab.   The patient received first of two planned dose of mRNA-1273 (Lot # 015M20A) intramuscularly on 10-FEB-2021 for prophylaxis of Covid 19 infection.  On an unknown date in Feb 2021, after vaccination, the patient discovered that she had osteonecrosis of the jaw. The patient had bone exposed in the jaw about a week after getting the vaccine. Patient took a bone density drug, Xgeva (denosumab).  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event Osteonecrosis of jaw was unknown.; Reporter's Comments: Based on the current available information, the pathogenesis of osteonecrosis formation and mechanism of action of mRNA-1237 vaccine, the event of osteonecrosis of jaw is assessed as unlikely related. The patient's medical history of active breast cancer with bone metastasis is a contributing factor and confounds causality assessment. Further information has been requested.