chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site urticaria, Injection site warmth, Pruritus
Clinical narrative: hives from injection site; hives from injection site across chest; blood feeling cold; itching of the chest; experienced hot / at the injection site; experienced / red at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. On 4th January 2021, several hours after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, pruritus and feeling cold. On 5th January 2021, the patient experienced injection site hives and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site hives and feeling cold were unknown and the outcome of the pruritus and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site hives, pruritus, hives and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and few hours after vaccination the patient had hot and red area at injection site, on the same evening of injection patient had itching of her chest. On the next morning, the patient had hives from the injection site across her chest with itching, the patient also experienced blood feeling cold since receiving the dose of Shingrix. It was stated that till 21st January 2021 the patient was still experienced some hives and itching but not as severe. The patient received Benadryl for treatment for those experiences. The patient demographics was not provided. This case was linked with US2021015613 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015613:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives from injection site; hives from injection site across chest; blood feeling cold; itching of the chest; experienced hot / at the injection site; experienced / red at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. On 4th January 2021, several hours after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, pruritus and feeling cold. On 5th January 2021, the patient experienced injection site hives and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site hives and feeling cold were unknown and the outcome of the pruritus and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site hives, pruritus, hives and feeling cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and few hours after vaccination the patient had hot and red area at injection site, on the same evening of injection patient had itching of her chest. On the next morning, the patient had hives from the injection site across her chest with itching, the patient also experienced blood feeling cold since receiving the dose of Shingrix. It was stated that till 21st January 2021 the patient was still experienced some hives and itching but not as severe. The patient received Benadryl for treatment for those experiences. The patient demographics was not provided. This case was linked with US2021015613 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015613:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: fatigue; right side of head headache that felt tender/ head tender; throat hurting; right side gland swelling; right side of neck pain; right shoulder soreness; sore right arm; achy muscles; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had history of Shingles). Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 15th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 15th January 2021, less than a day after receiving Shingrix, the patient experienced fatigue, headache, throat pain, swollen glands, neck pain, shoulder soreness, pain in arm and muscle pain. On an unknown date, the outcome of the fatigue, headache, throat pain, swollen glands, neck pain, shoulder soreness, pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, throat pain, swollen glands, neck pain, shoulder soreness, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix in the right arm and in the same evening, the patient experienced achy muscles, a sore right arm, right shoulder soreness, right side of neck pain, right side gland swelling, throat hurting, right side of head headache that felt tender, and fatigue. Till the time of reporting, the adverse effects were not resolved. The reporter did not consent to followup.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: fatigue; right side of head headache that felt tender/ head tender; throat hurting; right side gland swelling; right side of neck pain; right shoulder soreness; sore right arm; achy muscles; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had history of Shingles). Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 15th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 15th January 2021, less than a day after receiving Shingrix, the patient experienced fatigue, headache, throat pain, swollen glands, neck pain, shoulder soreness, pain in arm and muscle pain. On an unknown date, the outcome of the fatigue, headache, throat pain, swollen glands, neck pain, shoulder soreness, pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, headache, throat pain, swollen glands, neck pain, shoulder soreness, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix in the right arm and in the same evening, the patient experienced achy muscles, a sore right arm, right shoulder soreness, right side of neck pain, right side gland swelling, throat hurting, right side of head headache that felt tender, and fatigue. Till the time of reporting, the adverse effects were not resolved. The reporter did not consent to followup.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Paraesthesia, Pyrexia, Rash pruritic
Clinical narrative: tingling; itchy rash; chills; fever; diarrhea; weight loss; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 21st January 2021, 1 days after receiving Shingrix, the patient experienced itchy rash, chills, fever, diarrhea and weight loss. On 22nd January 2021, the patient experienced tingling. On an unknown date, the outcome of the tingling and itchy rash were not recovered/not resolved and the outcome of the chills, fever and diarrhea were recovered/resolved and the outcome of the weight loss was unknown.   The reporter considered the tingling to be related to Shingrix. It was unknown if the reporter considered the itchy rash, chills, fever, diarrhea and weight loss to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose Shingrix in left arm and 2 days after the vaccination patient had tingling. The patient also experienced itchy rash, chills, fever, diarrhea and weight loss. The patient stated most side effects mentioned started on Thursday and most of them resolved but the weight loss and the tingling not resolved, and the rash was better but not completely gone. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: tingling; itchy rash; chills; fever; diarrhea; weight loss; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 21st January 2021, 1 days after receiving Shingrix, the patient experienced itchy rash, chills, fever, diarrhea and weight loss. On 22nd January 2021, the patient experienced tingling. On an unknown date, the outcome of the tingling and itchy rash were not recovered/not resolved and the outcome of the chills, fever and diarrhea were recovered/resolved and the outcome of the weight loss was unknown.   The reporter considered the tingling to be related to Shingrix. It was unknown if the reporter considered the itchy rash, chills, fever, diarrhea and weight loss to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose Shingrix in left arm and 2 days after the vaccination patient had tingling. The patient also experienced itchy rash, chills, fever, diarrhea and weight loss. The patient stated most side effects mentioned started on Thursday and most of them resolved but the weight loss and the tingling not resolved, and the rash was better but not completely gone. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: arm pain / is still slightly present  / a shooting pain and spasm down her arm; ithing all over; achiness/shooting pain; chills; she still could not lift her arm; spasm down her arm; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2XG53, expiry date 12th February 2022) for prophylaxis.   Concurrent medical conditions included rotator cuff tear (torn rotator cuff in right arm).   On 1st December 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. In December 2020, the patient experienced low grade fever, generalized pruritus, shooting pain, chills, mobility decreased and spasms. The patient was treated with steroids nos (Oral Steroid (Brand Unknown)), muscle relaxants (Muscle Relaxant) and naproxen (Aleve). On an unknown date, the outcome of the low grade fever, generalized pruritus and chills were recovered/resolved and the outcome of the pain in arm, shooting pain, mobility decreased and spasms were not recovered/not resolved.   It was unknown if the reporter considered the low grade fever, pain in arm, generalized pruritus, shooting pain, chills, mobility decreased and spasms to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received first dose in her left arm. The patient experienced arm pain on the vaccination day and that night she experienced chills, low grade fever, itching all over and achiness. Those symptoms lasted a day or two. The arm pain persisted and was still slightly present.  The patient reported that a week following the vaccination, she still could not lift her arm and when she stretched it, it caused a shooting pain and spasm down her arm. On 7th January 2021, the patient's doctor prescribed an oral steroid, a muscle relaxer and was told to take Alleve. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021AMR061146.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061146:different dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: arm pain / is still slightly present  / a shooting pain and spasm down her arm; ithing all over; achiness/shooting pain; chills; she still could not lift her arm; spasm down her arm; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2XG53, expiry date 12th February 2022) for prophylaxis.   Concurrent medical conditions included rotator cuff tear (torn rotator cuff in right arm).   On 1st December 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. In December 2020, the patient experienced low grade fever, generalized pruritus, shooting pain, chills, mobility decreased and spasms. The patient was treated with steroids nos (Oral Steroid (Brand Unknown)), muscle relaxants (Muscle Relaxant) and naproxen (Aleve). On an unknown date, the outcome of the low grade fever, generalized pruritus and chills were recovered/resolved and the outcome of the pain in arm, shooting pain, mobility decreased and spasms were not recovered/not resolved.   It was unknown if the reporter considered the low grade fever, pain in arm, generalized pruritus, shooting pain, chills, mobility decreased and spasms to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received first dose in her left arm. The patient experienced arm pain on the vaccination day and that night she experienced chills, low grade fever, itching all over and achiness. Those symptoms lasted a day or two. The arm pain persisted and was still slightly present.  The patient reported that a week following the vaccination, she still could not lift her arm and when she stretched it, it caused a shooting pain and spasm down her arm. On 7th January 2021, the patient's doctor prescribed an oral steroid, a muscle relaxer and was told to take Alleve. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021AMR061146.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061146:different dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Incorrect route of product administration, Injected limb mobility decreased, Limb injury, Pain
Clinical narrative: Couldn't use thumb; Numbness; A lot of pain; Cannot raise arm above the eye or shoulder level; Outside of the injection site has become hard; I can feel a knot; Needle was inserted way down into the triceps and nowhere close to the deltoid muscle; A spontaneous report was received from a nurse who was a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced needle was inserted way down into the triceps and nowhere close to the deltoid muscle/incorrect route of product administration, couldn't use thumb/ limb injury, a lot of pain/pain, numbness/hypoesthesia, injection site has become hard/ injection site induration and unable to raise arm above eye or shoulder level/ injected limb mobility decreased.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17-FEB-2021., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in her left arm for prophylaxis of COVID-19 infection.  On 19-Feb-2021, She reported that there was an administration error wherein the needle was inserted about two inches above the elbow into the triceps and was nowhere near the deltoid muscle. She stated that the the patient experienced pain in thumb and could not use it, numbness, outside of the injection site become hard, knot and could not raise her arm above shoulder level.    No laboratory details were provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, needle was inserted way down into the triceps, was considered resolved.  The outcomes of the events, couldn't use thumb, a lot of pain, numbness, injection site has become hard and unable to raise arm above eye or shoulder level, were considered unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 030M20A) with  associated AEs reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Couldn't use thumb; Numbness; A lot of pain; Cannot raise arm above the eye or shoulder level; Outside of the injection site has become hard; I can feel a knot; Needle was inserted way down into the triceps and nowhere close to the deltoid muscle; A spontaneous report was received from a nurse who was a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced needle was inserted way down into the triceps and nowhere close to the deltoid muscle/incorrect route of product administration, couldn't use thumb/ limb injury, a lot of pain/pain, numbness/hypoesthesia, injection site has become hard/ injection site induration and unable to raise arm above eye or shoulder level/ injected limb mobility decreased.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17-FEB-2021., prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in her left arm for prophylaxis of COVID-19 infection.  On 19-Feb-2021, She reported that there was an administration error wherein the needle was inserted about two inches above the elbow into the triceps and was nowhere near the deltoid muscle. She stated that the the patient experienced pain in thumb and could not use it, numbness, outside of the injection site become hard, knot and could not raise her arm above shoulder level.    No laboratory details were provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, needle was inserted way down into the triceps, was considered resolved.  The outcomes of the events, couldn't use thumb, a lot of pain, numbness, injection site has become hard and unable to raise arm above eye or shoulder level, were considered unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 030M20A) with  associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose is schduled on the 44th day; A spontaneous report was received from a consumer concerning a female patient, who received the first dose of Moderna's COVID-19 vaccine  (mRNA-1273) and experienced second dose is scheduled on the 44th day (inappropriate schedule of vaccine).  No prior medical history and concomitant medications were reported.   On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection and is past 28 days but within 42 days so far and the second dose is scheduled on 44th day. The patient would like to know if it would be ok to take up the second dose on 44th day after the first one.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event inappropriate schedule of vaccine is unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with no associated AEs reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Duplicate therapy error, Interchange of vaccine products
Clinical narrative: received the complete Pfizer vaccination series 3 weeks ago, and were inadvertently administered a first dose of Moderna; received the complete Pfizer vaccination series 3 weeks ago, and were inadvertently administered a first dose of Moderna; A spontaneous report was received on 18 Feb 2021 from a pharmacist concerning unknown age female patient who received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine.  The patient medical history provided was dementia. No relevant concomitant medications were reported.  On 18 Feb 2021, patient received their first of two planned doses of Moderna's mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. The patient received the complete Pfizer vaccine series, 3 weeks prior to the Moderna's vaccine. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine, was considered resolved.; Reporter's Comments: This is a case of female patient of unknown age who received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine (duplicate therapy error) Lot number: unknown. There was no associated adverse event reported for the event of wrong product administered
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site swelling
Clinical narrative: Intramuscular route was administered as other (subcutaneous); Injection site was 3&1/2" above her elbow in the back of her arm; A spontaneous report was received from a type concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site was 3 and 1/2 above her elbow in the back of her arm(injection site swelling) and incorrect route of product administration via subcutaneous route.  The patient's medical history was not provided. Concomitant medications was not reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: 032L20A) subcutaneously in left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced injection site was 3 and 1/2 above her elbow in the back of her arm and administered subcutaneously.  No treatment details was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of injection site was 3 and 1/2  above her elbowin the back of her arm was unknown and intramuscular route administered as other (subcutaneous) was recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with reported event of injection site swelling.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Oral herpes, Pruritus, Rash
Clinical narrative: One of her eyes and mouth were dropping a little bit/Bell's palsy; Broken out with fever blisters; Rash and itching all over the trunk; Itching all over the trunk; A spontaneous report was received from a patient's spouse in the concerning a 77-year-old female patient who experienced one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus and broke out with fever blisters/database: oral herpes.   The patient's medical history was not reported. Concomitant medications included metoprolol, lisinopril, acetylsalicylic acid, omeprazole rabeprazole sodium, vitamin D, duloxetine, folic acid, vitamin A, balofloxacin, vitamin B12 and amlodipine.  On 25-Feb-2021, one day before the start of symptoms, this patient received the planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 012A21A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient developed a rash and itching all over the trunk. The events resolved on 27-Feb-2021. On 28-Feb-2021 the husband noticed one of the patient's eyes and her mouth were drooping a little bit. He took her to the ER (Emergency Room) because he thought she was having a stoke. She had also broken out with fever blisters. They ran tests NOS and everything was normal. The treating Physician said it was Bell's palsy and it was due to the vaccination. The events were treated with prednisone 15 mg and valacyclovir 1 gram.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the events, one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis and broke out with fever blisters/database: oral herpes is unknown. The outcome for the events, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus is recovered.; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Expired product administered, Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Green Bruise on the Side of Injection Site; Itchy Injection Site; Red patch ping-pong ball size on the injection site; Sore Arm (from wrist to shoulder); Injected with Expired Vaccine; A spontaneous report  was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injected with expired vaccine, red patch ping-pong ball size on the injection site, itchy injection site, sore arm (from wrist to shoulder), green bruise on the side of injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) injected with expired vaccine . On 10 Feb 2021, after a week,  the patient experienced a red patch ping-pong ball size on the injection site, it was Itchy, and sore from wrist to shoulder. On the side of the injection site was turning green like it was bruised.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event of  injected with expired vaccine was not applicable, while with respect to the events of red patch ping-pong ball size on the injection site, itchy injection site, sore arm (from wrist to shoulder),green bruise on the side of injection site was unknown  The outcome of event of  injected with expired vaccine was resolved, while the outcome of the events of red patch ping-pong ball size on the injection site,itchy injection site,sore arm (from wrist to shoulder),green bruise on the side of injection site was unknown.  The reporter did not provide an assessment for the events injected with expired vaccine, red patch ping-pong ball size on the injection site, itchy injection site, sore arm (from wrist to shoulder), green bruise on the side of injection site.; 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Bone pain, Dizziness, Ear discomfort, Fibromyalgia
Clinical narrative: Dizzy; short term memory sucks and it's frustrating; Can't see well; Fibromyalgia; bone pain; Neuropathy; Feeling aches in the body; Bells palsy-paralysis on the left side of the face/ pressure on the left side of the face and neck; headache; Ringing in the ears; Pressure in the ears; A spontaneous report was received from consumer concerning a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pressure in ears/ear discomfort, ringing in ears/tinnitus,  pressure on the left side of the face and neck which was found to be Bell's Palsy/facial paralysis, Headache, neuropathy peripheral, fibromyalgia, memory impairment, couldn't see well/visual decrease, feeling aches in the body/myalgia, and dizziness.  The patient's medical history included neuropathy and fibromyalgia and past cancer. No relevant concomitant medications were reported.   On 03 Feb 2021, the patient received the first of two doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24FEB2021 the patient began experiencing pressure and a ringing in the ears and then started like a pressure on the left side of the face and neck. On 25FEB2021, the patient started having a  headache and on 26FEB2021 the paralysis on the left side of the face began. The patient said that it worsened, couldn't eat, couldn't speak, and went to the hospital. The patient said that they had a CT Scan, and the result was that it wasn't a stroke. Vitals were taken and blood work came back normal.  The conclusion was Bell's Palsy.  The patient stated that they couldn't see well and were dizzy.  The patient said that they were experiencing fibromyalgia and neuropathy that they had when they had cancer.  The patient also mentioned that they were experiencing some bone pain and that their short term memory was not good and was frustrating.    Treatment of these events were not reported.  The outcome of the events, ear discomfort, tinnitus, facial paralysis, headache, neuropathy peripheral, fibromyalgia, memory impairment, visual decrease, myalgia and dizziness were considered unknown.; 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 neuropathy, fibromyalgia and past history of cancer remains the contributing factors. Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Memory impairment, Myalgia, Neuropathy peripheral, Tinnitus
Clinical narrative: Dizzy; short term memory sucks and it's frustrating; Can't see well; Fibromyalgia; bone pain; Neuropathy; Feeling aches in the body; Bells palsy-paralysis on the left side of the face/ pressure on the left side of the face and neck; headache; Ringing in the ears; Pressure in the ears; A spontaneous report was received from consumer concerning a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pressure in ears/ear discomfort, ringing in ears/tinnitus,  pressure on the left side of the face and neck which was found to be Bell's Palsy/facial paralysis, Headache, neuropathy peripheral, fibromyalgia, memory impairment, couldn't see well/visual decrease, feeling aches in the body/myalgia, and dizziness.  The patient's medical history included neuropathy and fibromyalgia and past cancer. No relevant concomitant medications were reported.   On 03 Feb 2021, the patient received the first of two doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24FEB2021 the patient began experiencing pressure and a ringing in the ears and then started like a pressure on the left side of the face and neck. On 25FEB2021, the patient started having a  headache and on 26FEB2021 the paralysis on the left side of the face began. The patient said that it worsened, couldn't eat, couldn't speak, and went to the hospital. The patient said that they had a CT Scan, and the result was that it wasn't a stroke. Vitals were taken and blood work came back normal.  The conclusion was Bell's Palsy.  The patient stated that they couldn't see well and were dizzy.  The patient said that they were experiencing fibromyalgia and neuropathy that they had when they had cancer.  The patient also mentioned that they were experiencing some bone pain and that their short term memory was not good and was frustrating.    Treatment of these events were not reported.  The outcome of the events, ear discomfort, tinnitus, facial paralysis, headache, neuropathy peripheral, fibromyalgia, memory impairment, visual decrease, myalgia and dizziness were considered unknown.; 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 neuropathy, fibromyalgia and past history of cancer remains the contributing factors. Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Dizzy; short term memory sucks and it's frustrating; Can't see well; Fibromyalgia; bone pain; Neuropathy; Feeling aches in the body; Bells palsy-paralysis on the left side of the face/ pressure on the left side of the face and neck; headache; Ringing in the ears; Pressure in the ears; A spontaneous report was received from consumer concerning a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pressure in ears/ear discomfort, ringing in ears/tinnitus,  pressure on the left side of the face and neck which was found to be Bell's Palsy/facial paralysis, Headache, neuropathy peripheral, fibromyalgia, memory impairment, couldn't see well/visual decrease, feeling aches in the body/myalgia, and dizziness.  The patient's medical history included neuropathy and fibromyalgia and past cancer. No relevant concomitant medications were reported.   On 03 Feb 2021, the patient received the first of two doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24FEB2021 the patient began experiencing pressure and a ringing in the ears and then started like a pressure on the left side of the face and neck. On 25FEB2021, the patient started having a  headache and on 26FEB2021 the paralysis on the left side of the face began. The patient said that it worsened, couldn't eat, couldn't speak, and went to the hospital. The patient said that they had a CT Scan, and the result was that it wasn't a stroke. Vitals were taken and blood work came back normal.  The conclusion was Bell's Palsy.  The patient stated that they couldn't see well and were dizzy.  The patient said that they were experiencing fibromyalgia and neuropathy that they had when they had cancer.  The patient also mentioned that they were experiencing some bone pain and that their short term memory was not good and was frustrating.    Treatment of these events were not reported.  The outcome of the events, ear discomfort, tinnitus, facial paralysis, headache, neuropathy peripheral, fibromyalgia, memory impairment, visual decrease, myalgia and dizziness were considered unknown.; 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 neuropathy, fibromyalgia and past history of cancer remains the contributing factors. Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypokinesia, Vaccination complication
Clinical narrative: Vaccine hit me so hard; Couldnt move any part of my body; Brain fog; This spontaneous report from was received from a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine hit me so hard/vaccination complication, couldn't move any part of my body/ hypokinesia and brain fog/feeling abnormal.  The patient's medical history and concomitant medications were not reported.  On 28 Feb 2021 the patient received her second dose of mRNA-1273 (Lot number: 012A21A) solution for injection  intramuscularly prophylaxis of COVID-19 infection.   On 28 Feb 2021, the patient  experienced a strong reaction and couldn't move any parts of body. She said the vaccine hit so hard. She had brain fog. She's never experienced anything like that. She got stuck on the garage floor for so long until her daughter and son in law came to rescue her. She was taken to the emergency room Sunday evening (28 Feb 2021).   On the night of 03 Mar 2021, the patient was released from the hospital.  As of 04 Mar 2021, the patient felt better.  The hospital performed CT scans and she was hydrated with IV fluids.   The outcome of all events were unknown.; 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, International normalised ratio
Clinical narrative: INR of 12.5 and he was hospitalized; A spontaneous report was received on 04 Mar 2021 from a consumer concerning, a 56-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced international normalized ratio (INR) of 12.5 and was hospitalized.   The patient's medical history, as provided by the reported included back pain and muscle spasms. Concomitant medications included hydrocodone bitartrate, paracetamol, cefixime and warfarin (blood thinner) was reported.   On 24 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 001A21A) in the left arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, after the vaccination, the patient's international normalized ratio (INR) was increased from 3.5 to 12.5 which resulted in hospitalization. Treatment information included vitamin K and blood transfusion.   Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the event, international normalized ratio (INR) of 12.5, was considered unknown.; 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: Ulcer haemorrhage
Clinical narrative: Bleeding ulcer; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced bleeding ulcers.  The patient's medical history was not provided by the reporter.  Concomitant medication use was not provided.   On 05-Feb-2021, the patient received the first of two planned doses of mRNA-1273 (lot: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05-Mar-2021, the patient experienced bleeding ulcers and had to go to emergency room.    No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, bleeding ulcers, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Hallucination
Clinical narrative: hallucinating; couldn't stand on her own; dizziness; incoherent; right arm at injection site was black and blue; pains all over body; fever; extremely tired; chills; A spontaneous report  was received from a consumer concerning a 57-year-old, female patient, (her daughter) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, pains all over  body, right arm was black and blue at the injection site ,fever, felt extremely tired, couldn't stand on her own, dizziness, incoherent and hallucinating.  The patient's current medical history, as provided by the reporter, included pre-existing multiple sclerosis and fibromyalgia.  Concomitant medications was not reported .   On 10-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date after receiving mRNA-1273, the patient felt chills, pains all over her body and her right arm was black and blue at the injection site.  She developed a fever, felt extremely tired, was unable to stand on her own, was dizzy, incoherent and was hallucinating.  Her second dose was scheduled for 10-FEb-2021 and her mother was unsure as whether or not to have the vaccine administered.   Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, chills, pains all over body, right arm was black and blue at the injection site, fever, felt extremely tired, couldn't stand on her own, dizziness, incoherent and hallucinating, were considered unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Incoherent, Myalgia, Pyrexia, Vaccination site bruising
Clinical narrative: hallucinating; couldn't stand on her own; dizziness; incoherent; right arm at injection site was black and blue; pains all over body; fever; extremely tired; chills; A spontaneous report  was received from a consumer concerning a 57-year-old, female patient, (her daughter) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, pains all over  body, right arm was black and blue at the injection site ,fever, felt extremely tired, couldn't stand on her own, dizziness, incoherent and hallucinating.  The patient's current medical history, as provided by the reporter, included pre-existing multiple sclerosis and fibromyalgia.  Concomitant medications was not reported .   On 10-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date after receiving mRNA-1273, the patient felt chills, pains all over her body and her right arm was black and blue at the injection site.  She developed a fever, felt extremely tired, was unable to stand on her own, was dizzy, incoherent and was hallucinating.  Her second dose was scheduled for 10-FEb-2021 and her mother was unsure as whether or not to have the vaccine administered.   Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, chills, pains all over body, right arm was black and blue at the injection site, fever, felt extremely tired, couldn't stand on her own, dizziness, incoherent and hallucinating, were considered unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Rash, Urticaria
Clinical narrative: angioedema; red bumps; hives; A spontaneous report was received from a consumer concerning a 65 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red bumps, hives and Angioedema.  The patient's medical history was not provided. Concomitant product use included sertraline hydrochloride and zolpidem tartrate.   On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 batch no: 025J20A intramuscularly in the left arm for prophylaxis of COVID-19 infection.  About a week post vaccination (17 Jan 2021), the patient noticed some red bumps on body which accelerated to hives all over body within a few days. Eventually, on 01 Feb 2021, the patient experienced an episode of angioedema and went to the emergency room.   Treatment included self-medication with antihistamines Benadryl and Xyrtec.   The outcome of the events is unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; A spontaneous report was received from a HCP concerning about a 86 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patient's medical history was not reported. Concomitant medications were not reported.  On 05 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026A21A) via intramuscular in left deltoid for prophylaxis of COVID-19 infection.  On 06 Mar 2021 the patient died next day after vaccination, who left quite well after vaccination from the facility, the reason for death is not known.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event is not applicable.  The outcomes of all the event is not applicable.; Reporter's Comments: This is a case of death in a 86 years old female patient, with unknown past medical hx or current co morbid conditions and concomitant medications, who died one day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Seizure
Clinical narrative: strong seizures; strong pins and needles sensations in left side extremities; A spontaneous report was received from a pediatrician concerning herself, a 40-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced strong pins and needles sensations in left side extremities/paraesthesia and seizures.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 JAN 2021, prior to the onset of events the patient received the first of the two planned doses of mRNA-1273 (Batch Number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID 19 infection.  On 14 Jan 2021, the patient experienced strong seizures, and strong pins and needles sensations in her left side extremities, which are still mildly ongoing. She is being evaluated by a specialist. No treatment information was provided.  Action taken with mRNA-1273 in response to the events is unknown.  The outcomes of events, paraesthesia and seizures, were considered recovering.; 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.