chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Severe nausea/vomiting, SOB, throat swelling, dizziness, headache, chills.  HRT recommended ED visit. She had IVF and Zofran. Symptoms improved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Vomiting
Clinical narrative: Severe nausea/vomiting, SOB, throat swelling, dizziness, headache, chills.  HRT recommended ED visit. She had IVF and Zofran. Symptoms improved.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Other- Bells Palsy-Medium
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Red rash, a bit swollen around injection site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain, Pruritus, Swelling
Clinical narrative: chills,pain,swelling,itching and redness
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Myalgia, SARS-CoV-2 test positive
Clinical narrative: Jan 2 when I experienced muscle aches; afternoon: fevers, chills, whole body aches - highest temp got to 101.9. Appt with doctor on Jan 3rd . Treated with OTC Tylenol - 500 mg Q4-6; OTC ibuprofen - 400 mg Q4-6; rotating between those two and drinking fluids. Symptoms lasted ended Monday January 4th. Tested COVID January 5 - and on 6th - positive result.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the arm. No fever, headache, fatigue, burning or any other symptom but the rash. It is about 3 inches wide an one inch in height. There is no pain in the arm either.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Restlessness
Clinical narrative: fatigue, soreness, minor aches, restlessness, minor temp
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushing of the face
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot to touch
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: 12/31/20:left a message saying she got the vaccine 5 days ago and is experiencing severe neck pain that shoots down her neck and back :  saw PCP - f/u 1/8/21 :I still have a little neck pain left and my glands are still slightly swollen. Getting my 2nd dose today. I have paperwork from Pfizer that I need to fill out for their data keeping.  Pain was excruciating for nearly 2wks and started to settle down a few days ago, where I don?t have to sit with a heating pad or take motrin and flexaril.  f/u 1/28/21-"My neck still hurts, worse on certain days, but is bearable. I haven?t had any imaging done and just heard of another person with same symptoms. My 2nd dose was fine. No pain at all, not even at injection site. I will keep you posted if anything changes. I?m hoping it will just go away on it?s own. I?ve heard it takes months".  Referred employee back to PCP.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Hyperhidrosis, Hypotension, Nasopharyngitis, Pallor
Clinical narrative: PATIENT WAS SWEATING. SHE LOOKS PALE AND WAS COLD. SHE INDICATED HER SIGHT BLURRED. AFTER 45 MINUTES SHE WAS FINE.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: PATIENT WAS SWEATING. SHE LOOKS PALE AND WAS COLD. SHE INDICATED HER SIGHT BLURRED. AFTER 45 MINUTES SHE WAS FINE.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Lip swelling, Movement disorder, Night sweats
Clinical narrative: Pt was vaccinated at 10 am on 1/25/21 He stated that at 3:00 am on 1/26/21 he began having severe chills trouble moving and extreme thirst. He started to experience tachycardia and was diaphoretic. He stated that at 8 am 1/26 he had tingling in his lips and they began to swell. He stated taking 50 mg of diphenhydramine orally at this time. He had swelling and tingling of his face, eyes and tongue shortly after the oral diphenhydramine. He called an ambulance and was taken to the ER. At the ER he was given IV diphenhydramine and kept 2 hours for observation. He was also given oral steroids. He was sent home 1/26 with prescription oral steroids. He stated he has continues to experience tachycardia  with average HR at 110. He also continues to experience night sweats but stated this symptom is improving.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Periorbital swelling, Swelling face, Swollen tongue
Clinical narrative: Pt was vaccinated at 10 am on 1/25/21 He stated that at 3:00 am on 1/26/21 he began having severe chills trouble moving and extreme thirst. He started to experience tachycardia and was diaphoretic. He stated that at 8 am 1/26 he had tingling in his lips and they began to swell. He stated taking 50 mg of diphenhydramine orally at this time. He had swelling and tingling of his face, eyes and tongue shortly after the oral diphenhydramine. He called an ambulance and was taken to the ER. At the ER he was given IV diphenhydramine and kept 2 hours for observation. He was also given oral steroids. He was sent home 1/26 with prescription oral steroids. He stated he has continues to experience tachycardia  with average HR at 110. He also continues to experience night sweats but stated this symptom is improving.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Thirst
Clinical narrative: Pt was vaccinated at 10 am on 1/25/21 He stated that at 3:00 am on 1/26/21 he began having severe chills trouble moving and extreme thirst. He started to experience tachycardia and was diaphoretic. He stated that at 8 am 1/26 he had tingling in his lips and they began to swell. He stated taking 50 mg of diphenhydramine orally at this time. He had swelling and tingling of his face, eyes and tongue shortly after the oral diphenhydramine. He called an ambulance and was taken to the ER. At the ER he was given IV diphenhydramine and kept 2 hours for observation. He was also given oral steroids. He was sent home 1/26 with prescription oral steroids. He stated he has continues to experience tachycardia  with average HR at 110. He also continues to experience night sweats but stated this symptom is improving.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Electrocardiogram
Clinical narrative: Sensation of anxiety and minor "chest pressure" began 1/25/21 and continued at least through 1/26/21.    Watchful waiting was recommended.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chest X-ray, Culture urine negative, Injection site rash
Clinical narrative: 1. Abdominal pain, Left side towards the back, leading to 2.  vasovagal reaction, near fainting episode. 2-3 hours.  3. Rash covering entire left upper arm at site of injection site and surrounding it
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Presyncope, Rash
Clinical narrative: 1. Abdominal pain, Left side towards the back, leading to 2.  vasovagal reaction, near fainting episode. 2-3 hours.  3. Rash covering entire left upper arm at site of injection site and surrounding it
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Both arms and legs have rash and swollen legs and feet.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pharyngeal swelling, Streptococcus test negative
Clinical narrative: I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in  about 2 weeks after the vaccine. The rapid strep test was NEG.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: severe chills, muscle aches, general malaise, fever starting approx 11 hours after the vaccine and last 4 hours
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: DEVELOPED CHILLS, BODY ACHES, FLU LIKE SYMPTOMS FOR 2 HOURS ONE DAY AFTER THE VACCINATION, TOOK EXCEDRIN AND IT GOT BETTER
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Body aches; chills; headache; nausea; arm sore
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 1/25/21 @ 12:16 PM: Spoke with client who stated on day 5 after injection, he noted a 2" x 1" red bump that was warm to touch at injection site/arm.  Client denies any pain to site.   Advised client to call PCP for advise on how to treat.  Client was agreeable.    1/27/21 @ 3:25 PM:  Client stated PCP ordered him Claritin and topical steroid ointment for treatment of injection site.  Client stated the redness is fading and denies any pain to area.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SEVERLY SWOLLEN LYMPH NODES UNDER ARM ON SIDE OF VACCINATION
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Patient has history of anxiety so she was anxious even before taking the vaccine but she was fine before leaving.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Throat irritation, Throat tightness
Clinical narrative: 10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began to close up and was given PO Benadryl - no relief. Required Epinephrine and transport to ER
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient noticed indurated erythema, swelling, warmth, and pain at injection site on left arm.  Patient to be treated with antibiotics for cellulitis.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth
Clinical narrative: Patient noticed indurated erythema, swelling, warmth, and pain at injection site on left arm.  Patient to be treated with antibiotics for cellulitis.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Lip swelling, Rhinorrhoea, Swelling face
Clinical narrative: Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage.  Similar to reaction to hot peppers.  Took 1 Benadryl tablet.  Symptoms subsided over 24-hour period.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Extreme fatigue, headache, SOB, palpitations, dizziness, fogginess; went to ED at 10:00 AM Tuesday morning
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Injection site pain, Neck pain, Neuralgia
Clinical narrative: mild to moderate neuropathic pain starting at injection site, shooting distally towards the dorsum of arm and hand, has progressively worsen over the past day and starting today towards neck (L) and left side of face.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Myalgia, Pain, Swelling
Clinical narrative: day 1: pain?welling?redness day 1 evening: muscle aching  day 2 and 3: muscle aching and fatigue  day 4: recovered  day 8: pain,welling, redness appeared again day 11: recovered
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: pt states developed itching and a 4x3 hot, red, hard swollen spot around the injection area.  pt states the spot in now pink and itching has subsided since taking a Benadryl per PCP instructions.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Red arm ("Covid Arm") and rash on arm, thighs, and trunk. Pictures available on request.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Feeling cold, Pain in extremity
Clinical narrative: States woke up at 3am 1/28/2021, with chills, bundled up in multiple blankets but is unable to get warm. Does not have a thermometer but feels as if has an elevated temperature. Left arm and up into shoulder area is extremely painful and aches constantly, pain increases with any touch.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: States woke up at 3am 1/28/2021, with chills, bundled up in multiple blankets but is unable to get warm. Does not have a thermometer but feels as if has an elevated temperature. Left arm and up into shoulder area is extremely painful and aches constantly, pain increases with any touch.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Three red blotches on and near vaccinated site
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Hypersensitivity, Vaccination site pain, Vaccination site vesicles
Clinical narrative: Pain, redness, and blisters at vaccination site.  Patient went to the ER twice and treated for allergic reaction and cellulitis.  Patient still with residual open wound of L upper arm.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: Pain, redness, and blisters at vaccination site.  Patient went to the ER twice and treated for allergic reaction and cellulitis.  Patient still with residual open wound of L upper arm.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Impaired work ability, Malaise, Myalgia, Palpitations
Clinical narrative: Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pruritus
Clinical narrative: fatigue nausea headache pruritis
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 9 days after 1st covid vaccination  I developed red raised itching painful at injection site. 5 days later still with same symptoms
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 8 days post vaccination noticed site became reddened, firm, warm and itchy.  Hydrocortisone applied and took Advil, had temp 99.3.  Area is subsiding very slowly
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The shot location showed a red buffy skin ring 4cm in length. It almost looked like the shape of ringworm however it is not itching. The area feels hot not normal temp.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Received the immunization @8:00 PM on 1/25/2021. On 1/26/2021, woke @07:00 feeling chilly, dizzy and headache behind my eyes. My energy level was very low too. Took my temperature @ 09:00 and it was 101.1. I took Aspiring @325 mg every 4-6 hours plus used cold wet cloths to calm my fever down. I was not able to walk or drive a car with confidence. Also, I had painful sensation with lights on. No appetite--Did not eat anything until 1/27/2021 in the afternoon. On 1/27/2021, my hunger came back and fever down to normal. I was able to drink juices and eat some soup. Today, I had some breakfast of Tofu and scrambled eggs. But still feel a bit "floaty."
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Impaired driving ability, Pyrexia
Clinical narrative: Received the immunization @8:00 PM on 1/25/2021. On 1/26/2021, woke @07:00 feeling chilly, dizzy and headache behind my eyes. My energy level was very low too. Took my temperature @ 09:00 and it was 101.1. I took Aspiring @325 mg every 4-6 hours plus used cold wet cloths to calm my fever down. I was not able to walk or drive a car with confidence. Also, I had painful sensation with lights on. No appetite--Did not eat anything until 1/27/2021 in the afternoon. On 1/27/2021, my hunger came back and fever down to normal. I was able to drink juices and eat some soup. Today, I had some breakfast of Tofu and scrambled eggs. But still feel a bit "floaty."
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: headache, nausea, body aches, chills, fever 103.5
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Disorientation, Dizziness, Headache
Clinical narrative: Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Steroid therapy, Tinnitus
Clinical narrative: late Saturday, headache, buzzing in head, doctor Monday steroid shot, Thursday night buzzing in head again soreness of shoulder
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired VAQTA was administered to a patient; This spontaneous report was received from a registered nurse and immunization coordinator and refers to a 19 years old female patient. She had no illness at the time of vaccination. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 13-JAN-2021 (also reported as 11-JAN-2021, discrepant information), the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, intramuscularly in the left deltoid, lot # S023220 was confirmed to be valid, expiration date was 20-OCT-2020 for prophylaxis. This vaccine had no prior temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient rolled over the morning after receiving vaccine, the patient's arm was sore. This case is one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252428:same reporter US-GLAXOSMITHKLINE-US2020AMR252430:same reporter US-GLAXOSMITHKLINE-US2020AMR252425:same reporter
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal filler injection, Injection site pain, Injection site pruritus, Injection site swelling, Throat irritation
Clinical narrative: Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25.  Patient had previously had filler with no reaction and at this treatment has significant swelling and pain in treated area along with itching of treated area and throat  and tongue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: Pt had vaccine on Friday 1/22 and then had dermal filler on Monday 1/25.  Patient had previously had filler with no reaction and at this treatment has significant swelling and pain in treated area along with itching of treated area and throat  and tongue.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient rolled over the morning after receiving vaccine, the patient's arm was sore. This case is one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252429:Same reporter, different patient US-GLAXOSMITHKLINE-US2020AMR252428:same reporter, different patient US-GLAXOSMITHKLINE-US2020AMR252425:same reporter, different patient
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Incorrect dose administered, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: arm where the vaccine was given became swollen; arm where the vaccine was given became swollen, red; arm where the vaccine was given became swollen, red and hot; This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2020, the patient received the 2nd dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. In December 2020, less than 2 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling arm, erythema of extremities and extremities hot feeling of. On an unknown date, the outcome of the swelling arm, erythema of extremities and extremities hot feeling of were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities and extremities hot feeling of to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was vaccinated with Bexsero on unknown arm. The patient had reaction after vaccination, the arm where the vaccine was given became swollen, red and hot. No details on how soon after injection these symptoms developed. No information on whether events resolved or not. The patient was also administered allergy shots in the opposite arm on the same day. Attempted to follow up with HCP but unable to contact. Voicemail left with HCP office to obtain patient initials and lot and expiration date
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Had lymph adenopathy; This case was reported by a other health professional and described the occurrence of lymphadenopathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was unknown.   It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced lymphadenopathy after 1st injection. The patient requested full ingredient list, as she was planning on getting Pfizer COVID 19 vaccine and wanted to avoid a similar experience. No further details was provided. The reporter consented to follow-up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: very itchy rash started on 10th day and was over 6 inches long,  It is fading on third day, after applying benadryl cream.  But it's steill itchy and can still be seen.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chest X-ray, Computerised tomogram, Cough, Dysphagia
Clinical narrative: feeling short of breath; Difficulty swallowing; bilateral leg weakness; Pain; Fatigue; Losing voice; Itching at the injection site; Redness, swelling and itching at the injection site; Redness, swelling and itching at the injection site; Headache; Cough; Congestion; A spontaneous report was received from a customer who was also a 37-years-old female patient who developed congestion, cough, aphonia, headache, shortness of breath, dysphagia, fatigue, bilateral leg weakness and pain, and redness, swelling and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received her first of two planned doses of mRNA-1273 vaccine intramuscularly (site was not reported) for prophylaxis of COVID-19 infection. Approximately 2 hours later, the patient developed cough, headache, congestion, and redness, swelling, and itching at the injection site.   On 09 Jan 2021, she experienced worsening coughing, and she began losing her voice.   On 10 Jan 2021, the patient experienced shortness of breath, dysphagia, and bilateral leg weakness and pain. She was subsequently admitted overnight in the emergency room where she received intravenous fluids, diphenhydramine hydrochloride, and dexamethasone. A computerized tomogram scan, chest X-ray, and laboratory tests were performed and produced normal results.  On 11 Jan 2021, the patient was discharged home, and she reported feeling much better. However, she still felt fatigued and continued to experience headaches.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, shortness of breath, dysphagia, cough, and aphonia, was considered recovering. The outcome of the events, headache and fatigue, was considered not recovered. The outcome of the events, bilateral leg weakness and pain, congestion, and redness, swelling, and itching at the injection site, was not reported.; Reporter's Comments: Based on the limited 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: Dyspnoea, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: feeling short of breath; Difficulty swallowing; bilateral leg weakness; Pain; Fatigue; Losing voice; Itching at the injection site; Redness, swelling and itching at the injection site; Redness, swelling and itching at the injection site; Headache; Cough; Congestion; A spontaneous report was received from a customer who was also a 37-years-old female patient who developed congestion, cough, aphonia, headache, shortness of breath, dysphagia, fatigue, bilateral leg weakness and pain, and redness, swelling and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received her first of two planned doses of mRNA-1273 vaccine intramuscularly (site was not reported) for prophylaxis of COVID-19 infection. Approximately 2 hours later, the patient developed cough, headache, congestion, and redness, swelling, and itching at the injection site.   On 09 Jan 2021, she experienced worsening coughing, and she began losing her voice.   On 10 Jan 2021, the patient experienced shortness of breath, dysphagia, and bilateral leg weakness and pain. She was subsequently admitted overnight in the emergency room where she received intravenous fluids, diphenhydramine hydrochloride, and dexamethasone. A computerized tomogram scan, chest X-ray, and laboratory tests were performed and produced normal results.  On 11 Jan 2021, the patient was discharged home, and she reported feeling much better. However, she still felt fatigued and continued to experience headaches.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, shortness of breath, dysphagia, cough, and aphonia, was considered recovering. The outcome of the events, headache and fatigue, was considered not recovered. The outcome of the events, bilateral leg weakness and pain, congestion, and redness, swelling, and itching at the injection site, was not reported.; Reporter's Comments: Based on the limited 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: Injection site swelling, Laboratory test, Muscular weakness, Nasal congestion, Pain
Clinical narrative: feeling short of breath; Difficulty swallowing; bilateral leg weakness; Pain; Fatigue; Losing voice; Itching at the injection site; Redness, swelling and itching at the injection site; Redness, swelling and itching at the injection site; Headache; Cough; Congestion; A spontaneous report was received from a customer who was also a 37-years-old female patient who developed congestion, cough, aphonia, headache, shortness of breath, dysphagia, fatigue, bilateral leg weakness and pain, and redness, swelling and itching at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received her first of two planned doses of mRNA-1273 vaccine intramuscularly (site was not reported) for prophylaxis of COVID-19 infection. Approximately 2 hours later, the patient developed cough, headache, congestion, and redness, swelling, and itching at the injection site.   On 09 Jan 2021, she experienced worsening coughing, and she began losing her voice.   On 10 Jan 2021, the patient experienced shortness of breath, dysphagia, and bilateral leg weakness and pain. She was subsequently admitted overnight in the emergency room where she received intravenous fluids, diphenhydramine hydrochloride, and dexamethasone. A computerized tomogram scan, chest X-ray, and laboratory tests were performed and produced normal results.  On 11 Jan 2021, the patient was discharged home, and she reported feeling much better. However, she still felt fatigued and continued to experience headaches.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, shortness of breath, dysphagia, cough, and aphonia, was considered recovering. The outcome of the events, headache and fatigue, was considered not recovered. The outcome of the events, bilateral leg weakness and pain, congestion, and redness, swelling, and itching at the injection site, was not reported.; Reporter's Comments: Based on the limited 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site pruritus, Lymphadenopathy
Clinical narrative: First 2 days after vaccination, I had some injection site pain that was improving. Day 5 after vaccination, I developed lymphadenopathy on my left side with swelling into the chest area developing on day 6. Day 8 after vaccination, my injection site turned red and itchy and I began to have trouble breathing. I went to urgent care.  I saw P. A. She said that it was more likely that the difficulty breathing would be due to my asthma, but she could not recommend whether or not I should receive my second dose. She proscribed 20mg of Prednisone and refilled my albuterol prescription. About 20 hours later, my breathing is still difficult and my arm still itches.  We also discussed that the respiratory symptoms could be caused or exasperated by COVID-19, so I am waiting on results from a covid test.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Respiratory symptom, SARS-CoV-2 test
Clinical narrative: First 2 days after vaccination, I had some injection site pain that was improving. Day 5 after vaccination, I developed lymphadenopathy on my left side with swelling into the chest area developing on day 6. Day 8 after vaccination, my injection site turned red and itchy and I began to have trouble breathing. I went to urgent care.  I saw P. A. She said that it was more likely that the difficulty breathing would be due to my asthma, but she could not recommend whether or not I should receive my second dose. She proscribed 20mg of Prednisone and refilled my albuterol prescription. About 20 hours later, my breathing is still difficult and my arm still itches.  We also discussed that the respiratory symptoms could be caused or exasperated by COVID-19, so I am waiting on results from a covid test.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema; Urticaria; A spontaneous report was received from a physician concerning a 46-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema and urticaria.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date after receiving the vaccine, the patient experienced angioedema and urticaria.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, angioedema and urticaria, was not reported.; Reporter's Comments: This spontaneous report refers to a 46-year-old female patient who experienced unexpected event of angioedema and urticaria a week after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown.  There is limited description of the event of angioedema.  However, based on temporal information provided and in the absence of any other etiological factors, a causal association cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: A dose leaked around and down the arm; A spontaneous report was received from other healthcare professional concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine, whose dose leaked around and down the arm.    There were no medical history and concomitant medications provided by the reporter.  On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient's vaccine dose leaked around and went down the arm. Patient was not revaccinated. No additional information was available at the time of this report. No treatment information was provided for the event. Reporter provided consent to follow-up.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event dose leaked around and down the arm was considered to be resolved on on an unknown date.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of Incorrect dose administered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-005623: US-MODERNATX, INC.-MOD-2021-005687: US-MODERNATX, INC.-MOD-2021-005689: US-MODERNATX, INC.-MOD-2021-005692:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation
Clinical narrative: 1-2 drops rolled down and vaccine leakage out of the patient's arm; she did not get the full dose; A spontaneous report was received from a pharmacist concerning an elderly (over 65 years old), female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 1-2 drops rolled down and vaccine leakage out of the patient's arm and she did not get the full dose.  There were no medical history and concomitant medications reported.  On 19-Jan-2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm using one-inch needle for prophylaxis of COVID-19 infection and one or two drops rolled down and leaked out of the patient's arm in which she did not get the full dose.  The pharmacist reported that the patient tolerated vaccine well.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events "1-2 drops rolled down and vaccine leakage out of the patient's arm and she did not get the full dose" was recovered.; Reporter's Comments: This concerns an elderly female patient who received the first of two planned doses of mRNA-1273 (lot# 028L20A) intramuscularly in the left arm using one-inch needle for prophylaxis of COVID-19 infection and experienced one or two drops of the vaccine leakage out of the arm and did not get the full dose.. There were no reported adverse events associated with this event of one or two drops that rolled down and vaccine leakage out of the patient's arm and felt she did not get the full dose.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysstasia, Fatigue, Feeling cold
Clinical narrative: Extreme nerve pain, extreme body aches, violent migraines, extreme diarrhea from midnight to 6 am, difficulty walking, hot flashes, cold flashes, congestion, high fatigue, difficulty sleeping due to high painand difficulty standing due to light headiness.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hot flush, Migraine, Neuralgia, Pain
Clinical narrative: Extreme nerve pain, extreme body aches, violent migraines, extreme diarrhea from midnight to 6 am, difficulty walking, hot flashes, cold flashes, congestion, high fatigue, difficulty sleeping due to high painand difficulty standing due to light headiness.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sleep disorder
Clinical narrative: Extreme nerve pain, extreme body aches, violent migraines, extreme diarrhea from midnight to 6 am, difficulty walking, hot flashes, cold flashes, congestion, high fatigue, difficulty sleeping due to high painand difficulty standing due to light headiness.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, IIIrd nerve paralysis
Clinical narrative: Third cranial nerve palsy; A spontaneous report was received from a 63-year-old male pharmacist who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed third cranial nerve palsy.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 5 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient began to have blurred vision which progressed into double vision. He then experienced a headache that felt similar to when you have the wrong prescription glasses or cross-eyed. On 06 Jan 2021, he was seen by his ophthalmologist who ordered a CT scan which was negative. His eyelids were drooping and he wore an eye patch on the right eye because his right eye is completely shut. The patient reports that the muscle that keeps the pupil in focus in the middle is paralyzed, so his pupil is turned to the right and down, which is what was causing the double vision.The treatment of the event include eye patch.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, third cranial nerve palsy, was considered unknown.; Reporter's Comments: This case concerns a 63 year old male patient, who experienced a serious unexpected event of IIIrd nerve paralysis. The events of IIIrd nerve paralysis occurred 6 days after first dose of mRNA-1273, lot # 037K20A. Diagnostics included a CT scan, which revealed no abnormality. Treatment for the event include eye patch and no other details were provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received two doses of the Moderna COVID-19 vaccine on the same day; A spontaneous report was received from a pharmacy concerning a 50 year old female patient who patient received two doses of the Moderna COVID-19 vaccine on the same day with the use of mRNA-1273.   There was no medical history provided. There were no concomitant medications provided.  On 08 Jan 2021, the patient received the first and second of two planned doses of mRNA-1273 (Batch # unknown), in her right deltoid, for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient received two doses of the Moderna COVID-19 vaccine on the same day. It was noted that there were no adverse reactions identified at the time of this report. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event of patient received two doses of the Moderna COVID-19 vaccine on the same day, was considered not provided as the patient received two doses.  The outcome for the event of injected air into vaccine was recovered/resolved at the time of this report.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of inappropriate schedule of product administration.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site mass
Clinical narrative: Pharmacist told him that the injection had been subcutaneous; Has a large knot that he can move around, it is posterior to the deltoid; A spontaneous report was received from a health care professional concerning a 50-year-old, male consumer who received Moderna's COVID-19 vaccine and experienced a has a large knot that he can move around, it is posterior to the deltoid (Injection site mass) and  pharmacist told him that the injection had been subcutaneous (Incorrect route of product administration).  The patient's medical history was not provided. Concomitant medications were Amlodipine and Descvy.   On Unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19-Jan-2021, the patient received the second dose of two planned doses of mRNA-1273 (Lot Number: 028L20A) subcutaneously in the right arm for prophylaxis of COVID-19 infection.  On 19-Jan-2021, after receiving the vaccine, the patient experienced large knot that he can move around posterior to the deltoid. Treatment for the event was not provided.  On 21-Jan-2021, the pharmacist told him that the injection had been given subcutaneously. 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 for the event, large knot that he can move around, posterior to the deltoid is unknown. The outcome for the event, pharmacist told him that the injection had been given subcutaneously was considered resolved on 21-Jan-2021.; Reporter's Comments: This case concerns a 50 years old male patient, who experienced incorrect route of product administration, and a non-serious unexpected event of injection site mass. There were no reported AEs associated with this case of incorrect route of product administration. The events of injection site mass occurred 1 days (same day) after second dose of mRNA-1273, lot # 028L20A. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events (injection site mass) a causal relationship cannot be excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient passed out in chair in waiting area. Was treated in the room for sinus brady and nausea. 18 g IV established 1 mg atropine and 4mg Zofran administered. Pt. started to "Feel Better". Not sinus rhythm and nausea subsided. Pt. transported to the hospital via Ambulance for further treatment if needed and monitoring.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to 17 1/2 years old; A spontaneous report was received from a pharmacist concerning a 17-year old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine administered to 17 1/2 years old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received a dose of mRNA-1273 (lot number 041L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the 17 1/2-year-old patient verbally stated that she was of 20-years-old. Hence, she was administered with first dose of Moderna vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered to 17 1/2 years old, was considered to be resolved on an unknown date.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for COVID-19 vaccine , mRNA-1273, lot # 041L20A. There were no reported AEs associated with this case of Product administered to patient of inappropriate age .
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered twice the dose; A spontaneous report was received from a nurse concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was administered twice the dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.   On 22-Jan-2021, The patient was administered with twice the dose of vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event administered twice the dose was considered to be resolved on 22-Jan-2021.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event of administered twice the dose (Inappropriate dose of vaccine administered) for mRNA-1273 (Lot # unknown, Expiration date-unknown). There were no reported AEs associated with the event of administered twice the dose.