chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient reports right sidedness numbness starting two days after vaccination.  Next day numbness was on left side.  Numbness has resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, minor swelling and itching at injection site. Applied OTC 1% Hydrocortisone anti-itch cream and itching resolved. Repeated 12 hours later with same results.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye movement disorder, Flushing, Hyperhidrosis, Nausea, Pallor
Clinical narrative: pt was sitting in pharmacy waiting area after receiving first shingles dose and complained of feeling flush; about 10 minutes later, he was  sweating and complained of nausea; Shortly thereafter, he put his head back, his eyes rolled back and he became very pale; i tapped his shoulders and called his name - he responded with mumbling; EMS was called; EMS arrived and reported the following vitals - 99% on room air, HR 54, BP 87/46; oriented x 3; ultimately,  they transported him to the hospital
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Vital signs measurement
Clinical narrative: pt was sitting in pharmacy waiting area after receiving first shingles dose and complained of feeling flush; about 10 minutes later, he was  sweating and complained of nausea; Shortly thereafter, he put his head back, his eyes rolled back and he became very pale; i tapped his shoulders and called his name - he responded with mumbling; EMS was called; EMS arrived and reported the following vitals - 99% on room air, HR 54, BP 87/46; oriented x 3; ultimately,  they transported him to the hospital
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling cold, Hallucination, Injected limb mobility decreased, Insomnia
Clinical narrative: PT STATES 'ON 2-9-21 SHE STARTED SEEING AND TALKING TO DEAD PEOPLE, SHE WAS UNABLE TO EAT OR SLEEP FOR A WEEK'. SHE ALSO HAD FEVER, CHILLS AND A SORE ARM AFTER THE SHOT. SHE WEN TO THE ER ON 2-22-21 AND WAS RELEASED WITHOUT TREATMENT.  SHE ALSO SAW HER PCP ON 2-22-21 AND WAS GIVEN ZOLOFT WHICH HAS HELPED SOME. SHE STATES SHE 'TOOK HERSELF OFF ALL HER MEDS SO HER SYSTEM WOULD BE CLEAN FOR THE SHOT.' 2-24-21 9AM TC - STATES 'LEGS TINGLE TODAY'. ADVISED HER TO CALL HER PCP ABOUT GETTING BACK ON HER MEDS TO HELP HER FEEL BETTER, STATES SHE 'WILL CALL PCP TODAY'.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: PT STATES 'ON 2-9-21 SHE STARTED SEEING AND TALKING TO DEAD PEOPLE, SHE WAS UNABLE TO EAT OR SLEEP FOR A WEEK'. SHE ALSO HAD FEVER, CHILLS AND A SORE ARM AFTER THE SHOT. SHE WEN TO THE ER ON 2-22-21 AND WAS RELEASED WITHOUT TREATMENT.  SHE ALSO SAW HER PCP ON 2-22-21 AND WAS GIVEN ZOLOFT WHICH HAS HELPED SOME. SHE STATES SHE 'TOOK HERSELF OFF ALL HER MEDS SO HER SYSTEM WOULD BE CLEAN FOR THE SHOT.' 2-24-21 9AM TC - STATES 'LEGS TINGLE TODAY'. ADVISED HER TO CALL HER PCP ABOUT GETTING BACK ON HER MEDS TO HELP HER FEEL BETTER, STATES SHE 'WILL CALL PCP TODAY'.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Pallor
Clinical narrative: Patient started with a heavy feeling in chest Vital signs done elevated BP 156/65, HR 72, SpO2 97%. patient felt better return to sit with family, but then became SOB w/ tightness in chest 50 mg Benadryl and 2 L/m O2 applied. patient's color returned to facial feature, patient feeling better BP elevated second presentation to 168/64 HR 71, SpO2 100% 2L/m NC. Patient is now improving with BP 158/63, HR 72, RR 20, SpO2 97% ra. 1200 hr BP 155/65,
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: After 13 days, she was not using her arm to get up.  Very sore at injection site.  No visable  redness or inflammation.  2nd day she said it felt better.  3 rd day, not using the arm again.  Can?t raise arm over head.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Adverse reaction s/p first dose Moderna Vaccine. Patient developed at 1311 warm, flush feeling, dizziness, diaphoretic, light headed, pale and nausea. Denied difficulty breathing, throat swelling or swallowing. 1311 BP 148/110, HR 69, SPO2 98%. BS 124 constant monitoring (DM I). Rapid response called. 1316 BP 80/47, HR 80, SPO2 98% transported by rapid response team to emergency department.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Adverse reaction s/p first dose Moderna Vaccine. Patient developed at 1311 warm, flush feeling, dizziness, diaphoretic, light headed, pale and nausea. Denied difficulty breathing, throat swelling or swallowing. 1311 BP 148/110, HR 69, SPO2 98%. BS 124 constant monitoring (DM I). Rapid response called. 1316 BP 80/47, HR 80, SPO2 98% transported by rapid response team to emergency department.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic taste lasted for approximately 5 days, decreasing in strength over time. Within 10-15 minutes of getting the vaccine, parts of my face went partially numb (primarily under my lips and along my right cheek). The numbness was largely improved after 1.5 weeks, but I continue to experience it intermittently 3+ weeks later. I also had severe jaw pain that lasted for about 2 weeks, on and off. Within about an hour of receiving the vaccine, I noticed a small amount of rectal bleeding as well; this resolved within the same day. Beyond that, my symptoms were "normal" -- pain at the injection site, mild nausea and chills on the day of the vaccine. I spoke with 5 different doctors about the facial numbness, and none of them were able to advise me on why that might have happened. My primary care physician recommended against getting the second shot until we have more information about what would cause these side effects.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Numb chin syndrome, Pain in jaw, Rectal haemorrhage
Clinical narrative: Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic taste lasted for approximately 5 days, decreasing in strength over time. Within 10-15 minutes of getting the vaccine, parts of my face went partially numb (primarily under my lips and along my right cheek). The numbness was largely improved after 1.5 weeks, but I continue to experience it intermittently 3+ weeks later. I also had severe jaw pain that lasted for about 2 weeks, on and off. Within about an hour of receiving the vaccine, I noticed a small amount of rectal bleeding as well; this resolved within the same day. Beyond that, my symptoms were "normal" -- pain at the injection site, mild nausea and chills on the day of the vaccine. I spoke with 5 different doctors about the facial numbness, and none of them were able to advise me on why that might have happened. My primary care physician recommended against getting the second shot until we have more information about what would cause these side effects.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swelling around the eyes.   They are still swelled and my doctor put me on hydroxyzine 25mg
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Swelling face
Clinical narrative: 90 minutes after vaccine, experienced left side facial swelling, redness, hot to the touch
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: COVID arm 14 days after vaccination (shot 1)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: experienced symptoms 12 hours later that I had to call in for my shift for today. I experienced headache and fatigue yesterday afternoon and developed back aches at 2030At 2330, I developed fever (100.5) with chills, nausea, diarrhea and faint feeling. I started blacking out while walking to get water and had to kneel down to the floor to prevent myself from passing out. I had tingling in my hands and feet for an hour after. I took ibuprofen at 0145, and fell asleep around 0230. As of now, I feel back to normal, other than sore arm and lingering fatigue. My fever is gone and temp back down to 98.3. I had COVID back in early December, so I expected this type of immune response with the first vaccine dose.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: experienced symptoms 12 hours later that I had to call in for my shift for today. I experienced headache and fatigue yesterday afternoon and developed back aches at 2030At 2330, I developed fever (100.5) with chills, nausea, diarrhea and faint feeling. I started blacking out while walking to get water and had to kneel down to the floor to prevent myself from passing out. I had tingling in my hands and feet for an hour after. I took ibuprofen at 0145, and fell asleep around 0230. As of now, I feel back to normal, other than sore arm and lingering fatigue. My fever is gone and temp back down to 98.3. I had COVID back in early December, so I expected this type of immune response with the first vaccine dose.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: experienced symptoms 12 hours later that I had to call in for my shift for today. I experienced headache and fatigue yesterday afternoon and developed back aches at 2030At 2330, I developed fever (100.5) with chills, nausea, diarrhea and faint feeling. I started blacking out while walking to get water and had to kneel down to the floor to prevent myself from passing out. I had tingling in my hands and feet for an hour after. I took ibuprofen at 0145, and fell asleep around 0230. As of now, I feel back to normal, other than sore arm and lingering fatigue. My fever is gone and temp back down to 98.3. I had COVID back in early December, so I expected this type of immune response with the first vaccine dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea, Nausea, Pain in extremity
Clinical narrative: Patient called the to report adverse effects following vaccination with Moderna, especially following her second dose. )Her first dose was given on 1/16/21, and she immediately experienced nausea. Pt stated in was administered in the L arm, but ALERT IIS stated R arm.) After the second dose, she reported immediate nausea, milder than after the first vaccine, and then  "breathing trouble"--a "squeezing heart" sensation that began about 10 minutes after vaccination and lasted for close to one hour. She also immediately began to have pain in her Left arm (the 2nd vaccine dose was administered in her Right arm). This pain has continued to grow and intensify; she called in on 2/24/21 and on 2/25/21 reported that it is even worse. She is planning to go to an urgent care but finds it difficult as she has 5 children at home.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Panic attack, Pharyngeal swelling, Urticaria
Clinical narrative: Difficult to swallow, then unable to swallow and swelling of the throat 2 minutes after vaccine. Shortness of breath then panic attack.  Hives back and buttocks.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy treated with steroids
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Nausea, Pruritus, Skin warm
Clinical narrative: Covid Arm, itching, hot, small welts/little hives in armpit, headache, tired, nausea
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Covid Arm, itching, hot, small welts/little hives in armpit, headache, tired, nausea
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Headache, Sensation of foreign body
Clinical narrative: Patient reports globus sensation ("golf ball in throat") and hoarseness starting about 5 minutes after injection.  She was observed for 30 minutes and was leaving the vaccination site but was noted to have vocal change.  She was given a dose of diphenhydramine 50 mg IM after about 1 hour and transported to ED.  She reports she was given prednisone, observed for about 2 hours, then discharged home.  Other than a headache, she denies any other symptoms (rash, itching, dyspnea, dizziness, nausea).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 2nd dose of Moderna given 2/25/21 after 1st dose of Pfizer vaccine (given 2/2/21). Recipient asked if she knew she was receiving Moderna and she said yes. I said she would be given Moderna. When we finished, I turned over her card and saw "3 weeks" written on back of card. The I noted Pfizer was written on the front of card. No side effects noted. Recipient called. She stated facility where she received 1st dose did not have any vaccines and she was told to get it 3 weeks later. It was explained that she received 2 different vaccines (different manufacturers) and that she should have receive the same type of vaccine. She stated, " I'm sorry, I just wanted to get it". She was told she should not repeat a dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Within the first 18hrs I developed the expected chills, achiness, headache, fatigue but that went away.   The entire next week I was nauseous on and off, then noticed that the nausea has been lingering around for the past 4 weeks, not every day and not all day. I vomited on 5 different occasions and have had a headache on and off. Today I have diarrhea in addition to the nausea.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Within the first 18hrs I developed the expected chills, achiness, headache, fatigue but that went away.   The entire next week I was nauseous on and off, then noticed that the nausea has been lingering around for the past 4 weeks, not every day and not all day. I vomited on 5 different occasions and have had a headache on and off. Today I have diarrhea in addition to the nausea.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: I have developed a large reddened area at the site of injection. It is warm to the touch and extremely itchy. The pruritis is extreme. It has tripled in size and hardness in 24hrs
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Pain in extremity
Clinical narrative: Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetaminophen. Having a slow recovery. Today, 4th day after the vaccination with second dose still have pain but is lower.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: nauseous, diarrhea, body aches, fever, sore arm,
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arrhythmia, Chest pain, Chills, Fatigue
Clinical narrative: Nasal congestion, chills no fever, exhaustion, pain at injection site. Palpitations and arrythmla.  Tylenol and bismuth subsalicylate for bloating and chest pain.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nasal congestion, Palpitations
Clinical narrative: Nasal congestion, chills no fever, exhaustion, pain at injection site. Palpitations and arrythmla.  Tylenol and bismuth subsalicylate for bloating and chest pain.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Malaise, Skin weeping, Swelling
Clinical narrative: Swelling, redness, oozing, pain of injection arm, general malaise- returned to vaccine site at CVS and had NP examine, steroid prescribed, also made visit to my mother?s internal medicine dr and he examined as well; my mom was told to discontinue steroids and not to get 2nd dose of vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Hyperhidrosis, Tremor
Clinical narrative: Sweats, shakes, bone ache
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pnemovax 23 vaccine given on 02/17/21
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: Headache, low grade fever (<100 F), body aches, chills, sweats, fatigue.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, low grade fever (<100 F), body aches, chills, sweats, fatigue.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, General physical health deterioration
Clinical narrative: Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining".    It is unknown what side effects he was having.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cardiac disorder, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining".    It is unknown what side effects he was having.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate, Mass, Muscle spasms, Nasal mucosal disorder
Clinical narrative: Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining".    It is unknown what side effects he was having.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Pneumonia, Pyrexia, Renal failure
Clinical narrative: Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining".    It is unknown what side effects he was having.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan, X-ray
Clinical narrative: Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining".    It is unknown what side effects he was having.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Area approximately 6 inches long and 4 inches wide became red and hot to the touch.  No rash or swelling but did itch.  This is 6th day after this occurred.  I saw the doctor yesterday (Wednesday) and showed him my arm.    He said if it wasn?t better by Friday to let him know and he would give me an antibiotic.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Lethargy, Pyrexia
Clinical narrative: 2 hours after vaccine I developed arm ache at injection point and low grade fever that climbed over next 4-5 hours to 100.8 on non-contact digital read  thermometer. Lethargic and sleepy for next 36 hours. Pain in arm got worse during this time to point that I just didn't want to move at all. Mitigated with Tylenol during these 36 hours of adverse reaction, was quite effective.  I'm an athlete, my pain threshold is very high; this condition sucked for 36 hours.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal rigidity, Diarrhoea, Nausea
Clinical narrative: Sx developed a few hours after injection of abdominal pain/spasms, nausea, and loose stool. Sx are still persisting now. Tm states the sx are worse at night. Set TM up for testing on 2/12 from 830-930 at BMCJ negative. TM has been working this whole time. MD follow up for sx, MD gave meds that relieved sx, did not advise against second dose
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient was found at 6 AM on 01/21/2021 - he passed away during his sleep
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE reported.; Patient administered VARIVAX during a temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 09-FEB-2021, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) dose  reported as 0.5 ml, lot # T021826, expiry date 25-JUN-2022, for prophylaxis. (formulation, concentration, dose number, route of administration and frequency were not reported).  Digital data logger was involved. The vaccine underwent the temperature excursion at range - 9.51 degree of Celsius (C) for 56 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA004947: US-009507513-2102USA005061: US-009507513-2102USA004607:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; the vaccine expired on 06-FEB-2021 and was administered on 08-FEB-2021; This spontaneous report was received from a nurse and refers to a 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 08-FEB-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # 1660942, expiration date 06-FEB-2021 for prophylaxis. No adverse events were reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Injected limb mobility decreased
Clinical narrative: unable to lift her left (injection) arm / very painful to put on a shirt; severe joint pain in her left shoulder / right shoulder and both hips also have pain/pain; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number GM2Y4, expiry date 10th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th September 2020,refer case US2021002009).   On 20th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 20th November 2020, less than a day after receiving Shingrix, the patient experienced arthralgia. In January 2021, the patient experienced injected limb mobility decreased. The patient was treated with celecoxib (Celebrex). On an unknown date, the outcome of the arthralgia and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the arthralgia and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient was still experiencing severe joint pain in her left shoulder. Her right shoulder and both hips also had pain. The pain was worse at night.  The patient used Celebrex for the joint pain. The patient had blood work done for a rheumatology consult and she saw an orthopedic surgeon on 6th January 2021. The patient was unable to lift her left (injection) arm and it was very painful to put on a shirt. The reporter consented to follow up. This case has been linked with case US2021002013, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002013:same reporter US-GLAXOSMITHKLINE-US2021002009:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: chills; fever; very swollen / injection site; painful injection site; This case was reported by a consumer and described the occurrence of chills 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 chills, fever, injection site swelling and injection site pain. On an unknown date, the outcome of the chills, fever, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the chills, fever, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient had received 1st Shingrix vaccination and had a very swollen and painful injection site with injection. The patient had chills and fever also. For tolerance of 2nd dose US2021AMR013034.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013034:SAME reporter
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Joint stiffness, Joint swelling, Sensation of foreign body, Throat irritation
Clinical narrative: Left knee swelled up; Burning of throat; Lump in the throat; Stiffness in left knee; felt miserable; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of joint swelling (received shingrix on 19th August 2020, refer case US2021012441).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable. On an unknown date, the outcome of the swelling of knees and stiff knees were not recovered/not resolved and the outcome of the burning in throat and lump feeling in throat were recovered/resolved and the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the swelling of knees, burning in throat, lump feeling in throat, stiff knees and feeling miserable to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received flu vaccine and felt miserable afterwards.  The patient stated that within a day or two her left knee swelled up, developed a lump in her throat, and there was also burning in the throat.  The patient described the lump as the size of a large grape that was located right in the middle where the Adam's apple would be and that it was no longer there, but it did take a long time for it to go away.  The patient was still had stiffness in the left knee that says was better, but not back to normal.  The patient never had any reactions like this before and was otherwise healthy.  The patient did visit her HCP where they did an ultrasound and was also sent to an endocrinologist but a diagnosis was never made. The reporter did not consent to follow up. Not all information was available and did not give permission to follow up with their HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012441:same reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Underdose, Urticaria, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash that was very itchy/arm look different; Hives/ rash from the jaw to the neck; Painful circle of rash at the site of the injection; Painful circle of rash at the site of the injection; When they received the vaccine they noticed some liquid dripped; A spontaneous report was received from a consumer concerning 70 year old female patient.  The patient's medical history was not provided.  Concomitant medication included unspecified blood pressure medication, unspecified cholesterol medication, unspecified thyroid medication, Women's One A Day, Aspirin, Colace, Vitamin C, Vitamin D, two unspecified nasal sprays, and allopurinol.  On 29Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 011L01A) in the left arm for prophylaxis of COVID-19 infection.  On 29Jan2021, the patient noticed some liquid dripped during the vaccination, and experienced a very painful circle of rash at the injection site.  On an unspecified day, 7th day after the vaccination, the patient experienced her arm looking very different with a bigger rash that was very itchy.  On an unspecified date, the next day, the patient experienced a rash that reached her neck and it turned into something like hives and was very itchy.  The patient was treated with Keflex, clindamycin, and hydroxyzine.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of incorrect dose administered, vaccination site rash, vaccination site pain, rash pruritic, and urticaria was unknown.; Reporter's Comments: This report refers to a case of vaccine underdose,  administered for mRNA-1273, lot # 011L01A with  associated adverse events of vaccination site rash, vaccination site pain, rash pruritic, and urticaria. 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Syncope, Urticaria
Clinical narrative: Faint; Hives up and down both of her arms; Felt warm; A spontaneous report was received from a healthcare professional, concerning a 80-year-old, female patient who was administered Moderna's COVID-19 vaccine and felt warm, faint and hives occurred afterwards up and down both of her arms. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042670A) intramuscularly, for prophylaxis of COVID-19 infection.  On 19-Jan-2021, right after getting her vaccine patient felt warm and faint afterwards. Approximately, eight or nine days after the injection, patient had hives up and down both of her arms. Patient was concerned if it was a systemic allergic reaction and likeliness of another reaction in future with increased severity. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, felt warm, faint and hives occurred afterwards up and down both of her arms were considered unknown.; Reporter's Comments: This report concerns a 80--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 042670A , and felt warm, faint and hives occurred afterwards up and down both of her arms. Very limited information regarding this event has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling hot, Product administered at inappropriate site, Vaccination site swelling
Clinical narrative: down to wrist was really hot; swelled, but just a little puffy; administered too high on shoulder; hurting and pain across back; pain on back of shoulder, deep, felt like a toothache; A spontaneous report was received from a consumer concerning a 65 Years-old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced administered too high on shoulder(Product administered at inappropriate site), hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), down to wrist was really hot(Feeling hot), deep pounding sensation in the middle of back(Musculoskeletal discomfort), swelled, but just a little puffy(Injection site swelling), nervous wreck(Nervousness).    The patient's medical history was not provided. concomitant medication includes Advil.    02-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  02-Feb-2021, The patient feels vaccine may have been administered too high on shoulder(Product administered at inappropriate site) and also experienced events of hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), down to wrist was really hot(Feeling hot), deep pounding sensation in the middle of back(Musculoskeletal discomfort), swelled, but just a little puffy(Injection site swelling), nervous wreck(Nervousness). No Laboratory details provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events down to wrist was really hot(Feeling hot), swelled, but just a little puffy(Injection site swelling) is resolved and the outcome for hurting and pain across back(Back pain), pain on back of shoulder, deep, felt like a toothache(Arthralgia), deep pounding sensation in the middle of back(Musculoskeletal discomfort), nervous wreck(Nervousness) is 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 of back pain, arthralgia, feeling hot and vaccination site swelling, a causal relationship cannot be excluded. The event of product administered at inappropriate site is assessed to be not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: 2nd dose was scheduled for 25Jan2021, but she has not received yet; COVID-19 virus test positive; A spontaneous report was received from a consumer concerning a 62-year-old, female patient who was administered Moderna's COVID-19 vaccine and tested positive for COVID and her 2nd dose was scheduled but she has not received yet.  The patient's medical history included high blood pressure and high cholesterol. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number:025L20A) unknown route of administration on 30 Dec 2020.   Patient received the first dose on 30 Dec 2020. Patient tested positive for COVID on 20 Jan 2021. Her second dose was scheduled for 25 Jan 2021, but she has no received yet. Patient wanted to know if she should receive the 2nd Moderna vaccine. No treatment information was provided.  Consent to follow up was given.  The second dose of mRNA-1273 was discontinued in response to the event.  The event, her 2nd dose was scheduled but she has not received yet were considered resolved. The outcome for the event tested positive for COVID considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a female patient, received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: given a lesser dose; A spontaneous report was received from a consumer concerning a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an accidental underdose.  The patient's medical history was not provided.  Concomitant medications were not provided.  On 12 FEB 2021, the patient received her first dose of mRNA-1273 (lot number 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient was called thirty minutes after receiving her first dose of the vaccine by the pharmacist to have her come back to the facility.  The pharmacist explained that there was a medication error and they wanted to make sure that the patient got the full dose.  Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, accidental underdose was considered recovered.; Reporter's Comments: This case concerns a 67-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting accidental underdose without any associated adverse events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Heart rate, Pyrexia
Clinical narrative: Rapid heartbeat; Shortness of breath; Pain at injection site; Chills; Fatigue; Fever; A spontaneous report was received from a consumer concerning a 25 years-old, female patient who experienced rapid heartbeat/MedDRA PT: tachycardia, shortness of breath/MedDRA PT: dyspnoea, pain at injection site/MedDRA PT: vaccination site pain, chills/MedDRA PT: chills, fatigue/MedDRA PT: fatigue, and fever/MedDRA PT: pyrexia.  The patient's medical history included anemia and low immune system. Concomitant product use was not provided by the reporter.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 025A202A) intramuscularly (injection site not provided) for prophylaxis of COVID-19 infection.  On 23 Jan 2021, after receiving vaccination, the patient experienced pain at injection site, chills, fever, fatigue and shortness of breath. On 24 Jan 2021, the patient experienced rapid heartbeat. The patient was hospitalized and during hospitalization, heart rate was noted as 125 bpm which reduced down to 110 bpm. The patient was discharged on 25 Jan 2021. Following hospitalization, patient had ongoing fever and was advised to contact hospital for direction regarding readmission.   Treatment included self-administered Tylenol, six times daily.  Action taken with mRNA-1273 in response to the events was unknown.  The events chills and shortness of breath were considered resolved on 24 Jan 2021. The events pain at injection site, fatigue, and rapid heartbeat were considered resolved on an unknown date. The event fever was considered not resolved.; Reporter's Comments: This case concerns a 25-year-old female who experienced serious expected events of tachycardia and dyspnea along with nonserious expected events of fever, chills, fatigue and vaccination site pain.  The events occurred 1 day after the first dose of mRNA-1273. Treatment included Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site pain
Clinical narrative: Rapid heartbeat; Shortness of breath; Pain at injection site; Chills; Fatigue; Fever; A spontaneous report was received from a consumer concerning a 25 years-old, female patient who experienced rapid heartbeat/MedDRA PT: tachycardia, shortness of breath/MedDRA PT: dyspnoea, pain at injection site/MedDRA PT: vaccination site pain, chills/MedDRA PT: chills, fatigue/MedDRA PT: fatigue, and fever/MedDRA PT: pyrexia.  The patient's medical history included anemia and low immune system. Concomitant product use was not provided by the reporter.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 025A202A) intramuscularly (injection site not provided) for prophylaxis of COVID-19 infection.  On 23 Jan 2021, after receiving vaccination, the patient experienced pain at injection site, chills, fever, fatigue and shortness of breath. On 24 Jan 2021, the patient experienced rapid heartbeat. The patient was hospitalized and during hospitalization, heart rate was noted as 125 bpm which reduced down to 110 bpm. The patient was discharged on 25 Jan 2021. Following hospitalization, patient had ongoing fever and was advised to contact hospital for direction regarding readmission.   Treatment included self-administered Tylenol, six times daily.  Action taken with mRNA-1273 in response to the events was unknown.  The events chills and shortness of breath were considered resolved on 24 Jan 2021. The events pain at injection site, fatigue, and rapid heartbeat were considered resolved on an unknown date. The event fever was considered not resolved.; Reporter's Comments: This case concerns a 25-year-old female who experienced serious expected events of tachycardia and dyspnea along with nonserious expected events of fever, chills, fatigue and vaccination site pain.  The events occurred 1 day after the first dose of mRNA-1273. Treatment included Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Was given a lesser dose; A spontaneous report was received from a healthcare professional and a consumer concerning 70 year old male patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 12Feb2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12Feb2021, the vaccine provider (pharmacist) performed an accidental underdose.  The pharmacist informed the patient to go back and receive the full recommended dose.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The event, accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error of accidental underdose for mRNA-1273(lot number 031M20A), with no associated AEs
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Incorrect route of product administration, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: injection site bled; arms is swollen; Arm is painful; Arm is red; Arm is tender; not injected properly into muscle; A spontaneous report was received from a healthcare professional who was also a 63 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was not injected properly into muscle / incorrect route of product administration, and experienced injection site bleeding / vaccination site haemorrhage, arm was swollen / peripheral swelling, arm was painful / painful extremity, arm was red / erythema, and arm was tender / tenderness.  The patient's medical history was not provided.  Concomitant medication included metformin, tamoxifen, Synthroid, spironolactone, Protonic, vitamin D, and magnesium.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On an 12Feb2021, the patient received the second of the planned doses of mRNA-1273 (lot number 041L20A) for prophylaxis of COVID-19 infection.  On 12Feb2021, the patient experienced injection site bleeding, arm swollen, painful, hot, and tender.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, not injected properly into muscle, was resolved on 12 Feb 2021. The outcome of the events, injection site bleeding, arm was swollen, arm was painful, arm was red, and arm was tender, was not provided.; 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: Vaccination site haemorrhage
Clinical narrative: injection site bled; arms is swollen; Arm is painful; Arm is red; Arm is tender; not injected properly into muscle; A spontaneous report was received from a healthcare professional who was also a 63 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the vaccine was not injected properly into muscle / incorrect route of product administration, and experienced injection site bleeding / vaccination site haemorrhage, arm was swollen / peripheral swelling, arm was painful / painful extremity, arm was red / erythema, and arm was tender / tenderness.  The patient's medical history was not provided.  Concomitant medication included metformin, tamoxifen, Synthroid, spironolactone, Protonic, vitamin D, and magnesium.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On an 12Feb2021, the patient received the second of the planned doses of mRNA-1273 (lot number 041L20A) for prophylaxis of COVID-19 infection.  On 12Feb2021, the patient experienced injection site bleeding, arm swollen, painful, hot, and tender.  No treatment was reported.  Action taken with the mRNA-1273 was not reported.  The outcome of the event, not injected properly into muscle, was resolved on 12 Feb 2021. The outcome of the events, injection site bleeding, arm was swollen, arm was painful, arm was red, and arm was tender, was not provided.; 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a vaccine outside the six hour window; A spontaneous report was received from a consumer concerning a patient (demographics not provided) who received a vaccine outside the six hour window.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received dose of mRNA-1273 (Lot # unknown) (dose number, route of administration and injection site not provided) for prophylaxis of COVID-19 infection.  On unknown date, the patient received mRNA-1273 vaccine outside the six hour window.   Action taken with mRNA-1273 in response to the event was not provided.  The event, received a vaccine outside the six hour window was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of patient of unknown age and gender who experienced Expired product administered for mRNA-1273 (lot # unknown) with no associated adverse events. The patient received mRNA-1273 vaccine outside the six hour window. Very limited information regarding this event has been provided at this time.  Further information has been requested.