chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was given a booster dose of vaccine that expired on Jun2020, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient's mother). This case involves a 15 month old male patient was given a booster dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number was not provided) (Expiry date: On an unknown date in June-2020) via unknown route in unknown administration site for prophylactic vaccination on an unknown date in Feb-2021 (expired product administered)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported that the pediatrician's office called in the adverse event but the mother has more questions. Mother wanted to know if there are safety implications or dangers to children who received an expired dose. Mother asked for the shelf life of ActHIB.   She asked if there are safety implications or dangers for taking expired dose and expired product (system required document) SRD was discussed with her.   She also asked for the shelf life and it was discussed that expiration date given that vaccine is stored appropriately is considered. She asked if there are number of months or years indicated for the shelf life but call was disconnected before caller was assisted with this question.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Unevaluable event
Clinical narrative: a patient was administered an expired dose of Acthib, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Global Medical Information (GMI) (Reference number- 00491867) and transmitted to Sanofi on 24-Feb-2021.  This case involves patient (gender and age unspecified) was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number was not provided) (Expiry date: 21-jun-2020) via unknown route in unknown administration site for prophylactic vaccination on 23-Feb-2021 (expired product administered)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Hypoaesthesia, Limb immobilisation, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: After two hours sore arm ... left side of face slightly numb proceeded by a sharp pain down leg following by an unnatural involuntary movement of toes for about 2 minutes sharp pain then stiffness and inability to move . Numbness followed  by a release and weakness .
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After two hours sore arm ... left side of face slightly numb proceeded by a sharp pain down leg following by an unnatural involuntary movement of toes for about 2 minutes sharp pain then stiffness and inability to move . Numbness followed  by a release and weakness .
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy, bumpy, swollen  rash on right shoulder extending to right  breast. Swelling of left hand, stiffness, hard to move fingers,  same rash as above between fingers.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: Awoke with red raised itchy rash around vaccination site on L arm.  Hydrocortisone ointment.    Day 2  no change
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hyperhidrosis, Lip injury, Pallor, Syncope
Clinical narrative: Patient was given a covid vaccine on 3/4/21 at approximately 5:40pm.  The administration went well according to the patient.  After approximately 10 minutes, while the patient was sitting in the post vaccination area, he appeared to be pale looking to the imx RPh.  The pharmacist asked him how he was doing, he replied "I am doing so-so".  The RPh got up to check on him further when the patient fell to the floor.  The RPh rolled him on his back, got him in a comfortable position,  and elevated his legs.  RPh applied gauze to a cut in his lip, and with the immediate assistance of the health screener, applied cold compress to his neck and forehead.  Patient experienced faintness and sweaty skin only.  Patient did not show any other symptoms.  After about15 minutes, patient said he felt like himself again, and wanted to sit up in a chair.  The RPh assisted him into a chair, where he sat for 5 minutes.  At the request of the patient, he wanted to go home.  RPh escorted patient to his car and watched him get inside safely.  1 hour later, RPh followed up with a phone call to the patient and he was on his way to an urgent care clinic to get a possible stitch for his lip.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: At 6:30 p.m. the day after receiving my first dose I began my period 6 days early.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Full blood count, Metabolic function test
Clinical narrative: Anaphylaxis happened within 12 minutes. I was administered epinephrine at the vaccine site, as well as in the ambulance. FURTHERMORE I was administered DiphenhydrAMINE, Famotidine, solu-MEDROL at the Emergency Department. Those are just a few of what I received. When I was finally discharged I was sent home with 2 epi-pens and a 4 day  dosing of Prednisone.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Sensation of foreign body
Clinical narrative: Anaphylaxis happened within 12 minutes. I was administered epinephrine at the vaccine site, as well as in the ambulance. FURTHERMORE I was administered DiphenhydrAMINE, Famotidine, solu-MEDROL at the Emergency Department. Those are just a few of what I received. When I was finally discharged I was sent home with 2 epi-pens and a 4 day  dosing of Prednisone.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Full blood count, Metabolic function test
Clinical narrative: At 11:10am patient received a Moderna Covid-19 vaccine. About 15 minutes later she developed diffucity breahting and said it felt like there was something stuck in her thraot. She was given one 0.3mg epinephrine  inject and 911 was called. After about 45 seconds after the inject she begain to breath better and 5 minutes later the EMT's arrived. She was transported to our local hospital Emergency room for further treatment. She wwas releasted a few hours later.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Sensation of foreign body
Clinical narrative: At 11:10am patient received a Moderna Covid-19 vaccine. About 15 minutes later she developed diffucity breahting and said it felt like there was something stuck in her thraot. She was given one 0.3mg epinephrine  inject and 911 was called. After about 45 seconds after the inject she begain to breath better and 5 minutes later the EMT's arrived. She was transported to our local hospital Emergency room for further treatment. She wwas releasted a few hours later.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: Facial numbness, blurred vision, dizziness, nausea, chills, headache, speech production affected
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Speech disorder, Vision blurred
Clinical narrative: Facial numbness, blurred vision, dizziness, nausea, chills, headache, speech production affected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: Headache, body aches, prickly itching all over head to toe, tiny rash face, arms, chest, abdomen, etc. No whelps  or bumps similar to heat rash? Similar to when I had a morphine drip from a cesarean delivery.  Just started itching that progressed to all over. Not just injection site. No swelling. No fever. No trouble breathing, no throat closing, slight tenderness  in neck.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headaches so bad that I feel like I'm going to throw up.  Happens every day.  Sometimes twice a day.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Myalgia, Neck pain, Pyrexia
Clinical narrative: Fever of 100, chills, muscle pain, headache and neck pain
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Impaired taste
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Paraesthesia, Paralysis
Clinical narrative: I have been experiencing some tingling on the left side of my face since receiving the first COVID-19 vaccination dose. It flare after receiving the second COVID-19 vaccination dose. The level of tingling varies throughout the day. It has not resulted in noticeable paralysis.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle ache, chills, fatigue
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration
Clinical narrative: I had a pink smear in the shape of 2 connected ovals that extended down below the injection site to my elbow.  It was pink like Pepto Bismol pink.  It was like a pink suntan = not a rough rash.  It didn't hurt. I had it for about 5 days getting lighter until it is gone now. I didn't think it could be part of the vaccine because it appeared about 10 days after the shot but I couldn't figure out how I got it.  Since it didn't hurt and no one could see it since I wear long sleeves, I just made sure it didn't get worse and didn't pursue it with medical treatment or advice.  It wasn't until I saw reporting on it that I realize it was a reaction to the shot.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site swelling, Pain of skin
Clinical narrative: Moderna COVID-19 Vaccine EUA,  1st evening (Sat the 6th) very sore to touch, 2nd day Red & swelling & knot began & hurt all the time, Following days Redness & swelling and knot grew until red was a couple inches large, by Tues the 9th while getting a blood test to check metal levels from hip replacement the nurse commented on how red and swollen the arm was & that she could see the knot.  It kept growing  & I had itching in hands & side too.  Began cold pack.  Redness grew to 2x3" & red was no longer a circle.  Thurs the 18th red was 4x5" oval.  Felt like a bee sting all the time.  Area felt warm. Fri 19th to Dr & prescribed 5 day Cephalexin in case infection as I have 2 artificial hips.  Redness decreased, but swelling still there.  Redness grew & decreased and grew.  Finally on the 25th it seemed more like what you would expect if you just received the vaccination.  Coldpacks may reduce swelling & showers increase redness. March 1st I had a cytoscope to check for bladder infection & was OK.  Given one antibiotic pill.  Arm still felt like bee sting.  Today, Thursday is just a bit of redness, still a small knot, & a visible swelling.  All much less.  An ache in my arm, but may be orthopedic related? as I have had a broken arm there years ago.  It's much better, but still not back to normal.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Moderna COVID-19 Vaccine EUA,  1st evening (Sat the 6th) very sore to touch, 2nd day Red & swelling & knot began & hurt all the time, Following days Redness & swelling and knot grew until red was a couple inches large, by Tues the 9th while getting a blood test to check metal levels from hip replacement the nurse commented on how red and swollen the arm was & that she could see the knot.  It kept growing  & I had itching in hands & side too.  Began cold pack.  Redness grew to 2x3" & red was no longer a circle.  Thurs the 18th red was 4x5" oval.  Felt like a bee sting all the time.  Area felt warm. Fri 19th to Dr & prescribed 5 day Cephalexin in case infection as I have 2 artificial hips.  Redness decreased, but swelling still there.  Redness grew & decreased and grew.  Finally on the 25th it seemed more like what you would expect if you just received the vaccination.  Coldpacks may reduce swelling & showers increase redness. March 1st I had a cytoscope to check for bladder infection & was OK.  Given one antibiotic pill.  Arm still felt like bee sting.  Today, Thursday is just a bit of redness, still a small knot, & a visible swelling.  All much less.  An ache in my arm, but may be orthopedic related? as I have had a broken arm there years ago.  It's much better, but still not back to normal.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: I noticed a mild tingling and numbness in lips and edge of tongue about 15 - 20 minutes after the vaccine during my 30 minute wait time. Also, around the same time, I developed a metallic taste in mouth that resolved quickly after drinking warm coffee. The lip/tongue issue was not concerning and resolved within an hour.  I do suffer from anxiety having experienced reactions to food and medicines although never anything severe.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: site of injection-red, round bump/blotch, 2inx2in, tender, sore, raised, itchy, 3 days, painful to touch
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Pt received the 2nd dose of COVID_19 Moderna vaccine on 2/26/21 and got a stroke on 3/1/21. Pt's girlfriend mentioned that the doctor believed that stroke was from a plaque in the carotid artery
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pharyngeal paraesthesia, Throat clearing, Urticaria
Clinical narrative: Slight tickling in the back of throat, clearing throat and small hive on left forearm, redness of skin.  Administered Zyrtec and resolved within 20 minutes.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Menstruation irregular
Clinical narrative: Lightheaded and dizzy Period came very early. It started on day 13 of my 56 day cycle.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: After 2nd injection, injection site was sore, hot and red with welps. Its been 7 days and and arm is still red, hot and itchy.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rectangular area in vicinity of vaccine site.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness and vertigo lasting for more than 1 week
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Swelling face, Wheezing
Clinical narrative: Face and throat swelling; wheezing loudly; labored breathing. 3rd morning post 1st injection, lasted 24 hours face swelling from onset; wheezing lasted 72 hours from onset (being 3rd day post 1st injection).  No medical treatment received because patient and caregiver were not warned that a DELAYED reaction to the vaccination could occur  Caregiver contacted primary doctor to report severe reactions, was asked if we sought epinepherine /ER  which we did not thinking patient had allergies, talked with cardiologist who thought patient was breathing like "an almost 90 year old".... PCP advised patient to not receive 2nd shot given 1st shot reaction.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient noted different vaccine names on his vaccination card (first dose, Moderna vaccine on 1/25/21). Second dose of vaccine was Pfizer EN6201. No new/abnormal side effects or reactions.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Dry eye, Fatigue
Clinical narrative: March 2, 2021 (3days after injection) 12:30pm sudden onset of severe  (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes.  March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Myalgia, Nausea, Renal pain
Clinical narrative: March 2, 2021 (3days after injection) 12:30pm sudden onset of severe  (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes.  March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: March 2, 2021 (3days after injection) 12:30pm sudden onset of severe  (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes.  March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: C/o lightheadedness/slight nausea 5 minutes after vaccination. Reports this happened with 1st vaccine. States it is anxiety regarding vaccination and not adverse reaction to vaccine. Sat w/ feet elevated. At 1529, feeling better. No lightheadedness. 1535 patient states she is back to baseline. Standing up without symptoms. Discharged to self. Walked back to vehicle with friend
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Nausea, Pain
Clinical narrative: Nasusa, 100.4 fever, chills, body aches, fatigue
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Swollen lymph node in my armpit on the side where I got the shot. Painful for 2 days, stayed tender and sore for a few more days after that.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea, Retching
Clinical narrative: Complaining of nausea, chest tightness, dry heaving. BP 182/106 (pulse 125), 97% O2 sat. Final BP 154/97 (pulse 94), 98% O2 sat.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: States felt lightheadness aabout 10 minutes fter received vaccination on way to post vaccination waiting area. Alerted staff. Pt to lay on cot. VS taken x3, VSS. Patient released to self without further incident
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, chills, fatigue
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Burning sensation, Full blood count, Metabolic function test, Rash macular
Clinical narrative: Patient developed macular, erythematous, burning rash of the neck, trunk, and extremities about 10 hours after the vaccine.  No urticaria.  No wheezing.  No oral or ocular lesions.  No GI or GU symptoms.  No fever.  No myalgia.  No fatigue.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Tryptase
Clinical narrative: Patient developed macular, erythematous, burning rash of the neck, trunk, and extremities about 10 hours after the vaccine.  No urticaria.  No wheezing.  No oral or ocular lesions.  No GI or GU symptoms.  No fever.  No myalgia.  No fatigue.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Neuralgia, Pyrexia
Clinical narrative: a. Minor "stinging" pain at injection site starting about 5 minutes after injection and lasting 2 to 3 minutes. b. 6 hours later general chill/low grade fever ~99.5 degrees F. lasting for about 4 hours.  c. Immediately after fever, nerve from lower back to right knee became very painful (more than ever before). This nerve had been giving me trouble for several years (spinal stenosis). A physical therapist alleviated the pain on 2/18 and 2/23, but the pain did not go away until 2/26. [This association of fever and reoccurrence or increased pain in areas where pain had receded has occurred in the past, usually associated with the flu. The same scenario occurred then; 4 to 8 hours of fever followed by sudden remission
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Injection site pain
Clinical narrative: I had whole body aches, extreme fatigue, chills, fever,  tachycardia (well over 100 beats per minute), unable to hold any item in my hands without it moving to and fro about 8 inches, some headaches, unsteady gait when ambulating. Almost felt like falling.   I didn't want to move in bed since it would only exacerbate the body aches and make it worse. Horrible time   1st dose 02/03/2021  Negligible side effects  (only sore injection site)  Date of 2nd dose 03032021
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Pain, Pyrexia, Tachycardia
Clinical narrative: I had whole body aches, extreme fatigue, chills, fever,  tachycardia (well over 100 beats per minute), unable to hold any item in my hands without it moving to and fro about 8 inches, some headaches, unsteady gait when ambulating. Almost felt like falling.   I didn't want to move in bed since it would only exacerbate the body aches and make it worse. Horrible time   1st dose 02/03/2021  Negligible side effects  (only sore injection site)  Date of 2nd dose 03032021
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Red rash at shot site, swollen and hard, itchy, pain on touch. Approximately 2 inches diameter. Back muscles ache. Chills.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Red rash at shot site, swollen and hard, itchy, pain on touch. Approximately 2 inches diameter. Back muscles ache. Chills.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Mass, Peripheral swelling
Clinical narrative: Red, swelling, rash over half of upper arm, hard lump under skin - all started after most other side effects were resolved. Injection was at or very near smallpox vaccination site - swelling, redness and itching began around that scar and has expanded to a larger part of the arm.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin induration
Clinical narrative: Red, swelling, rash over half of upper arm, hard lump under skin - all started after most other side effects were resolved. Injection was at or very near smallpox vaccination site - swelling, redness and itching began around that scar and has expanded to a larger part of the arm.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash macular, Swollen tongue
Clinical narrative: Swelling of tongue and throat, red itchy area on Left collar bone. Dr prescribed Benadryl and Prednisone 60mg 1xday for 5 days.  Symptoms started around 9pm in the evening of same day as vaccine was given.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Joint stiffness, Pain, Pain in extremity
Clinical narrative: Extremely sore arm 1 hour following vaccination  Body aches 6 hours after vaccination  Joint stiffness, headache, chills 9 hours after vaccination
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Pruritic red maculo-papular rash in injected are began same evening and progressed to other extremities and trunk over 96 hours.  No urticaria, no SOB, no edema.  Itching resolved with adequate doses of diphenhydramine followed by rash resolution.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Headache, Injection site mass
Clinical narrative: Flushing within 4 hours, 4 hours duration  Headache within 4 hours, duration 6 hours Chills within 4 hours, duration 4 hours Site soreness, lump and heat within 4 hours, still experiencing after 40 hours Extreme tiredness and sleepiness with 24 hours, still experiencing at 40 hours
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Somnolence
Clinical narrative: Flushing within 4 hours, 4 hours duration  Headache within 4 hours, duration 6 hours Chills within 4 hours, duration 4 hours Site soreness, lump and heat within 4 hours, still experiencing after 40 hours Extreme tiredness and sleepiness with 24 hours, still experiencing at 40 hours
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood lactate dehydrogenase, Chest X-ray, Confusional state, Full blood count
Clinical narrative: Patient had COVID-19 with pneumonia at the end of December 2020 and recovered.  Received vaccine in mid February and 2nd dose of vaccine on March 3rd.  Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Metabolic function test, Procalcitonin, Pyrexia, Tachycardia
Clinical narrative: Patient had COVID-19 with pneumonia at the end of December 2020 and recovered.  Received vaccine in mid February and 2nd dose of vaccine on March 3rd.  Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Patient had COVID-19 with pneumonia at the end of December 2020 and recovered.  Received vaccine in mid February and 2nd dose of vaccine on March 3rd.  Presented to the emergency department on the night of March 4th from correctional facility where she is incarcerated because of fever over 103 and lethargy/confusion and tachycardia of 115.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Shortly after my first dose of the vaccine (within a day) I started to notice a red, painful, swelling in the area where the shot was administered. It kept growing for about 3 days and then began to slowly go away. It then came back about 2 days after it had completely healed and was once again itchy, red, painful, and swollen but not as large. This lasted for about 2 days.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Yesterday evening around 11 I was going to bed my arm was itchy. When I went to scratch noticed the itchy area was my injection site. The area is also hot, red, and hard.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Shortly after vaccination had same side hand tingling followed by leg.  Resolved after 30 min.  No further complaints
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Mental status changes, Thrombocytopenia
Clinical narrative: altered mental status, acute on chronic thrombocytopenia, death
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: Medium-flow menstral-like bleeding the night after (approx. 32 hours) receiving the Pfizer COVID-19 vaccine. Light cramping.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle tightness
Clinical narrative: Fatigue, headache, tight jaw
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Injection site pruritus, Injection site swelling, Somnolence
Clinical narrative: Pain/ swelling at injection site Dizzy about 4 hours after shot (lasted only a few hours) Drowsy the first and second night 24 hours: site also became itchy
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Night sweats, Pain in extremity
Clinical narrative: Severe diarrhea and some night sweats. It lasted until the evening of March 3rd and I took pill pepto bismol that evening to control and again the following morning but the next night, the night of March 4th I had the night sweats. The diarrhea started with stomach pains on Sunday morning the 21st of February. I also had arm pain, and fatigue and a couple of night sweats Saturday the 20th. The diarrhea seems to be under control with the pepto bismol but I heard some rumbling last night.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Nausea
Clinical narrative: Body aches Chills  Headache  Fever 103 Nausea  Weakness, severe misery
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches Chills  Headache  Fever 103 Nausea  Weakness, severe misery
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Peripheral coldness, Pyrexia
Clinical narrative: Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a little better.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a little better.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Body tremors and fever of 102 degrees Fahrenheit
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Pain
Clinical narrative: Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Chills, shaking, cold extremities, then mild fever, aches, headache unable to sleep all night until 6 am. Following day unable to get out of bed, still aching, fatigue and headache. Third day still tired feeling a bit feverish but getting better. A more severe reaction than from first shot on 2/8/2021 with similar side effects that lasted about 3 days. Fatigue did not go away.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain
Clinical narrative: Chills, body aches and weakness, headache
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: One week after receiving injection, my left arm became swollen, red, hot and very itchy.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Feeling hot, Palpatory finding abnormal
Clinical narrative: PATIENT RECEIVED THE VACCINE, AND WILL SITTING IN THE RECOVERY ROOM, FELT HOT, DIZZY AND SWEATY AS WELL AS OBTUNDED. BP 90/42, HR 55 SAT 97 RR12 DIAPHORETIC, AROUSABLE, COHERENT CV PULSE DIFFICULT TO PALPATE, BRADYCARDIC PHYSICAL EXAM OTHERWISE UNREMARKABLE PLACED ON STRETCHER. MENTAL STATUS IMPROVED. VS 115/97, 75, 12, SAT 98 TRASNFERRED TO EMERGENCY ROOM FOR EVALUATION
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hypertension
Clinical narrative: heart rate went really high / fast heart rate; blood preassure shot up; This case was reported by a consumer via other and described the occurrence of heart rate increased in a 72-year-old 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, 24 hrs after receiving Shingrix, the patient experienced heart rate increased and blood pressure high. On an unknown date, the outcome of the heart rate increased and blood pressure high were recovered/resolved.   It was unknown if the reporter considered the heart rate increased and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient received Biotech COVID 19 vaccine on an unknown date. After receiving Shingrix, the patient's heart rate went really high, her blood pressure shot up and paramedics came. The reporter stated she was not sure if what was happening what directly related to the vaccine because the reaction was 24 hours later. The reporter stated she was not sure if she should receive the Pfizer COVID vaccine or not. She also would like to know if there might be a connection or common ingredient in the Pfizer COVID vaccine. For the tolerance of 2nd dose, refer linked case US2021AMR027274.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027274:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: heart rate went really high / fast heart rate; This case was reported by a consumer via other and described the occurrence of heart rate increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR027252).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced heart rate increased. The patient was treated with betamethasone + clioquinol + gentamicin + tolnaftate (Quadruple). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the heart rate increased was recovered/resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows: 6 hours after receiving Shingrix, the patient experienced fast heart rate. The reporter stated this lasted for quite a while and she already had medications in the house, and she had to Quadruple the amount that she would normally had taken. The reporter stated to this day she was still unsure what exactly in the Shingrix vaccine caused her reaction. The reporter stated she was not sure if she should receive the COVID vaccine or not. She also would like to know if there might be a connection or common ingredient in the Pfizer COVID vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027252:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient had soreness in arm after receiving Shingrix. The patient was asking what  was best to treat soreness in arm from Shingrix dose.
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: Adverse Event: rheumatoid arthritis flare / Brand Name: Shingrix; This case was reported by a consumer via other manufacturer and described the occurrence of rheumatoid arthritis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles shot (has received regular shingles shot).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the rheumatoid arthritis was unknown.   The reporter considered the rheumatoid arthritis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix which was terrible for her and experienced rheumatoid arthritis flare up. Due to medical reason the patient did not want to take the 2nd dose as it may put her back into a rheumatoid flare. The patient had been taking Prednisone as a treatment and was getting better. No further details were provided. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash vesicular
Clinical narrative: Redness at the injection site presented at the injection site /redness is a 4cm circle around the injection site; swelling at the injection site presented at the injection site / swelling is a 4cm circle around the injection site; area started to itch 2-3 days following the administration; shingles like rash presented down the left arm; This case was reported by a consumer and described the occurrence of injection site erythema in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching and vesicular rash. The patient was treated with triamcinolone. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching and vesicular rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and experienced redness and swelling. The redness and swelling was 4cm circle around the injection site. The reporter described it as looking like big, bad spider bite around the area. The area started to itch 2 to 3 days following the administration. The patient also experienced shingles rash a week following the vaccination. The patient was treated with triamicilone and the events resolved. The patient has not yet received the 2nd dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injection site extravasation
Clinical narrative: Some of the vaccine leaked from patient's arm; Patient received Shingrix but part came out of needle / Some of the vaccine leaked from patient's arm; Some of the vaccine leaked from patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of injection site leaking in a female patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 12th February 2021, the patient received the 2nd dose of Shingrix. On 12th February 2021, immediately after receiving Shingrix, the patient experienced injection site leaking, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in an unknown arm but some part came out of needle because the needle was loose. The reporter stated that some of the vaccine leaked from patient's arm immediately after vaccination with Shingrix, which led to injection site leaking, accidental exposure to product and exposure via skin contact. The reporter did not consent to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Laziness
Clinical narrative: feeling dragging.; tiredness; This case was reported by a consumer and described the occurrence of laziness in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 24th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced laziness and tiredness. On an unknown date, the outcome of the laziness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the laziness and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced tiredness and feeling dragging. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine exposed to a temperature of 32°F degrees for 7 and a half hours; A spontaneous report was received from a nurse concerning patients of unknown ages and genders who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history and  concomitant medication use was not reported .  On 23-Jan-2021, the patients received their planned dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Late Friday evening, 22-Jan-2021, approximately one day prior to the onset of event, the vaccine administrator removed vials from the freezer and put them in a refrigerator for usage during the vaccination event that was set to occur on Saturday, 23-Jan-2021. In the refrigerator, the vaccines were stored for seven and a half hours at 32°F. It was reported that the vials were cold on Saturday and were used during the vaccination event. They had record of all the patients who received this vaccines, but reporter did not consider this a temperature excursion because their information stated that "vials can be stored refrigerated between 2° to 8°C (36° to 46°F)" and reach a temperature of 36°F.   Treatment is not applicable  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event is not applicable; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, unknown lot number, with no associated AEs. Causality for the event is not applicable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness
Clinical narrative: Passed out; Felt tired; A spontaneous case report was received from a consumer concerning an 80 years-old female patient who experienced passed out (MedDRA PT: loss of consciousness) and felt tired (MedDRA PT: fatigue)  The patient's medical history included cancer. Concomitant product use included chemotherapy and other medications (not specified).   The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on an unknown date. On 16 Feb 2021, approximately one day prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #011M20A) intramuscularly in an unspecified site for prophylaxis of COVID-19 infection.  On 17 Feb 2021, one day after receiving the vaccination, the patient felt tired and passed out. The patient inquired if this was a normal side effect.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events passed out and felt tired 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 events, a causal relationship cannot be excluded. Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure increased, Chest pain, Dry mouth, Dysgeusia
Clinical narrative: heart raced 130 bpm; right arm went numb; bitter medicine taste; lips and tongue tingling; numbness of the lips; numbness of the throat; dry mouth; super thirsty; elevated blood pressure of 175/56; couldn't talk; shaking; terrible pain in chest and mid area; gassiness; headache; Nausea; 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  events like bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache.  The patient's medical history provided included Lupus and Sjogren's. No relevant concomitant medications were reported.     On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, The patient experienced the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache.  Laboratory details were not provided.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, nausea, right arm went numb, resolved on 12 Feb 2021.  The outcome of the event headaches was resolved on 13 Feb 2021.  At the time of the report the events of chest pain and gassiness were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of  Lupus and Sjogren's can be contributing factor. Further information has been requested.