chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Sleep disorder, Tinnitus
Clinical narrative: Ear pain and ringing in ear (tinnitus) very unbearable and loud, I had it for three days now. I can?t even sleep because of it.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Child maltreatment syndrome, Fatigue, Feeling abnormal, Influenza like illness, Injection site pain
Clinical narrative: Shakes Fever Fatigue Flu-like Symptoms Muscle Aches Mental Fog Soreness at Injection Site All Symptoms Lasted about 8 Hours
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Shakes Fever Fatigue Flu-like Symptoms Muscle Aches Mental Fog Soreness at Injection Site All Symptoms Lasted about 8 Hours
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dysphagia, Mobility decreased, Pharyngeal swelling, Pruritus
Clinical narrative: difficulty swallowing; swelling left side of throat; can't turn head to the left; overall body itching rash especially on neck, check and torso, which turned into large bruises
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: difficulty swallowing; swelling left side of throat; can't turn head to the left; overall body itching rash especially on neck, check and torso, which turned into large bruises
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Swelling
Clinical narrative: Large red bumps at first  now  it is  swollen and appears like cellulitis
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Blood glucose normal, Blood test, Computerised tomogram
Clinical narrative: Within 24 hours, normal side effects including, muscle pain and  aches; Resolved after 1 day  On 4/23/2021, 14 days after vaccine, patient began experiencing loss of appetite  On 4/26/2021, 16 days after vaccine midday on 2, patient began experiencing  sudden onset of upper stomach pain, heart palpitations   4/29/2021, patient went to ER due to extreme upper abdominal pain and intermittent back pain and intermittent heart racing. Prior to going to hospital, patient was healthy with no prior health issues or diagnoses. She also took baby aspirin, 81 mg several days prior to being admitted, took 2 chewable gas- except tablets and had her glucose checked  which was a 96.  Patient was not admitted and discharged the same day with a diagnosis of acute pancreatitis. She has had 2 children in the last 3 1/2 years and still nursing a 14 month old and hasn't count alcohol in years.  Pain meds prescribed but using them every 8 hours to manage pain and barely eating or drinking, yet pain still persists.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Heart rate increased, Myalgia, Palpitations, Pancreatitis
Clinical narrative: Within 24 hours, normal side effects including, muscle pain and  aches; Resolved after 1 day  On 4/23/2021, 14 days after vaccine, patient began experiencing loss of appetite  On 4/26/2021, 16 days after vaccine midday on 2, patient began experiencing  sudden onset of upper stomach pain, heart palpitations   4/29/2021, patient went to ER due to extreme upper abdominal pain and intermittent back pain and intermittent heart racing. Prior to going to hospital, patient was healthy with no prior health issues or diagnoses. She also took baby aspirin, 81 mg several days prior to being admitted, took 2 chewable gas- except tablets and had her glucose checked  which was a 96.  Patient was not admitted and discharged the same day with a diagnosis of acute pancreatitis. She has had 2 children in the last 3 1/2 years and still nursing a 14 month old and hasn't count alcohol in years.  Pain meds prescribed but using them every 8 hours to manage pain and barely eating or drinking, yet pain still persists.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: Within 24 hours, normal side effects including, muscle pain and  aches; Resolved after 1 day  On 4/23/2021, 14 days after vaccine, patient began experiencing loss of appetite  On 4/26/2021, 16 days after vaccine midday on 2, patient began experiencing  sudden onset of upper stomach pain, heart palpitations   4/29/2021, patient went to ER due to extreme upper abdominal pain and intermittent back pain and intermittent heart racing. Prior to going to hospital, patient was healthy with no prior health issues or diagnoses. She also took baby aspirin, 81 mg several days prior to being admitted, took 2 chewable gas- except tablets and had her glucose checked  which was a 96.  Patient was not admitted and discharged the same day with a diagnosis of acute pancreatitis. She has had 2 children in the last 3 1/2 years and still nursing a 14 month old and hasn't count alcohol in years.  Pain meds prescribed but using them every 8 hours to manage pain and barely eating or drinking, yet pain still persists.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Blood test abnormal, Chest X-ray normal, Cough, Dyspnoea
Clinical narrative: First day: severe chills (extreme body shaking), and body temperature alternating between overheating and moderate/severe chills every several hours. Body fatigue, temperature varying from low 99 F up to 101.3 F. These symptoms subsided after about 2 days. Also developing during this time was an asthma attack, characterized by wheezing, coughing, and difficulty breathing. Patient has had life-long history of asthma, moderate, well-maintained with albuterol inhaler (life-long) and Qvar redihaler (beginning in early-mid 2020). However, after the common symptoms subsided, the asthma attack prolonged for over a week (2nd injection on 22 Apr 2021, and present as of reporting (03 May 2021). Albuterol inhaler would ease the wheezing, but no effect on mitigating the coughing / difficulty breathing. Qvar redihaler had no effect. Asthma attack would alternate in waves (approximately every hour up to 4-6 hour cycles), of breathing mostly clearly (some difficulty persisting), and severe attacks when extremely difficult to breathe.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, Wheezing
Clinical narrative: First day: severe chills (extreme body shaking), and body temperature alternating between overheating and moderate/severe chills every several hours. Body fatigue, temperature varying from low 99 F up to 101.3 F. These symptoms subsided after about 2 days. Also developing during this time was an asthma attack, characterized by wheezing, coughing, and difficulty breathing. Patient has had life-long history of asthma, moderate, well-maintained with albuterol inhaler (life-long) and Qvar redihaler (beginning in early-mid 2020). However, after the common symptoms subsided, the asthma attack prolonged for over a week (2nd injection on 22 Apr 2021, and present as of reporting (03 May 2021). Albuterol inhaler would ease the wheezing, but no effect on mitigating the coughing / difficulty breathing. Qvar redihaler had no effect. Asthma attack would alternate in waves (approximately every hour up to 4-6 hour cycles), of breathing mostly clearly (some difficulty persisting), and severe attacks when extremely difficult to breathe.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: I had a fever reaching up to 104 F. I took Ibuprofen and Tylenol to drop it along with applying wet towels to my forehead and armpits. My fever increased to 104 F 4 times.   Vomiting: After the first two fever spikes, I woke up feeling no fever. But, all of a sudden I vomited 5 times.   I have had tiredness, muscle pain, and a really strong headache.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Lymphadenopathy, Pain in extremity, Paraesthesia
Clinical narrative: 4/26/21 Shortly after the shot, I felt funny the whole day.  4/27/21 Sore left arm.   02/02/21 Left arm pit's lymph node is swollen, left arm/hand loss of feeling. Feels tingly. Permanent damage? Maybe, hopefully not. I'm checking the box anyway.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Hypersomnia, Immediate post-injection reaction
Clinical narrative: Pain at injection point immediately; pain using right arm for routine tasks for the following 6-8 hours; injection site remains sore to the touch after 72 hours. No other pain the day of injection. Day after injection (approximately 18 hours later) the entire right arm ached; then the aching moved to the lower back and eventually both legs. Pain resolved at approximately 30 hours after injection; ache never affected left (non-injected) arm.  Minor headache seemed to be forming, but never progressed past the initial indications. Was extremely tired the day following the injection; took two naps (1-2 hours each) and slept 12 hours that night (i.e., injected Friday, tired all day Saturday and slept longer than normal Saturday night). Aside from soreness at injection point, no further signs/symptoms on Sunday (i.e., resolved around 36 hours after injection).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection point immediately; pain using right arm for routine tasks for the following 6-8 hours; injection site remains sore to the touch after 72 hours. No other pain the day of injection. Day after injection (approximately 18 hours later) the entire right arm ached; then the aching moved to the lower back and eventually both legs. Pain resolved at approximately 30 hours after injection; ache never affected left (non-injected) arm.  Minor headache seemed to be forming, but never progressed past the initial indications. Was extremely tired the day following the injection; took two naps (1-2 hours each) and slept 12 hours that night (i.e., injected Friday, tired all day Saturday and slept longer than normal Saturday night). Aside from soreness at injection point, no further signs/symptoms on Sunday (i.e., resolved around 36 hours after injection).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Injection site pruritus, Injection site urticaria
Clinical narrative: 36 hours after vaccination, ASTHMA  severity & frequency of attacks worsened; used rescue inhaler 2-3 times DAILY for 5 days (baseline rescue inhaler use 2-3 times per month); reported to Dr. 8 days after vaccination, large HIVES appeared with itching, first at injection site the size of lima bean; day 9 HIVES increased in size; days 10 onward HIVES increased in size and number nightly to now cover entire upper left arm (above to shoulder and below injection site down to elbow) - photos available - still ongoing at day 13.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: The joint pain in my left wrist is the worst, to the points where I can't pick up a cup. All my joints ache as well. I believe the technician said that sore joints was one of the side effects. I've been taking Tylenol for the pain.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue
Clinical narrative: 1st of the vaccine I only felt sore arm. After 24 to 48 hours, I started having Diarrhea, it didn't last long but it was probably the worst I ever had( green ). Later, I had stomach pain for a few hours. And felt tired for a while, around 2 days. I've had a few drinks the night before the symptoms started showing up, but I didn't have anything similar before, so it's most likely related to vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Dehydration, Ear discomfort, Fatigue
Clinical narrative: Had moderate adverse reaction in first 2-3 days after 2nd dose: chills, headache, fatigue, dehydration. Since then have been perfectly fine, except for a sensation of blood pulsing in the left outer ear. It feels like I now have a pulse point at the entrance to my ear, so much so that I hear it audibly. This has been constant since 3 days after my 2nd dose to now. It is uncomfortable and concerning.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had moderate adverse reaction in first 2-3 days after 2nd dose: chills, headache, fatigue, dehydration. Since then have been perfectly fine, except for a sensation of blood pulsing in the left outer ear. It feels like I now have a pulse point at the entrance to my ear, so much so that I hear it audibly. This has been constant since 3 days after my 2nd dose to now. It is uncomfortable and concerning.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Hyperglycaemia, Pain, Presyncope
Clinical narrative: The patient is a 32 y.o. female who presents for evaluation of light headedness, near syncope, vertigo and hyperglycemia since Covid vaccine.  32-year-old female with type 1 diabetes and history of anxiety with panic attack here complaining of borderline low blood sugars and feeling lightheaded since Covid vaccine on Sunday this past weekend.  Ports that she was feeling achy after the vaccine and then last night was feeling lightheaded.  She was lying down at night and felt that she was going to pass out.  She has room spinning but does report that her heart is racing.  Blood sugars have been around 70 which is low for her.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: The patient is a 32 y.o. female who presents for evaluation of light headedness, near syncope, vertigo and hyperglycemia since Covid vaccine.  32-year-old female with type 1 diabetes and history of anxiety with panic attack here complaining of borderline low blood sugars and feeling lightheaded since Covid vaccine on Sunday this past weekend.  Ports that she was feeling achy after the vaccine and then last night was feeling lightheaded.  She was lying down at night and felt that she was going to pass out.  She has room spinning but does report that her heart is racing.  Blood sugars have been around 70 which is low for her.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Incredibly bad period cramping. Worse than I?ve ever had. Period was on time and flow was normal.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Fatigue, Feeling cold, Feeling hot
Clinical narrative: "Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen lips since pt received the moderna vaccine on 2/11/21.  She also states she has burning in the chest. pt feels like she is very hot and then very cold. PCP found patient to be back at baseline now.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Parosmia, Pyrexia, Vital signs measurement
Clinical narrative: "Patient reports fatigue, subjective fever, redness in the cheeks, sensitivity to smell and swollen lips since pt received the moderna vaccine on 2/11/21.  She also states she has burning in the chest. pt feels like she is very hot and then very cold. PCP found patient to be back at baseline now.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes on back side of body, symptoms persist for over 2 days now.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incontinence, Malaise, Nausea, Syncope, Vomiting
Clinical narrative: Pt received dose #1 Moderna COVID vaccine 1/19/21 @ LPH Vaccine clinic. Overnight some nausea, malaise. 1/20/21 experienced a syncopal episode at home and BIBA to PVH ED. Vomiting, incontinence in route. Workup negative, given IVF and zofran, discharged. Per ED provider "Likely vasovagal syncope. Possibly related to reaction to vaccine. No worrisome findings in the evaluation today."
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Red raised itchy hives / welts all over inner thighs, hips, wrists, forearms, neck,  elbows, inner knees. Going on 10+ days
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen Lymph nodes under left armpit and left supraclavicular. It started from 3 days later after the injection, for the first 3-5 days, the armpit nodes were hurt, but then the pain ended. However, till today, there are still one mode under left supraclavicular and two nodes under left armpit that are not completely back to normal.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: fatigue, arm soreness, severe chills, fever, headache, nauseous
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue, arm soreness, severe chills, fever, headache, nauseous
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear. Started a few days after receiving my first dose of Moderna covid vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Swelling face
Clinical narrative: COVID 19 Pfizer vaccine dose#1 given 3/24/2021. COVID 19 Pfizer vaccine dose#2 given 4/16/2021. Developed puffiness and numbness on R side of face 4/29/2021. Evaluated on 5/2/2021 and diagnosed with Bell's Palsy. Will complete a four day course of steroid treatment.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: On day 8 after injection red rash on injection site; hot, severe itch, swollen. Approx 3 inches x 2 inches oblong shape/size.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electrocardiogram normal, Fatigue, Joint swelling, Lymphadenopathy
Clinical narrative: Swelling and pain in joints in both hands, both wrists, both feet, both ankles, both knees. Started in both index finger , 1st knuckle and spread through both hands and wrist over a course of 3 days. No fever. Severe fatigue. Swollen lymph nodes on left side of neck since vaccine date and has not reduced.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Swelling and pain in joints in both hands, both wrists, both feet, both ankles, both knees. Started in both index finger , 1st knuckle and spread through both hands and wrist over a course of 3 days. No fever. Severe fatigue. Swollen lymph nodes on left side of neck since vaccine date and has not reduced.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Chills, Headache, Injection site erythema, Injection site induration
Clinical narrative: Reactions that cleared within 24 hrs of injection: Fever of 100.7 Chills Congestion Fatigue  Achy muscles  Continuing symptoms: No menstrual cycle in 6 weeks (first dose was 4/3/2021) Injection sight swollen, hard, hot, and red Headache
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nasal congestion, Pain, Pyrexia
Clinical narrative: Reactions that cleared within 24 hrs of injection: Fever of 100.7 Chills Congestion Fatigue  Achy muscles  Continuing symptoms: No menstrual cycle in 6 weeks (first dose was 4/3/2021) Injection sight swollen, hard, hot, and red Headache
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Has a result from the first vaccination (Moderna)  I developed shingles
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia, Sleep disorder
Clinical narrative: Regular shoulder & arm soreness for the arm of injection at night of vaccination (had the same symptom for the first shot, was no big deal). Shoulder upper body (muscle) soreness started around the second day,  and I felt easily tired because of it. The real shoulder pain  (both shoulders) came on 5/3 early morning,  and I was not able to sleep because of it.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Vaccination site pain
Clinical narrative: large red, welp, sore arm around vaccination site.  Tiredness and slight headache.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: Numbness to peripheral body
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Muscle spasms, Neuralgia, Pain in extremity
Clinical narrative: Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus.   And I've did not have this before my vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Ultrasound Doppler normal, Vision blurred
Clinical narrative: Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus.   And I've did not have this before my vaccination.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Fibrin D dimer increased, Pain in extremity
Clinical narrative: The patient received the second dose of the Covid vaccine on 4/30/21, on 5/2/21 at 0230 the patient reported an episode of palpitations, chest pain, and left arm pain that was relieved after 1 hour. On 5/3/21 at 0230 the patient reported a second episode of palpitations, chest pain, and left arm pain that was not relieved, pt presented to the Clinic, to ED at 0340 on 5/3/21, the patient had an EKG and lab work done. Troponin I lab level was 4.52, which is over 100 times the normal limit.  Pediatric cardiology was consulted and the patient was sent to Hospital via life flight.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Troponin I increased, White blood cell count increased
Clinical narrative: The patient received the second dose of the Covid vaccine on 4/30/21, on 5/2/21 at 0230 the patient reported an episode of palpitations, chest pain, and left arm pain that was relieved after 1 hour. On 5/3/21 at 0230 the patient reported a second episode of palpitations, chest pain, and left arm pain that was not relieved, pt presented to the Clinic, to ED at 0340 on 5/3/21, the patient had an EKG and lab work done. Troponin I lab level was 4.52, which is over 100 times the normal limit.  Pediatric cardiology was consulted and the patient was sent to Hospital via life flight.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hot flush, Intermenstrual bleeding
Clinical narrative: The first shot in January gave me migraines on and off over the next 5 days, based on the left side of my head.  I usually get a migraine before my period, but always on my front right area behind my eye and above my ear, and only for 1 day. It was noticeable because they kept coming back and it was in a place I've never had a migraine start.  The second shot however on 2/9/21 is my main concern. my period was just ending after about 4 days.  a bit of spotting, but it was basically done. The next day after my shot though, I woke up soaked in blood. I spent the next 7-8 hours going through 7 Super-size Tampax Tampons. It seemed like I was flash flooding blood  which was weird because ..well if my lining had just shed over the previous 7 days, where did all the blood come from? It ebbed within 24 hours and was back to normal the day after that before it ended.  Over by 2/12/21.  And now, it is 5/3/21 and I have not had a period since and have basically had early menopause jump in and get hot flashes every day! I read that its not actually menopause until our period has been gone for 6 months or more, and mine has really only been nearly 3, but I'm pretty sure I just got sterilized.  And I was a healthcare worker so I got it early, and I don't think the older people getting the shot in line before me would have been raising the concern about their menses cycles because they don't have them anymore.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Hypertension, Supraventricular tachycardia, Tinnitus
Clinical narrative: High BP, Pounding in the ears   SVT During stress test 4-28-21
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, SARS-CoV-2 test, Sinusitis, Throat irritation
Clinical narrative: Tightness in chest and tickle in throat, headache similar to sinus infection.
Sex: U
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: finger flange break after administration; The removal flange safety guard not present; Syringes that had the finger flange break after administration; This non-valid spontaneous report was received from a health care professional via a company representative referring that multiple hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes (lot# and expiration dates not reported) had a finger flange break and the removable flange safety guard was not present.   The reporter advised that she was made aware of 2 hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes that had the finger flange break after administration on 08-FEB-2021. She reported that at least 1 of these episodes resulted in a finger laceration to the administrator (MARRS # 2102USA006456). It was reported that the syringe was not cracked, the syringe was broken into 2 or more pieces at syringe finger flange.  This is one of several reports received from the same source.  Follow up information has been received on 19-FEB-2021. The photographs of one syringe flange was received. The other broken syringe was discarded prior to pictures being taken.  Follow up information has been received on 16-MAR-2021. The office manager reported that her clinic only had 1 of the 2 broken hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number S028738, which has been verified to be valid, the expiration date was not reported but upon internal validation established as 03-APR-2022) syringes that were reported. Additionally, she added that there was "no way that the 2 syringes carne from the same package". combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA006456:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; the dose of ROTATEQ was administered today and expired on 4/1/2021; This spontaneous report as received from Medical Assistant regarding to a 2 month old female patient. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-APR-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S024843 with expiration date 01-APR-2021, 1 dosage form, orally for prophylaxis (expired product administered). There was no adverse event.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event reported  /consumer did not experience any side effects; The caller stated the consumer received the vaccine by accident; This spontaneous report was received from a patient`s mother, regarding a patient of 17-years-old, gender unknown, with historical conditions, historical drugs, and current concomitant therapies were not reported.  On 16-APR-2021 the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) for prophylaxis(route of administration, strength, formulation, dose, frequency and were not reported; lot number and expiration date were not provided).  The consumer`s mother reported that the patient received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) ( Wrong product administered).
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: it is unknown if the consumer had antibodies for the Measles component of the vaccine; This spontaneous report has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported.  On an unknown date (reported as over 40 years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis.   At the reporting time, the patient stated she still had antibodies for mumps and rubella. It was unknown if the patient had antibodies for the measles component of the vaccine (measles antibody negative). The patient wanted to know if there was a single dose measles vaccine. The outcome of the event was unknown.  The relationship between the event measles antibody negative and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; expiration date 26-OCT-2020, vaccines administered 22-APR-2021; A nurse reported a fourth dose of ROTATEQ was administered to a patient who is 12 months old. The patient has already received 3 doses of ROTATEQ; This spontaneous report was received from a nurse referring to a 12-month-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 22-APR-2021, the patient was vaccinated with an expired fourth dose (extra dose administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral, lot number 1660939 dose 4, expiration date reported as 24-JUN-2021, but upon internal validation was determined as 26-OCT-2020, for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation referring to a patient (pt.) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-AUG-2016, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for the long-term prevention of shingles and zoster-related conditions as prescribed and/or administered by a health care professional (HCP) at a primary care provider (PCP) office. On an unspecified date, the pt. claimed to be treated for herpes zoster and claimed damages as a result of injury to itself and economic losses. The outcome of the event was not reported. The reporter considered the evens to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: still dealing with pain on my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of forehead headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received shot 8 years before reporting day).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced forehead headache. On an unknown date, the outcome of the forehead headache was recovered/resolved.   It was unknown if the reporter considered the forehead headache to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient got a shot 8 years ago and still came down with it. The patient's physician send him/her to get the new vaccine shot a series of 2 Shots. The patient received Shingles vaccine and experienced pain on forehead. For tolerance of 2nd dose refer case US2021AMR094080.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094080:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The shot / i got it and about a year later i got the Shingles again / no fun/Suspected vaccination failure; The shot / i got it and about a year later i got the Shingles again / no fun; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a bad case of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient stated that vaccine did not keep you from getting the Shingles. You just get a lighter case. The patient had a bad case and when the shot to prevent it was offered, patient got it and about a year later he/she again got the Shingles but it was a lighter case. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: You can still get the shingles after you get the shot / I never had them until about 6 weeks after the shot/Suspected vaccination failure; shingles / They were bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingle shot and still got the shingles and they were bad. The patient stated that he/she never had them until about 6 weeks after the shot. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: child was nauseous; vomiting; had diarrhea; This case was reported by a nurse via sales rep and described the occurrence of nausea in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th April 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 27th April 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced nausea, vomiting and diarrhea. On an unknown date, the outcome of the nausea, vomiting and diarrhea were unknown.   The reporter considered the nausea, vomiting and diarrhea to be unlikely related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by a Registered Nurse on behalf of patient. The patient received 1st dose of Bexsero a day before reporting and on the same day evening, experienced nausea, vomiting and diarrhea.  The reporter did not believe that the patient's symptoms were related because they had around 40 calls recently of patients having diarrhea.   The reporter also stated that it was unknown if the child has had the COVID vaccine. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the liquid portion of Rotarix; Patient received only the liquid portion of Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L5G93, expiry date 27th August 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th April 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 27th April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, the patient received only the liquid portion of Rotarix (without the powder component), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: EXTREME PAIN DOWN RIGHT SIDE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced extreme pain down right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme pain down right side was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, every 1 total, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced confirmed immunological vaccine failure. On 28-APR-2021 the patient given test SARS-CoV-2 IgG antibody test and SARS-CoV-2 IgM antibody test. The results were found to be negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178015; Sender's Comments: V0:210458243-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: SYRINGE ADMINISTERED OUTSIDE SYRINGE TEMPERATURE REQUIREMENTS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced syringe administered outside syringe temperature requirements. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of syringe administered outside syringe temperature requirements was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, SARS-CoV-2 test
Clinical narrative: FEELING WEAK; TIRED; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced weak. On 03-APR-2021, the subject experienced tired. On 22-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Treatment medications included: Z pack (azithromycin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, weak, and loss of appetite. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Nasal congestion, Nausea, SARS-CoV-2 test
Clinical narrative: FEELING STUFFY; SLEEPING A LOT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included hysterectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. On 04-APR-2021, the subject experienced feeling stuffy. On 04-APR-2021, the subject experienced sleeping a lot. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: antimony potassium tartrate/papaver somniferum tincture/terpin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling stuffy, sleeping a lot, headache, and nausea on 05-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 66 year old male. The patient is healthy otherwise, concurrent conditions included green pepper allergy, prednisone allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, frequency one total administered in left arm on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On unspecified date, the patient underwent lab test include SARS-CoV-2 IgG antibody test which showed no detectable antibodies which considered as confirmed immunological vaccine failure and lack of efficacy. Patient's doctor recommended that to took another covid-19 vaccine (Moderna) since the antibody patient came out low and the doctor stated that it did not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:202104591580-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure .These events are considered not related. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: WEIRD SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced weird symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird symptoms was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 29-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE ACHES IN THE CALVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced muscle aches in the calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle aches in the calves was not reported. This report was non-serious.