chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Erythema, Fatigue, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Had pain in my shoulder (and  neck on my left side) as soon as the shot went in. At roughly three hours after the shot, I felt I was slurring my speech (I had to make a very concerted effort to make proper sentences and not slur) and was very dizzy. I also was having a hard time with lights. For example, I was unable to look in the mirror in my bathroom as the lights above the mirror were too bright for me. At three hours after the shot, I had severe pain in my left shoulder. Overall, I felt as I had been sedated or drugged. I tried walking to the nearest convenience store to get some food and I felt I was experiencing vertigo. Several days after the vaccine I had a slight cough and sore throat. I am still experiencing a slight cough on some day sand a slight sore throat.   I had a subtle red patch in the left shoulder area a couple days after the shot. Eight or nine days after the shot, I had covid arm and had a very visible red patch on my left shoulder. I have pictures of this.  I have been feeling very tired and dizzy ever since the first shot. My glands in my neck under my jaw line are also swollen. I do not know if it is either  wise or safe for me to get the second shot, which is scheduled for this Friday as it seems that I still have not recovered from the first shot. Can my immune system really take another round of this?  There are a couple other things that I have noticed. I don't seem to be thinking very clearly and I have noticed a remarkable number of type-os and poor syntax in emails that I send at work; this is not normal for me.   Finally, after the shot, I noticed that my muscles, when doing a little exertion such as pushups, would build lactic acid quicker and more blood seemed to be delivered to my working muscles. I still have not regained my strength and tire more easierly when playing tennis or hitting against the tennis wall, for example. This is also not normal and not how I felt before the first injection.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Oropharyngeal pain, Photophobia, Vertigo
Clinical narrative: Had pain in my shoulder (and  neck on my left side) as soon as the shot went in. At roughly three hours after the shot, I felt I was slurring my speech (I had to make a very concerted effort to make proper sentences and not slur) and was very dizzy. I also was having a hard time with lights. For example, I was unable to look in the mirror in my bathroom as the lights above the mirror were too bright for me. At three hours after the shot, I had severe pain in my left shoulder. Overall, I felt as I had been sedated or drugged. I tried walking to the nearest convenience store to get some food and I felt I was experiencing vertigo. Several days after the vaccine I had a slight cough and sore throat. I am still experiencing a slight cough on some day sand a slight sore throat.   I had a subtle red patch in the left shoulder area a couple days after the shot. Eight or nine days after the shot, I had covid arm and had a very visible red patch on my left shoulder. I have pictures of this.  I have been feeling very tired and dizzy ever since the first shot. My glands in my neck under my jaw line are also swollen. I do not know if it is either  wise or safe for me to get the second shot, which is scheduled for this Friday as it seems that I still have not recovered from the first shot. Can my immune system really take another round of this?  There are a couple other things that I have noticed. I don't seem to be thinking very clearly and I have noticed a remarkable number of type-os and poor syntax in emails that I send at work; this is not normal for me.   Finally, after the shot, I noticed that my muscles, when doing a little exertion such as pushups, would build lactic acid quicker and more blood seemed to be delivered to my working muscles. I still have not regained my strength and tire more easierly when playing tennis or hitting against the tennis wall, for example. This is also not normal and not how I felt before the first injection.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: One week after first shot of Moderna, my left arm started swelling and remain swollen at the area of injection. There are red dots at beginning follow by large red area of itchiness, heat, and pain.  The swollen area at first is 2 inch by 1.5 inch, and now grow to  6 inch by 3 inch.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: One week after first shot of Moderna, my left arm started swelling and remain swollen at the area of injection. There are red dots at beginning follow by large red area of itchiness, heat, and pain.  The swollen area at first is 2 inch by 1.5 inch, and now grow to  6 inch by 3 inch.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: 9-10 hrs after receiving vaccine I had bad HA,  fatigue & severe joint aches.   Severe enough I cnx'd my appt's the next day.   These sxm's were very similar to my sxm's when I had Covid 19.  Sxm's subsided  24 hrs after they started.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose was given on 5-14-2021 And should be given on 5-21-2021
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Lymphadenopathy, Malaise
Clinical narrative: Covid rash, sick with headaches, fever horrible chills ,back pain ,glands swollen. Everything except for rash within 10 hrs period of vacation.  Rash about a day later
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Covid rash, sick with headaches, fever horrible chills ,back pain ,glands swollen. Everything except for rash within 10 hrs period of vacation.  Rash about a day later
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Measles, Pruritus
Clinical narrative: She has measles like bumps it started below injection area didn't notice till she got home on both arms and legs and hands.  She still has them and they are itchy and red.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Breast pain, Breast swelling, Injection site pain, Lymphadenopathy
Clinical narrative: Arm  pain and burning in left deltoid where vaccine was given two weeks after. Left breast pain and swelling and swollen lymph node under armpit.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal death, Ultrasound abdomen
Clinical narrative: Fetal Death/ Intrauterine fetal death
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Localized erythema at site of injection. No systemic effects.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain Muscle pain in arm on injected arm  Treated with OTC acetaminophen (1000mg po x1 dose)
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling jittery, Heart rate increased, Ocular hyperaemia, Swollen tongue
Clinical narrative: Pt received vaccination at 0955. At approximately 10;15 another patient came over to the admin desk and notified us that pt wasn't doing well. I went over to evaluate and pt told me she felt fine and she would take a Benadryl when she got to the car. I assisted her to the back where we further evaluate her. She had clear signs of anaphylaxis (blood shot eyes, hives, swollen tongue, rapid heart beat) but did not want EPI. I advised her that EPI is NEEDED quickly and that Benadryl was not enough. She then agreed to let me EPI her. Epi was administer in the left thigh at 10;18. A set of vitals were then taken and patient was places on o2. The emergency department was called at 10;20 and arrived at  10;25. During this time another set of vitals were taken. Patient expressed feeling better but jittery.  Hives and tongue swelling had significant improvement but patient still had some symptoms so we advised the follow up team of our recommendation for second dose epi. Emergency team took control of patient.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt received vaccination at 0955. At approximately 10;15 another patient came over to the admin desk and notified us that pt wasn't doing well. I went over to evaluate and pt told me she felt fine and she would take a Benadryl when she got to the car. I assisted her to the back where we further evaluate her. She had clear signs of anaphylaxis (blood shot eyes, hives, swollen tongue, rapid heart beat) but did not want EPI. I advised her that EPI is NEEDED quickly and that Benadryl was not enough. She then agreed to let me EPI her. Epi was administer in the left thigh at 10;18. A set of vitals were then taken and patient was places on o2. The emergency department was called at 10;20 and arrived at  10;25. During this time another set of vitals were taken. Patient expressed feeling better but jittery.  Hives and tongue swelling had significant improvement but patient still had some symptoms so we advised the follow up team of our recommendation for second dose epi. Emergency team took control of patient.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Dull headache for two weeks
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Burning sensation, Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph  nodes under my arm swelled up two days after second injection. Day three my underarm and breast became very painful, felt like a burning sensation, even as swelling went down. This lasted over three weeks. I went to my OBGYN after two weeks who gave me a breast exam and stated it was reactive tissue from the vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacist gave a 12 year old female the Johnson and Johnson vaccine instead of the Pfizer vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Disturbance in attention, Dizziness, Dyspnoea, Fatigue
Clinical narrative: lightheadedness, fatigue, headaches, mood changes, shortness of breath, nausea, concentration issues, forgetfulness
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Memory impairment, Mood altered, Nausea
Clinical narrative: lightheadedness, fatigue, headaches, mood changes, shortness of breath, nausea, concentration issues, forgetfulness
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in the left ear. Bearable, but significant. No changes after 2.5 days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Dyspnoea, Joint lock, Muscle spasms
Clinical narrative: Moderna COVID-19 Vaccine EUA. No adverse reactions from first shot March 16, 2021. This reporting concerns the second dose April 14, 2021. Two weeks later I experienced locking and pain in both shoulders but more severe on the left side where the injection occurred. The shoulders would not rotate then "popped" , motion returned and the pain subsided.  The pain was quick and intense. Second issue, a similar locking pain across the shoulder blades that literally stopped my breathing until the pain subsided. Third issue, a similar cramping pain in the toes of both feet while walking, again slowly subsiding. All of these issues have occured daily since the second Moderna injection. I have contacted my primary care doctor for an appointment as well as reporting this here.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Discoloured vomit, Dizziness, Hypoaesthesia, Hypotension, Nausea
Clinical narrative: Patient has hx of anaphylactic reaction to Amoxicillin ( difficult breathing) arrived at the site with her mother, was informed about the risk of getting vaccinated at non-clinical setting due to her condition. Patient verbalized understanding, agreed to stay 30 minutes in observation area, proceeded with vaccination. After 5 minutes in observation ( 13:35 PM), patient complained of feeling nauseous, dizzy and tingling/ numbness in the upper extremities. Patient vomited x 2, 40 mL of greenish output, noted with pale complex. EMS presented at site was activated. Vital signs initiated, noted with low BP ( 60~/UNK), HR: 70, O2: 99, R:18 in room air. Patient was taken to the ambulance for further assessment by EMT. Patient received an Epinephrine shot to the L thigh by EMT at 13:52 PM. Blood pressure improved to 110/70, HR: 81, R:18, O2: 99%. Patient also received 1 albuterol treatment 6 LPM. Patient was taken to Hospital at 2:04 PM via Bus.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Paraesthesia
Clinical narrative: Patient has hx of anaphylactic reaction to Amoxicillin ( difficult breathing) arrived at the site with her mother, was informed about the risk of getting vaccinated at non-clinical setting due to her condition. Patient verbalized understanding, agreed to stay 30 minutes in observation area, proceeded with vaccination. After 5 minutes in observation ( 13:35 PM), patient complained of feeling nauseous, dizzy and tingling/ numbness in the upper extremities. Patient vomited x 2, 40 mL of greenish output, noted with pale complex. EMS presented at site was activated. Vital signs initiated, noted with low BP ( 60~/UNK), HR: 70, O2: 99, R:18 in room air. Patient was taken to the ambulance for further assessment by EMT. Patient received an Epinephrine shot to the L thigh by EMT at 13:52 PM. Blood pressure improved to 110/70, HR: 81, R:18, O2: 99%. Patient also received 1 albuterol treatment 6 LPM. Patient was taken to Hospital at 2:04 PM via Bus.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Vomiting
Clinical narrative: 12 hours after receiving 2 nd vaccine I started with diarrhea for 5 hours then vomited twice within the next hour then tired the rest of the day.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Heavy menstrual bleeding, Thrombosis
Clinical narrative: Transient moderate headaches and nose bleeds 3-7 days post-injection, including sneezing out blood clot Menstruation lasted longer than normal Mild fatigue 1-5 days post-injection
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Swelling and soreness at site. Tiredness/fatigue.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal
Clinical narrative: 12:15PM alerted patient was feeling dizzy, unwell. O2 saturation was checked(97%) Blood pressure was 106/80, pulse was 80. Patient was pale. 12:25PM blood pressure was 116/80 pulse 80. Patient still complaining of feeling hot and dizzy. had patient lie down on the floor with feet elevated. patients color and affect improved.   Patient started talking more and laughing. Medical emergency team came to evaluate patient. They had patient sit up 12:40PM Blood sugar was checked (109 ) Blood Pressure 129/85 and pulse 87  Facility Emergency team recommended to patient she be evaluated at emergency room since she was not feeling well yet. EMT called and arrived at 1:01PM. Patient transported to Emergency Room. 5-2-2021 6PM patient contacted by phone. She said she was feeling better. Emergency room took care of her. Patient stated that she was just tired and worn out. felt like she would sleep all day the next day.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna CoVid 19 vaccine given to patient 16 years old, when indicated only for patients 18 years and above.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: The day after I received the second shot, I woke up with dizzy spells, vertigo, a fever and chills. I could barley walk and I also threw up. I am not throwing up anymore but I am still feeling dizzy and I am having trouble functioning and walking everyday. The vertigo came and went for about four weeks. I am still experiencing these side effects. Please help.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: The day after I received the second shot, I woke up with dizzy spells, vertigo, a fever and chills. I could barley walk and I also threw up. I am not throwing up anymore but I am still feeling dizzy and I am having trouble functioning and walking everyday. The vertigo came and went for about four weeks. I am still experiencing these side effects. Please help.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Guillain-Barre syndrome, Muscle spasms, Pain, Pain in extremity
Clinical narrative: I was diagnosed by my neurologist with Guillain-Barre Syndrome.  9 days after my 2nd Pfizer shot (Sunday, March 28th), I felt tingling in my feet. On Monday night I felt tingling and pain in my feet, but I was sure it was passing and said nothing since the pain was manageable at a level 2?3. On Tuesday I was getting concerned. My feet were now tingling and in pain all day, and the pain had escalated to a level 5. On Wednesday I suddenly realized that my life could effectively be over soon. The pain was at a 7-8, and I could barely get through my day. My body felt like there were tiny needles shooting electricity into me, and it felt all-consuming. It was unrelenting, and I suddenly understood why the CEO (a COVID survivor) killed himself after suffering through constant ringing in his ears. It became CRYSTAL clear how chronic pain made regular working life impossible, and I wondered how I would get by on disability and how long it would take to kick in after applying. I started panicking while focusing enough to book a doctor?s appointment for that Friday. By the end of Wednesday my calves and thighs were severely cramped, and by Thursday my eyes were tingling and my hands and arms were tingling with pain. I feared MS since it runs in my family. I was terrified and confused and made an appointment with a PCP for Friday, April 2nd.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Subacute inflammatory demyelinating polyneuropathy
Clinical narrative: I was diagnosed by my neurologist with Guillain-Barre Syndrome.  9 days after my 2nd Pfizer shot (Sunday, March 28th), I felt tingling in my feet. On Monday night I felt tingling and pain in my feet, but I was sure it was passing and said nothing since the pain was manageable at a level 2?3. On Tuesday I was getting concerned. My feet were now tingling and in pain all day, and the pain had escalated to a level 5. On Wednesday I suddenly realized that my life could effectively be over soon. The pain was at a 7-8, and I could barely get through my day. My body felt like there were tiny needles shooting electricity into me, and it felt all-consuming. It was unrelenting, and I suddenly understood why the CEO (a COVID survivor) killed himself after suffering through constant ringing in his ears. It became CRYSTAL clear how chronic pain made regular working life impossible, and I wondered how I would get by on disability and how long it would take to kick in after applying. I started panicking while focusing enough to book a doctor?s appointment for that Friday. By the end of Wednesday my calves and thighs were severely cramped, and by Thursday my eyes were tingling and my hands and arms were tingling with pain. I feared MS since it runs in my family. I was terrified and confused and made an appointment with a PCP for Friday, April 2nd.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Anxiety, Apathy, Condition aggravated, Depression
Clinical narrative: Hours after receiving my second Moderna Covid vaccine on March 5, 2021 I began experiencing the following symptoms: - Extreme ongoing, debilitating fatigue which to the date of this submitted report has been resistant to treatment. - Spike in depression & Anxiety - Increased brain fog and struggles concentrating  - Spike in lack of motivation generally - Increased irritability, frustration, aggression, and impatience toward others. - Began having suicidal thoughts
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Frustration tolerance decreased, Impatience
Clinical narrative: Hours after receiving my second Moderna Covid vaccine on March 5, 2021 I began experiencing the following symptoms: - Extreme ongoing, debilitating fatigue which to the date of this submitted report has been resistant to treatment. - Spike in depression & Anxiety - Increased brain fog and struggles concentrating  - Spike in lack of motivation generally - Increased irritability, frustration, aggression, and impatience toward others. - Began having suicidal thoughts
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Suicidal ideation
Clinical narrative: Hours after receiving my second Moderna Covid vaccine on March 5, 2021 I began experiencing the following symptoms: - Extreme ongoing, debilitating fatigue which to the date of this submitted report has been resistant to treatment. - Spike in depression & Anxiety - Increased brain fog and struggles concentrating  - Spike in lack of motivation generally - Increased irritability, frustration, aggression, and impatience toward others. - Began having suicidal thoughts
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Exposure during pregnancy, Headache, Nausea, Pain in extremity
Clinical narrative: The patient visited due to a vaccine reaction with nausea, headaches, limb pain, and abdominal symptoms. No anomalies from the internal med. point of view (clinical and laboratory), so that the patient was referred to a gynecologic examination due to pregnancy. This examination did not show any anomalies. The treatment remained under outpatient conditions.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The patient visited due to a vaccine reaction with nausea, headaches, limb pain, and abdominal symptoms. No anomalies from the internal med. point of view (clinical and laboratory), so that the patient was referred to a gynecologic examination due to pregnancy. This examination did not show any anomalies. The treatment remained under outpatient conditions.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; Use of GARDASIL 9 outside of prescribing information. Second dose administered almost 6 months after first dose was administered in 3-dose series.; This spontaneous report was received from a pharmacist concerning a 27 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not report.      The patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 0.5 ml, intramuscularly; batch/lot# was not reported) on 30-NOV-2020 via a recommendation from a pharmacist as prophylaxis. She received her second dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 0.5 ml, intramuscularly; batch/lot# was not reported) on 18-APR-2021 as prophylaxis (inappropriate schedule of product administration). The second dose was almost 6 months after the first dose in a 3-dose series and was given further apart than recommended.  No additional adverse event (AE) was reported.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; Temperature excursion VARlVAX had been administered; This spontaneous report was received from a medical assistant referring to a 17-month-old patient of unknown age. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 12-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot #: T021826, expiration date was 25-JUN-2022, dose, strength, and route were not reported) for prophylaxis.  Temperature excursion of this vaccine was -58 degrees Fahrenheit and +5 degrees Fahrenheit (6.3 F) for 6 hours and 30 seconds, -58 degrees Fahrenheit and +5 degrees Fahrenheit (10.9 F) for 7 minutes and 30 seconds with previous temperature excursion. The digital data logger which was involved in recording excursion details.; Sender's Comments:  2104USA008022: 2104USA008185: 2104USA008342: 2104USA008255: 2104USA008022: 2104USA008081:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/ PQC reported; Temperature excursion; This spontaneous report was received from a medical assistant referring to a 17-month-old patient of unknown age. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 12-APR-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA)) (lot #: T029099, expiration date was 23-FEB-2022, dose, strength, and route were not reported) for prophylaxis.  Temperature excursion of this vaccine was -58 degrees Fahrenheit and +5 degrees Fahrenheit (6.3 F) for 6 hours and 30 seconds, -58 degrees Fahrenheit and +5 degrees Fahrenheit (10.9 F) for 7 minutes and 30 seconds with previous temperature excursion. The digital data logger was involved in recording excursion details.; Sender's Comments:  US-009507513-2104USA008134: US-009507513-2104USA008302: US-009507513-2104USA008088:
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered
Clinical narrative: The caller reports the consumer has shown no side effects to the vaccines administered; PROQUAD Dose/Frequency: Once, possibly twice; This spontaneous report was received from a consumer referring to of a nine-year-old female patient. Her pertinent medical history, concomitant drugs and drug allergies were not reported. The caller reports vaccine history of the consumer was unknown because the consumer was not in the country before age one or two.   On 23-APR-2021, patient was vaccinated with an unknown vaccine, from an unknown manufacturer, which is suspected to have been a vaccine for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (manufacture unknown) (lot #, expiration date, dose, strength, and route were not reported) for prophylaxis. However, there was no documentation of this vaccine, so it was unknown exactly what it included, what it was for, or what company manufactured it.  On 04-MAY-2021, the patient "following CDC guidelines for catchup vaccines," was administered with which they would be considering as the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #, expiration date, dose, strength, and route were not reported) for prophylaxis. She was vaccinated with a total of six vaccines including Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) that day. Reporter refused to say what the other five vaccines were.  The caller reports the consumer has shown no side effects to the vaccines administered 04-MAY-2021. Consent to contact the caller and the consumer's physician was denied, with the exception of emailing the caller a copy of the prescribing information. No additional adverse events or product quality complaints were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 26-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a healthcare provider at clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by health care providers for shingles and other zoster-related conditions. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: caused me pain in my legs ever since I got them; was causing my nerve pain.; This case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced leg pain and nerve pain. On an unknown date, the outcome of the leg pain and nerve pain were recovered/resolved.   The reporter considered the leg pain and nerve pain to be possibly related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient received  shingles shot and experienced pain in her/his legs ever since got them four months ago. The patient's orthopedic doctor said he thought that's what was causing her/his nerve pain. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102646:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: fatigue; high fever; nausea; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, fever and nausea. On an unknown date, the outcome of the fatigue, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient had fever, nausea, fatigue for a couple days. The patient stated would take that over the Shingles any day. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: arm is so sore; feel feverish; cannot hardly move my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, fever and mobility decreased. On an unknown date, the outcome of the pain in arm, fever and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient got the shingles vaccine and till the tie of reporting his/her arm was so sore and the patient felt feverish and could not hardly move arm. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix was inadvertently administered  that was stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2EC5G, expiry date 13th January 2023) for prophylaxis.   On 5th April 2021, the patient received Boostrix. On 5th April 2021, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The reporter was a clinical supervisor. The age at vaccination was not reported. The reporter called in to check stability of Boostrix vaccine stored at minimum 29 Fahrenheit temperatures for 48 hours.  The reporter stated that they had inadvertently administered Boostrix vaccine that was stored outside of normal range and needed to be discarded of the patient, which led to incorrect storage of drug. The reporter was unable to provide additional details of vaccine and patient. The reporter did not consent to follow-up. This case is 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102718:Same reporter US-GLAXOSMITHKLINE-US2021102717:Same reporter US-GLAXOSMITHKLINE-US2021102716:Same reporter US-GLAXOSMITHKLINE-US2021102721:Same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   Previously administered products included Shingrix (received full series 2 years ago).   On 12th May 2021, the patient received the 3rd dose of Shingrix. On 12th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Pharmacist reported a patient who received a third dose of Shingrix on the same day as reported, which led to extra dose administered.  The patient had received the full series 2 years ago and they were not aware of that. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose of Shingrix; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on June 2020.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. The patient missed to receive 2nd dose at appropriate time. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reported VAREs details pertains to 1st dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood potassium, Blood potassium decreased, Body temperature increased, Feeling abnormal
Clinical narrative: SEIZURES; POTASSIUM LEVEL DROPPED; SUGAR LEVELS DROPPED; WHITE BLOOD CELL COUNT DECREASED; NUMBNESS; SWOLLEN LYMPH NODES IN NECK; FELT LIKE DYEING; TEMPERATURE WENT UP; UNABLE TO GET UP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age received via social media. 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, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 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 unspecified date of 2021, the patient's temperature went up and White blood cell count decreased to 1800. The patient's sugar level was dropped although the patient was not having any sugar problems. The patient also experienced swollen lymph nodes in neck, seizures, and numbness. The patient's potassium level was dropped to 3.0. The patient was unable to get up off couch. The patient was hospitalized for 1 day. The patient also felt like dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  temperature went up, White blood cell count decreased, sugar levels dropped, swollen lymph nodes in neck, seizures, numbness, potassium level dropped, unable to get up and felt like dying was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210516164-COVID-19 VACCINE AD26.COV2.S-Seizures, Potassium level dropped, Sugar levels dropped, White blood cell count decreased, Numbness, Swollen lymph nodes in neck, Felt like dyeing, Temperature went up, Unable to get up . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Mobility decreased, Seizure, White blood cell count decreased
Clinical narrative: SEIZURES; POTASSIUM LEVEL DROPPED; SUGAR LEVELS DROPPED; WHITE BLOOD CELL COUNT DECREASED; NUMBNESS; SWOLLEN LYMPH NODES IN NECK; FELT LIKE DYEING; TEMPERATURE WENT UP; UNABLE TO GET UP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age received via social media. 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, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 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 unspecified date of 2021, the patient's temperature went up and White blood cell count decreased to 1800. The patient's sugar level was dropped although the patient was not having any sugar problems. The patient also experienced swollen lymph nodes in neck, seizures, and numbness. The patient's potassium level was dropped to 3.0. The patient was unable to get up off couch. The patient was hospitalized for 1 day. The patient also felt like dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  temperature went up, White blood cell count decreased, sugar levels dropped, swollen lymph nodes in neck, seizures, numbness, potassium level dropped, unable to get up and felt like dying was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210516164-COVID-19 VACCINE AD26.COV2.S-Seizures, Potassium level dropped, Sugar levels dropped, White blood cell count decreased, Numbness, Swollen lymph nodes in neck, Felt like dyeing, Temperature went up, Unable to get up . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: SEIZURES; POTASSIUM LEVEL DROPPED; SUGAR LEVELS DROPPED; WHITE BLOOD CELL COUNT DECREASED; NUMBNESS; SWOLLEN LYMPH NODES IN NECK; FELT LIKE DYEING; TEMPERATURE WENT UP; UNABLE TO GET UP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age received via social media. 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, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 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 unspecified date of 2021, the patient's temperature went up and White blood cell count decreased to 1800. The patient's sugar level was dropped although the patient was not having any sugar problems. The patient also experienced swollen lymph nodes in neck, seizures, and numbness. The patient's potassium level was dropped to 3.0. The patient was unable to get up off couch. The patient was hospitalized for 1 day. The patient also felt like dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  temperature went up, White blood cell count decreased, sugar levels dropped, swollen lymph nodes in neck, seizures, numbness, potassium level dropped, unable to get up and felt like dying was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210516164-COVID-19 VACCINE AD26.COV2.S-Seizures, Potassium level dropped, Sugar levels dropped, White blood cell count decreased, Numbness, Swollen lymph nodes in neck, Felt like dyeing, Temperature went up, Unable to get up . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: DEATH; STROKE; This spontaneous report received from a consumer concerned eight patients with unknown race and ethnicity. The patients' weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients had stroke and died after getting the Janssen Covid-19 vaccine, the patients died from unknown cause of death and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0.20210516928-covid-19 vaccine ad26.cov2.s-Death,Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; BODY ACHES; MILD FEVER; This spontaneous report received from a patient concerned a 58 year old female. Initial information was processed along with the additional information received on 12-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included interstitial lung disease, narrow angle glaucoma, hearing loss, arthritis, allergy, and hypersensitive pneumonitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on left arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced mild fever. On 23-MAR-2021, the patient experienced body aches. On 26-APR-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided),1.90 (positive),which was a low titer value as reported by the pulmonologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and mild fever on 23-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with the product quality control number 90000179304.; Sender's Comments: V0: 20210518116-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: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Chills, Diarrhoea, Fatigue
Clinical narrative: CHEST PAIN; MIGRAINES; STOMACH PAIN; DIARRHEA; SWELLING IN BOTH LEGS; BLURRED VISION; CHILLS; PAIN IN BOTH LEGS; TIRED FEELING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection (twice), and other 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: 042AZ1A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced chest pain. On 10-MAY-2021, the subject experienced migraines. On 10-MAY-2021, the subject experienced stomach pain. On 10-MAY-2021, the subject experienced diarrhea. On 10-MAY-2021, the subject experienced swelling in both legs. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced chills. On 10-MAY-2021, the subject experienced pain in both legs. On 10-MAY-2021, the subject experienced tired feeling. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, migraines, stomach pain, diarrhea, blurred vision, chills, pain in both legs, tired feeling, and nausea on 10-MAY-2021, was recovering from swelling in both legs, and the outcome of headache was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.