chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Drooling, Hyperhidrosis, Pallor
Clinical narrative: 1437: Pt arrived to observation area pale, diaphoretic and drooling. Pt disoriented for 4-5 minutes. Per daugher, pt not at baseline. Bp 84/52, 89, o2 sat 98% room air.      1443: Vital signs improved 142/74, 98%sat room air, no longer pail. Daughter request 911 and transfer to ER. Daughter stated pt had previously had a similar episode.    1452: pt care transferred to 911 and pt transferred to ER.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Constipation, Fatigue
Clinical narrative: Next day: physical chills, headache, body & joint aches, fatigue. Arm rash and swelling. Lymph nodes under arm swollen and sore. Rash hot to touch. Wednesday: lip tingling. Thursday: full blown lip sore. Saturday morning: ulcer type sore inside vagina. Constipation.  Headaches daily.  Monday 2/15 went to urgent care. Prescribed prednisone. Blood work ran.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Paraesthesia oral, Rash
Clinical narrative: Next day: physical chills, headache, body & joint aches, fatigue. Arm rash and swelling. Lymph nodes under arm swollen and sore. Rash hot to touch. Wednesday: lip tingling. Thursday: full blown lip sore. Saturday morning: ulcer type sore inside vagina. Constipation.  Headaches daily.  Monday 2/15 went to urgent care. Prescribed prednisone. Blood work ran.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Skin warm, Swelling, Ulcer, Urine analysis
Clinical narrative: Next day: physical chills, headache, body & joint aches, fatigue. Arm rash and swelling. Lymph nodes under arm swollen and sore. Rash hot to touch. Wednesday: lip tingling. Thursday: full blown lip sore. Saturday morning: ulcer type sore inside vagina. Constipation.  Headaches daily.  Monday 2/15 went to urgent care. Prescribed prednisone. Blood work ran.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature increased, Dizziness, Fatigue, Headache
Clinical narrative: Started experiencing local injection site pain within an hour of injection, took 2 Advils, then began getting light-headed @ 4 hours post injection, fatigued and nausea 8 hours post injection.  Took 2 more Advils @ 3 AM, nausea was worse during the night, took some Rolaids,  Nausea subsided @  11 AM on 2/13/2021.  Fatuque and site pain was increasing.  Did not take any more Advils or other medication except for regular prescription meds listed in this report.  Left arm site very bruised, lymph node tenderness of left armpit began early evening of 2/13.  Late evening 2/13, very bad headache, took 2 Advils with good relief.  No increased temperature until early morning 2/15, highest being 99.8 oral.  Took 2 tylenols on 2/15 @ 2;30 AM, Temperature decreased to 98.8 oral. and headache was diminished.  Fatigue, arm pain, and tenderness of the lymph node/left armpit continued.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Lymph node pain, Nausea, Pain in extremity
Clinical narrative: Started experiencing local injection site pain within an hour of injection, took 2 Advils, then began getting light-headed @ 4 hours post injection, fatigued and nausea 8 hours post injection.  Took 2 more Advils @ 3 AM, nausea was worse during the night, took some Rolaids,  Nausea subsided @  11 AM on 2/13/2021.  Fatuque and site pain was increasing.  Did not take any more Advils or other medication except for regular prescription meds listed in this report.  Left arm site very bruised, lymph node tenderness of left armpit began early evening of 2/13.  Late evening 2/13, very bad headache, took 2 Advils with good relief.  No increased temperature until early morning 2/15, highest being 99.8 oral.  Took 2 tylenols on 2/15 @ 2;30 AM, Temperature decreased to 98.8 oral. and headache was diminished.  Fatigue, arm pain, and tenderness of the lymph node/left armpit continued.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Following completion of vaccine series (2 weeks after last dose), client tested positive for Covid-19
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Headache, Injection site erythema, Injection site pain
Clinical narrative: 10 days after the vaccine I experienced terrible dizziness, falling into the wall, nausea, and headache. The next morning my arm was swollen, red, hot, and sore where I had received the injection. The arm remained that way the entire day but was gone the next day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: 10 days after the vaccine I experienced terrible dizziness, falling into the wall, nausea, and headache. The next morning my arm was swollen, red, hot, and sore where I had received the injection. The arm remained that way the entire day but was gone the next day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Swollen tongue, Tongue disorder
Clinical narrative: Approximately 20 minutes after the shot was administered my tongue began to feel tingly and thick.  It made swallowing feel awkward but there was difficulty in breathing.  When I got home, about 35-40 minutes after shot was administered I took some Benadryl.  About 1 1/2 hours I felt back to normal.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Following completion of vaccine series (2 weeks after last dose), client tested positive for Covid-19
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Insomnia
Clinical narrative: My mid back is aching and sleep is difficult. I have not experienced this type of back ach in the past. I am taking ibuprophen to help with ach.  This may get better but I wanted to report the problem in case it gets worse. Don't know the cause.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast swelling, Breast tenderness, Cellulitis, Erythema
Clinical narrative: On Friday evening, 24 hours after my 2nd vaccine, my left arm started to itch. My arm, underarm and left breast was very red, swollen, itchy,  tender to the touch and my arm felt sort of numb and weird.  Prior to feeling that way, I had a headache and the left side of my neck was tight and painful. I put some Benadryl gel and an ice pack on my arm and underarm. The following day it felt a little better but still had redness, swelling and itchiness. On Sunday when I went back to work, I had NP take a look at my arm. She felt I may have developed a cellulitis and prescribed Keflex 500mg QID x 7 days. Today, Monday, 2/15/2021, my arm is still a bit red and feels tight but is much better than it was on Friday and Saturday.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Muscle tightness, Neck pain
Clinical narrative: On Friday evening, 24 hours after my 2nd vaccine, my left arm started to itch. My arm, underarm and left breast was very red, swollen, itchy,  tender to the touch and my arm felt sort of numb and weird.  Prior to feeling that way, I had a headache and the left side of my neck was tight and painful. I put some Benadryl gel and an ice pack on my arm and underarm. The following day it felt a little better but still had redness, swelling and itchiness. On Sunday when I went back to work, I had NP take a look at my arm. She felt I may have developed a cellulitis and prescribed Keflex 500mg QID x 7 days. Today, Monday, 2/15/2021, my arm is still a bit red and feels tight but is much better than it was on Friday and Saturday.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin tightness
Clinical narrative: On Friday evening, 24 hours after my 2nd vaccine, my left arm started to itch. My arm, underarm and left breast was very red, swollen, itchy,  tender to the touch and my arm felt sort of numb and weird.  Prior to feeling that way, I had a headache and the left side of my neck was tight and painful. I put some Benadryl gel and an ice pack on my arm and underarm. The following day it felt a little better but still had redness, swelling and itchiness. On Sunday when I went back to work, I had NP take a look at my arm. She felt I may have developed a cellulitis and prescribed Keflex 500mg QID x 7 days. Today, Monday, 2/15/2021, my arm is still a bit red and feels tight but is much better than it was on Friday and Saturday.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered the first Pfizer vaccine as a medication error; he was not yet 16, the approved age.   The patient is doing well and reported no local or systemic side effects after the first dose.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient is a 77 year old female who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - itchiness no evidence of hives or skin rash upon assessment. Pt report no shortness of breath. Pt stated she feels fine otherwise. Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Other - benadryl giver per pt request 25mg PO o Allergy to COVID-19 vaccine documented in Allergies activity: No,  o Patient advised to discuss second dose considerations with a clinician
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Dizziness, Flushing
Clinical narrative: Patient received 1st dose of Pfizer COVID-19 Vaccine around 3:30 pm on February 13th and was asked to wait 30 minutes for observation due to previous history of anaphylaxis to peanuts and latex.    Around 3:43pm patient stated she felt dizzy and light headed and appeared flushed.    Her blood pressure taken at the onset of symptoms was 146/72 and patient stated she had chest pain (7/10 on pain scale).   She stated she felt the same way when she had previous anaphylaxis so an epipen was administered and 911 was called.   About 10 minutes later there was no improvement so a 2nd epipen was administered and she left with EMT.    We have been unable to reach for follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Rash, Rash macular, Skin discolouration
Clinical narrative: I received Moderna vaccine. First vaccination - 1/4/21. Second - 2/1/21. No significant reactions to either: no fever, chills, myalgias, fatigue, etc. However, about 1-2 weeks post the first vaccine, I developed mild distal finger joint stiffness and slight pain and swelling. Both hands. R>L. Involving 3rd - 5th fingers. Not symetrical. No other joint pains or spine pain.  There has been slight reddish soft tissue swelling  of distal phalanges  of involved fingers. Nails look normal.  Also, few punctate red spots - sl painful; they look like punctate hemorrhages. No systemic symptoms. Not requiring medication. Findings persistant till now. No involvement of toes. No generalized body rashes. I do not have psoriasis, but these findings are reminiscent of findings one would see with Psoriatic Arthritis. I am an MD (Internist). I thought this may be interesting since it looks to me like a possible immune-mediated reaction. I do have photographs available.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nodes (lymphadenopathy) under right arm pit.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Warm rash at injection site, itchy, radiating.  Started on day 13 after injection. Today is day 14, and rash is larger and still itching.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Woke up with a slightly itchy left arm with slight swelling and an area of redness approximately 2x4 inches.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nasopharyngitis, Pain in extremity, Skin discolouration
Clinical narrative: It wasn't a big deal., but I wanted to share in case more people report the same thing.  The day after I became incredibly cold and turned the color of ash gray. I felt strange for several hours. And my arm was the most sore it has ever been in my whole life for about 4 days.   But-what I wanted to share, is I am a perimenopausal woman, who has been having severe hot flashes for about 8 months. Sometimes 10 an hour, sometimes just 10 a day since I added in some OTC hormone support.  But, I have not had a single hot flash for 18 days, which has not happened in over 7 months.  It was like after being so incredibly cold after the vaccine, something in my body reset. I do not know if this will be permanent, but it has been the best three weeks in a long time. And, I just wanted to put it on record, as other women my age (almost 50) are vaccinated if it improves their menopause symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Headache, Oropharyngeal pain, Premature delivery
Clinical narrative: I had a headache, diarrhea, sore throat and congestion. The congestion lasted for about a week .My water broke on 1/20/2021 and gave birth on 1/21/2021 I was 34 1/2 weeks. It depends on how you look at it I think Covid caused the premature labor.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Premature labour, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had a headache, diarrhea, sore throat and congestion. The congestion lasted for about a week .My water broke on 1/20/2021 and gave birth on 1/21/2021 I was 34 1/2 weeks. It depends on how you look at it I think Covid caused the premature labor.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Migraine, Pain in extremity, Pyrexia
Clinical narrative: On the same day of vaccination on the night I started to have, chills, I had a migraine, fevers, & my arm was sore from the vaccine. This symptoms lasted for about 72hrs. I had to call the nurse line 4 hrs after I started feeling sick.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Heart rate increased, Pain, Pyrexia
Clinical narrative: Rapid heart rate (about an hour after); 101 degree fever, achy body, cough
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash pruritic, Skin discomfort, Skin warm
Clinical narrative: Covid Arm:   rash about 3 " in area of injection going up over shoulder. itchy, red and warm.  Lasted 3 days.  Not painful, just uncomfortable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, headache, body aching
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: I've been tired, dizzy and have had a headache since receiving the covid vaccine. I'm lethargic and have no energy. Initially upon returning home from receiving the vaccine, I felt dizzy and had chills. My face has been red and flushed on and off since the shot.  I felt fine before receiving the vaccine. I'm more than afraid to receive the second shot.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Lethargy
Clinical narrative: I've been tired, dizzy and have had a headache since receiving the covid vaccine. I'm lethargic and have no energy. Initially upon returning home from receiving the vaccine, I felt dizzy and had chills. My face has been red and flushed on and off since the shot.  I felt fine before receiving the vaccine. I'm more than afraid to receive the second shot.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Nurse reports VARIVAX administered after a temperature excursion; This spontaneous report was received from a licensed Practical Nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-JAN-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (route of administration not reported), lot # T024281 and expiration date 15-JUL-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 7.1 degree fahrenheit (°F) for 59 hours and 45 minutes on an unknown date; no previous temperature excursion were reported.; Sender's Comments:  US-009507513-2102USA000364: US-009507513-2102USA000622: US-009507513-2102USA000838:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; product storage error; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 04-FEB-2021, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1687009, expiration date 28-JUN-2021 for prophylaxis, that underwent a temperature excursion.  The temperature excursion was 13.7 degrees Celsius (°C) fon 1 hour. There were no previous temperature excursions. The call was due to digital data logger.
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 concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. On an unknown date in 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician for shingles and other zoster-related injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient 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 include 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 the events was not provided. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Pregnancy, Pregnancy test negative, Pregnancy test positive
Clinical narrative: caller reported receiving Gardasil 9 vaccine after the first pregnancy test was administered and reported the doctor said their was an error with the first pregnancy test not being very clear, the second pregnany test came back as positive; This spontaneous prospective pregnancy report was received from a patient of unknown age who was reporting on herself. The patient's pertinent medical history, drug, reactions, allergies and concomitant medications were not reported.   On an unspecified date, the patient became pregnant. The dates of last menstrual period (LMP), approximate date of conception, and estimated date of delivery (EDD) were not provided and were unable to calculate. The pregnancy outcome was pending.  On 05-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose #, route of administration, anatomical location, lot # and expiration date were not reported). During visit at the doctor's office (before vaccination), she had pregnancy test which came back negative. A doctor stated that there was an error with the first pregnancy test which was not being very clear. On the same day, she had another pregnancy test given a second time and reported the second pregnancy test came back as positive.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; expired vaccine PROQUAD was administered; This non-valid spontaneous report refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JAN-2021, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) 0.5 ml, lot # T015598, expiration date reported as 26-JAN-2021, but upon internal review astablished as 02-NOV-2021 (formulation, strength, frequency, route of administration were not reported). for prophylaxis. No adverse event was reported.  The report is non-valid due to lack of patient's identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Nervous system disorder
Clinical narrative: neurological problems; abdominal pain; This case was reported by a nurse and described the occurrence of neurological disorder nos in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In December 2020, 1 month after receiving Shingrix, the patient experienced neurological disorder nos and abdominal pain. On an unknown date, the outcome of the neurological disorder nos and abdominal pain were unknown.   It was unknown if the reporter considered the neurological disorder nos and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her early 50's age. The patient received Shingrix shot (unknown if dose 1 or 2) in early to mid November 2020 and about 1 month after the injection, neurological problems and severe abdominal pain were experienced. It was unknown if these events have resolved and vaccines lot number was unknown.  The patient indicated knowing of another individual (gender unspecified) that had the same issue. No additional details were known to the reporter. The reporter was open to receiving correspondence from safety department.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Oral herpes, Rash
Clinical narrative: rash on her collar bone; bad cold sore; burned underneath the cold sore; This case was reported by a consumer and described the occurrence of rash in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (had 3 strokes in 2018). Previously administered products included Zostavax (5 years ago from the reporting date), Xanax and statins. Concurrent medical conditions included drug hypersensitivity (sensitive to medications). Concomitant products included alprazolam (Xanax).   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, 34 days after receiving Shingrix, the patient experienced rash, cold sores and burning sensation. The patient was treated with medication unknown (Antipruritic (Unknown)). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the cold sores and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the rash, cold sores and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix shot and had symptoms for 1 day which were nothing major, similar to how she felt after a flu shot. Then within a month after vaccination, the patient developed a rash on her collar bone, she used an anti-itch cream which helped.  The patient also has a bad cold sore which had started blooming around 1st December 2020, and had not gone away. It was burned underneath the cold sore, the patient treats it with releive cream and also kept the area clean. The paient did not have a primary care physician at the time of reporting, she would try to get one around 20th January 2021. The patient takes a low dose of Xanax and reported years ago that Xanax from another pharmaceutical company did not work the same. The reporter mentioned that while taking a statin she threw up for 2 weeks and lost 30 pounds then was hospitalized. The reporter consented to follow-up. This case had been linked with US2020AMR248335, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Feverish / did not have a fever; Shaking; Headache / continues to get worse; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2021, the patient received the 1st dose of Shingrix (intramuscular). In January 2021, 5 hrs after receiving Shingrix, the patient experienced general body pain, chills, hot feeling generalized, tremor and headache. On an unknown date, the outcome of the general body pain, chills, hot feeling generalized, tremor and headache were unknown.   It was unknown if the reporter considered the general body pain, chills, hot feeling generalized, tremor and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and approximately five hours later, she started having body aches. The patient woke up at night feeling chills, feverish and shaking. The patient did not have a fever. The patient reported that she experienced headache less than a day, which continued to get worse. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Body aches; Chills; Feverish / did not have a fever; Shaking; Headache / continues to get worse; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2021, the patient received the 1st dose of Shingrix (intramuscular). In January 2021, 5 hrs after receiving Shingrix, the patient experienced general body pain, chills, hot feeling generalized, tremor and headache. On an unknown date, the outcome of the general body pain, chills, hot feeling generalized, tremor and headache were unknown.   It was unknown if the reporter considered the general body pain, chills, hot feeling generalized, tremor and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and approximately five hours later, she started having body aches. The patient woke up at night feeling chills, feverish and shaking. The patient did not have a fever. The patient reported that she experienced headache less than a day, which continued to get worse. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Flu-like symptoms; feeling bad; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and feeling bad. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 71 or 72 years. The patient experienced flu-like symptoms and feeling bad after 1st dose of Shingrix vaccination. For tolerance with 2nd dose refer case US2021AMR002678. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002678:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Flu-like symptoms; feeling bad; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and feeling bad. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 71 or 72 years. The patient experienced flu-like symptoms and feeling bad after 1st dose of Shingrix vaccination. For tolerance with 2nd dose refer case US2021AMR002678. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002678:same reporter
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle twitching, Syncope
Clinical narrative: Twitching of the face; Syncope; Weakness; A spontaneous report was received from a pharmacy intern, concerning a 23-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, weakness, and twitching of the face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient was working and experienced syncope and weakness.   On 06 Jan 2021, the patient reported experience twitching of the face beginning on an undisclosed date and she also continued to experience weakness. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, syncope, was unknown. The events, weakness and twitching of the face, were considered not resolved.; Reporter's Comments: This case concerns a 23-year-old, female, who experienced serious unexpected event of syncope, and non-serious unexpected events of asthenia and muscle twitching. The events of syncope, asthenia occurred 2 days after mRNA-1273 (Lot# 025J20-2A), while the event of muscle twitching occurred on an unspecified date after mRNA-1273 (Lot# 025J20-2A). Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelled up badly from it, my face was swollen and my arms and my back and my chest; Red upper body; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced swollen up badly in the face, neck, arms, back and chest, and redness on whole upper body.  The patient's medical history was not provided. Concomitant product use was not provided.  On 15 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that on 16 Jan 2021 he bad swelling in the face, neck, arms, back and chest and redness on whole upper body. Treatment for the event included an emergency room visit with hospitalization and steroids on 17 Jan 2021.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, experienced swollen up badly in the face, neck, arms, back and chest and redness on whole upper body, was considered unknown.; Reporter's Comments: This case concerns a male patient, who experienced serious unexpected event of swelling (face, neck, arms, back and chest) and non-serious unexpected event of erythema (upper body). The event occurred 2 days after mRNA-1273 (Lot# Unknown). Treatment included steroids. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; A spontaneous report was received from a reporter concerning a unknown patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient passed away. No treatment information was provided.  Action taken with RNA-1273 in response to the event was not applicable.  The patient died on unknown date. The cause of death was reported as unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided.  The fatal, unexpected event of death occurred on an unknown date after the administration of the first dose of mRNA-1273 on an unknown date. The cause of death was reported as unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the event, a causal relationship cannot be excluded. Additional information regarding the autopsy report, date of the mRNA administration, day of death, medical information and details of concomitant product are all required for further assessment of causality.; Reported Cause(s) of Death: Unknown cause of death
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease, Pruritus, Tremor
Clinical narrative: Parkinson is worse since the vaccine; both hands shaking; Is itchy in all my boy, still itchy; A spontaneous report was received from a healthcare professional who a 86 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching all over my body and Parkinson's is worse since the vaccine.  The patient's medical history included Parkinson's disease. Products known to have been used by the patient, within two weeks prior to the event, included pramipexole.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, two days post vaccination, the patient reported he had itching all over his body. He was unable to sleep without taking diphenhydramine due to the itching.   On unknown date, the patient also states he thought the vaccine made his Parkinson's worse. He reported  both of his hands had been shaking since he received the vaccine.   Treatment for the event included diphenhydramine and pramipexole.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itching all over my body and Parkinson's is worse since the vaccine, were considered unknown.; Reporter's Comments: This case concerns an 86-year-old, male, with medical history of Parkinson's disease, who experienced a serious event of Parkinson's disease aggravated after receiving first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second doses of Moderna Covid-19 vaccine too close to the first dose; A spontaneous report was received from a pharmacist concerning 2 patients who received a second dose of Moderna's COVID-19 Vaccine (mRNA-1273) too close to the first dose/ inappropriate schedule of product administration.   The patients' medical history was not provided. No relevant concomitant medications were reported.  The patients received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 02 Feb 2021, the patients received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   The event, second dose of Moderna's COVID-19 Vaccine (mRNA-1273) too close to the first dose, was considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect schedule of product administered for mRNA-1273 with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The dose spilled from the syringe and pour down from the arm; A spontaneous report was received from a physician, concerning a patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and the dose spilled from the syringe and poured down from the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 03L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient reported that while receiving the Moderna vaccine, the dose spilled from the syringe and poured down from their arm. The patient said it came down from the side of the needle. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergic to it; Initial information was received on 28-Jan-2021regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had allergic to it (hypersensitivity), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was allergic to it (hypersensitivity), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Influenza, Intensive care, Pneumonia
Clinical narrative: pnuemonia; flu; Initial information was received on 22-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (age and gender not specified) who had flu (influenza) and pnuemonia, while patient received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE   Medical history, medical treatment(s), past vaccination(s) concomitant medication, concomitant disease and family history or risk factor were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The patient was ended up in intensive care unit for a week and assessed as medically significant for pneumonia event.   It is unknown if the patient experienced any additional symptoms/events.  Patient should have listened to gut instinct and not trust them.   Each individual is different genetically. It affected patient adversely. Never again. The same with the rona vaccine.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown for both events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult patient who had influenza and pnuemonia after vaccination with INFLUENZA VACCINE (unknown manufacturer) and PNEUMOCOCCAL VACCINE .The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Ageusia, Deafness, Feeling cold
Clinical narrative: Lost taste; lost sound; Cold all the time; Initial information received on 06-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (age and gender not reported) who experienced lost taste (ageusia), lost sound (hypoacusis) and cold all the time (nasopharyngitis), while he/she received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious lost taste (ageusia), lost sound (hypoacusis) and cold all the time (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for all the events.  Reporter assessment for the causal relationship with suspect vaccine was not reported.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: two patient died after vaccination with INFLUENZA; Initial information received on 10-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves two patients (unspecified age and gender) who died after receiving INFLUENZA VACCINE (death).  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, two patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, two patients died after vaccination with INFLUENZA (death) unknown latency following the administration of INFLUENZA VACCINE..  The event was also assessed as medically significant.  It was unknown if the patients experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patients received a corrective treatment before death.  An autopsy was not done and the actual cause of death was not reported at the time of reporting.  The reporter could not provide any other information about the case.  Information on the batch number was requested.; Sender's Comments: This case concerns two patients (unspecified age and gender), who died after vaccination with INFLUENZA VACCINE (death) (produced by unknown manufacturer). The time to onset was unknown. However, patients medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: lost 2 friends who took it
Age: 0.33
Sex: F
Vaccine: DTAP, DTAPIPV, IPV
Symptoms: Extra dose administered, Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received mistakenly the wrong vaccine at the wrong age /no AE; patient received mistakenly the wrong vaccine at the wrong age /no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case was received from an other healthcare professional via Medical Information (Reference number- 00444616).  This case involves a four-month-old female patient who was administered DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] mistakenly at the wrong age (wrong product administered and overdose).  The caller stated that QUADRACEL was gave at the wrong age today and last week. Also stated that wrong vaccine was given at the wrong age. Caller clarified QUADRACEL was given today, 25-Jan-2021 to a 4-month-old and states she does not know what happened, but she believed they were supposed to be given DTaP (Daptacel) and IPV (unsure the trade name) separately.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HIB VACCINE CONJ (TET TOX) [HIBERIX].  On 25-Jan-2021, the patient received 0.5 mL dose (once) of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (lot number C5755AB and expiry date 07-Oct-2022) via intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due wrong vaccine administered and overdose (latency was on same day).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.