chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after getting the booster dose and these were worse than the 1st and 2nd doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses). At the time of the report, VACCINATION COMPLICATION (side effects after getting the booster dose and these were worse than the 1st and 2nd doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-404967, MOD-2021-426874 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inflammation, Insomnia, Muscle twitching
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), PAIN (all the arm aching, and it got worse), INFLAMMATION (maybe there is inflammation inside?), INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice) and NERVE INJURY (feels like nerve damage) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 039B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2021. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced PAIN (all the arm aching, and it got worse). On 15-Dec-2021, the patient experienced INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice). In December 2021, the patient experienced PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), INFLAMMATION (maybe there is inflammation inside?), NERVE INJURY (feels like nerve damage), MUSCLE TWITCHING (little twitches inside the arm from shoulder to elbow), PAIN (really painful), TENDERNESS (it was tender at first, but not now), FEELING ABNORMAL (felt tired and a little crappy for a day) and FATIGUE (felt tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. In December 2021, FEELING ABNORMAL (felt tired and a little crappy for a day) and FATIGUE (felt tired) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), PAIN (all the arm aching, and it got worse), INFLAMMATION (maybe there is inflammation inside?), INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice), NERVE INJURY (feels like nerve damage), MUSCLE TWITCHING (little twitches inside the arm from shoulder to elbow), PAIN (really painful) and TENDERNESS (it was tender at first, but not now) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication taken were birth control. For treatment patient used ice. Patient also reported that hot shower made it worse. Patient did not have headache. This case was linked to MOD-2021-426881, MOD-2021-426691, MOD-2021-426905 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Pain in extremity, Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), PAIN (all the arm aching, and it got worse), INFLAMMATION (maybe there is inflammation inside?), INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice) and NERVE INJURY (feels like nerve damage) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 039B21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2021. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced PAIN (all the arm aching, and it got worse). On 15-Dec-2021, the patient experienced INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice). In December 2021, the patient experienced PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), INFLAMMATION (maybe there is inflammation inside?), NERVE INJURY (feels like nerve damage), MUSCLE TWITCHING (little twitches inside the arm from shoulder to elbow), PAIN (really painful), TENDERNESS (it was tender at first, but not now), FEELING ABNORMAL (felt tired and a little crappy for a day) and FATIGUE (felt tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. In December 2021, FEELING ABNORMAL (felt tired and a little crappy for a day) and FATIGUE (felt tired) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm has been with excruciating pain ever since shot/ pain inside the arm/ it aches inside), PAIN (all the arm aching, and it got worse), INFLAMMATION (maybe there is inflammation inside?), INSOMNIA (waking up at night because of the pain/last night 4am she woke up and had to put ice), NERVE INJURY (feels like nerve damage), MUSCLE TWITCHING (little twitches inside the arm from shoulder to elbow), PAIN (really painful) and TENDERNESS (it was tender at first, but not now) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication taken were birth control. For treatment patient used ice. Patient also reported that hot shower made it worse. Patient did not have headache. This case was linked to MOD-2021-426881, MOD-2021-426691, MOD-2021-426905 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Tenderness, Vaccination complication
Clinical narrative: a lot of side effects/felt like covid; feeling dreadful for a weekend; arm tenderness; horrible headache; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a lot of side effects/felt like covid), FEELING ABNORMAL (feeling dreadful for a weekend), TENDERNESS (arm tenderness), HEADACHE (horrible headache) and FATIGUE (exhaustion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A, 005C21A and 939903) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (a lot of side effects/felt like covid), FEELING ABNORMAL (feeling dreadful for a weekend), TENDERNESS (arm tenderness), HEADACHE (horrible headache) and FATIGUE (exhaustion). At the time of the report, VACCINATION COMPLICATION (a lot of side effects/felt like covid), FEELING ABNORMAL (feeling dreadful for a weekend), TENDERNESS (arm tenderness), HEADACHE (horrible headache) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she experienced the longest and worst side effects with the first dose. Concomitant medications include Birth control. Treatment medications include Aleve.   This case was linked to MOD-2021-426881, MOD-2021-426691, MOD-2021-426900 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dysphagia, Dyspnoea, Feeling abnormal, Rash
Clinical narrative: Rash all over body, increased blood pressure, couldn't breath or swallow. Or talk. Felt weird
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Rash all over body, increased blood pressure, couldn't breath or swallow. Or talk. Felt weird
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Paraesthesia, Rash
Clinical narrative: Muscle pain in legs  Joint pain in legs Rash Tingling
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Adverse event presenting to pharmacist as Severe Hives/itching starting day 10 post booster vaccine. Hives are intermittent/continuous 24 hours a day and have lasted since day 10, now on day 4.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Swelling face
Clinical narrative: Facial swelling, pain and bruising in area where previous received derma-fillers. Injections were over a year ago. Some more that 2.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph nodes under arms. Pain and swelling began under left arm and moved to both mid-day 12/30/2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Chills, Fatigue
Clinical narrative: Extreme fatigue, headache, shivering/chills, night sweats, and muscle aches/soreness especially back and legs. Some joint pain in hips and ankles.  These started the next morning after vaccination. The next day I had several nightmares. And started to have a stabbing pain that I could feel in my chest and the same location in my back (like someone stabbing me from my back through to my chest)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia, Night sweats, Nightmare, Pain in extremity
Clinical narrative: Extreme fatigue, headache, shivering/chills, night sweats, and muscle aches/soreness especially back and legs. Some joint pain in hips and ankles.  These started the next morning after vaccination. The next day I had several nightmares. And started to have a stabbing pain that I could feel in my chest and the same location in my back (like someone stabbing me from my back through to my chest)
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal discomfort, Pruritus
Clinical narrative: Within minutes of vaccination, itching of cheeks and chin; then fullness in throat and sensation of difficulty swallowing.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: I am not sure exactly when I started getting the side effect but it was not immediately after the booster. I would say 7-10 days after the booster. The date I noted is approximate.  I am getting an itch all over my body but mostly on my back and legs. Even my scalp, fingers, toes and bottom of my feet too. It itches more if I wear tight clothes. For example, when I wear a bra I get an intense itch and redness where the elastic touches my skin. When I scratch my skin becomes very red and welts. I can clearly see where I scratched. I think the condition is called Dermatographia. I've never experienced this before.  An urgent care center prescribed me hydrocortisone cream to spot treat the itch. I am not using because calamine lotion helps. They also advised that I take Aleve during the day and Benadryl at night. I've been doing this for the past 3 days and it prevents the itch most of the day. When the meds wear out the itch comes back with the same intensity. It has not improved since it began.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives all over body 2 days following 2nd dose of Pfizer.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Client received first Moderna cover vaccine and received 2nd Pfizer vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Oligomenorrhoea, Ultrasound scan
Clinical narrative: Heavy menstrual period about two weeks after first vaccine dose. It was a continuous period until 7 months later, doctor prescribed megace 40mg to stop menstrual period. Still ongoing treatment and not sure if issue is resolved at this time.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Heart rate increased, Insomnia, Stress
Clinical narrative: Woke up with the feeling of my heart fluttering or beating fast and felt slightly out of breath.  Had to focus on relaxing and taking deeper breaths to alleviate it.  Found it difficult to sleep that night.  I had never experience this feeling before.    Several times since then, I have felt the same sensation and it seems to coincide with higher stress at work, but I've never had this sensation before I had the vaccine from stress or otherwise.
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Throat irritation
Clinical narrative: 5 minutes following vaccine administration, developed itchy throat, which of 2 hour duration. Resolved without treatment.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Pain in extremity, Palpitations
Clinical narrative: Had typical sore arm, tired, and shivers. However between the first and second vaccine and after the second vaccine I have on and off rapid heartbeat/palpitations
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Pain in extremity
Clinical narrative: Severe pain in the left foot (tarsals area), very weak and I wasn't able to walk it and it lasted for a day.  I applied cold compressed and it helped with the pain.  I was able to walk the next day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Computerised tomogram, Diarrhoea, Dizziness
Clinical narrative: 12/18  1500 onset of nausea 1730 onset of chills (temp not recorded) 1800 onset of extreme fatigue 2000 temperature measured at 100.7  12/19 0145 onset of vomiting (3x over 2 hours) 0155 onset of diarrhea (>10x over 12 hours) 0220 lightheadedness/feeling faint 0245 temperature measured at 100.3 0900 admitted to ER (local HCF) IV fluids and zofran administered CT scan More zofran Discharged from ER
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Influenza virus test, Metabolic function test, Nausea
Clinical narrative: 12/18  1500 onset of nausea 1730 onset of chills (temp not recorded) 1800 onset of extreme fatigue 2000 temperature measured at 100.7  12/19 0145 onset of vomiting (3x over 2 hours) 0155 onset of diarrhea (>10x over 12 hours) 0220 lightheadedness/feeling faint 0245 temperature measured at 100.3 0900 admitted to ER (local HCF) IV fluids and zofran administered CT scan More zofran Discharged from ER
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, SARS-CoV-2 test, Urine analysis, Vomiting
Clinical narrative: 12/18  1500 onset of nausea 1730 onset of chills (temp not recorded) 1800 onset of extreme fatigue 2000 temperature measured at 100.7  12/19 0145 onset of vomiting (3x over 2 hours) 0155 onset of diarrhea (>10x over 12 hours) 0220 lightheadedness/feeling faint 0245 temperature measured at 100.3 0900 admitted to ER (local HCF) IV fluids and zofran administered CT scan More zofran Discharged from ER
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Extreme back pain. Burning pulsating pain in all joints. Tingling in wrists, ankles and legs. Fever, chills, muscle pain and swollen lymph nodes.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Extreme back pain. Burning pulsating pain in all joints. Tingling in wrists, ankles and legs. Fever, chills, muscle pain and swollen lymph nodes.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had no adverse reaction after 15 minute waiting period in the pharmacy. Pharmacy staff will follow up with patients parents in future.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Dermatographia And hives started about 12days later. Been taking Allegra which has offered mild relief.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Urticarial skin rash started approximately 2-3 hours after booster dose administered. This did not happen with the first two Pfizer doses she received.  There were no new exposures in household or personal care products, no unusual foods ingested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Periarthritis
Clinical narrative: Patient had ongoing shoulder pain after injection, lasted until she presented 11/11/21. Exam consistent with bursitis vs adhesive capsulitis.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Since receiving the vaccine I have experienced a constant ringing in my right ear (that I did not have prior).  I also get headaches at the base of my skull that I did not have prior to receiving the vaccine.  I was hoping these side effects would subside over time but they have not.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Protein S increased, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: Just wanted to report that in March after my J & J vaccine I tested my blood and never got more than a count of 55 spike proteins, i was advised to mix and match and get one shot of Pfiezer, which I did on August 20.  The next day I was spotting vaginally for two days, after not having had my period for 8 years!  Two and a half months later, I had the same experience dark blood spotting, and then had a clear watery liquid for 3 days almost like wetting. Was not urine, was vaginal.  Doctor wants me to have endometrial test, I understand that I am not alone in this. Can you put me in touch with a study group or researchers?  Thank you.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Local reaction, Myalgia, Vaccination site erythema
Clinical narrative: local reaction with severe site pain, erythema, blister formation. Systemic symptoms of being tired, achy muscles
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: local reaction with severe site pain, erythema, blister formation. Systemic symptoms of being tired, achy muscles
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Anxiety, Bowel movement irregularity, Constipation, Ear discomfort
Clinical narrative: I full on started a menstrual cycle I believe a few days after injection. I went through all of the normal side effects including vomiting, and went into work three days after said injection. Shortly after, I started spotting, and now I appear to be having my full on period even though I am on birth control. I have also felt very tired, and I ended up sleeping all day today 12/30/2021. I also believe I was constipated for a period of 3-4 days which is unusual for me having a history of Crohn's. I have had a ton of prolonged bowel movements over the past two days. As of tonight, I have now developed the strangest sensation of enhanced hearing of low frequencies. I believe it is only in my right ear, but here is the following description I gave my mother: "idk what is going on, but tonight I have been hearing like, bass sounds over-amplified in my ear? like, walking sounds from upstairs and sometimes vehicles and the music from the bar across the st are abnormally loud. I can hear normal sounds fine enough though? maybe slightly muffled.... my ears do feel "full" though if I focus on it. hopefully it's gone tomorrow but it's fairly jarring to hear sounds that you should not normally be able to hear well heard OVER normal sounds. it's like I have super hearing for sounds no wants wants to hear lol. it would be cool if it was in normal hearing range, like voices, but instead it's like BOOM. someone took a single step nearby." I do not know if this is vax related, but I figured it should be included as it is something that happened shortly after with the constipation and odd super early period. I am hoping it will be gone tomorrow, but I have included it as an adverse event that is currently affecting me as I worry it may be some sort of swelling.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperacusis, Hypoacusis, Impaired work ability, Intermenstrual bleeding
Clinical narrative: I full on started a menstrual cycle I believe a few days after injection. I went through all of the normal side effects including vomiting, and went into work three days after said injection. Shortly after, I started spotting, and now I appear to be having my full on period even though I am on birth control. I have also felt very tired, and I ended up sleeping all day today 12/30/2021. I also believe I was constipated for a period of 3-4 days which is unusual for me having a history of Crohn's. I have had a ton of prolonged bowel movements over the past two days. As of tonight, I have now developed the strangest sensation of enhanced hearing of low frequencies. I believe it is only in my right ear, but here is the following description I gave my mother: "idk what is going on, but tonight I have been hearing like, bass sounds over-amplified in my ear? like, walking sounds from upstairs and sometimes vehicles and the music from the bar across the st are abnormally loud. I can hear normal sounds fine enough though? maybe slightly muffled.... my ears do feel "full" though if I focus on it. hopefully it's gone tomorrow but it's fairly jarring to hear sounds that you should not normally be able to hear well heard OVER normal sounds. it's like I have super hearing for sounds no wants wants to hear lol. it would be cool if it was in normal hearing range, like voices, but instead it's like BOOM. someone took a single step nearby." I do not know if this is vax related, but I figured it should be included as it is something that happened shortly after with the constipation and odd super early period. I am hoping it will be gone tomorrow, but I have included it as an adverse event that is currently affecting me as I worry it may be some sort of swelling.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Somnolence, Tinnitus, Vomiting
Clinical narrative: I full on started a menstrual cycle I believe a few days after injection. I went through all of the normal side effects including vomiting, and went into work three days after said injection. Shortly after, I started spotting, and now I appear to be having my full on period even though I am on birth control. I have also felt very tired, and I ended up sleeping all day today 12/30/2021. I also believe I was constipated for a period of 3-4 days which is unusual for me having a history of Crohn's. I have had a ton of prolonged bowel movements over the past two days. As of tonight, I have now developed the strangest sensation of enhanced hearing of low frequencies. I believe it is only in my right ear, but here is the following description I gave my mother: "idk what is going on, but tonight I have been hearing like, bass sounds over-amplified in my ear? like, walking sounds from upstairs and sometimes vehicles and the music from the bar across the st are abnormally loud. I can hear normal sounds fine enough though? maybe slightly muffled.... my ears do feel "full" though if I focus on it. hopefully it's gone tomorrow but it's fairly jarring to hear sounds that you should not normally be able to hear well heard OVER normal sounds. it's like I have super hearing for sounds no wants wants to hear lol. it would be cool if it was in normal hearing range, like voices, but instead it's like BOOM. someone took a single step nearby." I do not know if this is vax related, but I figured it should be included as it is something that happened shortly after with the constipation and odd super early period. I am hoping it will be gone tomorrow, but I have included it as an adverse event that is currently affecting me as I worry it may be some sort of swelling.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Developed itchy hives all over my body 9 days after getting my Moderna Booster shot. They were constantly appearing and very uncomfortable. After a few days I had a virtual doctors visit and was prescribed prednisone and antihistamines. The prednisone helped while taking it, but after I was finished the hives came back. This time it wasn?t as random, but when something rubs, brushes, or scratches my skin. This has continued for the past month now.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiac flutter, Chills, Cold sweat, Cough
Clinical narrative: Headache started immediately following injection  2 and booster. Also after booster within 2 days slight fever/chills/continued headache.  Day 5 skin clammy, epigastric pain, chest flutter, cough
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Pyrexia
Clinical narrative: Headache started immediately following injection  2 and booster. Also after booster within 2 days slight fever/chills/continued headache.  Day 5 skin clammy, epigastric pain, chest flutter, cough
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Heart rate increased, Nausea
Clinical narrative: Chills, rapid, pounding heart rate, chest pain, cough (when taking a deep breath) and nausea. Resting heart rate almost 40 beats more than usual baseline heart rate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Chills, rapid, pounding heart rate, chest pain, cough (when taking a deep breath) and nausea. Resting heart rate almost 40 beats more than usual baseline heart rate.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I have taken Moderna booster 3rd dose and the seasonal flu shot on the same date and time on two different arms at a pharmacy.   I am relatively healthy individual and never in the life had allergies or issues with any medication.   After a week or so upon the Moderna booster shot, I have been noticing a medium to severe itchiness all around the body - head to toes, including the palms. I also have hives.   Hives and itching temporarily stops when I take over the counter antihistamines, but again itching would get worsen within days after stopping to take antihistamines. It is little over a month now. Not a very severe or a life threatening condition.   Initially I thought itching was related to my international travel, but I returned back to US and still the itching not stopped.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Cardiac failure, Chest X-ray, Magnetic resonance imaging
Clinical narrative: HEART  FAILURE AFTER VACCINE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: HEART  FAILURE AFTER VACCINE
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Factor II mutation, Gene mutation identification test positive, Pulmonary embolism, Superficial vein thrombosis, Varicocele
Clinical narrative: Developed superficial thrombus in varicocele in left testicle, followed by multiple pulmonary embolisms.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever and chills lasting approximately 2-3 hours that occurred approximately 12 hours after receiving the booster.  During that timeframe episode, I also experienced several rounds of diarrhea and one round of simultaneous diarrhea and vomiting. Arm soreness also increased around this time and had been milder earlier in the day.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Tenderness
Clinical narrative: Right axilla swelling tenderness and constant pain due to probable lymph node swelling treated with ibuprofen but it?s not really helping
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Prenatal screening test, Ultrasound foetal abnormal, Uterine dilation and curettage
Clinical narrative: Got the vaccine on sept 27 and october 18 without realizing i got pregnant a week after i got my first dose. I was concerned. I did the Nipt test at 11wks. On my 12wks ob appt and ultrasound was the same day i got the result back- trisomy 22, baby had no heartbeat and stopped growing during ultrasound. Needless to say, i had a miscarriage and did d&c.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Mobility decreased, Muscular weakness, Oedema peripheral
Clinical narrative: Extreme body pain and lymph node swelling. Unable to move.  Left armpit (vaccine administered on left arm) so swollen as to be bruised. Body aches and muscle weakness due to pain extreme.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme body pain and lymph node swelling. Unable to move.  Left armpit (vaccine administered on left arm) so swollen as to be bruised. Body aches and muscle weakness due to pain extreme.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; temperature excursions; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 19-NOV-2021, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, and route were unknown; lot #T031820, has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 10-MAY-2022) for prophylaxis following a temperature excursion (product storage error). The reporter did not have any cycling information available, so there wasn't sufficient time and temperature data for evaluation. There was no previous temperature excursion. No adverse event was reported.       This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA005964:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got vaccine and got shingles/Suspected vaccination failure; Got shingles; Pain was so bad; This case was reported by a consumer via interactive digital media and described the suspected occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with analgesic, nos (Pain Medicine (Medication Unknown)). On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said Shingles vaccine did not work, got vaccine and got shingles.  The reporter said same as COVID vaccine, reporter's son in law had all COVID shots and got it.  The reporter was not against vaccines, had all just saying, sometimes they did not work. The patient got the shot for Shingles and still got it, the pain was so bad, needed pain medicines to help with it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Skin reaction; This case was reported by a pharmacist via call center representative and described the occurrence of skin reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that a patient received a dose of Shingrix and had skin reaction. The reporter reported that patient's demographic details were collected while pharmacist was talking only about gender and mentioned skin reaction since he/she did not know further information. The pharmacist was on a hurry and the call got disconnected while trying to reach the patient was on the other line. Pharmacist's first and last name was asked but he put reporter on hold instead of providing this information. The reporter did not consent to follow-up.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This spontaneous report received from a patient concerned an 81-year-old female of unspecified ethnicity. The patient's weight was 180 pounds, and height was 66 inches. The patient's concurrent conditions included: seasonal allergies, no alcohol use, and nonsmoker. The patient no medical history. The patient was previously treated with covid-19 vaccine (dose number is series 1) (suspension for injection, route of admin not reported, and batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The reporter did not report any adverse events following vaccination with covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-NOV-2021, the patient went to the emergency room and was diagnosed with blood clot (thrombosis in her left leg) (dose number in series 2). The patient was treated in the emergency room at hospital and was discharged on the same day. The patient was treated with blood thinners and the clot had resolved and everything was fine. It took couple weeks to resolve. The action taken with covid-19 vaccine was not applicable. The patient recovered from thrombosis in left leg/blood clot in an unspecified date in DEC-2021.This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211258312-COVID-19 VACCINE Thrombosis in left leg. 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: Adverse event, Ultrasound scan vagina
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: serious lung cancer (2002), breast cancer (2007), heart condition and endometriosis, and other pre-existing medical conditions included: patient had history of fertility treatments for 8 years in 1960s. The patient was not pregnant at the time of reporting. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of administration was not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. Five days after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 1), on 14-APR-2021, the patient began bleeding vaginally and she was not sure if it came out from feet or vaginal area. She called ambulance on morning of 14-APR-2021 and in the middle of night. She was not able to stand up. The patient had bleeding again on an unspecified date, was admitted to the hospital on 20-APR-2021, stayed with 4 doctors for 9 days and received a blood transfusion. After hospitalization, the patient also went to rehab center. The bleeding resolved after the hospital stay and patient had two transvaginal ultrasounds, the second being only a few weeks ago, with appearing normal results. The results of the first transvaginal ultrasound scan was not reported. The patient recovered from vaginal bleeding on an unspecified date in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of administration was not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on an unspecified date in DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series: 2), the patient experienced unspecified adverse event, and was hospitalized (date unspecified). Duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient was linked to 20210942041 (Dose number in series: 1).; Sender's Comments: V0:20211259260-COVID-19 VACCINE AD26.COV2.S-Unspecified adverse event. 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).
Age: 23.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Headache, Mobility decreased
Clinical narrative: ANKYLOSING SPONDYLITIS FLARE-UP; HEADACHE; LIMITING MOBILITY BEFORE NEXT INJECTION; This spontaneous report received from a consumer concerned a 23 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 20-AUG-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled injector, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On OCT-2021, the patient experienced limiting mobility before next injection. On an unspecified date, the patient experienced ankylosing spondylitis flare-up, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, recovered with sequelae from ankylosing spondylitis flare-up, and the outcome of limiting mobility before next injection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211259731-COVID-19 VACCINE AD26.COV2.S-Ankylosing spondylitis flare-up. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Intracardiac thrombus
Clinical narrative: BLOOD CLOT IN THE HEART; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in the heart, as per reporter "Meanwhile we have become your lab rats. I have already lost a relative to your experimental gene therapy. A blood clot in the heart. All my other unvaccinated relatives who got Covid are alive and well today. This is like playing roulette with a needle. Because they are using this experimental gene therapy on the public now to vacinnate for Covid. The problem is it has harming people with heart conditions and killing them. My relative died recently from a blood clot in the heart after being vaccinated. They do not know the harmful side effects or are not releasing it. They already said they will not release the data they have on this for 75 years. Why? What are they afraid of?". It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot in the heart on an unspecified date. This report was serious (Death). This case is a duplicate of 20211260756.; Sender's Comments: V0: 20211261187- covid-19 vaccine ad26.cov2.s -blood clot in the heart. 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: BLOOD CLOT IN THE HEART
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19. The patient was fighting with covid and vaccine did not work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209315.; Sender's Comments: V0:   20211263429-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccination 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
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: low grade fever (normally 97 point something and yesterday it was 99.5°F); really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127), FEELING ABNORMAL (didn't feel well) and PYREXIA (low grade fever (normally 97 point something and yesterday it was 99.5°F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068J21A, 019B21A and 016C21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (ESTROGEN) and PROGESTERONE for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEART RATE INCREASED (really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127) and FEELING ABNORMAL (didn't feel well). On 28-Dec-2021, the patient experienced PYREXIA (low grade fever (normally 97 point something and yesterday it was 99.5°F)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 28-Dec-2021, PYREXIA (low grade fever (normally 97 point something and yesterday it was 99.5°F)) had resolved. At the time of the report, HEART RATE INCREASED (really high erratic heart beat/ heart rate was over 120. At one point 150 and, while walking up the stair, 170/heart rate is 127) and FEELING ABNORMAL (didn't feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Body temperature: 99.5 degree f (High) High; 99.5 degree F. On an unknown date, Heart rate: 71-72 (normal) Resting heart rate; 71-72, 120 (High) Heart rate while riding bike: 120, 120-150 (High) Heart rate while sleeping: 120-150, 170 (High) Heart rate when going up stairs: 170 and 127 (High) 127; High.         Patient would not have noticed the heart rate if it was not for the watch   This case was linked to MOD-2021-431997 (Patient Link).