chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Throat tightness, Tryptase
Clinical narrative: Approximately 15 minutes after the vaccine administration, the patient reported numbness in mouth / jaw and difficulty swallowing. These symptoms are similar to the symptoms she had in the past after exposure to shellfish. The patient received 1 dose of epinephrine and 1 dose of diphenhydramine with improvement in symptoms. The patient subsequently went home, had recurrent symptoms, and went to a local emergency department for additional treatment. In the emergency department, she received steroids and anithistamines and symptoms resolved.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia
Clinical narrative: Approximately 15 minutes after the vaccine administration, the patient reported numbness in mouth / jaw and difficulty swallowing. These symptoms are similar to the symptoms she had in the past after exposure to shellfish. The patient received 1 dose of epinephrine and 1 dose of diphenhydramine with improvement in symptoms. The patient subsequently went home, had recurrent symptoms, and went to a local emergency department for additional treatment. In the emergency department, she received steroids and anithistamines and symptoms resolved.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Approximately 15 minutes after the vaccine administration, the patient reported numbness in mouth / jaw and difficulty swallowing. These symptoms are similar to the symptoms she had in the past after exposure to shellfish. The patient received 1 dose of epinephrine and 1 dose of diphenhydramine with improvement in symptoms. The patient subsequently went home, had recurrent symptoms, and went to a local emergency department for additional treatment. In the emergency department, she received steroids and anithistamines and symptoms resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, Muscle aches and chills
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Dec 30: Received Moderna vaccine #1  December 31:  Onset of injection site tenderness, warmth, swelling, redness  Jan 7 delayed reaction reappear at injection site-same as above (site tenderness, warmth, swelling, redness) but now  affected  area is larger and itchy  As of January 10 when composing this submission large area of swelling and redness remain while intermittent itchiness of site area
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Enlarged painful lymph nodes in axilla on arm where vaccine administered.  No
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature of 99 by 11:00 PM on 1/8, had a fever of 101.1 by 5:00 AM on 1/9, fever of 100 continued until 8:00 PM on 1/9
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis in left arm
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Bronchospasm, Fatigue
Clinical narrative: Reporting a temperature at T 100.2, fatigue and Having bronchospasm
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site inflammation
Clinical narrative: Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache.  Low grade ever lasted up to 1/8/21.  Even now still feeling  fatigue and frequent headache.  The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21.  On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache.  Low grade ever lasted up to 1/8/21.  Even now still feeling  fatigue and frequent headache.  The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21.  On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Discomfort, Dyspepsia, Dysphagia
Clinical narrative: Thursday January 7, 2021: Developed a hard lump around the injection site (A week to the day later).  Friday January 8, 2021: Arrived at work and around 9:30 felt short of breath. Had pulse and oxygen checked anyway; Pulse 99 (down from 107) and Oxygen 99. Dismissed it as being in my head. Proceeded through my day and it persevered.  After lunch, still felt short of breath. Contacted Infection Control nurse and was advised to leave work as it was also a COVID symptom.  Went home around 12:15; felt fatigued. Slept all day and night. Saturday January 9, 2021: Minor sore throat, feel as if coming down with a cold.  Back of sinuses felt hot upon breathing.  Bump at injection site gone completely (I massaged it Thursday and Friday). Minor discomfort with breathing; barely noticeable. In the afternoon time around 2pm, sudden and urgent diarrhea that lasted into the evening hours at bed.  Top of stomach burning (inside body). Diarrhea stopped, but nausea remained.  At bedtime, still felt as if coming down with a cold. Sunday January 10, 2021: Woke up feeling as if I was getting over a cold.  Nose stuffy on the side I slept on. Throughout the day, had the sniffles as the stuffiness went away.  Stomach still off; feeling nauseous.  No diarrhea (no bowel movement at all).  Throughout the afternoon tightness in chest/shortness of breath returned.  Towards the evening time still felt as if getting over a cold.  Contacted Human Resources and voice appeared hoarse. Ended phone call.  Touched my face and noticed a huge lump on my chin that felt like the lump at injection site.  Felt like a cyst. About 20 minutes later began to have difficulty swallowing; throat felt tight.  Drank a bottle of water and took two allergy pills with antihistamine.  An hour and a half after taking these,  tightness in throat is still present, but has not progressed any further; in fact, it appears to be slowly fading away.  (It's more like the feeling of having a "lump in your throat" (but I can't physically feel a lump).  The lump on my chin has noticeably diminished in size and is less painful to the touch. COVID test is scheduled for 1/11/21 at 10:30am. It feels as if my body is doing a "systems check."
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Fatigue, Injection site mass, Malaise
Clinical narrative: Thursday January 7, 2021: Developed a hard lump around the injection site (A week to the day later).  Friday January 8, 2021: Arrived at work and around 9:30 felt short of breath. Had pulse and oxygen checked anyway; Pulse 99 (down from 107) and Oxygen 99. Dismissed it as being in my head. Proceeded through my day and it persevered.  After lunch, still felt short of breath. Contacted Infection Control nurse and was advised to leave work as it was also a COVID symptom.  Went home around 12:15; felt fatigued. Slept all day and night. Saturday January 9, 2021: Minor sore throat, feel as if coming down with a cold.  Back of sinuses felt hot upon breathing.  Bump at injection site gone completely (I massaged it Thursday and Friday). Minor discomfort with breathing; barely noticeable. In the afternoon time around 2pm, sudden and urgent diarrhea that lasted into the evening hours at bed.  Top of stomach burning (inside body). Diarrhea stopped, but nausea remained.  At bedtime, still felt as if coming down with a cold. Sunday January 10, 2021: Woke up feeling as if I was getting over a cold.  Nose stuffy on the side I slept on. Throughout the day, had the sniffles as the stuffiness went away.  Stomach still off; feeling nauseous.  No diarrhea (no bowel movement at all).  Throughout the afternoon tightness in chest/shortness of breath returned.  Towards the evening time still felt as if getting over a cold.  Contacted Human Resources and voice appeared hoarse. Ended phone call.  Touched my face and noticed a huge lump on my chin that felt like the lump at injection site.  Felt like a cyst. About 20 minutes later began to have difficulty swallowing; throat felt tight.  Drank a bottle of water and took two allergy pills with antihistamine.  An hour and a half after taking these,  tightness in throat is still present, but has not progressed any further; in fact, it appears to be slowly fading away.  (It's more like the feeling of having a "lump in your throat" (but I can't physically feel a lump).  The lump on my chin has noticeably diminished in size and is less painful to the touch. COVID test is scheduled for 1/11/21 at 10:30am. It feels as if my body is doing a "systems check."
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: Thursday January 7, 2021: Developed a hard lump around the injection site (A week to the day later).  Friday January 8, 2021: Arrived at work and around 9:30 felt short of breath. Had pulse and oxygen checked anyway; Pulse 99 (down from 107) and Oxygen 99. Dismissed it as being in my head. Proceeded through my day and it persevered.  After lunch, still felt short of breath. Contacted Infection Control nurse and was advised to leave work as it was also a COVID symptom.  Went home around 12:15; felt fatigued. Slept all day and night. Saturday January 9, 2021: Minor sore throat, feel as if coming down with a cold.  Back of sinuses felt hot upon breathing.  Bump at injection site gone completely (I massaged it Thursday and Friday). Minor discomfort with breathing; barely noticeable. In the afternoon time around 2pm, sudden and urgent diarrhea that lasted into the evening hours at bed.  Top of stomach burning (inside body). Diarrhea stopped, but nausea remained.  At bedtime, still felt as if coming down with a cold. Sunday January 10, 2021: Woke up feeling as if I was getting over a cold.  Nose stuffy on the side I slept on. Throughout the day, had the sniffles as the stuffiness went away.  Stomach still off; feeling nauseous.  No diarrhea (no bowel movement at all).  Throughout the afternoon tightness in chest/shortness of breath returned.  Towards the evening time still felt as if getting over a cold.  Contacted Human Resources and voice appeared hoarse. Ended phone call.  Touched my face and noticed a huge lump on my chin that felt like the lump at injection site.  Felt like a cyst. About 20 minutes later began to have difficulty swallowing; throat felt tight.  Drank a bottle of water and took two allergy pills with antihistamine.  An hour and a half after taking these,  tightness in throat is still present, but has not progressed any further; in fact, it appears to be slowly fading away.  (It's more like the feeling of having a "lump in your throat" (but I can't physically feel a lump).  The lump on my chin has noticeably diminished in size and is less painful to the touch. COVID test is scheduled for 1/11/21 at 10:30am. It feels as if my body is doing a "systems check."
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Wheezing
Clinical narrative: 5 min - nausea 25 min- Nausea, diaphoretic, wheezing 30 min- Vitals WNL, symptoms resolving.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Rash
Clinical narrative: Chills, fatigue, rash all over my abdomen, sore arm(injections site)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin mass
Clinical narrative: A lump developed on the top of my left hand between wrist bone and pinkie finger. Noticed it about an hour after injection. No pain. Today is three days later and the lump is still there. Mild sore-type pain and occasionally feels like someone sticking pins around base of the lump. Have not seeked any medical advice.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Soreness, hot around the area of the injection.  Muscle pains
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash pruritic, Tenderness
Clinical narrative: Axillary tenderness on day 6, then gradual worsening of swelling, pain and erythema on left deltoid for a few days after. Then swelling and pain resolved but rash is spreading and now itchy.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: On the date of injection. My right arm was fine. Waited 15 mins. Everything was ok. Until 130 am at night. Woke up due to the heart palpitations and nausea that lasted 10-20 mins. Monitor the symptoms and it went away after 20 mins. Symptoms was mild.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 8 days after the first vaccine dose, I had itching, swelling, redness, and warmth at injection site on my right upper arm when I woke up in the morning. This is the first day I have had these symptoms.  The swelling and redness is about 4 inches in diameter and is very firm.  The symptoms have stayed the same all day and the swelling has not gone down yet.  I haven?t taken any medication for it or gone to a doctor yet.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: 3? Hard, painful, swollen lump at injection site.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pain in extremity
Clinical narrative: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration, day 2-3 complaint of severe headache and arm heaviness w/ pain, and no symptoms or complaints days 4-5.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Feeling jittery, Nausea
Clinical narrative: patient c/o feeling anxious, jittery and worried about vaccine. given H2), 120/80, 84, 98%  stayed on site 30 mins. no symptoms  or sob.  called next day 01/08 1042  am c/o of nausea, chills and fatigue. eating and drinking fluids instructed to call provider if symptoms get worse or 911
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Immediately after receiving the vaccine I felt fine. Around 7 pm that night I began having body aches that continually worsened throughout the night. At 2 am on Saturday I took my temperature and it was 101.6 F, at 3 am it was 102 F. The body aches, joint pain, fever, and headache continued through the next day until about 6 pm on Saturday. Also on Saturday around 12 pm I began experiencing severe nausea, abdominal pain, and dizziness. At one point it felt as if I was going to pass out. All the major symptoms finally subsided Saturday night around 6 pm. Saturday till Sunday I have felt fatigued and sore but otherwise fine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Immediately after receiving the vaccine I felt fine. Around 7 pm that night I began having body aches that continually worsened throughout the night. At 2 am on Saturday I took my temperature and it was 101.6 F, at 3 am it was 102 F. The body aches, joint pain, fever, and headache continued through the next day until about 6 pm on Saturday. Also on Saturday around 12 pm I began experiencing severe nausea, abdominal pain, and dizziness. At one point it felt as if I was going to pass out. All the major symptoms finally subsided Saturday night around 6 pm. Saturday till Sunday I have felt fatigued and sore but otherwise fine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration and no symptoms or complaints as of today.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Bad sore arm for 24 hours Possible migraine/headaches began 2-3 days later unsure if related to the vaccine. I normally don?t get migraines and it?s been lasting ever since, all day and has progressively slowly gotten worse, some very minor nausea at night from the headache. Not even Tylenol extra strength helps the pain.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Peripheral swelling, Tenderness
Clinical narrative: About five days after vaccine administration I noticed an inflammation of the area of the achilles tendon of left foot. Since I am not prone to inflammation of any sort nor did I have any strain or trauma, I took notice. I do not CHF (causing swelling of the ankles). The area of inflammation is tender, a bit red and a bit swollen. It is worrisome since I have never had anything like this in the past. I WILL NEED FOLLOW UP ON THIS. I AM UNSURE IF I SHOULD RECEIVE THE SECOND VACCINE. AND I WOULD LIKE TO KNOW IF SIMILAR INFLAMMATORY RESPONSES HAVE BEEN REPORTED, WHETHER IN ANKLE OR SOMEWHERE ELSE IN THE BODY.  I realize that this may not be a typical vaccine reaction BUT this is a brand new vaccine, has not been time-tested, is only permitted by the FDA to be administered under these emergency circumstances. SO all possible reactions must be taken seriously and recorded. We are the guinea pigs. Also. I was handed a packet of papers when I received the vaccine. To register for v-safe the only two options given for registration were smart phone browser or QR code. I do not have a cell phone. So this leaves me out of the loop, which I think is unfair and unwise. Why can computer registration not be made available, and if it can then why doesn't the instruction sheet tell of this? In rural areas not everyone has a cell phone nor is cell service available to all areas.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: I had a normal lump, red (lemon-sized), warm area surrounding the injection site.  This occurred within 2-3 days.  Within 2-3 more days, the area became more dusky and appeared to be resolving.  However, 9 days after the injection, the red area reappeared and was warm to the touch.  I called the nurse advice line for the base and they had me get it checked out.  (The only open location was the ER at a specific location.)  The ER doc advised it was an adverse reaction because it came back after resolving.  In addition, he advised to report it to the location that administered the vaccine.  I tried to do that, and they advised me to report it here.  Note: I have no health insurance and will be financially responsible for that ER visit.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. After second dose (1-2days later) numbness extended to both feet, all digits, soles, and outside foot
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Vision blurred
Clinical narrative: 30 minutes of blurred vision with flashes of light.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Tenderness and swelling at site of injection time 2 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Injection site rash, Neck pain, Pruritus
Clinical narrative: At 4:30pm on Saturday January 9, 2021 I experience a slight fever with chills and back and neck pain. Nothing alarming. I was still able to carry out my normal day activities that included cleaning, tidying, cooking. I did not check my temperature because there was no need, as I said, I could carry on with my day. My arm hurt a lot that day and there was a rectangular red rash around the injection site. That was about the weirdest part at 5:15pm today (Jan 10th, 2021). I noticed this gnarly rash on my chest and back and both shoulders. Red and a little itchy, warm to the touch. It is now 11:50pm same day and the relish has spread to under both of my breasts and down to the bottom of my back. I have pictures of the rash. No fever today. Also, I am both the patient and a member of the vaccination team at my company. My coworker and I are in charge of all admin associated with the vaccine. We are currently vaccinating all our staff. I was the first to get vaccinated in our company. And here it looks like I have an allergic reaction! I have never had an allergic reaction in the past to an injection. I just took some BENADRYL. I'll show a nurse at my clinic tomorrow. Hoping it doesn't spread anymore.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: At 4:30pm on Saturday January 9, 2021 I experience a slight fever with chills and back and neck pain. Nothing alarming. I was still able to carry out my normal day activities that included cleaning, tidying, cooking. I did not check my temperature because there was no need, as I said, I could carry on with my day. My arm hurt a lot that day and there was a rectangular red rash around the injection site. That was about the weirdest part at 5:15pm today (Jan 10th, 2021). I noticed this gnarly rash on my chest and back and both shoulders. Red and a little itchy, warm to the touch. It is now 11:50pm same day and the relish has spread to under both of my breasts and down to the bottom of my back. I have pictures of the rash. No fever today. Also, I am both the patient and a member of the vaccination team at my company. My coworker and I are in charge of all admin associated with the vaccine. We are currently vaccinating all our staff. I was the first to get vaccinated in our company. And here it looks like I have an allergic reaction! I have never had an allergic reaction in the past to an injection. I just took some BENADRYL. I'll show a nurse at my clinic tomorrow. Hoping it doesn't spread anymore.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Dysgeusia, Fatigue
Clinical narrative: Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Heart rate increased, Lymphadenopathy, Nausea
Clinical narrative: Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sensation of foreign body
Clinical narrative: Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Oropharyngeal discomfort
Clinical narrative: Flushing, lump in throat, body aches , fatigue, sore arm, increase BP , increase heart rate after 10-20 mins post vaccine, then mild headache , nausea, metallic taste, dizziness for 3 days , then developed swollen lymph nodes on left supra clavicular area , fever, chills , extreme fatigue on day 4. Increase BP for a week, my BP runs low -my baseline.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Dysgeusia, Fatigue
Clinical narrative: C/O- Feeling flush, like something in my throat  -Monitored, released from OBS area in 30 minutes
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Heart rate increased, Lymphadenopathy, Nausea
Clinical narrative: C/O- Feeling flush, like something in my throat  -Monitored, released from OBS area in 30 minutes
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test, Sensation of foreign body
Clinical narrative: C/O- Feeling flush, like something in my throat  -Monitored, released from OBS area in 30 minutes
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Oropharyngeal discomfort
Clinical narrative: C/O- Feeling flush, like something in my throat  -Monitored, released from OBS area in 30 minutes
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rubber sensitivity
Clinical narrative: About 12hrs after the vaccine was administered, I was at work and wearing nitrile gloves. After 10 minutes, the gloves began burning my hands so badly that I couldn't wear them any longer. I have never had an allergy or an adverse reaction to the gloves I was using. I washed my hands and attempted a different pair of nitrile gloves by a different manufacturer and had the same reaction. I then put on latex gloves, which still caused a burning sensation, but not to the same degree as the nitrile.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body Aches, Chills, tiredness
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Nausea
Clinical narrative: headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting 18 hours.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vertigo
Clinical narrative: headache, lightheadedness, vertigo, fever, chills, nausea, stomach cramps, tachycardia. All lasting 18 hours.
Age: 80.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Fatigue with localized soreness at site of injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Headache, Hypoaesthesia
Clinical narrative: Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date.  Information on lot/batch number has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient should have come back 8 weeks later; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 17-NOV-2020 the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). Patient should have come back 8 weeks later in approximately middle January 2021 for the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) but on 09-DEC-2020, the patient was received the dose (0.5 milliliter (unspecified route) lot # T028093 expiration date 24-APR-2022 for prophylaxis). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Auditory disorder, Back pain, Benign prostatic hyperplasia, Blindness, Colonoscopy
Clinical narrative: Infection in hand; This spontaneous report has been received from a licensed practical nurse via a lawyer, concerning a 65-year-old male patient.  The patient's medical history included chicken pox. The concurrent conditions included arthritis and degeneration of intervertebral disc. Concomitant medications were not reported.  On 15-NOV-2010 and 02-APR-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") by a license practical nurse at a physician's office (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for prophylaxis.  On an unspecified date, the patient experienced infection in hand which was considered an adverse reaction or side effect of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The outcome of the event was unknown.  The patient subsequently experienced Ophthalmic herpes zoster, blindness, sudden hearing loss, major depression, vaccination failure, skin infection, back pain, post herpetic neuralgia, chronic, obstructive coronary disease, colonoscopy, auditory disorder, benign, prostatic hyperplasia, restless legs syndrome, and herpes zoster while on therapy with Zoster Vaccine Live (ZOSTAVAX) (litigation case # 1706USA007417).; Sender's Comments:  US-009507513-1706USA007417:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Coronary artery disease, Herpes zoster, Major depression, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: Infection in hand; This spontaneous report has been received from a licensed practical nurse via a lawyer, concerning a 65-year-old male patient.  The patient's medical history included chicken pox. The concurrent conditions included arthritis and degeneration of intervertebral disc. Concomitant medications were not reported.  On 15-NOV-2010 and 02-APR-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") by a license practical nurse at a physician's office (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for prophylaxis.  On an unspecified date, the patient experienced infection in hand which was considered an adverse reaction or side effect of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The outcome of the event was unknown.  The patient subsequently experienced Ophthalmic herpes zoster, blindness, sudden hearing loss, major depression, vaccination failure, skin infection, back pain, post herpetic neuralgia, chronic, obstructive coronary disease, colonoscopy, auditory disorder, benign, prostatic hyperplasia, restless legs syndrome, and herpes zoster while on therapy with Zoster Vaccine Live (ZOSTAVAX) (litigation case # 1706USA007417).; Sender's Comments:  US-009507513-1706USA007417:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Restless legs syndrome, Skin infection, Sudden hearing loss, Vaccination failure
Clinical narrative: Infection in hand; This spontaneous report has been received from a licensed practical nurse via a lawyer, concerning a 65-year-old male patient.  The patient's medical history included chicken pox. The concurrent conditions included arthritis and degeneration of intervertebral disc. Concomitant medications were not reported.  On 15-NOV-2010 and 02-APR-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as "pneumonia") by a license practical nurse at a physician's office (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for prophylaxis.  On an unspecified date, the patient experienced infection in hand which was considered an adverse reaction or side effect of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  The outcome of the event was unknown.  The patient subsequently experienced Ophthalmic herpes zoster, blindness, sudden hearing loss, major depression, vaccination failure, skin infection, back pain, post herpetic neuralgia, chronic, obstructive coronary disease, colonoscopy, auditory disorder, benign, prostatic hyperplasia, restless legs syndrome, and herpes zoster while on therapy with Zoster Vaccine Live (ZOSTAVAX) (litigation case # 1706USA007417).; Sender's Comments:  US-009507513-1706USA007417:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: A unproperly vaccine was administered; This spontaneous report was received from a nurse referring to a 9-week-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) with a valid lot # S013439, expiration date reported as 03-MAR-2021, 2 mL, orally for prophylaxis. On 16-DEC-2020, the vaccine experienced a temperature excursion of 0.38 °C for 4 hours and 45 minutes and 11.09 °C for 1 hour and 30 mins. Previous temperature excursion of 17.52°C for 2 hours and 42 minutes. There was data logger involved.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Excursion - vaccine; Information has been received from a registered nurse concerning to a 12 month old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 21-DEC-2020, the patient was vaccinated with excursion temperature (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. T017688, exp. date 21-MAY-2022), 0.5 milliliter for prophylaxis.    Temperature: -13.3C Timeframe: 4 hours and 15 minutes Previous temperature excursion: No Call because of data logger
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE details available at this time; Caller reported temperature excursion. / Temperature -1 3.3C; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 17-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021638 and expiration date as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for a time frame of 4 hours and 15 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013095: US-009507513-2012USA013584: US-009507513-2012USA013603: US-009507513-2012USA013093:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No other AE details available at this time; Caller reported temperature excursion. / Temperature -1 3.3C; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 24-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021638 and expiration date reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for a time frame of 4 hours and 15 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013095: US-009507513-2012USA013596: US-009507513-2012USA013584: US-009507513-2012USA013095:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered; No other AE details available; This spontaneous report was received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.     On 04-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant human albumin (rHA) (strength and route of administration were not reported; lot# was T021638 and expiration date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021) 0.5 milliliter for prophylaxis, which experienced temperature excursion (product storage error).   No other adverse event (AE) details available at this time. The vaccine underwent temperature excursion of -13.3 degree Celsius for 4 hours 15 minutes. There were no previous temperature excursions. The digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Herpes zoster, Neuralgia
Clinical narrative: The product gave the patient shingles, on the right side all the way down, including her groin, front, and back of the legs. Then it travelled to the left side of her body; Her eye was twitching; This spontaneous information has been received from a female patient of unknown age, concerning herself via Agency. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On 14-JAN-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced shingles, on the right side all the way down, including her groin, front and back of the legs, then it travelled to the left side of her body (herpes zoster). On 03-DEC-2020, her eye was twitching (eye movement disorder) and the shingles travelled down her arm and shoulders. It was reported that it had been a severe thing and they would try a new technique in the center of her nervous system. They wanted to put six rods in her body and she would received tapentadol hydrochloride (NUCYNTA) in the emergency room (ER) until she could get the procedure done for the nerve pain she had. At the time of this report, the patient had not recovered from the adverse events.  The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX). The causal relationship between eye movement disorder and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This spontaneous report was received from a lawyer concerning a case in litigation and refers to currently 70 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.      On or about 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.         On an unknown date (reported as "subsequently"), the patient experienced bell's palsy (facial paralysis), and was treated with unspecified medications.      The outcome of facial paralysis was unknown.     The reporter considered facial paralysis to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of bell's palsy was considred medically significant.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation, concerning a currently 79-year-old patient (pt) of unknown gender. The pt's medical history, concurrent conditions, and concomitant medications were not reported.   On or about 10-JUN-2015, the pt was administered zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and herpes zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "subsequently"), the pt was treated by a health care provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster. The pt claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of the event was unknown. The reporter considered herpes zoster to be related to the suspect vaccine.
Sex: F
Vaccine: PPV, UNK
Symptoms: Anaphylactic reaction, Cyst, Cyst removal
Clinical narrative: She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically remove; anaphylactic reaction to Pneumovax; This spontaneous report as received from a 68 years old female retired medic via Pfizer referring to herself. The patient had a significant allergies to food related, nitrate plants and medications. The patient was allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, egg albumin, aluminum, baclofen, diphenhydramine hydrochloride (BENADRYL), benzene (BENZOL), clindamycin, and so on. The patient had an allergic reaction to egg component of influenza virus vaccine (unspecified). The patient was immunocompromised and had multiple sclerosis. The patient was taking immunosuppressants and interferon beta-1a (AVONEX).  In approximately January 2011 (reported as 10 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.  In approximately January 2011 (reported as 10 years ago), the patient had an anaphylactic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient received self medicating with an antihistamine. On an unknown date, the patient had a cyst develop on her arm from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine that had to be surgically removed. The outcome of anaphylactic reaction and cyst was unknown. The reporter considered the causal relationship between anaphylactic reaction and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related. The causality assessment between cyst and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, anaphylactic reaction was determined to be medically significant.
Sex: F
Vaccine: PPV, UNK
Symptoms: Anaphylactic reaction, Cyst removal, Vaccination site cyst
Clinical narrative: She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically remove; anaphylactic reaction to Pneumovax; This spontaneous report as received from a 68 years old female retired medic via Pfizer referring to herself. The patient had a significant allergies to food related, nitrate plants and medications. The patient was allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, egg albumin, aluminum, baclofen, diphenhydramine hydrochloride (BENADRYL), benzene (BENZOL), clindamycin, and so on. The patient had an allergic reaction to egg component of influenza virus vaccine (unspecified). The patient was immunocompromised and had multiple sclerosis. The patient was taking immunosuppressants and interferon beta-1a (AVONEX).  In approximately January 2011 (reported as 10 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.  In approximately January 2011 (reported as 10 years ago), the patient had an anaphylactic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient received self medicating with an antihistamine. On an unknown date, the patient had a cyst develop on her arm from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine that had to be surgically removed. The outcome of anaphylactic reaction and cyst was unknown. The reporter considered the causal relationship between anaphylactic reaction and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related. The causality assessment between cyst and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, anaphylactic reaction was determined to be medically significant.