chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination site erythema
Clinical narrative: On Jan . 19, Exactly one week after vaccine (part 1)  vaccine site developed a nickel size red area and about 1 1/2 inch above vaccine site a 2 inch red, hot, itchy patch appeared on my right shoulder. .  There had been no discoloration prior to this . I applied a clean cold wet washcloth to shoulder  area. For about an hour. That stopped itch. Next morning area still looked and felt the same-red, hot, itchy. I again applied clean cold washcloth to shoulder area. For about 30 minutes.  Then applied an over counter cream ( hydrocortisone 1% plus) just to shoulder area.  Used the cream again just before bed that Wednesday night and again Thursday night, only on shoulder. Itching stopped and did not resume. Redness and heat on rash faded each day until completely gone by Sunday January 24th., total of 6 days.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: 1545 PATEINT TOLD DAUGHTER SHE "FEELS LIKE SOMETHING IS IN HER THROAT" PATIENT IS SUCKING ON COUGH DROP AND IS ABLE TO SWALLOW. PATIENT IS ALERT AND ORIENTED X3. SPEAKING. 1610 PATIENT TOLD DAUGHTER SHE WAS OK TO GO HOME. PARAMEDIC INSTRUCTED DAUGHTER TO CALL 911 IF PATIENT STARTS FEELING SHORT OF BREATH OR IS UNABLE TO SWALLOW. PATIENT CONTI ES TO BE ALERT WITH ON DISTRESS NOTED
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Pharyngeal swelling, Swollen tongue
Clinical narrative: 4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: 1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down arm 0830 nausea, vomiting 0900 fever, tylenol and ibuprofen 1300 afebrile 1/30/21 - current (2/1/21) increased fatigue, muscle aches, loss of appetite, swollen axillary lymph nodes have persisted
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: 1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down arm 0830 nausea, vomiting 0900 fever, tylenol and ibuprofen 1300 afebrile 1/30/21 - current (2/1/21) increased fatigue, muscle aches, loss of appetite, swollen axillary lymph nodes have persisted
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Pink rash approximately 3 inches wide and 5 inches long on left deltoid appeared day following injection, area was warm to touch for 3 days, then rash remained until 1/29/2021.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abscess, Diverticulitis, Intestinal perforation, Pyrexia
Clinical narrative: On the evening following COVID-19 vaccine, patient had mild fever and experienced mild epigastric and bilateral upper quadrant pain.  Pain continued and patient presented to the ED on 1/31/2021 with  epigastric pain.  Final diagnosis appears to be acute diverticulitis with microperforation and early abscess formation.  No physician notes document that the two events are related; however timing is close.  Patient does not have a history of gallbladder disease, abdominal disease, etc.  Patient is currently admitted and followed by general surgeon.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Dyspepsia, Dyspnoea, Electrocardiogram ST segment elevation
Clinical narrative: pt presents with mid epigastric chest burning x1 hour after breakfast, 21 yo M w/ no known chronic medical conditions, presents w/ 2 hours MEG/central chest burning. Initial a/w mild SOB and LH; by time of my eval, LH/SOB had resolved and CP was 4/10. Pts sx completely resolved w/ GI cocktail. No exertional sx. No recent infectious sx.  VS w/o acute abn. Well-appearing, NAD. Normal CV exam; no edema. LCTAB.   PT  transferred for troponemia.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lipase normal, Metabolic function test normal, Myocarditis, Troponin increased
Clinical narrative: pt presents with mid epigastric chest burning x1 hour after breakfast, 21 yo M w/ no known chronic medical conditions, presents w/ 2 hours MEG/central chest burning. Initial a/w mild SOB and LH; by time of my eval, LH/SOB had resolved and CP was 4/10. Pts sx completely resolved w/ GI cocktail. No exertional sx. No recent infectious sx.  VS w/o acute abn. Well-appearing, NAD. Normal CV exam; no edema. LCTAB.   PT  transferred for troponemia.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: pt presents with mid epigastric chest burning x1 hour after breakfast, 21 yo M w/ no known chronic medical conditions, presents w/ 2 hours MEG/central chest burning. Initial a/w mild SOB and LH; by time of my eval, LH/SOB had resolved and CP was 4/10. Pts sx completely resolved w/ GI cocktail. No exertional sx. No recent infectious sx.  VS w/o acute abn. Well-appearing, NAD. Normal CV exam; no edema. LCTAB.   PT  transferred for troponemia.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactoid reaction, Blood pressure decreased, Cough, Dizziness, Fatigue
Clinical narrative: Anaphylactic  type reactions such as dizziness,  cough and throat swelling, BP drop - happened slowly within 1 hour with antihistamines taken 1 hour prior to injection ( Chlorphenerimine 4 mg, Pepcid 20 mg  tabs) Swelling of feet, hands, face in 1.5 hours. Used Flucatisone nasal spray x2 , albuterol puffs x 2 and pseudophed 15 mg tablet Continued to use Antihistamines for 3 - 4 days post injection for rash and swelling. VERY FATIGUED for 3 days.  Rash over trunk of body for 7- 10 days post injection
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Rash, SARS-CoV-2 antibody test positive, Swelling face
Clinical narrative: Anaphylactic  type reactions such as dizziness,  cough and throat swelling, BP drop - happened slowly within 1 hour with antihistamines taken 1 hour prior to injection ( Chlorphenerimine 4 mg, Pepcid 20 mg  tabs) Swelling of feet, hands, face in 1.5 hours. Used Flucatisone nasal spray x2 , albuterol puffs x 2 and pseudophed 15 mg tablet Continued to use Antihistamines for 3 - 4 days post injection for rash and swelling. VERY FATIGUED for 3 days.  Rash over trunk of body for 7- 10 days post injection
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, itchy, painful, hot lump about 4 inches under the skin at injection site one week after receiving the shot
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Took nap at 4PM and woke at 6PM with one of the worst headaches I have ever had. There is some tenderness at site on left arm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia oral
Clinical narrative: Tingling around mouth and tongue. Body aches the whole next day.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Rash pruritic
Clinical narrative: On 1-26-2021, he presented to ED after waking up at 1AM with lip swelling and diffuse itchy rash.  Rash involved both forearms, scalp, chest, abdomen, back, and legs.  He took 50 mg of Benadryl at home, but woke up with worsened symptoms.  Denied unusual foods, soaps, detergents, colognes, or medications.   Patient denied shortness of breath, throat or intraoral swelling or pain, chest pain, palpitations, cough, sore throat, nasal congestion, rhinorrhea, fever, chills, loss of sense of taste or smell, abdominal pain, n/v, diarrhea or dysuria.    Patient was treated with epinephrine 0.3 mg SQ, Solu-Medrol 125 mg, Benadryl 25 mg IV, and Pepcid 20 mg oral.  Patient was re-evaluated an hour and a half after receiving medication and lipedema and urticarial improved.  Patient was provided with an Rx for EpiPen kit, prednisone 40 mg daily for 3 days.  He was told to follow up with his PCP.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Paraesthesia oral, Pruritus, Rash
Clinical narrative: Received Vac 1/28/21 @10:40 am.  No adverse reaction first day.  Only slight swelling and slight pain x24 hrs.  on 1/29/21 started itching over abdomen area, gradually proceeded to cover entire trunk.  If scratched skin turned into welts of various sizes.  On 1/30/21 around 4:00 pm felt tingling around lips; by 7:00 pm lips were abnormally swollen to the point of interfering with my word pronunciation.  Took Benadryl 25 mg around 7:30 pm and swelling of upper lip began to decrease.  Night itching quite aggressive; rash progressed to scalp.  On 1/31/21 rash progressed to arms,  legs and feet.  On 2/1/21 rash progressed to forehead  and perimeter of face.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Received Vac 1/28/21 @10:40 am.  No adverse reaction first day.  Only slight swelling and slight pain x24 hrs.  on 1/29/21 started itching over abdomen area, gradually proceeded to cover entire trunk.  If scratched skin turned into welts of various sizes.  On 1/30/21 around 4:00 pm felt tingling around lips; by 7:00 pm lips were abnormally swollen to the point of interfering with my word pronunciation.  Took Benadryl 25 mg around 7:30 pm and swelling of upper lip began to decrease.  Night itching quite aggressive; rash progressed to scalp.  On 1/31/21 rash progressed to arms,  legs and feet.  On 2/1/21 rash progressed to forehead  and perimeter of face.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Malaise, Nausea
Clinical narrative: Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Immediately after vaccine administration had a brief episode of dizziness. The next morning (1/21/21) noted quarter-sized red rash at injection site along with fatigue, whole body aches, that later progressed into headache, nausea and overall feeling unwell. That evening experienced chills. The following morning (1/22/21) injection site redness/rash was roughly 3in in diameter and warm to touch. Right front shoulder pain began and still continues 12 days post vaccine administration.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills, body aches, headache, fever, fatigue
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash pruritic
Clinical narrative: Redness, Swelling and itching rash at the injection site 1 week post vaccination
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Headache, Injection site pruritus, Injection site rash, Vertigo
Clinical narrative: Itchy and rash where vaccine was ministered. My husband age 80  who got the vaccine same time as I in left arm and has the same rash , No other symptoms
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Localized redness around injection site
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain, Pain in extremity, Pain of skin
Clinical narrative: Had some numbness that started about 20 min after the injection that lasted for about 10 min. After about an hour, my arm was swollen and very painful to move and touch. I put an ice pack on and took Tylenol but the pain and swelling didn?t completely subside. I went to bed with Tylenol PM to help me sleep and woke up several times from the pain. Throughout the day today (2nd day), the pain has steadily gotten worse. I can barely move my arm due to the immense pain. The swelling is still there. I have been icing it and taking Tylenol but the pain has only gotten worse. I feel achy in my neck and the pain is radiating down my arm to my forearm, wrist, and fingers.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: Had some numbness that started about 20 min after the injection that lasted for about 10 min. After about an hour, my arm was swollen and very painful to move and touch. I put an ice pack on and took Tylenol but the pain and swelling didn?t completely subside. I went to bed with Tylenol PM to help me sleep and woke up several times from the pain. Throughout the day today (2nd day), the pain has steadily gotten worse. I can barely move my arm due to the immense pain. The swelling is still there. I have been icing it and taking Tylenol but the pain has only gotten worse. I feel achy in my neck and the pain is radiating down my arm to my forearm, wrist, and fingers.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: soreness @ injection site, 4 puffs of inhaler & advair diskus within 1st hour. No additional symptoms until 1:30 am where I was up all night. In severe systemic pain, fever, severe myo aches, some mild wheezing resolved with inhalers & migraine. Intermittent stuffy nose & sore throat but it goes away. Pain level 10. I can barely move. Dizzy & drinking water & taking otc pain meds. Unable to work or daily function
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: soreness @ injection site, 4 puffs of inhaler & advair diskus within 1st hour. No additional symptoms until 1:30 am where I was up all night. In severe systemic pain, fever, severe myo aches, some mild wheezing resolved with inhalers & migraine. Intermittent stuffy nose & sore throat but it goes away. Pain level 10. I can barely move. Dizzy & drinking water & taking otc pain meds. Unable to work or daily function
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: soreness @ injection site, 4 puffs of inhaler & advair diskus within 1st hour. No additional symptoms until 1:30 am where I was up all night. In severe systemic pain, fever, severe myo aches, some mild wheezing resolved with inhalers & migraine. Intermittent stuffy nose & sore throat but it goes away. Pain level 10. I can barely move. Dizzy & drinking water & taking otc pain meds. Unable to work or daily function
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Giant hive on right side of my body above my right thigh, on the side of my hip.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: 1. Pain at injection site x 48 hours 2. Arthralgia, both shoulders, both knees > 1 week
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Urticaria
Clinical narrative: on 1/31/2021 at 11am, I woke up raised red rashes all over my body.  my primary doctor advised to take zyrtec in Am and bennadryl at night. everytime antihistamine meds wears off, i seen coming back again the hives all over my body, face and lips. hives all over body and face shows up again today 2/1/21 at 1am, 11am, 9:30pm. antihistamine meds helps but keep coming back the hives. no known allergies my entire life. no changes in my diet or taking any supplement. `no pet in my house. no laundry soap changes. my doctor sent consult to allergy.  waiting for response.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Headache, Injection site pain, Injection site swelling
Clinical narrative: I woke up at 1am freezing w/Headache. All my joints are aching. And my nose is plugged. Pain scale for headache was about a 4-5. so it?s like I have a normal cold. The injection site hurts to touch. A teeny bit swollen.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: I woke up at 1am freezing w/Headache. All my joints are aching. And my nose is plugged. Pain scale for headache was about a 4-5. so it?s like I have a normal cold. The injection site hurts to touch. A teeny bit swollen.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Heart rate irregular, Pruritus
Clinical narrative: extreme itching and 11/2 inches big redspot on arm. The itching is so severe and cannot relieved by over counter hrdrocortisone, it make me feel my heart starting beat irregularly
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Injection site mass, Pain, Pruritus, Skin discolouration
Clinical narrative: At the time there was no pain or itchiness, only tenderness and pain the following 3 days.  There was also an undefined lump underneath the injection site that was tender like the rest of my arm.  Now, exactly 7 days later, the lump is more defined and very itchy. The skin is pink and slightly inflamed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: At the time there was no pain or itchiness, only tenderness and pain the following 3 days.  There was also an undefined lump underneath the injection site that was tender like the rest of my arm.  Now, exactly 7 days later, the lump is more defined and very itchy. The skin is pink and slightly inflamed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Musculoskeletal stiffness, Nausea
Clinical narrative: Intense arm pain and finger numbness, neck pain/stiffness on left side. Severe nausea and dizziness, vomiting/dry heaving. Headache, fever (102)
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia, Retching, Vomiting
Clinical narrative: Intense arm pain and finger numbness, neck pain/stiffness on left side. Severe nausea and dizziness, vomiting/dry heaving. Headache, fever (102)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Auditory disorder, Chest discomfort, Dizziness, Ear discomfort
Clinical narrative: Changes in hearing, faint, aches in hips and neck, tight chest. Faintness was within 10 minutes of administration of vaccine. And last about 2-3 minutes. Aches lasted 2 days.  Ears felt strange next day: felt as if plugged, seemed both like a loss of hearing and exaggerated hearing at same time. Roaring in ears.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Tinnitus
Clinical narrative: Changes in hearing, faint, aches in hips and neck, tight chest. Faintness was within 10 minutes of administration of vaccine. And last about 2-3 minutes. Aches lasted 2 days.  Ears felt strange next day: felt as if plugged, seemed both like a loss of hearing and exaggerated hearing at same time. Roaring in ears.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache.  Lasted approximately 12 hours
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pruritus, Rhinorrhoea, Thirst
Clinical narrative: Drippy nose almost 24 hours after vaccine injection followed by itchiness around mouth and nose for several hours. Took one antihistamine--chlorpheniramine. Began to feel chills 29 hours after injection. 36 hours after injection, awakened when both arms and legs felt numb. Very thirsty, 'cotton mouth'. Drank water. Will take another chlorpheniramine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Breast swelling, Labia enlarged, Lymphoedema, Oedema peripheral
Clinical narrative: Lymph edema started 3 days post injection. Started under arms. Day 4 it moved to left breast. Day 5 the swelling continued to left lower abdomen area and left labia. Skin is very tender to the touch in swollen areas
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Lymph edema started 3 days post injection. Started under arms. Day 4 it moved to left breast. Day 5 the swelling continued to left lower abdomen area and left labia. Skin is very tender to the touch in swollen areas
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Headache, Pyrexia
Clinical narrative: Chills Fever Pain in the middle of the chest Arthralgia Headache.          Tylenol and Advil depending on the severity of symptoms at the moment
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Malaise
Clinical narrative: Developed chills with aching long bones (thighs, low back, upper arms) early evening after injection. Profound malaise and fatigue with same pain and chills next day and continuing until 2/1/2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fear, Headache, Pain
Clinical narrative: Chils, headache, body ache ,diarreah, fever up to 104 Took 4 days to get better feels like if I had covid again very painful scare to take the2nd  dose
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chils, headache, body ache ,diarreah, fever up to 104 Took 4 days to get better feels like if I had covid again very painful scare to take the2nd  dose
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Rash
Clinical narrative: Extreme headache within 30 minutes of injection. Rash/skin redness- didn?t notice until 7 hours later; chest and entire face going into part of neck. Fatigue.  I took some Tylenol and fell asleep. When I woke up, only my chest was slightly red and the headache had dulled some.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Injection site mass, Injection site movement impairment
Clinical narrative: Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at injection site. 12 hours following vaccine, severe edema in Left Axilla. Multiple swollen lymph nodes and general edema. Unable to put arm down. Symptoms subsided after 48 hours, but are pain and mild swelling are still present.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Flu like symptoms approximately 8 hours following. Chills, headache, body aches. Large, hard lump at injection site. 12 hours following vaccine, severe edema in Left Axilla. Multiple swollen lymph nodes and general edema. Unable to put arm down. Symptoms subsided after 48 hours, but are pain and mild swelling are still present.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Facial pain, Facial paralysis, Magnetic resonance imaging
Clinical narrative: facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated.  Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; pediatric patient received an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not provided.   On 11-DEC-2020, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S017630, expiration date 06-DEC-2020, administered orally (dose and strength were not provided) for prophylaxis. No other adverse event was reported. The outcome was unknown.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a pregnant patient received VARlVAX/ she is pregnant after administration of VARlVAX; The patient did not experience and adverse events.; This spontaneous prospective pregnancy report was received from a 32-year-old female patient who was referring to herself. The patient had no pertinent medical history, drug reactions or allergies or concomitant medications.  The patient became pregnant with last menstrual period (LMP) calculated as 10-NOV-2020 and estimated date of delivery (EDD) as 17-AUG-2021, based on pregnancy gestation reported as 8 weeks and 2 days at the time of the report.  On 07-JAN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021821, expiration date not reported, but upon internal validation established as 25-JUN-2022, subcutaneously (exact dose not reported) for prophylaxis. The patient did not experience any adverse events. No lab diagnostics or studies were performed. The pregnancy outcome was pending.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX administered during a temperatute excursion; No additional adverse events reported; This spontaneous report was received from a physician regarding  to a 14 month old patient of unknown gender.  Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-JAN-2021, the patient was vaccinated with  an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025608, expiration date 18-AUG-2021, 0.5 milliliter for prophylaxis (route of administration was not provided).         The improperly stored suspect vaccine experienced a temperature of 0.0 degree Celsius (°C) for 2 hours and 11 minutes with no previous temperature excursion.   The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose of VAQTA was administered to a patient; This spontaneous report was received from a licensed practical nurse and refers to a 15-year-old male patient. His concurrent conditions included migraine without aura and myopia of both eyes. The patient's concomitant therapies included propranolol and sumatriptan succinate. There was no information about the patient's pertinent medical history or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product.  On 13-JUL-2015, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-JAN-2021, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, 0.5 milliliter, via intramuscular route in the left deltoid, lot # S032359, expiration date 11-JAN-2021 for prophylaxis. The vaccine was purchased with private funds at private doctor's office/ hospital.  On 14-JAN-2021, the patient was in the physician's office for his annual physical, which required second hepatitis a vaccine, inactivated (VAQTA) vaccination. The vaccine was pulled from storage location and given to a physician (M.D.) to verify that correct vaccine was retrieved to administer, expiration date was not checked. Expired vaccine was sent back to distributor (McKesson). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse reaction; hearingVaccination dates: 25-OCT-2017; 27-JUL-2019; 06-MAR-2020; 14-MAY-2020; This spontaneous report has been received from a lawyer and a 72-year-old male patient via a Plaintiff Fact Sheet. On 25-OCT-2017, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacture unknown) (strength, dose, route, lot #, expiration date were unknown) for prophylaxis. Then the patient also received the hepatitis b vaccine (recombinant)(manufacture unknown) vaccines on following dates: 27-JUL-2019; 06-MAR-2020 and 14-MAY-2020 (inappropriate schedule of product administration). There were no adverse reaction or side effects for the patient.   This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments:  US-009507513-2010USA001766: US-009507513-2101USA012802: US-009507513-2101USA012803:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired dose of PROQUAD that was accidently administered to a 4 year old patient today, 1/27 /21.; This spontaneous report was received from a nurse and refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # S022917, expiration date: 19-JAN-2021, 0.5mL SQ x 1 dose (formulation, strength, frequency, route of administration were not reported) for prophylaxis. On 27-JAN-2021, an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was accidently administered to the patient.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: fever; chills; red; swollen; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, chills, erythema and swelling. On an unknown date, the outcome of the fever, chills, erythema and swelling were recovered/resolved.   The reporter considered the fever, chills, erythema and swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, chills, so red and swollen for about a week. The patient had bad reaction to  Influenza vaccine Quadrivalent unspecified season vaccine. The reporter did not consent to follow up. This case has been linked with US2020AMR249292, reported by same reporter for same patient for Shingles vaccine..; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249292:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Inappropriate schedule of product administration, Nausea, Pain in extremity
Clinical narrative: experienced nausea / started the next day; chills /started the next day; drowsiness/ started the next day; sore arm / started the next day; dizziness that started the next day; accidentally received a third dose / on Friday 12/11/2020; This case was reported by a consumer and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 27th May 2022) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (1st dose received on 12th December 2019, reference case US2020AMR248211) and shingrix with an associated reaction of pain in extremity (2nd dose received on 11th February 2020, reference case US2020AMR248212).   On 11th December 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 11th December 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 12th December 2020, the patient experienced nausea, chills, drowsiness, pain in arm and dizziness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, chills, drowsiness, pain in arm and dizziness were recovering/resolving and the outcome of the extra dose administered was unknown.   The reporter considered the nausea, chills, drowsiness, pain in arm and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient accidentally received a third dose of Shingrix, which led to extra dose administered. The patient experienced nausea, chills, drowsiness, sore arm and dizziness that started the next day from vaccination.  The patient mentioned that all of these side effects were resolving at the time of reporting and she was started to feel better. The reporter asked if there are any special instructions since she did receive a third dose.  The reporter was provided with phone number to medical information and advised her to have her health care professional call for further information. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR248212:Same reporter US-GLAXOSMITHKLINE-US2020AMR248211:Same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Vaccine positive rechallenge
Clinical narrative: experienced nausea / started the next day; chills /started the next day; drowsiness/ started the next day; sore arm / started the next day; dizziness that started the next day; accidentally received a third dose / on Friday 12/11/2020; This case was reported by a consumer and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 27th May 2022) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (1st dose received on 12th December 2019, reference case US2020AMR248211) and shingrix with an associated reaction of pain in extremity (2nd dose received on 11th February 2020, reference case US2020AMR248212).   On 11th December 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 11th December 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 12th December 2020, the patient experienced nausea, chills, drowsiness, pain in arm and dizziness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, chills, drowsiness, pain in arm and dizziness were recovering/resolving and the outcome of the extra dose administered was unknown.   The reporter considered the nausea, chills, drowsiness, pain in arm and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient accidentally received a third dose of Shingrix, which led to extra dose administered. The patient experienced nausea, chills, drowsiness, sore arm and dizziness that started the next day from vaccination.  The patient mentioned that all of these side effects were resolving at the time of reporting and she was started to feel better. The reporter asked if there are any special instructions since she did receive a third dose.  The reporter was provided with phone number to medical information and advised her to have her health care professional call for further information. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR248212:Same reporter US-GLAXOSMITHKLINE-US2020AMR248211:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Biopsy skin normal, Paraesthesia, Rash
Clinical narrative: tingling feeling down her legs; joint pain in her legs; raised bumps/rash that appeared chicken pox-like on her face, neck, arms, thighs, legs, and shoulders / rash on chest / rash on back; This case was reported by a consumer and described the occurrence of tingling of extremity in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced tingling of extremity, joint pain and papular rash. The patient was treated with gabapentin. On an unknown date, the outcome of the tingling of extremity, joint pain and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity, joint pain and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient experienced rash that appeared chicken pox-like on her face, neck, arms, thighs, legs and shoulders.  The patient was seen by several dermatologists and the raised bumps were biopsied and proved negative. The patient also reports that she experienced joint pain in her legs, and tingling feeling down her legs. The patient was given Gabapentin to help alleviate symptoms which were still present at the time of reporting. The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Extra dose administered, Herpes zoster, Incorrect dose administered, Needle issue
Clinical narrative: stomach pain; needle came off of the syringe and she only received part of the dose / given another full dose; This case was reported by a nurse and described the occurrence of stomach pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix and Shingrix, the patient experienced stomach pain and accidental underdose. On 17th December 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the stomach pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was a nurse. The patient received the second dose of Shingrix vaccine in the left arm and while it was being administered the needle came off of the syringe and she only received part of the dose, which led to accidental underdose. The patient was then given another full dose of the Shingrix vaccine on the same day in the right arm. Patient did not have lot number or expiration date information to provide. The patient had stomach pain that lasted 1 day, started a day before reporting and finish 17th December 2020. The reporter did not consent to follow up and did not give consent to follow up with health care professional.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Prophylaxis, Syringe issue, Underdose
Clinical narrative: stomach pain; needle came off of the syringe and she only received part of the dose / given another full dose; This case was reported by a nurse and described the occurrence of stomach pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix and Shingrix, the patient experienced stomach pain and accidental underdose. On 17th December 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the accidental underdose was unknown.   It was unknown if the reporter considered the stomach pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was a nurse. The patient received the second dose of Shingrix vaccine in the left arm and while it was being administered the needle came off of the syringe and she only received part of the dose, which led to accidental underdose. The patient was then given another full dose of the Shingrix vaccine on the same day in the right arm. Patient did not have lot number or expiration date information to provide. The patient had stomach pain that lasted 1 day, started a day before reporting and finish 17th December 2020. The reporter did not consent to follow up and did not give consent to follow up with health care professional.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Impaired work ability, Injection site erythema
Clinical narrative: she had to call out from work the next day; Vomiting; Myalgia; Shivers; she was still very tired; injection site was Red; injection site was / Swelling; injection site was / hot from injection site to the elbow; This case was reported by a other health professional and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced vomiting, myalgia and shivers. On 4th December 2020, the patient experienced activities of daily living impaired. In December 2020, the patient experienced injection site erythema, injection site swelling, extremities hot feeling of and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient was a health care professional. On the night after receiving the Shingrix vaccine, the patient had shivers, myalgia and vomiting. The patient stated that she had to call out from work the next day. Patient was able to get out of bed on the third day, but she was still very tired. She also stated that the injection site was red, swollen, and hot from the injection site to the elbow. The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Loss of personal independence in daily activities, Myalgia
Clinical narrative: she had to call out from work the next day; Vomiting; Myalgia; Shivers; she was still very tired; injection site was Red; injection site was / Swelling; injection site was / hot from injection site to the elbow; This case was reported by a other health professional and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced vomiting, myalgia and shivers. On 4th December 2020, the patient experienced activities of daily living impaired. In December 2020, the patient experienced injection site erythema, injection site swelling, extremities hot feeling of and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient was a health care professional. On the night after receiving the Shingrix vaccine, the patient had shivers, myalgia and vomiting. The patient stated that she had to call out from work the next day. Patient was able to get out of bed on the third day, but she was still very tired. She also stated that the injection site was red, swollen, and hot from the injection site to the elbow. The reporter did not consent to follow up.