chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site rash, Nausea, Pain
Clinical narrative: pt stated the next day after getting the 2nd dose of the covid vax, she had chills, slight fever, body aches and slightly nauseated.  On 2/12/2021 she felt better, no fever, but noticed she had developed a slight rash around the injection site.  On 2/14/2021 she noticed some red streaks moving down her left breast that disappeared fairly quickly.  She had an apt w/ her Dermatologist on 2/15/2021 and the pt had a slight rash on her left arm.  On 2/16/2021 she noticed she had a 'covid arm' rash that covered 3/4 of her left upper arm.  On 2/18/2021 the rash was still noticeable and was itching so she took a Benadryl and then again on the 2/19/2021.  She saw her Dermatologist again on 2/24/2021, her rash is less red and seems to be disappearing.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: pt stated the next day after getting the 2nd dose of the covid vax, she had chills, slight fever, body aches and slightly nauseated.  On 2/12/2021 she felt better, no fever, but noticed she had developed a slight rash around the injection site.  On 2/14/2021 she noticed some red streaks moving down her left breast that disappeared fairly quickly.  She had an apt w/ her Dermatologist on 2/15/2021 and the pt had a slight rash on her left arm.  On 2/16/2021 she noticed she had a 'covid arm' rash that covered 3/4 of her left upper arm.  On 2/18/2021 the rash was still noticeable and was itching so she took a Benadryl and then again on the 2/19/2021.  She saw her Dermatologist again on 2/24/2021, her rash is less red and seems to be disappearing.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Sinusitis, Sleep disorder
Clinical narrative: Body muscle aches especially in legs, irregular sinus feelings (not serious-just unusual), sore left arm, 98.8 fever had a hard time sleeping last night.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Second dose given on day 15.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Patient experienced a rash and itching on her neck and face and returned to the pharmacy about 1 & 1/2 hours after getting the vaccine. No shortness of breath was present. Pharmacist gave diphenhydramine 50mg  to patient with water. Since her husband was with we recommended that he take her to the hospital (short distance away) for further observation.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: When I was getting the shot it felt like a burning feeling but that quickly went away. The next day my lymph nodes in my neck and throat area were swollen,  it was in my neck and my front left side of chest area. I had a sore throat. I went to the ER on the evening of the 19th. They checked my vitals and they did not think it was a reaction to the vaccine, it was my body's response to the vaccine. They said I could take Tylenol or Ibuprofen and Benadryl if I needed to. As of today the swelling went down and I feel fine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Patient states that they had a rash appear at the injection site that appeared at day 10 and last for three days
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received first dose of Moderna.  Patient was administered Pfizer vaccination for second dose in error.  No adverse reactions noted.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: On the morning after the vaccination, I woke up, turned to my left in bed, and got dizzy.  Rolled back onto my back, let my head clear, turned to my right, and got dizzy again.  Felt nauseous, but did not vomit.  Problem was worse with eyes closed than with eyes open.  Spent most of the day  in bed.  Vertigo slightly better on day 2 after vaccination, took Dramamine after consult with doctor.  Much better on day 3.  Essentially back to normal on day 4, but do experience slight dizziness upon waking before getting out of bed.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Very swollen arm. From elbow to shoulder and extremely painful.  Arm has bumps (Knotty), very tender and swelling is expanding over last couple of days- Can no longer tell that I   have an elbow.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives over majority of body.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Pt came up to the EMS table and stated she did not feel well. Pt lost conciousness from a standing position and was caught and lowered to the ground. Pt was unconcious for approx 5 minutes. Pt regained conciousness. Pt was placed in a wheelchair and wheeled to the examination room. Pt was monitored for 30 minutes. Pt states she is feeling better and would like to leave. Pt was walked out to her car. Pt was driven home by her mother. Pt did not require transport.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Cough, Headache, Insomnia
Clinical narrative: body aches, chills, headache, nausea, sore arm, fever, sinus congestion, sore throat, cough, difficulty sleeping, constipation
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches, chills, headache, nausea, sore arm, fever, sinus congestion, sore throat, cough, difficulty sleeping, constipation
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: body aches, chills, headache, nausea, sore arm, fever, sinus congestion, sore throat, cough, difficulty sleeping, constipation
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Pruritus, Rash macular
Clinical narrative: A red splotch first appeared a couple days after the injection. It was located right beneath the injection. It continued to grow with a slight itchiness.  It went away after a few days. It reappeared on Feb. 23 with more redness and larger, and it itches more.  I applied topical Benadryl but it doesn't seem to help the itching. The itching is annoying. There is no pain with slight swelling.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Sluggishness
Clinical narrative: Left hand felt sluggish almost like cramping, duration about 7 days or more.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: January 12, 2021: patient had a sore arm January 13, 2021: vaccination site left arm, "quarter-sized" red, hard, painful area. Patient also experienced chills, hard to move arm, fever (101) and muscle aches.  January 14, 2021: area became more "itchy" and patient began to have flu-like symptoms.  patient was referred to the ER by her PCM who then referred to back to Public Health around 8pm on January 14, 2021.  Patient was previously diagnosed with COVID-19 and it was lab confirmed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Mobility decreased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: January 12, 2021: patient had a sore arm January 13, 2021: vaccination site left arm, "quarter-sized" red, hard, painful area. Patient also experienced chills, hard to move arm, fever (101) and muscle aches.  January 14, 2021: area became more "itchy" and patient began to have flu-like symptoms.  patient was referred to the ER by her PCM who then referred to back to Public Health around 8pm on January 14, 2021.  Patient was previously diagnosed with COVID-19 and it was lab confirmed.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: 0900 RASH. 0912 NO SOB, NO INCREASE RASH. 0922 DENIES SOB OR RASH,SPEECH CLEAR,MOOD CALM.D/C HOME
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Additional Details: Pt DID NOT recieve Covid-19 vaccine at Pharmacy but inquired about side effects and what to do.  Pt states they had 1st dose of moderna Covid vaccine 2 weeks ago. Pt states they have had severe itching at injetion ever since injection and now the site is \"bumpy\" is as well.  Advised pt to take diphenhydramine for itching and swelling and to follow up with primary care dr in the am.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 y.o. scheduled into Moderna vaccine clinic and was given vaccine.  Vaccinator did not recognize by DOB that patient was 16. (Age not specified on form).  EUA for Moderna COVID vaccine is for persons age 18 and older. Patient did not have any reaction to 1st dose of Moderna vaccine.  She returned to clinic on 2/22/21 for 2nd dose and it was recognized that she was 16.  COVID Pharmacist consulted who in turn consulted with CDC/State officials. Per clinical considerations for the Moderna vaccine, 2nd dose of Moderna vaccine can be given to those 16-17y as off label use.  Mother and patient informed of EUA age cutoff for Moderna vaccine and re: clinical considerations/off label use.  Both gave verbal consent to patient having 2nd Moderna vaccine. 2nd dose given. No allergic reaction immediately following vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: The evening of the vaccine (Day 1 Jan 29), my arm was extremely painfully sore. That night, I developed a fever. Day 2 (Jan. 30), I had a fever, body aches, muscle aches, fatigue, and nausea throughout the day. My fever went up to 100.6. I treated it with Tylenol (2 extra strength every 6 hours).  The fever broke around 9 PM (24 hours after it started) Day 3 (Jan 31), I just had severe fatigue and a sore arm. The fever and aches and nausea were gone. Day 4 (Feb 1), I just was more tired than usual. and my arm was still sore. For the first week, my arm got less sore each day, and by Day 7, I was feeling great with no other adverse reactions remaining.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The evening of the vaccine (Day 1 Jan 29), my arm was extremely painfully sore. That night, I developed a fever. Day 2 (Jan. 30), I had a fever, body aches, muscle aches, fatigue, and nausea throughout the day. My fever went up to 100.6. I treated it with Tylenol (2 extra strength every 6 hours).  The fever broke around 9 PM (24 hours after it started) Day 3 (Jan 31), I just had severe fatigue and a sore arm. The fever and aches and nausea were gone. Day 4 (Feb 1), I just was more tired than usual. and my arm was still sore. For the first week, my arm got less sore each day, and by Day 7, I was feeling great with no other adverse reactions remaining.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: A couple of days - a normal kind of sore and it went away. 1 week later - quarter size lump - itchy, painful, hot - grew in the next four days - grew to the size of a grapefruit - it spread out - it had a bulls eye  - the center was as big as Cutie orange (and it was red and painful) and the redness spread from their extending out from center about 4 inches. It took up my entire upper arm - the redness day. It was painful to sleep on but I could use it. On the third day of it ( a Wednesday, 13th) - to check in with DR - Telehealth appt - employee health - recommended ibuprofen and ice packs for a few days. They advised if I got a fever etc to seek more treatment. It took about two weeks for it to go entirely away.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Sleep disorder
Clinical narrative: A couple of days - a normal kind of sore and it went away. 1 week later - quarter size lump - itchy, painful, hot - grew in the next four days - grew to the size of a grapefruit - it spread out - it had a bulls eye  - the center was as big as Cutie orange (and it was red and painful) and the redness spread from their extending out from center about 4 inches. It took up my entire upper arm - the redness day. It was painful to sleep on but I could use it. On the third day of it ( a Wednesday, 13th) - to check in with DR - Telehealth appt - employee health - recommended ibuprofen and ice packs for a few days. They advised if I got a fever etc to seek more treatment. It took about two weeks for it to go entirely away.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pain in extremity, Palpitations
Clinical narrative: 5 minutes after injection I experienced tingling all over, nausea, sweating, dizziness and racing heart rate.  It lasted for about 2 minutes and gradually subsided over next 5 minutes.  Soreness in arm is only symptom 3 hours post injection.  I did not notify health department staff because it subsided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 5 minutes after injection I experienced tingling all over, nausea, sweating, dizziness and racing heart rate.  It lasted for about 2 minutes and gradually subsided over next 5 minutes.  Soreness in arm is only symptom 3 hours post injection.  I did not notify health department staff because it subsided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Communication disorder, Dysstasia, Feeding disorder, Gait inability, Loss of personal independence in daily activities
Clinical narrative: PATIENT ON 2ND DAY AFTER VACCINATION  COULD NOT STAND OR WALK, COULD NOT UNDERSTAND COMMANDS OR CUES, COULD NOT FEED HERSELF, PRIOR TO VACCINATION AMBULATORY AND FEEDING HERSELF.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Systemic: Pt was injected with vaccine after RPh stuck herself with needle. -mild
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth ulceration, Oral pain, Swelling face, Ulcer
Clinical narrative: Very painful mouth ulcers (5) on lip and in mouth. Swollen around jaw line. Sore mouth.   Treatment: I am swishing orajel and mylanta with lidocaine to relieve pain.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphthous ulcer, Blister, Eye pruritus, Lip blister, Pain assessment
Clinical narrative: Very painful mouth ulcers (5) on lip and in mouth. Swollen around jaw line. Sore mouth.   Treatment: I am swishing orajel and mylanta with lidocaine to relieve pain.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling, Stomatitis
Clinical narrative: Very painful mouth ulcers (5) on lip and in mouth. Swollen around jaw line. Sore mouth.   Treatment: I am swishing orajel and mylanta with lidocaine to relieve pain.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 y.o. scheduled into Moderna vaccine clinic and was given 1st dose on 1/27/21.  Vaccinator did not recognize by DOB that patient was 17. (Age not specified on form).  EUA for Moderna COVID vaccine is for persons age 18 and older. Patient did not have any reaction to 1st dose of Moderna vaccine.  She returned to clinic on 2/24/21 for 2nd dose and it was recognized that she was 17.  On 2/23/21, COVID Pharmacist consulted about this same issue and pharmacist consulted with CDC/State officials at that time.  Per clinical considerations for the Moderna vaccine, 2nd dose of Moderna vaccine can be given to those 16-17y as off label use.  Mother and patient informed of EUA age cutoff for Moderna vaccine and re: clinical considerations/off label use.  Both gave verbal consent to patient having 2nd Moderna vaccine. 2nd dose given. No allergic reaction immediately following vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Nodule, Skin warm
Clinical narrative: Red inflamed circle on left arm, about the size of a tennis ball or so with heat, and a knot under the skin.  Given antibiotics, steroid shot, and allergy meds.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Swelling
Clinical narrative: I took daily intramuscular progesterone in sesame oil (PIO) injections (hip) for IVF treatment, with injections ending in May 2020. While taking PIO I had swelling and lumps at the injection sites which dissipated over time. Following the 2nd Moderna vaccine, the swelling and lumps reappeared. I believe this is related to the vaccine, as clinical trial participants with dermal facial fillers had similar immunological reactions.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: 101 FEVER CHILLS SWEATS BAD BODY ACHES COUGH
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: I experienced Covid Arm 7 days after my shot, as it became known to me after I looked up my symptoms and talked with my doctor. Started with itching at injection site, which became very warm. After about an hour or so I noticed it was very sore and swollen. It developed a red circle around it on the second day, and was at least 2 inches in diameter. It was hard, hot and itchy. Probably due to the swelling, my arm became sore from shoulder down through my hand for about 24 hours. Two days later the swelling began to go down, the heat went away, and I?d say the itching mostly subsided within the 48 hours since it started. All normal now!
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Livedo reticularis, Pain in extremity
Clinical narrative: I experienced Covid Arm 7 days after my shot, as it became known to me after I looked up my symptoms and talked with my doctor. Started with itching at injection site, which became very warm. After about an hour or so I noticed it was very sore and swollen. It developed a red circle around it on the second day, and was at least 2 inches in diameter. It was hard, hot and itchy. Probably due to the swelling, my arm became sore from shoulder down through my hand for about 24 hours. Two days later the swelling began to go down, the heat went away, and I?d say the itching mostly subsided within the 48 hours since it started. All normal now!
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, bodyaches
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Covid Arm. Silver dollar size red mark still on injection site with minimal swelling very little itching still at this date. Can feel lump under surface about size of tennis ball flat.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Pruritus, Throat tightness
Clinical narrative: On 02/23/21, 67 yo F presented to clinic for dose #2 of COVID-19 vaccine (Moderna). On 01/26/21, after receiving dose #1, pt experienced an allergic reaction. For second dose, pt pre-medicated with diphenhydramine. At 1537, pt was administered 0.5 mL in left deltoid (lot #024M20A). Within 10 minutes of injection, pt developed cough, chest tightness and itching. Pt was administered epinephrine 0.3 mg IM, albuterol 2.5 mg via nebulization, methylprednisolone 125 mg IV and diphenhydramine 50 mg IV. Due to pt's previous reaction, pt was transported to ED for additional monitoring. EMS administered famotidine 20 mg IV. On arrival to ED, pt was placed in observation. Due to persistent coughing and sensation of throat closing, pt was given second doses of epinephrine 0.3 mg IM , albuterol nebulization and diphenhydramine 25 mg PO. Pt was then held in observation x 4 hours with return to baseline. and no symptom recurrence. Pt discharged with instructions to return to ER for any symptom recurrence.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Error: Patient Too Young for Vaccine Administered
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: There has been no treatment. just a little bit ago today I started to have a dizzy feeling in my head. made me very week for about a second. i could  feel my body move like it might fall out. and i got up and moved to another chair and i felt it again. So far i have not felt it again
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Chills, Myalgia, Nausea
Clinical narrative: 3:15am Feb. 22nd  Shakes, chills, muscle and joint aches and nausea for 2 hours.  8:15am Shakes, chills, muscle and joint aches and nausea.  12 noon vomiting yellow bile 4 times.  Started feeling better about 5pm.  Feb. 23rd chills off and on every few hours feeling week and achey.aches.  Feb. 24th feeling nausea and achiness.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: 3:15am Feb. 22nd  Shakes, chills, muscle and joint aches and nausea for 2 hours.  8:15am Shakes, chills, muscle and joint aches and nausea.  12 noon vomiting yellow bile 4 times.  Started feeling better about 5pm.  Feb. 23rd chills off and on every few hours feeling week and achey.aches.  Feb. 24th feeling nausea and achiness.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Intense arm pain, starting at bicep all the way to the hand. Symptoms lasted 7 days.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: Anaphylaxis, severe body rash with hives that?s spread all over upper and lower body, along with neck and face.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Livedo reticularis
Clinical narrative: Pain and itching in the injection site, small red ring around site.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pruritus, Sensitive skin
Clinical narrative: I had two adverse reactions: 1) pain at injection site and fatigue starting the evening of the vaccination, lasting 2 days  2) on day 7 in the evening, my upper right arm started to itch.  The next morning, there was a large, red, hard area of swelling at the injection site that itched and was very sensitive.  This lasted 2-3 days, gradually fading and becoming less sensitive.  I've learned this is a reaction called "Covid arm."
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: After receiving her vaccine, client stated she started to cough.  Client stated she has a stuffy nose for the past 3 days.
Age: 1.33
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 19-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took a full course of unrefrigerated Vivotif; Spontaneous report received on 29JAN2020.  A female consumer reported that she "took a full course of unrefrigerated Vivotif" (PT: Product storage error). She was receiving Vivotif for immunisation. The consumer took a full course of unrefrigerated Vivotif from 22JAN2020 to 28JAN2020. She did not know that the vaccine needed to be refrigerated until she finished the full course. Her healthcare professional recommended her to restart the vaccination. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took all four doses of Vivotif which were unrefrigerated (Product storage error). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took all four doses of Vivotif which were unrefrigerated (Product storage error). Considering the nature of the event, the causality of the event is assessed as not applicable to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: toes on my left foot began to swell and itch; toes on my left foot began to swell and itch; Numbness radiated up my calve; arm pain / toes very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2021, the patient received Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced pain in extremity and numbness. On 21st January 2021, the patient experienced swelling of feet and localized itching. On an unknown date, the outcome of the pain in extremity, swelling of feet, localized itching and numbness were unknown.   It was unknown if the reporter considered the pain in extremity, swelling of feet, localized itching and numbness to be related to Shingrix.  Additional details were provided as follow: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. On Wednesday, the patient received shingle vaccine and experienced bad arm pain which was tolerable but the next evening the toes on left foot began to swell and itch and were very painful.  The numbness and pain radiated up to calve and the patient asked was this a side effect.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Myalgia, Pain in extremity
Clinical narrative: Violent shivering; feels cold to himself; forehead feels hot; arm is very sore; arm is very sore-muscles; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2021, the patient received Shingrix. On 22nd January 2021, 5 hrs after receiving Shingrix, the patient experienced shivering, feeling cold, feeling hot, pain in arm and muscle pain. On an unknown date, the outcome of the shivering, feeling cold, feeling hot, pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shivering, feeling cold, feeling hot, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follow: The case was reporter by patient's wife at 21:38:15. The age at vaccination was not reported. About 6 hours ago from the time of the reporting, the patient had a Shingrix vaccination and about an hour ago he began having violent shivering.  The patient felt cold to himself while his forehead felt hot (he was heavily covered up). The patient registers no temperature. His arm and muscle was very sore.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: her fingers and one toe swelled / swelling is on both hands but more pronounced on the left; The toe turned purple; intense itching on her fingers; reduced range of motion in her neck like a stiff neck; sores present on both hands; had reduced range of motion in her neck; sore arm that lasted 2-3 days; not feeling well; like she had the flu; Extreme fatigue presented lasting a week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling unwell, influenza-like symptoms and fatigue. On an unknown date, the patient experienced swelling of fingers, skin discoloration, pruritus, stiff neck, skin ulcer and mobility decreased. On an unknown date, the outcome of the pain in arm and pruritus were recovered/resolved and the outcome of the feeling unwell, fatigue and stiff neck were recovering/resolving and the outcome of the influenza-like symptoms, skin discoloration and mobility decreased were unknown and the outcome of the swelling of fingers and skin ulcer were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, influenza-like symptoms, fatigue, swelling of fingers, skin discoloration, pruritus, stiff neck, skin ulcer and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix in the left arm. The patient reported a sore arm that lasted 2 to 3 days.  The evening of the vaccination date, started to not feel well like she had the flu. Extreme fatigue presented lasting a week.  A few days after vaccination, the patient's fingers and one toe swelled, the toe turned purple.  The swelling was on both hands but more pronounced on the left side.  There was intense itching on her fingers.  The patient had reduced range of motion in her neck like a stiff neck.  Her fingers were still swollen and there were now sores present on both hands due to the swelling. Less than a month after receiving Shingrix the patient experienced Skin discolouration, Pruritus, Musculoskeletal stiffness, Skin ulcer and Mobility decreased and several days after receiving Shingrix the patient experienced the patient experienced swelling of fingers. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin discolouration, Skin ulcer
Clinical narrative: her fingers and one toe swelled / swelling is on both hands but more pronounced on the left; The toe turned purple; intense itching on her fingers; reduced range of motion in her neck like a stiff neck; sores present on both hands; had reduced range of motion in her neck; sore arm that lasted 2-3 days; not feeling well; like she had the flu; Extreme fatigue presented lasting a week; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling unwell, influenza-like symptoms and fatigue. On an unknown date, the patient experienced swelling of fingers, skin discoloration, pruritus, stiff neck, skin ulcer and mobility decreased. On an unknown date, the outcome of the pain in arm and pruritus were recovered/resolved and the outcome of the feeling unwell, fatigue and stiff neck were recovering/resolving and the outcome of the influenza-like symptoms, skin discoloration and mobility decreased were unknown and the outcome of the swelling of fingers and skin ulcer were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, influenza-like symptoms, fatigue, swelling of fingers, skin discoloration, pruritus, stiff neck, skin ulcer and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix in the left arm. The patient reported a sore arm that lasted 2 to 3 days.  The evening of the vaccination date, started to not feel well like she had the flu. Extreme fatigue presented lasting a week.  A few days after vaccination, the patient's fingers and one toe swelled, the toe turned purple.  The swelling was on both hands but more pronounced on the left side.  There was intense itching on her fingers.  The patient had reduced range of motion in her neck like a stiff neck.  Her fingers were still swollen and there were now sores present on both hands due to the swelling. Less than a month after receiving Shingrix the patient experienced Skin discolouration, Pruritus, Musculoskeletal stiffness, Skin ulcer and Mobility decreased and several days after receiving Shingrix the patient experienced the patient experienced swelling of fingers. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Decreased appetite, Diarrhoea
Clinical narrative: did not feel well for several days.; Vomiting; fatigue; diarrhea; stomach cramping in the lower right side; loss of appetite; nausea; trouble passing gas and not being able to burp which caused bloating; not being able to burp; bloating; soreness at the injection site; soreness at the injection site / with a lump; shivering; headache; This case was reported by a nurse and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site lump. On 1st January 2021, the patient experienced fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering and headache. On 2nd January 2021, the patient experienced vomiting. On an unknown date, the patient experienced feeling unwell. On 6th January 2021, the outcome of the injection site pain and injection site lump were recovered/resolved. In January 2021, the outcome of the fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering, headache, feeling unwell and vomiting were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering, headache, feeling unwell and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient was also a nurse. The patient received Shingrix in left arm. The patient experienced soreness at the injection site the day of the vaccine administration with a lump that lasted 6 days. The day following the vaccine administration, she experienced fatigue, diarrhea, stomach cramping in the lower right side of the stomach, loss of appetite, nausea and trouble passing gas and not being able to burp which caused bloating. These symptoms lasted several days. She also reported shivering and a headache the day following the vaccine administration and both lasted 24 hours. Vomiting presented 2 days later, on 2nd January 2021 that lasted 3 to 4 hours before resolving. The patient said she just did not feel well for several days. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eructation, Fatigue, Flatulence, Headache, Injection site mass
Clinical narrative: did not feel well for several days.; Vomiting; fatigue; diarrhea; stomach cramping in the lower right side; loss of appetite; nausea; trouble passing gas and not being able to burp which caused bloating; not being able to burp; bloating; soreness at the injection site; soreness at the injection site / with a lump; shivering; headache; This case was reported by a nurse and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site lump. On 1st January 2021, the patient experienced fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering and headache. On 2nd January 2021, the patient experienced vomiting. On an unknown date, the patient experienced feeling unwell. On 6th January 2021, the outcome of the injection site pain and injection site lump were recovered/resolved. In January 2021, the outcome of the fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering, headache, feeling unwell and vomiting were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering, headache, feeling unwell and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient was also a nurse. The patient received Shingrix in left arm. The patient experienced soreness at the injection site the day of the vaccine administration with a lump that lasted 6 days. The day following the vaccine administration, she experienced fatigue, diarrhea, stomach cramping in the lower right side of the stomach, loss of appetite, nausea and trouble passing gas and not being able to burp which caused bloating. These symptoms lasted several days. She also reported shivering and a headache the day following the vaccine administration and both lasted 24 hours. Vomiting presented 2 days later, on 2nd January 2021 that lasted 3 to 4 hours before resolving. The patient said she just did not feel well for several days. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Vomiting
Clinical narrative: did not feel well for several days.; Vomiting; fatigue; diarrhea; stomach cramping in the lower right side; loss of appetite; nausea; trouble passing gas and not being able to burp which caused bloating; not being able to burp; bloating; soreness at the injection site; soreness at the injection site / with a lump; shivering; headache; This case was reported by a nurse and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site lump. On 1st January 2021, the patient experienced fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering and headache. On 2nd January 2021, the patient experienced vomiting. On an unknown date, the patient experienced feeling unwell. On 6th January 2021, the outcome of the injection site pain and injection site lump were recovered/resolved. In January 2021, the outcome of the fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering, headache, feeling unwell and vomiting were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, fatigue, diarrhea, stomach cramps, appetite lost, nausea, gas, burping, bloating, shivering, headache, feeling unwell and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient was also a nurse. The patient received Shingrix in left arm. The patient experienced soreness at the injection site the day of the vaccine administration with a lump that lasted 6 days. The day following the vaccine administration, she experienced fatigue, diarrhea, stomach cramping in the lower right side of the stomach, loss of appetite, nausea and trouble passing gas and not being able to burp which caused bloating. These symptoms lasted several days. She also reported shivering and a headache the day following the vaccine administration and both lasted 24 hours. Vomiting presented 2 days later, on 2nd January 2021 that lasted 3 to 4 hours before resolving. The patient said she just did not feel well for several days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient got very sick after receiving a dose of Shingrix. Limited demographics and information were provided by the reporter as she was irate and disconnected the call. The reporter did not consent to follow-up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hemiplegia, Movement disorder, Muscular weakness
Clinical narrative: 50 % loss of movement in the right side of his body (arm and leg); lost the physical ability in the right arm and the right leg; can't walk without assistance; lost fifty percent movement on right side in his arm and leg. It is not hurting. It is weak; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), via an unspecified route of administration on 07Feb2021 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included high blood pressure, enlarged prostate, and COPD (chronic obstructive pulmonary disease). Ongoing concomitant medications included lisinopril, and tamsulosin hydrochloride (TAMSULOSIN). The patent was taking unspecified concomitant medications. The patient previously received flu shot months ago for immunization. The patient did not receive any vaccine 4 weeks prior to COVID vaccine. The patient was administered Pfizer COVID19 vaccination on this past Sunday, 07Feb2021. He was feeling alright on Sunday. On Monday (08Feb2021) when he woke up, he had lost fifty percent movement on right side in his arm and leg. It is not hurting. It is weak. He had lost the physical ability in the right arm and the right leg. The shot was given in left arm. He said he still has it and he can't walk without assistance. The events did not require a visit to the emergency room or to the physician office. He is scheduled to get the next shot on 04Mar2021 at 3:30PM. The patient has not recovered from the events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 50 years old) at a single dose for covid-19 immunization. Medical history included hypertension, gastrooesophageal reflux disease (GERD), obesity, and allergies: sulfa. Concomitant medications included hctz, escitalopram oxalate (LEXAPRO), losartan, metoprolol and omeprazole (PROTONIX [OMEPRAZOLE]). The patient is not pregnant. The patient had no other vaccine in four weeks and was not tested for covid post vaccination. On 09Feb2021, the patient experienced Bell's palsy. Therapeutic measures were taken as a result of the event Bell's palsy included prednisone and valacyclovir. Outcome of the event was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth haemorrhage, Myocardial infarction, Oral mucosal exfoliation
Clinical narrative: The roof of my mouth shedded (was raw) and bleed for a few days; The roof of my mouth shedded (was raw) and bleed for a few days; I felt like I was having a heart attack; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), intramuscularly on 29Jan2021 at 09:30 AM at a single dose for COVID-19 immunisation. The patient's medical history included asthma and known allergies to medication. Concomitant medications included paracetamol (TYLENOL) and metoprolol, which were reported as medications in two weeks. It was reported that other vaccines in four weeks were prescribed. On 31Jan2021 at 09:00 AM, the patient experienced the roof of her mouth shedded (was raw) and bled for a few days. A few days later (2021), she felt like she was having a heart attack. There was no treatment for the events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was recovered on 2021.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event myocardial infarction cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clot on lung after experiencing chest pain; This is a spontaneous report from a contactable consumer reported for himself. A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 14:00 on Arm left at single dose (Lot # EK9231) for covid-19 immunisation. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient with confirmed blood clot on lung after experiencing chest pain/chest tightness/left sided, thought that he was having a heart attack, shortness of breath on 03Feb2021, reported as non serious. Emergency room/department or urgent care. Blood thinner received for the events. Outcome of the events was unknown.