chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: An improperly stored dose of GARDASIL 9 was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drugs reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (dose, frequency, route of administration and anatomical location were not provided) as prophylaxis. The vaccine was under a temperature below 36 fahrenheit degrees (F) of 32.1 F during a time frime of 8 hours as recorded by a data logger. No previous temperature excursion was reported as well as no adverse effects.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine administered; This spontaneous report was received from a Nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 13-SEP-2019, the patient was adminstered one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) for prophylaxis (lot # R030924, expiry date: 10-JUL-2020). The vaccine was stored at 0.24 C (multiple) for 5 hours 30 minute. There was no previous temprature excursion. No adverse effect reported. It was reported that, this call was because of data logger. No PQC involved. No additional information available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles all over her body; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. Shingrix was discontinued. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccination at a different location so the reporter had limited information. The patient developed shingles all over her body about 2 days after receiving Shingix. She has elected not to receive the 2nd dose.The visit to this doctor was not related to Shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 2nd dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th September 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was in her 70's. The patient received Shingrix and experienced injection site soreness on the same day as the vaccine was administered. The event was resolved by 16th September 2019 when the GlaxoSmithKline employee saw the patient at the gym.  The GlaxoSmithKline employee who reported the event noted that the patient exercised in the gym regularly and appeared to be in good health.  The GlaxoSmithKline employee did not have the patient's name and contact information but would request the patient contact GlaxoSmithKline with additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Lethargy, Loss of personal independence in daily activities, Malaise, Pyrexia
Clinical narrative: Fever; Lethargy; Generally just felt bad; Missed one day of work; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, lethargy, feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the fever, lethargy, feeling unwell and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, lethargy, feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the Shingrix 3 months ago and missed one day of work because of fever, lethargy, and generally just felt bad.  The patient need the 2nd vaccine, just trying to figure work schedule.  The reporter asked should expect the same reaction or should reaction be milder.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash on her upper right thigh; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated the patient has a shingles rash on her upper right thigh 3 days after receiving the Shingrix vaccine. The reporter was transferred to medical information for additional assistance including whether the patient should receive the 2nd dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Malaise, Nausea, Urticaria
Clinical narrative: Felt ill; fatigue that prevented her from getting out of bed; Nausea; vomiting; Red welt below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema urticarial in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the patient experienced feeling unwell, fatigue, nausea and vomiting. On an unknown date, the outcome of the erythema urticarial, feeling unwell, fatigue, nausea and vomiting were unknown.   It was unknown if the reporter considered the erythema urticarial, feeling unwell, fatigue, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed A red welt below the injection site a day after the first dose of Shingrix. The patient went on to feel ill, had nausea, vomiting and fatigue that prevented her from getting out of bed. The reporter consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Felt ill; fatigue that prevented her from getting out of bed; Nausea; vomiting; Red welt below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema urticarial in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the patient experienced feeling unwell, fatigue, nausea and vomiting. On an unknown date, the outcome of the erythema urticarial, feeling unwell, fatigue, nausea and vomiting were unknown.   It was unknown if the reporter considered the erythema urticarial, feeling unwell, fatigue, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed A red welt below the injection site a day after the first dose of Shingrix. The patient went on to feel ill, had nausea, vomiting and fatigue that prevented her from getting out of bed. The reporter consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Rash macular, Swelling face
Clinical narrative: swelling; red cheeks/ ruddy cheeks; cheeks were hot; chills; blotches on chest; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th June 2019, less than a day after receiving Shingrix, the patient experienced facial swelling, red face, feeling of warmth facial, chills and blotchy. On 29th June 2019, the outcome of the facial swelling, red face, feeling of warmth facial, chills and blotchy were resolved with sequelae.   It was unknown if the reporter considered the facial swelling, red face, feeling of warmth facial, chills and blotchy to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the left arm. The patient stated that on the same day of vaccination experienced swelling on her face and the cheeks were hot and red and ruddy cheeks. The patient also experienced chills and blotches on her chest. The patient consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Swelling
Clinical narrative: Pt C/O allergic reaction redness and swelling believes it was accident given SC instead of IM
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Posture abnormal
Clinical narrative: After receiving a HPV injection, pts. color turned pallor, pt. became non-verbal, and began to slide from her chair. Pts. mother cuddled her & she did not slide from chair - within 30 seconds, pt. was alert and oriented and again verbal. Pt. never loss consciousness. Pt. was allowed to lye down in clinic room & observed.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Woke up shivering, whole body felt tight, muscle pain and weakness, fever 100.5, headache not relieved with Tylenol,loss of appetite,  exhaustion.  No energy to do anything. Slept 11 hours straight last night.  Felt better when awoke at 6:30. a.m.  All symptoms gone.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Muscle tightness, Myalgia, Pyrexia
Clinical narrative: Woke up shivering, whole body felt tight, muscle pain and weakness, fever 100.5, headache not relieved with Tylenol,loss of appetite,  exhaustion.  No energy to do anything. Slept 11 hours straight last night.  Felt better when awoke at 6:30. a.m.  All symptoms gone.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Increased upper airway secretion, Pharyngeal swelling
Clinical narrative: Increased secretions, throat swelling, extreme difficulty swallowing own secretions, took Benadryl 50 mg at home. No improvement after 45-60 minutes. Treated in ED with IV steroids and Benadryl. Symptoms resolved over 1 hour Oral steroids for 3 days at home
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus, Urticaria
Clinical narrative: Patient had her vaccine on 9/22 at 3:02pm. By the next day, she came home from school and had mosquito and quarter size hives all over her upper body, and was itching. I took her into where she had her vaccine done, and they couldn?t tell me if it was a directly related to the vaccine. Told me to give her Benadryl and apply hydro cortisone cream.  By early morning (9/24), her hives had spread all the way down her legs, and the hives were raised and  severely spread all across her back and stomach. I took her to the emergency room, and they said the rash matched that of her left arm where she received her vaccine. They prescribed her Cetirizine & presnizolone, along with a prescription to take home. The next morning (9/25), she had hives again (not as severe), and we have her the prescribed medication and she was better a few hours later. We have been continuing  to take the prescribed medicine.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Bladder catheter temporary, Blood glucose, Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: My infant rec'd 6 vaccines on 8/21. i have her vaccine record but do not have the specifics on the manufacturer/sites etc.  The evening of 8/21 she developed a fever. The afternoon of 8/22 she had a tonic clonic sz that was dx as febrile in nature.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Urine analysis
Clinical narrative: My infant rec'd 6 vaccines on 8/21. i have her vaccine record but do not have the specifics on the manufacturer/sites etc.  The evening of 8/21 she developed a fever. The afternoon of 8/22 she had a tonic clonic sz that was dx as febrile in nature.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Feeling abnormal, Full blood count, Lacrimation increased, Lymph node pain
Clinical narrative: Employee received MMR on 9/13/2019 r/t nonimmunity to Rubella. Employee complain of rash that started on face, knots to back of head, itching, "feeling funny in the right facial area" on 9/25/2019, employee to see clinic provider on 9/26/2019 with rash to face, neck, trunk, BUE's, BLE's to mid-thigh area, large amount of redness to both eyes with watering, itching, soreness to bilateral lymph nodes, dizziness.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody, Nodule, Ocular hyperaemia, Pruritus, Rash
Clinical narrative: Employee received MMR on 9/13/2019 r/t nonimmunity to Rubella. Employee complain of rash that started on face, knots to back of head, itching, "feeling funny in the right facial area" on 9/25/2019, employee to see clinic provider on 9/26/2019 with rash to face, neck, trunk, BUE's, BLE's to mid-thigh area, large amount of redness to both eyes with watering, itching, soreness to bilateral lymph nodes, dizziness.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Smear buccal
Clinical narrative: Employee received MMR on 9/13/2019 r/t nonimmunity to Rubella. Employee complain of rash that started on face, knots to back of head, itching, "feeling funny in the right facial area" on 9/25/2019, employee to see clinic provider on 9/26/2019 with rash to face, neck, trunk, BUE's, BLE's to mid-thigh area, large amount of redness to both eyes with watering, itching, soreness to bilateral lymph nodes, dizziness.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt in clinic today for raised, red area where injection was given. She reported it started the night of the injection the area was red, warm and raised. Area has been slowly going down in size, still noted today a quarter sized area that was red and raised.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Pyrexia, Tremor
Clinical narrative: Patient states that approximately 8-9 hours following vaccination (around 9pm), she started to develop a fever and what she reported as "extreme" chills.  She states that the shaking from the chills was enough that she was unable to hold a book or concentrate on anything.  She took a dose of acetaminophen and went to bed, waking midway through the night still running a fever of 100.3.  At the time she called me on 9/25/19, she stated that her fever was resolving, and she had not had any repeat episodes of the chills, but she wanted to inquire why those side effects were not listed on the VIS given at time of vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Muscle ache, tiredness, easily chilled, slight fever (100 F),swelling/redness/inflammation at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle ache, tiredness, easily chilled, slight fever (100 F),swelling/redness/inflammation at injection site.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: BRUISED AND SORE AT INJECTION SITE BEGINNING DAY OF ADMINISTRATION. STILL EXPERIENCING SORENESS AND BRUISING TODAY 9/26/2019
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site bruising
Clinical narrative: PATIENT CAME TO PHARMACY AND SHOWED ME HER RIGHT ARM. IT WAS RED AND INFLAMMED. LOOKED LIKE SHE HAD A SMALL BRUISE WHERE THE INJECTION WAS ADMINISTERED. SHE SAID IT STARTED ON 9-24-19, BUT HAD NOT SPREAD DOWN HER ARM AND STAYED LOCALIZED TO HER UPPER DELTOID AREA. SHE SAID SHE HAD NOT TAKEN ANY ANTIHISTAMINES OR ANTIPYRETICS. SHE STATED TO NOT HAVE A FEVER. I ADVISED HER TO TAKE EITHER TYLENOL OR IBUPROFEN IF IT WAS TENDER OR IF SHE DEVELOPED A LIGHT FEVER AND TO ALSO TAKE BENADRYL OR ANOTHER ANTIHISTAMINE TO HELP WITH THE REDNESS AND SWELLING, AND IF IT CONTINUED TO GET WORSE TO CONSULT WITH HER PRIMARY CARE PROVIDER.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient called and reported severe pain in right shoulder where Pneumovax was given earlier in the day, also reported swelling at site as well. Advised patient to take benedryl in case this was an allergic reaction and to go to the emergency room or urgent care for physician's evaluation.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Irritability, Lip swelling
Clinical narrative: Mom reported upper lip swelling about one hour after receiving seasonal flu vaccine in clinic. There was some fussiness but no other swelling, no hives, no difficulty or noisy breathing,  and no vomiting. Child was brought back to clinic and evaluated. She was given 12.5mg of diphenhydramine and observed for 1.5 hours without further symptoms. Strict precautions were given on symptoms and signs to look for to seek medical attention.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Half dollar size bruise
Age: 87.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt diagnosed with cellulitis and treated with steroid dose pack and doxycycline. Day 9 after shot and patient complains of redness, swelling and warm to the touch in the area of shingrix.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Adnexa uteri pain, Asthenia, Dysuria, Headache, Pain
Clinical narrative: Started feeling body aches and a sharp pain in my ovary around 4PM the following day 9/24.  I was drinking more water than normal.  When I urinated it felt warmer than usual.  As the evening went on I the aches increased, I had a severe all over headache, had occasional  sharp pains in my right ovary,  and I was vomiting, not able to keep anything down.  I was not urinating nor did I have a BM on 9/25.  Although much better today 9/26, I am fully functioning, but still feeling weak and noticed a rash on both sides of my neck. My headache is still present but much better (from an 8 pain score to a 3), but only after I took some Aleve this morning.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Urinary retention, Vomiting
Clinical narrative: Started feeling body aches and a sharp pain in my ovary around 4PM the following day 9/24.  I was drinking more water than normal.  When I urinated it felt warmer than usual.  As the evening went on I the aches increased, I had a severe all over headache, had occasional  sharp pains in my right ovary,  and I was vomiting, not able to keep anything down.  I was not urinating nor did I have a BM on 9/25.  Although much better today 9/26, I am fully functioning, but still feeling weak and noticed a rash on both sides of my neck. My headache is still present but much better (from an 8 pain score to a 3), but only after I took some Aleve this morning.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Asthenia, Blood glucose normal, Cold sweat, Depressed level of consciousness, Pallor
Clinical narrative: Injections given and patient asked to lie down for 5-7 minutes since receiving  Gardisil vaccine.  Patient in room with sibling. Sibling reported that after about 5 minutes patient got up from supine position, stood, became weak and fainted.  Sibling called for help. Patient was pale, clammy and semi- alert.  Placed back on bed in supine position and attended to by physician.  After about 25 minutes skin color pinked up and she was alert and felt well.  She got up to leave and in the waiting room became weak, dizzy and almost passed out again.  Patient was pale again and alert. She felt dizzy.  Placed in supine position on bed with knees up. Blood glucose level checked and at 99. B/P was at 72/40.  Given oral fluids and pretzels to eat.  Patient observed about 45 minutes and B/P was at 98/69.  No longer pale, alert and oriented and dizziness improving.  Patient rechecked by physician  and released to home.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Injections given and patient asked to lie down for 5-7 minutes since receiving  Gardisil vaccine.  Patient in room with sibling. Sibling reported that after about 5 minutes patient got up from supine position, stood, became weak and fainted.  Sibling called for help. Patient was pale, clammy and semi- alert.  Placed back on bed in supine position and attended to by physician.  After about 25 minutes skin color pinked up and she was alert and felt well.  She got up to leave and in the waiting room became weak, dizzy and almost passed out again.  Patient was pale again and alert. She felt dizzy.  Placed in supine position on bed with knees up. Blood glucose level checked and at 99. B/P was at 72/40.  Given oral fluids and pretzels to eat.  Patient observed about 45 minutes and B/P was at 98/69.  No longer pale, alert and oriented and dizziness improving.  Patient rechecked by physician  and released to home.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: 4 Hours after injection the patient reported an "egg shaped hard spot". 6 hours after injection this area grew to 4x5 inches. Patient took 2 Tylenol 500mg at this point. The area became swollen and red hot at this time. 7 hours after injection the area grew to 6x6inches. 9 hours after injection the area began itching. At 4:30AM the next day, the entire arm was swollen from the shoulder to the elbow. Patient was given a "steroid shot at urgent" care this morning and a Medrol pack to follow the next day. Patient was also given hydroxyzine 10mg.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cognitive disorder, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: Within 30 minutes of receiving the Boostrix Tdap shot, I suffered a severe allergic reaction. My whole body became heavy, and I was unable to move or get out of bed. I felt a wave of extreme fatigue and weakness wash over me and was in a mental fog. My mental intake and comprehension, as well as my response time was greatly slowed. I was able to finally get out of bed about an hour after the reaction, but stayed in a mental fog for weeks, if not months after that. The fatigue is overwhelming and has not gone away.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Hyporesponsive to stimuli, Mobility decreased
Clinical narrative: Within 30 minutes of receiving the Boostrix Tdap shot, I suffered a severe allergic reaction. My whole body became heavy, and I was unable to move or get out of bed. I felt a wave of extreme fatigue and weakness wash over me and was in a mental fog. My mental intake and comprehension, as well as my response time was greatly slowed. I was able to finally get out of bed about an hour after the reaction, but stayed in a mental fog for weeks, if not months after that. The fatigue is overwhelming and has not gone away.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Immediately upon injection I felt like I had received an electric shock.   A few hours later I began shivering severely and uncontrollably.   This lasted for hours.    Later I developed a severe headache.   I vomited and felt weak and dizzy.   I still feel ill.  I have never had a reaction to any vaccine like this.   I was very frightened until I googled Shingrix reactions and realized my problems were common.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Paraesthesia, Vomiting
Clinical narrative: Immediately upon injection I felt like I had received an electric shock.   A few hours later I began shivering severely and uncontrollably.   This lasted for hours.    Later I developed a severe headache.   I vomited and felt weak and dizzy.   I still feel ill.  I have never had a reaction to any vaccine like this.   I was very frightened until I googled Shingrix reactions and realized my problems were common.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Musculoskeletal disorder, Pain
Clinical narrative: After receiving my TDAP vaccine, I experienced the expected soreness in my left arm at the injection site. But in the early morning of the 3rd day I began feeling extreme pain, which only increased daily to the point where my husband insisted on taking me to the ER.  The pain feels as though my arm is being ripped out of it's socket. It is a constant pain that is only increasing over time. My left arm is completely useless. It is not paralyzed or anything, but is immobile unless I am willing to endure extreme, excruciating pain. The ER sent me home with instructions to follow up with my clinic when they opened that morning (I checked into the ER shortly before 04:00am on the morning of September 25, 2019). My clinic suggested Motrin for 48 hours and to see them if after 48 hours the pain did not decrease. The pain increased again overnight and my clinic was able to see me today, September 26th, around 11am. They suggested 72 hours of Motrin as needed, and told me if the pain is still there on Monday they will send me to a neurologist. Therefore, we are assuming there has been nerve damage.  There was never any swelling, redness, or signs of fever. I am 28 weeks pregnant, with 2 living boys whom have both been fully vaccinated with no issues. My due date is Dec 17, 2019.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder
Clinical narrative: Pain reported upon insertion of needle in upper left arm.  Patient said the pharmacist saw him wince in pain and ask if he wanted to continue and patient said yes.  Pharmacist finished administering vaccine and patient reports pain has been consistent in the area of administration since the time of the injection. It is now a week later and he is still reporting pain in the area of the injection site and he is not able to fully use his arm for lifting/etc at work.  It is not red or warm to the touch, hard or inflamed in any way when we observed it today.  Advised to use ibuprofen, tylenol or ice  and if it continues to seek medical attention.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Fatigue, Headache
Clinical narrative: Immunization given 09/24 in morning, by 11am patient experienced headache. Developed fatigue, fever by 3pm. Patient called primary doctor and was advised to treat symptoms and call back if temperature was over 100. Patient woke 09/25 arm was visibly swollen and red. Arm was warm to touch and area grew as day progressed. Patient came to pharmacy after 7pm. Arm was visibly swollen, redness was approximately 5 inches in diameter. Patient was still complaining of fatigue and fever and lower back and hip pain. Patient was still wearing the band aid and it appeared to be below the deltoid
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Immunization given 09/24 in morning, by 11am patient experienced headache. Developed fatigue, fever by 3pm. Patient called primary doctor and was advised to treat symptoms and call back if temperature was over 100. Patient woke 09/25 arm was visibly swollen and red. Arm was warm to touch and area grew as day progressed. Patient came to pharmacy after 7pm. Arm was visibly swollen, redness was approximately 5 inches in diameter. Patient was still complaining of fatigue and fever and lower back and hip pain. Patient was still wearing the band aid and it appeared to be below the deltoid
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Nasopharyngitis
Clinical narrative: after receiving shoT we wenT home and I kepT an eye on him because of family hisTory he sTarTed geTTing raspy at first I said maybe he caughT someThing buT he jusT kepT geTTing worse To fasT for a cold his sTomach sTarTed to hurT I gave him some sysrazine he sounded worse as Time wenT on I Took him back to Drs and Dr. (PA had done shoT) who gave me his # and sTronger for His sTomach
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nausea
Clinical narrative: Very nauseated for 3 days - couldn't bend over I was so sick to my stomach
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Computerised tomogram abdomen, Gastrointestinal obstruction
Clinical narrative: Pt felt fine had shingles shot Next day began to have acute abdominal pain found to have blocksage in ER
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Fall, Feeling cold, Hyperhidrosis
Clinical narrative: On 05/18/19 I received the first Shingrix shot without experiencing side effects.  On 07/17/19 I received the second Shingrix shot at 9:00 a.m. at the same Pharmacy and continued with my usual daily routine. At bed time (about 10:00 p.m.) I suddenly started to shiver uncontrolably and felt ice-cold for several minutes. When the shivers finally subsided, I fell asleep. The next morning (07/18/19) I felt slightly nauseated and very sweaty but forced myself to get up and feed the cat. When I was in the process of setting his bowl on the floor, I lost consciousness and collapsed on the concrete floor. My partner heard the shattering of the food bowl and found me. When I came to he helped me back to bed and called the ER at Hospital. The doctor on duty, urged my partner to bring me to the ER, since I had experienced syncope and collapse. By the time we reached the hospital, I was feeling well again (aside from a couple of bruises from the fall). Because the tests run by the ER staff showed no abnormalities, they concluded that the episode I had experienced was attributable to the Shingrix shot.  It turned out to be a very expensive shot.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Loss of consciousness, Nausea, Syncope
Clinical narrative: On 05/18/19 I received the first Shingrix shot without experiencing side effects.  On 07/17/19 I received the second Shingrix shot at 9:00 a.m. at the same Pharmacy and continued with my usual daily routine. At bed time (about 10:00 p.m.) I suddenly started to shiver uncontrolably and felt ice-cold for several minutes. When the shivers finally subsided, I fell asleep. The next morning (07/18/19) I felt slightly nauseated and very sweaty but forced myself to get up and feed the cat. When I was in the process of setting his bowl on the floor, I lost consciousness and collapsed on the concrete floor. My partner heard the shattering of the food bowl and found me. When I came to he helped me back to bed and called the ER at Hospital. The doctor on duty, urged my partner to bring me to the ER, since I had experienced syncope and collapse. By the time we reached the hospital, I was feeling well again (aside from a couple of bruises from the fall). Because the tests run by the ER staff showed no abnormalities, they concluded that the episode I had experienced was attributable to the Shingrix shot.  It turned out to be a very expensive shot.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, edema left arm
Age: 57.0
Sex: F
Vaccine: FLUR4, TDAP, VARZOS
Symptoms: Erythema, Flushing, Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: -Local reaction to (L) arm vaccine site including redness, swelling, itching and burning in (L) deltoid area.  -Treated with Elocon Cream & Cold compress application -Pt. also experienced redness/flushing of skin on chest
Age: 57.0
Sex: F
Vaccine: FLUR4, TDAP, VARZOS
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: -Local reaction to (L) arm vaccine site including redness, swelling, itching and burning in (L) deltoid area.  -Treated with Elocon Cream & Cold compress application -Pt. also experienced redness/flushing of skin on chest
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Just one case LSIL due to 6/58; This spontaneous report was received from a physician via a company representative referring to unspecified patients, one of them a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported), as primary prevention of anal cancer.  Information was identified on a slide presentation. The following information was reported:  Long-term follow up studies of 4 valent human papillomavirus (HPV) vaccine in male Data 11.5 years No new cases of condilomas fue to HPV 6/11 nor external genital lesions due to 6/11/16/18 No lesion high grade squamous intraepithelial lesion (HSIL) 6/11/16/18 Just one case low grade squamous intraepithelial lesion (LSIL) due to 6/58  On an unknown date, the patient experienced (LSIL). The outcome of the event was unknown.  The causality assessment was not provided by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; One dose of an improperly stored vaccine, VARIVAX, was administered to one patient.; Reporter confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 11-SEP-2019, the patient was vaccinated with one dose of an improperly stored, varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml), intramuscularly, as prophylaxis (strength, number of dose, and anatomical location of vaccination were not reported; lot number S002877 has been verified to be valid for varicella virus vaccine live (oka/merck); expiration date: 29-JAN-2019) (product storage error, and incorrect route of product administration). It was reported that sterile diluent (lot number S000130 has been verified to be valid); expiration date: 23-AUG-2021 (reported as possible dates) was used to reconstitute the aforementioned vaccine , also it was reported that it was stored in the correct storage temperature range.  The temperature and time frame were 8.1 degrees Fahrenheit (°F), for 20 minutes, respectively a previous temperature excursion were at  8.1 degrees Fahrenheit (°F) for 17 minutes and 9.5 degrees Fahrenheit (°F) for 21 minutes. A data logger was used. No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Red welt below injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema urticarial in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the outcome of the erythema urticarial was unknown.   It was unknown if the reporter considered the erythema urticarial to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, but was selected adult as per vaccine indication. The patient developed red welt below the injection site a day after the 1st dose of Shingrix. The symptoms lasted a few days. She did not have data for the 2nd patient. The reporter consented to follow up. This case was linked with the case , reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Influenza like illness, Injection site induration, Injection site pain
Clinical narrative: Site of injection is hard; Site of injection is painful; Site of injection is swollen; Many side effects (flu like); Swollen lymph nodes in neck and a really painful one under arm pit/enlarged lymph node; Malaise; Muscle aches; Temperature; Headache; Pain in left armpit; This case was reported by a consumer and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 1 day after receiving Shingrix, the patient experienced injection site induration, injection site pain, injection site swelling, influenza-like symptoms, lymphadenopathy cervical, malaise, muscle pain, fever, headache and axillary pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site induration, injection site pain, injection site swelling, influenza-like symptoms and malaise were unknown and the outcome of the lymphadenopathy cervical, fever, headache and axillary pain were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving.   It was unknown if the reporter considered the injection site induration, injection site pain, injection site swelling, influenza-like symptoms, lymphadenopathy cervical, malaise, muscle pain, fever, headache and axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient recieved shingrix and had many side effects flu like symptoms. The patient also had swollen lymph nodes in neck and a painful one under my arm pit. The patient had malaise, muscle aches, temperature, Headache, swollen lymph node in neck and pain in her left arm pit yesterday. The patient has worse arm pit pain and an enlarged lymph node. She noted the site of the injection was hard, swollen and painful. She has taken Tylenol and did not feel the muscle aches are better. She still has slight headache and temperature today. She did not believe the lymph node in her left arm pit was decreased in size. The one from her neck has resolved completely.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Myalgia, Pyrexia
Clinical narrative: Site of injection is hard; Site of injection is painful; Site of injection is swollen; Many side effects (flu like); Swollen lymph nodes in neck and a really painful one under arm pit/enlarged lymph node; Malaise; Muscle aches; Temperature; Headache; Pain in left armpit; This case was reported by a consumer and described the occurrence of injection site induration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 1 day after receiving Shingrix, the patient experienced injection site induration, injection site pain, injection site swelling, influenza-like symptoms, lymphadenopathy cervical, malaise, muscle pain, fever, headache and axillary pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site induration, injection site pain, injection site swelling, influenza-like symptoms and malaise were unknown and the outcome of the lymphadenopathy cervical, fever, headache and axillary pain were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving.   It was unknown if the reporter considered the injection site induration, injection site pain, injection site swelling, influenza-like symptoms, lymphadenopathy cervical, malaise, muscle pain, fever, headache and axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient recieved shingrix and had many side effects flu like symptoms. The patient also had swollen lymph nodes in neck and a painful one under my arm pit. The patient had malaise, muscle aches, temperature, Headache, swollen lymph node in neck and pain in her left arm pit yesterday. The patient has worse arm pit pain and an enlarged lymph node. She noted the site of the injection was hard, swollen and painful. She has taken Tylenol and did not feel the muscle aches are better. She still has slight headache and temperature today. She did not believe the lymph node in her left arm pit was decreased in size. The one from her neck has resolved completely.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Severe reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had a severe reaction to the Shingrix vaccination and thought that the reporter should be aware of.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Malaise, Rash erythematous, Rash papular
Clinical narrative: Malaise; Injection site soreness; Patch of pox-like lesions on my abdomen that were raised and red; it did indeed look like shingles; raised Rash / lesion; This case was reported by a consumer and described the occurrence of malaise in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced malaise, injection site pain, red rash, vesicular rash and raised rash. On an unknown date, the outcome of the malaise and injection site pain were unknown and the outcome of the red rash, vesicular rash and raised rash were recovered/resolved.   It was unknown if the reporter considered the malaise, injection site pain, red rash, vesicular rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient had chicken pox as a child and was exposed to it when, the patient's children also had chicken pox. The patient never had shingles previously. The patient had no evidence of severe allergic reaction after vaccination. Less than 2 years after vaccination with dose of Shingrix, the patient experienced red rash, vesicular rash and raised rash . Few days after, the patient had patch of pox like lesions on my abdomen that were raised and red, unlike any type of rash or bug bite. The patient contacted to doctor, who asked to sent a picture of the rash confirmed that it did indeed look like shingles, even though theoretically it should not occur with a non live virus vaccine. The patient stated that, rash resolved in 10 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Malaise; Injection site soreness; Patch of pox-like lesions on my abdomen that were raised and red; it did indeed look like shingles; raised Rash / lesion; This case was reported by a consumer and described the occurrence of malaise in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a child).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced malaise, injection site pain, red rash, vesicular rash and raised rash. On an unknown date, the outcome of the malaise and injection site pain were unknown and the outcome of the red rash, vesicular rash and raised rash were recovered/resolved.   It was unknown if the reporter considered the malaise, injection site pain, red rash, vesicular rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient had chicken pox as a child and was exposed to it when, the patient's children also had chicken pox. The patient never had shingles previously. The patient had no evidence of severe allergic reaction after vaccination. Less than 2 years after vaccination with dose of Shingrix, the patient experienced red rash, vesicular rash and raised rash . Few days after, the patient had patch of pox like lesions on my abdomen that were raised and red, unlike any type of rash or bug bite. The patient contacted to doctor, who asked to sent a picture of the rash confirmed that it did indeed look like shingles, even though theoretically it should not occur with a non live virus vaccine. The patient stated that, rash resolved in 10 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site irritation, Injection site pruritus, Pain in extremity
Clinical narrative: Injection Site Itching; Injection Site Irritation; Sore arm/Difficulty laying on her side due to the sore arm; Chills; Sleepiness; Red 3 inch circle at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on face, about 10 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 10th September 2019, the patient experienced chills and sleepiness. On 12th September 2019, the patient experienced injection site erythema, injection site itching and injection site irritation. On an unknown date, the outcome of the pain in arm, chills, sleepiness and injection site erythema were recovered/resolved and the outcome of the injection site itching and injection site irritation were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, sleepiness, injection site erythema, injection site itching and injection site irritation to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix on left arm. On the day of getting the vaccine, the patient had sore arm that lasted for about 3 days.  Due to the sore arm, she had difficulty laying on her side.  On the next day, the patient experienced chills and sleepiness that lasted for about one day.  On day 3 after vaccination, the patient noticed red 3 inch circle at injection site associated with itching and irritation. After 7 days, the redness had faded but the itching and irritation were still present periodically. The patient did not consent to follow-up. This case has been linked to US2019AMR168832, reported by the same reporter. No further details were provided.