chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Myalgia, Nausea, Pruritus
Clinical narrative: Symptoms within first 24 hrs of receiving vaccine: warmth, pain at injection site, headache, muscle pain, tiredness, fever, nausea, weakness, tiredness, chills.   Symptoms continued for next 24 - 48 hrs: warmth, pain at injection site, muscle pain, itching, baseball size strawberry color appearance on arm around the injection site
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Symptoms within first 24 hrs of receiving vaccine: warmth, pain at injection site, headache, muscle pain, tiredness, fever, nausea, weakness, tiredness, chills.   Symptoms continued for next 24 - 48 hrs: warmth, pain at injection site, muscle pain, itching, baseball size strawberry color appearance on arm around the injection site
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dizziness, Feeling abnormal, Hypoaesthesia, Limb discomfort
Clinical narrative: Employee (patient) was sitting talking and then stated her arm felt numb/heavy, donor lifted arm in lap.  Employee proceeded to stand up and held on to exam table and stated she felt dizzy.  She then laid on her right side and had moments of confusion and then moments of clarity.  She also had a twitch, when additional staff was called in, employee was alert and stated could she go home.  Then employee was having trouble sitting up. BP was 140/88 and pulse 94.  Employee then laid back down and had slow speech and would occasionally stare off.  Employee then called a family member to come pick her up from work, she was also smiling/laughing intermittently. She also stated she had only had coffee today.  She also said she had only approx. 4 hours of sleep. BP was checked again and it was  142/84 pulse 90.  Employee at times seemed dazed/confused or had delayed reaction. Employee laid back down and was talking normal for approx. 5-10 mins and then she began staring off again.  Family member arrived and she left approx. 0940 am.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Muscle twitching, Posture abnormal, Slow speech, Staring
Clinical narrative: Employee (patient) was sitting talking and then stated her arm felt numb/heavy, donor lifted arm in lap.  Employee proceeded to stand up and held on to exam table and stated she felt dizzy.  She then laid on her right side and had moments of confusion and then moments of clarity.  She also had a twitch, when additional staff was called in, employee was alert and stated could she go home.  Then employee was having trouble sitting up. BP was 140/88 and pulse 94.  Employee then laid back down and had slow speech and would occasionally stare off.  Employee then called a family member to come pick her up from work, she was also smiling/laughing intermittently. She also stated she had only had coffee today.  She also said she had only approx. 4 hours of sleep. BP was checked again and it was  142/84 pulse 90.  Employee at times seemed dazed/confused or had delayed reaction. Employee laid back down and was talking normal for approx. 5-10 mins and then she began staring off again.  Family member arrived and she left approx. 0940 am.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site discomfort, Myalgia, Nausea
Clinical narrative: Significant soreness at injection site, muscle aches, flu-like symptoms, some nausea, feeling tired.  Symptoms interfered with sleep and were significant in AM.   Got better as day went on.  Was able to go to work (06/20/2019),  but I was wondering if I could when I first woke up.  I expect symptoms to be resolved by  tomorrow or a bit later.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Significant soreness at injection site, muscle aches, flu-like symptoms, some nausea, feeling tired.  Symptoms interfered with sleep and were significant in AM.   Got better as day went on.  Was able to go to work (06/20/2019),  but I was wondering if I could when I first woke up.  I expect symptoms to be resolved by  tomorrow or a bit later.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Patient reports swelling from left bicep up into the top of left shoulder. Denies any other sympoms
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: patient experience a rash at injection site
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Had fever and vomiting for 3 days.  Per mom cried non-stop for over an hour the day following the vaccine.  Temp 104.5.  No concerns of dehydration.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue/Tired, muscle pain in legs and torso, headache & nausea
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Low grade fever and intermittent vomiting for 5 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vaccination site reaction
Clinical narrative: fever, pain, site reaction
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash morbilliform, Rhinorrhoea, Seizure
Clinical narrative: Seizure 24 hours following vaccine  6-12 days following vaccine fever runny nose cough and measles rash.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Mobility decreased, Pyrexia
Clinical narrative: Fever, unable to raise arm higher than 90 degree and swollen lymph nodes
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Donor has 1.5" by 1.5" warm swollen red area with no pain denies pain denies any other symptoms has full arm use. Donor reports just now noticing the area to right upper arm 06/20/2019 after donation today. Instructed to call or seek medical attention if area worsens or experiences pain or other symptoms  VIS  reviewed with donor.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary mass, Erythema, Induration, Injection site pain, Injection site warmth
Clinical narrative: Erythematous patch shortly after injection, followed by an area of raised induration. Knot felt underneath arm. Pain and warmth at site.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Erythematous patch shortly after injection, followed by an area of raised induration. Knot felt underneath arm. Pain and warmth at site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Malaise
Clinical narrative: Patient called 6/20/19 - She reported general malaise on Saturday 6/15/19 and has felt fine the past few days. Thurday 6/20/19 she reports redness localized to injection site and it is itchy and warm to the touch. She drew a pen around the affected area and will report any changes. It is approximately 1.5 x 3 inch area.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site pain, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: Pain that radiates from the injection site to the chest and scapula. Patient states pain is unbearable and took Tylenol and Motrin for it. Patient also states that she could not sleep because of the pain.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head, Cyanosis, Echocardiogram, Fall, Headache
Clinical narrative: she had a syncope, she said my head hurts too much I have nausea and she touched her stomach and fell to the floor she lost consciousness, then she opened her eyes but she was stiff and blue without being able to breathe was when we called the rescue
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test, Loss of consciousness, Musculoskeletal stiffness, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: she had a syncope, she said my head hurts too much I have nausea and she touched her stomach and fell to the floor she lost consciousness, then she opened her eyes but she was stiff and blue without being able to breathe was when we called the rescue
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Respiratory arrest, Syncope
Clinical narrative: she had a syncope, she said my head hurts too much I have nausea and she touched her stomach and fell to the floor she lost consciousness, then she opened her eyes but she was stiff and blue without being able to breathe was when we called the rescue
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Groin pain, Injection site pain, Joint stiffness, Musculoskeletal pain
Clinical narrative: Patient developed left-sided neck and shoulder pain/stiffness as well as right-sided butt, groin, leg, and knee pain/stiffness.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Patient developed left-sided neck and shoulder pain/stiffness as well as right-sided butt, groin, leg, and knee pain/stiffness.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient developed left-sided neck and shoulder pain/stiffness as well as right-sided butt, groin, leg, and knee pain/stiffness.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Blood glucose normal, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: PT GOT 3 ADACEL, MMR , AND TWINRX. SHE STARTED TO LOSE CONSCIOUSNESS AFTER 3RD SHOT. SHE WAS ABLE TO UNDERSTAND ME, BUT WAS NOT ABLE TO RESPOND. TECH CALLED 911. HER HUSBAND CAME IN TO TALK TO HER TO TRY TO KEEP HER ALERT. PT IS  DIABETIC. I ASK PT THAT MAYBE HER SUGAR WAS TOO LOW? HUSBAND AGREED TO GIVE HER A GLUCOSE TABLET. I CHECKED HER SUGAR LEVEL AFTER 5 MINS- IT WAS 184. SHE STARTED TO FEEL BETTER WHEN EMS ARRIVED. THEY CHECKED HER AND AFTER SITTING THERE FOR AWHILE, SHE REFUSED TO GO TO THE HOSPITAL WITH THEM
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Crepitations, Injected limb mobility decreased, Injection site pain
Clinical narrative: Per patient pain started immediately but they thought it was part of the shot. Pain was intense per patient. Pain lasted for weeks and now has left a click and trouble raising arm high with shoulder
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Next day patient developed fever and her injection site turned red and itchy. Urgent care MD suggested that it could be skin infection so he gave her Doxycycline100mg bid for 10days, hydrocortisone 1% and zyrtec10mg. a few days later patient developed a reaction to the doxycycline that was classified by her primary care MD as an allergic reaction. Her Arm has improved by then and The primary care MD told her to continue hydrocortisone cream and zyrtec and no need for a different antibiotic to replace doxycycline for the suspected skin infection. Patient said that her arm continued to improve without antibiotics until it fully cleared.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Seizure like phenomena, Tension, Tremor
Clinical narrative: Tension, shaking of upper Body x 10 seconds,  Resembling seizure
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Differential white blood cell count, Fibrin D dimer, Full blood count, Injection site pain
Clinical narrative: Side effects - Left arm swelling, very sore to touch, fever, body aches, also reported (L) shoulder & neck pain. Around 6/11/19 - 8:01 pm next day. Scheduled w/ MD for visit still having similar symptoms, pt was advised to take motrin/tylenol for control & ice pack till her appt on 6/12/19. Pt saw Dr., Doctor.'s Overview: on 6/12/19: Taking Tylenol 500 2 tabs & Motrin 400 q6HRS w/worsening pain over time. No H/O PCV in past but gets annual flu shot without event. H/O anaphalaxis to mascara with SOB & angioedema. No SOB, no angioedema, no dysphagia at current time. Doctor's Assessment/Plan @ visit 6/12/19:  - severe local RXN to PCV23, likely not cellulitis or DVT or abscess.  - Ultrasound to eval for DVT or abscess. - Tylenol & Motrin alternating, ice x20 minutes 4x/day.  - Start Zyrtec 10 1 tab daily, & Zantac 150 2xDay until resolved.  - epipen use if develops SOB, cough, or wheeze given history of anaphylactic reaction to mascara.  Relevant Orders: CBC with Diff, CMP, D-Dimer, US. Upper Extremity Arteries Duplex (Bilateral) Final Results: Subcutaneous edema @ the location of vaccination in the left arm. No abscess, no left upper extremity venous thrombosis.  6/14/19: Pt went to urgent care, still having low grade 99.0 fever, swelling & pain. MD final diagnosis states she had cellulits of (L) arm - advised to apply warm compress 3xday for 15 minutes @ a time. Take oral Keflex as prescribed, take probiotic such as Culturelle. Check temp 3 xday. If fever, spreading redness, or worsening symptoms, recheck. Follow up w/PCP.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Neck pain, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Side effects - Left arm swelling, very sore to touch, fever, body aches, also reported (L) shoulder & neck pain. Around 6/11/19 - 8:01 pm next day. Scheduled w/ MD for visit still having similar symptoms, pt was advised to take motrin/tylenol for control & ice pack till her appt on 6/12/19. Pt saw Dr., Doctor.'s Overview: on 6/12/19: Taking Tylenol 500 2 tabs & Motrin 400 q6HRS w/worsening pain over time. No H/O PCV in past but gets annual flu shot without event. H/O anaphalaxis to mascara with SOB & angioedema. No SOB, no angioedema, no dysphagia at current time. Doctor's Assessment/Plan @ visit 6/12/19:  - severe local RXN to PCV23, likely not cellulitis or DVT or abscess.  - Ultrasound to eval for DVT or abscess. - Tylenol & Motrin alternating, ice x20 minutes 4x/day.  - Start Zyrtec 10 1 tab daily, & Zantac 150 2xDay until resolved.  - epipen use if develops SOB, cough, or wheeze given history of anaphylactic reaction to mascara.  Relevant Orders: CBC with Diff, CMP, D-Dimer, US. Upper Extremity Arteries Duplex (Bilateral) Final Results: Subcutaneous edema @ the location of vaccination in the left arm. No abscess, no left upper extremity venous thrombosis.  6/14/19: Pt went to urgent care, still having low grade 99.0 fever, swelling & pain. MD final diagnosis states she had cellulits of (L) arm - advised to apply warm compress 3xday for 15 minutes @ a time. Take oral Keflex as prescribed, take probiotic such as Culturelle. Check temp 3 xday. If fever, spreading redness, or worsening symptoms, recheck. Follow up w/PCP.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Ultrasound scan, Vaccination site oedema
Clinical narrative: Side effects - Left arm swelling, very sore to touch, fever, body aches, also reported (L) shoulder & neck pain. Around 6/11/19 - 8:01 pm next day. Scheduled w/ MD for visit still having similar symptoms, pt was advised to take motrin/tylenol for control & ice pack till her appt on 6/12/19. Pt saw Dr., Doctor.'s Overview: on 6/12/19: Taking Tylenol 500 2 tabs & Motrin 400 q6HRS w/worsening pain over time. No H/O PCV in past but gets annual flu shot without event. H/O anaphalaxis to mascara with SOB & angioedema. No SOB, no angioedema, no dysphagia at current time. Doctor's Assessment/Plan @ visit 6/12/19:  - severe local RXN to PCV23, likely not cellulitis or DVT or abscess.  - Ultrasound to eval for DVT or abscess. - Tylenol & Motrin alternating, ice x20 minutes 4x/day.  - Start Zyrtec 10 1 tab daily, & Zantac 150 2xDay until resolved.  - epipen use if develops SOB, cough, or wheeze given history of anaphylactic reaction to mascara.  Relevant Orders: CBC with Diff, CMP, D-Dimer, US. Upper Extremity Arteries Duplex (Bilateral) Final Results: Subcutaneous edema @ the location of vaccination in the left arm. No abscess, no left upper extremity venous thrombosis.  6/14/19: Pt went to urgent care, still having low grade 99.0 fever, swelling & pain. MD final diagnosis states she had cellulits of (L) arm - advised to apply warm compress 3xday for 15 minutes @ a time. Take oral Keflex as prescribed, take probiotic such as Culturelle. Check temp 3 xday. If fever, spreading redness, or worsening symptoms, recheck. Follow up w/PCP.
Age: 53.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Contusion, Pain in extremity
Clinical narrative: The patient came in on 6/19/19 at 5:30pm and told me he'd had extensive bruising and soreness in his right arm after receiving vaccines at our pharmacy on 6/5/19. He said he sought treatment at the ER but didn't specify when or what treatment he received there. His right arm was still mildly bruised when I examined it. He believes the administering pharmacist "twisted the needle" when withdrawing a needle after giving one of the vaccines. He did not ask for medical advice, he simply wanted to let me know about the incident. I alerted his PCP, Dr, about the incident. She did not recommend further treatment.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe burning pain in shoulder where the injection was administered for 2 days. Right arm was mostly immobile during this time and had to use the left arm to lift/move the right arm. That pain changed to a continuous aching pain that lasted for several months.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Swollen injection site Sore "         " itching red bumbs over body
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Leg pain from the knee down. Hurts to walk. Getting worse
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Seizure
Clinical narrative: Seizure activity reported by dad occurring at home morning of 6/18/19
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Sleep apnoea syndrome, Syncope, Vertigo
Clinical narrative: vertigo; pins in hands/ pins and needles in her hands; sleep apnea; dizziness; This case was reported by a physician via call center representative and described the occurrence of dizziness in a female patient who received HAB (Twinrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Twinrix. On an unknown date, less than a month after receiving Twinrix, the patient experienced dizziness, vertigo, pins and needles and sleep apnea. On 12th June 2019, the outcome of the dizziness, vertigo, pins and needles and sleep apnea were recovered/resolved.   It was unknown if the reporter considered the dizziness, vertigo, pins and needles and sleep apnea to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated she was moving out of the country in a few weeks, but could be reached by email address or by phone if needed The patient had talked to someone from Glaxosmithkline (GSK) on that morning, but did not know who it was. The patient had a Twinrix vaccination and experienced dizziness, vertigo, and pins and needles in her hands for approximately two weeks. The patinet also experienced sleep apnea for approximately two days. The patinet was consulted her provider.  The patient issues were resolved as of 12th June 2019. The patinet did not know what the lot number or expiration date for the Twinrix vaccine she received.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Paraesthesia, Sleep apnoea syndrome, Vertigo
Clinical narrative: vertigo; pins in hands/ pins and needles in her hands; sleep apnea; dizziness; This case was reported by a physician via call center representative and described the occurrence of dizziness in a female patient who received HAB (Twinrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Twinrix. On an unknown date, less than a month after receiving Twinrix, the patient experienced dizziness, vertigo, pins and needles and sleep apnea. On 12th June 2019, the outcome of the dizziness, vertigo, pins and needles and sleep apnea were recovered/resolved.   It was unknown if the reporter considered the dizziness, vertigo, pins and needles and sleep apnea to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated she was moving out of the country in a few weeks, but could be reached by email address or by phone if needed The patient had talked to someone from Glaxosmithkline (GSK) on that morning, but did not know who it was. The patient had a Twinrix vaccination and experienced dizziness, vertigo, and pins and needles in her hands for approximately two weeks. The patinet also experienced sleep apnea for approximately two days. The patinet was consulted her provider.  The patient issues were resolved as of 12th June 2019. The patinet did not know what the lot number or expiration date for the Twinrix vaccine she received.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Identified in initial block
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Flu-like:  Fever up to 100.1, swollen lymph nodes in neck, painful arm with milder pain radiating outward to neck, lower arm, and right shoulder.  Second days saw all symptoms get better but not gone.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Flu-like:  Fever up to 100.1, swollen lymph nodes in neck, painful arm with milder pain radiating outward to neck, lower arm, and right shoulder.  Second days saw all symptoms get better but not gone.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient has the shingles on his arm and back / The rash started on holiday/ the rash starts at his arm and goes up his shoulder blade/ patient was diagnosed with shingles; Initial and follow-up information was received from a consumer referring her son, a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug allergies or previous reactions, and concomitant medications, were not reported.  Approximately on 12-APR-2019, also reported as "around 12-APR-2019, on or after this date", the patient was vaccinated with a dose of an unspecified "chickenpox vaccine", it was later confirmed by the reporter that the vaccine was varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, route of administration, anatomical location of injection site, lot # and expiration date were not reported).         On 27-MAY-2019, the patient developed a rash that started on his arm and went up to his shoulder blade, the mother first reported it as shingles. On 03-JUN-2019, the patient was medically diagnosed with shingles (herpes zoster). The patient sought medical attention and visited the doctor's office, and received treatment due to the event. It was reported that no laboratory diagnostics or studies were performed.  By the time of this report, the patient was not recovered from the event.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) administration and shingles (herpes zoster) occurrence was reported as related.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a dose of PROQUAD was inadvertently administered instead of VARIVAX/ this was human error and not product confusion; No adverse effects reported; This spontaneous report was received from a registered nurse, referring to a 1 year and 12 days old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.     On an unknown date, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis instead of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, route, dosage schedule, lot number and expiration date were not reported). Confirmed that this was human error and not product confusion.   No adverse effects were reported.
Age: 4.0
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Cough, Nasal congestion, Respiratory tract oedema, Wheezing
Clinical narrative: wheezing and swelling of the airway; coughing and nasal stuffiness; coughing and nasal stuffiness/ swelling of the nasal mucosa; wheezing and swelling of the airway; This spontaneous report was received from a physician and refers to a 4-year-old male patient. The patient had no concurrent conditions, medical history, concomitant medications and drug reactions or allergies.  On 11-JUN-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # R035700, expiry date: 09-DEC-2020 (dose, route of administration and anatomical location were not provided) and with a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # R035222, expiry date: 04-DEC-2020 (dose, route of administration and anatomical location were not reported), reconstituted with sterile diluent (dose, route of administration, lot #, expiry date and anatomical location were not provided), for routine immunization.   On 11-JUN-2019, within 5 minutes after vaccination, the patient experienced coughing and nasal stuffiness. Physician stated that upon examination the patient had swelling of nasal mucosa. The reporter also stated that when she examined the patient on the same date prior to vaccination, he did not have any swelling of the nasal mucosa while in the doctor's office. The patient received unspecified nasal drops for the swelling of the nasal mucosa. The patient then experienced wheezing and swelling of the airway, while still in doctor's office. The physician stated that the patient was administered an age appropriate dose of epinephrine and albuterol nebulizer treatment. The emergency number was called while the patient was still in the doctor's office. It was reported that the patient improved while in the office. He was transported via ambulance to the emergency room and was observed for 4 hours. No lab diagnostics or studies were performed.  The patient recovered from the events on 11-JUN-2019. The relatedness between the events and suspect therapies were not provided. The reporter requested lot checks for both vaccines.  The reporter considered the event of swelling of the airway as life threatening.  Upon internal review, the event of swelling of the airway was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Culture urine, Erythema, Limb injury, Pain in extremity, Skin warm
Clinical narrative: urinary tract infection; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; This spontaneous report was received from a nurse concerning to a 67 year old female patient. The patient's current conditions included hypertension, hypercholesterolaemia, diverticulitis, gastric ulcer, vitamin d deficiency, gastrooesophageal reflux disease. The patient's concomitant therapies included omeprazole (PRILOSEC), pravastatin, meloxicam (MOBIC), glucosamine, valsartan (DIOVAN) and vitamin d (unspecified). The patient' s drugs allergies included penicillin (unspecified), quinapril hydrochloride (ACCUPRIL) and sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA).  On 11-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, once dose, by intramuscular route (lot # R024025 and expiration date 02-SEP-2020) for pneumococcal prevention. On 12-JUN-2019, the patient developed a urinary tract infection on the night (clarified as burning and pressure). On 13-JUN-2019, the patient arrived back to clinic for medical attencion. While at the clinic, the patient ''barely hit her arm against the counter (limb injury), and her right deltoid was red, warm, and felt kind of sore''. She patient had performed a culture/sensitive and complete urinalysis (U/A) (results were pending). The patient was thus prescribed cephalexin (KEFLEX) 500 mg capsules by mouth three times daily.   The outcome of urinary tract infection, erythema, pain in extremity, feeling hot and limb injury was reported as not recovered.    The causal relationship between the events with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  was not provided.
Sex: F
Vaccine: PPV
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: urinary tract infection; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; barely hit her arm against the counter, and her right deltoid was red, warm, and felt kind of sore"; This spontaneous report was received from a nurse concerning to a 67 year old female patient. The patient's current conditions included hypertension, hypercholesterolaemia, diverticulitis, gastric ulcer, vitamin d deficiency, gastrooesophageal reflux disease. The patient's concomitant therapies included omeprazole (PRILOSEC), pravastatin, meloxicam (MOBIC), glucosamine, valsartan (DIOVAN) and vitamin d (unspecified). The patient' s drugs allergies included penicillin (unspecified), quinapril hydrochloride (ACCUPRIL) and sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA).  On 11-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, once dose, by intramuscular route (lot # R024025 and expiration date 02-SEP-2020) for pneumococcal prevention. On 12-JUN-2019, the patient developed a urinary tract infection on the night (clarified as burning and pressure). On 13-JUN-2019, the patient arrived back to clinic for medical attencion. While at the clinic, the patient ''barely hit her arm against the counter (limb injury), and her right deltoid was red, warm, and felt kind of sore''. She patient had performed a culture/sensitive and complete urinalysis (U/A) (results were pending). The patient was thus prescribed cephalexin (KEFLEX) 500 mg capsules by mouth three times daily.   The outcome of urinary tract infection, erythema, pain in extremity, feeling hot and limb injury was reported as not recovered.    The causal relationship between the events with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  was not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; intramuscular rather then subcutaneous route; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 29-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# N02146 has been verified to be non-valid; expiration date reported as 24-SEP-2019) by the intramuscular rather than subcutaneous route for prophylaxis (incorrect route of product administration). No adverse effects reported. The outcome of the event is unknown.
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did receive PEDVAXHIB series 2doses as an infant in 2003; No adverse event; This spontaneous report as received from a medical assistant refers to a 15 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2003(reported as near 2003), the patient was vaccinated with 2 doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) as an infant. On 17-JUN-2019, the patient was inadvertently vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R005114, 26-NOV-2020 dose 3, intramuscular for prophylaxis as the nurse retrieved vaccine in error. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 23-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: bald spots from the left side of her head, from the crown to the back/her hais is falling out in clumps/she is going bald; This spontaneous report as received from a consumer refers to her approximately 30 year old no pregnant daughter with no pertinent medical history or drug reactions or allergies. On an unspecified date in 2014, the patient was vaccinated with a dose (reported as shot) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported). There were no concomitant medications.          On an unknown date, " a couple months ago", the patient experienced bald spots from the left side of her head, from the crown to the back. Her hair was falling out in clumps, in the shower, she was going bald. The patient visited multiple doctors and received treatment for the adverse event. The patient's mother stated that patient's doctors thought it might be alopecia, but they did not know what it was. There were no laboratory tests or studies performed. At the time of the report, the patient had not recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had high fever after Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: feel weak; exhausted; feel like a I have been run over by a truck; This case was reported by a consumer via call center representative and described the occurrence of feelings of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced feelings of weakness, exhaustion and feeling unwell. On an unknown date, the outcome of the feelings of weakness, exhaustion and feeling unwell were unknown.   It was unknown if the reporter considered the feelings of weakness, exhaustion and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked how long do the side effects from the shingles vaccine last. The patient felt like the patient had been ran over by a truck. The patient was felt weak and exhausted. It was reported that the, if the patient would feel like this the day after reporting, I would have to call in sick.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain in jaw, Pyrexia
Clinical narrative: Fever; muscle aches; jaw pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, muscle pain and jaw pain. On an unknown date, the outcome of the fever, muscle pain and jaw pain were unknown.   It was unknown if the reporter considered the fever, muscle pain and jaw pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix a day before the date of reporting and had fever and muscle aches also had jaw pain. The patient asked whether these events had ever been reported.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick/ill; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. 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 information broadcasted in the radio the new shingle shots had made a lot of people ill. The reporter asked was this a side effect.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Basophil percentage decreased, Blood immunoglobulin G, Blood test, Eosinophil percentage increased, Granulocyte percentage
Clinical narrative: Thrombocytopenia; This case was reported by a physician and described the occurrence of thrombocytopenia in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the thrombocytopenia was recovering/resolving.   It was unknown if the reporter considered the thrombocytopenia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix in left deltoid. The patient developed severe thrombocytopenia (platelets 0) after the receiving of the of Shingrix. The patient was admitted to the intensive care unit (ICU), received 2 pools of platelets, IVIG and high doses of steroids, and platelets are somewhat improved at the date of reporting. Several lab tests were performed.      Lab Comments: On 15th June 2019, poikil, ovalo and polych was 1 plus.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Haematocrit decreased, Haemoglobin decreased, Immunoglobulin therapy, Intensive care, Lymphocyte count decreased
Clinical narrative: Thrombocytopenia; This case was reported by a physician and described the occurrence of thrombocytopenia in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the thrombocytopenia was recovering/resolving.   It was unknown if the reporter considered the thrombocytopenia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix in left deltoid. The patient developed severe thrombocytopenia (platelets 0) after the receiving of the of Shingrix. The patient was admitted to the intensive care unit (ICU), received 2 pools of platelets, IVIG and high doses of steroids, and platelets are somewhat improved at the date of reporting. Several lab tests were performed.      Lab Comments: On 15th June 2019, poikil, ovalo and polych was 1 plus.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume increased
Clinical narrative: Thrombocytopenia; This case was reported by a physician and described the occurrence of thrombocytopenia in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the thrombocytopenia was recovering/resolving.   It was unknown if the reporter considered the thrombocytopenia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix in left deltoid. The patient developed severe thrombocytopenia (platelets 0) after the receiving of the of Shingrix. The patient was admitted to the intensive care unit (ICU), received 2 pools of platelets, IVIG and high doses of steroids, and platelets are somewhat improved at the date of reporting. Several lab tests were performed.      Lab Comments: On 15th June 2019, poikil, ovalo and polych was 1 plus.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Monocyte percentage increased, Neutrophil count normal, Neutrophil percentage increased, Platelet count decreased, Platelet transfusion
Clinical narrative: Thrombocytopenia; This case was reported by a physician and described the occurrence of thrombocytopenia in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the thrombocytopenia was recovering/resolving.   It was unknown if the reporter considered the thrombocytopenia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix in left deltoid. The patient developed severe thrombocytopenia (platelets 0) after the receiving of the of Shingrix. The patient was admitted to the intensive care unit (ICU), received 2 pools of platelets, IVIG and high doses of steroids, and platelets are somewhat improved at the date of reporting. Several lab tests were performed.      Lab Comments: On 15th June 2019, poikil, ovalo and polych was 1 plus.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell count decreased, Red cell distribution width normal, Thrombocytopenia, White blood cell count decreased
Clinical narrative: Thrombocytopenia; This case was reported by a physician and described the occurrence of thrombocytopenia in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 2 days after receiving Shingrix, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the thrombocytopenia was recovering/resolving.   It was unknown if the reporter considered the thrombocytopenia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 81 or 82 years. The patient received Shingrix in left deltoid. The patient developed severe thrombocytopenia (platelets 0) after the receiving of the of Shingrix. The patient was admitted to the intensive care unit (ICU), received 2 pools of platelets, IVIG and high doses of steroids, and platelets are somewhat improved at the date of reporting. Several lab tests were performed.      Lab Comments: On 15th June 2019, poikil, ovalo and polych was 1 plus.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Incorrect route of product administration, Injection site induration, Injection site pain
Clinical narrative: severe pain at injection site; hard/firm infiltrate; severe pain in her shoulder join; Inappropriate route of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intraarticular). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, injection site induration, joint pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and joint pain were recovering/resolving and the outcome of the injection site induration and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site induration and joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix intra-articularly and experienced instant severe pain in her shoulder joint and the pain was there for at least a week, then started to subside very gradually. There was a mark at the site of injection and the infiltrate was hard/firm. The HCP did not have the patient's initials, exact age, date of administration, or lot/exp as it was given at a different facility. There is a discrepancy with respect to the event sever injection site pain, in structural field it is given hopwever as per narrative description there is no mention about sever injection site pain. As per narrative description the patient experienced instant severe pain in her shoulder joint. Hence it is coded along with the sever injection site pain.