chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm, Swelling face
Clinical narrative: The patient came to the pharmacy on 4/2/19 she said that she has an adverse reaction due a vaccine that she received in our pharmacy. On 3/27/19 two vaccines FLUARIX on right arm and PNEUMOVAX on left arm. On 3/29/19 she said that her left arm was swelling and hot but nothing further. On 3/30/19 the back of her ear was swelling then on Sunday 3/31/2019 the forehead was swelling and on Monday April 1, 2019 the area under the eyes start swelling she visit her primary physician on 4/2/19. Her primary physician sent a prescription of Methylprednisolone Dose pack.  Dr. (her primary physician) said that the patient apparently has an allergic reaction that her arm do not appear to has infection just a normal reaction at the site of the injection but her eyes are swelling he prescribe corticosteroids to relief the inflammation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS TO INJECTION SITE AND SURROUNDING AREA. GIVEN ZYRTEC AND BACTROBAN OINTMENT.
Age: 3.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Tdap vaccine on 3/15/19. Patient should of received Dtap considering she is age 3. No adverse affects reported to date 4/2/19.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: VERY LARGE AREA (COVERED ENTIRE UPPER ARM) OF REDNESS AND SWELLING - ALSO WARM TO TOUCH. APPLIED HYDROCORTISONE CREAM. ATARAX AN BACTROBAN OINTMENT PRESCRIBED.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Malaise, Pyrexia
Clinical narrative: Patient called the next day and reported injection site soreness and flu-like symptoms. She went home for the remainder of the day to rest. As the day progressed the experienced worsening of the Sx and reported a fever as high as 102. She continued with ibuprofen and rest. Sx started to subside around 3 PM on 03/29/2019 and she was afebrile as of 6 PM on 03/29/2019. Still is reporting feeling of malaise, but has returned to work.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: SLIGHT SWELLING ON INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Contusion, Rash, Swelling
Clinical narrative: Severe bruising underneath left arm and down left side onto breast and torso. Swollen underneath arm and in armpit. Sore under vaccinated arm. Bruising began on Saturday (vaccine was given on Thursday) presenting as dots and rope like down the arm and under arm. Bruising on breast and torso appeared on Monday.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion
Clinical narrative: Severe bruising underneath left arm and down left side onto breast and torso. Swollen underneath arm and in armpit. Sore under vaccinated arm. Bruising began on Saturday (vaccine was given on Thursday) presenting as dots and rope like down the arm and under arm. Bruising on breast and torso appeared on Monday.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Subjective fever, chills, body aches beginning around 0100 AM on 3/28. Took ALEVE in AM - symptoms resolved around 5 PM 3/28 with the exception of a rash at the vaccine site. Rash is tender, improving since initial injection. Rash is not painful or hard. Size of a Soup Can Lid.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain, Pruritus, Swelling
Clinical narrative: Patient got her first SHINGRIX vaccine at pharmacy approximately 6 months ago prior to coming here for her second dose on 3/7/19. She told me that when she got her first shot at pharmacy, the pain/redness disappeared about one week. After receiving her second vaccine shot by the staff pharmacist, she has been experiencing redness, swelling, and itching for a little over 3 weeks. She did not see a doctor or use any medications to help treat her symptoms after 3/7/19. She was given Hydrocortisone 1% cream with Aloe on 3/30/19 when she came into the store after speaking about her symptoms. She has been using the OTC medication for the past several days and since 4/2/19, the swelling/itching has subsided, the redness slightly got lighter, but she still states that she is still tender at the injection site. It seems like her symptoms have been improving after using the Hydrocortisone 1% cream w/Aloe.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Haematoma, Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Received HPV #4 on 3/11/19. CAME TO OFFICE TODAY 4/2/19. 5 days ago noticed a bump on the LEFT arm WHERE THE SHOT WAS ADMINISTERED. Painful to touch. Slight erythema over the site. Unable to extend arm fully due to pain. General: Well appearing patient, no acute distress. Extremities: Small 2 cm area of induration top of L deltoid, minimal surrounding erythema, very tender. Problem 1: HEMATOMA OF ARM. Cool compresses. MOTRIN or BENADRYL. Call for significant enlargement. Should resolve over time. Orders: EPF/Low - Est. Problem 2: VACCINE ADVERSE REACTION. Will report.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: Received HPV #4 on 3/11/19. CAME TO OFFICE TODAY 4/2/19. 5 days ago noticed a bump on the LEFT arm WHERE THE SHOT WAS ADMINISTERED. Painful to touch. Slight erythema over the site. Unable to extend arm fully due to pain. General: Well appearing patient, no acute distress. Extremities: Small 2 cm area of induration top of L deltoid, minimal surrounding erythema, very tender. Problem 1: HEMATOMA OF ARM. Cool compresses. MOTRIN or BENADRYL. Call for significant enlargement. Should resolve over time. Orders: EPF/Low - Est. Problem 2: VACCINE ADVERSE REACTION. Will report.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches, stomach discomfort.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Besides a sore arm after the injection, later in the evening I began to have some fibromyalgia symptoms. The fibromyalgia had been in remission since 2006 when I started taking a small dose of amitriptyline before bedtime. The fibromyalgia has increased in intensity in the days since January 19 and appears to be becoming chronic again. So far, I have taken extra strength TYLENOL and (homeopathic) rhus toxicodendron plus rubbing "DOTERRA DEEP BLUE RUB (a cooling agent) onto the most painful areas besides the arnica gel that I normally use. The fibromyalgia is starting to interfere with my daily activities so I will be contacting my primary care physician for ways to ease the symptoms and to learn the advisability of having the second dose of SHINGRIX vs the risk of getting shingles.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Fibromyalgia, Myalgia
Clinical narrative: Besides a sore arm after the injection, later in the evening I began to have some fibromyalgia symptoms. The fibromyalgia had been in remission since 2006 when I started taking a small dose of amitriptyline before bedtime. The fibromyalgia has increased in intensity in the days since January 19 and appears to be becoming chronic again. So far, I have taken extra strength TYLENOL and (homeopathic) rhus toxicodendron plus rubbing "DOTERRA DEEP BLUE RUB (a cooling agent) onto the most painful areas besides the arnica gel that I normally use. The fibromyalgia is starting to interfere with my daily activities so I will be contacting my primary care physician for ways to ease the symptoms and to learn the advisability of having the second dose of SHINGRIX vs the risk of getting shingles.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Severe low back pain. At site of pain, skin was red and hot to the touch. There were also several other "hot spots" along spine. Also general feelings of illness, pain at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Severe low back pain. At site of pain, skin was red and hot to the touch. There were also several other "hot spots" along spine. Also general feelings of illness, pain at injection site.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Pruritus generalised, Tremor
Clinical narrative: At 1130 Vaccine administered IM to L deltoid. At 1136 Employee states that a burning sensation to left arm. At 1138 Employee states that itching began BP: 138/92 Pulse: 94. At 1145 Employee states that she was itching all over body. BP: 142/98 Pulse: 100. BENADRYL 50mg given PO. At 1155 BP: 140/90 Pulse: 88. At 1200 Employee began shaking, still complains of itching all over body. At 1210 Employee was driven to Clinic by another employee. Employee states that at Clinic she was monitored until stable and given a prescription for ZYRTEC and scheduled for a follow up appointment. Clinic physician recommended colloidal oatmeal bath treatment. Employee states that she currently has mild itching.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chest pain, Dizziness, Headache, Musculoskeletal pain, Pain
Clinical narrative: Patient came to pharmacy after 24 hrs of vaccination complaining of throbbing pain on left side from head through left arm, shoulder, chest pain. his blood pressure was normal 120/73. Complained of dizziness and soreness on the left arm. Referred him to check with his doctor. Patient was reluctant to call office. Took aspirin after couple hrs of this pain, he feels little better now than before, still with some throbbing pain.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy after 24 hrs of vaccination complaining of throbbing pain on left side from head through left arm, shoulder, chest pain. his blood pressure was normal 120/73. Complained of dizziness and soreness on the left arm. Referred him to check with his doctor. Patient was reluctant to call office. Took aspirin after couple hrs of this pain, he feels little better now than before, still with some throbbing pain.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Cardiac arrest, Death
Clinical narrative: Spoke with mother 04/01/2019 called clinic stated patient had a cardiac arrest on 09/28/2018 and would like a Vaers completed.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Chest pain, Headache, Muscle spasms
Clinical narrative: Patient complained of pain in lower back and spasms, as well as headache. Initially complained of chest pain but says that improved over time.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Dyspnoea, Headache, Spinal pain, Tremor
Clinical narrative: Patient complained of pain in lower back and spasms, as well as headache. Initially complained of chest pain but says that improved over time.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt's arm started just red around injection site (2 days after injection), then came into pharmacy on 3-31-19 and redness spread over her entire upper arm and was slightly warm to the touch. She went to see her PCP on Monday 4-1-19, and was given rxs for KEFLEX and a MEDROL dose pack.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lethargy, Malaise, Pyrexia, Rash generalised
Clinical narrative: Low grade fever within 6 days of vaccine followed by rash of small bumps throughout the body, lethargy, malaise.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyschromatopsia, Fall, Head injury, Headache, Hypersomnia
Clinical narrative: PATIENT RECEIVED VACCINATION AT 12 PM ON 3/31/2019. SHE SAID HER LOW GRADE FEVER (99.2 - 99.3) AND A HEADACHE. SHE WOKE UP 4/1/2019 AND SAID HER VISION WAS NOT BLURRY, BUT THAT COLORS DID NOT LOOK CORRECT. SHE FELL AT 6:30 AM AND HIT HER HEAD, ELBOW, AND BACK FROM WHEN SHE BECAME UNCONSCIOUS. SHE SAID SHE WAS UNCONSCIOUS FOR APPROX. 10 MINUTES. SHE DID NOT EAT ON 3/31/2019 AND SLEPT MOST OF 4/1/2019. SHE SAID HER ARM WAS SWOLLEN ON 3/31/2019 BUT IS BACK TO NORMAL NOW.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypophagia, Joint injury, Loss of consciousness, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT RECEIVED VACCINATION AT 12 PM ON 3/31/2019. SHE SAID HER LOW GRADE FEVER (99.2 - 99.3) AND A HEADACHE. SHE WOKE UP 4/1/2019 AND SAID HER VISION WAS NOT BLURRY, BUT THAT COLORS DID NOT LOOK CORRECT. SHE FELL AT 6:30 AM AND HIT HER HEAD, ELBOW, AND BACK FROM WHEN SHE BECAME UNCONSCIOUS. SHE SAID SHE WAS UNCONSCIOUS FOR APPROX. 10 MINUTES. SHE DID NOT EAT ON 3/31/2019 AND SLEPT MOST OF 4/1/2019. SHE SAID HER ARM WAS SWOLLEN ON 3/31/2019 BUT IS BACK TO NORMAL NOW.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscle spasms, Pain, Pain in extremity, Paraesthesia
Clinical narrative: RASH ON ARM, WHEEZING, PAIN IN FOOT (SPASM), SHIVERING, ACHES, AND TINGLING BACK. LEFT MESSAGE WITH DR. PATIENT CONTACTING DR AS WELL.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Wheezing
Clinical narrative: RASH ON ARM, WHEEZING, PAIN IN FOOT (SPASM), SHIVERING, ACHES, AND TINGLING BACK. LEFT MESSAGE WITH DR. PATIENT CONTACTING DR AS WELL.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site discomfort, Vaccination site mass, Vaccination site pain
Clinical narrative: PATIENT DESCRIBED GETTING A LUMP AT VACCINATION SITE THAT IS A BIT PAINFUL, BUT TOLERABLE AND UNCOMFORTABLE WHEN SHE LEANS ON IT WHEN SLEEPING. OTHER THAN THAT, NO OTHER SIDE EFFECTS.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Facial pain, Headache, Nausea
Clinical narrative: Fever of 101.8, Chills, Nausea, Body Aches, Right side of head and face hurt, Arm red and sore.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101.8, Chills, Nausea, Body Aches, Right side of head and face hurt, Arm red and sore.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pyrexia, Sinusitis
Clinical narrative: Patient states got a fever day after receiving the immunization which happened for 2 days. Received Prednisone 20 mg take one tablet 2 times a day for 5 days on 1/14/2019 because of a sinus infection. 3 months later a bump has developed at the injection site. Patient states that they have not seen a doctor about their arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: The doctor suggested I should get a pneumococcal conjugate vaccine because I am over 65. I never had this vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram abnormal, Muscle spasms, Seizure like phenomena
Clinical narrative: Spasms of the hands/face to resemble seizures every 3-5 minutes for over 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Tenderness, Urticaria
Clinical narrative: 3 inch diameter local reaction consisting of raised redness and tenderness. Facial hives with itching. No breathing difficulty.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: According to pt, redness, swelling at injection site for at least 4 weeks. After 3 months, pt still feels knot at injection site. MD has been contacted today 4/2/2019 for this issue.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pain, Pyrexia, Tachyphrenia
Clinical narrative: This was the 2nd shot of the new shingles vaccine. After the first shot 4 months ago I had some modest fever, chills, achiness that evening, but it was gone the next day. After this 2nd shot, I got the same symptoms that evening but they continued all through today (the 2nd day)--they are still with me although beginning to diminish. I kind of expected these symptoms although not of this intensity. But the strange thing is last night I could not sleep at all night. I laid in bed trying to sleep but my mind kept racing at 100 mph all night, almost like I was drugged up on something; I could not stop it and could not sleep at all (as in 0 sleep). I certainly hope I can sleep tonight.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram head normal, Depressed level of consciousness, Electroencephalogram, Encephalopathy, Inflammation
Clinical narrative: Shortly after receiving vaccinations, pt developed somnolence progressing to lethargy and eventually obtundation. Pt admitted to PICU and an infectious/metabolic workup is ongoing (all essentially negative thus far). Labs demonstrate a mild to moderate inflammatory state however patient remains profoundly encephalopathic and is mechanically ventilated.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intensive care, Laboratory test, Laboratory test abnormal, Lethargy, Mechanical ventilation
Clinical narrative: Shortly after receiving vaccinations, pt developed somnolence progressing to lethargy and eventually obtundation. Pt admitted to PICU and an infectious/metabolic workup is ongoing (all essentially negative thus far). Labs demonstrate a mild to moderate inflammatory state however patient remains profoundly encephalopathic and is mechanically ventilated.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Somnolence
Clinical narrative: Shortly after receiving vaccinations, pt developed somnolence progressing to lethargy and eventually obtundation. Pt admitted to PICU and an infectious/metabolic workup is ongoing (all essentially negative thus far). Labs demonstrate a mild to moderate inflammatory state however patient remains profoundly encephalopathic and is mechanically ventilated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: 1 day post second SHINGRIX vaccination developed severe muscle and joint pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: After receiving SHINGRIX IM I developed a headache, severe chills, muscle pains and injection site pain. Also noted to have swollen lymph nodes under the arm where I got the shot. Symptoms have lasted 3 days now without improvement.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: 15 hours after SHINGRIX vaccination, pt reports N and V, fever of 100.8 degrees, severe headache, malaise, Symptoms lasted 12 hours, then subsided.
Age: 39.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Urticaria
Clinical narrative: Received an HPV and flu shot on 3/29 and broke out in hives all over body. Noticed graffiti around the hospital.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Influenza like illness, Pain
Clinical narrative: On 04/02/2019 the patient called to report an adverse event. Beginning after the vaccination on 03/14/2019 the patient reports a "very upset stomach", "whole body pain/flu-like symptoms", "left-knee pain ever since" and "staying in bed for 3 days".
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cough, Rash, Rash pruritic, Urticaria
Clinical narrative: Vaccines were given at around 1030. Mom brought child back at around 1330 because of itchy rash on trunk, arms, neck. On exam, child was coughing but no wheezing. Oropharynx normal. She had hives on trunk. Will have her take BENADRYL and f/up 4/3.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Urticaria
Clinical narrative: Hives on face for 10-15 minutes then went away, Rx sent to pharmacy for BENADRYL.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Severe swelling, redness of arm, pain and stiffness. Developed small blisters around redness. Headache, nausea, muscle ache all joints. Slight fever. Later after 4 days-developed severe itch. It still itches.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Severe swelling, redness of arm, pain and stiffness. Developed small blisters around redness. Headache, nausea, muscle ache all joints. Slight fever. Later after 4 days-developed severe itch. It still itches.
Age: 59.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Deafness, Eustachian tube dysfunction, Tympanometry abnormal
Clinical narrative: After receiving ADACEL TDaP vaccine at my primary provider office I began to experience hearing loss about 3 days later. I also received FLUZONE-QUAD at the same visit. This hearing difficulty persists to this date.
Sex: F
Vaccine: MMR
Symptoms: Dehydration, Pyrexia, Vomiting
Clinical narrative: This spontaneous report concerning a currently 16-year-old female patient was received from the patient's mother. The patient's medical history and concurrent conditions were not reported. The patient had history of allergy to "pink eye drops, same stabilizer as used in MMR, and ear drops". In approximately 2002 (reported as "17 years ago" - conflicting information), the patient was vaccinated with her first dose of M-M-R II for prophylaxis (dose, route, lot # and expiration date were unknown). Concomitant medications were not reported. Within 1 hour of vaccination, the patient experienced "severe vomiting, could not keep anything down and had a low grade fever". The vomiting led to dehydration, so the patient went to the hospital where she was admitted overnight (also reported as less than 24 hours). She received unspecified treatment; however no laboratory diagnostics were performed. At the time of reporting, the patient had recovered from the events. The causality assessment between the events and M-M-R II was not provided.
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer refers to a 65 year old male patient. The patient's medical history included hypertension and concurrent condition was allergic to bee stings. On 25-MAR-2019 the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number and expiration date were unknown) intramuscular for prophylaxis. Concomitant therapies included Lisinopril (LISINOPRIL) (manufacturer unknown) and red yeast (RED YEAST) (manufacturer unknown). On 25-MAR-2019,around 7pm the patient experienced severe pain radiating down his left arm to his fingertips and was unable to lift his arm over his head. The patient also developed fever of 100.9 F, so he took ALEVE for the pain and fever and iced the left shoulder but did not call the physician or go to the emergency room. He also had trouble in sleeping. On 18-MAR-2019 routine bloodwork test was performed and results were unknown. On 25-MAR-2019 annual physical diagnosis was performed and results were unknown. On 26-MAR-2019, the patient felt better his fever was gone and he could lift his arm over his head . The patient did contacted his physician and explained what had happened and what steps he took. The physician told him to continue with the ALEVE and ice packs and to call if any further symptoms developed or the pain increased again. The outcome of movement disorder, pain in extremity, vaccination site discomfort and pyrexia was reported as recovered/resolved.
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a consumer refers to a 65 year old male patient. The patient's medical history included hypertension and concurrent condition was allergic to bee stings. On 25-MAR-2019 the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number and expiration date were unknown) intramuscular for prophylaxis. Concomitant therapies included Lisinopril (LISINOPRIL) (manufacturer unknown) and red yeast (RED YEAST) (manufacturer unknown). On 25-MAR-2019,around 7pm the patient experienced severe pain radiating down his left arm to his fingertips and was unable to lift his arm over his head. The patient also developed fever of 100.9 F, so he took ALEVE for the pain and fever and iced the left shoulder but did not call the physician or go to the emergency room. He also had trouble in sleeping. On 18-MAR-2019 routine bloodwork test was performed and results were unknown. On 25-MAR-2019 annual physical diagnosis was performed and results were unknown. On 26-MAR-2019, the patient felt better his fever was gone and he could lift his arm over his head . The patient did contacted his physician and explained what had happened and what steps he took. The physician told him to continue with the ALEVE and ice packs and to call if any further symptoms developed or the pain increased again. The outcome of movement disorder, pain in extremity, vaccination site discomfort and pyrexia was reported as recovered/resolved.
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, Injected limb mobility decreased, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer refers to a 65 year old male patient. The patient's medical history included hypertension and concurrent condition was allergic to bee stings. On 25-MAR-2019 the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, lot number and expiration date were unknown) intramuscular for prophylaxis. Concomitant therapies included Lisinopril (LISINOPRIL) (manufacturer unknown) and red yeast (RED YEAST) (manufacturer unknown). On 25-MAR-2019,around 7pm the patient experienced severe pain radiating down his left arm to his fingertips and was unable to lift his arm over his head. The patient also developed fever of 100.9 F, so he took ALEVE for the pain and fever and iced the left shoulder but did not call the physician or go to the emergency room. He also had trouble in sleeping. On 18-MAR-2019 routine bloodwork test was performed and results were unknown. On 25-MAR-2019 annual physical diagnosis was performed and results were unknown. On 26-MAR-2019, the patient felt better his fever was gone and he could lift his arm over his head . The patient did contacted his physician and explained what had happened and what steps he took. The physician told him to continue with the ALEVE and ice packs and to call if any further symptoms developed or the pain increased again. The outcome of movement disorder, pain in extremity, vaccination site discomfort and pyrexia was reported as recovered/resolved.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Amniorrhoea, Amniotic membrane rupture test positive, Caesarean section, Exposure during pregnancy, Malaise
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of premature rupture of membranes in a 32-year-old female patient who received BOOSTRIX (batch number AH4LF, expiry date 8th July 2018) for prophylaxis. The patient's past medical history included cesarean section (C-section reported for a previous birth). Concurrent medical conditions included gestational diabetes (noted during 12th January 2016 visit). Concomitant products included Rhogam. On 12th February 2016, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was 17th March 2016. The patient received BOOSTRIX at week 35 of the pregnancy and during the third trimester of pregnancy. On 1 days after receiving BOOSTRIX, the patient experienced premature rupture of membranes and live birth. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the premature rupture of membranes, live birth and vaccine exposure during pregnancy were unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly. After 35 weeks and 2 days, the patient gave birth to a neonate via cesarean delivery. It was unknown if the reporter considered the premature rupture of membranes to be related to BOOSTRIX. See case US2019055880 for details regarding the baby case. Additional details were provided as follows: The medical assistant was reporting on behalf of physician that the patient who received a BOOSTRIX vaccination had blamed her child's developmental delayed diagnosis on the BOOSTRIX vaccine. The patient was 35 weeks 1 day into pregnancy when received BOOSTRIX. The patient also received a group B streptococcus vaginal culture that day. The next day, the patient's water broke, and she delivered baby via C-section. The patient recently contacted doctor's office to report the child was developmentally delayed and she feels it was because of the BOOSTRIX vaccination she received. The reporter did not specifically get permission for GSK to contact patient. The reporter gave phone number to call for patient to follow up, if she would like to.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nausea, Premature rupture of membranes, Vertigo
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of premature rupture of membranes in a 32-year-old female patient who received BOOSTRIX (batch number AH4LF, expiry date 8th July 2018) for prophylaxis. The patient's past medical history included cesarean section (C-section reported for a previous birth). Concurrent medical conditions included gestational diabetes (noted during 12th January 2016 visit). Concomitant products included Rhogam. On 12th February 2016, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was 17th March 2016. The patient received BOOSTRIX at week 35 of the pregnancy and during the third trimester of pregnancy. On 1 days after receiving BOOSTRIX, the patient experienced premature rupture of membranes and live birth. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the premature rupture of membranes, live birth and vaccine exposure during pregnancy were unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly. After 35 weeks and 2 days, the patient gave birth to a neonate via cesarean delivery. It was unknown if the reporter considered the premature rupture of membranes to be related to BOOSTRIX. See case US2019055880 for details regarding the baby case. Additional details were provided as follows: The medical assistant was reporting on behalf of physician that the patient who received a BOOSTRIX vaccination had blamed her child's developmental delayed diagnosis on the BOOSTRIX vaccine. The patient was 35 weeks 1 day into pregnancy when received BOOSTRIX. The patient also received a group B streptococcus vaginal culture that day. The next day, the patient's water broke, and she delivered baby via C-section. The patient recently contacted doctor's office to report the child was developmentally delayed and she feels it was because of the BOOSTRIX vaccination she received. The reporter did not specifically get permission for GSK to contact patient. The reporter gave phone number to call for patient to follow up, if she would like to.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Neonatal disorder, Premature rupture of membranes
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of premature rupture of membranes in a 32-year-old female patient who received BOOSTRIX (batch number AH4LF, expiry date 8th July 2018) for prophylaxis. The patient's past medical history included cesarean section (C-section reported for a previous birth). Concurrent medical conditions included gestational diabetes (noted during 12th January 2016 visit). Concomitant products included Rhogam. On 12th February 2016, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was 17th March 2016. The patient received BOOSTRIX at week 35 of the pregnancy and during the third trimester of pregnancy. On 1 days after receiving BOOSTRIX, the patient experienced premature rupture of membranes and live birth. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the premature rupture of membranes, live birth and vaccine exposure during pregnancy were unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly. After 35 weeks and 2 days, the patient gave birth to a neonate via cesarean delivery. It was unknown if the reporter considered the premature rupture of membranes to be related to BOOSTRIX. See case US2019055880 for details regarding the baby case. Additional details were provided as follows: The medical assistant was reporting on behalf of physician that the patient who received a BOOSTRIX vaccination had blamed her child's developmental delayed diagnosis on the BOOSTRIX vaccine. The patient was 35 weeks 1 day into pregnancy when received BOOSTRIX. The patient also received a group B streptococcus vaginal culture that day. The next day, the patient's water broke, and she delivered baby via C-section. The patient recently contacted doctor's office to report the child was developmentally delayed and she feels it was because of the BOOSTRIX vaccination she received. The reporter did not specifically get permission for GSK to contact patient. The reporter gave phone number to call for patient to follow up, if she would like to.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Aggression, Anaphylactic reaction, Cough, Eye swelling, Lethargy
Clinical narrative: This spontaneous report was received from a physician, via company representative and refers to a 2 year old male patient. The patient had none concomitant medications, medical history or previously drug reactions/ allergies. On 28-MAR-2019 the patient was vaccinated with the second dose of M-M-R II rHA (recombinant human albumin) lot # R024907 with expiration date on 30-AUG-2020 as vaccination (prophylaxis) (dose and route of administration were not reported) which was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiration date were not reported). While in the physician's office, patient sneezed approximately 5 times with a lot of mucous that came up (rhinorrhoea). Physician reported the patient then began to cough, gag and vomit and later experienced swelling of his face and "around his eyes". After that, the patient became lethargic. Emergency Medical Services (EMS) were called and when they arrived, the patient was treated with oxygen and dose of epinephrine (AUVI­Q). The patient was transferred to a hospital via ambulance however, it was unknown if he was admitted.  The outcome of the events and the causal relationship for both M-M-R II and sterile diluent (MERCK STERILE DILUENT) and the events were not reported.  All aforementioned adverse events were considered medically significant by the reporter since required oxygen and  epinephrine (AUVIQ) as intervention to prevent serious criteria.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Oxygen saturation decreased, Retching, Rhinorrhoea, Sneezing, Swelling face
Clinical narrative: This spontaneous report was received from a physician, via company representative and refers to a 2 year old male patient. The patient had none concomitant medications, medical history or previously drug reactions/ allergies. On 28-MAR-2019 the patient was vaccinated with the second dose of M-M-R II rHA (recombinant human albumin) lot # R024907 with expiration date on 30-AUG-2020 as vaccination (prophylaxis) (dose and route of administration were not reported) which was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiration date were not reported). While in the physician's office, patient sneezed approximately 5 times with a lot of mucous that came up (rhinorrhoea). Physician reported the patient then began to cough, gag and vomit and later experienced swelling of his face and "around his eyes". After that, the patient became lethargic. Emergency Medical Services (EMS) were called and when they arrived, the patient was treated with oxygen and dose of epinephrine (AUVI­Q). The patient was transferred to a hospital via ambulance however, it was unknown if he was admitted.  The outcome of the events and the causal relationship for both M-M-R II and sterile diluent (MERCK STERILE DILUENT) and the events were not reported.  All aforementioned adverse events were considered medically significant by the reporter since required oxygen and  epinephrine (AUVIQ) as intervention to prevent serious criteria.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician, via company representative and refers to a 2 year old male patient. The patient had none concomitant medications, medical history or previously drug reactions/ allergies. On 28-MAR-2019 the patient was vaccinated with the second dose of M-M-R II rHA (recombinant human albumin) lot # R024907 with expiration date on 30-AUG-2020 as vaccination (prophylaxis) (dose and route of administration were not reported) which was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiration date were not reported). While in the physician's office, patient sneezed approximately 5 times with a lot of mucous that came up (rhinorrhoea). Physician reported the patient then began to cough, gag and vomit and later experienced swelling of his face and "around his eyes". After that, the patient became lethargic. Emergency Medical Services (EMS) were called and when they arrived, the patient was treated with oxygen and dose of epinephrine (AUVI­Q). The patient was transferred to a hospital via ambulance however, it was unknown if he was admitted.  The outcome of the events and the causal relationship for both M-M-R II and sterile diluent (MERCK STERILE DILUENT) and the events were not reported.  All aforementioned adverse events were considered medically significant by the reporter since required oxygen and  epinephrine (AUVIQ) as intervention to prevent serious criteria.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Cough, Lethargy, Periorbital swelling, Retching, Secretion discharge
Clinical narrative: This spontaneous report was received from a physician, via company representative and refers to a 2 year old male patient. The patient had none concomitant medications, medical history or previously drug reactions/ allergies. On 28-MAR-2019 the patient was vaccinated with the second dose of M-M-R II rHA (recombinant human albumin) lot # R024907 with expiration date on 30-AUG-2020 as vaccination (prophylaxis) (dose and route of administration were not reported) which was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiration date were not reported). While in the physician's office, patient sneezed approximately 5 times with a lot of mucous that came up (rhinorrhoea). Physician reported the patient then began to cough, gag and vomit and later experienced swelling of his face and "around his eyes". After that, the patient became lethargic. Emergency Medical Services (EMS) were called and when they arrived, the patient was treated with oxygen and dose of epinephrine (AUVI­Q). The patient was transferred to a hospital via ambulance however, it was unknown if he was admitted.  The outcome of the events and the causal relationship for both M-M-R II and sterile diluent (MERCK STERILE DILUENT) and the events were not reported.  All aforementioned adverse events were considered medically significant by the reporter since required oxygen and  epinephrine (AUVIQ) as intervention to prevent serious criteria.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Sneezing, Swelling face, Vomiting
Clinical narrative: This spontaneous report was received from a physician, via company representative and refers to a 2 year old male patient. The patient had none concomitant medications, medical history or previously drug reactions/ allergies. On 28-MAR-2019 the patient was vaccinated with the second dose of M-M-R II rHA (recombinant human albumin) lot # R024907 with expiration date on 30-AUG-2020 as vaccination (prophylaxis) (dose and route of administration were not reported) which was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiration date were not reported). While in the physician's office, patient sneezed approximately 5 times with a lot of mucous that came up (rhinorrhoea). Physician reported the patient then began to cough, gag and vomit and later experienced swelling of his face and "around his eyes". After that, the patient became lethargic. Emergency Medical Services (EMS) were called and when they arrived, the patient was treated with oxygen and dose of epinephrine (AUVI­Q). The patient was transferred to a hospital via ambulance however, it was unknown if he was admitted.  The outcome of the events and the causal relationship for both M-M-R II and sterile diluent (MERCK STERILE DILUENT) and the events were not reported.  All aforementioned adverse events were considered medically significant by the reporter since required oxygen and  epinephrine (AUVIQ) as intervention to prevent serious criteria.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Sneezing, Swelling face, Unresponsive to stimuli, Vomiting
Clinical narrative: This spontaneous report was received from a physician, via company representative and refers to a 2 year old male patient. The patient had none concomitant medications, medical history or previously drug reactions/ allergies. On 28-MAR-2019 the patient was vaccinated with the second dose of M-M-R II rHA (recombinant human albumin) lot # R024907 with expiration date on 30-AUG-2020 as vaccination (prophylaxis) (dose and route of administration were not reported) which was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiration date were not reported). While in the physician's office, patient sneezed approximately 5 times with a lot of mucous that came up (rhinorrhoea). Physician reported the patient then began to cough, gag and vomit and later experienced swelling of his face and "around his eyes". After that, the patient became lethargic. Emergency Medical Services (EMS) were called and when they arrived, the patient was treated with oxygen and dose of epinephrine (AUVI­Q). The patient was transferred to a hospital via ambulance however, it was unknown if he was admitted.  The outcome of the events and the causal relationship for both M-M-R II and sterile diluent (MERCK STERILE DILUENT) and the events were not reported.  All aforementioned adverse events were considered medically significant by the reporter since required oxygen and  epinephrine (AUVIQ) as intervention to prevent serious criteria.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Patient suffered left shoulder pain with tingling pain radiating down to fingers. Difficulty raising arm. Went to Dr. and has been going to therapy for continued discomfort and tingling.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Middle insomnia, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Patient suffered left shoulder pain with tingling pain radiating down to fingers. Difficulty raising arm. Went to Dr. and has been going to therapy for continued discomfort and tingling.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Discomfort, Injection site pain, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Patient suffered left shoulder pain with tingling pain radiating down to fingers. Difficulty raising arm. Went to Dr. and has been going to therapy for continued discomfort and tingling.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient reported redness and swelling. Said she went to PCP and he said it was an injection due to administration.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Pyrexia, Rash
Clinical narrative: Patient reported redness and swelling. Said she went to PCP and he said it was an injection due to administration.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Toothache, Urticaria
Clinical narrative: Patient reported redness and swelling. Said she went to PCP and he said it was an injection due to administration.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient reported redness and swelling. Said she went to PCP and he said it was an injection due to administration.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Chest pain, Headache, Muscle spasms
Clinical narrative: Feeling of weakness, severe pain at bottom of spine which traveled slowly up spine to head. Difficulty breathing, tremor of right arm, Severe headache.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Dyspnoea, Headache, Spinal pain, Tremor
Clinical narrative: Feeling of weakness, severe pain at bottom of spine which traveled slowly up spine to head. Difficulty breathing, tremor of right arm, Severe headache.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Full blood count normal, Headache, Metabolic function test, Nausea
Clinical narrative: Headache, chills, nausea.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pain
Clinical narrative: 1st night: Had aches all over my body and severe chills. Could not sleep. Second day aches continued. Second night slept well no chills. Third morning back to normal. First dose 6 months ago I had no severe reaction.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Atrial fibrillation, Blood test, Chills, Echocardiogram
Clinical narrative: Started with joint pain, constant shivering, high fever, difficulty walking. Led to rabdomylosis and afib.  Patient was completely incapacitated and had to be transported by ambulance to the hospital. Had fevers of 103. Stayed for six days. Returned to hospital days later after dangerously low BP and heart rate. Taken by ambulance for a third hospital stay after significant afib event days later. No previous afib or health issue.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Gait disturbance, Heart rate decreased, Hypotension, Pyrexia
Clinical narrative: Started with joint pain, constant shivering, high fever, difficulty walking. Led to rabdomylosis and afib.  Patient was completely incapacitated and had to be transported by ambulance to the hospital. Had fevers of 103. Stayed for six days. Returned to hospital days later after dangerously low BP and heart rate. Taken by ambulance for a third hospital stay after significant afib event days later. No previous afib or health issue.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhabdomyolysis
Clinical narrative: Started with joint pain, constant shivering, high fever, difficulty walking. Led to rabdomylosis and afib.  Patient was completely incapacitated and had to be transported by ambulance to the hospital. Had fevers of 103. Stayed for six days. Returned to hospital days later after dangerously low BP and heart rate. Taken by ambulance for a third hospital stay after significant afib event days later. No previous afib or health issue.