chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 12-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 10-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 05-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 22-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). On 28-DEC-2018, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a consumer refers a 90 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first two doses of GARDASIL 9 (Strength, frequency, route, lot # and expiry date were not reported) to treat her basal cell carcinoma (Off label) (Product administered to patient of inappropriate age) as recommended in the official prescribing information. However, it was reported that the third and the final dose was given to a different basal cell carcinoma located on her legs which went away. There was no adverse reaction reported. There was no product quality complaint associated with this report. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1901USA009580.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concurrent conditions was not provided. On 17-JAN-2019, the patient was vaccinated with improperly stored doses of VARIVAX, lot # R017639, expiry date 20-JUN-2020, for prophylaxis (dose, strength, dose number, vaccination site and route of administration not provided). Concomitant therapies included sterile diluent which was properly stored. Multiple temperature excursions were reported as 6 degrees Fahrenheit to 14 degrees Fahrenheit for cumulative time frame of 7 hours. Previous multiple temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the Product storage error was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JAN-2019, the patient received a pediatric dose of VAQTA (lot: R006209; expiry date: 16-MAR-2019) 0.5 ml once intramuscularly. No adverse events reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a patient of unknown age. The patient's medical history, and concomitant therapies were not reported. The patient's concurrent condition included basal cell carcinoma. It was reported that her husband was possibly considering getting vaccinated with GARDASIL 9 series because their dermatologist had informed him that there was an unknown "study trial" conducted using GARDASIL 9 in a 90 year old woman to specifically treat her basal cell carcinoma. There was no adverse reactions reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1901USA007612.
Age: 53.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, injection site soreness.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Blood test, Dyskinesia, Electroencephalogram, Thyroid function test
Clinical narrative: A few weeks after my daughter was given the first part of the HPV shot she began having involuntary movements and sounds. I called her doctor who insisted that it was not the shot. She referred us to a neurologist. Over the next week or two, the movement got worse and worse. They are not as bad now, however, they still occur daily.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test, Paraesthesia, Psychomotor hyperactivity, Streptococcus test, Urinary incontinence
Clinical narrative: Patient experienced hand and leg paresthesias and urinary incontinence after receiving the flu vaccine. According mom patient was also abnormally hyper.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis
Clinical narrative: Patient experienced hand and leg paresthesias and urinary incontinence after receiving the flu vaccine. According mom patient was also abnormally hyper.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Gait inability, Injection site pain, Pain, Peripheral swelling
Clinical narrative: At the time of the injection I could tell it hurt my son (7) as the shot went into his thigh. I could see the pain on his face. My daughter(4)  had the same flu shot and her face did not show any signs of pain. After a few hours, he was unable to walk or put weight on it. He was in pain. His whole thigh was swollen and  bright red/pink red. It was also hot to the touch. This lasted 3-4 days.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Weight bearing difficulty
Clinical narrative: At the time of the injection I could tell it hurt my son (7) as the shot went into his thigh. I could see the pain on his face. My daughter(4)  had the same flu shot and her face did not show any signs of pain. After a few hours, he was unable to walk or put weight on it. He was in pain. His whole thigh was swollen and  bright red/pink red. It was also hot to the touch. This lasted 3-4 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood pressure decreased, Chills, Colitis ischaemic, Colonoscopy
Clinical narrative: Significant discomfort at injection site for approximately 4 days. During the evening after the injection, experienced significant chills necessitating wearing a coat. The next day, continued experiencing chills. Experienced significant lethargy. I normally drink a considerable amount of water every day, but didn't have the energy to get up to get some, possibly leading to dehydration. Ate very little (1/2 orange for lunch, 1 pc pizza for dinner). At around 6pm, went to bathroom. Experienced stomach cramps; attempted to get up to get PEPTO-BISMOL. Didn't make it to closet before collapsing. My wife called 911 because I had momentarily blacked out and couldn't get up. After EMTs arrived, threw up. They carried me out to ambulance. Blood pressure was 60-something over 30-something. I spent 4 nights in the hospital (January 17-20).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Hypophagia, Hypotension, Injection site discomfort, Lethargy
Clinical narrative: Significant discomfort at injection site for approximately 4 days. During the evening after the injection, experienced significant chills necessitating wearing a coat. The next day, continued experiencing chills. Experienced significant lethargy. I normally drink a considerable amount of water every day, but didn't have the energy to get up to get some, possibly leading to dehydration. Ate very little (1/2 orange for lunch, 1 pc pizza for dinner). At around 6pm, went to bathroom. Experienced stomach cramps; attempted to get up to get PEPTO-BISMOL. Didn't make it to closet before collapsing. My wife called 911 because I had momentarily blacked out and couldn't get up. After EMTs arrived, threw up. They carried me out to ambulance. Blood pressure was 60-something over 30-something. I spent 4 nights in the hospital (January 17-20).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Significant discomfort at injection site for approximately 4 days. During the evening after the injection, experienced significant chills necessitating wearing a coat. The next day, continued experiencing chills. Experienced significant lethargy. I normally drink a considerable amount of water every day, but didn't have the energy to get up to get some, possibly leading to dehydration. Ate very little (1/2 orange for lunch, 1 pc pizza for dinner). At around 6pm, went to bathroom. Experienced stomach cramps; attempted to get up to get PEPTO-BISMOL. Didn't make it to closet before collapsing. My wife called 911 because I had momentarily blacked out and couldn't get up. After EMTs arrived, threw up. They carried me out to ambulance. Blood pressure was 60-something over 30-something. I spent 4 nights in the hospital (January 17-20).
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Gait inability, Pain, Peripheral swelling, Skin warm
Clinical narrative: After a few hours, he was unable to walk and put weight on it. He was in pain. His whole thigh was swollen and  bright red/pink red. It was also hot to the touch and hurt to touch. This lasted 3-4 days. This is exactly what happened the year before. This injection was preservative free, while the one from 2015 was not.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness, Weight bearing difficulty
Clinical narrative: After a few hours, he was unable to walk and put weight on it. He was in pain. His whole thigh was swollen and  bright red/pink red. It was also hot to the touch and hurt to touch. This lasted 3-4 days. This is exactly what happened the year before. This injection was preservative free, while the one from 2015 was not.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Noticed some soreness in her right axilla and swelling and tenderness at the injection site on her arm. Some increased axillary tenderness today. Right upper arm with 8cm or moderate welling. Very mild erythema and warmth. Right axilla with no palpable swelling or nodule. No warmth or erythema but there is ttp. Right hand with normal sensation and cap refill.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Tenderness
Clinical narrative: Noticed some soreness in her right axilla and swelling and tenderness at the injection site on her arm. Some increased axillary tenderness today. Right upper arm with 8cm or moderate welling. Very mild erythema and warmth. Right axilla with no palpable swelling or nodule. No warmth or erythema but there is ttp. Right hand with normal sensation and cap refill.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Shortly after, his arm began to hurt  and became red/hot pink and hurt to touch it. His arm also became very swollen. It hurt for him to lift his arm or use it. It was also hot to touch it. This lasted for 3-4 days.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Shortly after, his arm began to hurt  and became red/hot pink and hurt to touch it. His arm also became very swollen. It hurt for him to lift his arm or use it. It was also hot to touch it. This lasted for 3-4 days.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Injection site pain
Clinical narrative: Patient states feeling pain deep in left shoulder also decreased strength left arm and hand.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients. The patients' historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route were not reported) both vaccines for prophylaxis, following a temperature excursion. The administered doses of the vaccines experienced a temperature excursion of 6 Fahrenheit (°F) to 14°F (-14 Celsius (°C) to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, with multiple excursions, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported. This case was considered non-valid due to lack of patient identifiers. As of 09-NOV-2018, all telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received from the registered nurse on 08-JAN-2019, referring to a 13-month old male patient. The patient had no allergies, birth defects or medical conditions. It was reported that the patient had two brothers/sisters. On 21-SEP-2018, the patient was vaccinated with an improperly stored dose of: M-M-R II (strength and dose were not provided), lot # N025894, subcutaneously, in the left thigh, for prophylaxis; of VARIVAX (strength and dose were not provided), lot # N035940, subcutaneously, in the right thigh; of VAQTA, (strength and dose were not provided), lot number R013858 (expiration date not provided), intramuscularly, in the left thigh; as prophylaxis; and of PREVNAR 13 (strength and dose were not provided), lot # reported as W11304, intramuscularly, in the right thigh. No previous temperature excursion was reported. There was no adverse effect reported (also reported that the patient received treatment for the event and the patient was recovered). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002757: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002764: US-009507513-1901USA002763: US-009507513-1901USA002762: US-009507513-1901USA002761: US-009507513-1809USA010598: US-009507513-1901USA002759: US-009507513-1901USA002758: US-009507513-1901USA002765: US-009507513-1901USA002756.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Back pain, Swelling face
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 19 years old male patient. There were no pertinent medical history or drug allergies in regards to the patient. On 09-JAN-2019 the patient was vaccinated with his first dose of GARDASIL 9 (lot # R024264, expiration date: 29-OCT-2019) intramuscularly for prophylaxis, along with the vaccination of MENACTRA, ADACEL and TRUMENBA. The reporter reported that the patient developed back pain and a bump on his forehead after receiving the GARDASIL 9. Lab diagnostics were not performed. The patient was currently not recovered. The causality assessments were not assessed.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 09-JAN-2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving, ZOSTAVAX, the patient suffered sudden and total sensorineural hearing loss of the left ear. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: a. the patient required and will continue to require healthcare and services; b. The patient incurred and will continue to incur medical and related expenses; and c. The patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Sudden and total sensorineural hearing loss of the left ear was considered disabling. Upon internal review sudden and total sensorineural hearing loss of the left ear was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This initial spontaneous report was received via a company representative who provided the name of an article found on the internet regarding a female patient of unknown age who was vaccinated with ZOSTAVAX. The article itself was not provided. The adverse reaction was not specified. Causality assessment was related. No further information is available.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on 13Oct2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. One month later (13Nov2017), she had hives all over her body which lasted for 9 months. The patient recovered from the event in Jul2018. The information on the lot number and expiration will be requested.
Sex: F
Vaccine: PNC13
Symptoms: Gastroenteritis viral, Influenza
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13, (lot number and expiry date were not reported), via an unspecified route of administration on Jan2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received a PREVNAR 13 vaccine in Jan2017 and right now, the patient was battling with a case of flu. She was battling from a case of the stomach flu. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Delirium, Fatigue, Headache
Clinical narrative: Top of head very sore 4 days; "head band" type headache 5 days; fatigue 5 days; severe full body; uncontrollable chills the first night and morning; severe thirst for 2 days; weakness all over; delirium; shakes and tremors all over, full body; had to remain in bed 4 days; took advil 2 pills for a total of 6 per day.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tension headache, Thirst, Tremor
Clinical narrative: Top of head very sore 4 days; "head band" type headache 5 days; fatigue 5 days; severe full body; uncontrollable chills the first night and morning; severe thirst for 2 days; weakness all over; delirium; shakes and tremors all over, full body; had to remain in bed 4 days; took advil 2 pills for a total of 6 per day.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Muscle aches, chills, fatigue, headache, pain and redness at injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches, chills, fatigue, headache, pain and redness at injection site.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Feeling hot, Feeling jittery, Headache, Nausea
Clinical narrative: Started feeling hot all over and jittery with cold sweat and nausea. Soon after then vomited. She still feels jittery and headache.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Started feeling hot all over and jittery with cold sweat and nausea. Soon after then vomited. She still feels jittery and headache.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient arrived Home from office a few hours after immunization. She noticed a small red bump. 2  days later, in the evening, she noticed it had gotten larger, more red, and started to itch. She was prescribed cetirizine today.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On day 2 patient reported pain, swelling, and redness. Around the infection site. Patient reported that it has not gotten worse on day 3; however was concerned that the infection site felt hard.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT REPORTED A RASH THAT STARTED 2 DAYS AFTER RECEIVING VACCINATION.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 1-25-2019 Client presented to health department today with Mother. She reports that client developed significant swelling at top of right thigh after vaccinations given on 1-15-2019. She reports that the swelling has gone away but that area has gotten red. Mom concerned. Assessed area on client's leg. Child has 3.5cm reddened area on right upper thigh at sight of varicella injection given on 1-15-19. Area is warm to touch. No swelling, knot, pustule, or drainage noted.  Area at injection site slightly darker in color than surrounding redness. Discussed with Mom appears to be local reaction to varicella but to seek medical care with any concerns.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Abnormal weight gain, Arthralgia, Autoimmune disorder, Eye pruritus, Eye swelling
Clinical narrative: In September of 2014, I received the first GARDASIL vaccine. Within a month I began developing unexplained symptoms. I saw my doctor in November 2014 and was diagnosed with chronic hives of unknown source. Also, I began experiencing muscle, nerve and joint pains, sensitivity to touch, extreme weight gain and purple striae. I was unable to get the hives under control with medications and began seeing an allergist who stated it was something autoimmune that had been triggered and it wasn't anything environmental causing the hives. I obtained a second opinion and they had stated the same thing. I had seen endocrinology, allergy/immunology, neurology, rheumatology and several general practitioners who all could not and still cannot find a cause for the development. I now have to be injected with several thousand dollar injection to control the hives and still have to take an antihistamine. My mother had done research and found articles stating the GARDASIL had unlisted side effects, one including an autoimmune disorder. Also, I was speaking with a coworker whose niece had the same problem but worse. My hives are triggered by anything, heat/cold, touch, pressure, lotions, etc. I still have not been able to lose the weight and swell up at times, so badly I can barely bend my neck. My eyes are constantly itchy and swollen and I had never had allergies or pain before this. I also was 120 pounds and gained 30 pounds within the few months of receiving the vaccine without making any changes.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Fibromyalgia, Hyperaesthesia, Musculoskeletal stiffness, Myalgia, Neuralgia
Clinical narrative: In September of 2014, I received the first GARDASIL vaccine. Within a month I began developing unexplained symptoms. I saw my doctor in November 2014 and was diagnosed with chronic hives of unknown source. Also, I began experiencing muscle, nerve and joint pains, sensitivity to touch, extreme weight gain and purple striae. I was unable to get the hives under control with medications and began seeing an allergist who stated it was something autoimmune that had been triggered and it wasn't anything environmental causing the hives. I obtained a second opinion and they had stated the same thing. I had seen endocrinology, allergy/immunology, neurology, rheumatology and several general practitioners who all could not and still cannot find a cause for the development. I now have to be injected with several thousand dollar injection to control the hives and still have to take an antihistamine. My mother had done research and found articles stating the GARDASIL had unlisted side effects, one including an autoimmune disorder. Also, I was speaking with a coworker whose niece had the same problem but worse. My hives are triggered by anything, heat/cold, touch, pressure, lotions, etc. I still have not been able to lose the weight and swell up at times, so badly I can barely bend my neck. My eyes are constantly itchy and swollen and I had never had allergies or pain before this. I also was 120 pounds and gained 30 pounds within the few months of receiving the vaccine without making any changes.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Skin striae, Swelling, Urticaria, Weight increased
Clinical narrative: In September of 2014, I received the first GARDASIL vaccine. Within a month I began developing unexplained symptoms. I saw my doctor in November 2014 and was diagnosed with chronic hives of unknown source. Also, I began experiencing muscle, nerve and joint pains, sensitivity to touch, extreme weight gain and purple striae. I was unable to get the hives under control with medications and began seeing an allergist who stated it was something autoimmune that had been triggered and it wasn't anything environmental causing the hives. I obtained a second opinion and they had stated the same thing. I had seen endocrinology, allergy/immunology, neurology, rheumatology and several general practitioners who all could not and still cannot find a cause for the development. I now have to be injected with several thousand dollar injection to control the hives and still have to take an antihistamine. My mother had done research and found articles stating the GARDASIL had unlisted side effects, one including an autoimmune disorder. Also, I was speaking with a coworker whose niece had the same problem but worse. My hives are triggered by anything, heat/cold, touch, pressure, lotions, etc. I still have not been able to lose the weight and swell up at times, so badly I can barely bend my neck. My eyes are constantly itchy and swollen and I had never had allergies or pain before this. I also was 120 pounds and gained 30 pounds within the few months of receiving the vaccine without making any changes.
Sex: F
Vaccine: FLUX
Symptoms: Ear congestion, Nasal congestion
Clinical narrative: I had the flu vaccination in hospital in April, was the first time to take this flu vaccination. A month after I had my nose and ear blocked and the problem is persistent and happens with frequency of around once a month since May 2018.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal pain
Clinical narrative: On Oct. 22, I got the second dose of SHINGRIX in my left arm. I was fine for a few weeks. About a month later, I started having bad shoulder pain in my left arm and slightly less pain in the right shoulder. Then I became very very achy, all over, unable to do any chores. I had hand and foot pain, finger swelling, inability to sleep because of the pain. I no longer can sleep on either side. This is very obviously related to the SHINGRIX shot, because I was fine previous to getting it. I still, today, on Jan. 10 cannot move my left arm out to the side without pain. It feels like the muscle has been weakened somehow. My fingers swell at night and get achy. I cannot wear my rings anymore. It is strange that these reactions are delayed, so long after the shot in October.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: On Oct. 22, I got the second dose of SHINGRIX in my left arm. I was fine for a few weeks. About a month later, I started having bad shoulder pain in my left arm and slightly less pain in the right shoulder. Then I became very very achy, all over, unable to do any chores. I had hand and foot pain, finger swelling, inability to sleep because of the pain. I no longer can sleep on either side. This is very obviously related to the SHINGRIX shot, because I was fine previous to getting it. I still, today, on Jan. 10 cannot move my left arm out to the side without pain. It feels like the muscle has been weakened somehow. My fingers swell at night and get achy. I cannot wear my rings anymore. It is strange that these reactions are delayed, so long after the shot in October.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Right arm became progressively more red and swollen, warm to touch, tender and tingly to hands, fever Tm 101, lasted 36-48 hours and resolved spontaneously.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tenderness
Clinical narrative: Right arm became progressively more red and swollen, warm to touch, tender and tingly to hands, fever Tm 101, lasted 36-48 hours and resolved spontaneously.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Injection site rash, Rash
Clinical narrative: Per mother that same night she had a mild rash but the rash has now spread to thighs, legs, arms and face. Patient prescribed: Benadryl Allergy Childrens Liquid, 12.5 MG/5ML, 6 ml as needed, Orally, every 8 hrs, 5 days, 120 ml Hydrocortisone Cream, 2.5 %, 1 application to affected area, Externally, Twice a day, 5 days, 30 Referral To: Allergy and Immunology TCH Allergy and Immunology Pediatric Allergist Reason:Allergic reaction after Hepatits A vaccine. Please evaluate. Patient's allergy got better after allergy medication.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Total 6-days reaction, Muscle Pain body, Redness upper left arm; Swelling upper left arm; Headache, Shivering, Fever for 6 days 99.8 - 100.9, Tired, Weak, Loose stools.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Total 6-days reaction, Muscle Pain body, Redness upper left arm; Swelling upper left arm; Headache, Shivering, Fever for 6 days 99.8 - 100.9, Tired, Weak, Loose stools.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 77.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Arthralgia, Blister, Blood test, Headache, Hypoaesthesia
Clinical narrative: Itching, bad rash, headaches, leg cramp, blisters, stiff neck, muscle weakness, numbness (L) foot, pain (R) shoulder and (L) hip. I have wt. lost at least 20lb. Presently wt 110. 5ft and 8" tall. I do not look like myself. All summer long, I wore long sleeves. I was ashamed of my arms, so skinny, with scars, and wrinkles, I lost a lot of muscle tone, all over my body. From the shingle shot. I have never had Chicken Pox. I told my Dr. before I took the shot. So she could evaluate the situation. My Dr. really didn't pay attention to me on it. I see her on my visit in Dec, 2018. She saw the wt I lost and the scars on my arms.
Age: 77.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Hypotonia, Muscle spasms, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Itching, bad rash, headaches, leg cramp, blisters, stiff neck, muscle weakness, numbness (L) foot, pain (R) shoulder and (L) hip. I have wt. lost at least 20lb. Presently wt 110. 5ft and 8" tall. I do not look like myself. All summer long, I wore long sleeves. I was ashamed of my arms, so skinny, with scars, and wrinkles, I lost a lot of muscle tone, all over my body. From the shingle shot. I have never had Chicken Pox. I told my Dr. before I took the shot. So she could evaluate the situation. My Dr. really didn't pay attention to me on it. I see her on my visit in Dec, 2018. She saw the wt I lost and the scars on my arms.
Age: 77.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Pruritus, Rash, Scar, Weight decreased
Clinical narrative: Itching, bad rash, headaches, leg cramp, blisters, stiff neck, muscle weakness, numbness (L) foot, pain (R) shoulder and (L) hip. I have wt. lost at least 20lb. Presently wt 110. 5ft and 8" tall. I do not look like myself. All summer long, I wore long sleeves. I was ashamed of my arms, so skinny, with scars, and wrinkles, I lost a lot of muscle tone, all over my body. From the shingle shot. I have never had Chicken Pox. I told my Dr. before I took the shot. So she could evaluate the situation. My Dr. really didn't pay attention to me on it. I see her on my visit in Dec, 2018. She saw the wt I lost and the scars on my arms.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 18-year-old patient of unknown gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 20-DEC-2012, when the patient was 12 years old, the patient was vaccinated with the first dose of GARDASIL (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. No adverse events were reported. On 04-JAN-2019 (reported as "now"), the patient wanted to complete the vaccination series with GARDASIL 9 (lot# and expiration date were not reported). At the time of this report, the patient was not yet vaccinated with GARDASIL 9.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JAN-2019, the patient was vaccinated with an extra dose of VARIVAX for prophylaxis, lot # R018143 and expiration date 25-JUN-2020 (dosage schedule, route and anatomical location were not reported). The vaccine were reconstituted with MERCK STERILE DILUENT, lot # N0126286 and expiration date 06-FEB-2020. No adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1 year old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On 22-JAN-2019, the patient was vaccinated with VARIVAX lot # R018780, expiration date 01-JUL-2020, 1 dosage form in the right thigh for and with PROQUAD lot # R020816, expiration date 16-JAN-2020, 1 dosage form in the left thigh (strength and route were not provided) both for prophylaxis. The vaccines were reconstituted with sterile diluent lot # R032351, expiration date 02-JUN-2021. No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009706: US-009507513-1901USA009707: US-009507513-1901USA009708: US-009507513-1901USA009709: US-009507513-1901USA009710: US-009507513-1901USA009711.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter.; Sender's Comments: US-009507513-1901USA009536:
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer sponsored program. A 47-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was allergic to other: pneumococcal vaccine on an unspecified date with outcome of unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Within two hours of ingesting a single tablet/capsule, experienced severe stomach cramping which lasted the entire morning until an analgesic was taken (ADVIL 400mg). Rested for the remainder of the day Reports that abdominal cramping remained upon awakening the following morning.  Continues to rest; no additional medication taken thus far and no additional medical follow up sought to date.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Muscle atrophy, Muscular weakness, Pain in extremity
Clinical narrative: Muscle at the sight of the injections has deteriorated to a notable colapse at the injection sight. At times the arm is sore and weak.
Age: 11.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Abdominal pain upper, Oral administration complication
Clinical narrative: Within two hours of ingesting oral typhoid capsule/tablet, experienced severe stomach pain which was described as occurring intermittently. The pain had subsided by 6pm (dinner time). Appetite unaffected by experience. No report of abdominal pain thereafter.
Age: 8.0
Sex: F
Vaccine: FLU4, TYP
Symptoms: Fatigue, Incoherent, Nail discolouration, Somnambulism
Clinical narrative: Within one hour of ingestion of a single dose of the oral typhoid vaccine experienced nausea and exhaustion which continued throughout the day and night. Also reports that the child was sleepwalking and incoherent. By the following morning feeling better.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia
Clinical narrative: Intense shivering. Room temperature was mid 60s with plenty of covers on bed. Shivering was strong enough to prevent sleep. Continued off and on for 3 hours then subsided. Shivering was strong enough to disturb sleeping partner.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Seizure
Clinical narrative: Pt experienced seizures on the morning of 1/23/2019. To my knowledge, he had a total of 5 seizures on that day. He had 4 in the morning and one in the evening after he was transported to Hospital.