chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child received 2 PROQUAD vaccines on the same day and same time. No adverse effects noted at time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Arthralgia, Culture negative, Incisional drainage, Injection site cellulitis, Injection site infection
Clinical narrative: Pt began having arthralgias the evening after receiving vaccines. Pt came into clinic on 11/3/2018 with small, red, blisters on Right arm at injection site. Very itchy. Center of blisters purple in color. Infected area opened and wound culture sent. Negative culture. Pt started on antibiotics on 11/3/2018 for diagnosis of cellulitis. Area has improved. Physician questions vaccine reaction vs. spider bite.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site pruritus, Injection site vesicles, Skin discolouration
Clinical narrative: Pt began having arthralgias the evening after receiving vaccines. Pt came into clinic on 11/3/2018 with small, red, blisters on Right arm at injection site. Very itchy. Center of blisters purple in color. Infected area opened and wound culture sent. Negative culture. Pt started on antibiotics on 11/3/2018 for diagnosis of cellulitis. Area has improved. Physician questions vaccine reaction vs. spider bite.
Age: 72.0
Sex: M
Vaccine: FLUA3, TDAP
Symptoms: Cough, Loss of consciousness
Clinical narrative: Patient says 2, 3 days after vaccination he started to experience a cough that is similar to a whooping cough. It was severe enough that he reported passing out while at a diner for an estimated time of approximately 30 seconds (he was with a friend). He did not seek medical attention for it.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-OCT-2018, the patient was inadvertently vaccinated with two doses of PROQUAD lot # N021727, expiration date: 06-FEB-2019 (dose and route of administration were not provided) for prophylaxis. On 23-OCT-2018, the patient should have received one dose of rHA PROQUAD and one dose of DTAP vaccine (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. The vaccine was reconstituted in sterile diluent. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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.  The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a physician administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries.  On or about 2016, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 2016, The patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX, (lot# and route unknown) vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by her healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider at a healthcare facility recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-JAN-2010, a health care provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 18-SEP-2015, the patient was treated by a health care provider (unspecified healthcare professional) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-JAN-2015 and 11-FEB-2015, the patient was treated by a registered nurse at a military hospital for herpes zoster and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Cold sweat, Headache, Hot flush, Hypoaesthesia
Clinical narrative: SWOLLEN L ARM 4 INCH BY 5 INCH AREA ABOUT 2 INCHED BELOW INJECTION SIGHT. AREA IS SORE, PAINFUL TO TOUCH, MODERATELY SWOLLEN LEGS, CRAMPS, HOT FLASHES, COLD CHILLS, FLU LIKE SYSTEMS, COLD SWEATS, ITCHY AND HOT LEGS AT NIGHT, SWOLLEN L UNDERARM, NAUSEA, LEGS BLOTCHY AND DISCOLORED, TINGLING SENSATION THROUGH OUT BODY, NUMBNESS IN L ARM. HEADACHES.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Muscle spasms, Nausea
Clinical narrative: SWOLLEN L ARM 4 INCH BY 5 INCH AREA ABOUT 2 INCHED BELOW INJECTION SIGHT. AREA IS SORE, PAINFUL TO TOUCH, MODERATELY SWOLLEN LEGS, CRAMPS, HOT FLASHES, COLD CHILLS, FLU LIKE SYSTEMS, COLD SWEATS, ITCHY AND HOT LEGS AT NIGHT, SWOLLEN L UNDERARM, NAUSEA, LEGS BLOTCHY AND DISCOLORED, TINGLING SENSATION THROUGH OUT BODY, NUMBNESS IN L ARM. HEADACHES.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Oedema peripheral, Paraesthesia, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: SWOLLEN L ARM 4 INCH BY 5 INCH AREA ABOUT 2 INCHED BELOW INJECTION SIGHT. AREA IS SORE, PAINFUL TO TOUCH, MODERATELY SWOLLEN LEGS, CRAMPS, HOT FLASHES, COLD CHILLS, FLU LIKE SYSTEMS, COLD SWEATS, ITCHY AND HOT LEGS AT NIGHT, SWOLLEN L UNDERARM, NAUSEA, LEGS BLOTCHY AND DISCOLORED, TINGLING SENSATION THROUGH OUT BODY, NUMBNESS IN L ARM. HEADACHES.
Age: 42.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Skin discolouration, Skin warm
Clinical narrative: SWOLLEN L ARM 4 INCH BY 5 INCH AREA ABOUT 2 INCHED BELOW INJECTION SIGHT. AREA IS SORE, PAINFUL TO TOUCH, MODERATELY SWOLLEN LEGS, CRAMPS, HOT FLASHES, COLD CHILLS, FLU LIKE SYSTEMS, COLD SWEATS, ITCHY AND HOT LEGS AT NIGHT, SWOLLEN L UNDERARM, NAUSEA, LEGS BLOTCHY AND DISCOLORED, TINGLING SENSATION THROUGH OUT BODY, NUMBNESS IN L ARM. HEADACHES.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Developed shoulder pain and decreased ROM within 24 hours of vaccination.  Pain persists through date of report.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Severe pain at the site of injection. Round red circle, the size of a baseball at site of injection. Skin at site of injection hot to touch. Pain continued for 7 days. Both skin and muscle underneath were painful. Pain with movement and pain with touch. Patient tried icing the area, tried using heat, and OTC ibuprofen. None of the treatment options were helpful.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states that she still has pain in her arm over one month later. She said that she can't lift her arm above her head. She was instructed to be evaluated by her physician to determine the cause of the pain and if any further medical testing is needed.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain, Periarthritis, X-ray
Clinical narrative: DR. FROZEN SHOULDER, STEROID SHOT IN THE SHOULDER ON 10/24/2018. MASSAGE THERAPY,  I'M TRYING TO GET PT AND HAVE NOT GOTTEN A DOCTORS ORDER. VERY VERY PAINFUL. THIS HAS BEEN GOING ON WAY TO LONG AND I'M HURTING. PLEASE PUT A WARNING IN REACTIONS. I DECLINED THE 2ND SHOT DUE TO THIS FROZEN SHOULDER. PAINFUL PAINFUL IF YOU NEED MORE INFORMATION CONTACT ME. I WOULD NOT HAVE GOTTEN THE SHOT IF I WAS GIVEN THE RISK TO A FROZEN SHOULDER. AND YES, I HAVE HAD THE SHINGLES LAST YEAR. I WOULD HAVE SHINGLES AGAIN BEFORE GOING THROUGH THIS EVER AGAIN. SHOULDER PAIN THAT CAN BE SEVERE AND LONGER LSTING IS NOT WHAT I'M HAVING. SORE SHOULDER AND A FROZEN SHOULDER IS A BIG DIFFERENCE.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Flatulence, Headache
Clinical narrative: The vaccine was administered on Thursday of last week. 2 hours after the vaccine I had severe gas and digestive distress. 5 hours after the vaccine I had fever and chills which persisted until the following morning. Thereafter headache and periods of fever for the following 3 days. Today, Tuesday, 5 days after the vaccine I continue to have headaches and gastronomical distress including gas, diarhea and abdominal distress as well as headache. My wife had the same shot at the same date and time and similar distress.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: The vaccine was administered on Thursday of last week. 2 hours after the vaccine I had severe gas and digestive distress. 5 hours after the vaccine I had fever and chills which persisted until the following morning. Thereafter headache and periods of fever for the following 3 days. Today, Tuesday, 5 days after the vaccine I continue to have headaches and gastronomical distress including gas, diarhea and abdominal distress as well as headache. My wife had the same shot at the same date and time and similar distress.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hyperaesthesia, Neuralgia
Clinical narrative: DEVELOPED A SMALL CASE OF SHINGLES LASTING 5 OR 6 DAYS. EXPERIENCED SHARP NERVE SPIKES RIGHT SIDE NECK AND BACK OF SHOULDER. SMALL BLISTERS AND SENSITIVITY TO CLOTHING.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Chest discomfort, Chest pain, Cough, Dysphonia
Clinical narrative: Lethargic, very tired. Achy. Chest tightness, cough with burning feeling inside throat and chest. Runny nose, sneezing. Hoarse voice; lost voice 3-4 days. No noted fever.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Lethargy, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Lethargic, very tired. Achy. Chest tightness, cough with burning feeling inside throat and chest. Runny nose, sneezing. Hoarse voice; lost voice 3-4 days. No noted fever.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Lethargic, very tired. Achy. Chest tightness, cough with burning feeling inside throat and chest. Runny nose, sneezing. Hoarse voice; lost voice 3-4 days. No noted fever.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Wrong product administered
Clinical narrative: Patient came in for the meningococcal vaccine and was mistakenly given the HPV (GARDASIL) vaccine.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Pt  stated had varicella vaccine on 10/30/2018 @ Clinic and then awoke next morning with swelling & reddness and hot to touch. Pt came to health services and was seen by provider. Diagnosis was local reaction and patient ordered to do warm compresses/take fexofenadine 180 1 tab QD given 15 tabs. and return to follow up with provider next day. Patient did not return for visit on 11/2/18 as directed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt stated significant injection site reaction of pain, redness, and swelling the size of a saucer. Also complained of flu like symptoms, aches, pain, low grade fever to the extent of missing work. Also complained of pain in the chest that eventually went away.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt stated significant injection site reaction of pain, redness, and swelling the size of a saucer. Also complained of flu like symptoms, aches, pain, low grade fever to the extent of missing work. Also complained of pain in the chest that eventually went away.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Peripheral swelling
Clinical narrative: Bad flu-like symptoms, severe swollen arm (pt states arm blew up like a balloon). All symptoms lasted about 7 days and was treated with an ice pack.
Age: 67.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Aphasia, Dizziness, Immobile, Intensive care, Laboratory test
Clinical narrative: Dizziness, altered mental status, unable to move, twitching, unable to talk or respond; pt was admitted to ED and currently in ICU.
Age: 67.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Mental status changes, Muscle twitching, Neurological examination, Unresponsive to stimuli
Clinical narrative: Dizziness, altered mental status, unable to move, twitching, unable to talk or respond; pt was admitted to ED and currently in ICU.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug history, and allergies were not reported. On an unknown date, the patient started the treatment with GARDASIL 9, lot number R022533, expiration date 12-NOV-2019 (dose, frequency, formulation, indication, and strength were not reported). On 23-OCT-2018, the patient inadvertently received a 4th dose of GARDASIL 9. No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to an adult patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions/allergies was not provided. On 22-OCT-2018, the patient was vaccinated with a dose of PROQUAD (lot # N025923 with an expiration date in 18-MAR-2019), subcutaneously, for prophylaxis (strength, dose and frequency were not provided). Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider at a healthcare facility recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-APR-2016, the patient's health care provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 10-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose normal, Dizziness, Full blood count normal, Gait inability
Clinical narrative: This spontaneous report was received from a physician and refers to a 17-year-old female patient. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 20-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # R010596, expiration date 11-DEC-2020 (exact dose and route of administration were not reported) for vaccination. On 20-SEP-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot # R010596, expiration date 11-DEC-2020 (exact dose and route of administration were not reported) for vaccination. On 23-SEP-2018 (reported as three days later), the patient was not able to walk, was dizzy and weak for an entire day. Since that day, the patient had episodes of being dizzy and had missed two days of school as well as gym class. One month later, on 24-OCT-2018, the patient had another similar episode, she could not walk up the stairs. The patient sought medical attention. On an unknown date in 2018, the patient had difference in blood pressure: sitting 100/75, lying 120/80 (units not provided) and her pulse was: sitting 80, lying 68 (units not provided). The physician noted that on an unknown date in 2018, the patients glucose was 140 (units not provided), yet this was not a fasting sugar. She stated that the fasting number was 89 (units not provided). The physician reported that on an unspecified date in 2018, complete blood count (CBC), complete metabolic profile (CMP), thyroid level, urine levels were all within range and neurological checks were normal. The patient would see a cardiologist. At the time of the report, the outcome of the events was not recovered which was also reported as ongoing. The causality assessment was not provided. The reporter considered the events as disabling.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Metabolic function test normal, Neurological examination normal, Thyroid function test normal, Urine analysis normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 17-year-old female patient. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 20-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot # R010596, expiration date 11-DEC-2020 (exact dose and route of administration were not reported) for vaccination. On 20-SEP-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot # R010596, expiration date 11-DEC-2020 (exact dose and route of administration were not reported) for vaccination. On 23-SEP-2018 (reported as three days later), the patient was not able to walk, was dizzy and weak for an entire day. Since that day, the patient had episodes of being dizzy and had missed two days of school as well as gym class. One month later, on 24-OCT-2018, the patient had another similar episode, she could not walk up the stairs. The patient sought medical attention. On an unknown date in 2018, the patient had difference in blood pressure: sitting 100/75, lying 120/80 (units not provided) and her pulse was: sitting 80, lying 68 (units not provided). The physician noted that on an unknown date in 2018, the patients glucose was 140 (units not provided), yet this was not a fasting sugar. She stated that the fasting number was 89 (units not provided). The physician reported that on an unspecified date in 2018, complete blood count (CBC), complete metabolic profile (CMP), thyroid level, urine levels were all within range and neurological checks were normal. The patient would see a cardiologist. At the time of the report, the outcome of the events was not recovered which was also reported as ongoing. The causality assessment was not provided. The reporter considered the events as disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-MAY-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long-term prevention of shingles and zoster related injuries (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 06-MAR-2017, the patient was treated for herpes zoster or shingles. On or about 11-JUL-2012, the patient sought subsequent treatment for continuing pain and was diagnosed with postherpetic neuralgia. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001976: US-009507513-1811USA001977: US-009507513-1811USA001975.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 19-SEP-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection, intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. On 01-NOV-2018, the patient was vaccinated with the second dose of PNEUMOVAX 23 intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. No known adverse effect was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001858: US-009507513-1811USA001977: US-009507513-1811USA001976.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001977: US-009507513-1811USA001975: US-009507513-1811USA001858.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001976: US-009507513-1811USA001975: US-009507513-1811USA001977.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Cough, Erythema, Feeling abnormal, Malaise
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). This consumer reported same PREVNAR 13 (batch number unknown), via an unspecified route of administration on an unspecified date (22Oct, year unspecified) at a single dose for immunization. Medical history included allergens (gluten, corn, dyes, animal-derived, other). The patient's concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine on 22Oct (year unspecified) and since then she feels awful, was horrible sick since. Patient heard that there was a formaldehyde and mercury in it. Patient also reported cold, cough, not feeling good, sneezing, her throat has been hurting, she has been sick, had chills and small fever, experienced arm red but no rash, all on an unspecified date. Patient stated that she did not want a vaccine, and stated that she was not happy and this was awful. Patient stated that she rarely get sick, that she did not take any medications. Patient stated that she notified a doctor about her symptoms but HCP did not really do anything about it, then she called her other doctor and was told by that HCP that they had the same symptoms after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein vaccination. The outcome of the events experienced feels awful, horrible sick since, cold, cough, not feeling good, sneezing, throat has been hurting, chills, small fever, reported arm red but no rash was unknown. No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018449607 same reporter, suspect product, and events/ different patient.
Sex: F
Vaccine: PNC13
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia, Sneezing
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). This consumer reported same PREVNAR 13 (batch number unknown), via an unspecified route of administration on an unspecified date (22Oct, year unspecified) at a single dose for immunization. Medical history included allergens (gluten, corn, dyes, animal-derived, other). The patient's concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine on 22Oct (year unspecified) and since then she feels awful, was horrible sick since. Patient heard that there was a formaldehyde and mercury in it. Patient also reported cold, cough, not feeling good, sneezing, her throat has been hurting, she has been sick, had chills and small fever, experienced arm red but no rash, all on an unspecified date. Patient stated that she did not want a vaccine, and stated that she was not happy and this was awful. Patient stated that she rarely get sick, that she did not take any medications. Patient stated that she notified a doctor about her symptoms but HCP did not really do anything about it, then she called her other doctor and was told by that HCP that they had the same symptoms after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein vaccination. The outcome of the events experienced feels awful, horrible sick since, cold, cough, not feeling good, sneezing, throat has been hurting, chills, small fever, reported arm red but no rash was unknown. No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018449607 same reporter, suspect product, and events/ different patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on 25Oct2018 at a single dose immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose PNEUMOVAX in 2017 (reported a year from the time of the report) for immunisation. On an unspecified date in Oct2018, after the vaccination, the patient reported arm swelling double the size down to the wrist, redness and discomfort. The patient reported that he could not follow-up with the physician who recommended to wrap in ice bandage, apply heat, elevate the arm and take antihistamine. The patient reported that symptoms improved however swelling and discomfort were still present under the arm. Outcome of event 'redness' was recovering; all other events were not recovered. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Chills, Cough, Erythema, Feeling abnormal, Malaise
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported same events for two patients. This is the second of two reports. A patient of an unspecified age and gender received PREVNAR 13; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine on an unspecified date and since then patient feels awful, was horrible sick since. Patient also had cold, cough, not feeling good, sneezing, throat has been hurting, has been sick, had chills and small fever, experienced arm red but no rash, all on an unspecified date. The outcome of the events experienced feels awful, horrible sick since, cold, cough, not feeling good, sneezing, throat has been hurting, chills, small fever, reported arm red but no rash was unknown. No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2018446765 same reporter, suspect product, and events/different patient.
Sex: U
Vaccine: PNC13
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia, Sneezing
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported same events for two patients. This is the second of two reports. A patient of an unspecified age and gender received PREVNAR 13; (batch number unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine on an unspecified date and since then patient feels awful, was horrible sick since. Patient also had cold, cough, not feeling good, sneezing, throat has been hurting, has been sick, had chills and small fever, experienced arm red but no rash, all on an unspecified date. The outcome of the events experienced feels awful, horrible sick since, cold, cough, not feeling good, sneezing, throat has been hurting, chills, small fever, reported arm red but no rash was unknown. No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2018446765 same reporter, suspect product, and events/different patient.
Sex: M
Vaccine: PNC13
Symptoms: Peripheral swelling, Tendon rupture, Tenoplasty
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Sanofi-Aventis Group (1-1510835783). A contactable healthcare professional reported that a 70-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 3 hours after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), it was reported that the patient's arm swelled causing ripped tendons requiring surgery. The patient reported that it took 2 years to recover. The outcome of the events was recovered on an unspecified date. Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might have played a contributory role in triggering the occurrence of arm swelled causing ripped tendons considering the plausible time association.  However, more information such as medical history and concomitant medications are needed for fully medical assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Myalgia, Pain
Clinical narrative: Inability to lift arm up to shoulder level. Cannot move arm backwards. Cannot stretch arm overhead while laying down without searing pain in upper arm muscle. Cannot put clothing on easily. Must keep left arm (where vaccine was administered) lower than shoulder when getting dressed. Unable to start with right arm in clothing, then left arm into clothing. No longer able to swim due to loss of arm movement.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Deafness unilateral, Ear discomfort
Clinical narrative: 50% loss of hearing in the right ear, 100% clogged.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Immunization was given before appropriate age. Per Health Department no treatment necessary.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects seen. MD called and advised to call CDC and poison control. CDC and poison control stated patient will be fine she will just have more muscle aches today.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Headache, Injection site pain, Tremor
Clinical narrative: Severe shaking/shivering total body symmetrical, headache frontal bilateral. I did not feel hot to touch. There was no sweating, no nausea, no dizziness, no myalgia, no pain except in upper arm at and near site of injection, no vomiting, no difficulty breathing, no hives, no rash. I didn't feel cold but tried to fix my shaking by heating the house holding on to heat pads and adding  bed covers. I was too shay to drink anything or take a temperature as my arms were wildly moving and my legs were so unsteadies to prevent walking to get to phone or kitchen. After it was over there were no other effects. Shivering/severe shaking lasted for 6 hours from 7 pm Oct 24  until 2 am Oct 25 I discussed this reaction with my physician Dr on Oct 30 at an annual visit because I was planning to get a Flu vaccine. I am holding back on flu vaccine this year in case I have developed some sensitivity to vaccines.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site reaction, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: During the injection, I felt a gushing of fluid into my shoulder. Removing the BandAid later that day, I noticed that the injection site was higher than normal. My shoulder pain and range of motion gradually worsened over the course of two weeks, to the point where I had difficulty moving my arm and completing basic tasks (showering, getting dressed, eating). I went to Occupational Health on 11/5/18, where a PA diagnosed me with "bursitis" but said that "it couldn't be from the flu shot" because she "never saw that before." The PA recommended ibuprofen 600 mg q6h for 5 days and ice packs. I went to my PCP's office later that same day. My PCP's NP agreed with the ibuprofen/ice and also recommended physical therapy.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance
Clinical narrative: During the injection, I felt a gushing of fluid into my shoulder. Removing the BandAid later that day, I noticed that the injection site was higher than normal. My shoulder pain and range of motion gradually worsened over the course of two weeks, to the point where I had difficulty moving my arm and completing basic tasks (showering, getting dressed, eating). I went to Occupational Health on 11/5/18, where a PA diagnosed me with "bursitis" but said that "it couldn't be from the flu shot" because she "never saw that before." The PA recommended ibuprofen 600 mg q6h for 5 days and ice packs. I went to my PCP's office later that same day. My PCP's NP agreed with the ibuprofen/ice and also recommended physical therapy.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Arthritis, Blood test, Borrelia test, Joint swelling
Clinical narrative: Wrists, fingers, knees, ankles swollen with redness and pain.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rheumatoid factor
Clinical narrative: Wrists, fingers, knees, ankles swollen with redness and pain.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: LLE weakness- probable Guillian- Barre.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Guillain-Barre syndrome, Respiratory tract infection
Clinical narrative: LLE weakness- probable Guillian- Barre.
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: Patient complained of adverse effects including chills (with no fever), weakness, and being tired for 1 day after receiving the vaccine. She said she had it on day 1 of the series and also after the second shot on day 3, On day 1 she also received the IG immogam. Spoke with pharmacist and MD who both said to continue the series.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Initial insomnia, Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in arm (3 weeks now) and it is causing trouble sleeping and daily pain. The pain started the same day as the injection and has not been getting better over the past weeks, as reported by the patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Pain at the time of injection, leading to severe pain and trouble sleeping, reporting that he almost went to the emergency room due to so much pain in the arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Injection site pain, Injection site swelling, Lacrimation increased
Clinical narrative: Patient's eyes are swollen, upper and lower lids, and significant watering. Patient states that she had not had that prior to immunization. Additionally she had pain and swelling at injection site. She has seen her ophthalmogist and her regular physician regarding her eyes. No diagnosis.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: After receiving vaccine patient started to complain of shortness of breath. Patient appeared to be short of breath, but no apparent distress noted. Called EMS immediately after patient reported symptoms. Patient transported to the hospital. Called patient the next day after vaccine was given. Patient states she was not given any medication at the hospital, but did receive a prescription for an EPI PEN. Patient reported that she felt a burning and tight sensation in chest, but that symptoms had gotten better when ambulance arrived.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe left shoulder pain; continued pain and limited range of motion after several weeks.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at site of injection.
Age: 58.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: I had burning, itching and hives on chest and upper back two days after the vaccine. I went to an Urgent Care facility to seek help. I was given a steroid injection and placed on antibiotic for 7 days. After taking the antibiotic for two days, I began to break out in the hives again. This lasted about 3 hours. My doctor advised me to take ZYRTEC.