chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX. Concomitant products included quinapril. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced chills. On 4th May 2018, the patient experienced fever. On an unknown date, the outcome of the fever and chills were not recovered/not resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received the vaccine on the left arm. The patient's body temperature went as high as 101.3 on the next day of vaccination. The husband reported that his wife planned to follow-up with her physician on an unknown date.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 5-year-old female (normal host with no significant medical history, no known allergies) who in May 1997 was vaccinated in the arm with one dose of varicella virus vaccine live. There were no concurrent medications. It was noted that a rash did not occur at the site of injection post-vaccination. On 13-DEC-2001, the child developed a rash consisting of papules and vesicles. There were approximately 50 lesions. There was no recent exposure to chicken pox or shingles. She presented to the physician who diagnosed her with herpes zoster along the right L-2 dermatome. On 13-DEC-2001 the physician obtained a specimen from one of the lesions. A Tzanck test showed multinucleated giant cells. The physician prepared a slide from the specimen, which will be submitted for PCR analysis. The patient subsequently recovered. Follow-up information indicated that the interpretation of the PCR analysis was "VZV positive, non typable". Additional follow-up information was received on 30-OCT-2002. The vesicular rash specimen was positive for VZV and PCR analysis of reamplified specimen identified the presence of Wild Type VZV. Subsequently, the patient's experience was reported in a published article, title as stated above, that a "previously well" 5 year old female who, at 15 months of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient presented to her pediatrician with a 10-day history of painful pruritic blisters which began on her left buttocks and spread to her left lateral thigh. Her physician considered herpes simplex, zoster and contact dermatitis and referred her to infectious disease. On examination, she was afebrile and had a vesicular rash involving the L-2 dermatome. The base of a vesicle was scraped and was VZV DFA-positive. Crusts of the lesion were removed and sent for DNA typing. No other studies were done, and the patient was reassured. The pain, pruritus and rash resolved within the week. The VZV isolate was typed as wild type VZV. It was reported that it was possible that preceding the varicella vaccine the patient had had a mild case of varicella that was not diagnosed or that after the varicella vaccine she was exposed to wild type VZV and was asymptomatically infected. The wild type VZV established latency and reactivated as zoster. It was noted that the patient has remained well for 2 years. This is an amended report. Event of wild type VZV was encoded from varicella zoster virus infection to Herpes Zoster. Additionally relatedness was updated from unknown to related per current guidelines. Sender's Comments: MERCK 0201USA03220: Mfr number.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 5-year-old female (normal host with no significant medical history, no known allergies) who in May 1997 was vaccinated in the arm with one dose of varicella virus vaccine live. There were no concurrent medications. It was noted that a rash did not occur at the site of injection post-vaccination. On 13-DEC-2001, the child developed a rash consisting of papules and vesicles. There were approximately 50 lesions. There was no recent exposure to chicken pox or shingles. She presented to the physician who diagnosed her with herpes zoster along the right L-2 dermatome. On 13-DEC-2001 the physician obtained a specimen from one of the lesions. A Tzanck test showed multinucleated giant cells. The physician prepared a slide from the specimen, which will be submitted for PCR analysis. The patient subsequently recovered. Follow-up information indicated that the interpretation of the PCR analysis was "VZV positive, non typable". Additional follow-up information was received on 30-OCT-2002. The vesicular rash specimen was positive for VZV and PCR analysis of reamplified specimen identified the presence of Wild Type VZV. Subsequently, the patient's experience was reported in a published article, title as stated above, that a "previously well" 5 year old female who, at 15 months of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient presented to her pediatrician with a 10-day history of painful pruritic blisters which began on her left buttocks and spread to her left lateral thigh. Her physician considered herpes simplex, zoster and contact dermatitis and referred her to infectious disease. On examination, she was afebrile and had a vesicular rash involving the L-2 dermatome. The base of a vesicle was scraped and was VZV DFA-positive. Crusts of the lesion were removed and sent for DNA typing. No other studies were done, and the patient was reassured. The pain, pruritus and rash resolved within the week. The VZV isolate was typed as wild type VZV. It was reported that it was possible that preceding the varicella vaccine the patient had had a mild case of varicella that was not diagnosed or that after the varicella vaccine she was exposed to wild type VZV and was asymptomatically infected. The wild type VZV established latency and reactivated as zoster. It was noted that the patient has remained well for 2 years. This is an amended report. Event of wild type VZV was encoded from varicella zoster virus infection to Herpes Zoster. Additionally relatedness was updated from unknown to related per current guidelines. Sender's Comments: MERCK 0201USA03220: Mfr number.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Headache, Incorrect dose administered, Vaccination site pain
Clinical narrative: Received a spontaneous report on 23JAN2018, 24JAN2018 and 25JAN2018 from personnel. The physician reported that on 23JAN2018, a employee who was on travel, received 5ml of BioThrax vaccine injected into the deltoid rather than the prescribed 0.5ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medics and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Headache, Injection site pain
Clinical narrative: Received a spontaneous report on 23JAN2018, 24JAN2018 and 25JAN2018 from personnel. The physician reported that on 23JAN2018, a employee who was on travel, received 5ml of BioThrax vaccine injected into the deltoid rather than the prescribed 0.5ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medics and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Arthralgia, Burning sensation, Mobility decreased, Pain, Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received BEXSERO (batch number 16D301, expiry date 28th February 2019). On 20th April 2018, the patient received BEXSERO. On 20th April 2018, immediately after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), pain in arm (serious criteria disability), burning sensation (serious criteria disability) and injected limb mobility decreased (serious criteria disability). In April 2018, the outcome of the pain in arm, burning sensation and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, pain in arm, burning sensation and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional information was received as follows: The reporting nurse stated that the patient had no other medical history. She had not received other vaccines within a month of receiving BEXSERO. The patient received a dose of BEXSERO on her left arm. The patient pretty immediately after vaccination, experienced pain, swelling and burning sensation which spread to her elbow and fingertips in her left arm. Initially the patient was unable to move her left arm due to pain. The patient was still experiencing persistent swelling in her left elbow, other symptoms had resolved as of 30th April 2018 when the reporting nurse last spoke to the patient. The reporting nurse stated that the patient had a physician's visit and was referred to physiotherapist because of her pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Peripheral coldness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received BEXSERO (batch number 16D301, expiry date 28th February 2019). On 20th April 2018, the patient received BEXSERO. On 20th April 2018, immediately after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), pain in arm (serious criteria disability), burning sensation (serious criteria disability) and injected limb mobility decreased (serious criteria disability). In April 2018, the outcome of the pain in arm, burning sensation and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, pain in arm, burning sensation and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional information was received as follows: The reporting nurse stated that the patient had no other medical history. She had not received other vaccines within a month of receiving BEXSERO. The patient received a dose of BEXSERO on her left arm. The patient pretty immediately after vaccination, experienced pain, swelling and burning sensation which spread to her elbow and fingertips in her left arm. Initially the patient was unable to move her left arm due to pain. The patient was still experiencing persistent swelling in her left elbow, other symptoms had resolved as of 30th April 2018 when the reporting nurse last spoke to the patient. The reporting nurse stated that the patient had a physician's visit and was referred to physiotherapist because of her pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Burning sensation, Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injected limb mobility decreased, Joint swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received BEXSERO (batch number 16D301, expiry date 28th February 2019). On 20th April 2018, the patient received BEXSERO. On 20th April 2018, immediately after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), pain in arm (serious criteria disability), burning sensation (serious criteria disability) and injected limb mobility decreased (serious criteria disability). In April 2018, the outcome of the pain in arm, burning sensation and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, pain in arm, burning sensation and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional information was received as follows: The reporting nurse stated that the patient had no other medical history. She had not received other vaccines within a month of receiving BEXSERO. The patient received a dose of BEXSERO on her left arm. The patient pretty immediately after vaccination, experienced pain, swelling and burning sensation which spread to her elbow and fingertips in her left arm. Initially the patient was unable to move her left arm due to pain. The patient was still experiencing persistent swelling in her left elbow, other symptoms had resolved as of 30th April 2018 when the reporting nurse last spoke to the patient. The reporting nurse stated that the patient had a physician's visit and was referred to physiotherapist because of her pain.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 17-year-old female patient who received BEXSERO (batch number 16D301, expiry date 28th February 2019). On 20th April 2018, the patient received BEXSERO. On 20th April 2018, immediately after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb (serious criteria disability), pain in arm (serious criteria disability), burning sensation (serious criteria disability) and injected limb mobility decreased (serious criteria disability). In April 2018, the outcome of the pain in arm, burning sensation and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, pain in arm, burning sensation and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional information was received as follows: The reporting nurse stated that the patient had no other medical history. She had not received other vaccines within a month of receiving BEXSERO. The patient received a dose of BEXSERO on her left arm. The patient pretty immediately after vaccination, experienced pain, swelling and burning sensation which spread to her elbow and fingertips in her left arm. Initially the patient was unable to move her left arm due to pain. The patient was still experiencing persistent swelling in her left elbow, other symptoms had resolved as of 30th April 2018 when the reporting nurse last spoke to the patient. The reporting nurse stated that the patient had a physician's visit and was referred to physiotherapist because of her pain.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Uveitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of panuveitis in a 75-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced panuveitis (serious criteria disability and GSK medically significant) and vision decreased. The patient was treated with Topical Steroids. On an unknown date, the outcome of the panuveitis and vision decreased were recovering/resolving. The reporter considered the panuveitis and vision decreased to be almost certainly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX on Thursday and experienced a decrease in vision in his left eye that night and worsened the next day (acute onset unilateral panuveitis). The patient could see perfectly in that eye beforehand. On Friday, the patient was only able to perceive light. It was much improved since starting on topical steroids. There was lack of other co-morbid conditions so reporting the health care professional felt that, from a causality perspective, this was almost certainly or probably related to SHINGRIX. The lab work was not conducted. The health care professional felt that it was disabling to the patient since the patient did not see well out of his other eye. Lot, expiration date, site and route of administration information was not available. The health care professional stated that the patient was also health care professional and would be fine with follow up if necessary. Phone number would be provided to GlaxoSmithKline safety upon request. Also, reporting physician would like follow up from Safety if there were other reports of this. The health care professional reported that it was not usual for Safety to follow up with this information but would be include request in report.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Uveitis, Visual impairment
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of panuveitis in a 75-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced panuveitis (serious criteria disability and GSK medically significant) and vision decreased. The patient was treated with Topical Steroids. On an unknown date, the outcome of the panuveitis and vision decreased were recovering/resolving. The reporter considered the panuveitis and vision decreased to be almost certainly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX on Thursday and experienced a decrease in vision in his left eye that night and worsened the next day (acute onset unilateral panuveitis). The patient could see perfectly in that eye beforehand. On Friday, the patient was only able to perceive light. It was much improved since starting on topical steroids. There was lack of other co-morbid conditions so reporting the health care professional felt that, from a causality perspective, this was almost certainly or probably related to SHINGRIX. The lab work was not conducted. The health care professional felt that it was disabling to the patient since the patient did not see well out of his other eye. Lot, expiration date, site and route of administration information was not available. The health care professional stated that the patient was also health care professional and would be fine with follow up if necessary. Phone number would be provided to GlaxoSmithKline safety upon request. Also, reporting physician would like follow up from Safety if there were other reports of this. The health care professional reported that it was not usual for Safety to follow up with this information but would be include request in report.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: Painful/tender, red, patchy in appearance.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Headache, Heart rate increased
Clinical narrative: Headache, chills, body pains, fever, insomnia, high pulse rate, upset stomach, swollen, itchy and pain in the area of the shot, lack of energy. This is the second day. I had the first vaccine in March 2018 with the same outcome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain, Pruritus, Pyrexia
Clinical narrative: Headache, chills, body pains, fever, insomnia, high pulse rate, upset stomach, swollen, itchy and pain in the area of the shot, lack of energy. This is the second day. I had the first vaccine in March 2018 with the same outcome.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: HPI 2016, he says Pneumonia vaccine may have not been valid. He got a new one for this reason on 5/8/2018. He says the next day he had redness and warmth of his shoulder. He says he was given ibuprofen and two ice packs. He says later that day, he had swelling of the arm and elbow. He returned the following day and the swelling is worse. The areas is itchy, red, and hot. Prescribed and gave Depo-Medrol injection. Vistaril given for itching.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Full blood count normal, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Patient began with redness/pain/warmth in left deltoid; then had redness, swelling, tingling, pain and numbness that began in bilateral fingers and toes that night and spread progressively proximal over next 48 hours (to metatarsal and metacarpal region). Redness/pain/warmth and PNEUMOVAX site began in right deltoid on day 2...after initial RXN had begun. She also began having some tingling around mouth on day 2...when she came in for treatment. Treated with prednisone taper...75% improved after 3 days. Still awaiting complete recovery.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site warmth, Metabolic function test normal, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient began with redness/pain/warmth in left deltoid; then had redness, swelling, tingling, pain and numbness that began in bilateral fingers and toes that night and spread progressively proximal over next 48 hours (to metatarsal and metacarpal region). Redness/pain/warmth and PNEUMOVAX site began in right deltoid on day 2...after initial RXN had begun. She also began having some tingling around mouth on day 2...when she came in for treatment. Treated with prednisone taper...75% improved after 3 days. Still awaiting complete recovery.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Red blood cell sedimentation rate normal
Clinical narrative: Patient began with redness/pain/warmth in left deltoid; then had redness, swelling, tingling, pain and numbness that began in bilateral fingers and toes that night and spread progressively proximal over next 48 hours (to metatarsal and metacarpal region). Redness/pain/warmth and PNEUMOVAX site began in right deltoid on day 2...after initial RXN had begun. She also began having some tingling around mouth on day 2...when she came in for treatment. Treated with prednisone taper...75% improved after 3 days. Still awaiting complete recovery.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX, lot # N021719, expiration date 10-AUG-2019, (dose, dose number, route, and frequency were not reported), for prophylaxis. Concomitant therapies included sterile diluent (MERCK, lot number N020144 Expiration date 01-NOV-2019). No adverse reactions were observed. The temperature excursion occurred possibly from 22-DEC-2017 to 02-JAN-2018, when no temperature was recorded and also possibly due to the "power was turned off and the freezer door was open". No previous temperature excursion. The digital datalogger was not involved. This is one of two reports from the same reporter. Follow-up information has been received from nurse on 03-MAY-2018. A phone call was placed to the reporter. A request was made to verify if any additional patients were vaccinated with the vaccines involved in a temperature excursion. The reporter had previously sent patient identifier information for one patient. The reported also stated that the health center would have been closed during that time frame so it may have vaccinated only one patient with the lot involved in the temperature excursion. Upon receipt of follow-up information it was determined that this case is now valid because three patient identifiers information was received. Follow up information has been received from nurse on 09-MAY-2018. A call was placed to the reporter. The reporter stated that at the time of the temperature excursion, the power was off for two days and the school would have been closed from 22-DEC-2017 to 02-JAN-2018. The reporter also stated that the vaccines at the time looked like ice had melted and then had refroze on top of the vaccines. The reporter shared that school would have opened after the winter break on 04-JAN-2018. The reporter stated three patients would have been vaccinated after that time. This report refers to a 25 year old patient of unknown gender. On 23-JAN-2018, the patient was vaccinated with improperly stored VARIVAX (lot # N021719, expiry date 10-AUG-2019) (dose, route and frequency were not reported) for prophylaxis. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA013481:
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Biopsy skin abnormal, Discomfort, Immunology test normal, Laboratory test normal
Clinical narrative: This literature marketed report as received from the authors of the published literature article, refers to an 18 year old female patient with no significant past medical history presented with bilateral lower extremity pain for the past 4 years. On an unknown date the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date (5 months after receiving HPV vaccine), the patient experienced pain Symptom localized to bilateral upper calves to knees. The pain was described as aching and pressure-like, worse with physical activity and severe by the end of the day. She noted bilateral hand tingling improved by wearing braces. She was initially diagnosed with patellar tendonitis with no response to nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or physical therapy. Magnatic Resonance Imaging (MRI) of the knees, brain, and lumbar spine were unremarkable. Autoimmune disease workup was negative. Electrodiagnosis (EDX) studies were unremarkable. Skin biopsy on the left thigh and calf showed low normal sweat gland fiber density of 38.8 and 39.5, respectively. The patient diagnosed through clinical presentation and neurological examination, supported by normal laboratory workup, normal EDX studies, and low normal sweat gland fiber density on unknown dates. The outcome of the event was unknown. The reporter considered small fibre neuropathy to be related to HPV vaccine (manufacturer unknown).
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Lumbar puncture normal, Neurological examination, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Orthosis user
Clinical narrative: This literature marketed report as received from the authors of the published literature article, refers to an 18 year old female patient with no significant past medical history presented with bilateral lower extremity pain for the past 4 years. On an unknown date the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date (5 months after receiving HPV vaccine), the patient experienced pain Symptom localized to bilateral upper calves to knees. The pain was described as aching and pressure-like, worse with physical activity and severe by the end of the day. She noted bilateral hand tingling improved by wearing braces. She was initially diagnosed with patellar tendonitis with no response to nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or physical therapy. Magnatic Resonance Imaging (MRI) of the knees, brain, and lumbar spine were unremarkable. Autoimmune disease workup was negative. Electrodiagnosis (EDX) studies were unremarkable. Skin biopsy on the left thigh and calf showed low normal sweat gland fiber density of 38.8 and 39.5, respectively. The patient diagnosed through clinical presentation and neurological examination, supported by normal laboratory workup, normal EDX studies, and low normal sweat gland fiber density on unknown dates. The outcome of the event was unknown. The reporter considered small fibre neuropathy to be related to HPV vaccine (manufacturer unknown).
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity, Paraesthesia, Small fibre neuropathy, Tendonitis
Clinical narrative: This literature marketed report as received from the authors of the published literature article, refers to an 18 year old female patient with no significant past medical history presented with bilateral lower extremity pain for the past 4 years. On an unknown date the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date (5 months after receiving HPV vaccine), the patient experienced pain Symptom localized to bilateral upper calves to knees. The pain was described as aching and pressure-like, worse with physical activity and severe by the end of the day. She noted bilateral hand tingling improved by wearing braces. She was initially diagnosed with patellar tendonitis with no response to nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or physical therapy. Magnatic Resonance Imaging (MRI) of the knees, brain, and lumbar spine were unremarkable. Autoimmune disease workup was negative. Electrodiagnosis (EDX) studies were unremarkable. Skin biopsy on the left thigh and calf showed low normal sweat gland fiber density of 38.8 and 39.5, respectively. The patient diagnosed through clinical presentation and neurological examination, supported by normal laboratory workup, normal EDX studies, and low normal sweat gland fiber density on unknown dates. The outcome of the event was unknown. The reporter considered small fibre neuropathy to be related to HPV vaccine (manufacturer unknown).
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23 (strength, route of administration, anatomical location, lot# and expiration date were not provided). It was reported that the first dose of PNEUMOVAX 23 was administered at "age 61 years" and the second dose "4 years 11 months after the first dose".  No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M035486, expiry date: 05-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degrees C to 1 degree C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from nurse refers to a 23 year old patient of unknown gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK, lot # N020144, expiry date: 01-NOV-2019). On 17-JAN-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N021719, expiry date: 10-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. The reporter stated that at the time of the temperature excursion, the power was off for two days and the school would have been closed from 22-DEC-2017 to 02-JAN-2018. The reporter shared that the school would have opened after the winter break on 04-JAN-2018. The reporter also stated that the vaccines at the time looked like ice had melted and then had refroze on top of the vaccines. The reporter stated 3 patients would have been vaccinated after that time. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA013481:
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Injection site nodule, Injection site swelling, Irritability
Clinical narrative: Patient had diarrhea and was fussy that night. That subsided over the next 12-24 hours. However, then 3 days later (yesterday) the patient developed a small nodule at the site of the injection. He has remained well-appearing without signs of lethargy or infection, just the small swelling near the injection site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: RED AREA ABOUT 3 INCH IN DIAMETER AT THE INJECTION SITE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The next day at injection site of KINRIX and PREVNAR - had pain and reddness and swelling (about the size of a silver dollar).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp. to 101.1 rectally after immunizations. No other Sx.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose increased, Blood pressure increased, Dizziness, Loss of consciousness
Clinical narrative: Patient was at work and described feeling dizzy while washing hands and then passed out. He fell straight down so he did not hit his head or sustain any injuries. When he came to, which was quickly according to patient, emt proceeded to check blood sugar and blood pressure both of which were slightly elevated according to patient(neither of which is out of the ordinary for patient acc to him).
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Blood test normal, Burning sensation, Computerised tomogram normal, Depressed level of consciousness, Electromyogram normal
Clinical narrative: I received the immunoglobulin shot in my right butt cheek, then received a first vaccine a day or two prior to the 2nd round. Then I received the 2nd round of RABAVERT around 8/10/2014. Hours after receiving the 2nd shot, my vision went red, my conscious state descended into a hazy dream state, my arms and legs began tinging and burning (pins and needles sensation) and I had perceived sensory loss in my appendages. My blood pressure was dangerously high and I could hardly walk/move my arms above my head or feel anything other than nerve pain for about 6 months. It was way too difficult to do many tasks that were once normal for me. EMG, MRI, CAT scans all came back negative for MS, ALS, tumors, etc. Peripheral Neuropathy was the diagnosis.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Gait disturbance, Hypertension, Loss of personal independence in daily activities, Mobility decreased, Neuralgia
Clinical narrative: I received the immunoglobulin shot in my right butt cheek, then received a first vaccine a day or two prior to the 2nd round. Then I received the 2nd round of RABAVERT around 8/10/2014. Hours after receiving the 2nd shot, my vision went red, my conscious state descended into a hazy dream state, my arms and legs began tinging and burning (pins and needles sensation) and I had perceived sensory loss in my appendages. My blood pressure was dangerously high and I could hardly walk/move my arms above my head or feel anything other than nerve pain for about 6 months. It was way too difficult to do many tasks that were once normal for me. EMG, MRI, CAT scans all came back negative for MS, ALS, tumors, etc. Peripheral Neuropathy was the diagnosis.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Paraesthesia, Sensory loss, Visual impairment
Clinical narrative: I received the immunoglobulin shot in my right butt cheek, then received a first vaccine a day or two prior to the 2nd round. Then I received the 2nd round of RABAVERT around 8/10/2014. Hours after receiving the 2nd shot, my vision went red, my conscious state descended into a hazy dream state, my arms and legs began tinging and burning (pins and needles sensation) and I had perceived sensory loss in my appendages. My blood pressure was dangerously high and I could hardly walk/move my arms above my head or feel anything other than nerve pain for about 6 months. It was way too difficult to do many tasks that were once normal for me. EMG, MRI, CAT scans all came back negative for MS, ALS, tumors, etc. Peripheral Neuropathy was the diagnosis.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # M035486, expiry date: 05-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degree C to 1 degree C for 8.25 hours. It was reported the exact temperature and time below 0 degree C was: -1.9 degree C for 15 minutes, -1.2 degree C for 15 minutes, -1.0 degree C for 15 minutes, -0.8 degree C for 15 minutes, -0.4 degree C for 15 minutes and -0.2 degree C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Limb discomfort, Musculoskeletal discomfort, Myalgia
Clinical narrative: Pt. reports three days after vaccine she developed widespread muscle and joint aches. This pain was quite intense and did last for two weeks. Still has hip and feet discomfort which are gradually resolving.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal discomfort, Blood glucose normal, Hyperhidrosis, Nausea
Clinical narrative: Within several minutes after patient received vaccine she began to feel nauseous, upset stomach, diaphoretic. After approximately 15 minutes with no improvement in symptoms EMS was contacted.  EMS came and assessed patient. Her blood pressure, pulse, and blood sugar were within normal limits.  After several minutes after EMS arrived patient began to feel normally. Patient refused further treatment and left facility on her own with a friend.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Blood lactic acid increased, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED REDNESS, TENDERNESS, IRRITATION, SWELLING, AND FEVER AT THE INJECTION SITE APROXIMATELY 3 HOURS AFTER INJECTION. NO INITIAL SYMPTOMS WERE NOTICED IMMEDIATELY AFTER INJECTION. AFTER THE FIRST DAY SYMPTOMS SPREAD THROUGHOUT ARM OF INJECTION SITE. SHE WENT.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: PATIENT EXPERIENCED REDNESS, TENDERNESS, IRRITATION, SWELLING, AND FEVER AT THE INJECTION SITE APROXIMATELY 3 HOURS AFTER INJECTION. NO INITIAL SYMPTOMS WERE NOTICED IMMEDIATELY AFTER INJECTION. AFTER THE FIRST DAY SYMPTOMS SPREAD THROUGHOUT ARM OF INJECTION SITE. SHE WENT.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Gait inability, Immunoglobulin therapy, Lumbar puncture, Paralysis, Peripheral swelling
Clinical narrative: Arm swelled within 1 hour to 4 times original size, by end of day could not walk, within 3 days paralyzed from neck down. After 2 weeks was administered a lower lumbar puncture and given 5 days worth of IVIG in 2 days because the paralysis was spreading to lungs and Neurologist stated I did not have 5 days to live.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: Pt called today stating that the day after vaccine she developed a sensation like "falling asleep" from the waist down to feet with gradual loss of feeling since 5/12/18. She has an appointment at her PMD on 5/18/18.  I encouraged her to call PMD again and possibly go to emergency room.  She was thankful for the call.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Rash about the size of a quarter around the injection site.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Patient has had intermittent pain in the left deltoid on and off since vaccination. No rash or swelling.  For certain movements, he has continued pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Pyrexia, Tremor
Clinical narrative: Sudden onset of chills, fever, shaking, no energy. Lasting 12 plus hours.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient received vaccines on 4-30-2018. Came back to the office on 5-4-2018 with left arm pain, redness, tenderness, raised 3x3 area and warmth to the touch. Was dx with cellulitis and given BACTRIM. Went to ED on 5-7-2018, no changes in treatment. Returned to PCP office on 5-9-2018 for a f/u and area was improving.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Patient received vaccines on 4-30-2018. Came back to the office on 5-4-2018 with left arm pain, redness, tenderness, raised 3x3 area and warmth to the touch. Was dx with cellulitis and given BACTRIM. Went to ED on 5-7-2018, no changes in treatment. Returned to PCP office on 5-9-2018 for a f/u and area was improving.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills, uncontrolled shivering.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Muscle/joint pain (knees), headache, fatigued. With first shot, I was feverish, and weak.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle/joint pain (knees), headache, fatigued. With first shot, I was feverish, and weak.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient complained of progressively worsening of redness/pain/swelling at injection site. She saw her primary on 5/8/18, who prescribed her cephalexin. She's been experiencing worsening of symptoms, more specifically, pain/stiffness in her neck, and he's been in and out of the ER. She is currently at hospital where she is waiting to hear back from Infectious disease.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient complained of progressively worsening of redness/pain/swelling at injection site. She saw her primary on 5/8/18, who prescribed her cephalexin. She's been experiencing worsening of symptoms, more specifically, pain/stiffness in her neck, and he's been in and out of the ER. She is currently at hospital where she is waiting to hear back from Infectious disease.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Eyelid disorder, Somnolence
Clinical narrative: Swimmy headed for 30 minutes - 1 hour, felt like eyes were puffy though they didn't look like it in the mirror, sleepy.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody, Arthralgia, Blood culture, Borrelia test, C-reactive protein
Clinical narrative: (L) knee swelling and pain. 16 days after vaccine. Patient placed on Augmentin 600/5 ml, 4 ml PO BID. Sent to lab for blood work and stat x-ray. Referral to ortho.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Joint swelling, Metabolic function test, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: (L) knee swelling and pain. 16 days after vaccine. Patient placed on Augmentin 600/5 ml, 4 ml PO BID. Sent to lab for blood work and stat x-ray. Referral to ortho.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: X-ray limb
Clinical narrative: (L) knee swelling and pain. 16 days after vaccine. Patient placed on Augmentin 600/5 ml, 4 ml PO BID. Sent to lab for blood work and stat x-ray. Referral to ortho.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Immediate pain upon injection followed by local redness, similar to cellulitis, some soreness between elbow and shoulder. Treated with AUGMENTIN, ZYRTEC (antihistamine) and steroid cream. Approximately two weeks for reaction to clear up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Decreased appetite, Insomnia, Ultrasound abdomen
Clinical narrative: Severe Stomach Pain, Severe Lower Back Pain, loss of Appetite, no sleep ... Over 60 hours of adverse sudden onset effects.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine analysis
Clinical narrative: Severe Stomach Pain, Severe Lower Back Pain, loss of Appetite, no sleep ... Over 60 hours of adverse sudden onset effects.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction
Clinical narrative: Local reaction to both vaccinations. Treated with ibuprofen, ice, Benadryl.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Nausea, Peripheral swelling
Clinical narrative: Severe nausea (no vomiting), fatigue, flu-like symptoms for 3 days post vaccine administration. Redness and swelling in arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest pain, Dyspnoea, Erythema, Fatigue
Clinical narrative: Patient had soreness and redness the first few days. Then by Friday, she has SOB, chest pain, extreme tiredness. Still doesn't have energy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: Patient had soreness and redness the first few days. Then by Friday, she has SOB, chest pain, extreme tiredness. Still doesn't have energy.