chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 14-APR-2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 18-NOV-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 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received 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. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) for the permanent prevention of shingles and zoster related injuries. Later in 2015, 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 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received 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 the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2012, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 13-FEB-2013, the patient was treated by a healthcare provider for shingles. And in April 2013, the patient was treated by another 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 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 13-OCT-2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 12-OCT-2016, the patient was treated by a healthcare provider at a medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA001303.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 12-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N032284, expiration date: 22-SEP-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA001303: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA007947.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 75-year-old female patient who received SHINGRIX (batch number 3GY56 ?, expiry date 7th March 2021) for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm, pain in arm and erythema of extremities. On an unknown date, the outcome of the swelling arm, pain in arm and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the swelling arm, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details reported as follows: The patient reported to the pharmacist she experienced swelling, redness, and pain below the injection site and the swelling was the size of her hand.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter's father had a reaction to the SHINGRIX vaccine and his arm was red. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Myalgia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired were unknown. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the reporter. This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient said that the initial SHINGRIX injection was much more painful. Within an hour after vaccination with SHINGRIX, his muscle became sore. The evening after it interfered with his sleep. The next morning after vaccination, the patient only had use of about 25 percent of that arm and had to cancel activities that morning. The reporter asked what did GlaxoSmithKline thought the issue was. This case was linked with the case US2018GSK194103, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site induration in a adult patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site induration and injection site swelling. On an unknown date, the outcome of the injection site induration and injection site swelling were unknown. It was unknown if the reporter considered the injection site induration and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received SHINGRIX on unknown arm. Area was indurated and raised about half a centimeter. About a centimeter in diameter. The reporter had not seen this type of reaction before. Always been a generalized redness with mild diffuse swelling of deltoid area. The reporter agreed to be contacted for follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported. Nurse at discussion table at conference shared that one of her friends had pain for 18 hours after receiving the SHINGRIX vaccine.
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a infant male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced difficulty breathing. On an unknown date, the outcome of the difficulty breathing was unknown. It was unknown if the reporter considered the difficulty breathing to be related to DTPa vaccine. Additional details were reported as follows: This case was reported by a consumer via Interactive Digital Media. The reporter had whooping cough in 1948. The reporter was about 2 and half and was so sick. The reporter remember part of it and would take a step and cough. His grandfather was an old school barber with home remedies up his sleeve. He got a teaspoon of sugar and poured kerosene on it. He had him ate it. No more coughing that night at least. The reporter was forced by his boss to had a flu shot in about 1974. He was sick for nearly 2 weeks. The reporter had one since. The reporter's grandson had a DPT shot as a baby. P for Pertussis. He had breathing issues his whole life of 25 years. This case has been linked with US2018GSK205808, reported by same reporter.
Sex: F
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pertussis in a child female patient who received INFANRIX for prophylaxis. On an unknown date, the patient received the 1st dose of INFANRIX. On an unknown date, unknown after receiving INFANRIX, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown. It was unknown if the reporter considered the pertussis to be related to INFANRIX. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient was scheduled for her 2nd round of INFANRIX shot, however, the mother stated that, the patient possibly had pertussis at the time of reporting. The reporter asked if it was recommended to give the scheduled INFANRIX shot if the patient was positive for pertussis or wait.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Local reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 65-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX (intramuscular). In July 2018, 1 day after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. The patient experienced a local site reaction (redness) about 6 to 7 inches down from where she received the vaccine. The reaction began 1 to 2 days after she received the vaccine and lasted for few days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 71-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced dizziness, nausea and blurred vision. On an unknown date, the outcome of the dizziness, nausea and blurred vision were recovered/resolved. It was unknown if the reporter considered the dizziness, nausea and blurred vision to be related to SHINGRIX. Additional details were provided as follows: Greater than 4 days after receiving SHINGRIX, the patient experienced dizziness, nausea and blurred vision. In November 2018, all symptom were resolved. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced a deep, long painful arm.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 2nd April 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced product supply issue. On 4th April 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was received via web callback form. The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in the left arm. The patient woke up the next morning and experienced flu-like symptoms that lasted for 2 days and resolved. Till the time of reporting, the patient had not received the 2nd dose of the SHINGRIX series. The patient was told that the 2nd dose of SHINGRIX was in short supply and not available. The patient asked whether did this effect the effectiveness of the drug. The patient stated that it was explained by GSK that the 2nd dose should be taken within 2 to 4 months, then it was changed it to 6 months. The patient asked to explain what was going on. The patient did not recall any details and could not be reached to obtain further details.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 3rd November 2018, the patient received the 1st dose of SHINGRIX. On 3rd November 2018, 3 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site tenderness were not recovered/not resolved and the outcome of the injection site warmth was recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: Around 5 pm, the patient received SHINGRIX. By 8 pm, the patient had redness, swelling, heat and tenderness at the injection site. At the time of reporting, the patient still had the symptoms, though the heat had improved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site discoloration and allergic reaction. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the injection site discoloration was recovering/resolving and the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site discoloration and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in the left arm approximately one week, before the date of reporting. The patient described that the SHINGRIX vaccine hurt when it was injected. He reported that within a day or so, he developed swelling and a large black and blue mark at the injection site. The swelling resolved within approximately three days. The black and blue mark was resolving. At the time of reporting, the outer edges of the mark were turning yellow and purple and the center was still black and blue although he felt everything was starting to fade. The patient's pharmacist told him that this was an allergic reaction and he should not receive the 2nd dose of SHINGRIX. The patient consented to be followed up. The patient gave permission for his physician to be contacted.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, skin breakout, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, skin breakout, injection site warmth and fever were recovered/resolved. It was unknown if the reporter considered the injection site erythema, skin breakout, injection site warmth and fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient developed broke out and fever, and a 2 to 3 inch circle around the injection site that was hot and red. The events were lasted for about 3 to 4 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 7th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 8th November 2018, the patient experienced fever, tiredness and headache. On an unknown date, the outcome of the fever, tiredness, headache and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the fever, tiredness, headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient experienced arm pain. On the reporting day, 1 day after receiving SHINGRIX, the patient woke up with feeling feverish, tired and a headache.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (1 to 2 times every year for the past 30 years from the reporting date). On 29th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: The healthcare professional stated that the patient had a history of reoccurring shingles. After vaccination with the dose of SHINGRIX the patient developed shingles. No further details provided regarding the event. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Product preparation issue, Underdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the pain in arm, injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient's arm was sore as a result of the injection and she experienced the red around the injection site. The patient also expressed concerns because she saw adjuvant liquid shoot out from the vial before mixing it with the antigen and she was concerned about she did not get a full dose, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The patient disconnected. She did not want to answer any questions nor provide demographics.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills and fatigue. In November 2018, the patient experienced pain. On an unknown date, the outcome of the injection site pain, chills, fatigue and pain were unknown. It was unknown if the reporter considered the injection site pain, chills, fatigue and pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left arm. After receiving a dose of SHINGRIX vaccine, the reporter's wife experienced pain at injection site, chills, achiness and fatigue. The patient planned to follow up with her physician on an unknown date. For tolerance to 2nd dose, refer case US2018GSK208988.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Confusional state, Discomfort, Fatigue, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of agitation in a 77-year-old male patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. Concurrent medical conditions included dementia. On 7th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th November 2018, immediately after receiving SHINGRIX, the patient experienced agitation, injection site pain, tiredness, pain and discomfort. On 9th November 2018, the patient experienced influenza-like symptoms. On 10th November 2018, the patient experienced confusion and activities of daily living impaired. On an unknown date, the outcome of the agitation, injection site pain, activities of daily living impaired, pain and discomfort were unknown and the outcome of the influenza-like symptoms and confusion were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the agitation, injection site pain, influenza-like symptoms, confusion, tiredness, activities of daily living impaired, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received his dose of SHINGRIX on his left deltoid at 11:30 PM. As soon as the SHINGRIX vaccine was administered, the patient became agitated and said that the area was really sore. The patient's wife explained that he had dementia and that he could not distinguish between discomfort and pain. On 7th November 2018 and 8th November 2018, the patient was tired. On 9th November 2018, the patient was agitated and started flu like symptoms. On 10th November 2018 and 11th November 2018, the patient was confused and forgot how to brush his teeth, wash his face and swallow his medication. On 12th November 2018 and 13th November 2018, the patient was tired. The reporter consented to be followed up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of agitation in a 77-year-old male patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. Concurrent medical conditions included dementia. On 7th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th November 2018, immediately after receiving SHINGRIX, the patient experienced agitation, injection site pain, tiredness, pain and discomfort. On 9th November 2018, the patient experienced influenza-like symptoms. On 10th November 2018, the patient experienced confusion and activities of daily living impaired. On an unknown date, the outcome of the agitation, injection site pain, activities of daily living impaired, pain and discomfort were unknown and the outcome of the influenza-like symptoms and confusion were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the agitation, injection site pain, influenza-like symptoms, confusion, tiredness, activities of daily living impaired, pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received his dose of SHINGRIX on his left deltoid at 11:30 PM. As soon as the SHINGRIX vaccine was administered, the patient became agitated and said that the area was really sore. The patient's wife explained that he had dementia and that he could not distinguish between discomfort and pain. On 7th November 2018 and 8th November 2018, the patient was tired. On 9th November 2018, the patient was agitated and started flu like symptoms. On 10th November 2018 and 11th November 2018, the patient was confused and forgot how to brush his teeth, wash his face and swallow his medication. On 12th November 2018 and 13th November 2018, the patient was tired. The reporter consented to be followed up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The next day following the injection, she developed a fever. The reporter stated that her temperature was between 101 -102 degree F.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. An elderly female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medications included the influenza vaccine (FLU VACCINE II). On an unknown date, the patient experienced pain and swelling in arm. Patient approached the company representative in the waiting room, and mentioned she received the flu shot and pneumonia shot on same day in separate arms. She experienced pain and swelling in arm that received pneumonia shot. She did not specify which pneumonia vaccine. The action taken in response to the events for the vaccine was not applicable. Therapeutic measures were taken as a result of pain and swelling in arm and included treatment with unspecified antibiotics which she received after going to the urgent care. The clinical outcome for the events of pain and swelling in arm was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A female patient of an unspecified age received the PREVNAR 13, on an unspecified date and then on another unspecified date; both via unspecified routes of administration at single doses for immunization. The patient's medical history and concomitant medications were not reported. On unspecified dates, the patient developed lumps at the injection sites. The clinical outcome of the event, lumps at the injection sites, was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chest pain, Cough, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 76-year-old female patient received PREVNAR 13, via an unspecified route of administration in the arm from 06Sep2018 at single dose at single dose for pneumonia immunisation. Medical history was reported as none. Concomitant medication included COUMADIN. After vaccination the patient thought her arm was going to fall off because it hurt so bad and stated that she went to the emergency room and they kept giving her pain medications, but the pain medications were not helping and did not do any tests to see if anything was wrong with her arm, they gave her morphine, DILAUDID and BENADRYL and none of it helped. They sent her home with LORTAB and it did not help either. Patient reported that the pain continued in her shoulder and neck and part of her back and chest on the right side. Patient described the pain throbs and aches at night. Patient also mentioned that she even had a hard time putting her clothes on because of the pain. Patient also reported that she was coughing every now and then. Patient then went to the doctor's office, and was told that since she was on warfarin sodium and she might have a blood clot in her arm, but didn't do any tests or anything. Outcome of the events was unknown.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 76-year-old female patient received PREVNAR 13, via an unspecified route of administration in the arm from 06Sep2018 at single dose at single dose for pneumonia immunisation. Medical history was reported as none. Concomitant medication included COUMADIN. After vaccination the patient thought her arm was going to fall off because it hurt so bad and stated that she went to the emergency room and they kept giving her pain medications, but the pain medications were not helping and did not do any tests to see if anything was wrong with her arm, they gave her morphine, DILAUDID and BENADRYL and none of it helped. They sent her home with LORTAB and it did not help either. Patient reported that the pain continued in her shoulder and neck and part of her back and chest on the right side. Patient described the pain throbs and aches at night. Patient also mentioned that she even had a hard time putting her clothes on because of the pain. Patient also reported that she was coughing every now and then. Patient then went to the doctor's office, and was told that since she was on warfarin sodium and she might have a blood clot in her arm, but didn't do any tests or anything. Outcome of the events was unknown.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A elderly female patient (Age: Over 65-year-old) received PREVNAR 13, via an unspecified route of administration in the winter of 2017 single dose for immunisation, and influenza vaccine, via an unspecified route of administration in the winter of 2017 for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced flu-like symptoms after being vaccinated and went to the hospital, as a result. Outcome of event was unknown. Sender's Comments: Reported flu-like symptoms is not related to the use of PREVNAR 13 more likely representing an intercurrent medical condition. 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.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events two patients. The is the second of two reports. This consumer reported for her sister that a female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The consumer reported she had an infection after getting the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The physician's assistant looked at her arm that was swollen and red telling the caller it's cellulitis and said had to get antibiotics because her arm blew up (swollen) and turned red. The consumer (therapist) said the same thing happened to their sister when she got the pneumococcal vaccine. The outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018463224 same reporter, similar drug/event, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable healthcare professional via a Pfizer-sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on 22Oct2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient returned to the clinic on 25Oct2018 and reported having redness, swelling and heat couple inches of injection site on left arm in Oct2018. The patient was given 5 day oral treatment. Information on batch number has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Body temperature increased, Full blood count normal, Headache, Human chorionic gonadotropin normal
Clinical narrative: Got home from appointment with headache-> 3 tablets MOTRIN at 4:30pm->fell asleep->9pm woke up with worse headache and neck pain and body aches->temp 102F w/neck stiffness and nausea->I instructed patient to visit the ED for evaluation (over the telephone)->patient brought to Hospital via ambulance as patient was too weak to get into car. Vitals: 101.1 degree F, HR 102, RR 20, 100% on room air, BP 138/79, 10/10 pain. Given BENADRYL 50mg IV, REGLAN 10mg IV, 1 liter fluid bolus of normal saline->then later given TYLENOL 650mg PO and MOTRIN 800mg PO->discharged home with stable vitals.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: International normalised ratio increased, Metabolic function test normal, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: Got home from appointment with headache-> 3 tablets MOTRIN at 4:30pm->fell asleep->9pm woke up with worse headache and neck pain and body aches->temp 102F w/neck stiffness and nausea->I instructed patient to visit the ED for evaluation (over the telephone)->patient brought to Hospital via ambulance as patient was too weak to get into car. Vitals: 101.1 degree F, HR 102, RR 20, 100% on room air, BP 138/79, 10/10 pain. Given BENADRYL 50mg IV, REGLAN 10mg IV, 1 liter fluid bolus of normal saline->then later given TYLENOL 650mg PO and MOTRIN 800mg PO->discharged home with stable vitals.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Prothrombin time prolonged, Somnolence
Clinical narrative: Got home from appointment with headache-> 3 tablets MOTRIN at 4:30pm->fell asleep->9pm woke up with worse headache and neck pain and body aches->temp 102F w/neck stiffness and nausea->I instructed patient to visit the ED for evaluation (over the telephone)->patient brought to Hospital via ambulance as patient was too weak to get into car. Vitals: 101.1 degree F, HR 102, RR 20, 100% on room air, BP 138/79, 10/10 pain. Given BENADRYL 50mg IV, REGLAN 10mg IV, 1 liter fluid bolus of normal saline->then later given TYLENOL 650mg PO and MOTRIN 800mg PO->discharged home with stable vitals.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: (R) arm injection - that night (R) hand numbness and tingly that persisted until today. No pain at the site or in the shoulder region.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain, redness, swelling at the injection site. Fever, nausea and headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pain, redness, swelling at the injection site. Fever, nausea and headache.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient says her arm hearts. (patient got flu shot on 11/04/18).
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: 11/19/2018 A.M.: Nausea/vomitting; low grade fever 100F; chills.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Ultrasound scan
Clinical narrative: Redness at site and rash. Went to ED. Patient was diagnosed with cellulitis but per MD d/t break in skin and not from vaccine. Started on cephalexin.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Burning sensation, Loss of personal independence in daily activities, Pain, Paraesthesia
Clinical narrative: Patient began experiencing burning/tingling in her feet in the middle of the night the she received the vaccine. Over the next several days, these symptoms began traveling up her legs, and ultimately into her left arm. Patient reports burning pain and weakness with difficulty in daily activities. She began taking OTC advil and drinking protein shakes. She did not see a doctor. She is still experiencing these side effects (though she reports they have lessened) at this time. I encouraged her to make an appointment to see her family doctor as soon as possible. Patient reports that she has had numerous flu shots in the past with no adverse effects.
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dysstasia, Gait inability, Ill-defined disorder, Muscle rigidity
Clinical narrative: Patient reports onset of general weakness 4 days after administration of vaccine. Weakness gradually progressed to the point of inability to walk and, eventually, stand. Weakness became associated with limb rigidity. Amid these events, patient became febrile and this prompted presentation to the hospital where he was admitted with acute illness presumed to be secondary to pneumonia.