chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, 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. Previously administered products included SHINGRIX ((refer case US2018205828)). On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced headache. In November 2018, the patient experienced injection site pain, chills and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, chills, headache and pain were unknown. It was unknown if the reporter considered the injection site pain, chills, headache and pain to be related to SHINGRIX. Additional details were received as follows: After receiving a dose of SHINGRIX vaccine, the reporter's wife experienced pain at injection site, chills, achiness and headache. The patient planned to follow up with her physician on an unknown date. Follow up information received from consumer on 13th December 2018: The patient did not go to the physician, stayed at home and treated herself.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of burning sensation in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster. In November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, 7 days after receiving SHINGRIX, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was recovered/resolved. It was unknown if the reporter considered the burning sensation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced burning sensation one week after vaccination end of November, in the area where previously had zoster episodes. The event gone in about a week. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cancer (no spleen due to cancer). On 14th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the husband who reported for her wife. The age at the vaccination was not reported. The patient received SHINGRIX vaccine and experienced slight reaction. The reporter reported that initial reason he called GlaxoSmithKline was the lack of availability for the vaccine. This case has been linked to US2018190915 (husband's case) and US2018GSK229702 (same patient).
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (1st dose received on 14th May 2018, refer case US2018GSK229696). On 24th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms (serious criteria other: serious as per reporter). On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. 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 reported by the husband who reported for his wife. The age at the vaccination was not reported but could be 76 years or 77 years. The patient experienced flu like symptoms. The first two days the patient stayed in the house resting. The patient was back to normal after two weeks. The patient was otherwise in good health. The side effects were much more serious with the 2nd vaccine. The reporter reported that initial reason he called GlaxoSmithKline was the lack of availability for the vaccine. This case has been linked to the case US2018GSK229696 (same patient), US2018GSK229698 and US2018190915 (husband's case).
Age: 61.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tremor muscle in a 61-year-old male patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. Co-suspect products included FLUCELVAX for prophylaxis. On 6th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and FLUCELVAX. In October 2018, 3 days after receiving SHINGRIX, the patient experienced tremor muscle. In October 2018, the outcome of the tremor muscle was recovered/resolved. It was unknown if the reporter considered the tremor muscle to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient experienced muscle tremors all over his body that lasted approximately 30 minutes. In October 2018, 3 days after receiving FLUCELVAX, the patient experienced tremor muscle.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Hypervigilance, Insomnia, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty sleeping in a 73-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 1st December 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and hyperalertness. On an unknown date, the patient experienced shingles, red confluent rash cheeks and discomfort. On an unknown date, the outcome of the difficulty sleeping, shingles and red confluent rash cheeks were recovered/resolved and the outcome of the hyperalertness and discomfort were unknown. It was unknown if the reporter considered the difficulty sleeping, shingles, red confluent rash cheeks, hyperalertness and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX in left deltoid and 5 hours later the patient stated that her body went into high alert and she could not sleep that night. One week after receiving the 2nd dose, the patient developed a red, raised strip along her cheekbone that was uncomfortable. The patient believed it was shingles and the red strip went away after 2 days. The patient was not seen by a doctor.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dehydration, Feeding disorder, Herpes zoster, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 16th October 2018, 8 days after receiving SHINGRIX, the patient experienced vomiting, stomach pain, unable to eat, leg pain and feeling unwell. On 18th October 2018, the patient experienced dehydration and weight loss. On an unknown date, the patient experienced shingles and rash. The patient was treated with Pain Medication and Intravenous Fluids. On an unknown date, the outcome of the vomiting, stomach pain, unable to eat, leg pain, dehydration, shingles, rash, feeling unwell and weight loss were recovered/resolved. It was unknown if the reporter considered the vomiting, stomach pain, unable to eat, leg pain, dehydration, shingles, rash, feeling unwell and weight loss to be related to SHINGRIX. Additional details were reported as follows: A few days after vaccination the patient felt ill with vomiting, stomach pain, a terrible pain in her leg and she could not eat. She went to the emergency room on 18th October 2018, a couple days after the symptoms started and she was diagnosed with dehydration (she had lost 5 pounds in 3 days) and given intravenous fluids and pain medication. She did not vomit anymore, but she still could not eat through the weekend, then she developed a rash on her right leg from the top of her knee to her thigh, about 3 by 4 of the way around her leg. The rash occurred where she previously had the leg pain. The patient saw her physician and was diagnosed with shingles and started on treatment. The pain and rash had resolved, but she still had marks where the shingles developed. The reporter consented to follow up. Emergency room visit was required.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Vomiting, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. On 16th October 2018, 8 days after receiving SHINGRIX, the patient experienced vomiting, stomach pain, unable to eat, leg pain and feeling unwell. On 18th October 2018, the patient experienced dehydration and weight loss. On an unknown date, the patient experienced shingles and rash. The patient was treated with Pain Medication and Intravenous Fluids. On an unknown date, the outcome of the vomiting, stomach pain, unable to eat, leg pain, dehydration, shingles, rash, feeling unwell and weight loss were recovered/resolved. It was unknown if the reporter considered the vomiting, stomach pain, unable to eat, leg pain, dehydration, shingles, rash, feeling unwell and weight loss to be related to SHINGRIX. Additional details were reported as follows: A few days after vaccination the patient felt ill with vomiting, stomach pain, a terrible pain in her leg and she could not eat. She went to the emergency room on 18th October 2018, a couple days after the symptoms started and she was diagnosed with dehydration (she had lost 5 pounds in 3 days) and given intravenous fluids and pain medication. She did not vomit anymore, but she still could not eat through the weekend, then she developed a rash on her right leg from the top of her knee to her thigh, about 3 by 4 of the way around her leg. The rash occurred where she previously had the leg pain. The patient saw her physician and was diagnosed with shingles and started on treatment. The pain and rash had resolved, but she still had marks where the shingles developed. The reporter consented to follow up. Emergency room visit was required.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site scar, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site discoloration and injection site scar. The patient was treated with ARNICARE. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site warmth was recovered/resolved and the outcome of the injection site discoloration and injection site scar were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discoloration and injection site scar to be related to SHINGRIX. Addition details were provided as follows: The patient received SHINGRIX injection around 18th, 19th or 20th November 2018 in the left deltoid. The reporter stated that, by the next day she had a red mark about 3 inches wide and warm to the touch. The day after the shot the patient showed her left deltoid (4 to 6 inches below the shoulder) to her neurologist who was concerned it was a blood clot and referred her to her regular physician. The patient saw her regular physician that same day (day after receiving shot) who said it was not a blood clot but it was a reaction to the shot. The patient also showed her pharmacist who advised her to use an over-the-counter topical gel for three days called ARNICARE. The redness was now kind of scarred and the area was no longer warm to the touch but there was still a black and blue area at the injection site the size of a quarter in the shape of a heart with a white dot where the needle went in.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, no adverse event). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient received 2 doses of SHINGRIX. The patient was fine with the first shot but after the second shot the patient had flu like symptoms for a couple of days. The patient received the 1st dose at different location than the 2nd dose. The reporter gave limited information.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the right arm and experienced redness and soreness at the injection site for a week. The patient did not consent to follow up. For tolerance to 2nd dose, refer case US2018GSK228978.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and stiffness shoulder. On an unknown date, the outcome of the injection site pain, injection site swelling and stiffness shoulder were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling and stiffness shoulder to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for herself. Three months before the date of reporting, on 28th or 29th August 2018, the patient received SHINGRIX in the left deltoid. The patient developed tenderness, swelling, and soreness at the injection site and these symptoms have lasted for approximately 3 months. The patient stated that approximately 2 weeks before the date of reporting, the symptoms started to get a little better. The Patient also stated that her left shoulder joint seemed a bit stiff. The physician did not consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, 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 Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu vaccine on left arm. The patient received the Flu vaccine (unknown manufacturer) in October 2018. The patient states that her left arm was a little sore after receiving the vaccine, and this soreness lasted for a couple of days. The patient stated that the soreness was minor. The reporter did not consent to follow up. The reporter did not wish to provide any additional information.
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The healthcare professional reported a colleague mentioned a patient had a possible episode of Guillain-Barre following vaccination with SHINGRIX and an unknown flu vaccine. The reporter did not consent to follow-up. The healthcare professional unable to provide any further information as this was not his patient and was only mentioned off handedly.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Anxiety, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain on site of injection, fever (99 F), muscle pain, overall uneasiness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Whole body rash, fever - lasted over 1 week. Was given antibiotics.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Pyrexia, Screaming
Clinical narrative: Fever, high pitched scream, diarrhea.
Age: 0.42
Sex: F
Vaccine: IPV, PNC13
Symptoms: Rash
Clinical narrative: Rash developed on face.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Insomnia, Nausea, Pain in extremity
Clinical narrative: Nausea, bad headache, stomach ache, inability to sleep, sore arm starting 8 hours after second shot and continuing throughout the night and following morning.
Age: 26.0
Sex: F
Vaccine: FLU4, HEP, HEPA, VARCEL
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: CLIENT RETURNED AFTER 40 MINUTES WITH ITCHING, GENERALIZED RASH INCLUDING WHELPS. NO RESPIRATORY SYMPTOMS. BP 132/72.INITIAL TREATMENT WITH COOL CLOTH AND ICE.  HEALTH DEPT PHYSICIANN CONTACTED BENADRYL 50 MG ORDERED.THIS WAS ADMINISTERED AND CLIENT OBSERVED FOR 30 MINUTES. ITCHING AND RASH RESOLVING. CLIENT RELEASED WITH FAMILY.
Age: 56.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Nodule, Swelling
Clinical narrative: Patient reported a 1/4-1/2 dollar size red swollen area on Left arm with bruising and a 1/4 size knot on he right arm. Patient returned for follow-up employment vaccination on 12/5 and the right arm injection site was now red and swollen as well. Caregiver reports no loss of function or motion in either arm. Patient was told to treat with TYLENOL, Ibuprofen and ice. Patient has since recovered.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Influenza virus test negative, Injection site rash
Clinical narrative: Temp. 102.5 Pulse 110 Blood Pressure 148/82, Nausea, headache, pain in right arm, rash and swollen around injection site, lightheaded, chills, I went to urgent care, and they checked for flu, which came back negative. They then gave me an injection of TORADOL for the fever. Told me to take 1000mg. of TYLENOL.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Temp. 102.5 Pulse 110 Blood Pressure 148/82, Nausea, headache, pain in right arm, rash and swollen around injection site, lightheaded, chills, I went to urgent care, and they checked for flu, which came back negative. They then gave me an injection of TORADOL for the fever. Told me to take 1000mg. of TYLENOL.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Haemorrhage, Injection site pain, Pain in extremity
Clinical narrative: Client was followed up with about six weeks or so after vaccination d/t billing question. She had notable but not concerning bleeding at the time of vaccination. She stated her arm hurt and continued to hurt afterwards. She reported bruising for about 3-4 weeks. She did not receive any follow-up care nor did she have any complaints at the time of phone call.
Age: 25.0
Sex: M
Vaccine: FLUR4, HPV9
Symptoms: Fatigue, Gait disturbance, Joint swelling, Pain, Rash
Clinical narrative: After receiving the shot, later that night I started getting extremely sore and tired. Walking became more difficult. Within that week I had broken out with red dots all over my legs, the worst part being my ankles. I had problems with swelling around my ankles and knees and lower back. Walking was difficult and painful. I went back to the doctor and he informed me I had a hypersensitivity reaction (type 3), and prescribed me a steroid (MEDROL 4 MG Oral Tablet Therapy Pack - 4 MG). I took the steroid as prescribed. However, the symptoms have persisted. I am now seeing a doctor about this problem as persisting problem, which he believes may be hypersensitivity/autoimmune vasculitis caused by the reaction to the shot. It has been 2 months and I still have lasting symptoms. My ankles continue to swell and red dots will reappear.
Age: 25.0
Sex: M
Vaccine: FLUR4, HPV9
Symptoms: Rash erythematous, Swelling, Type III immune complex mediated reaction
Clinical narrative: After receiving the shot, later that night I started getting extremely sore and tired. Walking became more difficult. Within that week I had broken out with red dots all over my legs, the worst part being my ankles. I had problems with swelling around my ankles and knees and lower back. Walking was difficult and painful. I went back to the doctor and he informed me I had a hypersensitivity reaction (type 3), and prescribed me a steroid (MEDROL 4 MG Oral Tablet Therapy Pack - 4 MG). I took the steroid as prescribed. However, the symptoms have persisted. I am now seeing a doctor about this problem as persisting problem, which he believes may be hypersensitivity/autoimmune vasculitis caused by the reaction to the shot. It has been 2 months and I still have lasting symptoms. My ankles continue to swell and red dots will reappear.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-JAN-2009, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 24-OCT-2016, the patient was treated by a healthcare provider for shingles. On 24-MAR-2017, the patient passed away. The cause of death was not provided. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The cause of death was not provided.  Upon internal review passed away was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: passed away.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a healthcare provider for shingles at a medical center. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 25-JAN-2013, a nurse administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 08-JAN-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-SEP-2013, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider 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 2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-APR-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), 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: 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, a pharmacist, 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 or about 10-JAN-2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 05-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), 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, a pharmacist, 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 or about 11-MAR-2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JAN-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), 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: 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(s) a pharmacist at a pharmacy recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-SEP-2015, a pharmacist at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-JAN-2017, the patient was treated by a healthcare provider at a physician's office 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. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: FLUR4
Symptoms: Neuropathy peripheral
Clinical narrative: Initial information received on 11-Dec-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 30 years old female patient who experienced neuropathy on her arm, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious neuropathy on her arm (neuropathy peripheral) 2 weeks following the administration of Influenza Quadrivalent Recombinant Vaccine. This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was neuropathy on her arm. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for neuropathy on her arm. List of documents held by sender: none. Sender's Comments: This case concerns a 30 years old female patient who developed neuropathy on her arm 2 weeks after vaccination with FLUBLOK QIV. The time to onset is compatible. However, there is no information regarding patient's past medical history, medical condition at time of vaccination and lab tests ruling out alternate etiologies, particularly nutritional and neurologic. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in on 12/20/18 and presented symptoms of swelling redness, warmth to touch, painful to touch at injection site. Symptoms started on 12-12-18 but pt didn't call in until 12/20/18. Pt was prescribed BACTRIM 800-160 MG 1 Tab, orally, twice a day, for 14 days. Lab: CBC with Differential/Platelet.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Crying, Head injury, Immediate post-injection reaction, Nervousness, Syncope
Clinical narrative: Immediately following 3rd immunization patient fainted back and hit her head on the wall. By the time provider entered the room, extremities with tonic clonic posturing. She immediately sat up and started crying, cold came back. Ice applied to head. Had apple juice. Felt shaky but better. Monitored for 30 min. Pt says this happened in the past when in foster care.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Tonic clonic movements
Clinical narrative: Immediately following 3rd immunization patient fainted back and hit her head on the wall. By the time provider entered the room, extremities with tonic clonic posturing. She immediately sat up and started crying, cold came back. Ice applied to head. Had apple juice. Felt shaky but better. Monitored for 30 min. Pt says this happened in the past when in foster care.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Immediate post-injection reaction, Injected limb mobility decreased, Injection site swelling, Malaise
Clinical narrative: Immediate swelling at injection site, spread to whole arm (Left). Could not bend arm, extremely tender to touch. Chills started on 12/15/18 and nausea much improved today, but pt reports feeling overall unwell. Still arm stiffness, some swelling. Did seek urgent care before today's office visit. VS WNL.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Musculoskeletal stiffness, Nausea, Peripheral swelling, Tenderness, Ultrasound scan normal
Clinical narrative: Immediate swelling at injection site, spread to whole arm (Left). Could not bend arm, extremely tender to touch. Chills started on 12/15/18 and nausea much improved today, but pt reports feeling overall unwell. Still arm stiffness, some swelling. Did seek urgent care before today's office visit. VS WNL.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in lips/face started shortly after vaccine given. The following morning, developed twitching/tingling/numbness in my left arm (arm that received vaccine) and throughout my lower face.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumonia 23 given only 21 days after dose of PREVNAR 13 on 11/28/19 by other provider's office. Patient received Pneumonia 23 at earlier interval than recommended 8 weeks. Merck manufacturer contacted and spoke with Dr. Dr. advised only reaction may be redness/soreness at site but otherwise should not have any system effect. Dr. also did not recommend other vaccination of pneumonia to correct early dose. Only recommended starting pneumonia series again in 4-5 years due to high risk group.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm was in pain and had soreness at time of administration on 12/10/2018. Between 12/10/2018 and 12/20/2018 soreness resolved, but pain still remained. Patient seen Dr. and he indicated shot was administered to high. Patient is taking Ibuprofen for the pain currently.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Injection site erythema, Injection site pain, Malaise, Odynophagia
Clinical narrative: Onset, about 6 hours later of local left deltoid arm pain, area became red in 2 days, and from start was very painful; pain in whole body all night long. Arm pain and redness resolved after 7-8 days. The redness and swelling was worsened by day 5, finally better bu 8th day. Was sick with malaise and body pain for that week to 8 days. Right ear and jaw pain starting that first night, hurt to open mouth or move jaw. Still (by December 20, 2018) has some residual pain in the right ear and right jaw joint, which comes and goes. One night had pain with swallowing.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pain in jaw, Swelling
Clinical narrative: Onset, about 6 hours later of local left deltoid arm pain, area became red in 2 days, and from start was very painful; pain in whole body all night long. Arm pain and redness resolved after 7-8 days. The redness and swelling was worsened by day 5, finally better bu 8th day. Was sick with malaise and body pain for that week to 8 days. Right ear and jaw pain starting that first night, hurt to open mouth or move jaw. Still (by December 20, 2018) has some residual pain in the right ear and right jaw joint, which comes and goes. One night had pain with swallowing.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Fainting after above vaccines given.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, Syncope
Clinical narrative: Flu like symptoms, aches, fever 99.8 , syncope at 2:30 am when up to bathroom. Reported to MD office today. As of time of writing, still symptomatic.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Rash maculo-papular, Rash pruritic
Clinical narrative: 2 days after administration of PNEUMOVAX, patient noticed itchy rash at site of injection. In the days following, he developed diffuse maculopapular rash which spread across entire body, sparing only face and distal extremities. He was started on a course of prednisone 50 mg daily for 5 days.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Sleep disorder
Clinical narrative: Patient says she can't lift her arm more than shoulder height, today is first time she has reported this adverse event since immunization was given on 10-31-18, included is soreness and inability to sleep on left side.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: A little less than 24 hours after getting vaccine at my place of employment (I work in an internal medicine outpatient facility), I started to feel lightheaded, feverish, achy and had a headache. These symptoms worsened over the next 24 hours. I developed a fever, profound diaphoresis, muscle aches that lasted another 12 hours. I treated with Acetaminophen, cool baths and the symptoms went away by day 3 after receiving the vaccine. To note, the area of injection is very large, red and firm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: A little less than 24 hours after getting vaccine at my place of employment (I work in an internal medicine outpatient facility), I started to feel lightheaded, feverish, achy and had a headache. These symptoms worsened over the next 24 hours. I developed a fever, profound diaphoresis, muscle aches that lasted another 12 hours. I treated with Acetaminophen, cool baths and the symptoms went away by day 3 after receiving the vaccine. To note, the area of injection is very large, red and firm.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Cough, Fatigue, Rash, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Cough, runny nose, congestion, rash on neck, tiredness. No fever.