chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Asthenia, Chills, Feeling abnormal, Feeling cold
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18 year-old female patient of an unspecified race and ethnicity received at a physician's office the first dose of TRUMENBA via an unspecified route of administration on 10Apr2018 in the afternoon at 0.5 ml single in the right arm for immunization. No other vaccines were given on that day. The patient medical history and concomitant medications were unknown. The patient experienced pain injection site, headache, nausea, sweaty, shaky, cold, chills, stomach pressure sensation of, felt like she couldn't get up, weird dreams, didn't know if she was awake or asleep all on 10Apr2018. Events were described as follows: within an hour from the vaccination, the patient's arm vaccination site started to hurt. The office did explain to the patient that pain at injection site was expected. Later that evening at approximately 07:00 pm the patient had headache and nausea. The patient became very sweaty, shaky, cold and was experiencing chills. The patient felt pressure on her stomach like she needed to go to the bathroom, but she did not have to go. The patient felt like she could not get up, she felt like she had weird dreams and she did not know if she was asleep or awake. The patient got up in middle of night thinking she had to go to the bathroom, but she did not have to go. On 11Apr2018 she had no energy (the reporter was unsure if the patient went to school and then returned home early from school on 11Apr2018 or missed the full school day). She was also experiencing more sweatiness and nausea. The patient's mother called the doctor's office at 08:46 on 11Apr2018 and the patient returned to the physician's office. Events outcome was unknown. The reporter wanted to speak to a doctor to learn if she would still give the second dose to the patient in six months. The information on the batch/lot number has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hyperhidrosis, Injection site pain, Nausea, Tremor
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18 year-old female patient of an unspecified race and ethnicity received at a physician's office the first dose of TRUMENBA via an unspecified route of administration on 10Apr2018 in the afternoon at 0.5 ml single in the right arm for immunization. No other vaccines were given on that day. The patient medical history and concomitant medications were unknown. The patient experienced pain injection site, headache, nausea, sweaty, shaky, cold, chills, stomach pressure sensation of, felt like she couldn't get up, weird dreams, didn't know if she was awake or asleep all on 10Apr2018. Events were described as follows: within an hour from the vaccination, the patient's arm vaccination site started to hurt. The office did explain to the patient that pain at injection site was expected. Later that evening at approximately 07:00 pm the patient had headache and nausea. The patient became very sweaty, shaky, cold and was experiencing chills. The patient felt pressure on her stomach like she needed to go to the bathroom, but she did not have to go. The patient felt like she could not get up, she felt like she had weird dreams and she did not know if she was asleep or awake. The patient got up in middle of night thinking she had to go to the bathroom, but she did not have to go. On 11Apr2018 she had no energy (the reporter was unsure if the patient went to school and then returned home early from school on 11Apr2018 or missed the full school day). She was also experiencing more sweatiness and nausea. The patient's mother called the doctor's office at 08:46 on 11Apr2018 and the patient returned to the physician's office. Events outcome was unknown. The reporter wanted to speak to a doctor to learn if she would still give the second dose to the patient in six months. The information on the batch/lot number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: The following is verbatim from the article: BACKGROUND: Influenza-associated pediatric deaths became a notifiable condition in 2004. METHODS: We analyzed deaths in children aged less than 18 years with laboratory-confirmed influenza virus infection reported to the Centers for Disease Control and Prevention during the 2010-2011 to 2015-2016 influenza seasons. Data were collected with a standard case report form that included demographics, medical conditions, and clinical diagnoses. RESULTS: Overall, 675 deaths were reported. The median age was 6 years (interquartile range: 2-12). The average annual incidence was 0.15 per 100 000 children (95% confidence interval: 0.14-0.16) and was highest among children aged less than 6 months (incidence: 0.66; 95% confidence interval: 0.53-0.82), followed by children aged 6-23 months (incidence: 0.33; 95% confidence interval: 0.27-0.39). Only 31% (n = 149 of 477) of children aged 6 months had received any influenza vaccination. Overall, 65% (n = 410 of 628) of children died within 7 days after symptom onset. Half of the children (n = 327 of 654) had no preexisting medical conditions. Compared with children with preexisting medical conditions, children with none were younger (median: 5 vs 8 years old), less vaccinated (27% vs 36%), more likely to die before hospital admission (77% vs 48%), and had a shorter illness duration (4 vs 7 days; P less than .05 for all).CONCLUSIONS: Each year, influenza-associated pediatric deaths are reported. Young children have the highest death rates, especially infants aged less than 6 months. Increasing vaccination among children, pregnant women, and caregivers of infants may reduce influenza associated pediatric deaths. This case involves a two patients (age reported as less than seven months) who were partially vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient died due to influenza. The patients were less than 7 months of age and therefore did not have time for full vaccination before death. The median time from symptom onset to death was 5 days (IQR: 2-11 days). Relevant lab investigations and corrective treatment were not reported. It was not reported if the autopsy was performed or not. List of documents held by sender: none. Sender's Comments: This literature article describes two patients (less than 7 months of age, other details unknown) who died in association with Influenza infection. These patients were partially immunized with Influenza vaccine (unknown manufacturer). It is not a case of vaccination failure as complete immunization schedule was not followed. Time to onset, type and serotype of influenza infection are not reported. Based upon the reported information, the role of vaccine cannot be assessed. Reported Cause(s) of Death: Influenza.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on chin and parts of body. Recommended patient take antihistamines to help with the itching which is her only complaint.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Erythema, Flushing, Headache
Clinical narrative: Patient phoned on 4/13/18 at 12:35 pm and stated, "I received the PREVNAR 13 vaccine on 4/10/18 around 5:30 or 6 pm and started on Wednesday morning, 4/11/18, around 10 am with chills, flushing, severe headache pain level 7, severe joint/muscle pain, swollen face, couldn't raise the arm that the vaccine was given in, arm was very painful, and I had a 4 x 6 inch rectangular swollen reddened tricep area. I did not have a thermometer to check my temperature. I had no difficulty breathing. I took ibuprofen, but it didn't help much with the inflammation or pain." Patient was offered appointment for evaluation. Patient declined. Patient stated, "I am feeling better and only have the slight puffiness in my face. All other symptoms have resolved." Informed patient that I will report her adverse reactions to VAERS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Injected limb mobility decreased, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient phoned on 4/13/18 at 12:35 pm and stated, "I received the PREVNAR 13 vaccine on 4/10/18 around 5:30 or 6 pm and started on Wednesday morning, 4/11/18, around 10 am with chills, flushing, severe headache pain level 7, severe joint/muscle pain, swollen face, couldn't raise the arm that the vaccine was given in, arm was very painful, and I had a 4 x 6 inch rectangular swollen reddened tricep area. I did not have a thermometer to check my temperature. I had no difficulty breathing. I took ibuprofen, but it didn't help much with the inflammation or pain." Patient was offered appointment for evaluation. Patient declined. Patient stated, "I am feeling better and only have the slight puffiness in my face. All other symptoms have resolved." Informed patient that I will report her adverse reactions to VAERS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling face
Clinical narrative: Patient phoned on 4/13/18 at 12:35 pm and stated, "I received the PREVNAR 13 vaccine on 4/10/18 around 5:30 or 6 pm and started on Wednesday morning, 4/11/18, around 10 am with chills, flushing, severe headache pain level 7, severe joint/muscle pain, swollen face, couldn't raise the arm that the vaccine was given in, arm was very painful, and I had a 4 x 6 inch rectangular swollen reddened tricep area. I did not have a thermometer to check my temperature. I had no difficulty breathing. I took ibuprofen, but it didn't help much with the inflammation or pain." Patient was offered appointment for evaluation. Patient declined. Patient stated, "I am feeling better and only have the slight puffiness in my face. All other symptoms have resolved." Informed patient that I will report her adverse reactions to VAERS.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Needle issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and needle issue. On an unknown date, the outcome of the injection site pain and needle issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received were as follows: The age at vaccination was not reported. The health care professional reported that a lot of resistance when administering the SHINGRIX vaccine and a lot of pain with the injection. Additional information was received as follows: The health care professional reported that the needle was becoming dull from the stoppers of the vials when reconstitution and drawing up the SHINGRIX dose. The HCP believes the dull needle before injection the next patient and this has resolved the issue. The HCP decided to change needle before injecting the next patient and this has resolved the issue. The HCP did not have any patient information available but had this issue with 3 prior patients.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Came to clinic with concern of vaccine reaction. Received Rabies vaccine #2 on 4/16/18 at approximately 1400. Noticed at 1800 hives on lower arms. Hives spread to axillary regions, buttocks, lower back, and neck by this am. Per patient no known exposrure to anything else yesterday. Per patient she took PO BENADRYL. No facial or neck swelling. No difficulty breathing. RN spoke with Dr. upon patient arrival and he indicated to put a referral in to see him if she needed anohter dose in series. Patient does and therefore referral placed. Per patient her only allergy is tomatoes and has had hives with exposure to them. Did not eat tomato products yesterday.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, shivering, weak and tired.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Local reaction, Pain, Skin discolouration, Swelling
Clinical narrative: Local reaction, 6 cm x 6 cm induration, discoloration, pain and swelling.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated by a physician (facility not specified) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain of herpes zoster. On or about 21-MAY-2016, the patient was treated (by an unspecified health care professional) at an urgent care facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-MAR-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine was administered at a private doctor's office/hospital. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-MAR-2017, he was treated by a physician for a blistering vesicular outbreak, which was then diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Paralysis
Clinical narrative: This spontaneous report was received from a medial assistant via a company representative, referring to a 20 year old female, patient who was his/her niece. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant medication were unknown by the reporter. On an unknown date in approximately April 2015 (reported as "3 years ago"), the patient was vaccinated with a dose of GARDASIL 9 (route, dosage information, lot number and expiration date were not informed) for prophylaxis, at an unspecified facility. On an unknown date, after an unspecified amount of time following the dose of GARDASIL 9, the patient suffered an unspecified amount of paralysis. The medical assistant explained that the adverse event was reported at the time. It was unknown if laboratory diagnostics or studies were performed or if the patient sought medical attention and the reporter stated in addition that, the patient was not treated at the facility. The outcome of paralysis was unknown. The causality assessment between paralysis and therapy with GARDASIL 9 was not provided. Upon internal review the event paralysis was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-SEP-2010, the patient was vaccinated with live ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JUL-2013, the patient was treated at a Dermatology office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 06-APR-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 06-DEC-2016, the patient sought further treatment from the physician for ongoing and worsening symptoms of shingles pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections.  The patient has been prescribed acyclovir, LYRICA, tramadol and gabapentin for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-DEC-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-DEC-2017, the patient was treated at a medical clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender (First name could be a female or male).  Medical history, concurrent conditions, and concomitant medications were not provided. During 2013, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-MAY-2016, the patient was treated by a physician at a physicians group, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2016, the patient was treated by a physician for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 04-MAY-2016, the patient sought further treatment for continuing and worsening symptoms of zoster infections. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Previously administered products included ZOSTAVAX. Concurrent medical conditions included allergic reaction to antibiotics (allergic reaction to Clindamycin) and drug allergy (lisinopril allergy: severe cough). Concomitant products ZOCOR, Losartan, melatonin, Vitamin C, vitamin D, and SYNTHROID. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site itching and injection site erythema were recovering/resolving. The reporter considered the injection site pain, injection site itching and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. All the events experienced by the patient after vaccination with SHINGRIX were specific to injection site and redness size was described as 50 cent coin. The patient had denied permission to contact her physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Arm sore by the evening as expected. Vaccine did not hurt going in as in comparison to the first dose. By next morning 4/13, arm was so sore that couldn't lift it out of bed. Overall malaise, sick to stomach that couldn't drink coffee; stayed in bed until 12:30pm since still felt a bit nauseated. By evening ate some. Felt similar to Flu-like symptoms. Next day, felt better and arm was not as sore by then. Patient did not call doctor. Patient took extra doses of Ibuprofen to help with the soreness.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, burning, swelling, and tenderness at injection site. Symptoms first noticed 12 hrs post injection.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Dysphemia, Headache
Clinical narrative: Child started stuttering on the next day. Has had a headache. No illness noted.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Gastroenteritis viral, Immediate post-injection reaction
Clinical narrative: The patient had a sore arm as soon as she received the shot. A couple of hours later around 4 oclock, the arm felt like it had been injured. Very high level of pain associated with it. Patient could not move her arm at all. She felt like it was locked to her body. She went to bed and got chilly. Today, the arm arm still hurts and she feels like whatever was injected did not move from the arm. Then as time went on she felt like whatever was in the arm started to move into her body finally. She is able to move her arm only about half way up. Currently she feels like her arm and knee are starting to get stiff. She says that overall she does not feel like herself. Her stomach was bothering her this morning and she feels like shes recovering from a cold or stomach virus.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Joint stiffness, Mobility decreased, Musculoskeletal stiffness, Nasopharyngitis, Pain in extremity
Clinical narrative: The patient had a sore arm as soon as she received the shot. A couple of hours later around 4 oclock, the arm felt like it had been injured. Very high level of pain associated with it. Patient could not move her arm at all. She felt like it was locked to her body. She went to bed and got chilly. Today, the arm arm still hurts and she feels like whatever was injected did not move from the arm. Then as time went on she felt like whatever was in the arm started to move into her body finally. She is able to move her arm only about half way up. Currently she feels like her arm and knee are starting to get stiff. She says that overall she does not feel like herself. Her stomach was bothering her this morning and she feels like shes recovering from a cold or stomach virus.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted after immunizations were given. Patient was nervous and worked up prior to receiving vaccine. Mother stood in front of patient in chair and patient rested head on mother. RN rubbed back and fanned patient. Patient monitored for 15 minutes. No injury and incident resolved. Child has fear of needles.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash vesicular
Clinical narrative: Pt had shot yesterday felt fine all day, this morning has some itching on mid to left lower back. As the day went on it became a burning/pain sensation when she looked she noticed a rash as well that looked like shingles.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Headache, Insomnia
Clinical narrative: 4/16/18: (2:30pm)- received vaccine in the left arm. (8:30pm)- arm was sore. (11:30pm)- I went to bed but I was freezing/shivering, high fever, massive headache, nausea, neck pain/stiffness, a little soreness on left side of throat, muscles in my legs and body felt very weak to get up and go to the bathroom, slight heart palpitations lasting about 5 seconds. I was going to call 911 but it went away. I didn't get to sleep until about 3:30am after my husband gave me 2 ADVIL and put cool rag on my forehead. I am still very drained and weak the next day. I feel wiped out and still have a headache, back of the neck pain, and feel still cold but fever went away. Arm is still sore but no rash or swelling at site of injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal stiffness, Nausea, Neck pain, Oropharyngeal pain
Clinical narrative: 4/16/18: (2:30pm)- received vaccine in the left arm. (8:30pm)- arm was sore. (11:30pm)- I went to bed but I was freezing/shivering, high fever, massive headache, nausea, neck pain/stiffness, a little soreness on left side of throat, muscles in my legs and body felt very weak to get up and go to the bathroom, slight heart palpitations lasting about 5 seconds. I was going to call 911 but it went away. I didn't get to sleep until about 3:30am after my husband gave me 2 ADVIL and put cool rag on my forehead. I am still very drained and weak the next day. I feel wiped out and still have a headache, back of the neck pain, and feel still cold but fever went away. Arm is still sore but no rash or swelling at site of injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: 4/16/18: (2:30pm)- received vaccine in the left arm. (8:30pm)- arm was sore. (11:30pm)- I went to bed but I was freezing/shivering, high fever, massive headache, nausea, neck pain/stiffness, a little soreness on left side of throat, muscles in my legs and body felt very weak to get up and go to the bathroom, slight heart palpitations lasting about 5 seconds. I was going to call 911 but it went away. I didn't get to sleep until about 3:30am after my husband gave me 2 ADVIL and put cool rag on my forehead. I am still very drained and weak the next day. I feel wiped out and still have a headache, back of the neck pain, and feel still cold but fever went away. Arm is still sore but no rash or swelling at site of injection.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Passed out right after yellow fever shot given. Provided all necessary treatment. Dr. aware. V/S taken every 15 mins. All vital signs within normal limits. Vomited X 3 and Passed out X3. Pt felt better after vomiting. Pt was able to take sips of water and alert prior to leaving. Did escort patient out by wheelchair and father at patient side. Dr. did see patient prior to leaving. Encouraged to take it easy and rest for the rest of the day. The site of the shots no concerns noted.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Cerebrovascular accident, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 13-OCT-2014, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the male patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-JUL-2017, the male patient was treated by a physician at a clinic, for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 01-AUG-2017, he sought further treatment from a physician at a medical care group for treatment of continued and worsening herpes zoster outbreaks and an acute stroke. The patient has been prescribed valacyclovir (VALTREX), gabapentin and acyclovir for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. The event of acute stroke was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 15-OCT-2015, the patient was inoculated at a store pharmacy (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the female patient subsequently contracted a persistent strain of herpes zoster. On or about 15-MAY-2016, the patient was treated (by an unspecified health care professional) at a primary care facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. On or about 04-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-MAR-2017, she was treated at a physician's office (by an unspecified health care professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus
Clinical narrative: Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-APR-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did function as intended, and the patient subsequently suffered severe complications the same day she was vaccinated. Shortly after being vaccinated on or about 06-APR-2016, the patient was treated at a family health care and was diagnosed with Ramsay Hunt Syndrome. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and gabapentin for management of her zoster virus related injuries and complications. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, Ramsay Hunt Syndrome was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-JUN-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-APR-2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient had been prescribed valacyclovir, triamcinolone and hydrocodone for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. In 2015, the patient was inoculated at a clinic (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-APR-2016, the patient was treated (by an unspecified health care professional) at a hospital (It was not further specified if the patient was admitted to the hospital.) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 18-NOV-2008, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 22-SEP-2014, the patient was treated at a medical clinic for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a family medicine facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-MAY-2016, the patient was treated at a family medicine facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir and triamcinolone acetonide cream for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2017, the patient was treated at physician office for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles with complications. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 15-JAN-2016, the patient was inoculated at a physician office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-MAY-2016, the patient was treated at physician office for onset of a severe vesicular rash, accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Vaccination error
Clinical narrative: KINRIX was given in error. Parent has not reported any adverse reactions.
Age: 78.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Patient came in for HIB but was given Hep B instead.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration
Clinical narrative: Was given subcutaneously instead of intramuscular. Patient experienced some redness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Injection site pain, Loss of consciousness
Clinical narrative: Right after receiving the shot, patient complained of pain at the injection site, and feeling a little dizzy. Patient was advised to remain seated, and was given a cup of water. Approximately 2 minutes after that, patient fainted for about 30 seconds. Patient regained consciousness. We called 911, and the EMT came and checked on patient (blood pressure was 120/50, blood sugar was normal, EKG was normal). Patient said she feels fine and did not want to go to the hospital. Clinical RPh and PDM was contacted. Incident report was filed. Primary care MD was notified.