chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 09-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 11-JUL-2011, prescribed by a physician and administered by a staff member, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-DEC-2015, the patient was treated at a medical facility for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. On or about 02-AUG-2016, the patient received subsequent treatment at a health care facility for ongoing and worsening symptoms of zoster, and the new diagnosis of post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to shingles infections. The patient has been prescribed LYRICA for management of her painful condition. As a direct and proximate result of these malfunctions, 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: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 17-AUG-2011, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-SEP-2014, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient had been prescribed acyclovir (manufacturer unknown), hydromorphone (manufacturer unknown) and ondansetron (manufacturer unknown) for management of her painful condition. As a direct and proximate result of these malfunctions, 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: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 06-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 22-JUL-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-DEC-2016, the patient was treated by a physician in a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. On or about 04-FEB-2017, the patient received subsequent treatment at a physician's office for ongoing and worsening symptoms of shingles accompanied by post-herpetic neuralgia, a chronic condition of nerve damage secondary to zoster infections. On or about 17-FEB-2017 and 23-MAY-2017, the patient was subsequently treated at a physician's office for ongoing and uncontrolled symptoms related to her zoster breakouts. The patient has been prescribed LYRICA, VALTREX, gabapentin, hydrocodone, NORCO and LIPODERM patches for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, 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: M
Vaccine: DTOX
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. The reporter considered the vaccination failure and pertussis to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the reporter had 3 sons who all were highly allergic to the pertussis in the DPT vaccine so they ended up having the DT shots without the P but her daughters were fine and did not have an issue. None of her sons ever got whooping cough but one of their sons (the patient) did have whooping cough and he did have the vaccine. This was something the reporter always wondered about. This case was considered as suspected vaccination failure, since the laboratory confirmation and time to event onset was not provided. The reporter was not willing to contact for GlaxoSmithKline safety team to discuss further.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Confusional state, Headache, Injection site erythema, Injection site pain
Clinical narrative: 9-24-17 Malaise, h'ache inj site red, tender. 9-25-17 Temp 104.5+ vomiting, confusion, severe h'ache. ER-IV fluids, packed in ice. Admitted. 9-26-17 Discharged.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Vomiting
Clinical narrative: 9-24-17 Malaise, h'ache inj site red, tender. 9-25-17 Temp 104.5+ vomiting, confusion, severe h'ache. ER-IV fluids, packed in ice. Admitted. 9-26-17 Discharged.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. noticed redness, itching, and swelling at the injection site was noticed by patient on 10/01/2017. Pt. has not had difficulty breathing or swallowing. Pt. also has no cough or wheezing. Pt. was advised to use TYLENOL/MOTRIN, ice, and rest. Pt. informed that provider will report her adverse event to VAERS. Pt. will also follow up with any new or worsening Sx.
Age: 37.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Client was given MMR-V, too old for this vaccine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient called and stated that she came in on Monday and got a shot. Patient stated that she noticed a lump on her arm, on the area where she got shot. Patient stated that it is not red, not swollen, not warm to touch and she has not had any fevers or chills. She said area was tender to touch.
Age: 58.0
Sex: F
Vaccine: FLU4, HEP, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient developed a fever of 102.6, chills, body aches and then significant swelling, pain and redness in her L deltoid. Recommended Ibuprofen by mouth and Ice to deltoid for 15 mins multiple times per day.
Age: 58.0
Sex: F
Vaccine: FLU4, HEP, PPV
Symptoms: Pyrexia
Clinical narrative: Patient developed a fever of 102.6, chills, body aches and then significant swelling, pain and redness in her L deltoid. Recommended Ibuprofen by mouth and Ice to deltoid for 15 mins multiple times per day.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site pain, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Client woke up at 0500 on 10/10/17 with fever, body aches and Left shoulder pain. Client stayed home from school. Grandmother (guardian) gave client ibuprofen. Fever cleared. Client sent home from school on 10/11/2017 with fever and headache.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypersomnia, Induration, Injection site erythema, Malaise, Pain
Clinical narrative: General malaise, ill feeling the day after vaccine given. Slept all day. Developed 10x10mm erythema at site of injection. Mild induration. Pain. No fever.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: Patient experienced swelling of her arm, and flu like symptoms, he had fever of 101F, she had to see MD and was prescribed a doxycycline 100mg bid for 10 days.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Basophil percentage, Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood phosphorus
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Calcium ionised normal, Carbon dioxide normal
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Eosinophil count increased, Eosinophil percentage increased, Gamma-glutamyltransferase, Globulin, Glomerular filtration rate decreased
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphadenopathy, Lymphocyte count normal, Lymphocyte percentage decreased
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count normal
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Platelet count normal, Protein total normal
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash maculo-papular, Rash pruritic, Red blood cell count normal, Red cell distribution width normal, Reticulocyte count
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 84.0
Sex: M
Vaccine: FLUC4
Symptoms: Reticulocyte percentage normal, Tenderness, Urticaria, White blood cell count increased
Clinical narrative: Supraclavicular lymph adenopathy 2.6 cm X 1.2 cm. Urticaric type of rash that is itchy but very painful to featherlight touch. Also has maculopapular rash to body. Non-vesicular or non-pustular.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Contusion, Erythema, Injection site induration, Injection site nodule
Clinical narrative: On the day of the injection, my arm was bruised and developed a hard knot on the site. Within 24 hours I had a red hot rash from my elbow to my shoulder. This healed in about 10 days. 7-10 days after the injection, I developed muscle and joint pain in both legs, knees and ankles. A sharp pain in the left foot on the side. 14 days after the injection I noticed red raised sores on my neck, then my face, by 16 days I had 6-8 itching oozing sores on my face, neck arm head and stomach. The Co health dept assured me I was contagious and my nurse practitioner at my doctor's office examined me and both concluded chicken pox. I was given Acyclovir to take 4x a day for 7 days. I have not returned to work in an elementary school because of the warning of contagious.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain in extremity, Skin ulcer, Wound secretion
Clinical narrative: On the day of the injection, my arm was bruised and developed a hard knot on the site. Within 24 hours I had a red hot rash from my elbow to my shoulder. This healed in about 10 days. 7-10 days after the injection, I developed muscle and joint pain in both legs, knees and ankles. A sharp pain in the left foot on the side. 14 days after the injection I noticed red raised sores on my neck, then my face, by 16 days I had 6-8 itching oozing sores on my face, neck arm head and stomach. The Co health dept assured me I was contagious and my nurse practitioner at my doctor's office examined me and both concluded chicken pox. I was given Acyclovir to take 4x a day for 7 days. I have not returned to work in an elementary school because of the warning of contagious.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: On the day of the injection, my arm was bruised and developed a hard knot on the site. Within 24 hours I had a red hot rash from my elbow to my shoulder. This healed in about 10 days. 7-10 days after the injection, I developed muscle and joint pain in both legs, knees and ankles. A sharp pain in the left foot on the side. 14 days after the injection I noticed red raised sores on my neck, then my face, by 16 days I had 6-8 itching oozing sores on my face, neck arm head and stomach. The Co health dept assured me I was contagious and my nurse practitioner at my doctor's office examined me and both concluded chicken pox. I was given Acyclovir to take 4x a day for 7 days. I have not returned to work in an elementary school because of the warning of contagious.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: The patient experienced severe pain at the injection site. She experienced overall body pain, aches, and stiffness.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Patient presented to the pharmacy on 10/11/2017 stating on 10/10 he had a low grade fever of 100 and redness covering whole upper arm.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient was fine until later that night of imz. She came to pharmacy next day with arm swollen and hot. Told her to try BENADRYL and if no resolution then call her doctor.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after FLUZONE Vaccine was administered, a rash that was warm to the touch appeared below the injection site on the left deltoid, and the rash spanned all the way down to the patient's elbow. The rash did not itch and was not painful for the patient.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo, Vomiting
Clinical narrative: Severe vertigo, vomiting ongoing since waking up the day after flu vaccine.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Paraesthesia
Clinical narrative: Paresthesias about 5 weeks after second GARDASIL injection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to the pharmacy with deltoid discomfort around previous injection site - redness, swelling, and erythyma. Patient stated previous injection site itched this morning and she started scratching it, patient was advised to go to urgen care for treatment.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on left deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of Monday, 10/9/17, the rash was starting to disappear.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Right deltoid area is red, slightly swollen and hard, sent her to the ER they gave her prednisone and Benadryl. Told her to take Benadryl and prednisone for 5 days and to return if it gets worse.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on chest back legs arms.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dizziness, Headache
Clinical narrative: Approximately 5 minutes after receiving the vaccine the patient started with complaints of dizziness, chest pain and headache. Skin color was good and skin was dry to touch. Patient did not lose consciousness and was responding to verbal commands. 6:10 pm BP 90/44, P 72. Gave drink and snack and had patient lie down. No medications were given. Patient had no SOB or wheezing, and no rash, hives or flushing skin were noted. 6:25 pm BP 102/68, P 62. Symptoms resolved and at 6:35 pm patient was sent home with her parents with instructions to follow up with primary care doctor.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This vaccine was given too soon, one month after first dose.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT SHOWED PHARMACIST ON 10/11/2017 IN THE MORNING, SHE HAS ENTIRE RIGHT ARM SWELL AND RED. RECOMMEND HER TO GO SEE MD TO DETERMINE WHETHER SHE HAS INFECTION OR ADVERSE EFFECT FROM VACCINE. PATIENT HAD PNEUMOVAX 23 IN THE PAST WITHOUT ANY PROBLEM.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on right deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of Monday, 10/9/17, the rash was disappearing.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Dermatitis diaper, Irritability, Pyrexia, Vomiting
Clinical narrative: BLISTERS ON BOTTOM/DIAPER RASH, LOW GRADE TEMPS, FUSSY AND VOMITING.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling & warm, shot area and surrounding area for about 3 weeks.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on right deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. Rash started to disappear early this week.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia, Dysphonia, Oropharyngeal pain
Clinical narrative: Sore throat, couldn't swallow, raspy voice.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe Hives on trunk, back, buttocks, neck, arms, armpits, extremely itchy. BENADRYL given, along with hydrocortisone 2% cream. Dr.'s office notified of reaction.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on left deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of the week of 10/8/17  the rash was starting to disappear.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: about 4 hours after receiving the shot, I started getting hives on my wrists and thighs. At first I thought it was bug bites but realized they were hives. They gradually got worse overnight and spread to my torso. They subsided when I used Benadryl, but peaked about 24 hours after the shot and covered my arms, torso, abdomen and legs. They subsided after 3 more Benadryl and completely went away about 8 pm that evening. I can't think of any other variables that would have contributed to the hives.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Fall, Feeling abnormal
Clinical narrative: Patient was administered the injections and asked to wait in the store for a few minutes before going home to ensure she was feeling alright. The patient went to walk around the store and stopped to speak to her daughter and was standing at the side of a shopping cart. The patient went to walk away from the spot and fell. The patient never lost consciousness but was unsure of the reason why she fell. The patient denied any syncope but did report that she "just didn't feel right". The pharmacist measured the patient's blood pressure which was 118/78 mmHg which the patient reported was normal range for her. The patient was further monitored in the store with no additional episodes and was taken home by her daughter. The pharmacist called the patient at 2:35 pm and the patient reported that she was sore from the fall but denied any further episodes of falling or feeling different. The pharmacist notified the patient's PCP of the patient's fall.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Headache, Muscle spasms, Pain
Clinical narrative: 8 hours post vaccination, patient was shivering and very cold. She couldn't speak, had uncontrolled muscle spasms, severe headache and pain, and when she got to the ER she was vomiting.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Speech disorder, Vomiting
Clinical narrative: 8 hours post vaccination, patient was shivering and very cold. She couldn't speak, had uncontrolled muscle spasms, severe headache and pain, and when she got to the ER she was vomiting.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on left deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of early week of 10/08/17, the rash was starting to disappear.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Mobility decreased
Clinical narrative: Patient reported SEVERE back pain about probably about 10 minutes after receiving vaccine. No lightheadedness, no trouble breathing, no nausea. Just VERY SEVERE back pain to point where patient cannot move. Called ambulance and patient was taken to emergency room.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Hyperhidrosis, Hypersomnia, Injection site pain
Clinical narrative: Administration of shot was painful. 2 hours after shot, felt faint, nausea, and arm was very sore. Immediately needed to lay down. Arm became so sore I couldn't move it at all.  Went to bed and slept for 23 hours with chills and sweats. Low (100) fever 23 hours later and very painful arm.  Symptoms gradually decreased over the next 24 hours, total of 48 hours.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Administration of shot was painful. 2 hours after shot, felt faint, nausea, and arm was very sore. Immediately needed to lay down. Arm became so sore I couldn't move it at all.  Went to bed and slept for 23 hours with chills and sweats. Low (100) fever 23 hours later and very painful arm.  Symptoms gradually decreased over the next 24 hours, total of 48 hours.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient complaining of severe diarrhea and vomiting starting 2 days after he received the vaccination and continuing through today. He was instructed to contact his pcp.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on right deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of early week of 10/08/17, the rash was starting to disappear.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Muscle tightness, Syncope
Clinical narrative: Syncopal episode with four extremity tensing and "jerking" movements. Episode lasted about 90 seconds. Pt. recovered fully following rest and oral intake of liquids.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 17-DEC-2008, at a drug store, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-JUL-2011, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. On or about 15-JUL-2011, the patient received subsequent treatment by a physician for ongoing symptoms of shingles breaking out on new areas of her arms. The patient has been prescribed FAMVIR for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has 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.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Hyperhidrosis, Injection site mass, Mobility decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a female patient who received BEXSERO (batch number 16B701, expiry date 1st February 2019). On 27th September 2017, the patient received BEXSERO. On 27th September 2017, less than a day after receiving BEXSERO, the patient experienced vomiting, headache, muscle pain, fever chills, mobility decreased, sweating, injection site mass and chills. On an unknown date, the outcome of the vomiting, mobility decreased and sweating were recovering/resolving and the outcome of the headache, muscle pain, fever chills and chills were recovered/resolved and the outcome of the injection site mass was not recovered/not resolved. It was unknown if the reporter considered the vomiting, headache, muscle pain, fever chills, mobility decreased, sweating, injection site mass and chills to be related to BEXSERO. Additional details were provided as follows: This case was reported by licensed practical nurse. The age at vaccination of patient was not reported. The patient experienced multiple adverse reactions including vomiting for 12 hours, sweating on the palms of hands and bottoms of feet, a knot formed on the arm at location of injection and trouble moving arm. The knot at location of injection still remains 5 days post-vaccination.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a female patient who received BEXSERO (batch number 16B701, expiry date 1st February 2019). On 27th September 2017, the patient received BEXSERO. On 27th September 2017, less than a day after receiving BEXSERO, the patient experienced vomiting, headache, muscle pain, fever chills, mobility decreased, sweating, injection site mass and chills. On an unknown date, the outcome of the vomiting, mobility decreased and sweating were recovering/resolving and the outcome of the headache, muscle pain, fever chills and chills were recovered/resolved and the outcome of the injection site mass was not recovered/not resolved. It was unknown if the reporter considered the vomiting, headache, muscle pain, fever chills, mobility decreased, sweating, injection site mass and chills to be related to BEXSERO. Additional details were provided as follows: This case was reported by licensed practical nurse. The age at vaccination of patient was not reported. The patient experienced multiple adverse reactions including vomiting for 12 hours, sweating on the palms of hands and bottoms of feet, a knot formed on the arm at location of injection and trouble moving arm. The knot at location of injection still remains 5 days post-vaccination.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: Redness at site, greater than 1 inch in diameter.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: Flu symptoms - fever 99.9, aches in joints and muscles, sensitive skin on back, backache, headache, chills, stomach ache, weakness these symptoms lasted 1 day, 2nd day mainly weakness.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hyperaesthesia, Influenza, Myalgia, Pyrexia
Clinical narrative: Flu symptoms - fever 99.9, aches in joints and muscles, sensitive skin on back, backache, headache, chills, stomach ache, weakness these symptoms lasted 1 day, 2nd day mainly weakness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Sunburn
Clinical narrative: Patient reports that her arm was sore off and on since receiving her flu shot. This week, she was in the water and the arm was sunburned and slightly swollen. She states that only the arm that received the flu shot was burnt. She also states that now it is sore again since getting the sunburn and it feels like she just got the flu shot again. She has been taking pain reliever (TYLENOL) and putting ice on it which has been helping.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia
Clinical narrative: Patient complained of headache and muscle leg pain in both legs approximately 5 hours after receiving vaccination.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Myalgia, Tenderness
Clinical narrative: Fatigue, chills, whole body muscle aches, tender right arm, and headaches for 2 full days after the injection.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain in jaw, Paraesthesia
Clinical narrative: EXPERIENCED JAW PAIN IN BILATERAL LOWER JAWS WITH SHOOTING NERVE PAINS FROM MOUTH TO EARS ON THE LEFT SIDE FROM 9/28/17 UNTIL 10/04/17. EXPERIENCING NERVE PAINS THROUGHOUT BODY IN CHEST, BACK, ARMS AND LEGS WITH TINGLING IN HANDS AND FEET BILATERALLY FROM 10/5/17 UNTIL PRESENT DATE.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient arm 2 inches below inj site became red and hot and painful. Patient saw physician and was given Doxycycline for cellulitis. After 2 to 3 days the arm was much improved.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: Severe Pain in the vaccinated arm and limited range of motion that has persisted for weeks.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: We got an rx from dr for prednisone and ventolin, on the prednisone rx dr wrote a message that says dear pharmacist, pt developed dyspnea after receiving flu shot. When I spoke to patient she explained that her or the doctor are not sure if the shot really made the patient short of breath, but she started being short of breath the next day after the shot.
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling, Pain
Clinical narrative: ACCORDING TO PATIENT, HE STARTED SEEING SWELLING AT THE SITE OF INJECTION. SITE OF INJECTION STILL SWOLLEN AND PATIENT COMPLAIN OF PAIN OF 10/11/17 WHEN I FIRST GOT TO KNOW OF THE ADVERSE EVENT. PATIENT SAYS HE WENT TO SEE HIS DOCTOR AND WAS GIVEN CREAM TO APPLY AT THE SITE BUT COULD NOT DISCLOSE THE NAME OF THE CREAM.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen arm at injection site, warm to touch, slight itching and redness. Doctor told her she probably had an infection and told her to use cool compresses and watch for increase in redness. No antibiotics were given. Customer decided to take BENADRYL to relieve itching.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Asthenia, Dyspnoea, Fatigue, Headache
Clinical narrative: Headache and fever (lasting about 24 hours) and extreme muscle fatigue, tiredness/weakness, sweating, difficulty breathing, upset stomach still present as of 10/9/17.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Muscle fatigue, Pyrexia
Clinical narrative: Headache and fever (lasting about 24 hours) and extreme muscle fatigue, tiredness/weakness, sweating, difficulty breathing, upset stomach still present as of 10/9/17.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site reaction
Clinical narrative: Patient had immediate localized reaction at injection site and bleeding. Cold pack was applied for about 10 minutes and swelling subsided. Bruise remained at injection site with redness.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Patient had immediate localized reaction at injection site and bleeding. Cold pack was applied for about 10 minutes and swelling subsided. Bruise remained at injection site with redness.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Shortly after the vaccination was given, a pea sized lump developed under the injection site. Within 48 hours the area was approximately 2 inches in diameter, raised, hard and pink. She iced and massaged the area, getting no relief. She has some discomfort in her left shoulder and neck but is able to carry out her daily ADL's and work.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal discomfort
Clinical narrative: Shortly after the vaccination was given, a pea sized lump developed under the injection site. Within 48 hours the area was approximately 2 inches in diameter, raised, hard and pink. She iced and massaged the area, getting no relief. She has some discomfort in her left shoulder and neck but is able to carry out her daily ADL's and work.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site induration, Injection site mass, Injection site warmth, Nasopharyngitis
Clinical narrative: 10-6-17 noticed lump on left leg where shots had been given on 9-28-17. Had cold sx and slight fever of 99.5 over the weekend. On 10-9-17 seen in office with 1.5cm round cellulitis firm indurated, non fluctuant area on left thigh slightly warm. Diagnosed with Cellulitis and treated with SULFATRIM Ped Susp given 4ml po BID for 10 days.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: 10-6-17 noticed lump on left leg where shots had been given on 9-28-17. Had cold sx and slight fever of 99.5 over the weekend. On 10-9-17 seen in office with 1.5cm round cellulitis firm indurated, non fluctuant area on left thigh slightly warm. Diagnosed with Cellulitis and treated with SULFATRIM Ped Susp given 4ml po BID for 10 days.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Contusion, Injected limb mobility decreased, Injection site joint pain, Injection site swelling, Pain
Clinical narrative: Patient came in and reported that he had a reaction to the PNEUMOVAX-23 vaccine. He received the vaccine on 10/04/17 in the left arm and came in today (10/10) in the morning to report the following: Swelling in left arm, not limited to injection site. However, the whole arm was not swollen today and looked normal. Unable to lift arm for 2 days after receiving the vaccine. He was physically able to lift arm, but could not because it was painful. Today he showed me that he could lift his arm without any issue. He mentioned there was bruising on his left hand in the knuckle area. He said there were several on his knuckles, but today there was only one visible red/purple bruise on one of his knuckles. I double checked patient's profile to see if any blood thinners were on file, but none present. He reported a knot in his shoulder on top of the bone and stated he noticed it today. I felt the area he pointed at, but I could only feel bone- when I spoke to him later on the phone, he mentioned it felt like bone so this was unclear to me. He only has some pain when he lifts his arm straight up and it hurts at the shoulder joint.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient came in and reported that he had a reaction to the PNEUMOVAX-23 vaccine. He received the vaccine on 10/04/17 in the left arm and came in today (10/10) in the morning to report the following: Swelling in left arm, not limited to injection site. However, the whole arm was not swollen today and looked normal. Unable to lift arm for 2 days after receiving the vaccine. He was physically able to lift arm, but could not because it was painful. Today he showed me that he could lift his arm without any issue. He mentioned there was bruising on his left hand in the knuckle area. He said there were several on his knuckles, but today there was only one visible red/purple bruise on one of his knuckles. I double checked patient's profile to see if any blood thinners were on file, but none present. He reported a knot in his shoulder on top of the bone and stated he noticed it today. I felt the area he pointed at, but I could only feel bone- when I spoke to him later on the phone, he mentioned it felt like bone so this was unclear to me. He only has some pain when he lifts his arm straight up and it hurts at the shoulder joint.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Pt received flu vaccination, sat down on bench outside of pharmacy waiting for her sister and mother to receive the vaccines and passed out within 1-2 minutes of receiving the vaccine. Patient woke up after less than 10 seconds, laid on the bench for 2-3 minutes then sat up without any other complications.  We offered her water and support, but Mother was with the patient and supported her. Patient rested while the other 2 received their flu shots. She sat for another 5 minutes and stood up and walked under her own power without assistance.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient received a FLUZONE HIGH DOSE flu shot on 9-28-17. She came into the pharmacy on 10-6-17 to pick up a prescription and while talking to her she mentioned that a few days after her flu shot she developed a rash on her neck. She did go into her doctor to look at and he said it might be a reaction to the shot. She did not think she had received the high dose shot the year before but when I informed her that she had she mentioned that she did not feel right after receiving the shot  in 2016. The doctor wants her to try the regular flu shot next year and if she has a reaction to it then to stop the seasonal flu vaccines.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Parotitis
Clinical narrative: 3 weeks after vaccine, right sided parotitis without other symptoms; symptoms mild. Did also have Kinrix 10/9/17.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Patient stated she developed flu-like symptoms the day following vaccine administration. Fever, chills, fatigue, sweating. Symptoms resolved in a day and a half.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Pt complained of joint pain throughout body, especially left arm.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Hyperhidrosis, Loss of consciousness, Muscular weakness
Clinical narrative: Pt's son called and stated she was vomiting, having muscle weakness, feeling lightheaded, and was sweating. (She passed out but the son told me she almost fainted, was not aware of the fall this morning). You stated she did pass out on the brick steps. She is feeling much better now (I talked to her at 5:51 pm on 10/11/17). She doesn't feel like she needs to see the doctor. She did fall on her steps and feels like she might have bruised her ribs. I did tell her to take it easy and to see the doctor if continuing to have any other issues. She did reiterate that she is feeling fine now.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Pt's son called and stated she was vomiting, having muscle weakness, feeling lightheaded, and was sweating. (She passed out but the son told me she almost fainted, was not aware of the fall this morning). You stated she did pass out on the brick steps. She is feeling much better now (I talked to her at 5:51 pm on 10/11/17). She doesn't feel like she needs to see the doctor. She did fall on her steps and feels like she might have bruised her ribs. I did tell her to take it easy and to see the doctor if continuing to have any other issues. She did reiterate that she is feeling fine now.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site swelling, Peripheral swelling
Clinical narrative: A nurse from center called to notify me that the child was seen by a physician there today a few hours after receiving vaccines at our clinic for swelling from his left shoulder to his fingers and also red streaking to that arm.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Patient received FLUARIX 10/4/17 with no problems immediately following shot. Patient states then when he got home and the following morning/day his left hand began swelling and turning black/blue. The swelling progressed to approximately his wrist and the black/blue discoloration only appeared on the the hand. He had pain traveling up the arm to the elbow. He had no swelling, redness, pain around the injection site, only in the lower part of the arm. He said the black/blue discoloration lasted about a day or two but when he came to the pharmacy to report this his hand was still quite swollen. He said he had not been bitten by anything and there was no trauma to the area. I referred the patient to their doctor and he was going to call today.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given 2 doses of flu vaccine 6 days apart. Error was discovered while entering data. Attempting to reach out to the patient. Outcome unknown.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: The patient complains of stiff neck, swelling under the arm that was injected, and a "stinging" type sensation down her arm. No treatment has been sought by the patient.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying for 6 hours.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient with history of vasovagal syncope with vaccination. Vaccine administered with patient in Semi-Fowler's position. Patient maintained position for 15 minutes. Patient left clinic with mother, sister and brother after denying dizziness and stating she "felt fine". Mother reported after patient was seated in car, she fainted. Time was approximately 5:50. Patient's sister immediately came to clinic for documenting provider to respond. Patient was conscious, alert and oriented x3. BP 102/60, Pulse 62, Respirations 15, O2 sats 99%, Temperature 97.6 Deg F. After 10 minutes, when patient stated she felt better, patient's mother said they were going home. Reviewed signs of severe allergic reaction with parent with instructions to call 911 if she thinks it is a severe allergic reaction. Mother verbalized understanding. A follow up call to mother was made at 7:30 PM and mother reported patient was doing well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Redness, swelling (2 1/2"), itching, black and blue patch above injection with red blood spots, has lasted 5 days and still has not gone away.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Redness, swelling (2 1/2"), itching, black and blue patch above injection with red blood spots, has lasted 5 days and still has not gone away.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Fall, Nausea, Vomiting
Clinical narrative: About 7 hours after patient received the vaccine, he complained of nausea. He didn't finish all of his dinner. Throughout the evening dizziness & nausea increased. He vomited a few times. In the middle of the night he fell while he was on his way to the bathroom. The following day he stayed home as he was still experiencing lightheadedness. He reports that it has been gradually improving over the course of the day. I instructed patient that if he is not improving tomorrow, he may want to go to the doctor to be examined to rule out other issues.