chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Infection via vaccinee
Clinical narrative: INFECTION VIA VACCINEE; COUGH; A spontaneous report has been received from the regulatory authority. The report concerns a female patient (age 8 years, height 128 cm).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number 2019) once/single administration, via nasal route, during 2019.     On 23-Oct-2019, the patient experienced cough (preferred term: Cough). On an unknown date, the patient experienced infection via vaccinee (preferred term: Infection via vaccinee).     The patient recovered with sequelae from the event of cough after 3 weeks on 15-Nov-2019. The outcome of the event of infection via vaccinee was unknown.     The events were considered serious (disability and important medical event) by reporter.     ; Sender's Comments: Cough and infection via vaccine are not listed in the company core data sheet for Q/LAIV (Fluenz Tetra). Due to limited information on the exact start date of drug, exact onset date of infection via vaccine, concurrent diseases, concomitant medication, relevant medical history, risk factors, etiologic and diagnostic workup, it is not possible to make conclusive assessment of causal relationship of events with suspect drug.
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Body temperature decreased, Chills, Diarrhoea, Enterocolitis
Clinical narrative: passes out; walks like a drunk man; has a condition called FPIES (Food Protein Induced Enterocolitis Syndrome); food allergy; He eats a certain food and 2 or 3 hours later he vomits; diarrhea; blood pressure drops; he turns grey; temperature drops; shivers; Vaccine exposure via breast milk; This case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a 6-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (transmammary). On an unknown date, unknown after receiving Boostrix, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown.  Additional information was received as follows: The case was reported by patient's mother. The patient's mother received vaccine in the 1st trimester of her another pregnancy. On 25th January 2018, the patient's mother received Boostrix and the patient was fed via breast milk, which led to vaccine exposure via breast milk. The patient was 6 months old when his mother was breast feeding. This case has been linked to the case US2018046823, reported for mother.   Follow up report received from consumer on 13th December 2019: The patient mother reported that her son was over a year at the time of reporting. She said that her son had health issues and had seen many doctors  The reporter said the patient had something going on right now that the doctors could not seem to diagnose.  She said around the age of one her son started walking but he walks around like a drunk man. The reporter said that any of his health conditions were not related to the vaccines. She said the patient had condition called FPIES (Food Protein Induced Enterocolitis Syndrome). It was food allergy where he reacts to food. The patient ate a certain food and 2 to 3 hours later he vomited and had diarrhea and then his blood pressure dropped and he turned grey and his temperature dropped and he had shiver and then he passed out. Later his temperature came to normal and he wake up and the nurse breastfed but sometimes the patient would have to go to the emergency room and get IV fluids and Zofran. It was unknown if the reporter considered the faint, stumbling, feeling abnormal, allergic gastroenteritis, food allergy, vomiting, diarrhea, blood pressure decreased, skin discoloration, body temperature decreased and shivering to be not related to Boostrix.      Lab Comments: On an unknown date patient's blood pressure and body temperature was dropped
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: Exposure via breast milk, Food allergy, Gait disturbance, Loss of consciousness, Skin discolouration
Clinical narrative: passes out; walks like a drunk man; has a condition called FPIES (Food Protein Induced Enterocolitis Syndrome); food allergy; He eats a certain food and 2 or 3 hours later he vomits; diarrhea; blood pressure drops; he turns grey; temperature drops; shivers; Vaccine exposure via breast milk; This case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a 6-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (transmammary). On an unknown date, unknown after receiving Boostrix, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown.  Additional information was received as follows: The case was reported by patient's mother. The patient's mother received vaccine in the 1st trimester of her another pregnancy. On 25th January 2018, the patient's mother received Boostrix and the patient was fed via breast milk, which led to vaccine exposure via breast milk. The patient was 6 months old when his mother was breast feeding. This case has been linked to the case US2018046823, reported for mother.   Follow up report received from consumer on 13th December 2019: The patient mother reported that her son was over a year at the time of reporting. She said that her son had health issues and had seen many doctors  The reporter said the patient had something going on right now that the doctors could not seem to diagnose.  She said around the age of one her son started walking but he walks around like a drunk man. The reporter said that any of his health conditions were not related to the vaccines. She said the patient had condition called FPIES (Food Protein Induced Enterocolitis Syndrome). It was food allergy where he reacts to food. The patient ate a certain food and 2 to 3 hours later he vomited and had diarrhea and then his blood pressure dropped and he turned grey and his temperature dropped and he had shiver and then he passed out. Later his temperature came to normal and he wake up and the nurse breastfed but sometimes the patient would have to go to the emergency room and get IV fluids and Zofran. It was unknown if the reporter considered the faint, stumbling, feeling abnormal, allergic gastroenteritis, food allergy, vomiting, diarrhea, blood pressure decreased, skin discoloration, body temperature decreased and shivering to be not related to Boostrix.      Lab Comments: On an unknown date patient's blood pressure and body temperature was dropped
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: passes out; walks like a drunk man; has a condition called FPIES (Food Protein Induced Enterocolitis Syndrome); food allergy; He eats a certain food and 2 or 3 hours later he vomits; diarrhea; blood pressure drops; he turns grey; temperature drops; shivers; Vaccine exposure via breast milk; This case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a 6-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (transmammary). On an unknown date, unknown after receiving Boostrix, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown.  Additional information was received as follows: The case was reported by patient's mother. The patient's mother received vaccine in the 1st trimester of her another pregnancy. On 25th January 2018, the patient's mother received Boostrix and the patient was fed via breast milk, which led to vaccine exposure via breast milk. The patient was 6 months old when his mother was breast feeding. This case has been linked to the case US2018046823, reported for mother.   Follow up report received from consumer on 13th December 2019: The patient mother reported that her son was over a year at the time of reporting. She said that her son had health issues and had seen many doctors  The reporter said the patient had something going on right now that the doctors could not seem to diagnose.  She said around the age of one her son started walking but he walks around like a drunk man. The reporter said that any of his health conditions were not related to the vaccines. She said the patient had condition called FPIES (Food Protein Induced Enterocolitis Syndrome). It was food allergy where he reacts to food. The patient ate a certain food and 2 to 3 hours later he vomited and had diarrhea and then his blood pressure dropped and he turned grey and his temperature dropped and he had shiver and then he passed out. Later his temperature came to normal and he wake up and the nurse breastfed but sometimes the patient would have to go to the emergency room and get IV fluids and Zofran. It was unknown if the reporter considered the faint, stumbling, feeling abnormal, allergic gastroenteritis, food allergy, vomiting, diarrhea, blood pressure decreased, skin discoloration, body temperature decreased and shivering to be not related to Boostrix.      Lab Comments: On an unknown date patient's blood pressure and body temperature was dropped
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Inappropriate schedule of product administration, Joint swelling, Muscle spasms
Clinical narrative: Painful ebow/lower arm swollen; cramping in finger; redness of elbow; swollen elbow; Pain in elbow; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of intestinal obstruction (1st dose receive on 2nd October 2019, kindly refer case US2019205765). Concomitant products included cyanocobalamin (Vitamin B12).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 11th November 2019, 5 days after receiving Shingrix, the patient experienced erythema of extremities, swelling of elbows and pain in elbow. On 12th November 2019, the patient experienced hand swelling and finger cramps. In November 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the erythema of extremities, swelling of elbows, pain in elbow, hand swelling, finger cramps and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling of elbows, pain in elbow, hand swelling and finger cramps to be related to Shingrix.  Additional details were provided as follows: The patient received injection on an unknown arm. On 6th November 2019, the patient received 2nd dose of Shingrix, which was earlier than the recommended schedule, which led to drug dose administration interval too short. The day before reporting, the patient woke up and her right elbow was swollen, painful and red an she went to he doctor. The doctor recommended to apply ice and a wrap the elbow. On the day of reporting, that morning the patient stated that when she woke up, her right hand and lower right arm were swollen and she developed cramping in the fingers of her right hand. Emergency room visit was required. The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Painful ebow/lower arm swollen; cramping in finger; redness of elbow; swollen elbow; Pain in elbow; Drug dose administration interval too short; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of intestinal obstruction (1st dose receive on 2nd October 2019, kindly refer case US2019205765). Concomitant products included cyanocobalamin (Vitamin B12).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 11th November 2019, 5 days after receiving Shingrix, the patient experienced erythema of extremities, swelling of elbows and pain in elbow. On 12th November 2019, the patient experienced hand swelling and finger cramps. In November 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the erythema of extremities, swelling of elbows, pain in elbow, hand swelling, finger cramps and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling of elbows, pain in elbow, hand swelling and finger cramps to be related to Shingrix.  Additional details were provided as follows: The patient received injection on an unknown arm. On 6th November 2019, the patient received 2nd dose of Shingrix, which was earlier than the recommended schedule, which led to drug dose administration interval too short. The day before reporting, the patient woke up and her right elbow was swollen, painful and red an she went to he doctor. The doctor recommended to apply ice and a wrap the elbow. On the day of reporting, that morning the patient stated that when she woke up, her right hand and lower right arm were swollen and she developed cramping in the fingers of her right hand. Emergency room visit was required. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife who reported for her husband. The age at vaccination was not reported. The patient's wife reported that, the patients experienced some side effects after receiving the dose of Shingrix. The reporter wanted to know should he go to his primary care.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Itching at the site; injection site hives; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced injection site itching and injection site hives. On an unknown date, the outcome of the injection site itching and injection site hives were unknown.   It was unknown if the reporter considered the injection site itching and injection site hives to be related to Fluarix Tetra.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Fluarix quadrivalent and had hives and itching at the site and extending away from the site as well. The reporter asked was fluarix quadrivalent hypoallergenic.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Pain in extremity, Product administered at inappropriate site
Clinical narrative: experienced arm pain following dose one of Shingrix; administer Shingrix in a location other than the deltoid; administer Shingrix in a location other than the deltoid; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) and (batch number YA724, expiry date 29th January 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) and (batch number YA724, expiry date 29th January 2022) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On 7th August 2019, the 1st dose was an unknown dose. On 7th August 2019, the patient received the 2nd dose of Shingrix. On 7th August 2019, the 2nd dose was an unknown dose. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in extremity, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the vaccine administered at inappropriate site and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix and Shingrix.  Additional details were provided as follows: The physician may administered Shingrix in a location other than the deltoid because the patient experienced arm pain following dose one of Shingrix. The vaccine administration facility is the same as primary reporter. The physician reports the patient noted arm pain after receiving dose one.  HCP could not specify which arm.  The follow up consent was granted. The case US2019219218 was found to be duplicate of case US2019AMR220254. Hence case US2019219218 would be deleted and all the information of this case will be added in case US2019AMR220254 which is case of record for this patient.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: The first shot I only had muscle soreness; This case was reported by a consumer via sales rep and described the occurrence of muscle soreness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle soreness. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the muscle soreness was recovered/resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 60 or 61 years old. The patient had only muscle soreness which went away after a day or so. Other medications had taken since the shot included advil for muscle soreness. For tolerances of 2nd dose, refer case US2019AMR221110.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: "bumps on lower back, hips, shoulders, under breasts, and vaginal area"; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, 2 weeks after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient 2 weeks after vaccination developed a rash on lower back, hips, shoulders, under breast, and in vaginal area. The patient did not consent to follow up. This case has been linked to US2019222795, reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb
Clinical narrative: left arm became really red and swollen; left arm became really red and swollen; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 63-month-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema of extremities and extensive swelling of vaccinated limb. On an unknown date, the outcome of the erythema of extremities and extensive swelling of vaccinated limb were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and extensive swelling of vaccinated limb to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and her left arm became red and swollen from her shoulder to her elbow.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Severe itching at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional case details were reported as follows: The batch number was updated from SKK99 to 5KK99, as per sales data sheet. The patient received Shingrix and experienced severe itching at injection site and no rash. The reporter asked how to proceed with 2nd dose of Shingrix.  Adverse event was collected. The reporter did not consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: pain at injection site/Injection site burning/soreness at injection site; itching at injection site; rash at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site itching and injection site rash. On an unknown date, the outcome of the injection site pain, injection site itching and injection site rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site itching and injection site rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and has experienced pain, rash, soreness, burning and itching at the injection site. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia
Clinical narrative: neck pain and stiffness, body pain (like the flu), very sore at shot, tingling in arm of shot
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix vaccine inadvertently at appointment today. Patient did not have any signs or symptoms of adverse reaction to vaccine when leaving clinic. Patients mother informed to advise clinic of any adverse reactions that may occur over the next 7-10 days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Full blood count, Injection site pain, Pain, Red blood cell sedimentation rate
Clinical narrative: Patient received a she reports a shingrix  in July.  She had discomfort during the injection and over the next week to 10 days she developed significant pain in region of the injection in the upper arm.  The symptoms have been persisting and uncomfortable.  She has sleep disruption.  She notes when she lays down at night everything seems worse.  She has not developed weakness.  She has not noticed a swelling. She denies fever she has not had any rash.  She has pain with very specific movements during the day but most of the symptoms are present at night when she has pain that is quite pronounced sharp burning.  She has not developed grasp weakness
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, X-ray limb
Clinical narrative: Patient received a she reports a shingrix  in July.  She had discomfort during the injection and over the next week to 10 days she developed significant pain in region of the injection in the upper arm.  The symptoms have been persisting and uncomfortable.  She has sleep disruption.  She notes when she lays down at night everything seems worse.  She has not developed weakness.  She has not noticed a swelling. She denies fever she has not had any rash.  She has pain with very specific movements during the day but most of the symptoms are present at night when she has pain that is quite pronounced sharp burning.  She has not developed grasp weakness
Age: 62.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Local reaction, Pain, Swelling, Urticaria
Clinical narrative: localized reaction swelling and pain hives as well
Age: 38.0
Sex: F
Vaccine: FLU4, HEPAB, TDAP
Symptoms: Anxiety, Dry mouth, Hypertension, Rash, Urticaria
Clinical narrative: Patient received 3 vaccines. Approximately 5-10 minutes post administration, friend noticed patient began to have rash. Pt brought back into immunization space by staff who observed patient with urticaria to face, neck, chest and upper back. Patient denied shortness of breath. Noted with clear and equal LS bilaterally. Patient denied tingling / itching in throat, feeling of throat closing or heavy tongue. Did state felt mouth was dry. Mild anxiety noted. Patient initially hypertensive with normal HR. Oxygen saturation 96%. Patient observed for 30 minutes with diminishing urticaria and dry mouth. Blood pressure decreased to normotensive range with HR remaining stable and oxygen saturation at 99%. Patient reported feeling much better. Sent home and instructed to take 50 mg benadryl PO (per Dr. instruction) follow up with physician and educated on symptoms that required emergency department visit. Verbalized understanding and all question s/ concerns answered. Noted to be without urticaria and dry mouth upon departure. Denied any other sign and symptoms.
Age: 54.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: the patient had redness and swelling from their deltoid to elbow; the patient had redness and swelling from their deltoid to elbow; This spontaneous report was received from a physician via company representative and refers to a 54-year-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On an unspecified date in 2019 (reported as within the past month), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent (PNEUMOVAX23) lot # S012246 has been verified to be a valid lot, expiration date was not provided, but upon internal validation established as 10-FEB-2021, intramuscular, injection (strength and dose were not provided) for prophylaxis. On an unspecified date in 2019 (reported as after an unknown amount of time), the patient experienced redness and swelling from their deltoid to elbow. The patient sought medical attention and visited the doctor's office. The patient required treatment with antibiotics (unspecified).   The outcome of the events was reported as recovered (on unspecified date in 2019). The relatedness between the events and the vaccine was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Herpes zoster, Rash
Clinical narrative: painful rash to the back of the left ear with pain that radiated into the left ear/diagnosed with shingles/herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-JUL-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered a painful rash to the left ear with pain that radiated into the left ear. The patient was diagnosed with shingles/herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  The event of shingles/ herpes zoster was considered to be disabling.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Exfoliative rash, Herpes zoster, Malaise, Rash
Clinical narrative: shingles rash; rash on back/ Patchy rash/ rash on rib cage/ rash on forearms, her elbows, and her shins; red blisters; blisters/ blister oozing; scaly rash; poison ivy rash; itchy rash; very unpleasant; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2019, 3 days after receiving Shingrix, the patient experienced shingles, rash, red rash, blistery rash, rash scaly, poison ivy rash, itchy rash and feeling unwell. On an unknown date, the outcome of the shingles, rash, red rash, blistery rash, rash scaly and feeling unwell were recovering/resolving and the outcome of the poison ivy rash was unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, red rash, blistery rash, rash scaly, poison ivy rash, itchy rash and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient noticed that she had a rash on her back. The rash was a group of red blisters. Then she noticed that more patches of this rash began to show up lower on her back near the sacrum. Then a patch developed on the front of her chest on her rib cage on both sides, on both forearms, her elbows, and her shins. She said that some of the blisters oozed. In some areas the rash area had become red and scaly, in others its a collection of sores almost like poison ivy. It was very unpleasant  She had intense itching on these patches, especially between 3 am and 4 am during the night. Some patches were starting to fade but she still had the intense itching. She stated that she went to see her physician on Monday, 11th November 2019. she went to her physician for routine physical and she showed the rashes to her. She did not feel that it was anything for the reporter to be concerned about and said it could be from the vaccine or from something else. Did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular, Skin weeping
Clinical narrative: shingles rash; rash on back/ Patchy rash/ rash on rib cage/ rash on forearms, her elbows, and her shins; red blisters; blisters/ blister oozing; scaly rash; poison ivy rash; itchy rash; very unpleasant; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2019, 3 days after receiving Shingrix, the patient experienced shingles, rash, red rash, blistery rash, rash scaly, poison ivy rash, itchy rash and feeling unwell. On an unknown date, the outcome of the shingles, rash, red rash, blistery rash, rash scaly and feeling unwell were recovering/resolving and the outcome of the poison ivy rash was unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, red rash, blistery rash, rash scaly, poison ivy rash, itchy rash and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient noticed that she had a rash on her back. The rash was a group of red blisters. Then she noticed that more patches of this rash began to show up lower on her back near the sacrum. Then a patch developed on the front of her chest on her rib cage on both sides, on both forearms, her elbows, and her shins. She said that some of the blisters oozed. In some areas the rash area had become red and scaly, in others its a collection of sores almost like poison ivy. It was very unpleasant  She had intense itching on these patches, especially between 3 am and 4 am during the night. Some patches were starting to fade but she still had the intense itching. She stated that she went to see her physician on Monday, 11th November 2019. she went to her physician for routine physical and she showed the rashes to her. She did not feel that it was anything for the reporter to be concerned about and said it could be from the vaccine or from something else. Did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: experienced flu-like symptoms following the second dose of Shingrix; headache; chills; fatigue; nausea; muscle soreness; fever; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on unknown date and had muscle soreness, refer case US2019AMR221202.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, chills, fatigue, nausea, muscle soreness and fever. The patient was treated with ibuprofen (Advil) and sumatriptan (Imitrex Tablet). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, headache, chills, fatigue, nausea, muscle soreness and fever were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, chills, fatigue, nausea, muscle soreness and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Within 8 hours after vaccination, the patient experienced  flu-like symptoms, which was including headache, fatigue, muscle soreness, chills, fever and nausea. Other medications had taken since the shot included advil for muscle soreness and Imitrex tablet for the headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: experienced flu-like symptoms following the second dose of Shingrix; headache; chills; fatigue; nausea; muscle soreness; fever; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on unknown date and had muscle soreness, refer case US2019AMR221202.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, chills, fatigue, nausea, muscle soreness and fever. The patient was treated with ibuprofen (Advil) and sumatriptan (Imitrex Tablet). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, headache, chills, fatigue, nausea, muscle soreness and fever were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, chills, fatigue, nausea, muscle soreness and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Within 8 hours after vaccination, the patient experienced  flu-like symptoms, which was including headache, fatigue, muscle soreness, chills, fever and nausea. Other medications had taken since the shot included advil for muscle soreness and Imitrex tablet for the headache.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The patient received the flu vaccine and was sick for 5 days after that. No additional details were available. The patient consented to follow up. This case has been linked to US2019227021, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypersensitivity, Periorbital swelling, Swelling face, Vomiting
Clinical narrative: Allergic reaction including vomiting, puffy face and eyes.  Pt was seen in ER two days after vaccination.  Pt was given IVF, steroid, and zofran in the ER.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt had vaccine in the office; mom nursed child for about 15 minutes in the office and noticed small red area at site of vaccination. Pt has two vaccines one in each leg and only the left thigh had reaction.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Achiness, fever, muscle pain, headache, shivering
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Tremor
Clinical narrative: Leaving messages for patient about the second shot and finally reached patient today.  Patient was weak and shaking for 5 days after the first shot and did not want to take the second dose.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: skin ulceration
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Vomiting
Clinical narrative: Pain, red swollen arm about five inches wide at injection site, fussiness for four days, vomiting four days after vaccine.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Blood test normal, Borrelia test negative, Chest X-ray normal, Magnetic resonance imaging normal
Clinical narrative: The patient had an acute neuromuscular toxicity reaction. She was seen in 5 hospitals after the symptoms of progressive weakness and paralysis started in her feet and moved to her head and neck. She was tested for Gillian -Barre and other viral illness and all were ruled out.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Neuromuscular toxicity, Paralysis
Clinical narrative: The patient had an acute neuromuscular toxicity reaction. She was seen in 5 hospitals after the symptoms of progressive weakness and paralysis started in her feet and moved to her head and neck. She was tested for Gillian -Barre and other viral illness and all were ruled out.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Attention deficit/hyperactivity disorder, Disturbance in attention, Emotional disorder, Laboratory test, Muscle twitching
Clinical narrative: Fever, shaking, twitches, lost ability to focus, outburst, extreme adhd
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, shaking, twitches, lost ability to focus, outburst, extreme adhd
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: After receiving shot on 12/10/19 in the morning, pt developed hives from neck to feet that night and went to the ER at 1am.  Pt was given steroids for treatment.  Pt spoke with her MD, but first contacted the pharmacy on 12/16/19 about the event. As of 12/117/19, patient has yet to fully recover.  Still has rash on legs.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient not experiencing additional symptoms at this time; VARIVAX concomitantly and inadvertently with PROQUAD.; Information has been received from a nurse referring to a 12 months old patient of unknown gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 18-NOV-2019, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis, concomitantly and inadvertently with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. This was related to human error. The patient did not experience additional symptoms at the reporting time. The outcome of the event was unknown.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: After getting titers, titers showed no immunity after receiving three vaccinations of M-M-R II; Patient received M-M-R II on 05-JUL-1996, 04-FEB-2000 and in September 2019; This spontaneous report was received from a physician, referring to a 24-year-old female patient. The patient has no recurring condition or medical history, allergies to medications or drugs were not reported. Concomitant medications included an unspecified birth control therapy.   On 05-JUL-1996, 04-FEB-2000 and on an unspecified date if September 2019, the patient received the doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided).   It was reported that, after gerring titers, titers showed no immunity after received the three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (antibody test negative). On an unknown date the patient underwent to an unspecified blood test for immunity.   At the time of this report, the outcome of the antibody test negative was not provided.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pyrexia, Sluggishness
Clinical narrative: Mild fever; Sluggish feeling; This is a spontaneous report from a contactable Health Care Professional through a Pfizer sales representative.   A 68-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose and influenza vaccine, both received on an unspecified date (at the same time in different sites), at the pharmacy, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient complained of a mild fever and sluggish feeling. Clinical outcome of the adverse events was unknown at time of this report.  The information on the lot number has been requested.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Ammonia increased, Bipolar disorder, Electroencephalogram normal, Emotional distress, Magnetic resonance imaging normal
Clinical narrative: Loud ringing ear's/brain about two (2) month's after injection. Complained to DR. Recieved M.R.I of brain and E.E.G during next six (6) month's. Talked to brain doctor about three (3) time's during course of investigation (2017). Remembered notice given before injection stating ringing in brain possible side effect. Informed brain doctor. DR. stated; "Nothing can be done." Note: M.R.I./E.E.G report clear. Note: Previous done with-in year of injection. (maybe more) About one (1) year ago doctor gave me pills for ringing in brain. Ten (10) day supply. Ringing stopped for two (2) seconds. Doctor refused to supply more pills. Ringing persists, to date. Extreme misery for me. I pray for death. I suffer horribly. Thursday "12-12-19" I suffer horribly. I pray for Death. P.S. I am "only" asking for help with "cure". CDC refused to aid me claiming: "It's no big deal". It "IS" big deal. I suffer from ammonia gass build up on brain and bi-polar depression with "severe" manic episodes. I desperately need help. The ringing causes me severe distress. The ringing in my brain from your vaccine (2016) cause's me "sever" distress. I ask for "NO" money. I ask for "CURE". C.D.C refuses to help me.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Mania, Tinnitus
Clinical narrative: Loud ringing ear's/brain about two (2) month's after injection. Complained to DR. Recieved M.R.I of brain and E.E.G during next six (6) month's. Talked to brain doctor about three (3) time's during course of investigation (2017). Remembered notice given before injection stating ringing in brain possible side effect. Informed brain doctor. DR. stated; "Nothing can be done." Note: M.R.I./E.E.G report clear. Note: Previous done with-in year of injection. (maybe more) About one (1) year ago doctor gave me pills for ringing in brain. Ten (10) day supply. Ringing stopped for two (2) seconds. Doctor refused to supply more pills. Ringing persists, to date. Extreme misery for me. I pray for death. I suffer horribly. Thursday "12-12-19" I suffer horribly. I pray for Death. P.S. I am "only" asking for help with "cure". CDC refused to aid me claiming: "It's no big deal". It "IS" big deal. I suffer from ammonia gass build up on brain and bi-polar depression with "severe" manic episodes. I desperately need help. The ringing causes me severe distress. The ringing in my brain from your vaccine (2016) cause's me "sever" distress. I ask for "NO" money. I ask for "CURE". C.D.C refuses to help me.
Age: 61.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Wrong product administered
Clinical narrative: Pediatric Hep A given instead of Adult Hep A  MMRV given instead of MMR
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Feeling of body temperature change, Pyrexia
Clinical narrative: Reaction: 12 hours after receiving the injection, I started to get the chills. I went to bed and literally felt I was on fire all night. I went from burning up to freezing and not until 12 hours later did the fever go away.   Although I don't have the specifics on the first shot, I felt "horrible" with that shot too for 12 hours but did not have the fever like I had the second time.