chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site indentation, Injection site mass, Injection site pain, Injection site rash, Injection site scar
Clinical narrative: I noticed the spot where I received the shots; the rash is very itchy; There is now a rash around the site where I received the shot and the rnsh is very itchy; There is now a rash around the site where I received the shot and the rnsh is very itchy; the spot where I received the shots hurt; can't sleep on that side; my right arm is in so much pain; I noticed a big lump; a blister on the lump and then a few days later it scarred over; a blister on the lump and then a few days later it scarred over; there is a hole in the same place; This spontaneous report was received from a 76-year-old female patient and refers to herself. Concurrent conditions included diabetes and high blood pressure. Concomitant therapies included metformin and enalapril. The patient had an allergy to perfumes, kiwi, strawberry and pineapple.   On 06-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the right arm (dose, route of administration, lot# and expiration date were not provided) and with flu shot (dose, route of administration, anatomical location, lot# and expiration date were not provided), both for prophylaxis. On the same day, the patient notice the spot where she received the shots hurt and on an unknown date in October 2019 (reported as a few days later) she noticed a big lump, a blister on the lump and on an unknown date in October 2019 (reported as a few days later) it scarred over. The scar had fallen off but at the time of the report there was a hole in the same place. There was a rash around the site where the patient received the shot and the rash was very itchy. Her right arm was in so much pain that the patient could not sleep on that side and she was a side sleeper. The patient applied neosporin and wash with peroxide. The patient also went to a pharmacist then she went to the doctor. There was no lab diagnostics or studies performed. Pt wanted to know how many people experienced a big lump, blister, scar and itchiness after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the flu shot. Pt also asked if her reactions were from pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or the flu shot and how long her reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) would last.  The outcome of scarring over was reported as recovering. The outcome of the rest of the events was not recovered. The relatedness between the events and suspect therapies was not provided.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site vesicles, Insomnia, Rash pruritic
Clinical narrative: I noticed the spot where I received the shots; the rash is very itchy; There is now a rash around the site where I received the shot and the rnsh is very itchy; There is now a rash around the site where I received the shot and the rnsh is very itchy; the spot where I received the shots hurt; can't sleep on that side; my right arm is in so much pain; I noticed a big lump; a blister on the lump and then a few days later it scarred over; a blister on the lump and then a few days later it scarred over; there is a hole in the same place; This spontaneous report was received from a 76-year-old female patient and refers to herself. Concurrent conditions included diabetes and high blood pressure. Concomitant therapies included metformin and enalapril. The patient had an allergy to perfumes, kiwi, strawberry and pineapple.   On 06-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the right arm (dose, route of administration, lot# and expiration date were not provided) and with flu shot (dose, route of administration, anatomical location, lot# and expiration date were not provided), both for prophylaxis. On the same day, the patient notice the spot where she received the shots hurt and on an unknown date in October 2019 (reported as a few days later) she noticed a big lump, a blister on the lump and on an unknown date in October 2019 (reported as a few days later) it scarred over. The scar had fallen off but at the time of the report there was a hole in the same place. There was a rash around the site where the patient received the shot and the rash was very itchy. Her right arm was in so much pain that the patient could not sleep on that side and she was a side sleeper. The patient applied neosporin and wash with peroxide. The patient also went to a pharmacist then she went to the doctor. There was no lab diagnostics or studies performed. Pt wanted to know how many people experienced a big lump, blister, scar and itchiness after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the flu shot. Pt also asked if her reactions were from pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or the flu shot and how long her reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) would last.  The outcome of scarring over was reported as recovering. The outcome of the rest of the events was not recovered. The relatedness between the events and suspect therapies was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: pain at injection site; fever; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 3rd October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fever and nausea. On an unknown date, the outcome of the injection site pain, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported but it could be 59 or 60 years After vaccination with dose of Shingrix, the patient had pain at the injection site, fever, and nausea which last for approximately three days. The reporter consented to follow up. For the tolerence of 2nd dose refere case US2019AMR224793.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient experienced redness and swelling after receiving Shingrix. .
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix at the pharmacy and had a rash afterwards on her arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Herpes zoster
Clinical narrative: Development of Shingles after the first dose of Shingrix.; Adverse event; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 6th October 2019, 4 days after receiving Shingrix, the patient experienced shingles and adverse event. On an unknown date, the outcome of the shingles and adverse event were unknown.   It was unknown if the reporter considered the shingles and adverse event to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that, after receiving 1st dose of Shingrix had shingles. The healthcare professional also stated that he reported the adverse event after the patient developed Shingrix. The reporter called to ask whether the patient should receive the 2nd dose of Shingrix or not. The reporter consented to follow up
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Choking, Cough, Dysarthria, Dysphagia, Dysphonia
Clinical narrative: leg and "quad" pain; right shoulder and bicep pain/ left shoulder pain; bicep pain/ qud pain; swallow issues; "coughing and choking"; choking; flu like symptoms; voice changes, hoarseness; slurred speech; This case was reported by a consumer via call center representative and described the occurrence of choking in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced choking (serious criteria GSK medically significant), influenza-like symptoms, voice alteration, slurred speech, swallowing difficult and cough. On 6th September 2019, the patient experienced shoulder pain and muscle pain. On 25th September 2019, the patient experienced leg pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On 1st September 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the choking, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough were not recovered/not resolved.   It was unknown if the reporter considered the choking, influenza-like symptoms, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and within two to three hours he developed voice changes, slurring, hoarseness, coughing, choking, and swallow issues. The patient stated that he also developed flu like symptoms and those resolved in two or three days. On 6th September 2019, 8 days after vaccination, the patient developed right shoulder and bicep pain.  He stated that on 25th September 2019, 27 days after vaccination he developed left and quad pain.  On 5th December 2019, he developed left shoulder pain. He stated that the leg and shoulder issues all continue at the time of reporting, unresolved.  The patient reported that the shoulder pain was treated by physician with cortisone injections.  The patient had endoscopy, barium swallow studies and saw a neurologist regarding these symptoms and all this tests were normal. Emergency room visit was required. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Endoscopy normal, Influenza like illness, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: leg and "quad" pain; right shoulder and bicep pain/ left shoulder pain; bicep pain/ qud pain; swallow issues; "coughing and choking"; choking; flu like symptoms; voice changes, hoarseness; slurred speech; This case was reported by a consumer via call center representative and described the occurrence of choking in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced choking (serious criteria GSK medically significant), influenza-like symptoms, voice alteration, slurred speech, swallowing difficult and cough. On 6th September 2019, the patient experienced shoulder pain and muscle pain. On 25th September 2019, the patient experienced leg pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On 1st September 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the choking, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough were not recovered/not resolved.   It was unknown if the reporter considered the choking, influenza-like symptoms, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and within two to three hours he developed voice changes, slurring, hoarseness, coughing, choking, and swallow issues. The patient stated that he also developed flu like symptoms and those resolved in two or three days. On 6th September 2019, 8 days after vaccination, the patient developed right shoulder and bicep pain.  He stated that on 25th September 2019, 27 days after vaccination he developed left and quad pain.  On 5th December 2019, he developed left shoulder pain. He stated that the leg and shoulder issues all continue at the time of reporting, unresolved.  The patient reported that the shoulder pain was treated by physician with cortisone injections.  The patient had endoscopy, barium swallow studies and saw a neurologist regarding these symptoms and all this tests were normal. Emergency room visit was required. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Swallow study
Clinical narrative: leg and "quad" pain; right shoulder and bicep pain/ left shoulder pain; bicep pain/ qud pain; swallow issues; "coughing and choking"; choking; flu like symptoms; voice changes, hoarseness; slurred speech; This case was reported by a consumer via call center representative and described the occurrence of choking in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, less than a day after receiving Shingrix, the patient experienced choking (serious criteria GSK medically significant), influenza-like symptoms, voice alteration, slurred speech, swallowing difficult and cough. On 6th September 2019, the patient experienced shoulder pain and muscle pain. On 25th September 2019, the patient experienced leg pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On 1st September 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the choking, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough were not recovered/not resolved.   It was unknown if the reporter considered the choking, influenza-like symptoms, voice alteration, slurred speech, shoulder pain, muscle pain, swallowing difficult, leg pain and cough to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and within two to three hours he developed voice changes, slurring, hoarseness, coughing, choking, and swallow issues. The patient stated that he also developed flu like symptoms and those resolved in two or three days. On 6th September 2019, 8 days after vaccination, the patient developed right shoulder and bicep pain.  He stated that on 25th September 2019, 27 days after vaccination he developed left and quad pain.  On 5th December 2019, he developed left shoulder pain. He stated that the leg and shoulder issues all continue at the time of reporting, unresolved.  The patient reported that the shoulder pain was treated by physician with cortisone injections.  The patient had endoscopy, barium swallow studies and saw a neurologist regarding these symptoms and all this tests were normal. Emergency room visit was required. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: shiver; body pains; This case was reported by a physician via call center representative and described the occurrence of shivers in a adult 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 day after receiving Shingrix, the patient experienced shivers and general body pain. On an unknown date, the outcome of the shivers and general body pain were unknown.   It was unknown if the reporter considered the shivers and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had body pains and shiver within 24 hours of vaccination. No other information was provided before the physician ended the chat and wanted to know if it was fine to receive the 2nd dose of Shingrix in a patient with these side effects. The reporter did not consent to follow-up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Influenza like illness, Lymphadenopathy, Malaise
Clinical narrative: These symptoms started the evening the vaccine was administered and lasted for a few days: glandular swelling, red, itching welts on neck, face, wrist and chest, lip tingling, facial flushing.  Flu-like symptoms: fever, malaise, sore throat started the day after vaccine administered and lasted until 12/14 Patient is feeling better now and did not seek medical treatment for these symptoms.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Paraesthesia oral, Pruritus, Pyrexia, Urticaria
Clinical narrative: These symptoms started the evening the vaccine was administered and lasted for a few days: glandular swelling, red, itching welts on neck, face, wrist and chest, lip tingling, facial flushing.  Flu-like symptoms: fever, malaise, sore throat started the day after vaccine administered and lasted until 12/14 Patient is feeling better now and did not seek medical treatment for these symptoms.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: two days after vaccine 3x3 rash that is red, also arm at site of injection is achy
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy skin, Injection site reaction, Local reaction, Wound
Clinical narrative: Patient got a local reaction at the site of his flu shot, which he described as a wound. He happened to be visiting a dermatologist at a later date who noticed the wound on his arm. The dermatologist stated that it looked precancerous and she took a biopsy from the spot. The results are not known to the reporter at this time.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Breath holding, Crying, Differential white blood cell count, Full blood count, Immediate post-injection reaction
Clinical narrative: Patient was crying hard with administration of the vaccines.  Held his breath for a few seconds from crying hard.  Immediately developed petechiae on right upper cheek area and right forehead, observed by nurse administering vaccines. Calmed easily after this.  Observed and examined by primary CNP after this and no new rash developed.  No other symptoms.  Mom contacted on 12/16/19 and areas had resolved.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Petechiae
Clinical narrative: Patient was crying hard with administration of the vaccines.  Held his breath for a few seconds from crying hard.  Immediately developed petechiae on right upper cheek area and right forehead, observed by nurse administering vaccines. Calmed easily after this.  Observed and examined by primary CNP after this and no new rash developed.  No other symptoms.  Mom contacted on 12/16/19 and areas had resolved.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: 101.7 fever later same night vaccine was administered, as well as red and warm to the touch at site of injection. Better next am, but then developed a rash/hives and swelling size of a fist at the site of the injection 12/16/19.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: 101.7 fever later same night vaccine was administered, as well as red and warm to the touch at site of injection. Better next am, but then developed a rash/hives and swelling size of a fist at the site of the injection 12/16/19.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: pt reports area is warm to touch, slightly swollen over the phone. pt also reported diarrhea, vomiting, lightheaded, dizziness. Pt advised to go to UC
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain, Swelling, Tenderness
Clinical narrative: Pain at injection site (expected); pain in shoulder and neck on right side. Just over 24 hours later, area above right collar bone (same side as injection in right arm) was swollen and very tender to touch. I had pain when tilting my head to the right or shrugging right shoulder. Lymph node (presumably) bulged when shrugging shoulder. Pain and swelling lasted 3-4 days.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Tremor
Clinical narrative: Received Shingrix Vial in AM. 11/22/19. About 10 PM had shaking chills, so bad went right to bed.  Awoke at around 6 AM in ANOTHER room and ANOTHER bed. no idea how/when i got there.  Chills subsided, had no idea when or how i got into this other room.  Felt better by then.  Took temp at 8 AM - 101.  Everything normal  by next day.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Wrong dose
Clinical narrative: wrong dose
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever within 24 hours up to 102 rectally @ 6:30am on 12/19/19
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, IPV, MNQ, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Flu High dose by error instead of Flu IIV4 standard dose at this visit. No adverse event occurred, only medication error.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Hypersomnia, Influenza like illness, Pain
Clinical narrative: With both shots (first one in July 2019) after 24 hours I felt like I was hit by a truck - flu-like symptoms, body aches, exhaustion, couldn't stay warm - slept for 12-16 hours.  Side effect lasted for about 18 hours.  Fine the following day.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Parents took patient to the emergency room on 5/1/19 at 8:54 a.m. They stated that the child had developed a fever after receiving vaccines on 4/29/19 and that the morning of 5/1/19 the patient was sitting on his dad's lap and suddenly had a seizure. It lasted 1-1/2 minutes. Following the seizure he became active again but not quite back to normal.  His temperature in the emergency room was 100.1 degrees Fahrenheit. He was given 100 mg liquid ibuprofen and monitored for an hour with no recurrent seizure. He was then discharged.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: 8 x 9 cm of erythema on the right thigh and 12 x 9 cm on the left -> Cellulitis of lower extremity. Cephalexin 500mg 3 times daily for 10 days was prescribed for treatment.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Call to office with C/O injection site redness. Area is warm to touch. Afebrile.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient is not experiencing any symptoms; improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection, lot number S007811 (verified to be a valid lot number) expiration date 14-MAR-2021, (exact dose, frequency and route of administration were not provided) for prophylaxis, that was reconstituted with properly stored (STERILE DILUENT) lot number S026842 (verified to be valid lot number), expiration date 19-MAY-2022. It was reported that the patient did not experienced any symptoms.  Administered dose of vaccine experienced the temperature excursion of 47.1 degrees Fahrenheit for 32 minutes. There was previous temperature excursion of 48 degrees Fahrenheit for 4 hours and 5 minutes. Data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Patient was administered an improperly stored PROQUAD; This spontaneous report was received form a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 03-DEC-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis, lot #S008572, expiration date on 16-SEP-2020 (dose, frequency, anatomical location and route of administration were not reported) which was improperly stored. The vaccine underwent temperatures from -14 degrees Celsius (°C) to 10 °C (-12.2°C) for 30 minutes, which was not called by the digital data logger with a supported outcome. There were no previous temperature excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Retinal detachment
Clinical narrative: Retinal Detachment; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 25-AUG-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route 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, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from retinal detachment. As a direct and proximate result of the vaccination, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt 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 the vaccination, the pt had 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 related.  Upon internal review, the event of retinal detachment was determined to be medically significant. The reporter considered the event to be disabling.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue
Clinical narrative: medication leaked around the needle,defect in the syringe where the luer lock connects to the needle,No AE.; while giving flu vaccines where the medication leaked around the needle, no AE.; Initial information received on 09-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves four patients (age and gender unknown) for whom it was reported that while giving flu vaccines the medication leaked around the needle due to defect in the syringe where the luer lock connects to the needle for the vaccine QUADRIVALENT INFLUENZA VACCINE [FLUZONE QUADRIVALENT].  The patient' medical history, treatments, vaccinations, family history and concomitant medications were not reported.  On an unknown date, these patients were vaccinated with a dose of the QUADRIVALENT INFLUENZA VACCINE [FLUZONE QUADRIVALENT] (lot UT6656KA and expiration date 30-JUN-2020) via unknown route and site of administration.  It was an actual medication error case due to vaccine underdose and Syringe issue.  It was reported that 4 different people while giving flu vaccines where the medication leaked around the needle. One employee received a needlestick because of the malfunction. In my opinion, there is a defect in the syringe where the luer lock connects to the needle.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received a Flublok Quadrivalent on 07Nov2019, no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA327372 (same reporter).  This case involves a 17 years old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1952, expiry date: 30-Jun-2020) via intramuscular route in the right deltoid on 07-Nov-2019.  The concomitant vaccine included Menactra.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age of vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort, Feeling abnormal, Feeling hot, Pyrexia, Sudden hearing loss
Clinical narrative: sudden hearing loss; ear felt like it kept popping; boiling, feverish and terrible; Initial information received on 27-Nov-2019 regarding an unsolicited valid serious case received from a non-healthcare professional.  This case involves a 69 years old female patient who experienced sudden hearing loss (sudden hearing loss), ear felt like it kept popping  (ear discomfort) and boiling, feverish and terrible (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiration date not reported) via intramuscular route in unknown administration site.  On an unknown date, the patient developed boiling, feverish and terrible (pyrexia) (1 day) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  On an unknown date, the patient developed a serious sudden hearing loss (sudden hearing loss) and her ear felt like it kept popping (ear discomfort) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. This event was assessed as medically significant.  Other relevant tests included no laboratory data reported.  Final diagnosis was sudden hearing loss, ear discomfort and pyrexia.   The patient was treated with intra-otic cortisone (cortisone) injections, CETIRIZINE HYDROCHLORIDE (ZYRTEC) and with mineral dose pack.  The outcome was Unknown for pyrexia and as recovering for all the other events.  Information on the batch number was requested.; Sender's Comments: This case concerns a 69 years old female patient who presented with sudden hearing loss, ear discomfort and pyrexia after vaccination with Fluzone high dose. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 4 months old female patient was given an expired 0.5 ml dose of Act-HIB vaccine/No AE; Initial information received on 05-Dec-2019 regarding an unsolicited non-valid non-serious case received from an other health professional.  This case involves a four months old female patient who was vaccinated with an expired HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 04-Dec-2019, the patient received a 0.5 ml dose of expired suspect HIB (PRP/T) VACCINE (lot number: UI914AA and expiry date: 28-Nov-2019) via unknown route in the left thigh.  It was an actual medication error due to expired vaccine used.  No side effects were noted..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old patient was given Pentacel, no AE; Initial and follow up information received on 09-Dec-2019 and 11-Dec-2019  regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ083AAA, Exp. Date 11-Oct-2020) via intramuscular route in the right thigh on 04-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no side effects were noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received first dose of Fluzone Quad on 13Nov2019 and then inadvertently received the second dose on 09Dec2019, no adverse event; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.   This case involves a six months old male patient who was vaccinated with a 0.5ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 13-Nov-2019 and 0.5 ml second dose of same vaccine on 09-Dec-2019 via an intramuscular route in the left thigh (lot number UJ239AB and expiration date 30-Jun-2020).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate schedule of vaccine administered.  No adverse event or symptoms were reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLU3
Symptoms: Body temperature increased, Bursitis, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: neurological issue; acute bursitis; unable to lift my left arm 45 degrees and suffered non-stop pain; lack of sleep; extreme pain in my left shoulder; patient had had a 101.5 temperature; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old patient who experienced neurological issue (neurological symptom), acute bursitis (bursitis), temperature 101.5 (pyrexia), unable to lift left arm 45 degrees and suffered a non-stop pain (mobility decreased), lack of sleep (insomnia) and extreme pain in my left shoulder (musculoskeletal pain), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left shoulder.  On an unknown date, the patient developed a non-serious neurological issue (neurological symptom), acute bursitis (bursitis), temperature 101.5 (pyrexia), unable to lift left arm 45 degrees and suffered a non-stop pain (mobility decreased), lack of sleep (insomnia) and extreme pain in my left shoulder (musculoskeletal pain) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: On an unknown date the body temperature 101.5.  Laboratory details were not reported.  Final diagnosis was neurological symptom, bursitis, pyrexia, mobility decreased, insomnia and musculoskeletal pain.    It was not reported if the patient received a corrective treatment.  The event outcome for neurological symptom, bursitis, pyrexia, mobility decreased, insomnia and musculoskeletal pain was reported as unknown.  Information on batch number is requested.
Sex: U
Vaccine: FLU3
Symptoms: Nervous system disorder
Clinical narrative: neurological issue; acute bursitis; unable to lift my left arm 45 degrees and suffered non-stop pain; lack of sleep; extreme pain in my left shoulder; patient had had a 101.5 temperature; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old patient who experienced neurological issue (neurological symptom), acute bursitis (bursitis), temperature 101.5 (pyrexia), unable to lift left arm 45 degrees and suffered a non-stop pain (mobility decreased), lack of sleep (insomnia) and extreme pain in my left shoulder (musculoskeletal pain), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left shoulder.  On an unknown date, the patient developed a non-serious neurological issue (neurological symptom), acute bursitis (bursitis), temperature 101.5 (pyrexia), unable to lift left arm 45 degrees and suffered a non-stop pain (mobility decreased), lack of sleep (insomnia) and extreme pain in my left shoulder (musculoskeletal pain) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: On an unknown date the body temperature 101.5.  Laboratory details were not reported.  Final diagnosis was neurological symptom, bursitis, pyrexia, mobility decreased, insomnia and musculoskeletal pain.    It was not reported if the patient received a corrective treatment.  The event outcome for neurological symptom, bursitis, pyrexia, mobility decreased, insomnia and musculoskeletal pain was reported as unknown.  Information on batch number is requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: -sore arm & knot @ injection site (day following inj.) -> kept getting larger -> redness a few days after -pt had been to family dr, urgent care, & cardiologist in past 2 months w/ no treatment for arm. ER visit = cellulitis on 12/11 but can't take prescribed abx.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Full blood count, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Vaccination Date 12-4-19. Pt presented to ER 2 days later. 6 days prior to vacs he had fever.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Pain upon injection followed by immedate bubble-like swelling of site. Site became swollen with a diameter of approximately 1-2 inches and protruding from the body approximately 0.25 inches.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Muscle atrophy, Pain in extremity
Clinical narrative: Pain in right arm, with muscle wasting.  Came to see Dr 10-9-2018 and was given a medrol pack that didn't help.  Came back to the office  12-17-2019 and referred to an Orthopedic for evaluation and treatment.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: nausea ,fatigue fever,swelling and extreme soreness at injection site.unable to use arm without extreme pain
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: nausea ,fatigue fever,swelling and extreme soreness at injection site.unable to use arm without extreme pain
Age: 59.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Disturbance in attention, Headache, Hyperhidrosis, Nausea, Vomiting projectile
Clinical narrative: Diaphoresis, Nausea, Headache, Projectile Vomiting, difficulty concentrating.    She has improved today (12/19/2019) although is not yet feeling fully recovered.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Pt was suppose to get Hep B, but received Hep A
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: IPOL, 0.1cc was given intradermally (rather than IM or SQ) in a patient's Lt FA.  Tubersol 0.1cc was supposed to be administered.  Patient was notified of incorrect solution and incorrect route of administration.  Instructed patient to report any rashes, irritation of skin, or other side effects noticed, at the site of the IPOL intradermal site.  Sanofi-Pastuer notified and called for guidance regarding possible side effects of administering IPOL intradermally.  They were not aware of any side effects given the small dose (0.1cc) and route.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Vertigo
Clinical narrative: PATIENT CALLED TO STATE THAT HE WAS NOT FEELING WELL AND THAT THE "ROOM WAS SPINNING"
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives and itching on bilateral shoulders, arms, legs, trunk at 1300 on 12/17/19, 3 hours post injection of HPV Gardasil 9 #2 injection. Denied any SOA or hives on face or neck. Seen at 10:00 AM on 12/18/19 by NP for remaining hives on lower right leg. No other symptoms present. No treatment given.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: states "white bumps" which after 24 hours became "red Bumps". Initially started on bilateral ankle and proceeded cover arms and trunk
Sex: F
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: nurse reported "misdosing of MMRV"; No symptoms reported; unspecified an adult female patient received PROQUAD; This spontaneous report as received from a registered nurse, and refers to a female patient of unknown age. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided. Concomitant therapies included sterile diluent.      On unknown dates, it was reported that there were some missing-dosing of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (reported as "MMRV"). On 02-DEC-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S008574 with an expiration date in 16-SEP-2020), for prophylaxis (strength, dose, frequency, and route were not provided). No symptoms reported.
Sex: U
Vaccine: HPV9
Symptoms: Manufacturing product shipping issue, No adverse event
Clinical narrative: The patient was administered a dose of GARDASIL 9 that was shipped late.; The patient was administered a dose of GARDASIL 9 that was shipped late.; No additional adverse effect reported.; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that was shipped late,  with  lot # 1621934, and expiration date 29-JAN--2022 via intramuscular route for prophylaxis. Patient did not had any symptoms. No additional adverse effect were reported.