chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Heart rate increased, Influenza like illness, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cardiac fibrillation. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 24th May 2018, the patient experienced tiredness, muscle pain and mobility decreased. On an unknown date, the patient experienced pain in thigh, heart rate increased, influenza like illness and wrist pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the tiredness, fever, pain in thigh, heart rate increased, influenza like illness, muscle pain and mobility decreased were recovered/resolved and the outcome of the wrist pain was recovering/resolving. The reporter considered the tiredness, fever, heart rate increased, influenza like illness, muscle pain and mobility decreased to be related to SHINGRIX. It was unknown if the reporter considered the pain in thigh and wrist pain to be related to SHINGRIX. Additional details were provided as follows: On Thursday, at 11:30 am or 12:00 pm, the patient received the SHINGRIX. That evening the patient began to feel tired and she went to bed. All through the night the patient felt like very muscle in her body was hurting and felt like had to keep stretching because her body felt like it was seizing up. The patient heart rate was 80 BPM which was unusual for her because it usually runs around 57 BPM. The next morning, the patient called her pharmacy to ask if what she was experiencing was normal. The pharmacist asked the patient if she had fever. She said her temperature normally runs around 97.5 degree F, however, when she checked it, her temperature was 99.1 degree F. The patient said that she almost felt like she had the flu and took TYLENOL but the rest of Friday was just a wipe out. The patient started feeling better on Saturday but yesterday both wrists were still hurting and she was experiencing a little bit of discomfort in her left thigh. On the date of reporting, the patient was still having a little bit of joint pain in her wrists but all other symptoms have resolved.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cardiac fibrillation. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced fever. On 24th May 2018, the patient experienced tiredness, muscle pain and mobility decreased. On an unknown date, the patient experienced pain in thigh, heart rate increased, influenza like illness and wrist pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the tiredness, fever, pain in thigh, heart rate increased, influenza like illness, muscle pain and mobility decreased were recovered/resolved and the outcome of the wrist pain was recovering/resolving. The reporter considered the tiredness, fever, heart rate increased, influenza like illness, muscle pain and mobility decreased to be related to SHINGRIX. It was unknown if the reporter considered the pain in thigh and wrist pain to be related to SHINGRIX. Additional details were provided as follows: On Thursday, at 11:30 am or 12:00 pm, the patient received the SHINGRIX. That evening the patient began to feel tired and she went to bed. All through the night the patient felt like very muscle in her body was hurting and felt like had to keep stretching because her body felt like it was seizing up. The patient heart rate was 80 BPM which was unusual for her because it usually runs around 57 BPM. The next morning, the patient called her pharmacy to ask if what she was experiencing was normal. The pharmacist asked the patient if she had fever. She said her temperature normally runs around 97.5 degree F, however, when she checked it, her temperature was 99.1 degree F. The patient said that she almost felt like she had the flu and took TYLENOL but the rest of Friday was just a wipe out. The patient started feeling better on Saturday but yesterday both wrists were still hurting and she was experiencing a little bit of discomfort in her left thigh. On the date of reporting, the patient was still having a little bit of joint pain in her wrists but all other symptoms have resolved.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer and described the occurrence of shivering in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 26th May 2018, the patient received the 1st dose of SHINGRIX. On 27th May 2018, 1 days after receiving SHINGRIX, the patient experienced shivering. On 27th May 2018, the outcome of the shivering was recovered/resolved. The reporter considered the shivering to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. This event was reported as a general adverse event which was listed in the GlaxoSmithKline product literature. The patient's shivering was not serious nor was a physician involved.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program from a contactable consumer who reported about herself. A 71 year old female patient received PREVNAR 13 on an unspecified date, at single dose, for immunization.  Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pneumonia. Clinical  outcome was unknown at time of this report. The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc., (manufacturer reference number 00840225). A contactable pharmacist reported an unspecified patient received a dose of PREVNAR 13 (lot number and expiration date unknown by reporter) on an unspecified date in Apr2017. Pharmacist reported the patient was diagnosed with pneumonia "since receiving" dose of PREVNAR 13, date unspecified. No additional information provided. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy (pneumonia  occurred after the vaccination schedule with pneumococcal 13-valent conjugate vaccine) in this patient cannot be completely excluded.
Sex: F
Vaccine: HPVX, MENB
Symptoms: Dizziness, Fatigue, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer-sales representative. A 14-year-old female patient received TRUMENBA and unspecified dose number of HPV vaccine, both via an unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue and dizziness/out of it on an unspecified date. The outcome of the events was unknown. Information on batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Blood test normal, Erythema, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age  received PREVNAR 13, via an unspecified route of administration on 04Jun2018 at around 03:30 PM at a single dose for immunization. Medical history included central regional pain syndrome which the patient got from a knee replacement on unspecified date and glaucoma. Concomitant medication included XALATAN for glaucoma, Aspirin, oxycodone at 5 mg four times a day and vitamins. In the evening of 04Jun2018 (around 10 o'clock ), the patient experienced red hives all over legs and arms. The patient had a blood test right before and reported that everything was fine. The patient applied hydrocodone cream in response to the event. The outcome of the event was not recovered. Information regarding batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received PREVNAR 13 (Lot number: S51635, Expiration date: 30Oct2018), via an unspecified route of administration on the left arm in 2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received a dose of the product about one week ago on an unspecified date in 2018, and his left arm was still swollen at the site and his left arm was itchy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Headache, pain at injection site, pain in shoulder, myalgia.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, swelling, pain, warmness at injection site 1 day after injection. Patient informed pharmacy on 6/8/18. She had been using ice on the injection site.
Age: 69.0
Sex: M
Vaccine: DTP
Symptoms: Asthenia, Dizziness, Dyspnoea, Injection site swelling
Clinical narrative: Patient arrived at clinic 4 days after tetanus injection stating that he had SOB and weakness, dizziness from tetanus shot. He also noted that his left arm was swollen, and RN who examined him noted, that the left deltoid was slightly larger than the right, but no redness or inflammation was noted. Vitals taken were all WNL. RN recommended ice, elevation, rest, and OTC ibuprofen or ADVIL. Another RN followed up with patient and patient noted that he was a lot better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Redness and warmth at injection site, headache, muscle aches.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt. arm at the injection site was swollen, red, hot and painful. It was swollen for 1 week - the upper arm also spasmed at the injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms
Clinical narrative: Pt. arm at the injection site was swollen, red, hot and painful. It was swollen for 1 week - the upper arm also spasmed at the injection site.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Patient states the day he received zoster vaccine he developed blotchy rash to abdominal and chest area with itching. He denies any swelling or itching sensation to tongue or throat. He denies any pain. Rash to chest has now resolved.
Age: 83.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Hypersensitivity, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Pt reported L arm was red, painful swollen on 6/30, approximately 24 hrs after vaccine given. Returned to ED for eval mgmt, Dx w/ allergic Rxn, treated with SOLUMEDROL IM BENADRYL, Rx's prednisone but didn't take. Patient is a 83 y.o. female presenting to the emergency department with diffuse hives of the left upper extremity after receiving ZOSTAVAX yesterday. Patient states that she had had myalgias throughout the day. She denies facial edema, shortness of breath, chest pain, chest tightness, nausea, vomiting or abdominal pain. No alleviating measures have been attempted. Patient had been afebrile. Patient is the caretaker of her elderly husband.
Age: 83.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: Pt reported L arm was red, painful swollen on 6/30, approximately 24 hrs after vaccine given. Returned to ED for eval mgmt, Dx w/ allergic Rxn, treated with SOLUMEDROL IM BENADRYL, Rx's prednisone but didn't take. Patient is a 83 y.o. female presenting to the emergency department with diffuse hives of the left upper extremity after receiving ZOSTAVAX yesterday. Patient states that she had had myalgias throughout the day. She denies facial edema, shortness of breath, chest pain, chest tightness, nausea, vomiting or abdominal pain. No alleviating measures have been attempted. Patient had been afebrile. Patient is the caretaker of her elderly husband.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Itching and hot red area.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Fatigue, Hypotension, Inappropriate schedule of drug administration, Injection site erythema
Clinical narrative: Client came to our local office of health to receive the second dose in her Varicella series. Series was started years ago but never finished. Came in to clinic, filled out the screening form. No contraindications noted. Vaccine was prepared upon client arrival to clinic using aseptic technique, dose of 0.5ml administered in subcutaneous tissue the left arm. No complications during administration. Client tolerated well. She stayed in the office for 15 minutes of observation per protocol and was without complaint at time of leaving office. She called the office the next day 6/8/18 to report that she had experienced a local reaction and possibly a systemic reaction to the vaccine. She reported local redness/swelling at injection site "egg size" per client. She also reported that at 2-3pm the same day of the vaccine she had experience fatigue followed by nausea, vomiting and diarrhea. On the same day as receiving the varicella vaccine at our clinic she had also received a Tdap from an occupational health clinic, she went back to the occupational health clinic the next day 6/8/19 and at that time she reported to the practitioner the reactions from the previous day (fatigue, N/V/D). She reports during the assessment 6/8/19 she was still found to have a mild temperature (99f) and slightly low blood pressure (96 systolic). Client reports that the clinician told her to notify our clinic regarding the systemic reaction so that a report could be filed and that the occupational health clinic would also file a report as she had received a Tdap from them the same day at 9am.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Local reaction, Nausea, Vomiting
Clinical narrative: Client came to our local office of health to receive the second dose in her Varicella series. Series was started years ago but never finished. Came in to clinic, filled out the screening form. No contraindications noted. Vaccine was prepared upon client arrival to clinic using aseptic technique, dose of 0.5ml administered in subcutaneous tissue the left arm. No complications during administration. Client tolerated well. She stayed in the office for 15 minutes of observation per protocol and was without complaint at time of leaving office. She called the office the next day 6/8/18 to report that she had experienced a local reaction and possibly a systemic reaction to the vaccine. She reported local redness/swelling at injection site "egg size" per client. She also reported that at 2-3pm the same day of the vaccine she had experience fatigue followed by nausea, vomiting and diarrhea. On the same day as receiving the varicella vaccine at our clinic she had also received a Tdap from an occupational health clinic, she went back to the occupational health clinic the next day 6/8/19 and at that time she reported to the practitioner the reactions from the previous day (fatigue, N/V/D). She reports during the assessment 6/8/19 she was still found to have a mild temperature (99f) and slightly low blood pressure (96 systolic). Client reports that the clinician told her to notify our clinic regarding the systemic reaction so that a report could be filed and that the occupational health clinic would also file a report as she had received a Tdap from them the same day at 9am.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival erythema, Gingival pain, Gingival swelling, Gingival ulceration, Mouth ulceration
Clinical narrative: Unsure if related to SHINGRIX or not. I started developing extreme lower jaw gum sensitivity 48 hours after receiving vaccine. I do not have gingivitis and see my dentist for check ups routinely. The next day, I developed right side salivary gland pain and swelling. The following day, I developed left side salivary gland swelling and pain. The gum sensitivity increased and became swollen, red, and inflamed. During this time, I started to develop mouth ulcers to my gum line, tongue and inner lip. Some of the ulcers were red, raised, and inflamed. The other ulcers appeared as flat white spots. The gum swelling has improved at this point although it is still very sensitive. The initial mouth ulcers are improving and others are still appearing mostly as red, inflamed spots at this point. I have done nothing for treatment except comfort measures.  Ibuprofen, soft diet, cold fluids.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Noninfective gingivitis, Oral mucosal erythema, Salivary gland enlargement, Salivary gland pain, Tongue ulceration
Clinical narrative: Unsure if related to SHINGRIX or not. I started developing extreme lower jaw gum sensitivity 48 hours after receiving vaccine. I do not have gingivitis and see my dentist for check ups routinely. The next day, I developed right side salivary gland pain and swelling. The following day, I developed left side salivary gland swelling and pain. The gum sensitivity increased and became swollen, red, and inflamed. During this time, I started to develop mouth ulcers to my gum line, tongue and inner lip. Some of the ulcers were red, raised, and inflamed. The other ulcers appeared as flat white spots. The gum swelling has improved at this point although it is still very sensitive. The initial mouth ulcers are improving and others are still appearing mostly as red, inflamed spots at this point. I have done nothing for treatment except comfort measures.  Ibuprofen, soft diet, cold fluids.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Skin lesion, Urticaria
Clinical narrative: A few hours after receiving HAVRIX, the patient started to develop hives. The hives started in her groin and spread to upper extremities and ankles. She was given Benedryl at home and woke up with a few mild lesions on her ankles. She denied any tongue swelling or shortness of breath.  Patient was seen the next day by PA-C and was instructed to continue Benadryl every 4 hours as needed.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Pain in extremity
Clinical narrative: Patient called office 06/08/18 @ 4:25pm. Reported that she had pain all the way around her back, down her left arm and into the wrist and hand. Pt states it feels like joint pain. Pt was advised to take either TYLENOL or ibuprofen for pain relief, and to apply a cold compress to joints/hand to provide comfort.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Cyanosis, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately after injection the patient became pale and his lips turned blue. He was made to lay down with his knees elevated. He was give a lollipop and recovered fully within 5 minutes.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Cyanosis, Immediate post-injection reaction, Pallor, Retching
Clinical narrative: Immediately after the injection, the patient became pale, her lips turned blue and she began gagging (no vomiting). She was made to lay down with her knees elevated and was given a lollipop. She recovered fully within 2 minutes.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Injection site pain, Pallor
Clinical narrative: My daughter reported intense pain at injection site, then folded over and began to shake and tremor all over. She was not responding to me I laid her down on the bed, the nurse came in and took her vital signs. My daughter started to respond to me after as the nurse entered the room.  My daughter was pale and sweating. When she tried to get up a few times later she had to lie back down as she became pale lightheaded and her blood pressure was low. She was given crackers and a gingerly which she was able to keep down and began to feel better. Her blood pressure seemed to be better and her other vital signs seemed to be normal. The doctor came in to examine her and released her to go home but not to school and call if anything else happened.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: My daughter reported intense pain at injection site, then folded over and began to shake and tremor all over. She was not responding to me I laid her down on the bed, the nurse came in and took her vital signs. My daughter started to respond to me after as the nurse entered the room.  My daughter was pale and sweating. When she tried to get up a few times later she had to lie back down as she became pale lightheaded and her blood pressure was low. She was given crackers and a gingerly which she was able to keep down and began to feel better. Her blood pressure seemed to be better and her other vital signs seemed to be normal. The doctor came in to examine her and released her to go home but not to school and call if anything else happened.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling, hardness and pain at vaccination site extending through shoulder and neck. Treatment includes physical therapy, acupuncture, cupping, application of medical marijuana gel and wan hua (a chinese oil to relieve pain), and soaking with epsom salts. I continue to have the pain.
Age: 69.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain to R arm, no swelling, redness, or warmth on assessment. ROM impaired due to pain.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness, Skin warm
Clinical narrative: Stiffness in arm; not able to raise up very high; Redness; Fever in arm;  for 5 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Eye swelling, Eyelid oedema, Oedema mucosal
Clinical narrative: Pt left office after immunizations, called back approx 10 minutes later & stated left eye was swollen. Returned to office & was examined by Physician. " Returned after 30 minutes with dramatic left periorbital swelling, more of the inferior lid than superior. Some musocal swelling at the lateral margin, too."
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness at least 3 inches in diameter, swelling, pain, itch and one small blister. Patient denied any warmth, dizziness, weakness, headche, shivering/chills, fever, stomach pain or nausea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Lethargy, Myalgia
Clinical narrative: Sick-blinding headache, could not focus her eyes, fever, muscle aches, shivering, shortness of breath, nausea and very lethargic.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vision blurred
Clinical narrative: Sick-blinding headache, could not focus her eyes, fever, muscle aches, shivering, shortness of breath, nausea and very lethargic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site streaking, Oedema peripheral
Clinical narrative: Red striations just below injection site. Swelling in the armpit area (left side). Painful joints and fatigue.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Felt like flu., "yucky", malaise, unable to do daily activities for 5 days, headache, pain in arm, redness, tired, shivering, fever, very mild PPN. That is: I hit the jackpot for side-effects.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Felt like flu., "yucky", malaise, unable to do daily activities for 5 days, headache, pain in arm, redness, tired, shivering, fever, very mild PPN. That is: I hit the jackpot for side-effects.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, soreness, warm and raised. Symptoms lasted 10 days. No respiratory issues.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Sleep disorder
Clinical narrative: 3" x 2" area of redness to the right and below the actual injection site. The area is feverish and painful (pt states she cannot sleep on her arm, too painful). Contacted Dr at the patient's request. They stated this was an expected side effect and pt didn't need a followup appointment or further care.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Area underneath the injection site (about 4 inches long by 1 inch wide) became red, a little inflamed, and warm about 1 day after the injection.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: Area underneath the injection site (about 4 inches long by 1 inch wide) became red, a little inflamed, and warm about 1 day after the injection.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Flatulence, Intussusception, Irritability, Pallor
Clinical narrative: Vomiting, diarrhea, fussiness, pallor, intussusception like behaviors, about a week long from onset of symptoms.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: Vomiting, diarrhea, fussiness, pallor, intussusception like behaviors, about a week long from onset of symptoms.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cold sweat, Dizziness, Fall, Hyperhidrosis, Pallor
Clinical narrative: Patient was fine 10 minutes post vaccine. Walked out to lobby and mother reported he looked a little pale so she told him to sit. He missed the chair and collapsed onto the floor. Patient alert and oriented when nurse arrived, No bodily injuries noted. Patient reported feeling dizzy, noted sweating and clamminess. Nurse gave patient juice box and granola bar and kept under observation for the next 10 minutes. Patient regained color, no longer sweating, or dizzy.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Immediately after receiving the vaccine are was extremely painful and progressively got worse through the next few days. Had difficulty sleeping that night on 6/8/18 and unable to raise arm with out pain. Today mother reported still needed help getting dress this morning.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, began approx. 5 mins after injection. Parent advised to remain in clinic for 15 minutes to observe patient. No difficulty breathing. Sx began to resolve. Advised parent to monitor and call 911 or go to ER if s/sx worsened or any difficulty breathing or lethargy. Advised cold compress and children's Tylenol as needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Rash erythematous
Clinical narrative: Immediate erythematous rash.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Localised infection
Clinical narrative: PATIENT STATES HAS INFECTION IN LEFT ARM, HAS BEEN TO MD AND HAS BEEN PRESCRIBED UNKNOWN ANTIBIOTICS.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash, Skin warm
Clinical narrative: Patient reported that she went to medical doctor due to rash forming on both arms and waist approximately 1 month post vaccination. Was told by MD that it looks like shingles but unsure due to bilateral nature. I concured but advised her to seek medical attention by dermatologist sooner rather than later. She returned today, 6-11-18, with rash continuing and is perfuse. She states she has burning, itching, hot to touch, etc. She state her MD said he would bet it is shingles and/or advers reaction to vaccine.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient is currently still experiencing left arm soreness/tenderness off and on at the injection site. It worsens the more he uses his arm. Patient has not followed up with PCP yet, but pharmacy did recommend for him to do so.
Age: 52.0
Sex: F
Vaccine: HEP, PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Pt complaining of left arm muscle soreness and pain, as well as redness and heat at injection site which has persisted for past 4 days. Symptoms have not been relieved with OTC tylenol, ibuprofen, or cold compresses.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt was unresponsive 5 min into getting the shot. It could've been possible anaphylactic reaction. Called 911 right away and Rph gave Epipen 0.3 injection. Pt did not lose consciousness though.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot swollen arm at site of injection, body aches and chills, fever and flu-like symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Red, hot swollen arm at site of injection, body aches and chills, fever and flu-like symptoms.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site rash
Clinical narrative: Rash, itching, irritation occuring at the site of injection and still continuing currently (as of 06/11/2018); patient reports doctor has prescribed both topical steroids and oral steroids and that it has improved some after using/taking those, but that it then always recurs after discontinuing.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient did report expected sore arm and general ache, but wanted a report done because she got a tingle and a little burning sensation by her nose and upper lip on the left side.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Scab, Vaccination complication
Clinical narrative: Nurse from Doctor's office called 6/11/18 stated that patient had a reaction to SHINGRIX vaccine. She has redness and scabbing size of 2 inches by 1.5 inches on her left chest, not at the injection site. It started 2 weeks after vaccination and lasted more than 6 weeks. She still has some scabbing currently not resolved yet.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Arthralgia, Dizziness, Dyspnoea, Headache
Clinical narrative: Within a couple hours my throat started feeling tight and I couldn't breathe right. I woke up in the morning and felt like I was being choked. I took my inhaler and it only helped enough for me to wait to go to the hospital until my partner came home. I went to the hospital and they gave me a breathing treatment. I haven't been hospitalized for a breathing treatment in 5 years. I do not smoke and am not around toxins, I am a stay at home mother. And it rained all this weekend and there are no allergens in the air. Saturday night my throat was still tight but didn't notice anything more. Sunday morning and night my thinking was off and I couldn't move my body without joint pain and pain in my arm. It's now Monday and I have a headache that is unbearable, pain in my abdomen, and dizziness along with being pale in color. I have made sure to stay up on water to make sure it's not dehydration, that is not the case.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Pallor, Thinking abnormal, Throat tightness
Clinical narrative: Within a couple hours my throat started feeling tight and I couldn't breathe right. I woke up in the morning and felt like I was being choked. I took my inhaler and it only helped enough for me to wait to go to the hospital until my partner came home. I went to the hospital and they gave me a breathing treatment. I haven't been hospitalized for a breathing treatment in 5 years. I do not smoke and am not around toxins, I am a stay at home mother. And it rained all this weekend and there are no allergens in the air. Saturday night my throat was still tight but didn't notice anything more. Sunday morning and night my thinking was off and I couldn't move my body without joint pain and pain in my arm. It's now Monday and I have a headache that is unbearable, pain in my abdomen, and dizziness along with being pale in color. I have made sure to stay up on water to make sure it's not dehydration, that is not the case.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient inadvertently received a MMRV and a Varicella on the same date. This was reported to Coordinator, PCP, DON of facility. No known reaction has occurred. Instructed to file report.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swollen redness.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Oxygen saturation decreased, Oxygen saturation increased, Rash, Vomiting
Clinical narrative: Coughing, wheezing, rash on cheeks, decreased pulse ox (92-94%), vomiting x2, gave epi pen jr 0.15 mg. Oxygen saturation increased. 911 was called took to hospital.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: Coughing, wheezing, rash on cheeks, decreased pulse ox (92-94%), vomiting x2, gave epi pen jr 0.15 mg. Oxygen saturation increased. 911 was called took to hospital.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vaccination error
Clinical narrative: Patient given unnecessary dose of ADACEL.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Pt developed rash in groin area that spread to include buttocks, low back and few spots on legs, arms and face. He will start ZYRTEC BID and OTC hydrocortisone then follow up if needed. In addition, he was advised to D/C new hair shampoo.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Muscle spasms, Nasal congestion, Paraesthesia, Throat irritation
Clinical narrative: The patient started C/O scratchy throat and nasal congestion. She is having muscle spasms in arm Tdap was given. Last night had for 7 hours. She is having occasional tingling in lower legs and today can feel in thighs. She is having back pain and neck spasms. She was seen at the Clinic on 6/8/18 for muscle spasms in neck, tinnitus of both ears and back pain. The patient states that she has all of these symptoms in the past, but not all at once of this severe. It was explained at visit that her symptoms may not be side effects. She called today wanting this to be sent.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: The patient started C/O scratchy throat and nasal congestion. She is having muscle spasms in arm Tdap was given. Last night had for 7 hours. She is having occasional tingling in lower legs and today can feel in thighs. She is having back pain and neck spasms. She was seen at the Clinic on 6/8/18 for muscle spasms in neck, tinnitus of both ears and back pain. The patient states that she has all of these symptoms in the past, but not all at once of this severe. It was explained at visit that her symptoms may not be side effects. She called today wanting this to be sent.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Vomiting
Clinical narrative: 6/5/18 - 6/10/18- general tiredness, 6/5/18- vomiting, 6/6/18- vomiting/diarrhea (stopped on 6/10/18), 6/5/18-6/10/18 - no appetite.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: On 6-8-18 pt. came in office with hives. Pt. received vaccines yesterday. Mom states she had similar reaction previously and Mom gave BENADRYL and it went away in a few hrs. Mom states has been getting worse over the last couple hrs. BENADRYL and Prednisolone given in office.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, tenderness at injection site, ice plus/minus BACTIRM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Day 1 started red, hot and bump - took TYLENOL for 1st 3 days and use ice pack on and off because it was hot. Had another bump 1 inch down. Started with headache, chills, tired feeling from days 1-3. Arm was tender and sore to where couldn't touch for 2-3 days. It became redder gradually and larger everyday. On 6/10/18 got larger, hot, itchy and took TYLENOL again. Slight headache on 6/11/18. Saw Doctor on 6/11/18 received Prednisone taper and VISTARIL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Day 1 started red, hot and bump - took TYLENOL for 1st 3 days and use ice pack on and off because it was hot. Had another bump 1 inch down. Started with headache, chills, tired feeling from days 1-3. Arm was tender and sore to where couldn't touch for 2-3 days. It became redder gradually and larger everyday. On 6/10/18 got larger, hot, itchy and took TYLENOL again. Slight headache on 6/11/18. Saw Doctor on 6/11/18 received Prednisone taper and VISTARIL.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-NOV-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-NOV-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Pyrexia, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Shingrix (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. Previously experienced adverse reactions included fever (The patient had fever with past unspecified vaccinations). On 15th February 2018, the patient received the 1st dose of Shingrix .5 ml. On 16th February 2018, 1 days after receiving Shingrix, the patient experienced fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth. The patient was treated with paracetamol (Tylenol). In February 2018, the outcome of the fever and sleep disturbance were recovered/resolved. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself. At 13:00, the patient received Shingrix vaccine on the left arm. The day after the vaccine was administered, she noticed her upper arm was bright red from her shoulder to her elbow. It was hot to the touch and itchy. It remained bright red for about 3 days and at the reporting time was less red and looked as if it might bruise. The patient developed a light fever for which she took Tylenol. The patient also said for a couple of nights, her sleep was disturbed which she compared to hallucination. The patient's arm was still a lighter shade of red, hot to touch and itchy at the reporting time. The patient did not take any other medications and no other vaccines had been administered within the last 4 weeks. The patient did report the adverse events to the Centers for Disease Control (CDC) but pharmacist encouraged her to report to GlaxoSmithKline as well. Follow up information was received from pharmacy manager on 30th May 2018: The Shingrix was accidentally administered by subcutenous route, which led to inappropriate route of vaccination. The registered pharmacist mistook it for Zostavax. On an unknown date, less than a year after receving Shingrix the patient had soreness. The contributing factors for the medication error were reported as they did not have enough staff so registered pharmacist had to fill, did phone calls, run register verified, type plus administed vaccines. The VAERS details were updated. Sender's Comments: US2018028288: Previous VAERS submission in paper format.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Shingrix (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. Previously experienced adverse reactions included fever (The patient had fever with past unspecified vaccinations). On 15th February 2018, the patient received the 1st dose of Shingrix .5 ml. On 16th February 2018, 1 days after receiving Shingrix, the patient experienced fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth. The patient was treated with paracetamol (Tylenol). In February 2018, the outcome of the fever and sleep disturbance were recovered/resolved. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself. At 13:00, the patient received Shingrix vaccine on the left arm. The day after the vaccine was administered, she noticed her upper arm was bright red from her shoulder to her elbow. It was hot to the touch and itchy. It remained bright red for about 3 days and at the reporting time was less red and looked as if it might bruise. The patient developed a light fever for which she took Tylenol. The patient also said for a couple of nights, her sleep was disturbed which she compared to hallucination. The patient's arm was still a lighter shade of red, hot to touch and itchy at the reporting time. The patient did not take any other medications and no other vaccines had been administered within the last 4 weeks. The patient did report the adverse events to the Centers for Disease Control (CDC) but pharmacist encouraged her to report to GlaxoSmithKline as well. Follow up information was received from pharmacy manager on 30th May 2018: The Shingrix was accidentally administered by subcutenous route, which led to inappropriate route of vaccination. The registered pharmacist mistook it for Zostavax. On an unknown date, less than a year after receving Shingrix the patient had soreness. The contributing factors for the medication error were reported as they did not have enough staff so registered pharmacist had to fill, did phone calls, run register verified, type plus administed vaccines. The VAERS details were updated. Sender's Comments: US2018028288: Previous VAERS submission in paper format.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Shingrix (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. Previously experienced adverse reactions included fever (The patient had fever with past unspecified vaccinations). On 15th February 2018, the patient received the 1st dose of Shingrix .5 ml. On 16th February 2018, 1 days after receiving Shingrix, the patient experienced fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth. The patient was treated with paracetamol (Tylenol). In February 2018, the outcome of the fever and sleep disturbance were recovered/resolved. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself. At 13:00, the patient received Shingrix vaccine on the left arm. The day after the vaccine was administered, she noticed her upper arm was bright red from her shoulder to her elbow. It was hot to the touch and itchy. It remained bright red for about 3 days and at the reporting time was less red and looked as if it might bruise. The patient developed a light fever for which she took Tylenol. The patient also said for a couple of nights, her sleep was disturbed which she compared to hallucination. The patient's arm was still a lighter shade of red, hot to touch and itchy at the reporting time. The patient did not take any other medications and no other vaccines had been administered within the last 4 weeks. The patient did report the adverse events to the Centers for Disease Control (CDC) but pharmacist encouraged her to report to GlaxoSmithKline as well. Follow up information was received from pharmacy manager on 30th May 2018: The Shingrix was accidentally administered by subcutenous route, which led to inappropriate route of vaccination. The registered pharmacist mistook it for Zostavax. On an unknown date, less than a year after receving Shingrix the patient had soreness. The contributing factors for the medication error were reported as they did not have enough staff so registered pharmacist had to fill, did phone calls, run register verified, type plus administed vaccines. The VAERS details were updated. Sender's Comments: US2018028288: Previous VAERS submission in paper format.