chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Contusion, Erythema, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: pt experienced bruising. She stated 2 days after the vaccine her arm starting getting red, swollen and itchy. pt states arm is warm to touch and has a red circle right below where vaccinations were administered. Pt was going to contact doctor immediatley after visiting the pharmacy .
Age: 77.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Skin warm
Clinical narrative: pt experienced bruising. She stated 2 days after the vaccine her arm starting getting red, swollen and itchy. pt states arm is warm to touch and has a red circle right below where vaccinations were administered. Pt was going to contact doctor immediatley after visiting the pharmacy .
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Reddened, painful, itchy area at injection site the size of a hockey puck.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 9/24/19-redness, swelling and itching at site of flu vaccine  9/26/19-The size of the red skin has increased by 1.5 fingers approx. It?s bigger in the bottom part. The top it is still intact. Same place mark. Patient says it hurts and that it?s uncomfortable.  She is scratching/ touching it.  9/26/19-blotchy pink 3 inch irregular rash at site of immunization  deltoid region.  Slight  induration right at site of shot-rest is soft and there is no tenderness and moving arm freely.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: 9/24/19-redness, swelling and itching at site of flu vaccine  9/26/19-The size of the red skin has increased by 1.5 fingers approx. It?s bigger in the bottom part. The top it is still intact. Same place mark. Patient says it hurts and that it?s uncomfortable.  She is scratching/ touching it.  9/26/19-blotchy pink 3 inch irregular rash at site of immunization  deltoid region.  Slight  induration right at site of shot-rest is soft and there is no tenderness and moving arm freely.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: On 10/01/2019 the evening of getting flu shot started having body aches by that night had a fever and chills along with body aches. Wednesday, October 2, 2019 symptoms got worse, Thursday, October 3, 2019 developed a rash all over my body, the rash is very itchy
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever of 100 degrees, aches, soreness at injection site
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; This spontaneous report as received from a physician via a company representative refers to a 72-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one dose subcutaneously for prophylaxis (frequency, lot # and expiration date were not provided). On 12-SEP-2019 (reported as within 24 hours after injection), the patient developed redness and swelling at the injection site. The patient sought medical attention, however there was no treatment given for the events. The outcome of the events was reported as recovered on the same date.  The causality assessment between the events and the suspect vaccine was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose of M-M-R II was administered; This spontaneous report as received from a Nurse refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions and previous drug reactions. Concomitant therapies included sterile diluent.  On 23-SEP-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dosage information, route of administration and anatomical locations were unknown) (lot # N025895, Expiry date: 19-SEP-2019) for prophylaxis.     The diluent that was used to reconstitute the vaccine had not expired. No adverse event. No additional information.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Immediate post-injection reaction, Malaise, Pain
Clinical narrative: Body aches; Significant Malaise; Stay in bed for 48 hours; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. In November 2018, immediately after receiving Shingrix, the patient experienced general body pain, malaise and bedridden. On an unknown date, the outcome of the general body pain, malaise and bedridden were recovered/resolved.   It was unknown if the reporter considered the general body pain, malaise and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's husband. Soon after receiving dose of Shingrix, the patient experienced significant malaise and body aches causing him to have to stay in bed for 48 hours. The reporter stated that, all symptoms were resolved after 48 hours. The sales representative indicated that, the reporter provided this information to her during a Congress she was attending and was unable to provide any additional details. For tolerance to the 2nd dose of Shingrix, refer case US2019AMR175952. This was 1 of the 4 cases, reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Malaise; Body aches; Fever of 101 degrees; This case was reported by a physician via sales rep and described the occurrence of malaise in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a month after receiving Shingrix, the patient experienced malaise, general body pain and fever. On an unknown date, the outcome of the malaise, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the malaise, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced malaise, body aches, and a fever of 101 degrees.  All symptoms resolved within two days. The field representative indicated that the reporter provided this information to her during a Congress she was attending.  The field representative was unable to provide any additional details.  This was report 1 of 4 cases, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: Bullous Pemphigoid generalized all over the body; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bullous pemphigoid was recovered/resolved.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The condition was generalized all over the body and eventually resolved. The patient was treated with high doses of steroids. Emergency visit was required. The reporter consented to follow up and provided address for further contact. The reporter did not provide any additional information. For tolerance of 2nd dose of Shingrix, refer case US2019176207.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: Low titers; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported, however the patient was infant at the time of vaccination series. The pharmacist reported, initial series of Engerix B was administered to the patient at an unknown location in 2000. At the age of 19, the patient was tested and was told that the titers were too low, which led to therapeutic response decreased. The vaccine lot number was not available since the series had not been restarted. The reporter did not consent to follow up.      Lab Comments: Lab test performed on unknown date
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Rash
Clinical narrative: Rash on buttocks / Rash as tingling and pnching feeling; Tingling feeling; Pinching feeling; This case was reported by a physician via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 15th September 2019, 3 days after receiving Shingrix, the patient experienced rash, tingling sensation and pain. On an unknown date, the outcome of the rash, tingling sensation and pain were unknown.   It was unknown if the reporter considered the rash, tingling sensation and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received second Shingrix vaccine and three days later, developed a rash on buttocks.  The patient describes the rash as tingling and pinching feeling.  The physician had not made a formal diagnosis of patient's event. The physician had no details regarding product or event at time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On 13th June 2019, 1 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, experienced hives that still had not clear up. The patient wanted to know how many people have called in to report side effects. The patient stated that, did not want clinical trial information from the PI. No addiational information was provided concerning this event. This case has been linked with case US2019AMR175765, reported by same reporter. The patient did not consent to follow up. The event outcome was reported as recovering which is discrepant so considered as not recovered as per narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a physician via sales rep and described the occurrence of fever in a 50-year-old 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, less than 2 years after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine and experienced fever. The field representative indicated that she was at a conference and was provided information from two separate contacts for three adverse events reports. The reporter unable to obtain additional details. This was 1 of 3 cases reported by same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Herpes Zoster Ophthalmicus; mild vesicular cutaneous eruption along the skin of the eye lids; This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and vesicular eruption. On an unknown date, the outcome of the ophthalmic herpes zoster and vesicular eruption were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and vesicular eruption to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received 1st dose of Shingrix on 25th or 26th April 2019.   The patient had a mild vesicular cutaneous eruption along the skin of the eyelids and mild form of HZ (herpes zoster) ophthalmicus, after receiving the first dose of Shingrix. The events lasted for about 2 to 3 weeks.   The patient was not sure if he would receive the 2nd dose of Shingrix. The patient did not know the address of facility where the vaccine was administered and no vaccine specifics were available. The patient did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain in right arm and shoulder with an hour of injection, worsened to where I couldn't raise my arm without much difficulty. Took Ibuprophen and it helped for a few hours. Got somewhat better overtime, thought I was going to recover in time. Still have pain at this time....though not nearly as bad as it was. Was hoping it would be resolve itself over time.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Rash all over upper-left arm. In subsequent days, customer reports pain in left hand. Recommended customer go to MD office to have arm and hand evaluated.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Very soon after the RZV shot, started to feel shoulder stiffness, rapid heart beat, feeling hot in my face.  As the day continued, started to feel a little dizzy and tired.  By evening I was not well at all.  Fever hot, feeling nausea, bad headache, Insomnia, some shivering.  Could not fall asleep.  Very weak when try to get up.  Unable to go to work this work.  No energy.  No strength.  Still feel some headache.  My ears are ringing.  Pulse is still a little fast.  Cannot sleep.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Impaired work ability, Initial insomnia, Insomnia
Clinical narrative: Very soon after the RZV shot, started to feel shoulder stiffness, rapid heart beat, feeling hot in my face.  As the day continued, started to feel a little dizzy and tired.  By evening I was not well at all.  Fever hot, feeling nausea, bad headache, Insomnia, some shivering.  Could not fall asleep.  Very weak when try to get up.  Unable to go to work this work.  No energy.  No strength.  Still feel some headache.  My ears are ringing.  Pulse is still a little fast.  Cannot sleep.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Pyrexia, Tinnitus
Clinical narrative: Very soon after the RZV shot, started to feel shoulder stiffness, rapid heart beat, feeling hot in my face.  As the day continued, started to feel a little dizzy and tired.  By evening I was not well at all.  Fever hot, feeling nausea, bad headache, Insomnia, some shivering.  Could not fall asleep.  Very weak when try to get up.  Unable to go to work this work.  No energy.  No strength.  Still feel some headache.  My ears are ringing.  Pulse is still a little fast.  Cannot sleep.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: States that on Monday, he had his 2019-2020 Influenza Vaccine (flu shot) from Employee Health. States that on Thursday, he started to feel itchiness at his arms and noted to have welchesThen on Friday, the welshes and itchiness scattered to the neck and torso. On Saturday around 0100 early dawn, he woke up with welches and itchiness at his arms, neck, abdomen, underarms and legs. States that he went to the Emergency Room because he thought he has scabies. He was treated for urticarial with Solumedrol. States that he is on his last pill. States that the moment he started the steroids, most of the welches and itchiness disappeared. States that the only bad experience he had with the steroids is that he does not like the weird feeling he has when he takes the medication. States he will finish the medication as prescribed
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Right arm injection sites became red, hot and swollen and entire arm swelled
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: arm is still in pain
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S009759 has been verified to be a valid lot number, expiration date 27-SEP-2020, recombinant Human albumin (exact dose, dose number, route and site of administration were not reported) for prophylaxis. The sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine was properly stored. No adverse effect was reported.  Administered dose of vaccine were exposed to the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.6 degrees Fahrenheit) for 56 hours and 40 minutes. Data logger was not involved. There was previous temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.2 degrees Fahrenheit) for 10 minutes. There was no adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: joint pain; muscle pain; headache severe; This case was reported by a nurse via sales rep and described the occurrence of joint pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced joint pain, muscle pain and headache. On an unknown date, the outcome of the joint pain, muscle pain and headache were unknown.   It was unknown if the reporter considered the joint pain, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced joint and muscle pain that felt like there was a golf ball in her arm. The patient also experienced severe headache.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Oral herpes, Pain
Clinical narrative: Cold sore; Didn't feel normal; Felt achy; Felt flu like symptoms; Was tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th July 2019, the dose was an unknown dose. On 17th July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and tiredness. On 18th July 2019, the patient experienced pain. On 19th July 2019, the patient experienced feeling abnormal. On an unknown date, the patient experienced cold sores. On an unknown date, the outcome of the influenza-like symptoms, pain, feeling abnormal and cold sores were recovered/resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, pain, feeling abnormal and cold sores to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and felt flu like symptoms and was tired. He rested the whole day. The second day he stayed in bed and felt achy and then the following day, he didn't feel normal and didn't do a lot. He also reported a cold sore several days after receiving the first shot of Shingrix.  All his symptoms were resolved. For tolerances of 2nd dose, refer case US2019AMR174145, reported by same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Anxiety, Asthenia, Bedridden, Decreased appetite, Influenza like illness
Clinical narrative: weakness; Loss of appetite; Thought "was going to die"; Laid in bed and couldn't get out of bed; Flu reaction; This case was reported by a other health professional via call center representative and described the occurrence of weakness in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced weakness, appetite lost, impending doom, bedridden and flu like symptoms. On an unknown date, the outcome of the weakness, appetite lost, impending doom, bedridden and flu like symptoms were unknown.   It was unknown if the reporter considered the weakness, appetite lost, impending doom, bedridden and flu like symptoms to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The health care professional stated that, unsure what Flu vaccine received last year. The patient received dose of Flu vaccine last year and experienced flu reaction of weakness, loss of appetite and thought was going to die and laid in bed and not getting out of bed. The reported asked, for any information or recommendation on getting flu vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Influenza like illness
Clinical narrative: brain fog; dizziness/light headed; bad flu like feelings; weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd September 2019, 1 days after receiving Shingrix, the patient experienced influenza like illness and weakness. On 24th September 2019, the patient experienced foggy feeling in head and dizziness. On an unknown date, the outcome of the influenza like illness, weakness and dizziness were resolved with sequelae and the outcome of the foggy feeling in head was recovering/resolving.   It was unknown if the reporter considered the influenza like illness, weakness, foggy feeling in head and dizziness to be related to Shingrix.  Additional details were received as follows: The age vaccination was not reported but could be between 58 or 59 years. The patient had bad flu symptoms, weakness, brain fog, dizziness and light headed. The patient stated that all events resolved except the brain fog. The patient did not consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: There is redness and it's still warm to the touch; There is redness and it's still warm to the touch; Swelling; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (reported as this past Monday) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that there was redness and it's still warm to the touch; and a little swelling on an unspecified date. The patients stated that he/she gets allergy shots so this was not unusual for him/her and getting little reactions like that. The patient was not concerned because there weren't any other side effects to speak of and was wondering how long he/she should watch it like that. The patient clarified that it was red but not like 'in slender' (not clarified). According to the patient, he/she had redness before with injections so just wondered what would be the normal course of time. Outcome of the events was unknown.  No follow-up attempts are possible. Information regarding the batch number cannot be obtained.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Headache, Myalgia, Nausea, Spinal pain
Clinical narrative: Mom called stated pt complained of spine pain, headache, nausea, & trouble walking. Mom took child to ER on 10/2/19. Called mom this morning stated the ER informed them pt was having muscle pain due to flu vaccine.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 2 inch area of erythema, warmth, itchiness to area around injection site of the flu vaccine.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: SWALLOWING INJECTION SITE   area spredding down arm  tissue became very hot    fluid  in the upper arm    had much pain when moving arm  took two tylenol  went to bed.    in the morning area of soreness much lower  almost to the elbow.  heat tenderness and redness on upper arm.   pain not as sever      during the day i was able to move shoulder and arm more   next mornimg now friday pain and swelling had gone to mid forearm arm was still very hot  to the touch     returned to the pharmacy and showed arm to the pharmacist she told me to continue with the tylenol and call my primary care doctor
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: SWALLOWING INJECTION SITE   area spredding down arm  tissue became very hot    fluid  in the upper arm    had much pain when moving arm  took two tylenol  went to bed.    in the morning area of soreness much lower  almost to the elbow.  heat tenderness and redness on upper arm.   pain not as sever      during the day i was able to move shoulder and arm more   next mornimg now friday pain and swelling had gone to mid forearm arm was still very hot  to the touch     returned to the pharmacy and showed arm to the pharmacist she told me to continue with the tylenol and call my primary care doctor
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeding disorder, Headache, Insomnia
Clinical narrative: Several hours after the injection, I experienced fatigue.  Within a short time after that, I had a fever, chills, and moderate nausea (to the point of not being able to eat).  During the night, I got a bad headache.  The fever, chills, and fatigue continued throughout the night as well and prevented a good night?s sleep.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Several hours after the injection, I experienced fatigue.  Within a short time after that, I had a fever, chills, and moderate nausea (to the point of not being able to eat).  During the night, I got a bad headache.  The fever, chills, and fatigue continued throughout the night as well and prevented a good night?s sleep.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Palpitations
Clinical narrative: Patient started experiencing palpitations and dizziness 2 minutes after receiving flu vaccine.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site oedema, Rash
Clinical narrative: Unknown vaccine information. The patient was vaccinated through a local vaccination clinic - 10/3/2019. He came into the walk-in clinic today 10/4/2019 with a large localized reaction. Erythema with slight edema to the upper left arm 12cm x 10cm. No systemic symptoms.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: After initial shot healed patient is left with a tiny bump on the skin of her arm in that spot. It looks like it wants to scab over, but it will not scab and remains a little bump at that injection site a year later.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye pruritus, Eye swelling, Headache, Respiratory tract congestion, Vision blurred
Clinical narrative: got shot at noon. by 10pm right eye was swollen itchy and foggy. had a severe headache and congestion
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Insomnia, Malaise
Clinical narrative: I just wanted to report my reaction to the shingles vaccine, which was stronger than I had thought possible from the nurse's advice at the time. In fact I had much greater side effects than I've ever had to a shot, with acute symptoms over five days and milder symptoms persisting today, eight days later. The list: significant swelling (swollen bright-red area radiating 2+ inches from injection site) and pain in the injected arm first three days, sleeplessness and malaise over five days with mild headache on fifth day, gradually reduced swelling and return of sleep on days 5-8. Now the area is gradually less red but still tender and itchy.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Tenderness
Clinical narrative: I just wanted to report my reaction to the shingles vaccine, which was stronger than I had thought possible from the nurse's advice at the time. In fact I had much greater side effects than I've ever had to a shot, with acute symptoms over five days and milder symptoms persisting today, eight days later. The list: significant swelling (swollen bright-red area radiating 2+ inches from injection site) and pain in the injected arm first three days, sleeplessness and malaise over five days with mild headache on fifth day, gradually reduced swelling and return of sleep on days 5-8. Now the area is gradually less red but still tender and itchy.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient received pneumonia vaccine on 9/30/19 at 18:53 in left deltoid.  On 10/1/19 at 15:30 pt complained of swelling, tenderness, warmth and pain in the left arm which he stated the previous night. Ice applied. MD notified. Keflex 500mg po QID started. Vitals signs 99.4-72-18 129/74.  Swelling, redness, and pain increased that evening  and due to his hx of DVT was sent to the local hospital ED for evaluation at 21:00.  Pt later returned with no new orders. Continued on Keflex.  Seen by MD in rounds 10/02/19 at about 9:00-10:00.  Afebrile. Tenderness, erythema and warmth noted. Area about 10cm in diameter.  Elevate arm and continue with ice packs and Keflex.  On 10/03/19 pt was seen by the nurse practitioner in rounds. Vital signs stable. Afebrile. Erythema and edema improving.  Pt routinely discharged.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient received pneumonia vaccine on 9/30/19 at 18:53 in left deltoid.  On 10/1/19 at 15:30 pt complained of swelling, tenderness, warmth and pain in the left arm which he stated the previous night. Ice applied. MD notified. Keflex 500mg po QID started. Vitals signs 99.4-72-18 129/74.  Swelling, redness, and pain increased that evening  and due to his hx of DVT was sent to the local hospital ED for evaluation at 21:00.  Pt later returned with no new orders. Continued on Keflex.  Seen by MD in rounds 10/02/19 at about 9:00-10:00.  Afebrile. Tenderness, erythema and warmth noted. Area about 10cm in diameter.  Elevate arm and continue with ice packs and Keflex.  On 10/03/19 pt was seen by the nurse practitioner in rounds. Vital signs stable. Afebrile. Erythema and edema improving.  Pt routinely discharged.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient developed "a not feeling well", followed by nausea, 102 fever, and vomiting. Still present at the time of writing this, 2 1/2 days later.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Patient called 2 days after receiving vaccine on 10/2/19 stating area has become red and is growing larger - referred patient to seek medical attention, patient will see NP at dr's office today at 12pm
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient complained of swollen injection site. Pain upon lifting arm. Recommended Benadryl and NSAID to patient. Informed if reaction worsens to seek medical attention from a Doctor.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Crying, Excessive eye blinking, Irritability, Poor feeding infant, Pyrexia
Clinical narrative: Fever for the last 2 days.  Had recent OM and amox, finished 5 days ago.  Had had congestion resolved during the amox course, but started again 4 days ago.  Seen for CPE 2 d ago, got vaccines, including flu.  Was "a mess" after coming back from school 2 days ago and has been fussier and not eating as well since.  Wet diapers ok but a bit less than usual.  bowel movements ok.  No vomiting.  Not wanting to lie down.  Not sleeping as well.   Overnight had a 2-3 minute stint of crying and having starts and blinking intermittently with interruption of crying and then resumption of crying.  15-20 sec between starts, repeated several times.  As the issue faded, had a few episodes of just arm shakes and then went back to sleep.  No further episodes, though was fussy the rest of the night intermittently. ?febrile seizure.  Will see neurology at Hospital
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Fever for the last 2 days.  Had recent OM and amox, finished 5 days ago.  Had had congestion resolved during the amox course, but started again 4 days ago.  Seen for CPE 2 d ago, got vaccines, including flu.  Was "a mess" after coming back from school 2 days ago and has been fussier and not eating as well since.  Wet diapers ok but a bit less than usual.  bowel movements ok.  No vomiting.  Not wanting to lie down.  Not sleeping as well.   Overnight had a 2-3 minute stint of crying and having starts and blinking intermittently with interruption of crying and then resumption of crying.  15-20 sec between starts, repeated several times.  As the issue faded, had a few episodes of just arm shakes and then went back to sleep.  No further episodes, though was fussy the rest of the night intermittently. ?febrile seizure.  Will see neurology at Hospital
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: red circle and itchy about size of orange
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has a golf ball size, red, raised, area on the outer Right thigh and injection site.  Parent denies fever, or rash since vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Penile pain, Penile ulceration, Pyrexia
Clinical narrative: Fever; Small painful sore on the mid shaft of penis; Penile ulcer; This case was reported by a physician via sales rep and described the occurrence of fever in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, penile pain and penile ulcer. On an unknown date, the outcome of the fever was unknown and the outcome of the penile pain and penile ulcer were recovered/resolved.   It was unknown if the reporter considered the fever, penile pain and penile ulcer to be related to Shingrix.  Additional information received were as follows: The patient returned on the reporting date after receiving Shingrix vaccine 2 months ago. The patient experienced fever that night then recuperated. Three days later after receivng Shingrix, the patient experienced a small painful sore on the mid shaft of his penis. The patient was widowed and dating. The patient never had penile sores in past.  The patient did not seek medical care at the time.  It took 3 weeks for the painful sore to resolve. At the reporting date, the patient asked if this could be related to the Shingrix vaccine and should he receive a second dose. The reporter had advised that he seek medical care for viral cultures should a second sore develop and no intercourse if a sore develops.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: drug exposure during pregnancy; This prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 26-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3N4F7, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. The patient's last menstrual period was on an unknown date and estimated date of delivery was 20th November 2019. The patient received Fluarix Quadrivalent 2019-2020 season during the third trimester of pregnancy. On 24th September 2019, unknown after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.  Additional details were provided as follows: The reporter stated that, the patient with estimated date of delivery on or around 20th November 2019 received the vaccine, which led to vaccine exposure during pregnancy. No other events reported.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Why does Prevnar 13 burn at a higher rate than other vaccines?/Prevnar 13 burns when it is administered at a higher incidence rate compared with other childhood vaccines.; This is a spontaneous report from two contactable physicians received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter inquired as to why did pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) burn at a higher rate than other vaccines. It was reported that pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) burnt when it was administered at a higher incidence rate compared with other childhood vaccines. The event took place after use of product. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Blood pressure increased, Chest pain, Dizziness, Feeling abnormal
Clinical narrative: Immediately, upon standing after Injections, I felt faint + nauseous; sat down + immediately felt searing, burning pain across neck, down to Lower Lumber for about 10 min. After 20 min. Felt well enough to go home. However, at 7 PM, I felt like a truck hit me! Extremely dizzy, nauseous, pain all over body, including my chest + High Blood Pressure 150/105 90 BPM - I proceeded to have uncontrollable shakes + Felt Freezing cold. Lasted 5 hrs. My husband, called my PCP to see what to do + kept in touch with him. My husband gave me 1 Advil + later 1 x strength Tylenol + slowly my Blood Pressure returned to 114/60 87 BPM at 11:50 PM. Extremely Terrifying Experience!
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Feeling cold, Immediate post-injection reaction, Nausea, Neck pain, Pain
Clinical narrative: Immediately, upon standing after Injections, I felt faint + nauseous; sat down + immediately felt searing, burning pain across neck, down to Lower Lumber for about 10 min. After 20 min. Felt well enough to go home. However, at 7 PM, I felt like a truck hit me! Extremely dizzy, nauseous, pain all over body, including my chest + High Blood Pressure 150/105 90 BPM - I proceeded to have uncontrollable shakes + Felt Freezing cold. Lasted 5 hrs. My husband, called my PCP to see what to do + kept in touch with him. My husband gave me 1 Advil + later 1 x strength Tylenol + slowly my Blood Pressure returned to 114/60 87 BPM at 11:50 PM. Extremely Terrifying Experience!
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Tremor
Clinical narrative: Immediately, upon standing after Injections, I felt faint + nauseous; sat down + immediately felt searing, burning pain across neck, down to Lower Lumber for about 10 min. After 20 min. Felt well enough to go home. However, at 7 PM, I felt like a truck hit me! Extremely dizzy, nauseous, pain all over body, including my chest + High Blood Pressure 150/105 90 BPM - I proceeded to have uncontrollable shakes + Felt Freezing cold. Lasted 5 hrs. My husband, called my PCP to see what to do + kept in touch with him. My husband gave me 1 Advil + later 1 x strength Tylenol + slowly my Blood Pressure returned to 114/60 87 BPM at 11:50 PM. Extremely Terrifying Experience!
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Induration, Limb mass, Pruritus
Clinical narrative: Hard lump on arm. Very sore next 2 or 3 days sores on head and on hairline - Eye lid swolen on left side - Itching over upper body.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Swelling of eyelid
Clinical narrative: Hard lump on arm. Very sore next 2 or 3 days sores on head and on hairline - Eye lid swolen on left side - Itching over upper body.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Within 24 hours of injection patient reported severe redness, pain and swelling from shoulder to elbow . Patient stated that she could barely move her arm. After 3 days, all symptoms resolved.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF A VERY SORE ARM, 100 DEGREE FEVER, FATIGUE, MUSCLE ACHES IN ARMS AND LEGS, FLU-LIKE SYMPTOMS THAT LASTED APPROXIMATELY 12 HOURS
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Trunk covered in hives 1 day after Shingrix injection
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Patients wife states the evening of his vaccine he experienced  a fever, chills, nausea and body aches...she reported this the next day...follow up call to check on  patient-wife stated he was feeling much better-fever free and not further complaints
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Was mistakenly give the wrong vaccine at well child visit. Was caught right away, parents notified, and no reaction to date.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Contusion, Erythema, Injection site cellulitis, Skin warm
Clinical narrative: Cellulitis to right arm at injection site spreading to forearm.  Hot to touch, bruised, erythema.  Denies any fever, nausea, vomiting, diarrhea, itching
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Flank pain, Herpes zoster, Neuralgia
Clinical narrative: Developed tender red bump on 9/28/19 on right upper abdomen. Then felt pain on her right flank and saw a similar red bump posteriorly. Pain radiated around torso like "nerve is burning".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular, Skin lesion, Swelling, Tenderness
Clinical narrative: Developed tender red bump on 9/28/19 on right upper abdomen. Then felt pain on her right flank and saw a similar red bump posteriorly. Pain radiated around torso like "nerve is burning".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test
Clinical narrative: Developed tender red bump on 9/28/19 on right upper abdomen. Then felt pain on her right flank and saw a similar red bump posteriorly. Pain radiated around torso like "nerve is burning".
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Redness rash on right upper arm at the site of injection. Warm to touch. Apply cold compress and to follow up if condition continues.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise
Clinical narrative: Severe headache lasting 4 days, general malaise
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, low grade fever
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Muscle swelling
Clinical narrative: patient stated that his muscle swelled the night of injection.  still red 3 days later when he called pharmacy to report. has been using ice on it .
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Anaphylactic reaction, Pruritus, Rash erythematous, Urticaria, Vomiting
Clinical narrative: Within one hour an anaphylactic reaction, acute emesis, red rash, pruitis-extreme hives-red-rash diffuse, stable vital signs, negative oral swelling, negative respiratory distress, negative wheezing, negative diarrhea
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Dyspnoea, Headache, Malaise, Ocular hyperaemia
Clinical narrative: Felt hoarseness within 2 hours and the hoarseness got progressively worse, eyes got very red, was difficult to take full breaths, head hurt, arm very sore. Called Pharmacy at 8:30 PM, was advised to take 2 benadryl and could take both ibuprofen and acitomenaphen.  Took 2 Benadryl and 2 ibuprofen. Still felt hoarseness in morning and eyes still red and did not feel well. Took 1 more Benadryl and 2 ibuprofen. Slept most of the day and by evening felt 80% better. The next morning 10/4/2019, felt all better.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Felt hoarseness within 2 hours and the hoarseness got progressively worse, eyes got very red, was difficult to take full breaths, head hurt, arm very sore. Called Pharmacy at 8:30 PM, was advised to take 2 benadryl and could take both ibuprofen and acitomenaphen.  Took 2 Benadryl and 2 ibuprofen. Still felt hoarseness in morning and eyes still red and did not feel well. Took 1 more Benadryl and 2 ibuprofen. Slept most of the day and by evening felt 80% better. The next morning 10/4/2019, felt all better.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Influenza, Injection site reaction, Malaise, Pyrexia
Clinical narrative: Flu symptoms, injection site reactions, fever and malaise